linjc16/ctgov huggingface dataset:
The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI) treatment in patients with functional dyspepsia.

Official Title
-----------------
The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.

Conditions
-----------------
Nonulcer Dyspepsia

Intervention / Treatment
-----------------
* Drug: Pantoprazol
* Drug: Folic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-45 years with symptoms of dyspepsia, no evidence of organic disease. Exclusion Criteria: Patients with alarm symptoms, Severe concomitant illness, Pregnancy or lactation, Alcohol or drug abuse, Use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, H2 receptor blockers, bismuth, or proton pump inhibitors in the preceding two weeks

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pantoprazole<br> | Drug: Pantoprazol<br>* 40mg/day, oral, 28 days<br>|
| Placebo Comparator: folic acid<br> | Drug: Folic Acid<br>* 5 mg/day, oral, 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale. |  | one year |
Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled

Study Overview
=================
Brief Summary
-----------------
To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.

Detailed Description
-----------------
Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: KI1106 4g, QD
* Drug: Atorvastatin Calcium 20mg, QD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Screening Visit Age: 20-80 High risk for cardiovascular disease according to NCEP APT III TG≥300mg/dL and 160mg/dL>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks 500mg/dL>TG≥200mg/dL and LDL-C<110mg/dL for subjects who were taking statins for 4 weeks Baseline Visit 500mg/dL>TG≥200mg/dL LDL-C<110mg/dL Reduction of LDL-C comparing screening visit Exclusion criteria: The patient has histories of acute artery disease within 3 months The patient has histories of operation revasculariation or aneurysm within 6 months The patient has histories of unexplained myalgia or diagnosed myalgia or rhabdomyolysis The patient has histories of effect able disease to the procedure and clinical trial result

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Investigational Group- KI1106<br>KI1106 tablet - daily administration | Drug: KI1106 4g, QD<br>* KI1106 4 Capsules<br>|
| Active Comparator: Control Group - Atorvastatin<br>Atorvastatin Calcium 20mg - daily administration | Drug: Atorvastatin Calcium 20mg, QD<br>* Atorvastatin Calcium 20mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation rate of Non HDL-C |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation rate of TG |  | 4 weeks, 8 weeks | 
| Variation rate of Non HDL-C |  | 4 weeks | 
| Variation rate of TC |  | 4 weeks, 8 weeks | 
| Variation rate of LDL-C |  | 4 weeks, 8 weeks | 
| Variation rate of VLDL-C |  | 4 weeks, 8 weeks | 
| Variation rate of Apo A-I |  | 4 weeks, 8 weeks | 
| Variation rate of Apo B |  | 4 weeks, 8 weeks |
Breast Cancer Recurrence Risk Counseling

Study Overview
=================
Brief Summary
-----------------
The number of breast cancer survivors is growing. Women with a personal history of breast cancer worry about their risk of getting cancer again. The current study will develop counseling about breast cancer recurrence risk and will also get an estimate of the preliminary impact of this counseling. The goal is to enable women to make better decisions about their treatment.

Official Title
-----------------
BRIM3: Breast Cancer Recurrence Risk Informational Materials Project

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Behavioral: BRIM3 educational intervention
* Behavioral: Wait List


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who (1) have a personal history of a single stage 0-2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic. Exclusion Criteria: Women who are unable to read/write in English.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRIM3 Educational intervention<br>Individuals will receive a booklet and counseling about risk. | Behavioral: BRIM3 educational intervention<br>* Breast Cancer risk education and counseling<br>|
| Other: Wait list Control<br>At the completion of the study, individuals in the wait list condition will receive a booklet. | Behavioral: Wait List<br>* Booklet at the end of study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative Perceived Risk of Breast Cancer | Comparative perceived risk will be assessed with a comparative risk item (i.e., compared those of the same gender and race; Lipkus, CEBP 2000). | 6 months | 
| Absolute Perceived Risk of Breast Cancer | Absolute perceived risk will be assessed with an absolute risk item to assess risk as a percentage (Kelly, PONC, 2005). | 6 months |
Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up

Study Overview
=================
Brief Summary
-----------------
This study is conducted within the frame of the Post-Market Surveillance (PMS) activities, as described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®. This study aims at collecting clinical data, to confirm the General Safety and Performance Requirements of Vectorio® which is a Lipiodol Resistant Mixing & Injection System for cTACE.

Official Title
-----------------
Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up

Conditions
-----------------
Oncology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male adult patient older than 18 years Patient with confirmed diagnosis of HCC and eligible for cTACE procedure Patient affiliated to national health insurance according to local regulatory requirements Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent form Exclusion Criteria: Patient with contraindications to cTACE procedure Patient with known contra-indication(s) to the use or with known sensitivity to Lipiodol or chemotherapeutic agent Pregnant or breast-feeding female patient. Patient unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study

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 |
| --- | --- |
| Vectorio® kit<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of leakage/breakage |  | During cTACE procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time necessary to obtain a water in oil emulsion defined as time between the filling of 20 mL-syringe with Lipiodol (T0) and the obtention of water in oil emulsion ready for injection (Te). | Collection of the time needed to obtain water in oil emulsion (Lipiodol/chemotherapeutic agent) | During cTACE procedure | 
| Ease of emulsion preparation through a rating scale | Rating scale: 0: Difficult - 1: Easy - 2: Very Easy (if rating is difficult, reason should be specified) | During cTACE procedure | 
| Need to perform remixing during cTACE procedure | Need to perform remixing : Yes/No - If Yes, how many times: Once, twice, three times, more | During cTACE procedure | 
| Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT | Lipiodol tumor uptake: 0-25%; 25-50%; 50-75%; 75-100% | During cTACE procedure | 
| Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs) |  | Study period |
Dry Needling in Subjects With Delayed Onset Muscle Soreness

Study Overview
=================
Brief Summary
-----------------
Investigation of the biomechanical response in delayed onset muscle soreness using dry needling vs. sham

Official Title
-----------------
Biomechanical Response to Dry Needling in Subjects With Delayed Onset Muscle Soreness: a Double Blind Randomized Control Trial

Conditions
-----------------
Delayed Onset Muscle Soreness

Intervention / Treatment
-----------------
* Other: Dry needling
* Other: Sham needling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participants of the study will be any healthy male or female between age of 18 to 35 able and willing to perform an exercise protocol using the gastrocnemius muscle willing to receive either sham or dry needling intervention Exclusion Criteria: current muscular pain prior trigger point therapy in the past 6 months medications that affect muscle function injury in the past 6 months any health condition that prevents exercising recent surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry needling<br>Dry needling intervention to the gastrocnemius muscle trigger point | Other: Dry needling<br>* The use of a solid filiform needle to treat trigger points<br>|
| Sham Comparator: Sham needling<br>Sham dry needling intervention to the gastrocnemius muscle trigger point | Other: Sham needling<br>* Simulated needling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Biomechanical stiffness (N/m) using MyotonPRO | Measuring Biomechanical stiffness ( N/m) change at the following time frames | baseline, immediately after intervention, 24 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pressure pain threshold using pressure algometry | Measuring Pressure pain threshold change at the following time frames | baseline, immediately after intervention, 24 hours after intervention |
Scintigraphic Comparison of Lung Deposition With Two Nebulizers During Invasive Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
Many devices are available for nebulising drug solution during invasive mechanical ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013) reported that jet nebulizers remained the mostly used. The aim of this study is to compare lung deposition of a radiolabeled administered with both nebulizers during invasive mechanical ventilation by planar scintigraphy.

Conditions
-----------------
Post-operative Neurosurgery

Intervention / Treatment
-----------------
* Drug: technetium-99m - Diethylenetriaminepentaacetic acid
* Device: Vibrating-mesh nebulizer
* Device: Jet Nebulizer
* Other: Planar scintigraphy
* Other: Preoperative spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive mechanical ventilation Healthy lungs Exclusion Criteria: Discontinued procedure due to adverse events.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nebulization with a vibrating-mesh nebulizer<br>Nebulization performed with a vibrating-mesh nebulizer | Drug: technetium-99m - Diethylenetriaminepentaacetic acid<br> <br> Device: Vibrating-mesh nebulizer<br> <br> Other: Planar scintigraphy<br> <br> Other: Preoperative spirometry<br> <br> |
| Active Comparator: Nebulization with a jet nebulizer<br>Nebulization performed with a jet nebulizer | Drug: technetium-99m - Diethylenetriaminepentaacetic acid<br> <br> Device: Jet Nebulizer<br> <br> Other: Planar scintigraphy<br> <br> Other: Preoperative spirometry<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary deposition |  | Immediately after nebulization by imaging assessment, an expected average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penetration index |  | Immediately after nebulization by imaging assessment, an expected average of 30 minutes | 
| Mechanical ventilation settings |  | During nebulisation time, an expected average of 15 minutes | 
| Lung function |  | Preoperative assessment, the day before inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aerosol delivery, Invasive mechanical ventilation, Jet Nebulizer, Vibrating-Mesh nebulizer
Use of the Pressure Right Device After Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective is to test the hypothesis that the use of the Pressure Right device in combination with ondansetron and dexamethasone would result in a lower incidence of postoperative vomiting (emesis) than the combination of antiemetic therapy alone.

Detailed Description
-----------------
The study design is a randomized, double-blinded and sham-controlled evaluation of the adjunctive Acupressure on the P6 point with Pressure Right to reduce the incidence of PONV and the need for rescue antiemetics leading to an improve quality of recovery after laparoscopic and ENT surgery. The two proposed study groups are: Group 1 (Sham-Control) 50 patients, will receive the sham Pressure Right (without acupressure button)30-45 min before induction of anesthesia and will be kept in place for 24h after discharge, and Group 2 (Pressure Right) 50 patients, will receive the Pressure Right device 30-45 min before induction of anesthesia and will be kept in place for 24h after discharge. In addition, all 100 study patients will receive a combination of antiemetics (ondansetron and dexamethasone) during the surgery.

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Device: Acupressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo major laparoscopic and ENT surgery procedures under genertal anesthesia. ASA Class I-III adults of either sex Willingness and ability to sign an informed consent document. Exclusion Criteria: Patients with known allergy, hypersensitivity or contraindications to 5-HT3 antagonist. Patients experienced vomiting or retching within 24 h before surgery. Patients with clinically-significant medical conditions. Pregnant and lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Acupressure|P 6 Pressure Point|

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
-----------------
Postoperative Nausea & Vomiting.
A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: QAX576
* Drug: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one draining enterocutaneous perianal fistula Diagnosis of Crohn's disease (CD) must have been established for at least 6 months At least one ineffective fistula treatment (but no previously failed anti-TNFα (tumour necrosis factor) antibody treatment) Patients should not suffer from any other health problems that may jeopardize their participation in the study. Exclusion Criteria: Current or recent (within 30 days of enrollment, or 5 half-lives of the compound, whichever is longer) use of anti-TNFα antibody treatment Active Crohn's disease Recent or pending abdominal or ano-rectal surgery, particularly presence of stricture, or abscess, or retention for which surgery might be indicated Previously failed anti-TNFα antibody treatment Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed) Other protocol-defined inclusion/exclusion criteria may apply

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QAX576<br> | Drug: QAX576<br> <br> |
| Other: Infliximab<br> | Drug: Infliximab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease, Fistula