linjc16/ctgov huggingface dataset:
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether sildenafil citrate is effective in improving uterine artery blood flow and oxidative stress in patients with unexplained recurrent miscarriages

Official Title
-----------------
Role of Sildenafil Citrate in Patients With Unexplained Recurrent Miscarriages: a Randomized Clinical Trial

Conditions
-----------------
Recurrent Miscarriage

Intervention / Treatment
-----------------
* Drug: Sildenafil citrate
* Drug: matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-35 years Three or more recurrent miscarriages before the 24th week of gestation with no apparent cause for their previous losses Three or more months have elapsed since the last abortion Postmenstrual period No other therapy allowed during our treatment course Exclusion Criteria: Concomitant use of organic nitrites, or nitrates Severe hepatic, renal, or cardiovascular impairment History of stroke or myocardial infarction Patients with retinitis pigmentosa.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil citrate<br> | Drug: Sildenafil citrate<br>* 25 mg orally, 4 times per day for 21 days<br>* Other names: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt;|
| Placebo Comparator: placebo<br> | Drug: matching placebo<br>* orally, 4 times per day for 21 days<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine arteries blood flow | Uterine arteries blood flow assessed by Doppler U/S by measuring Systolic / diastolic ratio, pulsatility index and resistance index | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitric oxide serum level as a marked of oxidative stress |  | 21 days | 
| Total antioxidant capacity serum level as a marker of oxidative stress |  | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sildenafil citrate, Doppler Ultrasonography, nitric oxide, total antioxidant capacity
Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
Congenital heart disease with need for early surgery in newborns is associated with an increased incidence in global impairment in development. The causes of these late adverse neurologic outcomes are multifactoral and include both fixed (or patient-specific factors) and modifiable factors. They relate to both the mechanism of central nervous system injury associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The importance of cerebral monitoring in neonates with congenital heart problems at risk of developing neurological complications is increasingly recognized. In this way the most vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in (timing of) treatment.

Official Title
-----------------
Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.

Conditions
-----------------
Heart Defects, Congenital

Intervention / Treatment
-----------------
* Other: measuring cerebral oxygenation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonates with admission on neonatal intensive care unit with congenital heart disease. Exclusion Criteria: No informed consent. (for the long term neurodevelopmental FU) no cerebral oxygen saturation in the first 3 day's of life gestational age < 37 weeks

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| measuring cerebral oxygenation<br>NIRS: Measurement of cerebral oxygenation using Near Infrared Spectroscopy (NIRS) during the pre-operative phase in neonates with congenital heart disease. | Other: measuring cerebral oxygenation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental follow up at 24 months | Neurodevelopmental assessment at 24 months using Bayley scales of infant development II | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebrovascular changes in the transitional phase | Cerebral oxygen saturation and autoregulatory capacity | first 3 days of life | 
| Association of cerebrovascular changes with short term outcome | short term outcome defined as cerebral ultrasound abnormalities at admission and discharge, ICU stay, hospital stay and mortality before discharge | time frame of 1 admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiology, Heart Defects, congenital, Patient Monitoring, Infant, Newborn
Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of Orantinib, an oral tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived growth factor receptor, and fibroblast growth factor receptor, in patients with advanced hepatocellular carcinoma (HCC).

Detailed Description
-----------------
As HCC is a highly vascular tumor, a number of antiangiogenic agents have been tested for the treatment of HCC. Orantinib is an orally administered, small-molecule, multiple receptor tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2 (VEGFR-2), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR). Phase I studies that have been conducted in Japan for patients with solid tumors recommended a dosage of 400 mg bid. As a potent antiangiogenic agent, Orantinib is also expected to be effective against HCC. However, because most HCC patients have accompanying liver cirrhosis or hepatitis, its safety must be reevaluated in the presence of liver function impairment.

Official Title
-----------------
Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Orantinib (TSU-68)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-74 PS 0-2 Patients who did not respond to surgery, RFA, TAE, chemotherapy, or radiotherapy Chid-Pugh A or B At least one measurable lesion by RECIST criteria Exclusion Criteria: Large amount of pleural effusion or ascites Esophageal varices Simultaneously active double cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Orantinib | Drug: Orantinib (TSU-68)<br>* 200 or 400 mg bid day 1～day 28 cycle until progression or unacceptable toxicity develops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step 1(Phase I) Safety |  | During chemotherapy | 
| Step 2(Phase II) Response rate(RR) |  | Until progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step 1(Phase I) Response rate(RR) |  | Until progression | 
| Step 2(Phase II) Safety |  | During chemotherapy |
Screening Study to Identify Patients With Complement Factor I Deficiencies

Study Overview
=================
Brief Summary
-----------------
This is screening study to identify patients with Complement Factor I deficiencies. The primary objective is to identify participants with CFI deficiencies and assess the prevalence in the screened population.

Official Title
-----------------
Screening Study to Identify Patients With Complement Factor I Deficiencies

Conditions
-----------------
Previous Diagnosis With a Complement-mediated Disease and/or With Clinical Manifestations Reasonably Associated With Complement Factor I Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An individual must meet all the following criteria to be eligible to participate in this study: A male or female ≥6 months of age who has been diagnosed with a complement-mediated disease in which a reasonable etiological association with CFI deficiency has been reported Affirmation of participant's informed consent or LAR's willingness to provide informed consent with signature confirmation before any study-related activities. (Study-related activities are any procedures that would not have been performed during normal clinical management of the participant.) The participant (if a minor) must be willing to give written informed assent if the minor is within the age groups 7 to 11 years old and 12 to 17 years old. Exclusion Criteria: 1) Diagnosis of age-related macular degeneration that is complement-related with no concurrent systemic complement involvement

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

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 |
| --- | --- | --- |
| Complement Factor I Deficiency Identification | Identification of participants with a CFI deficiency and percentage of those with a CFI deficiency versus total number of screened participants | At Screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics, Disease Characteristics, Medication Use | Demographics, disease characteristics (including disease history), and disease-related medication use. Complement levels and mutation data will also be collected from medical records, if previously assessed and available. | At Screening |
Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a retrospective observational study to investigate the short-term surgical outcomes, and long-term oncological outcomes of patients diagnosed with Ulcerative colitis and rectal cancer.

Detailed Description
-----------------
Inflammatory Bowel Disease (IBD) is a risk factor for the development of colorectal cancer (CRC). Despite improved targeted screening and timely prophylactic resection, up to 15% of all IBD-related mortality can be attributed to CRC. Previous reports suggest that IBD patients present with CRC at an earlier age and with more advanced disease than those with sporadic CRC. The literature is limited, however, with respect to colitis-associated rectal cancer (CARC), which has unique considerations such as surgical approach and the use of neoadjuvant therapy. Although total proctocolectomy is generally the procedure of choice for those with CARC, recent reports reported acceptable oncological outcomes after ileal pouch-anal anastomosis (IPAA) and ileorectal anastomosis (IRA). The impact of the type of surgical procedure on the oncologic outcome in patients with CARC is not well defined. The aim of this study is to investigate short-term surgical outcomes (postoperative complications at 30 days after surgery) and long-term oncological outcomes (disease-free survival) of CARC patients undergoing different surgical approaches.

Official Title
-----------------
Surgical and Oncological Outcomes in Patients With Ulcerative Colitis Associated Rectal Cancer: a Retrospective Study

Conditions
-----------------
Ulcerative Colitis, Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Total proctocolectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Ulcerative Colitis; Patients diagnosed with rectal cancer (within 15 cm from the anal verge); Patients who underwent surgery for rectal cancer between January 2004 and January 2020; All type of surgery will be included; Surgery in elective and emergency settings. Exclusion Criteria: Patients aged<18 years; Patients with a diagnosis of undetermined colitis; Insufficient follow-up data.

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 |
| --- |
|Procedure: Total proctocolectomy|Total proctocolectomy: surgical removal of the colon, rectum, and anus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcome | 30 days postoperative complications | 30 days after surgery | 
| Oncological outcome | Disease-free survival | 5 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative Colitis, Rectal Cancer
A Retrospective Study to Evaluate the Effectiveness of onabotulinumtoxinA in Preventing Headaches in Patients With Chronic Migraines

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of OnabotulinumtoxinA to prevent headaches in patients with Chronic Migraine.

Conditions
-----------------
Chronic Migraine, Headache

Intervention / Treatment
-----------------
* Biological: OnabotulinumtoxinA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of chronic migraines 15 or more headache days over a 30 day period A minimum of 2 consecutive treatment cycles of 100 units onabotulinumtoxinA and a minimum of 2 consecutive treatment cycles with the onabotulinumtoxinA dosing between 155 and 195 units Exclusion Criteria: Any treatment cycle dose of onabotulinumtoxinA greater than 200 units

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective review of medical records. | Biological: OnabotulinumtoxinA<br>* Previous treatment with onabotulinumtoxinA for Chronic Migraine.<br>* Other names: BOTOX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Headache Days |  | Up to 56 Weeks |
Factors Affecting Medical Student Learning in Simulation Scenarios

Study Overview
=================
Brief Summary
-----------------
Simulation is used to teach undergraduate and postgraduate healthcare professionals, however it is not known how best to use this resource. Using qualitative methods, this study aims to investigate how medical students learn during simulation scenarios and will compare students who are paired with peers with those who are solo during their scenarios. Video and audio data from simulations will be collected and analysed with anxiety and empathy questionnaire data and semi-structured interviews.

Detailed Description
-----------------
Medical students attending a simulation day will either perform their simulation paired with another student from the group or solo. Video data from the scenario and audio data from the feedback session will be retained. One week later students will perform a second scenario and the feedback following this will be retained. Students will also have a semi-structured interview and complete anxiety and empathy questionnaires.

Official Title
-----------------
Factors Affecting Medical Student Learning in Simulation Scenarios

Conditions
-----------------
Learning

Intervention / Treatment
-----------------
* Other: Simulation scenario
* Other: Simulation scenario


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All final year medical students at the study university who are allocated to attend the anaesthesia special study module Exclusion Criteria: Non-English speakers Visiting students who will be unable to complete the study Students who refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solo<br>Students will perform their simulation scenario solo and receive feedback within the group | Other: Simulation scenario<br>* Students will perform their simulation scenario solo and receive feedback within the group<br>|
| Experimental: Paired<br>Students will be paired with one of their peers for this simulation scenario | Other: Simulation scenario<br>* Students performing their scenario will be paired, not solo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Learning during simulation scenario as measured qualitatively |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Simulation, Learning, Medical Students, Empathy, Anxiety
Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction

Study Overview
=================
Brief Summary
-----------------
The massive weight loss leads an important excess of skin on thoracic level giving the aspect of a feminine breast with a relatively important ptose. Several techniques were described in the literature about gynaecomastia , but the post-bariatric pseudo-gynaecomastia was not handled yet enough. Moreover, there is no single consensual technique on this subject. The technique used in this service was described for the first time in 2008 ( 1 ) on a serie of 8 patients with an average follow-up of 13 months. Although the results are promising, no other publication was done, and the procedure remains badly represented in the world literature.

Official Title
-----------------
Post-massive Weight Loss Chest Contouring: Inferior Pedicle Technique in Pseudo-gynecomastia Correction

Conditions
-----------------
Gynecomastia

Intervention / Treatment
-----------------
* Procedure: Inferior pédicule gynaecomastia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inferior pedicle gynaecomastia surgery Age > 16 Exclusion Criteria: Age < 16

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Inferior pédicule gynaecomastia|Inferior pédicule gynaecomastia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aesthetic result score | patient answer to a satisfaction questionnaire | Average of 6 months post-surgery |
Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg tablets under fed conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions

Conditions
-----------------
Prophylaxis of Organ Rejection

Intervention / Treatment
-----------------
* Drug: Mycophenolate Mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mycophenolate Mofetil|Prophylaxis of Organ Rejection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | baseline, 2-period, 14 day washout |