linjc16/ctgov huggingface dataset:
Study of a New Protease Inhibitor, BMS-232632, in Combination With Other Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a new protease inhibitor known as BMS-232632. This drug will be given in combination with 2 other anti-HIV drugs (stavudine and didanosine). The effectiveness of BMS-232632 against HIV infection will be compared to that of nelfinavir, a protease inhibitor that is already commonly prescribed.

Detailed Description
-----------------
Patients are randomized to receive one of two drug regimens: BMS-232632, ddI, and d4T or NFV, ddI, and d4T. Three different doses of BMS-232632 are used in this study. Randomization is stratified for HIV RNA level (less than 30,000 copies/ml versus 30,000 or greater copies/ml). Patients remain on their drug regimen for 48 weeks.

Official Title
-----------------
Evaluation of the Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, Alone and in Combination With d4T and ddI as Compared to a Reference Combination Regimen

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Atazanavir
* Drug: Nelfinavir mesylate
* Drug: Stavudine
* Drug: Didanosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have an HIV blood level between 2,000 and 200,000 copies/ml. Have a CD4 cell count of at least 100 cells/mm3. Are 18 years of age or older. Are available for follow-up for at least 48 weeks. Agree to use a barrier method of birth control (such as condoms) during the study. Exclusion Criteria Patients will not be eligible for this study if they: Have ever received anti-HIV (antiretroviral) treatment. Have an HIV-related opportunistic infection or condition at the time of study entry. Have primary HIV infection, meaning they have recently been infected. Have had severe diarrhea within the 30 days before study entry. Have hemophilia. Have a history of pancreatitis, hepatitis, or a peripheral neuropathy. Are unable to tolerate oral medication. Are pregnant or breast-feeding. Abuse alcohol or drugs.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atazanavir|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Stavudine|nan|
|Drug: Didanosine|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
-----------------
Stavudine, Didanosine, Dose-Response Relationship, Drug, Drug Therapy, Combination, HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Nelfinavir
Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.

Study Overview
=================
Brief Summary
-----------------
The objective of the present study was to analyze the differences between the formulas used to estimate fat mass and to establish the existing relationship with the skinfold sum in anthropometry. A total of 2,458 active subjects participated in the study (mean age: 27.98±7.43 years-old). Basic measurements and skinfolds variables were measured following the guidelines of the International Society for the Advancement in Kinanthropometry (ISAK), and Kerr, Durnin-Womersley, Faulkner and Carter equations were used to assess fat mass. Significative differences were found between all the formulas for the percentage of fat mass and the fat mass in kilograms. The correlations among the skinfolds sums and the different equations were high and significative in all the cases. There were differences between all the formulas used to estimate the fat mass. The six or eight skinfold sums could be a valid and better alternative than the fat mass equations or the BMI to assess the subcutaneous fat mass in physically active adults.

Official Title
-----------------
Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.

Conditions
-----------------
Body Weight Changes, Body Weight

Intervention / Treatment
-----------------
* Other: Anthropometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be between 18 and 50 years old and to practice any sport in a regular basis Exclusion Criteria: To have overweight or obesity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Anthropometry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass weight | Fat mass weight was assessed with skinfold measurements and different prediction equations. Measured in kilograms | 6 years | 
| Fat mass percentage | Fat mass percentage was assessed with skinfold measurements and different prediction equations. Measured in percentage of total weight. | 6 years | 
| Six and eight skinfold sums | Skinfolds were measured with a caliper, using anthropometry technique describes by ISAK | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Weight and height will be combined to report BMI in kg/m^2 | 6 years | 
| Weight | Measured in kilograms | 6 years | 
| Height | Measured in meters | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fat mass, Body composition assessement, Health, Antropometry
No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the effect of no-commercial enteral diet for patients in home nutritional therapy in anthropometric and biochemical indices comparing to patients using commercial enteral diets.

Official Title
-----------------
No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices

Conditions
-----------------
Malnutrition

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in home nutritional therapy receiving no-commercial enteral diets Exclusion Criteria: baseline diseases others than neurological

Ages Eligible for Study
-----------------
Minimum Age: 60 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary therapy Standardized diet<br>The study was constituted by sixty-six patients, thirty-three in each group. Patients on not industrialized enteral diet (standardized diet group) entered at random in the study and were matched by gender, age, socioeconomic status and medical diagnosis to patients using commercial diet (commercial group). The evaluation consisted of anthropometric measures of weight, height, arm circumference, triceps skin fold and biochemical índices at baseline and at the end of the intervention. | Dietary Supplement: Dietary therapy<br>* A enteral diet formulation was developed to meet dietary requirements of adult patients. The formulation was standarized in household measures so that caregivers would prepare it and delivered it at the patients' home. Anthropometric measurements and blood samples were taken at baseline and at the end of the intervention which lasted four months.<br>|
| No Intervention: Dietary therapy Commercial diet group<br>The study was constituted by sixty-six patients, thirty-three in each group. Patients on not industrialized enteral diet (standardized diet group) entered at random in the study and were matched by gender, age, socioeconomic status and medical diagnosis to patients using commercial diet (commercial group). The evaluation consisted of anthropometric measures of weight, height, arm circumference, triceps skin fold and biochemical índices at baseline and at the end of the intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of malnourished patients (weight, height, arm circumference) | weight, height, arm circumference | Two years |
mTOR Inhibitors: the Lesions Induced by Papillomavirus for Transplant Patients.

Study Overview
=================
Brief Summary
-----------------
The injuries induced by Human Papillomavirus (HPV) (anogenital condyloma mainly) are more frequent among transplanted patients due to their immunosuppression. These injuries are benign but they have a negative impact on the patients' quality of life. The initial treatment is topical and then surgical. The injuries can relapse, especially among transplanted patients. The modification of the immunosuppressant treatment with a switch to mTOR inhibitors (mammalian Target Of Rapamycin) has shown its efficacy in preventing the recurrence of squamous cell carcinomas or treating Kaposi's disease. By analogy, this therapeutic strategy can be sometimes put forward to transplanted patients with HPV-induced injuries. The principal objective of this study is to describe the evolution of HPV-induced lesions in solid organ transplant patients.

Official Title
-----------------
Study MOTIF : mTOR Inhibitors: the Lesions Induced by Papillomavirus for Transplant Patients

Conditions
-----------------
Transplantation Organ

Intervention / Treatment
-----------------
* Other: review of medical patient file


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (Age ≥ 18 years) Transplanted patient (any organ), having developed HPV-induced lesions after transplantation Patient followed or having been followed at Edouard Herriot Hospital (HEH) Patient having been informed and not having objected to participating in the study Exclusion Criteria: Transplanted patient without HPV-induced lesions

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: review of medical patient file|The outcome measure is the evolution of HPV related lesions between : favourable evolution including partial or total regression unfavourable evolution including non-evolution or aggravation or recurrence.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of HPV related lesions in patient with switch | At one year of the switch by an inhibitor of mTOR then remotely of the switch (by tacking the last medical encounter) for the patients concerned by the switch. | at inclusion | 
| Evolution of HPV related lesions in patient without switch | At one year of the first HPV related lesions care then remotely (by tacking the last medical encounter) for the patients without the switch. | at inclusion |
Internet Walking Program and Pedometer in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Higher levels of physical activity are associated with better functional status, fewer hospital admissions, and lower mortality. The investigators studied the feasibility and safety of a novel program that combines a pedometer with a website to increase walking. This is a pilot study.

Conditions
-----------------
COPD, Internet Access

Intervention / Treatment
-----------------
* Behavioral: website and pedometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD able to ambulate internet access Exclusion Criteria: current pulmonary rehab

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: website and pedometer<br> | Behavioral: website and pedometer<br>* use of pedometer and website<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily step count |  | 90 days |
Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19

Study Overview
=================
Brief Summary
-----------------
A case-control trial was conducted to test the early postpartum period clinical outcomes of newborns born to pregnant women with and without COVID-19.

Official Title
-----------------
Comparison of Early Postnatal Clinical Outcomes of Newborns Born to Pregnant Women With COVID-19: A Case-control Study

Conditions
-----------------
Covid19, Vertical Transmission of Infectious Disease, Neonatal Infection, Pregnancy Related

Intervention / Treatment
-----------------
* Diagnostic Test: Reviewed clinical records and laboratory results


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women on labor or preterm labor. Pregnant women who underwent programmed or emergence cesarean Exclusion Criteria: Those who were transferred to another hospital without or within a short period of delivery

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 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 |
| --- | --- |
| COVID-19 case group<br>Newborns born to pregnant women diagnosed with COVID-19 during hospitalization for delivery | Diagnostic Test: Reviewed clinical records and laboratory results<br>* Retrospectively reviewed clinical records and laboratory results<br>|
| Control group<br>Newborns born to pregnant women who were not diagnosed with COVID-19 in their medical history and hospitalization for delivery | Diagnostic Test: Reviewed clinical records and laboratory results<br>* Retrospectively reviewed clinical records and laboratory results<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertical transmission | Determine the prevalence of COVID-19 in newborns born to pregnant women with COVID-19 with PCR from a nasopharyngeal swab. | 48 hours after birth | 
| Neonatal birth outcomes | Determine the neonatal outcomes of the newborn specifying the birth week of the newborn, delivery type (vaginal or cesarean), birth weight (g), APGAR scores in the first and fifth minutes after birth. | At birth | 
| Neonatal postnatal outcomes | Determine the prevalence of neonatal postnatal outcomes of the newborn specifying the respiratory system illness, intensive care need, oxygen need, neonatal mortality, general health status, and breastfeeding status. | Within 48 hours after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childbirth, COVID-19, Neonatal outcomes, Newborn, Pregnant women, Vertical transmission
A Clinical Evaluation of the OrSense Non-invasive Blood Hb/Hct Measurement Instrument, the Hemo-Monitor NBM200/MP

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.

Detailed Description
-----------------
Each subject will be placed in a comfortable position in a temperature regulated room. Participants will have two consecutive non invasive (NBM) measurements taken which involves inserting the thumb into a ring shaped sensor. After each non invasive measurement the sensor will be removed. Each measurement takes approximately 85 seconds and involves the finger cuff inflating (to over systolic pressure) and deflating several times in quick successions in order to measure and calculate the Hb values. The two non invasive measurements will be performed using the same finger. After the NBM system testing is complete and recorded, the subject will have a venous (venipuncture) blood sample collected in order to provide two blood tests performed on two different models of routine automated complete blood count or Hb blood analyzers.

Official Title
-----------------
A Clinical Evaluation of the OrSense Non-invasive Blood Hb/Hct Measurement Instrument, the Hemo-Monitor NBM200/MP

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants aged 18 years and over Exclusion Criteria: Participants under the age of 18 years Patients with significant deformity, degenerative changes or oedema of the fingers or hand Patients with localized infection, ulceration or skin breaks involving the fingers Patients with vascular disease or Raynaud's phenomenon affecting the fingers (vasospasm) Participants who are unable to give informed written consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| anemia<br>Measuring Hb valuse on anemia patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compre the Hb values from the NBM200 series gainst the Hb from the lab blood analyser on Hematology pateints |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Accurte Hb noninvasive measurement
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy, safety and tolerability of topically administered diclofenac gel versus placebo with respect to the symptom score (pain, temperature and size of erythema along the superficial vein)

Official Title
-----------------
A One Week, Double-Blind, Adaptive, Randomized, Multicenter Study to Compare the Efficacy, Safety and Tolerability of Topical Diclofenac Gel Versus Placebo in Patients With Superficial Thrombophlebitis

Conditions
-----------------
Superficial Thrombophlebitis of the Upper Limb

Intervention / Treatment
-----------------
* Drug: Diclofenac gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with indication of topical treatment for inflammatory, painful superficial thrombophlebitis of the upper limb Spontaneous or iatrogenic superficial thrombophebitis of the upper limb Exclusion Criteria: Hypersensitivity to the study drug, to actylsalicyclic acid and other non-steroidal antirheumatic agents and to the ingredients of the gel Paitents who had developed asthma, skin reactions or acute rhinitis to acetylsalicylic acid or other non-steroidal antirheumatic agents in the past Therapy with varicose vein remedies, antithrombotic or antiphlogistic agents as well as corticosteroids for more than 7 days prior to study start Acute deep vein thrombosis and thrombophlebitis extending into other deep veins Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Diclofenac gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's global assessment of drug effect at each visit |  |  | 
| Physician's global assessment of drug effect at each visit |  |  | 
| AUC of assessment of pain (visual analog scale) between treatment day 1 and day 5 |  |  | 
| AUC of assessment of inflammatory area of the superficial thrombophlebitis between treatment day 1 and 5 |  |  | 
| AUC of assessment of temperature of inflammatory area around superficial thrombophlebitis between treatment day 1 and 5 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs