linjc16/ctgov huggingface dataset:
Study of XL647 Administered Orally Daily to Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.

Official Title
-----------------
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: XL647


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has histologically confirmed malignancy that is metastatic or unresectable Subject has disease that is assessable by tumor marker, physical, or radiologic means Subject is at least 18 years old Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%) Subject has a life expectancy ≥ 3 months Subject has normal organ and marrow function Subject gives written informed consent Subject must use an accepted method of contraception during the study Female subjects of childbearing potential must have a negative pregnancy test Exclusion Criteria: Subject has received anticancer treatment within 30 days of first dose of XL647 Subject has received another investigational agent within 30 days of first dose of XL647 Subject has known brain metastases Subject has corrected QT interval (QTc) of > 0.45 seconds Subject is currently receiving anticoagulation therapy with warfarin Subject has uncontrolled intercurrent illness Subject is pregnant or breastfeeding Subject has known HIV

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: XL647|Tablets supplied in 50-mg strength administered orally daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety, tolerability, and maximum tolerated dose of XL647 |  | Inclusion until 30 days post last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize pharmacokinetics and pharmacodynamic effects of XL647 |  | At various time points from pre-dosing until post dosing | 
| Evaluate preliminary tumor response |  | Inclusion until disease progression | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solid tumors
Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone for Labor Induction

Study Overview
=================
Brief Summary
-----------------
Acidification of vaginal pH has been proposed as a potential factor that could help increase the efficacy of vaginal prostaglandins in labor induction. The aim of the present randomized controlled trial is to evaluate the impact of an acidic vaginal pH on the progress of labor induction with dinoprostone (Prostaglandin E2 - PGE2) vaginal tablet.

Official Title
-----------------
Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone (PGE2) Vaginal Tablet for Labor Induction in Full Term Pregnant Women: A Randomized Controlled Trial

Conditions
-----------------
Labor, Induced, Induced; Birth

Intervention / Treatment
-----------------
* Other: Vaginal washing with 5% acetic acid
* Other: Vaginal washing with 0.9% NS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Singleton pregnancy Full term (>37 weeks) Cephalic presentation Reactive NST (nonstress test) Absence of spontaneous uterine contractions No contraindications to vaginal delivery Exclusion criteria Multifetal pregnancy Fetal malpresentation Preterm delivery (<37 weeks) Advanced maternal age (>40 years) Bishop score > 7 Fetal macrosomia ( >4500 gr) Non reassuring NST (nonstress test) Suspected chorioamnionitis Previous cesarean delivery or other uterine surgery

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal washing 5% acetic acid<br> | Other: Vaginal washing with 5% acetic acid<br>* Induction of labor (vaginal tablet dinoprostone and vaginal washing with 5% acetic acid)<br>|
| Placebo Comparator: Vaginal washing 0.9% N/S<br> | Other: Vaginal washing with 0.9% NS<br>* Induction of labor (vaginal tablet dinoprostone and vaginal washing 0.9% NS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interval from induction to delivery | Time interval (minutes) | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interval from induction to active labor | Time interval (minutes) | 36 hours | 
| Interval from induction to second stage of labor | Time interval (minutes) | 36 hours | 
| Failure of induction of labor | Rate of participants with failure of induction of labor | 36 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor induction, dinoprostone, vaginal pH
Safety and Efficacy of VEC-162 on Circadian Rhythm in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of VEC-162 compared to matching placebo on circadian phase shift and sleep parameters.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of VEC-162 on Circadian Rhythm in Healthy Subjects

Conditions
-----------------
Circadian Rhythm Sleep Disorders

Intervention / Treatment
-----------------
* Drug: VEC-162


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No medical, psychiatric, or sleep disorders Ability to provide written informed consent Exclusion Criteria: Lifetime history of night shift work Evidence of any sleep disorder Psychiatric or neurological disorders

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VEC-162|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian Phase Shift | Exposure response to VEC-162 on induction of circadian phase shift as measured by Dim Light Melatonin Onset (DLMO) was defined as the time change between Night 3 and Night 4 when melatonin production reached 25% of the maximum melatonin concentration. Samples below LOQ of the melatonin assay were assigned 5 pg/ml. | Night 3 and Night 4 | 
| Mean Sleep Efficiency | Exposure response was measured by comparing the change in sleep efficiencies of VEC-162 and placebo treated subjects upon a sleep schedule phase advance. Sleep efficiency (total time asleep divided by the time allowed as an opportunity for sleep in a period multiplied by 100%, where time allowed for sleep was 8 hours or 480 minutes) was measured objectively by overnight polysomnographic recordings. Sleep efficiency was also compared in parts of the night by dividing the full night into thirds. | Night 4 and Night 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wake After Sleep Onset (WASO), and Latency to Persistent Sleep (LPS) | Wake After Sleep Onset is defined as the total time that is scored as awake in a PSG occurring between sleep onset and lights-on prompt. Latency to Persistent Sleep is defined as the number of epochs (one 30-second interval of the sleep episode) from the beginning of the recording (lights-out) to the start of persistent sleep (first 20 consecutive non-wake state) divided by 2. | Night 2 and Night 4 | 
| VEC-162 AUC |  | Night 4 | 
| VEC-162 Cmax |  | Night 4 | 
| VEC-162 Tmax |  | Night 4 |
Childhood Asthma and Schooling: The Truth Unveiled

Study Overview
=================
Brief Summary
-----------------
Childhood Asthma and Schooling: The Truth Unveiled.

Detailed Description
-----------------
Children with mild persistent asthma still performed worse than normal healthy children in school. The aim of the study was to evaluate school performance of children with mild persistent asthma in comparison with normal healthy children.

Official Title
-----------------
Childhood Asthma and Schooling: The Truth Unveiled

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of bronchial asthma Must be able to swallow tablets Exclusion Criteria: Steroid inhalation or ingestion

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
The effect of bronchial asthma on school performance
Does Sunbed Radiation With Mainly UVA Provoke Cutaneous Vitamin D Synthesis in Humans?

Study Overview
=================
Brief Summary
-----------------
We would investigate in a controlled, randomized open study in the winter season: 1) If serum levels of vitamin D (25(OH)D) increase in subjects treated with sunbed with sunlamps emitting mainly UVA and only 0·5% or 1·4% UVB compared to non-sunbed treated controls 2) If yes, are the 25(OH)D serum levels then dependent on the UVB dose?

Official Title
-----------------
Sunbed Radiation Provoke Cutaneous Vitamin D Synthesis in Humans, a Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Radiation: UV radiation
* Radiation: UV radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Females Above 50 years Younger with serum concentration of 25(OH)D below 50nmol/l Exclusion Criteria: No sunbed use last ½ year No sun holiday last ½ year No intake of vitamin D above 10 microgram/day

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UVB 0.5%<br> | Radiation: UV radiation<br>* UV radiation with 99.5% UVA and 0.5%UVB<br>|
| No Intervention: Controls<br> | |
| Active Comparator: UVB 1.4%<br> | Radiation: UV radiation<br>* UVB 1.4 % and UVA 98.6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of 25(OH)D |  | 18 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of PTH |  | 18 Days |
MAGIC Cell-5-Combicytokine Trial

Study Overview
=================
Brief Summary
-----------------
Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.

Official Title
-----------------
Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: G-CSF with/without darbepoetin, peripheral blood stem cell infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ST elevation acute myocardial infarction < 80years successful revascularization of culprit vessel Exclusion Criteria: uncontrolled congestive heart failure uncontrolled myocardial ischemia uncontrolled ventricular arrhythmia malignancy serious hematologic disease chronic renal failure

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: G-CSF with/without darbepoetin, peripheral blood stem cell infusion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of left ventricular ejection fraction measured by cardiac MRI |  | 6, 12, and 24month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wall motion score index exercise capacity BNP |  | 6,12, 24month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute myocardial infarction
Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of oxytocin infusion during abdominal myomectomy.

Detailed Description
-----------------
Myomectomy is indicated for symptomatic uterine fibroids. Fibroids have blood supply and 20% of the abdominal myomectomy cases might require blood transfusion because of the nature of the surgery. Oxytocin infusion is one of the intervention to decrease blood loss during myomectomy. To evaluate the effects and benefits of oxytocin infusion during abdominal myomectomy we decide to conduct this randomized study.

Official Title
-----------------
Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

Conditions
-----------------
Myomectomy

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Other: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-50 Patients who are candidate for abdominal myomectomy Exclusion Criteria: History of previous myomectomy. Suspected malignancy Patients with preoperative anemia Patients using hormonal treatments before the surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The abdominal myomectomy cases will be randomized into 2 separate groups in a parallel fashion using an online software at 1:1 ratio.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin infusion<br>Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia. | Drug: Oxytocin<br>* Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.<br>|
| Placebo Comparator: Placebo<br>Patients will receive pure normal saline infusion at the same rate and volume just before the surgery after the induction of general anesthesia. | Other: saline<br>* Patients will receive intravenous normal saline infusion just before the surgery after the induction of general anesthesia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss during surgery | estimated blood loss during the surgery measured by aspiration fluid. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss after abdominal myomectomy | change in Hematocrit Percentage (before and after the surgery) | 1 hour postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myomectomy, oxytocin, blood loss
Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC.

Detailed Description
-----------------
To register the follow-up data of patients who, because of a peritoneal surface malignancy, will undergo cytoreductive surgery and HIPEC. In this surgical intervention, the abdominal cavity is macroscopically cleared of tumor, by removing all visible tumor nodules, and is subsequently rinsed with hyperthermic (heated) chemotherapy, aiming to destroy all residual invisible tumor cells that might have stayed behind after the debulking. The eventual aim of this procedure is to improve the prognosis/survival of patients with malignancies localized on the peritoneal surface.

Official Title
-----------------
Register With Data From Patients With the Diagnosis of a Peritoneal Surface Malignancy, for Which Cytoreductive Surgery and Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) is Performed

Conditions
-----------------
Peritoneal Carcinomatosis, Pseudomyxoma Peritonei, Peritoneal Mesothelioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Registry<br>Patients with peritoneal carcinomatosis of colorectal origin, patients with pseudomyxoma peritonei (type DPAM or PMCA) and patients with peritoneal mesothelioma who are planned to undergo cytoreductive surgery and HIPEC because of a peritoneal surface malignancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To improve the prognosis/survival of patients with malignancies localized on the peritoneal surface. |  | Follow-up over a time period of at least 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIPEC, Hyperthermic (heated) chemotherapy after debulking
Cellular Immune Responses in the Liver in Chronic Hepatitis C (CHC) Patients

Study Overview
=================
Brief Summary
-----------------
In order to persist in the liver, HCV has numerous nonspecific and specific strategies to overcome the immunity of the host. The crucial step in the establishment of viral persistence and chronic hepatitis is the avoidance of specific antiviral cellular immune response in the liver. Treatment with pegylated interferon alpha (IFNα) in combination with ribavirin (RBV) is the standard therapy for chronic hepatitis C is. The response to IFNα / RBV therapy depends on the effective cellular antiviral immune response in the liver. The understanding of the interaction between HCV and cellular immune response is important for the effective use of existing diagnostic techniques, the Individual control and adjustment of the current therapeutic approaches and the development of future therapeutic and immunization strategies. In this study, the investigators want to investigate cellular Immune responses in the liver of HCV infected patients and characterize the influence of these immune responses to the response to IFNα / RBV therapy.

Official Title
-----------------
Characterization of Cellular Immune Responses in the Liver in Patients With Chronic Hepatitis C Virus Infection

Conditions
-----------------
Hepatitis C, Chronic, Liver Diseases, Virus Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven chronic hepatitis C aged between 18 and 65 willingness to give written informed consent to the study protocol Exclusion Criteria: history of having received any IFN, PEG-IFN or RBV not eligible for antiviral treatment with peginterferon and ribavirin by standard of care

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic Hepatitis C<br>Patients with chronic Hepatitis C (CHC) Genotype 1-4 who are naive to antiviral treatment | |

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
-----------------
ribavirin, HCV, hepatitis C virus, CHC, chronic hepatitis c, interferon, Hepatitis, Viral, Human, Anti-Infective Agents, peginterferon alfa-2a, peginterferon alfa-2b