linjc16/ctgov huggingface dataset:
PTHrP and Osteoporosis

Study Overview
=================
Brief Summary
-----------------
PTH-related protein, or ''PTHrP'', is a hormone which was discovered in 1987. As its name implies, it is closely related to another hormone discovered in the 1920's named parathyroid hormone or ''PTH''. PTH has been shown to be effective in treating osteoporosis in both animals and humans. PTHrP has been shown to be effective in treating osteoporosis in laboratory animals, and there are strong scientific reasons to think that it may be effective in humans as well. However, no human trials with PTHrP in the treatment of osteoporosis have been performed. The studies in this trial are focussed on determining whether PTHrP can indeed increase bone mass in postmenopausal women with osteoporosis, when administered daily by subcutaneous injection for three months.

Official Title
-----------------
Pathophysiology of PTH-related Protein in Humans.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Parathyroid hormone-related protein or ''PTHrP''


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy caucasian postmenopausal females between 50-75 years of age with low bone mineral density at the lumbar spine or hip as measured using dual energy x-ray absorptiometry or DXA. ON estrogen replacement treatment for at least three years. Exclusion Criteria: Heart, vascular, kidney, liver, lung, hormonal, musculo-skeletal disease (other than osteoporosis), rheumatic, blood diseases are exclusion criteria. High blood pressure Pregnancy Cancer Alcohol or drug dependence Prior use of a drug treatment for osteoporosis such as PTH, bisphosphonates, raloxifene, or calcitonin within the preceding five years

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Parathyroid hormone-related protein or ''PTHrP''|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
-----------------
parathyroid hormone-related protein, parathyroid hormone, anabolic skeletal therapy, postmenopausal women
Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if propofol could protect erythrocytes by directly scavenging free radicals from the blood current and increasing resistance of their cell membranes in patients submitted to gastroplasty.

Official Title
-----------------
Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

Conditions
-----------------
Hemolysis

Intervention / Treatment
-----------------
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients between BMI 40-50 kg/m2 Exclusion Criteria: patients with BMI under 40 kg/m2 and over 50 kg/m2 alcohol users illicit-drug users patients in regular use of anti-depressants, proton bomb inhibitors or calcium canal blockers patients transfused either recently, during the intra-operative period or within 10 hours post-operative patients previously known to be hypersensitive to any drug that is used during the study patients with any psychiatric disorder or dementia

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Propofol|Patients in the Propofol Group (PG) will be induced with target-controlled infusion (TCI) of propofol (Diprifusor, AstraZeneca) and remifentanil (Asena PK, Cardinal Health) at the target dose of 6.0 µg.ml-1 and 8.0 ηg.ml-1, respectively. The patients in the Sevoflurane Group (SG) will be induced with remifentanil TCI at target dose of 8.0 ηg.ml-1 and etomidate 0.5 mg.kg-1 in bolus.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count erythrocytes |  | After 10 hours post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilirubins(direct and indirect) |  | After 10 hours post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid obesity, General anaesthesia, Propofol, Sevoflurane
Respiratory Microbiome in COPD and Associated Inmune Response.

Study Overview
=================
Brief Summary
-----------------
Hypothesis: COPD patients with frequent exacerbations have different pulmonary and systemic immune response than COPD patients without frequent exacerbations and this is related to their microbiome.

Detailed Description
-----------------
The objective of this project is to determine the pulmonary microbiome and its relationship with the pulmonary and systemic inmune response in COPD patients with frequent (FE) and non frequent exacerbations (NE). The pulmonary immune response. -The role of mucins, antimicrobial peptides (AMPs), Matrix metalloproteinases (MMPs) and Toll-like receptors (TLRs) as lung defense mechanisms and their possible relationship with the microbiome in COPD and FE patients. The systemic immune response. -The pulmonary and blood inflammatory response and circulating bacterial products as markers of the systemic immune response.

Official Title
-----------------
Respiratory Microbiome in COPD. Relationship With Systemic and Pulmonary Inmune Response.

Conditions
-----------------
Pulmonary Disease (COPD), Chronic Obstructive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD according to national and international guidelines. Clinical stability (8 previous weeks). Signature of informed consent. Exclusion Criteria: Antibiotic treatment the previous 8 weeks. Other lung diseases. Active neoplasic disease. Terminal concomitant disease.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Relationship of pulmonary microbiome with the immune response (local and systemic). | Microbiome will be determined by using 16s RNA techniques. The inmune response will be studied with ELISA kits. | 6 months |
An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe clinical outcomes of metastatic breast cancer patients whose tumors overexpress the Her2neu protein and are being treated with trastuzumab (Herceptin)either alone or combination with chemotherapy or hormonal therapy.

Detailed Description
-----------------
In clinical practice, patients with metastatic breast cancer are being treated either with trastuzumab alone or trastuzumab in combination with chemotherapy or hormonal therapy as it has shown to increase survival. There is currently minimal information as to how long trastuzumab should be given after disease progresses on trastuzumab. This study is a chart review of the above-mentioned population which will capture information such as; what chemo or hormonal therapies are chosen by clinicians for Her-2 positive metastatic patients to combine with trastuzumab what the number of treatment regimens are (chemo or hormonal) given with trastuzumab what the clinical outcome of patients treated is what happens to the patients cardiac status with long term administration of trastuzumab what treatment patterns exist in the management of central nervous system metastases This study aims to generate a hypotheses that can be tested from the information collected after is has been analyzed to give clinicians further meaningful data to guide treatment decisions beyond treatment progression.

Official Title
-----------------
An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients must have metastatic breast cancer tumor must have been determined to be Her-2 positive 3+ by immunohistochemistry or gene-amplified by fluorescence-in-situ hybridization (FISH) must have received trastuzumab alone or in combination with chemotherapy or hormonal therapy must not have received trastuzumab in the adjuvant or neoadjuvant setting must have started trastuzumab treatment for metastatic disease any time between January 1996 to June 2003 Exclusion Criteria: patients who received trastuzumab prior to 1996
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
-----------------
Metastatic Breast Cancer, Her2neu, trastuzumab
Safe Renal Function In Long Term Heart Transplanted Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy

Official Title
-----------------
Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients

Conditions
-----------------
Kidney Diseases, Heart Transplantation

Intervention / Treatment
-----------------
* Drug: Everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart Transplant patients with more than 1 year of follow-up Creatinine lower than 3.5 mg/dl GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula) Cyclosporine in maintenance immunosuppressive therapy Patient must be able to sign an approve informed consent Prior History of acute rejection within the last 3 months Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used Exclusion Criteria: Patients who are recipients of multiple organ transplants Prior or current use of sirolimus or everolimus History of acute rejection within the last 6 months Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months Patient not able to attend all follow-up evaluations

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Everolimus<br>* cyclosporine dose reduced of 50% after introduction of everolimus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Diseases, Heart Transplantation, Everolimus, Cyclosporine Toxicity
Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites

Study Overview
=================
Brief Summary
-----------------
Treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. So far, there is no systematic analysis of patients with this indication available in the literature. This retrospective analysis offers the possibility to assemble already existing data within a reasonably short time frame. Based on this analysis, a prospective analysis can be designed.

Official Title
-----------------
Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites

Conditions
-----------------
Malignant Ascites

Intervention / Treatment
-----------------
* Device: Alfapump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with malignant ascites Patients with alfapump implanted for malignant ascites Patients 18 years or older at the time of death Exclusion Criteria: Patient is alive at the time of inclusion assessment

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 |
| --- |
|Device: Alfapump|Alfapump implant|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of LVP after implantation of the alfapump | The primary objective of the study is to evaluate the performance of the alfapump in reducing the need for large volume paracentesis (LVP) defined as paracentesis of five or more litres of ascites and not by pump paracentesis. | 3-6 months post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of alfapump in patients with malignant ascites | Device, procedure and therapy related AEs and SAEs | 3-6 months post implant |
Transdermal Contraceptive Patch - Endometrial Effects Study

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.

Official Title
-----------------
Single-center,Open-label, Uncontrolled Study to Investigate the Effects of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene on the Endometrium in a 21-day Regimen for 13 Cycles in 80 Healthy Women

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Ethinylestradiol/Gestogene (BAY86-5016)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requiring contraception Normal cervical smear Smokers not older than 30 years History of regular cyclic menstrual periods Exclusion Criteria: Pregnancy or lactation Obesity (BMI> 30 kg/m2) Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic) Use of other contraceptive methods than study medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Ethinylestradiol/Gestogene (BAY86-5016)<br>* 7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on the endometrium at cycle 13 |  | 13 treatment cycles (each consisting of 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical smear |  | 13 treatment cycles (each consisting of 28 days) | 
| Adverse events |  | 13 treatment cycles (each consisting of 28 days) | 
| Cycle control |  | 13 treatment cycles (each consisting of 28 days) | 
| Safety laboratory |  | 13 treatment cycles (each consisting of 28 days) | 
| Occurence of pregnancy |  | 13 treatment cycles (each consisting of 28 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fertility control, Contraception
Iodine Status in Pregnant Women in Israel

Study Overview
=================
Brief Summary
-----------------
Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women. Thus, screening first trimester healthy pregnant women for iodine status is of clinical value for mother and child as iodine deficiency might have implications on thyroid function as well as pregnancy outcomes

Detailed Description
-----------------
New emerging data suggest pregnant women in Israel are iodine deficient in the first trimester of pregnancy. This is of major concern as first trimester iodine sufficiency is critical for the development of the fetal brain. Our aim is to evaluate iodine consumption in first trimester pregnant women in Israel through dietary questioners, Urinary iodine samples and thyroid functions test assessed through blood samples. All data will be analyzed in a central lab.

Official Title
-----------------
Iodine Status in Pregnant Women in Israel

Conditions
-----------------
Iodine-Deficiency; Hypothyroidism

Intervention / Treatment
-----------------
* Diagnostic Test: Urine sample for iodine measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First trimester pregnant women with a singleton pregnancy Exclusion Criteria: Women with a known thyroid disease treated or untreated Women who received contrast material in the year previous to the study women with any chronic disease Women who receive chronic medication not including vitamins

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First trimester pregnant women<br> | Diagnostic Test: Urine sample for iodine measurement<br>* Women will be required to give a urine sample for iodine measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of average iodine consumption in food | Iodine consumption will be evaluated trough detailed food questionnaires. Data will be quantified and reported in micrograms per day | 1 year | 
| Evaluation of urinary iodine concentration | Women will give a spot urine sample for urinary iodine concentration measurement. All data will be analyzed and reported in micrograms/L. Data obtained will be compared to World Health Organization requirements | 1 year | 
| Thyroid function test measurement | Thyroid function will be evaluated through blood tests in the first trimester of pregnancy. Data will be analyzed in accordance with local guidelines. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Iodine deficiency, Thyroid
A Study to Evaluate Safety and Tolerability After Single Oral Dosing of AZD1656 in Japanese Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects

Official Title
-----------------
A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Oral Doses of AZD1656 in Japanese Healthy Male Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: AZD1656


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese males aged ≥20 and ≤40 years of age Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus Exclusion Criteria: Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1656 in 6 increasing oral single doses given to 6 groups (5 on active and 1 on placebo in each group) | Drug: AZD1656<br>* Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (AEs, blood pressure (BP), pulse, safety laboratory variables and electrocardiography (ECG) |  | Safety variables taken repeatedly during 24 hours on study day sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions | 
| Pharmacodynamic variables |  | Blood samples taken repeatedly during 24 hours on study day sessions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Japanese, healthy, volunteers