linjc16/ctgov huggingface dataset:
Phase 1 Study of NGM313 in Healthy Adult Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of NGM313, both single dose and multiple doses, in normal healthy overweight and obese adult participants.

Official Title
-----------------
A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM313 in Healthy Overweight and Obese Adult Participants

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Biological: NGM313
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI range 27-40 kg/m2, inclusive for the SAD module, and 27-40 kg/m2, inclusive for the MAD module; Normal clinical laboratory evaluations Normal ECG findings Exclusion Criteria: Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder Uncontrolled hypertension defined as sitting blood pressure systolic > 150 mm/Hg and/or diastolic > 90 mm/Hg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGM313<br>Administration of active NGM313 | Biological: NGM313<br> <br> |
| Placebo Comparator: Placebo<br>Administration of placebo comparator | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in weight in kilograms |  | 28 and 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in fasting glucose in mmol/L |  | 28 and 84 days |
Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia

Study Overview
=================
Brief Summary
-----------------
Previous studies of finasteride treatment in women with hair loss have failed to show positive results, yet, some women have responded anecdotally. Given that polymorphisms of the androgen receptor gene which confer androgen sensitivity impact male response to finasteride therapy, it was hypothesized that the same polymorphism in women may identify the group that will respond. This study is designed to test the impact of finasteride therapy on hair loss in postmenopausal women.

Detailed Description
-----------------
Androgen sensitivity in the cell is determined by the number of Cytosine-Adenine-Guanine repeats in the Androgen Receptor gene. Lower CAG repeats have been associated in previous studies with androgenic conditions such as acne, hirsutism and hair loss in men and women. Keeping this in mind, we tested women with hair loss in the frontal or vertex area, for their AR genotype. Patients were randomized to placebo or 1 mg finasteride therapy for 6 months. Global photographs and 2 tatooed areas of 1cm2 each were measured monthly to assess global appearance and hair counts for medication impact.

Official Title
-----------------
Study Evaluating the Association of CAG Repeat Polymorphisms and Finasteride Response in Women With Androgenetic Alopecia

Conditions
-----------------
Androgenetic Alopecia

Intervention / Treatment
-----------------
* Drug: Finasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with hair loss Exclusion Criteria: pre menopausal, metabolic or medication or non-androgenetic causes of hair loss, diffuse hair loss
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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: androgen receptor gene polymorphism<br>Medication response will be assessed according to androgen receptor genotype | Drug: Finasteride<br>* Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)<br>|
| Active Comparator: finasteride<br>medication for treating androgenetic alopecia in women | Drug: Finasteride<br>* Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacogenomics, androgen receptor gene, androgen sensitivity, CAG repeats, androgenetic alopecia, Pharmacogenomics in treatment for androgenetic alopecia in women
Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula

Study Overview
=================
Brief Summary
-----------------
In patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates.

Official Title
-----------------
A One Year Interventional Study in Patients With Vesicovaginal Fistula

Conditions
-----------------
Vesico Vaginal Fistula

Intervention / Treatment
-----------------
* Procedure: Extravesical VVF repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with Vesicovaginal fistula Exclusion Criteria: uretrovaginal fistula
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Active Comparator: extravesical VVF repair<br> | Procedure: Extravesical VVF repair<br>* Both standard transvesical and extravesical approach for VVF repair will be utilised<br>* Other names: Transvesical VVF repair;|
| Active Comparator: Transvesical VVF repair<br> | Procedure: Extravesical VVF repair<br>* Both standard transvesical and extravesical approach for VVF repair will be utilised<br>* Other names: Transvesical VVF repair;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | total time taken for surgery | 3 months | 
| complications | bladder spasms, bleeding | 3 months | 
| recurrence | patients who have recurrenec of symptoms | 3 months |
Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C

Study Overview
=================
Brief Summary
-----------------
Different Doses of rosuvastatin and atorvastatin will be used to see if HCV viral load changes and liver tests change.

Official Title
-----------------
Dose Finding Trial of Rosuvastatin and Atorvastatin Versus Hepatitis C

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

Intervention / Treatment
-----------------
* Drug: rosuvastatin
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis C Exclusion Criteria: HIV positivity

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rosuvastatin|nan|
|Drug: atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Gas Usage for Those With COPD Who Experience Low Oxygen Levels During Activities Only

Study Overview
=================
Brief Summary
-----------------
Several studies have described the use of supplemental oxygen during exertion or activities of daily living (ambulatory oxygen) in study populations that have different characteristics. This report, based on specialized randomized controlled trials, characterizes ambulatory gas usage among patients with COPD who experience low oxygen levels during activities.

Official Title
-----------------
Ambulatory Gas Usage in Patients With COPD and Exertional Hypoxemia

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

Intervention / Treatment
-----------------
* Drug: oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD dyspnea limiting daily activities desaturation less than or equal to 88% for 2 continuous minutes during a room air six-minute walk test Exclusion Criteria: less than or equal to 18 years old those who met criteria for mortality reduction with long-term oxygen those who received oxygen for palliative care or isolated nocturnal hypoxemia those unable to complete the questionnaires or provide informed consent
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

| Intervention/Treatment |
| --- |
|Drug: oxygen|cylinder and concentrator, dosage to maintain SpO2 above 92%, used during exertion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gas usage |  | 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ambulatory oxygen therapy, COPD, exertional hypoxemia
Predictive Value of Non-fasting Blood Lipid Levels for Cardiovascular Events in Community Population(PICC Study)

Study Overview
=================
Brief Summary
-----------------
Numerous studies have shown that non-fasting blood lipid levels are closely related to the occurrence of cardiovascular and cerebrovascular events, but it is still unclear in the Chinese population. The purpose of the study is to investigate the association between non-fasting blood lipid levels and adverse outcomes in Chinese community population.

Detailed Description
-----------------
Study population includes subjects who living in community, of any race or ethnicity, 18 or older years of age, and have provided written informed consent to provide biological sample at one or more study visits. Physical examination, questionnaire survey and biological sample collection will be conducted at baseline and the incidence of a composite of major adverse cardiovascular events will be investigated during follow-up.

Official Title
-----------------
Predictive Value of Non-fasting Blood Lipid Levels for Cardiovascular and Cerebrovascular Events in Community Population(PICC Study)

Conditions
-----------------
Lipid

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •≥18 years old; Signed informed consent; Life expectancy is greater than 1 year. Exclusion Criteria: mental disorder; is not willing to participate in the clinical study; suffered with other disease to quite the trial; violated the protocol.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality was confirmed through a combination of hospital medical records, telephone contacts with patients or family members, and death registration at the Center for Disease Control and Prevention. | Through study completion, an average of 1 years | 
| Cardiovascular Mortality | Cardiovascular mortality was defined as death attributable to an ischemic cardiovascular cause (including fatal cardiovascular events and stroke). | Through study completion, an average of 1 years | 
| Cardiovascular and cerebrovascular diseases | The number of and the incidence rate of cardiovascular and cerebrovascular diseases. | Through study completion, an average of 1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-fasting lipid, cardiovascular and cerebrovascular events, major adverse cardiovascular events
Inhalation of Lidocaine Before Intubation

Study Overview
=================
Brief Summary
-----------------
We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.

Detailed Description
-----------------
Sudden increases in blood pressure and heart rate after tracheal intubation and post-operative sore throat are two common undesirable side effects of general anesthesia and might lead to patients' morbidity or dissatisfaction. We investigated the possibility to attenuate both side effects with one single method, i.e. ultrasound-driven lidocaine inhalation immediately before induction.

Official Title
-----------------
The Effect of Ultrasonic Nebulizer Delivered Lidocaine on Circulatory Responses During Tracheal Intubation and Postoperative Sore Throat

Conditions
-----------------
Sore Throat

Intervention / Treatment
-----------------
* Drug: Lidocaine inhalation
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I or II. Patients scheduled for elective surgery under general anesthesia with orotracheal intubation Exclusion Criteria: patient's refusal to join, major surgery or expected operation duration longer than 3 hours, patients with a anticipated difficult airway, requiring a nasogastric tube in peri-operative stage, having recent upper respiratory tract infection (within 1 week) or pre-existing sore throat.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Inhalation of lidocaine before intubation | Drug: Lidocaine inhalation<br>* Lidocaine inhalation before intubation<br>|
| Placebo Comparator: Control<br>Normal saline inhalation before intubation | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Non invasive blood pressure every min for 3 min | 3 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative sore throat | Questionnaire for Post operative sore throat | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anesthetics,, local,, lidocaine;, nebulizers and vaporizers;, complications,, intubation,, intratracheal.
Molecular Mechanisms of Raspberries Effect on Insulin Resistance and Inflammation

Study Overview
=================
Brief Summary
-----------------
Red raspberries (Rubus idaeus) are a good source of health enhancing hydrolyzable and condensed tannins, flavonoids, anthocyanins, phenolic acids, rheosmin, potassium, carotenoids, vitamin C, and vitamin K1. Compared to other berries commonly consumed in the US, the health benefits of red raspberries to improve pre-diabetes mellitus (PDM) and type 2 diabetes have never been explored. The clinical study proposed in this project seeks to investigate the protective effect of whole red raspberries against insulin resistance, oxidative stress, and inflammation in PDM and type 2 diabetic patients. The in vitro study proposed in the project will assist in identifying the molecular mechanisms by which whole red raspberry protect islet cells against oxidative stress, insulin resistance and loss of cell function.

Official Title
-----------------
Molecular Mechanisms Underlying the Protective Effects of Whole Red Raspberries Against Insulin Resistance and Inflammation in Type 2 Diabetes

Conditions
-----------------
Inflammation, Insulin Resistance

Intervention / Treatment
-----------------
* Other: Raspberries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes Exclusion Criteria: hypoglycemic agents Pregnant or nursing a child chronic medication that does not have a stable dose for greater than one month anti-inflammatory medication inflammatory disease

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Raspberry Smoothies<br>Single serving smoothies drink made with red raspberries to be consumed daily for two weeks | Other: Raspberries<br>* Red raspberry smoothies drink<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Ratio of fasting insulin and glucose | 2 weeks | 
| A high-sensitivity C-reactive protein (hs-CRP) measured in milligrams per liter | Measure of systemic inflammation | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3,4-Dihydroxyphenylacetic acid (DOPAC) measured in nanograms per milliliter | Measure of systemic inflammation | 2 weeks |
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)

Study Overview
=================
Brief Summary
-----------------
The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).

Official Title
-----------------
Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance

Conditions
-----------------
Postural Tachycardia Syndrome

Intervention / Treatment
-----------------
* Drug: Saline
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28 Age between 18-65 years Male and female are eligible (although the majority of POTS patients are female). Able and willing to provide informed consent Exclusion Criteria: Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications) Pregnancy Other factors which in the investigator's opinion would prevent the subject from completing the protocol. Patients who are bedridden or chair-ridden

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Post Saline<br>Saline infusion 1L hours before exercise test | Drug: Saline<br>* IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study<br>* Other names: 0.9% saline;|
| Placebo Comparator: Placebo<br>Placebo given prior to exercise test | Other: Placebo<br>* Placebo x1 lactose tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in VO2max between saline day and placebo day | VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart. | Within 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity/Maximal Load (Watts) during peak VO2 | Maximal exercise load will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart. | Less than 2 weeks | 
| Cardiac output between exercise tests (inert gas rebreathing technique) |  | 2-10 Days between exercise tests | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthostatic intolerance, exercise capacity, tachycardia, POTS
The Related Factors With Resilience in Caregivers Whose Child With Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to explore caregivers stress, family functioning, social support and family resilience of families whose children had acute lymphoblastic leukemia. The significantly correlation among caregivers stress, family functioning, social support and family resilience was also explored.

Conditions
-----------------
Condition 1. Children With ALL Are Still Alive and the Age of 18 Years of Age., Condition 2. Has Been Completed to Guide the Treatment Regimen Were in Remission., Condition 3. Caregiver Can or Taiwanese Language Communicator.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as acute lymphoblastic leukemia children, children with cancer are still alive and the age of 18 years of age. Has been completed to guide the treatment regimen were in remission. Caregiver can or Taiwanese language communicator. Exclusion Criteria: - Children with metastatic cancer who end chemical treatment of more than one year

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| resilience in caregivers whose child with ALL<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |