cyrilzakka/clinical-trials huggingface dataset:
The Effect of Bezafibrate on Cholestatic Itch

Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;
* itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion.

Exclusion Criteria:

* Concomitant guideline-recommended as well as experimental antipruritic therapy, e.g.

rifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-B phototherapy; NB. Topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. Incidental use of these agents should be noted by patients in the diary, structural use should be noted on the CRF (section co-medication);

* Pregnancy, women of childbearing potential not using contraception, breast feeding;
* Cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ERCP) or surgical removal of a tumor compressing the bile duct;
* Use of opiates;
* Renal insufficiency (creatinine clearance \<60mL/min).
Diaphragmatic Function Description in Stroke Patients

Stroke is the leading cause of adult disability throughout the world. Motor function deficit is one of the common consequences. It is usually described for the peripheral muscles that there is a cortical representation contralaterale with a crossed cortico-spinal route: the consequence is a contralaterale motor disorder on the brain damage.

The impact of a stroke on diaphragm movements have been described in 6 studies: however, they were all observational and transversal studies evaluating diaphragm function.

Assessment using diaphragm thickness is another technique described in the literature. Visualization of diaphragm in the zone of apposition allows to assess diaphragm thickness at inspiration and expiration. The impact of a stroke on diaphragm thickening has been reported in only one recent observational study.

It seems that diaphragm would be damaged after a stroke, but unilateral or bilateral dysfonction is yet to be confirmed. Moreover, only a few measurements were performed in these studies, and not a diaphragm function follow-up.

To our knowledge, no longitudinal study evaluated diaphragm movements and diaphragm thickness fraction. This study is a preliminary study which aims to evaluate diaphragm function after a stroke and its evaluation within the first months.

Starting hypothesis is the following: after a stroke, patients with a unilateral motor dysfunction have a diaphragm dysfunction predominant on the same side as the motor dysfunction. After a few months, retrieval is insufficient and they could benefit from a specific reinforcement program.

Eligibility Criteria:
Inclusion Criteria:

* Men and women (age ≥ 18 years), hospitalized in the neuro-vascular or neurology department of the Groupe hospitalier Paris Saint-Joseph
* First episode of ischemic or hemorrhagic stroke diagnosed in the imaging and responsible for a unilateral motor deficit
* Minimum National Institute of Health Stroke Score of 5 for the total of items 4, 5 and 6 (paralysis facial and functioning of upper and lower limbs)
* Patient with medical insurance
* Francophone

Exclusion Criteria:

* History of neuromusclar pathology
* History of severe chronic respiratory pathology
* Malformation, chronic lesion or surgery of the diaphragm
* Recent thoracic and abdominal surgery
* National Institute of Health Stroke Score \> 20
* Limiting health care or life support patient
* Impossibility to understand and to make simple orders (whatever is the cause: change of consciousness, cognitive disorders, aphasias, etc...)
* Major handicap before stroke (Rankin modified score)
* Refusal to participate in the study
* Patient under guardianship or curatorship
* Patient deprived of liberty
Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

The purpose of this study is to determine whether nonsteroidal antiinflammatory drug lornoxicam in combination with low dose aspirin (100mg/day) is effective and safe in patients with Acute Coronary Syndrome without persistent ST-segment elevation.

Nonsteroidal Antiinflammatory drugs (NSAIDs) are the most frequently prescribed drugs in the world. There are a lot of controversial information published during recent years about NSAID cardiosafety. It is still unclear do NSAIDs develop cardioprotective or cardiotoxic effects in acute and chronic heart disease patients. Aim of the study was to investigate safety and efficacy of Lornoxicam, nonselective COX-inhibitor, in patients with acute coronary syndrome without ST-segment elevation (NSTEACS) and to evaluate the influence of Lornoxicam on C-reactive protein (CRP) and IL-6, IL-10 levels.

Eligibility Criteria:
Inclusion Criteria:

1. Unstable angina verified during first 48 hours after admitting to the hospital or
2. Acute Miocardial infarction without St-segment elevation verified during first 48 hours after admitting to the hospital

Exclusion Criteria:

1. High risk of bleeding of any location
2. Any kind of acute and active inflammatory process (excluding acute coronary syndrome)
3. Aspirin or NSAID Intolerability
4. No informed consent
5. Acute peptic stomach or duodenum ulcer
6. Acute or chronic renal failure (serum creatinin \>300 mmol/l)
7. Acute cerebrovascular bleeding
ABC/Trident® Ceramic Post Approval Study

The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.

The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February 3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original IDE study. Subjects who consented to participate in the Post Approval Study continued to be followed to collect limited patient reported data regarding status of the hip.

Eligibility Criteria:
Inclusion Criteria:

* The individual has signed a Patient Informed Consent (PIC), specific to this study, and approved by the Institutional Review Board (IRB).
* The individual is between the ages of 21 and 75 years.
* The individual is not classified as morbidly obese.
* The individual clinically qualifies for total hip arthroplastic surgery based on physical examination and medical history.
* The individual is diagnosed with a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant).
* The individual does not have an active infection within the affected hip joint.
* The individual has not had a previous total hip replacement or hip fusion to the affected hip joint.
* The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse).
* The individual does not have a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device.
* The individual does not have a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, nor receiving steroids in excess of physiologic dose requirements.
* The individual is skeletally mature.
* The individual is not pregnant.
* The individual is not a prisoner.
* The individual has no plans to relocate to another geographic area before the completion of the study.
IVF/ICSI Protocols in Poor Responders With Growth Hormone

in this study, we are trying to monitor the effect of the addition of growth hormone on the different down regulation protocols ( long, short, antagonist and microflare). The outcome will be primarily assessed by the clinical pregnancy rates.

Poor responders undergoing IVF/ICSI cycles have emerged as a major problem. the need to find a proper stimulation protocol is a must. in this study we are trying to detect the best stimulation protocol ,in addition to growth hormone ,that can give the highest pregnancy rates in these patients.

Eligibility Criteria:
Inclusion Criteria:

ESHRE consensus 2011,At least two of the following three features must be present:

* Advanced maternal age (≥40 years) or any other risk factor for POR;
* A previous POR (≤3 oocytes with a conventional stimulation protocol);
* An abnormal ovarian reserve test (i.e. AFC \< 5-7 follicles or AMH \< 0.5 -1.1 ng/ml).

Exclusion Criteria:

* female patients with causes of infertility other than poor ovarian reserve
* females suffering from congenital or acquired uterine anomalies
* females with focal uterine lesions
* females who had previous ovarian surgeries
* females with history of previous exposure to radiotherapy , or chemotherapy
* females refusing to get enrolled in the study
Evaluation of the Effects of Treatment With Bioarginin C in Adult Subjects Belonging to the Post-Covid Day Hospital

Long Covid could be much more frequent than it is thought to be. Few dwell on the great problem represented by the post covid syndrome. The virus often leaves important marks on our body, and those who recover face problems of various kinds: chronic fatigue, shortness of breath, dry cough, headache, cognitive difficulties.

On the duration and resolution of this syndrome, now recognized as a highly debilitating condition, there are still no great answers: for this reason it is always important to emphasize that contracting Covid, even in a not serious form, still means exposing oneself to long-term risks that are still not well codified by the scientific community. Guidelines and more tools are expected to best assist these patients.


Eligibility Criteria:
Inclusion Criteria:

subjects with proven positivity to the molecular test for Sars-cov2 with demonstration of microbiological healing patients discharged from FPG or other hospital structures; or only contact in PS; or home management age: range 20-60 years Fatigue operationalized as an affirmative answer to item "7" (CES-D)

Exclusion Criteria:

Pharmacological therapies with possible interactions with the mechanisms / processes under study (e.g. antihypertensive drugs, cortisone drugs, NSAIDs, immunosuppressants, nitrates)
Itch and Pain Characteristics in Skin Carcinomas

The objective of this study is to have better knowledge about sensations of patients with skin carcinomas and to have data about characteristics of pain and pruritus . All patients presenting with a suspicions lesion for skin carcinomas will be included and will respond to a questionnaire. Demographics data, and histological data about skin carcinomas will be collected.


Eligibility Criteria:
Inclusion Criteria:

all patients with suspected skin carcinoma aged 18 years or more

Exclusion Criteria:

* age under 18 years,
* inability to complete the questionnaire because of cognitive impairment
Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients

Virgin Coconut Oil (VCO) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. The role of VCO as an antivirus to treat COVID-19 requires further studies. A previous study has investigated the used of 30 ml of VCO to healthy volunteers for a month and reported no side effect. Here the investigators conduct a pilot trial to investigate the effect of VCO towards the clinical outcomes of COVID-19 patients in Indonesia.

The subjects of this pilot study are patients diagnosed with COVID-19 in Central Public Hospital Dr. Sardjito, Teaching Hospital of Universitas Gadjah Mada (UGM), and Yogyakarta COVID-19 referral hospitals (RSUD Wonosari and Sleman). The COVID-19 patients are recruited according to the inclusion and exclusion criteria, then divided randomly into two groups. Group I, the intervention group, consists of COVID-19 patients receiving standard therapy and 15 mL of VCO twice a day for 14 days. Group II, the control group, consists of COVID-19 patients receiving standard therapy and 15 mL of placebo twice a day for 14 days. Both groups are monitored for four weeks with a nasopharyngeal or oropharyngeal Polymerase Chain Reaction (PCR) swab test.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age ≥ 18 years old.
* COVID-19 patients diagnosed with nasopharyngeal/oropharyngeal PCR swab specimens that are treated in Central Public Hospital Dr. Sardjito, Teaching Hospital of Universitas Gadjah Mada (UGM), and Yogyakarta COVID-19 referral hospitals.
* Patients with mild and moderate pneumonia symptoms that are treated in Central Public Hospital Dr. Sardjito, Teaching Hospital of Universitas Gadjah Mada (UGM), and Yogyakarta COVID-19 referral hospitals.

Exclusion Criteria:

* Patients with liver function disorder.
* VCO hypersensitivity.
* Patients with severe pneumonia and/or Acute Respiratory Distress Syndrome (ARDS).
* Pregnant patients.
* Patients with malignant comorbidity.
* Critical or unconscious patients.
* Patients using other immunomodulators similar to VCO within less than three days before VCO administration.
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470

The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.

This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety, tolerability, PK and PD of HM12470 will be compared with that of commercially available insulin.

Eligibility Criteria:
Inclusion Criteria for T1DM:

* T2DM more than 12 monthM
* Age ≥18 and ≤70 years
* Body mass index between 18.0 and 35.0 kg/m2 inclusive.
* Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
* Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

Inclusion Criteria for T2DM:

* T1DM more than 12 monthM
* Age ≥18 and ≤70 years
* Body mass index between 18.0 and 30.0 kg/m2 inclusive.
* Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for \>12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
* Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).

Exclusion Criteria

* A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
* Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
* pregnant or lactating women
* participation in an investigational study within 30 days prior to dosing
* Clinically significant abnormal ECG at screening, as judged by the Investigator
The Effect of Lullaby and Breastmilk Smell on Preterm Newborns

The goal of this clinical trial is to investigate the effect of live lullaby from mother voice, and breast milk smell on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns who are between 35-37 weeks of gestation at the time of the study and the level of pospartum depression of mothers. The main hypothesis are:

H0: The live lullaby from mother voice and breast milk smell have no effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H1: The live lullaby from mother voice has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H2: The breast milk smell has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns H3: There is differences between the live lullaby from mother voice and the breast milk smell interventions in terms of preterm newborns' physiological parameters, comfort and maternal attachment levels.

H4: The postpartum depression level of mothers in experimental groups (lullaby group and breast milk group) is lower than the control group.

Participants will be in three groups according to the interventions. The preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (Lullaby group). The preterms in the second group (Breast milk group) are going to smell their mothers' breast milk. The preterms in the third group (Control group) are going to recieve rutin nursing care interventions.


Eligibility Criteria:
Inclusion Criteria:

* Parents' willingness to participate in the study
* Turkish literate parents
* Babies between 35-37 weeks of gestation
* Apgar score of 7 or higher at birth
* Stability of the baby (near discharge)
* Having mother's milk

Exclusion Criteria:

* Parents' reluctance to participate in the study
* Babies younger than 35 weeks and older than 37 weeks
* Babies receiving phototherapy
* Finding a congenital anomaly in infants
* Apgar score below 7 at birth
* Being connected to a mechanical ventilator
Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer

1. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis.
2. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a multivariable model will be constructed using quantitative parameters of PSMA PET/CT imaging, pre-treatment gene status, PSA, GS/ISUP and other clinical pathological parameters to further achieve accurate patient classification, guide treatment, and evaluate prognosis.

1. Construction of PSMA PET whole-body tumor burden classification:

1. Assessment of whole-body tumor burden on PSMA PET/CT images of mHSPC patients before new endocrine therapy.
2. PSMA PET/CT imaging evaluation of treatment response of the first three months after start of new endocrine therapy.
3. Based on the response results, the optimal threshold for whole-body tumor burden is obtained through ROC curve analysis, and a preliminary classification of whole-body tumor burden is obtained.

Verification 1: Follow up preliminary verification/improvement of this subtype Verification 2: External verification, reverifying the predictive performance of typing through the verification cohort.

2. Construction of multivariable predictive model for mHSPC patients with novel endocrine therapy:

1. Molecular imaging parameter measurement and collection of PSMA PET/CT images of mHSPC patients of 3 months after the start of new endocrine therapy.
2. Complete pre-treatment genetic testing, dynamic evaluation of serum PSA before and after treatment, and collection of clinical and pathological information.
3. Based on follow-up results, construct a multi factor model, screen significant factors, and achieve a predictive model for novel endocrine therapy in mHSPC patients Verification: External verification, verifying the predictive performance of the model through the verification cohort.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients confirmed to have metastasis by PSMA PET/CT before new endocrine therapy.

  * Those who have not undergone androgen deprivation treatment in the past, or have currently received androgen deprivation treatment for no more than 120 days without progress, or have received androgen deprivation treatment in the past (treatment time less than 24 months and no progress within 12 months after completion).

    * Patients with KPS score ≥ 50 (ECOG/WHO equivalent).

      * Patient age\>18 years old.

Exclusion Criteria:

Patients who cannot understand and voluntarily participate in this trial, donnot sign an informed consent form, and aren't able to cooperate independently in completing the examination.
Comparison of the Acute Effects of Auricular Vagus Nerve Stimulation and Deep Breathing Exercise

The goal of this clinical trial is to investigate whether vagus stimulation and breathing exercises are more effective in healthy adults.

Are vagal stimulation and breathing exercises effective on autonomic functions and the somatic system in healthy adults? Participants' results for autonomic functions and somatic system will be compared for both groups.


Eligibility Criteria:
Inclusion Criteria:

* could read and write Turkish

Exclusion Criteria:

* being 18 years or older having no known acute or chronic disease, and no previous treatment with vagus nerve stimulation