cyrilzakka/clinical-trials huggingface dataset:
Proleukin and Rapamune in Type 1 Diabetes

This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. The study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes progression.

At the time of diagnosis with type 1 diabetes, 15-40% of beta cells may remain active and healthy in the pancreas, capable of producing insulin the body needs to regulate blood glucose levels. Because even small amounts of natural insulin production can decrease the long term effects of diabetes, it is essential that these cells are preserved.

This trial will test whether a combination of the drugs Proleukin (IL-2) and Rapamune (sirolimus) may be safely administered to recently diagnosed type 1 diabetes patients and whether it causes changes to the immune system that can halt the autoimmune destruction of the remaining beta cells. This drug combination has been found to be effective for long-term diabetes prevention in mouse models of type 1 diabetes.

This study is a phase I study for individuals 18-45 years of age who have been diagnosed with type 1 diabetes in the past 3-48 months. All participants will be treated with Proleukin (administered subcutaneously 3x per week) for 28 days and Rapamune (taken orally, daily) for 12 weeks. The study will last for 12 months, with additional follow-up of 24 months. The majority of study visits occur within the first 6 months. Mixed meal tolerance tests, in which participants take a milkshake-like drink and have blood sampled over a 2 or 4-hour period, will take place during an initial screening visit and three additional times during the first year. All participants will also receive intensive diabetes management designed to maintain stable blood glucose levels.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 1 diabetes (per ADA criteria) more than 3 but less than 48 months prior to enrollment;
* 18 to 45 years of age;and
* Positive for at least one islet cell autoantibody (GAD65-antibody, CA512-antibody and/or ICA).

Exclusion Criteria:

* Chronic use of glucocorticoids or other immunosuppressive ages 4 weeks before enrollment;
* History of recurrent infections, other autoimmune diseases, cardiac disease, cataracts or other chronic medical conditions that investigators believe could compromise participant safety;
* Females who are pregnant, lactating intend to get pregnant, or are unwilling to undergo pregnancy testing during the study;
* Males who intend to father a pregnancy during the first 6 months of the study; or
* Participation in another clinical study within the last 30 days.
Healthy Habits, Happy Homes: An Intervention to Improve Household Routines for Obesity Prevention

While childhood obesity rates may have plateaued in some US population subgroups, such as whites and those of higher socioeconomic status, overall rates of obesity remain high and racial/ethnic and socioeconomic disparities appear to be widening. Among the most promising approaches for childhood obesity prevention and management are interventions that begin early in life and that support change at the individual and community levels.

The goal of this project is to develop and test an intervention delivered to racial/ethnic minority and low income parents of 2-5 year old children in their homes, designed to promote adoption of household routines and parenting strategies that are preventive of obesity. To achieve this goal, the investigators will work with community health centers in Boston, Cambridge, and Somerville to recruit families to participate in an individual-level randomized controlled trial. The investigators partner community health centers include the Roxbury Comprehensive Community Health Center, Dimock Community Health Centers, and the Cambridge Health Alliance (CHA).

Participants will be randomized to receive either 1) mailed educational materials for the duration of the 6-month program (control), or 2) home-based health coaching visits and phone calls with a health educator, text messages, and educational materials promoting the adoption of household routines and target behaviors (intervention).

The investigators goal is to evaluate the feasibility and effectiveness of the investigators designed intervention (as compared to the control condition) using baseline and post-intervention data. In order to do so, the investigators will assess change from baseline to post-intervention in the investigators key behavioral outcomes of interest, including adoption of three household routines:

1. Regularly eating meals together as a family
2. Obtaining adequate sleep
3. Limiting screen-viewing time


Eligibility Criteria:
Inclusion Criteria:

* Parent with child between 2-5 years old
* Child has a TV in the room where s/he sleeps
* Parent is comfortable reading, writing and having conversations in English or Spanish
* Child was seen for a well-child care visit at one of collaborating community health centers in the last 90 days

Exclusion Criteria:

* Parent is not 18 years or older
* Family is planning to move from the Boston area in the net 6 months
* Child has a physical/mental health condition which requires chronic care
Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

The project is designed as a randomized controlled intervention trial in which 60 young trained (n = 30) (Population A) and recreationally active (n = 30) women (Population B) with regular menstruation are divided into four groups. Population A will receive a low-calorie diet + exercise or an energy balanced diet + exercise over 10 days. Population B will receive a low-calorie diet without exercise, or an energy balanced diet over 10 days. The participants are matched in pairs based on training history and randomized. Before the diet period, the groups will undergo a 6-day control period, during which all participants must take an energy-balanced diet (± training). After the 10 days of the diet intervention period, the groups will receive an energy-balanced diet for 2 days. Before, during, and after the trial period, participants will perform performance tests. In addition, 3 muscle biopsies, 2 adipose biopsies, blood samples, urine samples will be taken during the period, as well as resting metabolic rate, electrocardiogram, flow-mediated vasodilation, and body composition over the trial period. Muscle protein synthesis rate will be measured over the period using stable isotope technique, which includes ingestion of heavy water (D2O) and collection of saliva samples daily (days 0 to 16). The primary measurement parameter is changes in muscle protein synthesis rate.


Eligibility Criteria:
Inclusion Criteria:

* age 18-30
* BMI 18.5-30
* Regular training at least 4 times a week and a maximum of 10 times a week (≥1 times strength training, ≥1 times endurance training / interval training or interval-based sports

Exclusion Criteria:

* • Irregular menstruation within the last 6 months (shorter end 24 days or longer end 35 days cycle)

  * Used hormonal contraception within the last 3 months for the trial.
  * Injuries / pain in the lower body, which prevents participation in intense strength training
  * Medication consumption that may affect protein metabolism and inflammatory parameters.
  * Diabetes
  * Smoking
  * Unstable weight / major weight loss (weight fluctuations of more than 5 kg in the last six months)
  * Do not eat animal products
  * Eating disorder
  * Pregnancy
  * Blood donor within the last month
  * Cannot read or understand Danish
Mental Health, Gender-Based Violence, and Stunting in Tanzania

One in three children under the age of five in Tanzania experience stunting, which is defined as impairments in growth and development that often occur after poor nutrition, poor health, and low psychosocial stimulation. Research suggests that mental health problems of parents may be related to stunting outcomes and parental mental health is closely related to experiences of intimate partner violence, also called gender-based violence. However, very little research exists on the connection between these elements, and interventions may be necessary in order to reduce the impacts that mental health and gender-based violence may have on stunting.

This study is a secondary data analysis of de-identified survey and stunting data that were conducted as a part of a needs assessment by a local nonprofit organization in Tanzania. The needs assessment was conducted to inform a mental health initiative organized by the established nonprofit across 5 villages in rural Tanzania. This project's primary aims are:

* To determine the prevalence of mental health and family relationship problems in five villages
* To determine associations between intimate partner violence (IPV) mental health and substance use and childhood stunting


Eligibility Criteria:
Inclusion Criteria:

* Living within the 5 rural villages
* participating in a local nonprofit
* pregnant or having a child under 2 years old

Exclusion Criteria:

* Living outside of the 5 villages
* Not participating in the local nonprofit
* Not pregnant or having a child under 2 years old
Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of Primary Insomnia based on sleep history and the investigator's judgment
* Must be willing to stay overnight at a sleep laboratory
* Must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
* Regular bedtime is between 9 PM and 12 AM (midnight)

Exclusion Criteria:

* Breast feeding, pregnant or planning to become pregnant during the study
* Within the past 6 months before starting the study you have a history of significant cardiovascular disorder such as unstable angina, congestive heart - failure or acute coronary syndrome
* Currently participating or have participated in a study with an investigational compound or device within the last 30 days
* Has traveled across 3 or more time zones in the last 2 weeks or plans on traveling across 3 or more time zones at any time during the study
* Has done shift work within the past 2 weeks
* Has donated blood products within the last 8 weeks
* Has difficulty sleeping due to a medical condition
Efficacy of Mobilization With Post- Isometric Relaxation in Neck Pain Associated With Myofascial Trigger Points

purpose of the study: to determine the effectiveness of cervical mobilization with PIR in reducing pain and improving neck ROM and function in people with mechanical neck pain associated with MTrPs

This study will be based on a randomized controlled design which will be comparative in nature. Participants will be recruited using the convenience sampling method and will be randomly divided into two groups A and B respectively. Thirty participants of mechanical neck pain associated with upper Trapezius trigger point pain will be recruited from the Physiotherapy department, at the Najran University, Saudi Arabia. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly assigned into two equal groups A and B.

Group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and PIR technique while group B will receive the hot pack, active Stretching, isometric exercise intervention, and cervical Mobilization.

Eligibility Criteria:
Inclusion Criteria:

* age 20-40 years,
* having mechanical neck pain located in the neck or scapular regions along with 1-2 MTrPs which,
* on palpation replicated their chief complaints in the upper Trapezius muscle (unilateral).

Exclusion Criteria:

* known cases of fibromyalgia syndrome,
* cervical radiculopathy or myelopathy,
* history of cervical spine surgery,
* congenital or acquired postural deformity, presence of MTrPs in bilateral upper Trapezius muscles,
* patients who received any treatment for their pain one month prior to the study.
Priority-Matching Correction Technique in Degenerative Lumbar Scoliosis

Surgical outcomes, including radiographic outcomes, patient-reported outcomes, postoperative complications, and revision surgery rates, were compared in patients with degenerative lumbar scoliosis (DLS) who underwent correction surgery with reference to our priority-matching correction technique and the standard reported by Obeid and colleagues. Our findings may provide tangible guidance for surgical decision-making in DLS.


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of DLS based on radiography and previous medical record,
2. Age \&gt; 50 years

Exclusion Criteria:

1. Leg length discrepancy,
2. A history of spinal or pelvic surgery,
3. A history of neuromuscular diseases, arthritis or tumor.
Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide

The CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the subject compliance as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* essential hypertension
* under candesartan treatment

Exclusion Criteria:

-
Hyperinflammation and Hyperferritinemia in Critically Ill Patients

Analysing trajectory of critically ill patients with signs of hyperinflammation


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients
* admission between 01.01.2020 and 31.12.2024 (5yrs)

Exclusion Criteria:

* none
Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation

Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic heart failure
* functional MR 2+ - 4+
* LVEF 20% - 50%

Exclusion Criteria:

* MR of organic origins
* significant co-morbidities
Double Blinded, Randomized, Placebo-controlled Clinical Study for Nelumbinis Semen

Nelumbinis Semen, has been widely used as treatment of post-menopause symptoms in women for hundreds of years in many Asian countries. This study examines whether PM011, standardized herbal medicine made from Nelumbinis Semen, treats stress in above 5 of BDI score of human subjects and discusses its potential as treatment for depressed patients.

Nelumbinis Semen, has been widely used as treatment of post-menopause symptoms in women for hundreds of years in many Asian countries. This study examines whether PM011, standardized herbal medicine made from Nelumbinis Semen, treats stress in above 5 of BDI score of human subjects and discusses its potential as treatment for depressed patients. Subjects were divided into three groups, the placebo-treated group (n = 10), the PM011-2.4 g treated group (n = 11) and PM011-4.8 g treated group (n = 11) per day. Alpha/Beta ratio of electroencephalogram (EGG), Beck Depression Inventory (BDI) and Stress Response Inventory (SRI) were conducted in order to measure changes in stress before and after 2 weeks of PM011 treatment.

Eligibility Criteria:
\<Inclusion Criteria\>

* Volunteers were selected based on following meet conditions;Men and women, who have willingness and capacity to comply with the study protocol, are included if they were aged 18 to 65 years.
* Volunteers, who can understand Korean and English alphabet are selected.
* Volunteers, who can communicate with clinical trial performer fully, comply with the all tests and medical examinations performed by study protocol.
* All volunteers or their protectors understand purpose of study fully and sign their names or seal.
* Volunteers, who do not come under exclusion criteria are selected.
* BDI score of Volunteers, who can be \>= 5.

\<Exclusion Criteria\>

* Volunteers were excluded if they are applied to following meet conditions; Volunteers with fasting glucose level over 126 mg/dl.
* Volunteers with hypertension as having over 140 mmHg of systolic blood pressure or 90 mmHg of diastolic blood pressure.
* Volunteers with blood thyroid stimulating hormone below 0.3 or over 4.0.
* Men with hemoglobin below 13.0 g/dl and women with hemoglobin below 12.0 g/dl.
* Volunteers with abnormality of liver function as having over 1.5 times of normal levels of ALT or AST.
* Patients with infections in upper airways or chronic diseases.
* Mental illness patients with such as alcoholism.
Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure

Oocyte quality is a key limiting factor in female fertility which is primarily reflected in morphological features. Centrally located cytoplasm granulation (CLCG) is one type of cytoplasmic dimorphism exhibited by oocytes that could be linked to pesticide exposure with a significant risk of decreased ICSI outcomes.

This retrospective study included 633 women who were part of an intracytoplasmic spermatozoa injection (ICSI) program between 2009 and 2011. The participants lived in the Picardy region of France and had been exposed to pesticides. The participants were divided in two groups based on prevalence of oocytes with CLCG (LCLCG \[n= 83\]: low prevalence of oocytes with CLCG under 25%. HCLCG \[ n= 68\]: high prevalence of CLCG over 75%). The embryological and clinical outcomes were analysed for both groups and were calculated using the difference between the two values.

Oocyte quality is a key limiting factor in female fertility which is primarily reflected in morphological features. Centrally located cytoplasm granulation (CLCG) is one type of cytoplasmic dimorphism exhibited by oocytes that could be linked to pesticide exposure with a significant risk of decreased ICSI outcomes.

This retrospective study included 633 women who were part of an intracytoplasmic spermatozoa injection (ICSI) program between 2009 and 2011. The participants lived in the Picardy region of France and had been exposed to pesticides. The participants were divided in two groups based on prevalence of oocytes with CLCG (LCLCG \[n= 83\]: low prevalence of oocytes with CLCG under 25%. HCLCG \[ n= 68\]: high prevalence of CLCG over 75%). The embryological and clinical outcomes were analysed for both groups and were calculated using the difference between the two values. The included population in the investigator's retrospective study consisted of 633 couples who attended a reproductive medical center and who were part of an ICSI program between 2009 and 2011.

Eligibility Criteria:
Inclusion Criteria:

* couples who attendes a reproductive medical center
* couples that were part of a ICSI program between 2009 and 2011
* women were normo-responders
* female \> 18 years \<35 yeas old

Exclusion Criteria:

* female \< 18 years \> 35 yeas old
* couple with severe male infertility factors on oocyte activation and subsequent embryo development
Photobiomodulation Dosimetry s in Patients With Orofacial Pain

This project aims to validate a dosimetry model for photobiomodulation treatment in patients with orofacial pain and tension-type headache symptoms. The study will involve 240 participants divided into four age groups. Different treatment approaches will be applied, including local photobiomodulation and systemic laser therapy. Various physiological measurements will be taken before, during, and after the treatments, including skin type, weight, height, blood pressure, and heart rate. Additionally, data from questionnaires on pain and headache symptoms will be analyzed. Monte Carlo simulation will be employed to validate the model based on these measurements and light transmission. The research addresses the need for effective pain management strategies in cases where medication-based treatments may have unwanted side effects.


Eligibility Criteria:
Inclusion Criteria Individuals of both sexes, between 7 and 65 years of age Exclusion Criteria

Participants with the following characteristics will be excluded:

Pregnant individuals Individuals with arrhythmia Individuals with Thrombocytopenia Individuals with Sickle Cell Anemia Individuals with a pacemaker Individuals with alterations in coagulation factors
Periosteal Stimulation for Knee Osteoarthritis

185 veterans with chronic knee pain and advanced knee osteoarthritis will be recruited to participate in this study designed to test the effectiveness of a special type of electrical acupuncture called periosteal stimulation (PST). Participants will be divided into three groups. They will receive PST or a control condition once a week for 10 weeks. Two-thirds of the participants will receive booster sessions periodically over the course of the next 6 months. Everyone will be called monthly during the 6 month period and then will be asked to return for an evaluation on site at the end of this period.

We have performed a promising initial trial of periosteal stimulation (PST, that is, electrical stimulation of 4 acupuncture needles around the knee that touch periosteum) as an analgesic for older veterans with advanced knee osteoarthritis (OA) and daily pain. The primary aim of the proposed trial is to optimize and sustain the efficacy of PST for reducing pain in veterans with advanced knee OA and unrelieved pain by combining it with booster PST. Our secondary aims are to 1) improve physical performance in these individuals, and 2) ascertain the physical and psychological predictors of response to PST. In a randomized controlled clinical trial, 180 veterans (age 50 and older) with persistent knee pain who have x-ray evidence of advanced OA will be assigned to one of three intervention groups: 1) control PST once a week for 10 weeks (i.e., needle placement with brief stimulation of non-periosteal needles), 2) PST once a week for 10 weeks followed by tapering PST boosters over 6 months, or 3) PST once a week for 10 weeks followed by tapering control-PST boosters over 6 months. Prior to initiating the intervention, immediately after the last session, and 6 months later, the following parameters will be assessed: 1) pain severity (WOMAC), 3) physical performance (gait velocity, stair climb, repetitive chair rise, timed up and go), and 4) psychological function (mood, coping, self-efficacy). Monthly telephone calls will assess pain, interim illness and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* English speaking,
* Knee pain on most days of the past 3 months that is more severe than pain in other parts of the lower body,
* Advanced knee OA by x-ray,
* age 50-89

Exclusion Criteria:

* Non-ambulatory or severely impaired mobility (i.e., require the use of a walker),
* Folstein MMSE \< 24,
* Severe uncorrected visual or hearing impairment,
* Knee pain due to factors other than OA,
* Large knee effusion,
* History of corticosteroid or hyaluronic acid injection in the affected knee(s) during the preceding 3 months,
* Acute or terminal illness,
* Immune suppression,
* Anticoagulation therapy,
* Pacemaker,
* Prior PST treatment
* Active participation in other studies currently
* Age \>89
Feasibility & Acceptability of a Virtual Sister Circle Intervention for Black Women With Depressive Symptoms

The purpose of this study is to evaluate the feasibility and acceptability of a protocol for middle- and older-aged Black women with depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Identify as Black or African American
* Identify as female
* Age 40 years and older
* Community-dwelling
* Self-report of experiencing depressive symptoms
* Ability to commit to the 8-week intervention
* Access to Zoom
* Speak and read English

Exclusion Criteria:

* Have a diagnosis of bipolar, but is not taking medication for the condition
* Experiencing psychosis