linjc16/ctgov huggingface dataset:
Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections

Study Overview
=================
Brief Summary
-----------------
This is a study clinical, multicenter, Phase III trial, to evaluate the efficacy and safety of tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Detailed Description
-----------------
Study Clinical, multicenter, Phase III, to evaluate the efficacy and safety of 10mg/g tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Official Title
-----------------
Study Clinical, Multicenter, Phase III, to Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections Like Tinea Foot, Tinea and Tinea Crural Body

Conditions
-----------------
Fungal Infections, Tinea Pedis, Tinea Cruris, Tinea Corporis

Intervention / Treatment
-----------------
* Drug: Clotrimazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both sexes, of any race, aged 12 years; Ability to understand and sign the IC (for patients older than age) in the case of minors monitoring and consent of a guardian; Clinical diagnosis of fungal infections for tinea pedis (ringworm of the feet) or tinea cruris (ringworm of the groin region), or tinea corporis (ringworm in other body areas); Direct mycological exam positive for fungi; Exclusion Criteria: Pregnant women or nursing mothers; Use of topical or oral antifungal; Use of steroids; Allergy or hypersensitivity to any component of product; Clinical cases of tinea infection by bacteria and / or eczema, tinea extensive and onychomycosis.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tonaftato<br>Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days. | Drug: Clotrimazole<br>* Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g. | Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days. | 97 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fungal infections, tinea, tonaftato
Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes

Study Overview
=================
Brief Summary
-----------------
The thymus gland is a specialized organ in the chest that plays a central role in the adaptive immune system throughout development until puberty. In response to stress, the fetal thymus gland may shrink, or involute. The investigators propose a prospective cohort study that will enroll pregnant women admitted to labor and delivery for the management of preterm labor and/or preterm premature rupture of membranes from 28-36 weeks gestation. Based on sonographic thymus measurements, the investigators will develop a clinical prediction tool to identify babies who are at increased risk for adverse neonatal outcomes. A reliable non-invasive predictor of adverse neonatal outcome using thymic ultrasound measurements has the potential to affect clinical management, improve outcomes for premature babies, and direct further research efforts.

Official Title
-----------------
Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcome in Women at High Risk for Preterm Delivery

Conditions
-----------------
Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy between 28-36 weeks gestation Active spontaneous preterm labor symptoms (contractions, cervical dilatation and/or PPROM) Exclusion Criteria: Non-singleton pregnancies Gestational hypertension/preeclampsia Major fetal anomalies Known fetal aneuploidy Intrauterine Fetal Demise

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm Admits<br>Women who are admitted for preterm labor observation and management | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Distress | Neonatal respiratory compromise defined as respiratory distress requiring any CPAP (continuous positive airway pressure) and or ventilator therapy. | Date of delivery up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PPROM, Pregnant, Preterm, Premature, labor
Study of Algorithm for Epilepsy Alert Device

Study Overview
=================
Brief Summary
-----------------
An accelerometer with transmitting ability is worn on the wrist. Data of movements during seizures will be analyzed to upgrade algorithm that will identify seizures.

Detailed Description
-----------------
Patients undergoing Video-EEG telemetry will wear movement sensor on their wrist. The sensor will transmit continuous data to a laptop. Seizures' data (tonic or clonic) will be analyzed and transformed into an algorithm (up-graded existing preliminary algorithm). In the second phase the algorithm will need to identify seizure events within one minute of the onset. Both specificity (false positive) and sensitivity (false negative) will be than calculated.

Official Title
-----------------
Epilepsy Alert Device - Epilert Performance

Conditions
-----------------
Motor Seizures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing Long Term Monitoring for motor seizures Exclusion Criteria: Invasive recording Psychogenic seizures

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 65 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
-----------------
alert, motor seizures, accelerometer, algorithm, detection
The Effect Of Tramadol, Metamizol and Dexketoprofen Combination On Chronic Pain Development After Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Non Coronary Heart Surgery scheduled for the study , in patients with acute postoperative period Use of tramadol retard, metamizol and dekxketoprofen the effects on pain and character has been seen in the chronic phase targeted.

Detailed Description
-----------------
This prospective study analyzed surgical thoracotomy and sternotomy patients treated with analgesic drug when higher than 4 regularly. Clinical parameters include general demographics, preoperative and postoperative clinical examination status, pain scores, neuropathic pain scores, medication side effects, additional analgesic, antiemetic and lacsatif needs, vital functions, chest drains, blood transfusion needs, duration of cardiopulmonary bypass, cross clamp time and anaesthesia time. The screening tests for neuropathic pain is the Douleur Neuropathique 4. Using at postopertative 3.month DN4 questionnaires predict persistent postoperative neuropathic pain.

Official Title
-----------------
The Effect Of Tramadol, Metamizol and Dexketoprofen Combination On Chronic Pain Development After Heart Surgery

Conditions
-----------------
Heart Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included between 20-70 years ASA 1-4 Euroscore value lower than 7 Undergoned non coronary heart surgery (minithoracotomy and sternotomy) Intensive care has been discharged from the service in 24 hours , with patients given tramadol retard , metamizol, Dexketoprofen on postoperatif first day to discharged from the hospital. Exclusion Criteria: Diabetes mellitus Chronic renal failure COPD Uncontrolled hypertension Epilepsy Psychiatric disease Malignancy Patients with a history of cerebrovascular disease Patients with ischemia Patients suffering from chronic pain and analgesic use Patients taking antidepressants and antiepileptic drug Off-pump technique used or redo undergo cases Ongoing postoperative time thoracic or mediastinal drains more than 48 hours remaining patients, bleeding or patients who received repeated revisions due to infection More than 24 hours remaining in intensive care patients Patients with long discharge duration 1 week Patients who discontinued due to side effects of tramadol may begin after medicines. Postoperative wound infection.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropathic pain assesement by DN4 score after minithoracotomy and sternotomy |  | outcome measure assessed 3 months after the surgery |
Tolerability of ALK Tree Tablet

Study Overview
=================
Brief Summary
-----------------
This trial is performed to assess the tolerability of the ALK Tree Tablet in patients with birch pollen induced allergy

Official Title
-----------------
A Randomised, Multiple Dose, Dose Escalation, Double-Blind, Placebo-Controlled Phase I Study Investigating the Safety of ALK Tree Tablet in Adult Subjects With Birch Pollen Induced Rhinoconjunctivitis (With/Without Asthma).

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Drug: Betula Verrucosa allergen extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical history of birch pollen induced rhinoconjunctivitis (with or without mild to moderate asthma ) of at least two years prior to trial entry requiring symptomatic treatment during the birch pollen season. Positive Skin Prick Test response to Betula verrucosa Positive specific IgE against Bet v1 FEV1 ≥ 70% of predicted value Exclusion Criteria: No clinical history of perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed and sensitised No clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis No conjunctivitis, rhinitis or asthma at the screening or randomisation visit No history of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis No history of angioedema

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Betula Verrucosa allergen extract|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
-----------------
Tolerability of ALK Tree Tablet in patients with birch pollen induced allergy
Organ Protection With Sevoflurane Postconditioning

Study Overview
=================
Brief Summary
-----------------
Organ protection, volatile anesthetics, postconditioning, hepatic surgery

Detailed Description
-----------------
This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury in the liver with sevoflurane postconditioning upon reperfusion.

Official Title
-----------------
Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion: Postconditioning

Conditions
-----------------
Hepatectomy

Intervention / Treatment
-----------------
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: older than 18 years patients undergoing liver resection (benign or malignant tumors) Exclusion criteria: non-german speakers laparoscopic liver resection coagulopathy (platelets < 50'000/ml, Quick < 50%) liver cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Sevoflurane<br>Sevoflurane for pharmacological postconditioning | Drug: Sevoflurane<br>* 3.2 Vol % for postconditioning<br>|
| Experimental: Propofol<br>Anesthesia maintenance with propofol instead of Sevoflurane postconditioning | Drug: Sevoflurane<br>* 3.2 Vol % for postconditioning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver transaminase AST | Peak value | Postoperative phase until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALT peak value |  | Postoperative phase until discharge | 
| Course of transaminases |  | From the day before surgery, to 6 hours after surgery, up to postoperative day 7 | 
| Postoperative complications |  | Postoperative phase until discharge | 
| Length of hospital stay |  | Postoperative phase until discharge | 
| Need for prolonged intensive care unit stay (>24 hours) |  | Postoperative phase until discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemia reperfusion injury, Organ protection
Video Telehealth Exercise Training in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to begin an exercise program for patients with a cystic fibrosis (CF) exacerbation.

Detailed Description
-----------------
The study will enroll 25 patients with CF during an introduction visit and initiate an ambulatory 1) tailored exercise regimen and 2) behavior change techniques focused on adherence and sustainability of exercise. The intervention will be delivered via a data-enabled smartphone with video capabilities facilitating live and interactive two-way video-conferencing using a HIPAA compliant app. Participants will receive supervised exercise paired with coaching on behavior change techniques over 12 weeks in 3 weekly 1-hour sessions, and will have monthly phone follow-ups and clinic follow-ups at 3 and 6 months.

Official Title
-----------------
Video Telehealth Exercise Training in Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Cystic Fibrosis 18 years old and older clinically stable with no exacerbation within 6 weeks Exclusion Criteria: any comorbidity that precludes exercise -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supervised exercise plan<br>patients will receive a tailored exercise regimen and behavior change techniques focused on adherence to the exercise program. These will be delivered by using a video platform, much liker telehealth clinic appointments. These telehealth visits will be over a 12-week period, occur 3 times a week, and last for 1 hour each. | Other: Exercise<br>* supervised exercise paired with coaching on behavior change techniques over 12 weeks (3 weekly sessions) and will have monthly phone follow-ups and clinic follow-ups after 3 and 6 months.<br>* Other names: Behavior Change Coaching;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability | Feasibility and acceptability will include patients willingness to participate | 6 months |
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas

Study Overview
=================
Brief Summary
-----------------
Raltegravir is the first marketed strand-transfer inhibitor of HIV-1 that was FDA approved in 2007. It is currently one of the preferred treatment regimens for HIV by the Department of Health and Human Services. It has become a widely used antiretroviral therapy option for HIV infected patients. It provides good tolerability and a favorable lipid profile for patients when compared to some other antiretroviral treatment options. Little data is reported about efficacy in a minority patient population. Moreover, data in an indigent minority population in the United States has not been aggregated before. Therefore this study will investigate the efficacy of raltegravir in minority women residing in Houston, TX who are HIV infected.

Official Title
-----------------
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: raltegravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected women who picked up raltegravir in the year 2013 at Thomas Street Health Center. Minority women -Black/African American, Hispanic/Latino Exclusion Criteria: n/a

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women that picked up raltegravir 2013<br>minority women that picked up raltegravir at Thomas street Health Center 2013 | Drug: raltegravir<br>* HIV therapy component<br>* Other names: issentress;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of raltegravir in study participants by measuring CD4 count and viral load |  | 24 weeks of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capture data on concomitant conditions that may have led to participants switching to raltegravir from medical records (eg. Diabetes mellitus) |  | 24 weeks of therapy | 
| Assess tolerability of raltegravir by capturing symptoms |  | 24 weeks of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV infection, raltegravir use, women
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR).

Study Overview
=================
Brief Summary
-----------------
The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a stable upright position during 20 min. This is an addendum to the previous study with record number clinical trials.gov NCT02124863

Official Title
-----------------
Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) in Infants

Conditions
-----------------
Gastro-oesophageal Reflux

Intervention / Treatment
-----------------
* Other: sitting position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each child under the age of one year that was referred for 24h pH-MII monitoring to exclude pathological gastro-oesophageal reflux (GOR) Exclusion Criteria: : prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (Nissen fundoplication)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 365 Days

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

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

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 |
| --- | --- |
| Other: sitting position<br>infants are in a sitting position for 20 minutes | Other: sitting position<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of reflux episodes | number of reflux episodes is counted over 20 min period of time | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastro-oesophageal reflux, intrapulmonary percussive ventilation, positioning