linjc16/ctgov huggingface dataset:
Back Pain and Male Sexual Disfunction

Study Overview
=================
Brief Summary
-----------------
Back pain is a common hormonal disorder in men that may affect the phases of male sexual function. The investigators investigated sexual function in male patients with back pain. A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the as control group were evaluated with a detailed medical and sexual history, including a international erectile function index (IEFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Detailed Description
-----------------
A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the as control group were evaluated with a detailed medical and sexual history, including a international erectile function index (IEFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Official Title
-----------------
Phase 4 Study Back Pain and Male Sexual Disfunction

Conditions
-----------------
Marriage, Life Event

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patient with back pain 20 - 45 years old Active sexual life Exclusion Criteria: Younger than 20, older than 45 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
sexual life, back pain
Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

Study Overview
=================
Brief Summary
-----------------
Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.

Official Title
-----------------
Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device

Conditions
-----------------
Cutaneous Leishmaniasis

Intervention / Treatment
-----------------
* Device: Heat pack conduction-heat therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR aged 8-80 years old with no more than 3 lesions ulcerative and non-ulcerative ulcers less than 4 cm diameter. allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia) capable of signing an informed consent or having capable guardians (in the case of minors). Children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians. Exclusion Criteria: lesions less than 2cm from the nose, mouth, ears, or eyes. clinically diagnosed with mucosal involvement. evidence of lymph node involvement on exam. unable or unwilling to commit to the treatment and follow-up plan. prior CL treatment within last 1 month. pregnant or lactating uncontrolled severe systemic illness or immunocompromised state.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Heat pack conduction-heat therapy|Hand warmer heat pack with reliable (and monitored) temperature (50-52 degrees Celsius) will be applied to lesion borders for 3 minutes (fractionated to 90 second intervals or less) every day, for 7 consecutive days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria

Study Overview
=================
Brief Summary
-----------------
A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.

Official Title
-----------------
A Randomized Doubleblind Placebo Controlled Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria

Conditions
-----------------
Diabetes Mellitus, Nephropathy, Blood Pressure

Intervention / Treatment
-----------------
* Drug: Spironolacton (hexalacton(R))
* Drug: placebo tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 diabetes age 18-80 years microalbuminuria Exclusion Criteria: blood pressure> 160/100 mmHg persistent macroalbuminuria pregnancy or in risc of this P-Potassium>5.7 mmol/l Eplerone treatment

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>60 days treatment with tablet hexalacton 25 mg OD. | Drug: Spironolacton (hexalacton(R))<br>* Tablet Spironolacton 25 mg OD<br>|
| Placebo Comparator: 2<br>Inactive drug of 25 mg OD | Drug: placebo tablet<br>* placebo tablet 25 mg OD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| albuminuria, expected decrease |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR |  | 60 days | 
| ambulatory blood pressure |  | 60 days | 
| plasma renin, angiotensin, aldosteron |  | 60 days |
Tonsillectomy in Recurrent Tonsillitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether tonsillectomy is effective in preventing further streptococcal pharyngitis episodes in patients with recurrent tonsillitis.

Detailed Description
-----------------
Tonsillectomy is widely used worldwide in recurrent streptococcal tonsillitis, but its effect remains unknown. In this randomized controlled trial, the effect of tonsillectomy (compared to watchful waiting) in preventing further culture proven symptomatic streptococcal pharyngitis episodes is studied. In addition, symptoms after the operation, side effects, and life quality issues are recorded.

Official Title
-----------------
Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial

Conditions
-----------------
Tonsillitis

Intervention / Treatment
-----------------
* Procedure: (adeno)tonsillectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 3 tonsillitis episodes during the preceding year (at least one verified by culture or antigen testing) Exclusion Criteria: Other serious illness Long term antibiotic treatment for other disease Documented immunologic disorder Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 14 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: (adeno)tonsillectomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbiologically confirmed streptococcal pharyngitis episodes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects |  |  | 
| symptoms |  |  | 
| quality of life issues |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent tonsillitis, streptococcus, tonsillectomy, prevention
Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)

Study Overview
=================
Brief Summary
-----------------
This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.

Official Title
-----------------
A Phase I/II Multicenter, Dose-escalation Study of Oral Nilotinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ALL (Philadelphia Positive Acute Lymphocytic Leukemia)(Extension Study)

Conditions
-----------------
Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: Nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who complete CAMN107A1101 and obtained Informed concent by document Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Nilotinib<br> | Drug: Nilotinib<br> <br> * Other names: AMN107;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best hematologic response rate and Best cytogenetic response rate. |  | 3 years | 
| Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Myelogenous Leukemia, CML, Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive, ph+ ALL, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)
A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.

Official Title
-----------------
A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Safety, Efficacy, and Tolerability Study of Two Doses of Epinastine Nasal Spray (0.05% and 0.1%) vs. Placebo in Subjects With Seasonal Allergic Rhinitis

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Epinastine Nasal Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A documented history of seasonal allergic rhinitis to mountain cedar pollen Exclusion Criteria: Significant medical condition Cardiovascular abnormality Have a significant physical obstruction in the nose Started or had a change in immunotherapy within the 30 days prior to screening Have nasal ulceration(s) or any active nasal bleeding Require use of allergy medications during the study Require use of asthma medications other than as needed albuterol

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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: Epinastine Nasal Spray|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nasal symptom scores |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in non-nasal symptom scores and quality of life scores |  |  | 
| Standard safety assessments |  |  |
Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density

Study Overview
=================
Brief Summary
-----------------
One group will receive today's standard rehabilitation program following hip fracture surgery. The intervention group will have maximal strength training incorporated in their program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over 4 sets for leg press and abduction resistance exercise at  85% of maximal strength is carried out. Muscle strength, balance and bone density will be compared between the groups following the 8-week rehabilitation period. The feasibility of the intervention for the patient group will be evaluated based on compliance with training program and possible adverse events related to the operated hip.

Conditions
-----------------
Rehabilitation

Intervention / Treatment
-----------------
* Other: Maximal Strength Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 65, hip fracture surgery Exclusion Criteria: COPD, Heart failure, Dementia

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 95 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Today's standard care | |
| Experimental: Intervention group<br>Maximal Strength Training | Other: Maximal Strength Training<br>* leg pres and abduction exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | 1RM leg press, and hip abduction | 8 weeks | 
| Balance | unipedal stance test | 8 weeks | 
| Bone Density |  | 8 weeks |
Clinical Test of Blood Glucose Test Strips

Study Overview
=================
Brief Summary
-----------------
Blood glucose test strips are tested with the test meters to test the accuracy of the blood pressure monitoring function.

Official Title
-----------------
Clinical Test of Blood Glucose Test Strips

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: blood glucose monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients with blood glucose within the range of ISO15197 Exclusion Criteria: The patients with blood glucose out of the range of ISO15197

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 78 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Andon<br>Andon blood glucose test strips with test meter | Device: blood glucose monitor<br>* Blood glucose monitor is used to monitor the blood glucose level of the human-being.<br>* Other names: Andon or lifescan blood glucose monitor;|
| Active Comparator: Lifescan<br>Lifescan blood glucose test strips with test meter | Device: blood glucose monitor<br>* Blood glucose monitor is used to monitor the blood glucose level of the human-being.<br>* Other names: Andon or lifescan blood glucose monitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose value |  | 5 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood glucose
Effects of Fresh Watermelon Consumption on Satiety and Cardiometabolic Health

Study Overview
=================
Brief Summary
-----------------
The goal of the proposed study is to determine the effects of fresh watermelon fruit consumption on satiety, metabolic parameters and weight management.

Official Title
-----------------
Effects of Fresh Watermelon Consumption on Satiety and Cardiometabolic Health

Conditions
-----------------
Satiety

Intervention / Treatment
-----------------
* Other: Watermelon
* Other: Low fat cookies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-55 years old BMI 25-40 Exclusion Criteria: Smoker Pregnant woman Required dietary supplement use Required medication of metabolic disorders Allergy to watermelon or gluten

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Watermelon<br> | Other: Watermelon<br>* Participants will consume 100 Kcal of watermelon fruit (2 cups) daily for 4 weeks.<br>|
| Active Comparator: Low fat cookies<br> | Other: Low fat cookies<br>* Participants will consume 100 Kcal of low fat cookies daily for 4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Satiety | Hunger feeling (appetite) will be examined using visual analog scale (0-10): 0 is least and 10 greatest. | 0, 20, 40, 60, 90 and 120 minutes post snack consumption |
A Study To Investigate The Effect Of PD-217,014 On Abdominal Pain/Discomfort In Patients With IBS.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of abdominal pain/discomfort associated with irritable bowel disease.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Investigate The Effect Of Pd-217,014 In Patients With Irritable Bowel Syndrome (IBS)

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: PD-217,014


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females having Irritable bowel syndrome as defined by the Rome II criteria. Patients must have had normal examination of colon anatomy within the last 5 years Exclusion Criteria: Patient with an organic gastrointestinal disease. Patients with poor renal function. Patients with severe constipation.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PD-217,014|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effect of PD-217,014 on the relief of abdominal pain/discomfort in patients with irritable bowel syndrome. Primary endpoint is a responder, defined by having adequate relief for > or = 50% of the active treatment period (4 weeks). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effect of PD-217,014 on the patient's global assessment of IBS symptoms, stool frequency & consistency and on abdominal bloating (change from baseline to week 4). |  |  |