cyrilzakka/clinical-trials huggingface dataset:
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH).

This study has two phases: Phase 2 and Phase 3.

The primary objectives of this study are:

Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24.

Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.


Eligibility Criteria:
Key Inclusion Criteria:

* HIV-1 RNA ≥ 500 copies/mL at screening.
* Antiretroviral (ARV) treatment-naive, except the use of oral pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or F/TAF, up to 1 month prior to screening.

Key Exclusion Criteria:

* Prior use of any long acting parenteral antiretrovirals (ARVs) such as monoclonal antibodies, broadly neutralizing antibodies targeting HIV-1, LEN, injectable cabotegravir (including oral cabotegravir lead-in), and/or injectable rilpivirine.
* Documented resistance to the integrase strand-transfer inhibitor class, specifically, resistance-associated mutations E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
* Any of the following laboratory values at screening:

  1. CD4 cell count \< 200 cells/mm3 at screening.
  2. Estimated glomerular filtrations arate \< 60 mL/min according to the Modification of Diet in Renal Disease formula.
  3. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) \> 1.5 × upper limit of normal (ULN).
  4. Direct bilirubin \> 1.5 × ULN.
  5. Platelets count \< 50,000 cells/mm3.
  6. Hemoglobin \< 8.0 g/dL.
* Active or occult hepatitis B virus infection.
* Active hepatitis C virus infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Cytal® Wound Matrix and MicroMatrix® Wound Study

This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.

A single-site, prospective, observational clinical study of Cytal® Wound Matrix alone or in combination with MicroMatrix® for the management of wounds. Up to 100 patients with multiple wound types including but not limited to, venous ulcers, diabetic foot ulcers, trauma wounds, and external surgical wounds will be treated either with Cytal® Wound Matrix alone or with Cytal® Wound Matrix and MicroMatrix® for wounds exceeding 3mm in depth. Wound healing efficacy, effect of treatment on patient-reported quality of life, complete wound management, wound-related adverse event, and wound pathology will be measured. The protocol defined patient follow-up is 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has at least one wound that the treating physician determines may be treated with Cytal® with or without MicroMatrix®.
2. Subject is at least 21 years of age.
3. Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
4. Subject or legal representative is willing to provide informed consent.
5. For females of reproductive potential, confirmed negative urine pregnancy test at enrollment.

Exclusion Criteria:

1. Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
2. Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
3. The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.
4. The subject's wound shows evidence of infection as determined by the Principal Investigator (which may be indicated by the presence of: elevated WBC, pus, moderate or greater discharge, abnormal odor, or acute osteomyelitis).
5. Wound with exposed organs or hardware.
6. Wound with burn etiology.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4

This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.


Eligibility Criteria:
Inclusion Criteria:

* Chinese healthy male adult subjects aged 18-45 years old
* Body mass index \[BMI between 19.0-24.0 kg/m2
* Hemoglobin A1c (HbA1c)≤6%

Exclusion Criteria:

* Abnormalities that were assessed by the investigators to be clinically significant at screening included vital signs, physical examination, laboratory testing, anteroposterior and lateral chest radiography, and 12-lead ECG
* Known severe allergies (e.g., allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, allergy requiring glucocorticoid treatment) or known allergic history to the ingredients of the investigational drug used in this study
* Participants had donated blood ≥ 200 mL within 6 months before screening, or had donated blood components, or had a total blood loss of ≥ 200 mL due to any reason, or history of blood transfusion or use of blood products
* Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive
* Participated in other clinical trials and used investigational drugs or medical devices within 3 months before screening
An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer

To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Untreated metastatic pancreatic cancer
* 2. Life expectancy of at least 3 months
* 3. Patients with ECOG performance status 0 or 1

Exclusion Criteria:

* 1. Patients with severe complication
* 2. Patients with multiple primary cancers
Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus

This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
* Body mass index 18.5-29.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period
Functional DN for Shortened HS Muscle

The aim of this study is to find whether functional dry needle is helpful to increase the length of shortened hamstring muscle or not

Single pretest-post clinical trial to find immediate effects of functional dry needling to increase the length of the shortened hamstring. This study will be carried on single group which will include male subjects only. The data will be recorded before and immediately after the treatment. A monofilament stainless steel needle will be inserted on three points on hamstring muscle which will include semitendinosus, semimembranosus and bicep femoris. Treatment session will consist of 1 minute 20 seconds for each point on the hamstring and the manipulation will be performed by "Pistoning technique" in which the needle will be drawn out (not fully out of skin) after inserted and then again pushed in and data will be recorded after the treatment session on the basis of increase in length of hamstring which will be measure through 90-90 SLR (AKE) and on the lower extremity functional scale (LEFS)

Eligibility Criteria:
Inclusion Criteria:

* Having hamstring length less than 80 degree during 90-90 SLR on goniometer,
* also the subject that suffers from knee Osteoarthritis,
* Spondylosis,
* LBP,
* Lumber radiculopathy,
* Subjects with MTrPs and those with hyper lordosis were recruited in the study

Exclusion Criteria:

* subjects suffering from blood clotting disorders such as hemophilia,
* those with deformities such as leg length discrepancy,
* compromised immune system,
* vascular diseases,
* Diabetes,
* People with congenital or metabolic bone disease such as Spondyloepiphyseal Dysplasia and Pregnancy were excluded from the study
Prospective Study of Adjuvant Radiotherapy in High Risk Bladder Cancer.

This prospective interventional study aims at evaluating the safety and efficacy of an adjuvant radiation treatment in cases of muscle-invasive bladder cancer, submitted to radical cystectomy and presenting clinic-pathological characteristics of high risk of recurrence.

Bladder cancer represents the ninth neoplasm in the world, with approximately 430,000 new cases diagnosed in 2012. Of them, around 118,000 were diagnosed in Europe, and 52,000 had died from this disease.

Patients with advanced bladder cancer (stage ≥pT3) have a five-year overall survival of \~50% after cystectomy and pelvic lymphadenectomy +/- chemotherapy with approximately half of recurrences in the pelvis, either as isolated failures or synchronous with distant metastases. In fact, radical cystectomy with or without chemotherapy has a 5-year overall survival of approximately 60% for patients with pathologic T2 disease confined to the bladder but only 10-40% for stage ≥pT3 when disease extends into the extravesicular tissues.

Pelvic failures after radical cystectomy are common, especially for ≥pT3 urothelial carcinoma with a cumulative incidence of locoregional failure of 32% at 5 years in the SWOG 8710 cohort. Adjuvant radiation therapy (RT) can reduce locoregional failure and may even improve overall survival, but currently has no defined role, in part because of toxicity reported in older series using 1980s radiation techniques.

An externally validated risk stratification to identify patients at highest risk for local-regional failure who are most likely to benefit from adjuvant RT has been developed based on pathologic T-stage, surgical margin status, and extent of the lymph node dissection.

Local-regional recurrence following radical cystectomy for patients with locally advanced urothelial carcinoma is common. The risk of local-regional recurrence is not diminished with chemotherapy, and salvage treatment is rarely successful. Adjuvant RT can reduce locoregional failure and may even improve overall survival, but currently has no defined role, in part because of toxicity reported in older series using 1980s radiation techniques. Several lines of evidence support the hypothesis that improved local control may lead to improved disease-free and overall survival.

This prospective interventional study aims at evaluating the safety and efficacy of an adjuvant radiation treatment in cases of muscle-invasive bladder cancer, submitted to radical cystectomy and presenting clinic-pathological characteristics of high risk of recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Karnofsky index \> 60 % (ECOG \< 2)
* Histologically confirmed muscle-invasive bladder cancer (MIBC) submitted to radical cystectomy.
* Pathological T-stage \> pT3, and/or pathological N-stage \> pN1, and/or residual tumor present after surgery (R\>1)
* No distant metastases
* Written informed consent

Exclusion Criteria:

* Prior RT in the pelvic region
* Presence of distant metastases
* Pregnancy
* Inability to consent
A Randomized Controlled Pilot Trial Comparing Irish Set Dancing to Usual Care for People With Parkinson's Disease

Primary aim is to conduct a pilot trial to determine:

1. The feasibility and efficiency of randomisation procedures and study design
2. If recruitment rates are sufficient to adequately power a larger trial

The secondary aim is to determine the efficiency of set dancing in comparison to a control for people with Patkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of idiopathic Parkinson's disease (Hackney et al 2007; Marchant et al 2010), stage 1-2.5 on the modified Hoeln and Yahr scale for staging of Parkinson's disease (Batson 2010)
* Able to walk three meters with an assistive device
* Over 18 years of age
* Not pregnant
* Have access to a computer/DVD player to allow them to participate in the home exercise programme

Exclusion Criteria:

* A serious cardiovascular and/or pulmonary condition (Lodder et al 2004)
* A neurological deficit other than Parkinson's disease (Batson 2010; Marchant et al 2010)
* Evidence of a musculoskeletal problem (Duncan and Earhart 2012), contraindicating participation in exercise participation(Lodder et al 2004)
* A cognitive or hearing problem which will affect their ability to follow instructions or hear the music (Batson 2010)
* Participated in regular dance classes in the past six months (Marchant et al 2010)
Blood Biomarkers Based Screening for HPV-driven OPC

The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus (HPV)-related oropharyngeal cancers (OPC) early using simple blood tests. The success of this strategy will be evaluated by the number of participants positive for both HPV16-E6 serology and HPV circulating tumor DNA (ctDNA) whose early management has allowed the detection of a cancerous lesion and/or whose HPV ctDNA results have normalized after surgical intervention. If this study is conclusive, it could pave the way for the implementation of a national screening strategy for HPV-related OPC.

OPC caused by HPV are the most common head and neck cancers and are expected to increase in the future, especially since HPV vaccines are not widely used. Currently, there are no screening strategy available for these cancers, but developing such approaches could enable the earlier management of patients and thus improve prognosis while reducing treatment related toxicities.

Traditional screening methods like imaging or examination are not effective for OPC because early lesions are undetectable. However, studies suggest that using certain blood tests to detect HPV-related OPC early might be efficient:

* Antibodies directed against a specific protein of HPV called HPV16-E6 are present in most cases of HPV-related OPC and it has been shown that they can, be detected several years before the cancer diagnosis.
* HPV ctDNA can be found in the blood of almost all patients with HPV-related cancers. After treatment, HPV ctDNA can detect relapses before they are visible on imaging tests (microscopic disease) We propose to test the use of these two blood tests to identify individuals at high risk of developing OPC and offer them appropriate medical follow-up. HPV16-E6 serology will be conducted on 10,000 men over 50 years of age without symptoms who have consented to participate in the project. These participants will be included during routine visits to the biomedical analysis laboratory.

Individuals positive for HPV16-E6 test will be contacted (approximately 100 participants). They will be offered to continue the study to receive an initial assessment and regular monitoring for 5 years (HPV ctDNA test, regular clinical examinations, imaging examinations if needed). In case of identification of suspicious lesions, appropriate management will be proposed according to the standard recommendations. If no lesion is detected but HPV ctDNA remains positive, preventive surgery may be considered.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥50 years from the general population
* Man
* No previous history of HPV-driven cancer or head neck cancer
* Willingness to complete follow up visits

Exclusion Criteria:

* Aged \< 50 years
* Woman
* History of HPV-driven cancer or head and neck cancer
* Psychiatric conditions
* Inability to complete follow up visits
* Severe medical condition (life expectancy \<5 years)
* Previous prophylactic HPV vaccination
The Use of Nutrigenomics in Sports Nutrition

The study's aim is to determine if nutrigenomics-based dietary advice is a greater motivator for dietary change amongst an athlete population. Specifically, the investigators will be examining whether nutrigenomics-based personalized dietary advice results in greater changes in dietary intake and body composition amongst athletes compared to personalised population-based sports nutrition advice. It is hypothesized that the Nutrigenomics in Sports Nutrition group would engage in greater dietary changes and better adhere to the dietary advice compared to the standard advice group.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Competes in representative sports team
* Has access to the internet and smart phone device
* Able to speak English

Exclusion Criteria:

* N/A
Ultrasonic Measurements of the Clitoris in Fetuses

Abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies. To the investigators knowledge there is no published nomogram of the clitoris size through gestation and it's assessment is usually subjective. The purpose of this study is to create a nomogram of clitorial size through gestation by measuring its size in fetuses of different age in the second and third trimester.


Eligibility Criteria:
Inclusion Criteria:

* well dated pregnancy
* singleton pregnancy
* female fetus
* appropriate for gestational age

Exclusion Criteria:

* small for gestational age
* other fetal anomalies
* maternal conditions that can cause exposure of the fetus to high androgen environment
Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy

The purpose of this study is to evaluate a new method of hemostasis, floseal gel, in tonsillectomy and adenoidectomy, with the goal of decreasing post operative and intraoperative morbidity.

Blood loss and postoperative morbidity following adenotonsillectomy in children can be significant. The current technique for performing a tonsillectomy is "cold steel tonsillectomy" with electocautery hemostasis and a newer technique of coblation tonsillectomy. Postoperative pain has been shown to be increased in patients undergoing extensive electrocautery, with less pain seen in patients undergoing coblation tonsillectomy. The purpose of the study is to evaluate the clinical efficacy and complications of Floseal matrix hemostatic sealant for use in patients undergoing adenotonsillectomy compared with two other currently used techniques.

The study is a prospective, controlled clinical trial comparing Floseal hemostasis in "cold steel" knife dissection tonsillectomy with cautery hemostasis in "cold steel" knife dissection tonsillectomy and coblation tonsillectomy in a pediatric population. All children under the age of 18 without previous documented coagulopathy scheduled to undergo tonsillectomy will be offered enrollment in the study. Informed consent will be obtained from the patient's legal guardian. The goal of this study is to determine if Floseal reduces intraoperative blood loss, time to hemostasis, and postoperative morbidity in patients undergoing tonsillectomy compared with two other commonly used methods. Also, we wish to evaluate the complication rates following Floseal administration compared to those of electrocautery and coblation.

Eligibility Criteria:
Inclusion Criteria:

* Patients less than 18 years old scheduled for a routine adenotonsillectomy

Exclusion Criteria:

* Down syndrome
* Craniofacial abnormality
Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interaction With Methotrexate

This study is planned to explore the effect of food on the oral pharmacokinetics, the intravenous pharmacokinetics and the absolute bioavailability of BAY1834845. Furthermore, this study will investigate the effect of BAY1834845 on the pharmacokinetics of orally administered methotrexate in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male; healthy according to complete medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests as listed in the exclusion criteria given below.
* Age 18-50 years (inclusive) at the first screening visit.
* Body mass index: \>=18 kg/m² and \<=30 kg/m².
* Sexually active men must agree to practice adequate methods of contraception (protection).

This applies for the time period between signing of the informed consent form and up to 90 days after the last administration of the study drug(s).

Exclusion Criteria:

* Any contraindications for intake of BAY 1834845 or methotrexate, gastrointestinal, liver, renal, lung or cardiovascular disorders, malignant tumors, known severe allergies, known or suspected immunodeficiency
* Medication history: drugs known to induce/inhibit liver enzymes
* Smoking
* Clinically relevant findings in

  * physical
  * ECG, blood pressure
  * laboratory values
* Known hypersensitivity to study drug(s)
Composition and Function of Gut Microbiota in Porto-sinusoidal Vascular Disease Associated With Variable Common Immunodeficiency

This aim of this study is the evaluation of the gut microbiota imbalance occurrence and its characterization in patients with common variable immunodeficiency associated to an enteropathy with or without porto-sinusoidal vascular disease.

Common variable immunodeficiency (CVID) is the most common symptomatic humoral deficiency in adults and is accompanied by digestive symptoms. It is associated with intestinal dysbiosis and half of the patients exert a clinical digestive disease, called enteropathy. Hepatic complications characterized by porto-sinusoidal vascular disease are observed in 10% of the CVID patients. This complication is associated with a high morbi-mortality. In our center experience and in the literature, clinical occurrence of enteropathy and hepatic disease are highly correlated. Considering (i) the anatomical link between the intestinal tractus and the portal circulation, (ii) the clinical correlation between enteropathy and the liver disease and (iii) the established relation between gut microbiota and alcoholic cirrhosis, we speculate that patients whom develop portosinusoidal complications exert a peculiar intestinal dysbiosis.

This study could contribute to a better understanding of the hepatic disease development, hence allowing us to suggest novel therapies based on gut microbiota modification.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with a common variable immunodeficiency according to immune deficiencies classification associated with :

  * enteropathy and porto-sinusoidal vascular disease
  * enteropathy without porto-sinuoidal vascular disease
* Subject with health insurance (AME excepted)
* Verbal agreement to participate at the study

Exclusion Criteria:

- Laxatives in the month preceding stool sample