linjc16/ctgov huggingface dataset:
Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.

Official Title
-----------------
A Phase 2a Double-Blind Placebo-Controlled 2-Period Crossover Study to Evaluate the Safety and Efficacy of BCX4161 as a Prophylactic Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema

Conditions
-----------------
Hereditary Angioedema

Intervention / Treatment
-----------------
* Drug: BCX4161
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Written informed consent Clinical and laboratory diagnosis of Hereditary Angioedema Type I or II An average angioedema attack frequency of 1/week Acceptable birth control measures Key Exclusion Criteria: Concurrent use of defined treatments for prophylaxis Pregnancy or breast-feeding Clinically significant medical condition, laboratory abnormality or medical history

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BCX4161<br>400 mg TID for 28 days | Drug: BCX4161<br> <br> |
| Placebo Comparator: Placebo<br>TID for 28 days | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of acute angioedema attacks |  | Over 28 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events and laboratory abnormalities |  | Over 28 days of treatment | 
| Number of attack free days |  | Over 28 days of treatment | 
| Angioedema Quality of Life scores |  | Over 28 days of treatment | 
| Angioedema activity scores |  | Over 28 days of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral Prophylaxis
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.

Official Title
-----------------
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients

Conditions
-----------------
Familial Adenomatous Polyposis

Intervention / Treatment
-----------------
* Drug: curcumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Familial adenomatous polyposis 18 years of age or older 5 or more adenomas of colorectum or ileum Exclusion Criteria: Female patient of child bearing age not on effective birth control pills Pregnant women White blood cell (WBC) count less than 4000 Platelets (Plts) less than 100,000 Blood urea nitrogen (BUN) greater than 25 Creatine greater than 1.5 Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial Malignancy Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease Patient on warfarin or anti-platelet drugs

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

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lower GI<br> | Drug: curcumin<br>* curcumin 500 mg by mouth, three times a day for 9 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polyp number and size |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects and medication compliance |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch
Dietary Supplements and Aging Muscle

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether older adults (ages 65-89) who consume the dietary supplement Juven (Abbott Laboratories) versus placebo for 6 months will demonstrate increases in fat-free mass, muscle volume,and physical function.

Official Title
-----------------
Dietary Supplements and Aging Muscle: Specific Amino Acids to Combat Sarcopenia

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Dietary Supplement: Juven
* Dietary Supplement: Juven


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 65-89 Ambulatory Exclusion Criteria: Cognitive impairment History of renal or hepatic disease History of hypotension History of peripheral artery disease Uncontrolled hypertension Uncontrolled diabetes Self-reported claustrophobia Current smoker Steroid or androgen use with the previous 3 months Individuals with pacemakers and defibrillators

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 89 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juven<br>Participants in the treatment arm will receive the dietary supplement Juven. | Dietary Supplement: Juven<br>* Participants in the treatment arm will be asked to consume 2 packets of Juven drink mix each day for a period of six months.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Juven<br>* Participants in the placebo arm will be asked to consume two packets of an orange-flavored drink mix each day for a period of six months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat-free mass as determined by a four-compartment model of body composition |  | Baseline, 3-months, 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appendicular lean mass as determined by dual energy X-ray absorptiometry |  | Baseline, 3-months, 6-months | 
| Muscle volume as determined by magnetic resonance imaging |  | Baseline and 6-months | 
| Physical function as determined by questionnaire and a battery of physical performance tests |  | Baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcopenia, Aging, Muscle, Dietary Supplement, HMB, Arginine, Glutamine
Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

Study Overview
=================
Brief Summary
-----------------
Giving infiltration analgesia around the neck of the womb (= paracervical block, PCB) is frequently experienced as a painful procedure by women undergoing follicle aspiration. Two sedation protocols, where in the one protocol a low dose of alfentanil hydrochloride is already administered before the PCB, will be compared with each other and pain relief measured using the 'Visual Analogue Scale' and the 'Short-Form McGill Questionnaire'

Official Title
-----------------
Pain Evaluation During Follicle Aspiration: Comparison of Two Sedation Protocols

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Low dose of alfentanil hydrochloride
* Drug: Normal dose of alfentanil hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women and female infertility patients Between 18 and 43 years of age Exclusion Criteria: Patients with a known allergy to alfentanil hydrochloride or comparable drugs (morphine, cocaine)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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>Administration of low dose of alfentanil hydrochloride before paracervical block | Drug: Low dose of alfentanil hydrochloride<br>* Administration of low dose alfentanil hydrochloride before paracervical block<br>|
| Active Comparator: 2<br>Administration of alfentanil hydrochloride dose after paracervical block | Drug: Normal dose of alfentanil hydrochloride<br>* Normal dose of alfentanil hydrochloride is administered after paracervical block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  | During and immediately after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sensation, relief, during, surgery
Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI

Study Overview
=================
Brief Summary
-----------------
Since the absorption of clopidogrel through the gastrointestinal tract is limited, we want to examine whether adding clopidogrel by chewing will overcome the limited gastrointestinal absorption, and hence will improve the prevention of platelet aggregation.

Official Title
-----------------
Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI

Conditions
-----------------
Platlet Aggregation, Major Bleeding Outcomes

Intervention / Treatment
-----------------
* Drug: clopidogrel by chewing
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female older than 18 years old with non-ST myocardial infarction Exclusion Criteria: Current treatment with anticoagulation medication, any type of cerebro vascular event in the past, active bleeding, active peptic ulcer disease, pregnant women, any inability to sign an informed consent of participate in the study

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clopidogrel by chewing<br> | Drug: clopidogrel by chewing<br>* 600 mg clopidogrel by chewing<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo p.o<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet aggregation and bleeding events |  | 6 months |
Mood and Anti-craving Effects of Varenicline in Psychiatric Inpatients

Study Overview
=================
Brief Summary
-----------------
This study of psychiatric inpatients will assess mood effects of varenicline, as well as assess if varenicline decreased nicotine cravings acutely. This study will also measure side effects of varenicline when given in addition to other psychiatric and non-psychiatric medications.

Detailed Description
-----------------
This study will measure mood effects and rapid anti-craving effects of varenicline in psychiatric inpatients. Patients will be offered to participate in the trial if they wish to stop smoking or wish to decrease nicotine cravings while in the hospital. They will not be able to use nicotine replacement products when taking varenicline. Patients will be assessed with the QIDS-SR16, Minnesota Nicotine Withdrawal Scale as well as the Frequency, Intensity, and Burden of Side Effects (FISER) at baseline and daily during the trial; patients will be asked to enroll for the duration of their hospitalization. Patients will be assessed as to whether they wish to continue varenicline post-discharge.

Official Title
-----------------
Assessment of Response to Open-label Treatment With Varenicline in Psychiatric Inpatients

Conditions
-----------------
Smoking, Depressive Disorder

Intervention / Treatment
-----------------
* Drug: varenicline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to Butler Hospital during study period. Current tobacco users ages 18-65. Able to give written, informed consent. Exclusion Criteria: Past adverse reaction to varenicline. Treatment with varenicline on admission to Butler Hospital. Renal failure or dialysis (3) Current pregnancy or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: varenicline|varenicline 0.5mg daily for days 1-3, 0.5mg twice daily for days 3-7, then 1mg twice daily for length of hospitalization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in Quick Inventory of Depressive Symptoms (QIDS-SR) |  | duration of hospitalization | 
| improvement in Minnesota Nicotine Withdrawal Scale |  | days (duration of hospitalization) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no significant intolerability, measured by the Frequency, Intensity, and Burden of Side Effects (FIBSER) and Adverse Events Checklist (SAFTEE-SI) |  | duration of hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
craving, smoking, depression
Study Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016

Study Overview
=================
Brief Summary
-----------------
This is intended to provide an initial safety assessment of HSD-016 and also to evaluate how the drug is absorbed and eliminated and its effect on the body in healthy subjects.

Official Title
-----------------
Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: HSD-016
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Men or women of nonchildbearing potential aged 18 to 50 years. Healthy as determined by investigator on the basis of medical history and physical examination, laboratory test results, and 12-lead ECG. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day. Exclusion criteria: No history of thyroid abnormalities. No presence or history of any disorder that may prevent the successful completion of the study. No history of drug abuse. No use of any systemic steroids for 3 months. No history of claustrophobia.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>HSD-016 | Drug: HSD-016<br> <br> |
| Placebo Comparator: 2<br>placebo | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated from reported AEs, scheduled physical, vital sign measurements, 12 lead ECGs, and clinical laboratory test results. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of drug concentrations will be evaluated after receiving multiple doses of HSD-016 |  | 3 months |
Fetal Neurobehavioral Development in Methadone Maintained Pregnancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.

Detailed Description
-----------------
This study will examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) plasma methadone levels. Anecdotal clinical observations suggest that fetal activity is increased at trough methadone levels and decreased at peak methadone levels, yet the investigators do not understand how in utero methadone exposure affects fetal neurobehavioral state development.

Official Title
-----------------
Methadone, Buprenorphine and Fetal Development

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Device: Toitu 320/325


Participation Criteria
=================
Eligibility Criteria
-----------------
Actively enrolled pregnant patients in CAP SA treatment. Inclusion Criteria: Maternal age 18-40 years Single intrauterine fetus Estimated gestational age of 32 weeks DSMIV criteria for opioid dependence according to e-module of the SCID Daily methadone maintenance at a stable dose for greater than a week Exclusion Criteria: Concurrent DSMIV axis I diagnosis that would preclude informed consent procedures (i.e., schizophrenia, major depression) or confound study outcomes (e.g., Alcohol Dependence) Presence of a serious medical or psychiatric illness requiring chronic medication or other intervention (i.e., HIV infection) that may confound data interpretation Evidence of preterm labor Evidence of prescription drug use (e.g., antidepressants, tranquilizers) Presence of major congenital fetal malformation Recent use (last month) of other illicit drugs (e.g., cocaine, marijuana) based on self report or positive on-Trak urine drug toxicology at time of actograph sessions Split methadone dosing schedule

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Toitu 320/325|Fetal monitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal heart rate |  | 120 minutes | 
| fetal movement |  | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal abstinence syndrome |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methadone, fetus
Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients

Study Overview
=================
Brief Summary
-----------------
Surgical site infections (SSIs) are one of the major hospital acquired infections and responsible for the most cost among the hospital acquired infections. The objective of this study is to assess the neutrophil functional profiles and their associations with SSIs.

Official Title
-----------------
Neutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Other: Surgical Site Infection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for an elective open gastrointestinal surgical procedure or spine fusion surgery Exclusion Criteria: On chronic immunosuppressive drugs such as chronic corticosteroid use preexisting immunodeficiency diseases

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 19 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 |
| --- | --- |
| Spine Surgery<br>Pediatric patients presenting for elective spine fusion surgery at Boston Children's Hospital | Other: Surgical Site Infection<br>* infection at the site of the surgery (spine or abdomen)<br>|
| Abdominal Surgery<br>Pediatric patients presenting for elective abdominal surgery at Boston Children's Hospital | Other: Surgical Site Infection<br>* infection at the site of the surgery (spine or abdomen)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil populations | compare neutrophil population between patients with SSI and without SSI by delineating transcriptomic profiles | up to 3 days | 
| Neutrophil functional impairment | illustrate neutrophil subpopulation associated with neutrophil functional impairment and SSIs by probing phagocytosis and reactive oxygen species formation | up to 3 days |