cyrilzakka/clinical-trials huggingface dataset:
A Cohort Trial Comparing AutoloGel Therapy to Usual and Customary Care in Venous Leg Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, cohort-controlled trial in which venous leg ulcers (VLU)n will be treated using AutoloGel and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care (UCC)

Recurrence of ulcers in the leg is common; two-thirds of patients are likely to experience recurring ulcers after the first ulcer. While treatment of the underlying venous disease, depending on the mode of treatment, can lower the recurrence rate in many patients, it does not affect recurrence. AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. The aim of this trial is to demonstrate the effectiveness, measured as complete wound healing, in a prospective, open-label trial in which venous leg ulcers will be treated using AutoloGel and standard of care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care

Eligibility Criteria:
Inclusion Criteria:

1. Medicare/Medicaid eligible
2. ≥18 years of age
3. Proven venous disease
4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located between and including the knee and the ankle
5. For subjects with potentially multiple eligible VLUs, the largest ulcer will be selected. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
6. Debrided ulcer size between 2 cm2 and 200 cm2
7. Demonstrated adequate compression regimen
8. Duration ≥ 1 month at first visit
9. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

Exclusion Criteria:

1. Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
2. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
3. Ulcer not of VLU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
4. Any malignancy other than non-melanoma skin cancer
5. Subjects who are cognitively impaired and do not have a healthcare proxy
6. Serum albumin of less than 2.5 g/dL
7. Plasma Platelet count of less than 100 x 109/L
8. Hemoglobin of less than 10.5 g/dL
9. Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration
Secondary HIV Prevention and Adherence Among HIV-infected Drug Users

This study will test whether 3H+ (Holistic Health for HIV) is comparable to the original HHRP+ (Holistic Health Recovery Program) in reducing HIV risk behaviors and improving ART (Antiretroviral Therapy) adherence in a randomized controlled comparative effectiveness trial among 256 HIV+ persons in drug treatment who report unsafe injection drug use practices or sexual risk behavior.

HIV-infected drug users (DUs) remain a target population as they represent a significant vector for the transmission of new HIV infections (Avants et al., 2004; Margolin et al., 2003), which occur through preventable drug- and sex-related HIV risk behaviors. Though numerous evidence-based HIV risk reduction interventions are now widely available as complete intervention packages, few evidence-based interventions have been designed for implementation within common drug treatment community-based organizations (CBOs), such as methadone maintenance programs (MMPs), where many high-risk HIV-infected drug users seek treatment. Moreover, the few evidence-based interventions that are applicable to drug treatment CBOs are not designed to be "community-friendly" and, hence, are unlikely to be implemented as intended or durable within these critical settings.

The investigators have developed a significantly shortened version of the comprehensive evidence-based Holistic Health Recovery Program (HHRP; Avants et al., 2004; Margolin et al., 2003). This shortened version, Holistic Health for HIV (3H+), has demonstrated feasibility and acceptability as well as preliminary evidence of effectiveness in an uncontrolled study within a resource-limited drug treatment CBO. Therefore, this randomized controlled comparative effectiveness trial (RCT) will test the efficacy and cost-effectiveness of 3H+ versus the original gold standard evidence-based intervention(EBI), Holistic Health Recovery Program for HIV+s (HHRP+), targeting HIV+ drug users (DUs).

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Opioid dependent and enrolled in methadone maintenance treatment
* Report drug- or sex-related HIV risk behavior in previous 6 months
* Able to read and understand the questionnaires, the Audio Computer Assisted Self Interview (ACASI), and consent form
* Available for the full duration of the study with no anticipated circumstances impeding participation
* Not actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of the PI who is a licensed clinical psychologist in Connecticut.

Exclusion Criteria:

-
Evaluation of the Active Living Every Day Exercise Program for People With Arthritis

The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.

Evidence has shown that regular moderate-intensity physical activity improves symptoms and function in persons with arthritis. A 20-week behavior-based program was developed by the Cooper Institute, Brown University, and Human Kinetics to help people with sedentary lifestyles become and stay physically active. A randomized trial evaluated the effectiveness and efficacy of a similar program on which Active Living Every Day is based (ALED) on cardiovascular disease risk factors, cost-effectiveness, and cardiorespiratory fitness. However, the current research supporting ALED is limited for people with arthritis. The primary goal of this study is to assess the effectiveness and feasibility of the Active Living Every Day Physical Activity Program (ALED) for people with arthritis. The primary goal will be accomplished through a twenty week randomized controlled trial conducted with 400 participants residing in the 17 Area Agencies on Aging housed in the Councils of Government in North Carolina, including both urban and rural counties. This project is designed to evaluate the effectiveness of the ALED program in changing arthritis-related health outcomes and to investigate the feasibility of conducting the ALED program in a public health setting.

Objectives:

1. To demonstrate that the ALED program can increase physical activity and fitness levels among people with arthritis.
2. To demonstrate that the Active Living Every Day has arthritis-specific benefits.
3. To evaluate the feasibility of disseminating the Active Living Every Day program through the NC public health network.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported arthritis or chronic joint symptoms
* Currently exercising less than 3 times per week
* Plan to be in community for at least 1 year
* Physician release for participation in physical activity

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Cognitive impairment
* Serious medical condition where exercise is contradindicated
* Severe physical or mental impairment
Osteopathic Medicine in Fibromyalgia Syndrome

The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.

An osteopathic treatment could have a positive and durable effect on pain and quality of life on patients with fibromyalgia.

This technique, in addition to the standard treatment in a multidisciplinary care center, could be efficient by releasing muscle tension.

This is a 24 months multicenter (2 recruiting centers, 1 care center), randomized, and placebo-controlled study. The purpose is to evaluate the analgesic efficacy of a 6 weeks osteopathic treatment compared to a 6 week standard treatment on patients with fibromyalgia. It includes 6 osteopathic/standard sessions of 20 minutes (of one week apart), a follow-up at 3 months, 6 months and 12 months.

The primary aim of this study is to evaluate the pain after each osteopathic session, at the end of the 6 weeks treatment, and after each visit, judging by the patient's pain measured by a numeric scale (EVA).

The secondary aims of this study, based on clinical exams and questionnaires are to evaluate the quality of life, the patient activity and the sleep improvement after osteopathic treatment, and to investigate if osteopathic medicine improves fatigue, comorbidities, and decrease additional visits and medical investigations.

This study will also allow to identify the profile of the osteopathic treatment responders patients

Eligibility Criteria:
Inclusion Criteria:

1. Patient Male or female aged at least of 18
2. Patient with fibromyalgia, according to the American College of Rheumatology (ACR) 1990 criteria, with a global level of pain of 50 over a 100 mm EVA scale
3. Patient suffering from fibromyalgia for over a year
4. Patient with stable medical/non medical treatment for at least 1 month before the recruitment
5. Patient referred to a medical center for a multidisciplinary approach
6. Patient who can be followed for at least 12 months after the end of the osteopathic sessions
7. Patient giving his informed consent to participate in the study
8. Patient affiliated to or beneficiary of social insurance

Exclusion Criteria:

1. Treatment by physical approach in progress or not older than 3 months : physiotherapy, kinesitherapy, rehabilitation or manual treatment (osteopathic or chiropractic care, manual medicine)
2. Unability to attend 6 sessions, meaning one weekly session, of osteopathy, at Hôtel Dieu
3. Severe psychiatric pathology : major depression, psychosis
4. Pregnancy or breast feeding
5. The patient is already included in another clinical study
6. Patient under judicial protection
Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer

This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.


Eligibility Criteria:
Diagnosis Criteria:

All patients should have histologically confirmed colorectal adenocarcinoma with hepatic metastases and primary tumours completely resected during the operation and with colorectal metastatic to the liver confirmed pathologically after the operation as well as with negative surgical margin.

Main criteria for inclusion:

* Aged 18-75 years
* Diagnosed as colorectal adenocarcinoma which only spread to the liver and with no extra-hepatic metastases
* Prior curative resection of primary tumours (R0 resection) or concurrent feasible curative resection of primary tumours and hepatic metastases (R0 resection is met)
* Performance status ECOG 0-1
* No serious complication occurred during or after metastases resection and affected subsequent treatment.
* Hematology: White blood count ≧ 4.0X10\^9/L, Absolute neutrophil count ≧1.5X10\^9/L, Platelet count ≧ 100 X10\^9/L, Hemoglobin ≧ 100g/L
* Blood biochemistry: Total bilirubin ≦2mg/dL , Direct bilirubin equal or less than 1.5 times upper limit of normal (ULN), Alanine aminotransferase (ALT) no greater than 2.5 times ULN, Aspartate aminotransferase (AST) no greater than 2.5 times ULN, Serum creatinine no greater than ULN, or glomerular filtration rate equal or greater than 60 mL/min/1.73m\^2
* Not pregnant or nursing at present
* Fertile patients must use effective contraception
* Able to withstand major operative procedure
* No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
* No prior hepatic artery infusion therapy with 5-FU or floxuridine
* No prior systemic chemotherapy for metastatic disease
* No other concurrent chemotherapy
* Able to understand and sign off informed consent form
Food for Thought: Executive Functioning Around Eating Among Children

Scientific knowledge of the cognitive-developmental processes that serve to support children's appetite self-regulation are surprisingly limited. This investigation will provide new scientific directions for obesity prevention by elucidating cognitive-developmental influences on young children's ability to make healthy food choices and eat in moderation.

Appetite self-regulation (ASR) has been described as involving children's use of eating-specific, "top-down" cognitive processes to moderate "bottom-up" biological drives to eat. Much of the research to date on ASR has focused on the role of bottom-up drives in shaping children's behavioral susceptibility to obesity. Alternatively, little is known about the cognitive-developmental processes that shape children's ability to make healthy food choices and eat in moderation during early childhood. The goal of this exploratory investigation is to produce rigorous evidence of cognitive developmental influences on healthy eating behaviors and weight status during preschool through the development of new measures of top-down ASR. Participants will be 125 preschoolers and their primary caregiver. Existing measures of executive functioning in children will be adapted to create new measures of eating-specific, top-down ASR. Associations with children's eating behaviors, body mass index z-scores, food parenting will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Child ages 4 to 6 years of age
2. Caregiver reporting primary responsibility for child feeding outside of childcare
3. Caregiver legal guardian

Exclusion Criteria:

1. Caregiver \<18 years of age
2. Child major food allergies
3. Child medication use, developmental disability, or medical conditions known to affect food intake and/or growth; color blindness
4. Child in foster care
3D Versus 2D Laparoscopic Ovarian Cystectomy

This is a prospective randomized study involving 80 patients. All participates will be given written information on 3D laparoscopy. They will be randomized according to computer-generated random sequence into two groups, 2D and 3D group. The operation will then be performed either using 2D or 3D laparoscopy. Surgeons are allowed to change to the other type of laparoscopy if difficulty encountered. After the operation, the surgeons will be required to fill in a questionnaire self-evaluating the performance using Global rating scale component of the intraoperative assessment tool (GOALS), any discomfort encountered, any need for change of laparoscopy and their preference on the type of laparoscopy.

The level of complexity of the operation, duration of operation, blood loss and complications will be recorded.

Laparoscopy has greatly replaced laparotomy in most gynaecological operations including oncological procedures. Laparoscopic approach is the mainstay for ovarian cystectomy nowadays. However the loss of depth perception and dexterity remains the drawback of laparoscopy. With the development of robotic surgery, the three-dimension vision and presence of "wrist" motion allowed surgeon to perform more complicated operations in sophisticated manner. Expensive instruments and the need for prolonged time of setup restricted the extensive use of it. Having those considerations in mind, three-dimension (3D) laparoscopy is another possible alternative. With the advancement of technology in 3D vision, it may provide better precision especially in perception of depth and spatial orientation. Dizziness, nausea, headache and ocular fatique are occasional side effects in 3D surgery which created concerns of the surgeons.

There have been studies using standardized tasks shown that 3D laparoscopy will improve the performance in surgeon both objectively and subjectively especially when performing complex task. It was suggested to be able to fasten the learning curve for beginners. The operation time was shorter when laparoscopic cholecystectomy was performed using 3D imaging without any major complications encountered.

Yet evidence in the applicability and use in clinical service in gynaecological operations are still inadequate. The investigators would like to evaluate the difference of 2D versus 3D laparoscopic ovarian cystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Planned for laparoscopic ovarian cystectomy
* Willing and able to participate after the study has been explained
* Those understand either Cantonese, Putonghua or English

Exclusion Criteria:

* essential data are missing from the participants records making it impossible to judge treatment outcome.
Features of the Clinical Course and Prognosis in Patients With Idiopathic Pulmonary Hypertension When Using Modern Strategies of Specific Therapy

This study will be performed based on a retrospective analysis of the cases of 150-170 patients with IPAH observed at the Research Institute of Clinical Cardiology over the past 10 years, for a comparative assessment of the survival of groups of patients with IPAH diagnosed in the period 2004-2013 and 2014-2023.

The demographic, clinical, functional, hemodynamic characteristics of patients, comorbidity, blood biomarker levels, received PAH-specific and symptomatic therapy will be assessed in order to determine the clinical characteristics of patients with IPAH.

The prospective part of study will include 50 patients with IPAH.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years;
* verified diagnosis of IPAH

Exclusion Criteria:

* age under 18 years;
* Other etiology op PAH,
* ischemic heart disease confirmed by MSCT of the coronary arteries or coronary angiography;
* diseases of the musculoskeletal system that prevent 6MWT
* severe liver dysfunction (more than 9 points on the Child-Pugh scale, class C)
* severe renal dysfunction (CC less than 15 ml/min), need for hemodialysis
Development Cellular Models of the Ear and Nose to Study the Mechanisms of Hearing

Development of cells culturesissued from Nose and Ear to study auditory mecanisms.

Study of the cis-Modulation of the gene GJB2 for the patients with early presbycusis to identify the genetic cause of hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Hearing loss Presbycusis Exostosis

Exclusion Criteria:

* Genetic hearing loss
Study of BGG492 in Patients With Chronic Subjective Tinnitus

This study will assess the efficacy of a two week treatment with BGG492 in patients with chronic subjective Tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with THI (Tinnitus Handicap Inventory) severity grade 3, 4 or 5 (moderate, severe or catastrophic), chronic (\> 6 months and \< 36 months) subjective tinnitus
* Willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance
* Willing and able to refrain from engaging in activities or work involving loud noise exposure

Exclusion Criteria:

* Patients diagnosed with tinnitus of THI severity grade equal to 2 or 1
* Patients with diagnosis of intermittent or pulsatile tinnitus
* Patients who have tinnitus as a concomitant symptom of a treatable otological disease (such as otitis media, Menière's disease, otosclerosis), neurological tumors or/and have temporo-mandibular joint disorders
* Patients with a history of frequent middle ear infections (\> 3 infections per year during the last 3 years)
* Patients with diagnosed anxiety disorders, depression, schizophrenia or other significant psychiatric diseases requiring current drug treatment or patients who required treatment in the previous 3 months for these diseases.
* Patients with current unilateral or bilateral hearing loss of 75 dB or more in one or more tested frequencies (125 Hz, 250 Hz, 1 kHz, 2 kHz, 4 kHz, 6 kHz, 8 kHz)
* Patients with Vestibular Schwannoma
* Patients with a cochlear implant
* Patients with regular intake of central nervous system acting drugs for the treatment of tinnitus in the previous 6 months prior to initial dosing

Other protocol-defined inclusion/exclusion criteria may apply
Wide Area Circular Ablation Versus Extra-wide Area Circular Ablation in Persistent Atrial Fibrillation

Ablation of atrial fibrillation is an established method for treatment of subjects with atrial fibrillation with goal of restoration of sinus rhythm. Among different methods, wide area circular ablation (WACA) is shown to provide the same results with fewer complications. This project will compare WACA with extra-wide area circular ablation (E-WACA) in subjects who are considered for ablation of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* All subjects with symptomatic persistent atrial fibrillation who are scheduled for clinically indicated ablation of AF.

Exclusion Criteria:

* Subjects younger than 18 year of age.
* Subjects who are pregnant.
* Subjects who are unable to provide consent.