linjc16/ctgov huggingface dataset:
Acupuncture for Fatigue in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.

Official Title
-----------------
Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease

Conditions
-----------------
Parkinsons Disease

Intervention / Treatment
-----------------
* Procedure: Acupuncture
* Other: Acupuncture to treat fatigue in Parkinson disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PD Patients 40-99 years of age Patients who have significant fatigue Patients must be on a stable medication regimen for the treatment of PD Exclusion Criteria: Patients who have had previous acupuncture within the past six months Patients who have had deep brain stimulation (DBS) Patients with dementia, depression, or sleep disorder Patients who are currently taking medications known to affect fatigue, such as stimulants

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Randomized Subjects receive a sham acupuncture.<br>Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. | Other: Acupuncture to treat fatigue in Parkinson disease<br>* Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.<br>|
| Active Comparator: Randomized Subjects receive real acupuncture.<br>Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. | Procedure: Acupuncture<br>* Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups | The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatigue, Parkinsons Disease
Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This study is placebo controlled, double blind, randomised, two arm dose escalation of a new product for specific immunotherapy in cat allergic patients

Official Title
-----------------
Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial

Conditions
-----------------
Allergy to Cat Dander

Intervention / Treatment
-----------------
* Drug: IVN201
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: History and subjective symptoms of cat dander allergy including cat specific allergic rhinitis Age 18 to 65 years Positive reaction to at least one concentration of cat dander allergen in skin prick test, intradermal provocation test and nasal provocation test Exclusion criteria: Chronic infectious disease Acute infections Episode of non-allergic rhinitis within the last 4 weeks Use of allergen known to predict anaphylactic reactions Treatment with any other investigational drug within 3 months before trial entry Vaccination within the last week Nasal surgery within the last 8 weeks Progressive fatal disease Drug or alcohol abuse within the last 5 years Cat ownership A history of significant cardiac insufficiency (NYHA stage III-IV) Coexisting severe disease, e.g. cardiovascular diseases Acute or history of obstructive respiratory insufficiency ( FEV1 <70%) Hepatic insufficiency Relevant anaemia (as judged by investigator) Blood donation within the last 30 days or intended blood donation (during the study or 30 days after participation) Pregnancy or breast feeding Sexually active woman of childbearing potential not actively practicing birth control by using a medically accepted device or therapy Lack of compliance or other sililar reason, that the investigator believes, precludes satisfactory participation in the study Systemic glucocorticoid therapy Allergic asthma and chronic medication with steroids at doses exceeding 200ug/day Treatment with ATII antagonists, B-blocker, ACE inhibitors

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Study drug | Drug: IVN201<br>* Intralymphativ injection of the study drug<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saftety tolerability and efficacy |  | 2009 |
Alfentanil: Simultaneous Testing Pilot

Study Overview
=================
Brief Summary
-----------------
To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.

Official Title
-----------------
Novel Noninvasive Assessment of Cytochrome P4450 Activity: Simultaneous Testing Pilot

Conditions
-----------------
Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A

Intervention / Treatment
-----------------
* Drug: Alfentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant female, 18-40 yr. old Good general health with no remarkable medical conditions such as liver, kidney, heart, or lung failure BMI between 20-33 Provide informed consent Exclusion Criteria: Known history of liver or kidney disease Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affect CYP3A (including oral birth control medications) Females who are pregnant or nursing Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction) Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential). History of bradycardia Respiratory rate <10 History of significant pulmonary disease History of pre-existing medical condition predisposing to respiratory depression Systolic blood pressure <100 mgHg and diastolic blood pressure <70mmHg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Experimental: Alfentanil<br>Alfentanil (0.5-1 mg IV bolus) followed 3 hours later or simultaneously by 1-4 mg oral deuterium-labeled (d3) alfentanil on each study visit. | Drug: Alfentanil<br>* No drug treatment before alfentanil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity | AUC(0-inf) | 9 hours |
Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to develop risk prediction models for the early detection of high-risk patients with structural, rhythmological or inflammatory cardiovascular diseases.

Official Title
-----------------
Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease (riskINN )

Conditions
-----------------
Healthy, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Decision-eligible male and female patients ≥18 years of age Acute or chronic condition due to structural, rhythmologic, or inflammatory cardiovascular disease Informed consent for participation in the clinical trial Exclusion Criteria: missing infromed consent pregnant or breast-feeding women

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 |
| --- | --- |
| Patients with cardiovascular diseases<br>Recording clinical data - especially risk parameters - from patients suffering from cardiovascular diseases | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure |  | from inclusion to end of study (max. 4 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total mortality |  | from inclusion to end of study (max. 4 years) | 
| cardiovascular mortality |  | from inclusion to end of study (max. 4 years) | 
| stroke |  | from inclusion to end of study (max. 4 years) | 
| myocardial infarction |  | from inclusion to end of study (max. 4 years) | 
| hospitalization due to decompensated heart failure |  | from inclusion to end of study (max. 4 years) | 
| hospitalization due to cardiovascular condition |  | from inclusion to end of study (max. 4 years) | 
| admission to intensive care unit |  | from inclusion to end of study (max. 4 years) | 
| severe arrythmic events |  | from inclusion to end of study (max. 4 years) |
Intracranial Arterial Stenosis and Resin of Cannabis Use

Study Overview
=================
Brief Summary
-----------------
There is an association between intracranial arterial stenosis and ischemic stroke in young adults. The aim of this study is to evaluate the prevalence of intracranial arterial stenosis in asymptomatic regular resin of cannabis users in comparison with control subjects.

Official Title
-----------------
Prevalence of Intracranial Arterial Stenosis in Regular Resin of Cannabis Users Compared to Control Subjects: a Preliminary Study of Feasibility

Conditions
-----------------
Cannabis Users

Intervention / Treatment
-----------------
* Other: Cerebral MRI and MRA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: regular resin of cannabis users Exclusion Criteria: taking vasoactive medications taking other illicit drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabis users<br>Cerebral MRI and MRA | Other: Cerebral MRI and MRA<br> <br> |
| Active Comparator: healthy volunteers<br>Cerebral MRI and MRA | Other: Cerebral MRI and MRA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of intracranial arterial stenosis on cerebral MRA | Rate on cerebral MRA the presence of cerebral Intracranial Arterial Stenosis segmental narrowing defined by at least two intra-cranial arteries compared with a cohort of non cannabis controls subjects. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Silent ischemic stroke on cerebral MRI | Evaluate on cerebral MRI the presence of sequelae of ischemic stroke defined by a parenchymal hyperintensity in a vascular territory defined on a T2 sequence. | 3 months | 
| -new intracranial arterial stenosis at 3 month follow-up | Evaluate a cerebral MRA at 3 months the presence of new intracranial stenosis among cannabis users, according to the prosecution or stopping use | 3 months | 
| -Reversibility of intracranial arterial stenosis at 3 month follow-up | Evaluate on cerebral MRA at 3 months reversibility stenosis present at T0 in cannabis users having stopped their consumption | 3 months |
Adjuvant Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy

Official Title
-----------------
A Prospective Multicenter Phase II Study of MabThera (Rituximab) Plus 2 Weekly CHOP Followed by Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma

Conditions
-----------------
Non Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Radiation: Low dose total body irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previously untreated, pathology verified aggressive non-Hodgkin lymphoma of the diffuse large B-cell type according to the WHO classification. Age between 60 years and 80 years.Positive for an anti-CD20 antibody. Good performance status and normal initial normal blood count. Exclusion Criteria: Patients with previous lymphoma associated with immune suppression of any sort. Diagnosis or history of indolent lymphoma or other malignancies. Marked impairment of any vital organ such as the heart, lung, liver or kidneys.

Ages Eligible for Study
-----------------
Minimum Age: 60 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

| Intervention/Treatment |
| --- |
|Radiation: Low dose total body irradiation|Low dose total body irradiation is given 3 weeks after the end of chemo-immunetherapy in the form of 4 daily fractions 0.2 Gy per fraction to be repeated after 2 weeks of rest|

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
-----------------
Diffuse large B-cell lymphoma, Elderly patients, Low dose total body irradiation, RCHOP14
Retrospective Follow-up of BIOLUX P-I/-II

Study Overview
=================
Brief Summary
-----------------
The aim is to collect long-term clinical data from 132 patients from Belgium, Germany and Austria who had previously participated in either of the BIOLUX P-I or P-II studies. Patients in these studies were treated with either a percutaneous transluminal angioplasty (PTA) balloon catheter or a drug-coated Passe-18-Lux balloon (DCB). The purpose of Retro-BIOLUX P-I-II is to collect clinical data from patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB to analyze the long-term effects.

Official Title
-----------------
Retrospective 5-year Safety Analysis of the BIOLUX P-I and P-II Studies in Subjects Requiring Revascularization of Infrainguinal Arteries

Conditions
-----------------
Overall Mortality

Intervention / Treatment
-----------------
* Device: Passeo-18
* Device: Passeo-18 Lux


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject was previously enrolled in either BIOLUX P-I or BIOLUX P-II Subject was treated either with Passeo-18 PTA or Passeo-18 LUX Written informed consent by subject or subject's legal representative or impartial witness/waiver Exclusion Criteria: Subject did neither participate in BIOLUX P-I nor BIOLUX P-II Subject was neither treated with Passeo-18 Lux nor with Passeo-18 PTA Subject is not willing to sign an informed consent /data release form

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- |
| Passeo 18 PTA<br>Previous treatment with uncoated Passeo 18 PTA balloon catheter | Device: Passeo-18<br>* POBA<br>|
| Passeo-18 Lux DCB<br>Previous teatment with Passeo-18 Lux DCB | Device: Passeo-18 Lux<br>* DCB<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival at five years after index procedure, defined as death from any cause | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, defined as the time in days after index procedure to date of death from any cause. |  | 60 months | 
| Major amputations of target extremities |  | 60 months | 
| Clinically-driven target lesion revascularization |  | 60 months | 
| Cause of death (descriptive analysis) at five years after treatment within BIOLUX P-I/-II. |  | 60 months |
Effect of Prevnar 13 on Ear Infections in Children

Study Overview
=================
Brief Summary
-----------------
Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar. It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar. Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.

Detailed Description
-----------------
Infants who have completed the Prevnar 13 infant vaccination series who provide consent and fit the study inclusion criteria to participate in the study will be recruited.

Official Title
-----------------
a Phase 4, Postmarketing Study Evaluating The Impact Of Prevnar 13 (Trademark)(13-valent Pneumococcal Conjugate Vaccine; 13vpnc) In Reducing Acute Otitis Media And Nasopharyngeal Colonization Caused By Streptococcus Pneumoniae In Healthy Children

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Procedure: Tympanocentesis
* Procedure: Nose/throat swab
* Biological: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has received full (3-dose) infant series of Prevnar 13 Exclusion Criteria: Prior vaccination with any 7vPnC. Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS). Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 30 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Procedure: Tympanocentesis<br>* To be performed as needed on children presenting with acute otitis media<br>Procedure: Nose/throat swab<br>* To be performed at every study visit<br>Biological: Observational<br>* Observational Study Only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM) | MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. | Baseline up to Month 36 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute otitis media, Prevnar 13, Streptococcus pneumoniae, nasopharyngeal colonization.