linjc16/ctgov huggingface dataset:
Fetal Kidney in Estimation of GA in Pregnancy

Study Overview
=================
Brief Summary
-----------------
A true estimation of gestational age (GA) plays animportant role in quality of maternity care such asassessment of fetal growth and to schedule the labordate. Any inaccurate estimation may lead to peri-natalmorbidity and mortality due to iatrogenic pre- or post-maturity .

Detailed Description
-----------------
Several longitudinal studies have been performed in the western countries concerning sonographic measurement of fetal kidney length. Initially these were done for diagnosis of renal malformation in utero & later on they were to find out the correlation between the fetal kidney length and the gestational age

Official Title
-----------------
Fetal Kidney in Estimation of GA and Maturity

Conditions
-----------------
Gestational Age and Maturity

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single fetus. pregnant ladies. with no medical disorders Fetal kidneys are normally seen Exclusion Criteria: Medical disorders with pregnancy Renal anomalies Renal agesnesis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasound|US will be made to assess kidneys|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who will have accurate GA calculated by Kidney parameters | describes the efficiency of kidney parameters to estimate GA | within 2 months |
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Indoxyl sulfate (IS) is a uremic toxin that accelerates the progression of chronic kidney disease (CKD). AST-120 (Kremezin®; Kureha Corporation, Tokyo, Japan) removes indole, which is the precursor of IS, in the intestine, and reduces the accumulation of IS. This drug has been shown to retard the deterioration of renal function in CKD patients through reducing the levels of IS. IS was reported to promote aortic calcification and stimulate the proliferation of vascular smooth muscle cells (VSMC). IS also inhibits endothelial proliferation and wound repair. With this background, the investigators will performed the study whether AST-120 improve the endothelial dysfunction in CKD patients.

Detailed Description
-----------------
The purpose of this study is to examine whether Kremezin, Indoxyl sulfate lowering agent improve endothelial dysfunction in stage 3,4 chronic kidney disease patients

Official Title
-----------------
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Kremezin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Chronic kidney disease (Stage3 - Stage4) Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information Exclusion Criteria: Acute gastric or duodenal ulcer Severe constipation

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AST-120<br>AST-120 administration 2g three times a day | Drug: Kremezin<br>* AST-120 2g three times a day<br>* Other names: AST-120 (Kremezin) 2g three times a day;|
| No Intervention: Control<br>Control Chronic Kidney disease stage 3,4 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of FMD(Flow Mediated Dilatation) | FMD (Flow Mediated Dilatation): percent change of FMD response to hyperemia and after sublingual nitroglycerin on brachial artery. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Indoxyl Sulfate |  | 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Indoxyl sulfate, AST-120
Korean Red Ginseng Rg3 Extract on Arterial Stiffness and Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the acute effect of a standardized extract of KRG (Rg3-KRG) consisting of 30% total ginsenosides, including 10% Rg3 ginsenoside on arterial stiffness and blood pressure, as measured by the following parameters: aortic augmentation index, peripheral blood pressure, central blood pressure

Official Title
-----------------
Acute Effect of Rg3-enriched Korean Red Ginseng (Steamed Panax Ginseng C.A. Meyer) Standardized Extract on Arterial Stiffness and Aortic and Brachial Blood Pressure in Healthy Individuals

Conditions
-----------------
Arterial Stiffness, Blood Pressure

Intervention / Treatment
-----------------
* Dietary Supplement: Ginseng
* Dietary Supplement: Wheat Bran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Age 18-70 years BMI < 30 kg/m2 Brachial systolic blood pressure < 140 mmHg Brachial diastolic blood pressure < 90 mmHg Main Exclusion Criteria: BMI >30kg/m2 Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg) Pregnancy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ginseng<br>Encapsulated 400mg Rg3-KRG extract | Dietary Supplement: Ginseng<br>* 400mg of encapsulated Rg3-KRG<br>|
| Placebo Comparator: Wheat Bran<br>400mg Wheat Bran capsule | Dietary Supplement: Wheat Bran<br>* 400mg of encapsulated wheat bran<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the acute effect of Rg3-KRG on arterial stiffness in healthy adult volunteers, as measured by aortic augmentation index (AIx). |  | Two weeks (measurements taken on two separate visits with minimum one week washout) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the acute effect of Rg3-KRG on aortic and brachial blood pressure in healthy adult volunteers. |  | Two weeks (measurements taken on two separate visits with minimum one week washout) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ginseng, clinical trial, vascular, ginsenosides, blood pressure
Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.

Study Overview
=================
Brief Summary
-----------------
To determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.

Official Title
-----------------
Amniotic Fluid Optical Density Determination Between 28 and 36 6/7 Weeks of Pregnancy and Its Relationship With the Diagnosis of Neonatal Respiratory Distress Syndrome.

Conditions
-----------------
Respiratory Distress Syndrome, Newborn

Intervention / Treatment
-----------------
* Procedure: Preterm fetus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy between 26 and 36 6/7 weeks. Exclusion Criteria: Problems in the handling of the amniotic fluid sample that prevented the calculation of the optical density.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Preterm fetus<br>Patients with pregnancies between 26 and 36 6/7 weeks of pregnancy. Before the birth, a sample of amniotic fluid was taken and analyzed using optical density at 650nm. A value above 0.15 was considered an indication of fetal lung maturity. | Procedure: Preterm fetus<br>* A sample of amniotic fluid was taken before the birth of fetus between 26 and 36 6/7 weeks of pregnancy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Distress Syndrome, Newborn | Diagnosis of Respiratory Distress Syndrome in the neonatal period. The diagnosis was made by the neonatologist in charge (using clinical and radiological parameters). | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Distress Syndrome, Newborn
Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
Autologous Fat Derived Stem Cell treatment of ED. To assess safety and primary efficacy of stem cell infusion in refractory ED. To investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction.

Official Title
-----------------
Phase 1 Study of the Use of Autologous Penile Stem Cells in Men With Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Procedure: liposuction for retrieval of own stem cells from fat cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 40 years old and older suffering from moderate to sever erectile dysfunction - Exclusion Criteria: Inability to give informed consent or attend follow up Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease Viral disease from infectivity viewpoint Major penile fibrosis or severe Peyronie's disease Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI) Severe primary venous leakage ED (defined as EDV more than 10cm/s after ICI) Prior systemic chemotherapy, or radiotherapy to donor or recipient area Not in potentially active sexual relationship Age less than 40 or over 70

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stem cells injection in penis<br>Treatment Injection of adipose derived cells into penis experimental;randomised | Procedure: liposuction for retrieval of own stem cells from fat cells<br> <br> |
| No Intervention: controled arm<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events that occur during or after the procedure to measure safety and tolerability | to assess efficacy and safety of injection of stem autologous stem cells in penis of ED patients | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stem cells injections, erectile dysfunction
Pre-approval Access Single Patient Request for Teclistamab (JNJ-64007957)

Study Overview
=================
Brief Summary
-----------------
Teclistamab pre-approval access in relapsed or refractory multiple myeloma.

Official Title
-----------------
PRE-APPROVAL ACCESS (PAA) Single Patient Request (SPR) TREATMENT GUIDELINES for Teclistamab (JNJ-64007957) for Treating Physician Use

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Teclistamab


Participation Criteria
=================
Eligibility Criteria
-----------------
Must have relapsed/refractory multiple myeloma (RRMM) and have evidence of disease progression after last therapy. Must have exhausted all available treatment options accessible as local standard of care (example. proteasome inhibitors [PIs], immunomodulatory imide drugs [IMIDs], anti CD38 monoclonal antibodies [mAbs] and therapies targeting Exportin 1 [XPO1] and B cell maturation antigen [BCMA]). Must not be eligible for a clinical trial with teclistamab or other medicines in this setting

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Teclistamab|Teclistamab will be administered subcutaneously (SC).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparative Study of Laparoscopic Versus Open Appendectomy in Children

Study Overview
=================
Brief Summary
-----------------
The study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Each group will be tracked for their baseline characteristics, events during operation and recovery, pain medication requirements, duration of hospital stay, and patient/family satisfaction. The investigators hypothesize that their will be no difference in the parameters measured between the techniques of appendix removal.

Official Title
-----------------
Randomized, Prospective, Single Blinded Trial of Laparoscopic Versus Open Appendectomy in Children

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: laparoscopic appendectomy
* Procedure: open appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children under the age of 18 years with diagnosed appendicitis Exclusion Criteria: Refusal of consent Primary language other than English or Spanish.

Ages Eligible for Study
-----------------
Maximum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>children randomized to open appendectomy | Procedure: open appendectomy<br>* open operation for removal of appendix<br>|
| Active Comparator: 2<br>children randomized to laparoscopic appendectomy | Procedure: laparoscopic appendectomy<br>* appendix removal via scope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications, length of stay, pain medication requirements |  | within 30 days of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient/family satisfaction |  | within 7 days of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis, laparoscopy, randomized trial, children, pediatric
Maximal Leg Press Strength Training Study for Coronary Artery Disease Patients

Study Overview
=================
Brief Summary
-----------------
Maximal strength training has been shown to increase muscular strength, muscular volume and work economy. An 8 week maximal leg press training regime will be conducted on cardiac heart failure patients to evaluate whether they increase their maximal leg press strength, work economy, serum testosterone and quality of life. The study hypotheses are that: Aerobic work capacity will increase due to increased work economy, without increases in maximal oxygen uptake. Strength training will increase serum testosterone.

Official Title
-----------------
Maximal Leg Press Strength Training for Coronary Artery Disease Patients. Training Effect on Serum Testosterone and Work Economy

Conditions
-----------------
Heart Failure, Coronary Artery Disease

Intervention / Treatment
-----------------
* Behavioral: Strength training intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed coronary artery disease Stable coronary artery disease 1.5 mm depression in ST segment during a cycling strain test Between 18-70 years of age Exclusion Criteria: Unstable coronary artery disease Other limitations to exercise than coronary artery disease Participants in other study interventions

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Strength training intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal leg press strength |  |  | 
| Work economy |  |  | 
| Serum testosterone |  |  | 
| Quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac heart failure, Leg press, Maximal strength training, Serum testosterone, Work economy
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture

Study Overview
=================
Brief Summary
-----------------
There are two surgical approaches (incision types) used by surgeons who do total hip replacements. The purpose of this study is to determine which type of surgical approach (incision type) produces the best results for patients who have a total hip replacement. Null Hypothesis : There is no difference in complication rate, functional outcome, surgical time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or ORIF for femoral neck fractures.

Detailed Description
-----------------
Patients undergoing Total hip Arthroplasty following displaced femoral neck fracture, will be consented and randomized to one of two surgical approaches ( anterior or posterior).

Official Title
-----------------
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture

Conditions
-----------------
Femur Fracture

Intervention / Treatment
-----------------
* Procedure: posterior approach
* Procedure: anterolateral approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Displaced femoral neck fracture Age 65 years or older Acute, femoral neck fracture Exclusion Criteria: Cognitive impairment Active Infection Limited functional capacity (nursing home resident, non-ambulatory, severe cardiorespiratory disease) Limited life expectancy Pathologic fracture (tumor) Acetabular fractures

Ages Eligible for Study
-----------------
Minimum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: anterolateral approach<br>surgical intervention THA anterolateral approach | Procedure: anterolateral approach<br>* anterolateral surgical approach<br>* Other names: Total hip Athroplasty following fracture;|
| Other: posterior approach<br>surgical intervention THA posterior approach | Procedure: posterior approach<br>* Surgical approach for Total Hip Arthroplasty<br>* Other names: Total hip Athroplasty following fracture;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dislocation rates | Radiographic variables: AP and lateral views of hip and pelvis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other complications | Hospital readmission, reoperation | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical approach for total hip arthroplasty