louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03826966: Comprehensive CBT (Cognitive Behavioral Therapy) Via reSET App
Official title: Comprehensive CBT (Cognitive Behavioral Therapy) Via Reset for a Hub and Spoke MAT (Medication Assisted Treatment) System of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Opioid-use Disorder
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Research Foundation for Mental Hygiene, Inc.
First posted: 2019-02-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is being done to find out whether an app based cognitive behavior therapy called reSET improves the adherence to and outcome of buprenorphine treatment for opioid use disorder (OUD) in the setting of a Hub and Spoke implementation system.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Starting outpatient treatment for OUD within the PACMAT Hub and Spoke system (either the Hub or one of the Spokes)
* Planning maintenance treatment with buprenorphine
* Willing to participate in the study
* Can read, write and comprehend English

Exclusion Criteria:

* Planning an outpatient detoxification, or treatment other than buprenorphine maintenance (e.g. methadone maintenance, Vivitrol, or counseling with no medication)
* Judged by the evaluating physician or allied clinician to need a higher level of care (e.g. residential or inpatient treatment)
* Unwilling to participate in the study
* Under the age of 18
* Unable to read, write and comprehend English

Primary outcomes:
measure: Retention in treatment on MAT for 6 months after enrolling in the study
timeFrame: 6 months
Secondary outcomes:
measure: Opioid and other substance abuse as assessed through biological specimen
timeFrame: 6 months
measure: Opioid and other substance abuse as assessed through participant self-report
timeFrame: 6 months
measure: Cravings to use drugs as assessed by the reSET app
timeFrame: 6 months
measure: Overall mental health symptoms related to depression and anxiety as assessed by the K-10
timeFrame: 6 months
measure: Mental health symptoms specific to depression as assessed by the PHQ-9
timeFrame: 6 months
measure: Mental health symptoms related to PTSD as assessed by the PCL-C
timeFrame: 6 months
measure: Health status as assessed by the EuroQol
timeFrame: 6 months
measure: Coping strategies as assessed by the CSS
timeFrame: 6 months
measure: Social Connectedness as assessed by the SCS
timeFrame: 6 months
measure: HIV Risk as assessed by the SERBAS
timeFrame: 6 months
measure: Satisfaction of using reSET as a form of treatment as measured by a qualitative interview
timeFrame: 6 months
measure: Effectiveness of the reSET app content as measured by the IAFF
timeFrame: 6 months
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Pennsylvania Psychiatric Institute, Opioid Treatment Program
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02998866: Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects
Official title: Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Cryoballoon Pulmonary Vein Isolation
Esophageal Effects
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation.

Detailed description: When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.

Eligibility criteria: Inclusion Criteria:

1. Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation
2. Age \>18 years
3. Planned AF cryoablation procedure

Exclusion Criteria:

1. LA diameter \>55mm
2. Severe LVH (LV wall ≥ 15mm)
3. LA thrombus
4. Decompensated heart failure
5. Plans for left atrial ablation lesions beyond isolation of the pulmonary veins
6. History of previous pulmonary vein isolation
7. Inability to place esophageal temperature probe or TEE probe
8. Previously documented phrenic nerve injury
9. Known esophageal pathology (complete GI history worksheet)

Primary outcomes:
measure: Temperature Decline
timeFrame: 90 days or when complications resolve
measure: Measurements of esophagus to each pulmonary vein
timeFrame: 90 days or when complications resolve
measure: Create Recommendations for esophageal temperature-guided ablation
timeFrame: 90 days or when complications resolve
measure: Assessment of additional Adverse Events
timeFrame: 90 days or when complications resolve
Secondary outcomes:
measure: Data collection on Phrenic Injury
timeFrame: 90 days or when complications resolve
Other outcomes:
Locations:
Study officials:
affiliation: The Heart Hospital Baylor of Plano
name: Brian Deville, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03681366: Myopia Control Using Optimized Optical Defocus RCTs
Official title: Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: myopia
Myopic Defocus
contact lens
myopia control
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 167
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

Detailed description: The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.

Eligibility criteria: Inclusion Criteria:

* Age at enrolment: 8-13 year; Hong Kong Chinese
* Spherical equivalent refractions (SER): -1.00 to -5.00D
* Astigmatism: -1.00D or less
* Anisometropia: 1.25D or less
* Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
* Contact lens corrected monocular VA: 0.1 logMAR or better
* Normal binocular function
* Willingness to wear contact lenses regularly
* Parents' understanding and acceptance of random allocation of grouping and masking

Exclusion Criteria:

* Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
* Strabismus or decompensated phoria (checked by cover test at far and near in screening)
* Known contraindications for contact lens wear
* Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development

Primary outcomes:
measure: Cycloplegic Refraction Change in SER
timeFrame: 12 months
Secondary outcomes:
measure: Axial length
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU
Study officials:
affiliation: School of Optometry, The Hong Kong Polytechnic University
name: Carly SY Lam, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02283866: Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil
Official title: Bispectral Index-Guided Versus Fixed Dose Administration of Desflurane During Balanced Anesthesia With Remifentanil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stabilizing Hypnotic Depth and Vital Sign During Balanced Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern anesthesia. The purpose of this study is to compare two methods of administering desflurane, an volatile anesthetic during balanced anesthesia. The investigators hypothesized that administering desflurane at 1 MAC (minimum alveolar concentration) during balanced anesthesia will be more beneficial in terms of stability of the patient's vital signs and hypnotic depth than administering desflurane according to the patient's BIS (bispectral index) value.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for operation under balanced anesthesia using desflurane and remifentanil

Exclusion Criteria:

* Refusal of consent
* General anesthesia with agents other than desflurane and remifentanil
* Patients with allergy to neuromuscular blocker, volatile anesthetics, opioids
* History of malignant hyperthermia
* Patients taking CNS stimulants
* Chronic alcohol abuser
* Patients with severe depressed left ventricular function, EF \< 30%
* Patients with convulsive disorders
* ASA class IV, V, VI
* Patients with systolic arterial blood pressure lower than 90mmHg before surgery
* Patients needing inotropic infusion during surgery
* Anesthesia time less than 30 minutes

Primary outcomes:
measure: The difference of 'wobble' value of the patients' BIS value between the two groups
timeFrame: Every second from 10 minutes after skin incision to 10 minutes before surgery end.
Secondary outcomes:
measure: The difference of 'wobble' value of the patients' systolic arterial blood pressure value between the two groups
timeFrame: Every 2.5 minutes from 10 minutes after skin incision to 10 minutes before surgery end
Other outcomes:
measure: Eye opening time to prodding after stopping of anesthetics.
timeFrame: 1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Woo Jung
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang SM, Jung YS, Jung CW, Kim WH, Yoon SB, Lee HC. Comparison of bispectral index-guided and fixed-gas concentration techniques in desflurane and remifentanil anesthesia: A randomized controlled trial. PLoS One. 2020 Nov 5;15(11):e0241828. doi: 10.1371/journal.pone.0241828. eCollection 2020.
Clinical trial NCT04890366: Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke
Official title: Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Dimethyl Fumarate
immune modulator
Alteplase
Acute Ischemic Stroke
edema
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 50
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: The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in combination with alteplase in patients with Acute Ischemic Stroke.


Eligibility criteria: Inclusion Criteria:

1. more than 18years old
2. NIHSS score≥5
3. MRI shows anterior circulation infarction
4. Patients who meet Alteplase thrombolytic therapy within 4.5h
5. The time from onset to DMF application was less than 24 hours

Exclusion Criteria:

1. Hemorrhagic stroke
2. Patients who have received or plan to receive endovascular therapy
3. Other diseases of the central nervous system
4. Pre-existing neurological disability (mRS Score \>2)
5. Vertebrobasilar artery obstruction
6. Difficulty swallowing
7. Patients who cannot accept MRI examination
8. Abnormal liver function (transaminase higher than 2 times the normal upper limit)
9. The lymphocyte count was lower than the lower limit of normal value
10. Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used
11. Patients known to have hypersensitivity to dimethyl fumarate or any excipients
12. Pregnant and lactating women

Primary outcomes:
measure: changes in lesion volume
timeFrame: baseline to day 7
measure: changes in hemorrhage volume
timeFrame: baseline to day 7
measure: changes in National Institutes of Health Stroke Scale (NIHSS)
timeFrame: baseline to day 7
Secondary outcomes:
measure: The Modified Rankin Scale (mRS)
timeFrame: day1
measure: The Modified Rankin Scale (mRS)
timeFrame: day3
measure: The Modified Rankin Scale (mRS)
timeFrame: day7
measure: The Modified Rankin Scale (mRS)
timeFrame: day14
measure: The Modified Rankin Scale (mRS)
timeFrame: day90
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day 3
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day 7
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day 14
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: day 90
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Junwei Hao, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00231166: Safety, Efficacy, Dose-finding Study of a Monoclonal Antibody in Patients With Multiple Myeloma
Official title: A Phase I, Dose-finding Trial of HCD122, an Anti-CD40 Monoclonal Antibody, in Patients With Multiple Myeloma That is Relapsed or Has Not Responded to Prior Therapy (CHIR1212-C12101)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: dose-finding
monoclonal antibody
Multiple Myeloma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of MM requiring treatment
* Refractory or Relapsed Disease
* At least one prior treatment regimen
* Male or Female
* \>18 years of age

Exclusion Criteria:

* Prior Allogeneic bone marrow transplant (prior autologous transplant allowed)
* Intracranial disease or epidural disease
* Clinically significant cardiac dysfunction or other significant organ dysfunction

Primary outcomes:
measure: Safety, pharmacokinetics and pharmacodynamics at multiple doses
timeFrame: At the completion of each dose escalation cohort
Secondary outcomes:
measure: Clinical response after various doses
timeFrame: Once a month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute StudyCoordinator:CHCD122A2102
state: Massachusetts
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center Dept. of St. Vincent's Cancer
state: New York
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania--Abramson Cancer Center StudyCoordinator:CHCD122A2102
state: Pennsylvania
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center Dept. of FHCRC
state: Washington
city: Herston
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Prahran
country: Australia
facility: Novartis Investigative Site
state: Victoria
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03256266: Effect of Antigens or Therapeutic Agents on in Vitro Human Intestinal Organoids
Official title: Establishment of Small Intestinal Human Organoids to Check the Influence of Nutrient Antigens or Therapeutic Agents
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intestine Disease
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Patients with patients with Food intolerances, Food allergy, intestinal disorders, glutensensitivity, healthy controls who underwent a gastroduodenoscopy or coloscopy for therapeutical intervention or screening

Brief summary: The study evaluates the effect of nutrient antigens or therapeutic agents on human small intestinal organoids.

Detailed description: Small intestinal biopsies will be taken to establish human intestinal organoids in vitro. The organoids will be propagated and various antigens will be checked for their effects on proliferation, production of inflammatory components or signal cascade.

Eligibility criteria: Inclusion Criteria:

* patients with gastrointestinal disorders and therapeutical indication of gastroduodenoscopy or coloscopy
* healthy controls for preventive medical check-up

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: Determination of proliferation, apoptosis, histology, and cytokine Expression before and after Antigen provocation of organoids with gluten peptides, nutritional Antigens, Glucagon like peptide antagonist, or Tumor nekrose factor antagonists
timeFrame: baseline vs 24h vs 48h vs 72h
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Study officials:
References:
Clinical trial NCT04067466: Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group
Official title: Effect on Appetite Satisfaction and Short-term Satiety of Different Plant Compositions in the Adolescent Age Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiety
Appetite
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates the satiating effect of two types of food supplements made from various types of fibres in the subsequent intake of other foods, in satiety, and in the regulation of hormones

Detailed description: This study assessing the effect on appetite satisfaction and short-term satiety of different plant compositions in the adolescent age segment wants to assess the satiating effect of two types of food supplements made with various types of fibers (inulin, maltodextrins, guar gum and dehydrated plums) in the subsequent intake of other foods, in satiety, and in the regulation of hormones (ghrelin, leptin and insulin) and other peptides involved in the mechanisms of satiety

Eligibility criteria: Inclusion Criteria:

* Men and women between 15 and 30 years old.
* Subjects with IMC\<25 kg/m2
* Subjects who have a habit of having breakfast, lunch and dinner every day
* Subjects who are willing to comply with the study procedures

Exclusion Criteria:

* Subjects taht are taking any medicines that affect the appetite or food intake
* Presence of endocrine-metabolic diseases
* Eating disorders
* Subjects who are following a special diet
* Subjects who have changed their body weight by more than 10% in the last three months prior to the study
* Subjects who follow a restrictive dietary pattern such as vegetarians, gluten-free diets, weight loss diets, etc.

Primary outcomes:
measure: Assessment of satiety using objective methods (blood analysis)
timeFrame: Change from week 1 to week 2
measure: Assessment of satiety (blood analysis)
timeFrame: Change from week 1 to week 2
measure: Assessment of satiety using a subjective method (visual analogue scale)
timeFrame: Change from week 1 to week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: GENUD Research Group, Universidad de Zaragoza
state: Aragón
Study officials:
affiliation: Universidad de Zaragoza
name: Luis Moreno Aznar
role: PRINCIPAL_INVESTIGATOR
References: