linjc16/ctgov huggingface dataset:
Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder

Study Overview
=================
Brief Summary
-----------------
A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.

Detailed Description
-----------------
A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.

Official Title
-----------------
Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder

Conditions
-----------------
Breech Presentation; Before Labor

Intervention / Treatment
-----------------
* Procedure: external cephalic version


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-cephalic presentation, singleton pregnancy, term gestation, No previous attempt at ECV in this pregnancy, signed informed consent. Exclusion Criteria: • Any contraindication for vaginal delivery

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?
-----------------

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: ECV with Full urinary bladder<br>ECV with Full urinary bladder | Procedure: external cephalic version<br>* external cephalic version<br>|
| Active Comparator: ECV with empty urinary bladder<br>ECV with empty urinary bladder | Procedure: external cephalic version<br>* external cephalic version<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECV success rate | ECV success rate | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breech; ECV; version
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Donors with CM will be solicited from a waiting list of patients awaiting BMT from the waiting list of MUD searches. Maximally matched donor will be searched for each eligible CML patient with a goal in mind to find other patients with CML that share both class I and class II determinants. Sharing of one class I II will be considered eligible for participation in the study. Peripheral blood and PBMC from the donors will be isolated, washed and irradiated. The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals for a total of 6 injections.

Official Title
-----------------
Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Biological: Allogeneic tumor cell vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above the age of 55 consenting to participate in the study. Patients with documented CML with Philadelphia chromosome t (9:21) Patients with no HLA matched sibling. Patients eligible for BMT for who no matched unrelated donor can be identified after completion of an international donor search lasting for more than six months, or patients that have failed BMT. Patients with contra-indication to BMT. Patients refusing BMT. Patients who failed interferon alpha, ARAc and/or Glivec. Exclusion Criteria: Patients requiring immunosuppressive therapy or corticosteroids.

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- |
|Biological: Allogeneic tumor cell vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both. |  |  |
ECT Schizophrenia Serotonin Study

Study Overview
=================
Brief Summary
-----------------
We suggest to investigate serotonin uptake in schizophrenia patients receiving ECT

Detailed Description
-----------------
We suggest to investigate serotonin uptake in schizophrenia patients receiving ECT

Official Title
-----------------
Serotonin Uptake to Lymphocytes and Citalopram Platelets Binding of Treatment-Resistant Schizophrenia Patients Before and After Electroconvulsive Therapy

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must meet DSM-IV criteria for schizophrenia, as assessed by the Structured Clinical Interview - Patient Version (SCID) (First et al., 1995). Ages 18 -55 Men and/or women - Exclusion Criteria: History of neurological disorders, active substance abuse in the previous 3 months. Estimated IQ less then 70. SSRIs treatment 4 weeks prior to the study. Any subject suffering from inflammatory fever disease will be excluded from the study. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- | --- |
Pain Compared Between the First and the Second Surgery in Staged BTKA

Study Overview
=================
Brief Summary
-----------------
postoperative pain and analgesic consumption between the first and the second surgery would be compared in patients undergoing staged bilateral total knee arthroplasty (BTKA).

Detailed Description
-----------------
postoperative pain and analgesic consumption is compared between the first and second total knee arthroplasty (TKA) operation.

Official Title
-----------------
Comparison of Postoperative Pain in the First and Second Knee in Staged Bilateral Total Knee Arthroplasty: Clinical Evidence That Central Sensitization Increases Systemic Pain Sensitivity

Conditions
-----------------
Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective bilateral staged total knee arthroplasty at a 1-week interval under spinal anesthesia, age <=85 American Society of Anesthesiologists physical status of I to II Exclusion Criteria: any contraindication to spinal anesthesia or femoral nerve block such as coagulopathy; conversion to general anesthesia; preexisting pain syndrome; abnormal liver function or renal test results; severe heart, liver, or renal disease; history of stroke or neurologic deficits; psychiatric disorder; chronic opioid use; drug dependency; allergy to study medications; inflammatory joint disease; previous surgery on or trauma of the knee; difference in preoperative VAS score of ≥ 20 (at rest and at maximum knee flexion) between each side of the knee; body mass index of ≥ 40 kg/m2; and inability to comprehend the VAS or to use patient-controlled analgesia (PCA.

Ages Eligible for Study
-----------------
Maximum Age: 85 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 |
| --- | --- |
| BTKA<br>patients undergoing bilateral staged total knee arthroplasty | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | visual analogue scale | from the end of the TKA surgery until postoperative 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption | patient controlled analgesia (fentanyl) | from the end of the TKA surgery until postoperative 48 hour | 
| rescue analgesic | ketoprofen | from the end of the TKA surgery until postoperative 48 hour | 
| antiemetics | antiemetics total amount | from the end of the TKA surgery until postoperative 48 hour |
Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease

Study Overview
=================
Brief Summary
-----------------
The exploration of neoplastic pulmonary pathology is based on computed tomography and bronchoscopy. This allows targeted samples of the identified lesions. A new ultrasonographic method is proposed as a non invasive and non irradiating technic by using a dedicated probe easily introduced via the channel of the fibrescope, so as to complete the identification of peripheral lesions.

Detailed Description
-----------------
The main objective of the study is to assess the ability of endobronchial ultrasonography to diagnose peripheral pulmonary lesions during the bronchoscopy and to correlate the abnormalities to computed tomography and/or histology. The dedicated probe consist of a linear array of 2-3 mm in diameter connected to a commercial unit.

Official Title
-----------------
Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease

Conditions
-----------------
Pulmonary Neoplasms

Intervention / Treatment
-----------------
* Device: Dedicated ultrasonographic probe during bronchoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Assumed proximal neoplastic pulmonary pathology Planned bronchoscopy and biopsy Exclusion Criteria: Pregnancy Breastfeeding

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dedicated ultrasonographic probe during bronchoscopy|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
-----------------
Pulmonary, Neoplasms, Endobronchial, Ultrasonography, Primary
SERPIN D1 and Its Role in Lung Cancer Invasion and Metastasis

Study Overview
=================
Brief Summary
-----------------
To evaluate the correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

Detailed Description
-----------------
Lung cancer is the leading cause of cancer death in Taiwan and world wild. Although there were progresses in the diagnosis and treatment of lung cancer, the incidence and mortality rate of lung cancer increased in recent years. In many cases, lung cancer is not diagnosed and treated until cancer cells have already invaded surrounding tissues and metastasized throughout the body. Only 15% of lung cancer patients were operable at presentation and about half of them had long term survival. The remaining almost died of metastatic disease. Detecting lung cancers when they are at their earliest stages, and identify cancers with metastatic potential will have a higher probability of truly curing the disease. Molecules that are expressed uniquely or at high level by tumor cells in comparison to normal tissues and that may be secreted into accessible fluids such as blood, urine, or sputum may be useful as lung cancer biomarkers. By using tools in SAGE Genie of Cancer Genome Anatomy Project (CGAP), we identified a secreted protein, SERPIN D1, as an overexpressed gene in non-small cell lung cancer as compared with normal lung and any other normal tissue. In an established panel of human lung adenocarcinoma cell lines with different invasive activities (CL1-0 cells and its sublines CL1-1, and CL1-5, in ascending order of activity), we detected that the expression of SERPIN D1 was higher in CL1-5 than in CL1-0 and CL1-1. According to our preliminary results, we hypothesize that SERPIN D1 may play a role in lung cancer invasion and metastasis and may serve as a serum biomarker for prognosis stratification. For this study, we are going to evaluate the potential correlation between SERPIN D1 expression in clinical specimen (including surgical specimen and blood sample) and lung cancer metastasis.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-small cell lung cancer patient, pathological proved Exclusion Criteria: -

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 |
| --- | --- | --- |
Oral Verapamil in Acute Paroxysmal Supra Ventricular Tachycardia(PSVT) Recurrence Control

Study Overview
=================
Brief Summary
-----------------
PSVT is a common rhythm disorder in emergency department which can be recurrent in some cases. Intravenous Adenosine is the drug of choice in PSVT control in acute settings but is a very short acting agent. Providing a complementary medication to decrease the rate of recurrence of PSVT after its initial control will be promising. This study evaluates the role of the oral Verapamil in recurrence control of PSVT in emergency situations.

Conditions
-----------------
Paroxysmal Supraventricular Tachycardia

Intervention / Treatment
-----------------
* Drug: Verapamil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years old PSVT on emergency department presentation Exclusion Criteria: Instability in hemodynamic status Allergy to Verapamil

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verapamil<br>40 mg Verapamil Per Oral | Drug: Verapamil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Control |  | 2 hours |
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

Detailed Description
-----------------
Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.

Official Title
-----------------
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Biological: Sipuleucel-T


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be at least 18 years of age Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT) Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T Subjects must understand and sign an informed consent form prior to their first leukapheresis Exclusion Criteria: •None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sipuleucel-T<br> | Biological: Sipuleucel-T<br>* Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.<br>* Other names: APC8015;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). | The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T). | Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T. |
MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)

Study Overview
=================
Brief Summary
-----------------
This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.

Official Title
-----------------
MITRAFIT Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)

Conditions
-----------------
Mitral Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Patient is a candidate for mitral valve repair, with our without concomitant procedures. Subject is willing to give informed consent for collection of his/her clinical data. Exclusion Criteria: Severe organic lesions with retracted chordae Congenital malformations with lack of valvular tissue Severe valvular calcifications Evolving bacterial endocarditis Known Sensitivity to Nickel or Chromium

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| • Ability of the Cardinal ring to reduce mitral valve regurgitation |  | 30 day | 
| • Percentage of patients in whom the size of the ring is adjusted |  | 6 months | 
| • Technical feasibility of adjustment. | The ability of the surgeon to adjust the Cardinal ring when required, will be measured on a scale of 1-3 (1- successfull, 3- unsuccessful) | 6 months | 
| • The occurrence of serious device related adverse events in all patients. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mitral, valve, annuloplasty, mitral regurgitation
High Resistant Starch (RS) Cookies and Appetite Control

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn starch on food intake and appetite control of a cohort of healthy students. Cookies were prepared with increasing RS content and were fed to 18 healthy students in a blind trial versus a placebo. Parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet diaries, respectively).

Official Title
-----------------
Effect of High Resistant Starch-cookies on Food Ingestion and Appetite Control in a Cohort of Healthy Students

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: High RS cookies
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self-reported healthy not suffering disorders of lipid metabolism and eating disorders Exclusion Criteria: pregnant or breast-feeding consuming an energy-restricted diet vegan or vegetarians

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 24 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational product<br>The investigational products are RS starch cookies (40 g resistant starch) from high amylose maize starch. Nine young healthy volunteers (males and females) consumed RS rich cookies (40 g RS) in two separate occasions. | Dietary Supplement: High RS cookies<br>* High RS cookies ingestion in healthy young adults<br>|
| Placebo Comparator: Placebo<br>The placebo products are common wheat-maize cookies (2 g RS). Nine young healthy volunteers (males and females) consumed placebo in two separate occasions. | Dietary Supplement: Placebo<br>* Placebo cookies ingestion in healthy young adults<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of RS on appetite regulation | Ad libitum test meal | One day | 
| Consumption of RS on appetite regulation | 12-h diet diaries | One day |