linjc16/ctgov huggingface dataset:
Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine wether autologous bone graft from iliac crest enhances bone union of tibial osteotomies, in the treatment of varus knee deformity.

Detailed Description
-----------------
Opening-Wedge High Tibial Osteotomy is a classic procedure,but the use of autologous bone graft from iliac crest causes pain and bleeding. Bone union occur even without bone graft, but no clinical trials compared results of the twoo procedures.

Official Title
-----------------
Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy. A Randomized Clinical Trial

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: high tibial osteotomy
* Procedure: higi tibial osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: varus knee deformity unicompartmental arthrosis Exclusion Criteria: patellar arthrosis lateral arthrosis inflammatory diseases bone healing impair drugs or diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>autologous bone graft | Procedure: high tibial osteotomy<br>* addition of bone graft to fill the osteotomy gap<br>* Other names: opening-wedge higi tibial osteotomy;|
| Experimental: 2<br>without bone graft | Procedure: higi tibial osteotomy<br>* the gap of the tibia is unfilled<br>* Other names: opening-wedge higi tibial osteotomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical based bone union time |  | after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X-ray femoro-tibial angle |  | 6 months, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteotomy, knee, varus deformity, bone graft
Antenatal Micronutrient Supplementation and Birth Weight

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of Nepal.

Detailed Description
-----------------
Maternal micronutrient deficiencies are common in the developing world and may influence intrauterine growth and fetal and neonatal health and survival. Currently, policies for antenatal supplementation beyond iron-folic acid are not in place in these settings. And yet, the efficacy of such supplementation strategies has not been well established. Specifically, it is not clear if multiple micronutrient combinations will enhance fetal growth and newborn health and survival compared to single or smaller combinations of micronutrients. Also, while birth weight may serve as a proxy measure of newborn health, infant morbidity and mortality needs direct examination. Comparisons: Pregnant women received daily folic acid, folic acid plus iron, folic acid plus iron plus zinc, or a multiple micronutrient supplement containing 11 other nutrients all with vitamin A compared to a control group that received only vitamin A.

Official Title
-----------------
Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal

Conditions
-----------------
Low Birth Weight, Infant Mortality, Pregnancy, Nutritional Status

Intervention / Treatment
-----------------
* Drug: Nutritional supplements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Married women of reproductive age identified as a new pregnancy using a urine test Exclusion Criteria: Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant <9 months of age

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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: Nutritional supplements|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight |  |  | 
| 3-month infant mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant morbidity |  |  | 
| Maternal morbidity |  |  | 
| Maternal nutritional status |  |  | 
| Weight gain during pregnancy |  |  | 
| Infant growth |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Micronutrients, Supplementation, Pregnancy, Birth weight, Infant mortality
Screening Expiratory Flow Limitation by Flow-time Curve

Study Overview
=================
Brief Summary
-----------------
Expiratory flow limitation (EFL) is defined as a dynamic condition that expiratory flow cannot be further increased with higher expiratory driving pressure. Under mechanical ventilation, it can cause intrinsic positive end-expiratory pressure (PEEP) and dynamic hyperinflation, and be associated with worse clinical outcome. The detection of EFL however needs special maneuvers and offline analysis of flow-volume curves, which are infeasible in routine practice and cannot be used during real-time monitoring. The investigators propose a new and simple approach using flow derived parameters to detect EFL in real time without needing any intervention.

Official Title
-----------------
Screening Expiratory Flow Limitation by Flow-time Curve

Conditions
-----------------
ARDS, Human

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years, intubated or tracheostomized Receiving invasive mechanical ventilation in assist/control mode with PEEP ≥ 5 cmH2O Receiving continuous intravenous sedation Displaying a monotonous regular breathing pattern with no obvious asynchrony Exclusion Criteria: Severe hypoxemia in baseline clinical ventilator settings (SpO2 < 90%) Hemodynamic instability (mABP <60 mmHg, systolic arterial pressure >180 mmHg, heart rate <40/min or >150/min)

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome (Presence / absence of EFL) will be determined by off-line analysis of recorded flow-volume loops during PEEP reduction. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of intrinsic PEEP caused by the EFL. |  | 2 years |
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging

Study Overview
=================
Brief Summary
-----------------
Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging

Detailed Description
-----------------
The aim of this study is to obtain human muscle samples for cell culturing to analyze muscle cell development in real-time to uncover factors that influence growth.

Official Title
-----------------
Mapping Human Muscle Satellite Cell Fate By Real-Time

Conditions
-----------------
Flaccid Muscle Tone

Intervention / Treatment
-----------------
* Procedure: muscle biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
-Inclusion Criteria: men 20-29 yrs BMI between 20 and 34.9 Fasting Glucose <110 mg/dL Blood Pressure <160/100mm Hg Non-Diabetic LDL-Cholesterol <160mg/dL Triacylglycerol <400 mg/dL Makers of kidney, liver, and heart functions within 10% of clinical normalcy <1.5hr /wk of habitual aerobic exercise training and no resistance exercise training in the past 6 months Exclusion Criteria: men <20or>29 yrs BMI between <20 and >34.9 Fasting Glucose >110 mg/dL Blood Pressure >160/100mm Hg Non-Diabetic LDL-Cholesterol >160mg/dL Triacylglycerol >400 mg/dL Pre-existing kidney or liver conditions -->1.5hr /wk of habitual aerobic exercise training and no resistance exercise training in the past 6 months Currently taking prescribed blood thinners

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: muscle biopsy<br>a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed | Procedure: muscle biopsy<br>* a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging | this study is to obtain human muscle samples for cell culturing which will be exposed to a novel real-time imaging technique in order to elucidate factors that influence muscle satellite cell growth. | <10 hrs |
Database of Data Collection

Study Overview
=================
Brief Summary
-----------------
For several years, the Paoli-Calmettes Institute has been centralizing the retrospective collection of clinical data of patients operated on for histologically proven breast cancer.

Detailed Description
-----------------
The current cohort (G3S) fed by more than 20 centers has more than 25,000 patient records. The collection centralizes the main characteristics of the patients, the tumor and the treatments. Also included are the date of first recurrence, the localization (local, regional or distant) as well as the death or the date of the latest news. The current database is also updated regularly.

Official Title
-----------------
Database of Data Collection in Senological Surgery

Conditions
-----------------
Surgery of Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Surgery of breast cancer
* Other: Clinical data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients operated for histologically proven breast cancer. Exclusion Criteria: Patient below age of 18 years

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients operated for breast cancer<br>patients operated for histologically proven breast cancer | Procedure: Surgery of breast cancer<br>* Surgery of breast cancer<br>Other: Clinical data collection<br>* The collection centralizes the main characteristics of the patients, the tumor and the treatments. Also included are the date of first recurrence, the localization (local, regional or distant) as well as the death or the date of the latest news.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| follow-up of patients operated for breast cancer |  | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, breast cancer
Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)

Study Overview
=================
Brief Summary
-----------------
This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.

Official Title
-----------------
A Multi-centre, Single Intravenous Dose, Exploratory Dose-finding, Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP) in RhD Positive, Non-splenectomized Adult Subjects.

Conditions
-----------------
Immune Thrombocytopenic Purpura

Intervention / Treatment
-----------------
* Drug: Sym001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed presence of thrombocytopenia with platelet count < 30,000/mm3 at the pre-dose visit. History of isolated ITP RhD-positive serology. Previous treatment and response to first line therapy for ITP Exclusion Criteria: Known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings. Suspected infection with HIV, Hepatitis C, H. pylori. Clinical splenomegaly History of abnormal bone marrow examination. Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale. Underlying haemolytic condition History of splenectomy. Subject is pregnant, breast feeding or intends to become pregnant.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients treated with Sym001 | Drug: Sym001<br>* Each cohort will receive one single dose of Sym001 according the assigned dose level.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs) |  | 6 weeks post dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of platelet counts |  | From day 1 through week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic, ITP
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are: To examine the side effects and patient acceptability of oral versus intravaginal metronidazole. To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV To study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.

Detailed Description
-----------------
This is a randomized, placebo-controlled intervention trial. Women diagnosed as BV+ by Gram stain at 12-16 weeks gestation are randomly assigned to the following treatment groups: oral metronidazole (250 mg TID x 7 days) with intravaginal placebo; intravaginal metronidazole (5g 0.75% gel BID x 5 days) with oral placebo. African American, Hispanic, Asian/Pacific Islander, Native American, and white women are eligible. Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 are excluded.

Official Title
-----------------
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)

Conditions
-----------------
Vaginosis, Bacterial, Premature Birth, Birth Weight, Chorioamnionitis

Intervention / Treatment
-----------------
* Drug: oral versus vaginal metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American, Hispanic, Asian/Pacific Islander, Native American, and white women. - Exclusion Criteria: Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18. -

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oral versus vaginal metronidazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in vaginal flora |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm delivery |  |  | 
| low birth weight |  |  | 
| chorioamnionitis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacterial Vaginosis, Metronidazole
Subjective Perception of Ocular Prosthesis Wear

Study Overview
=================
Brief Summary
-----------------
The loss of an eye, whether congenital or acquired, is a severe psychological trauma with negative impact on the quality of life of the patient. While rehabilitation with a customized ocular prosthesis anatomically restores the facial appearance, the final outcome is largely determined by the subjective satisfaction of the patient. By investigating the level of subjective perception, the quality of care can be improved.

Official Title
-----------------
Subjective Perception of Ocular Prosthesis Wear

Conditions
-----------------
Anophthalmos, Unilateral, Prosthesis User

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acquired anophthalmia Informed consent ocular prosthesis wear for minimum of 2 years Exclusion Criteria: congenital anophthalmia microphthalmia

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of care | disease specific score | 1 hour |
Epidemiologic Study Evaluating Infections in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess the prevalence and demographic and clinical characteristics of infections in elderly people admitted to Internal Medicine wards in Spain, as well as the etiology and resistance pattern for the main causal agents, and outcome.

Official Title
-----------------
Epidemiologic Study of Infections in Elderly Patients

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Other: Clinical record review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients > 65 years of age that are hospitalized in an Internal Medicine ward and have an active infection (skin and soft tissue, intra-abdominal, or respiratory infections) from the community that needs antibiotic treatment Patients must have at least one sample processed for microbiological diagnosis Exclusion criteria: COPD exacerbation Urinary tract infections Hospital acquired infections Other infections not in inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| 1<br>Infected elderly patients | Other: Clinical record review<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of each kind of infection will be measured from a descriptive point of view, using relative and absolute frequencies. |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study the etiology and resistance pattern for the main causal agents. |  | 5 months | 
| Describe the demographic features, co-morbidities, concomitant treatment and outcome of patients. |  | 5 months |