linjc16/ctgov huggingface dataset:
Limb Loss Self-Management Program

Study Overview
=================
Brief Summary
-----------------
The goal of the project is to develop and test the efficacy of a community-based self-management intervention for reducing pain, depression, and improving self-efficacy and function in person with limb loss

Detailed Description
-----------------
Approximately 1.2 million Americans are living with the loss of a limb and the incidence is increasing due to increases in the prevalence of diabetes. Pain, emotional distress, reduced functional abilities are common conditions following limb loss and reduce quality of life. Self-management interventions have been found to be effective in reducing the secondary conditions associated with arthritis and diabetes. Self management uses the principles of cognitive-behavioral therapy including education, self monitoring, problem solving, and skill acquisition. The goal of the project is to develop and test the efficacy of a community based self management intervention for reducing pain, depression, and improving self efficacy and function in persons with limb loss using a randomized controlled design. 50 groups of 8-10 persons will be randomized to either a control group or a treatment group.

Official Title
-----------------
Limb Loss Self-Management Program: Promoting Amputee Life Skills

Conditions
-----------------
Congenital or Acquired Limb Deficiency

Intervention / Treatment
-----------------
* Behavioral: Community-based eight session group self-management program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 or older congenital or acquired limb loss Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Community-based eight session group self-management program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported pain |  |  | 
| depressed mood |  |  | 
| positive affect |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in activities and participation |  |  | 
| improved quality of life |  |  |
Endometriosis and Brominated Flame Retardant (ENDOTOX Study)

Study Overview
=================
Brief Summary
-----------------
The investigators wish to highlight, in a Case-Control design, if there is an increased concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis with surgical indication ) versus bioaccumulation recorded in a control cohort ( women recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis ) . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes described by the HAS) and previous breastfeeding experience (yes / no , opposite the release expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .

Official Title
-----------------
Looking for a Link Between Endometriosis and Exposure to Lipophilic Environmental Chemicals Like Brominated Flame Retardant (ENDOTOX Study)

Conditions
-----------------
Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criterion for de cases : Age : 18-45 years old Deep endometriosis with or without endometriomas that need surgery (clinical examination, MRI, surgery) Accessing to the omental and/or parietal adipose tissue Non opposition of the patients for the samples collection and consent for the present study. Inclusion criterion for the controls : Patients without any history of endometriosis and without suggestive symptomatology. Often patients operated for cesarean section. Possible access to the adipose tissue of the omentum or abdominal wall Exclusion criterion for the cases : Pregnancy Death Exclusion criterion for controls : Pregnancy Death

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case Group<br>38 women with severe and deep endometriosis, aged 18 to 45 years old and hospitalized at Nantes University Hospital for surgical indication of endometriosis lesions ablation. | |
| Control Group<br>38 women aged 18 to 45 years old without suggestive signs of endometriosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of brominated flame retardant (BFR) in adipose tissue and serum |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of dioxins in adipose tissue and serum |  | baseline | 
| Concentrations of polychlorinated biphenyls (PCBs), |  | baseline | 
| Concentrations of organochlorine pesticides (OCPs) in adipose tissue and serum |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis, chemical contaminants, BFRs
Methylome Study in Sporadic Limb Malformations

Study Overview
=================
Brief Summary
-----------------
Some limb malformations are known to be sporadic (non hereditary). For these malformations, no molecular cause was identified, even after whole genome sequencing. Methylation of CpG islands is an epigenetic process which is usually not transmitted to the descents. We hypothesize that sporadic limb malformations may be due to a methylation anomaly. This study will include patients with Amelia or Femur Fibula Ulna Syndrome. With patients consent, we will study the methylome on DNA samples already available in our laboratory. Each patient sample will be paired to a control of same tissue, age and sex. By bioinformatics comparison, we will identify differentially methylated candidate regions.

Official Title
-----------------
Methylome Study in Patients Affected With Sporadic Limb Malformations

Conditions
-----------------
Amelia, Femur Fibula Ulna Syndrome

Intervention / Treatment
-----------------
* Other: Methylome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Specific consent for this study DNA available in the laboratory For amelia : agenesia of 2 or 4 limbs For Femur-Fibula-Ulna Syndrome : hypoplasia or agenesia of the femur uni or bilateral with hypoplasia or agenesia or bowing of the fibula and/or of the ulna Exclusion Criteria: No consent No available DNA or poor quality of the DNA sample Patient under tutorship Pregnancy or nursing mother Patient non covered by the French social security
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 |
| --- | --- |
| Patients with amelia<br>Patients with severe hypoplasia or agenesia of at least two limbs who gave their consent for the research and for whom a DNA sample is available in our laboratory | Other: Methylome<br>* Epigenetic study : analysis of DNA methylation<br>|
| Patients with Femur-Fibula-Ulna Syndrome<br>Patients with anomaly of at least one femur, one fibula and with oligodactyly who gave their consent for the research and for whom a DNA sample is available in our laboratory. | Other: Methylome<br>* Epigenetic study : analysis of DNA methylation<br>|
| Healthy subjects<br>Healthy subjects used as controls, who gave their consent for the research and for whom a DNA sample is available in our laboratory. | Other: Methylome<br>* Epigenetic study : analysis of DNA methylation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differentially Methylated Regions |  | through study completion an average of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amelia, Femur-Fibula-Ulna Syndrome, Methylation, Limb development, Gene regulation
Diurnal Variation in Rectal Diameter

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the diurnal variation of rectal diameter in healthy and constipated children using transabdominal ultrasound.

Official Title
-----------------
Diurnal Variation in Rectal Diameter Measured by Transabdominal Ultrasound in Healthy and Constipated Children.

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Procedure: Transabdominal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Constipated Inclusion Criteria: Children from 4 to 12 years with previously diagnosed simple constipation defined by ROME III criteria, which at inclusion is in maintenance therapy with PEG + E and has been in treatment for at least 1 month. Exclusion Criteria: Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases. Children receiving drugs known to affect bowel function during a 2 month period before initiation besides laxatives. Healthy inclusion Criteria: Children between 4 and 12 years of age. Healthy exclusion Criteria: Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases. Children receiving drugs known to affect bowel function during a 2 month period before initiation. Children with a previous history of constipation, fecal incontinence and / or urinary tract infections.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 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 |
| --- | --- |
| Healthy<br>Transabdominal ultrasound | Procedure: Transabdominal ultrasound<br>* Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.<br>|
| Constipated<br>Transabdominal ultrasound | Procedure: Transabdominal ultrasound<br>* Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectal diameter |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
constipation, children, healthy, rectal diameter
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants

Study Overview
=================
Brief Summary
-----------------
Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB nomogram. The investigators hypothesize that the hour-specific TcB nomogram can predict neonatal hyperbilirubinemia in term and late-preterm Chinese infants, and plan appropriate follow-up for hyperbilirubinemia in newborns.

Detailed Description
-----------------
Neonatal hyperbilirubinemia is very common; it is not always a benign condition. If left untreated, it can have devastating consequences including cerebral palsy and hearing loss. It is therefore critical to be able to identify the newborns at risk for severe hyperbilirubinemia.

Official Title
-----------------
Development of Transcutaneous Bilirubin Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants: a Multicenter Study in China

Conditions
-----------------
Hyperbilirubinemia, Neonatal

Intervention / Treatment
-----------------
* Device: Transcutaneous bilirubinometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term or late-preterm newborn infants with GAs of ≥35 weeks and birth weights of ≥2,000 g were included. Exclusion Criteria: All sick newborn infants who were admitted to the intensive care unit.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcutaneous bilirubinometry|Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of transcutaneous bilirubin levels from baseline to each postpartum examination up to 168 hr after birth | During the first postnatal day, transcutaneous bilirubin (TcB) measures were performed at 12-hour time intervals up to the age of 168 hr. TcB data are used to develop an hour-specific TcB nomogram. | Every 12 hr for 168 hr. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive ability of an hour-specific TcB nomogram | Evaluate the rate of rise of bilirubin for different time periods and percentile curves and to assess predictive ability of these percentile curves for hyperbilirubinemia, defined as requirement of phototherapy. | At the 28 days after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperbilirubinemia, Neonatal, Transcutaneous Bilirubin
Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of Connective Tissue Graft and Pediculated-Connective Tissue Graft for extraction socket closure on soft tissue landmarks and ridge dimensions.

Detailed Description
-----------------
45 subjects were randomized into two groups Experimental: Main treatment group P-CTG group Active Comparator: Control group CTG group.

Official Title
-----------------
Effect of Two Methods of Soft Tissue Augmentation for Socket Closure on Soft Tissue Landmarks and Ridge Dimensions- Results From Software-based Analysis of Clinical Data

Conditions
-----------------
Recession, Gingival

Intervention / Treatment
-----------------
* Procedure: P-CTG
* Procedure: CTG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Based on the Extraction Defect Sounding(EDS) Classification given by Caplanis et al, Systemically healthy subjects within the age group of 20-50years with extraction defect type 2 and type 3 were included in this study Exclusion Criteria: Medically compromised patients Subjects who underwent radiotherapy or chemotherapy and Smokers

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 45 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main treatment group<br>soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG) | Procedure: P-CTG<br>* soft tissue closure of extraction sockets was done by pediculated connective tissue grafts (P-CTG)<br>* Other names: Experimental group;|
| Active Comparator: Control group<br>soft tissue closure of extraction sockets was done by connective tissue grafts (CTG) | Procedure: CTG<br>* soft tissue closure of extraction sockets was done by connective tissue grafts (CTG)<br>* Other names: Control group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BL Gain | The displacement from the baseline to 6-months in BL dimensions was calculated and was described as BL gain. | Baseline to 6 months | 
| Total displacement (TD) | The total displacement (TD) from the baseline to 6-months in MD dimensions was calculated and was described as TD gain. | Baseline to 6 months | 
| Angle of Displacement (AOD) | The Angle of Displacement (AOD)) from the baseline to 6-months in MD dimensions was calculated and was described as AOD Change. | Baseline to 6 months |
Insulin Resistance and Severity of Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
this is an observertional study aimed at Study the association between Insulin resistance estimated by HOMA and Angiographic Severity of Coronary Artery Disease in Non Diabetic & Non Obese Patients.

Official Title
-----------------
HOMA Estimated Insulin Resistance as a Marker for Angiographic Severity of Coronary Artery Disease in Non Diabetic & Non Obese Patients.

Conditions
-----------------
Insulin Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing coronary angiography (CA) for ACS or stable angina in the Catheterization Laboratory of internal Medicine department and El Noor specialized cardiac center at the study period. Exclusion Criteria: age < 18 years, pregnancy or breastfeeding, BMI >30 Kg/m2 and presence of pre-diabetes or overt diabetes.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group1<br>subjects with evidence of insulin resistance estimated by high HOMA level | |
| group 2<br>subjects without insulin resistance estimated by normal HOMA level | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA IR level estimated by Two-site immunoenzymometric assay |  | 4 months |
Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin

Study Overview
=================
Brief Summary
-----------------
Portal hypertension is not a disease in itself. Rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by more than 5 mm Hg.

Detailed Description
-----------------
Indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic C infection, it may also reduce hepatic vascular resistance and portal pressure by improving liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis, so it could be an effective therapy for portal hypertension. It might even improve survival of patients with cirrhosis after variceal bleeding.

Official Title
-----------------
Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin

Conditions
-----------------
Portal Hypertension

Intervention / Treatment
-----------------
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive diagnosis of cirrhosis by US (coarse echogenic pattern, bulky caudate lobe, attenuated hepatic veins) Clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly, ascites and encephalopathy grade I-II) Exclusion Criteria: Pregnancy Hepatic encephalopathy grade III-IV Hepatocellular carcinoma Treatment with statins in the previous 3 months Hypersensitivity to statins Previous surgical shunt or TIPS Treatment with calcium channel blockers
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simvastatin<br>Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks | Drug: Simvastatin<br>* Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks plus the routine treatment<br>* Other names: Corvast;|
| No Intervention: no treatment<br>no treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Reduced Portal Pressure After Intervention | the number of Patients with Reduced Portal Pressure After Intervention | 6 Months |