cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Effects of Selective Exercise Training in Multiple Sclerosis

Selective exercise programs specific to muscle groups, with the workload to be done in line with the muscle's own structure, can enable more strength to be released with less fatigue in MS, and this increase in strength can increase balance and functional activities. to determine the effects of type training (selective exercise training), eccentric and concentric training on function, balance, fatigue and muscle architecture.

Recovery and enhancement of muscle function in MS is one of the main goals in physiotherapy and rehabilitation. In literature studies, it is stated that eccentric and concentric exercises are effective exercise approaches in increasing strength and reducing fatigue. However, the best exercise method is not yet clear in terms of providing better performance adaptation with less fatigue. Considering the architectural features of the lower extremity muscles, it is aimed to increase the angle of pennation with programs that include concentric strengthening of the quadriceps, gastro-soleus and gastrocnemius muscles, which are suitable muscle groups to produce large forces by design. With programs that include eccentric strengthening of the hamstring and tibialis anterior muscles that function in a wide range of motion and have high excursion ability, it is aimed to increase fiber length.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-50,
* With an Extended Disability Status Scale (EDSS) score of 4 or less,
* No regular exercise habit
* Able to walk on the treadmill,
* No pregnancy,
* Not receiving corticosteroid treatment in the last month,
* Fampridine etc. in the last 1 month. not taking medication,
* Patients who have not received Botox treatment in the last 6 months

Exclusion Criteria:

patients who do not agree to volunteer
Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer

This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy.

The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-1
* Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT
* Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1
* Adequate hematologic, hepatic and renal function (within 14 days)

Exclusion Criteria:

* Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation
* Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days)
* Indwelling surgical drains
* Grade 2 or higher QTc prolongation
* History of major organ transplant
* History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)
Fasted Exercise and LDL-C

Cardiovascular disease (CVD) is the leading cause of death in the UK and worldwide with low density lipoprotein cholesterol (LDL-C) being one of the most important modifiable risk factors. Physical activity is inexpensive and research shows that it consistently improves high density lipoprotein and triglyceride concentrations. However, fails to improve LDL-C concentrations. Preliminary research suggests fasted exercise could potentially improve LDL-C concentrations. The majority of research in these areas have also mostly been done in males with the results generalised to females. As it is known that lipid metabolism and CVD risk is different between sexes it is possible that the response to fasted exercise may also be different between sexes. This aim of this study is to assess the effect of physical activity performed before or after a meal on plasma LDL-C concentrations in men and women and explore sex differences. The study will also assess the effect of fasted exercise on other CVD risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Body mass index 20-40kg/m2
* Physically inactive (exercise for less than 150 minutes per week)

Exclusion Criteria:

* Weight instability (\>5kg change in body mass over last 6 months)
* Diagnosis of diabetes or CVD
* Pregnant or lactating
* Any medical condition or medication that could introduce bias into the study (eg. lipid disorders, lipid or glucose metabolism altering medications eg statins)
Study of Kinetics and Efficacy of the Immune Response Against COVID-19 Among Hospital Staff

COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff.

A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic.

Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool.

Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding.

The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* Military or civilian or contactual volunteer on duty at Percy hospital during the COVID-19 pandemic.

Exclusion Criteria:

* Individuals who have displayed a severe form of early-onset COVID-19 who required intensive care management or hospitalization;
* Presence of factors modulating immunity with congenital or acquired immunosuppression:

  * Medication: cancer chemotherapy, immunosuppressive drugs, biotherapy, corticosteroids
  * Uncontrolled HIV infection or CD4 \<200/mm3 infection
  * History of solid organ or hematopoietic stem cell transplants
Internet-based Support for Young People With ADHD and Autism - a Controlled Study

Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next of kin. After treatment the young people are interviewed regarding the quality of the intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual and is assessed at the same time points as the intervention group. The individuals are not randomized due to difficulties to recruit if the individuals do not know group assignment in advance.

Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are consecutively included in the project and are offered coaching and support during eight weeks over the internet (chat and e-mail) twice a week. Data is collected before and after the intervention as well as six months after end of treatment using self-report questionnaires (Sense of Coherence (SOC), Rosenberg Self Esteem Scale, Manchester Short Assessment of Quality of Life (MANSA), Montgomery Asberg Depression Rating Scale (MADRS), and Hospital Anxiety and Depression Scale (HAD)). A parent or a partner completes an assessment scale for the next of kin. When treatment is completed, the young people are interviewed using a structured interview pertaining to the quality of the intervention. A comparison group matched for age, gender and neuropsychiatric diagnosis is offered treatment as usual (TAU) and is assessed at the same time points as the intervention group. The individuals are not randomized to the intervention and comparison groups due to difficulties to recruit if the individuals do not know group assignment in advance. In all, 24 individuals will be offered the intervention and 24 individuals will receive TAU.

Eligibility Criteria:
Inclusion Criteria:

* ADHD and/or autism spectrum disorder
* Age 15 to 30

Exclusion Criteria:

* No current antisocial behaviour, psychotic symptoms and/or alcohol/substance abuse
Automated Breast Radiation Therapy Using an MR-Guided Process

In the proposed research study, we are investigating the feasibility of integrating automated planning tools to MR images acquired using a novel MR-guided linac, for on-line adaptive radiation treatment. However, these on-line automation tools require further technical refinement and clinical validation. The goal of this research proposal is to develop an on-line MR-guided radiation therapy process for adapting breast IMRT treatment. Such an approach will provide early stage breast cancer patients timely access to high-quality adaptive treatments without exposure to additional ionizing radiation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cGy in 16 fractions, 5000 cGy in 25 fractions or 4000 cGy in 16 fractions.
* Female patients with any stage of breast cancer.
* Patients with prior treatment such as surgery or chemotherapy for any type of cancer.
* Able to provide a written informed consent.
* ≥ 18 years of age.

Exclusion Criteria:

* Patients who will not receive 4240 cGy in 16 fractions, 5000 cGy in 25 fractions, or 4000 cGy in 16 fractions
* Males.
* Patients who received partial breast radiation and not the standard dose.
* Patients who are unable to provide informed consent.
* \< 18 years of age.
Change of Neutrophil Gelatinase-Associated Lipocalin(NGAL) Following Sodium Phosphate Bowel Preparation(Pilot Study)

Oral phosphate purgative is the preferred bowel regimen on the basis of better tolerability, cost effectiveness, and efficacy. There are also numerous reports of patients with even previously normal renal function developing acute and chronic kidney disease after use of oral phosphate purgative. Several uncontrolled case reports and case series suggest a potential link between oral phosphate and acute kidney injury and/or chronic kidney disease1. Its use is contraindicated in patients with preexisting renal disease because of the risk for developing acute renal failure, so called acute phosphate nephropathy, or electrolyte disturbance. Since most of the outpatients who are going to undergo a colonoscopy are exposed to this agent, it is important to detect or prevent vulnerable patients. We would seek a sensitive and rapid diagnosis method of acute kidney injury following sodium phosphate bowel preparation. Within a few hours, NGAL mRNA is highly upregulated after kidney injury, such as renal ischemia-reperfusion and cisplatin nephropathy, NGAL induction precedes the elevation of classical markers for kidney damage such as serum creatinine. The investigators will investigate the change of NGAL following sodium phosphate bowel preparation.


Eligibility Criteria:
Exclusion Criteria:

* Who takes ACE-inhibitor, ARB
* Has a renal or heart disease
* Has a serum electrolyte disturbance
Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer

Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients (arginine, glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate the activity of the immune system and provide an additional benefit beyond the nutritional support, this intervention type is called immunonutrition. Despite these possible benefits, their utility has been proven in few clinical scenarios, for example in with patients with upper gastrointestinal cancer undergoing surgical resection; based on this, current guidelines recommend that patients should receive oral/enteral nutritional support with an specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides) , but there is a lack of evidence for supporting its use in other clinical conditions including patients with cancer that receive systemic treatment


Eligibility Criteria:
Inclusion Criteria:

* - Patients with Gastrointestinal tumor undergoing systemic treatment (chemo-radio-immuno therapy or their combination)
* Body weight loss \>5% in the previous three months or \>10% in the previous six months
* Both sexes
* Age between 18-85 y-old.

Exclusion Criteria:

* Life expectancy \< 2 weeks
* MDRD \< 15 mL/min
* End-stage liver disease
* Any musculoskeletal, cardiovascular and/or neurological disorders that could affect exercising.
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease

The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis.

This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.

Participants will undergo three study visits, and up to 4 safety visits, over 9 weeks.

At 7 AM in the first study visit, the participants will have taken 25mg empagliflozin once or matching placebo, thus producing peak plasma levels by 10 AM. One week later the participant will return for the crossed over to the alternate study drug.

At the conclusion of the 2nd study visit, all participants will be provided with empagliflozin 10mg tabs to be taken daily for 56 days (8 weeks). At each study visit and safety visit, participants will undergo a PET test.

Eligibility Criteria:
Inclusion Criteria

1. Patients actively undergoing PD with a reliably functioning PD catheter
2. Stable peritoneal dialysis prescription
3. PD vintage \> 3 months
4. Age \>18 years of age

Exclusion Criteria:

1. History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
2. Use of an SGLT2 inhibitor within the prior 30 days
3. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
4. Anemia with hemoglobin \<8g/dL
5. Inability to give written informed consent or follow study protocol
6. Contraindication to receiving loop diuretics
User Evaluation of the MiniMed 620G and 640G Insulin Pumps

This six center international study will include two United Kingdom National Health Service centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The objective of the study is to evaluate subject acceptance of the a new insulin pump and transmitter together with the accompanying training materials. Descriptive data from participant questionnaires and device uploads will be evaluated.

Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of age upwards, who currently use an insulin pump in the management of their type 1 or type 2 diabetes, will be invited to participate. Each subject will be trained on the study device and then use it for approximately six weeks. During this time there will be three in-clinic visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of this period, they will revert back to their original insulin pump and complete a questionnaire on the study pump training materials, features and usability.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 7 years or older at time of screening
* Subject is current insulin pump user for at least 3 months
* Subject has the following Continuous Glucose Monitoring experience as determined by the Investigator:

  * Has experience and is able to insert/change sensor by herself/himself and
  * Has experience and can recharge the transmitter and
  * Has experience and can read sensor data in real-time on her/his pump screen
* Subject has signed a Patient Informed Consent form and is willing to comply with the study procedures;
* Subject is willing to complete study questionnaires throughout the study
* Must have one of the following clinical diagnosis:

  * Type 1 diabetes, for a minimum of 6 months prior to enrollment
  * Insulin requiring type 2 diabetes, for a minimum of 6 months prior to enrollment

Exclusion Criteria:

* Female subject has a positive urine pregnancy screening test.
* Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn
* Subject has any condition that, in the opinion of the Investigator or qualified Investigational Center staff, may preclude him/her from participating in the study and completing study related procedures.
* Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Center staff
* Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes

Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial hyperglycemia are of great importance. The quantity and source of carbohydrates affect post-prandial glycemia more than any other dietary factor. These findings serve as the physiologic basis for a growing interest in carbohydrate-restricted diets in the management of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting total carbohydrate intake to less than 130 grams per day. Although case series and prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for adults with T1DM, data in the pediatric T1DM population is limited. The investigators will conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and quality of life (QOL) in pediatric T1DM patients on a LCD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T1DM for at least 12 months
* Age 13 to 21 years
* Total daily dose of insulin 0.5 to 1.25 units/kg/day
* Current use of an insulin pump and CGM
* HbA1c between 7% and 10%
* Tanner stage 3 to 5 on physical exam
* Participant or parent of participant use of smart phone
* Able to read and speak English

Exclusion Criteria:

* Any episode of diabetic ketoacidosis (DKA) in the last 12 months
* Any episode of severe hypoglycemia (defined as requiring assistance from another person, including coma, seizures, or episodes requiring glucagon, IV dextrose or oral carbohydrate administered by another person) in the last 12 months
* Any prior abnormal fasting lipid panel (LDL \> 130)
* Additional dietary restrictions
* Following a weight-loss or otherwise restrictive diet
* Use of medication or supplements other than insulin to control blood glucose
* Use of medication or other supplements to lower lipids
* Pregnancy or breast feeding
* History of hemoglobinopathy
A Retrospective and Prospective Natural History Study of Patients With WHIM Syndrome

This natural history study is a prospective and retrospective, observational study of WHIM patients. WHIM syndrome is a rare, genetic, primary immunodeficiency disorder (a disorder in which the body's immune system does not function properly). WHIM is an acronym for some of the symptoms of the disorder - Warts, Hypogammaglobulinemia (low levels of certain antibodies), Infections and Myelokathexis (too many white blood cells in the bone marrow).This study includes 10-year retrospective (Retrospective Phase) and up to 5-year prospective (Prospective Phase) components.

Given the rarity of patients with WHIM syndrome, this study is being conducted to better understand the clinical course of untreated patients with WHIM syndrome.

The goals of this Natural History Study are to define both the frequency and diversity of WHIM syndrome by specific genetic mutation, as well as to understand the clinical course and phenotype of untreated WHIM patients.

Eligibility Criteria:
Inclusion Criteria:

1. Has a confirmed clinical diagnosis of WHIM syndrome.
2. Has signed the current approved informed consent form; patients under 18 years of age will sign an approved informed assent form and must also have a signed parental consent.
3. Be willing and able to comply with the study protocol.

Exclusion Criteria:

1. Has, within 6 months prior to Day 1, received a CXCR4 antagonist.
2. Currently participating in an investigational study for treatment of WHIM.
3. Has any other medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical study.
Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire

This study is a cross-sectional observational study design that aimed to include 2000 IBS patients. We used several validated questionnaires, to assess IBS characteristics (such as subtype, severity), psychological features (QoL, anxiety and depression) and assess nutritional triggers.

Subjects filled in the questionnaire online, and was spread across the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* IBS-like symptoms

Exclusion Criteria:

* younger than 18 years