linjc16/ctgov huggingface dataset:
Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Detailed Description
-----------------
Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Official Title
-----------------
Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Conditions
-----------------
Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Drug: Rifaximin
* Drug: Nitazoxanide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhotic patient with at least one previous episode of hepatic encephalopathy. Adult Patients aging from 20 to 65 years old Exclusion Criteria: Active GIT bleeding. Major psychiatric illness (psychosis & epilepsy). Renal insufficiency (S.Cr 2mg/dl).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rifaximin<br>550 mg Rifaximin tablets twice daily for six months. | Drug: Rifaximin<br>* Rifaximin 550 mg twice daily for 6 months<br>* Other names: Gastrobiotic, Trencedia;|
| Experimental: Nitazoxanide<br>500 mg Nitazoxanide tablets twice daily for six months. | Drug: Nitazoxanide<br>* Nitazoxanide 500 mg twice daily for 6 months<br>* Other names: Nanazoxid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of encephalopathy episodes during treatment | The number of encephalopathy episodes during treatment | 6 months |
Open-Label Absorption, Distribution, Metabolism, Excretion (ADME) and Pharmacokinetics (PK) Following a Single Oral Dose of AZD1236 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of [14C] AZD1236 in healthy male subjects.

Official Title
-----------------
An Open-Label. Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of 60 mg of [14C] AZD1236 in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: 14C-AZD1236


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Non-smokers Exclusion Criteria: Subjects who are exposed to radiation exposure as part of their occupation Subjects exposed to radiation levels above background of >5 mSv in last year, >10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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

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 |
| --- | --- |
| Experimental: 1<br>14C-AZD1236 | Drug: 14C-AZD1236<br>* Oral solution 1mg/mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile. Concentration of AZD1236 in plasma |  | Before and after dosing | 
| Total Radioactivity |  | Before and after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination |  | Before and after dosing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADME, safety, oral solution
Sleep Apnea: Mechanism and Cerebrovascular Consequences

Study Overview
=================
Brief Summary
-----------------
This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in selected patients with stroke. We will select a subset of patients with stroke in the prior 3 months who are most likely to have ventilatory instability as a cause of the upper airway obstruction as indicated by the absence of obesity, an abnormal hypocapnic apnea threshold and resolution of obstructive apnea during CO2 administration. Following baseline polysomnography, patients will be randomly assigned to acetazolamide (250 mg hs [at bedtime]) versus placebo for 7 days. Polysomnography will be repeated and then subjects will cross-over therapies for another 7 days followed by a final nocturnal polysomnography.

Detailed Description
-----------------
This study never enrolled patients. It was a component of a larger VA Merit grant and the other aims of the grant were completed but due to logistic issues and recruitment challenges this particular protocol was never made active.

Official Title
-----------------
Sleep Apnea: Mechanism and Cerebrovascular Consequences

Conditions
-----------------
Stroke, Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Drug: acetazolamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We will select non-obese patients (body mass index [BMI] <30 kg/m2) with stroke diagnosed during the 3 previous months and obstructive sleep apnea on screening sleep study (apnea-hypopnea index [AHI] >15 events/hr of study time). Patients with stroke will be selected based on the following criteria: 85 years old or less with a history of ischemic stroke within 3 months resulting in mild to moderate neurological impairment (Rankin scale < 3) Exclusion Criteria: Hemorrhagic stroke, A history of chronic obstructive lung disease, Left ventricular ejection fraction (LVEF) <55% Evidence of nasal or pharyngeal obstruction on physical examination.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: acetazolamide<br> <br> |

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
-----------------
sleep apnea, stroke, ventilatory control
Ventricular Shunt and Drain Infections - Timing of Reimplantation

Study Overview
=================
Brief Summary
-----------------
The retrospective study will help determine whether or not placement of new devices prior to the recommended time was associated with a high risk of relapse or treatment failure.

Detailed Description
-----------------
The following information will be collected from the medical record retrospectively: demographic data (age, gender, ethnicity, height, weight), past medical history, laboratory results, microbiologic data, data on the patients' devices (type of device, data that it was placed, exchanged or removed), treatment and clinical and microbiological outcomes. This will all be collected retrospectively.

Official Title
-----------------
Ventricular Shunt and Drain Infections - Timing of Reimplantation

Conditions
-----------------
Ventricular Shunt Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that were cared for by the PI for the purpose of treating an infected ventricular shunt or drainage device for the central nervous system. Exclusion Criteria: Those patients records that do not meet entry criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
ventricular shunt
Survey of Satisfaction on Traditional Chinese Medicine Jing-Guan-Fang (JGF) for COVID-19 Prevention

Study Overview
=================
Brief Summary
-----------------
the retrospective observation study, the first line to care CAVID-19

Detailed Description
-----------------
The satisfaction of using nature herbal medicine for frontline medical staffs to prevent COVID-19: a retrospective clinical study. The medical frontline staffs have the high risk to be infected during working. The stress and load were acuminated, especially when they got the similar symptoms as COVID-19. NHM has been used to early prevention for thousands of years9-12. It was well accept to take NHM for early prevention in many Asia-Pacific countries. Although many NHM remedies of COVID-19 treatment or prevention were reported, but the related study were lacking. To understand the pressure and the satisfaction of frontline medical staffs after taking JGF for early prevention we conducted this retrospective clinical study to explore the relationship in different groups.

Official Title
-----------------
Department of Chinese Medicine, Branch of Linsen, Chinese Medicine, and Kunming, Taipei City Hospital, Taipei, Taiwan Institute of Traditional Medicine, National Yang-Ming University, Taipei, Taiwan.

Conditions
-----------------
Corona Virus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The person first-line medical staff in hospital the inspection personnel in airport self-quarantine at home. self-quarantine at office. Exclusion Criteria: no willing to participate allergy to herbal medicine severe illness evaluated by physician

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| the number confirmed COVID-19 cases | The isolated person and first-line care person who taking JGF | 8 weeks | 
| The person with COVID-19 like symptoms | The isolated person and first-line care person who taking JGF | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improving rate of COVID-19 like symptoms | The isolated person and first-line care person who taking JGF | 8 weeks | 
| The satisfaction% to taking JGF | The isolated person and first-line care person who taking JGF | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
natural herbal medicine, Chinese medicine
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy

Study Overview
=================
Brief Summary
-----------------
This open-label, multicenter trial will evaluate the efficacy and safety of treatment with AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to imatinib mesylate therapy.

Official Title
-----------------
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy

Conditions
-----------------
Leukemia, Myeloid, Chronic

Intervention / Treatment
-----------------
* Drug: AMN107


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase Males or females ≥ 18 years of age Exclusion Criteria: Impaired cardiac function Acute or chronic liver or renal disease Use of therapeutic coumadin Central nervous system (CNS) infiltration Additional protocol-defined inclusion/exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMN107<br> | Drug: AMN107<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytogenetic response within 12 months |  | Every 6 months for 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the rate of hematologic response at 12 months |  | Every Visit for 12 months | 
| To determine the rate of molecular response at 12 months |  | Every 3 months for 12 months | 
| To evaluate the time to cytogenetic and molecular response |  | At 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMN107, CML, Bcr Abl, cytogenetic response, Chronic Myelogenous Leukemia (CML), imatinib mesylate
Oxytocin Effects on Food Motivation Pathways

Study Overview
=================
Brief Summary
-----------------
Oxytocin is a peptide hormone produced in the brain that regulates food intake. However, the mechanisms for this effect in humans is not yet clear. In this study, the investigators will therefore examine the effect of a single dose of intranasal oxytocin (compared to placebo) on levels of appetite-regulating hormones and functional magnetic resonance imaging activation of areas of the brain involved in food motivation.

Official Title
-----------------
Oxytocin Effects on Food Motivation Pathways

Conditions
-----------------
Overweight and Obesity

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-45 years old BMI 25-40 Regular breakfast eater (at least 4 times per week) Stable weight within the past three months Exclusion Criteria: Psychiatric disease, use of psychotropic medications History of eating disorder History of excessive exercise within the last three months (having run more that 25 miles in any one week or having exercised more than ten hours in any one week) History of diabetes mellitus Active substance abuse Hematocrit lower than the normal range Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection) History of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms) Untreated thyroid disease Tobacco use Cardiac pacemaker, surgical aneurysm clips, neurostimulator, implanted pumps, metal fragments in body/eyes, nitroglycerin patch, severe claustrophobia

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>Oxytocin 24 IU x 1 | Drug: Oxytocin<br>* Single dose, intranasal<br>* Other names: Syntocinon;|
| Placebo Comparator: Placebo<br>Placebo 24 IU x 1 | Drug: Placebo<br>* Single dose, intranasal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional magnetic resonance imaging activation of food motivation brain regions |  | Functional magnetic resonance imaging at T60 min after oxytocin/placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hormone levels (cholecystokinin, glucagon-like peptide-1) |  | Blood draws at T0, T30, T60, T120 min after oxytocin/placebo |
ED50 of Dexmedetomidine to Prevent Emergence Agitation in Children

Study Overview
=================
Brief Summary
-----------------
There are several recommended doses of dexmedetomidine for prevention of emergence agitation in children. In this study, the investigators examine ED50 in prevention of emergence agitation after tonsillectomy or adenoidectomy in children.

Detailed Description
-----------------
To investigate ED50, Dixon's up and down method will be used.

Official Title
-----------------
ED50 of Dexmedetomidine for Reduction of Emergence Agitation Incidence Undergoing Tonsillectomy or Adenoidectomy in Desflurane Anesthesia Following Sevoflurane Induction in Children

Conditions
-----------------
Agitation

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tonsillectomy or adenoidectomy Exclusion Criteria: recent URI

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dexmedetomidine, children<br> | Drug: Dexmedetomidine<br>* dexmedetomidine, 0.1ug/kg up or down<br>* Other names: precedex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| agitation |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 30 minutes |
Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if Rimexolone (FID 109980) is a safe and effective treatment of dry eye.

Official Title
-----------------
Phase II Study of AL-2178 (FID 109980) in the Treatment of Dry Eye

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: Rimexolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented dry eye history ocular symptoms tear use dry eye ocular signs Exclusion Criteria: Under 18

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining; dry eye sympton |  | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining; dry eye sympton |  | Prolonged |
Evaluation of the Effect of Saffron (Crocus Sativus) on Pain Control After Root Canal Therapy in Teeth With Vital Pulps

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether saffron is effective in the pain control after root canal therapy in vital teeth.

Detailed Description
-----------------
Among patients refer to endodontics department of Zahedan Faculty of Dentistry whom with moderate to severe pain in a single canal tooth will be selected and randomly divided in 2 groups of saffron and placebo. After root canal therapy each patient in each group will receive a box of 8 similar capsules. They will use 1 capsule exactly after treatment completion and then each 6 hours up to 48 hours. Patients will record their pain intensity in each time period according to Visual Analog Scale(VAS)and finally mean pain intensity will be compared between 2 groups.

Conditions
-----------------
Post-treatment Pain Following Root Canal Therapy

Intervention / Treatment
-----------------
* Other: starch
* Other: saffron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have at least one vital tooth with one root canal and moderate to severe pain Exclusion Criteria: teeth with periapical lesions patients with history of: allergy to saffron diabetes mellitus cardiovascular disorders kidney and liver diseases blood and hormonal disorders electrolyte imbalance women in pregnancy or breast feeding period and use of analgesics or opioids during 4 hours before treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Starch capsule<br>starch with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day) | Other: starch<br>* 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)<br>|
| Active Comparator: Saffron capsule<br>saffron with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day) | Other: saffron<br>* 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)<br>* Other names: Crocus sativus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in VAS score | Patients will record their pain intensity in each time period according to Visual Analog Scale (VAS) | Every 6 hours after treatment completion up to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, root canal therapy