linjc16/ctgov huggingface dataset:
The Search for Viral and Bacterial Etiology of Varicocele

Study Overview
=================
Brief Summary
-----------------
This study is to answer the question is there any relationship between viral ( HSV 1 , HSV 2 , HPV 6/11, CMV, HHV 6 , HHV 8, BKV) or bacterial (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Fusobacterium nucleatum) infection and occurrence of varicocele in men.

Official Title
-----------------
The Search for Viral and Bacterial Etiology of Varicocele

Conditions
-----------------
Varicocele, Viral Infection, Bacterial Infections, Sonic Hedgehog Expression, VEGF Expression

Intervention / Treatment
-----------------
* Procedure: subinguinal microscopic varicocelectomy
* Procedure: open hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in experimental arm - varicocele grade II or III and infertility and/or pain Exclusion Criteria: in control arm: presence of varicocele in ultrasound before surgery

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microsurgery urology<br>20 patients with varicocele (grade II or III) undergoing subinguinal microsurgery varicocelectomy due to infertility and/or pain in the scrotum. | Procedure: subinguinal microscopic varicocelectomy<br>* During the procedure approximately 1cm long fragment of varicose vein will be taken for further investigation.<br>|
| Active Comparator: open general surgery<br>20 patients (without varicocele) undergoing open hernia repair. | Procedure: open hernia repair<br>* During the procedure approximately 1cm long fragment of spermatic cord vein will be taken for further investigation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of presence od viral or bacterial infection, level of expression of SHH and VEGF in varicose vein wall. . | Qualitative and quantitive analysis (presence and concentration - µl or U/µl in two different laboratory tests.) to detect genetic material (DNA, mRNA) of bacteria/viruses will be performed. The outcomes from both gropus will be compared. | one year after finishing recruitment |
Skintel Integration Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI) (MI).

Official Title
-----------------
Skintel Integration Study for Use With the Elite+ Laser System

Conditions
-----------------
Skin Type From I-VI on Non-hair Bearing Skin

Intervention / Treatment
-----------------
* Device: Skintel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older Able to read, understand, and sign the Informed Consent Form Willing and able to comply with all study requirements Exclusion Criteria: Hypersensitivity to light in the near infrared wavelength region Sun-damaged skin (treatment contraindicated with Alex laser only) Unprotected sun exposure (for Alex laser within four weeks of treatment; for Nd:YAG laser within one week of treatment), including the use of tanning beds or tanning products, such as creams, lotions and sprays Take medication which is known to increase sensitivity to sunlight Seizure disorders triggered by light Take anticoagulants Take or have taken oral isotretinoin, such as Accutane®, within the last six months Take medication that alters the wound-healing response History of healing problems or history of keloid formation Active localized or systemic infection, or an open wound in area being treated Significant systemic illness or an illness localized in area being treated History of skin cancer or suspicious lesions Lupus Have received or are receiving or gold therapy Pregnancy, planning on becoming pregnant or have been pregnant recently

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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial. The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skintel<br> | Device: Skintel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index |  | 9 months |
Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.

Official Title
-----------------
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Cilta-cel OOS Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for treatment with cilta-cel per United States Prescribing Information (USPI) Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion Favorable participant benefit/risk assessment determined by Janssen medical review Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP) A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cilta-cel OOS Therapy|Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male subjects.

Official Title
-----------------
Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: NNC0113-0987


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male aged 18 between 55 years (both inclusive) at the time of signing informed consent Good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator Body mass index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive) Exclusion Criteria: History of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator Blood pressure above 140 mmHg systolic and/or above 90 mmHg diastolic or pulse above 90 beats per minute at the screening visit Smoking more than 5 cigarettes or the equivalent per day (including use of nicotine substitute products) History of significant drug abuse, or a positive drug test at the screening visit Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0113-0987<br> | Drug: NNC0113-0987<br>* For oral administration. All subjects will be treated for 10 consecutive days with five days on 5 mg NNC0113-0987 followed by five days on 10 mg NNC0113-0987. Dose escalation is chosen to increase gastrointestinal tolerability.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NNC0113-0987 plasma concentration time curve |  | From time 0 to 24 hours after the 10th dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed NNC0113-0987 plasma concentration |  | 0 to 24 hours after the 10th dosing |
The Prognostic and Predictive Value of the CA-125 Marker in Lung Cancer Monitoring

Study Overview
=================
Brief Summary
-----------------
The tumor associated CA-125antigen for diagnosis and follow-up of ovarian cancer was well defined. Increased serum CA125 level may have many diagnoses other than ovarian cancer, including breast, colorectal and lung cancer. 80% lung cancer patients were diagnosed at advanced stage. Malignant pleural effusion secondary to lung cancer represented the condition of cancer cell involved pleura. The CA-125 level may reflect the extent of tumor involved in pleura (tumor burden), it could be correlated with the prognosis. This study was performed to examine the properties of CA-125 by measuring pleural and blood CA-125 levels in lung cancer with or without malignant pleural effusion; meanwhile to examine whether the rate of decline in CA 125 during primary therapy as a surrogate indicator for survival.

Official Title
-----------------
Determination of the Prognostic and Predictive Value of the Cancer Antigen-125 (CA-125) Marker in Lung Cancer Monitoring

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: serum and pleural effusion CA-125 level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proved lung cancer Exclusion Criteria: History of other cancers within the past 5 years Pregnancy or breast milk feeding TB pleuritis and peritonitis

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: serum and pleural effusion CA-125 level|serum and pleural effusion(if exist) CA-125 are collected: at time of diagnosis every 3 month during treatment stop at the progression or after 12 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic Value of the cancer antigen-125 in lung cancer | Comparison of CA-125 level in serum between lung cancer patients with or without malignant pleural effusion The correlation between serum and pleural effusion CA-125 level | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prognostic value of the cancer antigen-125 in lung cancer | Association of serum/ pleural effusion CA-125 level with Disease-Free Survival and Overall Survival The correlation of CA-125 response at the 3rd , the 6th month between tumor lesion change Analysis of survival in relation to CA-125 response | 24 months |
Concurrent Xeloda and Radiotherapy for Bone Metastases

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Radiosensitization using Xeloda should improve the rate of complete pain relief. Primary Objective: To determine the frequency of pain relief for the proposed regimen. Secondary Objective(s): To determine the duration of pain relief and narcotic relief for the proposed regimen. To determine the frequency of narcotic relief for the proposed regimen. To determine the toxicity of concurrent UFT and radiotherapy in patients with bone metastases.

Official Title
-----------------
Concurrent Xeloda and Radiotherapy for Bone Metastases

Conditions
-----------------
Solid Tumors, Bone Metastases

Intervention / Treatment
-----------------
* Drug: Xeloda
* Procedure: External Beam Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be 18 years of age or older. The patient must have epithelial malignancy. Radiographic evidence of bone metastasis is required. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging. The patient must have pain that appears to be related to the radiographically documented metastasis. Patients must have an estimated life expectancy of 3 months or greater. Signed study-specific informed consent. Karnofsky performance status  40. Calculated creatinine clearance > 50 ml/min

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xeloda|nan|
|Procedure: External Beam Radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of pain relief for the proposed regimen, using a scale that takes into account the subjective feeling and the use of analgesics |  | after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of pain relief and narcotic relief for the proposed regimen after one year |  |  | 
| The frequency of narcotic relief for the proposed regimen after one year |  |  | 
| The toxicity of concurrent UFT and radiotherapy in patients with bone metastases after one year |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid Tumors, Bone Metastases, Radiotherapy, Xeloda, Concurrent, Radiosensitization
Study of CS-3150 in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.

Detailed Description
-----------------
Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension. Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.

Official Title
-----------------
A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: CS-3150
* Drug: Eplerenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged 20 years or older at informed consent Subjects with essential hypertension satisfying the following blood pressure criteria; Sitting SBP: ≥ 140 mmHg and < 180 mmHg Sitting DBP: ≥ 90 mmHg and < 110 mmHg Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg Exclusion Criteria: Secondary hypertension or malignant hypertension Diabetic nephropathy or diabetes mellitus with albuminuria Serum potassium level < 3.5 or ≥ 5.1 mEq/L Reversed day-night life cycle including overnight workers eGFR < 60 mL/min/1.73 m^2

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-3150 2.5 mg<br>CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks | Drug: CS-3150<br> <br> |
| Experimental: CS-3150 5.0 mg<br>CS-3150 5 mg, orally, once daily after breakfast for 12 weeks | Drug: CS-3150<br> <br> |
| Active Comparator: Eplerenone<br>Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks | Drug: Eplerenone<br> <br> * Other names: Inspra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting blood pressure | Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP). | Baseline to end of Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 24 hour average blood pressure | Change from baseline in 24 hour average systolic and diastolic blood pressure. | Baseline to end of Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential hypertension, Mineralocorticoid receptor antagonist, Esaxerenone, Ambulatory blood pressure monitoring
The Effect of Music on Quality of Life in Fibromyalgia Patients

Study Overview
=================
Brief Summary
-----------------
This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS).

Detailed Description
-----------------
This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS). Women diagnosed with FMS for at least 6 months included in the study. 16 patients were in the music treatment group and 51 patients were in the control group. Patients in music treatment group were given a music CD which includes nature sounds recommended by the Turkish Psychological Association. The patients were evaluated with Fibromyalgia Impact Questionnaire (FIQ) before and after the treatment.

Official Title
-----------------
The Effect of Therapeutic Use of Music on Quality of Life in Fibromyalgia Patients: a Randomized Controlled Trial

Conditions
-----------------
Fibromyalgia, Music Therapy, Quality of Life

Intervention / Treatment
-----------------
* Other: music therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients over the age of 18 Being diagnosed as FMS according to 2010 American College of Rheumatology (ACR) criteria for FMS Having the diagnosis of FMS at least six months Exclusion Criteria: Patients with hearing problems, pregnancy, another accompanying central sensitization syndrome or schizophrenia Patients with psychiatric illness Patients whose pharmacological treatment for FMS changed within the last three months Patients without a listening device Patients who do not have a cognitive level to answer the questions in the scale

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 |
| --- | --- |
| Music therapy group<br>Music therapy lasted 30 minutes every day for a total of 20 days. | Other: music therapy<br>* music includes nature sounds recommended by the Turkish Psychological Association<br>|
| Control group<br>No treatment given. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire | Changes in Fibromyalgia Impact Questionnaire, the total score is between 0-100. Higher total scores indicate higher disability | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibromyalgia, music therapy, fibromyalgia Impact Questionnaire