linjc16/ctgov huggingface dataset:
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. One group receives copolymer 1, a mixture of synthetic polypeptides composed of 4 amino acids, subcutaneously each day for 2 years. The other group receives an injection of placebo daily for 2 years.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: copolymer 1


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinically or laboratory-supported definite multiple sclerosis Neurologically stable for at least 30 days prior to entry Expanded Disability Status Scale score no greater than 5 At least 2 documented relapses within 2 years prior to entry Onset of first relapse at least 1 year prior to randomization --Prior/Concurrent Therapy-- Biologic therapy: No prior copolymer 1 Immunosuppressive therapy: No prior cytotoxic immunosuppressives, i.e.: Azathioprine Cyclophosphamide Cyclosporine At least 30 days since corticosteroids Radiotherapy: No prior lymphoid irradiation --Patient Characteristics-- Not HIV or HTLV-I seropositive No insulin-dependent diabetes mellitus No Lyme disease No requirement for aspirin or chronic nonsteroidal anti-inflammatory drugs No pregnant or nursing women Adequate contraception required of fertile women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: copolymer 1|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
-----------------
multiple sclerosis, neurologic and psychiatric disorders, rare disease
Early Exposure to Lead and Adolescent Development

Study Overview
=================
Brief Summary
-----------------
This prospective cohort study examines the role of prenatal and early postnatal lead exposure on the neuropsychological status and social adjustment of adolescents enrolled in the Cincinnati Lead Study. We are examining the relationship between moderate exposure to lead and neuropsychological deficits, difficulties in peer relationships, personality disturbances and juvenile delinquency. This birth cohort of approximately 300 subjects has been followed since 1980 with regularly scheduled assessments of blood lead concentrations, health history, social and hereditary factors, and neurobehavioral development.

Conditions
-----------------
Lead Poisoning

Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects for the Cincinnati Lead Study were recruited prenatally if their mothers resided in areas within Cincinnati, Ohio where there has historically been a high incidence of lead poisoning. Infants were eligible for follow-up if they were greater than 1500 grams at birth and had no disqualifying medical conditions such as defined genetic syndromes or other serious complications that may adversely affect neurobehavioral development.

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lead, Prenatal, Development, Children, Psychology, Toxicology, Teratology
High Dose Inhaled Mannitol Study

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the safety and tolerability of high doses of inhaled mannitol in subjects with bronchiectasis to further direct development of an improved drug delivery system.

Official Title
-----------------
A Pilot Study to Investigate the Feasibility and Tolerability of Inhaling a High Dose of Dry Powder Mannitol (IDPM) Per Breath Administered Via a Dry Powder Inhaler Loaded With a Single Capsule in Subjects With Bronchiectasis

Conditions
-----------------
Bronchiectasis

Intervention / Treatment
-----------------
* Drug: mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult subjects with non-CF bronchiectasis FEV1 > 50 % predicted and > 1.0L Exclusion Criteria: bronchiectasis due to CF or endobronchial lesion respiratory infection requiring IV antibiotics in last 4 weeks pregnancy significant haemoptysis in last 6 months active TB end stage ILD contraindications as determined by investigator

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mannitol|inhaled mannitol - single doses of either 70 mg or 90 mg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emitted dose |  | single measure |
Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain

Study Overview
=================
Brief Summary
-----------------
There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with scrotal pain that we found published. We proposed a pilot study using Botox to block the nerves on a small group of men with chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have had temporary relief from a testicular cord block using local anaesthetic drug. The encourage results of the pilot study has given us the background information to proceed with a formal randomised control trial of Botox vs placebo. We hypothesized that Botox injections to block the testicular nerve will be effective in providing long term pain relief for men with scrotal pain.

Official Title
-----------------
Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain

Conditions
-----------------
Scrotal Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65 Have nociceptive scrotal pain, Have no identifiable, reversible causes for the scrotal pain Have failed standard medical therapy Have responded temporarily to cord blocks Exclusion Criteria: Are interested in trying to conceive with their partners in the next 6 months, Have any local infection near the site of the injections, Have had an allergic reaction to Botox in the past, Are unable to provide informed consent Have a history of motor neuron disease or neurogenic bladder Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto (rivaroxaban) or other blood thinners

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

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

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 |
| --- | --- |
| Experimental: Botox<br>Botox 200 units reconstituted in 10ml of normal saline for a one-time injection | Drug: Botox<br> <br> * Other names: OnabotulinumtoxinA;|
| Placebo Comparator: Saline<br>Saline 10ml of normal saline for a one-time injection | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the visual analog scales for pain | A measure of the change in the visual analog scales for pain. | 6 months after entering in trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in scrotal pain | It will be assessed by the Chronic Epididymitis Symptom Index score. | 6 months after entering in trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scrotal pain, Botox
Italian Registry of Arthritis on Biologic Therapy

Study Overview
=================
Brief Summary
-----------------
The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.

Official Title
-----------------
Study of Efficacy and Safety of Biologic Drugs in the Therapy of Rheumatoid Arthritis and Spondyloarthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis Patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine) Patients eligible to begin conventional biologic therapy Exclusion Criteria: Any criteria excluding treatment with biologic drugs according to international guidelines

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 80 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
-----------------
Rheumatoid arthritis, Seronegative polyarthritis, Biologic drugs, Safety efficacy biologics polyarthritis
Evaluation of Gastric Residuals and Feedings Progression

Study Overview
=================
Brief Summary
-----------------
This study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared with no measurement.

Detailed Description
-----------------
The evaluation of gastric residuals as a measure of enteral tolerance in term and especially preterm newborns is a widely used practice in different centers worldwide. However, until now, it continues to be a controversial practice, since its real usefulness is not clear. Our study proposes to evaluate and compare two groups of preterm newborns born between 26 + 0/7 and 33 + 6/7 weeks, randomized to measure or not measure gastric residuals and determine if this practice delays the full feeding achievement.

Official Title
-----------------
Evaluation of Gastric Residuals in Preterm Newborns: What Impact Does it Have on Feedings Progression?

Conditions
-----------------
Infant, Premature, Diseases, Nutrition, Enteral

Intervention / Treatment
-----------------
* Procedure: Aspiration of gastric residuals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants born between 26+0 to 33+6 weeks post-menstrual gestational age. Enteral feeds starting during the first week of life. Signed informed consent from parents or guardians. Exclusion Criteria: Perinatal asphyxia Sepsis and hemodynamic instability Major congenital malformations Surgical requirement during the first week of life Hemodynamic instability and vasoactive drugs requirement Moderate or severe respiratory failure with Oxygenation Index > 8

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 48 Hours

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine aspiration of gastric residuals<br>Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach. | Procedure: Aspiration of gastric residuals<br>* Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.<br>|
| No Intervention: No aspiration of gastric residuals<br>Infants will not have routine aspiration of gastric contents prior to each feeding. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach full feeds | Time in days to reach full feeds defined as receiving 150 ml/kg/day tolerated for at least 24 hrs. | Baseline to 8 weeks |
A Study of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Study Overview
=================
Brief Summary
-----------------
Incomplete Closed Protocol

Official Title
-----------------
Vistide (Cidofovir Intravenous) Treatment IND Protocol for Relapsing Cytomegalovirus Retinitis in Patients With AIDS

Conditions
-----------------
Cytomegalovirus Retinitis, HIV Infections

Intervention / Treatment
-----------------
* Drug: Cidofovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Information not available

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cidofovir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Anesthesia Preferences in the COVID-19 Pandemic: General Anesthesia or Regional Anesthesia?

Study Overview
=================
Brief Summary
-----------------
As the COVID-19 pandemic continues, humanity has started to adapt to it. In our study, we aimed to examine the adaptation of anesthetists to the pandemic and its behavioral reflection on their work.

Detailed Description
-----------------
All surgeries and anesthesia methods performed in the university hospital were examined. The cases and anesthesia practices of the departments were examined. Years with and without pandemics were compared.

Official Title
-----------------
Anesthesia Preferences in the COVID-19 Pandemic: General Anesthesia or Regional Anesthesia?

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

Intervention / Treatment
-----------------
* Other: retrospective cohort study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all operations Exclusion Criteria: those who refuse to have surgery non-operational
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pandemic time group<br>The surgeries performed during the COVID-19 pandemic and the anesthesia techniques applied for these surgeries | Other: retrospective cohort study<br>* retrospective patient file review<br>|
| normal time group<br>The surgeries performed during the non-pandemic period and the anesthesia techniques applied in these surgeries | Other: retrospective cohort study<br>* retrospective patient file review<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia Preferences in the COVID-19 Pandemic: General or Regional Anesthesia? | number of operations and number of anesthesia methods | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Regional anesthesia, General anesthesia
Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.

Study Overview
=================
Brief Summary
-----------------
This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy. Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.

Official Title
-----------------
Endocuff-assisted Colonoscopy: a Randomized Back-to-back Colonoscopy Study of Adenoma Detection.

Conditions
-----------------
Adenomatous Polyps

Intervention / Treatment
-----------------
* Device: EndoCuff-assisted colonoscopy
* Device: Standard Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colonoscopy: Screening , Surveillance, Diagnostic Exclusion Criteria: Pregnancy age<18 years age > 80 years known colonic strictures chronic inflammatory bowel disease active inflammation

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endocuff assisted Colonoscopy<br>Endocuff assisted Colonoscopy | Device: EndoCuff-assisted colonoscopy<br>* Adenoma detection rate<br>* Other names: EC-assisted colonoscopy;|
| Active Comparator: Standard Colonoscopy<br>Standard colonoscopy | Device: Standard Colonoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate |  | 20 min. |
Study of Norepinephrine Levels and Sympathetic Nervous System Activity

Study Overview
=================
Brief Summary
-----------------
Brain and nerve cells communicate with each other by releasing and picking up chemicals called neurotransmitters. Norepinephrine is a neurotransmitter used by part of the nervous system activated during stress called the sympathetic nervous system. The sympathetic nervous system is involved with regulating blood pressure and pulse rate. Researchers believe the level norepinephrine in the blood can be used to measure activity of the sympathetic nervous system. This study is designed to answer important questions about rates of release of norepinephrine into the blood stream, removal of released norepinephrine, and the sympathetic nervous system response to stress. Researchers will attempt to measure levels of norepinephrine and activity of the sympathetic nervous system in patients with high blood pressure, normal patients with family histories of high blood pressure, patients taking drugs that can effect levels of norepinephrine, and patients with diseases or conditions directly affecting the sympathetic nervous system.

Detailed Description
-----------------
In order to examine sympathetic nervous system function in neurocardiological disorders and catecholaminergic effects of dietary manipulations or neuropsychiatric drugs, the protocol calls for evaluations of the kinetics of 3H-norepinephrine or 3H-epinephrine in patients with hypertension, dysautonomias, or disorders thought to involve abnormal catecholaminergic function, and in normotensive normal volunteers. Apparent spillover and clearance rates are estimated based on the norepinephrine or epinephrine concentration during the infusion and their steady-state specific activities, under resting conditions and in response to physiological or pharmacological manipulations thought to affect sympathetic outflows.

Official Title
-----------------
Plasma Catecholamine Kinetics

Conditions
-----------------
Autonomic Nervous System Disease, Healthy, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Must be greater than or equal to 18 years of age. Must not be pregnant or lactating.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yohimbine, Stress, Catecholamines, Sympathoadrenal Response, Sympathetic Nervous System, Hypertension, Autonomic Failure