linjc16/ctgov huggingface dataset:
Phase III Randomized, Double-Blind, Placebo-Controlled Study of 3,4-Diaminopyridine for Demyelinating Polyneuropathy

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the efficacy of 3,4-diaminopyridine in patients with stable chronic demyelinating polyneuropathy.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to oral 3,4-diaminopyridine (3,4-DAP) or placebo administered for 4 days. After a washout of at least 5 days, patients cross to the alternate therapy for 4 days.

Conditions
-----------------
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention / Treatment
-----------------
* Drug: ,4-diaminopyridine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical diagnosis of demyelinating neuropathy, i.e.: Hereditary motor and sensory neuropathy type I Chronic inflammatory demyelinating polyneuropathy meeting American Academy of Neurology AIDS Task Force criteria Multifocal motor neuropathy and conduction block Clinically stable for at least 6 months prior to entry --Prior/Concurrent Therapy-- At least 6 months since change in immunosuppressive dose --Patient Characteristics-- Age: 20 to 80 Hepatic: No predisposition to hepatic disease Renal: No predisposition to renal disease Cardiovascular: No predisposition to cardiac disease Other: No other medical condition affecting neuropathy or study evaluation No predisposition to seizures

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ,4-diaminopyridine|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
-----------------
demyelinating neuropathy, neurologic and psychiatric disorders, rare disease
Melatonin Decreases Eye Pressure in Normotensive Patients

Study Overview
=================
Brief Summary
-----------------
Agomelatine is a melatonin drug used to treat depressive disorder. Agomelatine may also some effects on ocular pressures. In this study, we aimed to demonstrate that melatonin decreases intraocular pressures when given depressive patients.

Detailed Description
-----------------
Melatonin has been shown to be effective to decrease intraocular pressure in experimental animal researches. Agomelatine is a melatonin derivative drug approved for the treatment of depression, which is also available in our country. Depending on animal experiments, it can be assumed that agomelatine can decrease intraocular pressure. Demonstrating that agomelatine is effective to reduce eye pressure may give a concurrent treatment of depressive patients with glaucoma. With this it may be possible to treat both diseases at the same time with single drug. In this study, the researchers intended to investigate the changes in ocular tension in normotensive depressive patients treated with agomelatine.

Official Title
-----------------
Melatonin Decreases Eye Pressure in Depressive Patients With Normal Intraocular Pressure

Conditions
-----------------
Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Agomelatine 25 MG Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Depressive patients suitable for Agomelatine therapy for the treatment of their primary disease. Exclusion Criteria: - Any past history of ocular surgery, ocular trauma or existing ocular diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 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 |
| --- | --- |
| Study group<br>The investigators analyze the intraocular pressure changes on patients who have been using Agomelatine for their primary depressive disorder. For the treatment of depression, patients will have been started routinely Agomelatine tablet of 25 mg orally. The investigators measure the eye pressure for one months in those patients receiving standard depression treatment. | Drug: Agomelatine 25 MG Oral Tablet<br>* We will treat our patients with Agomelatine tablet of 25 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | mmHg | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Agomelatine, Depression, Intraocular pressure
Study on Fermentable Carbohydrates in Healthy Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.

Detailed Description
-----------------
Breast-fed infants have a lower occurrence of episodes of sickness compared with formula-fed infants, and this has been ascribed to their different flora composition. The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants. Additionally, other metabolic parameters will be investigated and compared to breast-fed infants.

Official Title
-----------------
Study on Fermentable Carbohydrates in Healthy Infants

Conditions
-----------------
Infant, Growth, Nutrition, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Fermentable carbohydrates.
* Other: Standard infant formula.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born in Reus and Tarragona area Healthy Normal feeding behaviour Exclusion Criteria: Serious respiratory, neurological, gastrointestinal or metabolic disorders Infections or other serious diseases that could interfere in normal feeding or growth Parents or guardians cannot be expected to comply with protocol Parents or guardians have not command on Catalan or Spanish language

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Intervention<br>This group will be fed a diet enriched with fermentable carbohydrates. | Dietary Supplement: Fermentable carbohydrates.<br>* Infant formula enriched with fermentable carbohydrates.<br>|
| Placebo Comparator: 2: Placebo.<br>The placebo group will be fed a diet without addition of fermentable carbohydrates. This placebo formula will have the same nutritional values than the intervention (energy, proteins, carbohydrates, fat, vitamins & minerals). | Other: Standard infant formula.<br>* Standard infant formula.<br>|
| No Intervention: BF<br>The 2 intervention groups will be compared with a breast-fed infants control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children well-being and appropriate growth |  | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes will be metabolic parameters. |  | Up to 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbohydrates, Infant, Intestine, Faeces, Growth, Diet
Superior Laryngeal Nerve Block For Awake Endotracheal Intubation Study

Study Overview
=================
Brief Summary
-----------------
Awake tracheal intubation is the standard management for patients as risk for airway compromise. It is also commonly done in cases where there is significant cervical spine pathology i.e. cervical myelopathy or instability. The anesthetic technique used for the awake intubation is crucial to the patient's safety. One of the most important aspects of the anesthetic technique is airway anesthesia prior to placement of an endotracheal tube. The superior laryngeal nerve is responsible for mediating the cough reflex around the vocal cords. The investigators have developed an approach to reliably block the superior laryngeal nerve by injecting local anesthetic near the nerve in a unique approach. Injecting local anesthetic into or through the thyrohyoid membrane will effectively block the superior laryngeal nerve

Official Title
-----------------
Superior Laryngeal Nerve Block For Airway Anesthesia Efficacy Study

Conditions
-----------------
Awake Endotracheal Intubation, Difficult Intubation, Airway Anesthesia

Intervention / Treatment
-----------------
* Procedure: Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients between the ages of 18-80 requiring an awake intubation for endotracheal intubation. Ability to speak and understand English Exclusion Criteria Allergy to lidocaine Emergent operative case Therapeutic anticoagulation Mouth opening less than 2 cm

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Assessment of Superior Laryngeal Nerve Block Technique<br> | Procedure: Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark<br>* The needle is introduced just lateral to midline above the thyroid notch in a slightly medial direction so as to enter the thyrohyoid membrane, and inserted about 1-1.5 cm. Three milliliters of 2% lidocaine is injected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is to assess the efficacy of blocking the superior laryngeal nerve by using cough at the vocal cords on a 4 point scale |  | Immediate Perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to placement of block |  | Immediate Perioperative Period |
Long-term Results of the Stapled Transanal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele

Study Overview
=================
Brief Summary
-----------------
Rectal static disorders, including the rectocele, represent a frequent functional pathology which affects the quality of life of affected patients. Among vaginal treatments, the STARR technique corresponds to rectal resection by transanal approach using a stapler. The American Gastroenterology Association (AGA) has concluded that service to patients is insufficient. The technical and functional results published are mostly short-term studies. The investigators seek to assess the technical and functional results of Operation STARR, based on a series of consecutive expert center cases, to confirm or refute the conclusions of the AGA recommendations.

Official Title
-----------------
Single-center Retrospective Study of the Long-term Results of the Stapled TransAnal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele in Consecutive Patients

Conditions
-----------------
Rectocele; Female

Intervention / Treatment
-----------------
* Procedure: STARR surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient operated for rectocele for 10 or more Age 18 and over Informed patients Exclusion Criteria: Patient objection

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: STARR surgery|This intervention is carried out under general anesthesia or spinal anesthesia. It consists of the circular resection of the surplus of rectal mucosa. Rectal resection and suturing is performed using automatic mechanical forceps introduced through the anus.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term results of the STARR operation. | Dyschezia postoperatively | 10 years |
A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Study Overview
=================
Brief Summary
-----------------
Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-[(diphenylmethyl)sulfinyl]acetamide) is a novel wake- and vigilance-promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

Official Title
-----------------
A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Conditions
-----------------
Substance Dependence, Amphetamine Dependence

Intervention / Treatment
-----------------
* Drug: modafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 50 years Patient is agreeable to conditions of study and signs consent form

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

| Intervention/Treatment |
| --- |
|Drug: modafinil|Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model |  | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methamphetamine addiction, meth dependence
School Response to Families Who Have Children With Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to investigate school response to families who have children with cancer. It is anticipated that the results of this study will enhance the support that schools can give to the population of families who have a child with cancer. The study will involve the parents in these families, the principal and an educator in the school of the child with cancer. Measurement tools will include surveys, interviews, and other relevant educational and medical documents.

Official Title
-----------------
School Response to Families Who Have Children With Cancer

Conditions
-----------------
Carcinomas, Squamous Cell Carcinoma, Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Self administered Surveys
* Procedure: Interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will not be recruited. Only parents, the school principals and the teachers will be recruited. Subjects will be 15 sets of parents who have had school-age children treated for cancer within the last 5 years.

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: Self administered Surveys|nan|
|Procedure: Interviews|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of support | Identify significant patterns. Documents, interview, surveys and the quantitative instrument will be analyzed with an inductive cross-case analysis. Inductive analysis means that the patterns, themes, and categories emerged out of the data rather than being imposed on them prior to data collection and analysis. A cross-case analysis means that the information will be grouped together according to answers from different people, themes, perspectives or issues. Then, a content analysis will be conducted which includes the process of identifying, coding, and categorizing the primary patterns in the data. In the final step, the data will be interpreted. Interpretation, by definition, goes beyond description. Interpretation means attaching significance to what was found offering explanations, drawing conclusions, making inferences, building linkages, attaching meaning, imposing order and dealing with rival explanations | one time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinomas (including Squamous Cell and Adenocarcinoma)
Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the effect of repaglinide on postprandial lipemia in subjects with type 2 diabetes.

Official Title
-----------------
Repaglinide Versus Glyburide: Comparitive Effect on Postprandial Lipemia: An Open-labeled, Randomized, Parallel Group Study in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: repaglinide
* Drug: glyburide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed patients with type 2 diabetes currently treated with diet and exercise alone (HbA1c below 10%) Subjects with type 2 diabetes treated with sulphonylurea (HbA1c below 8.5%) Males or non-pregnant, non-lactating females Subjects should have normal renal function Exclusion Criteria: Type 1 or other specific causes of diabetes Marked symptomatic diabetes Uncontrolled treated/untreated hypertension Known or suspected allergy to the trial products or related products

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: repaglinide<br> | Drug: repaglinide<br>* Dose individually adjusted and conducted according to labeling<br>|
| Active Comparator: glyburide<br> | Drug: glyburide<br>* Dose individually adjusted and conducted according to labeling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride levels post standardised fat tolerance test |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoglycemic episodes |  |  | 
| Change in HbA1c (glycosylated haemoglobin A1c) |  |  | 
| Change in FPG (fasting plasma glucose) |  |  |
Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who Smoke

Study Overview
=================
Brief Summary
-----------------
This is a single dose inpatient and outpatient study to test whether an effect on the ability of platelets to stick to white blood cells in subjects who smoke.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Randomized, Single-Dose, 2-Period Crossover Study of the Pharmacodynamics of Orally Administered PSI-697 in Healthy Subjects Who Smoke

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PSI-697
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12?lead electrocardiogram (ECG). Smoker of at least 1 pack or more of cigarettes per day (20 plus or minus 3 cigarettes) for more than 1 year as determined by history. Exclusion Criteria: Exclusion Criteria: Any diagnosed bleeding disorder. Any major surgical procedure within 6 months before study day 1. Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSI-697<br> | Drug: PSI-697<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of platelet monocyte aggregates |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects who smoke, healthy subjects