cyrilzakka/clinical-trials huggingface dataset:
Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass Study

The aim of the study is to compare PTFE-graft bypass surgery versus Viabahn endoprosthesis for femoropopliteal arterial occlusion in intermittent claudication and critical ischaemia in patients who would be technically amenable for both treatments. The primary objective is to compare primary patencies of the two treatments. The secondary objective of the study is to evaluate secondary patency, functional status, the quality of life and costs of the new endovascular therapy.

Femoropopliteal bypass graft surgery with PTFE-prosthesis has proven to be an acceptable treatment for stable incapacitating claudication and critical ischaemia in patients with superficial femoral artery occlusion. Preliminary results of a thrupass endoprosthesis in the treatment of femoral lesions are promising. Less morbidity and better cost-effectiveness are suggested to be achieved in treatment of chronic lower limb ischaemia with endovascular treatment comparing to surgical treatment.

A randomised multicentre trial aims to enrol a pilot group of 60 + 60 patients to be followed for 3 years. Patients are treated either with Viabahn thrupass endoprosthesis (Gore corp.) or with 6 mm PTFE-prosthesis bypass graft surgery. Primary patency at three years is the primary end point and secondary patency, functional success, costs and quality of life are the secondary end points.

Eligibility Criteria:
Inclusion Criteria:

1. Superficial femoral artery occlusion from 5 to 25 cm in length above the knee joint.
2. Patient must be equally eligible for both procedures.
3. Patient must present intermittent claudication with resistance to medical therapy and exercise or critical ischaemia.
4. Normal adjacent vessel diameter must be between 4.8 and 6.5 mm.
5. At least one patent distal run-off vessel and at least 1 cm of healthy superficial femoral artery below and above the lesion to allow proper placement of the endoprosthesis.
6. Patient must be 18 years or older.
7. Women of childbearing age must have negative pregnancy test prior to inclusion.

Exclusion Criteria:

1. Known allergy or contraindications to aspirin, clopidogrel, dipyridamole or anticoagulants.
2. Bleeding diatheses
3. Presence of one or several previously placed endoprosthesis or grafts in the superficial femoral artery segment.
4. Planned other endovascular therapy of the same segment.
5. Other than 6-7 mm diameter endoprosthesis or 6 mm PTFE-prosthesis is needed.
6. Presence of evolving malignant cancer or any other illness posing an immediate threat to life.
7. Life-expectancy less than 2 years due to co-morbidity or other situation that would make the patient unlikely candidate for follow-up visits.
8. Participation in another vascular clinical study less than 30 days prior to inclusion.
9. Patients unable to fill out the prescribed quality of life questionnaires themselves or unable to understand the full meaning of the informed consent.
Ultrasound and Mammography for Screening Breast Cancer in Chinese Women

Early detection of breast cancer through screening has been a common practice in the United States and several European countries for decades.It is effective in reducing the mortality of breast cancer and improving the postoperative quality of life of patients. Mammography has been the standard imaging method for the screening, and in recent years, a supplemental ultrasound exam is also recommended.A prospective, multi-center, randomized trial is needed to define an optimal screening strategy that suits Chinese women and the socioeconomics of China.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent；
* residence from community or working units

Exclusion Criteria:

* pregnancy；
* lactation；
* known metastatic cancer；
* signs or symptoms of breast disease；
* presence of breast implants, breast surgery within prior 12 months；
* had mammography or ultrasound exam within prior 12 months
* males.
EFFECTS OF RejuvaMatrix ™ ON TELOMERES

Lying for 30 to 60 minutes daily in a field of 75 decibels of electromagnetic energy at 54 to 78 GHz will allow telomeres of white blood cells to regenerate

Individuals who are post menopausal and who do not have an implanted electronic device, such as a pacemaker will have base line white blood cell telomeeres measured at Repeat Diagnostics in Vancouver. They will be supplied with a two inch foam mat in the center of which is copper screen with one pound of crushed sapphire. The mat looks like a mattreess and is placed on top of the regular mattress. Participants are provided with a Tesla coil to be attached to a copper wire coming from the copper screen. They will also be provided with a timer so that they can set the Tesla coil to be activated for a maximum of 60 minutes while they sleep.

Telomeres will be measured at the end of each year for 5 years.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Implanted electronic device
* Major, debilitating disease
* Person living with an individual who has an implanted device
* Person who is or could become pregnant
Health Behavior Nudge Strategies for Chronic Disease Patients: the Study of Hypertension and Type 2 Diabetes

This study is conducted from the perspective of behavioral economics, where individuals often display bounded rationality in decision-making, opting for habitual choices rather than those most advantageous to themselves. Nudge strategies can utilize individuals\&#39; cognitive and motivational shortcomings to influence behavior. Therefore, the study first examines the decision-making biases present in patients with hypertension (HP) and type 2 diabetes mellitus (T2DM) regarding the maintenance of healthy behaviors based on individuals' bounded rationality; subsequently, it develops an intervention program to encourage healthy behaviors in HP and T2DM patients alongside nudge strategies; finally, it assesses the intervention effects of the program on blood pressure, blood glucose, and health behaviors in HP and T2DM patients.

The study was conducted in Lanzhou City, Gansu Province, China. The research selected two communities of similar scale and level, recruiting 133 patients with HP and T2DM. A six-month quasi-experimental study was performed, where the intervention group implemented nudging strategies while the control group received standard community nursing. By measuring the patients\&amp;#39; blood pressure and blood glucose levels, and utilizing the Diabetes Self-Care Scale, Hypertension Self-Management Behavior rang Scale，Patient Activation Measure，Short-Form Health Survey, Activity of Daily Living Scale to assess the behavioral changes in both groups, validated the intervention effect of the nudging strategy on the health behaviors of patients with HP and T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Previously diagnosed with hypertension, type 2 diabetes, or hypertension combined with type 2 diabetes
* Able to use mobile phones or other electronic devices
* Informed consent

Exclusion Criteria:

* Patients who are pregnant or breastfeeding;
* Patients with severe diabetes, hypertension complications, or other serious illnesses;
* Patients with hearing or vision impairments;
* Patients with cognitive impairments or mental illnesses;
* Patients with acute complications.
Influence of Lipid Lowering on Impaired Coronary Flow

This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow

Multicenter, prospective study. 105 patients with stable chest pain, and moderate CAD, statin naive (and LDL cholesterol \>2 mM), and at least one translesional FFRct value \<0.81 are randomized (patients with significant CAD in the left main or other proximal segments are excluded from the study) to either "atorvastatin 40 mg daily" or "rosuvastatin 40 mg + ezetimibe 10 mg daily" treatment. Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months. At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation (HeartFlow) are performed. The primary endpoint is changes in FFRct values from 0 to 18 months. Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥35 y
* Symptoms suggestive of stable CAD
* No pre-CTA known CAD
* At least one lesion with FFRct \<0.81
* Sinus rhythm
* LDL cholesterol \>2.0 mM
* Statin use \>2 months
* Life expentancy \< 3 years
* Signed informed consent

Exclusion Criteria:

* Known CAD
* Poor CTA image quality inadequiate for FFRct analysis (determined by corelab)
* Significant CAD in the left main or proximal coronary segments
* Referral to invasive catheterization
* Statin intolerance
* BMI \>40
* Allergy to ionidated contrast
* Pregnancy
Intergenerational Transmission of Traumatic Stress

Millions of U.S. parents have experienced trauma, putting them at risk for maladaptive parenting practices, which then confer vulnerabilities to their children. This study aims to enhance understanding of how parental emotional dysregulation associated with traumatic stress impedes effective parenting. The study employs neurophysiological methods (electroencephalogram; EEG) to address some of the challenges inherent in the study of emotion (particularly in trauma-exposed individuals) and to identify potential biomarkers of traumatic stress and response to intervention.

This research study consists of a randomized controlled trial of 60 families of preschool-aged children in which a parent/caregiver has their own history of childhood interpersonal trauma or loss.

Parent/caregiver participants and their preschool-aged child will participate in two phases of assessment (baseline/Time 1 and follow-up/Time 2). Each phase of assessment will include parent/caregiver participant completion of self-report questionnaire measures, a parent-child interaction task (which will be video-recorded for later behavioral coding) and a parent EEG assessment. After the Time 1 (T1) assessments, participants will be randomized to either the FOCUS-Early Childhood Program group (n = 30; experimental group) or the parent education curriculum website group (n = 30; active comparator group).

The T2 assessment phase will begin at 3-months post-baseline. The FOCUS-EC Program is an 8-week program, so families should have completed the program by 3 months post-baseline. In the event that a family that was randomized to the FOCUS-EC Program group has not completed the program by the 3-month mark, the T2 assessment will be initiated once the program has been completed (up to 6 months post-baseline).

Eligibility Criteria:
Inclusion Criteria:

* Parent/caregiver (must be legal guardian) of a 3- to 6-year-old child
* Child must cohabitate with the parent/caregiver
* Parent/caregiver participant must have experienced some form of interpersonal trauma during their own childhood (e.g., abuse, neglect, witnessing domestic violence)
* Parent/caregiver must be English-speaking
* Parent/caregiver must have access to internet and Webcam

Exclusion Criteria:

* Does not meet inclusion criteria
* Parent/legal guardian does not want the child to participate in the study
* Significant neurological disorder (included in pre-screening protocol)
* Active psychosis/mania (as assessed by staff)
* Significant child developmental delays (as assessed by staff)

Families excluded from the study will be provided with a list of online and/or community resources.
IUD Insertion During Cesarean Section

Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant woman aged between 18 to 40 years old.
2. Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
3. Body mass index between 19-30 kg/m2
4. Seeking contraception after delivery.

Exclusion Criteria:

1. History of menorrhagia or severe dysmenorrhea.
2. History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
3. Patients who have bleeding disorders.
4. Anemia (Hb \< 9 g %).
5. Chronic depilating diseases reducing immunity such as Diabetes.
6. Structural uterine anomaly or large uterine fibroids distorting anatomy.
7. History of previous IUD expulsion or removal for complications.
8. Unexplained uterine bleeding.
9. Copper allergy or Wilson disease.
10. Gestational trophoblastic disease with persistently elevated Beta HCG.
11. Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
12. Complications during cesarean section e.g. postpartum hemorrhage.
13. Cesarean section during placenta previa.
The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

The goal of this interventional study is to evaluate the efficacy of probiotics with prebiotics on overweight.

200 eligible participants with overweight will be enrolled and randomized to consume four study products for 3 months.

Reseachers will compare the four groups to evaluate whether there is significant improvement on overweight for participants in the study product of probiotics with prebiotics.

This study is a multi-center, four arms, randomized, double-blind controlled trial. 200 Eligible participants of 25 to 45 years old with overweight will be randomized in four equal size groups to receive one of the four products of probiotics with and without prebiotics and consume one bottle once in a day for 3 months. All participants will visit the study site for 3 times, once a month, all relevant clinical data will be captured, and recorded in to CTMS (Clinical Trial Management System). Data will be analyzed and reported after the completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Chinese males or females, age between 25-45;
* Overweight population: BMI 24-27.9;
* Blood lipids in high potential risks but without medication; TG \> 5mol/L, LDL \>= 3.4 mmol/L, TC \>= 5.2 mmol/L.
* Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
* Agree to avoid medication treatment for weight management, including blood lipids and sugar control.

Exclusion Criteria:

* Have used any medication for weight management at least one month before this study.
* Subject having done plastic surgery for weight management.
* Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
* Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
* Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease.
* Have a history of any disease or the presence of health condition on the study sites that the Investigator feels would interfere with the study.
* Be taking antihistamines (\> 3x/week) or anti-inflammatory (\> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrollment.
* Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, pregnancy, lactation and hepatitis.
* Have any cuts/abrasions on the test site at baseline.
* The subject is an employee of sponsor or the site conducting the study.
Non Surgical Management for Uterine Residua After Pregnancy Termination, Abortion or Delivery

The aim of the study is to find out whether conservative treatment - expectant management or medical therapy using misoprostol is beneficial in the case of uterine residua, and which treatment is better.

Retained products of conception are estimated to occur after approximately 1-6% of pregnancies, probably more often after termination of early pregnancies then after term pregnancy. Complication are abdominal pain, infection, bleeding and for the long term - intrauterine adhesions.Blood clots in the uterine cavity can cause similar complications. The definitive treatment is curettage or hysteroscopy, both of which are carried out under general anesthesia and require an operating theater. Although expectant management and uterotonic drugs are practically used in such situation, they are not described in the literature.This study compare between the outcome of misoprostol treatment and expectant management in the case of intrauterine residua after completion of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* women with sonographic examination reveals suspicion of intra-uterine residua after completion of pregnancy
* intrauterine cavity, including endometrium, will be at least 15mm

Exclusion Criteria:

* the need for emergency surgical treatment (curettage)
* fever - at least 38 celsius degree
* women who had medical termination of pregnancy and the examination is after less then 2 weeks since treatment
Psychological Treatments for Scleroderma

This study will examine the effectiveness of two psychological treatment approaches designed to help people who have scleroderma with three important areas of daily living: pain, depression, and distress about changes in appearance. The study will also evaluate the impact of depression on the two psychological treatments. Because psychological approaches requiring a trained professional can be expensive and are often not available to most patients, this study will also look at the effectiveness of a self-help treatment approach.

This study will examine the efficacy of psychological interventions designed to target important areas of daily living for people with scleroderma: pain, depression, and distress about disfigurement. The study will also examine the effect of clinical depression on impact of the psychological treatments. Because psychological interventions requiring a trained professional can be costly and are often not available to the majority of patients, the study will also examine the efficacy of a self-help intervention.

The study will recruit 201 patients with systemic sclerosis who report symptoms of pain, depression, or distress about disfigurement and will randomly assign them to one of three interventions: individual cognitive behavioral therapy, self-help cognitive behavioral intervention facilitated by a psychologist, or a disease/health education intervention. An individual blinded to intervention assignment will collect measures of pain, functioning, distress about disfigurement, and mood at baseline and following the 8-week intervention period.

Both the cognitive-behavioral self-help materials and the educational materials (eight written chapters and audiotapes) will be designed for home use but will be supplemented by two individual sessions and two telephone contacts with the professional. Patients will be followed for 1 year after completing the active intervention phase.

These findings will increase understanding of the quality of life of individuals with scleroderma and determine whether self-help interventions can be used effectively to manage pain, depression, and distress about disfigurement.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CREST or systemic sclerosis
* Short-Form McGill Pain Questionnaire score 6 or higher
* Satisfaction with Appearance score of 15 or higher
* Beck Depression score of 10 or higher

Exclusion Criteria:

* Patients reporting severe depression with suicidal ideation
* Delirium, dementia, or cognitive impairment (Mini Mental State Examination (MMSE) \< 24))
* Terminal illness with a life expectancy of less than 1 year
An Internet-based Weight Loss and Exercise Intervention for Breast Cancer Survivors

The purpose of this study is to test the effectiveness of a behavioral weight loss and exercise intervention delivered via the internet at different cancer centers in New England. The investigators hypothesize that participants will lose 7% of their body weight. The research is being done because many women who are treated for breast cancer are overweight and treatment for breast cancer is often accompanied by weight gain. Individuals who are overweight may be more likely to have their breast cancer come back. Also women who exercise at least three hours a week seem to have less chance of their cancer coming back. The investigators hope to identify an effective weight loss and exercise intervention for breast cancer survivors that can be easily accessed by many people.

This study is designed to determine the feasibility of conducting a distantly delivered-weight loss and exercise intervention for patients who have been treated for breast cancer at three cancer centers, and to evaluate the efficacy of an Internet-based behavioral weight loss and exercise intervention delivered to overweight/obese breast cancer survivors in three New England locations.

Participants will be recruited from three New England Cancer Centers - the Vermont Cancer Center, Norris Cotton Cancer Center at Dartmouth University and the University of Massachusetts Cancer Center. Participants from each center will undergo baseline assessments that include diet assessment, body measurements (height, weight, etc), a physical activity assessment and be asked to complete a series of questionnaires.

Patients that meet the minimum requirements will be enrolled on the study. They will participate in weekly on-line "chats" about behavioral and diet modifications led by a qualified facilitator. Participants will also engage in increasing amounts of aerobic activity (typically walking) throughout the course of the intervention. The intervention lasts 6 months. At the end of those 6 months, participants will have the same assessments that were collected at baseline. Following the collection of those assessments, participants will have completed the study.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer diagnosis
* Completion of surgery, chemotherapy +/- radiation for stage I, II, or III breast cancer 2-12 months prior to study initiation
* BMI between 27 and 50
* patient self-report of ability to walk for 10 minutes without interruption or pain
* access to computer and the internet

Exclusion Criteria:

* metastatic disease
* prior receipt of chemotherapy for other malignancy
* pregnancy at the time of study entry
* limited food choices due to celiac sprue or inflammatory bowel disease
* illiteracy
* non-English speaking