linjc16/ctgov huggingface dataset:
Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.

Detailed Description
-----------------
Secondary endpoints are to evaluate: the objective response rate (RR) of the combination; the toxicity and the safety profile of the combination; the duration of response (RD) and time to treatment failure (TTF); the overall survival (OS) RR, TTP and OS according to baseline plasma VEGF levels (introduced with Amendment 1 dated 8/11/2007)

Official Title
-----------------
Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma

Conditions
-----------------
Mesothelioma

Intervention / Treatment
-----------------
* Drug: Bevacizumab, Pemetrexed, Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven malignant pleural mesothelioma, inoperable, non previously treated with chemotherapy including intracavitary administration PS 0-1 Measurable and/or evaluable lesions according to RECIST criteria Adequate organ function Exclusion Criteria: Uncontrolled hypertension Evidence of bleeding diathesis or coagulopathy Pregnancy or breast-feeding

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: Bevacizumab, Pemetrexed, Carboplatin|Bevacizumab: 15 mg/kg intravenous infusion over 30 to 90 minutes, following chemotherapy, on Day 1 every 3 weeks Pemetrexed: 500 mg/m2 intravenous infusion over 10 minutes on Day 1 every 3 weeks Carboplatin: AUC 5 intravenous infusion over 1 hour on Day 1 every 3 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (TTP) from first day of treatment until first observation of disease progression or death due to any cause or the last date the patient was known to be progression free or alive. |  | At the end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma. |  | Two months after the end of enrollment | 
| Overall survival (OS) computed as the time between the first day of treatment and the date of death or the last date the patient was known to be alive. |  | At the end of study |
Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH

Study Overview
=================
Brief Summary
-----------------
Adult patients suffering from acquired brain damage run the risk of developing PSH. This group of patients is admitted to our unit, the Neurointensive Stepdown Unit, at Silkeborg Regional Hospital for intensive care and early neurorehabilitation. After weaning from intensive carethey are transferred to Hammel NeuroCentre. Aim is to assess whether HRV-derived variables in the frequency domain mirror therapeutic and/or nursing and/or pharmacologic interventions. To the extent clinically available BRS and metabolism are included in the assessment.

Detailed Description
-----------------
See report: Honore H, Eggertsen K, Sondergaard S: A study into the feasibility of using HRV variables to guide treatment in patients with paroxystic sympathetic hyperactivity in a neurointensive step-down unit. NeuroRehabilitation 2019, 44(1):141-155.

Official Title
-----------------
Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH

Conditions
-----------------
Autonomic Nervous System Imbalance

Intervention / Treatment
-----------------
* Other: Physio-/occupational therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of PSH according to Baguley scoring table Exclusion Criteria: No symptoms of PSH

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Physio-/occupational therapy|Physio-/occupational therapy, ADL|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference before vs after intervention in frequency domain parameters of HRV | HRV parameters: low frequency (LF, 0.04-0.15 Hz), high frequency (HF, 0.15-0.4 Hz) in terms of peak frequency (Hz), absolute power (ms2, natural logarithm transformed values of absolute powers of VLF, LF, and HF bands), relative power (absolute power/total power), normalized power (%, normalized units, n.u.), total power given by VLF + HF + LF (ms2) and LF/HF ratio. | immediate | 
| Qualitative description expressed as goal attainment scaling (GAS) of therapeutic interventions | Two independent ratings on a 5-point scale, -2 to +2 | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSH, Rehabilitation, Medication, ANS
A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to establish a modified minimally invasive surgical technique for sinus floor augmentation with a residual bone height of 3-6mm. Hypothesis: The investigators expect that the present surgical technique allows to achieve an adequate implant bed of at least 10mm height after a healing period of 3-5 months. Further the modification of the technique enables a reduced patient stress level.

Conditions
-----------------
Atrophy, Maxillary Sinus

Intervention / Treatment
-----------------
* Procedure: sinus floor elevation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: residual bone height of 3-6mm residual bone width of >4mm Exclusion Criteria: not treated periodontal disease smoker (>5cig/day) acute or chronic sinusitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sinus floor elevation<br> | Procedure: sinus floor elevation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height of augmentation |  | after 4-5months |
Development of Child With Equinus Deformity Idiopathic

Study Overview
=================
Brief Summary
-----------------
Identification and characterization of the link between psychomotor development and the appearance of associated signs in children with Equinus Deformity  considered isolated at birth.

Detailed Description
-----------------
The main objective of this study is to define the frequency of developmental abnormalities in children with Equinus Deformity Idiopathic compared to the general population The secondary objective is to identify the prenatal and / or neonatal characteristics that could be predictive of the occurrence of developmental abnormalities in Prenatal and postnatal follow-up data are derived from the child's medical file. To complete these data and after inclusion, parents of children carrying Equinus Deformity Idiopathic will be sent a questionnaire that assesses overall psychomotor development and lists the medical events since the birth of their child (scoliosis, epilepsy ...).

Official Title
-----------------
Development of Child With Equinus Deformity Idiopathic

Conditions
-----------------
Equinus Deformity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children born between January 2002 and August 2015 Prenatal or postnatal diagnosis of idiopathic or syndromic Equinus Deformity Followed by the pediatric orthopedic service of Rennes University Hospital Parent having received the information on the protocol and having not expressed their opposition. Exclusion Criteria: Parents opposing the study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of developmental abnormalities (with the exception of Equinus Deformity) in children with Equinus Deformity idiopathic compared to the general population. |  | through study completion an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
developmental abnormalities, psychomotor development
Study of MK0869 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (0869-071)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and tolerability of an investigational drug for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy.

Official Title
-----------------
Open-label Extension to: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy

Conditions
-----------------
Nausea, Vomiting, Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: MK0869, aprepitant / Duration of Treatment: 3 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy. Patient must have completed participation in the main study for this protocol. Exclusion Criteria: Patient has a central nervous system malignancy. Patient will receive radiation to the abdomen or pelvis.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0869, aprepitant / Duration of Treatment: 3 days|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse experiences using the National Cancer Institute (NCI) criteria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemotherapy-Induced Nausea and Vomiting
The Impact of Metabolic Syndrome on Patients Undergoing Elective Laparotomy

Study Overview
=================
Brief Summary
-----------------
Worldwide, the rising incidence of obesity has led to the identification of an obesity related syndrome, called metabolic. This syndrome is characterized by central obesity, hypertension, insulin resistance and altered lipid levels. Taking into consideration the rising incidence of obesity, anesthetists will more frequently encounter patients with metabolic syndrome, in their everyday practice. Moreover, the comorbidities that are related to the metabolic syndrome, increase the risk for perioperative complications. Therefore, strategies that will evaluate and modify the risk will be of great importance in the management of these patients, in order to maximize peri-anaesthetic and surgical safety. The aim of the study is to assess the incidence of metabolic syndrome and the impact of its presence on the outcome of patients undergoing elective laparotomy.

Conditions
-----------------
Metabolic Syndrome, Anesthesia, Perioperative Outcome, Complications

Intervention / Treatment
-----------------
* Procedure: Elective abdominal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients are undergoing elective laparotomy of estimated duration of more than one hour. All operations will be performed under general anesthesia. Exclusion Criteria: Endstage neoplasia Procedures performed within 1 hour of admission Emergency cases
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with metabolic syndrome<br>Patients fulfilling criteria to establish the diagnosis of metabolic syndrome | Procedure: Elective abdominal surgery<br> <br> |
| Patients without metabolic syndrome<br>Patients not fulfilling criteria of the metabolic syndrome | Procedure: Elective abdominal surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative and postoperative adverse cardiac and cerebrovascular events as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines. |  | 2 Weeks | 
| Postoperative pulmonary complications as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines. |  | 2 Weeks | 
| Acute Kidney Injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines |  | 2 Weeks | 
| Surgical site infection (superficial or deep) as defined by European Perioperative Clinical Outcome (EPCO) definitions guidelines. |  | 2 Weeks |
Modifying Group Therapy for Bipolar Substance Abusers - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to modify Integrated Group Therapy (IGT), which is has been found successful for patients with bipolar disorder (BD) and substance use disorder(SUD), so that it can be more readily adopted by community drug abuse treatment programs. IGT is being reduced from 20 to 12 sessions in this trial, and is being conducted by front-line drug counselors, to test its effectiveness in a more community-based setting. The training has been expanded so that counselors without much psychopathology training or cognitive behavioral therapy experience can conduct IGT.

Detailed Description
-----------------
IGT is being compared with 12 sessions of Group Drug Counseling (GDC) in a randomized controlled trial, with a sample size of 60 subjects. GDC is the type of treatment one would likely receive in a community drug abuse treatment program, in that it focuses primarily in substance use, unlike IGT, which focuses equally on SUD and BD issues. Patients are followed for a year after the end of the group therapy, to examine the long-term effects of the treatment, and also to examine the longer-term relationship of substance use and mood. Patients in the trial must be taking a mood stabilizer to enter the study. Any drug of abuse is accepted, and all subtypes of BD are accepted.

Official Title
-----------------
Modifying Group Therapy for Bipolar Abusers

Conditions
-----------------
Bipolar Disorder, Substance Dependence

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bipolar disorder substance dependence taking a mood stabilizer Exclusion Criteria: acute psychosis no substance use in past 60 days no prescribing doctor will not be in area for next 15 months lives too far away

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Addiction severity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
substance abuse
Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.

Official Title
-----------------
Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin glargine
* Drug: NPH human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents Body mass index between 26 and 40 kg/m2 HbA1c between 7.5% and 10.0% Fasting plasma glucose >7.8 mmol/L and fasting C-peptide > or =0.25 nmol/L

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin glargine|nan|
|Drug: NPH human insulin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety data (Adverse events, vital signs, laboratory values, etc.) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin naive
Clinical Evaluation of the Photoallergy Potential of Atralin Gel

Study Overview
=================
Brief Summary
-----------------
To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.

Official Title
-----------------
Clinical Evaluation of the Photoallergy Potential of Atralin Gel (Tretinoin Gel 0.05%)

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

Intervention / Treatment
-----------------
* Drug: Atralin (tretinoin) gel, 0.05%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal, healthy volunteers 18 years of age and older Exclusion Criteria: Less than 18 years of age

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Safety when exposed to sunlight | Drug: Atralin (tretinoin) gel, 0.05%<br>* Assess photoallergic reactions for tretinoin 0.05% and vehicle, measured as skin reactions following induction and challenge.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UV Induced skin irritation |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tretinoin, exposure to UV light, phototoxicity, Safety when exposed to sunlight
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Intravenous Tedisamil Sesquifumarate in the Rapid Conversion to Normal Sinus Rhythm in Female Subjects With Recent Onset Atrial Fibrillation or Flutter

Conditions
-----------------
Atrial Flutter, Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Tedisamil sesquifumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to sign informed consent before screening examinations are performed and before the study drug is administered Females > 18 years of age Subjects with documented (60 second rhythm strip) symptomatic atrial fibrillation or flutter (duration > 3 hours and < 45 days) at the time of randomization Subjects who are in no distress and hemodynamically stable (supine systolic blood pressure > 90 mmHg and diastolic blood pressure < 105 mmHg) Exclusion Criteria: Pregnancy and lactation Acute myocardial infarction and cerebrovascular accidents Coronary syndromes and congestive heart failure (CHF) New York Heart Association (NYHA) IV Life-threatening ventricular arrhythmias and electrocardiogram (ECG) abnormalities Concurrent antiarrhythmic treatments

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tedisamil sesquifumarate|nan|

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
-----------------
Atrial fibrillation, atrial flutter, anti-arrhythmic agents, conversion to normal sinus rhythm