louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00042224: Electroconvulsive Therapy in Clozapine Refractory Schizophrenia
Official title: ECT in Clozapine Refractory Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Keywords: Electroconvulsive Therapy
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-07-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate electroconvulsive therapy (ECT) in patients who have not responded adequately to clozapine.

Detailed description: ECT augmentation of clozapine will be compared to clozapine monotherapy in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.

Eligibility criteria: Inclusion criteria:

* Diagnosis of schizophrenia according to DSM-IV criteria
* Duration of illness 2 years or greater
* Resistance to at least 2 antipsychotics
* Clozapine resistance
* Capacity to give informed consent
* For women of childbearing capacity, a negative pregnancy test and patient agreement to use a medically accepted form of contraception
* Brief Psychiatric Rating Scale score of at least a 4 on one of the four psychotic items on the psychotic sub-scale or a score of 12 on these 4 items combined.
* Clinical Global Impressions (CGI) - severity rating of at least moderate (score of 4)
* Receiving at least two 400 mg doses of chlorpromazine equivalents for at least 4 weeks (may include newer antipsychotics)
* Having substantial psychotic symptoms despite at least 12 weeks of treatment (at least 8 weeks at a consistent dose)

Exclusion criteria

* schizoaffective disorder; bipolar disorder;
* current affective episode;
* Electroconvulsive Therapy (ECT) within the past 6 months
* history of epilepsy; severe neurological or systemic disorder that could significantly affect cognition, behavior, or mental status (other than tardive dyskinesia or neuroleptic-induced parkinsonism); psychoactive substance dependence (other than nicotine or caffeine) within 1 month prior to entering the study
* a score of less than 18 on the 24-item Hamilton Depression Rating Scale (HAM-D)
* clinical determination that mood stabilizers were necessary and therefore could not be discontinued.
* pregnancy.
* affective disorders and prominent depressive symptoms because ECT is well known to be effective in those situations, and we wanted to avoid contamination of our results by improvement solely driven by the treatment of the affective symptoms.

Primary outcomes:
measure: Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
Study officials:
affiliation: New Jersey Medical School
name: Georgios Petrides, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02227524: Trekking Poles to Aid Multiple Sclerosis Gait Impairment
Official title: Trekking Poles to Aid Multiple Sclerosis Gait Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Walking
Gait
Lead sponsor: Rowan University
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: In this study, the investigators will examine a sample of persons with multiple sclerosis (MS) to determine whether their walking function and ability is different depending on which walking assistive device is used.

Detailed description: In this study, the investigators will examine a sample of persons with multiple sclerosis (MS) to determine whether their walking function and ability is different depending on which walking assistive device is used. In addition, the investigators will examine the psychosocial impact and amount of fatigue induced by each assistive device. Data collection will consist of a series of assessments via survey and physical performance. The analyses will consist of appropriate comparisons of means to determine if the use of different assistive devices alters any of the outcomes.

Eligibility criteria: Inclusion Criteria:

* Be 18-64 years old with a confirmed diagnosis of MS
* Have perceived walking difficulty
* Have an EDSS score of \< 6, calculated by the physician
* Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

* Have had a MS exacerbation in the prior 8 weeks
* Have other serious medical conditions that would impair their ability to participate in gait performance testing (i.e. severe rheumatoid arthritis or osteoarthritis)
* If the physician deems a participant unsafe to go home with devices
* Cannot communicate in English
* Possess greater than a mild decrease in mentation (i.e. a score of \>2 on the Mental Functions item of the FSS)
* Inability or unwillingness of individual to give written informed consent

Primary outcomes:
measure: Composite measures of walking
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stratford
country: United States
facility: Rowan University School of Osteopathic Medicine
state: New Jersey
Study officials:
affiliation: Rowan University School of Osteopathic Medicine
name: Donald Barone, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02052024: Myobloc Atrophy Study
Official title: Myobloc Atrophy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spasticity Secondary to Either a Disorder or Trauma
Spinal Cord Injury (SCI)
Brain Injury
Tumor
Stroke
Keywords: Spasticity
Modified Ashworth Scale
MYOBLOC
Botox
Muscle Atrophy
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Solstice Neurosciences
First posted: 2014-01-31
Enrollment: 10
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 present pilot study is designed to assess the extent to which BOTOX and MYOBLOC cause muscle atrophy in spastic patients. The primary objective is to assess whether there is statistically significant difference in muscle atrophy between the two groups over a one year period.

Detailed description: Botulinum toxin has long been used as a clinical application for the treatment of overactive skeletal and smooth muscles, i.e. spasticity. The benefits of botulinum therapy are indisputable, however, muscle atrophy is one main adverse effect that may hinder a patient's strength and decrease the ability for the practitioner to accurately administer botulinum toxin to a specific muscle group. This, in turn may cause unintentional weakness of adjacent muscle groups through inaccurate targeting or diffusion of botulinum toxin. Currently, only two serotypes (abbreviated to BTX-A (BOTOX, XEOMIN and DYSPORT) and BTX-B (MYOBLOC), respectively) are used in clinical practice for spasticity. Research has shown that both BTX-A and BTX-B are efficacious in the treatment of spasticity. However, there is no documented literature evaluating if there is a statistically significant difference in the degree of muscle atrophy using BTX-A versus BTX-B.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 or older with spasticity secondary to either a disorder or trauma, such as a spinal cord injury (SCI), a brain injury, a tumor, a stroke, multiple sclerosis (MS), or a peripheral nerve injury.
* Participants must have the ability to provide written consent to participate in the study.

Exclusion Criteria:

* Patients who have received BTX-A or BTX-B in the past in the skeletal muscle group under investigation or patients who have had an allergic response to BTX-A or BTX-B in the past.
* Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral Sclerosis. Females who are pregnant or breastfeeding. Subjects taking Aminoglycosides or other agents interfering with neuromuscular function.

Primary outcomes:
measure: Volume and Cross-Sectional Area of Muscle
timeFrame: 36 Weeks
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: 36 Weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: MedStar Georgetown University Hospital
name: Fernando Pagan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05512624: Integrating a Mental Health Intervention Into Primary Health Care for Refugees
Official title: Integrating an Evidence-based Mental Health Intervention Into Primary Health Care to Improve Outcomes for Refugees With Hypertension, Diabetes, and Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Adherence
Mental Health Issue
Self Efficacy
Hypertension
Epilepsy
Diabetes
Lead sponsor: International Rescue Committee
Sponsor class: OTHER
Collaborators: name: Khon Kaen University
name: Johns Hopkins University
First posted: 2022-08-23
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed randomized waitlisted control trial
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the impact of an evidence-based mental health intervention (Common Elements Treatment Approach) on medication adherence, behavioral improvement and clinical outcomesamong adults taking medication for hypertension, diabetes and epilepsy using a two-arm randomized wait-list controlled trial among adult refugees in Mae La camp, Thailand.


Eligibility criteria: Inclusion Criteria:

* A. Inclusion criteria:

  1. Patients who was diagnosed by physician based on ICD 10 to have diabetes, hypertension or diabetes with hypertension comorbidity, or epilepsy.
  2. Registered in chronic database system of the camp.

B. Exclusion criteria:

1. who are younger than 18 years old
2. who have severe physical illness
3. who have severe mental disorders
4. who will not stay in the camp until the end of the program
5. who are not willing to participate in the program

Exclusion Criteria:

-

Primary outcomes:
measure: Medication Adherence Report Scale
timeFrame: Baseline, Endline, Past two weeks
measure: Pill Count Medication Adherence
timeFrame: Baseline, Endline, Past two weeks
Secondary outcomes:
Other outcomes:
measure: Substance use
timeFrame: Baseline, Endline, Past two weeks
measure: Physical activity
timeFrame: Baseline, Endline, Past two weeks
measure: Diet
timeFrame: Baseline, Endline, Past two weeks
measure: Sleep Quality
timeFrame: Baseline, Endline, Past two weeks
measure: Mental Health Symptoms
timeFrame: Baseline, Endline, Past two weeks
measure: Disease management self-efficacy
timeFrame: Baseline, Endline, Past two weeks
measure: Non hypertensive blood pressure
timeFrame: Baseline, Endline, present
measure: HbA1C change
timeFrame: Baseline, endline, present
measure: Fasting plasma glucose
timeFrame: Baseline, endline, present.
measure: Incidence of seizure
timeFrame: Baseline, Endline, present.
Locations:
city: Mae Sot
country: Thailand
facility: Mae La Refugee Camp
Study officials:
References:
Clinical trial NCT00748124: PleuraSeal Pivotal Study (US)
Official title: A Prospective Multicenter Randomized Clinical Study to Evaluate the PleuraSeal Sealant System as an Adjunct to Standard Closure Techniques for Control of Visceral Pleural Air Leaks Following Elective Pulmonary Resection Via Open Thoracotomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Open Thoracotomy
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 230
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 effectiveness of Confluent Surgical's PleuraSeal Sealant System in the treatment and control of intra and postoperative air leaks following pulmonary resection via an open thoracotomy. The performance of the PleuraSeal Sealant System as an adjunct to conventional closure techniques (i.e. surgical staples or sutures) will be compared to conventional surgical techniques alone.


Eligibility criteria: Inclusion Criteria:

* Elective pulmonary lobectomy, segmental and/or wedge resection in one or more lobes via an open thoracotomy

Primary outcomes:
measure: Proportion of subjects remaining air leak free from time of skin closure to hospital discharge.
timeFrame: 75 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Confluent Surgical
state: Massachusetts
Study officials:
References:
Clinical trial NCT01875224: Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression
Official title: Open-Label, Randomized Comparison of NODAT in Renal Transplant Patients Receiving a Nulojix (Belatacept) Regimen Versus Standard Therapy Immunosuppression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: New Onset Diabetes After Transplant
Kidney Transplantation
Keywords: kidney transplant
diabetes after transplant
belatacept
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2013-06-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with NODAT will be approached with the opportunity to participate in this study. If they agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm (belatacept) or the control arm (their current medication regimen). If a patient is randomized to the study arm, they will be tapered off of their current regimen when they have started receiving their monthly belatacept infusions. The control arm will mean the patient will continue their current, standard of care medications, but following the tacrolimus trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting blood glucose) will be measured during the study to monitor the progression of NODAT in all patients.


Eligibility criteria: Inclusion Criteria:

* Written informed consent must be given by patient.
* Adult patients between age 18 and 65
* Thymoglobulin induction at the time of transplant
* Patient must be Epstein-Barr Virus seropositive

Exclusion Criteria:

* Patient who received an blood type incompatible transplant, or with T-cell or B-cell positive crossmatch
* Patients with Hepatitis B, Hepatitis C, HIV or a clinically significant systemic infection within 30 days prior to transplant
* History of stroke, severe cardiac disease or cardiac failure

Primary outcomes:
measure: Increased insulin sensitivity
timeFrame: 12 months
measure: Decreased insulin resistance
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Bruce Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03118024: Perioperative Management of DIEP Flaps
Official title: Perioperative Management of Deep Inferior Epgastric Perforator (DIEP) Flap for Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mammaplasty
Microsurgery
Free Tissue Flaps
Keywords: deep inferior epigastric perforator flap
fluid restriction
catecholamine restriction
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure \> 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free deep inferior epigastric artery flaps for breast reconstruction.


Eligibility criteria: Inclusion criteria:

* Informed consent for study participation
* Every patient undergoing breast reconstruction (primary and secondary reconstruction) with deep inferior epigastric perforator flap at our hospital is offered to participate in the study

Exclusion criteria:

* No informed consent for study participation
* Patients with a high thromboembolic risk profile
* During pregnancy and breastfeeding
* Minors
* Patients with a health care proxy

Primary outcomes:
measure: Free flap survival rate
timeFrame: 5 days postoperatively
Secondary outcomes:
measure: Period of hospitalization
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University hospital of Regensburg
Study officials:
References:
citation: Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-570. doi: 10.1097/PRS.0b013e31825dbf73.
citation: Motakef S, Mountziaris PM, Ismail IK, Agag RL, Patel A. Emerging paradigms in perioperative management for microsurgical free tissue transfer: review of the literature and evidence-based guidelines. Plast Reconstr Surg. 2015 Jan;135(1):290-299. doi: 10.1097/PRS.0000000000000839.
Clinical trial NCT04945824: A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects
Official title: An Open-label, Multi-center, Bilateral, Human Factors Study to Evaluate the Utilization and Safety of a Novel Intracanalicular Insertion Device in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Each subject's participation is expected to last for approximately 1 month from the DEXTENZA insertion.


Eligibility criteria: Inclusion Criteria:

* Are a healthy adult subject aged 18 years or older with no known significant health problems
* Are willing to refrain from wearing contact lens for the duration of the study
* Are willing and able to comply with clinic visits and study related procedures
* Are willing and able to sign the informed consent form

Exclusion Criteria:

* Have known significant health problems
* Are women of reproductive potential
* Are breastfeeding
* Are a known steroid responder
* Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
* Have a history of complete punctal occlusion in one or both punctum
* Currently use topical ophthalmic steroid medications
* Are unwilling or unable to comply with the study protocol
* Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular

Primary outcomes:
measure: Ease of insertion as assessed by Post-Insertion Investigator Questionnaire
timeFrame: Assessed at Visit 1 (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Ocular Therapeutix, Inc.
state: South Dakota
Study officials:
References:
Clinical trial NCT01021124: Latent Tuberculosis Infection in Bone Marrow Transplant Recipients
Official title: A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Hematopoietic Stem Cell Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: tuberculosis
bone marrow transplant
diagnosis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 409
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bone marrow transplant recipients

Brief summary: The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. Quantiferon-Gold In-Tube assay) for diagnosis of latent tuberculosis infection (LTBI) in bone marrow transplant recipients. For this purpose, the investigators enrolled bone marrow transplant recipients and observed the developement of tuberculosis after the transplantation.

Detailed description: All adult bone marrow transplant recipients admitted to Asan Medical Center will be enrolled.

Quantiferon-Gold In-Tube assay will be performed.

Isoniazid prophylaxis will be given only to patients with clinical risk factors (i.e. recent contact with active pulmonary TB patient or inadequate treatment history with abnormal CXR). However, isoniazid prophylaxis will be not given based on positive TST or positive Quantiferon-Gold In-Tube assay.

Eligibility criteria: Inclusion Criteria:

* Age 16 or more
* Bone marrow transplant recipients

Exclusion Criteria:

* Recent contact of patients with active pulmonary tuberculosis
* Suspected active tuberculosis

Primary outcomes:
measure: development of tuberculosis
timeFrame: after transplantation
Secondary outcomes:
measure: all cause mortality
timeFrame: after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Han Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YM, Lee SO, Choi SH, Kim YS, Woo JH, Kim DY, Lee JH, Lee JH, Lee KH, Kim SH. A prospective longitudinal study evaluating the usefulness of the interferon-gamma releasing assay for predicting active tuberculosis in allogeneic hematopoietic stem cell transplant recipients. J Infect. 2014 Aug;69(2):165-73. doi: 10.1016/j.jinf.2014.02.019. Epub 2014 Mar 16.
citation: Moon SM, Lee SO, Choi SH, Kim YS, Woo JH, Yoon DH, Suh C, Kim DY, Lee JH, Lee JH, Lee KH, Kim SH. Comparison of the QuantiFERON-TB Gold In-Tube test with the tuberculin skin test for detecting latent tuberculosis infection prior to hematopoietic stem cell transplantation. Transpl Infect Dis. 2013 Feb;15(1):104-9. doi: 10.1111/j.1399-3062.2012.00765.x. Epub 2012 Jul 23.