louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01402960: Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain
Official title: Exploration of Parameters of tDCS in Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: High-Definition Transcranial Direct Current Stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation.


Eligibility criteria: STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
4. Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
5. Must have the ability to feel pain as self reported

Exclusion Criteria:

1. Pregnancy
2. Contraindications to tDCS

   * metal in the head
   * implanted brain medical devices
3. History of alcohol or drug abuse within the past 6 months as self reported
4. Use of carbamazepine within the past 6 months as self reported.
5. Severe depression (with a score of \>30 in the Beck Depression Inventory)
6. History of neurological disorders as self reported.
7. History of unexplained fainting spells as self reported,
8. History of head injury resulting in more than a momentary loss of consciousness as self reported
9. History of neurosurgery as self reported

Primary outcomes:
measure: Change in pain scales
timeFrame: Measured for approximately 5 weeks
Secondary outcomes:
measure: Change in cutaneous hyperalgesia/allodynia
timeFrame: Measured for approximately 5 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital (SRH)
name: Felipe Fregni, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00438360: Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis
Official title: A 24-week, Double-blind, Randomized, Placebo-controlled, Multicenter Study, to Evaluate the Effectiveness of Cyclosporine 2,5 mg/kg/Day Bid Twice a Week on Reducing Relapse Rate, in Maintenance Patients With Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Keywords: Cyclosporine, chronic plaque psoriasis, intermittent therapy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-22
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.


Eligibility criteria: Inclusion criteria:

* Outpatients 18 years of age and older (max 65 years)
* Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI before cyclosporine continuous treatment course) entering a maintenance period
* Disease remission obtained with only cyclosporine as systemic therapy (maximum dose 5 mg/kg/day) for \>8 weeks and \<16 weeks
* PASI still \<75% of PASI before cyclosporine continuous treatment course, at randomization to study treatment (8±2 days after disease remission)

Exclusion criteria:

* Abnormal renal function (creatinine ≥ 10% the upper limit of the reference range)
* Severe chronic degenerative diseases
* Severe uncontrolled hypertension
* Body weigh \>110 kg
* Abnormal liver function
* Hyperkalemia or hyperuricemia
* Clinically significant impairment of hematopoietic and cardiovascular function
* Concomitant therapy with nephrotoxic medications
* Patients with malignancy or a history of malignancy
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
* Clinically significant uncontrolled bacterial, viral or fungal infection
* Evidence of drug and/or alcohol abuse

Primary outcomes:
measure: Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of Participants With Clinical Relapse
timeFrame: 24 weeks
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: baseline and week 24
measure: Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis
timeFrame: Baseline and week 24
measure: Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus
timeFrame: Baseline and week 24
measure: Safety / Tolerability Assessed by Adverse Events
timeFrame: 24weeks
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT00894660: A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
Official title: A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Falciparum Malaria
Keywords: Bioequivalence, Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
* BMI of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities.
* A positive urine drug screen, history of regular alcohol consumption.

Primary outcomes:
measure: AUC and Cmax of amodiaquine
timeFrame: 1 month
Secondary outcomes:
measure: Tolerability
timeFrame: 1 month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01353560: Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study 1-Survey
Official title: Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study 1-Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Care
Keywords: integrative medicine
barriers to utilization
communication
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Beth Israel Deaconess Medical Center
First posted: 2011-05-13
Enrollment: 1509
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. All new patients coming into the Osher Clinical Center (OCC) for any medical reason.
2. All physicians in the 5 included departments/divisions (Women's Health, Orthopedics, Obstetrics and Gynecology, General Medicine, and Rheumatology) are eligible to participate in the survey. Other BWH physicians whom OCC patients have identified as their referring doctors and given us permission to contact, will also be eligible to participate in the survey.

Brief summary: Despite widespread and growing popularity of complementary and alternative medicine (CAM) in the US, there currently exist significant gaps in our knowledge regarding CAM use, clinical effectiveness, safety and cost- effectiveness. With previous funding support from NCCAM, the Harvard Medical School (HMS) Osher Research Center established and trained a multidisciplinary integrative team of CAM and conventional providers to work collaboratively to provide state-of-the-art "integrative care" in a coordinated and individualized fashion. The Osher Integrative Care Center (OCC) was opened in fall 2007, physically located within the Ambulatory Care Center of the Brigham and Women's Hospital (BWH) at 850 Boylston Street in Chestnut Hill, MA. The focus of this survey study is to characterize the decision-making process of both patients and conventional providers with respect to communication about and referral to an integrative care team in an academic hospital outpatient setting.


Eligibility criteria: Inclusion Criteria:

* New patient coming into Osher Clinical Center for any medical reason.
* Physician affiliated with any of included division/department (see above).

Exclusion Criteria:

* Patient has been seen at Osher Clinical Center within past 3 months for any reason.

Primary outcomes:
measure: Characterization of decision-making process for patients of CAM therapies and conventional providers
timeFrame: 3.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Osher Clinical Center at Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Julie E Buring, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02489760: Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
Official title: Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: Etanercept
Adalimumab
Ankylosing Spondylitis
Switch Study
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.

Detailed description: This single-centre, open-labeled randomized controlled study will evaluate the safety and efficacy of adalimumab in etanercept-treated Ankylosing Spondylitis(AS) patients.

Thirty patients will be enrolled and randomized equally into two arms.

Dosage and Administration：For standard dose(etanercept 50 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously biweekly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously twice a week for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.For half dose(etanercept 25 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously monthly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously weekly for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously monthly for another 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.
* Stable background therapy as non-steroid anti-inflammatory for 2 weeks.
* Stable glucocorticoid for 4 weeks.
* Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks.
* Stable anti-TNF biologics for 4 weeks.
* Written informed consent.

Exclusion Criteria:

* Serum creatinine ≥3.0 mg/dl.
* GPT≥5 times the laboratory's upper limit of normal.
* Pregnant or breast-feeding women.

Primary outcomes:
measure: Bath AS disease activity index (BASDAI)
timeFrame: weeks 8
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Wei C- C, M.D.
role: STUDY_DIRECTOR
References:
citation: Wei JC, Tsou HK, Leong PY, Chen CY, Huang JX. Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial. Front Med (Lausanne). 2020 Oct 30;7:566160. doi: 10.3389/fmed.2020.566160. eCollection 2020.
Clinical trial NCT03745560: Intraoperative EABR for Decision Making
Official title: Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation with Intraoperative EBERA and Correlation to Hearing Results - a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vestibular Schwannoma
Hearing Loss
Keywords: Cochlear implant
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing translabyrinthine vestibular schwannoma resection and cochlear implantation

Brief summary: In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.

Detailed description: Patients undergoing translabyrinthine vestibular schwannoma resection are included in the study. Preoperatively an eABR is carried out, as well as before and after tumor resection.

Postoperatively patients are fitted with a cochlear implant as routinely carried out. The postoperative hearing results with cochlear implant are correlated to the eABR results. The study is an observational study since eABR measurements are not part of the study. A correlation between eABR results categorized in three groups (good response, weak response, no response) with monosyllable understanding with cochlear implant (measured with Freiburger monosyllables test).

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection
* Patients wanted hearing rehabilitation with a cochlear implant

Exclusion Criteria:

* patients who do not want to be part of the study

Primary outcomes:
measure: Correlation of eABR results to postoperative hearing results
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH, MUW
Study officials:
affiliation: MUW, Allgemeines Krankenhaus
name: Christoph Arnoldner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01795560: Follow up by US Following Hospitalization With Periappendicular Abscess Refusing to be Operated on Within a Few Weeks.
Official title: US Follow-up After Appendicitis Attack.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disorder of Appendix
Keywords: Periappendicular abscess
Ultrasound
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed in the last 10 years suffering from periappendicular abcess.

Brief summary: Follow up via ultrasonic abdoman after patients who were giagnosed and treated as periappendicular abcess and refused to be operated later on in the "interval period ". To ass what occured to their appendics ?

Detailed description: During the last 10 years patients were hospitalized and treated with antibiotics due to the diagnosis of periappendicular abcess. they were invited to be operate after wards -appendectomy, electively few weeks later on. All these patients refused to be operated. What happend to their appendics few months or years later on via ultrasonic abdomen view??

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed in the last 10 years suffering from periappendicular abcess.

Exclusion Criteria:

* after appendectomy

Primary outcomes:
measure: Size and Condition of the Appendix.
timeFrame: 6 months to 12 years following Appendicitis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center, Infectious Diseases Unit
name: Gershon Keren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04532060: Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
Official title: A Randomized Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Health Care Associated Infection
Lead sponsor: São Paulo State University
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2020-08-31
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: This randomized clinical trial assessed antimicrobial Photodynamic Therapy (aPDT) mediated by Photodithazine (PDZ) to treat patients with denture stomatitis (DS). Methodologies: Patients with DS were randomly assigned to the groups: aPDT (n=30) and nystatin (NYS, n=35). aPDT patients received 6 aPDT sessions, three times a week for 15 days, which involved PDZ (200 mg/L) topical application (20 min) on the palate and upper denture, followed by light emitting diode (LED) illumination (660 nm, 50 J/cm²). NYS patients were instructed to rinse one dropper of this medication for one minute, four times a day, for 15 days. Microbiological collections of dentures and palates were performed and cultured on blood agar and CHROMAgar Candida. Microbial viability was determined, and photographs of the palates were taken for clinical evaluation. Data were analyzed by Repeated Measure Linear Model and Bonferroni (p≤0.05).


Eligibility criteria: Inclusion Criteria:

* Edentulous denture wearers clinically diagnosed with denture stomatitis.

Exclusion Criteria:

* patients who received antibiotics, antifungal or steroids in the past 3 months prior to the beginning of the research, women in the reproductive phase, patients who had worn the same denture in the past 10 years, diabetics, anemics, immunocompromised and under cancer treatment.

Primary outcomes:
measure: Microbial Viability at baseline
timeFrame: The recovery of microorganisms was performed before the tretaments (at the baseline - initial).
measure: Microbial Viability at the end of the treatments
timeFrame: The recovery of microorganisms was performed immediately at the end of the treatments.
measure: Microbial Viability on day 15
timeFrame: The recovery of microorganisms was performed on day 15 after the end of the treatments.
measure: Microbial Viability on day 30
timeFrame: The recovery of microorganisms was performed on day 30 after the end of the treatments.
measure: Microbial Viability on day 45
timeFrame: The recovery of microorganisms was performed on day 45 after the end of the treatments.
Secondary outcomes:
measure: Clinical evaluation
timeFrame: Standardized photographs of the palates were taken prior to the beginning of the treatments (initial) and up to 45 days after the end of the treatments.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00757380: Trypan Blue Versus Brillant Blue for Epiretinal Membranes
Official title: Membranepeeling With Trypan Blue Versus Membranpeeling With Brillant Blue for Patients With Idiopathic Epiretinal Membranes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Epiretinal Membranes
Keywords: epiretinal membranes
vitreoretinal dyes
membranepeeling
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2008-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Membraneppeling alone versus Membranepeeling with Membrane Limitans Interna Pelling using two different Dyes for Epiretinal Membrane Surgery.


Eligibility criteria: Inclusion Criteria:

* Idiopathic eperetinal membranes
* Phakic or pseudophakic eyes
* Age over 60 years

Exclusion Criteria:

* Secondary epiretinal membranes
* Severe ocular pathologies

Primary outcomes:
measure: Visual acuity
timeFrame: 3 months
Secondary outcomes:
measure: Microperimetry optical coherence tomographie questionnaire (metamorphopsien)
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study officials:
affiliation: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
name: Katharina Kreppler, Univ. Doz. Dr.
role: STUDY_CHAIR
affiliation: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
name: Christiane I Falkner-Radler, Dr.
role: PRINCIPAL_INVESTIGATOR
References: