cyrilzakka/clinical-trials huggingface dataset:
TMS for Post Stroke Depression

The purpose of this study is to find alternative treatments for patient's suffering from depression after having a stroke.This study aims to show that accelerated rTMS is a safe, effective,and convenient treatment for patient's suffering from post-stroke depression in the acute to subacute phase. This will be an open label trial and thus all participants will receive the active rTMS intervention.

The primary objectives of this project are as follows:

1. To assess the efficacy TMS in PSD. We hypothesize that there will be a decrease in the HAMD score in patients receiving TMS
2. To assess the feasibility of an accelerated protocol using rTMS in patients with acute to subacute stroke and co-existing PSD. We hypothesize that the accelerated protocol will promote compliance in our patient population and that the administration of this intervention is feasible.
3. To assess the safety of rTMS in patients with acute to subacute stroke. We hypothesize that the side effects of TMS will be minimal and the therapy will be well-tolerated and safe in individuals with recent strokes and co-existing PSD.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 22-85 years old
* Radiographic evidence of acute or subacute stroke
* Ischemic stroke diagnosed within the last 2 weeks to 6 months
* HAMD depression score 8 or greater
* Able to provide written informed consent
* Agree to participate in all study procedures

Exclusion Criteria:

* Metallic objects or neurostimulators implanted intracranially
* Stroke in the area of stimulation
* Current thoughts of SI or self-harm as assessed by the M.I.N.I. Suicide Scale score \> 8
* ASRM (Altman Self Rating Mania Scale) score \> 6 (6 or above indicates likelihood of manic symptoms)
* Current use of illicit substances
* Known history of epilepsy or seizure disorder
* Clinically significant EKG abnormalities including QTC prolongation \>450 ms in men or \>480 ms in women
Alleviating Effects Against High Intraocular Pressure by Oral Intake of Cordyceps Cicadae Mycelia

This study will investigate the effects of lowering intraocular pressure by oral intake of Cordyceps cicadae mycelia, to provide evidence-based data for high intraocular pressure relief.

Study purpose This study investigated the effeicacy of oral Cordyceps cicadae mycelia for the relief of high intraocular pressure.

Subjects

1. The total recruitment of subjects is 60 people, aged between 20 to 75 years.
2. Subjects with intraocular pressure more than or equal to 21 mmHg are included, irrespective of whether on us of Taflotan (saflutan).

Methods

1. Informed consents will be obtained from subjects first. The subjects with pre-test intraocular pressure over or equal 21 mm Hg are advised to orally take two capsules containing a total of 500 mg of Cordyceps cicadae mycelia. After 90 minutes, the subjects are evaluated for intraocular pressure.

The pre-test and and post-intake intraocualr pressure and blood pressure data will be compared by paired t test for significant differences if any.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 and 75 years old, regardless of gender.
2. Pre-test confirmation of high intraocular pressure.
3. Subjects should understand the trial and agree to join the project.

Exclusion Criteria:

1. Age under 20 or over 75 years.
2. Use intraocular pressure lowering drugs other than Taflotan (saflutan).
3. Using beta-blockers or diuretics.
4. Being pregnant.
5. Disabled individuals with specific diseases or malfunction, for example tumours at terminal stage, blindness.
6. Loss of self-consciousness and behavioral capacity.
7. Patients with major diseases.

Withdrawal criteria All subjects may withdraw at any time without any reason. The act of withdraw does not affect rights for them to seek medical advice or treatments.
Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost

The purpose of the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.

The randomization is between 50 Gy / 25 fractions and 40 Gy/15 fractions, 5 fractions weekly. In patients treated with boost 2 dose levels are accepted: 16 Gy/8 fractions and 10 Gy/5 fractions. These boost treatments will be provided as simultaneous integrated boost, where the overall treatment time in general is shortened 5 days. Thus the dose levels for boost patients are:

63 Gy / 51.52 Gy / 28 fractions, 57 Gy / 50 Gy / 25 fractions, 52.2 Gy / 42.3 Gy / 18 fractions, and 45.75 Gy / 40 Gy / 15 fractions.

The primary endpoint is arm lymphedema 3 years after radiation therapy, but other late radiation morbidities will also be evaluated along with recurrence and sites of recurrence. Follow up of morbidity will continue for 10 years.

The hypothesis is that women operated for early breast cancer with indication for loco-regional radiation therapy can be offered moderately hypofractionated therapy without developing more late radiation induced morbidity compared to normofractionated radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

Operated for early node-positive breast cancer with indication for loco-regional breast radiotherapy

Exclusion Criteria:

Previous radiotherapy to chest wall, pregnant/lactating, comorbidity which may hinder 10 years follow up
Prevention of Myopia of Prematurity by Calcium Supplementation

The purpose of this study is to determine if supplementation of calcium by the enteral route (gut feeding) to extremely low birth weight infants will lead to less myopia (nearsightedness) at 6-12 months postnatal age.

Secondly, the study will determine if calcium supplementation is well tolerated, if it reduces the molding of these premature infants' heads, and if it decreases myopia at the 18-22 month postnatal age visit.

All infants admitted meeting the 401-1000gm birthweight and less than 14 day of age entry criteria will be screened for entry into the study. Infants may be excluded for the following: Major congenital malformations, including complex congenital heart disease (except open ductus arteriosus, atrial and ventricular septal defects), pulmonary malformations, bowel or anal stenosis or atresia, renal dysplasias, chromosomal anomalies, hydrops fetalis, bowel perforation or necrotizing enterocolitis stage 2A or greater before randomization.

Written informed consent of one parent or legal guardian must be obtained. The infants are randomized to receive unsupplemented feedings of breast milk or formula, or feedings supplemented with Ca-gluconate as outlined below.

Randomization will be stratified into the following groups: 401-750 g and 751-1000 g and performed according to a balanced block scheme with variable block size (2-6) using sealed opaque envelopes.

Total parenteral nutrition is given by nursery unit standards. Infant positioning is done by nursery unit standards.

Feeding mixtures:

Supplementation is started when enteral feeding amounts to 100 ml/kg. At that time, fortification is also introduced in infants receiving breast milk. Fortified human milk or 24 cal/oz formula, e.g. Similac Special Care 24 (SSC24), is used in all participating infants. Human milk is fortified with 1 pk Enfamil human milk fortifier per 25 ml (BMHMF).

Control group: Fortified human milk or 24 cal/oz formula. Supplemented group: Ca-gluconate powder (molar weight 430.4 g) will be measured with household measuring spoons (e.g. Rubbermaid (R)) and added to the feeding mixtures.

One eye exam will be performed at 6-12 months during routine follow-up visit. A second eye exam will be performed at 18-2 months during a follow-up visit which is part of the NICHD newborn follow-up clinic. Head measurements, specifically, front-to-back and side-to-side will be measured at randomization, 36 weeks postmenstrual age or discharge, whichever occurs first, and during the follow up visits. Urinalysis will be collected weekly.

Eligibility Criteria:
Inclusion Criteria:

* Infants with a birthweight of 401 - 1000 g and postnatal age less than 14 days

Exclusion Criteria:

* Major congenital malformations including

  * complex congenital heart disease (except open ductus arteriosus, atrial and ventricular septal defects)
  * pulmonary malformations
  * bowel or anal stenosis or atresia
  * renal dysplasias
  * chromosomal anomalies
  * hydrops fetalis
  * bowel perforation or necrotizing enterocolitis stage 2A or greater before randomization.
Dietary Lipids, Energy Expenditure and Obesity Biomarkers

The purpose of this study is to determine whether the modulation of dietary lipids are effective in the treatment of obesity and comorbidities.

Obesity is a complex disease of multifactorial etiology and difficult to control. Among lifestyle changes proposed to the treatment of this disease and comorbidities, there is the modulation of dietary lipid composition. This study aimed to evaluate the effects of the modulation of fatty acid (FA) polyunsaturated (PUFA) and monounsaturated (MUFA) in energy expenditure (EE), weight loss, body composition, lipid and glycemic profile, free fatty acids (FFA), glycerol, adiponectin, leptin, blood pressure (BP), feeding behavior and expression of PPARα and PPARγ2 genes in adipose tissue (AT) of obese women. It was conducted a parallel, randomized, controlled, single-blind study with dietary intervention (DI) for 60 days, where 32 women with obesity classes I and II were distributed into three groups: G1 = diet rich in n-3 PUFA and n-6 (n = 10); G2 = MUFA-rich diet (n = 11); and G3 = control (n = 11). For G1 and G2 were prescribed normocaloric diets with similar macronutrient composition, varying only the type of lipids offered. In order to achieve the desired intake of unsaturated FA, both groups received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner (G1 = mix of virgin olive oil \[VOO\] and soybean oil \[SO\], overall of 35.2g to 52.8g / day; G2 = VOO, overall of 35.2g to 50.6 g / day), besides gelatin capsules (G1 = 2 g of fish oil / day; G2 = 1 capsule of 1g of SO / day). G3 was instructed to keep their eating habits and consuming placebos (1 sachet of 2g of SO and 1 capsule of 1g of SO / day).

Eligibility Criteria:
Inclusion Criteria:

* obesity grades I and II (body mass index between 30 and 39,99 kg/m2);
* completion of basic education (former 4th primary series).

Exclusion Criteria:

* menopausal;
* weight loss more than three kilograms (3 kg) in the last three months;
* diagnosis of diabetes mellitus, heart disease, hypertension, nephropathy, liver diseases , thyroid dysfunction; gastrointestinal disorders , acquired immunodeficiency syndrome or cancer;
* cholecystectomy in the past 12 months and other recent surgeries;
* pregnancy or lactation;
* smokers;
* drugs to lipid-lowering, diabetes, hypertension, depression, or obesity;
* food history of allergy or intolerance to vegetable oils (olive oil, soy or canola), fish oil, fish and / or seafood.
Collaborative Quality Improvement (C-QIP) Study

The overarching goal of this study is to develop, implement, and evaluate the effect of a collaborative quality improvement (C-QIP) intervention (consisting of non-physician health workers, text messages for a healthy lifestyle, and a clinical decision support system) on processes of care and clinical outcomes among individuals with previous cardiovascular disease in India.

Specific objectives of this study are:

1. To describe current practices, context, challenges, and opportunities regarding chronic management of cardiovascular disease from the patient, caregiver, provider, and health administrator perspectives in India.
2. To assess the transferability of components of internationally successful multifaceted quality improvement strategies and chronic care models to the Indian healthcare context.
3. To conduct a pilot study to assess the acceptability, feasibility, and implementation fidelity of the C-QIP strategy among individuals with cardiovascular disease attending out-patient clinics in India.
4. Among individuals with cardiovascular disease, evaluate the effect of C-QIP strategy on processes of care and clinical outcomes, health-related quality of life, and costs at 1 year compared with usual care.

Eligibility Criteria:
Inclusion Criteria:

Participants should be:

* age ≥18 years, both sexes
* confirmed diagnosis of cardiovascular disease (ischemic heart disease, stroke, or heart failure irrespective of ejection fraction)
* able to provide written informed consent.

Exclusion Criteria:

* pregnant women
* those with any serious or uncontrolled medical condition (e.g., cancer) that may restrict the patient to come for follow-up.
Achieving Cardiovascular Health Equity in Community Mental Health: Optimizing Implementation Strategies

In this trial, the investigators will examine the uptake of the evidenced-based IDEAL Goals program, a heart disease risk reduction program, while testing different implementation strategies with our partners in Michigan and Maryland who serve persons with serious mental illness (SMI).

In this trial, the investigators will work with Michigan and Maryland mental health programs to improve the uptake of the 18-month heart disease risk reduction program, IDEAL Goals, to be delivered to persons with SMI enrolled in their behavioral health homes.

Eligibility Criteria:
Community Mental Health Program site staff participants:

Inclusion Criteria

1. Ages 18 and Older
2. English Speaking
3. Agree to complete applicable data collection
4. Agree to engage with the program according to their role (e.g., training, IDEAL Goals program delivery).
Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma

The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patient's tumor.

The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individual patient's tumor. The study is being conducted in Houston, Texas with patients enrolled into one of two treatment arms. The two treatment arms are either subcutaneous injection or intradermal injection, both with HSPPC-96. To be treated with HSPPC-96 patients must undergo surgery to remove the kidney tumor and a portion of this tissue will be sent to Antigenics' manufacturing facility for processing.

Eligibility Criteria:
Inclusion Criteria:

* Suspected metastatic renal cell carcinoma (AJCC Stage IV) with intact primary tumor
* No previous therapy for metastatic renal cell carcinoma
* Measurable disease (RECIST criteria)
* Primary tumor greater than or equal to 7cm on CT or MRI
* ECOG performance status 0-1
* At least 18 years old
* Life expectancy \> 3 months
* Adequate cardiac function (NYHA I-II)
* Not pregnant
* Provide written informed consent
* Absence of multiple liver metastases, brain or threatening bone metastases (axial skeleton and/or pathological features)
* Planned complete nephrectomy

Exclusion Criteria:

* History of primary or secondary immunodeficiency, or patients using systemic corticosteroids or cyclosporin A
* Other cancer (including renal cell carcinoma) within the last five years (with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin)
* Embolization of the renal artery prior to nephrectomy
* Active, uncontrolled infection or other serious medical illnesses, preventing study completion, in the opinion of the Principal Investigator
The Effects of Hesperidin and Flaxseed in Prediabetes

To study the effects of Hesperidin and flaxseed supplement in patients with prediabetes, 50 patients will be randomly allocated to control group or 2 capsules Hesperidin and 30 gram flaxseed for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, blood pressure, blood sugar, inflammatory and anthropometric factors will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 70 years prediabetes: impaired fasting glucose (\>100 mg/dL) and/or HbA1C 5.7% to 6.5%, and overweight or obese with body mass index range of 25 to 40 kg/m2

Exclusion Criteria:

* pregnancy or lactation
* A history of Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis
* Following program to lose weight in recent 3 mo
Nitrate Use to Obtain Radial Spasm Embarrassment (NURSE - TTS Trial)

Transradial cardiac catheterization and percutaneous coronary intervention are increasingly being performed worldwide in elective and emergency procedures, with many centres adopting the transradial route as their first choice of arterial access. One of the most common complications encountered during transradial procedures is radial artery spasm. The aim of this study is to evaluate the Efficacy and Safety of the use of transdermal Glyceryl trinitrate patches applied to skin before cardiac catheterization to prevent the occurrence of radial artery spasm during transradial access cardiac catheterization.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 -85 years old who has been admitted for scheduled coronary angiography by radial artery

Exclusion Criteria:

* Prior same radial artery catheterization
* Positive Allen test
* Severe Hypotension (SBP\<100 mmHg)
* Pregnancy
* Ongoing Acute Myocardial Infarction
* Ongoing cardiogenic shock
* Known History of Nitrates intolerance/allergy
The Effect of 6 Weeks Saturated and Polyunsaturated High-Fat Diets on Insulin Sensitivity and Health Parameters

The aim of the intervention is to gain insight into the long term effect of dietary fatty acid quality on insulin sensitivity and health parameters in healthy men.

Whole body and peripheral insulin sensitivity were measured, together with analyses of plasma hormones and metabolites. The plasma proteome was also analyzed. Molecular adaptations in skeletal muscle and adipose tissue were subject for investigation. Furthermore, gut microbiota population number and diversity will be analyzed from faeces samples obtained before and after the intervention.

Two experimental diets with a high fat content (65 E% fat), enriched in either saturated or polyunsaturated fatty acids, were provided for 6 weeks to healthy men, in a randomized controlled intervention study with two arms.

Healthy, untrained, non-obese male subjects (27-45 years) were included in the study. The experimental diets are eucaloric, and thus provided so the subjects remains weight stable.

Before and after the intervention, two experimental days was conducted (2 experiments before and 2 experiments after the intervention).

At pre-intervention, subjects completed a high-fat meal test and insulin sensitivity was measured by the hyperinsulinemic-euglycemic clamp. On both days, blood and tissue biopsies were obtained. These two experimental days were repeated at the end of the 6 weeks intervention.

The hyperinsulinemic-euglycemic clamp was combined with stable isotope infusion (deuterium labelled glucose) in order to measure hepatic glucose production. Before the clamp, a catheter is inserted into the femoral vein, to enable measurement of insulin stimulated glucose uptake across the leg. Biopsies are obtained by the needle biopsy method from the vastus lateralis muscle and peri-umbilical subcutaneous adipose tissue. Blood samples were analyzed for glucose, insulin, inflammatory markers, gut hormones, adipokines, plasma fatty acid composition, and lipoprotein profile. Indirect calorimetric was also applied to measure substrate oxidation during the experimental days.

Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects
* 27-45 years
* BMI 22-31
* maximal oxygen uptake \<48 ml/kg/min

Exclusion Criteria:

* smokers
* use of medication
* parents with type-2 diabetes
Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients

Hyperglycemia in the hospital is associated with multiple adverse outcomes. Previously, the mobile insulin scheme was used for its control. However, in the last decade, several studies have shown that the insulin basal-bolus (basal plus) regimen is associated with better glycemic control and a lower risk of hypoglycemia.

Introduction:

Hyperglycemia in the hospital is associated with multiple adverse outcomes. Previously, the mobile insulin scheme was used for its control. However, in the last decade, several studies have shown that the insulin basal-bolus (basal plus) regimen is associated with better glycemic control and a lower risk of hypoglycemia.

Objective:

To compare the sensitive scheme of Umpierrez and the correction factor suggested by Davidson (1700/total dose of insulin) for the correction of hyperglycemia in patients with type 1 diabetes mellitus.

Methods:

Unblinded, randomized, controlled clinical trial in patients with hyperglycemia and type 2 diabetes mellitus hospitalized at a hospital in Bogotá, Colombia, between 2016 and 2018. A probabilistic sampling with randomly permuted blocks was performed. The Umpierrez sensitive correction scheme and the Davidson correction factor were compared by evaluating glycemic control at 2 and 5 hours, and the presence of hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus who presented hyperglycemia (above 140 mg/dl) located in the general ward, emergency room or hospitalization and who received a basal or basal bolus insulin scheme.

Exclusion Criteria:

* pregnancy, with acute decompensation of diabetes (diabetic ketoacidosis-hyperosmolar state) or type 1 diabetes
Compliance With LDL-Lowering Therapy (Study P05467)(COMPLETED)

This observational study is being conducted in patients receiving statin treatment as secondary prevention of coronary heart disease under the current standard of care in compliance with European guidelines. The purpose of the study is to evaluate the percentage of these patients that reach target LDL levels. Additionally this study will measure the patient's compliance to treatment as assessed by counting the returned tablets. Both assessments will be made at visits conducted 6-8 weeks after the first visit and 28-32 weeks after the first visit.


Eligibility Criteria:
Inclusion Criteria:

* willingness to participate in the study
* 18 years of age or more
* clinically established cardiovascular disease to be considered as patients in secondary prevention
* prior therapy with any statin without achieving goal (2.5 mmol/L of LDL cholesterol) at last lipid check performed

Exclusion Criteria:

* None