linjc16/ctgov huggingface dataset:
Effect of Squat Training on Body Composition, Muscular Strength and Motor Fitness for Youth- Randamized Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of body mass-based squat training on body composition, muscular strength and motor fitness in adolescents.

Detailed Description
-----------------
Body composition Percent body fat by bioimpedance muscle thickness at the thigh anterior by ultrasound Muscle strength Maximal voluntary knee extension torque by myometer Motor fitness sprint velocity by non-motorized treadmill Jump height by a matswitch system.

Official Title
-----------------
Phase 1 Study of Child Exercise Training

Conditions
-----------------
Physical Conditioning

Intervention / Treatment
-----------------
* Other: squat exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adolescents Exclusion Criteria: Participants do not have medical and orthopedic disorder.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br> | Other: squat exercise training<br>* Intervention may include squat exercise for 8 weeks<br>* Other names: school-based exercise training;|
| Experimental: Control group<br> | Other: squat exercise training<br>* Intervention may include squat exercise for 8 weeks<br>* Other names: school-based exercise training;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent body fat by bioelectrical impedance |  | Eight week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knee extension strength by myometer |  | eight weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
squat exercise
Efficacy, Usability Study of the GlucoTab System for Glycaemic Management in Type 2 Diabetic Patients at General Wards

Study Overview
=================
Brief Summary
-----------------
Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.

Official Title
-----------------
An Open, Single-centre, Non-controlled Study of Efficacy, Safety and Usability of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Device: GlucoTab System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained after being advised of the nature of the study Male or female aged ≥18 years Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycaemia which requires s.c. insulin therapy Exclusion Criteria: Type 1 diabetes, gestational diabetes Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient Pregnancy Any mental condition rendering the patient incapable of giving his consent Known or suspected allergy to insulin glargine or insulin aspart Continuous parenteral nutrition Participation in another trial which can influence the software algorithm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GlucoTab System<br> | Device: GlucoTab System<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy |  | duration of hospital stay (maximum three weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blood glucose measurements per day |  | duration of hospital stay (maximum three weeks) | 
| Adherence to the insulin dose suggestion of the GlucoTab system |  | duration of hospital stay (maximum three weeks) | 
| Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day |  | duration of hospital stay (maximum three weeks) |
A Single Patient IND for PD-0325901

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide access for a single patient to PD-0325901 who was previously enrolled in a phase I clinical trial.

Official Title
-----------------
A Phase I Single Patient IND for PD-0325901

Conditions
-----------------
Prior Treatment With PD-0325901 With Ongoing Clinical Response

Intervention / Treatment
-----------------
* Drug: PD-0325901


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior treatment with PD-0325901 with ongoing response Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PD-0325901|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Open-Label Compassionate Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients

Study Overview
=================
Brief Summary
-----------------
This protocol provides for the availability of spiramycin under compassionate-use conditions for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised immune system, thus deriving additional information regarding its safety and efficacy profile.

Official Title
-----------------
Open-Label Compassionate Use Study of Spiramycin for the Treatment of Diarrhea Due to Chronic Cryptosporidiosis in Immunocompromised Patients

Conditions
-----------------
Cryptosporidiosis, HIV Infections

Intervention / Treatment
-----------------
* Drug: Spiramycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity. Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study. Concurrent Medication: Excluded: Other investigational drugs. Patients with known sensitivity to macrolide antibiotics are excluded. Consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity. Patients with a compromised immune system may have hepatic abnormalities or even hepatitis. If the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study. Prior Medication: Excluded within 7 days of study entry: Other investigational drugs. Diagnosis of chronic diarrhea due to cryptosporidiosis and a compromised immune system but not limited to patients with AIDS. Patients receiving chemotherapy for a malignancy. Patients who are iatrogenically immune-suppressed following organ transplantation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Spiramycin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spiramycin, AIDS-Related Opportunistic Infections, Immune Tolerance, Cryptosporidiosis, Diarrhea, Drugs, Investigational, Acquired Immunodeficiency Syndrome
COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.

Official Title
-----------------
COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Conditions
-----------------
Patients at Risk for Melanoma

Intervention / Treatment
-----------------
* Other: SAMScore questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients more than 18 years old, consulting their GP, assessed at risk for melanoma according to the SAMScore signed the consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: SAMScore questionnaire|Patients assessed at high risk according to the SAMScore|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence ratios between those of the COPARIME cohort and those of the general population. | Number of melanomas detected / Number of patients at high risk of melanoma defined by our selection tool. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability to develop a melanoma at one year. |  | 1 years | 
| Cost ratio for a screened melanoma. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cohort, Melanoma, targeted screening, risks function, cost effectiveness
Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.

Detailed Description
-----------------
Antiretroviral treatment during pregnancy is remarkably effective in preventing the transmission of mother-to-child viruses. Molecules of the class of anti-integrases are still little used during pregnancy, but their prescription is increasing given their intrinsic effectiveness and their overall tolerance profile. The integrase of HIV-1, responsible for the integration of viral DNA in cellular DNA, has a functional similarity with human RAG1 / 2 proteins, responsible for V (D) J recombination. RAG1 / 2 proteins alteration is associated in human clinic with immune disturbances of varied severity. The objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.

Official Title
-----------------
Impact of in Utero Exposure to Anti-integrase Antiretrovirals on the Newborn Immune System

Conditions
-----------------
Anti-integrases

Intervention / Treatment
-----------------
* Biological: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No parental opposition after information. Exposed group : Newborn at term exposed to raltegravir (RTG) before 8 weeks of gestation and until the end of pregnancy. Children exposed to elvitegravir (ETG), dolutegravir (DTG) or bictegravir (BTG) may be included but will be analyzed separately. Control group : - Term neonate exposed to antiretroviral therapy without anti-integrase. Exclusion Criteria: Prematurity less than 36 weeks of gestation. Organ dysfunction. Acute or chronic fetal distress, need for hospitalization in neonatology, malformation syndrome.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborns exposed<br>Newborns exposed in-utero to raltegravir | Biological: Blood test<br>* Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup<br>|
| Newborns controls<br>Newborns exposed to antiretroviral therapy without anti-integrase | Biological: Blood test<br>* Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn immunity | T cells immune repertoire integrity | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-integrases treatment, Antiretroviral treatment, Pregnancy
Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution

Study Overview
=================
Brief Summary
-----------------
This is a comparative, open label, parallel group, non interventional study to further demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product according to the instructions for use six times daily in both eyes over a period of 28 days. Response to treatment is recorded at day 28.

Official Title
-----------------
Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution (BAT04) Compared to HA Eye Drops in the Treatment of Dry Eye Disease

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Other: Medical device, drug-like


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female person aged 18 years Demonstrated mild to moderate keratoconjunctivitis sicca ( dry eye) Acute symptoms of dry eye: DEWS 1-3 tear break-up time TBUT <10s agreement to abide by the routinely provided doctor's appointment for follow-up (reflected in the planned visits of observation plan resist) Exclusion Criteria: inflammation of the anterior segment or trauma Contact lens wearers Any disease that can, in the opinion of the treating physician to affect the outcome of the study. Patients with known intolerance to one of the substances used Surgical procedures to the eyes in the last 6 weeks before inclusion in the trial patients with addictive disorders or substance abuse fallow in the past 12 months, as well as persons incapable of giving consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Medical device, drug-like|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break Up Time |  | V1 and V2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop
EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

Study Overview
=================
Brief Summary
-----------------
The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal. The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy. The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.

Official Title
-----------------
A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas

Conditions
-----------------
Polyp, Adenoma, Cancer

Intervention / Treatment
-----------------
* Device: EndoCuff-assisted colonoscopy
* Device: Standard colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent Exclusion Criteria: pregnancy age<18 years known colonic strictures chronic inflammatory bowel disease active inflammation s/p colonic resection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endocuff-assisted colonoscopy<br>Endocuff-assisted colonoscopy | Device: EndoCuff-assisted colonoscopy<br>* EC-assisted colonoscopy<br>|
| Active Comparator: Standard colonoscopy<br>Standard Colonoscopy | Device: Standard colonoscopy<br>* Standard colonoscopy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate | completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body. | 25 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polyp detection rate |  | 1 Week | 
| number of LGIN and HGIN adenomas detected | LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia | one week | 
| polyp distribution |  | 25 minutes | 
| procedure time |  | 25 Minutes | 
| withdrawal time | without intervention time due to polypectomy | 10 Minutes | 
| ileum intubation rate |  | 10 minutes | 
| total colonoscopy rate |  | 25 minutes | 
| adverse events | perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy | 25 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon cancer, adenoma, colon polyps
A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.

Official Title
-----------------
A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Lanthanum carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who participated in LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 and received lanthanum carbonate Patients must continue to require treatment with a phosphate binder for hyperphosphatemia male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter Exclusion Criteria: Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed possible or related to study medication Pregnant or lactating women
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lanthanum carbonate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent adverse events |  | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pre-dialysis serum phosphate levels |  | Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24. | 
| Control of pre-dialysis serum phosphate levels |  | Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24. | 
| Plasma lanthanum levels |  | Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24. |