linjc16/ctgov huggingface dataset:
Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.

Official Title
-----------------
Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects.

Conditions
-----------------
Breast Cancer, Tumors, Leukemia

Intervention / Treatment
-----------------
* Drug: Bosutinib (SKI-606)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive on study day 1. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥ 1 year (with follicle-stimulating hormone [FSH] ≥ 38 mIU/mL) and must have a negative serum pregnancy test result before administration of test article. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg. Healthy as determined by the investigator on the basis of screening evaluations. Exclusion criteria: Family history QT prolongation, syncope, seizure, or unexplained cardiac related death. Presence or history of any disorder that may prevent the successful completion of the study. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Bosutinib (SKI-606)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples |  | 5 weeks |
Survey: Clinical Outcome After Bowel Resection in Women Due to Endometriosis

Study Overview
=================
Brief Summary
-----------------
Endometriosis is one of the most frequent benign diseases that can affect women in their reproductive age. In severe form, the colon or rectum may be involved. It has been shown that the surgical treatment improve typical symptoms like pain and dyspareunia. The investigators evaluated the functional results and quality of life after laparoscopic colonic resection for endometriosis

Detailed Description
-----------------
A clinical analysis of thirty women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012. Quality of life and pain was documented postoperatively. We conduct a telephone survey, which starts at May 2014.

Official Title
-----------------
Survey: Clinical Outcome After Bowel Resection in Women Due to Endometriosis

Conditions
-----------------
Bowel Endometriosis

Intervention / Treatment
-----------------
* Procedure: laparoscopic colonic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Clinical diagnosis of endometriosis Exclusion Criteria: Unwillingness to participate on the survey

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bowel endometriosis<br>laparoscopic colonic resection | Procedure: laparoscopic colonic surgery<br>* women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scala for pain | comparison of pain before and after the operation (one year later), value 0 til 10; 0= no pain, 10= strong pain | one year after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dyspareunia | comparison of dyspareunia before and one year after the operation | one year after the operation | 
| dysuria | comparison of dysuria before and one year after the operation | one year after operation | 
| obstipation | comparison of obstipation before and one year after the operation | one year after operation | 
| pain during defecation | comparison of pain during defecation before and one year after the operation | one year after operation | 
| rectal bleeding | comparison of rectal bleeding during menstruation before and one year after the operation | one year after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, quality of life
CICATRIX in the Treatment of Recent Post-surgical Scars

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of recent post-surgical scars. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to be recruited and randomized for the study is 90.

Official Title
-----------------
Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Recent Post-surgical Scars

Conditions
-----------------
Post-surgical Scars

Intervention / Treatment
-----------------
* Other: Cicatrix
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent (less than 48 hours) post-surgical wound Exclusion Criteria: Post-surgical wound with sepsis Usage of steroids within 30 days Malignant neoplastic conditions Alcoholism Handicap and/or psychiatric condition preventing treatment accomplishment.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Cicatrix | Other: Cicatrix<br>* Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.<br>* Other names: Cosmetic;|
| Placebo Comparator: B<br>Placebo | Other: Placebo<br>* Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse effects at week 4 (end of the treatment) |  | 4 weeks | 
| Photographs of lesions at week 4 (end of the treatment) |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-surgical scars, Asian Gotu Kola, Asian Pennywort
PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices

Study Overview
=================
Brief Summary
-----------------
Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark, and all LVAD centres of the World that wish to participate. The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs using data from studies already conducted.

Detailed Description
-----------------
Background and purpose: Peak oxygen uptake (pVO2) is used extensively in HF to predict prognosis and time for heart transplantation. Many centers are increasingly measuring pVO2 in LVAD supported HF patients, though this has mostly been for research or rehabilitation purposes. It is unknown if pVO2 predicts outcome in LVAD treated HF patients. The investigators will pool data from all willing centers of the World to investigate the prognostic value of pVO2 (e.g. outcome in LVAD supported patients) and, secondly the investigators will investigate wether the predictive power of pVO2 in LVAD recipients depends on the treatment indication (BTT and DT). Methods: Data is collected in anonymized form from all centers willing to contribute data. Hypothesis: The hypothesis is that lower pVO2 is associated with higher rates of death or urgent transplantation (primary endpoint).

Official Title
-----------------
Investigation of the Prognostic Value of pVO2 in Recipients of Left Ventricular Assist Devices

Conditions
-----------------
Left Ventricular Assist Device, Prognosis, Advanced Heart Failure

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Durable LVAD implantation VO2 in stable post implant phase Exclusion Criteria: No VO2 data available Concomittant RVAD (temp/durable device)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Durable LVAD recipient with post implant VO2<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome after implantation | Survival/ongiong on device/explant/htx after LVAD implantation | Stable-phase post implant VO2 (e.g. >3months and up to 13 year post implant) |
Validation of a Tool for Assessing Gambling Problems Related to the Practice of Poker: the Copenhagen Poker Screen (CHAPS)

Study Overview
=================
Brief Summary
-----------------
If the addiction to games of chance and gambling is a disease of increasing knowledge, the emergence of poker rout evaluation procedures, prevention and treatment usually offered to players in need. In the case of poker, which unlike other games has a real part to address and which damages are expressed differently, the evaluation can not be done identically to other games. This problem has often been emphasized in the literature, in particular the lack of specific tools for the identification of poker gambling problems. Thus, the fact of developing a specific evaluation tool could allow poker to take into account the specificity of poker among other games. This would be part of the evaluation complement batteries currently available to players in general by offering a specific tool, and secondly to allow the assessment of the aspects of the problems often absent for other games . The goal here is to develop and validate a specific tool detection of problem gambling in the particular context of poker.

Conditions
-----------------
Addiction

Intervention / Treatment
-----------------
* Behavioral: Canadian Index Excessive Game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects who had a practice of poker over the past 12 months Exclusion Criteria: Participants who have already completed the survey (on the basis of their declaration)

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Canadian Index Excessive Game|self-administered questionnaire Canadian Index Excessive Game|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validate an evaluation tool of problem gambling within the specific framework of poker |  | 10 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disorders related to gaming and gambling; poker
Neonatal Pulse Oximetry Compared With Apgar Scores

Study Overview
=================
Brief Summary
-----------------
Apgar score is a subjective measure to assess prognosis and future outcome of a newborn. Pulse oximetry taken at 1, 5 and 10 minutes will be correlated to apgar scores in respective times in an goal to assess the usability of pulse oximetry as an added tool in determining the newborn prognosis

Official Title
-----------------
Newborn Pulse Oximety as a Predictor for Newborn Status and Future Outcome As Compared With the Apgar Score

Conditions
-----------------
Newborns Delivered at KMC OB/GYN Department

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns delivered vaginaly or by C-section at Kern Medical Center labor and delivery ward Exclusion Criteria: known cardiopulmonary disease of the newborn
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 |
| --- | --- | --- |
Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ketamine, midazolam, and meperidine are more effective than midazolam and meperidine alone for procedural sedation and analgesia in pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side effects and the necessity of rescue doses.

Detailed Description
-----------------
90 patients will be included. The sedation will include 0.1mg/kg, max 5mg iv of midazolam, 1mg/kg, max 50mg iv of meperidine, and placebo (0.9%NaCl) or ketamine 0.5mg/kg iv. Rescue doses will be given as usual, using meperidine and or midazolam 50% of the initial dose.

Official Title
-----------------
Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation

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

Intervention / Treatment
-----------------
* Drug: ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children =/> 10 years of age Undergoing elective diagnostic colonoscopy ASA score class 1-3. Exclusion Criteria: Children younger than 10 years of age Known epilepsy under treatment ASA score class 4 or more Interventional colonoscopy (e.g.polypectomy)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketamine<br>group with triple sedation (ketamine, midazolam, meperidine) | Drug: ketamine<br>* 0.5mg/kg ketamine iv<br>* Other names: no other names;|
| Placebo Comparator: placebo<br>group with conventional sedation and placebo ( midazolam, meperidine and placebo) | Drug: ketamine<br>* 0.5mg/kg ketamine iv<br>* Other names: no other names;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year | after one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| necessity of cardiopulmonary intervention (Oxygen requirements) | according to Observer'sAssessment of Alertness/Sedation (OAAS) score | after one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, gastroscopy, colonoscopy, sedation, ketamine
A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the time course of PF-00241939 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

Official Title
-----------------
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers.

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

Intervention / Treatment
-----------------
* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). A positive urine drug screen. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. Pregnant or nursing females.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>PF-00241939 300ug using Inhaler A | Drug: Treatment A<br>* PF-00241939 300ug using Inhaler A<br>|
| Active Comparator: Treatment B<br>PF-00241939 300ug using Inhaler B | Drug: Treatment B<br>* PF-00241939 300ug using Inhaler B<br>|
| Active Comparator: Treatment C<br>PF-00241939 300ug using Inhaler C | Drug: Treatment C<br>* PF-00241939 300ug using Inhaler C<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUClast & Cmax. |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½. |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics
Effect of Repeated Exposures to Compressed Air on Patients With AIDS

Study Overview
=================
Brief Summary
-----------------
The exposure of human beings to markedly altered environments (ambient pressure and inhaled gas mixtures) has profound effects on their innate immune capacity to effectively combat viral illnesses. This Phase IIA clinical trial examines the effects of an exposure to a 4 atmospheric environment has on HIV-infected humans whose clinical condition has progressed to formal AIDS status.

Official Title
-----------------
Effect of Repeated Exposure to Compressed Air on Patients With AIDS (Acquired Immunodeficiency Syndrome)

Conditions
-----------------
AIDS

Intervention / Treatment
-----------------
* Device: Hyperbaric chamber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD4 count <200 Viral load > 5000 Exclusion Criteria: Opportunistic infection Concurrent neoplasm (see protocol) Immunomodulators HIV vaccination Investigational HIV drugs (see protocol) Pregnant women Major organ transplant

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: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hyperbaric chamber|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 - Safety |  |  | 
| 2 - Viral Load measure (blood and intracellular) |  |  | 
| 3 - CD4/CD8 levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADL measurements |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIDS, HIV, Hyperbaric Chamber, treatment experienced