linjc16/ctgov huggingface dataset:
Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride Tablet under fed conditions.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Naratriptan Hydrochloride 2.5 mg Tablets Under Fed Conditions

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: naratriptan hydrochoride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to naratriptan hydrochloride or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naratriptan hydrochoride|2.5 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 9 days |
Short Term Comparative Study of Xalatan With Benzalkonium Chloride vs. Travatan Z Without Benzalkonium Chloride in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Compare the effect of Xalatan with benzalkonium chloride on the ocular surface to those effects observed with Travatan Z without benzalkonium chloride after a single dose

Official Title
-----------------
Short Term Comparative Study of Xalatan With Benzalkonium Chloride vs. Travatan Z Without Benzalkonium Chloride in Healthy Volunteers

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Travatan® Z
* Drug: Xalatan®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma Exclusion Criteria: Age

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Travatan® Z|nan|
|Drug: Xalatan®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break Up Time |  | Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Onset |
Tempus CRC Surveillance Study: A ctDNA Biomarker Profiling Study of Patients With CRC Using NGS Assays

Study Overview
=================
Brief Summary
-----------------
The study is an observational multicenter evaluation of participants with colorectal cancer (CRC) who will receive longitudinal plasma ctDNA biomarker profiling in addition to their standard-of-care therapy and disease surveillance.

Official Title
-----------------
Tempus CRC Surveillance Study: A Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients With Colorectal Cancer (CRC) Using Comprehensive Next-Generation Sequencing (NGS)Assays

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known or suspected colorectal adenocarcinoma (Stage I to IV disease) Planning to undergo or has undergone a surgical resection for suspected adenocarcinoma of the colon or rectum with curative intent. 18 years old or older Willing and able to provide informed consent Willing to have additional blood samples collected during routine surveillance visits Exclusion Criteria: Not willing to have additional blood samples collected Pathology that is not consistent with colorectal adenocarcinoma

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 |
| --- | --- |
| Participants with stage I-IV colorectal cancer (CRC)<br>This protocol will include participants with stage I-IV CRC who are scheduled to undergo or have undergone a surgical resection with curative intent. | Other: Observation<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-Free Survival | Recurrence-Free Survival as assessed by standard radiographic imaging, measured from the day of completion of definitive treatment to first radiographic recurrence or death | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity defined as the proportion of participants who develop recurrence who have ctDNA detected. | 2 years | 
| Specificity | Specificity defined as the proportion of participants who do not develop recurrence who do not have ctDNA detected. | 2 years | 
| Positive Predictive Value | Positive predictive value (PPV) defined as the proportion of participants who have ctDNA detected who recur. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Oncology, Observational, Genomic Profiling, Precision medicine, CRC, Colorectal Cancer, NGS, Biomarkers
Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.

Official Title
-----------------
A Randomized, Open-Label Study of Continuous Therapy With Cyclosporine and Sirolimus Versus Induction With Cyclosporine and Sirolimus Followed by Continuous Therapy With Sirolimus in Renal Allograft Recipients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Sirolimus
* Drug: cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus Exclusion Criteria: Evidence of active systemic or localized major infection at the time of initial sirolimus administration Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening. Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sirolimus|nan|
|Drug: cyclosporine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalence of graft survival at month 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function; biopsy-confirmed acute rejection, grade of acute rejection; subject and graft survival; incidence of infection, malignancy, treatment failure, and of chronic rejection as determined by protocol biopsies; quality of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal allograft, Renal, Kidney, Transplant
Patient Reported Symptoms in Ovarian Cancer (PRECISION)

Study Overview
=================
Brief Summary
-----------------
This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.

Official Title
-----------------
Patient Reported Symptoms in Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred > 6 months after platinum-based chemotherapy This must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma Are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy Are currently under observation or being treated with bevacizumab as a second-line maintenance therapy Have a valid email address and access to the internet Provide voluntary written informed consent Speak and read English fluently Exclusion Criteria: Current participation in a blinded clinical trial for ovarian cancer treatment. (Participation in a trial involving only supportive care medicines and/or growth factors is acceptable) Another primary diagnosis of cancer in a different site

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression |  | Up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDASI-OC Symptom Severity Score |  | Up to 9 months | 
| MDASI-OC Symptom Interference Score |  | By month 9 | 
| HRQoL scores |  | Up to 9 months |
18616 - Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose.

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY 987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose ) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: BAY987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY 987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation Number - X71-144)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)

Study Overview
=================
Brief Summary
-----------------
Nanocrystalline silver (very small particles of silver) is the active ingredient in Acticoat dressings, which have been approved for the treatment of burns and other wounds. Silver has been used for decades as an effective antimicrobial agent. In animal studies, nanocrystalline silver cream (NPI) has also demonstrated anti-inflammatory activity. Thus, nanocrystalline silver cream is being evaluated in the treatment of inflammatory skin conditions such as atopic dermatitis (eczema). Approximately 180 study subjects with a definitive diagnosis of mild to moderate eczema will be enrolled in this study. Subjects will be randomly assigned to treatment with placebo, 0.5% NPI or 1% NPI for the 6-week treatment period. Assessments of treatment effect and safety will be performed weekly. Upon completion of the study, subjects may be eligible for 12 weeks of open-label treatment with 1% NPI.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Two Concentrations of Nanocrystalline Silver Cream (NPI) Applied Twice Daily in Adults With Mild to Moderate Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis, Eczema

Intervention / Treatment
-----------------
* Drug: Nanocrystalline silver cream (NPI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Male or female, any race, 18 to 65 years of age. Females must be post-menopausal, surgically sterile, or if of child-bearing potential, not pregnant (confirmed by test) and using an adequate method of birth control. Subjects must have eczema that covers a minimum of 5% total body surface area. Subjects must agree not to use other eczema medications for the 6-week study treatment period. Subjects must not be enrolled in another investigational drug study. Subjects must not be allergic to silver or cocoa butter.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nanocrystalline silver cream (NPI)|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
-----------------
Atopic Dermatitis, Eczema
Diet, Genetic Variation and Prostate Cancer Among African Americans

Study Overview
=================
Brief Summary
-----------------
This is a single center pilot study to asses the feasibility of conducting a larger population-based study. It is an investigator-initiated study funded yb the UC Davis Cancer Center's Development Award Program. The hypothesis is that the percent african ancestry in an individual may determine their prognosis if diagnosed with prostate cancer.

Official Title
-----------------
Diet, Genetic Variation and Prostate Cancer Among African Americans

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identification as a male with African ancestry Between ages of 35-75 Exclusion Criteria: No African ancestry Not between ages of 35-75 -

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Controls (No prostate cancer) | |
| 2<br>Cases (Prostate Cancer Diagnosed) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there a difference in ancestry percentage between the controls (no cancer) and the cases (prostate cancer) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer
Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study

Study Overview
=================
Brief Summary
-----------------
A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture.

Detailed Description
-----------------
Background: Rectus sheath plication within abdominoplasty is a standard treatment for diastasis of the recti muscles. Previous studies assessing the efficacy and endurance of the correction of recti diastasis have mostly been performed with small groups of patients, short follow-up periods and/or with questionable methodology Methods: A comparative prospective study assessing the outcomes of recti muscle diastasis correction with absorbable suture. The investigators assess the outcomes by physical and ultrasonographic examinations and a patient questionnaire, which asks about the number of pregnancies and the types of deliveries, other abdominal surgeries before or after the abdominoplasty, the interval of time required to return to full activity, postoperative pain, and the overall satisfaction with the final result. During the examination, the inter-recti distances are measured at 3 levels: halfway between the xyphoid and umbilicus, just above the umbilicus and halfway between the umbilicus and pubis. The same examination is done on a control group of nulliparous women.

Official Title
-----------------
Evaluation of the Long-term Stability of Sheath Plication Using Absorbable Sutures in Patients With Diastasis of the Recti Muscles: an Ultrasonography Study

Conditions
-----------------
Diastasis Recti

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women after rectus sheath plication for diastasis recti Exclusion Criteria: Abdominal wall defect other then umbilical hernia
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 |
| --- | --- |
| Control group<br>Nulliparous women | |
| Diastasis<br>Patients after rectus sheath plication due to diastasis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the long-term stability of sheath plication using absorbable sutures in patients with diastasis of the recti muscles |  | 12-41 months |