cyrilzakka/clinical-trials huggingface dataset:
Telenutrition Center: Examining the Implementation of Behavioral Therapy for Obesity

The Telenutrition Center will use the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) Framework to assess the implementation of an evidence-based, intensive behavior therapy (IBT) for obesity intervention (with a motivational interviewing \[MI\] framework) based on the Centers for Medicaid and Medicare Services (CMS) IBT for obesity benefit. The intervention will be examined under real-world conditions with technology supplementation to address obesity and related chronic disease among young adult (18-50 years of age) African Americans across the state. The intervention contact will model the CMS IBT for obesity benefit according to the patient contact schedule (of weekly visits in the first month, biweekly in months 2-7, and once a month per months 8-12) and include nutrition, stage of change and other physical and psychosocial assessments. Program delivery will be assisted by the "Bridge2U" web and mobile platform and supported in both clinic and community settings. The proposed project will shed new light on how IBT for obesity (and similar) models may be amended to facilitate the provision of health care resources in areas with limited to no resources, such as the state of Mississippi.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \>/=28
* 25 to 50 years of age
* history or risk of preventable co-morbidities (ie. diabetes, hypertension, and/or dyslipidemia)

Exclusion Criteria:

* Body mass index \<28
* \<25 years of age
* \>50 years of age
* no history or risk of preventable obesity comorbidities
* Any disease diagnosis (ie. cancer) where weight loss is contraindicated
Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea

To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea

The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain). Subjects will be asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Females aged below 40 years old.
2. Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic ultrasonography.
3. Female subject who is:

   * using adequate contraception since last menstruation and no plan for conception during the study.
   * non-lactating.
   * has negative pregnancy test (urine) within 14 days prior to the study.
4. Informed consent form signed.

Exclusion Criteria:

1. Sensitivity to study product.
2. Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic pathology).
3. Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co-investigator.
4. Participation of any clinical investigation during the last 30 days.
Evaluating a Tailored Cognitive Behavioral Therapy for Adolescent and Young Adult Cancer Patients

This project's overall goal is to test the feasibility, acceptability and efficacy of two coach-assisted, computer-based, cognitive- behavioral therapy (C-CBT) interventions in treating depression and anxiety in adolescent and young adult cancer survivors. The two coach-assisted interventions will be compared to the standard C-CBT intervention.

This will be a three-arm randomized controlled trial with two treatment arms and one control arm. Participants in the first treatment arm will receive a coach-assisted C-CBT intervention called "Beating the Blues" (BtB). A second treatment arm will receive a coach-assisted, animated C-CBT intervention called "Entertain Me Well" (EMW). Both treatment arms will have 8 weekly sessions that contain core components of CBT. A coach will provide between-session support throughout the 8 sessions. The control arm will use the standard care of BtB without coach assistance.

Eligibility Criteria:
Inclusion Criteria:

* Cancer survivor, either receiving active treatment or completed cancer treatment
* Experiencing depression and anxiety as measured by PHQ-9 or GAD-7

Exclusion Criteria:

* Severe medical or mental condition (e.g. suicidal ideation)
* Medical condition that prevents patients from operating a computer or tablet
* Receiving end-of-life care
Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD

This Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will be randomized in Cohorts 1 and 2 to receive AL-001 administered via suprachoroidal space injection, Cohort 3 to receive Aflibercept.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥ 50 and ≤ 85.
2. The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
3. The study eye has response to anti-VEGF injections.
4. The subject or their legal representative agrees to participate in this study and signs a written ICF.

Exclusion Criteria:

1. Non-wAMD induced CNV or macular edema in the study eye.
2. Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
3. Uncontrolled glaucoma in the study eye.
4. History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
5. Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
6. Ametropia (high myopia or high hyperopia) \> 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
7. Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
8. None of intraocular inflammation in the study eye.
9. Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.
LivRelief Varicose Veins Cream in the Treatment of Varicose Veins

Phase IV interventional design where all participants used the test product as per package instructions for 6-weeks. Baseline observations were compared to those collected after 6-weeks of treatment.

The use of the marketed natural product, LivRelief Varicose Veins Cream, was observed in 32 patients with lower limb varicose veins. Participants were recruited from the patient population at The Mayer Institute in Hamilton Ontario, Canada. Patients that agreed to participate in the study and met the eligibility criteria were provided with a 6-week supply of the cream to use at home as directed on the product packaging. The following study measures were performed at the clinic prior to the first use of the cream, then again at the clinic after 6 weeks of use: CEAP (Clinical, Etiological, Anatomical, Pathophysiological) classification and VCSS (Venous Clinical Severity score). These are assessments performed by the doctor or nurse to determine the severity of their varicose veins and CVI (chronic venous insufficiency), measurements taken of the circumference of their legs to measure swelling of the legs, photographs of the varicose veins, a quality of life enjoyment and satisfaction questionnaire (QLES-Q-SF) completed by the subjects to describe their satisfaction with various aspects of their life over the last week and documentation of any reactions to the treatment. The cream was applied to their varicose veins twice a day for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* At least 19 years of age.
* Presence of lower limb varicose veins.

Exclusion Criteria:

* Allergy to witch-hazel or any allergies in the cream.
* Intent to undergo surgical treatment varicose veins within the next six weeks.
* Pregnant or breastfeeding or planning to be pregnant.
* Any Dementia or Major Cognitive dysfunction that would preclude the individual's ability to provide informed consent or complete the Case Report Form.
* Any unstable medical condition (including but not limited to cardiovascular, cardiac/hypertension disease, moderate to severe kidney disease, and moderate to severe liver disease)
* Any medical condition that would preclude the participant's or a caregiver's ability to administer the product on a daily basis for the time period required to complete the study.
* An active ulcer at the site of product application (as evaluated during CEAP screening).
HCV Treatment Initiation During Acute Psychiatric Admission

Hepatitis C virus (HCV) disproportionally affects certain populations, including those facing substance use and mental health challenges. In the past, many individuals with mental illness were not treated due to the psychiatric side-effects of interferon. However, the development of highly effective, direct-acting antivirals (DAA) has revolutionized HCV treatment such that cure rates are \>95% with 8-12 weeks of simple, safe, and well-tolerated therapy.

A recent systematic review reported that across 13 North American studies, HCV prevalence among people admitted to psychiatric hospitals was a staggering 17.4% (13.2-22.6%). Despite these concerning figures, mental health facilities have not been a focus of HCV elimination efforts to date. The Centre for Addiction and Mental Health (CAMH) in Toronto is the largest mental health facility in Canada, with a psychiatric emergency department seeing \~35 patients per day with many admitted to the acute psychiatric units for safety and stabilization. Currently, psychiatric patients screened for HCV at CAMH have a 75% 'no show' rate at the Toronto Centre for Liver Disease (TCLD), which is located less than 5km away, suggesting that referral upon discharge is ineffective.

This study will be the first trial to evaluate whether it would be feasible and beneficial to initiate treatment during an acute psychiatric admission rather than referring to specialty upon discharge. The combination of broad HCV screening with rapid linkage to treatment has led to successful elimination of HCV within defined populations, so-called micro-elimination. The investigators hypothesize that HCV treatment can be effectively delivered by providers in psychiatric care facilities, which will improve treatment uptake over traditional referral models.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic HCV infection, positive HCV RNA
2. Aged 18 to 80
3. Willingness and capacity to provide informed consent, or consent is provided by a substitute decision maker

Exclusion Criteria:

1. Presence of or history of decompensated cirrhosis (evidence of decompensation with history of either ascites, variceal hemorrhage, or hepatic encephalopathy)
2. Platelets \< 75,000/mm3, total albumin \<35 g/L, total bilirubin \>34 μmol/L, INR \>1.5
3. History of current or past hepatocellular carcinoma.
4. HBV (HBsAg +ve) co-infection or untreated HIV co-infection
5. Prior HCV antiviral therapy with DAA with or without peginterferon/ribavirin
6. Chronic liver disease other than mild nonalcoholic or alcoholic fatty liver disease from a cause other than HCV
7. Pregnancy/breastfeeding/inability to use contraception
8. Use of concomitant contraindicated medications
Argyle Safety Fistula Cannula With Anti-reflux Valve Clinical Study

The purpose of the investigation is to confirm the safety and performance of the Argyle™ Safety Fistula Cannula with Anti-reflux Valve for hemodialysis treatment.

The study will be performed at up to 5 US hemodialysis clinics.

Qualified patients who choose to participate and sign informed consent will be enrolled in the study. The investigational sites chosen to participate in this study will be trained on the insertion procedure using plastic fistula cannulas according to established curriculum. A combination of didactic training followed by insertion using a cannulation arm will be conducted. Cannulation on consented subjects will begin after the inserter demonstrates proficiency on the cannulation arm. Proficiency definitions are outlined in the protocol. After two supervised (by Medtronic and/or dedicated, trained super user) successful cannulations on consented subjects, the clinician will be permitted to cannulate without supervision.

Data supporting the primary, secondary, and exploratory objectives will be captured following thirty-six (36) hemodialysis sessions for each enrolled subject.

Cannulations will be performed by a minimum of five different clinicians at up to 5 dialysis clinic sites.

The investigational sites chosen to participate in this study will be trained on the insertion procedure using plastic fistula cannulas for a pre-determined period and according to established curriculum. A combination of didactic training followed by insertion using a cannulation arm will be conducted. After two supervised (by Medtronic and/or dedicated, trained super user) successful cannulations on consented subjects, the clinician will be permitted to cannulate without supervision and the data collection for the primary and secondary objectives will begin. Hemodialysis sessions will be performed, according to the investigator's prescription, throughout the duration of the study. Dialysis adequacy will be verified at baseline and during the mid-week session on weeks 1, 3, 6 and 12. Other than the blood sampling, there are no study-specific procedures, other than cannulation with the Argyle™ Safety Fistula Cannula with Anti-Reflux Valve, that will be required.

Eligibility Criteria:
Inclusion Criteria:

* Subject who is aged 18 years or older who signed informed consent
* Subject is undergoing in-center hemodialysis
* Subject has an arteriovenous fistulae (AVF) fistula that was determined to be mature by standard clinical definition

Exclusion Criteria:

* Subject is enrolled in another study that could confound the results of this study, without documented pre-approval
* Subject with an existing arteriovenous graft
* Subjects with known allergies to plastics
* Subjects who are unable to read or respond to the questionnaire about satisfaction
PIONEER: Intraoperative and Perioperative OCT Study

OCT provides high-resolution information regarding the anatomic structure of the tissues of the eye in a 2-dimensional and 3-dimensional view. Much of this information is not able to be recognized by a clinician. Utilizing this information during surgery will allow for ophthalmic surgeons to better understand how surgical procedures impact the anatomic structure of the eye.

Over the last decade, optical coherence tomography (OCT) has become a critical component to the evaluation of ophthalmic disease. Similar to ultrasound, OCT uses light to reconstruct an image of the tissue of interest. In effect, OCT has become to function as a light biopsy, allowing clinicians to visualize subtle pathologic changes in the tissue, such as macular edema or subretinal fluid. The use of OCT in the clinic setting has become the standard for monitoring diseases such as macular degeneration and diabetic retinopathy. It has quickly become the most frequent ordered diagnostic test in ophthalmology.

Due to restraints in the size and structure of the imaging equipment, the use of OCT in the operating room has been limited. More recently, modifications to OCT table-top models as well as the development of hand-held OCT probes have allowed for the translation of OCT technology into the operating room. The high resolution anatomic information that is gained from OCT imaging is a natural complement to the ophthalmic surgeon. Using OCT during vitreoretinal surgery has revealed subtle changes in the microarchitecture of the retina in diseases such as retinal detachment, macular hole, and optic pit, that were not previously known. Using OCT during lamellar corneal transplant procedures, anterior segment surgeons have been able to image proper placement of the graft that was previously unattainable with a standard surgical microscopic view.

Using information gained from OCT, surgeons may be able to improve surgical decision making and improve clinical outcomes. For this study, subjects undergoing ophthalmic surgery, including vitreoretinal surgery and anterior segment surgery, would have OCT imaging performed in the perioperative period, intraoperative period, or both to document architectural changes in the ocular tissues. This information would be prospectively collected and reviewed for associations with anatomic and functional outcomes.

A microscope-mounted OCT system will be used to assess feasibility and utility of imaging during ophthalmic surgical milestones.

Eligibility Criteria:
Inclusion Criteria:

* The study population includes any patient requiring ophthalmic surgery

Exclusion Criteria:

* Children under the age of 18
* Cognitive/Mentally impaired or unable to provide consent
* Media opacity precluding OCT scanning
Tuberculosis Volatile Organic Compounds

The Pulmonary Colonization Test is a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of mycobacterial organisms in the lower respiratory tract. It consists of:

* A breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample of room air.
* Analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography.
* Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection.
* Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas chromatography.

This study will test the hypothesis that the investigators can identify the presence of mycobacteria in an individual by sampling the breath of patients with active tuberculosis and by sampling "head space" above culture media of sputum provided. This study will test the hypotheses:

* that the investigators can identify positive cultures for mycobacterium tuberculosis through sampling of the headspace above the cultures prior to standard laboratory culture identification
* that the investigators can identify control of tuberculosis by sampling exhaled breath


Eligibility Criteria:
Inclusion Criteria:

* Suspected tuberculosis infection or disease
* Positive tuberculosis skin test
* Positive sputum culture for TB
* X-rays indicated possible tuberculosis infection or disease
* ability to give breath and sputum samples at regular intervals

Exclusion Criteria:

* Heavy smoker
* History of or active pulmonary disease other than tuberculosis
Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

This multicenter, open-label extension study will evaluate the long-term tolerability and safety for patients completing study CSMS995 0802. During this extension study, all patients will receive open-label treatment of octreotide acetate in microspheres every 4 weeks for 2 years for the treatment of moderately severe to severe NPDR and low risk PDR.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent provided prior to participation in the extension study
* successful completion of study CSMS995 0802
* willingness to comply with all study requirements

Exclusion Criteria:

* more than 8 weeks interval since the completion of study CSMS995 0802
* premature discontinuation from study CSMS995 0802

Other protocol-defined inclusion/exclusion criteria may apply.
The Effect of Dietary Fiber-enriched Cereals on Glycemic Control and Secretion of Gut Hormones

The aim of this study is to assess whether dietary fiber-enriched cereals effect on postprandial glucose levels and plasma glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) concentration in patients with type 2 diabetes mellitus.

Fifteen subjects with type 2 diabetes mellitus will be provided with study meals based on either dietary fiber-enriched cereals or conventional cereals upon two separate admissions in a cross-over fashion. The study meals will be provided at 6 p.m. and 10 p.m. on the day of admission, and 8 a.m. on the next day. A hamburger with coke as mixed meal will be given for lunch at noon on the second day. Blood sampling will be done every 30 minutes from 8 a.m. to 4 p.m. on the second day. The plasma levels of glucose, GLP-1, GIP, insulin, glucagon, and free fatty acid will be measured.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* HbA1c 6.5\~8.5%
* on life style modification or metformin monotherapy at the time of screening

Exclusion Criteria:

* on sulfonylurea or insulin therapy at the time of screening
* allergy to wheat, flour, other cereals or nuts
* lactose intolerance
* pregnancy / lactation
Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis

To evaluate the safety and effectiveness of PRP injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury.


Eligibility Criteria:
Inclusion Criteria:

* The age range of the participants was 20 to 60 years old. Through a comprehensive clinical and imaging examination, it was conclusively determined that the individuals had knee osteoarthritis or experienced injuries to the cart, and meniscus surrounding the knee joint.
* The preoperative routine tests and examinations revealed no contraindications.
* Revised sentence: "Informed consent of the patient

Exclusion Criteria:

* The platelet count or function exhibits significant abnormalities、Systemic infection transmitted through the bloodstream.
* Prolonged usage of anti-inflammatory drugs and systemic corticoid administration.
* In injection site or damage to the skin.
* Patients with tumors or undergoing radiotherapy and chemotherapy.
* Pregnant or breastfeeding women.
* Individuals with mental illnesses who are unable to cooperate with follow-up procedures.
* Contraindications for MRI、Patients or their families do consent to participate in the study.
* Other circumstances that render participation in the study unsuitable.