linjc16/ctgov huggingface dataset:
Preterm Delivery Prevention in Twins With Progesterone

Study Overview
=================
Brief Summary
-----------------
Twin pregnancies have very high preterm delivery rate. Until now, no RCT has proven benefit of progesterone in this population. In contrast, singleton pregnancies are treated with this hormone. The objective is to compare 180mg/day progeterone vaginal gel with 180mg/day with placebo, from 18 weeks to 34 weeks. The sample size was calculated and 213 cases in each group are needed to demonstrate a reduction of preterm delivery <34weeks from 13% to 7%.

Official Title
-----------------
Prevención de Parto Prematuro en Gemelares: Ensayo Aleatorio Con Progesterona Vaginal.

Conditions
-----------------
Pregnancies

Intervention / Treatment
-----------------
* Drug: Progesterone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Monochorionic or Dichorionic twin pregnancies 18 weeks to 24 weeks at inclusion. Exclusion Criteria: Cerclage before inclusion Contractions, rupture of the membranes, cervix dilation, Short cervix (15mm or 20mm if there is history of preterm delivery Monoamniotic twins, Major malformation, Selective IUGR, TRAP, TTTS. Younger than 14 years.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progesterone<br>Daily administration of vaginal progesterone, 180mg, in gel, from 18 weeks to 34 weeks. | Drug: Progesterone<br>* Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.<br>* Other names: Progendo gel;|
| Placebo Comparator: Placebo<br>Placebo Gel, for daily use from 18 weeks to 34 weeks. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery <34 weeks | Spontaneous labor under 34 weeks. | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery <37 weeks | Spontaneous delivery under 37 weeks | 14 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
twin pregnancy, progesterone, preterm delivery, >14 years, Abscense of cerclage,, TTTS, hemorrage,, history of thrombosis., cervix >15mm
Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the normal hemoglobin curve during cesarean delivery and for the first 24 hours after surgery to aid in the creation of an algorithm to detect life-threatening bleeding earlier.

Detailed Description
-----------------
Acute and life threatening blood loss is the most common cause of morbidity and mortality for pregnancy women in the US. To date, the only means we have of monitoring the amount of blood loss during a delivery is by the physician estimating the amount. This has been shown to not be very accurate and leads to confusion on when and how much a women should be transfused during a hemorrhage. New devices have been developed over the last few years to monitor blood levels in a accurate and non-invasive fashion. We aim here to use a non-invasive blood monitoring system to evaluate normal blood loss in women undergoing scheduled cesarean delivery. We hope that this will allow us to create a baseline that can be used in subsequent studies to identify women who are losing more blood than normal so that we may intervene faster and avoid unnecessary morbidity.

Official Title
-----------------
Non-Invasive Hemoglobin Monitoring of Women Undergoing Cesarean Delivery

Conditions
-----------------
Complications of Pregnancy, Childbirth and the Puerperium

Intervention / Treatment
-----------------
* Device: Masimo Rainbow Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing scheduled cesarean delivery Exclusion Criteria: Blood disorders (i.e. thalassemia, sickle cell), hypertensive disorders, obstetric risk factors for hemorrhage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women Undergoing Scheduled Cesarean Delivery<br>We will be recruiting women who are scheduled for an elective repeat or primary cesarean delivery. | Device: Masimo Rainbow Sensor<br>* Non-Invasive Hemoglobin Measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Hemoglobin over time |  | 24 hours |
Comparing Land-based and Aquatic Reduced Exertion High Intensity Interval Training in Sedentary Young Adults

Study Overview
=================
Brief Summary
-----------------
Previous research has found improvements in performance (VO2max) and clinical (insulin resistance) with cycling REHIIT. In some populations (e.g. obese, arthritic) aquatic exercise is a safer, more enjoyable option. However, to date, no study has yet examined whether aquatic REHIIT confers the same benefits as land-based REHIIT. Therefore, the purpose of this study is to determine whether there are significant differences in clinical and performance outcomes between a land-based and comparable aquatics based Reduced Exertion High Intensity Interval Training (REHIIT) protocol.

Official Title
-----------------
Comparing Land-based and Aquatic Reduced Exertion High Intensity Interval Training in Sedentary Young Adults

Conditions
-----------------
Physical Performance

Intervention / Treatment
-----------------
* Other: Aquatic Based Exercise
* Other: Land Based Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking sedentary individuals; Sedentary will be defined as less than 150 minutes of exercise/week as defined by the CDC and American College of Sports Medicine All subjects will be screened with a resting 12 lead EKG to ensure they are safe to exercise Exclusion Criteria: Any vulnerable populations will be excluded including adults unable to consent/Cognitively Impaired individuals who are not yet adults pregnant or nursing women prisoners or other detained individuals

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aquatic Based Exercise<br>maximal jump squats in a pool | Other: Aquatic Based Exercise<br>* 10 minutes of exercise with two 20 second sprints three days per week for 8 consecutive weeks<br>|
| Active Comparator: Land Based Exercise<br>cycle ergometer | Other: Land Based Exercise<br>* 10 minutes of exercise with two 20 second sprints three days per week for 8 consecutive weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cardiorespiratory Fitness | Percent changes in VO2 is milliliters of oxygen per kilogram of body weight per minute (oxygen in milliliters, weight in kilograms, and time in minutes and expressed in ml/kg/min). | Baseline to 8 weeks |
Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Olanzapine-Referenced, Parallel Group Safety, Efficacy, and Tolerability Study of SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

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

Intervention / Treatment
-----------------
* Drug: SCA-136 (200 mg)
* Drug: SCA-136 (400 mg)
* Drug: olanzapine (15 mg)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of schizophrenia Ability to remain hospitalized for at least first 4 weeks of study Needs hospitalization due to worsening of schizophrenia Exclusion Criteria: Type 1 or 2 diabetes Previous use of clozapine Serious medical illness other than schizophrenia

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: SCA-136 (200 mg)|nan|
|Drug: SCA-136 (400 mg)|nan|
|Drug: olanzapine (15 mg)|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to day 42 on the positive subscale of the SCI-PANNS |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to day 42 on: |  |  | 
| SCI-PANNS total score |  |  | 
| negative symptom sub-scale score of SCI-PANNS |  |  | 
| general psychopathology subscale score of SCI-PANNS |  |  | 
| response rate based upon SCI-PANNS total score |  |  | 
| BPRS score |  |  | 
| CGI-S score |  |  | 
| CGI-I score |  |  | 
| Cognitive assessments scores |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.

Official Title
-----------------
Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Childrens

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: EMS Mometasone gel
* Drug: Mometasone spray nasal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Consent of the patient; Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma); Exclusion Criteria: Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study; Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; Patients with history of hypersensitivity to any of the formula compounds; Participation in clinical trial in the year prior to this study; Pregnancy or risk of pregnancy and lactating patients; Patients who were in use of drugs that can interfere with evaluation; Decongestants dependent patients or patients receiving allergen specific immunotherapy; Patients on treatment with monoamine oxidase inhibitors (MAOIs).

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMS Mometasone gel<br>The patient should administer 1 spray in each nostril once daily. | Drug: EMS Mometasone gel<br>* The patient should administer 1 spray in each nostril once daily.<br>|
| Active Comparator: Mometasone spray nasal<br>The patient should administer 1 spray in each nostril once daily. | Drug: Mometasone spray nasal<br>* The patient should administer 1 spray in each nostril once daily.<br>* Other names: Nasonex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse events occurrences |  | 28 days |
Galectin-3 Level in Ankylosing Spondylitis Patients

Study Overview
=================
Brief Summary
-----------------
Forty-five AS patients and 35 healthy controls were enrolled in this study. Patients diagnosed with AS according to Modified New York criteria were included in the study. Clinical and laboratory measurements, duration of symptoms, age and body mass index (BMI) of AS patients were performed and compared with age and BMI matched control group.

Detailed Description
-----------------
Detailed histories of all participants were obtained, and systemic and rheumatologic examinations were performed. We excluded all participants who had a history of hyperlipidemia, liver, renal, hematological, familial thyroid, neoplastic, autoimmune infectious diseases and receiving anti-inflammatory drugs. We measured serum galectin-3 levels using a commercial chemiluminescent microparticle immunoassay. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess disease activity in AS patients.

Official Title
-----------------
Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Other: Serum galectin-3 concentration was measured.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ankylosing spondylitis patients Healthy controls Exclusion Criteria: Hyperlipidemia Liver diseases Renal diseases Hematological diseases Familial thyroid diseases Neoplastic diseases Autoimmune infectious diseases Receiving anti-inflammatory drugs.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 45 ankylosing spondylitis patients.<br>Patients diagnosed with ankylosing spondylitis according to Modified New York criteria were included in the study. | Other: Serum galectin-3 concentration was measured.<br>* Serum galectin-3 concentration was measured using a commercial chemiluminescent microparticle immunoassay.<br>|
| 35 controls<br>Healthy controls | Other: Serum galectin-3 concentration was measured.<br>* Serum galectin-3 concentration was measured using a commercial chemiluminescent microparticle immunoassay.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship Between Galectin-3 Level and Disease Activity in Ankylosing Spondylitis Patients | Correlation | 5 months |
Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C

Study Overview
=================
Brief Summary
-----------------
This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).

Official Title
-----------------
A Prospectively Randomized Study on Neoadjuvant Radio-Chemotherapy in Patients With Operated Rectal Carcinoma Dukes B and C (pT2, pN1-3; pT3-4, pN0-3; M0.

Conditions
-----------------
Rectal Cancer Dukes B, Dukes C

Intervention / Treatment
-----------------
* Drug: Fluourouracil
* Drug: Leucovorin
* Drug: MAb 17-1A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically verified operable rectal cancer Dukes B and C (Stage II, T2-4, N0-3, M0), R0 Age: 18-80 years Karnofsky Performance Status > 80 Adequate bone marrow reserve (leukocytes > 4,000, thrombocytes > 105/mm3, Hb > 10g %), renal and hepatic functions (total bilirubin and creatinine < 1.25 x ULN) Exclusion Criteria: Colon cancer R1, R2; carcinosis peritonei Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy Previous application of a murine or chimeric monoclonal antibody or antibody fragment Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months pre-study Known hypersensitivity to animal protein Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell. gravis, cerebral seizure disorder, et al. Pregnancy or lactation

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

| Intervention/Treatment |
| --- |
|Drug: Fluourouracil|nan|
|Drug: Leucovorin|nan|
|Drug: MAb 17-1A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluorouracil, Leucovorin, MAb 17-1A, Rectal cancer
International Plastic Bronchitis Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the international plastic bronchitis registry is to understand the natural course and long term health outcomes of subjects diagnosed with plastic bronchitis due to different types of casts. This provides essential data for identifying best practices and treatments. The secondary aim is to understand the structure of casts and mechanism of their formation.

Detailed Description
-----------------
Plastic bronchitis (PB) patients have casts removed during bronchoscopy as part of their routine care or that they are able to expectorate (cough out) casts naturally. The casts are normally discarded. Patients that agree to participate in the registry ship the airway casts and medical history to Dr. Bruce Rubin's Research Laboratory at Virginia Commonwealth University Richmond Virginia, USA. The lab evaluates the biopolymer composition and structure of the airway casts by immunohistochemistry in order to identify microscopic differences between expectorated casts of subjects with plastic bronchitis and sputum from other populations (cystic fibrosis,chronic obstructive pulmonary disease , and normal airways). The lab also conducts in vitro evaluation of clearability, adhesivity, cohesivity, and inflammatory mediator concentrations to better understand the nature of the disease.

Official Title
-----------------
International Plastic Bronchitis Registry

Conditions
-----------------
Plastic Bronchitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Plastic bronchitis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Plastic bronchitis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| natural course and long term health outcomes | The purpose of the intrnational plastic bronchitis registry is to understand the natural course and long term health outcomes of patients diagnosed with plastic bronchitis. This provides essential data for identifying possible causes of this disease and potential treatments. | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plastic bronchitis, PB