cyrilzakka/clinical-trials huggingface dataset:
Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization

Chronic endometritis is a persistent inflammation of the endometrium. Chronic endometritis is asymptomatic or little symptomatic. Sometimes, patient with chronic endometritis can have genital bleeding, pelvic chronic pain, pain during sexual relations, persistent vaginal white loosing. The hysteroscopy can detect the presence or absence of chronic endometritis.

Some studies showed that the endometritis could have an impact on the embryo implantation and could explain recurrent miscarriages or repeated embryo implantation failures.

The goal of this study is to evaluate the frequency of the chronic endometritis in patients with recurrent miscarriages or repeated embryo implantation failures


Eligibility Criteria:
Inclusion Criteria:

Group repeated miscarriages

* Women aged 18 to 43 years
* ≥ 2 miscarriages before 14 weeks of gestation
* Genetic (karyotype x2), thrombophilic and endocrine assessment should be completed

Group of implantation failure in In-vitro fertilization

* Women aged 18 to 45 years
* Absence of pregnancy after 3 good quality embryos transferred in women under 35 years and 4 embryos in the 35 years and over.

Exclusion Criteria:

* Positive pregnancy test
* Unexplained bleeding
* Incomplete miscarriage assessment
* Uterine malformation
* Antibiotic treatment during or within one month prior to the biopsy
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors

This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists.
4. Subjects with life expectancy ≥3 months.
5. Patients must have at least one measurable lesion as defined by RECIST v1.1.
6. Patients who have sufficient baseline organ function.

Exclusion Criteria:

1. Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \>10 mg/day or equivalent).
2. Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
3. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain.
4. 8. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
5. History or evidence of active infections (Grade ≥2).
6. History or evidence of significant inflammatory or vascular eye disorder.
7. History of an allogeneic bone marrow or solid organ transplant.
8. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312.
9. History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312.
10. History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
11. Subjects experiencing unresolved Grade \>1 toxicity before the start of treatment.
LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year

Exclusion Criteria:

* Diabetic ketoacidosis
* Any other severe disease
* Pregnancy or fertile female without contraception
* Alcohol/drug abuse, selected prohibited concomitant medication
* Nightshift work
Impact of Core Performance on Functional Parameters in Multiple Sclerosis

Optimal trunk control relies on somatosensory, motor and musculoskeletal integrity, which is often damaged in multiple sclerosis (MS). Researches on postural control in people with MS (PwMS) have revealed that reduced somatosensory conduction may adversely affect some functions. PwMS have increased postural sway in upright posture than healthy people. They move closer and slower when reaching out or taking a step. Trunk controls are weak and postural responses are delayed. The activation of core muscles is very important for an effective trunk control. Because the core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. The decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. There are a limited number of studies in the literature showing that core stability is reduced in PwMS. Our knowledge about the effects of this reduction on function in PwMS is very limited.

The aim of this study is to evaluate core strength and endurance and determine its effect on postural control, knee muscle strength, physical capacity and fatigue parameters in individuals with MS. Also relationship between these parameters will investigate.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with MS according to McDonald's criteria
* Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score
* No attacks during the last 3 months
* Being an ambulatory
* Volunteering to participate in the study

Exclusion Criteria:

* Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes
* Doing regular sports
* Being involved in another physiotherapy and rehabilitation program related to MS
Awareness of Iron Status Evaluation in UGIB

BACKGROUND: Data on the awareness of the need to evaluate iron status and IDA prevalence in acute UGIB are limited.

OBJECTIVES: This study aimed to investigate the rate of evaluation of iron status and prevalence of iron deficiency anemia (IDA) and the associated factors in patients with anemia hospitalized for acute upper gastrointestinal bleeding (UGIB).


Eligibility Criteria:
Inclusion Criteria:

* patients \&gt; 18 years of age who were admitted because of acute UGIB and were diagnosed with anemia from UGIB during hospitalization.

Exclusion Criteria:

* patients who had previously undergone endoscopy at another institution before admission
* patients who had a definite cause of UGIB that was inconclusive
* incomplete data for analysis.
Effects of Creatine Supplementation in Breast Cancer Survivors

The purpose of this study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy.

The primary objective of this study is to determine the effects of creatine supplementation in modulating strength and physical function in breast cancer survivors that have recently completed chemotherapy. The primary hypothesis for this objective is that creatine will lead to significantly greater gains in strength and physical function in breast cancer survivors compared to exercise alone. The secondary objective is to determine if supplemental creatine can increase intramuscular storage of creatine and alter energy storage. The hypothesis for this objective is that creatine supplementation will significantly increase intramuscular concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective is that the creatine group will have significantly greater muscle cross-sectional area and significantly lower intramuscular fat compared to controls. The final objective for this study is to test the hypothesis that creatine supplementation will improve body composition in breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years of age
* Recent (within 6 months) completion of chemotherapy
* Willing to attend 3 virtual exercise sessions per week
* Able to take oral medications
* Participant is willing and able to provide consent to participating in the study
* Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.

Exclusion Criteria:

* Physical indications where performing exercise may be limited and/or contraindicated
* Poorly-controlled hypertension (blood pressure \> 160/95mmHg)
* Current tobacco use (within 6 months)
* Anabolic steroids use
* Pitting edema
* Currently undergoing chemotherapy
* History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation).
* Pregnant or plan to get pregnant during the study
* Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), androgens, progestational agents, or other appetite stimulants
* Serum creatinine \> 1.5 x ULN or Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.
* Currently taking creatine supplements
Incidence of Influenza, Downstream Complications of Influenza & Hospitalizations in Elderly Vaccinated With Fluarix™

This study will investigate the incidence of influenza, disease and various possible downstream complications and hospitalizations or emergency room visits after routine annual vaccination of the elderly population with Fluarix™.

This study will investigate the incidence of influenza, disease and various possible downstream complications, such as pneumonia, ischemic HD (unstable angina or MI), congestive heart failure, acute cerebrovascular disease, COPD exacerbation and hospitalizations or emergency room visits, and will evaluate the feasibility of health outcome surveillance and the validity of using questionnaires instruments, after routine annual vaccination of the elderly population with Fluarix™.

Eligibility Criteria:
Inclusion Criteria

All subjects must satisfy to the following criteria at study entry:

* (1) A male or female age 65 years at the time of the first vaccination,
* (2) Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits, disease reporting by phone, and completion of Questionnaires) should be enrolled in the study
* (3) Written informed consent obtained from the subject
* (4) Availability to follow up by phone during the study period
* (5) Subjects with residence status allowing free mixing with general community.

Exclusion Criteria

The subject must not be included in the study for:

* (1) history of hypersensitivity to a previous dose of influenza vaccine
* (2) history of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate,
* (3) use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Improving Individual Glycemic Response With Exercise Intensity

Large interindividual variability exists in the glycemic response to exercise program, resulting in a subset of individuals known as exercise non-responders (NRs). Increasing the intensity of an exercise intervention has been proposed as one method for rescuing NRs by producing beneficial changes. However, this theory has not been tested on NRs classified using glycemic outcomes. This study will evaluate if increasing the intensity of an exercise intervention will elicit a response within previous exercise NRs.

Exercise can effectively slow the progression towards Type 2 diabetes (T2D). However, data suggest large interindividual variability exists in glycemic response to exercise, resulting in a subset of individuals known as exercise non-responders (NRs). Emerging research proposes that altering the parameters of an exercise intervention to provide a sufficient stimulus can elicit a response in those previously identified as NRs. To date, no research has attempted to rescue previously classified NRs based on glycemic outcomes by altering the parameters of an exercise intervention.

This study will implement an exercise program targeted at achieving the Canadian Physical Activity Guidelines, and calculate the number of NRs. We will then evaluate if increasing the intensity of exercise will elicit response to the treatment in the NRs.

Sixty adults living with prediabetes or T2D will be recruited into one of a control group, or an exercise group. The exercising participants will begin a 16-week exercise intervention, targeted at achieving 150 minutes of moderate to vigorous intensity (equating to 4.5 METs) aerobic physical activity per week. Following the 16-week exercise program, participants will be randomized into two groups, each completing an additional 12 weeks of exercise. The first will maintain the same time and intensity, while the other will complete the 150 minutes per week at an intensity equal to 6.0 METs. Randomization will occur in blocks in order to ensure an equal number of NRs in each group.

Eligibility Criteria:
Inclusion criteria:

1. Community-dwelling adults aged 19 years or older.
2. Currently living with prediabetes or T2DM as diagnosed by a physician and confirmed by an HbA1c value of 5.7% or above, as verified by duplicate testing.
3. Not currently partaking in a self-reported regular physical activity regimen, defined as consistent participation in running or jogging activity, attending physical activity or exercise classes on a weekly basis, or averaging 10,000 steps per day or more over the course of 7 days.

Exclusion criteria:

1. Self reported as currently diagnosed as having, or being treated for, low iron concentrations or anemia.
2. Diagnosed with any red blood cell altering condition.
3. Currently living with any cardiovascular disease which would impact the ability to safely participate in exercise training.
4. Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track exercise intensity.
Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant

The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through telepresence (audio and video) and remote control. Specifically, the goals of this study are to corroborate bench testing, assess the performance of the system, gain understanding of the workflows, customer experience, and logistics.

The intent of the remote support model is to provide the same support that would typically be provided by a local support person, only remotely. As such, the remote support person would only perform actions that a local support person would routinely do under the direction of a physician. This may involve observing patient data, providing technical support and advice, and performing testing and device reprogramming via remote control of the programmer.


Eligibility Criteria:
Inclusion Criteria:

* Planned IPG implant or planned ICD (without CRT) implant
* Signed informed consent

Exclusion Criteria:

* Pacing dependency
* Defibrillation threshold testing planned
* Basal ventricular rate \>110 beats per minute
* Younger than 18 years
* Pregnant
* Currently involved in another IPG or ICD related clinical trial
Tele-monitoring of Patients With Home Mechanical Ventilation (HMV) Trough Telemedicine System (MyVENT)

The purpose of this study is to improve HMV treatment adherence using an integrated telemedicine platform (MyVENT system)

The investigators propose a study to evaluate the effect of using tele-monitoring in the follow-up of patients with HMV in order to improve their compliance and evaluate its cost-effectiveness. Telemedicine will be provided by an integrated platform composed by a website and a smartphone application for achieve a real feedback between patients and clinicians.

Design: Prospective randomized clinical study that will include 184 patients with HMV. The study will be divided in two phases, the first one consisting on the website and App system development and the second one consisting on a clinical trial where the two follow-up systems (standard care vs MyVENT group) will be compared.

Randomization: Patients will be randomised into two groups, HMV treatment management with standard care vs. telemedicine follow up.

Intervention:

Group 1:MyVENT group: patients will be followed up by tele-monitoring support. MyVENT System will be updated with data extracted from the ventilation equipment. This information and the results of the complementary tests will be sent to the clinician.

Moreover, with MyVENT APP patients will receive information about their treatment and advices to improve therapy if needed.

Group 2: Standard care. In this group all the visits will be performed at hospital following daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over to 18 years old.
* Signed informed consent.
* Good knowledge about the use of smartphones.
* Patients with Chronic Obstructive Pulmonary Disease (COPD), obesity-hypoventilation syndrome and chest wall disorders who had started HMV at least three months before their inclusion.

Exclusion Criteria:

* Chronic pathology limiting life expectancy less than 1 year.
* Psychiatric limiting problems.
* Pregnancy
Study of the Glymphatic System in Migraine

This study aimed to investigate the role of the glymphatic system in the initiation of migraine attacks, using non-invasive magnetic resonance imaging techniques and a validated model of migraine induction by nitroglycerin administration. Secondarily, the relationship between the function of the glymphatic system during nitroglycerin-induced migraine attacks and sleep architecture and plasma levels of migraine-involved neuropeptides will be investigated.


Eligibility Criteria:
Inclusion Criteria:

For patients:

• Diagnosis of migraine, by the ICHD-3 criteria;

For both patients and healthy controls:

* Age between 18 and 60 years;
* Willing and able to comply with scheduled visits.

Exclusion criteria

For patients:

* Overuse of acute medications for headache;
* Continuous or daily headache;
* Other primary headache disorders, with the exception of infrequent tension-type headache.

For healthy controls:

• Any subject with frequent tension type headache, migraine, cluster headache, other pain syndromes or neurological conditions.

For both patients and healthy controls:

* Allergy to nitroglycerin;
* Major psychiatric disorders such as bipolar affective disorder and schizophrenia;
* Cardiovascular diseases that contraindicated the use of nitroglycerin;
* Intracranial hypertension;
* Cerebral haemorrhage;
* Cerebral trauma;
* Pulmonary toxic oedema;
* Closed angle glaucoma;
* Anaemia;
* Pregnancy and breastfeeding;
* Aortic stenosis or significant hypotension (SBP\<90mmHg or \<100mmHg and symptomatic) precluding nitroglycerin administration;
* Use of sildenafil;
* Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study;
* Any person where MRI scanning is contraindicated (metal implants, pacemaker, claustrophobia, etc.);
* Use of illicit drugs;
* MRI head showing any brain pathology, such as space-occupying lesions;
* Any person unable to understand and follow the instructions of the investigators.
Fecal Microbiota Transplant for Improvement of Metabolism

The purpose of this study is to study the impact of gut bacteria on weight. Fecal microbiota transplantation (FMT) transfers intestinal bacteria by a "stool transplant" from a healthy, lean person to a person with obesity.

Multiple lines of evidence suggest that gut microbiota play an important role in regulating human metabolism. In this study, subjects will receive FMT capsules from lean metabolically healthy donors to study effects on body weight and insulin sensitivity. Subjects who participate will be randomized 1:1 to receive either active FMT capsules or placebo capsules. Subjects and providers will be blinded to treatment assignment. The study will last for 24 weeks. Subjects will be asked to come to MGH for a baseline visit at week 0, return for 6 weekly visits and come back at week 12. Major study outcomes include change in weight, insulin sensitivity, and body composition. Fecal samples will also be collected for intestinal microbiome analysis.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥30 kg/m2
* Because of frequent study mandated visits, only subjects living within reasonable driving distance of Massachusetts General Hospital may be enrolled

Exclusion Criteria:

* Pregnant women
* Use of diabetic medications or weight loss medications in the preceding 1 year
* Significant gastrointestinal disorders
* Significant food allergies
* Immunosuppressed patients
Reference Curve on Bone Mineral Density in Men

In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are the three factors that explain the lower incidence of osteoporosis in men.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged between 20 and 30 years
* Caucasians

Exclusion Criteria:

* Lack of express consent
* Pieces of metal or plastic parts in field
* Diseases which cause technical difficulties for the correct evaluation of the hip and spine (severe dysplasia, hip surgery or lumbar spine)
* Adult protect buy the law