louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02535468: T2Bacteria Panel Pivotal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Lead sponsor: T2 Biosystems
Sponsor class: INDUSTRY
First posted: 2015-08-28
Enrollment: 2430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates participating in the prospective arm of the study will come from the hospital population who have had a blood culture ordered per routine standard of care. The contrived arm of the study is open to any participants that meet the study enrollment criteria. The study population for both arms is defined as all subjects who meet the study eligibility criteria, provide informed consent, and provide the clinical specimens under this protocol.

Brief summary: The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood "clinical samples".


Eligibility criteria: Inclusion Criteria:

* Subject or subject's legally authorized representative (LAR) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
* Subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only).
* Subject is between 18-95 years of age.

Exclusion Criteria:

* Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
* Subject has had previous specimens tested by the T2Bacteria Panel with valid results.
* Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.

Primary outcomes:
measure: Sensitivity
timeFrame: Up to 19 hours post blood collection
measure: Specificity
timeFrame: Up to 19 hours post blood collection
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT01956968: Flexibility, Range of Motion and Strength Among Patients With Differing Response to the Scapular and Humeral Assistance Tests
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Pain
Keywords: Shoulder pain, Scapular dyskinesia, Physical examination
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 130 subjects referred to physical therapy due to shoulder pain.

Brief summary: Shoulder pain may result from abnormal arm or shoulder blade (scapular) movement. These abnormal movements may result from a variety of flexibilty, motion or strength impairments. Therefore identifying any abnormal arm or scapular movement, as well as any impairments that are associated with them can help clinicians plan a proper management strategy for patients presenting with shoulder disorders. Our hypothesis is that specific impairments will be associated with abnormal arm movement, while other impairments will be associated with abnormal scapular movement among patients with shoulder pain.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older, main complaint of shoulder pain, ability to elevate arm in the scapular plane to at least 135 degrees, pain during scapular plane elevation, can read Hebrew.

Exclusion Criteria:

* Signs or symptoms suggesting cervical spine origin, previous fracture around shoulder complex, traumatic onset of shoulder pain, Fibromyalgia, Rheumatiod arthritis, previous shoulder surgery, loss of 50% or more of passive range of motion in 2 or more planes of motion, positive lag signs, positive apprehension test, pregnancy.

Primary outcomes:
measure: Shoulder internal rotation range of motion
timeFrame: Baseline
measure: Posterior capsule flexibility
timeFrame: Baseline
measure: Pectoralis minor resting length
timeFrame: Baseline
measure: Scapular dyskinesis
timeFrame: Baseline
measure: Scapular upward rotation range of motion
timeFrame: Baseline
measure: Shoulder elevation torque
timeFrame: Baseline
measure: Shoulder external rotator torque
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bat-Yam
country: Israel
facility: Bat-Yamon Physical Therapy Clinic - Clalit Health Services
Study officials:
affiliation: Ariel University
name: Alon Rabin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03578068: Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15
Official title: Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recovery of Function
Keywords: Quality of Recovery
Postoperative
Surgery
French
Translation
Validation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery

Brief summary: After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. It provided a valid, extensive and efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into French, and do a full psychometric evaluation of the French version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, orthopedic, \[...\], gynecological surgery, in the University Hospital of Strasbourg. The secondary objectives will be to evaluate the quality of recovery of the patients who undergone surgery at Strasbourg University Hospital, and to evaluate the incidence of postoperative complications occurring within three months postoperatively and a possible association with the QoR-15F.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery
* Patient agreeing to use his data for research purposes

Exclusion Criteria:

* Patient operated on a surgery for which it is highly probable that the postoperative management does not allow him to propose the completion of the J1 questionnaire
* Patient unable to express non-opposition to participation in the study
* Patient expressing opposition to participating in the study

Primary outcomes:
measure: QoR-15F score Title: QoR-15F score Description: Time Frame: 24h befor surgery Outcome 2 Title: QoR-15F score Description: Time Frame: 24h after surgery
timeFrame: 24h after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service D'Anesthesiologie - Reanimation Chirurgicale
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Eric Noll, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.
Clinical trial NCT00138268: Pilot Study Freeze and Transport Immune Cells
Official title: Pilot Study to Optimize and Standardize Umbilical Cord Blood Collection and the Isolation, Freezing and Transportation of Cells for Studies of Cellular Immune Responses to Immunization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria
Hepatitis B
Pertussis
Poliomyelitis
Tetanus
Keywords: umbilical cord blood, vaccine, pregnant women
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2005-08-30
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: To evaluate and standardize umbilical cord specimen collection and laboratory procedures to evaluate cellular and serological immune responses in neonates and young infants

Detailed description: To evaluate: 1) The procedures for obtaining umbilical cord blood; 2) the methods for ensuring immune cell viability, freezing, and shipping; 3) the conditions for optimization of immune cell isolation procedures.

Eligibility criteria: Inclusion Criteria:

For the portion of the pilot study conducted at the UCLA CVR, an umbilical cord blood sample will be obtained from approximately 8 to 12 healthy pregnant women who are delivering neonates at the Obstetrical delivery ward of Harbor- UCLA Medical Center. Informed consent will not be obtained because the blood will be obtained after delivery from a clamped umbilical cord attached to the placenta (afterbirth) that otherwise would be discarded.

Exclusion Criteria:

A cord blood sample will not be collected from women who have requested special arrangements for a cord blood registry service.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: UCLA Center For Vaccine Research
state: California
Study officials:
References:
Clinical trial NCT01720368: OPERA Database - Crohn's Protocol
Official title: IBD-OPERA Database IBD OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database - Crohn's Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Keywords: IBD
Crohn's
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2012-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women over 18 years of age with Crohn's disease

Brief summary: The investigators believe that patients with Crohn's disease are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.


Eligibility criteria: Inclusion Criteria:

* Adults (over 18 years of age) with physician diagnosed Crohn's disease
* A current or past prescription of anti-TNF
* Access to medical record for validation of clinical information

Exclusion Criteria:

* Unwilling or unable to provide informed consent for study participation
* Unable to access or use the internet
* Ulcerative colitis or IBD-U
* Illiterate or does not possess minimum level of literacy required to complete questionnaire

Primary outcomes:
measure: Validity of patient self reporting
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT04967768: The Influence and Effects of the COVID-19 Pandemic on Orthopaedic Resident Training
Official title: The Influence and Effects of the COVID-19 Pandemic on Orthopaedic Resident Training: a Nationwide Cross-sectional Survey in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Educational Problems
Covid19
Burnout, Student
Depression
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-07-20
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Orthopedic Residents in Turkey

Brief summary: Orthopedic residents, like all other healthcare professionals, face unique challenges during the coronavirus disease 2019 (COVID-19). The rapid spread of COVID-19 has forced healthcare systems around the world to adapt. As in many other specialties, it has led to many changes in the training of orthopedic residents including restructuring of surgical training, a reduction in elective surgery cases, and re-assignment of residents to COVID-19-related clinical duties. As a result, the standard training curriculum has been interrupted and the number of surgical cases has decreased, limiting the ability of the residents to meet the range and number of patient follow-up and treatment requirements set by the Turkish Orthopedics and Traumatology Education Council (TOTEK).

The already stressful work environment of orthopedic residents has become more stressful and anxious with the COVID-19 pandemic.

There are no well-designed survey studies that have shown the impact of the COVID-19 pandemic on orthopedic resident education and well-being from the resident's perspective. Therefore, the purpose of this nationwide survey study was to document and analyze the effects of the COVID-19 pandemic on the real-life experiences of orthopedic residents in Turkey.


Eligibility criteria: Inclusion Criteria:

Volunteering to answer survey questions

Exclusion Criteria:

Incomplete answers to survey questions or refusing to participate in the survey

Primary outcomes:
measure: The impact of the COVID-19 pandemic on orthopaedic resident training
timeFrame: 30.12.2020 - 15.01.2021
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Research and Training Hospital
Study officials:
References:
Clinical trial NCT04018768: Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery
Official title: Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for isolated arthroscopic shoulder instability surgery

Brief summary: This will be a single-center, prospective observational study. The study will compare post- operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (Motrin) and Percocet (to be used as needed) while the other cohort will receive only Percocet. Both pain management options are considered to be standard of care.


Eligibility criteria: Inclusion Criteria:

* ASA class I-II
* Patients scheduled for arthroscopic shoulder instability surgery

Exclusion Criteria:

* Contraindication to ibuprofen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age or older than 65
* Any patient considered a vulnerable subject
* Patients on pain medication prior to surgery

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Score
timeFrame: 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery
measure: Change in Verbal Rating Scale (VRS)
timeFrame: 30 Minutes, 1 Hour Post Surgery, 2 Hours Post Surgery, 3 Hours Post Surgery, 4 Hours Post Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York Langone Health
name: Kirk Campbell
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bloom DA, Baron SL, Luthringer TA, Alaia MJ, Strauss EJ, Jazrawi LM, Campbell KA. Preoperative Opioid Education has No Effect on Opioid Use in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Prospective, Randomized Clinical Trial. J Am Acad Orthop Surg. 2021 Oct 1;29(19):e961-e968. doi: 10.5435/JAAOS-D-20-00594.
Clinical trial NCT00740168: Bevacizumab Treatment and Retinal Vessel Monitoring
Official title: Analysis of Retinal Vessel Reaction and Monitoring of Circulation Parameters During Bevacizumab Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: bevacizumab
cancer
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2008-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients with first bevacizumab treatment

Brief summary: Bevacizumab might influence the dynamic vessel function after being administered intravenously.

Detailed description: By monitoring different vessel and circulation parameters (e.g. dynamic retinal vessel analyzer) the study will clarify the potential hemodynamic effects of bevacizumab.

Eligibility criteria: Inclusion Criteria:

* patients who wish and need bevacizumab treatment for underlying disease

Exclusion Criteria:

* previous bevacizumab treatment
* known eye disease, eye surgery or eye trauma in history
* myopia \>-2.0 dpt
* hyperopia \> +2.0 dpt.
* relevant media opacity of the lens
* acute heart disease, ischemic insult, proven coronary heart disease
* cardiac arrhythmia or vessel anomalies
* seizure disorder or episode in history
* migraine
* treatment with corticosteroids within 4 weeks before study inclusion
* intake of vasoactive drugs like AT-1 or glitazone
* pregnancy

Primary outcomes:
measure: Diameter of retinal vessels and dynamic vessel reaction
timeFrame: Measurements before and after administration
Secondary outcomes:
measure: Baroreflex sensitivity, heart frequence variability, reaction to handgrip test
timeFrame: Measurements before and after administration
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Autonomic lab (ANF)
state: Sachsen
Study officials:
affiliation: Neurological University Clinic
name: Tjalf Ziemssen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reimann M, Folprecht G, Haase R, Trautmann K, Ehninger G, Reichmann H, Ziemssen F, Ziemssen T. Anti-Vascular endothelial growth factor therapy impairs endothelial function of retinal microcirculation in colon cancer patients - an observational study. Exp Transl Stroke Med. 2013 May 13;5(1):7. doi: 10.1186/2040-7378-5-7.
Clinical trial NCT00979368: Safety Study of BMS-816336 in Healthy Male Subjects
Official title: Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Dyslipidemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* BMI of 18 to 32 kg/m²
* Men only, ages 18-55 years

Exclusion Criteria:

* Sexually active men not using effective birth control if their partners are WOCBP
* Any significant acute or chronic medical illness
* Family history of Gilbert's disease
* History of Pancreatitis
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EGG or clinical laboratory determinations
* QTc interval \> 450 msec (corrected for heart rate using Fridericia's correction method, QTcF)
* Second- or third-degree A-V block or clinically relevant ECG abnormalities
* History of allergy to 11-β-HSD-1 inhibitors or related compounds
* Prior exposure to BMS-816336
* Use of St. John's Wort (Hypericum) within 4 weeks prior to the first dose of study drug and throughout the study
* Use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration
* Use of any glucocorticoid topical creams within 4 weeks of study drug administration
* Use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment

Primary outcomes:
measure: Exposure to the investigational drug will be measured to assess safety and tolerability
timeFrame: Within 72 hours following dosing
Secondary outcomes:
measure: To assess the single dose Pharmacokinetics of BMS-816336
timeFrame: During 72 hours following dosing
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: