linjc16/ctgov huggingface dataset:
DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.

Study Overview
=================
Brief Summary
-----------------
Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.

Official Title
-----------------
DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.

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

Intervention / Treatment
-----------------
* Drug: Levonorgestrel IUD or Copper IUD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-49 years old female. Women who is visited by a gynecology or primary care physician and starts contraception with an IUD/IUS. Women that has not used hormonal contraception in any form in the last 3 months. Women who have no problems listening, reading or writing. Women who gives their written consent to participate in the study. Exclusion Criteria: Women who have contraindications to use IUDs. Women with previous experience with IUDs. Women who initiates the use of IUDs for other purposes other than contraception. Woman who is participating in a clinical trial at the time of initiating the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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 |
| --- | --- |
| Group 1<br> | Drug: Levonorgestrel IUD or Copper IUD<br>* Women who initiate the use of an IUD at the time of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on quality of life of women initiating IUD in a Spanish population assessed by questionnaire. |  | After 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic Data (Age, Place of Birth, Level of Education, Employment status, Personal marital situation, etc.) assessed by questionnaire. |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HRQoL, IUD, Contraception, SEC-QoL
Clinician Access to Soldier Suicide Information (CASSI)

Study Overview
=================
Brief Summary
-----------------
The overall objective of this project is to conduct a feasibility study using data proved by Department of Defense National Center for Telehealth and Technology (T2) toward the ultimate goal of establishing a mechanism by which VA clinicians could access data on Veterans regarding suicidal thoughts and/or behaviors that occurred when they were on active duty, as documented in the Department of Defense Suicide Event Report (DoDSER).

Detailed Description
-----------------
As a first step toward the overall goal of this project, the investigators will use data from T2 to conduct the first stage of a feasibility study. Specifically, the investigators will attempt to match Social Security numbers (SSNs) of Soldiers who have had suicidal thoughts and/or behaviors in the DoDSER against SSNs of Veterans seeking mental health services at any VA in the United States. Once this first step has been accomplished, the investigators also aim to describe the group of Veterans with DoDSERs who are accessing VA services (i.e., demographic information, military service variables, and health care utilization variables) in an attempt to better understand this group. It is anticipated that if this study is successful, a next step would be to explore the possibility of DoDSER data sharing with VA partners toward attainment of the following long-term goals: 1. Sharing information on history of active duty suicidal thoughts and/or behaviors among discharged individuals seeking mental health services in VA systems; 2. Facilitating identification of these Veterans; 3. Reducing VA clinician burden though effective access to existing data that may help in assessment and treatment planning; 4. Lowering health care costs through effective early management; 5. Improving quality of care for Veterans seeking services through VA outpatient mental health clinics.

Official Title
-----------------
Clinician Access to Soldier Suicide Information (CASSI)

Conditions
-----------------
Suicide

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Identified with a history of suicidal thoughts and/or behaviors, as recorded in the Army DoDSER Exclusion Criteria: Death by suicide contained in the Army DoDSER (i.e., this information will not be sent to us by T2)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- | --- |
Rheumatology Clinical Registry

Study Overview
=================
Brief Summary
-----------------
The ACR Rheumatology Clinical Registry (RCR) is a tool developed to assist members in practice improvement, local population management, and efficient, successful participation in national quality programs. RCR integrates evidence-based quality measures aimed at improving care and drug safety for patients with rheumatoid arthritis, osteoarthritis, osteoporosis, gout and juvenile idiopathic arthritis.

Official Title
-----------------
American College of Rheumatology Clinical Registry

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Rheumatoid Arthritis Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- | --- |
| Quality of the treatment of rheumatoid arthritis and other diseases |  | Up to a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Submission to federal reporting programs |  | Up to a year |
Single-dose Escalation Trial of M2ES in Healthy Volunteer

Study Overview
=================
Brief Summary
-----------------
This is a randomized double-blinded placebo-controlled，single-dose escalation trial in healthy volunteer.

Detailed Description
-----------------
Randomized double-blinded placebo-controlled，single-dose escalation trial in health volunteer,to determine the safety and the max tolerate dose in health volunteer.

Official Title
-----------------
Randomized ，Placebo-controlled,Single-dose Escalation Trial of M2ES in Healthy Volunteer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: placebo
* Drug: M2ES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physical and mental healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening. 19 to 45 years of age. Body mass index (19-25 kg/m2) ,the body weight ≥55kg for male subject,≥45kg for female. Negative pregnant test, no menstrual period for female. willing to comply with the protocol. Exclusion Criteria: Be allergic to endostatin Have taken any drug during the last 2 weeks Have Participated any clinical trail during the last 2 week Cardiovasculre, respiratory, Liver, renal, gastro-intestinal hematologic endocrine and mental disease HIV-1 infected HBV, HBV infected ,Hepatitis B surface antigen positive

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M2ES 7.5-90mg<br>M2ES dose escalating | Drug: M2ES<br>* M2ES IV 7.5mg-90mg<br>* Other names: M2ES esculating;|
| Placebo Comparator: Placebo<br>placebo contract | Other: placebo<br>* placebo<br>* Other names: placebo conparator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability | To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Subjects With Advanced Solid Tumors | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) behavior | Pharmacokinetic (PK) behavior of two different doses in healthy volunteers | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer
Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation

Study Overview
=================
Brief Summary
-----------------
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Femina (Lactic Acid) Pocket BR.

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Pocket BR.

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 18 and 60 years old; Phototype Skin I,II, III e IV Integral skin test in the region; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression drugs one month before the study; Personnel history of atopy; History of sensitivity or irritation for topic products; Active cutaneous disease; Use of new drugs or cosmetics during the study; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lactic Acid | Drug: Lactic Acid<br>* Drug: Lactic Acid (Dermacyd Femina)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. |  | Throughout the study | 
| The sensibility will be evaluated according to the skin type. |  | Throughout the study |
Effect of PDRN in Post-operative Scars

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to evaluate the efficacy of PDRN administration in early wound healing phase on prevention of post-operative scars after open thyroidectomy.

Official Title
-----------------
Early Postoperative Injections of Polydeoxyribonucleotide Prevents Hypertrophic Scarring After Thyroidectomy: A Randomized Controlled Trial

Conditions
-----------------
Scar

Intervention / Treatment
-----------------
* Procedure: Polydeoxyribonucleotide (PDRN)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Participants who underwent open thyroidectomy between February 2019 and March 2021 at the Thyroid Cancer Center, Department of otorhinolaryngology, Seoul National University Bundang Hospital Exclusion Criteria: age younger than 20 years or older than 60 years history of keloid development requirement for modified radical neck dissection previous neck surgery current pregnancy or breast feeding allergy to PDRN taking medications that may affect inflammation and would healing such as isotretinoin, anti-cancer drugs, high dose corticosteroids, and anticoagulants uncontrolled medical diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDRN injected group<br>The participants in treatment group had received two consecutive injections of PDRN one day and two days after the surgery. A total 1mL of PDRN was injected along the suture line at distance of 1cm in each session. | Procedure: Polydeoxyribonucleotide (PDRN)<br>* A total 1mL of PDRN was injected along the suture line at distance of 1cm in one day and two days after the surgery.<br>|
| No Intervention: Control group<br>The participants in control group were left untreated. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Vancouver Scar Scale (0 normal skin 15 worst) at the 3-month follow-up | modified Vancouver Scar Scale (0 normal skin 15 worst) | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective symptoms at the 3-month follow-up | Pain and itching were assessed using a visual analog scale (VAS) ranged from 0 (no) to 10 (worst). | at 3 months | 
| Erythema and pigmentation at the 3-month follow-up | Erythema Index (EI, arbitrary unit) and the Melanin Index (MI,arbitrary unit) | at 3 months | 
| Scar Height (mm) at the 3-month follow-up | 3D images of the scars were acquired with an Antera 3D® camera (Miravex Limited, Dublin, Ireland) | at 3 months |
Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that home based HIV counseling and testing can increase male partner uptake of HIV testing during pregnancy. The investigators study aims through a randomized clinical trial to determine whether a home-based model (HBM) versus a partner-friendly clinic model (PFM) can increase male uptake of HIV counseling and testing during pregnancy.

Official Title
-----------------
Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy: A Randomized Clinical Trial

Conditions
-----------------
Male Partner, HIV Counseling and Testing, Home Based, Pregnancy

Intervention / Treatment
-----------------
* Other: HIV counseling and testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women and their male partners Exclusion Criteria: Non-pregnant, minors, inability to live in study area for 6 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Partner friendly arm<br>Proportion of males counseled and tested using routine standards of prenatal care | Other: HIV counseling and testing<br>* Male partner HIV counseling and testing<br>|
| Experimental: Home based arm<br>Proportion of male partners accepting HIV counseling and testing following home visits for couple HIV counseling and testing during pregnancy | Other: HIV counseling and testing<br>* Male partner HIV counseling and testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Male Partners Counseled and Tested for HIV During Pregnancy | To determine male partner acceptability of counseling and testing within a six week period following the counseling and testing of the pregnant woman. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male partner, HIV counseling and testing, Home based, Pregnancy
Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy. This protocol also includes patients with metastatic breast cancer who have not had mastectomy but have advanced tumor remaining within the breast. Doxil is the drug adriamycin (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount of lipid (fat). This chemotherapy is in a newer form which can be better delivered to the tumor tissue without causing as much systemic toxicity. We are combining heat treatment with this drug in an effort to further increase the delivery of drug to the tumor, which may give an increased tumor response. Methods: The patients will be treated with chemotherapy followed by heat treatment. This will be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor.

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

Intervention / Treatment
-----------------
* Drug: Doxil
* Procedure: heat treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with recurrent or metastatic breast cancer

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Doxil|nan|
|Procedure: heat treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
18850 - Human Photoallergy Test

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential of a test material to produce a photoallergic response.

Official Title
-----------------
Human Photoallergy Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: Sunscreening Sport Spray Rest (BAY987519)
* Other: Untreated skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be male or female between the ages of 18 and 60 inclusive; be lightly pigmented (Fitzpatrick Skin Type I, II, III); have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164; be in general good health as determined by the subject's medical history and in the discretion of the investigator. Exclusion Criteria: have a visible sunburn; have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products. subjects who are employees of the CRO and/or Bayer or is a household member of an employee

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987519<br>All subjects are patched . | Drug: Sunscreening Sport Spray Rest (BAY987519)<br>* 50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.(Formulation Number - RB# Y51-002 )<br>Other: Untreated skin<br>* One site is patched without treatment as control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions is evaluated by 5 point grading scale |  | Up to 72 hours |