cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease

This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients. The study will be conducted over one year in four cohorts of patients with different forms of MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who have suffered a single clinical event but do not comply with diagnosis criteria for definite MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution of patients and with the reverse transcriptase activity, inflammatory markers assessed by cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003, is performed in parallel and is part of another dedicated protocol).


Eligibility Criteria:
Inclusion Criteria:

* Signature of an informed consent;
* Male or female between 18 and 60 years of age;
* Patients with PPMS (Revised McDonald criteria 2010) or patients with SPMS or CIS or patients with RRMS (Revised McDonald criteria 2010) ideally without IFN beta therapy at the T0 visit for RRMS patient only.

Exclusion Criteria:

* Positive serology for hepatitis B or C or HIV;
* Acute infection at inclusion;
* Severe psychiatric disorder;
* Autoimmune disease other than MS;
* Pregnancy or breastfeeding;
* Heavy smokers i.e. more than 10 cigarettes per day;
* History of alcohol or drug abuse in the last 3 years;
* Participation in a clinical trial (within the last 3 months).
Blood Loss and Transfusion Requirement in Infants Treated With Tranexamic Acid

The primary objective of this study is to investigate whether tranexamic acid (TXA) reduces perioperative blood loss and transfusion requirement in infants undergoing craniosynostosis surgery.

Blood loss during pediatric craniosynostosis surgery can be significant and this may be exacerbated by a dilutional coagulopathy. Multimodal blood conservation strategies may limit allogeneic transfusions, although RCTs are few and limited. It is essential to investigate these techniques to determine their potential to reduce allogeneic blood transfusions and their associated cost and morbidity.

Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator. The result is inhibition of fibrinolysis and clot degradation.

Recent studies in adults undergoing cardiac surgery demonstrated that people with different genotypes for the plasminogen activator inhibitor-1 (PAI-1) gene may have varying degrees of bleeding. PAI-1 inhibits the transformation of plasminogen to plasmin thereby decreasing plasmin-induced fibrinolysis. Thus, PAI-1 promotes clot stability and the PAI-1 polymorphism will affect the degree of bleeding and response to TXA during craniosynostosis surgery.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged 2 months to 2 years undergoing anterior cranial vault reconstruction

Exclusion Criteria:

* Known bleeding disorder as this may increase the risk of bleeding
* Current antifibrinolytic therapy as these patients may bleed less
* Patient or family history of thromboembolic disease as there may be potential risk of thrombosis
* Use of NSAIDS within 5 days of surgery as this may increase the risk of bleeding
* Known allergy to TXA
* History of renal insufficiency as TXA is renally excreted
* Acquired colour vision defects as one of the first signs of long term TXA toxicity is colour vision disturbance.
Quality of Life After Permanent Interstitial Iodine Seed Prostate Brachytherapy

Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for localized prostate cancer

Retrospective Evaluation of Quality of life data collected on men who underwent iodine seed brachytherapy at the University Hospital Zurich

Eligibility Criteria:
Inclusion Criteria:

* Male \> 18 years of age
* iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich

Exclusion Criteria:

* No iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich
Bystander Intervention for Hazardous Drinking

The objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches. A set of students will be engaged to serve as peer leaders to assist in reducing hazardous drinking behavior among their peers. This new intervention, a Bystander Brief Motivational Intervention (BBMI) spans Stages 1A and 1B of the stage model of behavioral therapies research and will utilize qualitative methods, an open trial, and a small controlled pilot trial within the targeted college community.

The objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches. Established elements from Bystander Intervention (awareness of the problem, addressing pluralistic ignorance, skill building), Brief Motivational Intervention (client-centered foundation, corrective information about community norms, protective behavioral strategies) and Social Network Analysis (measuring network ties, identifying the influence of network members), will be integrated into a brief intervention that pays particular attention to the connectedness of residents in dormitory social networks. Social network analytic methods will be used to assess the primary peer network (the college residence) and a set of individuals exposed to others drinking risks will be identified to receive the intervention. This set of students will be engaged to serve as peer leaders to assist in reducing hazardous drinking behavior among their peers. This new intervention, a Bystander Brief Motivational Intervention (BBMI) spans Stages 1A and 1B of the stage model of behavioral therapies research and will utilize qualitative methods, an open trial, and a small controlled pilot trial within the targeted college community.

Eligibility Criteria:
Inclusion Criteria:

* First-year students in one of two residence halls. The subset of participants who were selected for intervention or control had to have been exposed to others who showed risk signs in the past month.

Exclusion Criteria:

* None
Efficacy Trial of MySmileBuddy

This study seeks to evaluate the best way to encourage a healthy diet and proper fluoride use in children at greatest risk for tooth decay. To do so, this study will evaluate whether or not a family focused intervention, MySmileBuddy, is able to reduce tooth decay progression in Hispanic preschoolers at high risk of this disease.

Tooth decay in young children has traditionally been treated through surgical dental repair, an approach that does not address the oral hygiene and dietary behaviors that cause the disease. Professionals agree that behavioral strategies to prevent tooth decay are needed, but they have not been well studied in Hispanic children in the United States that have disproportionately high rates of this disease. Use of fluoridated toothpaste twice a day and consumption of a healthy diet can both prevent tooth decay and stop it from progressing.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 24 to 71 months of age, have a minimum of 12 teeth present, and have early childhood caries (ECC)
* Will reside in the New York City (NYC) metropolitan for the following 12 months
* Parents must be 18 years or older and must report having a cell phone with texting capabilities

Exclusion Criteria:

* Children with developmental delays or medical conditions that would impede oral dietary intake, at-home oral hygiene practices, or receipt of oral exams
* Children with parents who are under the age of 18 years of age, do not report having a mobile phone, do not plan to reside in the New York City (NYC) metropolitan area for the following 12 months
* Children of parents who do not provide consent to participate.
Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial

It is well known that "over-treatment" of straightforward infections should be avoided as far as possible. Evidence-based data on non antibiotic treatment options for common conditions are therefore needed urgently. This randomised-controlled double blind trial examines whether initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist, reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients presenting with typical UTI symptoms will be included by their GPs and receive randomised either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial antibiotic treatment. Patients record symptom severity and drug intake in a diary and complete a final questionnaire after 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Women (18-75 years) with suspected UTI
* at least two symptoms of UTI (dysuria, urgency of micturition, frequency, lower abdominal pain)
* Written informed consent

Exclusion Criteria:

* signs of complicated UTI (e. g. temperature \> 38°C, loin tenderness)
* conditions that may lead to complicated infections (i.e. renal diseases, patients with urinary catheter)
* pregnancy/ breastfeeding
* current self-medication with UU preparations e.g. z.B. Cystinol®, Uvalysat®, Arctuvan®
* antibiotic use in the last 7 days
* previous UTI in the past 2 weeks
* history of pyelonephritis
* contraindications for trial drugs
* serious diseases
* inability to understand trial Information
* current participation in another clinical trial or participation in another clinical trial within the last 4 weeks
Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders

To evaluate topical A-007 in patients with advanced malignancies including Kaposi's sarcoma and lymphoproliferative disorders.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Maintenance antihormones, hormones, and glucocorticoids.

Patients must have:

* Histologically proven metastatic cancer including Kaposi's sarcoma and lymphoproliferative disorders to the skin or cutaneous sites. NOTE:
* Primary basal or squamous cell cancer of the skin is allowed.
* Failed both primary and secondary chemotherapy and/or immunotherapy protocols.
* Measurable skin or cutaneous lesions. 4 Life expectancy of at least 20 weeks.

Prior Medication:

Required:

* Prior therapy for cutaneous lesions from Kaposi's sarcoma or lymphoproliferative disorders.

Allowed:

* Prior maintenance steroids and hormone/antihormone therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active infections other than medically stable HIV infection.
* Active congestive heart failure, any persistent arrhythmia or transient serious arrhythmia (ventricular tachycardia, sinoatrial arrest, etc.), or progressive cardiomyopathy.
* Unstable blood pressure.
* Seizures or other CNS disorders.
* Severe unstable diabetes mellitus.
* Coagulopathies.
* Thrombotic disease.
* Any other medical conditions that would prevent completion of study or produce significant risk to patient.

Concurrent Medication:

Excluded:

* Concomitant chemotherapy or immunotherapy.
* Ongoing corticosteroid therapy (unless maintenance).

Patients with the following prior conditions are excluded:

* History of active cardiopulmonary or respiratory disease.
* History of sun hypersensitivity and photosensitive dermatoses.
* History of allergy or hypersensitivity to cosmetics, toiletries, or other dermatological products.
Effects of Exercise on Alignment and Muscle Parameters in Forward Head Posture

It is aimed to investigate the effect of corrective exercise program on alignment, muscle activation and biomechanical properties of muscles in medical students with forward head posture.

Forward head posture (FHP) is a common postural abnormality that can be seen in all age groups. It is characterized by the head position being forward relative to the neck in the sagittal plane. The anterior displacement of the head is mainly assessed through examination of the craniovertebral angle (CVA) and a CVA of ˂50° is described as a FHP. Therapeutic exercises have shown to be effective in FHP and related symptoms in many studies. One of the exercise programs applied is the corrective exercise program. Within the scope of this program, deep cervical flexor muscles and shoulder retractors are strengthened, cervical extensors and pectoral muscles are stretched. This exercise protocol has been reported to provide relief in neck pain, improvement in CVA and shoulder angle. However, the number of studies examining the effect of corrective exercise program for the affected muscle groups in FHP on muscle activation parameters is limited, and there is no study examining the effect on the biomechanical properties of the muscles.

In this study, it is aimed to investigate the effect of corrective exercise program on alignment, muscle activation and biomechanical properties of muscles in medical students with forward head posture.

Eligibility Criteria:
Inclusion Criteria:

* Medical students with a Craniovertebral angle ˂ 50°

Exclusion Criteria:

* History of chronic pain in cervical region
* Presence of spinal deformity and malalignment
* Disease, fracture or surgery affecting the spine-shoulder-pelvic region
* Presence of malignancy
* BMI outside the normal range
* Presence of medical condition that prevents participation in physical exercise program
* Presence of neuromuscular disease
* Involvement in regular and professional sports activities
Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE who live in Japan.


Eligibility Criteria:
Key Inclusion Criteria:

* A clinical diagnosis of hereditary angioedema (HAE) Type 1 or Type 2, defined as having a C1-INH functional level and a C4 level below the lower limit of the normal (LLN) reference range, as assessed during the Screening period.
* Access to and ability to use one or more acute medications approved by the relevant competent authority for the treatment of acute attacks of HAE
* Subjects must be medically appropriate for on-demand treatment as the sole medicinal management for their HAE during the study.
* Subjects must have a specified number of expert-confirmed attacks during the run-in period of 56 days from the Screening visit.
* Acceptable effective contraception
* Written informed consent

Key Exclusion Criteria:

* Pregnancy or breast-feeding
* Any clinically significant medical condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject's safety or ability to participate in the study
* Any laboratory parameter abnormality that, in the opinion of the Investigator, is clinically significant and relevant for this study
* Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology
* Use of C1-INH within 14 days or use of androgens or tranexamic acid within 28 days prior to the Screening visit for prophylaxis of HAE attacks, or initiation of these drugs during the study
* Current participation in any other investigational drug study or received another investigational drug within 30 days of the Screening visit
* Prior enrollment in a BCX7353 study
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture

Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
* Clearly defined strings

Exclusion Criteria:

* Allergies to used medication
* International Normalised Ratio more than 2.0
* Pregnancy and breastfeeding
* Previous treatment for DC in affected finger
* Former inclusion in the study with another string
* Activity in disease at time of study
* PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed invasive breast cancer
2. Stage IIIB, IIIC with T4 lesion or Stage IV disease
3. Breast cancer must be ER-positive and/or PR-positive
4. Age ³ 18 years of age
5. ECOG performance status 0, 1 or 2
6. Able to swallow and oral medication
7. Adequate end organ function
8. Written informed consent

Exclusion Criteria:

1. Prior hormonal therapy for metastatic disease
2. Prior chemotherapy for metastatic disease
3. Prior treatment with sorafenib
4. Brain metastases or leptomeningeal disease
5. Evidence or history of bleeding
6. Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer

The purpose of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 (Part 1: dose escalation) and further evaluate the safety at RP2Rs (Part 2: dose expansion) in participants with advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic castration-resistant prostate cancer (mCRPC) as defined by Prostate Cancer Working Group 3 (PCWG3): Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
* Measurable or evaluable disease per PCWG3 criteria; all participants must have a serum PSA value greater than or equal to (\>=2) nanograms per milliliter (ng/mL) at time of screening
* Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
* Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \[NYHA\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
Development and Feasibility of Psycho-Educational Weight Reduction Program for Young Adults

The main aim of the study was to assess the efficacy of psycho-educational weight reduction program for reducing emotional eating and obesity

All participants who provide written informed consent will go through a screening process to evaluate their eligibility for study entrance after being briefed about the study and any potential risks. Individuals who met the eligibility requirements will then be randomly assigned to the control group and the experimental group.

Eligibility Criteria:
Inclusion Criteria:

* Individuals must be enrolled at a university.
* Based on World Health Organizations age range young adults were selected for the current study i-e 19 years to 35 years (WHO; 2019).

Exclusion Criteria:

* The young adults who diagnosed with any chronic health concern, either psychological or physical must not be included in the current study.
* The individuals who joined any kind of weight loss program or gym were also not included in the study.
* Individuals older than 35 were not included in the current study either.
Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.

The goal of this demonstration project or observational study is to evaluate the feasibility and acceptability of a pharmacist-managed cabotegravir long acting injectable for PrEP program in a community pharmacy setting.

The main question it aims to answer are:

* Is the program feasible and acceptable at the end of 1 year of operations?
* What are the facilitators and barriers of the program? Participants who want to start the FDA approved cabotegravir long acting injectable medication for PrEP will have the option participating in surveys and a review of their electronic health records. Medication will be administered based on FDA approved labeling guidelines and their PrEP care will be part of standard of care per CDC.

Pharmacists who want to provide the service to their patients will have the option of participating in surveys pre and post implementation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at the time of screening
* Weight ≥ 35 kg
* HIV-negative status
* Willing to provide informed consent and undergo all required study procedures.

Exclusion Criteria:

* Unknown or positive HIV status
* Coadministration of drugs that significantly decrease cabotegravir concentrations according to the FDA package insert.
* Any participants that do not meet criteria for management under CDTA