cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.


Eligibility Criteria:
Key Inclusion Criteria:

* Genotype 1 or 4 chronic HCV infection
* Have received a kidney transplant more than 6 months before the Baseline visit
* Cirrhosis determination
* Screening laboratory parameters within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain -resolved skin cancers)
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Planned or anticipated second kidney transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Blood Loss After Early TXA in Hip Fractures.

Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.

Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation.

Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then receive repeat doses prior to skin incision and again after the end of surgery. Control group will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA doses prior to surgery and again after the end of surgery. The perioperative doses will not be blinded.

Eligibility Criteria:
Inclusion Criteria:

* Femoral neck, intertrochanteric, subtrochanteric femur fracture
* Age \>18
* Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon

Exclusion Criteria:

* Age \<18
* Concomitant fracture
* Preoperative anemia needing blood transfusion before surgery
* Severe comorbidity (active cancer, severe pulmonary disease, ESRD)
* Allergy for tranexamic acid
* History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months
* Myocardial infarction in the previous 12 months
* Renal function impairment (creatinine clearance \<30 mL/min), or kidney transplant
* History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)
Dose Escalation by Boosting Radiation Dose Within the Primary Tumor Using 18FDG-PET/CT for Unresectable Thoracic Esophageal Cancer

Most local failures after definitive chemoradiation for unresectable esophageal cancer occur in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective dose boost to the esophageal GTV could be safely delivered using a simultaneous integrated boost (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the esophageal GTV defined prior to treatment may improve local tumor control.


Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically proven diagnosis of esophageal squamous cell carcinoma.
2. ECOG performance status 0-1.
3. Able to swallow semifluid diet.
4. Patients must not have received either radiotherapy or chemotherapy.
5. Technically unresectable, medically inoperable, or surgery declined by the patient.
6. SUVmax in the pre-treatment FDG-PET scan \> 5 for the primary tumor and the length of the primary tumor ≤10cm.
7. Normal liver and renal function and adequate bone marrow reservation.
8. Meet the requirements of the dose limitation to the critical organ: V20≤25%，Dmean≤15Gy for lung; Dmax ≤45Gy for spinal cord，Dmean ≤20Gy for liver.
9. Written, signed informed consent.

Exclusion Criteria:

1. Other malignancy histology.
2. Any evidence of visceral metastases.
3. Prior radiotherapy to the thorax or systemic therapy for esophageal cancer.
4. Evidence of deep esophageal ulcer or esophageal perforation.
5. Weight loss ≥10% within half year or cachexia.
6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
7. History of cardiac disease: congestive heart failure \> NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months.
8. Concurrent uncontrolled medical conditions.
9. Pregnant or lactating women.
10. Drug addiction, alcoholism or AIDS.
11. Uncontrolled seizures or psychiatric, behavioural disorders.
An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Social Attention

The purpose of this study is to explore the effects of endogenous opioids on self-esteem and attentional bias toward social cues. This is achieved by administering the drug naltrexone, which temporarily decreases endogenous opioid activity.


Eligibility Criteria:
Inclusion Criteria:

* good physical health,
* normal kidney and liver function results from within previous year

Exclusion Criteria:

* allergy to naltrexone
* kidney or liver injury or disorder
* bipolar, panic, or psychotic disorders
* epilepsy
* smoking more than 15 cigarettes per day
* pregnancy
* substance abuse
* use of opioid analgesics, cocaine, recreational drugs (e.g., marijuana, LSD, ecstasy, etc.), or prescription medication (except oral contraceptives) within the past 10 days
* use of over-the-counter drugs (e.g., analgesics, anti-inflammatories, sleeping aids, etc.) or alcohol within the past 24 hours
* current experience of pain (e.g., headache)
* use of anti-diarrheal medications in the 7 days prior to the study.
Employing eSBI in HIV Testing for At-risk Youth

The purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender women) on frequency of substance use and engagement within the HIV (human immunodeficiency virus) and PrEP (pre-exposure prophylaxis) care continuum.

The purpose of this study is to assess the feasibility, acceptability and test the initial efficacy of eSBI, (electronic screening and brief intervention for alcohol use) coupled with STTR (Seek, Test, Treat, and Retain) in comparison to STTR only among YMSM (young men who have sex with men) and YTW (young transgender women) on frequency of substance use and engagement within the HIV and PrEP (pre-exposure prophylaxis) care continuum. We will do this with the following aims:

Aim 1: Assess the feasibility, acceptability and initial efficacy of electronic Screening \& Brief Intervention + Seek, Test, Treat and Retain (eSBI+ STTR) compared to STTR-only to reduce alcohol and other substance use among 450 YMSM and YTW in Chicago, ages 16-25, at 1, 3, 6, and 12 months post-intervention.

Aim 2: To explore the initial efficacy of eSBI+STTR in comparison to STTR-only on secondary exploratory outcomes within the HIV and PrEP care continuum among YMSM and YTW.

Aim 3: Determine the degree to which sub-groups of youth are differentially impacted by eSBI+STTR based on socio-demographic characteristics and co-morbid mental health problems to inform future targeting and/or tailoring of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* aged 16 to 25 years
* seeking testing for HIV infection
* HIV-negative or HIV status unknown (per self-report)
* Male who has had sex with men OR transgender woman who has had sex with men (i.e., born male, identify as female/transgender, and at any point in the gender transition process)
* English-speaking.

Exclusion Criteria:

* volunteer seems distraught or emotionally unstable (i.e. suicidal, manic, exhibiting violent behavior)
* volunteer seems intoxicated or under the influence of psychoactive agents
3D Ultrasound Measurement of Junctional Zone Thickness and Its Relation to Implantation Success

100 patients aged 21-40 years old, diagnosed as primary or secondary infertility . These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.


Eligibility Criteria:
Inclusion Criteria:

* infertile women

Exclusion Criteria:

* congenital uterine anomalies medical disease contraindicating pregnancy
Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry

Common Flutter ablation technique use low X-ray based three-dimension (3D) navigation for catheter tracking, have become a popular implementation to treat patient's underlying arrhythmia. Compared with fluoroscopy, the gold standard X-ray based method, this recent technique provides the required anatomical information and reduce risk associated with ionizing radiation exposure. Besides Practical Guidelines "as low as reasonably achievable (ALARA) to minimize and normalize radiation exposure had been published so far. The risk of developing acute radiation associated injuries still remains high. In the present study we will compare two groups of patients undergoing into cavotricuspid isthmus (CTI) ablation using either the 3D navigation ("Ensite NavX system") (n = 25) or conventional fluoroscopy (n = 25). Further developing the 3D navigation technique will help to increase safety during the treatment, for both patients and the personnel and increase the success rate during the electrophysiological (EP) interventional procedures.


Eligibility Criteria:
Inclusion Criteria:

* Sick adult patients with Atrial Flutter arrythmia
* patients able to consent.
* patients scheduled to receive cavotricuspid isthmus ablation treatment

Exclusion Criteria:

* patients who do not meet inclusion criteria
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.


Eligibility Criteria:
Inclusion Criteria:

* Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation
* Ability to understand the nature of the study
* Willingness to provide written informed consent
* Ability and willingness to perform all follow-up visits at the study site
* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept

Exclusion Criteria:

* Planned for conduction system pacing
* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
* Known pregnancy or breast feeding
* Age less than 18 years
* Participation in another interventional clinical investigation
* Life-expectancy less than 12 months
Study to Assess the Safety and Performance of The VitalaTM Continence Control Device With Natura Moldable Skin Barriers

This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.

A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the Vitala (TM) Continence Control Device When Worn With SUR FIT Natura® Moldable Technology(TM) Skin Barrier Products Over a 12 Hour Period.

This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Is of legal consenting age.
* Is able to read, write, and understand the study, the required procedures, and the study related documentation.
* Has signed the informed consent.
* Has an end colostomy of at least 12 weeks duration with formed or semi-formed effluent.
* Currently uses a SUR-FIT Natura® Moldable skin barrier or is willing to wear SUR-FIT Natura® Moldable Skin Barrier in 45mm or 57mm flange sizes. Enrollment will target as many moldable product users as possible.
* The investigator is relatively sure the subject will be able to wear a SUR-FIT Natura® Moldable Skin Barrier in 45mm or 57mm flange.
* Is willing to remove and replace the skin barrier wafer after three days, or more often if desired.
* Has a stoma that protrudes no more than 2 cm at rest (lying down on back).
* Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
* Has the ability to do complete self-care.

Exclusion Criteria:

* Has known skin sensitivity to any component of the products being tested.
* Has a skin rating of "L2" or greater according to the SACSTM Rating Scale.
* Is receiving radiation in the area of the pouching system.
* Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.
* Requires convexity.
* Requires a pouch belt while wearing Vitala™.
* Has participated in a clinical study within the past 30 days.
Effects of Vision Training on Sportive Performance in Professional Wrestlers

This study examines the effects of vision training on the sportive performance of professional wrestlers. In wrestling, rapid decision making, timely opponent detection and effective execution of strategic moves are highly dependent on visual perception skills. In this context, our study investigated how vision training improves wrestlers' sportive performance and neck proprioception.

This study examines the effects of vision training on the sportive performance of professional wrestlers. In wrestling, rapid decision making, timely opponent detection and effective execution of strategic moves are highly dependent on visual perception skills. In this context, our study investigated how vision training improves wrestlers' sportive performance and neck proprioception.

Before the study, ethical approval was obtained from Marmara University Faculty of Medicine Ethics Committee with the number 09.2022.1084. The study was started with 28 athletes from the Turkish Greco-Roman A National Team and was carried out on 27 athletes after one athlete in the control group was injured. The athletes who were examined by an ophthalmologist before the study, who did not have any visual problems and who did not have a history of surgical operation and / or injury that would adversely affect the balance in the last 6 months were randomly divided into 2 groups. The 14-member vision training group was subjected to a vision training program that included eye exercises accompanied by a physiotherapist for 5 sessions per week in addition to their routine training for 8 weeks, while the control group continued their routine training. Performance measurements were performed in both groups at the beginning of the study, in the middle of the training (week 4.), at the end of the training (week 8.) and 4 weeks after the training (week12.). Performance evaluations; Wrestling Specific Shuttle Run, Squat-Bench Press Maximum Strength, The Mc-Gill Endurance (Flexion, Extension and Lateral Plank Endurance Tests), Pro-agility Agility, Stork Static Balance, Star Dynamic Balance (Anterior, Posterolateral and Posteromedial directions) and Neck Proprioception tests (cervical region flexion, extension, right lateral flexion, left lateral flexion, right rotation and left rotation). The measurement results were statistically evaluated both within and between groups. The effect of the training program on the visual training and control groups was compared in a time-dependent manner. The effect x time interaction was evaluated by ANOVA analysis.

Eligibility Criteria:
Inclusion Criteria:

* wrestling federation of turkey to take part in the national wrestling team Being between 18-35 years old

Exclusion Criteria:

* having any eye disease having any systemic disease balance problems has had an operation that affects vision and balance (e.g. anterior cruciate ligament) within the last 6 months history of any traumatic brain injury in the last 6 months any serious upper/lower extremity injury in the last three months
Infant Pulse Oximetry in Pakistan Study

Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid, portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting. In this research study, we propose to test the hypothesis that the use of pulse oximetry to detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible for the identification of the infants most urgently in need of medical care. We will enroll 1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi. Infants will undergo brief clinical assessment by a community health worker (CHW) based on the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm, assessment by two pulse oximetry devices, and examination by a physician. The primary outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain measurement, number of infants for who repeat measurements are required), and concordance between paired measurements on separate devices.


Eligibility Criteria:
Inclusion Criteria:

* Infant presenting to the Bilal or Bhains PHC in Karachi, Pakistan
* Age 0 - 59 days

Exclusion Criteria:

* Clinic visit is for scheduled injectable antibiotic administration (e.g., SAT trial)
Integrating the "Ottawa Model" for Smoking Cessation Into Primary Care Practice

This proposal outlines the design of a cluster randomized controlled trial to compare the effectiveness of a new approach to integrating smoking cessation services into routine interactions with patients in the primary care setting using an adaptation of the Ottawa Model for Smoking Cessation (OMSC). The OMSC aims to systematically identify the smoking status of all patients, provide brief cessation advice, and offer evidence-based cessation support to those interested in embarking on a quit attempt. This study will provide important new evidence to assist with the development of a more comprehensive cessation system in the province of Ontario and across Canada.

A multi-component intervention has been designed to facilitate the uptake of the OMSC using best evidence regarding the integration of smoking cessation intervention into primary care practice. The secondary objective of the study is to examine the incremental value of providing tailored performance feedback to primary care practitioners when delivered as part of the OMSC intervention program.

Eligibility Criteria:
Practice Inclusion Criteria:

* Is a primary care practice (family health team, family health group, family health network, community health centre);
* Has a minimum of five full time physicians on staff or sees an average of 50 patients per day;
* All physicians within the practice are willing to participate in the study.

Practice Exclusion Criteria:

* Primary care practices with less than 5 family physicians in a shared clinic space will be excluded.
* Clinics who have already implemented the OMSC will also be excluded.

Patient Inclusion Criteria:

* Current smoker (\>5 cigarette per day on most days of the week);
* 18 years of age or older;
* Scheduled for an annual exam or non-urgent medical appointment with a physician or nurse practitioner;
* Able to read and understand English or French;
* Has a home or mobile telephone which can be used to receive follow-up telephone counselling calls;
* Has the mental capacity to provide informed consent and complete study protocols.

Patient Exclusion Criteria:

* Unable to read and understand English or French;
* Do not have a home or mobile telephone which can be used to receive follow-up calls;
* Do not have the mental capacity to provide informed consent and complete study protocols.
A Study of MKC-442 in HIV-Positive Patients

The purpose of this study is to see if it is safe and effective to give MKC-442 plus at least two other anti-HIV drugs to patients who have never been treated with nonnucleoside reverse transcriptase inhibitors but who have been treated with nucleoside reverse transcriptase inhibitors and protease inhibitors. This study also determines how long a drug combination including MKC-442 is effective.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from plasma, administration of at least 2 available antiviral agents by prescription may be given with MKC-422.

Patients must have:

- HIV infection with HIV-1 RNA greater than or equal to 2,000 by Roche Amplicor method, within 30 days of entry.

Prior Medication:

Allowed:

* Prior nucleoside reverse transcriptase and protease inhibitors.
* Cytotoxic chemotherapy more than 30 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort.
* Inadequately controlled seizure disorder.
* Acute and clinically significant medical event within 30 days of screening.
* Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of the listed laboratory values.

Prior Medication:

Excluded:

* Non-nucleoside reverse transcriptase inhibitor therapy.
* Any unapproved experimental antiretroviral therapy.

Prior Treatment:

Excluded:

* Radiation therapy within 30 days of entry, except to a local lesion.
* Transfusion of blood or blood products within 21 days of screening.

Risk Behavior:

Excluded:

Active substance abuse that may interfere with compliance or protocol evaluations.