louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02227836: Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis
Official title: Efficacy of Allergy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: Allergy Patch testing
Eosinophilic Esophagitis
EoE
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to see if allergy patch testing (APT) can help predict effective dietary therapy in patients with eosinophilic esophagitis.

Detailed description: Patients are referred to Mayo Clinic Rochester with an establish diagnosis of EoE and are nonresponsive to proton pump inhibitor (PPI) medical therapy. Eligible patients will then meet with one of three investigators complete the Mayo Dysphagia Questionaire-30 Day (MDQ-30) following which a standardized Allergy Patch testing (APT) will be conducted. Thereafter, a standard clinically indicated Six Food Elimination Diet treatment completed. Patients will follow up with one of three investigators following the elimination diet who will be blinded to the results of the APT. During this visit responders and nonresponders will be identified and nonresponders will complete a directed elimination diet based on APT results.

Eligibility criteria: Inclusion criteria:

* Adults ages 18-90
* Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field (eos per HPF) on index esophageal biopsy
* Persistent symptoms and/or greater than or equal to 10 eos per HPF on esophageal biopsy after at least 8 weeks of twice daily PPI therapy

Exclusion criteria:

* Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
* Topical swallowed steroids within 8 weeks of study enrollment
* Dermatologic conditions precluding application of Finn chambers to the skin for APT
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Primary outcomes:
measure: Sensitivity of Patch Testing
timeFrame: up to 120 hours after application of patch test
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Karthik Ravi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eckmann JD, Ravi K, Katzka DA, Davis DR, See JA, Geno DR, Kryzer LA, Alexander JA. Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study. Dig Dis Sci. 2018 Mar;63(3):694-702. doi: 10.1007/s10620-018-4928-4. Epub 2018 Jan 18.
Clinical trial NCT06608836: Acute Effects of Cryotherapy on Muscle Properties
Official title: Acute Effects of Cryotherapy on Muscle Mechanical Properties and Muscle Activation Changes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cryotherapy Effect
Keywords: cryotherapy
muscles
acute effect
muscle strength
electromyography
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Okan University
First posted: 2024-09-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main aim of this study is to investigate the acute effects of cryotherapy on muscle mechanical properties, muscle strength, and activation changes in healthy subjects.

Detailed description: What changes occur in muscle stiffness following cryotherapy application? How does cryotherapy affect muscle strength? How does cryotherapy impact muscle activation? Are there differences in muscle mechanical properties, muscle strength, and muscle activation between different cryotherapy methods (ice massage and cold spray)? How do the effects of cryotherapy on muscle mechanical properties, muscle strength, and muscle activation change over time?

Eligibility criteria: Inclusion Criteria:

* Being willing to participate in the study
* Being between the ages of 18 and 35

Exclusion Criteria:

* Having undergone orthopedic surgery involving the lower extremity

Primary outcomes:
measure: myoton pro device
timeFrame: 3 months
measure: muscle strength
timeFrame: 3 months
measure: electromyography device
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Okan University
name: Gamze Aydın, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00645736: CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study
Official title: Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Keywords: Chronic Hepatitis B
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 788
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diagnosis of chronic hepatitis B who have been prescribed antihepadnaviral therapy for at least 6 months.

Brief summary: This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.

Detailed description: This is a naturalistic cross-sectional study of chronic hepatitis B subjects receiving nucleoside or nucleotide antihepadnaviral therapy.

It is anticipated approximately 800 subjects will be recruited at 20 Australian sites. Data will be collected on the study subjects and analyses performed to describe factors contributing to the emergence of viral mutations in Australian patients with chronic hepatitis B.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years and over
* Provided informed consent
* Diagnosis of chronic hepatitis B (HBsAg documented for at least 6 months)
* Currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis B management
* Been taking current antihepadnaviral therapy for at least 6 months prior to recruitment
* Negative tests for HIV Ab, Hepatitis C Ab and Hepatitis D Ab within the previous 2 years

Exclusion Criteria:

* Known or suspected co-infection with HIV, Hepatitis C or Hepatitis D
* Concomitant immunosuppression / immunomodulatory therapies
* Diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months
* Current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial
* Current Child Pugh class C classification (current Child Pugh score \> 9)
* Other known or suspected cause of chronic liver disease
* Any other reason that, in the investigator's opinion, participation in the study would not be in the participant's best interest.

Primary outcomes:
measure: Descriptive statistics for clinical and viral characteristics of the study population
timeFrame: Single timepoint (blood draw)
Secondary outcomes:
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Gilead Sciences Pty Ltd
state: Victoria
Study officials:
affiliation: Gilead Sciences Pty Ltd
name: Howard Wraight
role: STUDY_DIRECTOR
References:
Clinical trial NCT01982136: Functional Outcome of Urethral Reconstructive Surgery
Official title: Prospective Long-term Single Center Cohort Study Assessing Functional Outcome of Urethral Reconstructive Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urethral Stricture
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 175
Sex: MALE
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: All patients who underwent urethral reconstruction in our center from 2009 to this date

Brief summary: The analysis of the long-term outcomes and quality-of-life parameters after urethral reconstruction surgery.

Detailed description: Urethroplasty is the surgical repair of a urethral stricture. Depending on the location, severity and length of the stricture, various techniques can be performed.

The first procedure consists of the excision of the stenotic segment and end-to-end anastomosis. Other procedures consist of widening the urethra with buccal mucosa as free graft or with vascularized (genital) skin flaps. The results of these techniques have been described in prospective cohort studies, but to date there is little good data about the functional outcome and quality-of-life with longer follow-up after this surgery.

The purpose of this study is to prospectively follow patients for functional outcome parameters and quality-of-life to obtain long-term information concerning these surgeries.

Eligibility criteria: Inclusion Criteria:

* male
* urethral stricture surgery
* informed consent

Exclusion Criteria:

* loss of follow-up
* not willing to participate

Primary outcomes:
measure: Quality Of Life: change from baseline (=preoperative value)
timeFrame: 6m, 1y, 2y, 3y, 4y
Secondary outcomes:
measure: Functional outcomes: micturition: change from baseline (=preoperative value)
timeFrame: 6m, 1y, 2y, 3y, 4y
measure: Functional outcomes: erection: change from baseline (=preoperative value)
timeFrame: 6m, 1y, 2y, 3y, 4y
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Frank Van der Aa, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00946036: Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Torrent Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2009-07-24
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: * Objective:

  * To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions.
* Study Design:

  * Single-dose, open-label, randomized two-way crossover.


Eligibility criteria: Inclusion Criteria:

* Male or female, smoker or non smoker, 18 years of age and older.
* Capable of consent.
* BMI\>= 19.0 and \<30.0 kg/m2

Exclusion Criteria:

* Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication.
* Positive testing for hepatitis B, hepatitis C, or HIV at screening.
* ECG abnormalities or vital sign abnormalities(blood pressure).
* History of significant alcohol or drug abuse within one year prior to the screening visit.
* History or allergic reactions to heparin, sertraline or other related drugs.
* Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication.
* Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
* History of seizures, suicide attempt, bipolar disorder or manic episodes.
* Depot injection or an implant of any drugs with in 6 months prior to administration of study medication.
* Breastfeeding subject.
* Positive urine pregnancy test at screening.
* Female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration. Acceptable methods of contraception:

  1. Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration)
  2. Condom or diaphragm + spermicide.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Anapharm Inc.
state: Quebec
Study officials:
References:
Clinical trial NCT04926636: A System and Process to Improve the Satisfaction With Hearing Health Products
Official title: A System and Process to Improve the Satisfaction With Hearing Health Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Innovative Design Labs Inc. (IDL) and its collaborators, proposes to create a cloud-based system which integrates advances and techniques from Health and Wellness Coaching (HWC) into the Hearing Aid (HA) fitting and trial process.

Detailed description: As of 2015, 28.8 million U.S. adults could benefit from using hearing aids and the prevalence of hearing loss in the United States is predicted to rise significantly due to an aging population and the growing use of personal listening devices. However, only 28.5% of individuals who could benefit from a HA actually wears one. The non-use of hearing aids by people with hearing loss has many far-reaching implications for their physical health, mental health, and their social life. As the market moves towards a, direct-to-consumer distribution model following the 2017 FDA directive, more patients will be receiving therapy for hearing loss. While in traditional practice, an audiologist assists the patient with support adjusting to their new therapy, there is no person fulfilling that role in the direct-to-consumer model. Hypothesis: The investigators hypothesize that the integration of Health and Wellness Coaching, aided by cloud-based tools, into this process will increase patients' satisfaction and usage of hearing health products. Specific Aims: 1) Create patient/coach interaction protocol and training; 2) Develop a cloud-based Health Coaching Interface; 3) Evaluate system effectiveness through a clinical trial.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Significantly reduced cognitive ability (assessed using the Montreal Cognitive Assessment MoCA)
* Lack of proficiency communicating in English

Primary outcomes:
measure: COSI Goal Achievement
timeFrame: 3 months
measure: AQoL-8D Score
timeFrame: 3 months
Secondary outcomes:
measure: Hours of Hearing Aid Use
timeFrame: 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT00422136: Genetics of Middle Ear Disease
Official title: Genetic Epidemiology of Otitis Media
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media
Keywords: middle ear
otitis
genetics
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2007-01-15
Enrollment: 2121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families with 2 or more full sibs who had tympanostomy tubes inserted

Brief summary: The goal of this study is to identify the genes that contribute to susceptibility to recurrent/persistent middle ear disease. Five hundred families with at least 2 children who have undergone tympanostomy tube insertion will be enrolled. A blood sample will be obtained from the children who had tubes and any available parent (at least 1), as well as any siblings without significant histories of middle ear disease.

Detailed description: Using the twin study approach, the investigators demonstrated that time with middle ear effusion (MEE), number of episodes of MEE and numbers of episodes of acute otitis media (AOM) have a strong genetic component. The point estimate of heritability of time with MEE was 0.73. While there is significant evidence that susceptibility to recurrent/persistent OM is largely genetically determined, the specific genes which confer susceptibility are unknown. The overall research strategy to identify genes underlying OM is to apply a three-stage study design that will allow the investigators to balance cost efficiency with statistical power. Five hundred evaluable pairs of siblings with a history of tympanostomy tube insertion (affected), their parent(s) and available non-affected full siblings will be recruited. A blood sample will be obtained from each subject for genotyping.

Eligibility criteria: Inclusion Criteria:

* families: 2 or more full sibs who had tympanostomy tubes inserted

Exclusion Criteria:

* major congenital malformations
* medical conditions with a predisposition for OM (e.g. cleft palate, Down syndrome, or other craniofacial malformations
* cared for in the Intensive Care Unit as neonate
* been on assisted ventilation
* known sensorineural hearing loss

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: ENT Research Center, Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Margaretha L Casselbrant, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casselbrant ML, Mandel EM, Jung J, Ferrell RE, Tekely K, Szatkiewicz JP, Ray A, Weeks DE. Otitis media: a genome-wide linkage scan with evidence of susceptibility loci within the 17q12 and 10q22.3 regions. BMC Med Genet. 2009 Sep 3;10:85. doi: 10.1186/1471-2350-10-85.
Clinical trial NCT00617136: Perioperative Temperature Management
Official title: Perioperative Temperature Management: A Big Small Problem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: Surgery
Anesthesia
Hypothermia
Temperature
Perioperative
Temperature Management
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aim to investigate the effects of prewarming of patients undergoing elective orthopedic surgery on intraoperative temperature control and blood loss and postoperative patient discomfort and glucose and insulin levels.

Detailed description: Hypothermia, defined as a core temperature below 36 degrees celsius, is commonly seen in patients undergoing surgery. Intraoperative hypothermia is related to postoperative patient discomfort, impaired wound healing, increased blood loss, anxiety and disturbances in glucose and insulin levels. Prewarming of patients prior to surgery may result in maintenance of intraoperative temperature and reduce postoperative complications. We therefore aim to investigate the effects of prewarming of patients undergoing elective orthopedic surgery on intraoperative temperature control and blood loss and postoperative patient discomfort and glucose and insulin levels.

Objective of the study:

Does preoperative heating of patients undergoing elective orthopedic surgery reduce the incidence of intraoperative hypothermia and postoperative comfort and modulate postoperative glucose and insulin blood levels?

Study design:

Multi-center, prospective, randomized clinical trial.

Study population:

Patients undergoing an elective orthopedic hip- or knee replacement

Eligibility criteria: Inclusion Criteria:

* Patients undergoing an elective orthopedic knee- or hip replacement
* Participation based on informed consent
* \> 18 years old and \< 85 years old

Exclusion Criteria:

* BMI 18.5 \> x \< 40
* Pregnancy
* Non elective trauma patients
* Infectious or febrile patients (\> 37.5oC)
* Diabetes Mellitus
* Combined surgery
* Anemia (Hb \< 4.0 mmol/l)

Primary outcomes:
measure: Incidence of perioperative hypothermia
timeFrame: During surgery (1 hour after start warming)
Secondary outcomes:
measure: Perioperative blood loss
timeFrame: During surgery
measure: Patient discomfort as defined by pain, nausea and vomiting, shivering and thermal discomfort
timeFrame: During surgery
measure: Postoperative glucose and insulin levels
timeFrame: 1 hour after surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Hoofddorp
country: Netherlands
facility: Spaarne Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Christa Boer, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02235636: A Randomized Cross-over Trial of Comparison Between Robotic and Laparoscopic Suturing for Gastric Defect by Novices
Official title: Da Vinci Robot Compared to Laparoscopic Suturing for Closure of Gastric Incision Among Novice: a Randomized Cross Over Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Suturing for Closure of Gastrotomy
Laparoscopic Suturing
Robotic Surgical Suturing
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical students with no prior experience in surgery

Brief summary: To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and conventional Laparoscopic surgical suturing among novice

Detailed description: Background Da Vinci® Robotic Surgical System (DVRSS) has been widely applied to perform complex minimally invasive surgical procedures across different specialties. This study aimed to investigate the impact of DVRSS on surgical proficiencies among inexperience novice surgeons and compared to conventional laparoscopic surgery.

Methods Twenty medical students (n=20) without surgical experience were enrolled. After a constructive training for basic surgical techniques, participants were randomly allocated into DVR or laparoscopy group. Participants were asked to close five cases (also named five tasks) of a 2cm long incision on pig stomach by using DVR or laparoscopy. Surgical time, successful closure rate and pneumatic bursting pressure of gastric incision withstanding were recorded. In addition, participant performance and workload were quantified by using performance score, scales of Global Rating Scale Assessment (GSA) and NASA-Task Load Index (NASATLI).

Eligibility criteria: Inclusion Criteria:

* Medical Students with no prior surgical experience

Exclusion Criteria:

* Surgeons
* Age \< 16 or \> 60
* Disability and not able to control the Da Vinci Robot through the console

Primary outcomes:
measure: Task performance
timeFrame: 1 day
Secondary outcomes:
measure: Rate of success in closure of gastrotomy
timeFrame: 1 day
measure: Pneumatic bursting pressure for gastric incision
timeFrame: 1 day
measure: Assessment of participant workload
timeFrame: 1 day
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: CUHK Jockey Club Minimally Invasive Surgical Skills Center
Study officials:
affiliation: Department of Surgery, The Chinese University of Hong Kong
name: Philip W Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References: