louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05361447: Diazepam Trial in GAD65 Associated Epilepsy
Official title: Open Label Single Center Trial Evaluating the Efficacy and Safety of Diazepam in GAD65 Associated Epilepsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: GAD 65 Antibody-associated Epilepsy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 0
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: The purpose of this study is to determine whether diazepam reduces the frequency of seizures in GAD65 antibody associated epilepsy.

Detailed description: GAD65 is an intracellular enzyme that plays a key role in the conversion of glutamate to gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the CNS. Benzodiazepines augment the sensitivity of the GABA-A receptor to GABA, prolonging its inhibitory effect, perhaps enhancing the potential for neural inhibition in conditions in which GABA is depleted.

GAD65 antibodies have been identified in a subset of patients with drug resistant focal epilepsy and limbic encephalitis. While it has not been definitively determined that these antibodies cause GAD65 inhibition and GABA depletion directly, diazepam, a common benzodiazepine, has been established as a mainstay of therapy for stiffperson's syndrome, a condition that is commonly associated with GAD65 antibody positivity. Given these observations, diazepam has been used by the investigators in a small number of patients with intractable epilepsy in the setting of GAD65 antibody positivity, with some encouraging anecdotal results with one patient being rendered seizure free for three years.

The purpose of this study is to generate prospective data on use of diazepam in patients with epilepsy related to high-titer GAD65 antibody positivity.

Eligibility criteria: Inclusion Criteria:

* High-titer serum GAD65 positivity \> 20 nmol/L High-titer serum GAD65 IgG seropositivity titer \>20 nmol/L and/or CSF GAD65 seropositivity titer \> 0.02 nmol/L.
* Drug-resistant focal epilepsy, having failed 2 previous anti-seizure medications.
* Stable treatment for the 1 month prior to enrollment.
* Patients must be able to give informed consent or have an appropriate representative available to do.

Exclusion Criteria:

* Alternative etiology for epilepsy.
* Already on another benzodiazepine.
* On a regularly scheduled opiate.
* Co-existing antibodies associated with seizures.
* Pregnancy or breast feeding.

Primary outcomes:
measure: Change in seizure frequency
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kelsey Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02571647: Evaluation of Screening for Visual Disorders of the Old Subject in Consultation Memory
Official title: Evaluation of Screening for Visual Disorders of the Old Subject in Consultation Memory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Disorders
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for the study will be all patients 65 and older, in consultation from memory or day hospital Clinical Gerontology ambulatory center at Nantes University Hospital.

Geriatrician who will see the patient Clinical Gerontology ambulatory center be informed of the study and gather written consent and that of his legal representative, if applicable.

Brief summary: Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly. Yet the visual deficit impacts the quality of life, the evolution of the autonomy and psycho-behavioral disorders in cognitive diseases. The main objective of the study is to evaluate the prevalence of visual disorders among elderly patients at consultant outpatient center of Nantes clinical gerontology as part of the consultation geriatric memory. Secondary objectives are to describe ophthalmological diseases detected and taken into the proposed ophthalmic load, to determine if there are associations between eye diseases and cognitive disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation to determine the cognitive profiles and geriatric evaluation and ocular pathological, depending on the assessment of arterial stiffness. The results of this study will build a testing strategy to promote access of older patients with cognitive impairment to vision care.


Eligibility criteria: Inclusion Criteria:

* Elderly over 65 years,
* Subject to consultation from memory Clinical Gerontology ambulatory center Nantes University Hospital
* Current use of spoken French
* Patient (or legal guardian, if applicable) has given its written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Life expectancy lower 1 year
* Mobility limitation preventing the installation retinal
* Major disorders and productive behavior does not allow participation in diagnostic procedures.
* Inability to respond to instructions when performing ophthalmological examinations.

Primary outcomes:
measure: Number of participants with presence of an ophthalmological disease (symptomatic or not) after clinical evaluation.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Gilles BERRUT, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01610947: Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity
Official title: Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondyloarthritis
Keywords: Spondyloarthritis
Anti-TNF
Adalimumab
Etanercept
Infliximab
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 398
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: Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.


Eligibility criteria: Inclusion Criteria:

* Adult patients with spondyloarthritis according to ASAS criteria
* Stable low disease activity for at least 6 months
* Already treated by TNF blocking drug (adalimumab, etanercept or infliximab)

Exclusion Criteria:

* Raised acute phase reactants
* participation in another clinical trial
* Structural progression of peripheral joint damage
* Scheduled surgery within 12 months
* pregnancy

Primary outcomes:
measure: Proportion of patients remaining in low disease activity
timeFrame: 12 months
Secondary outcomes:
measure: Medico-economic comparison of arms
timeFrame: 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Lapeyronie Hospital
Study officials:
References:
Clinical trial NCT01210547: Three-dimensional Assessment of Craniofacial Structures
Official title: Assessment of Dental, Skeletal Pattern, and Soft Tissue Using Three-dimensional Images
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malocclusion
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current patients attending the University of Minnesota School of Dentistry Orthodontic Clinic, and who voluntarily agreed to participate in this study.

Brief summary: The goal of this project is to reduce the radiation exposure in orthodontic patients by the use of a new imaging protocols based on non-ionizing orthodontic records (e.g. digital dental models, three-dimensional photograph) The first step in this process is to develop and validate an orthodontic analysis able to assess craniofacial proportions, dental, skeletal, and facial soft tissue. The investigators working hypothesis is that data from three-dimensional facial photographs and from digital dental casts can be registered accurately and consistently, and the diagnostic information about tooth position and facial soft-tissue derived from them are comparable to x-ray derived data


Eligibility criteria: Inclusion Criteria:

* Full permanent dentition
* Complete set of digital orthodontic records
* Must be able to follow directions

Exclusion Criteria:

* Incomplete orthodontic records

Primary outcomes:
measure: Assessment of dental and soft tissue position relative to cone-beam computed tomography (CBCT)
timeFrame: At the time of initial orthodontic records
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Orthodontic Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Brent E Larson, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00855647: Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
Official title: Hypofractionated Radiotherapy for Localized Prostate Cancer (With CyberKnife or With IMRT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 99999
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: To demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and effective in the treatment of low-risk localized prostate cancer.


Eligibility criteria: Inclusion Criteria:- Eligible patients will have clinical stage T1c through T2b, initial PSA level \<10 and a biopsy Gleason score of 3+3 or 3+4 with fewer than 50% of biopsy cores involved.

* Patients who have had any form of prior curative treatment (surgery, radiotherapy, cryotherapy) will not be eligible. A prior course of hormone therapy of less than 3 months duration will be allowed.
* Adult men will be considered.
* No life expectancy restrictions will apply.
* Performance Status will not be considered.
* No requirements for organ or marrow function will be made
* Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:- No prior prostate treatment will be allowed.
* The use of other concurrent Investigational Agents will not be allowed.
* No exclusion requirements due to co-morbid disease or incurrent illness.
* No requirements regarding history of allergic reactions.
* Pregnancy or nursing patients is not applicable (ie. patients are male).

Primary outcomes:
measure: PSA response that achieves a stable nadir over time.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Christopher R. King
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00057447: Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients
Official title: Phase I/II Study of the Safety of Subcutaneous Interferon Gamma-1b Combined With Rituximab in Patients With Low Grade/Follicular Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: lymphoma
Lead sponsor: InterMune
Sponsor class: INDUSTRY
First posted: 2003-04-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL)

International study with sites in the Czech Republic and Poland


Eligibility criteria: * Relapsed or progressive low-grade/follicular NHL who are candidates for rituximab therapy
* Patients who were on other therapy including CHOP or radiation
* Previous therapy must have concluded 30 days prior to enrollment
* Demonstrable CD20-positive tumor population in lymph nodes or bone marrow

Primary outcomes:
measure: time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: Intermune Inc
state: California
Study officials:
affiliation: InterMune
name: Williamson Bradford, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05702047: Comparing Nose & Mouth Breathing During Exercise
Official title: Comparing Nose & Mouth Breathing During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare physiological responses in cardiovascular variables between nose and mouth breathing at rest and during exercise.

Detailed description: Breathing patterns can affect the cardiovascular system. Little is known about how nose versus mouth breathing affects cardiovascular variables (blood pressure, heart rate, etc.) at rest and during exercise. It has been suggested that breathing through the nose can cause calmness and lower blood pressure. However, research is needed to examine the extent to which breathing through the nose affects cardiovascular variables at rest and during exercise. Therefore, we will compare cardiovascular variables between nose-only and mouth-only breathing. The rate of breathing will be fixed (using an audible metronome) for both breathing conditions (nose-only vs mouth-only) based on an individual's free breathing (i.e., no breathing cues) breathing rate.

Eligibility criteria: Inclusion Criteria:

* Body mass index: ≤30 kg/m2
* Resting Blood pressure: ≤140/90 mmHg

Exclusion Criteria:

* Overt cardiovascular (e.g., diagnosed hypertension), respiratory, neurological, renal, liver, and/or metabolic health condition
* Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes)

Primary outcomes:
measure: Blood Pressure During Exercise Between Study Arms
timeFrame: Up to one day
measure: Heart Rate During Exercise Between Study Arms
timeFrame: Up to one day
Secondary outcomes:
measure: Rating of Perceived Exertion During Exercise Between Study Arms
timeFrame: Up to one day
measure: Rating of Perceived Breathlessness During Exercise Between Study Arms
timeFrame: Up to one day
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Joseph Watso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02116647: Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect
Official title: Role of Psychoanalysis in Prevention of Girl Child Maltreatment and Neglect: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abuse Neglect
Social; Deprivation, Maltreatment Syndrome (Infant or Child)
Keywords: Gender discrimination
Psychoanalysis
Randomized controlled trial
Lead sponsor: Macmillan Research Group UK
Sponsor class: INDUSTRY
Collaborators: name: Sonal Foundation, India
First posted: 2014-04-17
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In India, precisely northern states, skewed sex ratios, female feticide and higher child mortality rates for girls have become serious concern. The female child mortality as a result of son preference have increased during the last several decades .Since families cannot know the sex of the fetus due to Indian government policies, maltreatment and serious neglect has been tools to ensure there are few survivors.


Eligibility criteria: Inclusion Criteria:

* Families having girl child before
* High risk families with high expectation of having son

Exclusion Criteria:

* Families having son before
* Relocation and moving out of town during study period
* Not ready to consent for intervention

Primary outcomes:
measure: Post Natal Depression
timeFrame: Change from baseline in Edinburgh Postnatal Depression Scale at 6 weeks
Secondary outcomes:
measure: Mother-infant interaction
timeFrame: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
Other outcomes:
measure: Abuse and neglect outcomes
timeFrame: Upto six weeks reported incidences of abuse and maltreatment
Locations:
city: Ahmadabad
country: India
facility: Sonal Foundation
state: Gujarat
city: Jhunjhunu
country: India
facility: NMP Medical Research Institute
state: Rajasthan
Study officials:
affiliation: Sonal Foundation, India
name: Bharat Chaudhari, MA
role: STUDY_DIRECTOR
affiliation: Goldington Family Center, UK
name: Mandy Conlon, MA
role: STUDY_CHAIR
References:
Clinical trial NCT03336047: The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness
Official title: The Effect of Personal Activity Intelligence Versus 10,000 Steps Daily on Cardiorespiratory Fitness in Overweight and Obese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Physical Activity
Keywords: Exercise
Actigraphy
Prevention and Control
Cardiorespiratory Fitness
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A high physical fitness can prevent cardiovascular disease. Which form of exercise training is efficient at improving fitness is well known. The challenge is to get people to do it. Personal activity intelligence (PAI) is an algorithm developed for this challenge. It gives a score that tells the users whether they are active enough to achieve the maximum health benefit of exercise based on their heart rate. It has been shown that people who obtain 100 PAI a week have less cardiovascular disease, but intervention studies showing that PAI can improve physical fitness are so far lacking.

Step counters have received a lot of attention and 10 000 steps a day is a common recommendation, but little is known about the physiological adaptations to this intervention.

This study will compare the effect of physical activity with a value of 100 PAI points a week with 10 000 steps a day in healthy, but overweight (body mass index \> 25) participants between 30 and 50 years of age.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) \> 25
* Low physical activity (less than 50 PAI points calculated from a questionnaire)

Exclusion Criteria:

* Cancer diagnosis
* Cardiac arrhythmia
* Angina
* Previous myocardial infarction
* lung disease
* heart disease
* uncontrolled hypertension
* kidney disease
* orthopedic or neurological limitations
* planned surgery during the intervention
* participation in other research studies conflicting with the current study

Primary outcomes:
measure: Maximal oxygen uptake
timeFrame: After the intervention period (8 weeks)
Secondary outcomes:
measure: Body composition
timeFrame: After intervention period (8 weeks)
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
state: Sør Trøndelag
Study officials:
affiliation: Norwegian University of Science and Technology
name: Fredrik Hjulstad Bækkerud
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, phd prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02251847: The Efficacy and Safety of a Combination Therapy of Rosuvastatin and Ezetimibe Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: cholesterol
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-09-29
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Detailed description: To evaluate efficacy and safety of a combination therapy of rosuvastatin and ezetimibe versus monotherapy of rosuvastatin in hypercholesterolemia patients

Eligibility criteria: Inclusion Criteria:

* Hypercholesterolemic patient

Exclusion Criteria:

* Has history of hypersensitivity to HMG-CoA reductase inhibitor and Ezetimibe

Primary outcomes:
measure: Percent change from baseline to 8 week in LDL-Cholesterol
timeFrame: baseline and 8 week
Secondary outcomes:
measure: Percent change from baseline to 4 week in LDL-Cholesterol
timeFrame: baseline and 4 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center
name: Tae Hoon Ahn
role: PRINCIPAL_INVESTIGATOR
References: