louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05128890: Evaluation of Resection Techniques for Pancreatic Tumors
Official title: Evaluation of Resection Techniques for Pancreatic Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Liver Tumor
Pancreas Tumor
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 431
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)

Brief summary: The objective of this study is to compare open and minimally invasive pancreatic and liver resection techniques and analyze the different outcome variables from the clinical standpoint.

The plan is to investigate patient survival, length of stay, complication rates, operative time, transfusion rate, 30 and 90-day readmission rate, and hospital charges.

Detailed description: The plan is to conduct a retrospective chart review of patients who have undergone pancreatic and liver resection by using Meditech and Epic. A non-identified database will be created after retrospectively reviewing each patient case involving pancreatic or liver resection at MDMC. The study period will start in January 2006 until December 2020. Variables will include demographics, clinical disease diagnoses, and operative parameters as well as indirect charges from the hospitalizations.

Eligibility criteria: Inclusion Criteria:

* Patients that have undergone pancreatic or liver resection surgeries from January 2006 until December 2020 at Methodist Dallas Medical Center (MDMC)
* Patients 18 years old or older

Exclusion Criteria:

* Patients that have not undergone pancreatic resection surgeries
* Patients under 18 years of age

Primary outcomes:
measure: Patient Survival
timeFrame: through study completion, an average of 1 year
measure: Length of stay
timeFrame: Up to 1 year
measure: Complication rates
timeFrame: through study completion, an average of 1 year
measure: Operative time
timeFrame: up to 10 hours
measure: Transfusion rate
timeFrame: through study completion, an average of 1 year
measure: 30 and 90 day readmission rate
timeFrame: through study completion, an average of 1 year
measure: Hospital charges
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Liver Institute, Methodist Dallas Medical Center
name: Alejandro Mejia, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04322890: Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation
Official title: Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
EGFR Gene Mutation
ALK Gene Mutation
ROS1 Gene Mutation
MET Gene Mutation
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.

Detailed description: The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.

Our study was set up with several group with EGFR mutant, ALK fusion, ROS1 fusion, RET fusion, BRAF mutation, NRG1 fusion, MET alteration, KRAS mutation, etc.

Eligibility criteria: Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age ≥ 18 years.
3. Histologically or cytologically confirmed, Stage IV NSCLC.
4. Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc.
5. ECOG 0-1.
6. Predicted survival ≥ 12 weeks.
7. Adequate bone marrow hematopoiesis and organ function
8. Presence of measurable lesions according to RECIST 1.1.

Exclusion Criteria:

The patient did not match from the Inclusion Criteria.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Time from first subject dose to study completion, or up to 36 month
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years
measure: Objective Response Rate (ORR)
timeFrame: Time from first subject dose to study completion, or up to 36 month
measure: Adverse events (AEs) according to CTCAE 5.0
timeFrame: From first dose until 28 days after the last dose, up to 24 month
measure: Patient reported outcome (PRO)
timeFrame: To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Yongchang Zhang
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01257490: Integrated Smoking Cessation Treatment for Low Income Community Corrections
Official title: Integrated Smoking Cessation Treatment for Low Income Community Corrections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-12-09
Enrollment: 689
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study recruited cigarette smokers under supervision in community corrections (e.g., probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12 weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of bupropion treatment and 4 sessions of intensive counseling around smoking cessation. The study was stratified on race such that equal proportions of African Americans and Caucasians were enrolled in the two study groups. It was hypothesized that smokers receiving intensive counseling will have higher quit rates compared to smokers receiving brief advice to quit.


Eligibility criteria: Inclusion Criteria:

* At least 19 years or older
* Enrolled in criminal justice community supervision (e.g., probation, parole, drug court, community corrections, etc)
* Smoking at least 5 cpd for the past year
* Maintained in an unrestricted environment (e.g., not currently in a correctional facility or treatment facility) living in the Birmingham Area and surrounding communities

Exclusion Criteria:

* Pregnant or nursing (all women in this study will be required to use an acceptable form of contraception throughout the administration of the medication)
* Known sensitivity to Zyban or Wellbutrin
* History of seizures
* Current or prior anorexia or bulimia
* Abrupt withdrawal from alcohol or benzodiazepines
* Moderate to severe kidney problems
* Moderate liver problems
* Cognitive impairment such that they cannot provide informed consent

Primary outcomes:
measure: smoking cessation
timeFrame: 3 months
measure: smoking cessation
timeFrame: 6 Month
measure: smoking cessation
timeFrame: 9 Month
measure: smoking cessation
timeFrame: 12 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Substance Abuse
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Karen L Cropsey, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02469103: The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis
Official title: The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colitis, Ulcerative
Keywords: capsule colonoscopy
ulcerative colitis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 150
Sex: ALL
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: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the accuracy of second generation colon capsule (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using conventional endoscopy as the gold standard.

Detailed description: Consecutive patients with ulcerative colitis will be recruited. Second generation colon capsule endoscopy (C2) and conventional colonoscopy will be performed one after another on the same day. Colonic mucosal inflammation will be scaled by physicians who review C2 videos and those who perform conventional colonosocpies independently. Physicians who review C2 videos and colonoscopists will be blinded to the findings of colonoscopies and C2 videos, respectively.The accuracy of C2 in evaluating mucosal inflammation will be evaluated, using conventional endoscopy as the gold standard.

Eligibility criteria: Inclusion Criteria:

* age 18-80 years
* suspected or known UC
* written informed consent

Exclusion Criteria:

* patients with severe UC according to Truelove and Witts' criteria
* current pregnancy/lactating
* patients with a pacemaker or other implanted electromedical device
* the presence of dysphagia
* patients at higher risk of capsule retention (including Crohn's disease, small bowel tumor, radiation enteropathy, previous intestinal surgery, acute abdominal pain without regular defecation)
* patients with a contraindication to bowel preparation (congestive heart failure, renal insufficiency, a life-threatening condition)
* patients with an allergy to polyethylene glycol, sodium phosphate solution, metoclopramide or bisacodyl suppository

Primary outcomes:
measure: Number of participants with extent and severity of colonic inflammation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Siew Ng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi HY, Chan FKL, Higashimori A, Kyaw M, Ching JYL, Chan HCH, Chan JCH, Chan AWH, Lam KLY, Tang RSY, Wu JCY, Sung JJY, Ng SC. A prospective study on second-generation colon capsule endoscopy to detect mucosal lesions and disease activity in ulcerative colitis (with video). Gastrointest Endosc. 2017 Dec;86(6):1139-1146.e6. doi: 10.1016/j.gie.2017.07.007. Epub 2017 Jul 14.
Clinical trial NCT04486703: Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn
Official title: Effect of Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn: a Twelve-week Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Burn
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current study was to evaluate the effect of physical therapy rehabilitation program combined with music therapy on pediatric with lower limb burn. Methods. A twelve-week randomized controlled study including thirty lower limb pediatric burned patients who randomly divided into two groups, Group(A) received physical therapy rehabilitation program combined with music therapy in addition to routine medical care while Group (B) received physical therapy rehabilitation program without music therapy. Pain was assessed by visual analogue scale (VAS) and range of motion (ROM) was assessed by goniometer, and gait assessed by GAIT Rite. Assessment was carried before and after treatment


Eligibility criteria: Inclusion Criteria:

* Lower limb 2nd degree burn since 6 weeks
* Burn affect skin around ankle and knee joint,
* Both sex, age ranged between 10 to 15 years old
* Patients have sufficient cognition and education enough to understand the requirements of this study

Exclusion Criteria:

* All patients with age more than 15 years or less than 10 years
* Patients with hearing problems
* Acute viral diseases, acute tuberculosis, mental disorders
* Those with pace makers, diabetics, cardiac, renal patients
* Patients with genetic disease
* 3rd degree burn and 1st degree bum

Primary outcomes:
measure: pain in the lower limb
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
References:
Clinical trial NCT04164303: Conservative Management of DeQuervain's Tendinopathy With an Orthopaedic Manual Therapy Approach Emphasizing First CMC Manipulation: A Retrospective Case Series
Official title: Conservative Management of DeQuervain's Tendinopathy With an Orthopaedic Manual Therapy Approach Emphasizing First CMC Manipulation: A Retrospective Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DeQuervain's Tendinopathy
Keywords: DeQuervain's tendinopathy
CMC manipulation
Physical Therapy
Lead sponsor: Regis University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with DeQuervain's tendinopathy.

Brief summary: This is a retrospective review of three patients with DeQuervain's Tendinopathy (DQT) that had successful outcomes with a manual therapy focused approach provided by Physical Therapist management.

Detailed description: DeQuervain's tendinopathy (DQT) is a musculoskeletal disorder that limits hand function of affected individuals. Management of DQT can include splinting, activity modification, medications, corticosteroid injections, Physical Therapy, and surgery. There is limited evidence to support the combination of manual therapy and exercise interventions within an Orthopaedic Manual Physical Therapy (OMPT) approach when managing patients with DQT. Three patients identified with DQT underwent a multi-modal treatment regimen including carpometacarpal (CMC) thrust and non-thrust manipulation, end range radiocarpal mobilization, mobilization with movement (MWM), strengthening exercises, and grip proprioception training. Outcomes were assessed using the numeric pain rating scale (NPRS), Jamar hand dynamometer grip strength, and the Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire. These measures were administered at baseline and discharge.

Eligibility criteria: Inclusion Criteria:

Five or more items present on the DQT screening tool devised by Batteson et al.:

* Pain over the radial styloid
* Tenderness over the dorsal thumb
* Pain with active thumb flexion
* Localized swelling over the thumb
* Positive Finkelsteins test
* Thickening of the tendon sheath of the first dorsal extensor compartment
* Pain with resisted thumb extension.

Exclusion Criteria:

* Cardiovascular disorders
* Non-musculoskeletal complaints
* Auto-immune disorders
* Patients who had received previous treatment for their condition

Primary outcomes:
measure: Change from Baseline Quick Disabilities of the Arm, Shoulder, and Hand questionnaire at 8 weeks
timeFrame: up to 8 weeks
measure: Change from Baseline Numeric Pain Rating Scale at 8 weeks
timeFrame: up to 8 weeks
measure: Change from Baseline Grip strength at 8 weeks
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01300403: Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis
Official title: Acute Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Dynamic and Static Pulmonary Volumes of Patients With Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Centro Universitário Augusto Motta
First posted: 2011-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the acute physiological effects of expiration with the glottis open in lateral posture (ELTGOL) and Flutter valve in dynamic and static lung volumes in patients with bronchiectasis and, secondarily, to study the effect of these techniques in sputum production.


Eligibility criteria: Inclusion Criteria:

Patients with clinical and radiological criteria of bronchiectasis

Exclusion Criteria:

* heart failure
* pneumonia
* chest pain
* inability to perform the procedures
* asthma
* cystic fibrosis

Primary outcomes:
measure: Dynamic and static lung volumes
timeFrame: In the week 1, 2 and 3. Before (baseline) and after each intervention.
Secondary outcomes:
measure: Sputum production
timeFrame: Sputum was colected during the interventions
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Fernando S Guimarães, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01817803: A Prospective, Single-center, Open-label, Pilot Study to Compare the Effectiveness and Safety of Diuretics Add-On Strategy in Chronic Heart Failure Patients (DIOS 1)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Heart failure
diuretics
kidney
glomerular filtration rate
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients


Eligibility criteria: Inclusion Criteria:

1. dyspnea at rest or minimal activity
2. tachypnea (respiratory rate \> 20/min) or rales or pulmonary edema on chest X-ray
3. who need diuretics add over 40mg of daily furosemide dose

Exclusion Criteria:

1. Hospitalization for acute heart failure decompensation
2. cardiogenic shock (Systolic Blood Pressure \< 80mmHg)
3. Need or plan for renal replacement therapy (dialysis, kidney transplant)
4. serum creatine level \> 2.5mg/dl
5. serum potassium (K+) \> 5.5mg/dl
6. daily spironolactone dose \> 50mg
7. previous thiazide or metolazone user
8. Age \> 75 years old or poor compliance patients 9. allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics 10. life expectancy \< 6 months (e.g. metastatic malignancy, liver cirrhosis) 11. pregnancy or women at age of childbearing potential

Primary outcomes:
measure: efficacy and safety of diuretics add-on strategy
timeFrame: D+0, D+7, D+30, D+90
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04364503: Compliant Analysis of Patient Samples and Data
Official title: Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies And/or Population-based Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Cancer
Infectious Disease
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Laboratory Corporation of America
First posted: 2020-04-28
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Arm 1 - Female or male patient samples submitted to Sequenom or LabCorp affiliate for routine clinical care testing that no longer need to be maintained for clinical purposes.

Arm 2 - Female or male subjects of scientific interest who have provided written informed consent/assent.

Brief summary: Patients of scientific interest who have provided a commercial sample to LabCorp or one of its' affiliates will have their de-identified remnant samples and/or data used for research and development. Other commercial patients will be followed up on after informed consent is obtained.

Detailed description: Arm 1 - Remnant commercial samples and data that has been de-identified of personal health information in compliance with HIPAA may be used for R\&D studies or population-based analysis by LabCorp or affiliates.

Arm 2 - Collection of samples and/or data from commercial test patients requiring follow-up or from subjects of scientific interest after informed consent is obtained.

Eligibility criteria: Inclusion Criteria:

* Arm 1
* All samples and data are de-identified and HIPAA compliant
* Arm 2
* Subject is of scientific interest to the Sponsor or treating physician
* Subject provides written informed consent and has a clinical sample and/or supporting clinical data collected.

Exclusion Criteria:

* Arm 1
* Subject is from a US state or a country where local law restricts the use of de-identified data and/or remnants of specimens for research and/or development
* Arm 2
* Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent

Primary outcomes:
measure: Remnant samples and data for research and development
timeFrame: Retrospective and Prospective collection. Samples and data may be collected for up 12 months after enrollment.
measure: Sample and data collection from subjects of scientific interest
timeFrame: Prospective collection. Samples and data may be collected for up to 12 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sequenom, Inc
state: California
Study officials:
affiliation: Sequenom, Inc.
name: Graham P McLennan
role: PRINCIPAL_INVESTIGATOR
References: