louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02520453: Adjuvant Durvalumab for Esophageal Cancer
Official title: Randomised, Double-blind, Phase II Trial of Adjuvant Durvalumab or Placebo for Completely Resected Esophageal Squamous Cell Carcinoma Previously Treated With Neoadjuvant Concurrent Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adjuvant Durvalumab vs Placebo for 1 year after complete resection of esophageal cancer following neoadjuvant CCRT.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed squamous esophageal cancer, irrespective of PD-L1 status
* The enrolment should be done during the time interval from 20 days to 56 days after complete resection after neoadjvuant CCRT (no residual tumor after operation)
* Clinical tumor stage before neoadjuvant CCRT should be T3-4N0M0 or T1-4N1-3M0
* Available tumor specimen for biomarker analysis acquired before neoadjuvant CCRT or at operation

Exclusion Criteria:

* Other PD-1 or PD-L1 inhibitors history
* Mean QT interval corrected for heart rate (QTc) ≥470 ms using Bazett's correction
* Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
* Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded

Primary outcomes:
measure: Disease-free survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: MA
Study officials:
affiliation: Samsung Medical Center
name: Jong-Mu Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06150053: Dose Dense Chemotherapy in Elderly Patients > 80 Years Old With DLBCL
Official title: Dose Dense Chemotherapy in Elderly Patients > 80 Years Old With DLBCL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DLBCL
Old Age; Debility
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 79
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with DLBCL

Brief summary: Multi-center retrospective analysis of patients with DLBCL aged ≥80 years old treated with R-CHOP-14 compared to other regimens. Patient data including baseline characteristics, histology, dose intensity and treatment outcomes will be extracted from hospital medical electronic records. Relative dose intensity (RDI) will be calculated as the percentage of the dose intensity achieved divided by the intended dose intensity. Primary endpoints are overall (OS), progression-free (PFS) and event-free survival (EFS), defined as time from diagnosis to death, death or progression/relapse, progression/relapse or treatment discontinuation.


Eligibility criteria: Inclusion Criteria:

* histologically proven, untreated diffus large B-cell lymphoma (DLBCL)
* diagnosis between 2005 - 2019
* age ≥80 at diagnosis

Exclusion Criteria:

- diagnosis revision at a later timepoint

Primary outcomes:
measure: Overall survival (OS) death or progression/relapse, progression/relapse or treatment discontinuation.
timeFrame: through study completion, an average of 2 years
measure: Progression-free survival (PFS)
timeFrame: through study completion, an average of 2 years
measure: Event-free survival (EFS)
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Relative Dose intensity
timeFrame: within the treatment period, up to 36 weeks
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Saarland University Medical Center
state: Saarland
Study officials:
References:
Clinical trial NCT03781453: POWERPLAY Phase 2: Development and Evaluation in Male-dominated Workplaces
Official title: POWERPLAY: Building Employee Health and Safety Through Prevention in Male-dominated Workplaces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Men
Health Behavior
Mental Health Wellness 1
Health Knowledge, Attitudes, Practice
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Athabasca University
name: University of Alberta
name: Newcastle University
name: University of Melboune
name: University Technology Sydney
First posted: 2018-12-19
Enrollment: 498
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental, pre-post study design
Primary purpose: PREVENTION

Brief summary: With funding from the Alberta Ministry of Labour (Grant #095244772), a program called POWERPLAY (www.powerplayatwork.com), designed to promote men's health at work, will be evaluated in workplaces in Alberta.

Detailed description: In year 1, this project includes two main research components: 1. A pragmatic (real world) study will be conducted employing a quasi-experimental (not a randomized controlled trial), before and after design to evaluate the effectiveness of the POWERPLAY program. 2. An integrated set of research activities (systematic review, sleep behaviors and consultation groups) will be used to provide the basis for developing recommendations for promoting sleep health in male-dominated workplaces, and inform the development and testing of a POWERPLAY sleep health module (REST-UP) in Year 2.

Eligibility criteria: Inclusion Criteria:

* Men employed in participating workplaces, full-time or part-time, in any position within the organizations.

Exclusion Criteria:

* Although females may participate in the POWERPLAY program and surveys, they will not be included in the evaluation.

Primary outcomes:
measure: Moderate to Vigorous Physical Activity
timeFrame: 4 months
measure: Mental Wellness
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Saskatchewan
country: Canada
facility: Shell Canada Ltd (Scotford Site)
state: Alberta
city: Rocky Mountain House
country: Canada
facility: Roper Ventures
state: Alberta
city: Prince George
country: Canada
facility: PeroxyChem
state: British Columbia
Study officials:
References:
Clinical trial NCT01549353: Gum Chewing After Gynecologic Laparoscopy
Official title: Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Care
Lead sponsor: Klinikum Klagenfurt am Wörthersee
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Gum chewing has been reported to stimulate bowel motility after open surgery, such as cesarean section and other abdominal surgeries. In general, after laparoscopic surgery problems with reduced bowel motility are not as common as after open surgery. In this study the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel motility after gynecologic laparoscopic surgery. Further the investigators study patient satisfaction and potential side effects of postoperative gum chewing.


Eligibility criteria: Inclusion Criteria:

* all gynecologic laparoscopic surgery
* normal level of CA 125 postmenopausal

Exclusion Criteria:

* loose teeth
* chronic obstipation
* laparotomy
* operations longer then 3 h

Primary outcomes:
measure: Time to return to active bowel movements
timeFrame: participants will be followed for the duration of hospital stay
Secondary outcomes:
measure: patient satisfaction with postoperative gum chewing
timeFrame: participants will be followed for the duration of the hospital stay
measure: Number of participants with adverse events
timeFrame: participants will be followed for the duration of hospital stay
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Woerthersee
state: Carinthia
Study officials:
References:
citation: Husslein H, Franz M, Gutschi M, Worda C, Polterauer S, Leipold H. Postoperative gum chewing after gynecologic laparoscopic surgery: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):85-90. doi: 10.1097/AOG.0b013e3182983e92.
Clinical trial NCT06158451: Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in LSTR
Official title: Clinical and Radiographic Evaluation of Zinc Oxide-Propolis Mixture Versus Modified Triple Antibiotic Paste in Lesion Sterilization and Tissue Repair (LSTR) for the Treatment of Necrotic Primary Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Periapical; Infection
Keywords: propolis
modified triple antibiotic paste
lesion sterilization and tissue repair
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate and compare the clinical effectiveness of zinc oxide-propolis mixture with triple antibiotic paste in LSTR as root canal filling material in necrotic primary molars.

Detailed description: The promising results of propolis as a natural antibiotic in previous in- vivo studies made it interesting to combine propolis to the golden standard zinc oxide eugenol as an intracanal medication in pulp affected primary molars and use this mix as a natural substitute to the modified triple antibiotic paste (m-TAP) and therefore overcoming the antibiotic bacterial resistance, allergy and developmental anomalies that might arise in permanent successor teeth from m-TAP usage.

Eligibility criteria: Inclusion Criteria:

* Children:

  1. Cooperative children aged 4 -7 years old.
  2. Systemically healthy.
* Teeth:

Clinical criteria:

1. Necrotic primary mandibular second molar teeth.
2. Spontaneous pain or tenderness to percussion
3. Deep carious lesion with pulp exposure.
4. Presence of chronic apical abscess or sinus tract Tooth should be restorable. (Thakur et al., 2021)

Radiographic criteria:

1. Coronal-radiographic evidence of a deep carious lesions or lesion approximating pulp
2. Radicular discontinuity of lamina dura, furcation involvement less than or equal to half of shortest root in vertical dimension. (Thakur et al., 2021)

Exclusion Criteria:

* Children:

  1. With physical or emotional alteration.
  2. Children with systemic disease.
  3. Previous history of allergy to antibiotics used in the study.
  4. Children that will not attend follow up. • Teeth:

  <!-- -->

  1. Non restorable carious primary molars.
  2. Grade III mobility

Primary outcomes:
measure: Postoperative pain
timeFrame: 1 year
measure: Tenderness to percussion
timeFrame: 1 year
measure: Swelling / sinus tract
timeFrame: 1 year
measure: Mobility
timeFrame: 1 year
Secondary outcomes:
measure: Radiographic success
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Sherine Badr, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02267551: Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery
Official title: Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Simulation for Preparation of Robotic Surgery
Keywords: robotic surgery
simulation
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2014-10-17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to determine whether a group of resident physicians otherwise naïve to robotic surgery can demonstrate equal levels of proficiency during their first robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer or the daVinci Skills Simulator.


Eligibility criteria: Inclusion Criteria:

* Obstetrics and gynecology or general surgery residents in ACGME accredited programs naïve to robotic surgery training
* Completion of the online orientation to daVinci Surgical System

Exclusion Criteria:

* Performance of any robotic surgical procedures as the console surgeon
* Performance of any robotic simulator protocols
* Any significant amount of time spent on a virtual reality robotic simulator

Primary outcomes:
measure: Operative Time
timeFrame: at time of supracervical hysterectomy
Secondary outcomes:
measure: Estimated Blood Loss
timeFrame: during the surgical procedure
measure: Surgical Skill Rating
timeFrame: following completion of the procedure
measure: Continued success with robotic surgery after participation in the study
timeFrame: during the 12 months following surgical procedure
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
Study officials:
References:
citation: Culligan P, Gurshumov E, Lewis C, Priestley J, Komar J, Salamon C. Predictive validity of a training protocol using a robotic surgery simulator. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):48-51. doi: 10.1097/SPV.0000000000000045.
Clinical trial NCT04750551: BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).
Official title: BreEStim for Post-Stroke Motor Recovery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Motor Recovery
Keywords: Finger flexor spasticity
Motor Recovery
BreEStim
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment.


Eligibility criteria: Inclusion criteria:

* has post stroke ≥ 6 months , medically stable;
* Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
* MAS score ≥ 1, i.e., detectable finger flexor hypertonia;

Exclusion criteria include:

* Patients with visual deficit/neglect; hearing or cognitive impairment;
* Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);
* Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
* Patients received botulinum toxin injection to the arm/fingers \<4 months, or phenol injections \< 2 years;
* Patients with a pacemaker;
* Women who are pregnant.

Primary outcomes:
measure: Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)
timeFrame: Baseline, 5 minutes after intervention
Secondary outcomes:
measure: Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale
timeFrame: Baseline, 5 minutes after intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: Sheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01484951: AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
Official title: Assessing the Safety and Efficacy of Switching to AZARGA® (Brinzolamide/Timolol Fixed Combination) as Replacement Therapy in Patients With Uncontrolled Intraocular Pressure in Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Open-angle glaucoma
Ocular hypertension
Pigment dispersion glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
* Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
* Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
* Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
* Any abnormality preventing reliable applanation tonometry in either eye.
* Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
* Pregnant or lactating.
* Participation in any other investigational study within 30 days of screening visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy
timeFrame: Week 8
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT04161651: Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
Official title: Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: eversense
type 1 diabetes
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: DYN Diagnostic LTD
First posted: 2019-11-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of Long-Term Implanted Sensor in Patients on Quality of life

Detailed description: Assess satisfaction and acceptance of long-term implanted single sensor use (eversense XL) for up to 6 months in type 1 insulin-using patients

Eligibility criteria: Inclusion Criteria:

1. Male or Female diagnosed with type 1 diabetes mellitus
2. Age \> 18
3. Insulin treatment for at least 1 year (Either MDI of CSII)
4. HbA1c \< 11%
5. Signing informed consent and willing to apply with study procedure

Exclusion Criteria:

1. History of severe hypoglycaemia in the last 3 months
2. History of DKA in the last 3 months
3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition
4. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
5. Any condition that require MRI imaging or planned MRI during the trial period
6. Known topical or local anaesthetic allergy
7. Known allergy to glucocorticoids
8. History of hepatitis B, hepatitis C or HIV
9. Any Bleeding disorder or taking anticoagulant medication
10. Participation in other clinical trial
11. Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Primary outcomes:
measure: changes in quality of life evaluated questionnaires (DTSQ)
timeFrame: 6 months
Secondary outcomes:
measure: Change in HBA1C
timeFrame: 3 / 6 months
measure: CGM Time In Range (70-180 mg/dl)
timeFrame: 3 / 6 months
measure: CGM Time in hypoglycaemia below 70 mg/dl
timeFrame: 3 / 6 months
measure: CGM Time in hypoglycaemia below 54 mg/dl
timeFrame: 3 / 6 months
measure: CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit]
timeFrame: 3 / 6 months
measure: Change in HFS-ii (hypoglycaemia fear survey II)
timeFrame: 6 months
measure: Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)
timeFrame: 6 months
measure: Any adverse event related to study device
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06348251: FoodSteps for Binge Eating & Food Insecurity
Official title: Evaluating a Digital Intervention for Binge Eating and Weight Management Among Adults With Food Insecurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating
Type 2 Diabetes
Food Insecurity
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 years or older
* Recurrent binge eating (≥12 episodes in the past 3 months)
* Type 2 diabetes mellitus
* Food insecure status (e.g. difficulty accessing food)
* Interested in losing weight and reducing binge eating
* Willing to use a mobile application
* Has a smartphone with Internet access and capacity for calls and text messaging
* Has a valid email address
* Not pregnant
* English-speaking

Exclusion Criteria:

* Diagnosis for which the study/intervention is not clinically indicated
* Currently receiving clinical services for weight management or binge eating
* Started or recently (within the past month) changed dosage of a medication for binge eating, weight management, or diabetes

Primary outcomes:
measure: Recruitment and retention rates
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References: