cyrilzakka/clinical-trials huggingface dataset:
Genetically Informed Smoking Cessation Trial

The investigators' goal is to identify the most appropriate smoking cessation treatments for smokers based on genetic information. Smokers try to quit smoking but relapses are common.

The investigators' goal is to determine whether genetic markers can be used to optimize smoking cessation pharmacotherapy to enhance efficacy, medication adherence, and reduce side effects. Smoking is a leading cause of preventable death and disability, and smoking cessation reverses the risk of mortality. However, cessation failure is common despite available cessation medications, which are associated with different efficacy, side effects, adherence, use constraints, and costs. This challenge can be addressed by improving current treatments via personalized medicine based on individual genetic markers to maximize efficacy and minimize side effects.

The investigators propose a prospective, genotype-based stratified randomization trial to compare two smoking cessation medications (combination NRT \[patch and lozenge\], varenicline vs. placebo) for 3 months in 720 smokers with known genotypes.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥21 years of age), seeking treatment for smoking cessation.
2. Able to speak English,
3. Active smoking (Cigarettes Per Day (CPD) ≥5), and exhaled Carbon Monoxide (CO) ≥8 ppm
4. Agree to participate in this randomized smoking cessation trial with follow up assessments up to 12 months.

Exclusion Criteria:

1. Pregnancy or breast feeding,
2. Active use or recent use (\< or equal to 1 month) of medication or e-cigarettes for nicotine dependence/smoking cessation, or use of e-cigarettes for more than 9 days in the prior month,
3. Allergy to nicotine patch, lozenge, or varenicline,
4. Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards (women only),
5. Significant cardiac conditions (myocardial infarction, unstable angina, coronary angioplasty, cardiac bypass) or serious arrhythmia in past 6 months,
6. Current heavy alcohol consumption (≥6 drinks/day, 6 days/week),
7. Active psychosis or poorly controlled depression within the past 6 months,
8. Any prior suicide attempt or suicidal ideation within the past 6 months,
9. End stage renal disease with hemodialysis.
The Hepatitis C Transplant Collaborative

In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.

Organ offers from donors with prior or chronic hepatitis C virus (HCV) exposure have been historically underutilized for orthotopic heart transplantation because of the post-transplantation risks \[1, 2\]. The use of HCV antibody-positive (Ab+) donors was associated with attenuated survival benefit after heart transplant and increased coronary allograft vasculopathy in the era before new highly effective direct-acting antiviral agents (DAAs) were developed \[3-5\]. These DAAs target multiple steps in the HCV replication life cycle \[6\]. Newer, well-tolerated, oral direct-acting antivirals (DAAs) have recently been transforming thoracic transplant outcomes after donor-derived HCV transmission. Moreover, now that HCV nucleic-acid testing (NAT), a polymerase chain reaction (PCR)-based approach to detecting viral activity, is widely available and used on all US donor organs, transplant centers have more relevant information about the donor, allowing better risk assessments.

As a result, the utilization of HCV NAT+ donor hearts for transplantation is rapidly gaining momentum, with the obvious benefits of an enlarged donor pool \[7\]. Appropriately, clinical safety trials are currently underway, including a multicenter effort led by the PI of this proposal. Moreover, since the last \~2 years many transplant centers across the nation have started transplanting HCV NAT+ donor organs as standard of care. We estimate that the number of HCV+ cardiac transplants is quickly outpacing the number of trial participants. Hence, it is imperative that safety assessments and risk analyses 'catch up with the real world'.

Eligibility Criteria:
Inclusion Criteria:

1. Recipient of a proven HCV NAT+ donor heart.
2. Re-transplant patients will be included.

Exclusion Criteria:

1. Multi-organ transplantation
Outcome of Operative Management of Posterior Wall of Acetabulum Fracture

Background: Historically, acetabular fractures were treated conservatively which leading to long lasting morbidity like severe pain, limitation of movement and osteoarthritis. Now, evidence suggest surgery for all acetabular fractures for better outcome.

Objectives: To evaluate the clinical and functional outcomes of open reduction and internal fixation of posterior wall of acetabulum fractures.

Methods: This prospective clinical trial was conducted at Chittagong Medical College hospital, Chattogram, from January 2022 to February 2024. Sample size was 32 with fractures as per set criteria and was treated surgically. The outcome variables were functional (according to modified Merle D'Aubigne and Postel score) and radiological (according to Matta's grading). Evaluation was done at 6th weeks and at 03rd, 06th, 09th months. Detailed history, clinical examination, investigations, operative details, post-operative outcome and other parameters were documented. Data were collected in data collection form and were analyzed at the end of the study by using SPSS-25. P-value was considered as statistically significant when it was less than 0.05 and confidence interval was set at 95% level.


Eligibility Criteria:
Inclusion Criteria:

* Posterior wall fracture with unstable hip joint
* Posterior wall fracture with posterior column or transverse fracture
* incarcerated osteochondral fragment
* Age more than 18 years and less than 60 years
* injury within 03 weeks.

Exclusion Criteria:

* open fracture
* associated other acetabular fracture
Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix

The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.

The purpose of the study is to verify the performance of PSD Veritas in providing staple line protection for surgical procedures that buttress the stomach and other staple lines during roux-en-Y surgery. The study is designed as two separate patient groups. One will enroll patients into a group where linear staple lines are buttressed at the stomach. The second portion of the trial will enroll patients into a group where the circular staple line at the GJ and linear staple lines at the stomach are buttressed with PSD Veritas.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years or older
* Patient willing to comply with follow-up evaluations
* Patient understands nature of procedure and provides informed consent
* Female patient has stated that she is not pregnant and will not become pregnant during trial.

Exclusion Criteria:

* Patient currently enrolled in another device/drug trial that competes for same patient population
* Patient with short life expectancy (12 months) wherever the cause is not linked to obesity
* BMI is equal or less than 40 and equal to or less than 65
* Patient does not meet National Institute of Health (NIH) criteria for gastric by-pass surgery
* Patient has had previous buttress or other material used in the staple lines that will affect the outcome of this trial.
* Patient has known sensitivity to bovine material
Effects of Medical and Surgical Weight Loss on Metabolism

This study will follow ,morbidly obese subjects as they undertake weight loss before and after laparoscopic gastric banding, examining markers of glucose and lipid metabolism, adipokines and measures of body fat.


Eligibility Criteria:
Inclusion Criteria:

* morbidly obese subjects with type 2 diabetes or metabolic syndrome
* age \<70

Exclusion Criteria:

* contra-indications to bariatric surgery
The Effects of Glucose Control and Weight Loss Between Beinaglutide and Dulaglutide in Type 2 Diabetes With Overweight or Obesity.

This study is a multi-center, open label, randomized controlled trial that main purpose of this study is to evaluate the differences of glucose control and weight loss between Beinaglutide and Dulaglutide in type 2 diabetes with overweight or or Obesity.

About 2/3 of patients with type 2 diabetes are overweight or obese in China, several studies had confirmed that overweight and obesity could cause type 2 diabetes. GLP-1 receptor agonist could control diabetes meanwhile loss the patient weight. This is a multi-center, openlabel, 1:1 randomized controlled trial to investigate the differences of glucose control and weight loss between two GLP-1 receptor agonist, Beinaglutide and Dulaglutide, in type 2 diabetes with overweight or Obesity. The study comprises the 0-2 weeks of screening period and the 16-week intervention period. 120 patients according to the inclusion/exclusion criteria would recruit from 4 sites in China, then the participant will be randomized to three times a day of subcutaneous beinaglutide(dose escalate to 0.2mg), or once-weekly of 1.5mg subcutaneous dulaglutide for 16-week. The primary endpoint is the change from baseline to week 16 in HbA1c. The second endpoint is the change from baseline to week 16 in weight.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 70 years old from all sex;
2. Diagnosed with type 2 diabetes and HbA1c between 7% to 10%;
3. BMI from 24 to 35kg/m² or waistline longger than 90cm（male）/85cm（female）;
4. Volunteer to participate in the study with informed consent;

Exclusion Criteria:

1. Type 1 diabetes or other specific types of diabetes;
2. Taking drugs of GLP-1 receptor agonist、TZDs and SGLT2 inhibitor within 3 months of screening;
3. Taking insulin or insulin analogues more than 7 days within 3 months of screening;
4. Pregnancy, breastfeeding or planned pregnancy;
5. History of acute or chronic pancreatitis;
6. Taking glucocorticoids(oral or intravenous) continuously more than 7 days within 6 months of screening;
7. Alanine aminotransferase or aspartate transaminase more than 3 times of the normal upper limit, total bilirubin more than 2 times of the normal upper limit;
8. renal impairment (estimated glomerular filtration rate\<60mL/min per 1.73 m²);
9. History of gastrointestinal disease;
10. History of malignant tumor within 5 years of screening;
11. History of organ transplantation or AIDS;
12. History of glaucoma;
13. History of hyperthyroidism or hypothyroidism;
14. History of medullary thyroid carcinoma or multiple endocrine neoplasia II;
15. History of abnormal of Calcitonin or thyroid tumor;
16. History of alcohol abuse;
17. Recruited by other clinical trials within 3 months of screening;
18. Taking drugs of weight loss within 3 months of screening;
19. History of bariatric surgery;
20. History of mental disorders;
21. History of rheumatic diseases or autoimmune diseases;
22. Allergic to beinaglutide or dulaglutide;
23. Participants who estimated would not be suitable for the study by the investigators.
Cryotherapy in Combination with Red Light PDT for Actinic Keratosis of Full Face

40 patients randomized 1:1 to receive cryotherapy followed by 10% ALA gel Red light PDT vs. to 10% ALA gel Red Light PDT followed by cryotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;
2. 6-12 actinic keratosis grade I, II, and III on the full face.
3. Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during study participation.
4. Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
5. Able and willing to give written informed consent prior to performance of any study-related procedures

Exclusion Criteria:

1. Presence of other skin conditions that may affect the study participant, investigator's ability to assess treatment, or intolerance to any ingredient in 10% ALA gel.
2. Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other topicals and treatments for AK within the treatment area or within 2 cm of the treatment area, within 12 weeks of baseline.
3. Use of liquid nitrogen, excision, curettage, dermabrasion, chemical peel or laser resurfacing in the treatment area within 60 days.
4. Use of systemic retinoids (eg, isotretinoin, acitretin) within 6 months
5. Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
6. Use of any investigational drug within 4 weeks prior to enrollment or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
7. Any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis

This study is to evaluate the efficacy and safety of topical application of NP000888 ointment compared to vehicle in plaque and fingernail psoriasis subjects.

Duration of administration: 24 weeks


Eligibility Criteria:
Inclusion Criteria:

* Subject with a clinical diagnosis of plaque psoriasis defined as an IGA score at least 2 (mild) at Screening and Baseline visits
* Subject with a plaque psoriasis total Body Surface Area (BSA) involvement of at least equal to 3% but less than 20% at Screening and Baseline visits
* Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a fingernail PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits

Exclusion Criteria:

* Subject with guttata, erythrodermic, exfoliative, inverse, pustular or palmo plantar, infected or ulcerated psoriasis or psoriasis involvement \>=20% BSA or an unstable form of psoriasis, defined as at least one flare in the previous month before Screening visit
* Subject with chronic plaque psoriasis who are candidates for systemic therapy at Screening and Baseline visits
* Subject with clinical signs of psoriatic arthritis at Screening and Baseline visits
* Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a nail-PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits.
Non-Interventional Long Term Follow-up Study of Participants Previously Enrolled in the RESTORE Study

This study will be conducted following Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Eligible subjects will be consented to return for scheduled study visits for this study following their completion in study NTXMCO-002 (RESTORE). They will not receive a second treatment with MCO-010 (or a repeated sham injection) in this study

This study is designed to follow subjects with Retinitis Pigmentosa (RP) previously enrolled in study NTXMCO-002 (RESTORE, NCT04945772). In that study, 18 of 27 enrolled subjects received MCO-010, an ambient light-activated, Multi-Characteristic Opsin (MCO) transgene in an adeno-associated virus serotype 2 (AAV2) vector via intravitreal injection (IVT) and 9 of 27 received a sham injection. Those who received the sham injection will not be continued in the long-term, follow-up study for drug safety. MCO-010 has the potential to restore vision irrespective of the underlying gene mutation, and because it is directed at bipolar retinal cells, intact photoreceptors are not required. Further details on MCO-010 and the underlying disease under investigation are included in the protocol for RESTORE and are not repeated herein.

The current study is a non-interventional long-term safety follow-up of the subjects who completed RESTORE, in accordance with FDA guidance on recipients of human gene therapy products.

Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in study NTXMCO-002 (RESTORE)
* Able to comprehend and give informed consent.
* Able to comply with testing and all protocol tests.
* Agree to participate for the full 3-year duration of follow-up to the best of their ability and barring any unforeseen circumstances.

Exclusion Criteria:

* Not applicable. Subjects will be included in this study and will be consented after completion of all assessments at their final RESTORE study visit
Does Intensive Task Specific Training Improve Balance After Acute Stroke?

The aim of this study is to investigate whether additional task specific physiotherapy treatment and a self administrated home training program results in better balance compared to traditional follow up care.

Increased risk of falling is a major problem after stroke and impaired balance is one of the main reasons for falling. Early and intensive physiotherapy seems to be beneficial for functional outcome after stroke although it is still unknown whether one specific physiotherapy technique is better than another.

Comparison: Traditional follow up care by the community health care system with additional task specific physiotherapy three times a week and a daily self administrated home training program compared to traditional follow up care by the community health care system.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the stroke unit with a diagnosis of stroke
* Living in the city of Trondheim
* Included 4 - 14 days after first sign of symptoms
* Modified Rankin Scale \> 3 before admission to hospital
* Scandinavian Stroke Scale (SSS) less than 58 points and more than 14 points
* SSS leg item less than 6 points or SSS movement item less than 12 points
* Discharged to home or a rehabilitation clinic
* Mini Mental State Examination Score more than 20 points
* Able and willing to provide informed consent

Exclusion Criteria:

* Seriously heart- and lung-diseases
* Other diseases which makes it difficult to evaluate the function
* Already included in the trial
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)


Eligibility Criteria:
Inclusion criteria:

* Chronic HCV infection
* HCV genotype 1
* No previous treatment for hepatitis C infection
* Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
* Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months

Exclusion criteria:

* HCV genotype different from genotype 1 or co-infection with other HCV genotype
* Co-infection with Hepatitis B or HIV
* Any other cause of relevant liver disease other than HCV
* Presence or history of hepatic decompensation
* Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (\> ULN) in past 6 months

Other protocol-defined inclusion/exclusion criteria may apply.
Testosterone Treatment in Men with Chronic Kidney Disease

This study in being conducted in men who have low testosterone and chronic kidney disease. The investigators will evaluate the effects of an oral testosterone preparation, JATENZO, on testosterone levels and hemoglobin (red blood cells).

* Purpose. The purpose of this research is to find out if JATENZO will help increase testosterone levels in men with hypogonadism and chronic kidney disease, determine if there is any improvement in testosterone levels, hemoglobin (red blood cells), muscle strength, lean mass and sexual function.
* The dug will be daily for 6 months. Study Procedures. Every 2-4 weeks, the study participant will come in person for a research visit. Investigators will collect a blood sample at certain visits, do a brief physical exam, and obtain vital signs such as height, weight, blood pressure. The study also involves completing questionnaires, measuring body composition by a scan and testing muscle strength. The dose of JATENZO may be adjusted based on the testosterone levels.

Eligibility Criteria:
Inclusion Criteria:

* Men between ages of 18-85 years of age
* eGFR 15-45 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) equation
* Subnormal total serum T concentrations (\<300 ng/dl) on two separate occasions in morning
* Symptoms of hypogonadism (as per Endocrine Society guidelines): low libido, erectile dysfunction, fatigue, irritability, depressed mood, poor concentration, increased body fat, decreased muscle bulk, reduced physical performance, sleep disturbance, loss of body hair (15)
* Normal iron stores as defined by serum ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20%.

Exclusion Criteria:

* Use of TRT currently or in the past 6 months, including use of over-the-counter androgen containing health supplements (e.g., DHEA)
* Hematocrit \>48% (as per Endocrine Society guidelines)(15)
* Treatment with erythropoiesis stimulating agents (ESA)
* Uncontrolled blood pressure (\>180/100 mm Hg)
* Heart Failure, class III or IV
* Myocardial infarction, stroke, or heart surgery in the past 3 months
* Breast cancer
* History of prostate cancer
* Prostate specific antigen (PSA) \>4 ng/ml, unless prostate cancer has been ruled out by a urologist (documented in physician notes)
* HIV or untreated hepatitis C
* Untreated, severe obstructive sleep apnea
* Initiated iron replacement in the last 3 months
* deep venous thrombosis or pulmonary embolism in the last 3 months
* recurrent (more than once) deep venous thrombosis or pulmonary embolism
* use of warfarin
* Planning to have children in the next one year