linjc16/ctgov huggingface dataset:
CP-481,715 Nickel Allergy Study.

Study Overview
=================
Brief Summary
-----------------
To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine receptor-1 antagonist.

Official Title
-----------------
Placebo-Controlled, Randomized, Parallel Group, Multiple-Dose Study to Evaluate the Effects of CP-481,715 on Clinical Response and Cellular Infiltration Following Contact Allergen Challenge to the Skin of Nickel Allergic Subjects.

Conditions
-----------------
Dermatitis, Allergic Contact

Intervention / Treatment
-----------------
* Drug: CP-481,715


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A history of nickel allergy confirmed by a visual positive reaction (graded at least ++) to T.R.U.E. TEST. Exclusion Criteria: Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding contact allergic dermatitis or untreated, asymptomatic, seasonal allergies at time of dosing).

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-481,715|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of CP-481,715 on clinical response and cell infiltration after nickel challenge |  |  |
An Observational Study of RoActemra/Actemra (Tocilizumab) in Smoking Versus Non-Smoking Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This observational study will assess the efficacy and safety of RoActemra/Actemra (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from patients treated in routine clinical practice with intravenous RoActemra/Actemra will be collected for 12 months each.

Official Title
-----------------
An Observational Study of the Efficacy of RoActemra in Smoking vs Non-smoking Patients With Rheumatoid Arthritis.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, > 18 years of age Rheumatoid arthritis, defined as fulfilling at least 4 of 7 American College of Rheumatology (ACR) criteria Treatment with RoActemra/Actemra Exclusion Criteria: Participation in interventional clinical studies

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease activity score (DAS 28) |  | 12 months | 
| Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 36 months | 
| Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire |  | 12 months | 
| Rate of patients achieving remission (DAS <2.6) |  | 36 months | 
| Change in blood lipids |  | 12 months | 
| Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate |  | 36 months |
Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to characterize paraffin oil induced granulomatous disease. We will investigate pathogenesis and natural history of paraffin disease. Subsequently, through further translational studies, we intend to identify novel treatments to be tested in future randomized clinical trials.

Official Title
-----------------
Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments

Conditions
-----------------
Hypercalcemia, Renal Injury, Paraffinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previous intramuscular injection of paraffin or other oil Exclusion Criteria: none

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia | Hypercalcemia in plasma (exploratory not intervention study). yes or no and level. | at first examination or developed during observation period until 2025 | 
| Number of patients with concentration of parathyroid hormone PTH in plasma below normal range | PTH level in plasma indicator of hypercalcemia | at first examination or developed during observation period until 2025 |
High-definition Transcranial Direct Current Stimulation (HD-tDCS) Verbal Learning

Study Overview
=================
Brief Summary
-----------------
This project will use a new form of non-invasive brain stimulation called high-definition transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the brain important for learning and memory will improve verbal learning and memory compared to sham HD-tDCS.

Official Title
-----------------
Enhancing Verbal Learning and Memory Using High-Definition Transcranial Direct Current Stimulation (HD-tDCS)

Conditions
-----------------
Verbal Learning and Memory

Intervention / Treatment
-----------------
* Device: HD-tDCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 - 40 years Right-handed Exclusion Criteria: concurrent medication likely to affect mental performance current history of drug or alcohol abuse or dependence any psychiatric or neurological disorder, recent head injury, or history of seizure or stroke.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham HD-tDCS<br> | Device: HD-tDCS<br> <br> |
| Active Comparator: Active HD-tDCS 1<br> | Device: HD-tDCS<br> <br> |
| Active Comparator: Active HD-tDCS 2<br> | Device: HD-tDCS<br> <br> |
| Active Comparator: Active HD-tDCS 3<br> | Device: HD-tDCS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ray Auditory Verbal Learning Test (RAVLT) |  |  |
Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not

Study Overview
=================
Brief Summary
-----------------
Purpose: Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not Comparison of the ultrasound semiology of enthesitis in the 3 populations Comparison of the MASEI scores in the 3 populations

Official Title
-----------------
Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.

Conditions
-----------------
Peripheral Entheses

Intervention / Treatment
-----------------
* Biological: BLOOD SAMPLES
* Device: Radiographs of the sacroiliac joints
* Device: Radiographs of heels
* Device: SCAN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Axial spondyloarthritis according to the ASAS classification criteria 18-45 years old Athletes are defined by sport activities greater than or equal to 6 hours per week Non athletes are defined by sport activities lesser than or equal to 1 hour per week Exclusion Criteria: - History of heel or ankle surgery Recent corticosteroid infiltration of the heel or the ankle

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the patients with SpA<br> | Biological: BLOOD SAMPLES<br> <br> Device: Radiographs of the sacroiliac joints<br> <br> Device: Radiographs of heels<br> <br> Device: SCAN<br> <br> |
| Experimental: sports subjects<br> | Biological: BLOOD SAMPLES<br> <br> Device: Radiographs of the sacroiliac joints<br> <br> Device: Radiographs of heels<br> <br> Device: SCAN<br> <br> |
| Other: control subjects<br> | Biological: BLOOD SAMPLES<br> <br> Device: Radiographs of the sacroiliac joints<br> <br> Device: Radiographs of heels<br> <br> Device: SCAN<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enthesitis detection | Number of subject having at least an enthesitis in every group of subjects | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MASEI scores |  | 12 months |
Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the short and long term complications after an abdominal or vaginal hysterectomy and to detect the prevalence of occult/subclinical haematomas and vaginal cuff abscesses and the postoperative course of these. The investigators will also evaluate the physical and mental well being after a hysterectomy with a questionnaire and correlate these results with the occurrence of complications.

Detailed Description
-----------------
Hysterectomy is the most common major gynaecological operation performed worldwide. The overall average rate of hysterectomy in the United States is 5.6 per 1000 women. There are three different procedures to perform a hysterectomy. The surgery can be approached abdominally, vaginally or as a laparoscopically assisted hysterectomy. This study will contribute to the improvement of knowledge in short and long term complications and especially the prevalence of occult and subclinical haematomas and vaginal abscesses after abdominal or vaginal hysterectomy. The occurrence of short and long term complications will have an influence on the general well being of the patient. We will also evaluate the physical and mental well being of the patient after a hysterectomy. After statistical analysis of the study outcome parameters, some conclusions can be drawn for the treatment policy after an abdominal or vaginal hysterectomy to reduce the complication rate and improve the general well being of our patients.

Official Title
-----------------
Prospective Investigation of the Incidence of Complications After Vaginal and Abdominal Hysterectomy

Conditions
-----------------
Hysterectomy

Intervention / Treatment
-----------------
* Procedure: hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Benign indication for undergoing of a hysterectomy Written informed consent of the patient Exclusion Criteria: Inability to undergo an operation due to high surgical or anaesthetic risk Malignancy as indication for the hysterectomy Patients with an enterocele or rectocele and who need prolapse surgery
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hysterectomy|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
-----------------
vaginal hysterectomy, abdominal hysterectomy, complications, physical well being, mental well being
Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model

Study Overview
=================
Brief Summary
-----------------
This study proposes evaluation of an educational tool, a laparoscopic virtual reality simulator. The purpose of this study is to determine whether training on the LapSim Simulator transfers to improved laparoscopic cholecystectomy operative performance in an animal model.

Detailed Description
-----------------
This is study protocol involves the training and evaluation of general surgery interns on a laparoscopic simulator (LapSim®, Surgical Science Ltd, Göteborg, Sweden, version 3.0.

Official Title
-----------------
Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model

Conditions
-----------------
Gallstones

Intervention / Treatment
-----------------
* Behavioral: Virtual reality laparoscopic simulator training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical interns (PGY 1) are eligible Twenty-five (25) participants will comprise this group Exclusion Criteria: Prior clinical experience with laparoscopic surgery as the assistant surgeon. Prior simulation training (mechanical, PC-based or otherwise).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Virtual reality laparoscopic simulator<br>Virtual reality laparoscopic simulator training: Residents will participate in a structured approach to teaching laparoscopic skills to beginning surgeons with a virtual reality trainer will improve skills prior to actual operative experience. | Behavioral: Virtual reality laparoscopic simulator training<br>* The aim of this project is to determine whether a structured approach to teaching laparoscopic skills to beginning surgeons with a virtual reality trainer will improve skills prior to actual operative experience. We aim to show that with the virtual reality trainer, operative skills will be improved and that overall operative time will be decreased.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Global Outcomes Assessment of Laparoscopic Skills |  | 5 weeks, 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resident training, laparoscopic skills, surgical skills assessment
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

Detailed Description
-----------------
A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.05% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.05% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Official Title
-----------------
A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.05% to RETIN-A® (TRETINOIN) CREAM, 0.05% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Tretinoin cream, 0.05%
* Drug: RETIN-A® (tretinoin) cream, 0.05%
* Drug: Vehicle of the test product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below). Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 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
Interventional Model Description: Bioequivalence
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tretinoin cream, 0.05%<br>Apply once a day application, under at-home use conditions. | Drug: Tretinoin cream, 0.05%<br>* Tretinoin cream, 0.05%<br>* Other names: Tretinoin;|
| Active Comparator: RETIN-A® (tretinoin) cream, 0.05%<br>Apply once a day application, under at-home use conditions. | Drug: RETIN-A® (tretinoin) cream, 0.05%<br>* RETIN-A® (tretinoin) cream, 0.05%<br>* Other names: Tretinoin;|
| Placebo Comparator: Vehicle of the test product<br>Apply once a day application, under at-home use conditions. | Drug: Vehicle of the test product<br>* Vehicle of the test product<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of Bioequivalence | Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts | 12 weeks |
Effects of Soy Consumption on Symptoms of Menopause

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the way soy consumption affects menopausal symptoms in middle-aged Japanese women.

Detailed Description
-----------------
For the past 20 years, Japanese women have reported fewer menopausal symptoms than their North American counterparts. One explanation for the disparity is the differences in diet. Evidence suggests that Japanese women consume large amounts of soy, a phytoestrogen that is structurally similar to the hormone estrogen. However, there is a lack of menopause-related research data from non-Western populations. This study will be a long-term observation of the effects of soy consumption in menopausal Japanese women. This study will last 6 months. Participants will complete a dietary log and a menopausal symptom checklist daily. There will be three or four study visits. During these visits, participants will complete a diet questionnaire, have a blood sample collected, and be interviewed about their menopausal symptoms. Six months after study completion, participants will be sent a questionnaire about any recent menopausal symptoms they may have experienced.

Official Title
-----------------
Influence of Soy Consumption on Menopause

Conditions
-----------------
Menopause

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese resident Menopausal Exclusion Criteria: Hysterectomy, removal of ovaries, or tubal ligation with subsequent menstrual changes Hormones for menopause or birth control pills within 5 years of study entry Recent major illness Medication that could affect naturally-produced hormones

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 55 Years

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

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
-----------------
Women, Soy Foods, Middle Aged