linjc16/ctgov huggingface dataset:
Childhood Passive Smoking: Cohort Study of Cardiac Risk

Study Overview
=================
Brief Summary
-----------------
To determine the effects of long-term exposure to passive smoking on the cardiovascular and oxygen transport systems in pre-adolescent twins.

Detailed Description
-----------------
BACKGROUND: The adverse health effects of actively inhaled cigarette smoke include impaired pulmonary function, increased coronary and cerebrovascular disease, chronic pulmonary disease, and cancer. Infants and young children of smoking parents are at increased risk for lower respiratory tract infections and small airways disease than are children of non-smoking parents. What is less clear is how the oxygen transport system of the growing child is affected by the long-term exposure to and passive inhalation of cigarette smoke and if this exposure represents a risk for the subsequent development of atherosclerotic heart disease. DESIGN NARRATIVE: A sample of 300 pre-adolescent twin pairs was recruited from an established population-based twin study. The three cohorts of twins and their parents were initially evaluated in a cross-sectional study and then followed longitudinally for up to three years. In the initial testing cycle the following data were collected: genotype; general health; anthropometric measures; resting and exercise noninvasive evaluation of hemodynamic parameters including blood pressure, heart rate, cardiac output, left ventricular mass, and oxygen consumption; hematocrit and blood levels of 2,3-DPG, cotinine, thiocyanate, and erythropoietin; spirometric and pulmonary flow data; lipid levels. There were three follow-up exams. The availability of repeated measures of oxygen delivery and its determinants in twins and their parents permitted both a unique analysis of genetic and environmental factors during the process of developmental change and measurements of the risks of accelerated atherosclerotic/ischemic heart disease and of the development of reactive airway disease. The following hypotheses were tested: genetic factors accounted for a significant proportion of the variation in the hematologic and cardiovascular determinants of systemic oxygen delivery; adaptive responses of the oxygen delivery system differed in the same individual before and after puberty; passive smoking in children was an incremental risk factor for the development of accelerated atherosclerotic/ischemic cardiovascular disease; passive smoking in children was a contributing factor in the development of reactive airway disease.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Lung Diseases, Coronary Arteriosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Indomethacin Use in Pain Relief During Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion.

Official Title
-----------------
Rectal Indomethacin Use in Pain Relief During Intrauterine Device Insertion: A Randomized Controlled Trial

Conditions
-----------------
Family Planning

Intervention / Treatment
-----------------
* Drug: indomethacin suppositories
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women not taken analgesics or anxiolytics in the 24 hours prior insertion Women not taken misoprostol prior to intrauterine device insertion Women who will accept to participate in the study Exclusion Criteria: Any contraindication to intrauterine device placement

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: indomethacin<br>indomethacin suppositories | Drug: indomethacin suppositories<br>* The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure<br>|
| Placebo Comparator: placebo<br>placebo suppositories | Drug: placebo<br>* The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score during IUD insertion |  | intraoperative |
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).

Official Title
-----------------
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study

Conditions
-----------------
Chronic Pain, Intractable Pain, Low Back Pain, Pain, Neuropathic, Pain, Back

Intervention / Treatment
-----------------
* Device: Spinal Cord Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU). Subject signed a valid, EC/IRB-approved informed consent form. Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained. In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain. Key Exclusion Criteria: Subject meets any contraindication in BSC neurostimulation system local DFU. Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy. Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information. Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.

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: Spinal Cord Stimulation<br>SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor. | Device: Spinal Cord Stimulation<br>* Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters<br>* Other names: neurostimulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception Threshold | Percent change in perception threshold from sitting to standing | up to 15 days post-screening |
The Pulmonary Protection Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation capacity after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).

Official Title
-----------------
Pulmonary Dysfunction After Open Heart Surgery: Randomized Clinical Trial With Focus on Lung-protective Interventions

Conditions
-----------------
Chronic Obstructive Lung Disease

Intervention / Treatment
-----------------
* Procedure: Perfusion of the lungs
* Drug: HTK Custodiol
* Other: Standard ECC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned and urgent surgery on legally competent patients over 18 years: Coronary Artery Bypass Graft Surgery Aortic Valve Replacement Coronary Artery Bypass Graft Surgery + Aortic Valve Replacement Transcatheter Aortic-Valve Implantation Spirometry FEV1 measurement show less than or equal to 80% of the anticipated. We expect that these patients provide the largest signal with lung protective interventions in relation to lung healthy patients. Exclusion Criteria: Previous surgery on the heart or lungs Previous thoracic irradiation Preoperative heart failure (ejection fraction below 20%). Surgical demanding mitral regurgitation Unstable patients (heart rate above 100 and systolic blood pressure below 100 mmHg) Intubated patients Patients with an ongoing preoperative treatment with antibiotics for suspected pneumonia. Patients with renal insufficiency requiring hemodialysis Pregnant and lactating

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary perfusion<br> | Procedure: Perfusion of the lungs<br>* Pulmonary perfusion with oxygenated blood during ECC.<br>|
| Experimental: Pulmoplegia<br> | Drug: HTK Custodiol<br>* Pulmoplegia before ECC.<br>|
| Other: Control group<br> | Other: Standard ECC<br>* ECC after standard procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation Index | To investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation index after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation). | From pre operation until 24 hours post operation |
Risk Factors for Thrombosis in Immune Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
Immune thrombocytopenia (ITP) is a rare autoimmune disease (annual incidence: 3-4/105 inhabitants) leading to an increased risk of spontaneous bleeding. ITP is said primary when not associated to other systemic disease (lymphoma, systemic autoimmune disease, chronic infectious disease…). First-line treatment is based on corticosteroids. Intravenous immunoglobulin (IVIg) is added in case of serious bleeding. In about 70% of adult cases, ITP becomes persistent or chronic (lasting >3 months and >12 months, respectively). Second-line treatments are then indicated. Among them, thrombopoietin-receptor agonists (TPO-RAs), romiplostim and eltrombopag are increasingly used. Splenectomy is used as ultimate treatment. Paradoxically, the risk of thrombosis is higher in ITP patients in comparison with the general population, due to the release of young hyperactive platelets from bone marrow. The incidence of thrombosis in ITP patients has been estimated between 0.5 and 3/100 patients-years. However, risk factors for thrombosis in ITP are not known, except splenectomy that is used in very few patients now. The role of other ITP treatments in thrombosis occurrence has been evoked, particularly for corticosteroids and IVIg. TPO-RAs have been associated with a risk of thrombosis in clinical trials and pharmacovigilance studies, even in case of low or normal platelet count. However, this risk has not been measured in the real-life practice, adjusted for other risk factors for thrombosis.

Official Title
-----------------
Risk Factors for Thrombosis in Immune Thrombocytopenia

Conditions
-----------------
Immune Thrombocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Incident primary ITP adults Exclusion Criteria: Secondary as well as prevalent ITP patients on July, 30th 2009 are excluded by the algorithm

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Risk for thrombosis in adult primary ITP patients treated with ITP treatment | Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP treatment | from July 2009 until June 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk thrombosis in adult primary ITP patients treated with TPO-RAs. | Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP patients treated with TPO-RAs. | from July 2009 until June 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombosis
Urine pH and Diet Net Acid Load

Study Overview
=================
Brief Summary
-----------------
Presently, the gold standard for testing diet acid intake is a urine collection done for many hours, usually 24 hours, which must be analyzed in a research lab for net acid excretion. So, getting information about diet acid intake is difficult. Many people have suggested doing a much simpler test, which is checking the pH of the urine when you wake up. But, no one has studied if this simpler method is a valid method for estimating the 24 hour net acid excretion. Diet acid load may be important in many diseases associated with aging, such as loss of bone and muscle, and the development of kidney disease.

Detailed Description
-----------------
the primary outcome variable is morning urine pH and 24 hour urine net acid excretion

Official Title
-----------------
Alterations in Urine pH With Differing Diet Net Acid Loads

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

Intervention / Treatment
-----------------
* Other: high or low acid diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no medical or psychological problems able to come to UCSF for study Exclusion Criteria: pregnant or trying to become pregnant Hg < 10 abnormal screening labs anyone unable to follow study directions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: feeding a high acid diet x 24 hrs<br>2 diets, one low and one high net acid loads | Other: high or low acid diet<br>* high or low acid diets<br>|
| Active Comparator: low acid diet<br> | Other: high or low acid diet<br>* high or low acid diets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high acid diet | correlation between first morning urine pH and 24 hour net acid excretion | 6 months | 
| low acid diet | correlation between first morning urine pH and 24 hour net acid excretion | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans

Study Overview
=================
Brief Summary
-----------------
Objective: To compare the effect of guided tissue regeneration (GTR) + concentrated growth factors (CGF) + bone graft and CGF + bone graft in the treat of II° furcations of human mandibular molars. Methods: At least thirty II°furcation involvements in mandibular molars will be included and randomly divided into two groups. The experimental group will accept GTR + CGF + bone graft therapy, and the control group will accept CGF + bone graft therapy. The clinical examination and cone beam computed tomography (CBCT) will be performed at baseline and 1 year post-surgery.

Official Title
-----------------
The Effect of Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans

Conditions
-----------------
Concentrated Growth Factors, Periodontal Regeneration, Furcation Defects

Intervention / Treatment
-----------------
* Procedure: GTR + CGF + bone graft
* Procedure: CGF + bone graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: II° furcation involvements in mandibular molars after periodontal therapy. Exclusion Criteria: not healthy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>GTR+CGF+bone graft, CGF | Procedure: GTR + CGF + bone graft<br>* Guided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements<br>* Other names: CGF Centrifuge machine;|
| Active Comparator: controlled<br>CGF+bone graft | Procedure: CGF + bone graft<br>* CGF combined with bone graft to treat mandibular furcation involvements<br>* Other names: CGF Centrifuge machine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical measurement | Probing depth | 1 year | 
| clinical parameter | clinical attachment loss | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic parameter | cone beam computerized tomographic scanning | 1 year |
Faslodex Observations During Regular Use by Advanced Mammacarcinoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify which patients, receiving Faslodex within the approved label, benefit most from Faslodex treatment.

Official Title
-----------------
Faslodex Observations During Regular Use by Advanced Mammacarcinoma Patients

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal Locally advanced or metastatic hormone sensitive breast cancer with known estrogen receptor (ER) and progesterone receptor (PR) status Patient had a recurrence during or after adjuvant anti-oestrogen treatment or progression of the disease during anti-oestrogen treatment Exclusion Criteria: Life threatening metastases

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Breast Cancer
Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

Study Overview
=================
Brief Summary
-----------------
CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial, sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several secondary objectives were determined. The microfracture procedure will be conducted in one operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two operative steps: Arthroscopy to collect cartilage; Implantation following arthrotomy about 6 weeks following arthroscopy. Both groups will follow the same rehabilitation program.

Official Title
-----------------
Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

Conditions
-----------------
Knee Chondral, Osteochondral Defect

Intervention / Treatment
-----------------
* Procedure: CARTIPATCH® procedure
* Procedure: Microfracture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: isolated femoral osteochondral lesion aged 18 to 45 grade 3 or 4 lesion (ICRS) sized 2,5 to 7,5cm2 lesion depth under 10mm IKDC score below 55 no prior surgical treatment Exclusion Criteria: pregnancy or breastfeeding allergy arthrosis varus or valgus angle greater than 6° kissing lesion affection of the patella excessive laxity meniscal pathology history severe chronic disease BMI > 30 HIV, Hepatitis B, C, HTLV, Syphilis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Chondrocytes Implantation<br> | Procedure: CARTIPATCH® procedure<br>* Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.<br>|
| Active Comparator: Microfracture<br> | Procedure: Microfracture<br>* Tiny fractures are created at the cartilage surface to stimulate cartilage growth.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation scoring system: IKDC |  | 18 months |