linjc16/ctgov huggingface dataset:
Diaphragmatic Height Index: the New Diagnostic Test for Phrenic Nerve Dysfunction

Study Overview
=================
Brief Summary
-----------------
Diaphragmatic contraction is controlled by phrenic nerve which consists of anterior rami of 3rd- 5th cervical nerve roots. Usually, It can't be evaluated from history taking and physical examination. Thus the diaphragmatic elevation on chest radiograph is assumed to identify the phrenic nerve dysfunction. Normally, the right diaphragm is higher than the left side about 1.5 ± 0.9 centimeters or 0.5 ± 0.3 time of vertebral height. Although there are several methods to determine the diaphragmatic elevation from previous studies, the accuracy, reliability, intra and inter-observer variation are problem. Neurotization is the effective procedure to restore upper extremity function in root avulsion type. Phrenic nerve is one of the common donor nerves which used for this procedure. But sometimes, concomitant injury of this nerve can occur. Therefore, the investigators established Diaphragmatic height index (DHI) from chest radiograph to use as the diagnostic test for phrenic nerve dysfunction.

Official Title
-----------------
Diaphragmatic Height Index: the New Diagnostic Test for Phrenic Nerve Dysfunction

Conditions
-----------------
Respiratory Paralysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brachial plexus injured patients who underwent the neurotization in our institute between 2005-2008 Non brachial plexus injured patients who underwent the other orthopedic operation in our institute between April-June 2009 Exclusion Criteria: Concomitant pneumothorax and/or hemothorax Concomitant pulmonary contusion Previous pulmonary disease Chest wall deformity Thoracic or thoracolumbar scoliosis (>10 degrees) Hepatomegaly Incomplete data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Group A<br>Brachial plexus injured patients with phrenic nerve dysfunction | |
| Group B<br>Brachial plexus injured patients without phrenic nerve dysfunction | |
| Group C<br>Non brachial plexus injured patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cut-off point of DHI for diagnosis of phrenic nerve dysfunction |  | upto 3 years |
A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness

Study Overview
=================
Brief Summary
-----------------
BACKGROUND:flight simulator have become an important component in pilot training. However, they are known to be associated with motion sickness like symptoms defined as Simulator Sickness (SS). Prevention countermeasures against motion sickness have been studied extensively focusing on cholinergic blockers and antihistamines. Most comparataive studies emphasized the effectiveness of scopolamine over outher agents. Evidence, though, on prophylaxis against SS is sparse. OBJECTIVE: to assess the effectiveness of oral scopolamine versus oral cinnarizine or placebo for SS prevention in helicopter pilots. DESIGN: a prospective, placebo controlled double-blind. SETTING: Israel Air Forse (IAF) Helicopter Aircaft vWeapon System Trainer. PARTICIPANTS: IAF experienced helicopter pilots. INTERVENTION: 0.6 mg oral scopolamine or 50 mg oral cinnarizine or placebo 1 hour before beginning of a 3 sortie simulator training

Official Title
-----------------
A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness

Conditions
-----------------
Simulator Sickness

Intervention / Treatment
-----------------
* Drug: scopolamine
* Drug: cinnarizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 21 to 50 years, qualified helicopter pilots history of average TS score in SSQ more than 7.48 Exclusion Criteria: known vestibular, visual or central nervous system pathology fever of more than 37.2 degrees any MS like symptom prior to simulator training any compromising acute health problem

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: scopolamine|0.6 mg|
|Drug: cinnarizine|50 mg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finding more effective treatment to the motion sickness symptoms during and after simulator training. | To record a significant difference in motion sickness symptoms reduction during and after simulator training, after taking cinnarizine, scopolamine or placebo. We predict that scopolamine will prove to be more effective than cinnarizine with fewer side effects that can compromise pilot's performance during training. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
simulator sickness, scopolamine, cinnarizine
Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

Study Overview
=================
Brief Summary
-----------------
Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.

Official Title
-----------------
A Multicenter, Open-Label, Controlled, Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma

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

Intervention / Treatment
-----------------
* Drug: montelukast sodium
* Drug: Comparator: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683) OR: Patient is in good, stable health Patient has been fed solid foods for at least 1 month Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines Exclusion Criteria: Patient was hospitalized at the start of the study or had any major surgery 4 weeks prior Patient had an allergy to apples or applesauce

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 2 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>Montelukast | Drug: montelukast sodium<br>* Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks<br>* Other names: Montelukast;|
| Active Comparator: 2<br>Usual Care | Drug: Comparator: Usual Care<br>* Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | Up to 52 weeks of treatment |
Racial Differences in Orthostatic Tolerance

Study Overview
=================
Brief Summary
-----------------
Our central hypothesis is that baroreflex sensitivity is attenuated in black women compared to white women, and that this dysregulation will be apparent during orthostatic challenges. We expect that the cumulative stress index (CSI), a measure of maximal orthostatic tolerance, is higher in Black women (BW) compared to White women (WW).

Official Title
-----------------
Racial Differences in Orthostatic Tolerance

Conditions
-----------------
Orthostatic Tolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women between 18-25 yrs of age Exclusion Criteria: history of high blood pressure, uterine fibroids, diabetes, epilepsy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- |
| 0<br>white women | |
| 1<br>Black women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| orthostatic tolerance |  | 1 |
Evaluation of the Peel Force of New Adhesives From the Skin

Study Overview
=================
Brief Summary
-----------------
This study investigates the impact and adhesion of new adhesives to the skin.

Official Title
-----------------
Evaluation of the Peel Force of New Adhesives From the Skin

Conditions
-----------------
Stoma Ileostomy

Intervention / Treatment
-----------------
* Other: Standard adhesive 1
* Other: Standard adhesive 2
* Other: Standard adhesive 3
* Other: P-4
* Other: P-15
* Other: P-16


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have intact skin on the area used in the investigation Exclusion Criteria: Currently receiving or have within the past 2 months received radio- and/or chemotherapy Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Have dermatological problems in the abdominal area (assessed by investigator)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testing of 6 adhesive strips<br>Each subject tests six adhesive strips on pre-striped skin. Standard adhesive 1 standard adhesive 2 Standard adhesive 3 P-4 P-15 P-16 The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits. | Other: Standard adhesive 1<br>* This strip consists of a standard hydrocolloid adhesive found in ostomy products<br>Other: Standard adhesive 2<br>* This strip consists of a standard hydrocolloid adhesive found in ostomy products<br>Other: Standard adhesive 3<br>* This strip consists of a standard hydrocolloid adhesive found in ostomy products<br>Other: P-4<br>* Newly developed adhesive P-4<br>Other: P-15<br>* Newly developed adhesive P-14<br>Other: P-16<br>* Newly developed adhesive P-8<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peel force | The peel force (N) needed to peel off adhesive strips from the skin | 21 days |
Predictors of Chronic Non-specific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the lower back for at least three months with no known causes. The CNSLBP prevalence is estimated of 90% among all types of the LBP. The LBP imposes high direct and indirect costs on the patients and the society. Whereas a specific pathology has not been identified for CNSLBP, mechanical factors (e.g. changes in muscle length, strength, or endurance) may contribute to the pain and disability.

Official Title
-----------------
Relationships Between Muscular Impairments, Pain, and Disability in Patients With Chronic Non-specific Low Back Pain: a Cross Sectional Study

Conditions
-----------------
Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic non-specific LBP, LBP duration ≥ 6 months. Exclusion Criteria: spinal osteoarthritis, spondylolisthesis, history of vertebral fractures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Change of Pain intensity | Visual Analogue Scale | Baseline | 
| Change of Disability | Oswestry disability index | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic low back pain, disability, endurance
Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease

Study Overview
=================
Brief Summary
-----------------
To measure the frequency of persistent liver dysfunction (raised liver enzymes, serum albumin, prothrombin time, etc) in recovered COVID -19 patients. To compare the hepatic manifestations in post COVID -19 patients with and without liver disease

Detailed Description
-----------------
The digestive tract, particularly the liver, has recently been reported to be affected by SARS-CoV-2. Although abnormal liver enzymes were regularly described as an extra-pulmonary clinical feature, and almost one half of patients experienced grades of hepatic injury. liver damage in patients with SARS infections was primarily manifested in the mild and moderate elevation of alanine and/or aspartate aminotransferases (ALT and AST) with some degree of hypoalbuminemia and hyperbilirubinemia during the early stage of the illness.

Official Title
-----------------
Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: liver function , prothrombin time , INR , US .


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients previously diagnosed by COVID 19 eg : PCR and / or HRCT chest, lab of more than 1 month duration. Exclusion Criteria: Patients less than 18 y. Patients with acute COVID 19.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group non cirrhotic<br>compare liver function 1m after COVID-19 and that at beginning of infection | Diagnostic Test: liver function , prothrombin time , INR , US .<br>* analytic<br>|
| cirrhotic patients<br>compare liver function 1m after COVID-19 and that at beginning of infection | Diagnostic Test: liver function , prothrombin time , INR , US .<br>* analytic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the long term effect of COVID 19 on the liver | to evaluate the changes in liver function (bilirubin ,liver enzymes , albumin , prothrombin time and INR in patients post COVID_19 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| : Effect of COVID 19 on diseased liver | to evaluate the changes in liver function(bilirubin , liver enzymes , albumin , prothrombin time , INR) in cirrhotic post COVID_19 | 1 month |
17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts

Study Overview
=================
Brief Summary
-----------------
Plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. Some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as Compound W)or by other treatments that may be painful and affect mobility. No treatment is consistently effective and most patients fail treatment multiple times. Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that may improve the activity of salicylate in wart treatment by improving the ability to penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may improve cures of common foot plantar warts in subjects who also be receiving other standard-of-care treatment.

Official Title
-----------------
New Formulation of Salicylate to Improve Treatment of Common Skin Warts

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Drug: 17% Salicylate with ethyl pyruvate
* Drug: Salicylates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: evidence of skin plantar wart(s) Exclusion Criteria: iodine allergy

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 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: 17% Salicylate with Ethyl Pyruvate<br>Subjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks. | Drug: 17% Salicylate with ethyl pyruvate<br> <br> * Other names: Compound W;|
| Active Comparator: 17% salicylate<br>subjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks | Drug: Salicylates<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone. | Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone. |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Warts, salicylic acid, ethyl pyruvate
A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED

Study Overview
=================
Brief Summary
-----------------
This is an exploratory study to evaluate the clinical feasibility of medical deivce 'AVATAMED' for predicting the clinical response to TMZ (temozolomide) in glioblasotma patients.

Detailed Description
-----------------
Glioblastoma patients who would take TMZ treatment will be screened for in vitro drug screening experiment. Patients whose tumor specimen pass the drug screening process will be finally enrolled. Actual clinical response to TMZ treatment will be compared to drug screening results derived from AVATAMED, a medical software device to predict the drug response based on in vitro assay using patient-derived tumor cells.

Official Title
-----------------
A Clinical Study to Explore the Feasibility of AVATAMED in Predicting the Cilnical Response to Temozolomide in Glioblastoma Patients, a Single-center, Prospective Study

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Device: AVATAMED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent histologically confirmed glioblastoma patients who will take TMZ treatment KPS >70 adequte end-organ function prior major surgery > 4 weeks (prior minor surgery > 1weeks) prior standard concurrent chemo-radiation therapy > 4 weeks prior radiation therapy (including stereotactic radiosurgery) > 12 weeks Exclusion Criteria: contraindication to TMZ prior anti-cancer therapy except standard of care (*standard of care includes surgery, Stupp regimen, and radiotherapy) uncontrolled systemic medical illness pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AVATAMED|tumor specimen will be sent for in vitro drug screening experiment and the result will be analyzed by 'AVATAMED' to predict the clinical response|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 month PFS rate | the fraction of patients without disease progression at 6 months after the TMZ treatment | 6 month |