linjc16/ctgov huggingface dataset:
Sexual Function Changes in High-Risk Pregnancies

Study Overview
=================
Brief Summary
-----------------
Sexual Function Changes in High-Risk Pregnancies

Detailed Description
-----------------
Background and Aim: Sexual functions generally decrease during pregnancy, and high-risk pregnancies are more severe clinical conditions that cause couples to reduce or abstain entirely from their intimacy. However, the evidence on the sexual functions in high-risk pregnancies is scarce. Therefore, this study aimed to evaluate the sexual function changes in high-risk pregnancies compared to normal pregnancies. Methods: A total of 200 pregnant women (100 women in high-risk pregnancy and normal pregnancy groups each) were included. Demographic and obstetric data were collected, and participants completed The Female Sexual Function Index (FSFI).

Official Title
-----------------
Sexual Function Changes in High-Risk Pregnancies

Conditions
-----------------
Sexual Dysfunctions, Psychological, High Risk Pregnancy, Sexual Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: study grup Pregnant women who ; followed up for HrP in the second trimester (14th to 28th gestational weeks), between 20 to 40 years old, followed up at our perinatology department with a diagnosis of IUGR, cholestasis, diabetes, preeclampsia, fetal anomaly control grup admitted for routine second-trimester ultrasonography assessment but with no risk for pregnancy Exclusion Criteria: Pregnant women who ; younger than 20 or older than 40 years of age, gestation in the 1st or 3rd trimester, presence of psychiatric or chronic disorders like rheumatic or heart diseases, -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| patient<br>The women who followed up for HrP (high-risk pregnancy ) were invited to participate and women with HrP in the second trimester (14th to 28th gestational weeks), between 20 to 40 years old, and followed up at our perinatology department with a diagnosis of IUGR (intrauterine growth retardation ), cholestasis, diabetes, preeclampsia, or hypertension were included. | |
| control<br>The pregnant women admitted for routine second-trimester ultrasonography assessment but with no risk for pregnancy formed the control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual dysfunction rate in high risk pregnancies | Sexual dysfunction rate | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sexual dysfunction, high-risk pregnancy, FSFI, quality of life
Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation

Study Overview
=================
Brief Summary
-----------------
The objective is to observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.

Detailed Description
-----------------
To observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.

Official Title
-----------------
Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation

Conditions
-----------------
Trans Catheter Aortic Valve, Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject selected for transcatheter heart valve replacement Signed informed consent to participate in the study Exclusion Criteria: Inability to sign written informed consent. Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 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 |
| --- | --- | --- |
| Clinical outcome of patients undergoing transcatheter valve replacement | Mortality, change in New York Heart Association class, change in ejection fraction. | 12 months |
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas

Study Overview
=================
Brief Summary
-----------------
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.

Official Title
-----------------
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas

Conditions
-----------------
Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas, Intolerance to Breast Milk

Intervention / Treatment
-----------------
* Other: Amino Acid-based Formula with high DHA and ARA
* Other: Amino Acid-based Formula with lower DHA and ARA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0 to 6 months of age inclusive Born at ≥ 37 weeks gestation Birth weight of 2500 g (5 lb 8 oz) or more Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk Infants with symptoms suggestive of cow's milk allergy Signed Informed Consent Exclusion Criteria: Infants who for whatever reasons were not discharged home as per routine Infants with metabolic illness requiring a special formula Infants fed with nasogastric tube

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1 - AA Formula with DHA and ARA<br>Marketed AA formula with Docosahexanoic Acid (DHA) and Arachidonic Acid (ARA) | Other: Amino Acid-based Formula with high DHA and ARA<br> <br> |
| Other: Arm 2 - AA Formula with alternative levels of DHA and ARA<br> | Other: Amino Acid-based Formula with lower DHA and ARA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of fatty acids in whole blood of infants |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  | 4 months | 
| Occurrence of allergic manifestations |  | 4 months | 
| Occurrence of adverse events |  | 4 months | 
| Incidence of gas |  | 4 months | 
| Incidence of fussiness |  | 4 months | 
| Stool characteristics |  | 4 months | 
| Body length |  | 4 months | 
| Head Circumference |  | 4 months |
Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou

Study Overview
=================
Brief Summary
-----------------
A single-arm, prospective study to explore the incidence of lung cancer, the high-risk factor of lung cancer, and the cost-effectiveness of early screening of lung cancer in the general population over 40 years old with low-dose computed tomography in Guangzhou, China

Official Title
-----------------
Mass Screening With Low-Dose CT for Lung Cancer in Guangzhou

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: Low-dose computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age of 40 years among the residents in Guangzhou Exclusion Criteria: Persons who had a diagnosis of lung cancer or treatment-related to lung cancer with the past 5 years

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening group<br> | Device: Low-dose computed tomography<br>* The Low-dose computed tomography is conducted according to the guideline suggested by American College of Radiology.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of lung cancer | The incidence of lung cancer among the overall people in the screening | 11 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of lung cancer among people with high-risk factors | The incidence of lung cancer among people with high-risk factors | 11 years | 
| The incidence of lung cancer among people with non-high-risk factors | The incidence of lung cancer among people with non-high-risk factors | 11 years | 
| High risk factors associated with lung cancer (by questionnaire) | Every participant has to complete a questionnaire before undergoing an LDCT examination. Univariate analysis and multivariate logistic regression analyses will be performed to determine the high risk factors associated with lung cancer | 11 years | 
| Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments) |  | 11 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Screening
DP13 - A Phase II Study in Patients With Primary Aldosteronism

Study Overview
=================
Brief Summary
-----------------
The purpose of the present phase II study is to determine whether DP13 displays the clinical safety and efficacy profile to support further development in patients with primary aldosteronism.

Detailed Description
-----------------
A phase II, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled study in 36 patients with primary aldosteronism to determine the dose-dependent efficacy, safety and tolerability of DP13 after a 2-week single-blind placebo run-in period followed by a randomized 8-week double-blind treatment period. After an additional single-blind, 2-week DP13 placebo withdrawal period, patients are switched to standard of care.

Official Title
-----------------
DP13 - A Phase II Study in Patients With Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of DP13, Over an 8-week Treatment Period

Conditions
-----------------
Primary Aldosteronism

Intervention / Treatment
-----------------
* Drug: DP13


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a guideline-recommended diagnosis of primary aldosteronism Exclusion Criteria: Patients with primary aldosteronism and hyperkalemia prolonged QT intervals refusal of special contraception measures

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DP13 low<br>DP13 for 8 weeks | Drug: DP13<br>* DP13 systemic administration<br>|
| Experimental: DP13 middle<br>DP13 for 8 weeks | Drug: DP13<br>* DP13 systemic administration<br>|
| Experimental: DP13 high<br>DP13 for 8 weeks | Drug: DP13<br>* DP13 systemic administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aldosterone | Change in aldosterone from baseline | 8 weeks | 
| Change in ambulatory blood pressure | Change in ambulatory blood pressure from baseline | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events | Occurrence of treatment-emergent adverse events and serious adverse events over entire study duration | 12 weeks | 
| Change in blood pressure | Change in blood pressure from baseline | 12 weeks |
Perioperative Management of DIEP Flaps

Study Overview
=================
Brief Summary
-----------------
By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure > 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free deep inferior epigastric artery flaps for breast reconstruction.

Official Title
-----------------
Perioperative Management of Deep Inferior Epgastric Perforator (DIEP) Flap for Breast Reconstruction

Conditions
-----------------
Mammaplasty, Microsurgery, Free Tissue Flaps

Intervention / Treatment
-----------------
* Drug: Crystalloid Solutions
* Drug: Catecholamines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Informed consent for study participation Every patient undergoing breast reconstruction (primary and secondary reconstruction) with deep inferior epigastric perforator flap at our hospital is offered to participate in the study Exclusion criteria: No informed consent for study participation Patients with a high thromboembolic risk profile During pregnancy and breastfeeding Minors Patients with a health care proxy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluid restriction<br>Crystalloid fluid max. 2.0 ml/kg/h, no administration of colloids, noradrenaline max. 0.15 µg/kg/min | Drug: Crystalloid Solutions<br>* crystalloid restrictive anesthesia protocol<br>|
| Active Comparator: Catecholamine restriction<br>Noradrenaline max. 0.04 µg/kg/min, fluids max. 8.0 ml/kg/h | Drug: Catecholamines<br>* catecholamine restrictive anesthesia protocol<br>* Other names: Norephinephrine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free flap survival rate | Rates of (partial) flap loss in each study arm | 5 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period of hospitalization | Length of postoperative hospitalization in each study arm | up to 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep inferior epigastric perforator flap, fluid restriction, catecholamine restriction
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.

Detailed Description
-----------------
In this double-blind crossover study, patients will be randomized to receive pasteurized breast milk including BSSL or pasteurized breast milk without BSSL for the first 7 days. After a wash-out period of 2 days the patients will crossover to the other treatment regimen and receive an additional 7 days treatment. The primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.

Official Title
-----------------
A Prospective, Randomized, Double-blind Crossover Study Comparing 0.15 g/L rhBSSL Added to Pasteurized Breast Milk Versus Placebo During One Week of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

Conditions
-----------------
Replacement Therapy in Preterm Infants

Intervention / Treatment
-----------------
* Drug: rhBSSL
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants less than or equal to 32 weeks of gestational age appropriate for gestational age enterally fed with pasteurized breast milk

Ages Eligible for Study
-----------------
Maximum Age: 32 Weeks

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhBSSL<br> | Drug: rhBSSL<br>* 0.15 g/L rhBSSL added to pasteurized breast milk; one week treatment<br>* Other names: bucelipase alfa (INN);|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* One week treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficient of Fat Absorption measured in stool |  | Stool collected for a 72-hour period during the final 3 days of each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in length and body weight |  | Baseline and after one week of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Replacement therapy, Pasteurized breast milk, Preterm infants, BSSL
Trends in Trans-Fatty Acid Intake Between 1980 and 1997

Study Overview
=================
Brief Summary
-----------------
To examine trends in trans-fatty acid intake by using newly available nutrient data to recalculate 24 dietary recalls from the Minnesota Heart Survey.

Detailed Description
-----------------
BACKGROUND: In recent years concern has arisen about the potential health hazards of trans-fatty acids in the American diet. Dietary intake of trans-fatty acids has been linked to unhealthy shifts in serum lipid profiles and to coronary heart disease (CHD) in a number of studies. Although several studies have estimated intakes of trans-fatty acids in U.S. populations, presently data is lacking regarding trends in intake of trans-fatty acids in the population. Furthermore, it is unclear how trends in intake of trans-fatty acids may be related to changes in other dietary and non-dietary CHD risk factors and CHD mortality. DESIGN NARRATIVE: The study used newly available nutrient data to recalculate dietary data collected as part of the Minnesota Heart Survey (MHS) to examine trends in intake of trans-fatty acids. The MHS was an ongoing observational epidemiologic study of trends in risk factors and cardiovascular morbidity and mortality among independent cross-sectional probability samples of the Minneapolis-St. Paul, Minnesota, metropolitan area. Surveys were conducted in 1980-1982, 1985-1987, 1990-1992 and 1995-1997. Diet was among the CVD risk factors measured as part of each survey. In this research, 24-hour dietary recalls collected from MHS participants were recalculated using an updated food and nutrient database that included trans-fatty acid values (16:1, 18:1, 18:2, and total). Intake estimates resulting from recalculation were analyzed to examine temporal trends in trans-fatty acid intake between 1980 and 1997, and to examine the relationship of temporal trends in trans-fatty acid intake to temporal changes in other dietary and non-dietary CHD risk factors and changes in CHD mortality. The MHS data provided a unique opportunity to examine a dietary constituent only recently recognized as a potential risk factor for CHD.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases

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 |
| --- | --- | --- |
Reconstruction of Complex Proximal Humeral Fractures.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3D planning compared to conventional 2D planning.

Official Title
-----------------
Reconstruction of Complex Proximal Humeral Fractures.

Conditions
-----------------
Osteoarthritis of the Shoulder, Complexe Proximal Humeral Fractures

Intervention / Treatment
-----------------
* Procedure: Shoulder replacement surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty patients > 18years Exclusion Criteria: contraindication for computertomography pregnancy previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture

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: Computer-assisted 3D planning<br>Realization of the fracture reconstruction according to the computer-assisted 3D preoperative plan | Procedure: Shoulder replacement surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative analysis of the accuracy of an automatic algorithm for the reconstruction of proximal humeral fractures | Accuracy of the reconstruction of complex proximal humeral fractures. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, 3D, complexe proximal humeral fracture, shoulder, shoulder replacement, accuracy, computer-assisted