linjc16/ctgov huggingface dataset:
Patient Preference Study

Study Overview
=================
Brief Summary
-----------------
In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.

Official Title
-----------------
A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: AL-3862+timolol ophthalmic suspension
* Drug: Dorzolamide+timolol ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sign informed consent; Diagnosis of glaucoma or ocular hypertension; On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy); IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye; Pregnant, nursing, or not using highly effective birth control methods; Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study; History of bronchial asthma or severe chronic obstructive pulmonary disease; Other protocol-defined exclusion criteria may apply.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AL-3862+timolol, then COSOPT<br>AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later. | Drug: AL-3862+timolol ophthalmic suspension<br> <br> Drug: Dorzolamide+timolol ophthalmic solution<br> <br> * Other names: COSOPT;|
| Other: COSOPT, then AL-3862+timolol<br>Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later. | Drug: AL-3862+timolol ophthalmic suspension<br> <br> Drug: Dorzolamide+timolol ophthalmic solution<br> <br> * Other names: COSOPT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a stated preference for either study medication |  | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean ocular discomfort score |  | Day 1, 1 minute after drop instillation |
Safety Study of SPARC1104

Study Overview
=================
Brief Summary
-----------------
Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

Detailed Description
-----------------
Safety study of SPARC1104

Conditions
-----------------
Spasticity

Intervention / Treatment
-----------------
* Drug: SPARC1104 modified dose regimen I
* Drug: SPARC1104 modified dose regimen II
* Drug: SPARC1104 modified dose regimen III


Participation Criteria
=================
Eligibility Criteria
-----------------
Willingness to participate and give written informed consent Men and women ≥ 18 years of age Sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. Examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. The practice of contraception must have started at least 3 months prior to trial entry. If female, negative pregnancy test result at Screening Diagnosed with MS and a known history of spasticity Meet one of the following criteria o Subjects who completed the double-blind randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol violation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC1104 group 1<br> | Drug: SPARC1104 modified dose regimen I<br>* Subjects who exited study CLR_09_21<br>|
| Experimental: SPARC1104 group 2<br> | Drug: SPARC1104 modified dose regimen II<br>* Subjects who received prior treatment regimen I<br>|
| Experimental: SPARC1104 group 3<br> | Drug: SPARC1104 modified dose regimen III<br>* Subjects who received no prior treatment regimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spasticity
Mechanisms and Biomarkers for Tumor Immunogenicity Modulation in Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate mechanisms that dictate tumor immunogenicity and to explore potential biomarkers that could help predict changes of tumor immunogenicity and therapeutic response in patients with cervical cancer after chemoradiotherapy or surgery.

Detailed Description
-----------------
Patients pathologically confirmed with cervical cancer or benign gynecologic tumor that requires chemoradiotherapy or surgery will be recruited to this study. Tumor samples, normal epithelium of the cervix or other biological samples will be obtained from patients who will receive surgery to establish the baseline status of tumor/mucosal immunogeneicity. For patients undergoing definite radiotherapy, tumor biopsies, collection of blood samples and microbiota will be performed before and during the course of treatment and when the disease progressed. These biological specimens will be used to investigate signaling pathways that determine tumor immungenenicity and their dynamic changes during treatment and to explore feasible biomarkers that could reflect and help monitor the inter- and intra-patient varariation of tumor immunogenicity.

Official Title
-----------------
Investigating Mechanisms That Dictates Tumor Immunogenicity and Exploring Biomarkers That Could Help Predict the Anti-tumor Immune Response in Patients With Cervical Cancer

Conditions
-----------------
Cervical Cancer, Benign Tumor of Uterus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathological proven diagnosis of cervical cancer or benign gynecologic tumor and will undergoing panhysterectomy or pathological proven diagnosis of cervical cancer and will undergoing radiotherapy Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery Patient must provide study-specific informed consent prior to study entry Exclusion Criteria: History of autoimmune diseases History of immunotherapy History of pelvic radiotherapy Will receive immunotherapy during the course of treatment Contraindications for biopsy, such as high bleeding risk
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 |
| --- | --- | --- |
| Expression status of biomarkers during treatment and follow-up | Expression status of biomarkers in patients' biological specimens through the course of treatment and during follow-up as assessed by a variety of means, including RNA-seq, DNA-seq, RT-qPCR, IHC, WB, flow cytometry and ELISA. | From the date of enrollment until the date of disease progression, assessed up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical cancer, Tumor immunogenicity
Health & Aging Brain Study: Health Disparities TAU Project

Study Overview
=================
Brief Summary
-----------------
By doing this study we are trying to learn more about brain aging in Mexican Americans. Participants will be asked to complete a screening visit to determine if it is safe to undergo a PET scan. If eligible, participants will undergo a medical procedure that takes a picture of their brain. This procedure is called a PET scan of the brain.

Official Title
-----------------
Health & Aging Brain Study: Health Disparities TAU Project

Conditions
-----------------
Brain Aging in Mexican Americans

Intervention / Treatment
-----------------
* Diagnostic Test: PET scan of the brain with Flortaucipir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the Health & Aging Brain Study: Health Disparities Amyloid Project Exclusion Criteria: Not a participant in the Health & Aging Brain Study: Health Disparites Amyloid Project Medical condition that precludes safe use of PET tracer
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mexican American Adults<br>No intervention | Diagnostic Test: PET scan of the brain with Flortaucipir<br>* PET scan of the brain with non FDA approved Radio tracer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of Tau in the brain as measured by PET imaging |  | 1 year |
Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to characterize the medical management of squamous cell carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M) disease (between 01July2013 and 30 June 2014) in the real-world setting.

Official Title
-----------------
Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (18 years old or older) with a confirmed diagnosis or R/M head and neck, may be living or deceased at time of enrollment in the study Diagnosis of R/M head and neck cancer between 01July2013 and 30June2014 (study index period) Exclusion Criteria: If female patient, pregnant or lactating between 01July2013 and 30June2014 Enrolled in cancer treatment-clinical trials since diagnosis of R/M head and neck cancer during the study index period

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 |
| --- | --- |
| Population with R/M SCCHN<br>Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN) patients diagnosed between 01July2013 and 30June2014, alive or deceased, at the time of data collection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Therapy Response defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) based on physician's assessment for each therapy regimen |  | approximately 12 months | 
| Overall Survival(OS) of patients with an Index diagnosis of R/M SCCHN |  | approximately 12 months | 
| Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN |  | approximately 12 months | 
| Recurrent-Free Survival(RFS) of patients with an Index diagnosis of R/M SCCHN |  | approximately 12 months | 
| Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN |  | approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of R/M SCCHN-related health care resource use |  | approximately 12 months | 
| Treatment selection conditional on patient demographics, comorbidities, disease severity, and other characteristics as well as clinician demographics, therapy preferences, and other characteristics |  | approximately 12 months | 
| Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics |  | approximately 12 months |
Examination of Left Atrial Fibrosis Using MRI

Study Overview
=================
Brief Summary
-----------------
This study evaluates images obtained from a standard clinical cardiac MRI for evidence of fibrosis.

Official Title
-----------------
Examination of Left Atrial Fibrosis Using MRI

Conditions
-----------------
Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ years of age being scheduled for a standard of care MRI Exclusion Criteria: - patient unable to provide informed 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients referred for standard of care MRI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Hepatitis C Virus (HCV) Treatment Completion or Withdrawal

Study Overview
=================
Brief Summary
-----------------
Qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis C.

Detailed Description
-----------------
Qualitative pilot study of patient' views of their experiences with antiviral treatment for hepatitis C. Two groups of patients will be sampled: nine who completed a 24 or 48 week course of treatment and nine who withdrew from treatment prior to planned end. Interview data will be analyzed using narrative and grounded theory methods to identify attributes of treatment experience that may discriminate between completion and withdrawal.

Official Title
-----------------
Patients' View of Hepatitis C Treatment Completion or Withdrawal

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ever initiated anitiviral treatment for hepatitis C. Exclusion Criteria: none

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 |
| --- | --- |
| Hepatitis C patients<br>patients who initiated antiviral treatment for hepatitis C | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attributes of Treatment Experience | Four basic reasons for persisting in antiviral treatment were identified: cure the disease, concern about diminishing time to act (avoid bad end), demonstation of personal strength, and redemption for past behavior. | Zero to five years since ending treatment. |
Modulation of Immunity by Hormonal Contraceptives

Study Overview
=================
Brief Summary
-----------------
Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).

Detailed Description
-----------------
Feminization of the HIV pandemic is impetus for better understanding of the risk factors promoting male to female sexual transmission. One putative risk factor is hormonal contraceptive use. Our laboratory recently reported that dendritic cell activation, virus-specific T cell expansion, and memory T cell development were impaired among female mice administered depot-medroxyprogesterone acetate (DMPA) prior to viral infection of mucosal tissue, and we now are enrolling women into a clinical investigation exploring the immunomodulatory effects of several common hormonal contraceptive forms. Completion of this research will provide important comparative evaluation of the capacity of these drugs to modulate host defenses combating genital tract infection, eventually supplying healthcare providers more informed recommendations regarding appropriate hormonal contraceptive choices among women at risk for acquisition of HIV.

Official Title
-----------------
Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

Conditions
-----------------
Contraception

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: not pregnant regular menstrual cycle Exclusion Criteria: use of oral contraceptive or Mirena in 3 months prior to enrollment use of depot-medroxyprogesterone acetate in 6 months prior to enrollment diagnosis of sexually transmitted infection in 30 days prior to enrollment history of cervical malignancy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 25 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 |
| --- | --- |
| Mirena<br>Women interested in beginning use of Mirena | |
| Depot-medroxyprogesterone acetate<br>Women interested in beginning use of depot-medroxyprogesterone acetate | |
| Oral Contraception<br>Women interested in beginning use of oral contraception | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ectocervical permeability |  | Baseline and 1 month |
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: GK Activator (2)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients 30-75 years of age; type 2 diabetes mellitus for >3 months before screening; treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications). Exclusion Criteria: type 1 diabetes mellitus; women who are pregnant, breast-feeding or not using adequate contraceptive methods.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: GK Activator (2)<br>* Escalating doses po bid<br>|
| Experimental: 2<br> | Drug: GK Activator (2)<br>* Escalating doses po bid<br>|
| Experimental: 3<br> | Drug: GK Activator (2)<br>* Escalating doses po bid<br>|
| Experimental: 4<br> | Drug: GK Activator (2)<br>* Escalating doses po bid<br>|
| Placebo Comparator: 5<br> | Drug: Placebo<br>* po bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c mean change from baseline, compared to placebo. |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional parameters of glycemic and lipid control. |  | Week 12 | 
| AEs, laboratory parameters. |  | Throughout study | 
| Pharmacokinetic and exposure-response relationship |  | Throughout study |