louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05261230: Vedic Counselling for Women Victims of Domestic Abuse
Official title: Trauma Focused Vedic Counselling for Women Victims of Domestic Abuse: Community-based Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Post Traumatic Stress Disorder
Lead sponsor: Active Natural Limited
Sponsor class: INDUSTRY
Collaborators: name: NMP Medical Research Institute
First posted: 2022-03-02
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Vedic Counselling is the whole person approach, system of total life style counselling based on 'Vedic Laws of right living, right actions, right relationship and right awareness'.Vedic Counselling was developed as trauma focused therapy for this study to treat female victims of domestic abuse.


Eligibility criteria: Inclusion Criteria:

* Female survivors of Domestic Abuse
* 18 years old or older
* Sign informed consent

Exclusion Criteria:

* Severe mental illness that requires specialized treatment
* Terminally ill
* Under psychiatric medication
* Chronic illnesses

Primary outcomes:
measure: Symptoms of Post-Traumatic Stress Disorders (PTSD)
timeFrame: Change from baseline PTSD symptoms at 12-weeks
Secondary outcomes:
measure: Symptoms of Anxiety
timeFrame: Change from baseline anxiety at 12-weeks
measure: Symptoms of Depression
timeFrame: Change from baseline depression at 12-weeks
measure: Symptom of Stress
timeFrame: Change from baseline stress at 12-weeks
measure: Self-Esteem
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Research Institute
state: Rajasthan
Study officials:
affiliation: Gyansanjeevani
name: Sadhana Sharma
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00994630: Biomarkers for Bipolar Disorder: Chaperones and Reticulum Endoplasmatic Stress Response CHAP´s Study
Official title: Biomarkers for Bipolar Disorder: Chaperones and Reticulum Endoplasmatic Stress Response CHAP´s Study
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Bipolar Disease Type I
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bipolar Disease type I manic phase

Brief summary: The purpose of this study is to determine expression of chaperones proteins from the endoplasmatic reticulum stress response system in bipolar I patients (manic phase) compared to healthy controls.

Hypothesis: There is no difference in chaperones proteins expression between bipolar I manic patients and healthy controls


Eligibility criteria: Inclusion Criteria:

* Bipolar Disease type I manic phase
* YMRS \> 14
* HDRS \< 9

Exclusion Criteria:

* Use of lithium, divalproate, or carbamazepine in therapeutic levels over the past 30 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao paulo
country: Brazil
facility: Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo
Study officials:
affiliation: Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Brazil
name: Ricardo A Moreno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Brazil
name: Marcio G Soeiro de Souza, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00405730: Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
Official title: Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataracts
Keywords: Cataracts
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-11-30
Enrollment: 227
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: To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation


Eligibility criteria: Inclusion Criteria:

* Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 18.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Patients with Day 14 Cure
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux
Study officials:
References:
citation: Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33.
Clinical trial NCT01388530: Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Official title: An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Attention-Deficit/Hyperactivity Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: NeuroSigma, Inc.
First posted: 2011-07-06
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.


Eligibility criteria: Inclusion Criteria:

* male and female youth age 9 to 14 years with Diagnostic and Statistical Manuel -IV (DSM-IV) ADHD, combined subtype as determined by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) and clinical interview
* minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-Rating Scale (ADHD-RS)S
* Clinical Global Impression- Severity (CGI-S) score at baseline
* no current medications with central nervous system (CNS) affects
* parents able and willing to monitor proper use of the stimulation device and complete all required rating scales.

Exclusion Criteria:

* impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator; 2) current diagnosis of pervasive developmental disorder or major depression.
* history of lifetime psychosis or mania
* current suicidality
* history of seizure disorder, tic disorder, or head injury with loss of consciousness.

Primary outcomes:
measure: ADHD-IV Rating Scale (ADHD-RS)
timeFrame: Baseline and Week 8.
Secondary outcomes:
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Week 8
measure: Conners Global Index - Parent
timeFrame: Baseline and Week 8.
measure: Attention Network Task - Incongruent Reaction Time
timeFrame: Baseline and Week 8.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: James J McGough, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03831230: Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response
Official title: Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Keywords: ex vivo
predictive tests
tumor models
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 160
Sex: FEMALE
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: Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study.

Brief summary: Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old.
* Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study.
* Patient to be managed by surgery (laparoscopy and / or laparotomy).

Exclusion Criteria:

* Pregnant woman
* Persons deprived of liberty or guardianship (including curatorship)
* History of any other clinically active malignancy in the last 5 years prior to inclusion

Primary outcomes:
measure: Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests
timeFrame: Collection of blood, urine, tumor and ascite samples at the time of ovarian surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François BACLESSE
Study officials:
References:
Clinical trial NCT02344030: Comparsion of King Vision® Standard Blade and King Vision® Channeled Blade in Patients Scheduled for Tracheal Intubation
Official title: Comparative Study of King Vision® Standard Blade and King Vision® Channeled for Tracheal Intubation: a Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Keywords: airway
videolaryngoscope
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 44
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: Comparison of intubation time from the time to fix the Trachealtube to the first end-tidal CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV channeled blade

Detailed description: In the proposed clinical trial the time measured until the first manual ventilation at 44 study participants with elective anesthesia by using the KV standard blade and KV channeled blade. Bedside the time for tracheal intubation, we documented the view on the monitor which is connected to the instrument, the C\& L classification and POGO Scale.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 Years No concurrent participation in another study
* capacity to consent
* Present written informed consent of the research participant
* Elective surgery under general anesthesia

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients
* Emergency situations in the context of a Difficult Airway Management
* ASA classification\> 3
* situations where the possibility of accumulated gastric contents
* Participation in another study

Primary outcomes:
measure: comparison of different time for tracheal intubation
timeFrame: <2min
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University JG, Mainz
name: Marc Kriege, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16.
citation: Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30.
citation: Kriege M, Alflen C, Noppens RR. Using King Vision video laryngoscope with a channeled blade prolongs time for tracheal intubation in different training levels, compared to non-channeled blade. PLoS One. 2017 Aug 31;12(8):e0183382. doi: 10.1371/journal.pone.0183382. eCollection 2017.
Clinical trial NCT00104130: Study of KOS-862 (Epothilone D) in Metastatic Prostate Cancer
Official title: A Phase 2 Study of KOS-862 Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Hormone Resistant Prostate Cancer Who Have Progressed Following Initial Therapy for Metastatic Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-02-24
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study KOS-862 in men with metastatic prostate cancer who have failed a docetaxel-containing regimen.

Detailed description: This study is a Phase 2, single arm study of KOS-862 in men with metastatic prostate cancer who have failed a docetaxel-containing regimen. PSA response is the primary end-point and objective responses will be checked as available.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Metastatic disease.
* One previous treatment including docetaxel (Taxotere).
* At least 3 weeks since last surgery/radiation/chemotherapy
* ECOG Performance Status of 0, 1 or 2

Exclusion Criteria:

* Active brain metastases

Primary outcomes:
measure: prostate cancer
measure: prostate-specific antigen (PSA) response
Secondary outcomes:
Other outcomes:
Locations:
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Tucker
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente NW Oncology Clinic
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT04013230: Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families
Official title: Group Sessions and Web-based Treatment Targeting Children With Obesity Age 5-12 Years and Their Families - a Randomized Controlled Trial of Children With Obesity in Northern Sweden
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood obesity
BMI SDS
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Västernorrland County Council, Sweden
First posted: 2019-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the efficacy of group sessions and a web-based program for children with obesity age 5-12 years and their parents.

The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program and will be offered to children aged 5-12 years with obesity (International Obesity Task Force-BMI \>30), and their parents.

Detailed description: Obesity in children and adolescents worldwide has increased from 1 % in 1975 to about 6 % in 2016. Experts have estimated that the world will have more obese children and adolescents than underweight at the year 2022. Preventing and reversing excess weight gain in children is important since obesity often tracks into adulthood with adverse health consequences.

Web-based interventions have been shown to be effective, to have a beneficial treatment outcome and have been proposed to have great potential to reach many children and improve cost effectiveness.

This is a randomized controlled study with cross-over design. The intervention consist of a doctor's appointment, four group-based education sessions over four weeks, psychical activity on prescription and a 12-week web-based treatment program. The control group will have standard care treatment consisting of doctor's appointment and, in some cases, contact with dietician.

Eligibility criteria: Inclusion Criteria:

* Obesity according to International Obesity Task Force (IOTF)
* Be able to speak and write Swedish
* Have internet access in parents' home

Exclusion Criteria:

* Obesity together with other severe disease including neuropsychiatric disorder

Primary outcomes:
measure: Change in BMI-SDS
timeFrame: At baseline, 2, 4 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sollefteå
country: Sweden
facility: Outpatient peadictric clinic in Sollefteå hospital
city: Sundsvall
country: Sweden
facility: Outpatient peadiatric clinic in Sundsvalls hospital
city: Umeå
country: Sweden
facility: Umeå university
Study officials:
affiliation: Umeå University
name: Sven-Arne Silfverdal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00807430: Treatment Period and Long-term Effect of Functional Electric Stimulation (FES) for Bruxism
Official title: A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Bruxism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bruxism
Keywords: Bruxism
EMG
Biofeedback
Lead sponsor: Medotech A/S
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 48
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: To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.


Eligibility criteria: Inclusion Criteria:

* Signed and dated ICF
* 18 years or older
* Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b)
* Average pain more that 3 on a Visual Analog scale (VAS) in the baseline period

Exclusion Criteria:

* Contraindication of concommitant diseases for the study judged by investigator
* Daily use of pain medication, e.g. prophylaxis against migraine or headache.
* Patients who are using occlusal splints in the treatment period.

Primary outcomes:
measure: Primary outcome is to reduce the EMG activity per hour per night
timeFrame: 10 weeks after start of treatment
Secondary outcomes:
measure: Secondary outcome is to evaluate long-term effect of FES om EMG activity
timeFrame: after end of treatment with FES
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Odontologisk Institut
Study officials:
affiliation: Medotech A/S
name: Troels B Mortensen
role: STUDY_DIRECTOR
References:
Clinical trial NCT00175630: The Effect of Femoral Nerve Block on Postoperative Opioid Use After Anterior Cruciate Ligament (ACL) Reconstruction
Official title: Effect of Femoral Nerve Block on Opioid Requirements Following Anterior Cruciate Ligament Reconstruction: A Double Blind, Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pain, Postoperative
Keywords: ACL reconstruction
morphine sparing
preemptive analgesia
Post-operative pain and post- operative opioid use
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of a femoral nerve block on opioid requirements following anterior cruciate ligament (ACL) reconstruction. This is a double blind, prospective randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Schedule for primary elective anterior cruciate ligament reconstruction
* Tolerance to bupivacaine
* Tolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
* Informed consent

Exclusion Criteria:

* Patients who received a femoral nerve block more than 1 hour prior to surgery
* Complex associated injuries or pre-existing conditions that will delay time to ambulation
* Children with tibial avulsion fractures
* Allergic and/or sensitive to bupivacaine and/or NSAIDs
* 30% over ideal body weight
* Acute ACL reconstruction (done less than 2 weeks after injury)
* Pre-existing femoral nerve injury
* Psychiatric patients on psychotropic agents
* History of drug or alcohol dependence or recreational drug use
* Refusal to provide informed consent

Primary outcomes:
measure: Postoperative morphine requirement
Secondary outcomes:
measure: Pain rating
timeFrame: immediately post-op
measure: Opioid surgical time
timeFrame: time from end of anaesthesia to first requirement of morphine
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital, Department of Orthopaedics
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Christopher Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References: