linjc16/ctgov huggingface dataset:
Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of 600 mg daily oral dose of rifampin (CYP3A4 inducer) on the pharmacokinetics of a single 400 mg oral dose of nilotinib in healthy subjects

Official Title
-----------------
A Phase I Open-label, Two Period, Single Center Study to Assess the Effect of 600 mg Daily Oral Dose of Rifampin (CYP3A4 Inducer) on the Pharmacokinetics of a Single 400 mg Oral Dose of Nilotinib in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects: Body weight must be ≥50 kg and <100 kg, with a body mass index (BMI) >18 but <33. Exclusion Criteria: Female who is pregnant, test positive for a serum pregnancy test or currently breast feeding. Contraindication to receiving nilotinib or rifampin. Smokers or use of tobacco products or products containing nicotine in the last 30 days A past medical history of clinically significant Electrocardiogram abnormalities, or a history/family history of long QT-interval syndrome. Other protocol-defined inclusion/exclusion may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifampin + nilotinib<br> | Drug: Nilotinib<br>* Semi-synthetic antibiotic derivative of rifamycin B and is known to induce cytochrome P-450 (CYP) enzymes.<br>* Other names: AMN107A, Tasigna;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of 600 mg rifampin on the pharmacokinetics (PK) of a single 400mg (2 x 200mg capsules) oral dose of AMN107 |  | at pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose after AMN107 administration on Days 1 and 16. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of a single 400mg (2x200mg capsules) oral dose of AMN107 given alone and concomitantly with 600mg rifampin |  |  | 
| To determine the ratio of 6ß - hydroxylcortisol to cortisol in urine as an in-vivomarker of CYP3A4 induction with rifampin treatment4. |  | on Days -1, 11, 15 and 19 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nilotinib, Rifampin, PK, healthy subjects
Mechanical Versus Manual Cardiopulmonary Resuscitation

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators compared mechanical and manual chest compressions in in-hospital cardiac arrest cases.

Detailed Description
-----------------
In this study, the investigators analyzed cardiopulmonary resuscitations performed over a 2-year period in an emergency department of a training and research hospital and compared success of manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge. Investigators present the study as an in-hospital cardiac arrest study; however, all of the resuscitation performed in the cases included in the study were performed in the emergency department.

Official Title
-----------------
Mechanical Versus Manual Chest Compression: A Retrospective Study in In-hospital Cardiac Arrest

Conditions
-----------------
Cardiac Arrest, Resuscitation

Intervention / Treatment
-----------------
* Other: Manuel chest compressions handled by clinicians
* Device: LUCAS™ 2 Chest Compression System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 age Cardiac arrest cases In-hospital cardiac arrest cases Resuscitations performed in emergency department Exclusion Criteria: <18 age

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 |
| --- | --- |
| Manuel compression<br>Manuel chest compressions will be handled by clinicians | Other: Manuel chest compressions handled by clinicians<br>* Compressions will be handled by human efforts<br>|
| Mechanical compression<br>Mechanical chest compressions will be handled via mechanical chest compression device | Device: LUCAS™ 2 Chest Compression System<br>* LUCAS-2 model piston-based mechanical chest compression device was used for mechanical chest compressions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate on the 30th day | Mortality rates from the hospital admission to the 30th day | 30 days | 
| Rate of the return of spontaneous circulation | Rate of return of the spontaneous circulation with duration at least five minutes | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiopulmonary Resuscitation, Chest compression, In-hospital, Mechanical, Manuel
Evaluation of Chronic Pain After Nerve Section During Thoracotomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if controlled nerve section reduces chronic pain after thoracotomy.

Official Title
-----------------
Post Thoracotomy Pain After Nerve Section

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Nerve section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients included for anterior or lateral thoracotomy Exclusion Criteria: Unable to give consent due to age, cognitive reduction or otherwise Neurological disease or symptoms affection thoracic area Chronic pain prior to surgery Inability to supply the patient with an epidural catheter Pneumonectomy Prolonged infection at surgical site Invasive tumor growth Need for repeated surgery at site

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NS<br>Nerve section of intercostal nerve during surgery | Procedure: Nerve section<br>* Intercostal nerve is divided during surgery<br>|
| No Intervention: Control<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (NRS) |  | 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QST parameters (sensory thresholds to cool/Warmth) |  | 3 months postoperatively | 
| Social well-being (HADS / PCS) |  | 3 months postoperatively | 
| Function (pain impairment of Activities of Daily Life) |  | 3 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracotomy, Nerve section, QST, Quantitative Sensory Test, Muscle sparing Posterolateral thoracotomy, Chest, Wall, Surgical, Incision, Tumors or cancer of the lung
Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare intensive and standard training for human insulin inhalation powder in patients with type 2 diabetes.

Official Title
-----------------
Standard Training Versus Intensive Training for HIIP Delivery System Usage in Insulin-Naïve Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: LY041001 (HIIP)
* Drug: LY041001 (HIIP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 12 months Age 18 or older. Taking at least 1 oral antihyperglycemic medication. Have an HbA1C between 7.5 and 12. Be a nonsmoker Exclusion Criteria: Body Mass Index (BMI) greater than 40. Have frequent episodes of severe hypoglycemia. Have advanced autonomic neuropathy. Have history of asthma. Have chronic obstructive pulmonary disease (COPD).

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: LY041001 (HIIP)<br>* Inhalation, capsule, TID 3 times per day min 6 IU max 60 IU<br>|
| Experimental: B<br> | Drug: LY041001 (HIIP)<br>* Inhalation, Capsule, TID 3 times per day min 6 IU max 60 IU<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypothesis that std training for HIIP system is noninferior to intensive training by 1.2 mmol/L with respect to overall 2-hr postprandial glucose excursion of (SMBG) in type 2 diabetes patients that have been on preprandial trmt with HIIP |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the suitability of the HIIP delivery system for type 2 diabetes patients |  | 4 weeks | 
| Compare the SMBG profiles of preprandial HIIP administration with standard training and with intensive training Assess patient compliance with the HIIP delivery system Directions for Use (DFU) provided by the Sponsor with and without intensive training |  | 4 weeks | 
| Compare the test meal blood glucose profiles of preprandial HIIP administration with standard training and with intensive training |  | 4 weeks |
Outcomes of Obstetric Patients With COVID-19 Disease in the ICU

Study Overview
=================
Brief Summary
-----------------
Although several studies are conducted in the general population researching the clinical and laboratory parameters predicting the progression to severe disease in COVID-19, the data are very few in obstetric patients. Therefore,the investigators aimed to evaluate the characteristics, prognosis, laboratory parameters, and mortality of obstetric patients followed up in the intensive care unit (ICU) due to severe COVID-19 disease and to determine the factors affecting mortality.

Detailed Description
-----------------
This study was a single-center, retrospective, and observational trial and carried out with the principles of the Declaration of Helsinki. All patient demographics and information were analyzed retrospectively from the patient files. Demographic data, obstetric histories, comorbidities, treatments received in the intensive care unit (ICU), delivery types, anesthesia types, and outcomes of newborns and mothers were retrospectively evaluated from the medical records. The need for the mechanical ventilator, the length of stay in the ICU, and outcomes of mothers were recorded. Laboratory findings were noted on the first day of admission to the ICU, including routine complete blood count, liver and kidney function, coagulation parameters, C-reactive protein (CRP), and albumin levels. Then neutrophil to lymphocyte (N/L) ratio, platelet to lymphocyte (P/L) ratio, and CRP to albumin (CRP/Alb) ratio were calculated. Deceased patients were evaluated in detail.

Official Title
-----------------
Evaluation of Outcomes of Obstetric Patients With COVID-19 Disease Followed up in the Intensive Care Unit

Conditions
-----------------
COVID-19, Obstetric Anesthesia Problems, Intensive Care Unit, Morality

Intervention / Treatment
-----------------
* Other: intensive care follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstetric patients (during the pregnancy and postpartum period, from the beginning of pregnancy and up to 42 days after delivery) hospitalized in the intensive care unit of our tertiary care hospital Patients who had positive PCR nasopharyngeal swabs for COVID-19 Exclusion Criteria: Patients who had negative PCR nasopharyngeal swabs for COVID-19 and were clinically suspicious

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: intensive care follow-up|The need for the mechanical ventilator, the length of stay in the intensive care unit, and outcomes of mothers were recorded. Deceased patients were evaluated in detail.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensive care follow-up | mortality | up to 200 days |
Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.

Detailed Description
-----------------
This is a longitudinal double-blind 12-week study of the clinical and biochemical response to clozapine or chlorpromazine in a group of treatment-refractory schizophrenic patients. The study has 4 phases: (1) A recruitment period; (2) a period of discontinuation of psychotropic medication; (3) a drug-washout period; and (4) a 12-week double-blind trial of clozapine or chlorpromazine.

Official Title
-----------------
Clozapine Response and Biogenic Amines in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Clozapine
* Drug: Chlorpromazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19-60 years of age Diagnosis of schizophrenia BPRS score > 50 Clinical Global Impressions rating > 4 One of the following: BPRS items rated greater than or equal to 4, conceptual disorganization, suspiciousness, hallucinations, unusual thought content. At least 2 six-week trials of different neuroleptics given at a dosage equivalent to at least 600 mg per day of chlorpromazine OR at least 1 eight-week trial of a neuroleptic given at a dosage equivalent to at least 800 mg per day of chlorpromazine. The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent. Exclusion Criteria: History of substance dependence within the past 2 months Major medical problems precluding the use of clozapine Pregnancy or lactation A serious suicide/homicide risk

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 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: Clozapine|nan|
|Drug: Chlorpromazine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical measures: Brief Psychiatric Rating Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms, Simpson-Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clozapine, Chlorpromazine, Schizophrenia, Biochemistry
Group Yoga Therapy at a College Counseling Center

Study Overview
=================
Brief Summary
-----------------
Clients of the student counseling center at Oklahoma State University who are interested in participating in the study will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Outcome of the three conditions will be compared.

Detailed Description
-----------------
Clients will be screened for appropriateness for group treatment and yoga. They will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Each condition will run concurrently for 8 weeks. Outcome measures will be administered before trial commencement and after the trial ends.

Official Title
-----------------
A Controlled Trial of Group Yoga Therapy at a College Counseling Center

Conditions
-----------------
Psychological Distress, Mindfulness

Intervention / Treatment
-----------------
* Other: Psychotherapy Group
* Other: Yoga class
* Other: Yoga Therapy Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students at Oklahoma State University Appropriate for group therapy Physically capable of doing yoga Exclusion Criteria: non-students inappropriate for group therapy treatment physical injuries not appropriate for yoga participation

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: Traditional Group<br>Traditional process psychotherapy group | Other: Psychotherapy Group<br>* Traditional process group<br>|
| Experimental: Yoga Therapy Group<br>Psychotherapy group integrating yoga and process dialogue | Other: Yoga Therapy Group<br>* Yoga psychotherapy group integrating yoga and process dialogue<br>|
| Active Comparator: Yoga Class<br>Yin yoga class | Other: Yoga class<br>* Yin yoga class<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Counseling Center Assessment of Psychological Symptoms-62 | Change in psychological symptoms from baseline on the Counseling Center Assessment of Psychological Symptoms-62 at 8 weeks is being assessed. | change from baseline at 8 weeks | 
| Outcome Questionnaire- 45.2 | Change in psychological symptoms from baseline on the Outcome Questionnaire- 45.2 at 8 weeks is being assessed. | change from baseline at 8 weeks | 
| Mindful Attention and Awareness Scale | Change in mindfulness from baseline on the Mindful Attention and Awareness Scale at 8 weeks is being assessed. | change from baseline at 8 weeks |
Stuttering and Apraxia of Speech: the Efficacy of an Intervention Program

Study Overview
=================
Brief Summary
-----------------
Subjects' utterances were submitted to acoustic analysis before and after the intervention program applied on prosodic basis.

Detailed Description
-----------------
The study has the aim of developing knowledge, methodology and technique in the prosody area, for its application on the speech therapy, with the assistance of a feedback system - with WinpitchPro (Philippe Martin). A database was constituted on the basis of a patterned corpus (EUROM1) by its translation, recording and editing on .wav format. Throughout model-sentences, an experimental intervention program initiates with the participation of 2 adults with stuttering problem and 2 with apraxia of speech. The efficacy of the therapeutic procedure is tested on the basis of the acoustical and the statistical analyses which have compared the first and the second speech samples taken before and after the twenty (20) therapy sessions held in a prosody approach only.

Official Title
-----------------
The Speech Prosody of People With Stuttering and Developmental Apraxia: the Efficacy of an Intervention Program

Conditions
-----------------
Stuttering, Developmental Apraxia of Speech

Intervention / Treatment
-----------------
* Behavioral: speech therapy with the assistance of an acoustical analysis program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of stuttering Clinical diagnosis of apraxia of speech 18 years of age or older Portuguese native language Agreement by the participant to enroll on 20 therapy sessions scheduled in a 3 month period Exclusion Criteria: History of major medical illness unrelated to primary diagnosis of developmental stuttering and developmental apraxia of speech Significant abnormalities on general physical and neurological examination unrelated to primary diagnosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Speech treatment on prosodic basis<br>Patients receive 20 therapy sessions over a course of 3 months, with one double session per week. | Behavioral: speech therapy with the assistance of an acoustical analysis program<br>* Two weekly speech sessions realized on individual basis for three months period<br>|

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
-----------------
Stuttering, Apraxia of speech, Motor control, Prosody, Pitch range, Speech rate, fluency disorders