linjc16/ctgov huggingface dataset:
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands

Study Overview
=================
Brief Summary
-----------------
Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the treatment of platysmal bands.

Official Title
-----------------
A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Platysmal Bands

Conditions
-----------------
Platysmal Bands

Intervention / Treatment
-----------------
* Biological: AbobotulinumtoxinA dose 1
* Other: Placebo
* Biological: AbobotulinumtoxinA dose 2
* Biological: AbobotulinumtoxinA dose 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe platysmal bands at maximum contraction as assessed by the Investigator using a photographic scale Platysmal bands graded as Level 3 or 4 at maximum contraction as assessed by the subject using a photographic scale Exclusion Criteria: Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AbobotulinumtoxinA dose 1<br>AbobotulinumtoxinA dose 1 injected into platysma bands | Biological: AbobotulinumtoxinA dose 1<br>* Treatment of platysmal bands<br>|
| Placebo Comparator: placebo<br>placebo injected into platysma bands | Other: Placebo<br>* Treatment of platysmal bands<br>|
| Active Comparator: AbobotulinumtoxinA dose 2<br>AbobotulinumtoxinA dose 2 injected into platysma bands | Biological: AbobotulinumtoxinA dose 2<br>* Treatment of platysmal bands<br>|
| Active Comparator: AbobotulinumtoxinA dose 3<br>AbobotulinumtoxinA dose 3 injected into platysma bands | Biological: AbobotulinumtoxinA dose 3<br>* Treatment of platysmal bands<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo | A responder is defined as a subject who achieves grade 1 or 2 in platysmal band severity on the Investigator Live Assessment (ILA). | Month 1 after treatment |
Triage Now: an Observational, Prospective Multimarker Study of Biomarkers in Patients Presenting With Chest Pain

Study Overview
=================
Brief Summary
-----------------
Study of diagnostic tests for heart attack for patients with chest pain.

Detailed Description
-----------------
Study of multiple biomarkers, including myeloperoxidase, in the evaluation of patients presenting with suspected acute coronary syndrome.

Official Title
-----------------
TRIAGE NOW: Triage in Acute General Chest Pain Patients Evaluation

Conditions
-----------------
Acute Coronary Syndrome, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chest pain and ACS in differential diagnosis Age> 18 years Ability to give informed consent Exclusion Criteria: Trauma Vulnerable populations Known inflammatory condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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
-----------------
ACS, NSTEMI, Myeloperoxidase, nonST segment elevation myocardial infarction
Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.

Official Title
-----------------
Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

Conditions
-----------------
Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: accepted informed consent preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage) Exclusion Criteria: rejected informed consent patients not fit to surgery (according to the general health condition and the clinical tumor stage) pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy |  | 5 years | 
| Number of metastasis or micrometastasis in the sentinel lymphnodes identified through immunofluorescence analysis of pancytokeratins |  | 5 years | 
| Overall survival | Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes. | 5 years | 
| Disease-free survival | Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes. | 5 years |
Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors

Study Overview
=================
Brief Summary
-----------------
Comparative study to determine whether several fertility monitoring products - the DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the DuoFertility monitor.

Detailed Description
-----------------
The investigators plan to recruit 30 women who are currently trying to conceive, and ask them to use the 3 fertility monitors for duration of 3 menstrual cycles. Additionally, during the study the women will be asked to fill in online questionnaires to assess the usability of the monitors. As the spouse is often a critical partner in the purchase decision and compliance, the investigators will also ask the spouse to complete similar online questionnaires.

Official Title
-----------------
Pilot Study Comparing Fertility Monitors: DuoFertility Monitor, LadyComp/Babycomp Monitor and Clearblue Ovulation Tests in Support of FDA Application

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing and able to give informed consent for participation Females aged 18 to 44 years Have a body mass index (BMI) above 19 and below 29 Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months Minimum menstrual cycle 24 days Maximum menstrual cycle 33 days Female participants willing to use the 3 fertility monitors for at least 3 cycles. Willing to fill in regular questionnaires and study diaries Exclusion Criteria: Women aged younger than 18 years, or older than 44 years Have a BMI less than 18 or greater than 29 Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases Polycystic ovary disease Endometriosis or other pelvic pathology (including proven tubal disease) Taking steroids, including oral contraceptives or anti inflammatory drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 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 |
| --- | --- | --- |
Population-based Age-stratified Seroepidemiological Investigation Protocol for Coronavirus 2019 (COVID-19) Infection in the Federation of Bosnia and Herzegovina

Study Overview
=================
Brief Summary
-----------------
This study is the second cross-sectional study conducted in the region. In the first cross sectional study, conducted in the winter of 2020, we aimed to estimate the seroprevalence of SARS-CoV-2 IgG antibodies among blood donors in Sarajevo Canton. We also assessed immune durability among seropositive participants after 6 months. In total, of 1015 blood donors aged 18-65 years in Sarajevo Canton between 2 November and 3 December 2020 were recruited and population-weighted seroprevalence in Sarajevo Canton was 19.2% (95% CI: 16.7-21.6%). The aim of this second cross-sectional study is to measure the seroprevalence SARS-CoV-2 antibodies and assess antibody kinetics in the blood donor population after 12 months.

Official Title
-----------------
Population-based Age-stratified Seroepidemiological Investigation Protocol for Coronavirus 2019 (COVID-19) Infection in the Federation of Bosnia and Herzegovina

Conditions
-----------------
COVID-19, Seroprevalence, Antibody

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals identified for recruitment into the investigation, resident of Canton Sarajevo between 18-65 years, irrespective of prior COVID-19 infection. Exclusion Criteria: Refusal to give informed consent or to attend follow-up appointments; currently experiencing COVID-19 symptoms or in the last 14 days; and close contact with a confirmed case of COVID-19 within 14 days prior to donation.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons aged 18-29<br> | |
| Persons aged 30-39<br> | |
| Persons aged 40-65<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprevalence of SARS-CoV-2 IgG antibodies | Crude seroprevalence among blood donors will be adjusted to age and sex distribution in cantonal population and to test sensitivity and specificity using Bayesian statistical modeling. | November 2021-December 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess factors associated with seropositivity. | Chi-squared test will be conducted on categorical variables. | November 2021-December 2021 | 
| Assess antibody response across types of immunity. | Among those with positive anti-S antibodies, geometric mean titers will be compared across participants with natural immunity, vaccine-induced immunity, and hybrid of natural and vaccine-induced immunity. | November 2021-December 2021 |
Study of Laparoendoscopic Single Site Adnexal Surgery for Benign Ovarian and Tubal Disease

Study Overview
=================
Brief Summary
-----------------
To compare the safety and efficacy between single-port and three-port adnexal surgery in patients with benign ovarian and tubal disease

Official Title
-----------------
Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Adnexal Surgery

Conditions
-----------------
Benign Ovarian or Tubal Disease

Intervention / Treatment
-----------------
* Procedure: Single-port laparoscopic adnexal surgery
* Procedure: Three-port laparoscopic adnexal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who undergo laparoscopic adnexal surgery due to following benign adenxal disease Benign teratoma Endometrioma Mucinous cystadenoma Serous cystadenoma Benign Brenner tumor Ectopic pregnancy(cornual, tubal, ovarian pregnancy, etc.) paratubal cyst, parovarian cyst Risk reducing bilateral salpingooophorecotmy due to familial breast/ovarian cancer syndrome Other benign adnexal disease requiring surgery American Society of Anesthesiologist Physical Status classification I-II. Patient who have signed written informed consent Exclusion Criteria: Uncontrolled medical disease Active infectious disease Previous pelvic radiation therapy Patient who requires further procedure excluding adnexal surgery Patient who has other pain source excluding adnexal disease Pregnant and lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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 |
| --- | --- |
| Experimental: Single-port surgery group<br>Single-port laparoscopic adnexal surgery | Procedure: Single-port laparoscopic adnexal surgery<br> <br> |
| Active Comparator: Three-port surgery group<br>Three-port laparoscopic adnexal surgery | Procedure: Three-port laparoscopic adnexal surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hospital stay |  | within 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | within 1 week after surgery | 
| postoperative analgesics requirement |  | within 1 week after surgery | 
| quality of life |  | within 6 months aftr surgery | 
| surgical stress response |  | within 2 days after surgery | 
| operating time |  | immediately ater surgery | 
| transfusion requirement and amount |  | within 1 week after surgery | 
| postoperative complication |  | within 1 months after surgery |
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.

Detailed Description
-----------------
A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.

Official Title
-----------------
A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Pharmacokinetics and Efficacy of Intravenous Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labour

Conditions
-----------------
Labor, Induced

Intervention / Treatment
-----------------
* Drug: Serelaxin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 40 years Normal pregnancy At least 40 weeks of gestation Otherwise healthy Exclusion Criteria: Anemia or hypertension Presence of chronic disease Endometriosis Known fetal anomaly Substance abuse History of cancer

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7.5 µg/kg/d<br>Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A. | Drug: Serelaxin<br> <br> |
| Experimental: 25 µg/kg/d<br>Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A. | Drug: Serelaxin<br> <br> |
| Experimental: 75 µg/kg/d<br>Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B. | Drug: Serelaxin<br> <br> |
| Experimental: Placebo<br>Participants who received IV infusion of placebo, some during part A and others during part B. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical ripening |  | Through 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression to active labor and delivery |  | Within 7 Days of Drug Infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relaxin, pregnancy, cervical ripening, normal pregnancy at least at 40 weeks of gestation
Fovea ERM After Fovea-sparing ILM Peeling

Study Overview
=================
Brief Summary
-----------------
To report cases who had received previous fovea-sparing internal limiting peeling membrane and developed secondary fovea epiretinal membrane contraction

Detailed Description
-----------------
Purpose: To report the rare complication of foveal epiretinal membrane (ERM) formation on residual internal limiting membrane (ILM) with severe contraction after previous fovea-sparing internal limiting membrane (ILM) peeling. Study design: Retrospective case series Methods: We report patients who previously received fovea-sparing ILM peeling and complicated with foveal ERM formation and contraction.

Official Title
-----------------
Severe Foveal Epiretinal Membrane Contraction After Previous Fovea-sparing Internal Limiting Membrane Peeling Surgery

Conditions
-----------------
Epiretinal Membrane, Internal Limiting Membrane Wrinkling

Intervention / Treatment
-----------------
* Procedure: fovea-sparing internal limiting membrane peeling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who developed secondary fovea epiretinal membrane after previous fovea-sparing internal limiting membrane surgery Exclusion Criteria: patients who did not receive previous fovea-sparing internal limiting membrane surgery
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| epiretinal membrane group<br>Patients developed secondary fovea epiretinal membrane | Procedure: fovea-sparing internal limiting membrane peeling<br>* fovea-sparing internal limiting membrane peeling surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Snellen visual acuity change | 6 months | 
| Optical coherence tomography finding | fovea change on optical coherence tomography | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fovea-sparing internal limiting membrane peeling, Epiretinal membrane.
A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial cancer patients.

Detailed Description
-----------------
Postoperative radiotherapy (RT) is the most used adjuvant treatment in high risk endometrial cancer (HREC), and it appears to reduce the incidence of pelvic relapses but doesn't seem to improve survival. Paclitaxel (P) has shown in vitro and clinical activity against endometrial cancer, and it is also a potent radiosensitizer by blocking dividing cells in G2/M phase. This study is to evaluate the efficacy and safety of a treatment with concomitant weekly chemotherapy with paclitaxel and RT in high risk advanced endometrial cancer.

Official Title
-----------------
A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Drug: paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undertaken total hysterectomy, bilateral salpingoophorectomy, washing cytology, pelvic and paraaortic lymph node dissection Patients must have the diagnosis of endometrioid type adenocarcinoma with stage III, IV. Patients must have a GOG performance of 0, 1, or 2. Patients must have expected life span over 6 months. Exclusion Criteria: Patients with peripheral neurotoxicity over grade 2 in CTC criteria. Patients with history of chemotherapy or radiation treatment. patients with history of arrhythmia,congestive heart failure. Patients with intractable infection.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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: paclitaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two year progression free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrial cancer, high risk, weekly paclitaxel, Cuncurrent chemoradiation