cyrilzakka/clinical-trials huggingface dataset:
Epidemiology of Coronary Heart Disease in Men Aged 40 and Over

To examine whether the prevalence of subclinical coronary and aortic atherosclerotic disease is different among Japanese in Japan, Japanese in Hawaii, and black and white Americans.

BACKGROUND:

Substantial change toward a more Westernized lifestyle has taken place among younger individuals who were born after World War II (WWII) in non-Western countries including Japan. Data from national sample surveys in Japan clearly demonstrate that risk factor profiles for coronary heart disease (CHD) are very similar to those in the United States (US) in this post WWII cohort. Men in Japan do have a considerably higher prevalence of cigarette smoking and men in the US have a higher prevalence of obesity. CHD mortality among men in Japan is, however, still less than a half of that in the US. Careful review of mortality statistics confirms this. This difference remains unique among industrialized countries.

DESIGN NARRATIVE:

The study is a collaboration between Dr. Akira Sekikawa at the University of Pittsburgh and Dr. J. David Curb of the Pacific Health Research Institute in Honolulu, Hawaii. The study tests the null hypothesis that there are no differences in the extent of atherosclerosis among Japanese men in Japan, Japanese American men in Hawaii, and US white and black men in this post WWII birth cohort. The project is based on recent and ongoing successful Japan/US collaborations in the INTERMAP, INTERLIPID and Honolulu Heart Program studies including development of the first standardized US/Japan diet tables. The investigators will examine 300 white men and 100 black men aged 40-49, randomly selected from Allegheny County, PA, 300 Japanese American men aged 40-49 from the population-based sample recruited from the offspring of the members of the Honolulu Heart Program cohort, and 300 Japanese men aged 40-49, randomly selected from Kusatsu City, Japan. The Japanese recruitment and examination has already been supported in Japan. The extent of atherosclerosis and risk factor profiles for CHD will be evaluated and compared, as well as the relationship of specific risk factors to the measures of atherosclerosis. The measures of subclinical disease proposed include calcium scores of coronary artery and aorta measured by electron beam computed tomography (EBCT) and carotid intima thickness measured by ultrasound. Other proposed measures include dietary intake by food frequency questionnaire, total cholesterol, LDLc, HDLc, lipids by NMR spectroscopy, blood pressure, cigarette smoking, thiocyanate, omega-3 fatty acid, alcohol consumption, body mass index (BMI), intra-abdominal fat, and others.

Eligibility Criteria:
Inclusion:

- Men aged 40-49 at the time of enrollment

Exclusion:

-Individuals with clinical cardiovascular disease (coronary heart disease, stroke), and other severe disease
Treatment of Thoracic Outlet Syndrome (TOS) With Botox

The purpose of this study is:

1. To assess the effect of BOTOX injection to the scalene muscles on the severity of pain from TOS.
2. To assess the effect of BOTOX injection on numbness and tingling and quality of life.

Background:

Thoracic Outlet Syndrome (TOS) is a symptom complex consisting of pain, paresthesias and often functional impairment caused by compression of the neurovascular supply to the upper limb. Impingement may occur at the interscalene triangle, and both anesthetic blockade and chemodenervation of the scalene muscles have been shown to temporarily improve symptoms of TOS in non-randomized controlled trials.

Objective:

To assess the effect of Botulinum Toxin Type A (BTX-A) injections into the scalene muscles on pain, paresthesias and function in subjects with TOS.

Hypothesis:

BTX-A injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with TOS. This will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo.

Intervention:

Each subject will receive an injection under EMG guidance into the anterior and middle scalene muscles of either 75 units of BTX-A (experimental group), or normal saline (control group). Both groups will be provided with a stretching and strengthening exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 19 years
* Medically stable
* Able to give informed consent
* Meets criteria for clinical diagnosis of TOS
* Symptoms of TOS present for at least six months
* Have had EMG studies and a CT or MRI scan of the cervical spine

Exclusion Criteria:

* Prior treatment with BTX-A
* Allergy to BTX-A
* History of botulinum toxicity
* Prior scalenectomy
* Surgery for TOS planned within six months
* Use of blood thinners, i.e., warfarin; unfractionated or low molecular weight heparin
* History of Myasthenia Gravis, Eaton-Lambert Syndrome or Shy-Drager Syndrome
* Unable to complete follow-up assessments at 6 weeks, 3 months and 6 months
* Any abnormalities on EMG, CT or MRI studies suggesting an alternate diagnosis
* Pregnancy or planned pregnancy within six months
The McGill RAAS-COVID-19 Trial

Coronavirus disease (COVID-19) related pneumonia significantly impact patients with underlying cardiovascular (CV) conditions. Animal studies suggest that drugs commonly used to treated CV diseases may increase the ability of COVID-19 to infect cells. The RAAS-COVID-19 trial aims to assess whether temporarily holding these CV drugs in patients who are admitted with COVID-19, versus continuing them, in patients admitted with COVID-19 can impact short term outcomes.

Open-label, pragmatic, randomized, study of approximately 40 adults. The following groups of participants will be considered: i) within 48 hours of diagnosis of COVID-19; ii) who have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site (Royal Victoria Hospital, Montreal General Hospital, and Jewish General Hospital \[all in Montreal, Quebec, Canada\]). Participants will be randomized 1:1 to an upfront temporary discontinuation) of RAAS inhibition for the duration of the hospitalization (and to consider re-initiate after day 7 of admission or on discharge) versus a strategy continuation of RAAS inhibition. Re-initiation of held RAAS inhibition will be based on treating team's clinical judgement. The RAAS-COVID-19 RCT will evaluate whether an upfront strategy of temporary discontinuation of RAAS inhibition compared to the continuation of RAAS inhibition among patients admitted with established COVID-19 infection and on chronic RAAS inhibition therapy impacts short term clinical outcomes and biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Hospitalization with a Covid-19 infection
* Chronically treated with RAAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month
* Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample
* Participants are within 48 hours of diagnosis of COVID-19 or have received a diagnosis of COVID-19 from another facility and are within 48 hours of transfer to a study recruitment site

Exclusion Criteria:

* Shock requiring vasoactive agents.
* Requiring invasive mechanical ventilation.
* History of malignant hypertension
* Use of five or more antihypertensive drugs.
* History of heart failure with reduced ejection fraction
* History of hospitalization for acute heart failure in past 3 months
* History of hospitalization for hemorrhagic stroke in the past 3 months.
* History of CKD with an eGFR \<45 ml/min/1.73m2
* History of COPD GOLD III/IV
* History of end-stage dementia
* History of active liver cirrhosis
* RAAS blockers therapy previously stopped \> 48h.
* Anticipated discharge in less than 24 hours.
* History of current active cancer receiving chemotherapy
* Inability to obtain informed consent.
Single-port Versus Multi-port Robotic Surgery for Rectal Cancer

Single-port versus multi-port robotic surgery for rectal cancer

This study is a phase 2a clinical trial based on the IDEAL framework, which aims to evaluate the safety and short-term clinical efficacy of single-port robotic total mesorectal excision by comparing it with multi-port robotic total mesorectal excision. The primary endpoint is short-term clinical efficacy, including intraoperative complications, blood loss, conversion rate, operation time, postoperative complications within 30 days, time to first flatus after surgery, and postoperative hospital stay. Secondary endpoints include incision length, visual analog scale (VAS) scores for postoperative pain on days 1-3, completeness of mesorectal excision grading, positive circumferential resection margin rate, positive distal resection margin rate, and the number of harvested lymph nodes.

Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer with the lower tumor margin less than 15 centimeters from the anal verge (defined by MRI);
* Histological biopsy confirms adenocarcinoma of the rectum;
* Stage I-III (assessed by MRI and abdominal CT), including downstaging after neoadjuvant therapy;
* Intends to perform anal sphincter-preserving surgery and plans for primary anastomosis;
* Informed consent has been obtained from the patient and family;
* Age greater than 18 years old.

Exclusion Criteria:

* Previous rectal resection (excluding local excision);
* Emergency surgery due to complications from rectal tumors;
* Pregnancy;
* Signs of acute intestinal obstruction;
* Multifocal colorectal tumors requiring multisegment bowel resection;
* Familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active Crohn's disease, or active ulcerative colitis;
* Planned synchronous resection of abdominal organs;
* History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
* Absolute contraindications to general anesthesia or prolonged abdominal insufflation, such as severe cardiovascular or respiratory diseases (ASA classification \>III);
* Preoperative MRI suggests tumor invasion of the levator ani muscle or external anal sphincter, and preoperative assessment indicates inability to achieve curative resection or the need for abdominoperineal resection;
* Clinical or radiological evidence of distant metastasis of rectal cancer;
* Unsuitable for robotic surgery;
* Local excision of tumor;
* Anal cancer.
EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair

Phase 4 study evaluating the effectiveness of EXPAREL when infiltrated into the the Transversus Abdominis Plane (TAP).

This is a prospective, open-label, non-randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL to infiltrate into the TAP unilaterally.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, aged 18-75 years inclusive, and ASA physical status 1-3.
* Undergoing open repair of a unilateral abdominal hernia below the level of the umbilicus.
* Abdominal incision length of 3-12 cm.
* Subjects must be physically and mentally able to participate in the study and complete all study assessments.
* Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.

Exclusion Criteria:

* History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
* Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP infiltration.
* Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
* Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
* Any female subject who is currently pregnant.
* Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
Effects of Instrument Assisted Soft Tissue Mobilization on Healthy Tissue Regarding Range of Motion and Gait

The goal of this clinical trial is to study the effects of instrument assisted soft tissue mobilization (IASTM) in healthy tissue of adult volunteers. The main questions it aims to answer are:

* Does IASTM treatment have an effect on range of motion (ROM) as measured in the ankle and knee?
* Does IASTM treatment have an effect on movement patterns including gait - how a person walks? Researchers will compare pre-test and post-test data from the same individual on their day with treatment to the pre-test and post-test data from the same individual on their day without treatment to see if ROM or gait are effected by use of IASTM.

Participants will:

* Complete a past medical and injury history questionnaire
* Have ankle and knee range of motion (ROM) measurements taken on both lower extremities using a goniometer
* Undergo a gait analysis to determine center of gravity, center of pressure, step length, stride length, and stride frequency using Noraxon MyoMuscle Ultium Insoles
* Undergo IASTM treatment techniques using the HawkGrips tools including applying emollient to the skin to reduce friction on the surface followed by scanning the gastroc/soleus complexes and Achilles tendons using the HG8-Scanner tool for 15 strokes in each direction to identify areas of concern, then the concave tool corresponding to the size of the structure being treated will be used (HG6-Large Multi-Curve, HG5-Medium Multi-Curve, HG4-Small Multi-Curve) for 15 strokes in each direction. Treatment techniques should last for 10 minutes in total on each side.
* Complete the ankle and knee ROM measurements as well as gait analysis again to document progress at the end of the first session.
* Return three to seven days after the first session in which the subject will have the walking treatment.
* Undergo the same baseline pre-test measurements for range of motion and gait analysis as the first session
* Experience the walking treatment by walking for the same time period that the IASTM treatment took at the first session
* Undergo the post-test range of motion and gait analysis for data comparison.

No further information to note than what is described in the summary or elsewhere

Eligibility Criteria:
Inclusion Criteria:

* Individuals from a small regional university student body, faculty and staff may choose to volunteer to participate in this study.

Exclusion Criteria:

* Acute spinal cord injury with neurological deficits
* Neurological disorders
* Acute lower extremity injury such as sprain or strain
* Acute lower extremity pain causing gait deviation
* Any type of lower extremity fracture within the past 12 months
* Lumbar disc pathology with radicular symptoms
* Use of blood thinning or clotting medications
* Known connective tissue disorder
the Effects of GnRHa Add up to Routine Luteal Phase Support on Frozen Embryo Implantation in Frozen Embryo Transfer .

The aim of the present prospective randomized controlled study was to determine the effects of GnRHa add up to routine luteal phase support on frozen embryo implantation in frozen embryo transfer (FET).

Some recent data have suggested a beneficial effect of GnRHa administered in the luteal phase on the outcome of assisted reproduction techniques. In those studies, the dose and administration time of GnRHa are inconsistent. Single administration on third day after embryo transfer and multiple dose injection during luteal phase are the most common way. The GnRHa included Triptorelin 0.1mg, Leuprorelin 1mg and Buserelin 600ug et al. The exact underlying mechanism is still not clear, although it has been hypothesized that GnRH agonist either supports the corpus luteum function by inducing LH secretion by the pituitary gonadotrophin cells or stimulates the endometrium GnRH receptors . Tesarik et al.postulated a direct effect of GnRH agonist on the embryo, evidenced by increased β-HCG secretion.

Currently, available data suggest that inadvertent administration of a GnRH agonist during a conception cycle is not accompanied by an increased risk of birth defects. On the basis of the currently strong available evidence, it appears that GnRH agonist supplementation during luteal phase significantly improve the outcome of ART treatment. Most of the former researches focused only on fresh embryo transfer in IVF/ICSI cycles. In one prospective controlled study, a single dose of Triptorelin 0.1mg was administrated 6 days after ICSI in oocyte donor cycles and the implantation rate was improved significantly.GnRH agonist administration at the time of implantation enhances embryo developmental potential, probably by a direct effect on the embryo.

Eligibility Criteria:
Inclusion Criteria:

* infertile women with frozen thawed embryo transfer after HRT endometrial preparation.
* more than 20 years old, and less than 37 years old.
* BMI less than 28kg/m2.
* more than 1 transplantable embryo after thawing.
* patients should sign the informed consent and have the willing to follow up.

Exclusion Criteria:

* uterine malformation
* diameter of intramural myoma more than 3cm
* the thickness of endometrium less than 7mm on the progesterone supportive day.
Magnesium Supplementation and Blood Pressure Reduction

This double-blind, placebo-controlled randomized clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure.

This double-blind, placebo-controlled randomized clinical trial will test whether a magnesium glycinate supplement (480 mg/day) taken for 12 weeks lowers blood pressure in 60 adults aged 30-74 who have elevated blood pressure or stage 1 hypertension and are not taking anti-hypertensive medication. Animal studies, epidemiologic studies, and small randomized trials suggest that supplemental Mg may reduce blood pressure, but the evidence is not definitive.

Eligibility to participate in the trial will be determined by a 2-stage screening process -- completion of a pre-screening form online followed by an in-person screening clinic visit. Eligible participants will assigned by chance (like a coin toss) to daily magnesium or to placebo and will receive a supply of study capsules via U.S. mail. Participants will take 4 study capsules per day (2 capsules in the morning and 2 capsules in the evening).

Assessments at the screening visit include seated blood pressure; 24-hour ambulatory blood pressure (monitor will be worn by the participant for 24 hours and then returned via mail); pulse; weight, height, waist and hip circumference measurements; fasting blood and urine collection; and health and diet questionnaires. Participants will return for clinic visits at 6 weeks and at 12 weeks to assess these measures, including 24-hour ambulatory blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of systolic blood pressure 120-139 mmHg or diastolic blood pressure 80-89 mmHg at prescreening
* Measured seated systolic blood pressure 120-149 mmHg or measured seated diastolic blood pressure 80-94 mmHg at screening visit
* Body mass index less than 40 kg/m2
* Total Mg intake from supplements of no more than 100 mg/day
* Willing to maintain current diet and supplement use patterns during the intervention period

Exclusion Criteria:

* History of antihypertensive use
* History of cardiovascular disease (myocardial infarction, stroke, revascularization \[coronary artery bypass graft or percutaneous transluminal coronary angioplasty\], or angina pectoris)
* History of invasive cancer diagnosed within the last 5 years (non-melanoma skin cancer permitted)
* History of type 1 or 2 diabetes
* History of renal disease
* History of kidney failure
* History of dialysis
* History of pancreatitis
* History of inflammatory bowel disease
* History of hypermagnesemia
* Women who are pregnant, nursing, or intend to become pregnant during the treatment period
* Plan to relocate out of Boston area within the next year
* Unwillingness and/or inability to swallow 4 pills per day
* Inability to provide written informed consent
* Excessive antacid or laxative use within the past 3 months
Specific Oral Tolerance Induction to Cow's Milk Allergy

Background: Limited published evidence shows specific oral tolerance induction (SOTI) to be a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization from evolving towards persistent allergy. The aim of this study was to evaluate the safety and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment alternative to elimination diet.

Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs were included in this multicenter study and were randomly divided into two different groups. Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30 (group B: control group) were kept on a milk-free diet and followed-up on for one year.


Eligibility Criteria:
Inclusion Criteria:

1. -Infants between 24-36 months of age.
2. -IgE-mediated allergy to CMPs meeting all the following diagnostic criteria:

   * Immediate-type clinical manifestations, skin (urticaria, angioedema and/or erythema), digestive (acute vomiting and/or diarrhea) or respiratory (bronchospasm and/or rhinitis) involvement in the first two hours after cow's milk ingestion.
   * Skin test readings ≥ 3 mm and specific IgE titers \> 0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
3. -Persistence of CMP allergy in the four weeks prior to tolerance induction, based on the following criteria:

   * Skin (prick) test readings ≥3 mm and specific IgE titers (CAP-FEIA) \>0.35 kU/l for whole cow's milk or someone of isolated CMPs (casein, alpha-lactalbumin, beta-lactoglobulin )
   * Double-blind placebo-controlled challenge (DBPCFC) positive to cow's milk.
4. -Written informed consent from the parents.

Exclusion Criteria:

1. -Clinical manifestations of anaphylactic shock after the ingestion of cow's milk.
2. -Non-IgE-mediated or non-immunological adverse reactions to cow's milk.
3. -Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
4. -Patients receiving immunosuppressor therapy.
5. -Patients receiving beta-blockers (including topical formulations).
6. -Associated diseases contraindicating the use of adrenalin: cardiovascular disease or severe hypertension