linjc16/ctgov huggingface dataset:
Placental Cord Drainage After Vaginal Delivery

Study Overview
=================
Brief Summary
-----------------
Placental Cord Drainage after Vaginal Delivery A randomized clinical trial

Official Title
-----------------
Placental Cord Drainage After Vaginal Delivery: A Randomized Clinical Trial

Conditions
-----------------
Blood Loss

Intervention / Treatment
-----------------
* Other: Cord drainage
* Other: Cord clamping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy. Pregnancy with vertex presentation. Gestational age37 up to 42 weeks Patient expected to have spontaneous vaginal delivery. Maternal age 18 years old or more. Exclusion Criteria: Previous history of Postpartum hemorrhage. Antepartum hemorrhage Multiple pregnancies Instrumental deliveries Coagulation disorders Over distended uterus (hydramnios, large fetus). Patient with extensive extended vaginal or cervical tear. Rupture uterus. Secondary arrest of cervical dilatation. Persistent occipito-posterior. Deep transverse arrest of fetal head.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cord drainage<br> | Other: Cord drainage<br>* Cord drainage<br>|
| Active Comparator: Cord clamping<br> | Other: Cord clamping<br>* Cord clamping<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss |  | 1 hour |
Cryoablation for Advanced and Refractory Desmoid Tumors

Study Overview
=================
Brief Summary
-----------------
Desmoid tumors, also called aggressive fibromatosis, are rare, locally invasive tumors with no potential for metastasis. The incidence is approximately 2 to 4 per million per year in the general population. The watch and wait policy is the standard of care for newly diagnosed patients in Europe. Patients who progress have first-line medical treatment, surgery is no longer the treatment because there is a high rate of recurrence (> 60%) and radiotherapy is not very suitable because the patients are often young and the tumors are large. Cryoablation seems to be an effective therapeutic option that should be evaluated.

Official Title
-----------------
Cryoablation for Advanced and Refractory Desmoid Tumors

Conditions
-----------------
Desmoid Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years old) Having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment Having not expressed their opposition, after being informed, to the reuse of their data for the purposes of this research. Exclusion criteria: Subject who expressed their opposition to participating in the study Patient already included in another ongoing study Subject under guardianship or curatorship Subject under safeguard of justice

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 |
| --- | --- | --- |
| Progression-free survival assessed using RECIST(Response evaluation criteria in solid tumors) criteria |  | at 6 months after cryoablation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Desmoid tumors, Fibromatosis, Invasive tumors, Radiotherapy, Cryoablation
Validity of the Spanish Version of Subjective Well-being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Observational, short-term prospective, multicenter study to assess psychometric properties of the Spanish version of SWN-K scale in patients with schizophrenia.

Official Title
-----------------
Validity of the Spanish Version of Subjective Well-being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder (DSM-IV TR criteria) Stabilized out-patients Under treatment with an oral antipsychotic drug Exclusion Criteria: Administration of a depot antipsychotic drug Participation in another clinical trial within 4 weeks prior to enrolment into this study

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 |
| --- | --- | --- |
| SWN-K |  | 7 days | 
| PANSS |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-I |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, subjective well-being, psychometric validation
To Evaluate the Effect of MCS® in Prostate Cancer Prevention

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of MCS® compared with placebo in reducing the risk of biopsy-detectable prostate cancer in high-risk subjects after 104 weeks (24 months) of treatment.

Official Title
-----------------
A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS® in Prostate Cancer Prevention

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: MCS®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high-risk subjects of prostate cancer. Male subject with age from 50 to 75 years old. Subject is able to understand and willing to comply with the study procedures and has signed the informed consent form (ICF). Exclusion Criteria: Subjects who are or will be taking long-term hormonal agents that may affect the normal physiology of sex hormone function. Subjects with a PSA > 10.0 ng/ml. Subjects with a history of prostate cancer. Subject participated in another investigational agent study in the past 30 days or is planning to do so during the study period. Subjects are considered ineligible for the study as judged by the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo arm | Drug: Placebo<br> <br> |
| Active Comparator: MCS® 15 mg/day<br>MCS® soft capsule | Drug: MCS®<br> <br> |
| Active Comparator: MCS® 30 mg/day<br>MCS® soft capsule | Drug: MCS®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative biopsy-detectable prostate cancer rate |  | Week 104 (Month 24) |
Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.

Official Title
-----------------
A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A

Conditions
-----------------
Haemophilia A, Congenital Bleeding Disorder

Intervention / Treatment
-----------------
* Drug: Advate®
* Drug: turoctocog alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe haemophilia A (FVIII level less than or equal to 1%) Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial Exclusion Criteria: Presence of any bleeding disorder in addition to haemophilia A Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor Abnormal renal function tests Known hypersensitivity to Advate®

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 55 Years

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

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: Advate®/turoctocog alfa<br> | Drug: Advate®<br>* Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session<br>Drug: turoctocog alfa<br>* After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session<br>* Other names: N8;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of FVIII 30 min after administration, half-life, AUC, and clearance |  | at 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibitor development |  | at 30 days |
Acetabular Labral Tear in Dysplastic Hips

Study Overview
=================
Brief Summary
-----------------
A prospective case-control study of the clinical and radiographic outcome of periacetabular osteotomy in patients with and without preoperative acetabular labral tears.

Conditions
-----------------
Developmental Dysplasia of the Hip, Labrum

Intervention / Treatment
-----------------
* Procedure: labrum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Developmental dysplasia of the hip Exclusion Criteria: contraindication for magnetic resonance arthrography severe deformities of the femural head
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dysplasia<br>Patients with developmental dysplasia of the hip undergoing PAO | Procedure: labrum<br>* Two years follow-up after PAO, to find any differences among patients with and without known acetabular labral tears<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Telomere Length and Other Parameters of Telomere Dysfunction in PSC and Colitis

Study Overview
=================
Brief Summary
-----------------
PSC is a chronic cholestatic disorder. The investigators intend to study some telomere parameters and telomere length in order to predict a premalignant state.

Detailed Description
-----------------
Primary sclerosing cholangitis (PSC) and colitis are chronic inflammatory disorders with malignant potential. Telomerase is an enzyme complex that lengthens telomeres and has enhanced expression in numerous malignancies. In this study, we evaluated the telomerase gene copy number, telomere length, cells in senescence, aneuploidy and additional parameters of telomere dysfunction from peripheral blood lymphocytes of patients.

Official Title
-----------------
Primary Sclerosing Cholangitis Telomere Length

Conditions
-----------------
Primary Sclerosing Cholangitis, Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent documented PSC and inflammatory bowel disease Exclusion Criteria: under 18 years, above 80 y known active malignancy decompensated cirrhosis patients who cannot sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy control<br> | |
| IBD<br>patients with inflammatory bowel disease, study group | |
| PSC<br>patients with primary sclerosing cholangitis, study group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telomere length |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cells with increased telomerase RNA component (TERC) expression |  | 1.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telomeres, PSC
UNC Pleural Fluid Registry

Study Overview
=================
Brief Summary
-----------------
Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.

Official Title
-----------------
University of North Carolina Pleural Fluid Registry

Conditions
-----------------
Lung Cancer, Lung Infection, Breast Cancer, Malignant Pleural Effusion, Empyema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are 18 years or older Inpatients and outpatients Diagnosed with pleural fluid, are referred for and undergo clinically indicated drainage who have clinical evidence of: pulmonary infection (such as fever, leukocytosis, new or worsening infiltrate on chest x-ray, or clinical deterioration) with effusion malignancy Exclusion Criteria: A subject will not be eligible for inclusion in this registry if, in the investigator's (or treating clinician's) opinion, the patient has any concurrent medical condition that may preclude their ability to undergo pleural fluid drainage safely. Incarcerated individuals

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pleural Fluid Registry<br>Any subject who has pleural fluid buildup from lung cancer, breast cancer, or lung infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of a pleural fluid registry | Biological specimens and corresponding clinical data from subjects will be collected during standard of care procedures and medical record abstraction to support the creation of a pleural fluid registry. | 32 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biospecimen, pleural fluid, lung cancer, cancer, infection, breast cancer
Evaluation of Mineral Absorption in Infants Fed Infant Formula

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure calcium absorption in infants fed formula with and without prebiotics.

Detailed Description
-----------------
Infants will be fed formula and blood drawn and urine collected to measure calcium absorption.

Official Title
-----------------
Evaluation of Mineral Absorption in Infants Fed Infant Formula

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: Calcium absorption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, term infants Exclusion Criteria: Breast fed infants Use of vitamin/mineral supplements Currently on medication

Ages Eligible for Study
-----------------
Minimum Age: 56 Days
Maximum Age: 70 Days

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

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

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 |
| --- | --- |
| Active Comparator: 1<br>cow-milk based infant formula | Procedure: Calcium absorption<br>* formula with or without prebiotics<br>|
| Experimental: 2<br>cow-milk based infant formula with prebiotics | Procedure: Calcium absorption<br>* formula with or without prebiotics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium absorption |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Term, Infant
Tiotropium 18ug Inhalation Capsule Using a Handihaler® Among Korean COPD Patients

Study Overview
=================
Brief Summary
-----------------
This is a descriptive observational open non-comparative study of the safety and efficacy of tiotropium inhalation capsule given at 18mcg once a day for 30 days among Korean patients with COPD. At Visit 1, patients who are diagnosed as COPD will be prescribed tiotropium inhalation capsule at 18mcg once daily (at the same time). Patients' FEV1 will be assessed before start of treatment (Visit 1) and at the end of the 30 day treatment period (Visit 2). Occurrence of adverse events will also be asked from the patient at the end of the 30 day treatment period. Patients will be informed by the attending physicians to immediately report the occurrence of serious adverse events.

Detailed Description
-----------------
Study Design:

Official Title
-----------------
Regulatory Requisite Post Marketing Surveillance to Assess the Safety and Efficacy of Spiriva® HandiHaler® (Tiotropium Bromide Inhalation Powder 18mcg, q.d.) in Korean COPD Patients: A 30-Day, Open Label, Non-interventional Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 40 years old Diagnosed as COPD No Previous Spiriva administration No Contraindication for Spiriva according to the product label Exclusion Criteria: patients with history of hypersensitivity to atropine and its derivatives (e.g. ipratropium oxitropium or any component of this product).

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint for this postmarking study is the occurrence of adverse events, anytime during the 30 day study period, which might or might not be connected with the use of Spiriva® 18 mcg inhalation capsule |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints include change in post bronchodilator FEV1 and assessment of any change in overall severity of the disease from baseline to the end of 30 day treatment. |  | 30 days |
Study Evaluating Bifeprunox in Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder

Conditions
-----------------
Depression Bipolar

Intervention / Treatment
-----------------
* Drug: Bifeprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 to 65 years of age, inclusive. Diagnosis of Bipolar Disorder and must be experiencing a depressive episode. Exclusion Criteria: This is a follow on study to protocol 3168A2-304. Only subjects who have participated in the previous study are eligible.

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary measurement scales will be used: |  |  | 
| Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 |  |  | 
| Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8 |  |  | 
| Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 |  |  | 
| Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 |  |  | 
| Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8 |  |  |