louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03052569: Expanded Access to RXDX-105 for Cancers With RET Alterations
Official title: Expanded Access to RXDX-105 for the Treatment of Cancers With RET Alterations
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cancers With RET Alterations
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-02-14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access to RXDX-105 will be given to patients with cancers harboring RET alterations who have not received TKIs that target RET alterations, who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for RXDX-105.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced cancer with RET alterations
* Unable to participate in an ongoing RXDX-105 clinical trial
* Willing and able to provide written, signed informed consent
* Medically suitable for treatment with RXDX-105

Exclusion Criteria:

* Prior treatment with a TKI that has activity against RET alterations
* Currently enrolled in an ongoing clinical study with any other investigational agent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Www.Ignyta.Com
state: California
Study officials:
References:
Clinical trial NCT02086669: Pneumatic Dilatation or Surgical Myotomy for Achalasia
Official title: Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Achalasia
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2014-03-13
Enrollment: 56
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: Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

Detailed description: Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

During follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures.

Health Related Quality of Life (HRQL) has been regularly checked.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed achalasia
* Age 18-80 years
* Informed consent

Exclusion Criteria:

* Previous treatment for achalasia.
* Stage IV achalasia.
* Unwillingness to participate.

Primary outcomes:
measure: Treatment failures
timeFrame: At least five years after intervention
Secondary outcomes:
measure: Dysphagia scoring
timeFrame: At least five years after intervention
measure: Health Related Quality of Life
timeFrame: At least five years after intervention.
measure: Direct medical costs.
timeFrame: At least five years after intervention.
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Lars Lundell, Professor
role: STUDY_CHAIR
References:
citation: Persson J, Johnsson E, Kostic S, Lundell L, Smedh U. Treatment of achalasia with laparoscopic myotomy or pneumatic dilatation: long-term results of a prospective, randomized study. World J Surg. 2015 Mar;39(3):713-20. doi: 10.1007/s00268-014-2869-4.
Clinical trial NCT00132769: A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
Official title: A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 106
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: This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications
* Other criteria also apply

Exclusion Criteria:

* Other major illnesses
* Past history of certain other disorders
* Certain prohibited medications

Primary outcomes:
measure: Change From Baseline in Swollen Joint Count
timeFrame: Baseline and the average of Treatment Weeks 8, 10 and 12
Secondary outcomes:
measure: Percentage of Participants With American College of Rheumatology 20% Response [ACR20]
timeFrame: Baseline and the average of Treatment Weeks 8, 10 and 12
measure: Change From Baseline in Tender Joint Count
timeFrame: Baseline and the average of Treatment Weeks 8, 10 and 12
measure: Patient Global Assessment of Disease Activity
timeFrame: The average of Treatment Weeks 8, 10 and 12
measure: Investigator Global Assessment of Disease Activity
timeFrame: Treatment Week 12
measure: Patient Global Assessment of Response to Therapy
timeFrame: Treatment Week 12
measure: Health Assessment Questionnaire Disability Index
timeFrame: The average of Treatment Weeks 8, 10 and 12
measure: Patient's Assessment of Pain
timeFrame: Treatment Week 12
measure: Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein
timeFrame: Baseline and the average of Treatment Weeks 8, 10 and 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03244969: Bone Healing Study
Official title: Study of the Granulation Tissue Formation in the Early Fracture Hematoma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bone Fracture
Keywords: Hematoma fracture, angiogenesis, bone formation
Lead sponsor: Kazan Federal University
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with fractures of the upper and lower extremities underwent surgical bone recunstruction.

Brief summary: The aim of the research is to identify structural tissue changes in the early fracture hematomas.

Detailed description: The fracture hematomas obtained during reconstructive bone surgery from patients with bone fractures will be examined. Histological methods and ultra-thin sections for electron microscopy will be used to identify structural tissue changes in the granulation tissue in different period of time after bone fracture. Immunohistochemical analysis will be performed to estimate the dynamic of proliferation, differentiation and cell migration during granulation and reticulofibrosis bone tissues development.

Eligibility criteria: Inclusion Criteria:

* Patients with fractures of the upper and lower extremities
* Patients for whom the surgical bone reconstruction are indicated

Primary outcomes:
measure: Granulation tissue formation
timeFrame: 23 days
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Igor Plaksa
Study officials:
References:
Clinical trial NCT02468869: Improving Discharge Communication in the Emergency Department Through Information Structuring
Official title: Improving Discharge Communication in the Emergency Department Through Information Structuring: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Information Structuring Skills
Empathy Skills
Keywords: Recall
Discharge communication
Satisfaction
Adherence
Information structuring
Empathy skills
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Max Planck Institute for Human Development
First posted: 2015-06-11
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of the proposed study is to assess the potential of information structuring for improving discharge communication. Specifically, the investigators aim to examine the advantages of an information-structuring skills training for physicians (compared to an empathy skills training) on discharge communication and associated patient outcomes, such as patients' information recall and adherence to physician recommendations. The investigators hypothesize that patients receiving structured discharge information from their trained physicians will be able to recall more information and show higher adherence to recommendations relative to controls (i.e., patients receiving discharge information from doctors trained in empathy skills).


Eligibility criteria: Inclusion Criteria:

* Outpatients with chest pain
* Outpatients with abdominal pain

Exclusion criteria:

* Patients younger than 18 years of age (limited ability to provide informed consent)
* Patients with limited ability to communicate in German, the default language at the hospital (confounder related to language proficiency)
* Patients with dementia (confounder arising from pathological memory deficits)

Primary outcomes:
measure: Patients' recall of the information provided during discharge communication
timeFrame: 3 times: immediately after discharge, one week after discharge, one month after discharge
Secondary outcomes:
measure: Adherence to recommendations
timeFrame: 2 times: one week and one month after discharge
measure: Patient satisfaction in four dimensions
timeFrame: Immediately after discharge
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Emergency Department
state: Baselstadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Roland Bingisser, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03556969: Use of Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia: A Prospective Observational Study
Official title: Use of Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from both genders, ranging from young to very old patients.

Brief summary: This observational study is to evaluate Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients having hip surgery under spinal anesthesia and propofol sedation

Exclusion Criteria:

* ASA class IV or above
* pregnancy
* inability to measure noninvasive blood pressure on the arm
* preexisting hemodynamic instability
* known peripheral artery occlusive disease
* known autonomic nerve dysfunction
* uncontrolled hypertension

Primary outcomes:
measure: 5-minute perfusion index change
timeFrame: After sedation until start of surgery (an average of 20 minutes)
measure: 10-minute perfusion index change
timeFrame: After sedation until start of surgery (an average of 20 minutes)
measure: baseline perfusion index
timeFrame: After sedation until start of surgery (an average of 20 minutes)
measure: 5-minute perfusion index
timeFrame: After sedation until start of surgery (an average of 20 minutes)
measure: 10-minute perfusion index
timeFrame: After sedation until start of surgery (an average of 20 minutes)
Secondary outcomes:
measure: 5-minute perfusion index change difference
timeFrame: After sedation until start of surgery (an average of 20 minutes)
measure: 10-minute perfusion index change difference
timeFrame: After sedation until start of surgery (an average of 20 minutes)
measure: baseline perfusion index difference
timeFrame: After sedation until start of surgery (an average of 20 minutes)
measure: 5-minute perfusion index difference
timeFrame: After sedation until start of surgery (an average of 20 minutes)
measure: 10-minute perfusion index difference
timeFrame: After sedation until start of surgery (an average of 20 minutes)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University, School of Medicine
Study officials:
References:
Clinical trial NCT04970069: Preoperative Education
Official title: The Effect of Preoperative Education on Postoperative Opioid Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 1057
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will evaluate the effect of preoperative education on postoperative opioid.

Detailed description: The investigators propose a randomized trial to be performed at the Cleveland Clinic. Patients will be assigned to: 1) an educational video focused on postoperative analgesia modalities, opioids, and realistic pain expectations (analgesic education); or, 2) an educational video focused on other aspects of the perioperative experience.

Eligibility criteria: Inclusion Criteria:

* Modified informed consent
* Adults ≥18 years
* American Society of Anaesthesiologists physical status 1-4
* Scheduled for hip arthroplasty, laparoscopy assisted colorectal surgery
* Personal visit the PACE clinic
* Anticipated overnight postoperative hospitalization
* Reasonable English fluency

Exclusion Criteria:

* Opioid use for more than 30 consecutive days within three preoperative months, at a daily dose of 15 mg or more of morphine or equivalent
* Regional block or epidural analgesia

Primary outcomes:
measure: Opioid Consumption
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Time-weighted Average Pain Scores
timeFrame: 72 hours after surgery, or until discharge, whichever was earlier
measure: Satisfaction With Post Operative Pain Management
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Alparslan Turan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00971269: Pilot Study of NASHA/Dx Gel for Fecal Incontinence
Official title: A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Fecal Incontinence
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 16
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: TREATMENT

Brief summary: The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.


Eligibility criteria: Inclusion Criteria:

1. Fecal incontinence with at least 2 episodes/week
2. Symptom duration at least one year
3. Failed attempt of conservative therapy
4. Age 18-80
5. Written informed consent
6. Available for follow-up
7. Fully compliant with protocol

Exclusion Criteria:

1. Active inflammatory bowel disease
2. Total external sphincter defect at ultrasound and clinical examination
3. Bleeding diathesis or anticoagulant therapy
4. Rectal prolapse or intussusceptions
5. Present anal sepsis
6. Anorectal implants
7. Recent anorectal surgery (within 6 months)
8. Rectal anastomosis
9. Pregnancy, postpartum (one year) or breast feeding

Primary outcomes:
measure: Change in fecal incontinence episodes
timeFrame: Follow up during a four week period and after 6 and 12 months
Secondary outcomes:
measure: Side effects related to treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: 751 82 Uppsala
country: Sweden
facility: Department of Surgery, University Hospital
Study officials:
References:
Clinical trial NCT03134469: Efficacy of Probiotics on Excessive Gas Accumulation
Official title: Efficacy of Probiotics on Excessive Gas Accumulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flatulence
Bloating
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Efficacy of probiotics on excessive gas accumulation


Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-50 years, at the time of signing the informed consent.
* Willing and able to give written informed consent for participating in the study
* Willing to comply with all study procedures

Exclusion Criteria:

* Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
* Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
* Known gluten intolerance, lactose intolerance, milk protein allergy
* Vegetarian diet
* Intake of antibiotics within four weeks prior to the start of the study
* Hypersensitivity to any of the ingredients in the investigational product (IP)
* Regular intake of probiotics within four weeks prior to the start of the study
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
* Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Primary outcomes:
measure: Breath hydrogen
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
city: Uppsala
country: Sweden
facility: CTC Clinical Consultants
Study officials:
References:
Clinical trial NCT01314469: Quality of Life in Patients With Intermediate Uveitis
Official title: Influence of Macular Edema on Quality of Life in Patients With Non-infectious Intermediate Uveitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Keywords: Quality of life in patients with macular edema compared to patients without macular edema.
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
First posted: 2011-03-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intermediate uveitis

Brief summary: The aim of this study is to determine if macular edema is associated with less visual function and quality of live in patients with intermediate uveitis


Eligibility criteria: Inclusion Criteria:

* Pars planitis

Exclusion Criteria:

* Patients with any other diseases
* Patients under age 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Ophthalmology at St Franziskus Hospital
Study officials:
References:
Clinical trial NCT00213369: Neuromodulation of Aspiration Secondary to Stroke
Official title: Neuromodulation of Aspiration Secondary to Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorders
Keywords: aspiration
stroke
motor evoked potential
cortical evoked potential
neuromodulation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stroke patients

Brief summary: Aspiration could induce major respiratory affection. They are often present after stroke. The aim of this study is to facilitate swallowing recuperation in stroke patients using peripheral laryngeal stimulation and to understand its mechanisms using motor evoked potential and cortical evoked potential.


Eligibility criteria: Inclusion Criteria:

stroke aspiration

Exclusion Criteria:

pace maker tracheostomy epilepsy pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: eric verin, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: