linjc16/ctgov huggingface dataset:
Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Follow-Up Study with Retarded Release Phosphatidylcholine in Ulcerative Colitis Objectives: The objective of the study is to evaluate the follow up of patients treated with retarded release phosphatidylcholine in three controlled, randomized studies. Main question is to investigate whether treatment with phosphatidylcholine could spare patients the intake of steroids and immunosuppressants without clinical deterioration. Study population: Retarded release phosphatidylcholine in chronic-active ulcerative colitis. Retarded release phosphatidylcholine in steroid dependent ulcerative colitis. Dose finding study for retarded release phosphatidylcholine Outcome parameters: Definition of remission: SCCAI <2,5 Likert scale: grade 1 or 2 subjective impression of remission: yes/no no blood in stool Definition of relapse: subjective impression: yes/no SCCAI ≥ 5 blood in stool Definition of low clinical activity: SCCAI < 5 Primary endpoint: sparing effect of steroids and/or immunosuppressants by rPC in chronic active UC. Secondary endpoints maintenance of continuous remission improvement of disease activity: a. clinical activity (SCCAI) b.life quality (SIBDQ-D) c.Likert Score relapse rate: a. time to first relapse b. clinical activity during relapses c. number of relapses in relation to length of treatment

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Retarded release phosphatidylcholine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients from previous studies with retarded release phosphatidylcholine Exclusion Criteria: patients with less then 6 weeks follow-up after end of initial study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Retarded release phosphatidylcholine|2g phosphatidylcholine, given QTD|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of Minirin Melt in Patients With Nocturia

Study Overview
=================
Brief Summary
-----------------
This is a confirmation of safety profile for Minirin Melt in clinical practice.

Official Title
-----------------
Minirin Melt Tolerance With Nocturia in the Common Practice Conditions in Czech Republic

Conditions
-----------------
Nocturia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from Nocturia Exclusion Criteria: habitual or psychogenic polydipsia known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics moderate and severe renal insufficiency know hyponatremia syndrome of inappropriate ADH secretion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- | --- |
| Number of participants with adverse events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with nocturnal voiding |  | 12 months | 
| Number of participants with adverse events |  | 12 months |
CB1R in Synthetic Psychoactive Cannabinoids

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine whether the CB1R availability is lower in synthetic psychoactive cannabinoid subjects using the most widely available synthetic psychoactive cannabinoids at the time the study is initiated.

Official Title
-----------------
CB1R Availability in Synthetic Psychoactive Cannabinoid Users

Conditions
-----------------
Drug Dependence

Intervention / Treatment
-----------------
* Other: [11-C]OMAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Able to provide written consent Age 18-55 Current Synthetic Psychoactive Cannabinoids consumption Exclusion: MRI metal exclusions and claustrophobia Education completed is less than 12 years

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Synthetic Psychoactive Cannabinoid Users<br>Synthetic Psychoactive Cannabinoid dependent subjects who are frequent spice/K2 users will receive the radiotracer [11-C]OMAR. | Other: [11-C]OMAR<br>* The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron Emission Tomography (PET Imaging) | CB1R availability using [11-C]OMAR PET imaging Change in CB1R availability (e.g. volume distribution). | Change in CB1R availability from baseline throughout one test day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CogState Battery | 2. Changes in Cognition during withdrawal using a computerized battery Changes in cognitive functions such as attention, memory, motor functioning, and processing speed. | Change in CB1R availability from baseline throughout one test day | 
| Electroencephalogram | 3. Changes in brain rhythms measured by Electroencephalography Changes in electroencephalographic (EEG) brain rhythms related to information processing. | Change in CB1R availability from baseline throughout one test day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
K2, Spice, Synthetic Marijuana
Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.

Study Overview
=================
Brief Summary
-----------------
It is only between peak viremia and viral setpoint in natural acute HIV-1 infection that the immune response overwhelms viral replication resulting in a plasma viral load decline. The aim will be to characterize these immune responses, how they develop and their progeny. This will require the need to identify HIV-1 infected individuals before peak viremia and follow them to post viral setpoint. This protocol describes a pilot study to evaluate the feasibility of identifying, enrolling and following acute and early HIV-1 infected individuals from voluntary counselling and testing centres in Masaka, Bukomansimbi, Kalungu, Lwengo, Sembababule and Lyantonde districts.

Official Title
-----------------
A Pilot Study to Evaluate the Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.

Conditions
-----------------
Acute Human Immunodeficiency Virus Type I Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females and males. Able and willing to provide informed consent. Willing to undergo HIV testing using GeneX pert Viral Load assay. Able and willing to provide accurate locator information for tracking purposes and willing to be contacted by study staff. Willing to complete interviewer administered questionnaires on risk factors and if infected, questions related to the route and timing of exposure. Exclusion Criteria: Has any condition that in the opinion of the principal investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives. Participation in a current clinical trial unless approved by the investigators and IAVI medical monitor.

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 |
| --- | --- | --- |
| To measure the number of individuals who are Genexpert HIV Viral load assay positive and Alere Determine HIV-1/2 Negative. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, immune responses, cell death, acute
Spirometric Predicted Values in Bolivia

Study Overview
=================
Brief Summary
-----------------
There is no local predicted values for spirometry available in Bolivia. The aim of the present study is to establish moderne predicted values for healthy non-smokers recruited in a major city of Bolivia, Santa Cruz De La Sierra.

Detailed Description
-----------------
There is no local predicted values for spirometry available in Bolivia. To establish the predicted spirometric normal values in Bolivia, 500 healthy men and women, non-smokers will be recruited to perfom spirometry using following the actual ATS/ERS 2005 guidelines. The spirometer is a Bodybox 5500 (Medisoft, Belgium). The tests will be performed by a highly-trained pneumologist, Dr A. Ajata. Anthropometric variables recorded: age, sex, weight, standing and sitting height. Spirometric variables recorded: FEV1, FVC, PEF, FEV6, FEF25,50,75 and MEF Statistical anaysis will be done using R and SPSS softwares. Predicted equations will be compared with existing ones, especially the new GLI-2012 predicted equations.

Official Title
-----------------
Establishment of Spirometric Predicted Values in Bolivia

Conditions
-----------------
Spirometry, Respiratory Function Tests

Intervention / Treatment
-----------------
* Diagnostic Test: spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy and non-smokers Exclusion Criteria: unhealthy smokers subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: spirometry<br>single spirometry: only a routine diagnostic test | Diagnostic Test: spirometry<br>* only measurement of spirometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Forced expiratory volume in one second (Liter) | measurements done one time at recruitment during spirometry | 
| FVC | forced vital capacity (Liter) | measurements done one time at recruitment during spirometry | 
| FEV1/FVC ratio | FEV1/FVC ratio , % | measurements done one time at recruitment during spirometry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standing height | Standing height | measurements done one time at recruitment just before spirometry | 
| seated height | seated height | measurements done one time at recruitment just before spirometry |
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)

Study Overview
=================
Brief Summary
-----------------
Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.

Official Title
-----------------
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% BID and Bromfenac 0.09% BID

Conditions
-----------------
Post Operative Anterior Chamber Inflammation (Flare)

Intervention / Treatment
-----------------
* Drug: Ketorolac Tromethamine 0.45%
* Drug: Bromfenac 0.09%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be 18 years of age or older Scheduled for cataract surgery by phacoemulsification Subject must be willing to comply with all study requirements and be willing to give informed consent Exclusion Criteria: Any subject that has a history of uveitis or active iritis Subject can have no previous intraocular surgery with the exception of refractive surgery. but not within 6 months No ocular use of prostaglandins within 2 weeks of surgery Use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs (NSAIDs) or immunosuppressants within 14 days prior to surgery Contraindications to NSAIDs Active ocular infection

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bromfenac 0.09%<br>bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days. | Drug: Bromfenac 0.09%<br>* Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively<br>|
| Active Comparator: Acuvail<br>Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days. | Drug: Ketorolac Tromethamine 0.45%<br>* Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Inflammation (Flare) | Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber. | Day 14 of treatment |
Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)

Official Title
-----------------
Phase II Study Evaluating The Role Of Exemestane On Clinical And Pathologic Response Rates, And Its Aromatase Activity As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients.

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: exemestane (Aromasin®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal patients with unilateral breast cancer T2 to T4, N0-1, M0, non inflammatory, operable, hormonal receptors positive Exclusion Criteria: Patients with bilateral breast cancer T4d, inflammatory, non operable, hormonal receptors negative
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: exemestane (Aromasin®)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate breast conservative surgery rate; To evaluate intratumoral anti-aromatase activity. |  |  |
Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of a combined vaccination schedule of the 13-valent pneumococcal conjugate (PCV13) and 23valent plain polysaccharide vaccine (PPV23) on the establishment of immunological memory in HIV-infected adults on ART.

Official Title
-----------------
Study of the Immunogenicity and Immunological Memory Induced by the 13valent Pneumococcal Conjugate(PCV13) and 23valent Plain Polysaccharide Vaccine(PPV23) in HIV-infected Adults

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Biological: PCV13
* Biological: PPV23


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD4 T cell count >200cells/μl on ART Exclusion Criteria: no previously recorded allergy to PCV, PPV23 no intravenous immunoglobulin (IVIG) given within the previous 6 months no other vaccine given within the previous 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCV13<br> | Biological: PCV13<br> <br> |
| Experimental: PPV23<br> | Biological: PPV23<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry) | immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by flow cytometry) | One month post-PCV13, PPV23 | 
| immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry) | immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by flow cytometry) | One month post-PCV13, PPV23 |
Medication Adherence Enhancement in Heart Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention.

Official Title
-----------------
Medication Adherence Enhancement in Heart Transplant Recipients: a Randomized Clinical Trial

Conditions
-----------------
Medication Adherence, Self Management, Rejection

Intervention / Treatment
-----------------
* Behavioral: behavioral adaptation and symptom management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all eligible patients with follow-up at our outpatient clinic written informed consent sufficient German language skills to read and answer a battery of questionnaires > 18 years minimum 6 mts post HTX Exclusion Criteria: illiteracy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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: 1<br>intervention group | Behavioral: behavioral adaptation and symptom management<br>* behavioral adaptation and symptom management<br>|
| No Intervention: 2<br>control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events (composite endpoint) |  | at month 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence behavior measurement variables from MEMS system |  | first 3 month | 
| Immunosuppression level |  | Month 3, 12 and 60 | 
| All individual components of the composite endpoint occurence of adverse events |  | at month 60 | 
| Immunosuppression level |  | month 12 | 
| Immunosuppression level |  | at month 60 |
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized. The information gained from this study will help us determine when children children need to receive therapy to help prevent this type of blood clot from forming.

Official Title
-----------------
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures

Conditions
-----------------
Deep Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 1 month-12 years undergoing elective neurosurgical procedures. Exclusion Criteria: Patients undergoing outpatient neurosurgical procedures Patients with known DVT Patients with known hypercoagulable state Patients at high risk for DVT (discretion of surgeon in consultation with the hematology service)

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 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 |
| --- | --- | --- |
| Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism | The number of participants with post-operative ultrasound without evidence of thromboembolism | within 72 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep vein thrombosis, Children, Pediatric, Anti-coagulant, Neurosurgical procedures, Blood Clot