linjc16/ctgov huggingface dataset:
Prolactin and FGF21 in Gestational Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Prolactin (PRL) and PRL receptor (PRLR) signaling has been validated to play an important role in the modulation of glucolipid metabolism. However, the role of serum PRL levels in gestational diabetes mellitus (GDM) remains unclear. The investigators aimed to explore the possible influence of serum PRL within or without normal range on the development of GDM.

Official Title
-----------------
Prolactin and FGF21 in Gestational Diabetes Mellitus

Conditions
-----------------
Gestational Diabetes Mellitus in Pregnancy, Hyperprolactinemia Pregnancy

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 to 45 years completed a 75-g oral glucose tolerance test (OGTT) females with pregnancy Exclusion Criteria: severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism mental illness genetic disease current or previous treatment that might affect PRL and insulin secretion diabetes before pregnancy loss to follow-up, or withdrawal from the study unable to understand and comply with the study protocol.

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 |
| --- | --- |
| GDM and Non-GDM<br> | Diagnostic Test: Blood sampling<br>* blood sampling<br>|
| Pregnant group and non-pregnant group<br> | Diagnostic Test: Blood sampling<br>* blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational diabetes mellitus (GDM) | GDM is defined as a glucose intolerance resulting in hyperglycaemia of variable severity with onset during pregnancy. It can be diagnosed by the criteria: a fasting plasma glucose (FPG) concentration of O126 mg/dl on two separate occasions or a random blood glucose concentration of O200 mg/dl on two separate occasions. | 2019-2023 | 
| PRL | serum prolactin level | 2019-2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance (IR) | It was considered to be IR if HOMA-IR >2.5 | 2019-2023 | 
| HOMA-IR | It was calculated as: fasting plasma glucose (FPG) x fasting insulin (FINS)/22.5 | 2019-2023 | 
| OGTT | OGTT was performed after an overnight fasting in each patient and blood samples were taken at 0, 30, 60, 120, and 180 min to determine the concentrations of plasma glucose. | 2019-2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prolactin, Gestational Diabetes Mellitus, Insulin resistance, Fibroblast growth factor 21
Memantine and Validation of a New Alzheimer's Disease Scale

Study Overview
=================
Brief Summary
-----------------
To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.

Official Title
-----------------
Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: memantine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type. Signed informed consent prior to the initiation of any study specific procedures. Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests. Exclusion Criteria: Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease. Intake of any medication that is contra-indicated in combination with memantine. History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose. Known or suspected history of alcoholism or drug abuse within the past 2 years. Current or previous treatment with memantine or participation in an investigational study with memantine.

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Memantine<br> | Drug: memantine<br>* memantine tablets, OD, 12 weeks<br>* Other names: Axura;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of new scale regarding content, reliability and responsiveness for DAT symptoms |  | at post baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD. |  | at a post baseline visit |
Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).

Official Title
-----------------
Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV) Tumour sample (block of slides) available for KRAS analysis Exclusion Criteria: Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access. Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)

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 |
| --- | --- | --- |
| To analyze the frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC. |  | March 31, 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The frequency and type of KRAS mutation in a sample of the Brazilian population with advanced NSCLC, KRAS mutation in population with advanced NSCLC
The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery

Study Overview
=================
Brief Summary
-----------------
This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a commercial collagen matrix called Duragen. In this study, our sterile, cGMP manufactured collagen hydrogel dressing will be seeded with the stromal vascular fraction (SVF) mechanically isolated from lipoaspirate taken intra-operatively. This SVF contains pro-regenerative adipose stem cells (ASCs). The ASC-seeded hydrogel will be used as a supplement to Duragen to reinforce the skull base closure. The goal is to establish safety as well as to secondarily evaluate for effectiveness in reducing CSF leak postoperatively.

Official Title
-----------------
The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery

Conditions
-----------------
CSF Leak

Intervention / Treatment
-----------------
* Device: Duragen with Collagen Hydrodel and ASCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 18 Planned for skull base surgery Able to understand and willing to sign a written informed consent form Exclusion Criteria: active skull base infection no plan for DuraGen repair by operating surgeon

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogel recipient<br> | Device: Duragen with Collagen Hydrodel and ASCs<br>* Duragen combined with collagen hydrogel and patient's stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of CSF leak |  | 6 months active participation (date of surgery + 6 months follow up via chart review) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 6 months active participation (date of surgery + 6 months follow up via chart review) | 
| Need for reoperation |  | 6 months active participation (date of surgery + 6 months follow up via chart review) | 
| Postoperative hematoma |  | 6 months active participation (date of surgery + 6 months follow up via chart review) | 
| Postoperative infection |  | 6 months active participation (date of surgery + 6 months follow up via chart review) | 
| Need for rehospitalization |  | 6 months active participation (date of surgery + 6 months follow up via chart review) | 
| Death |  | 6 months active participation (date of surgery + 6 months follow up via chart review) |
EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

Study Overview
=================
Brief Summary
-----------------
The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.

Official Title
-----------------
A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

Conditions
-----------------
Adenocarcinoma, Metastasis, Pancreas Neoplasms

Intervention / Treatment
-----------------
* Drug: Gemcitabine alone
* Drug: EndoTAG-1 and Gemcitabine
* Drug: EndoTAG-1 and Gemcitabine
* Drug: EndoTAG-1 and Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inoperable adenocarcinoma of the pancreas Histologic or cytologic confirmation At least 18 years of age Exclusion Criteria: Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment Major surgery within 4 weeks prior to enrollment Major cardiovascular disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gemcitabine | Drug: Gemcitabine alone<br>* Gemcitabine monotherapy 1000 mg/m2 weekly<br>|
| Experimental: 2<br>EndoTag-1 + Gemcitabine | Drug: EndoTAG-1 and Gemcitabine<br>* EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly<br>|
| Experimental: 3<br>EndoTag-1 + Gemcitabine | Drug: EndoTAG-1 and Gemcitabine<br>* EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly<br>|
| Experimental: 4<br>EndoTag-1 + Gemcitabine | Drug: EndoTAG-1 and Gemcitabine<br>* EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | Median | 
| 6-month-survival-rate |  | 6 Months | 
| Overall survival |  | Median | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and percentage of patients with Adverse Events |  | 28 days after last patient out | 
| Number of clinically significant abnormal laboratory values |  | Last patient out | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenocarcinoma of the pancreas, Locally advanced, Metastatic
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).

Official Title
-----------------
A Single-Dose Bioequivalence Study Comparing Artesunate Tablet (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Conditions
-----------------
Falciparum Malaria

Intervention / Treatment
-----------------
* Drug: Artesunate (Test)
* Drug: Artesunate (Comparator)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. BMI of 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs). An informed consent document signed and dated by the subject or a legally acceptable representative. Exclusion Criteria: Evidence or history of clinically significant abnormalities. A positive urine drug screen, history of regular alcohol consumption.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artesunate (Pfizer)<br> | Drug: Artesunate (Test)<br>* Oral tablet, single dose, 1 x 100 mg<br>|
| Active Comparator: Artesunate (Arsuamoon® Tablets Guilin-China)<br> | Drug: Artesunate (Comparator)<br>* Oral tablet, single dose, 2 x 50 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC and Cmax of active metabolite of artesunate |  | 30-Aug-2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | 30-Aug-2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bio-equivalence, Healthy Volunteers
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether mutations in genes coding for Na/Pi-cotransporters are associated with aortic valve calcification. A patient population with premature aortic valve calcification treated with aortic valve replacement will be screened for mutations in these specific genes. Furthermore, aortic valve tissue received from the operations, will be examined for the presence of Na/Pi-cotransporters, and for molecular characterization of the transporters.

Official Title
-----------------
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease

Conditions
-----------------
Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with aortic valve calcification that will be treated with an aortic valve replacement. Age ≤ 65 years. Signed and dated informed consent. Exclusion Criteria: Inability to provide informed consent Earlier radiation therapy of the thorax Severe renal disease (patients in treatment with dialysis)

Ages Eligible for Study
-----------------
Maximum Age: 65 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 |
| --- | --- | --- |
| Mutations in sodium-phosphate cotransporters in patients with calcific aortic valve disease | Mutations in genes coding for Na/Pi-cotransporters | At the time of aortic valve replacement |
Hypotensive Anesthesia With Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end

Detailed Description
-----------------
to do sleeve gastrectomy under hypotensive anesthesia till compete stapling then hypertensive at the end of the operation to check bleeding

Official Title
-----------------
the Effect of Hypotensive Anesthesia With Sleeve Gastrectomy

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: hypotensive anesthesia
* Procedure: normotensive anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese patients with BMI more than 40 or more than 35 with comorbidity patients fit for laparoscopic surgery give approval to share in the study Exclusion Criteria: patients refused to share in the study patients unfit for surgery patients aged less than 18 and older than 50 patients with BMI less than 35 patient with previous upper abdominal surgery either for obesity or other diseases patients with GERD

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypotensive anesthesia<br>hypotensive anesthesia group | Procedure: hypotensive anesthesia<br>* hypotensive anesthesia<br>|
| Active Comparator: normotensive anesthesia<br>normotensive anesthesia group | Procedure: normotensive anesthesia<br>* normotensive anesthesia group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | operative time from skin to skin | 20-120 minutes | 
| intraoperative bleeding or oozing | intraoperative bleeding or oozing by the number of used gauzes and clips | 0-120 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative bleeding | the incidence of postoperative bleeding | 2-36 hours |
Changes in Renal Function and Body Composition in Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Changes in renal function and body composition in patients with pulmonary hypertension

Detailed Description
-----------------
This prospective single-center study is designed to analyze changes in renal function and body composition in patients with suspected or pre-diagnosed pulmonary hypertension at pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus Giessen.

Official Title
-----------------
Prospective Evaluation of Changes in Renal Function and Body Composition in Patients With Pulmonary Hypertension

Conditions
-----------------
Pulmonary Hypertension, Renal Function Abnormal

Intervention / Treatment
-----------------
* Diagnostic Test: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects older than 18 years at pulmonary hypertension outpatient clinic Subjects who signed informed consent forms Exclusion Criteria: Patients refusing to participate or withdraw consent during follow-up
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary Hypertension<br>Adult outpatients with suspected or prediagnosed pulmonary hypertension irrespective of subclass and all chronic kidney disease stages | Diagnostic Test: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in renal function in patients with pulmonary hypertension | Estimated GFR based on Chronic Kidney Disease Epidemiology Collaboration-creatinine-cystatin C will be used to determine renal function at baseline and at 1 year follow-up | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hydration status in patients with pulmonary hypertension | Bioimpedance analysis will be used to determine hydration status at baseline and at 1 year follow-up | 1 year | 
| Changes in nutritional status in patients with pulmonary hypertension | Bioimpedance analysis will be used to determine lean tissue and fat mass at baseline and at 1 year follow-up | 1 year | 
| Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality | pulmonary hypertension-associated morbidity and mortality (defined as escalation of pulmonary hypertension-specific therapy, unscheduled hospitalization and all-cause mortality) will be prospectively assessed during follow-up period | 1 year |