linjc16/ctgov huggingface dataset:
Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: ONO-2333Ms Experimental 2
* Drug: Placebo
* Drug: ONO-2333Ms Experimental 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with recurrent major depressive disorder Exclusion Criteria: Patients with treatment resistance for depression History of alcohol abuse/dependence, substance abuse/dependence within 6 months Has clinically significant unstable medical condition Has significant risk of suicide

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>1-2 mg of ONO-2333 | Drug: ONO-2333Ms Experimental 1<br>* 1-2 mg QD(once a day) for 8 weeks<br>|
| Experimental: Experimental 2<br>5-10 mg of ONO-2333 | Drug: ONO-2333Ms Experimental 2<br>* 5-10 mg QD(once a day) for 8 weeks<br>|
| Placebo Comparator: Placebo<br>placebo comparator | Drug: Placebo<br>* 0 mg QD(once a day) for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to treatment endpoint in the MADRS total score |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to treatment endpoint in the HAM-D17, QIDS-SR16, CGI-S, CGI-I, PGI score |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-2333Ms, Major Depressive Disorder
Role of Serum Total Antioxidant Level in Preterm Labor

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.

Detailed Description
-----------------
Study design: This is a prospective case-control study. Setting: The study will be conducted at Ain Shams University Maternity Hospital. Population of the study: A total of 70 pregnant women attending the outpatient obstetric clinic and inpatient of Obstetrics and Gynecology department or when they will be admitted to the delivary room of Ain Shams university hospital. Patient will be divided in to two groups. Group A: 35 pregnant women diagnosed with preterm labor(Preterm labor pain at least 3 contraction every 20 minutes ,cervical dilatation < 2cm and effacement< 50%) which will deliver within one week maximum after hospitalization. Group B: 35 pregnant women( controls )with uncomplicated pregnancies at a similar gestational ages followed routinely in the antenatal care unit. Every case will be subjected to:- Written informed consent before the study. Complete history . Complete general and abdominal examination. Infection markers(CRP,WBCs count, urine analysis ). Gestational age determination by the last menstrual date or Ultrasonography. Local pelvic examination.

Official Title
-----------------
the Role of Serum Total Antioxidant Level in Preterm Labor

Conditions
-----------------
Preterm Labor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm labor(pregnant between 28th and 37th week). Singleton pregnancy. Amnion membranes were intact Exclusion Criteria: Past history of preterm labor or premature delivery. Urinary tract infections and any other infections. Poly- or oligohydramnios. Fetal distress, fetal or uterine anomaly. Membranes rupture and placenta pathology. Preeclampsia or intrauterine growth retardation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| preterm labor cases<br>Group A: 35 pregnant women diagnosed with preterm labor(Preterm labor pain at least 3 contraction every 20 minutes ,cervical dilatation < 2cm and effacement< 50%) which will deliver within one week maximum after hospitalization. | |
| control group<br>Group B: 35 pregnant women( controls )with uncomplicated pregnancies at a similar gestational ages followed routinely in the antenatal care unit. | |

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
-----------------
antioxidant preterm labor
Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated. STUDY OBJECTIVES Primary: Objective response rate Secondary: Progression free survival, Overall survival and Safety of Tarceva

Detailed Description
-----------------
Study Design: Phase II trial, open label, non-randomized and multicenter. Expected total enrollment: 46 Study start: January, 2006 Study completation: January, 2008

Official Title
-----------------
Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Tarceva (erlotinib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years. Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB). Measurable disease. Written informed consent must be obtained prior to the inclusion into the trial. Karnofsky performance status of 80%. Patients must have been treated with no prior chemotherapy or radioterapy. Patients must have adequate bone marrow, liver and renal function. Bone Marrow: WBC > 3000 x 103/mm3, Platelets > 100 x 103/mm3, Hgb > 10.0 gm/dl, ANC >1500 x 103/mm3, Hepatic:Bilirubin < 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase < 5 x normal, Renal:Creatinine < 1.5 mg/dl (132 µmol/l). Exclusion Criteria: Female patients who are pregnant or lactating. Patients who have used other investigational agents within 21 days prior to study entry. Patients who have received prior treatment with erlotinib or other anti-EGFR agent. Significant comorbidity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Tarceva (erlotinib)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  |  | 
| Overall survival |  |  | 
| Safety of Tarceva |  |  |
ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital

Study Overview
=================
Brief Summary
-----------------
Falls are one of the most common NHS adverse events. With an increasing number of frail elderly patients being admitted this risk is likely to increase. In order to be able to assist patients with bed exit in a timely manner monitoring might be of help. In ZeroFall we will test the reliability of monitoring devices to notify care givers if a patient is attempting to exit the bed.

Detailed Description
-----------------
In ZeroFall we intend to observe patients on risk of fall with two different devices during their hospital stay: The information from a no-touch optical sensing device that analyses movement and an under the mattress sensor that has already been used in a previous study at Bangor. Both are compatible with an existing monitoring system by Philips Healthcare and CE marked.

Official Title
-----------------
ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital

Conditions
-----------------
Delirium of Mixed Origin

Intervention / Treatment
-----------------
* Device: bed exit detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with risk of fall more than 24 hours on the ward Exclusion Criteria: Patients with predominantly palliative needs

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
Intervention Model: Sequential Assignment
Interventional Model Description: The study has several distinct phases: Silent Phase: The devices run in the background, activity is blinded for clinicians, settings are optimized by the research team. Run-In Phase: Bed exit notifications are turned on, notifications will be configurable for acceptability by clinical teams. Data extraction and data evaluation will be tested. Phase I: Data collection of bed exit data of sensors as well as data related to falls Phase II: Data collection of bed exit data with optimization of predictive algorithms Phase III: Data collection for validation using predictive data for early notification
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bed Exit Detection On<br>prevention of fall by a true bed exit detection | Device: bed exit detection<br>* bed exit detection to avoid patients fall<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of true bed exit detections vs number of false bed exit detections | A reference device and two observers will classify if a bed exit was true | 12-15 months |
EUS Guided Celiac Neurolysis

Study Overview
=================
Brief Summary
-----------------
Hypothesis: - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma. Rationale: Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.

Official Title
-----------------
Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain

Conditions
-----------------
Pancreatic Cancer Pain

Intervention / Treatment
-----------------
* Procedure: EUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease 2. Cytologic or histologic confirmation of pancreatic carcinoma 3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days 4. EUS clinically indicated (for non-study purposes) Exclusion Criteria: 1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000 2. Abdominal surgery within 1 month 3. Prior celiac plexus or ganglia neurolysis. 4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days. 5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS 1<br> | Procedure: EUS<br>* EUS Guided Therapy<br>|
| Active Comparator: EUS 2<br> | Procedure: EUS<br>* EUS Guided Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed using a numerical rating scale (NRS) from 0 to 10. | pain response will be measured | Baseline to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celiac Plexus, Pancreatic cancer, Pancreas cancer, Neurolysis, Pain
Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation

Study Overview
=================
Brief Summary
-----------------
The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.

Detailed Description
-----------------
Subjects will screen at St. Luke's Hospital in San Francisco to determine their eligibility. Once enrolled the study will take two weeks. During the first week subjects attend daily, hour-long outpatient visits at San Francisco General Hospital. At these visits subjects will receive an oral dose of l-methamphetamine, have their vitals read, answer questionnaires and receive a blood draw. During the second week of the study subjects are admitted to San Francisco General Hospital for a week long inpatient stay. During this stay the subject continues to receive l-methamphetamine but also receives three doses of d-methamphetamine on three separate days. In addition the subject receives blood draws, has their urine collected, and answers questionnaires.

Conditions
-----------------
Nasal Congestion

Intervention / Treatment
-----------------
* Drug: l-methamphetamine
* Drug: d-methamphetamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Males and Females Between the Ages of 18 and 50 Must have some experience with methamphetamine

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: l-methamphetamine<br> | Drug: l-methamphetamine<br>* 5mg of l-methamphetamine per day throughout the 2 week study<br>* Other names: l-MA;Drug: d-methamphetamine<br>* 15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13<br>* Other names: d-MA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum samples |  | Predose and Multiple Timepoints Post Doses | 
| Urine Samples |  | 24 Hour Inpatient Collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaries |  | Predose and Multiple Timepoints Post Doses | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methamphetamine, inpatient, d-MA, l-MA, APRL, San Francisco, metabolism, Metabolism of methamphetamine
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency

Study Overview
=================
Brief Summary
-----------------
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency

Official Title
-----------------
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: Vitamin D3 B.O.N. Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with vitamin D deficiency Exclusion Criteria: Subjects who experienced a hypersensitivity to the cholecalciferol Subjects with Hypercalcemia Subjects with Hypercalciuria Subjects with renal impairment Subjects with calcium stone Subjects diagnosed with sarcoidosis or pseudo-hypoparathyroidism Subjects who are to take vitamin D supplements during the study period

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 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: Vitamin D deficiency<br> | Drug: Vitamin D3 B.O.N. Injection<br>* cholecalciferol 200,000IU<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 25(OH)D concentration |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 1,25(OH)2D concentration |  | 12 months |
Factors Influencing Cancer Patients Participation in Clinical Trials in China.

Study Overview
=================
Brief Summary
-----------------
This research studies factors affecting Chinese patient participation in cancer clinical trials and their knowledge regarding clinical trials. The investigators design this study to determining how patients makes decisions about participating in a clinical trial and know about patients' attitude toward clinical trials. The investigators aim to find ways to make cancer clinical trials in China more efficient and satisfied patients participating in clinical trials in China.

Official Title
-----------------
Assessing Knowledge and Affecting Factors Associated With Cancer Patients Participation in Clinical Trials in China.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of malignancy Aged 18 years or older Ability to understand and complete the questionnaire independently or with the help of a relative or staff member of the oncology department Patients have been consented to join an oncology treatment clinical study and have begun active treatment of an oncology clinical trial Exclusion Criteria: • Not meeting all eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| The patient related factors and the doctor related factors that influence patient decision regarding participation in a cancer clinical trial will be explored by questionnaire. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncology patients' understanding and attitude of clinical trials towards cancer clinical research will be evaluated by questionnaire. |  | 1 year | 
| The actual experience of participants in a cancer clinical trial will be investigated by questionnaire. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient, questionnaire, clinical trial
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine SR
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 to 65 years A documented diagnosis of major depressive disorder Exclusion Criteria: Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine SR|nan|
|Drug: Escitalopram|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of quetiapine SR compared with placebo in the treatment of patients with major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder, MDD