linjc16/ctgov huggingface dataset:
Methylphenidate Treatment of Cancer-Related Fatigue

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.

Official Title
-----------------
Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue

Conditions
-----------------
Cancer-related Fatigue

Intervention / Treatment
-----------------
* Drug: Methylphenidate hydrochloride
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of Cancer MFI >40 Karnofsky Index >=70 outpatient patient are able to give informed consent Exclusion Criteria: treatment with psychostimulants in the past two weeks before screening active tumor disease depression (HADS >10) cachexia (BMI <18kg/m2) clinically relevant kidney disorders clinically relevant liver disorder pathological ECG-finding high blood pressure occlusive arterial disease angina pectoris cardiac arrhythmias CHD post heart-attack status post stroke status known elevated intra-ocular pressure known enlarged prostates latent and manifest hyperthyreosis alcohol, medication or drug dependency in the past six months or manifest drug abuse participation in a clinical study within the past 30 days participation in this study at an earlier point in time simultaneous participation in another clinical trial women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse) pregnancy (positive pregnancy test) or lactation period

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Methylphenidate hydrochloride<br>* sustained release, dosage according to an individual titration schedule<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* dosage according to an individual titration schedule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (EORTC-QLQ C30) |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatigue, Cancer, Methylphenidate,
Defects in Opsonophagocytosis in Premature Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to characterize innate immune function of premature infants, and identify defects that may be responsible for the development of bacterial sepsis.

Detailed Description
-----------------
Sepsis is an important problem in preterm infants and carries a significant morbidity and mortality. It is estimated that 20% of premature infants surviving beyond the first three days of life will have one or more culture-proven bacteremic sepsis. There is increasing epidemiologic and biologic evidence suggesting that preterm newborns are more susceptible to infection than term newborns and adults. Immaturity of the immune system, and, in particular, defects in innate responses to pathogens are of foremost importance in the pathogenesis of neonatal sepsis. The aims of the study are the: Determination of the opsonic capacity of plasma from premature infants, vs. term newborns, and identification possible molecular innate immune defect(s) in preterm plasma. Characterization of the role of TLR2 and TLR4 responses in phagocytes from premature infants using classical TLRs agonists. Determination of the capacity of plasma from premature infants to sustain TLR pathways, with a particular attention paid to the possible role of soluble MD-2 in plasma from premature infants in TLR-dependent opsonophagocytosis. Determine prognostic factors for neonatal sepsis. The identification of a quantitative and/or qualitative defect in innate plasma protein(s) in premature newborns has the potential of identifying those infants who are likely to develop a neonatal sepsis.

Official Title
-----------------
Defects in Opsonophagocytosis in Premature Infants as a Factor for the Development of Neonatal Sepsis

Conditions
-----------------
Prematurity, Neonatal Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature or term delivery Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Premature infants of less than 28 weeks of gestational age | |
| 2<br>Premature infants of more than 28 weeks and less than 32 weeks of gestational age | |
| 3<br>Term newborns | |
| 4<br>Adults | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte phenotype, opsonophagocytic function, and whole blood response to pathogens |  | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte phenotype, opsonophagocytic function during neonatal sepsis |  | 1 week after recruitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prematurity, VLBW, sepsis, innate immunity
Impact of Intrathecal Morphine on Sleep Apnea Syndrome

Study Overview
=================
Brief Summary
-----------------
Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic episodes is unknown. The objective of this randomised controlled trial is to investigate the effect of intrathecal morphine and surgery on apneic episodes.

Official Title
-----------------
Impact of Intrathecal Morphine on Sleep Apnea Syndrome After Hip Arthroplasty Performed Under Spinal Anaesthesia

Conditions
-----------------
Sleep Apnea Syndromes

Intervention / Treatment
-----------------
* Drug: Bupivacaine with normal saline
* Drug: Bupivacaine with intrathecal morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physical status I - III patients scheduled to undergo hip arthroplasty Exclusion Criteria: planned surgical duration more than 3 hours contraindication to spinal anaesthesia severe respiratory disease patient known and treated for sleep apnea syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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 |
| --- | --- |
| Placebo Comparator: Bupivacaine with normal saline<br> | Drug: Bupivacaine with normal saline<br>* Isobaric bupivacaine 15 mg + normal saline 0.5 cc<br>|
| Active Comparator: Bupivacaine with intrathecal morphine<br> | Drug: Bupivacaine with intrathecal morphine<br>* Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea hypopnea index while lying supine |  | postoperative night 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea hypopnea index while lying in another position than supine |  | postoperative night 0 | 
| mean pulse oxymetry |  | postoperative night 0 | 
| STOP-BANG questionnaire |  | 24 h before surgery | 
| Berlin questionnaire |  | 24 h before surgery | 
| Epworth questionnaire |  | 24 h before surgery | 
| pain scores (numeric rating scale, 0-10) |  | postoperative day 0, 1, 2 and 3 | 
| oxycodone consumption (mg) |  | postoperative day 0, 1, 2 and 3 | 
| postoperative nausea and vomiting (yes/no) |  | postoperative day 0, 1, 2 and 3 | 
| Pruritus (yes/no) |  | postoperative day 0, 1, 2 and 3 |
Drug Use Investigation for ROTARIX®

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.

Detailed Description
-----------------
This is non-interventional study conducted in one group received Oral Rotarix®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for Rotarix).

Official Title
-----------------
Drug Use Investigation for ROTARIX

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Biological: Oral Rotarix®
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation. Exclusion Criteria: • All infants included in the special drug use investigation of Oral Rotarix will be excluded.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rota Group<br>Subjects will receive Rotarix® as per routine practice. | Biological: Oral Rotarix®<br>* 2 doses administered orally.<br>Other: Data collection<br>* Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse events under clinical practice. |  | During the 31-day observation period after each vaccination. | 
| Occurrence of typical symptoms of intussusceptions and bloody stool. |  | During the 31-day observation period after each vaccination. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotavirus, Rotarix, Drug Use Investigation, Safety
Efficacy and Safety of PEMbrolizumab PD-L1-positive (>50% of Tumor Cells), Advanced NSCL Cancer(PEMBREIZH)

Study Overview
=================
Brief Summary
-----------------
This study was a French multicentric cross-sectional study retrospectively of 108 consecutive advanced NSCLC patients with a PD-L1 TPS ≥50% and without EGFR/ALK aberrations treated by pembrolizumab in first line.

Official Title
-----------------
Efficacy (Systemic and Cerebral) and Safety of PEMbrolizumab PD-L1-positive (More Than 50% of Tumor Cells), Advanced Non-small-cell Lung Cancer : A Study of Real Life in Brittany .

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung, Immunotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically or cytologically confirmed NSCLC PD- L1 TPS ≥ 50% stage III and IV WHO performance status of 0, 1 or 2 adequate organ function Exclusion Criteria: previous EGFR or ALK aberrations positive test for hepatitis B or C virus indicating acute or chronic infection known history of testing positive for human immunodeficiency virus (HIV) severe, uncontrolled autoimmune disease.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival with pembrolizumab | time from initiation of pembrolizumab to the date of disease progression or death | time from initiation of pembrolizumab to the date of disease progression or death ( 20 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pembrolizumab, first line treatment, PDL1 TPS > 50%, brain efficacy
Validation of Receptor Occupancy Simulation

Study Overview
=================
Brief Summary
-----------------
To estimate dopamine receptor occupancy by aripiprazole using computer simulation To measure dopamine receptor occupancy by aripiprazole in patients treated with the antipsychotics To validate the simulation result by comparing the receptor occupancy from the simulation with that from the patients

Conditions
-----------------
Dopamine Receptor Occupancy, Medication Satisfaction, Prolactin Level, Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of schizophrenia treated with aripiprazole or risperidone no change in dose of antipsychotics for at least 6 weeks total PANSS score should be below 80 Exclusion Criteria: Other psychiatric disorders rather than schizophrenia history of head trauma positive in urine hCG on antidepressant, anticholinergics or mood stabilizer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 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 |
| --- | --- |
| aripiprazole<br>Patient group who is treated with aripiprazole | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dopamine receptor occupancy | Measured using 11C-raclopride positron emission tomography | 72 hrs after the last administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton rating scale for depression | HAM-D score | Baseline and 72 hours after the last administration | 
| Barnes akathisia scale | BAS score | Baseline and 72 hours after the last administration | 
| Abnormal involuntary movement scale | AIMS score | Baseline and 72 hours after the last administration | 
| Simpson-Angus scale | SAS score | Baseline and 72 hours after the last administration | 
| Treatment satisfaction questionnaire for medication | TSQM score | Baseline and 72 hours after the last administration | 
| Medication satisfaction questionnaire | MSQ score | Baseline and 72 hours after the last administration | 
| N-back task | To measure the change in working memory performance | Baseline and 72 hours after the last administration | 
| Prolactin level | To explore the effect of receptor occupancy on the blood prolactin level | Baseline and 72 hours after the last administration | 
| Dopamine receptor occupancy |  | 3 hrs after the last administration | 
| Dopamine receptor occupancy |  | 24 hrs after the last administration |
Study of Decision Making in Patients Participating in Phase I Clinical Trials

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to improve the way in which clinical trials are conducted. PURPOSE: This clinical trial is studying patients' personality traits, reasons for participating in the trial, and understanding of their medical situation, prognosis, and risks and benefits of participating in a phase I trial.

Detailed Description
-----------------
OBJECTIVES: Determine the range of personality traits of patients enrolled in a phase I clinical trial. Determine these patients' understanding of their medical situation and prognosis. Determine these patients' understanding of risks and benefits of phase I clinical trials. Determine these patients' reasons for participating in a phase I clinical trial. Determine the risk/benefit trade-offs of these patients. Determine the existential outlook of these patients. Determine the information gathering nature of these patients. OUTLINE: This is a multicenter study. Before beginning phase I clinical trial treatment, patients complete a survey over 30-45 minutes administered by an interviewer. Patients then self-administer the Temperament and Character Inventory assessment over 30 minutes. PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study within 6 months.

Official Title
-----------------
Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients

Conditions
-----------------
Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Procedure: psychosocial assessment and care


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Consented to enrollment in a phase I cancer clinical trial PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Understands written English PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No concurrent enrollment in other clinical trials evaluating phase I patient attitudes

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

Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: psychosocial assessment and care|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
-----------------
psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
Extracardiac Complications After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Hypothesis of the study is that patients undergoing major cardiac surgery can develop extracardiac complications correlated to cardiopulmonary by pass.

Detailed Description
-----------------
To find out which are the main peri operative predictors of acute lung injury and other extracardiac complications, such as kidney injury, that prolonged Intensive Care Unit (ICU) length of stay after cardiac surgery. The main goal is to evaluate whether mechanical ventilation, in particular tidal volume, can be predictor of acute lung injure in this kind of patients.

Official Title
-----------------
Extracardiac Complications After Cardiopulmonary by Pass in Cardiac Surgery

Conditions
-----------------
Acute Lung Injury, Sepsis, Infections, Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac intervention with cardiopulmonary by pass, age > 18 years old Exclusion Criteria: off-pump surgery, heart and lung transplantations, patients on mechanical ventilation before intervention or admitted to Intensive Care Unit (ICU) before intervention.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Acute Lung Injury (ALI)<br>patients who might develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Lung Injury After Cardiac Surgery | to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 <300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease. | at seven days after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit (ICU) Length of Stay | If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation. | at 28 days |