louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04267614: This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients.
Official title: Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With Etanercept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 1226
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected from the Baghdad teaching hospital registry. The Rheumatology patient registry is a prospective longitudinal multicentre cohort initiated in 2012.

Brief summary: This study is to investigate the effect of etanercept in early versus delayed referral for management of rheumatoid arthritis patients assessing real-world patient data entered in the Iraq National Center of Rheumatology database between May 2012 and May 2017.


Eligibility criteria: Inclusion Criteria:

* Diagnosed RA patients.
* 18 years old and above.
* Did not receive pervious biological treatment.

Exclusion Criteria:

* Had previous biological treatment
* Use etanercept for less than 1 year

Primary outcomes:
measure: Disease Activity Score 28 (DAS28) at Month 12
timeFrame: Month 12 (from the data retrieved and observed during 1 month of this study)
measure: Clinical Disease Activity Index (CDAI) Score at Month 12
timeFrame: Month 12 (from the data retrieved and observed during 1 month of this study)
Secondary outcomes:
Other outcomes:
measure: Mean Change From Baseline in DAS28 at Month 12
timeFrame: Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)
measure: Mean Change From Baseline in CDAI Score at Month 12
timeFrame: Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)
Locations:
city: Baghdad
country: Iraq
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04946214: A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients
Official title: A Pilot Study Using a Digital Behavioral Intervention With a Smart Water Bottle to Improve Bladder Filling Compliance in Prostate Cancer Patients Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Radiation Toxicity
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine how to incorporate a smart water bottle to improve bladder filling for prostate cancer patients undergoing radiation therapy.


Eligibility criteria: Inclusion Criteria:

* Age older than 17 but less than 81.
* Non-metastatic prostate cancer patients undergoing definitive radiation treatment.
* Patients that self-identify as "smartphone owners".
* Patients with either iPhone (iOS 13.0 or higher) or Android (version 5.0.1 or higher) based smartphone access.
* English or Spanish speaking patients.

Exclusion Criteria:

* Patients with any history of pre-existing urinary retention.
* Patients with any history of kidney, urothelial tract or bladder cancer.
* Post-operative prostate patients.
* Patients that plan to be treated with pelvic lymph node radiation coverage.
* Patients without a functional bladder.
* Patients with a history of prior pelvic surgery or penile augmentation (circumcision is okay).
* Patients who have previously received any form of pelvic radiation.
* Patients unable to give informed consent.
* Patients who refuse to drink room-temperature water used for bladder filling.
* Patients without functional vision.
* Patients who are colorblind.
* Patient who refuse to use the smartphone app or who refuse consent.

Primary outcomes:
measure: Proportion of participants who did not continue to use the intervention through the study.
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Proportion of non-compliant participants as measured by survey
timeFrame: Up to 10 weeks
measure: Proportion of non-compliant participants as measured by bladder volume
timeFrame: Up to 10 weeks
measure: Bladder volumetric measurements
timeFrame: Up to 10 weeks
measure: Rectum Volumetric Measurements
timeFrame: Up to 10 weeks
measure: Patient's perception of bladder filling compliance as measured by Service User Technology Acceptability Questionnaire
timeFrame: Up to 10 weeks
measure: Proportion of patients refusing participation
timeFrame: Baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Lennar Medical Foundation
state: Florida
Study officials:
affiliation: University of Miami
name: Alan Dal Pra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06370455: Comparison of Septal Advancement Flap and Columellar Strut Effect on Nasal Tip
Official title: Comparison of Septal Advancement Flap and Columellar Strut in Preserving, Restructuring, and Reshaping the Nasal Tip Contour in Rhinoplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rhinoplasty
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of the study to compare and evaluate the effect of septal advancement flap in preserving and reshaping the nasal tip with columellar strut graft

Detailed description: The ideal tip support graft should support the exact position over time, avoid stiffness of a natural soft structure of the tip, be easily harvested typically septal cartilage, facilitate surgeon control of rotation and projection.

To address these desirable features the septal advancement flap (SAF) was developed. The septal advancement flap (SAF) is a rotational advancement flap of the superior and caudal aspects of the cartilaginous septum that enables the surgeon to create stable and accurate tip shape and position. This is a technically easy and reliable flap mainly applicable to primary rhinoplasty.

so investigator compare between this new technique and old one like columellar strut to know the effect on nasal tip

Eligibility criteria: Inclusion Criteria:

* Droopy nasal tip

Exclusion Criteria:

* severely deficient cartilaginous septum.
* previous nasal operations, history of cleft lip or cleft palate.
* bleeding disorders.

Primary outcomes:
measure: subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire
timeFrame: preoperative and one month postoperative
measure: measuring the degree of tip projection and rotation preoperative and postoperative
timeFrame: one month and three months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Otorhinolaryngology department -Tanta University Hospitals
Study officials:
References:
citation: Goncalves Ferreira M. Septal Advancement Flap: Preserving, Restructuring, and Reshaping the Nasal Tip Contour with a Novel Flap. Facial Plast Surg Aesthet Med. 2023 Jul-Aug;25(4):279-284. doi: 10.1089/fpsam.2023.0060. Epub 2023 Apr 10.
Clinical trial NCT04426955: Study of Camrelizumab (SHR-1210) in Combination With Concurrent Chemoradiotherapy in Locally Advanced Esophageal Cancer
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Camrelizumab (SHR-1210) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Cancer
Keywords: PD-1Antibody
locally advanced esophageal cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 396
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: This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of treatment with Camrelizumab (SHR-1210) + definitive chemoradiotherapy(dCRT) vs placebo+dCRT for locally advanced esophageal cancer patients in China. Camrelizumab (SHR-1210) is a humanized anti-PD1 IgG4 monoclonal antibody.

Detailed description: In this study, eligible subjects will be randomized into study arm or control arm. Participants receive camrelizumab or placebo + chemotherapy + radiation therapy . The chemotherapy regimens are : paclitaxel plus cisplatin Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) will be the primary outcomes.

Eligibility criteria: Inclusion Criteria:

1.18 to 75 years; 2.Histologically confirmed diagnosis of localized ESCC; 3.Measurable and/or non-measurable disease defined per RECIST v1.1; 4.ECOG Performance Status ≤ 1; 5.Adequate organ function

Exclusion Criteria:

1. Indicators of severe malnutrition;
2. A history of surgery for esophageal cancer;
3. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention;
4. Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy;
5. Received prior chemotherapy, radiotherapy, targeted therapy or immune-oncology therapies;
6. Active autoimmune diseases or history of autoimmune diseases that may relapse

Primary outcomes:
measure: PFS assessed by IRC
timeFrame: up to 3 years
Secondary outcomes:
measure: PFS assessed by investigators
timeFrame: up to 3 years
measure: OS
timeFrame: up to 3 years
measure: ORR
timeFrame: up to 3 years
measure: DoR
timeFrame: up to 3 years
measure: AE
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
References:
Clinical trial NCT06799455: Uncuffed Endotracheal Tube vs. no Endotracheal Tube
Official title: Comparison of Uncuffed Endotracheal Tube to no Endotracheal Tube in EBUS-TBNA Procedure Under Moderate Sedation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Pulmonary Diseases
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: Patient will be randomized 1:1 to UCETT vs no ETT (current standard procedure) when they scheduled for the EBUS-TBNA procedure.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a comparison of uncuffed endotracheal tube (UCETT) vs. no endotracheal tube (ETT) in endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) procedure under moderate sedation in terms of procedure tolerance, duration of the procedure, desaturation, amount of sedation medication usage.


Eligibility criteria: Inclusion Criteria:

* Any patient that is scheduled for EBUS-TBNA procedure

Exclusion Criteria:

* Those who are not safe to receive moderate sedation or flexible bronchoscopy

Primary outcomes:
measure: Desaturation
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: H. Erhan Dincer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00186355: Enrichment & Purging of Stem Cells in Non-Hodgkin's Lymphoma
Official title: Enrichment and Purging of Stem Cells in the Treatment of Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma, Non-Hodgkin
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-16
Enrollment: 97
Sex: ALL
Minimum age (years): 4
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the role of purging the hematopoietic cell graft on outcomes for non-Hodgkin's Lymphoma.

Detailed description: To study the use of peripheral blood stem cells which have been treated in an effort to remove tumor cells. The researchers hope to learn whether or not this will be more effective in removing the tumor cells as compared to other methods of purging (the removal of cancer cells).

Eligibility criteria: Inclusion Criteria:- relapsed NHL Exclusion Criteria:- liver dysfunction

Primary outcomes:
measure: PCR positivity in peripheral blood cell collections after cyclophosphamide
Secondary outcomes:
measure: Enrichment of hematopoietic stem cells
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Robert S Negrin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00357955: Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients
Official title: Combined Behavioral and Pharmacological Intervention for Cardiovascular Risk Reduction in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Dyslipidemia
Coronary Arteriosclerosis
Lead sponsor: Providence VA Medical Center
Sponsor class: FED
Collaborators: name: Rhode Island Foundation
First posted: 2006-07-28
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to study whether a multidisciplinary education in Diabetes and intervention for cardiac risk reduction in a group setting to modify patient behavior and adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and lipid control.


Eligibility criteria: Inclusion Criteria:

* All diabetic veterans with a Hb-A1c between 7.0- 9.0 % within the last 6 months will be eligible for the study

Exclusion Criteria:

* Patients without an Hb-A1c checked within the last 6 months.
* Patients who are unable to attend the group sessions, either because of lack of transportation, psychiatric instability (suicidal, psychotic), or organic brain injury that preclude them from diabetes self-care.

Primary outcomes:
measure: Percentage of Participans With A1c<7%, LDL Cholesterol <100mg/dL, Systolic Blood Pressure <130mm Hg and Diastolic Blood Pressure <80 mm Hg
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VAMC
state: Rhode Island
Study officials:
affiliation: Providence VAMC
name: Wen-Chih Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taveira TH, Friedmann PD, Cohen LB, Dooley AG, Khatana SA, Pirraglia PA, Wu WC. Pharmacist-led group medical appointment model in type 2 diabetes. Diabetes Educ. 2010 Jan-Feb;36(1):109-17. doi: 10.1177/0145721709352383. Epub 2009 Dec 4.
citation: Khatana SA, Taveira TH, Choudhary G, Eaton CB, Wu WC. Change in hemoglobin A(1c) and C-reactive protein levels in patients with diabetes mellitus. J Cardiometab Syndr. 2009 Spring;4(2):76-80. doi: 10.1111/j.1559-4572.2008.00042.x.
Clinical trial NCT06263855: Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients
Official title: Effect of Large Language Model in Assisting Discharge Summary Notes Writing for Hospitalized Patients: a Pilot Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Large Language Model
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 1015
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: This pilot study aims to assess the feasibility of carrying out a full-scale pragmatic, cluster-randomized controlled trial which will investigate whether discharge summary writing assisted by a large language model (LLM), called CURE (Checker for Unvalidated Response Errors), improves care delivery without adversely impacting patient outcomes.


Eligibility criteria: PATIENTS

Inclusion Criteria:

* Adult patients admitted to one of three participating cardiology services at Mayo Clinic in Rochester, MN

Exclusion Criteria:

* Minor patients (\<18)
* Patients admitted to a hospital service where CURE is not implemented

CLINICIANS

Inclusion Criteria:

* Clinicians who provide care to randomized patients included in this pilot

Exclusion Criteria:

* Clinicians who do not provide care to randomized patients included in this pilot

Primary outcomes:
measure: Rate of patient accrual
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Xiaoxi Yao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06050655: The Efficacy of Lingual Aligners in Adults.
Official title: The Efficacy of Lingual Aligners in Adults: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Malocclusion, Angle Class I
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the effectiveness of lingual aligners in adults.

The main question to answer is:

- Are lingual aligners effective in achieving desired and predicted tooth movements?

Detailed description: The aim of this pilot study is to assess the effectiveness and the accuracy of lingual aligners by evaluating the discrepancy between the predicted and the achieved amounts of tooth movements.

Also:

* Patient discomfort and pain
* Appliance defects
* Patient compliance
* Chair and treatment time

Key inclusion criteria:

* Adults older than 18 years old
* About to undergo orthodontic treatment

Key exclusion criteria:

* Patients with tooth extractions or tooth agenesis with space closure
* Patients with surface enamel defects
* Pregnant patients
* Syndromic patients or those with cleft lip and/or palate
* Patients with metabolic diseases

Eligibility criteria: Inclusion Criteria:

* Adults older than 18 years old
* About to undergo orthodontic treatment

Exclusion Criteria:

* Patients with tooth extractions or tooth agenesis with space closure
* Patients with surface enamel defects
* Pregnant patients
* Syndromic patients or those with cleft lip and/or palate
* Patients with metabolic diseases

Primary outcomes:
measure: Tooth movement
timeFrame: At the end of study completion, an average of 10 months.
Secondary outcomes:
measure: Patient discomfort / pain
timeFrame: Each patient visit, through study completion, an average of 10 months
measure: Appliance defects
timeFrame: Each patient visit, through study completion, an average of 10 months
measure: Patient compliance
timeFrame: Each patient visit, through study completion, an average of 10 months
measure: Chair and treatment time
timeFrame: Each patient visit, through study completion, an average of 10 months .
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
References:
Clinical trial NCT01266655: Baclofen for the Treatment of Alcohol Dependence
Official title: Baclofen for the Treatment of Alcohol Dependence - BACLAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alcohol Dependence
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is first evidence from preclinical and clinical studies for the efficacy of the selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of alcohol dependence according to ICD-10 (International Classification of Mental and Behavioural Disorders, 10th revision) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th revision) criteria
* An alcohol intake of at least two heavy drinking days per week on average (men ≥ 5 drinks per day; women ≥ 4 drinks per day) and an average overall consumption of 21 drinks per week or more for men and 14 drinks per week or more for women during the 4 weeks before detoxification (one standard drink is equal to 12 g absolute alcohol)
* Last alcohol consumption within 7-21 days before randomisation
* Sufficient German language capabilities

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinical significant medical conditions or observed abnormalities
* Psychiatric illness undergoing treatment with psychoactive drugs
* Epilepsy or epileptiform convulsions
* Addiction to drugs other than nicotine

Primary outcomes:
measure: Total abstinence from alcohol and cumulative abstinence duration
timeFrame: 13-16 weeks (depending on the individually tolerated baclofen dose)
Secondary outcomes:
measure: Number of adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin, Germany
name: Andreas Heinz, Prof., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beck A, Pelz P, Lorenz RC, Charlet K, Geisel O, Heinz A, Wustenberg T, Muller CA. Effects of high-dose baclofen on cue reactivity in alcohol dependence: A randomized, placebo-controlled pharmaco-fMRI study. Eur Neuropsychopharmacol. 2018 Nov;28(11):1206-1216. doi: 10.1016/j.euroneuro.2018.08.507. Epub 2018 Sep 11.