cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Range of Dermo-cosmetic Products to Treat Skin and Nail Toxicity Linked to Bispecific Anti-GPRC5D Bispecific Antibodies in Multiple Myeloma Patients". Myeloma". Descriptive Pilot Study

The aim of this study is to assess the efficacy of range of dermo-cosmetic products (hand/feet serum, nail strengthening solution nail strengthening solution, dissolving oil and gloves/slippers) based on natural products and designed for cancer patients)on bispecific Ac-induced skin and nail toxicity in MM patients treated with anti-CD3xGPRC5D bispecific antibodies.

The effects of supportive care products will be studied as a preventive measure in patients starting treatment with bispecific Ac and as a curative measure in patients undergoing treatment.

Patients will be able to apply the products directly at home according to the study schedule, and a skin and nail toxicity skin and nail toxicity will be performed each time the patient comes for administration of bispecific Ac. Follow-up will be for a total of 6 months (or less if progression occurs earlier), and patients will be asked to complete a quality-of-life questionnaire at protocol inclusion and after 1 month and 6 months of supportive care.


Eligibility Criteria:
Inclusion Criteria:

1. MM patient.
2. Patient starting anti-GPRC5D bispecific Ac therapy OR patient undergoing anti-GPRC5D bispecific Ac therapy with NCI-NCTCAE V5.0 grade ≥2 skin and nail toxicity.
3. Patient with written consent.

Exclusion Criteria:

1. Patients treated or considering treatment with dermatological drugs (dermocorticoids) normally used for hand-foot syndrome OR dermo-cosmetic products (serum or reparative solutions) other than those tested.
2. Patients with atomic dermatitis (eczema)
3. Patients allergic to one or more components of the products tested.
4. Pregnant or breast-feeding women.
5. Patients who are minors or under legal protection (guardianship or safeguard of justice).
6. Patient not affiliated to a social security scheme.
Metformin for the Treatment of Unexplained Oligozspermia

Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic abnormalities and chronic hypospermatogenesis similar to women with polycystic ovarian disease (PCOD). Infertile men with unexplained infertility and IR may benefit from treatment with metformin.

Recently insulin resistance (IR) has been recognized as the underlying pathogenesis of chronic anovulation, hyperandrogenism, and metabolic abnormalities associated with PCOD in women. IR could be the underlying pathogenesis of chronic hypospermatogenesis leading to oligospermia and azoospermia associated with other metabolic abnormalities in men. Metformin has proven as an effective medication for not only IR but several other aspects of the PCOD including reproductive abnormalities. Therefore, insulin sensitizers, particularly metformin can be introduced as a pharmaceutical option for unexplained oligozoospermia and azoospermia associated with insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* oligospermia ( \< 10 million per mil-litter )
* normal FSH
* high insulin

Exclusion Criteria:

* abnormal karyotype
* obstructive azoospermia
Trauma-informed Personalized Scripts (TIPS) for Relationship Abuse

This pilot study will evaluate a computer-based intervention titled "Trauma-informed Personalized Scripts" (TIPS). The goal of this intervention is to improve patient-provider communication about sensitive topics such as intimate partner violence (IPV) and reproductive coercion (RC). The main aim of this study is to pilot test TIPS in family planning clinics using a randomized study design to compare the basic version of TIPS (a computer-based assessment with provider scripts only) to an enhanced TIPS containing a tailored brief intervention for patients along with provider scripts. The investigators plan to recruit 240 female patients ages 16-29 for this study.


Eligibility Criteria:
Inclusion Criteria:

* Female
* age 16-29
* English speaking
* Plans to stay in the area for next 6 months

Exclusion Criteria:

* Female clients not of the specified age range.
* Clients who are intoxicated or otherwise not able to provide their own consent will not be eligible to participate.
* Clients who are not able to read English will also be excluded from this pilot study as the survey questions presented via the tablet computer have not been validated yet in any other language.
Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation

The objective for this study is to compare outcome measures from vestibular rehabilitation (VPT) delivered in a traditional method against a new device Incremental Velocity Error (IVE) that improves physiologic performance of the vestibulo-ocular reflex. Participants include active duty service members with mild traumatic brain injury (mTBI) and civilians with peripheral vestibular hypofunction. The investigators will use a clinical trial cross-over design with randomization to either the control (VPT) or experimental (IVE) group and measure vestibulo-ocular reflex function as well as subjective and functional outcomes in order to investigate the best means to improve delivery of vestibular rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years old
* Service members with mTBI and civilian patients with vestibular hypofunction, both of which reports vestibular symptoms (i.e. dizziness, imbalance).

Exclusion Criteria:

* Any subjects with a self-reported history of significant ophthalmic, neuromuscular, cardiovascular (except hypertension), renal/electrolyte and psychiatric disorders
* Those with uncontrolled severe hypertension (systolic BP of \>200 mm Hg and/or a diastolic BP of \> 110 mmHg at rest)
* Those with a recent history of alcohol and/or drug abuse within the past 6 months
Physical,Histological,and Genetic Analyses of Lipid-rich Atherosclerotic Plaques

Lipid-rich atherosclerotic plaques, or "vulnerable plaques" are prone to rupture, causing local intravascular thrombosis, with subsequent grave clinical consequences. Atherosclerotic plaques normally removed during surgery, and peripheral blood samples will be studied to achieve the following objectives:

"1" Define histological features of the vulnerable plaque, analyze its physical characteristics, and investigate selected gene expression.

"2" Study biomarkers of inflammation in conjunction with the presence of vulnerable plaques.

"3" Explore the potential role of infection in atherogenesis.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of symptomatic carotid stenosis exceeding 60%(TIAs or stroke within the last 6 months), and asymptomatic carotid artery stenosis (presenting with progressive carotid stenosis, exceeding 70%)
* Abdominal aortic aneurysm, and aortic occlusive disease
* Peripheral occlusive or aneurysmal disease

Exclusion Criteria:

* Non-compliant patients, incapable of granting approval by informed consent
Preventing Antibiotic-Associated DiarRhea Using Erceflora

To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic associated diarrhea among hospitalized immunocompetent Filipino children.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable children with mild to moderate illness admitted for treatment of bacterial infection.

Exclusion Criteria:

* Children with unstable medical condition
* In any form of immunocompromized state
* With contraindication to take medication
* Has taken antibiotics for 3 weeks before start of trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Radiofrequence Microtenotomy for Treatment of Achilles Tendinose

Prospective randomized controlled study using radio-frequency microtenotomy or physical therapy (eccentric training) for treatment of Achilles tendinose

Achilless tendinosis is a major clinical problem. There is a need for new studies to map the effectiveness of treatment. This study will compare treatment effectiveness between traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will be evaluated using MRI and /or ultrasound before and after intervention. The outcome measurment include VAS and function using ( FAOS FOOT \& ANKLE SURVEY) at 6,12 weeks and 6, 12 months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pain in Achilles tendon for at least 6 weeks.
* MR / ultrasound confirms diagnosis tendinose.
* Pain in sport and daily activities

Exclusion Criteria:

Other co-morbidity that constitutes contraindication for surgery, serious illness, bad compliance
MESS-study MRSA Eradication Study Skåne

The purpose of this study is to determine whether systemic antibiotic treatment with rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers


Eligibility Criteria:
Inclusion Criteria:

Colonized with MRSA in the throat Older than 5 years MRSA-bacteria sensitive for Rifampicin and Clindamycine or Trimethoprimsulfa -

Exclusion Criteria:

Allergy to the studymedication Healthcareworkers Pregnancy Active infection with MRSA Immunosuppression Treatment with other antibiotic during the studyperiod
CLiCK in the Critical Care Unit

Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADss are prone to complications such as infection, bacterial biofilm production, and catheter occlusion due to a thrombus. A CVAD is placed in up to 97% of patients in the intensive care unit, exposing this vulnerable population to risk of nosocomial infection and occlusion.

Current standard of care involves use of normal saline (for CVCs and PICCs) or citrate (for hemodialysis catheters) as a catheter locking solution. CVAD complications remain a problem with current standard of care.

4% tetrasodium Ethylenediaminetetraacetic acid (EDTA) fluid (KiteLock Sterile Locking Solution) possesses antimicrobial, anti-biofilm, and anti-thrombotic properties and is approved by Health Canada as a catheter locking solution. As such, it may be superior CVC locking solution than the present normal saline or citrate lock.

To our knowledge, the efficacy of an EDTA catheter locking solution has not yet been investigated in the intensive care patient population. Our team proposes to fill this knowledge gap by performing a multi-centre, cluster-randomized, crossover study evaluating the impact of KiteLock Sterile Locking Solution on a primary composite outcome of CLABSI, intraluminal occlusion, and alteplase use in the ICU of six ICU's compared to the standard of care saline lock.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age ICU/HAU Admission
* Presence of a central venous catheter requiring locking. This includes CVCs, IVADs, dialysis lines, and PICC lines.

Exclusion Criteria:

* Known or tested sensitivity to EDTA or edetate
* Confirmed or suspected pregnancy
* Patients who decline receiving blood products
* Physician, patient, or temporary substitute decision maker (TSDM) declines
* Currently enrolled in any other research study that may confound primary outcome measures. Co-enrollment in multiple studies will be considered on an individual basis
* Patients who were previously enrolled in the study. Patients who were enrolled in the first period are not eligible for (re-)enrolment in the second period, and patients who are enrolled in the study and transferred to another participating hospital are not eligible for (re-)enrollment at the receiving hospital. Patients who had been discharged from the unit to another hospital ward and are re-admitted to the critical care unit are no eligible for re-enrollment into the study.
The Biomarker Analysis in Locally Advanced Cervical Cancer

Sonic hedgehog (Shh) signaling, including Gli1, is critical to treatment resistance. For optimizing cervical cancer treatment, the pathological prognostic factors determine whether to administer adjuvant therapy. However, the majority of clinical results was from squamous cell carcinoma, rendering conclusions for adenocarcinoma less convincing. We aimed to examine the role of Shh signaling in long-term clinical outcomes of cervical adenocarcinoma after receiving major surgery.

Surgery, radiotherapy, and chemotherapy could achieve favorable locoregional control in cervical cancer. Although good local control results, distant failure plays a major role in patients with treatment failure.

We were interested in the potential biomarkers for recurrence after primary treatment for the following reasons. We wanted to identify patients at a high risk of recurrence. Such patients must be intensively monitored. We required baseline data, such as the actuarial relapse rate, for evaluation in an additional randomized study. Hence, we retrospectively analyzed the potential biomarkers for recurrence in cervical cancer. Statistical analysis of the data was done using the chi-square test. Disease free survival curves were constructed using the Kaplan-Meier method. Comparisons between curves were performed using the log-rank test. Multivariate analyses of factors associated with local and distant failure were made by logistic regression analysis.

From 1987 to 2002, 62 patients with cervical adenocarcinoma that received major surgery were enrolled for analysis of Shh signaling with a median follow-up period for 172.6 months (IQR 33.0-226.2 months). External beam radiotherapy with 50-60 Gy followed by brachytherapy with 30 Gy was delivered with or without concurrent weekly cisplatin 40 mg/m2. Clinical outcomes in terms of local recurrence, progression free survival (PFS) and overall survival (OS) will be analyzed. The expressions of Shh, Ptch-1, Smo and Gli1 were assessed by immunohistochemistry. Statistics will be performed using International Business Machines (IBM) Statistical Package for the Social Science (SPSS) v22.

Eligibility Criteria:
Inclusion Criteria:

* cervical cancer patients
* performance status Eastern Cooperative Oncology Group 0-1 (ECOG 0-1)

Exclusion Criteria:

* non-other cancer previously
Surgical Outcomes of Vaginal Prolapse Repair With Elevate

The purpose of this study is to evaluate outcomes in patients having vaginal prolapse repair with the Elevate prolapse repair kit and compare these outcomes to patients who had a repair with Prolift. .

The investigators hypothesize that the less invasive Elevate mesh results in a shorter operative time, lower blood loss, complications, postoperative pain and earlier discharge from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Women who have had a vaginal repair with Elevate prolapse repair kit

Exclusion Criteria:

* N/A
A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

This open-label, randomized, phase Ib study will assess the safety and efficacy of obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular Lymphoma (FL). Participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first. All participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point. Participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.


Eligibility Criteria:
Inclusion Criteria:

* Either CD20+ R/R B-cell follicular non-Hodgkin's lymphoma (after a maximum of 2 prior chemotherapy regimens) or CD20+ B-cell follicular non-Hodgkin's lymphoma with no prior systemic therapy
* Must have at least one bi-dimensionally measurable lesion (greater than \[\>\] 1.5 centimeters \[cm\] in its largest dimension by computed tomography \[CT\] scan)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

* For R/R participants recruited in Obinutuzumab + CHOP regimen, prior use of anthracyclines. For R/R participants recruited in Obinutuzumab + FC regimen, immediate prior treatment should not have contained fludarabine or fluoropyrimidines. For first-line recruited participants, prior systemic therapy
* Prior administration of rituximab within 56 days of study entry, or 3 months for any radioimmunotherapy
* Central nervous system lymphoma
* History of other malignancies within 2 years of study entry which could affect compliance with the protocol or interpretation of results
* Known active bacterial, viral (including human immunodeficiency virus \[HIV\]), fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
* Contraindication to any of the individual components of chemotherapy (as per local prescribing information), of the selected chemotherapy combination (FC, CHOP or bendamustine)
Effects of Aging and Aerobic Exercise Training on Brain Glucose Metabolism

Aging is associated with a loss of brain function and conditions such as dementia and Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the progression of age related degenerative diseases. Aerobic exercise training can increase brain volumes and is associated with decreased risk for degenerative brain conditions. However, little is know about the changes that occur to brain metabolism with aerobic training and aging.


Eligibility Criteria:
Healthy sedentary adults aged 18-30 or 65-80 years of all ethnicities will be eligible. Pregnant women, children, prisoners or other at risk populations will not be recruited.

Inclusion Criteria:

* Age 18-30 years or 65-80 years

Exclusion Criteria:

* Body mass index (BMI) \>31 kg/m2
* Smoking
* Pregnancy
* Participation in structured exercise (\>2 times per week for 30 minutes or longer)
* Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease
* Orthopedic problems that would keep them from being able to ride an exercise bicycle, lift weights or do a combination of these exercise
* Medications that are known to impact on mitochondrial function: Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist)
* Claustrophobia
Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral Artery Occlusions

Isolated vertebral artery occlusions (VAO) account for approximately one third of posterior circulation occlusions, but have been given the least attention among posterior circulation strokes. If the two recent ATTENTION and BAOCHE randomized clinical trials have proven the superiority of endovascular thrombectomy (EVT) in basilar artery occlusions, data on the effectiveness and harm of acute revascularization treatment on isolated VAO is scarce. We aim to investigate the impact of acute recanalisation treatments in acute ischemic stroke patients with isolated VAO.

In the absence of RCT, observational data with appropriate statistical methods may give indications on benefits and harms of treating neglected stroke situations like acute vertebral occlusion. Results may also lay the basis for prospective studies, such as randomized clinical trials.


Eligibility Criteria:
Inclusion criteria:

* Acute ischemic stroke limited to the posterior circulation
* Presence of uni- or bilateral VAO (intracranial and/or extracranial) on at least one initial imaging study (CTA, MRA, DSA)
* IVT, EVT or bridging-treated stroke patients between 01.01.2003 and 31.12.2021
* ≥ 18 years old

Exclusion criteria

* Extension of the occlusion into the basilar artery
* Presence of a more distal occlusion in the pc (tandem occlusion/multilevel poster circulation occlusions)
* Previously known chronic occlusion of the any segment of the vertebral artery/arteries
* Local ethical/legal conditions in participating center not fulfilled
House Dust Mite Allergen Reduction in Bedding: Purotex Impregnated Covers of Bekaert Textiles

Product information:

Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected for their ability to clean up house dust mite allergen along with other allergen types.

Study design:

* Placebo-controlled: the effect of the Purotex impregnated mattress and pillow covers will be compared to untreated, classical bedding covers (placebo).
* Cross-over design: There will be 2 'treatment' arms. One arm (Arm 1) in which the subjects will first use the Purotex impregnated covers (Set A=Purotex) during 2 months (=period A) and, after a wash out period of 1 month, the untreated covers (set B=placebo) during 2 months (=period B). In the second arm (Arm 2), the subjects will first use the untreated set (set A=placebo) and, after a wash out period the Purotex impregnated covers (set B=Purotex).
* Randomized: The subjects will be randomly assigned to one of the 2 treatment arms.
* Double blind: both the subjects and the investigators will not know to which treatment arm the subjects are assigned.

Study hypothesis:

We want to investigate:

* if there is a reduced concentration of HDM allergen in Purotex covers compared to untreated covers in real life
* if patients with allergic rhinitis to house dust mite use the Purotex covers, they experience an improvement of their quality of life and sleep, and an improvement of their allergic symptoms and global discomfort


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing to give/sign informed consent
* Subjects (male or female) must be at least 18 years old and maximum 65 years old at screening
* Clinical history of allergic rhinitis for at least 1 year
* Positive skin prick test for D. Pteronyssinus ± D. Farinae
* Positive nasal provocation test with the house-dust-mite allergen
* Specific IgE: Unicap positive to D. Pteronyssinus (d1) and D. Farinae (d2) (\> 0.7U/ml)
* VAS score for global discomfort caused by nasal- or other allergic symptoms during the previous 4 weeks ≥ 5.
* The concentration of Der p1 in the dust collected from own bedding (mattress and pillow), measured by ELISA is above the detection limit (≥ 0.488 ng/ml).

Exclusion Criteria:

* Patients sensitized to animals should not be included if they are symptomatic upon exposure and regularly exposed to animals: positive SPT to pets and pets at home
* Patients with an allergy to tree pollen (symptoms during the season + positive skin prick test) should not be included
* Subject pregnant or lactating
* Completed allergen specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
* SCIT or SLIT during the study period
* Regular use of oral corticosteroids for exacerbations of asthma
* Daily use of oral corticosteroids
* Daily use of cyclosporine or other immunosuppressant drugs
* Regular use of antibiotics
* History of anaphylactic reaction to an allergen
* Severe general diseases (especially cardiopulmonary disease with reduced lung capacity)