cyrilzakka/clinical-trials huggingface dataset:
Effects of Lower Limb Fitness Program in Children With DS

Down Syndrome is a congenital disorder resulting from the trisomy of the human chromosome 21, which will determine, among other characteristics, intellectual disability and growth retardation. Reduced muscular strength, cardiovascular capacity, sleep problems, and impaired walking performance are also observed in Down syndrome participants. The estimated global prevalence is around 0.1% of live births. Children with Down's syndrome (DS) often have greater postural sway and delay in motor development. Muscle weakness and hypotonia, particularly of the lower extremities are theorized to impair their overall physical health and ability to perform daily activities. Posture, balance, and movement issues are common in children with Down syndrome. The purpose of this study is to examine the effects of Lower Limb Fitness Program on dynamic balance and mobility in children with Down Syndrome. This study explore that Lower Limb Fitness Program could improve the dynamic balance and mobility in children with DS.

Group A: Experimental group:

Group A will receive Range of motion for 5 minutes involving movements that stretch and strengthen the muscles and improve the stability. Proprioceptive training for 5 minutes which involve Single-leg balance Start with 20-30 seconds per leg and gradually increase to 1 minute 2-3 sets per leg. Weight bearing exercises on an uneven surface (such as Bosu ball or stability disc) and jumping rope 5-10 minutes/session. All proprioceptive training done firstly with eyes open and then with close eyes. Squat-to-stand training proprioceptive training lower extremity. This intervention aims to get the muscles ready before the actual intervention and improve proprioceptive ability. Exercises will be given three times a week for 6 weeks with session conducting 45 minutes per sessions which involve Squat-to-stand training will repeat 30 times 3 sets for 20 min. 2minute break after 1 set.. Balance training which involves standing activities with support, progressing to unsupported as tolerated for 10 minutes/session.

Group B: Control group:

In control group routine therapy will be given 3 times a week for 6 weeks with session conducting 45 minutes per sessions which involve standing balance exercises, sitting from chair to stand, heal to toe stand will be performed.

Data will be assessed by assessor at baseline by single leg stance test and at the end of 6th session of treatment (Pre and post).

Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 years
* Both Genders.
* Single leg stance Test: If unable to stand for 5 seconds or less client at greater risk of injury from fall.
* Ability to understand and follow basic instructions.
* Deficits in Balance

Exclusion Criteria:

* Children who are unable to engage in a structured fitness program due to behavioral or physical limitations.
* Children who have undergone lower limb surgery or experienced significant lower limb injuries in the past six months
Flucelvax (TIVc or QIVc) Pregnancy Registry

The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine during pregnancy.


Eligibility Criteria:
Inclusion Criteria -

Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows:

* Sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date.
* Sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment.
* Reporter (e.g. HCP) contact information to allow for follow-up

Exclusion Criteria:

* N/A
Evaluation of Women With Endocrine and Reproductive-Related Conditions

This study was designed to allow inpatient and outpatient evaluation of women with a variety of reproductive and endocrine-related disorders for purposes of research and physician education.

The evaluations may include ultrasound examinations, blood, saliva, and/or urine samples. In some cases, specific laboratory or X-ray studies will be performed to confirm the diagnosis or assist in the treatment of the patient. These additional tests will be conducted within the guidelines of current gynecologic practice. In some cases, the patient will receive medical or surgical treatment for their disorder.

The purpose of this study is to provide an opportunity for physicians to evaluate women with medical conditions of reproduction. These evaluations and treatments will support clinical training and research for the accredited training program in reproductive endocrinology at the National Institute of Child Health and Human Development (NICHD).\<TAB\>

The specific objective of this protocol is to gain knowledge and collect data in order to allow for hypothesis generation in future research as well as give NICHD investigators and trainees hands on experience related to the diagnoses, management, treatment and follow-up of reproductive endocrine disorders. Such disorders include but are not limited to Polycystic ovarian syndrome, Endometriosis, Primary ovarian insufficiency, Recurrent pregnancy loss, Primary amenorrhea and Infertility. This information will be taken from standard medical care/procedures and follow up of patients and healthy volunteers. It allows investigation into the problems of these patients for the purpose of furthering general knowledge and teaching.

Eligibility Criteria:
* Inclusion Criteria:
* Subjects aged 1-85 with reproductive endocrine related conditions.
* Young women, women of reproductive age, and older women are the focus of this protocol.
* Girls with reproductive disorders under the age of 18 will be studied and their assent will be obtained if possible along with the consent of their parent/guardian.
* Reproductive disorders of men will be included.

Exclusion Criteria:

* Pregnant women over 23 weeks will be excluded, since there are no on-campus prenatal or neonatal facilities. If we see patients in consultation after 23 weeks, as is our practice, we will provide a report to the referring PI on that protocol as well as the patient's personal obstetrician. We do not provide long term obstetrical care.
* Patients specifically requesting in vitro fertilization will not be considered candidates and will not be seen under this protocol. These patients may be seen for a consultation, but will be referred for these services outside of the NIH.
* Pregnant patients requiring fetal surgery will be excluded since there are no on-campus neonatal facilities.
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris

The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to placebo for the treatment of moderate to severe acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 12 to 45 years of age with facial acne vulgaris
* Qualifying Investigator's Global Assessment severity score
* Qualifying number of non-inflammatory lesions
* Qualifying number of inflammatory lesions

Exclusion Criteria:

* Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
* Using medications that are reported to exacerbate acne
* Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin
* Have a known hypersensitivity or previous allergic reaction to any of the components
* Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
* Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
Observational Study to Assess Outcomes During Antipsychotic Treatment With Paliperidone ER or Other Oral Antipsychotics

The purpose of this non-interventional, observational and international registry study is to document the prescribing patterns in daily clinical practice and to assess long term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting.

PILAR is a non-interventional, observational, international registry on the use of oral antipsychotics in a naturalistic setting in patients with schizophrenia. Patients initiating a new oral antipsychotic treatment are candidates for documentation in this registry. All patients should be treated according to local labeling specifications. The overall study objective is to document prescribing patterns in daily clinical practice and to assess long-term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting. The primary objective is to prospectively document over one year treatment outcomes and healthcare utilization data that will enable a cost-effectiveness analysis of paliperidone ER compared to other oral antipsychotic treatments. Additional objectives are to retrospectively collect data over one year, which will allow the evaluation of treatment outcomes before and after treatment initiation with paliperidone ER or other oral antipsychotics. Evaluation of Adverse Drug Reactions (ADR) and Serious Adverse Drug Reactions (SADR) for the retrospective period, and Adverse Events (AE) and Serious Adverse Events (SAE) during the prospective period will be performed and reported. Dosing and administration of all treatments should be prescribed at the physician's discretion, and should be based on approved local labels. Dose adjustments or medication changes should be made by the treating physician based on clinical judgment and usual practice. Subjects should receive their medication according to usual care in their treatment setting, and no study drug will be provided. The documentation of the treatment will last one year.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* Switch to or start on paliperidone ER or another oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago
* Signed informed consent is available at the beginning of documentation
* Able and willing to fill-out self-administered questionnaires

Exclusion Criteria:

* Established treatment-refractory schizophrenia
* History of neuroleptic malignant syndrome
Application and Effect Evaluation of Medium Chain Fatty Acid Rich Milk Powder in Infants With Cholestatic Liver Disease

To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease and To evaluate the safety of feeding milk powder rich in medium chain fatty acids in infants with cholestatic liver disease.

This study will include all types of cholestatic liver disease in infants, randomized controlled study of the efficacy and safety of intervention with rich medium chain fatty acid milk powder,To verify the effect of feeding milk powder rich in medium chain fatty acids on improving the nutritional status and disease status of infants with cholestatic liver disease .

Eligibility Criteria:
Inclusion Criteria:

* meets the diagnostic criteria of cholestasis
* Artificial feeding (formula feeders)
* Age ≤6 months
* The course of cholestasis was \> 1 month
* Informed consent of the guardian

Exclusion Criteria:

* There are major non-cholestatic genetic diseases leading to nutritional intake disorders, such as gastrointestinal malformations
* Cholestasis with ascites and diarrhea
* In patients with oxidative impairment of medium chain fatty acids
Effectiveness to Weight Loss in Sedentary and Overweight People Using a Smartphone Application.

This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the effects of the addition of an ICT tool developed for the Smartphone application and a Smartband in support of behavioral and educational recommendations to reduce weight.

* Objetive: To develop and validate an application for the use in Smartphone in which the management of a SmartBand is included and evaluate the effect of adding this tool of information and communication technology (ICT), to a standardized intervention reduce weight, reduce sedestation time, increase physical activity and decrease total caloric intake in obese and sedentary subjects.
* Design and setting: A clinical of two parallel group, multicenter, randomized, aimed at assessing the effects of adding an ICT tool (intervention) to support behavioral and educational recommendations (control) in physical activity and weigh loss. Population: 700 obese and sedentary subjects will be included, 20 to 65 aged, selected by random sampling in 5 centers.
* Measurements and intervention: physical and sedeentary acivity will be assessed with an accelometer and IPAQ and Marshall Questionnaires, the nutrition by a food frequency and adherence to the Mediterranean diet survey and weight loss with body mass index and waist circumference. Vascular function with a wrist-worn tonometer (blood pressure, augmentation index and pulse rate) will be evaluated and also the Cardio Ankle Vascular Index and carotid intima media thickness. The advice on nutrition (plate method) and exercise will be common to both groups. The intervention group will be added a training for 3 months in use of ICT tool described, designed to foment a healthy and low-calorie diet and increased physical acivity and decreased sedentary.

Eligibility Criteria:
Inclusion Criteria:

* Obese subjects (IMC ≥ 27.5 to \<40), classified as sedentary according to the short physical activity questionnaire validated in the EVIDENT II study.

Exclusion Criteria:

* Older than 65 years are excluded, due to difficulties in the use of ICTs.
* Advanced respiratory, renal or liver disease.
* Several mental illness
* Coronary or cerebrovascular atherosclerotic disease, grade II or higher NYHA heart failure.
* Moderate or severe COPD
* Muscular-skeletal pathology that inhibit mobility
* Subjects who can not exercise or follow a hypocaloric diet.
* Oncologic disease in treatment diagnosed in the last 5 years.
* Terminal situation
* Pregnancy
* Bariatric surgery
* Those with any other circumstance that the investigators consider could interfere with the study procedures
Monoclonal Antibody Therapy in Treating Patients With Advanced Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of monoclonal antibodies in treating patients who have advanced cancer.

OBJECTIVES: I. Determine the toxicities associated with a 4-hour infusion of antitransferrin receptor antibodies with one antibody administered by itself for 1 hour before the second antibody infusion is started. II. Determine the pharmacokinetics of monoclonal antibodies E2.3 and A27.15.

OUTLINE: This is a dose escalating study. Patients receive antitransferrin antibody A27.15 IV over 4 hours. One hour after the initiation of the A27.15 infusion, infusion of antibody E2-3 is added by IV piggy back. In the absence of antimouse antibodies and toxic effects, treatment continues once every 4 weeks in patients achieving minimal, partial, or complete remission. Treatment ceases in patients experiencing stable or progressive disease. In the absence of dose limiting toxicity in the first 3 patients treated, subsequent cohorts of 6 patients each receive escalating doses of antitransferrin antibodies E2.3 and A27.15 on the same dose schedule. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the MTD. Patients are followed for 3 weeks.

PROJECTED ACCRUAL: This study will accrue 18-27 patients within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Refractory or recurrent advanced malignancy following known standard effective therapy or advanced malignancy for which no standard effective therapy exists Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 1800/mm3 Hematocrit at least 30 mg/dL Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal unless due to disease, then less than 3.5 times normal Transaminases less than 3 times upper limit of normal (ULN) (less than 5 times ULN if due to liver metastases) Renal: Creatinine no greater than 2.5 times normal Cardiovascular: No severe cardiac abnormalities Must have adequate venous access No history of sustained ventricular arrhythmia or unexplained syncope Pulmonary: No severe pulmonary abnormalities Other: Not pregnant or nursing Effective contraception required of fertile female patients No serious concurrent medical or psychiatric illness Adequate nutrition No human antimouse antibodies

PRIOR CONCURRENT THERAPY: At least 4 weeks since prior anticancer therapy and recovered If there was disease progression during therapy, at least 2 weeks since prior anticancer therapy and recovered Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Concurrent topical steroids used in the chronic management of cutaneous T cell lymphoma allowed No other concurrent hormone therapy Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified
A Comparison of Incisional Negative-Pressure Wound Therapy Versus Conventional Dressings Following Abdominal Surgery

The purpose of this study is to compare outcomes between incisional negative-pressure wound vacuum-assisted closure (VAC) therapy versus conventional dressings following abdominal surgery.

This study will prospectively compare rates of wound complications using incisional negative pressure wound therapy versus conventional dressings following abdominal reconstruction.

Patients will undergo abdominal surgery (panniculectomy, abdominoplasty, ventral hernia repair, or autologous flap reconstruction using abdominal donor tissue). Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days. After this time, the wound will be assessed for signs of infection, seroma, hematoma, skin and fat necrosis, skin dehiscence, and hernia during the follow-up appointments.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in this study are patients undergoing abdominal reconstruction, which includes panniculectomy, abdominoplasty, ventral hernia repair and patients undergoing autologous flap reconstruction using abdominal donor tissue.

Exclusion Criteria:

* Patients will be excluded from study if they have an actively infected wound involving the incision, abdominal malignancy, a history of enteric fistula formation, or a bleeding disorder.
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants

The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants following infection with Plasmodium falciparum.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m\^2) and 29.9 kg/m\^2.
* Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
* Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
* Participants who have any history of malaria.
* Participants who have participated in a previous malaria vaccine trial.
* Participants who have participated in a previous human malaria challenge trial.
Functional Testing and Performance in Tennis

The aim of this study was to correlate functional tests, clinical tests and rotator cuff strength with the speed of serve.

For that purpose, tennis players (ITN 2-4) will be recruted among tennis players in the Province of Liege. They will be assessed 2 times.

During the first assessment, lateral medicine ball throw, 2 ball throws, upper extremity y balance test and shoulder rotation range of motion will be assessed.

During the second assessment, lateral medicine ball throw, the 2 ball throws and rotator cuff strength will be assessed.

Forty healthy tennis players (ITN 2-4) will be recruted among players in the club of the Province of Liege.

First session :

* Clinical testing

  1. Upper extremity Y Balance Test
  2. Range of motion (internal/external rotation)
* Functional tests

  a. Lateral Medecine Ball throw (5 repetitions) b. Single arm ball throw (1,5kg) d. Core endurance test
* Assessment of serve speed (radar) during 15 serves

Second session :

* Clinical testing

  a. Assessment of rotator cuff muscles strength
* Functional tests

  1. Lateral Medecine Ball throw (5 repetitions)
  2. Single arm ball throw (1,5kg)

Eligibility Criteria:
Inclusion Criteria:

* playing tennis at a level of ITN2-4
* being healthy