louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02487433: A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers
Official title: A Phase 1, Randomized, Open Label, Single Dose, 2 Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (mr) 22 Mg Tablets In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: food effect
pharmacokinetics
healthy volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers and/or healthy female volunteers of non-childbearing potential who are 18 to 55 years of age;
* Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Clinically significant infections within the past 3 months

Primary outcomes:
measure: AUC inf
timeFrame: 48 hours post dose
measure: AUC last
timeFrame: 48 hours post dose
measure: Cmax
timeFrame: 48 hours post dose
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 48 hours post dose
measure: Plasma Decay Half-Life (t 1/2)
timeFrame: 48 hours post dose
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06651333: fMRI and Opioid Abstinence
Official title: Functional Connectivity Mechanisms of Opioid Abstinence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug Use Disorder
Opioid Dependence
Opioid-Related Disorders
Opioid Use
Opioid Abuse
Keywords: Relapse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-10-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be individuals with primary opioid use disorder who are at least 18 years old and enrolled in formal MOUD treatment (either methadone or buprenorphine) for less than 6 months. Investigators will recruit a sample that is 50% female and 50% male.

Brief summary: This project examines functional connectivity patterns associated with subsequent relapse to illicit opioids during treatment for OUD.


Eligibility criteria: Inclusion Criteria:

* recent initiation of methadone or buprenorphine at APT Foundation within the last year (i.e., period of time during which treatment drop-out and risk for relapse is highest);
* eligibility for MRI scanning;
* ability to commit to study visits.

Exclusion Criteria:

* current acute psychosis, mania, or suicidal ideation with intent, as assessed during screening with the SCID-5;
* current intoxication or acute withdrawal at time of study visit sufficient to prevent participation based on: behavioral observation, breathalyzer, and SOWS assessment;
* severe cognitive impairment as determined via trained clinical research staff through consent process and during consent quiz or as indicated by a PROMIS Cognitive Function tscore \<30 (i.e., severe impairment)
* past or present history of intellectual disability, developmental disorder, or neurological disease;
* head trauma with loss of consciousness \>30 min;
* organ dysfunction or any unstable or untreated medical conditions that may interfere with study participation.

Primary outcomes:
measure: Illicit opioid-use
timeFrame: At monthly visits for 6 months following neuroimaging
Secondary outcomes:
measure: MOUD retention
timeFrame: up to 9 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The APT Foundation
state: Connecticut
Study officials:
affiliation: Yale University
name: Sarah Yip, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01902433: Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy
Official title: Astym® Treatment Compared With Eccentric Exercise in the Management of Chronic Mid-substance Achilles Tendinopathy: A Multisite a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Achilles Tendon Pain
Lead sponsor: University of Indianapolis
Sponsor class: OTHER
Collaborators: name: Performance Dynamics
First posted: 2013-07-18
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the changes in pain and self-perceived function between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of soft tissue mobilization using instruments) and a specific exercise protocol that involves strengthening the calf and Achilles tendon. Astym® (A-stim) is not an acronym, but rather stands for "A Stimulation" of the body's healing response, describing the physiologic process which occurs with Astym treatment. Astym is the trademark name of a non-invasive treatment where instruments are applied topically to locate unhealthy soft tissue, and to transfer mild to moderate pressure to the underlying soft tissue structures. The aim of Astym treatment is to eliminate scar tissue and stimulate tissue regeneration. Both the principal investigator and co-investigator have been trained and certified in administering the Astym treatment. The specific exercise protocol will involve exercises that strengthen the Achilles and calf through eccentric exercise. Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.


Eligibility criteria: Inclusion Criteria

* Pain for 3 months or longer in the mid portion of only one Achilles tendon.
* Must read, speak and understand English

Exclusion Criteria

* Previous surgery to the Achilles tendon that is currently painful
* An injection into the Achilles tendon in the previous 4 weeks
* Have symptoms in both Achilles tendons concurrently
* Have taken fluoroquinolone antibiotics in the past 6 months

Primary outcomes:
measure: VISA-A
timeFrame: 1 year
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health
state: Indiana
city: Lehi
country: United States
facility: Utah Physical Therapy
state: Utah
Study officials:
affiliation: University of Indianapolis
name: Emily J Slaven, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03630133: Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Official title: A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Relievant Medsystems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting

Detailed description: This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature subjects age 25-70 years, inclusive
* Chronic lower back pain for at least six months
* Failure to respond to at least six months of non-operative conservative management
* Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
* Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1

Exclusion Criteria:

* Radicular pain by history or evidence of pain neurological deficit within the past one year.
* Previous surgery performed on the lumbar spine
* Current or history of symptomatic spinal stenosis
* Current or history of osteoporotic or tumor-related vertebral body compression fracture
* Current or history of vertebral cancer or spinal metastasis
* Current or history of spinal infection
* Metabolic bone disease
* BMI greater or equal to 40
* Any radiographic evidence of other important back pathology
* MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
* Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
* Subjects who are bed bound
* Demonstrates 3 or more Waddell's signs of Inorganic Behavior
* Any evidence of current systemic infection

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 3 months
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 3, 6, 9, and 12 months
measure: Oswestry Disability Index (ODI)
timeFrame: 6, 9, and 12 months
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
Study officials:
affiliation: Indiana Spine Group
name: Kevin Macadaeg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724633: Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients
Official title: Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemodialysis
Keywords: dialysate
sodium
hemodialysis
blood pressure
thirst
intradialytic symptoms
interdialytic weight gain
extracellular fluid balance
mechanisms
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 35
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: Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and intradialytic symptoms will be assessed.


Eligibility criteria: Inclusion Criteria:

* patients on 3 times weekly hemodialysis of at least 3 months
* elevated average ambulatory blood pressures
* current dialysate sodium prescription 140mEq/L
* average pre-dialysis serum sodium \<140mEq/L

Exclusion Criteria:

* frequent intradialytic hypotension
* estimated life expectancy \<1 year
* non-adherence to dialysis prescription
* pregnancy
* inability or unwillingness to complete study measures

Primary outcomes:
measure: Ambulatory blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: thirst
timeFrame: 3 months
measure: QOL Scores (KDQOL, mins to recovery)
timeFrame: 3 months
measure: intradialytic hypotension rate, intradialytic symptoms
timeFrame: 3 months
measure: mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Rita Suri, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05430633: Laparoscopic Versus Open Appendectomy in Pregnancy
Official title: Laparoscopic Versus Open Appendectomy in Pregnancy. 10 Year Results of Estonian Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Pregnancy Loss
Pregnancy Preterm
Lead sponsor: North Estonia Medical Centre
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 109
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population consists of pregnant women who were pregnant during appendectomy confirmed either before or after the surgical procedure. The population was derived from the billing information from years 2010-2020 of the national health insurance fund of Estonia.

Brief summary: The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.

Detailed description: The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.

Patients' medical records from 2010-2020 were extracted using billing information of the national health insurance fund of Estonia and ICD-10 codes (pregnancy, appendicitis).

Collected data was stored on RedCap electronic database and analyzed with R Studio.

Two group of patients were compared: pregnant patients who had laparoscopic appendectomy and pregnant patients who had open appendectomy.

Eligibility criteria: Inclusion Criteria:

Women with confirmed pregnancy who underwent appendectomy for acute appendicitis.

Exclusion Criteria:

Women who were not pregnant when having an appendectomy

Primary outcomes:
measure: Obstetrical outcomes
timeFrame: Pregnancy loss within 9 months from appendectomy
Secondary outcomes:
measure: Surgical outcomes
timeFrame: 30 days after appendectomy
Other outcomes:
Locations:
city: Tallin
country: Estonia
facility: North Estonia Medical Centre
Study officials:
References:
citation: Lee SH, Lee JY, Choi YY, Lee JG. Laparoscopic appendectomy versus open appendectomy for suspected appendicitis during pregnancy: a systematic review and updated meta-analysis. BMC Surg. 2019 Apr 25;19(1):41. doi: 10.1186/s12893-019-0505-9.
citation: Prodromidou A, Machairas N, Kostakis ID, Molmenti E, Spartalis E, Kakkos A, Lainas GT, Sotiropoulos GC. Outcomes after open and laparoscopic appendectomy during pregnancy: A meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;225:40-50. doi: 10.1016/j.ejogrb.2018.04.010. Epub 2018 Apr 9.
citation: Zeng Q, Aierken A, Gu SS, Yao G, Apaer S, Anweier N, Wu J, Zhao JM, Li T, Tuxun T. Laparoscopic Versus Open Appendectomy for Appendicitis in Pregnancy: Systematic Review and Meta-Analysis. Surg Laparosc Endosc Percutan Tech. 2021 May 3;31(5):637-644. doi: 10.1097/SLE.0000000000000943.
Clinical trial NCT00917033: Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy
Official title: Orotracheal Intubation of Morbidly Obese Patients. A Randomised Controlled Trial Comparing the GlideScope Videolaryngoscope to the Macintosh Direct Laryngoscope.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation, Endotracheal
Anesthesia, General
Obesity
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2009-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.


Eligibility criteria: Inclusion Criteria:

* Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen.
* Body Mass Index at least 35 kg/m2
* Written informed consent to participate

Exclusion Criteria:

* Mental illness
* Abuse of alcohol or other substances
* Previous difficult tracheal intubation
* Considered non-eligible for safety-reasons by the anesthetist in charge

Primary outcomes:
measure: Time to intubate
timeFrame: Measured during intubation (seconds)
Secondary outcomes:
measure: Number of intubation attempts
timeFrame: Measured during intubation (seconds)
measure: Lowest arterial oxygen saturation during intubation
timeFrame: Measured during intubation (seconds)
measure: Subjective difficulty of intubation
timeFrame: Measured during intubation (seconds)
measure: Cormack-Lehane Score
timeFrame: Measured during intubation (seconds)
measure: Airway mucosal trauma
timeFrame: Measured during intubation (seconds)
measure: Dental injury
timeFrame: Measured during intubation (seconds)
measure: Post-procedure sore throat
timeFrame: One hour post-operative
measure: Post-procedure hoarseness of voice
timeFrame: One hour post-operative
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anesthesia, Glostrup University Hospital
state: Glostrup
Study officials:
affiliation: Glostrup University Hospital
name: Lasse H Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03401333: Brief Interventions With Text Messaging to Reduce Adolescent Alcohol and Marijuana Use
Official title: Feasibility of Augmenting Brief Interventions With Text Messaging to Reduce Adolescent Alcohol and Marijuana Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Marijuana
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A brief motivational interview and four weeks of text messaging.
Primary purpose: PREVENTION

Brief summary: This study tests the feasibility of an intervention to prevent risky alcohol or marijuana use that adds a 4-week course of tailored text messaging to a brief motivational intervention for 13-18-year-old adolescents.


Eligibility criteria: Inclusion Criteria:

* 13 to 18 years old
* Able to provide consent or assent and parental permission
* have a functioning cell phone without pay-as-you-go text messaging

Exclusion Criteria:

* currently enrolled in any substance abuse program;
* have medical/psychiatric condition that precludes participation

Primary outcomes:
measure: Enrollment
timeFrame: Baseline
measure: Retention
timeFrame: 4 weeks
measure: Satisfaction
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
References:
Clinical trial NCT00502333: The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain
Official title: The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain Treated Within the Spanish National Health Service
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Neck Pain
Keywords: back pain
neck pain
prognosis
catastrophizing
coping strategies
disability
Prognosis for back and neck pain
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2007-07-17
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated within the Spanish National Health Service for subacute or chronic neck or back pain

Brief summary: The purpose of this study is to evaluate the influence of coping strategies and catastrophizing thoughts on disability and the prognosis of back and neck pain in patients treated within the Spanish National Health Service. Patients will be given a visual analog scale (VAS) to rate intensity of pain, the Roland Morris Questionnaire (RMQ) or the Neck Disability Index (NDI) to rate the degree of disability, and the Coping Strategies Questionnaire (CSQ) to rate coping strategies and catastrophizing. Questionnaires will be given at baseline and three months later.


Eligibility criteria: Inclusion Criteria:

* Subjects treated for back or neck pain in the Spanish National Health Service.
* Able to read and write Spanish.
* Have signed the informed consent form.

Exclusion Criteria:

* Diagnosis or "red flags" for systemic diseases (e.g., cancer, infection).
* Pain due to fracture or direct trauma to the neck or back.
* Criteria for referral to surgery (e.g., neurogenic claudication due to spinal stenosis, cauda equina syndrome, serious nerve root compression for more than 6 weeks due to disc herniation).

Primary outcomes:
measure: Disability
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Pain
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kovacs Foundation,Palma de Mallorca, Spain
name: Mario Gestoso, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04181333: Safety and Efficacy of Trastuzumab BS
Official title: TRASTUZUMAB BS for Intravenous Infusion 60 mg [Pfizer], TRASTUZUMAB BS for Intravenous Infusion 150 mg [Pfizer] General Investigation (Unresectable Advanced/Recurrent HER2-Overexpressing Gastric Cancer)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Recurrent HER2-Overexpressing Gastric Cancer
TRASTUZUMAB BS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-11-29
Enrollment: 8
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients

Brief summary: To confirm the safety and efficacy of this drug under the actual use


Eligibility criteria: Inclusion Criteria:

* Patients with unresectable advanced/recurrent gastric cancer who are confirmed to have HER2 overexpression and started treatment with this drug\*
* Patients who receive this drug\* for the first time after this drug\* is launched \* Not including the biological product, HERCEPTIN, and biosimilars of HERCEPTIN other than this drug

Exclusion Criteria:

- not specified in this study

Primary outcomes:
measure: The incidence of adverse drug reactions in this surveillance
timeFrame: 24 weeks
Secondary outcomes:
measure: Assessment of tumor response: Assess the tumor response according to RECIST Ver. 1.1.
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: