louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00654524: Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis
Official title: A Randomized Study Comparing Goserelin or Expectant Management Following Laparoscopic Surgery for Advanced Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endometriosis
Keywords: Endometriosis
Recurrence
Pregnancy Rate
Laparoscopy
Gonadotropin-Releasing Hormone
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2008-04-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to identify the recurrent rate and pregnancy rate of advanced endometriosis after laparoscopic surgery plus GnRHa goserelin acetate treatment.

Detailed description: In order to decrease endometriosis recurrence and enhance pregnancy rate after surgical therapy, it has been proposed to use a post-surgical gonadotropin-releasing-hormone agonist (GnRHa) treatment. Data on the short-term recurrence of advanced endometriosis is rare. Although operative treatment has resulted in increasing pregnancy rate comparing non surgery management for moderate to severe endometriosis, very few data of spontaneous pregnancy rate are available comparing GnRHa treatment or expectant management after surgery treatment. In this situation, the investigators conduct a prospective, randomized, controlled study to determine whether postoperative GnRHa (goserelin acetate) therapy for advanced endometriosis is effective in reducing endometriosis recurrence rate and improving reproductive outcome.

Eligibility criteria: Inclusion Criteria:

* Age \>=18 years old
* Normal menstruation for 3 months before enrollment (25-35 days）
* Advanced endometriosis confirmed histologically (r-AFS score III-IV) with laparoscopy or laparotomy-pelvic pain and/or dysmenorrhea and/or dyspareunia
* Agreement on the strict follow-up plan
* Without previous hormonal treatment
* Using nonhormonal method of contraception during this study

Exclusion Criteria:

* Serious heart diseases/pulmonary/liver/kidney diseases
* Previous non-endometriosis relevant surgery possibly influence to abdominal or pelvic pain
* Suspected malignancy in endometriosis
* Coagulation disorders with hemorrhagic tendency
* Pregnancy or lactation
* Allergy to GnRHa
* Previous ineffective treatment with GnRHa

Primary outcomes:
measure: The recurrent rate of advanced endometriosis
timeFrame: within one year after surgery or GnRH-a management
Secondary outcomes:
measure: The pregnancy rate following laparoscopic surgery for advanced endometriosis
timeFrame: within one year after surgery or GnRH-a treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Xinmei Zhang, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174224: At-risk Intervention and Mentoring Evaluation
Official title: Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Keywords: Violence
At-risk youth
Intentional Injury
Violence Intervention
Youth
recidivism
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 133
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if a hospital-based violence intervention programs can make sustainable behavior changes in at-risk youth using two key components, brief intervention at the hospital bedside and case management.

Detailed description: This study will be a randomized controlled trial. Youth presenting to the emergency department with an intentional injury (gunshot wound, stab wound, or assault) will be given a behavioral assessment. Participants will be categorized according to risk (low, moderate, high). Only moderate or high youth will continue in the study and be randomized. Low risk youths will receive the medical standard of care and be re-assessed at 18 months.

Randomization will place participants in one of two arms. Arm 1 will receive the standard of care PLUS a brief intervention with AIM outreach workers. Arm 2 will receive standard medical care PLUS a brief intervention PLUS case management.

Every randomized youth will be assessed for risk and protective factors and have have data collected at 6-month intervals (0, 6, 12, 18 months).

Eligibility criteria: Inclusion Criteria:

* 14-24 years of age , Intentional Injury (Gunshot Wound, Stab Wound, Assault)

Exclusion Criteria:

* Younger than 14, 25 or older, non-English speaking, unable to give informed consent/assent, sexual assaults, domestic violence, child neglect/abuse.

Primary outcomes:
measure: Violence Risk Scale
timeFrame: 0, 6, 12, 18 months
Secondary outcomes:
measure: Composite Score
timeFrame: 0, 6, 12, 18 months
measure: School Enrollment
timeFrame: 0, 6, 12, 18 months
measure: Hospital Recidivism
timeFrame: 0, 6, 12, 18 months
measure: Justice System Recidivism
timeFrame: 0, 6, 12, 18 months
measure: Employment
timeFrame: 0, 6, 12, 18 months
measure: Resource Utilization
timeFrame: 0, 6, 12, 18 months.
measure: Mortality
timeFrame: 0, 6, 12, 18 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health Medical Center
name: Katie Bakes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05031624: A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study of Single Ascending Doses of Subcutaneous CDX-0159 to Assess the Safety, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: CDX0159-05
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a study to determine the safety and pharmacokinetics of CDX-0159 administered subcutaneously in healthy subjects.

Detailed description: CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells.

The study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 administered subcutaneously in healthy subjects.

Eligibility criteria: Key Inclusion Criteria:

* An informed consent signed and dated by the subject.
* Healthy volunteer aged 18-55.
* In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
* Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 35 kg/m2
* No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives.
* Both males and females of child bearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
* Not a current smoker, vaper, or regular user of any nicotine or cannabinoid containing products
* Willing to follow all study rules

Key Exclusion Criteria:

* Women who are pregnant or nursing
* History of anaphylaxis or systemic reactions to food or other triggers
* Autoimmune disorders requiring more than topical medication
* Vaccination with live vaccines within 4 months prior to screening visit (subjects must agree to avoid live vaccination during the study and 4 months after).
* Positive urine test for alcohol and drugs of abuse.

Other Protocol defined inclusion and exclusion criteria could apply.

Primary outcomes:
measure: Safety as assessed by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials
timeFrame: Day 1 to Day 85
Secondary outcomes:
measure: CDX-0159 serum evaluations over time
timeFrame: Day 1 to Day 85
measure: Serum tryptase levels over time
timeFrame: Day 1 to Day 85
measure: Plasma levels over time
timeFrame: Day 1 to Day 85
measure: Measurement of Anti-drug Antibody development over time
timeFrame: Day 1 to Day 85
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion, Inc
state: Nebraska
Study officials:
References:
Clinical trial NCT02642224: Trauma Services Intervention to Prevent Violence
Official title: Trauma Services Intervention to Prevent Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Injury Due to Violence
Gunshot Wound, Contact
Keywords: Violence
firearm
guns
homicide
trauma
injury
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Pittsburgh Foundation
name: Hillman Foundation
name: RK Mellon Foundation
First posted: 2015-12-30
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Primary outcome: Research participants and their network contacts will be followed over 6 months to assess whether a social work case management protocol results in reduction of trauma services recidivism and criminal violence arrests.

Detailed description: Allegheny County, PA continues to suffer between 100-120 homicides each year, with perhaps 2-3 times as many gunshot injuries that require hospitalization. Firearm homicides overwhelmingly affect African American men aged 15-35. Building on prior efforts in violence prevention, the investigators propose to launch a hospital trauma service intervention that will take advantage of a "teachable moment" in the emergency room. All four hospitals providing Level I Trauma services in Allegheny County have agreed to host the program, an evidence-based effort developed by the National Network of Hospital Violence Intervention (NNHVI). Adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities. The investigators will offer the opportunity to participate in the research and receive the intervention to all gunshot victims identified in county Level I trauma services. Participants in the research protocol will be asked to recruit their high-risk social network members for the intervention.

Eligibility criteria: Inclusion Criteria:

1. Age 18+
2. Gunshot victim treated and discharged from Level I trauma facility; or member of social network of gunshot victim who may be high risk of firearm violence -

Exclusion Criteria:

1. Gunshot wound because of suicide attempt
2. Gunshot wound because of non-violent episode (e.g., hunting accident)
3. Unable to participate in research interview because of cognitive deficit
4. Planning to leave community as result of shooting
5. Discharged from trauma service to prison
6. Unable to provide informed consent -

Primary outcomes:
measure: Trauma services recidivism
timeFrame: 6 months
measure: Arrest for violent crime
timeFrame: 6 months
Secondary outcomes:
measure: Social work case management goals
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Graduate School of Public Health
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steven M Albert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03519724: Role of Curarization During Anesthesia for Gynecologic Surgical Laparotomy Procedures
Official title: The Role of Curarization During Anesthesia for Gynecologic Laparotomy Surgical Procedures: a Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Curarization, Postoperative Residual
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic gynecologic surgery, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years BMI between 16 and 40 Kg/m2 ECOG Performance Status tra 0 e 1 American Society Anesthesiologist (ASA) class 1 or 3 Able to provide informed consent to trial procedures

Exclusion Criteria:

* Age \< 18 or \> 75 years
* BMI \<16 o \> 40 Kg/m2
* ECOG Performance Status \>1
* Pregnancy
* Active or recent pelvic inflammation
* Anticipated airway difficulty
* Patients with history of allergy to rocuronium, neostigmine or sugammadex
* Allergy to NSAIDs
* Previous opioids consumption for chronic pain
* Patients receiving drugs for different medical conditions, that may prolong or shorten the duration of rocuronium effect (e.g aminoglycosides, magnesium)
* Hepatic or renal failure
* Persistent coagulopathy
* Neurological or cognitive disorders
* Conversion from laparoscopic to open surgery Onset of intraoperative complications

Primary outcomes:
measure: Overall pain in the first 48 hrs after gynecologic surgical procedures
timeFrame: First 48 hrs after gynecologic surgical procedures
measure: Recovery time (or Reversal time) from NMB (TOF≥0.9)
timeFrame: The recovery time (or Reversal time) will be measured in minutes after the administration of reversal agent at the end of the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Campus Bio-medico
state: RM
Study officials:
References:
Clinical trial NCT02299024: Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter
Official title: Prescribing Opioid Pain Relievers in the Emergency Department: Understanding and Optimizing the Encounter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use, Unspecified
Keywords: opioids
health literacy
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Emergency Medicine Foundation
First posted: 2014-11-24
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators overall study objective is to improve patients knowledge and safe use of opioid pain relievers upon discharge from the Emergency Department.

Detailed description: Recent studies indicate that emergency department (ED) discharge processes - including written and spoken communications - are inadequate, and patients often leave without the knowledge necessary to properly care for themselves. In the context of opioid pain relievers, this lack of knowledge is potentially dangerous, as patients may not possess the requisite knowledge for safe use of their medication or an awareness of the dangers of medication misuse.

The aim of this study was to evaluate the impact of an opioid information sheet and spoken counseling on patient knowledge about opioids and safe use behaviors. The investigators conducted a randomized controlled pilot test of a dual-modality educational intervention (written information sheet and spoken counseling about opioids) to assess if the intervention can increase patient knowledge about opioid pain relievers. These activities were intended to guide future modification of educational interventions and the future development of best practices for emergency physician spoken counseling about opioid pain relievers.

Eligibility criteria: Inclusion Criteria:

* prescribed an opioid pain reliever
* English Speaking

Exclusion Criteria:

* Non-English Speaking
* Clinically unstable, psychologically impaired or intoxicated as judged by the research staff member.
* Chronic opioid use, defined as daily or near daily use of opioid pain relievers for the past 90 days.
* admitted to hospital
* unable to complete follow up phone interview in 4 - 7 days.

Primary outcomes:
measure: Knowledge of medication name
timeFrame: 4-7 days
Secondary outcomes:
measure: Knowledge and counseling recall outcomes
timeFrame: 4-7 days
measure: Actual Use outcomes
timeFrame: 4-7 days
measure: Response to the intervention
timeFrame: 4-7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Danielle McCarthy, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02991924: Risk Factors of Medistinal Metastasis in Endoscopic Staging of Lung Cancer
Official title: Risk Factors of Medistinal Metastasis in Endoscopic Medistinal Staging of Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non Small Cell Lung Cancer
Keywords: endobronchial ultrasound
EBUS-TBNA
lung cancer
staging
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University Hospital
name: Samsung Medical Center
name: Asan Medical Center
name: Seoul National University Bundang Hospital
First posted: 2016-12-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-small cell lung cancer

Brief summary: The purpose of this study is to investigate risk factors for mediastinal lymph node metastasis in potentially operable non-small cell lung cancer in order to find indications for endoscopic mediastinal staging. Chest CT, integrated PET/CT, and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) +/- endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) are performed for mediastinal staging. CT and PET/CT findings, histologic types and other risk factors will be analyzed. The investigators develop the prediction method for mediastinal metastasis.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
* Potentially operable

Exclusion Criteria:

* M1 disease
* Inoperable T4 disease
* Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT
* Confirmed supraclavicular lymph node metastasis
* Pancoast tumours
* T1 ground glass opacity nodule (with solid part 1\<cm)
* Solid T1 (1\<cm)N0 M0 by CT \& PET/CT
* Inoperable patients (after evaluating medical and surgical operability)
* Patients who refused surgical treatment
* Contraindications for bronchoscopy
* Drug reaction to lidocaine, midazolam, fentanyl
* Pregnancy

Primary outcomes:
measure: Relative risk of risk factors for mediastinal metastasis
timeFrame: When confirmative diagnosis are available in all subjects ;3 years
Secondary outcomes:
measure: Diagnostic values of endoscopic staging
timeFrame: When confirmative diagnosis are available in all subjects ;3 years
measure: Survival
timeFrame: After the diagnosis ; 7 years
measure: Molecular test
timeFrame: for each subject; up to 60 days, available in all subjects ; 3 years
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center (NCC) Korea
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: Bin Hwangbo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03363724: Validation of HaGuide Software Module Accuracy in Mapping STN Boundaries in Parkinson's Disease Patients Who Underwent DBS Procedure
Official title: A Retrospective, Multi-Center, Clinical Validation of HaGuide Software Module Accuracy in Mapping Sub-thalamic Nucleus (STN) Boundaries in Parkinson's Disease Patients Who Underwent Deep Brain Stimulation (DBS) Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Deep Brain Stimulation
Keywords: Parkinson Disease
Deep Brain Stimulation
Microelectrodes recording
HaGuide
Alpha Omega Engineering Ltd.
Lead sponsor: Alpha Omega Engineering Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Colorado, Denver
name: Hadassah Medical Organization
name: Swedish Medical Center
First posted: 2017-12-06
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Parkinson's Disease who underwent implantation of DBS electrode in the STN for the treatment of Parkinson's Disease, using the Neuro-Omega device for navigation and procedure's MER digital recorded data is available.

Brief summary: HaGuide version 1.0 (Neuro-Omega Ltd.) is a software module add-on to the FDA cleared Neuro-Omega System (K123796). It was designed to facilitate the use of Neuro-Omega's system by automatically mapping visually the depth of STN landmarks intra-operatively. HaGuide algorithm computes and displays the STN entry and exit, as well as introduces a detection of a distinct DLOR-VMNR boundary. HaGuide visual display is added to the UI and it is supplementing and not replacing the previously cleared standard display (visual and audio) of the system.


Eligibility criteria: Inclusion Criteria:

1. Patient was diagnosed with Parkinson's disease;
2. Patient underwent implantation of DBS electrode in the STN for the treatment of Parkinson's disease, using the Neuro-Omega device for navigation;
3. Procedure's MER digital recorded data is available;

Exclusion Criteria:

1. DBS performed for any other movement disorder other than Parkinson's Disease including Parkinsonism;
2. The recording has a high intensity of noise that will not allow re-analysis using the HaGuide software, in such cases the HaGuide software indicates that the signal is not valid for analysis;
3. Missing data for primary end-point on the respective patient medical chart;
4. The collected data that is used for the validation is with high step size resolution;

Primary outcomes:
measure: HaGuide vs. Neurosurgeon measurements
timeFrame: 2 weeks
Secondary outcomes:
measure: DLOR vs. VMNR
timeFrame: 2 weeks
measure: DLOR Entry/exit
timeFrame: 2 weeks
measure: STN Length
timeFrame: 2 weeks
measure: DBS implant optimal track Identification
timeFrame: 2 weeks
measure: Sites/Users comparison
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: John A Thompson, Dr.
role: PRINCIPAL_INVESTIGATOR
References: