linjc16/ctgov huggingface dataset:
Time to Conceive: A Study of Fertility

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to learn a way to measure a person's fertility. After 1 year of trying, 1 out of every 7 women will not be pregnant. This is called infertility. This results in significant distress and anxiety. Infertility is common; however, the investigators have no markers to predict who will be infertile. For couples diagnosed with infertility, the investigators have used blood and urine hormone levels (follicle stimulating hormone (FSH), inhibin B, and antimullerian hormone (AMH)) to tell us who will get pregnant with fertility treatment. The investigators don't know if these hormone levels can predict if regular people trying to get pregnant will be able to get pregnant. This study will try to determine if these hormone levels can predict fertility and infertility.

Official Title
-----------------
Time to Conceive: A Study of Fertility: Biomarkers of Fertility

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women between the ages of 30 and 44 hoping to get pregnant and about to start trying or have been trying for less than 3 months living with male partner Exclusion Criteria: currently using birth control with no intention of stopping have been trying to get pregnant for more than 3 months have used hormone shots for birth control in the past year have renal failure have known fertility problems, such as polycystic ovarian syndrome (PCOS) plan on moving outside of the Triangle Area in the next 6 months

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 44 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br>Study participants will not be asked to make any changes to their daily lifestyle or existing health care routine. Participants also will not be asked to take any medications or change their diet. | Other: No intervention<br>* Study participants will not be asked to make any changes to their daily lifestyle or existing health care routine. Participants also will not be asked to take any medications or change their diet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conception | Examining time-to-pregnancy | 12 months, or until conception | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fertility, Trying to Conceive, Trying to Get Pregnant, Pregnancy
Clinical Evaluator Outcomes Reliability Study

Study Overview
=================
Brief Summary
-----------------
This study outlines structured Clinical Evaluator (CE) testing techniques that are proposed to be implemented across all sites participating in the Cooperative International Neuromuscular Research Group (CINRG) research studies. The study will determine if the selected techniques are reliable and reproducible across the CINRG network by evaluating the reliability and reproducibility of the measures between CEs

Official Title
-----------------
Cooperative International Neuromuscular Research Group (CINRG) Clinical Evaluator Outcomes Reliability Study

Conditions
-----------------
Dystrophinopathies

Participation Criteria
=================
Eligibility Criteria
-----------------
Dystrophinopathy Participant Inclusion Criteria: Site confirmed genetic diagnosis of a dystrophinopathy Aged 6 years and older Able to transfer to testing table Able to walk 10 meters without an assistive device Dystrophinopathy Participant Exclusion Criteria: Investigator assessment of inability to comply with protocol assessments Participants who have attention deficient disorder or other cognitive conditions that may limit attention span to perform protocol assessments

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dystrophinopathies<br> | |
| Gold Standard Clinical Evaluators (GS-CEs)<br> | |
| Sites Clinical Evaluators (CEs)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evaluator Assessments | The following assessments are conducted by certified physical therapists: Anthropometrics, goniometry, Brooke upper extremity and Vignos lower extremity scales, Performance Upper Limb Scale (PULS), North Star Ambulatory Assessment (NSAA), Six Minute Walk Test (6MWT), time to rise from floor, time to stand from a chair, time to climb four stairs, time to walk/run 10 meters, 9 Hole Peg Test (9HPT), Quantitative Muscle Tests (QMT), Manual Muscle testing (MMT), Force Vital Capacity (FVC), Force Expiratory Volume (FEV1), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), Peak Expiratory Flow Rate (PEFR) and Peak Cough Flow (PCF). The reliability of these commonly used measurements is fundamental to clinical research, our ability to have confidence in the data we collect and our ability to draw rational conclusions from the data. | One time visit |
Extracellular Fluid in Resistant Hypertension

Study Overview
=================
Brief Summary
-----------------
The optimal treatment of drug resistant (defined as BP> 140/85 despite three anti-hypertensive drugs including a diuretic) is not well defined. This study aims to test the hypothesis that resistant hypertension is caused by excessive expansion of extracellular fluid volume. A secondary objective is to study which of three different antihypertensive drugs would be most useful in drug resistant hypertension.

Detailed Description
-----------------
Following recruitment subjects will have ECV measured by 51Cr-EDTA determination of GFR, with Brochner-Mortensen correction applied. Subjects then receive the following drugs, in a randomised fashion, for a period of four weeks each, with BP & ECV measurement at end of each period: doxazosin GITS (Cardura XL) 4 mg b.d.; frusemide 40 mg b.d.; amiloride 5 mg b.d.; placebo.

Official Title
-----------------
A Study to Investigate the Contribution of Extracellular Fluid Volume Expansion to Drug Resistant Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Cardura XL 4 mg bd
* Drug: Amiloride 5 mg bd
* Drug: Furosemide 40 mg bd


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BP >140/85 3 antihypertensive drugs (ACE/ARB + calcium channel blocker + thiazide diuretic) Exclusion Criteria: Pregnancy Breast Feeding Unstable heart failure Chronic Liver Disease Creatinine >120 mcmol/L Contraindication to (or intolerance of) drug used in study BP > 180/110

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cardura XL 4 mg bd|nan|
|Drug: Amiloride 5 mg bd|nan|
|Drug: Furosemide 40 mg bd|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ECV; change in BP |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistant Hypertension, Extracellular Fluid Volume
Biopsy of Human Tumors for Cancer Stem Cell Characterization: a Feasibility Study

Study Overview
=================
Brief Summary
-----------------
To see if a limited sampling of tumor tissue from human subjects is a feasible way to gather adequate tissue for cancer stem cell quantification.

Official Title
-----------------
Biopsy of Human Tumors for Cancer Stem Cell Characterization: a Feasibility Study

Conditions
-----------------
Head and Neck Cancer, Head and Neck Cancers

Intervention / Treatment
-----------------
* Procedure: tumor biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Patients with malignant tumors seen at the Stanford University Cancer Center. Eligible patients will have a diagnosis of squamous cell carcinoma (HNSCC) and will have been seen in the Stanford Head and Neck Oncology Program. A decision to undergo surgery at Stanford will have been made, prior to recruiting patients for the study, and prior to obtaining the samples during surgery. (Histological confirmation of the diagnosis need not be made prior to obtaining consent.) 2. A definitive resection of a malignant tumor is planned. 3. Surgeon judgment that the definitive procedure will not be compromised by including FNA Core needle biopsy Cup forceps or punch biopsy of<4mm. 4. Informed consent documented prior to procedure

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: tumor biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the cancer stem cell population by flow cytometry |  | 1 month |
Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

Study Overview
=================
Brief Summary
-----------------
Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on cardiovascular risk factors measured by biochemical and ultrasound parameters compared with enzyme-inducing AEDs.

Official Title
-----------------
Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: eslicarbacepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years patients definitively diagnosed Focal Epilepsy based on clinical criteria and additional tests. patients with stable and identifiable antiepileptic treatment during the last two years. patients according to the investigator are able to provide clinical data necessary for the development of the study Patients who signed informed consent Exclusion Criteria: Patients who, according to their evolution and demands of clinical practice, their previous treatment has to be changed for this reason breach inclusion criteria and / or attachment to one of the study groups.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epileptic patients with AEDs and eslicarbacepine<br> | Drug: eslicarbacepine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid IMT millimeters |  | one year |
Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog

Study Overview
=================
Brief Summary
-----------------
The study aims to examine the effectiveness of the short acting GLP-1 analog, Lixisenatide to achieve glycemic control in type 2 diabetes patients, in patients with failure of long acting GLP-1 analog. Patients who fail to achieve significant improvement in diabetes control on basal insulin and Liraglutide will be switched to basal insulin and lixisenatide treatment for 12 weeks. The primary outcomes will be changes in HBA1C and weight.

Official Title
-----------------
A Pilot Single-Arm Open-Label Study to Evaluate the Efficacy of Treatment With Lixisenatide in Diabetes Mellitus Type 2 Patients With Failure of Other GLP-1 Analog

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: Lixisenatide
* Drug: Basal insulins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type Diabetes Mellitus on combination of basal insulin therapy and GLP1 analog, with secondary failure of non-fasting glycemic control Exclusion Criteria: Pregnant or lactating woman Renal failure (eGFR<30)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lixisenatide<br>S.C. Lixisenatide 10 mcg for 2 weeks and then 10 mcg for 10 weeks | Drug: Lixisenatide<br> <br> * Other names: Lyxumia;Drug: Basal insulins<br>* patients are on basal insulin treatment<br>* Other names: Glargine, Detemir, Degludec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c |  | 16 weeks | 
| Change in body weight |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes Mellitus, treatment, GLP-1
Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This study is to show the efficacy and safety of low dose diltiazem for the treatment of atrial fibrillation with rapid ventricular response in emergency room. We will compare the standard dose of diltiazem(0.25mg/kg) with low dose diltiazem(0.1mg/kg)in atrial fibrillation with rapid ventricular response in ED.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: low dose diltiazem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: atrial fibrillation with rapid ventricular response in emergency room Exclusion Criteria: age<18 systolic blood pressure<90mmHg no consent

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard dose diltiazem<br> | |
| Experimental: low dose diltiazem<br> | Drug: low dose diltiazem<br>* Low dose diltiazem: 0.15mg/kg over 2 minutes Standard dose diltiazem: 0.25mg/kg over 2 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of rate control |  | in 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation with rapid ventricular response
Comparison of Clinical Outcomes of Toric Intraocular Lens

Study Overview
=================
Brief Summary
-----------------
This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that of Tecnis toric IOL.

Detailed Description
-----------------
In cataract surgery, after phacoemulsification, intraocular lens should be implanted for patient's better visual acuity. When patient has large amount of corneal astigmatism, toric intraocular lens are recommended to correct the preexisting astigmatism.

Official Title
-----------------
Comparison of Clinical Outcomes of Toric Intraocular Lens

Conditions
-----------------
Astigmatism

Intervention / Treatment
-----------------
* Device: Precizon toric intraocular lens
* Device: Tecnis toric intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface) Exclusion Criteria: Amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery
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: Precizon toric intraocular lens<br>Cataract surgery and implantation of Precizon toric intraocular lens | Device: Precizon toric intraocular lens<br>* Phacoemulsification and implantation of Precizon toric intraocular lens<br>|
| Active Comparator: Tecnis toric intraocular lens<br>Cataract surgery and implantation of Tecnis toric intraocular lens | Device: Tecnis toric intraocular lens<br>* Phacoemulsification and implantation of Tecnis toric intraocular lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative refractive astigmatism | Diopter | postoperative 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative visual acuity | logMAR | postoperative 3 months |
A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of azithromycin given chronically for the treatment of serious nontuberculous mycobacterial infection in patients failing or intolerant of other available therapy.

Official Title
-----------------
A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy

Conditions
-----------------
Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection

Intervention / Treatment
-----------------
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Other antimicrobial drugs as long as documented on Case Report Form. Patients must have: Serious nontuberculous mycobacterial infection. Approval of eligibility from Pfizer Clinical Monitor. Patients below the legal age of consent must have consent of parent or guardian. NOTE: Pregnant women, women of childbearing potential, and children will not be specifically excluded from participation. However, patients and physicians should be aware that the safety of azithromycin during pregnancy and in long-term use in children and adults has not been established. The risks and benefits of azithromycin use in these patients will be considered in consultation with the physician and the Pfizer Clinical Monitor. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Disseminated Mycobacterium avium complex (MAC) who are eligible for treatment with azithromycin under protocol 066-162. Known hypersensitivity or intolerance to macrolide antibiotics. Patients with the following prior conditions are excluded: History of hypersensitivity or intolerance to azithromycin.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin|nan|

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
-----------------
Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, Azithromycin, Mycobacterium Infections, Atypical