linjc16/ctgov huggingface dataset:
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV; part2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether different types of breathing therapies in patients with COPD III-IV decrease dyspnea, increase activity and have impact on parasympathetic activities.

Official Title
-----------------
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea, Activity and Parasympathetic Activities in Patients With COPD III-IV

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: reflectory breathing therapy
* Procedure: conventional breathing therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inpatient rehabilitation COPD (Gold stage III and IV) Exclusion Criteria: severe exacerbation in the last four weeks acute infections fever neuritides severe osteoporosis skin disease manic depression

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional breathing therapy<br>first: conventional breathing therapy, second: reflectory breathing therapy | Procedure: conventional breathing therapy<br>* duration:4x30 minutes<br>|
| Experimental: Reflectory breathing therapy<br>first: Reflectory breathing therapy second:Conventional breathing therapy | Procedure: reflectory breathing therapy<br>* duration:2x60 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BORG-Scale | Instrument for self-reported dyspnea; modified BORG-scale ranges from 1 (no dyspnea) to 10 (maximum dyspnea) | Change from pre (minute 0) in Borg Scale and directly post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung volume | measured by a bodyplethysmograph | change from pre (minute0) in residual volume to post intervention | 
| physical activity | measured by Senswear | 48 h post intervention | 
| parasympathetic activities | measured via Biofeedback | baseline and post intervention | 
| Chronic Respiratory Questionnaire | health related quality of life | baseline and post intervention | 
| COPD Assessment Test | health related Quality of life | baseline and post intervention |
The Effects of Aggressive Patient Management on Cancer Therapy Management

Study Overview
=================
Brief Summary
-----------------
A study to see if coordinated aggressive patient management will improve patient treatment outcomes and is cost effective.

Detailed Description
-----------------
This is an observational study of the effects of aggressive patient management. The records of 50 patients treated under the aggressive management plan will be matched with the records of 50 previous patients and attempts made to assess the improvement, if any, found. Statistical analysis will compare the outcomes of the study group and the matched control group for initial completion of planned therapy as per prescription, weight loss during therapy, intercurrent illness, and intercurrent hospitalizations. Long term analysis will compare the study group's outcomes (compared to expected outcomes) compared to the matched control group.

Official Title
-----------------
The Effects of Aggressive Patient Management on Cancer Therapy Management

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

Intervention / Treatment
-----------------
* Behavioral: Patient management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: live 45 minutes from treatment facility family income less than 200% federal poverty guideline Exclusion Criteria: none

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

| Intervention/Treatment |
| --- |
|Behavioral: Patient management|Aggressive patient management will be implemented by a corps of patient manager volunteers backed by a transportation, nutrition, and social services network. The social services professionals will work with the volunteers to establish the support needed for each patient. The volunteer managers will in turn constantly monitor that such support is addressing the patient's ability to be treated. Access to sponsored housing will be coordinated. Nutritional support will be coordinated by the Dietary department and will consist of counseling, and supplements when necessary. Provision of supplemental feeding for housed patients will be arranged.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test effects of intensive patient management on patient's compliance with referral and subsequent treatment protocol. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test if increased compliance results in better therapy outcomes and fewer complications of the disease process as evidenced by increased survival and fewer intercurrent hospitalizations. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outcomes, Radiotherapy, Socio-economic, Cancer
ALPHA Sitagliptin Add on to Metformin (0431-103)

Study Overview
=================
Brief Summary
-----------------
Canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin

Official Title
-----------------
A 24 Week, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Adding Sitagliptin 100 mg Once Daily in Patients With T2DM Who Have Inadequate Glycemic Control on Metformin Therapy

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient Is Currently On Monotherapy With Metformin For At Least 10 Weeks Prior To Study Entry

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sitagliptin | Drug: sitagliptin phosphate<br>* Sitagliptin 100 mg/day - tablet for 24 weeks<br>* Other names: Januvia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at Week 24 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at Week 12 | HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent | Baseline and Week 12 |
The Efficacy of Fycompa (Perampanel) in Children With Epilepsy

Study Overview
=================
Brief Summary
-----------------
Fycompa (Perampanel), a new anti-epileptic drug that uses a new mechanism-AMPA receptor antagonist. Its initial indication is for local or generalized epilepsy in children and adults over 12 years old, but its effectiveness in the treatment of epilepsy in children At present, more evidence is still needed. We will study the effectiveness of Fycompa (Perampanel) in the treatment of epilepsy in children under the age of 18. It is expected that the clinical use of Fycompa (Parampanel) in Taiwan will be able to analyze and study the effectiveness of the clinical use of Fycompa (Parampanel) in the treatment of epilepsy in children, and compare it with foreign reports.

Official Title
-----------------
Director of Child Neurology, Department of Pediatrics, National Taiwan University Hospital

Conditions
-----------------
Neurologic Disorder

Intervention / Treatment
-----------------
* Drug: Perampanel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under 18 years of age suffering from epilepsy Patients who are taking Paraampanel Exclusion Criteria: Patients who are not in the above age groups and who are not using parampanel

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Perampanel|Efficacy of epilepsy drugs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of perampanel in young children with drug-resistant epilepsy | Because the current clinical research data on the use of Fycompa (perampanel) in children for the treatment of epilepsy is still insufficient, the purpose of this research is to review the efficacy of this drug in the treatment of children with epilepsy in our hospital in the past, so as to facilitate the future clinical treatment of children with epilepsy. Children have the possibility of therapeutic reference. | 17 years |
The Clinical Utility of Overtube Use at the Time of Endoscopy

Study Overview
=================
Brief Summary
-----------------
Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease® spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical, Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are to evaluate the efficiency of an overtube system for visualization of small bowel. The hypothesis is that this will permit more complete and efficient evaluation of the small intestine.

Official Title
-----------------
The Clinical Utility of Overtube Use at the Time of Endoscopy

Conditions
-----------------
Small Bowel Visualization

Intervention / Treatment
-----------------
* Device: overtube use during enteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects ≥ 18 years. Have an indication for enteroscopy as determined by the patient's physicians. These indications include, but are not limited to, obscure gastrointestinal bleeding, malabsorption, suspected small bowel tumor, small bowel strictures, small bowel ulceration, and abnormal imaging of the small bowel. Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida, as medically indicated. Subject must be able to give informed consent. Exclusion Criteria: Platelets < 75,000. INR > 1.6. NSAIDS within 48 hours of procedure. Pregnancy. Esophageal stricture. Inability to give informed consent.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: spiral overtube<br>Any subject that has been referred for spiral enteroscopy will be asked to participate in this study. The purpose is to gather data about the technical aspects of the procedure,diagnostic capability and treatment as well as long term follow up. | Device: overtube use during enteroscopy<br>* use of overtube for the regular scheduled enteroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Persistent or Recurrent Bleeding | The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy. | up to 6 yrs after after the endoscopy |
Thoracic Spine Manipulation for Patients With Thoracic Spine Pain

Study Overview
=================
Brief Summary
-----------------
The study includes two phases. In phase one the reliability of thoracic spine mobility measurements are studied in subjects with thoracic spine pain. In phase two the reliable measurements are used to measure the effects of thoracic spine manipulation in subjects with thoracic spine pain. The changes in pain is measured as well. In second phase the control group receives TNS treatment six times at home as a placebo so that the power of TNS is limited to very low level. The number of treatments are controlled as well as the time of treatment. The treatment group receives six manipulation treatments within 3 week period. The effects are measured immediately after the treatment weeks, and 3 and 8 week follow-up. Moreover the one year follow-up will be performed by mail questionnaire.

Detailed Description
-----------------
Outcome measures are intensity of pain (VAS, Roland-Morris questionnaire) thoracic mobility (measured with computer, tape measurements, inclinometer and manually).

Official Title
-----------------
The Effect of Manipulation for Thoracic Spine Pain and Mobility, and Reliability of Used Mobility Measurements.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Manipulation vs. TNS thoracic pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thoracic spine pain, 18-55 years old Exclusion Criteria: Inflammatory spine disease, previous surgery on thoracic spine area, osteoporosis

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manipulation<br>Subjects will receive 6 manipulation treatments within 3 weeks period. The manipulated segments are determined individually in baseline assessment. | Other: Manipulation vs. TNS thoracic pain<br> <br> |
| Sham Comparator: TNS for thoracic spine<br>6 TNS treatments at home for 20min in limited power of devices in three weeks period. | Other: Manipulation vs. TNS thoracic pain<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thoracic spine pain (Visual analogue scale) |  | up to 49 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thoracic spine mobility (computer controllod spine PA measurement, tape measurements, inclinometer) |  | Baseline, after treatment, 3, 8, and 49 week follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic spine, pain, manipulation
A New Micro Swim-up Procedure for Sperm Preparation in ICSI Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the microbiological safety and the efficacy of a new not expensive, easy and fast technique (Direct Microswimup) for sperm preparation in In Vitro Fertilization (IVF) treatments without the use of centrifuge, able to simplify the procedure and to avoid mismatches by ensuring the same results of the standard techniques in terms of fertilization rate, blastulation rate, pregnancy/abortion rate, cryostorage rate, and a better euploid status of the embryos.

Conditions
-----------------
Microswimup Procedure Efficacy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 8 oocytes retrieved at pickup oocyte insemination with ICSI technique only elective single embryo transfer (eSET) at blastocyst stage sperm concentration ≥ 1 X 106 /ml absence of antibiotic treatment in the previous four weeks for male patients Exclusion Criteria: recurrent miscarriages more than three in vitro fertilization treatment azoospermia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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 |
| --- | --- | --- |
| microbiological test | A standard bacteriological culture [based on inoculation of blood and chocolate agar plates and Brain-Heart Infusion broth, followed by incubation at 37°C for up to 72 hours] was performed in order to investigate the presence and amount of colonizing bacteria delivered with the semen at ejaculation and after treatment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| semen treatment efficacy | number of obtain blastocysts (%) and number of pregnancy (%) | 6 months |
Screening of Helicobacter Pylori in Children of Positive Infected Mothers

Study Overview
=================
Brief Summary
-----------------
Helicobacter pylori is aspiral shaped gram negative organism that colonized the gastric mucosa.it was showen that intra familial infection play role in transmission of H pylori and mother play the key role in transmission .

Detailed Description
-----------------
Prevelance of H pylori infection in children whose mother positive infected is different according to risks factors such as mother education,work out side or not , socioeconomic status, family size and breast feeding or not.H pylori in children can be represent with recurrent abdominal pain ,recurrent diarrhea,repeated vomitting ,pallor ,fulness,non variceal hematemesis,loss of appetite,reterded growth.complication of H pylori include gastric ulcer,duodenal ulcer,gastric atrophy may lead to gastric cancer and intestinal metaplasia.

Official Title
-----------------
Screening of Helicobacter Pylori Infection in Children of Positive Infected Mothers

Conditions
-----------------
H Pylori Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child with Dyspeptic symptoms Exclusion Criteria: malnutrition childs Patient with metabolic disorder

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 13 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 |
| --- | --- | --- |
| To assess prevelance of H pylori infection in children born of infected positive mother | By taken children whose mother infected ,how many of them infected by this microbe by taken these child and done the following investigastion as stool antigen test and biobsy if they are postive by test and then follow up by treatment | Period from April 2019 to April 2020 | 
| Asse the effect of Helicobacter pylori infection in children with anemia | By knowing effect of this microbe on growth development of children by measure weigt /height through body mass index and measure heamoglbin level By taken children whose positive H pylori follow effect of this microbe on heamoglbin level and do investigation as complete blood count By following test such as complete blood count and heamoglbin level and if this microbe increase level of anemia or not | Period from April 2019 to April 2020 |
Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the level of satisfaction among patients to whom Mirvaso® / Onreltea TM (trade mark) is prescribed.

Official Title
-----------------
Mirvaso® Utilisation and Patient Satisfaction Evaluation

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Other: Mirvaso® / Onreltea TM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients to whom the physician has already decided to prescribe Mirvaso® /OnrelteaTM according to package insert

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 |
| --- | --- |
| Mirvaso® / Onreltea TM<br> | Other: Mirvaso® / Onreltea TM<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question |  | Week 4 |
Ultrastructural Changes of Trabeculectomy Specimens in Patients With Uveitic Secondary Glaucoma

Study Overview
=================
Brief Summary
-----------------
Ultrastructural analysis of trabeculectomy specimens of patients with uveitic secondary glaucoma. To evaluate morphological changes and to compare to primary open angle glaucoma patients.

Conditions
-----------------
Uveitis, Secondary Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: secondary uveitic glaucoma IOP > 24 mmhg with topical and/or systemic therapy need for surgical intervention to control IOP
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphological changes |  | after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trabecular meshwork, electron microscopy