linjc16/ctgov huggingface dataset:
Anti-Mullerian Hormone (AMH) is a Marker for Ovarian Reserve. There Are Many Studies About AMH Changes in Ovarian Surgery, But Little is Known for Other Surgeries. We Seek to Investigate the Hormone Variations Before and After Uterine Artey Ligation for Postpartum Hemorrage (PPH)

Study Overview
=================
Brief Summary
-----------------
Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. There are many studies about AMH changes in ovarian surgery, but little is known for other surgeries. We seek to investigate the hormone variations before and after uterine artey ligation for postpartum hemorrage (PPH)

Detailed Description
-----------------
All patients belong to the same group. The blood samples will be collected at the time of surgery and 3 months after surgery from the patients who need uterine artery ligation for PPH. The blood samples will be centrifuged within 2 hours after being obtained and assessed on the same day. AMH concentrations will be measured with an enzymatically amplified two-sided immunoassay

Official Title
-----------------
Comparison of Serum Anti-Mullerian Hormone Levels Following Uterine Artery Ligation for PPH.

Conditions
-----------------
Anti-Mullerian Hormone Deficiency, Post Partum Hemorrhage

Intervention / Treatment
-----------------
* Other: anti- mullerian hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18- 40 years no systemic or endocrine diseases patients who had uterine artery ligation due to PPH Exclusion Criteria: Pregnancy with IVF or oosit donation Patients with endocrinopathy, diseases which require radiotherapy and chemotherapy etc. Patients with BMI >40

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: anti- mullerian hormone|All patients belong to the same group. The blood samples will be collected at the time of surgery and 3 months after surgery from the patients who need uterine artery ligation for PPH. The blood samples will be centrifuged within 2 hours after being obtained and assessed on the same day. AMH concentrations will be measured with an enzymatically amplified two-sided immunoassay|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1- Anti-Mullerian Hormone levels variation | Anti-Mullerian Hormone levels before and 3 months after surgery | 3 months |
Tissue Bank for Pulmonary Diseases

Study Overview
=================
Brief Summary
-----------------
The aim of this research study is to collect and store the specimens that are left over after patients undergo tests ordered by their physicians. These specimens will be used at a later time by researchers in the Pulmonary Division to develop a better understanding of pulmonary diseases or for the development of new treatments. Typical research studies that will be conducted on the stored tissue, fluid, or bacteria from the patient sample involve obtaining bacterial cultures, measurement of inflammatory markers, and examination of the characteristics of the tissue. Other similar tests may be done in the future; however, these tests have not all been determined at this time. It is important to note that no genetic testing will be performed on any samples that are obtained as part of this protocol.

Official Title
-----------------
Tissue Bank for Pulmonary Diseases

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open
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 |
| --- | --- | --- |
Phase 3 Study to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to eperisone HCl in efficacy and safety.

Official Title
-----------------
A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase Lll Clinical Trial to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients

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

Intervention / Treatment
-----------------
* Drug: DW-1030(eperisone HCl) 75mg
* Drug: Myonal Tab.(eperisone HCl) 50mg
* Drug: Placebo drug of DW-1030
* Drug: Placebo drug of Myonal Tab.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males/Females aged over 18 years Patients with symptom of Acute skeletomuscle myospasm and Back pain Patients with Pain VAS Value over 40 mm in Visit 2 Subjects who voluntarily or legal guardian agreed with written consent Exclusion Criteria: Patients with Back pain caused by spinal spondylosis, spinal stenosis, fractures, cancer, severe arthritis, osteoporosis, sciatica, infection Muscular patients such as myositis, muscular atrophy disease, increased muscle tone, myasthenia gravis Patients who had taken invasive procedures such as epidural injections or spinal stimulation to cure the back pain within 6 months from the screening point Patients who had taken passive physical therapy or ionphoresis within 12 hours from the screening point Patients with severe GI tract disorder, heart disease, hypertension Patients who had taken NSAIDS within 24hours from the screening point

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: DW-1030(eperisone HCl)<br>DW-1030(eperisone HCl) 75mg BID | Drug: DW-1030(eperisone HCl) 75mg<br> <br> Drug: Placebo drug of Myonal Tab.<br> <br> |
| Active Comparator: Myonal Tab.(eperisone HCl)<br>Myonal Tab.(eperisone HCl) 50mg TID | Drug: Myonal Tab.(eperisone HCl) 50mg<br> <br> Drug: Placebo drug of DW-1030<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration |  | 1, 3, 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of 100mm Pain VAS |  | -3, 1, 3, 7 day | 
| Oswestry Disability Index (ODI) |  | 1, 3, 7 day | 
| Physician's Global Assessment |  | 7 day | 
| The number of using rescue drugs and the total amount |  | 1, 3, 7 days |
International Cancer of the Head and Neck, Genetics and Environment (InterCHANGE) Study

Study Overview
=================
Brief Summary
-----------------
Our overall objective is to understand the role of lifestyle factors, genetics and HPV infection in the development and prognosis of head and neck cancer particularly in Asia.

Official Title
-----------------
International Cancer of the Head and Neck, Genetics and Environment (InterCHANGE) Study

Conditions
-----------------
Evaluate the Association Between Certain Environmental Exposures (e.g. Cigarette Smoking, Alcohol Drinking, Betel Nut Chewing…) and Head and Neck Cancers, Assess the Effect of Genetic Factors, Including Both SNP and Copy Number Variation (CNV) Through Analysis of Both Main Effect and Gene-gene Interaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 80 Incident head and neck cancer patients Oral, oropharynx and hypopharynx (C00-C14) Laryngreal cancer (C32) *Esophageal cancer if possible (C15) Exclusion Criteria: Salivary gland (C07-C08) Nasopharynx (C11) Thyroid (C79.3)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| head and neck cancer risk factor | evaluate the association between certain environmental exposures (e.g. cigarette smoking, alcohol drinking, betel nut chewing…) and head and neck cancers,assess the effect of genetic factors, including both SNP and copy number variation (CNV) through analysis of both main effect and gene-gene interaction | Four years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HEAD AND NECK
Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Obese Pregnant

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the accuracy of the Accuro Ultrasound Device in estimating the epidural space depth compared to the Standard Ultrasound Examination and with the measured needle depth during epidural and spinal insertion in pregnant obese patients

Detailed Description
-----------------
SpineNav3DTM technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D. All the subjects will have their lumbar area scanned for the measurements of the depth of the epidural space (recorded in cm) by two blinded anesthesiologists, one using standard ultrasounds and the other the Accuro Device. All measurements will be performed either in the sitting or in the supine position at L1/L2, L2/L3 and L3/L4 levels. Neuraxial anesthesia will be performed by using the previously marked interspace by a blinded anesthesiologist who will measure the epidural space depth during epidural or spinal insertion by marking the needle.

Official Title
-----------------
Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Obese Pregnant

Conditions
-----------------
Obesity, Pregnancy Related

Intervention / Treatment
-----------------
* Device: Accuro
* Device: standard ultrasound device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA Status >III obese BMI>30 term gestatio > 37 weeks singleton pregnancy undergoing elective cesarean section with spinal anesthesia requesting epidural labor analgesia Exclusion Criteria: contraindications to neuraxial block severe scoliosis previous spine surgery

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Accuro|ultrasound device (Accuro, Rivanna Medical, Charlottesville, VA) with automated pattern recognition software programmed (SpineNav3DTM technology) to calculate the depth to epidural space and identify bony landmarks|
|Device: standard ultrasound device|standard ultrasound device (o calculate the depth to epidural space and identify bony landmarks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidural space depth | the depth of the epidural space (recorded in cm) is defined as the distance from the skin to the posterior complex | up to 30 minutes |
A Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to build a well characterized cohort of patients that will be used to determine the genetic variants associated with obstructive sleep apnea (OSA)and its co-morbidities.

Detailed Description
-----------------
The purpose of building the cohort is to allow the performance of genome-wide association studies with a large sample of patients that have been well-characterized using standardized procedures.

Official Title
-----------------
A Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We will recruit subjects who are: 18 years of age and older. Willing and able to give informed consent AND any of the following: PSG (polysomnogram)requested by a physician based on clinical grounds AHI (Apnea-hypopnea index) ≥ 5 episodes per hour based on a prior PSG. Exclusion Criteria: Incapable of giving informed consent Under the age of 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Sleep Questionnaire | Responses to sleep questionnaire | upon enrollment |
The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of treatment with Circadin based on sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after the treatment

Official Title
-----------------
Open-label, Post-marketing Observational Study to Evaluate the Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

Conditions
-----------------
Insomnia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients aged ≥ 55 years suffering from non-organic insomnia according to International Classification of Diseases (ICD-10) Patients with sleep disorders manifested as poor sleep quality associated with impaired daytime functioning with or without one or more of the following criteria: difficulty falling asleep, frequent night awakenings, early morning awakenings Patients able to follow the study protocol Patients who have signed the Informed Consent prior to initiation of any observation-related procedures Patients with a global score of ≤17 inclusively on the modified Questionnaire Scoring Subjective Characteristics of Sleep Patients who have just been identified to receive treatment with Circadin Patients without previous treatment with Circadin Exclusion Criteria: Hypersensitivity to any components of Circadin Congenital galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency Pregnancy and lactation Alcohol or drug addiction Severe somatic and neurological conditions, exacerbations thereof, including autoimmune diseases or renal/hepatic insufficiency Intake of psychoactive medicines within the last 30 days before observational study entry Presence of clinically significant anxiety and depression as assessed by the Hospital Anxiety and Depression Scale Presence of pain that might be the cause for insomnia. Subjects suffering from breathing related sleep disorders

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- | --- |
| Change from baseline in quality of sleep questionnaire | Sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after treatment. | Baseline, 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in attention Questionnaire |  | Baseline, 3 weeks | 
| Change from baseline in memory Questionnaire |  | Baseline, 3 weeks | 
| Percentage of patients responding unsatisfied, effective therapy, very effective therapy, respectively, in the patient satisfaction assessment |  | 3 weeks |
Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.

Official Title
-----------------
A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis

Conditions
-----------------
Blepharoconjunctivitis

Intervention / Treatment
-----------------
* Drug: 1% Azithromycin and 0.1% Dexamethasone
* Drug: 1% Azithromycin
* Drug: 0.1% Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a clinical diagnosis of blepharoconjunctivitis Must be willing to discontinue contact lens wear for the duration of the study Additional inclusion criteria also apply. Exclusion Criteria: Have known sensitivity or poor tolerance to any component of the study medications. Have any clinically significant cardiovascular disorders Have any history of liver or kidney disease resulting in persisting dysfunction Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device. Additional exclusion criteria also apply.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: 1% Azithromycin and 0.1% Dexamethasone<br>* Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.<br>* Other names: AzaSite Plus;|
| Active Comparator: 2<br> | Drug: 1% Azithromycin<br>* Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.<br>* Other names: AzaSite;|
| Active Comparator: 3<br> | Drug: 0.1% Dexamethasone<br>* Subjects will dose topically to the eye and eyelid BID at approximately 12 hour intervals for 14 days in both eyes.<br>* Other names: Dexamethasone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The resolution of the clinical signs and symptoms. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial eradication |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blepharoconjunctivitis, Ophthalmology
Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.

Conditions
-----------------
Nonalcoholic Steatohepatitis, Liver Steatosis

Intervention / Treatment
-----------------
* Dietary Supplement: Nigella Sativa
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from Steatohepatitis Patients suffering from Liver Steatosis Exclusion Criteria: Patients suffering from viral hepatitis Patients with HIV infection Patients suffering from Wilsons Disease

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nigella Sativa Supplement<br>Fifty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest capsules containing 2 grams of Nigella Sativa divided into 1 grams twice a day. | Dietary Supplement: Nigella Sativa<br> <br> |
| Active Comparator: Patients receiving a placebo tablet<br>Twenty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest placebo capsules twice a day, that look like the capsules of those receiving the Nigella Sativa. | Dietary Supplement: Placebo<br>* Capsules that contain a placebo but look like the Nigella Sativa capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Nigella Sativa on Liver Triglyceride Concentration | The difference in change in the average liver triglyceride concentration will be measured by MRI Spectroscopy between the Nigella Sativa arm and the placebo arm, at start and end of the study. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Nigella Sativa on Improvement in NASH Activity Index | Improvement in Nash activity Index will be measured by the NAFLD Activity Score. | One year | 
| Effect of Nigella Sativa on Fibrosis Staging | Microscopic examination of two liver biopsies at start and end of the study, to determine fibrosis staging. | One year |