linjc16/ctgov huggingface dataset:
Does the Menstrual Phase Affect Gastric Emptying? Prospective, Observational Study

Study Overview
=================
Brief Summary
-----------------
This prospective observational study aimed to evaluate the relationship between menstrual phase cycles and gastric emptying in female volunteers of reproductive age.

Detailed Description
-----------------
Volunteers included in the study will be evaluated for gastric emptying with USG in both phases of the menstrual phase. In each phase, volunteers will be evaluated for gastric emptying of both liquid food intake and a light meal. At first, 400 ml of water will be drunk after 10 hours of fasting, and gastric content will be evaluated with USG after 2 hours. Secondly, after 10 hours of fasting, solid food intake will be evaluated. Then, after taking a light meal (toast and 200 ml tea), the volunteers will be evaluated by USG at the 6th hour.

Official Title
-----------------
Does the Menstrual Phase Affect Gastric Emptying? Prospective, Observational Study

Conditions
-----------------
Gastric Contents

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female volunteers of reproductive age have had a regular menstrual cycle for at least six months Exclusion Criteria: Pregnancy Stomach problem Using anticholinergics, opioids, and oral contraceptive drugs Hypothyroidism Diabetes mellitus Smokers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| The difference in gastric volume between the two menstrual phases | gastric emptying with USG will be evaluated in both phases of the menstrual phase | 1 month |
Safety Study of RPE65 Gene Therapy to Treat Leber Congenital Amaurosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether gene therapy is safe and effective for the treatment of severe childhood blindness caused by mutations in RPE65.

Detailed Description
-----------------
The main objective of the proposed trial is to determine the safety and efficacy subretinal administration of a recombinant adeno-associated viral vector (rAAV 2/2.hRPE65p.hRPE65) at three different dosage levels in individuals with autosomal recessive severe early-onset retinal degeneration due to mutations in RPE65. We have a comprehensive clinical monitoring plan to investigate the safety and efficacy of vector delivery.

Official Title
-----------------
An Open-label Dose Escalation Study of an Adeno-associated Virus Vector (AAV2/2-hRPE65p-hRPE65) for Gene Therapy of Severe Early-onset Retinal Degeneration

Conditions
-----------------
Retinal Degeneration

Intervention / Treatment
-----------------
* Biological: tgAAG76 (rAAV 2/2.hRPE65p.hRPE65)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of severe early-onset retinal dystrophy confirmed missense mutation(s) in RPE65 Exclusion Criteria: Visual acuity in the study eye better than 6/36 Snellen Hypertension Diabetes mellitus Tuberculosis Renal impairment Immunocompromise Osteoporosis Gastric ulceration Severe affective disorder) Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 30 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: A<br>Injection of vector | Biological: tgAAG76 (rAAV 2/2.hRPE65p.hRPE65)<br>* Single subretinal injection of vector suspension; up to 3x10e12 vector particles<br>* Other names: rAAV 2/2.hRPE65p.hRPE65;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular inflammation |  | at intervals up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual function |  | intervals up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal dystrophy, Leber congenital amaurosis, RPE65, gene therapy
Hepatitis C-Video vs. Brochure Education Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the most effective way to give patients information regarding hepatitis C virus infection. The investigators plan to compare the information retained by some patients who are given a brochure alone versus patients who watch an interactive video about hepatitis C.

Detailed Description
-----------------
Subjects will complete 3 questionnaires, including one about knowledge of Hepatitis C. The subject will then either watch a video or read a brochure about Hepatitis C, then take the same questionnaire again. The subject will then return in one month to take the Hepatitis C questionnaire again.

Official Title
-----------------
A Prospective Study Showing the Effect of Video Interactive Education on Medical Decision Making in Patients on Opiate Replacement Therapy (ORT) With a History of Hepatitis C

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Other: Hepatitis C Educational Brochure
* Other: Hepatitis C Educational Video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently on active treatment for opioid addiction/use English as primary language Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brochure intervention<br>Subjects will be asked to read an educational brochure about Hepatitis C | Other: Hepatitis C Educational Brochure<br>* Subjects will receive information about Hepatitis C through a brochure<br>|
| Experimental: Video intervention<br>Subjects will be asked to watch an educational video about Hepatitis C | Other: Hepatitis C Educational Video<br>* Subjects will receive information about Hepatitis C through a video<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved score on HCV Knowledge Questionnaire | subjects will be tested on their knowledge of Hepatitis C before and after educational intervention using a 25 question questionnaire | 4-6 weeks |
A SU011248 Expanded Access Protocol for Systemic Therapy of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

Study Overview
=================
Brief Summary
-----------------
A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248

Official Title
-----------------
A SU011248 Expanded Access Protocol for Metastatic RCC Patients Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

Conditions
-----------------
Metastatic Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: SU011248


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SU011248|SU011248 Expanded Access Protocol for Systemic Therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 2001-2012 |
Clinical Outcomes of Single Stage Versus Two-stage Treatment of Severe Obesity

Study Overview
=================
Brief Summary
-----------------
Laparoscopic Roux-en-Y gastric bypass (LRYGB) in super obese patients (BMI≥50kg/m2) is a challenging operation. Weight reduction with intragastric balloon (IGB) prior to LRYGB may improve operative outcomes and improves weight loss. We assessed 155 patients, with a BMI≥50 kg/m2 who underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group) in our institution. Two stage procedure was adopted for high-risk individuals.

Official Title
-----------------
Clinical Outcomes of Single Stage Versus Two-stage Laparoscopic Roux-en-y Gastric Bypass in the Management of Super Obesity: a Propensity Score Weighted Analysis'

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: Gatsric balloon insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients, with a BMI≥50 kg/m2, underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group) Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single stage pathway<br> | Procedure: Gatsric balloon insertion<br>* Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery<br>|
| Two stage pathway<br> | Procedure: Gatsric balloon insertion<br>* Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of total weight loss measured in kilograms following Bariatric Surgery | Percentage total weight loss is the proportion of weight lost in kilograms since the intervention of the weight before the intervention. This will be calculated by using the following formula. Initial weight is considered the weight on the day of surgery and Postop weight considered as the weight 24 months following Bariatric Surgery (intervention). Percent of total weight loss (%TWL)=((Initial Weight)-(Postop Weight)): Initial Weight x 100 Weight is expressed in kilograms. | 24 months after Bariatric Surgery | 
| Length of hospital stay in days following Bariatric Surgery | Hospital stay following laparoscopic gastric bypass surgery measured in days and compared between the groups. | 90 days following gastric bypass surgery |
Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.

Conditions
-----------------
Alzheimer's Desease

Intervention / Treatment
-----------------
* Drug: Donepezil Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients diagnosed with Alzheimer's Disease who are to be administered both donepezil hydrochloride and memantine hydrochloride in clinical practice. Exclusion criteria: Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| E2020<br> | Drug: Donepezil Hydrochloride<br>* Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.<br>* Other names: Aricept;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigations on adverse events and adverse drug reactions |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of dementia based on the Functional Assessment Staging Test (FAST) | FAST is a seven stage system based on level of functioning and daily activities. It focuses more on an individual's level of functioning and activities of daily living versus cognitive decline | Baseline, Month 3, Month 6, and Month 12 | 
| Change From Baseline in the Mini-Mental State Examination (MMSE) Score | The MMSE is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening. | Baseline and Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
donepezil hydrochloride, Alzheimer's Disease
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.

Official Title
-----------------
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study

Conditions
-----------------
Fibrocystic Disease of Breast, Breast Cancer

Intervention / Treatment
-----------------
* Device: Digital Breast Tomosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Any race or ethnicity At least 35 years old Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center Exclusion Criteria: Unable or unwilling to undergo informed consent Subjects who have breast implants Subjects who are unable or unwilling to tolerate compression Subjects who are pregnant or who think they may be pregnant Subjects who are currently lactating Men Women less than 35 years old Women greater than 80 years old Subjects whose breasts are larger than the tomosynthesis detector

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: observational<br>Observational | Device: Digital Breast Tomosynthesis<br>* Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup. |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Mammography, Benign masses, Breast Lump, Breast Biopsy, Breast Mass
Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using Levemir® under normal clinical practice conditions.

Official Title
-----------------
Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Type 2 diabetes Candidates of use of a basal insulin as part of their diabetes regimen Exclusion Criteria: Unwilling to adhere to therapy or follow up Pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 and type 2 diabetes patients<br> | Drug: insulin detemir<br>* Safety and effectiveness data collection in connection with the use of drug Levemir in daily clinical practice.<br>* Other names: NN304;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | during treatment |
Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The visual prognosis of optic neuritis not related to multiple sclerosis is unknown, both in terms of functional recovery and evolution. This prospective cohort study aim to assess the ophthalmological evolution of patients presenting an episode of optic neuritis (NO) not related to a multiple sclerosis or to a clinically isolated syndrome.

Official Title
-----------------
Evaluation and Follow-up of Optic Neuritis Not Related to Multiple Sclerosis

Conditions
-----------------
Optic Neuritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First onset of an optic neuritis lasting for less than 1 month With a brain MRI that does not meet the MS criteria Exclusion Criteria: Contra-indication to MRI Pregnant or lactating woman History of known ipsilateral optic neuritis Ophthalmologic comorbidity in the ipsilateral eye that may interfere with the interpretation of the examinations

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

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 |
| --- | --- | --- |
| Visual acuity (ETDRS scale) | Evolution over 1 year of the ophthalmological parameters of patients treated for an episode of optic neuritis not related to multiple sclerosis or a clinically isolated syndrome | 1 year | 
| Thickness of the layers of the retina with Optical Coherent Tomography(OCT), |  | 1 year | 
| Standard Humphrey Visual Field Test |  | 1 year |
Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.

Study Overview
=================
Brief Summary
-----------------
This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.

Official Title
-----------------
A Six Week Double-Blind, Randomized, Multicenter Comparison Study of the Analgesic Effectiveness of Celecoxib 200 mg BID Compared to Tramadol Hydrochloride 50 mg QID in Subjects With Chronic Low Back Pain

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Drug: Tramadol Hydrochloride 50mg
* Drug: Celebrex 200mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used. Exclusion Criteria: The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tramadol Hydrochloride 50mg|nan|
|Drug: Celebrex 200mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effects of treatment with celecoxib 200 mg BID and tramadol hydrochloride 50 mg QID on improvement in functionality and quality of life in subjects with chronic low back pain. |  |  |