cyrilzakka/clinical-trials huggingface dataset:
Fecal Microbiota Transplantation With Ruxolitinib and Steroids as an Upfront Treatment of Severe Acute Intestinal GVHD

Therapy of severe intestinal graft-versus-host disease (GVHD) despite the introduction of novel target agents is associated with worse outcome compared to the other forms. Response to steroids is observed only in about 10% of patients. The most promising approaches are JAK inhibition and fecal microbiota transplantation. In this pilot study we evaluate this combination treatment in the first line.

Acute intestinal GVHD grade III-IV after allogeneic stem cell transplantation the form with low effectiveness of corticosteroids. Despite high response rate to systemic immunosupressive agents, long term survival in this group is poor due to recurrent septic episodes and gut colonization with multidrug resistant bacteria. Fecal microbiota transplantation (FMT) from a healthy allogeneic donor, allows to restore numerous local and systemic microbiota functions, including immunomodulation and thus to reduce/stop the manifestations of GVHD. The therapeutic mechanism of action of FMT is based on competition for nutrients between obligate and pathologic bacterial strains, direct growth inhibition of the pathological pathogens, host immune system modulation, especially T-reg homeostasis, through interaction with the normal microbiota.In this pilot trial we combine FMT with ruxolitinib and steroids, one of the most effective option for refractory GVHD.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-70 years
* Histologically confirmed gastrointestinal acute GVHD
* Grade III-IV gastrointestinal GVHD based on 2016 MAGIC criteria
* Ability for oral drug intake
* Signed informed consent

Exclusion Criteria:

* Requirement for oxigen and/or vasopressor support
* Respiratory distress \>grade I
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits,creatinine clearance \< 60 mL/min
* Ongoing fluconazole therapy
* Any malignancy requiring systemic therapy at the time of enrollment
* Mixed chimerism at last evaluation
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Severe concurrent illness that can interfere with study procedures
* Somatic or psychiatric disorder making the patient unable to sign informed consent
Link Hepatitis C Notifications to Treatment in Tasmania

This project will utilise the notification process as a point of intervention to work with primary practitioners (GP) by contacting them directly when a notification of hepatitis C exposure is received by the Tasmanian department of Health (DoH). A designated role will exist within DoH of a specialist HCV health worker to contact GPs to provide supported assistance in the process of the follow up hepatitis C diagnoses with patients. The study will evaluate whether active follow up of providers with enhanced case management is effective in having patients linked to hepatitis C treatment compared to current standard of care of surveillance for new notifications. The study will also compare the cost-effectiveness of this approach compared to current standard of care after one of their patients is notified with a positive hepatitis C antibody result.


Eligibility Criteria:
Inclusion Criteria:

* General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health

Exclusion Criteria:

* Not based in Tasmania
* Practitioner from correctional service
* Specialist
* Nurse practitioner who initiated test
* Sexual health service doctor
* Family planning
* Trainee
VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus
* Continuous vulvovaginal symptoms
* Access to smartphone and tablet, laptop or computer
* Access to a valid email address

Exclusion Criteria:

* Unable to provide informed consent
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products
* Systemic hormonal therapy started less than 30 days before baseline
* Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline
* Ongoing topical HRT or corticosteroid treatment for the indication under investigation
* Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline
The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme

The goal of this observational study is to understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement.

Participants will undergo transthoracic echocardiography every 6 months, with annual visits for state-of-the-art scanning techniques including positron-emission tomography combined with computed tomography or magnetic resonance imaging with radiotracers designed to look at disease processes including fibrosis, calcification, inflammation and thrombosis activity.

This will be an observational cohort study using existing and prospectively recruited cohorts for both cross-sectional and longitudinal comparison across the spectrum of aortic stenosis severity. For existing cohorts of patients who have previously undergone research assessments, we will invite them for repeated assessments.

Participants will be reviewed every 6 months in the Clinical Research Facility (CRF) over a 4-year period. They will undergo clinical assessment, blood sampling, transthoracic echocardiography and advanced imaging annually including CT angiography, magnetic resonance and positron emission tomography (PET).

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>50 years
* Provision of informed consent prior to any study specific procedures
* Patients with bioprosthetic aortic valve replacements, including both surgically and transcatheter implanted valves
* Patients with severe aortic stenosis (peak velocity \>4.0 m/s; previously recruited patients)
* Patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s; new prospectively recruited patients)
* Patients with mild aortic stenosis (peak velocity 2.5-2.9 m/s; new prospectively recruited patients)
* Patients with aortic sclerosis (tri-leaflet thickened aortic valve with no obstruction of ventricular outflow)
* Age and sex-matched healthy volunteers

Exclusion Criteria:

* Inability or unwilling to give informed consent.
* Those with an allergy to iodinated contrast
* Patients with impaired renal function (eGFR of \<30 mL/min/1.73m2)
* Women who are pregnant or breastfeeding.
* Patients with known Rheumatic Heart Disease
* Patients with known Ochronosis
* Patients with known Familial Homozygous Hypercholesterolaemia
Amyloid-β Clearance Mechanisms in Alzheimer's Disease

The focus of this study is to examine the protein-plaque clearance (Aß) in relation to the blood-brain-barrier, the glymphatic system, brain lymphatic system and enzymatic degradation. In order to achieve this aim the investigators intend to study participants with a Subjective Cognitive Decline, Mild Cognitive Impairment and a mild Alzheimer's disease.

In this study, the investigators want to examine the different mechanisms of the accumulation and the clearance of Aß- deposits with imaging methods. One focus of the study is an improved characterisation of a blood-brain-barrier disorder (which seems to have an impact on the Aß-accumulation). Another main aim is to provide an improved mechanistic clearance model, which integrates crucial components such as the recently proposed cerebral glymphatic and lymphatic pathways, and which addresses the interaction between the different components and their individual contribution to Aβ removal from the brain. A possible connection between sleep and an altered transport mechanism will be analysed. The prospective study cohort (N \~60) will include patients with Mild Cognitive Impairment, mild clinical AD and Subjective Cognitive Decline. All study participants will undergo a detailed clinical and neuropsychological assessment according to a standardised protocol (i.a. MRI, PET, CSF, actigraphy). Follow-up assessments will not be performed in the present project, but are planned in a subsequent study, pending further funding.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of amnestic MCI or AD dementia or clinical normal
* Able to provide written informed consent
* Unchanged pharmacotherapy within 4 days prior to the study specific assessments
* Fluent in German

Exclusion Criteria:

* Unable to give informed consent or has a legal guardian
* Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder
* Clinically relevant depression
* Acute suicidality
* Current alcohol, drug or medication abuse
* History of severe traumatic brain injury within 3 months prior to inclusion
* Structural lesions of the basal ganglia or brain stem
* Severe neurological disorder including (but not limited to) epilepsy, systemic disorders, stroke, repeated transient ischaemic attacks, increased brain intracranial pressure, normal pressure hydrocephalus
* Severe medical disorders including (but not limited to) heart failure, respiratory failure, uncontrolled severe arterial hypertension
* Electronic implants (e.g. cardiac pacemaker) or other MRI contraindication
* Renal failure \> stage 3 (GFR \< 30 mL/min)
* Pregnancy
* Unresolved malignancies within two years prior to inclusion
* Severe current infections or other chronic or systemic disorders
* Other circumstances which preclude participation based on the investigator's judgement
Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder

The objective of this study is to analyze the physiological patterns of two groups of patients, one control and one with anxiety disorder and alcoholic abuse disorder using sensor data from mobile devices and wearables. This data will be compared to the data presented by three clinical questionnaires: State-trait Anxiety Inventory (STAI), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck's Depression Inventory (BDI-II) in order to determine the feasibility of remote collected data.

The objective of this study is to analyze the physiological patterns of two groups of patients, one control and one with anxiety disorder and alcoholic abuse disorder using sensor data from mobile devices and wearables. This data, collected by sensors, will be compared to the data presented by three clinical questionnaires: State-trait Anxiety Inventory (STAI), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck's Depression Inventory (BDI-II) in order to determine the feasibility of using remote collected data in routine clinical practice. Furthermore, patient satisfaction with the app will be evaluated after the data collection phase.

This is a unicentric, case-controlled, longitudinal, evaluational, national study with two groups, one control of healthy individuals without symptoms of anxiety or depression, and another experimental group in which participants fulfill the given selection criteria for the trial. There are a total of 60 participants split evenly between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age.
* Alcohol use disorder (DSM 5) as main substance.
* Anxiety (STAI \> percentile 33) and, if depressive symptoms, not clinically relevant as to accomplish DSM5 diagnostic criteria for mood disorders (major depressive disorder, bipolar disorder...).
* Having a mobile phone compatible with Android.
* Sign informed consent.

Exclusion Criteria:

* Mood disorder diagnoses (DSM5).
* Cognitive deficits that prevent the participation.
* Active intake of other substances (except for nicotine).
Does Coronavirus Disease 2019 (COVID-19) Pandemic Cause a Delay in the Diagnosis of Gastric Cancer Patients?

The aim of this study is to analyze whether COVID-19 causes a delay in the diagnosis of gastric cancer patients particularly in the TNM staging of the tumor, or not and to compare the number of newly diagnosed patients with gastric cancer before and during the COVID-19 pandemic period.

The study included the patients diagnosed with gastric cancer during the period between March 1, 2020, and December 31, 2020, in the pandemic group at the Adana City Training and Research Hospital, Department of General Surgery, Divisions of Gastroenterological Surgery and Surgical Oncology. For the baseline group, patients diagnosed with gastric cancer between January 1, 2019, and December 31, 2019, was included in the same department.

Clinical and pathological data of the patients were retrospectively collected from the hospital medical records. The following parameters were compared between the pandemic and baseline periods; age and gender distributions, mean monthly numbers of newly diagnosed patients, CEA and CEA-19.9 levels, the type of the surgery, the location of the tumor, the frequency of the patients receiving neoadjuvant treatment, American Society of Anesthesiologists (ASA) score, length of the hospital stay, clinical staging and pathologic TNM staging.

Eligibility Criteria:
Inclusion Criteria:

Patients newly diagnosed with gastric cancer at specified intervals will be included in the study.

Exclusion Criteria:

* Having an additional second primary tumor
Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer

Head and Neck invasive cancer usually requires surgery that is associated with modifications of the body structure of patient regarding breathing, eating and communication. These modifications are correlated with an important loss of autonomy in patients. During the study, while the patient is hospitalised after the surgery, the paramedical team will train the caregiver of the patient from experimental group a new dimension of autonomy in order to assure a safe return home. The level of learning depends on each caregiver and patient; therefore, an adapted training is provided.

This study evaluates the impact of paramedical care in accompanying caregivers of patients that had surgery for an ENT invasive cancer, by comparing the experimental group (paramedical care) to the standard group (standard care).

The hypothesis of the study is that a benefit will be seen in the experimental group, by reducing the caregiver burden, improving the quality of life of patients and lowering the rate of hospitalisations and prolonged hospitalisations in these patients.


Eligibility Criteria:
Inclusion Criteria Patients :

* Age between 18 and 85 years old
* ECOG ≤ 2
* Patient diagnosed with an head and neck squamous-cell carcinoma, stage T2-T4/N+, non-metastatic, localised at larynx, pharynx, oropharynx, oral cavity or maxillary, needing curative surgery, with indication of radiotherapy after surgery, in accordance to decision of the regular multidisciplinary meetings in cancerology
* No ongoing measure of corrective justice for the patient
* Informed consent form signed
* Patient covered by health system

Exclusion Criteria:

* Patient scheduled for surgery after radiotherapy or for surgery on site already irradiated
* Patient or caregiver that do not agree to participate in the study (the pair patient-caregiver is needed)
* History of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation
Homoarginine Supplementation in Patients After Stroke

This study represents a follow-up of the previous study "Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects" (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke (CT or MRI), high-risk transient ischemic attack (ABCD2-score \>= 4) or acute central retinal artery occlusion
* serum homoarginine \</= 2.1 umol/L
* signed informed consent

Exclusion Criteria:

* no acute stroke
* serum homoarginine \> 2.1 umol/L
* heart failure (NYHA \> 1)
* chronic kidney disease (GFR \<60 mL/min)
* not competent
* pregnancy, lactation
* no or withdrawn signed informed consent
Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age

Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.

We hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on.

The aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.

This is a prospective randomized controlled study.

120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery.

25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery.

25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age.

Vitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings.

Quantitative ultrasound (QUS) measurement of tibia and radius will be performed to newborns and at the age of one year.

Bone status of newborns at birth and at one year age in children will be compared between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women aged 20 to 40 years, of any parity status.
* Signed informed consent

Exclusion Criteria:

* Presence of diseases known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism, granulomatous disorders
* Treatment with medications known to affect vitamin D status such as anticonvulsivants, glucocorticoids, antirejection medication and retroviral agents
Compare the Clinical Efficacy of Prototype Toothpastes.

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers 18-65 years of age
* Good general health
* Must sign informed consent form
* Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients,
* relevant to any ingredient in the test products as determined by the dental/medical
* Professional monitoring the study.
* Dental Selection Criteria: Average full mouth GI score should be in the range of
* - 2.0. heavy plaque formers should be avoided. Target a full mouth PI
* (Quigley-Hein) to be in the range of 1.5-3.0
* If of child bearing potential and on birth control (diaphragm, birth control pills,
* Birth control implants, IUD (Intrauterine device), condoms)

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease
* 2 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that are currently affect salivary flow.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this
* study.
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* History of allergy to common dentifrice ingredients
* Presence of an orthodontic appliance which interferes with plaque scoring.
* History of allergy to natural remedies, such as herbal ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* Smoker
A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors

To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
* A histologically or cytologically confirmed solid tumor that is advanced, metastatic, and/or inoperable following prior standard chemotherapy, and/or for which, in the opinion of the investigator, there is no alternative therapy, or for which monotherapy with erlotinib is appropriate
* ≥ 18 years of age
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

* Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose (patients currently on erlotinib monotherapy may be enrolled into the study without a washout)
* Major surgery within 4 weeks prior to first dose
* Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms
* Pregnant or breastfeeding
* Significant gastrointestinal disorder that, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. significant, uncontrolled inflammatory bowel disease or extensive small bowel resection)
Interscalene Vs Infraspinatus-teres Minor (ITM) Interfascial Block in Shoulder Surgery

Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are usually performed. Interscalene brachial plexus block is one of the most preferred techniques among these.

Due to the phrenic nerve paralysis frequently seen in interscalene block, alternative diaphragm-sparing block techniques have emerged over time. One of these is the Infraspinatus teres minor interfascial block. Infraspinatus teres minor interfascial block can block both the suprascapular nerve and the axillary nerve, which are effective in the innervation of the shoulder, with a single-point injection.

The main aim of our study was to show that there is no difference between interscalene block and infraspinatus-teres-minor interfascial block in terms of their effects on postoperative analgesia in patients undergoing arthroscopic shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II-III
* Scheduled for arthroscopic shoulder surgery under general anesthesia

Exclusion Criteria:

* history of bleeding diathesis
* receiving anticoagulant treatment
* infection of the skin at the site of the needle puncture
* pregnancy or lactation
* patients who do not accept the procedure
* Allergy to local anesthetics
* Chronic pain syndromes requiring opioid intake