louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02593591: Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.
Official title: Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with treatment-refractory malignancy

Brief summary: The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information. Therefore, a big data of genome-clinical information is important.

To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS, duration of response and overall survival )of patients with advanced cancer, the investigators are going to take a tumor tissue of patients and process molecular profiling and receive molecular profile directed treatments.


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 19 years of age.
2. Subject has a histologically or cytologically confirmed diagnosis of Colorectal cancer.
3. Prior treatment with anti-PDL1 antibody or immune check point inhibitor or ramucirumab therapy in the First-line or maintenance setting is allowed
4. They must have refractory or progressive disease for which there is no further curative therapy available.
5. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status.
6. Must have a life expectancy of 3 months or more
7. Written and voluntary informed consent understood, signed and dated.

Exclusion Criteria:

1. Patients who do not have enough tissue for acquisition

Primary outcomes:
measure: Response rate
timeFrame: 1 year
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 1 year
measure: Duration of response
timeFrame: 1 year
measure: overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul, Korea, Republic Of
Study officials:
References:
Clinical trial NCT01879891: Exercise Intensity, Metabolic Rate and Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Women
Keywords: Exercise Intensity
Metabolism
Insulin
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 44
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary goal is to test the hypothesis high interval exercise increases energy expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise cumulatively over 23 hours during and following the exercise. Secondary goals are to evaluate exercise difficulty during moderate intensity exercise and high interval exercise as well as difficulty of activities of daily living and free living physical activity following rest, moderate intensity exercise and high interval exercise.

A secondary study is designed to evaluate potential mechanism. Hypotheses are that changes in muscle lipid metabolism, mitochondrial function, fat and cellular insulin signals will be increased following the high intensity interval exercise. In addition, these changes will be related to changes in insulin sensitivity and increases in protein metabolism and muscle damage.


Eligibility criteria: Inclusion Criteria:

* healthy premenopausal African-American or Caucasian women ages 19 - 42

Exclusion Criteria:

* subjects cannot be smoking,
* taking medications which alter energy expenditure or fuel utilization,
* be diabetic or have a body mass index (BMI) less than 18 or more than 35.
* Also subjects cannot be pregnant or have cardiopulmonary disease.

Primary outcomes:
measure: Exercise Intensity
timeFrame: 16 weeks
Secondary outcomes:
measure: Exercise Difficulty
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
References:
Clinical trial NCT01773291: Adjuvant Acupuncture for Severe Head Injury
Official title: Adjuvant Acupuncture Therapy in Patients With Severe Head Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injury
Keywords: Acupuncture; laser acupuncture; traumatic brain injury
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the therapeutic effect of acupuncture on severe head injury under conventional treatment. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.

Detailed description: Objective: To investigate the therapeutic effect of acupuncture on severe head injury under conventional treatment.

Methods: 90 subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less) are randomly divided into acupuncture, laser acupuncture and control group. We use restoring consciousness acupuncture (GV26 and 12 Well points) to treat the subjects 3 sessions per week under conventional treatment at Department of Neurosurgery. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' GCS and muscle power is measured.

Eligibility criteria: Inclusion Criteria:

* subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less)
* with informed consent

Exclusion Criteria:

* dilated pupils without light reflex
* serious complications during therapeutic course
* interruption of therapeutic course
* unfavored condition assessed by physician in charge
* without informed consent

Primary outcomes:
measure: Glasgow Coma Scale (GCS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Muscle Power (MP)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Wen-Long Hu, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeFina PA, Fellus J, Thompson JW, Eller M, Moser RS, Frisina PG, Schatz P, Deluca J, Zigarelli-McNish M, Prestigiacomo CJ. Improving outcomes of severe disorders of consciousness. Restor Neurol Neurosci. 2010;28(6):769-80. doi: 10.3233/RNN-2010-0548.
citation: Jennett B, Adams JH, Murray LS, Graham DI. Neuropathology in vegetative and severely disabled patients after head injury. Neurology. 2001 Feb 27;56(4):486-90. doi: 10.1212/wnl.56.4.486.
citation: Clauss R, Nel W. Drug induced arousal from the permanent vegetative state. NeuroRehabilitation. 2006;21(1):23-8.
Clinical trial NCT00530491: Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity
Official title: Prospective Randomized Controlled Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With FEV1 < 70% of Expected Value or < 1.5L
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiration Disorders
Keywords: lung resection
reduced pulmonary function
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2007-09-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 \< 70% of expected value or \< 1.5L who undergo resections of the lung.


Eligibility criteria: Inclusion Criteria:

* resection of the lung
* FEV1 \<70% of expected value or below 1.5L
* 18-80y
* given written informed consent

Exclusion Criteria:

* contraindication for epidural anesthesia
* prio ipsilateral thoracotomy
* chemotherapy \<6 weeks prior to study enter
* existing pneumonia (fever, elevated WCC, elevated CRP)

Primary outcomes:
measure: pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality
timeFrame: 1 year
Secondary outcomes:
measure: duration of ICU treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
name: Bernd M Muehling, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05746091: Arthroscopic Partial Trapezictomy With Hematoma Distraction in Basal Thumb Arthritis
Official title: Arthroscopic Partial Trapeziectomy With Hematoma Distraction in Basal Thumb Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The basal joint, also referred to as the carpometacarpal (CMC) joint, of the thumb is one of the joints most commonly affected by arthritis. CMC joint arthritis can lead to decreased grip and pinch strength and impairment of activities of daily living

Detailed description: The thumb CMC joint has been reported as the most painful joint when compared to other hand joints affected by OA. It is therefore no surprise that this is a common chief complaint of patients and has a significant effect on work and life satisfaction Patients often present with complaints of pain localized to the base of the thumb that is exacerbated when performing tasks such as opening a jar, turning a car key, and turning door Knob, this pain may be reproduced by resisted pinch and grip .

On physical examination, patients will have point tenderness at the thumb basal joint with swelling and crepitus when the basal joint is compressed - a positive grind test and a positive "hump" sign from dorsal CMC dislocation subluxation .

Eligibility criteria: Inclusion Criteria:

* Age: adult patient \> 20years.
* Gender: Males \& Females.
* Symptomtic patient.
* Failed conservative treatment of 6 months duration
* Eaton stage II, III and IV of base thumb arthritis

Exclusion Criteria:

* Patient presenting with flexor carpi radialis rupture
* Previous Zancolli arthroplasty
* Associated comorbidity as: RA,DM with joint destruction
* Infection
* Poor Skin Condition
* Active Pateint With High Joint Demand

Primary outcomes:
measure: DASH score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Alazhar
Study officials:
References:
Clinical trial NCT02321891: A Pilot Study to Determine a Candidate Protocol for Transcranial Electrical Stimulation in the Treatment of Anxiety
Official title: Optimizing Transcranial Electrical Stimulation for Clinical Applications (the OptES Study): A Pilot Study to Determine a Candidate Protocol for Treatment of Anxiety (OptES-Anx)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot study.

Detailed description: The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot study in patients with chronic pain. The investigators also seek to detect autonomic nervous system changes induced by the tDCS, and develop new methods for the measurement of autonomic nervous system functions.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Naïve to tDCS
* Right-handed
* Beck Anxiety Scores \>= 26

Exclusion Criteria:

* Metal implants inside skull or eye
* Severe skin lesions at the electrode placement area
* History of epilepsy or previous seizures
* Pregnant or breast-feeding
* Pacemaker
* History of intracerebral bleeding during the past six months
* Lifetime DSM-IV diagnosis of bipolar mood disorder or psychotic disorder
* DSM-IV diagnosis for substance abuse or dependence during the past six months

Primary outcomes:
measure: Beck Anxiety Inventory
timeFrame: 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: University of Eastern Finland
name: Soili M Lehto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04474691: staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback
Official title: staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Speech Sound Disorder
Keywords: speech
articulation
motor development
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2020-07-17
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Children with /r/ misarticulation will receive 16 sessions/8 weeks of intervention using staRt. Individual sessions will be randomly assigned to include the visual biofeedback display (visual-acoustic biofeedback treatment) or exclude it (traditional treatment). Participants will receive an equal number of sessions (8) of each type.
Primary purpose: TREATMENT

Brief summary: Previous research suggests that biofeedback can outperform traditional interventions for RSE, but no controlled studies have tested this hypothesis in the context of app-delivered biofeedback. The objective of this aim is to use the staRt app to test our working hypothesis that speakers will make larger gains in /r/ accuracy when app-based treatment incorporates biofeedback, compared to a non-biofeedback condition. With a network of cooperating SLPs, this project will recruit 15 children with /r/ misarticulation to receive 8 weeks of intervention using staRt. Individual sessions will be randomly assigned to include or exclude the visual biofeedback display. Randomization tests will be used to evaluate, for each individual, whether larger increments of change are associated with biofeedback and non-biofeedback sessions.


Eligibility criteria: Inclusion Criteria:

* Normal performance on a pure-tone hearing screening at 20 dB HL, a screening examination of oral-motor structure and function, and a test of receptive language.

Exclusion Criteria:

* History of major behavioral, neurological, or hearing impairment, per parent and/or SLP report.

Primary outcomes:
measure: F3-F2 Distance, an Acoustic Measure That Correlates With Perceptual Accuracy of /r/, Measured From /r/ Sounds Produced in Treatment Sessions.
timeFrame: F3-F2 distance was measured in all 16 treatment sessions (eight of each type), which were administered over eight weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References:
Clinical trial NCT02336191: Monitoring Living Donor Liver Functions by Thromboelastometry
Official title: Monitoring Post-transplant Living Donor Liver Functions by Thromboelastometry. A Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: THROMBELASTOGRAPHY and Liver Graft Functions
Keywords: living donor liver transplantation
graft function
thromboelastometry
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Living donor liver transplant recipients operated upon in mansoura university liver transplantion project

Brief summary: A prospective Observational study including 50 living donor liver transplant recipients to monitor the graft functions through thromboelastometry

Detailed description: This is a prospective observational study Includes 50 living donor liver transplant recipients performed in gastroenterology surgical center - Mansoura University liver transplantation program.

Study period: from June 2014 to May 2015 The early post-operative graft functions will be correlated with concomitant monitored thromboelastometric (TEM) parameters derived from a ROTEM Delt device

TEM Samples will be collected at the following times:

Pre-transplant 10 minutes post portal declamping at ICU admission Morning of Days from 1 to 7 Laboratory data relevant to graft functional status will be collected at the same times.

Eligibility criteria: Inclusion Criteria:

* Living donor liver transplant recipients successively performed in the liver transplantation program - Mansoura university

Exclusion Criteria:

* Non

Primary outcomes:
measure: r (correlation coefficient) between clot firmness time at 20 minutes, clotting time and INR
timeFrame: 20 minutes after starting the TEG test
Secondary outcomes:
measure: r (correlation coefficient) between clotting time , clot firmness time at 20 minutes and serum bilirubin
timeFrame: 20 minutes after the start of the TEG test
measure: r (correlation coefficient) between clotting time , clot firmness time at 20 minutes and serum SGPT
timeFrame: 20 minutes after the start of the TEG test
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Gastroenerology Surgical Center - Liver transplantation program
state: Dakahlia
Study officials:
affiliation: MAnsoura Faculty of Medicine
name: amr M Yassen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03383991: Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures
Official title: Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures in Patients Older Than 70 Years. A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humeral Fracture, Proximal
Keywords: Humeral Fracture, Proximal
Arthroplasty, Replacement, Shoulder
Reverse Total Shoulder Arthroplasty
Shoulder Hemiarthroplasty
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-12-27
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty.

The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.


Eligibility criteria: Inclusion criteria

* Displaced 3- or 4-part fracture of the proximal humerus
* Age over 70 years
* Independent living
* Low energy trauma

Exclusion criteria

* Pre-existing shoulder disease
* Severe cognitive dysfunction
* More than 14 days from injury to surgery
* Comorbidity that affects shoulder rehabilitation considerably
* Concurrent injury that affect shoulder rehabilitation considerably

Primary outcomes:
measure: Constant-Murley Score
timeFrame: 24 months
measure: WOOS (Western Ontario Osteoarthritis of the Shoulder) Index
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Per Olerud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska Academy
name: Carl Ekholm, MD
role: STUDY_DIRECTOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.