linjc16/ctgov huggingface dataset:
Validation and Predictive Equation for Sit-to-stand Test in Children

Study Overview
=================
Brief Summary
-----------------
Validation and development of predictive values for the one minute sit-to-stand test in children between 6 and 18 years.

Official Title
-----------------
Validation and Predictive Equation for Sit-to-stand Test in Children

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: sit-to-stand test
* Other: six minute walking test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participation in the national physical education program at school free of physical activity during one hour preceding the experiments Exclusion Criteria: diagnosis of chronic lung, cardiac or neuromuscular disease BMI higher than 85th percentile for children of the same age and sex a motor disability based on parents' answer to standardized questions.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sit-to-stand<br> | Other: sit-to-stand test<br>* to sit and stand from a chair<br>|
| Active Comparator: six minute walking test<br> | Other: six minute walking test<br>* to walk for six minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of sit-to-stand |  | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulsed oxygen saturation |  | 1 minute | 
| heart rate |  | 1 minute |
Early and Late Implant Failure

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the early and late implant loss rate in a sample of patients who had received implant-supportive restorative therapy in a university setting. Moreover, the study aimed to identify patient- and implant-related variables for implant failure

Official Title
-----------------
Implant Failure and Risk Indicators

Conditions
-----------------
Dental Implant Failed, Peri-Implantitis

Intervention / Treatment
-----------------
* Behavioral: Presence or absence of implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women over 18 years old Partially or totally edentulous patients with at least one implant placed at the university and at least 7 years before. Cemented, screwed, or mechanically retained prosthesis. Single and partial prostheses, as well as complete arch prosthesis (fixed and removable). Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Presence or absence of implant|We procedure to observed clinically the sample size, to be able to determine if the dental implant was present or no. If the implant was absent we recorded if it was early( prior to restoration) or late ( after prosthesis was delivered).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival | Early implant loss and late implant loss | October 2017 to March 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant failure | biological and mechanical complications | October 2017 to March 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental implant survival, implant failure, early implant failure, late implant failure
Imatinib in Adult Patients With Metastatic Ocular Melanoma

Study Overview
=================
Brief Summary
-----------------
The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.

Detailed Description
-----------------
Further study details as provided by Centre Oscar Lambret

Official Title
-----------------
A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic ocular melanoma Age > or = 18 years old Measurable metastases > or = 10 mm according to RECIST criteria PS-WHO < or = 1 or IK > 70 percent Normal hepatic function PNN > 1500/mm3, platelets > or = 100 000/mm3 Contraception Informed consent signed Exclusion Criteria: Patient with two prior lines of systemic treatment (chemotherapy, immunotherapy or association) Other evolutive neoplasic disease Severe hepatic insufficiency Severe renal insufficiency Somatic or psychiatric co-morbidity incompatible with the protocol Leptomeningeal or cerebral metastatic dissemination Pregnant or lactating woman Other antitumoral treatment Patient participating to another clinical trial with an experimental drug Known hypersensitivity to Imatinib or one of its excipients Resecable single metastasis

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

| Intervention/Treatment |
| --- |
|Drug: Imatinib|800 mg/day until disease progression or toxicity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free rate at 3 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free rate at 6 and 12 months |  |  | 
| Response rate according to RECIST criteria |  |  | 
| Toxicity |  |  | 
| Global survival,Progression-free survival |  |  | 
| Predictive genomic factors of response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular, Metastatic melanoma
Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating Gel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to check the safety under normal conditions of use through the emergence of signs of irritability and sensitization of the genital mucosa.

Official Title
-----------------
Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating Gel

Conditions
-----------------
Female Dry Genital Mucosa

Intervention / Treatment
-----------------
* Device: KL029 Intimate Lubricant Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age between 25 to 55 years old Regular Menstrual Cycle Intact skin in product analysis área No prior reactions to topical products Being a user of products from the same category Reading, understanding, agreement and signature of the informed consent form Exclusion Criteria: Pregnancy or risk of pregnancy Lactation Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection; Diseases that cause imune suppression; Endocrine disorders such as thyroid, ovarian or adrenal gland disorders; Any infection in the region where the product will be analyzed diagnosed at enrollment; Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Device: KL029 Intimate Lubricant Gel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence of signs of irritability and sensitization in the genital mucosa through Wilcoxon test | For the safety assessment, the variables will be evaluated for each experimental period using one-tailed Wilcoxon test to investigate the following hypotheses: H0: The median of the results of the variable under study is zero (no irritation) H1: The median of the results of the variable under study is greater than zero (no irritation) The Wilcoxon test is used because it is the ideal to compare variables collected with ordinal scale with a reference value. In this study, the reference value is zero (no irritation). The expectation is the absence of positive safety, ie higher scores than zero. If there are positive evidence of (mild, moderate or severe) for parameters erythema, peeling,blistering and swelling, the results are statistically evaluated. | 40 days |
Treatment of Choledocolithiasis by Laparoscopic Exploration

Study Overview
=================
Brief Summary
-----------------
There are three treatment options for choledocholithiasis: endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy; laparoscopic exploration of the main bile duct with concomitant cholecystectomy; and open cholecystectomy with exploration of the main bile duct. A retrospective, descriptive, observational study was taken of patients with a diagnosis of cholecystocholedocholithiasis that failed ERCP and who underwent laparoscopic cholecystectomy with exploration of the bile duct.

Detailed Description
-----------------
this study was revision of clinical files.

Official Title
-----------------
Treatment of Choledocolithiasis by Laparoscopic Exploration of The Bile Tract After Failed Endoscopic Cholangiopancreatography

Conditions
-----------------
Choledocholithiasis

Intervention / Treatment
-----------------
* Other: none, this is an observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service Exclusion Criteria: Less than 18 year old

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: none, this is an observational study|none, this is an observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TREATMENT OF CHOLEDOCOLITHIASIS | TREATMENT OF CHOLEDOCOLITHIASIS AFTER FAILED ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY | 2009-2018 |
Analysis of Intestinal Defensin Expression in Acute GVHD

Study Overview
=================
Brief Summary
-----------------
This study has the aim to analyze intestinal expression of endogenous antimicrobial peptides in patients with acute GVHD. The expression will be compared to intestinal expression of defensins in patients with colitis and patients without intestinal inflammation.

Detailed Description
-----------------
Acute graft-versus-host disease (GVHD) is a major cause of morbidity and mortality in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT). Acute GVHD is characterized by complex deficiencies of the mucosal antimicrobial barrier and intestinal dysbiosis, which contribute to disease pathogenesis. Defensins are endogenous epithelial cell-derived antimicrobial peptides, which can protect epithelial barrier integrity, shape the intestinal microbiota composition and contribute to host immunoregulation. Deregulated expression of defensins has been reported in patients with colitis, including Chron's Disease and ulcerative colitis. In this study, the investigators aim to analyze the expression of defensins in the intestine of patients with acute GVHD to study whether it is deregulated. The results will be valuable to study the role of defensins during acute GVHD pathogenesis or as potential biomarkers for disease activity.

Official Title
-----------------
Analysis of Intestinal Defensin Expression in Patients With Acute Graft-versus-Host Disease (GVHD)

Conditions
-----------------
GVHD,Acute, Ulcerative Colitis, Morbus Crohn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years diagnostic endoscopy was performed diagnosis results available written informed consent ability to understand the nature of the study and the study related procedures and to comply with them Exclusion Criteria: age < 18 years gastrointestinal cancer lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uninflamed intestine<br>Patients who underwent diagnostic endoscopy and received a diagnosis of no intestinal inflammation | |
| Colitis<br>Patients with active colitis | |
| Acute GVHD<br>Patients with acute gastrointestinal (GI) GVHD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defensin Expression (mRNA) | Analysis of alpha-defensin and beta-defensin mRNA expression by realtime PCR (qRT-PCR) | 3 years | 
| Defensin Expression (peptide) | Analysis of alpha-defensin and beta-defensin levels by immunohistochemistry | 3 years |
Metabolic Syndrome of Occupational Drivers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to discover the health status of occupational drivers. The health status includes data collection of body mass index, blood pressure, central obesity, anxiety scale scores, smoking habit and related cessation therapy, etc.

Detailed Description
-----------------
Occupational drivers' health is essential for passengers' safety. However, occupational drivers' health is damaged by long-term sitting and driving, lack of exercise, stress from traffic, and irregular diet. The objectives of this study were to assess the health status of occupational drivers in Taiwan. The measures included blood pressure, central obesity, fasting blood sugar, triglyceride, body mass index (BMI), anxiety scale scores, and metabolic syndrome, etc.

Official Title
-----------------
Analysis of Health Status of Occupational Driver

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metabolic syndrome hypertension anxiety scale scores Exclusion Criteria: hyperuricemia

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 64 Years

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

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

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
-----------------
occupational drivers, health status
Predictors of Anticoagulation Control on Warfarin Therapy

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to develop better dosing of anticoagulation medication in both Caucasian and African Americans through analysis of various genetic factors.

Detailed Description
-----------------
This is a prospective cohort study among adult patients requiring warfarin therapy. Patients presenting for anticoagulation will be identified at the start of therapy and followed throughout their course until they reach maintenance dose. We will then develop a dosing equation for warfarin using patient, environmental and genetic factors.

Official Title
-----------------
Predictors of Anticoagulation Control on Warfarin Therapy

Conditions
-----------------
Atrial Fibrillation, Deep Vein Thrombosis, Heart Valve Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Caucasians and African Americans who are new to warfarin therapy Exclusion Criteria: Under 21 years of age Non caucasian Non african american Have an abnormal INR before warfarin or heparin therapy Unable to provide consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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
-----------------
Atrial Fibrillation, deep vein thrombosis, anticoagulation, warfarin, coumadin
Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival

Study Overview
=================
Brief Summary
-----------------
This study was conducted to compare the significance of lymph node ratio and absolute count of positive lymph node count on overall survival in patients with rectal cancer who underwent resection with curative intent

Detailed Description
-----------------
Retrospective cohort study carried on 229 patients with non-metastatic rectal cancer, admitted in tertiary hospitals along 10 years, between 2012 to 2022, and underwent radical resection surgery with curative intent. Exclusion criteria included patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, early post-operative recurrence or death within 3 months. Demographic, histopathological, follow up and outcome data were collected. Demographics included age, gender, family history, and chief complaint at presentation. Histopathological data included tumor site, grade, vascular-perineural invasion, total number of lymph nodes removed, and positive lymph nodes. Lymph node ratio was defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in histopathology specimen. Survival was calculated for each patient based on time of surgery to time of death Statistical analysis will be used to evaluate the effect of lymph node ratio on overall survival.

Official Title
-----------------
Prognostic Significance of Lymph Node Ratio in Rectal Cancer on Overall Survival: An Alternative Not a Substitute

Conditions
-----------------
Cancer, Rectum

Intervention / Treatment
-----------------
* Other: Surgical resection for cancer rectum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with rectal cancer of stage I-III. patients underwent radical resection with curative intent. Exclusion Criteria: Patients with Familial Adenomatous Polyposis, multiple synchronous or metachronous rectal cancers. Early post-operative recurrence, or death within 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Surgical resection for cancer rectum|Curative resection for cancer recum|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Survival was calculated for each patient based on time of surgery to time of death. | up to 10 years (From date of surgery to the date date of death) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer Rectum, Lymph node ratio, Overall Survival, Prognosis
Effects of Exposed to Antipsychotics Throughout Pregnancy on Infants Development: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The primary aim of this prospective study is to evaluate the effect of antipsychotics on infant development especially neurobehavioral development which evaluated by the Bayley-III when mothers are treated with antipsychotics throughout their pregnancy.

Detailed Description
-----------------
The neurodevelopmental effect of antipsychotics on fetus has always been a major concern for women who need antipsychotic treatments and are in their reproductive years. The fear of harmful effects from antipsychotic on fetus and unplanned pregnancy commonly causes non-adherence to treatments. Even for those who are willing to maintain their antipsychotic treatments during pregnancy, the fear of potential harmful effects from antipsychotic on fetus can still exist. It is well known that non-adherence to antipsychotic treatments in patients with schizophrenia can cause most to relapse and poor treatment response. The consequences of relapse not only increase personal suffering, but also increase family and societal burden.Clearly, it is important to evaluate the safety of antipsychotics during pregnancy. However, up to now, most information about antipsychotics on reproductive safety and the effects on infant development come from case reports, case series, and retrospective studies.So the study was to investigate the developmental effects of antipsychotics on infants who were exposed to as fetus.

Official Title
-----------------
Safety Study for Infants Who Exposed to Antipsychotics as Fetus

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newborns exposed to antipsychotic as fetus no exposed to antipsychotic Exclusion Criteria: malformation liver dysfunction renal dysfunction cardiovascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Day

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 |
| --- | --- |
| infants who were exposed to antipsychotics as fetus<br> | |
| infants who were not exposed to antipsychotics as fetus<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antipsychotic, schizophrenia, infant development