linjc16/ctgov huggingface dataset:
The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men

Conditions
-----------------
Metabolic Syndrome, Hypogonadism

Intervention / Treatment
-----------------
* Drug: Nebido (testosterone undecanoate)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A signed informed consent to participate in the study Men aged 35 to 70 with testosterone levels below 12 nmol/L or free testosterone below 225 pmol/L Presence of the metabolic syndrome according to the IDF definition Exclusion Criteria: Patients under 35 or above 70 years. Participation in any clinical study within 30 days before the first injection of the drug Simultaneous participation in another clinical study Incapable subjects as well as prisoners Suspicion of a serious organic or mental disease according to medical history and/or clinical examination Prostate cancer, breast cancer or suspicion thereof Presence or history of hepatic tumors Acute or chronic hepatic disease Presence of renal diseases with renal failure Changes in biochemical or hematological laboratory values in spite of lack of clinical manifestations, in the investigator's opinion Suspected lack of the patient's compliance Hypersensitivity to the active substance

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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 |
| --- | --- |
| Active Comparator: 1<br>Men receiving Nebido | Drug: Nebido (testosterone undecanoate)<br>* Nebido (testosterone undecanoate) intramuscular 4 ml by scheme<br>|
| Placebo Comparator: 2<br>Men receiving Placebo | Drug: Placebo<br>* Placebo 4 mL intramuscular<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist-to-hip ratio |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome, hypogonadism, testosterone undecanoate
Retrospective Chart Review of Valstar

Study Overview
=================
Brief Summary
-----------------
This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.

Detailed Description
-----------------
Initial treatment for bladder CIS is TURBT followed by intravesical immunotherapy with BCG. Valrubicin is approved by the FDA for the treatment of BCG-refractory bladder CIS in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. The recommended course of therapy is 6 doses of 800 mg each administered intravesically once a week. While the benefit risk profile of valrubicin has been established in several clinical trials, current data on effectiveness and tolerability when used in clinical practice are lacking. This protocol outlines a retrospective study to evaluate the effectiveness, safety and tolerability of intravesical valrubicin in the treatment of NMIBC in a clinical practice setting.

Official Title
-----------------
A Retrospective Analysis to Evaluate the Effectiveness, Safety and Tolerability of Intravesical Valrubicin for the Treatment of Bladder Carcinoma in Situ in Clinical Practice

Conditions
-----------------
Carcinoma in Situ of Bladder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years old or greater diagnosis of CIS (physician defined in the medical record) treated with at least one IVe dose of valrubicin since 10/2009 and completed prescribed therapy or no longer receiving therapy at time of study enrollment willing and able to provide informed consent (unless waiver of informed consent is applicable and in place at that clinical site per Chapter 45 CFR part 46 Subpart A 46.117 Exclusion Criteria: route of administration of valrubicin other than intravesical

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Event-free survival | Event-free survival defined as recurrence, progression or death from any cause | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worsening-free Survival | Worsening-free survival defined as recurrence, progression, cystectomy, change of anti-bladder cancer therapy or death from any cause | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BCG, refractory, NMIBC, CIS, non-muscle invasive
A Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B

Study Overview
=================
Brief Summary
-----------------
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.

Detailed Description
-----------------
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B in healthy male subjects.

Official Title
-----------------
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers

Conditions
-----------------
Hyperlipidemias

Intervention / Treatment
-----------------
* Drug: AD-221
* Drug: AD-221A and AD-221B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight equal to or greater than 50kg and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit The Age equal to or greater than 19 in healthy volunteers at the time of screening visit Exclusion Criteria: Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system Subjects who judged ineligible by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221) | Drug: AD-221<br>* AD-221 Oral Tablet<br>Drug: AD-221A and AD-221B<br>* AD-221A Oral Tablet + AD-221B Oral Tablet<br>|
| Experimental: Sequence B<br>Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B) | Drug: AD-221<br>* AD-221 Oral Tablet<br>Drug: AD-221A and AD-221B<br>* AD-221A Oral Tablet + AD-221B Oral Tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Cmax of AD-221 | pre-dose to 72 hours | 
| Area Under the Curve in time plot (AUCt) | AUCt of AD-221 | pre-dose to 72 hours |
An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged >/= 18 years Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment Patients for whom the investigator has decided to start a treatment with Herceptin SC Trastuzumab treatment naive or non-naive (previously intravenous treatment) Informed consent Exclusion Criteria: Patients previously treated with Herceptin SC treatment

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 |
| --- | --- | --- |
| Safety (composite outcome measure): Incidence, nature, and severity according to NCI-CTCAE v. 4.0 of: adverse events (AEs), serious AEs, grade >/= 3 AEs, non-serious adverse drug reaction or causality unknown, AESI (congestive heart failure) |  | approximately 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data |  | Up to 12 months | 
| Number of modalities regarding dose and injection site of Herceptin SC administration |  | Up to 12 months | 
| Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire |  | Every 3 months, up to 12 months |
Patient Reported Outcomes After Surgery for Rectal Endometriosis

Study Overview
=================
Brief Summary
-----------------
To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.

Official Title
-----------------
PROCURE: Patient Reported Outcomes After Surgery for Deep Endometriosis Infiltrating the Muscular Layer of the Rectum: a Prospective Study

Conditions
-----------------
Endometriosis, Endometriosis, Rectum, Endometriosis-related Pain, Endometriosis; Bowel

Intervention / Treatment
-----------------
* Other: PROMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 - 45 years (both inclusive) BMI <35 Complaining of infertility and/or pain Deep endometriosis infiltrating the rectum on at least one imaging technique up to 15 cm from the anus and involving at least the muscularis layer in depth Exclusion Criteria: Refusal of bowel resection/stoma History of laparotomy for endometriosis (history of) Hysterectomy Suspected pelvic malignancy Pregnancy Impossibility for postoperative follow-up in our hospital

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conservative surgery<br> | Other: PROMS<br>* Patient Reported Outcomes after different types of surgery for rectal endometriosis<br>|
| Radical surgery (segmental resection)<br> | Other: PROMS<br>* Patient Reported Outcomes after different types of surgery for rectal endometriosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients experiencing one of the following symptoms at 12 months postoperatively: | constipation (1 stool/>5 consecutive days) frequent bowel movement (≥3 stools/day) defecation pain anal incontinence (involuntary loss of gas or stools) dysuria bladder atony requiring self-catheterization | 12 months postoperatively | 
| The determination of possible risk factors for radical surgery. | based on patient complaints, preoperative imaging techniques and intra operative finding | 3 months postoperatively |
Accuracy of Anthropometric Equations for Estimating Body Fat in Professional Male Soccer Players Compared With DXA

Study Overview
=================
Brief Summary
-----------------
This study aimed to analyze the accuracy of different anthropometric equations to estimate body fat in professional male soccer players, setting DXA body fat as the reference.

Detailed Description
-----------------
The study consisted of evaluating anthropometric measurements and body composition with DXA in professional male soccer player aged 18 years and older. Standardized and certified personnel carried out anthropometric measurements and DXA whole body scan the same day. Body fat was estimated with several anthropometric equations. These equations were divided into two groups: 1) Derived from non-athletic samples; and 2) Derived from athletic samples. The body fat estimated from anthropometric equations was compared with DXA, and those with non-significant differences were further analyzed for calculating mean differences and 95% limits of agreement with DXA. This analysis was carried out for all equations.

Official Title
-----------------
Accuracy of Anthropometric Equations for Estimating Body Fat in Professional Male Soccer Players Compared With DXA

Conditions
-----------------
Body Composition

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed contract with the team Exclusion Criteria: Injured

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants<br>Professional male soccer players from the second professional Mexican division. | Other: No intervention<br>* Cross-sectional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat by DXA | Body fat obtained from a whole body DXA scan transformed from grams to percentage. | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body fat, Soccer players, DXA
SOLX Gold Shunt for Refractory Glaucoma

Study Overview
=================
Brief Summary
-----------------
To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional surgical treatments have failed.

Official Title
-----------------
Clinical Evaluation of the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Refractory Glaucoma

Conditions
-----------------
Glaucoma, Glaucoma, Open Angle

Intervention / Treatment
-----------------
* Device: SOLX Gold Shunt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary open-angle glaucoma age 21 or over refractory glaucoma, with IOP ≥ 24 mmHg on medications and failed prior incisional glaucoma surgery detectable visual field defect (negative MD score) written informed consent available for up to 24 months follow-up Exclusion Criteria: either eye with VA worse than count fingers angle closure glaucoma episode within past 12 months uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma diagnosis of pigmentary glaucoma or pseudoexfoliative glaucoma other significant ocular disease, except cataract active ocular infection expected ocular surgery in next 12 months no suitable quadrant for implant systemic corticosteroid therapy > 5 mg/day prednisone intolerance to gonioscopy or other eye exams mental impairment interfering with consent or compliance pregnancy known sensitivity to anticipated medications used at surgery significant co-morbid disease concurrent enrollment in another drug or device study

Ages Eligible for Study
-----------------
Minimum Age: 21 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: SOLX Gold Shunt<br> | Device: SOLX Gold Shunt<br>* Single use implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change in IOP |  | 1 & 2 years | 
| Percentage change in IOP from baseline |  | 1 & 2 years | 
| Average change in number of glaucoma medications |  | 1 & 2 years | 
| Visual acuity changes |  | 1 & 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma shunt, Ocular implant, Gold, Trabeculectomy
Rewarding Sexually Transmitted Infection (STI) Prevention and Control in Tanzania

Study Overview
=================
Brief Summary
-----------------
This project evaluates the effect of a combined economic and psycho-social intervention to reduce risky sexual activity and its consequences. The main hypothesis to be tested is that risky sexual activity and resulting sexually transmitted infections (STIs) can be reduced through an intervention of counseling, regular STI testing, and positive reinforcement using cash rewards. The intervention is being implemented in a population of young people in rural Tanzania where more conventional behavioral change interventions have had limited effect in battling a generalized HIV epidemic.

Official Title
-----------------
Encouraging Safe Sexual Practices Among Youth Using Cash Rewards: A Randomized Trial in the Kilombero/Ulanga Districts, Tanzania

Conditions
-----------------
Sexually Transmitted Diseases

Intervention / Treatment
-----------------
* Behavioral: Cash reward


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Plan to live in study area for next 12 months Exclusion Criteria: Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High reward<br> | Behavioral: Cash reward<br>* Enrollees testing negative for treatable sexually transmitted infections will receive cash rewards.<br>|
| Experimental: Low reward<br> | Behavioral: Cash reward<br>* Enrollees testing negative for treatable sexually transmitted infections will receive cash rewards.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sexually transmitted infections measured in laboratory testing (Chlamydia, Gonorrhea, Syphilis, Trichomonas, Mycoplasma genitalium, HSV-2, HIV) |  | 4, 8, and 12 months |