linjc16/ctgov huggingface dataset:
Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.

Detailed Description
-----------------
The effect of menopause on body composition and cardiovascular risk in healthy caucasian women has been the subject of much study. In contrast, there are few data available on menopause in African-American women. Since menopause is associated with potentially preventable health risks in women, this proposal is aimed at characterizing the perimenopausal period in terms of body fat, energy balance, and insulin action in both caucasian and African-American women. The study will address 4 general hypotheses: Menopause increases both total and visceral abdominal fat Changes in body composition and body weight at menopause are mediated, at least in part by changes in 24-hour energy expenditure and/or food intake Menopause results in decreased insulin sensitivity that may predispose certain women to develop diabetes later in life African-American women may respond to the shifts in reproductive hormones at menopause differently than caucasian women.

Official Title
-----------------
Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin

Conditions
-----------------
Menopause

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 47-52 yr, at time of enrollment Body Mass Index 25-40 Normal oral glucose tolerance test by National Diabetes Data Group criteria Premenopausal, defined by FSH levels <30mIU/ml and at least 5 menstrual periods in the last 6 months Able to confirm ethnic heritage of past 2 generations in family Exclusion Criteria: hypertension or hypercholesterolemia requiring medication regular use of medications that influence glucose tolerance use of oral contraceptives within the past 6 months history of myocardial infarction or significant coronary vascular disease or stroke history of endocrine, kidney, or liver disease or malignancy any psychopathology, including eating disorders, substance abuse, and major depression unable to complete longitudinal study commitment, including anticipating moving out of the area within the next 5 years.

Ages Eligible for Study
-----------------
Minimum Age: 47 Years
Maximum Age: 52 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin Sensitivity, Total abdominal fat, Visceral abdominal fat, Reproductive Hormones, Menopause, Diabetes, Fat Distribution, Sex Hormones
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women

Study Overview
=================
Brief Summary
-----------------
This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.

Official Title
-----------------
A Phase I, Partially Blinded, Randomized, Placebo Controlled, Active Comparator Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Post-menopausal Women After Daily Oral Doses of PTH134

Conditions
-----------------
Post-menopausal Osteoporosis

Intervention / Treatment
-----------------
* Drug: PTH134
* Drug: Placebo
* Drug: Forsteo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old Exclusion Criteria: Use of estrogen or hormone replacement therapy Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose. Use of bisphosphonates and strontium ranelate Cancer or history of malignancy of any organ system Any radiation therapy to the skeleton. Any known clinically significant disease affecting calcium metabolism. Any history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia. History or clinical evidence of any impairment of thyroid function Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTH134<br> | Drug: PTH134<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Forsteo<br> | Drug: Forsteo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum calcium levels after 12 weeks of treatment |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis
A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

Study Overview
=================
Brief Summary
-----------------
To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.

Detailed Description
-----------------
Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks. Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. Patients undergo follow-up at 2 weeks post-treatment.

Official Title
-----------------
An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

Conditions
-----------------
Candidiasis, Esophageal, HIV Infections

Intervention / Treatment
-----------------
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: AIDS or other immunocompromising condition. Candidal esophagitis. Life expectancy of at least 2 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Evidence of non-candidal systemic fungal infection. Abnormalities that may preclude esophagoscopy or endoscopy. Unable to tolerate fluconazole. Unable to give informed consent. Enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the Pfizer Clinical Monitor). Other condition that would make patient unsuitable for enrollment. Concurrent Medication: Excluded: Concomitant oral or topical antifungal agent. Other experimental medications. Patients with the following prior condition are excluded: History of allergy to imidazoles or azoles. Prior Medication: Excluded: Any oral or topical antifungal therapy within the past 3 days. Active use of illicit or illegal drugs.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 70 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: Fluconazole|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
-----------------
Esophagitis, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Immunocompromised Host
A Single Blind Study to Evaluate the Safety, Tolerability and Explore the Efficacy of 8.0 mg ASM8 Inhaled Daily for 14 Days in Severe Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the safety and tolerability of 8.0 mg of ASM8 when given daily for 14 days by the Aeroneb® Go nebulizer to subjects with moderate to severe asthma.

Detailed Description
-----------------
The safety and tolerability of ASM8 will be assessed by performing a physical exam and vital signs, measuring the use of concomitant medication, routine laboratory tests, urinalysis, sputum analysis, serum IL-1 and TNF-α, lung carbon monoxide diffusion capacity, pulse oximetry and measuring AEs There are 5 study phases: screening (phase 1), run-in (phase 2), treatment A (phase 3) with Active or Placebo, treatment B(phase 4) with Active or Placebo and end of study (phase 5) that includes a wash out period and a final visit.

Official Title
-----------------
A Phase II, Two-centre, Single Blind Study to Evaluate the Safety, Tolerability and Explore the Efficacy of 8.0 mg ASM8 Inhaled Daily for 14 Days in Adult Subjects With Moderate to Severe Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: ASM8


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be diagnosed with asthma for 3 or more months Have moderate to severe asthma as defined by ATS criteria Exclusion Criteria: No history of pulmonary or health problems for which the Investigator considers that participation in this protocol is a risk for the subject

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ASM8|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum total cells, differential and sputum levels of IL-1 and TNF alpha | Sputum total cells, differential (neutrophils, macrophages, bronchial cells and lymphocytes) and sputum levels of IL-1 and TNF alpha at the end of each treatment and at the final visit will be reported as absolute counts (10x6 cells/mL) and percentages (%) and change in % from baseline will also be presented. | 56 days |
The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables

Study Overview
=================
Brief Summary
-----------------
The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. We will perform a 24 hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we also examine the patient using a SphygmoCor.

Detailed Description
-----------------
Purpose of the study is to examine the effect of amiloride and spironolactone on Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK), Pulsewave velocity, augmentation index central bloodpressure, Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and Ambulatory bloodpressure

Official Title
-----------------
The Effect of Amiloride and Spironolactone on Renovascular and Cardiovascular Variables in Patients With Essential Hypertension in a Doubleblinded, Randomized, Placebo-controlled, Crossover Study.

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Spironolactone
* Other: Placebo
* Drug: Amiloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertension, BMI 18,5-30, non-smoker Exclusion Criteria: Smoking Not using contraceptives Other illnesses Drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amiloride<br> | Drug: Amiloride<br>* 1 tablet twice a day for 28 days<br>|
| Active Comparator: Spironolactone<br> | Drug: Spironolactone<br>* 1 tablet twice a day for 28 days<br>|
| Placebo Comparator: Placebo<br>1 tablet twice a day for 28 days | Other: Placebo<br>* 1 tablet twice a day for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloodpressure |  | 24-hours and examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood pressure, PWV, HRV, PWV, potassium
The Influence of AMH on Ovarian Responsiveness to Ovulation Induction With GnRH in Women With PCOS

Study Overview
=================
Brief Summary
-----------------
The investigator suggests that PCOS women with high AMH levels are resistant to ovarian stimulation and may need adjustment of the dose of gonadotrophin.

Detailed Description
-----------------
There is a correlation between high levels of AMH and the severity of PCOS. Excessive AMH may have a negative effect on the sensitivity of the resting follicles to gonadotropins. This is an observational prospective study to investigate the impact of circulating AMH on gonadotrophin induction in women with PCOS.

Official Title
-----------------
The Influence of Anti-Müllerian Hormone on Ovarian Responsiveness to Ovulation Induction With Gonadotrophins in Women With Polycystic Ovarian Syndrome

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Merional ®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women of age 18 - 35 years BMI 20 - 30 kg/m2 Anovulatory infertility Diagnosis of PCOS based on Rotterdam consensus criteria (two of three criteria: Oligo/anovulation, hyperandrogenaemia and sonographic appearance of polycystic ovaries) Exclusion Criteria: Women Above 35 years or under 18 years Women with BMI above 30 kg/m2 or under 20 kg/m2 Normally ovulating women Patients with marked hyperandrogenaemia were screened for congenital adrenal hyperplasia (by measuring serum concentration of 17alpha hydroxyl-progesterone) or Patients with Cushing syndrome (by measuring urinary free cortisol)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Merional ®|Using the long protocol of controlled ovarian hyperstimulation (COH). Down regulation by (Decapeptyl ®, Ferring) 0.1mg subcutaneously once daily starting from day 18 of the preceding cycle, human menopausal gonadotrophin (hMG) (Merional ®, IBSA) 75 IU starting from cycle day two after confirmation of down regulation (thin endometrium, number of follicular activity, E2 < 50 pg/mL). hMG dose is optimized according to age, BMI, antral follicles count (AFC), the local protocol, FSH level and previous response. Usually PCO patients start by 150 IU.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good response to hMG therapy defined as occurrence of > 3 mature follicles after treatment. | Good response to hMG therapy defined as occurrence of > 3 mature follicles after treatment. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-Müllerian hormone, Ovarian stimulation, Polycystic ovary syndrome, Intracytoplasmic sperm injection
Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester

Study Overview
=================
Brief Summary
-----------------
To evaluate the percentage of severe heart defect diagnosed with the use of color Doppler at a routine fetal scan in the second trimester of pregnancy

Detailed Description
-----------------
Almost all women in Norway have a routine ultrasound examination in the second trimester, however, the detection rate of heart defect are only around 50%. In this study we use color Doppler at three different levels in the fetal heart; the four chamber view, the outlet of the aorta on on the level of the great arteries. All heart defects at delivery are recorded and compared with the ultrasound findings.

Official Title
-----------------
Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester.

Conditions
-----------------
Congenital Heart Defects

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant 2nd trimester Exclusion Criteria: Unwilling
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>Pregnant females in the 2nd trimester. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy | The number of *fetuses with* heart defects detected by color Doppler in the second trimester was compared to the number of *fetuses with* major heart defects detected at birth. | 2nd trimester | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, Pregnancy, Fetal heart defects, Color doppler
Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this post-marketing surveillance is to obtain further information about the tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice

Official Title
-----------------
Post-marketing Surveillance (in Accordance With § 67,6 AMG) of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Berodual®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of Chronic obstructive respiratory tract disease Patients of either sex, including children over 6 years Exclusion Criteria: - Contraindications listed in the Instructions of Use/Summary of Product Characteristics of Berodual® metered-dose inhaler

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| chronic obstructive respiratory tract disease patients<br> | Drug: Berodual®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall severity of the clinical picture rated on a 4-point scale |  | after 3 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dyspnea and/or asthma attacks rated on a 4-point scale |  | after 3 and 6 weeks | 
| Number of dyspnea episodes rated on a 4-point scale |  | after 3 and 6 weeks | 
| Number of awakenings due to night-time dyspnea rated on a 4-point scale |  | after 3 and 6 weeks | 
| Assessment of morning coughing with expectoration on a 4-point scale |  | after 3 and 6 weeks | 
| Assessment of tolerability on a 4-point scale |  | after 3 and 6 weeks | 
| Number of patients with adverse drug reactions |  | up to 6 weeks | 
| Changes in pathological auscultation findings rated on a 3-point scale |  | after 3 and 6 weeks | 
| Changes in concomitant medication |  | up to 6 weeks | 
| Assessment of efficacy on a 4-point scale |  | after 3 and 6 weeks |
The Mechanical Characterisation of Human Saphenous and Popliteal Vein

Study Overview
=================
Brief Summary
-----------------
Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue.

Detailed Description
-----------------
The aim of this study is to mechanically characterise saphenous and popliteal vein segments that have been deemed waste following varicose vein procedures, lower limb amputation and lower limb bypass surgery. By characterising the stress-stretch relationship of the vein vessel wall, treatment techniques can be better understood. Mechanical device design can be bteer informed and the the suitability of vein as a conduit for bypass and AVF procedures can be assessed.

Official Title
-----------------
The Mechanical Characterisation of Human Saphenous and Popliteal Vein

Conditions
-----------------
Peripheral Vascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients aged 18 years or older Patients undergoing varicose vein procedures or; Patients undergoing lower limb amputation or; Patients undergoing lower limb bypass surgery Exclusion Criteria: Patients unable to give informed consent Seriously ill/unconscious patients

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 |
| --- | --- | --- |
| The identification of vein tissue mechanical distension and stretching properties. | Vein tissue will undergo inflation-extension testing and unilaxial testing. The vein tissue will be cross-sectioned and rings of venous tissue will be mechanically characterised according to the properties exhibited. | 2 years |