linjc16/ctgov huggingface dataset:
Psychiatric Disorders With Prolonged Infertility

Study Overview
=================
Brief Summary
-----------------
Psychiatric disorders in women with prolonged infertility with or without IVF/ICSI failure will be included then a questionnaire will be applied plus psychiatric examinatins

Detailed Description
-----------------
All patients will be recruited from both psychiatry and obstetrics and gynecology departments. Referred cases from gynecologists and Assisted reproductive technologies centers were also included. Inclusion criteria: Infertile couples Infertility >= 5 years invitro fertilization /intracytoplasmic spem injection failure for group 1 and not included for group 2

Official Title
-----------------
Psychiatric Disorders Among Egyptian Women With Prolonged Infertility With or Without Invitro Fertilization /Intracytoplasmic Spem Injection Failure

Conditions
-----------------
Psychiatric Disorder, Invitro Fertilization /Intracytoplasmic Spem Injection Failure

Intervention / Treatment
-----------------
* Behavioral: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile women prolonged infertility ≥ 5 years Failed invitro fertilization /intracytoplasmic spem injection for group 1 not bearing any children accepting to share in the study. Exclusion Criteria: patients with diagnosed psychiatric or neurologic disorders patients with diabetes mellitus or any anatomical defects in genital tract patients who didn't complete their questionnaires.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVF/ICSI failure<br>These patients had prolonged infertility with one or more failure of IVF/ICSI cycles | Behavioral: Questionnaire<br>* All included patients will be exposed to questionnaires and psychiatric diagnostic tests<br>* Other names: Psychiatric diagnostic tests;|
| Prolonged infertility only<br>These patients had prolonged infertility without any trials of IVF/ICSI cycles | Behavioral: Questionnaire<br>* All included patients will be exposed to questionnaires and psychiatric diagnostic tests<br>* Other names: Psychiatric diagnostic tests;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and types of psychiatric disorders among prolonged infertility couples | Incidence and most common types of psychiatric disorders | 6 months |
Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia

Conditions
-----------------
Hypertension, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Telmisartan + Amlodipine + Rosuvastatin
* Drug: Telmisartan + Amlodipine
* Drug: Telmisartan + Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults both male and female who are ≥19,<80 years old at screening, 140mmHg≤ SBP<180mmHg & 90mmHg≤ DBP<110mmHg & LDL-C≤250mg/dL & triglyceride<400mg/dL Exclusion Criteria: at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg secondary hypertension or secondary dyslipidemia patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease women who are pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 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: Test<br>qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin) | Drug: Telmisartan + Amlodipine + Rosuvastatin<br>* Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo<br>|
| Active Comparator: Reference 1<br>qd PO, Micardis(telmisartan) + Crestor(rosuvastatin) | Drug: Telmisartan + Rosuvastatin<br>* Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo<br>|
| Active Comparator: Reference 2<br>qd PO,Twynsta(telmisartan/amlodipine) | Drug: Telmisartan + Amlodipine<br>* Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline |  | 8-week | 
| Change of LDL-C(Low Density Lipid Cholesterol) from baseline |  | 8-week |
Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Refractory Asthma

Study Overview
=================
Brief Summary
-----------------
Extracorporeal leukocytapheresis (LCAP) or granulocytapheresis (GCAP) has been used in the treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown promising safety and efficacy. LCAP and GCAP seem to be effective for steroid-resistant inflammation. The investigators have already reported safety and efficacy of GCAP in refractory asthma and expect the beneficial effect of LCAP in refractory asthma. In this study, in order to improve the therapeutic effect of LCAP by increasing the quantity of leukocytes that were removed, the investigators conducted a clinical study to investigate safety and efficacy of high-dose LCAP performed using a larger filter and an increased dose of the blood volume per body weight treated, as an possible therapy for refractory asthma.

Official Title
-----------------
Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Patients With Refractory Asthma

Conditions
-----------------
Bronchial Asthma

Intervention / Treatment
-----------------
* Procedure: Leukocytapheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients fulfilled the 2001 criteria for refractory asthma in American Thoracic Society. Exclusion Criteria: Pregnant women. Patients with severe cardiovascular diseases. Patients with infective diseases. Patients with leukocytopenia or anemia.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Leukocytapheresis<br>* 5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of morning peak flow rate (PEFR) or evening PEFR |  | 4 weeks after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An improved score of asthma control test |  | 4 weeks after the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal leukocytapheresis
Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women of different backgrounds with stress urinary incontinence who may also have other various medical conditions.

Official Title
-----------------
Study of Duloxetine HCl in Women of Different Demographic Characteristics and Co-Morbidities With Stress Urinary Incontinence: Evaluation of Efficacy and Safety

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: duloxetine HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age 18 years or older who have for the 3 months prior to study entry at least 1 episode per week of stress urinary incontinence or stress predominant urinary incontinence defined as twice as many stress as urge urinary incontinence episodes per week. Women of non-childbearing potential by reason of hysterectomy, surgical or natural menopause. Women of childbearing potential should be using a medically accepted means of contraception. Must provide informed consent. Must not have urinary tract infection at screening. Exclusion Criteria: Sensitivity to duloxetine Unstable medical conditions Pregnancy Acute liver damage Suicidal in the opinion of the investigator

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: duloxetine HCl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in weekly incontinence episode frequency as noted by patient diaries from baseline to endpoint in Hispanic women and also in African American women with SUI or stress predominant mixed urinary incontinence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline to endpoint analysis for the Patient Global Impression of Improvement, Incontinence Quality of Life, and pad use as noted by patient diaries |  |  |
Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the enhancement of the recovery of bowel function and in shortening the hospital stay.

Detailed Description
-----------------
Patients were randomized in two groups. The first group underwent a three days postoperative transcutaneous tibial nerve stimulation. The second group underwent a sham stimulation. Aim of the study is to evaluate the role of tibial nerve stimulation in the postoperative recovery after colorectal surgery.

Official Title
-----------------
Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery

Conditions
-----------------
Postoperative Ileus, Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: Tibial nerve stimulation
* Procedure: Sham tibial nerve stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that underwent colorectal surgery Exclusion Criteria: Severe comorbidities Postoperative or intraoperative complications
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Underwent tibial nerve stimulation<br>Patients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days | Procedure: Tibial nerve stimulation<br>* patients underwent a three days postoperative transcutaneous tibial nerve stimulation<br>|
| Sham Comparator: Did not undergo tibial nerve stimulation<br>Patients that underwent standard postoperative protocol + sham tibial nerve stimulation (standard postoperative protocol+sham tns) | Procedure: Sham tibial nerve stimulation<br>* patients did not undergo a postoperative transcutaneous tibial nerve stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bowel function recovery (Time to first bowel movement or flatus) | Time to first bowel movement or flatus | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postoperative hospital stay | Length of postoperative hospital stay | 30 days | 
| Post-operative vomiting (episodes of vomiting) | Episodes of vomiting | 30 days | 
| Use of NG Tubes (Nasogastric tube (re)insertions) | Nasogastric tube (re)insertions | 30 days |
Comparsion of King Vision® Standard Blade and King Vision® Channeled Blade in Patients Scheduled for Tracheal Intubation

Study Overview
=================
Brief Summary
-----------------
Comparison of intubation time from the time to fix the Trachealtube to the first end-tidal CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV channeled blade

Detailed Description
-----------------
In the proposed clinical trial the time measured until the first manual ventilation at 44 study participants with elective anesthesia by using the KV standard blade and KV channeled blade. Bedside the time for tracheal intubation, we documented the view on the monitor which is connected to the instrument, the C& L classification and POGO Scale.

Official Title
-----------------
Comparative Study of King Vision® Standard Blade and King Vision® Channeled for Tracheal Intubation: a Prospective Randomised Study

Conditions
-----------------
Hypoxemia

Intervention / Treatment
-----------------
* Device: channeled blade
* Device: standard blade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Years No concurrent participation in another study capacity to consent Present written informed consent of the research participant Elective surgery under general anesthesia Exclusion Criteria: Age <18 years Existing pregnancy Lack of consent inability to consent emergency patients Emergency situations in the context of a Difficult Airway Management ASA classification> 3 situations where the possibility of accumulated gastric contents Participation in another 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard blade<br>Standard Blade: tracheal intubation with standard blade | Device: channeled blade<br>* In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve<br>Device: standard blade<br>* In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve<br>|
| Experimental: channeled blade<br>Channeled Blade: tracheal intubation with channeled blade | Device: channeled blade<br>* In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve<br>Device: standard blade<br>* In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of different time for tracheal intubation | We want to measure the time for tracheal intubation | <2min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
airway, videolaryngoscope
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016

Study Overview
=================
Brief Summary
-----------------
This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and it's effect on the body in Japanese male subjects.

Official Title
-----------------
Single Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of HSD-016 Administered Orally To Healthy Japanese Male Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: HSD-016
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Men, aged 20 to 45 years inclusive at screening. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg Healthy as determined by the investigator on the basis of screening evaluations. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Exclusion: No presence or history of any disorder that may prevent the successful completion of the study. No history of drug abuse within 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>HSD-016 | Drug: HSD-016<br> <br> |
| Other: 2<br>placebo | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical labs, adverse events |  | 6 months |
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation

Study Overview
=================
Brief Summary
-----------------
This is a double-blinded, randomized, placebo-controlled trial evaluating the use of High-frequency Transcutaneous Electrical Nerve Stimulation (HfTENS) compared to sham TENS for pain control during medication abortion with mifepristone and misoprostol through 70 days' gestation.

Official Title
-----------------
A Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation

Conditions
-----------------
Abortion in First Trimester

Intervention / Treatment
-----------------
* Device: high frequency TENS treatment
* Device: Sham TENS treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seeking medication abortion with a definite, singleton, intrauterine pregnancy (IUP) < 70 days' gestation on ultrasound Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)22 score > 4 Age equal to or greater than 18 years Provide informed consent to participate Willing to adhere to study procedures, including access to a smart phone, ability to receive text messages and answer online surveys on smart phone Exclusion Criteria: Contraindication to medication abortion Allergy to mifepristone or misoprostol Contraindication or allergy to ibuprofen History of cardiac arrhythmia Presence of an implantable device with electrical discharge, i.e. cardiac pacemaker History of chronic pain disorder Any opioid use during previous 30 days Current or prior use of TENS BMI > 30

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENS<br> | Device: high frequency TENS treatment<br>* Treatment with high frequency for minimum of 1 hour after misoprostol administration<br>|
| Sham Comparator: Sham TENS<br> | Device: Sham TENS treatment<br>* Treatment with sham TENS device for minimum of 1 hour after misoprostol administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on numeric rating scale | Maximum pain score on an 11-point numeric rating scale, where 0 is no pain, and 10 is the worst pain. | 8 hours following misoprostol |
Acute Comfort of Lubricant Eye Drop FID 111421

Study Overview
=================
Brief Summary
-----------------
To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Lubricant Eye Drop FID 111421
* Other: Optive Lubricant Eye Drop


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dry eye Must not have worn contact lenses for 1 week preceding enrollment Exclusion Criteria: Age related

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubricant Eye Drop FID 111421<br>Lubricant Eye Drop FID 111421 1 drop each eye one time | Other: Lubricant Eye Drop FID 111421<br>* Lubricant Eye Drop FID 111421 1 drop each eye one time<br>|
| Active Comparator: Optive Lubricant Eye Drop<br>Optive Lubricant Eye Drop 1 drop each eye one time | Other: Optive Lubricant Eye Drop<br>* Optive Lubricant Eye Drop 1 drop each eye one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop Comfort Upon Instillation | Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable. | upon instillation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, artificial tears