linjc16/ctgov huggingface dataset:
The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to find out whether the plant compounds present in Hibiscus sabdariffa, a plant commonly used in herbal tea blends and other beverages, will have a beneficial effect on blood pressure in people with mildly elevated blood pressure.

Official Title
-----------------
The Effect of Hibiscus Sabdariffa L. Tisane on Blood Pressure in Prehypertensive and Mildly Hypertensive Men and Women

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: herbal therapy/botanical therapy (Hibiscus sabdariffa)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systolic blood pressure 120-150 mm Hg Diastolic blood pressure 95 mm Hg or less Body mass index (BMI) 18.5-34.9 kg/m2 Exclusion Criteria: Smoking Use of medications that influence blood pressure Cardiovascular disease Chronic kidney disease Diabetes Regular use of vitamin C supplements (min 500 mg/day) within prior 30 days Regular strenuous aerobic activity greater than 30 min/day Excessive intake of caffeine or alcohol Pregnancy within last 6 months or during study period Abnormal complete blood count (CBC), urinalysis or electrocardiogram (EKG)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: herbal therapy/botanical therapy (Hibiscus sabdariffa)|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
-----------------
pre-hypertension, mild hypertension
Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the burden of aesthetic complication in systemic sclerosis. Systemic sclerosis is associated with changes in skin aspect which can impact the appearance. Aesthetic burden will be assessed through several scales and compared to a control group of health subjects.

Official Title
-----------------
Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Other: appearance scales


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systemic sclerosis according to ACR-EULAR 2013 Exclusion Criteria: non French native aesthetic sequel from other conditions

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 |
| --- | --- |
| systemic sclerosis<br>patients with systemic sclerosis | Other: appearance scales<br>* appearance scales : AVS; ASWAP; DAS 59<br>|
| control<br>Healthy subjects | Other: appearance scales<br>* appearance scales : AVS; ASWAP; DAS 59<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual scale for aesthetic burden | Visual scale for aesthetic burden from 0 to 10 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Appearance Scale (SWAP) | The SWAP measures body image dissatisfaction in persons with visible disfigurement | Baseline | 
| Derriford Appearance Scale-59 (DAS) | The Derriford Appearance Scales measure the spectrum of psychological distress and dysfunction that is characteristic of disfigurements, deformities and aesthetic problems of appearance. | Baseline | 
| Multidimensional Body self Relations Questionnaire (MBSRQ) | The Multidimensional Body-Self Relations Questionnaire (MBSRQ) is a 69-item self-report inventory for the assessment of self-attitudinal aspects of the body-image construct. | Baseline |
SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

Official Title
-----------------
A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.

Conditions
-----------------
Early Stage Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Pardaprunox
* Drug: pramipexole
* Drug: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn & Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 10 at baseline. Exclusion Criteria: Diagnosis is unclear or a suspicion of other parkinsonian syndromes, Patients who have undergone surgery for the treatment of PD, Current presence of dyskinesias, Motor fluctuations or loss of postural reflexes, A history of non-response to an adequate course of l-dopa or a dopamine agonist, Patients for whom previously treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pardaprunox<br>* 12-42 mg<br>|
| Active Comparator: 2<br> | Drug: pramipexole<br>* 1.5-4.5 mg<br>|
| Placebo Comparator: 3<br> | Drug: Placebo Comparator<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment. |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease
The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.

Official Title
-----------------
The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: tirofiban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage Exclusion Criteria: hemodynamic instability history of MI old age > 80years Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose | Drug: tirofiban<br>* tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)<br>|
| No Intervention: 2<br>Aspirin, clopidogrel, unfractionated heparin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size and its transmural extent using MRI |  | within the first 30 days after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography |  | at 6 month after index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Angioplasty, Transluminal, Percutaneous Coronary, tirofiban, Magnetic Resonance Imaging, Myocardial Infarction
Study of the Regulation of Parathyroid Hormone Secretion in Pseudohypoparathyroidism

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Determine the relationship between serum calcium concentrations and parathyroid hormone secretion in patients with pseudohypoparathyroidism.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are tested for parathyroid hormone response following sequential graded intravenous infusions of sodium citrate and calcium gluconate. Assays include ionized calcium and intact parathyroid hormone.

Conditions
-----------------
Pseudohypoparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Pseudohypoparathyroidism, i.e.: Renal resistance to parathyroid hormone OR Albright hereditary osteodystrophy No other illness unless related to pseudohypoparathyroidism No pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endocrine disorders, pseudohypoparathyroidism, rare disease
TACE Plus Tegafur Versus TACE for Intrahepatic Cholangiocarcinoma After Curative Resection

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) plus Tegafur with TACE alone in patients with intrahepatic cholangiocarcinoma after curative resection

Official Title
-----------------
Anti-tumor Recurrence With Transarterial Chemoembolization (TACE) Plus Tegafur Versus TACE on Patients With Intrahepatic Cholangiocarcinoma After Curative Resection：A Randomized Controlled Study

Conditions
-----------------
Intrahepatic Cholangiocarcinoma

Intervention / Treatment
-----------------
* Procedure: TACE+Tegafur
* Procedure: TACE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients > 18 years and <=70 years of age. Pathological evidence of ICC Tumors can be completely resected. Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. Patients who can understand this trial and have signed information consent. Exclusion Criteria: Tumors can not be resected . Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma. Patients with a medical history of other malignant tumors. Subjects participating in other clinical trials. Liver function:Child C.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TACE+ Tegafur<br>Patients will be treated with Tegafur after resection soon, and TACE in 4 or 8 weeks after resection. | Procedure: TACE+Tegafur<br>* Tegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection.<br>* Other names: TACE followed by Tegafur;|
| Experimental: TACE<br>Patients will be treated with TACE alone in 4 or 8 weeks after resection. | Procedure: TACE<br>* TACE alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rates of each group |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence rate of recurrence of each group |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemoembolization, Therapeutic, Tegafur
Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912 in adult subjects with SBS-associated intestinal failure (SBS-IF).

Detailed Description
-----------------
The study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a safety follow-up period.

Official Title
-----------------
A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

Conditions
-----------------
Short Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: HM15912 Active
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women, aged 18 years of age or older with intestinal failure resulting in SBS at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is <18 years) Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol Diagnosis of SBS defined as remaining small bowel in continuity of estimated <200 cm (equal to 79 inches) and with the latest intestinal resection being at least 6 months prior to Screening and considered stable regarding the PN/IV need. No restorative surgery planned in the study period. Exclusion Criteria: Any history of colon cancer. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free for at least 5 years History of alcohol or drug abuse (within 1 year of screening)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active<br> | Drug: HM15912 Active<br>* Randomized, double-blind, placebo-controlled<br>|
| Placebo Comparator: Matching Placebo<br> | Drug: Placebo<br>* Randomized, double-blind, placebo-controlled<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) | after multiple subcutaneous (SC) doses | for 24 weeks |
Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)

Study Overview
=================
Brief Summary
-----------------
a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids

Official Title
-----------------
A 12 Week Multicenter, Open-label, Observational Study to Evaluate the Effectiveness of Montelukast Sodium (Singulair®), 4 or 5 mg/Day in Pediatric Subjects With Uncontrolled Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: montelukast sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient Is Diagnosed With Asthma For At Least 6 Months Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10) Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To Non-Adherence With Current Therapy Through The Preceding 6 Weeks Exclusion Criteria: As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol (Serevent)) Or A Combination Product (Advair Or Symbicort) Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 14 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: Montelukast<br> | Drug: montelukast sodium<br>* Montelukast 4-5 mg for 12 weeks, oral tablet<br>* Other names: Singular;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire (ACQ) | ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. | Week 0, 4, and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire (ACQ) | ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. | Week 0, 4, and 12 |
Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning

Study Overview
=================
Brief Summary
-----------------
Evaluate the effectiveness of the use of a 24% sucrose solution for pain management of preterm infants during endotracheal suctioning.

Detailed Description
-----------------
Many infants admitted to neonatal intensive care unit (NICU) undergo repeated invasive procedures. Recent studies have shown that the oral sucrose administration to neonates is safe and effective for pain relief during heel stick and venipuncture.Most data suggest the investigation of the effect of sucrose in other painful procedures such as in ventilated newborns.

Official Title
-----------------
Pain Relief of Newborn Preterm Infants During Endotracheal Suctioning: a Randomized Clinical Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants over 12 hours of life intubated clinically stable without use of analgesics or sedatives Exclusion Criteria: preterms with congenital malformations preterms with genetic syndromes preterms with Apgar score at 5´<7 preterms with meningitis preterms with diagnosed of necrotizing enterocolitis Ouvir Ler foneticamente

Ages Eligible for Study
-----------------
Maximum Age: 36 Weeks

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sucrose<br>0,5 ml/kg of sucrose administered 2 minutes prior the procedure | Drug: sucrose<br>* oral sucrose solution, 24%, 0,5 ml/kg, 2 minutes before start the suctioning sterile water, 0,5 ml/kg, 2 minutes before start the suctioning<br>* Other names: sugar;|
| Placebo Comparator: sterile water<br>0,5 ml/kg of sterile water administered 2 minutes prior the procedure | Drug: sucrose<br>* oral sucrose solution, 24%, 0,5 ml/kg, 2 minutes before start the suctioning sterile water, 0,5 ml/kg, 2 minutes before start the suctioning<br>* Other names: sugar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pain score | The tool that will be used is PIPP = Premature Infant Pain Profile. This avaliation begins prior to suctioning until 30 seconds after suctioning. Each infant will be avaliated 2 times (with sucrose and with placebo). The 2 avaliations in the same day. | within the first twelve hours after clinical stabilization, the PIPP will be done. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, sucrose, newborn, mechanical ventilation