linjc16/ctgov huggingface dataset:
Establishment of Normal Muscle Strength for French Population

Study Overview
=================
Brief Summary
-----------------
Normal values for muscle strength using hand held dynamometer and muscle mass using echography are largely unknown. The objective of the present study is to establish normal values of these measurements in population living in France.

Official Title
-----------------
Establishment of Normal Muscle Strength Measured by Hand-held Dynamometer and Muscle Mass Assessed by Ultrasonography for French Population

Conditions
-----------------
Muscle Mass, Muscle Strength

Intervention / Treatment
-----------------
* Other: measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Age 18-90 years Exclusion Criteria: Patients < 20 years and > 90 years, Athletes involved in international sport competition Rheumatic or neuromuscular disease Other decompensated pathological conditions Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| muscle strength ,muscle mass<br> | Other: measurements<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring muscle mass using echography |  | 5 weeks |
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

Detailed Description
-----------------
The duration of treatment is 4 weeks.

Official Title
-----------------
A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomiting

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: MK0869, aprepitant
* Drug: Comparator: ondansetron IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years of age. Patient is scheduled to undergo open abdominal surgery requiring overnight hospital stay (24-hour hospital stay after end of surgery). Patient is scheduled to receive general anesthesia. Patient is scheduled to receive postoperative medication.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0869, aprepitant|nan|
|Drug: Comparator: ondansetron IV|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of PONV in the 24 hours following end of surgery; Tolerability |  |  |
Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine how often patients who have atypical lobular hyperplasia (ALH) or lobular carcinoma in situ (LCIS) on core needle biopsy of an imaging (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at surgical removal of the area.

Detailed Description
-----------------
Patients will undergo a breast biopsy at which the area found to be ALH or LCIS on core biopsy will be removed surgically through a small incision in the breast. The surgical biopsy specimen will be carefully examined by a pathologist, and may be useful in guiding further therapy if needed. In the future, tissue from the surgical biopsy may be used to study genetic changes that may be responsible for cancer formation and prevention. The tissue will be kept for future research for up to 10 years.

Official Title
-----------------
The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma, DCIS, or Atypical Ductal Hyperplasia (ADH) in Patients Diagnosed With Lobular Neoplasia of the Breast by Core Needle Biopsy

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 20 years of age or older Imaging abnormality necessitating a core needle biopsy Core needle biopsy revealing ALH or LCIS Patients may have a history of fibroadenoma and/or proliferative breast lesions with atypia Exclusion Criteria: History and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS) A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS Received tamoxifen in the past

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy |  | Concomittant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALH, LCIS, DCIS, adjacent ipsilateral infiltrating carcinoma, core needle biopsy, Lobular neoplasia of the breast
Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles

Study Overview
=================
Brief Summary
-----------------
This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Detailed Description
-----------------
The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)

Official Title
-----------------
Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: LASIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopia up to -8.0 D and astigmatism up to -2.0D. Cases above 18 years of age with a stable refraction for at least one year. Exclusion Criteria: Keratoconus. Patients with collagen diseases. Previous LASIK or any other refractive surgery. Severe dry eye syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser in situ keratomileusis<br>A prospective clinical study including 20 eyes of 10 cases undergoing laser in situ keratomileusis (LASIK) | Device: LASIK<br>* All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of ocular aberrations | 3. Evaluation of ocular aberrations done using iTrace Visual Functional Analyzer (ray tracing technology) to quantify changes in total higher order aberrations, coma, spherical aberrations, secondary astigmatism and trefoil after LASIK surgery | 3 months | 
| Visual acuity | Unaided as well as best corrected visual acuity | 3 months | 
| Manifest refraction | Manifest refraction | 3 months |
Preventing Falls and Disability in Older Adults After Hip Fracture

Study Overview
=================
Brief Summary
-----------------
Patients who have suffered a first hip fracture have a higher risk of falling and sustaining another hip fracture compared with age-matched adults who did not fracture. Although exercise is key to reversing this pattern, there have been very few trials that aimed to improve muscle strength and balance as well as enhance bone health following hip fracture. Therefore, we propose to conduct an RCT that delivers either 12 months of standard care or standard care plus graduated exercise program for older women who have sustained a recent hip fracture.

Official Title
-----------------
Preventing Falls and Disability in Older Adults After Hip Fracture

Conditions
-----------------
Hip Fracture

Intervention / Treatment
-----------------
* Other: Standard Care for people after hip fracture
* Other: Standard Care + exercise intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older community dwelling women who have sustained a first hip fracture

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 105 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard Care for people after a hip fracture | Other: Standard Care for people after hip fracture<br> <br> |
| Experimental: 2<br>Standard Care + exercise intervention | Other: Standard Care + exercise intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fall rate, measured by self-reported daily fall diaries, will be collected monthly at the exercise classes and followed up by an independent investigator |  | Monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
older women, hip fracture, exercise intervention
Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL).

Detailed Description
-----------------
The salvage therapy in the patients with DLBCL is still controversial. The investigators conducted this study to evaluate the efficacy and tolerability of Rituximab combined with ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.

Official Title
-----------------
Phase II Study of Rituximab Combined With ESHAP in Patients With Relapse or Refractory DLBCL

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: Rituximab combined with ESHAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range 18-70 years old Histological confirmed diffuse large B cell lymphoma ECOG performance status no more than 2 Life expectancy of more than 3 months Relapse or refractory after the first-line chemotherapy of DLBCL No evidence of bone marrow involvement Normal laboratory values: hemoglobin > 8.0g/dl, neutrophil > 1.5×109/L, platelet > 80×109/L, serum creatine < 1× upper limitation of normal(ULN), serum bilirubin < 1× ULN, ALT and AST < 1.5× ULN Exclusion Criteria: Pregnant or lactating women Serious uncontrolled diseases and intercurrent infection The evidence of CNS metastasis and bone marrow involvement History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix History of allergic reaction/hypersensitivity to rituximab

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemo<br> | Drug: Rituximab combined with ESHAP<br>* Rituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5<br>* Other names: R-ESHAP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities |  | every cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DLBCL, Rituximab, ESHAP, Efficacy, Toxicity
Cesarean Section Study

Study Overview
=================
Brief Summary
-----------------
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups.

Official Title
-----------------
Effect,Tolerance and Safety of a Supplementation With a Probiotic in Healthy Newborn Term Infants Born by Cesarean Section Over a 12 Months Period Study

Conditions
-----------------
Diarrhea, Atopic Dermatitis

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent must be obtained from legal guardian(s) prior to randomization or any study related procedures healthy newborns born by Cesarean section singleton birth Age at enrollment in the study < 24h birth weight ≥ 2500g and ≤ 4300g gestational age ≥ 37 weeks and ≤ 42 weeks Exclusion Criteria: congenital diseases or malformations that may inhibit growth prenatal and/or postnatal diseases parents are expected to have difficulty complying with the feeding regime planned re-admittance to the hospital in the first 14 days of life antibiotic treatment at the time of enrollment in the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 24 Hours

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Formula + placebo<br> | Dietary Supplement: Probiotic<br> <br> |
| Experimental: Formula + probiotic<br>Formula + probiotic | Dietary Supplement: Probiotic<br> <br> |
| Experimental: Breastfed + probiotic<br>Breastfed + probiotic | Dietary Supplement: Probiotic<br> <br> |
| Placebo Comparator: Breastfed + placebo<br> | Dietary Supplement: Probiotic<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of diarrhea episodes between a probiotic vs. placebo |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea duration between a probiotic vs. placebo |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean section, probiotic, formula fed, gut microbiota
Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate Hyperplasia

Study Overview
=================
Brief Summary
-----------------
This study has 4 phases: screening phase (visit 1), treatment phase (visit 2 - 6 mths after treatment initiation), and end of treatment phase (visit 3 - end of year 1). Only in the case a serious adverse event (SAE) arises, will there be a follow up phase (visit 4).

Official Title
-----------------
A Pharmacovigilance Study to Evaluate Safety of AVODART (Dutasteride) Administration 0,5 mg Once Daily, for 52 Weeks, in Subjects With Benign Prostate Hyperplasia

Conditions
-----------------
Benign Prostatic Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject should fulfil criteria for the subscription of AVODART as these are mentioned in the SPC Subject should be diagnosed with benign prostate hyperplasia Subject's prostate volume should be equal or greater than 30 cm3 Exclusion Criteria: Known hypersensitivity to any of the AVODART compounds Suffers from a serious illness which either is not properly controlled or as per investigator´s judgment could interfere with the subject´s compliance into the trial Receives treatment with enzyme inhibitors CYP3A4 and CYP3A5. History of severe liver failure
Sexes Eligible for Study
-----------------
Male

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
benign prostate hyperplasia, Dutasteride, pharmacovigilance
Coronavirus Disease 2019 (COVID-19) Study of Hospitalized Patients in Hong Kong

Study Overview
=================
Brief Summary
-----------------
COVID-19 may cause another world-wide epidemic. This study is divided into 2 arms: (1) Prospective longitudinal observational study involving patients with laboratory-confirmed COVID-19 and (2) Retrospective study on patients with laboratory-confirmed COVID-19. Arm 1: We will collect EDTA blood, stool samples, rectal swab, urine, saliva, and specimens from upper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratory tract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis as appropriate. Arm 2: The remainder of specimens that were submitted for laboratory investigation as part of clinical management will be retrieved. Those specimens will only be used after all clinically indicated testing and confirmation procedures have been completed. Assistance from the Public Health Laboratory Service, Department of Health, will be invited to retrieve samples as well as participate in this study. Patients hospitalized for pneumonia in medical wards and ICU at the Prince of Wales Hospital tested negative for COVID-19 will be recruited as controls. Understanding the clinical, virological, microbiological and immunological profiles of this infection is urgently needed to facilitate its management and control.

Official Title
-----------------
Comprehensive Clinical, Virological, Microbiological, Immunological and Laboratory Monitoring of Patients Hospitalized With Coronavirus Disease 2019 (COVID-19)

Conditions
-----------------
Coronavirus Infections

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case are adults age ≥ 18 years old admitted to hospital with laboratory confirmed COVID-19 Controls are patients admitted for community-acquired pneumonia Exclusion Criteria: Patients who refuse to consent for study

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: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical | Patients' treatment and management during hospitalization. | 6 months | 
| Virological | Serial viral load changes during hospitalization. | 6 months | 
| Microbiological | Alterations in fecal microbiota composition (including virome, bacteria and fungi) in COVID-19 patients compared with healthy controls. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, Coronavirus disease 2019