linjc16/ctgov huggingface dataset:
Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)

Study Overview
=================
Brief Summary
-----------------
The aims of this trial are to evaluate the efficacy of bendamustin in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-baesd chemotherapy and to assess the treatment of toxicity.

Official Title
-----------------
Multicenter Phase II Study With Bendamustin for Patients With Refractory Soft Tissue Sarcoma

Conditions
-----------------
Sarcoma, Soft Tissue

Intervention / Treatment
-----------------
* Drug: Bendamustin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed metastatic or non-resectable soft tissue sarcoma Evidence of progression or relapse after an anthracycline-based and/ or ifosfamide-based chemotherapy At least 1 bidimensionally measurable tumor lesion according to RECIST criteria No previous radiation therapy on the only measurable lesion Willingness to receive regular follow-up Life expectancy more than 3 months ECOG status >= 2 Patients aged 18 years and beyond leucocytes > 2500/µl, thrombocytes > 75000/µl) Serum creatine < 1,5 times the upper limit of normal value, GFR > 60/ml Written patient informed consent Ability to give informed consent Exclusion Criteria: Previous or concurrent radiation of the index lesion (radiation of single lesion is allowed if not the index lesion) Insufficient liver function (bilirubin > 1.5 the upper limit of normal, prolongation of PT and aPTT > 1.5 the upper limit of normal; ASAT and ALAT > 3 the upper limit of normal (patients with liver metastases ASAT and ALAT > 5 the upper limit of normal) Active infection Prior therapy with Bendamustin hydrochloride Prior malignancies (other than adequately treated carcinoma in situ (CIS) of the cervix, bladder urothelium, basal cell carcinoma or adenoma of the colon including pTIS,pTIN), unless treated with curative intent and without evidence of disease > 5 years Symptomatic cardio- and/or cerebrovascular disease (NYHA-Scale III°) Interval since last chemotherapy < 4 weeks Evidence of CNS-metastases Evidence of pregnancy or lactation Woman of child-bearing potential without reliable methods of birth control

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: Bendamustin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Seroprevalence of Covid-19 in the Staff of the University Hospitals of Strasbourg

Study Overview
=================
Brief Summary
-----------------
The Grand Est region is one of the most affected regions in France during the first wave of the COVID-19 epidemic. A significant increase in the number of patients hospitalized for SARS-CoV 2 infection at the University Hospitals of Strasbourg (HUS) led to a sudden saturation of their capacities. Hospital workers appear to be a population at particular risk for this new infectious agent. The percentage of hospital workers who have been in contact with the virus or have contracted COVID-19 is unknown. The objective of this work is to determine the prevalence of SARS-CoV-2 positive serologies among hospital staff screened from June 22, 2020 to November 1, 2020 following a screening campaign offering serological testing to all volunteer HUS professionals.

Official Title
-----------------
Seroprevalence of SARS-CoV 2 in the Staff of the University Hospitals of Strasbourg

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult subject (≥ 18 years of age) Hospital staff practicing at HUS who performed SARS-CoV 2 serology in the period from 06/22/2020 to 11/1/2020 Exclusion criteria: - Subject not meeting inclusion criteria

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 |
| --- | --- | --- |
| To determine the positive seroprevalence of SARS-CoV-2 among hospital staff screened from June 22, 2020 to November 1, 2020 | Seroprevalence will be estimated by calculating the rate of seropositive subjects with its 95% confidence interval | Files analysed retrospectively from June 22, 2020 to November 1, 2020 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-COV-2, Prevalence of SARS-CoV-2
Collection of Blood Samples From SMART Study Participants for Future Genetic Studies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.

Detailed Description
-----------------
Despite progress in the treatment of HIV and a greater understanding of the pathophysiology of HIV infection, there are still unexplained differences in both the progression of untreated HIV infection and response to antiretroviral therapy. These differences are likely related to the unique genetic makeup of individuals with HIV infection. Particular genes may offer protection against HIV infection, while other genes may make disease progression more likely. Knowing more about the genetic makeup of HIV infected individuals may lead to the development of a targeted treatment strategy based on an individual's specific risk of disease progression and sensitivity to medication toxicity. The purpose of this substudy is to collect blood samples from SMART study participants. The samples will be used in future Community Programs for Clinical Research on AIDS (CPCRA) studies investigating the link between human genetic factors and clinical outcome data. This study will enroll individuals currently participating in the SMART study. Participants will provide one blood sample. Individual test results from future blood analyses will not be provided to a patient unless they may have profound health implications for that patient.

Official Title
-----------------
Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coenrollment in the SMART study Parent or guardian willing to provide informed consent, if applicable

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Experienced
ERG/EOG Study in AMD Patients Treated With Ranibizumab

Study Overview
=================
Brief Summary
-----------------
This is an open-label study assessing electrophysiologic testing of the retina with Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD.

Official Title
-----------------
ERG/EOG Study in AMD Patients Treated With Ranibizumab

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age >55 years Patients to be included in the study must have AMD with choroidal neovascularization BCVA between 20/20 - 20/400 Lesion size less than or equal to 12 MPS disc areas Exclusion Criteria: Prior treatment with an anti-VEGF agent within 6 months of enrollment in this study Pregnancy (positive pregnancy test) Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch Prior enrollment in the study Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated Participation in another simultaneous medical investigation or trial Media insufficient to obtain a view Other causes of CNV not related to AMD Active ocular or peri-ocular infection Ocular surgery within 1 month prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| AMD Patients<br> | Drug: Ranibizumab<br>* 0.05 ml of ranibizumab injected into the eye monthly for one year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ERG/EOG |  | 1 year |
P Wave and QT Dispersion in Psoriasis

Study Overview
=================
Brief Summary
-----------------
Background: Several reports have demonstrated an association between psoriasis and cardiovascular diseases. P wave dispersion (PWD) is the most important electrocardiographic (ECG) markers used to evaluate the risk of atrial arrhythmias. QT dispersion (QTD) can be used to assess homogeneity of cardiac repolarization and may be a risk for ventricular arrhythmias. Aim: To search PWD and QTD in patients with psoriasis. Methods: Ninety-four outpatient psoriasis patients and 51 healthy people were evaluated by physical examination, 12-lead ECG and transthoracic echocardiography. Severity of the psoriasis was evaluated by psoriasis Area and Severity Index (PASI).

Detailed Description
-----------------
Ninety-four outpatient psoriasis patients and 51 healthy people were included in the study. Patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease, significant valvular heart disease, chronic obstructive pulmonary disease, hypo or hyper-thyroidism, renal failure or any associated systemic disease were excluded. Diagnosis of psoriasis was confirmed by dermatological examination and/or punch biopsy. Severity of the psoriasis was evaluated by psoriasis area and severity index (PASI). Patients were evaluated by physical examination, 12-lead electrocardiography and transthoracic echocardiography.

Official Title
-----------------
Increased Risk of Atrial and Ventricular Arrhythmia in Long-lasting Psoriasis

Conditions
-----------------
Arrhytmia in Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease, significant valvular heart disease, chronic obstructive pulmonary disease, hypo or hyper-thyroidism, renal failure or any associated systemic disease were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 72 Years

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 |
| --- | --- | --- |
| duration of p wave and QT interval |  | 3 -360 months |
Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.

Official Title
-----------------
A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations

Conditions
-----------------
Microcystic Lymphatic Malformation

Intervention / Treatment
-----------------
* Drug: PTX-022


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be 13 years or older Diagnosed with Microcystic Lymphatic Malformations Able and willing to comply with all protocol-required activities Willing and able to provide written informed consent Exclusion Criteria: Any significant concurrent condition that could adversely affect participation. Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022 Patient's deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, including adherence to study drug administration and other protocol-required activities.

Ages Eligible for Study
-----------------
Minimum Age: 13 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
Interventional Model Description: This is an open-label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: PTX-022<br>PTX-022 QTORIN | Drug: PTX-022<br>* Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinician global assessment from Baseline to Month 4 |  | 4 months | 
| Change in patient global assessment from Baseline to Month 4 |  | 4 months |
Systematic Initiative to Increase Activity in Schools

Study Overview
=================
Brief Summary
-----------------
This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.

Detailed Description
-----------------
This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness. Forty-nine schools participated in the study providing de-identified fitness data for students for 3 consecutive years. Twenty-five schools initiated physical activity interventions in year one and 24 schools initiating physical activity interventions in year two.

Official Title
-----------------
Systematic Initiative to Increase Activity in Schools

Conditions
-----------------
Obesity, Cardiovascular Fitness

Intervention / Treatment
-----------------
* Behavioral: physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all children between 3rd and 8th grade Exclusion Criteria: children who could not perform PACER (exercise)

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention schools<br>These schools were promoting 4 strategies to increase physical activity in students. | Behavioral: physical activity<br>* 4 strategies are: (1) increased activity time during physical education class, (2) active recess, (3) opportunities for activity before and after school, and (4) active classroom breaks<br>|
| Control schools<br>These schools continued with standard programming for activity during year 1, and implemented intervention during years 2 and 3. | Behavioral: physical activity<br>* 4 strategies are: (1) increased activity time during physical education class, (2) active recess, (3) opportunities for activity before and after school, and (4) active classroom breaks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PACER fitness test | PACER is a 20 meter shuttle run in PE class | performed every 6 months each school year for 3 years |
Allogeneic HSCT in MDS Patients Based on Risk According to R-IPSS

Study Overview
=================
Brief Summary
-----------------
An intention-to-treat study to evaluate the impact of allogeneic HSCT with Total Marrow and Lymphoid irradiation (TMLI), followed by Treg/Tcon adoptive immunotherapy, on overall survival in patients affected by Myelodysplastic Syndrome (MDS), according to IPSS-R.

Detailed Description
-----------------
MDS patients with Intermediate, High, or Very-High R-IPSS risk will be enrolled. Allogeneic stem cell transplantation with regulatory and conventional T cell adoptive immunotherapy will be proposed to eligible High and Very-High risk MDS patients. Intermediate risk MDS patients will be assessed for risk modification every six months and moved to transplant in case of increased risk. Intermediate risk MDS patients will be also evaluated for the presence of molecular alterations (TP53, ASXL1, RUNX1). Overall survival of the entire cohort will be assessed as primary endpoint. Incidence of Treatment Related Mortality, acute Graft versus Host Disease, chronic Graft versus Host Disease, Relapse will be also assessed.

Official Title
-----------------
Allogeneic Transplantation in Patients With Myelodysplastic Syndrome Based on Risk According to Revised-International Prognostic Scoring System (R-IPSS)

Conditions
-----------------
MDS and Allogeneic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Other: MDS and AlloHSCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients affected by Myelodysplastic Syndrome with IPSS-R INT, HIGH or VERY HIGH; Age <71 years; Signature of the informed consent. Exclusion Criteria: Patients affected by Myelodysplastic Syndrome with IPSS-R VERY LOW or LOW; Patients affected by Myelodysplastic Syndrome/Myeloproliferative Neoplasm; Age >70 years; No signature of the informed consent

Ages Eligible for Study
-----------------
Maximum Age: 70 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 |
| --- | --- |
| Other: SINGLE ARM<br> | Other: MDS and AlloHSCT<br>* Allogeneic stem cell transplantation, based on TMLI and followed by infusion of donor regulatory T cells and conventional T cells and purified donor CD34+ hematopoietic stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | We will evaluate overall survival in patients with intermediate/High/very-High risk MDS | 4 years |
Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

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

Intervention / Treatment
-----------------
* Drug: Adapalene/Benzoyl Peroxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical diagnosis of acne vulgaris with facial involvement. A minimum of 20 but not more than 50 inflammatory lesions A minimum of 30 but not more than 100 noninflammatory lesions A score of 3 (Moderate) on the Investigator's Global Assessment Scale

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Adapalene/Benzoyl Peroxide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate on the Investigator's Global Assessment |  |  | 
| Change in inflammatory lesion counts |  |  | 
| Change in noninflammatory lesion counts |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in lesion counts (inflammatory, noninflammatory, total) |  |  | 
| Change in Investigator's Global Assessment (IGA) |  |  | 
| Subject's assessment of acne |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne vulgaris, Adapalene, Benzoyl Peroxide