louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01572142: Decrease in Sense of Smell and Associated Cognitive Decline in Parkinson's Disease
Official title: Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson disease
smell
cognitive
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 74
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Movement Disorders Clinic, Hospital, Primary Care, Community

Brief summary: The overarching goal of this prospective cohort study is to test the hypotheses that greater severity of hyposmia is associated with increased risk of cognitive decline in PD and that worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the goals of this project, patients with PD without dementia or at-risk of dementia or with dementia will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. AChE \[11C\]PMP or VAchT (vesicular acetylcholine transporter) \[F18\]-FEOBV PET will be performed both at study entry and at 2-years (± 6 months) follow-up. Brain MRI scans will also be performed at study entry and at 2-years (± 6 months) follow-up. Brain Beta-amyloid PET will be performed at study entry or at 2 years (± 6 months). Annual olfactory testing will be performed to better understand dynamic changes underlying the clinical and PET outcome measures.

Detailed description: Smell functions will be assessed using a test battery of odor identification, odor memory, and odor discrimination tests.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson disease
* Hoehn \& Yahr stage 2 and higher, and/or duration of motor disease 5 years or longer
* 50 and older

Exclusion Criteria:

* other disorders which may resemble PD
* subjects with definite dementia
* subjects with unstable or severe medical disorders
* subjects receiving neuroleptic, anticholinergic, or cholinesterase inhibitor drugs
* subjects in whom MRI imaging is contraindicated
* subjects who have received ionizing radiation that would, together with the current project exposures, exceed exposure limits permissible to research volunteers
* pregnant

Primary outcomes:
measure: Olfactory testing
timeFrame: Yearly follow up visits
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Universtiy of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory
state: Michigan
Study officials:
affiliation: University of Michigan
name: Nicolaas Bohnen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084642: Female Cancer Patients' Preference For Sexual Health Interventions
Official title: A Pilot Study Surveying Female Cancer Patients' Preference For Sexual Health Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Gynecologic Cancer
Keywords: Survey
Sexual Health Issues
10-034
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 229
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinics at MSKCC

Brief summary: The purpose of this study is to survey female cancer patients' awareness of and preference for methods to improve sexual health. This information will help to improve our understanding of the needs and preferences for sexual health strategies and interventions of our female patients.

The findings of this survey will also be used to develop feasible sexual health resources for our patients and enhance the success of grant proposals to support future sexual health interventions at MSKCC.


Eligibility criteria: Inclusion Criteria:

* Participants must be able to communicate in English to complete the tests.
* Study group of breast and/or gynecological cancer survivors.
* History of Primary diagnosis of breast and/or gynecological cancer
* At least 21 years of age.
* In the judgement of the consenting professional able to provide informed consent
* In the judgement of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments.

Exclusion Criteria:

* In the judgement of the consenting professional, the individual is able to provide informed consent.
* Patients with a psychiatric disorder precluding response to the surveys.

Primary outcomes:
measure: Participant' awareness of sexual health issues & preference for sexual health intervention
timeFrame: 2 years
Secondary outcomes:
measure: To assess & describe female cancer patients' attitudes towards & preference of methods to receive sexual health information (verbal or written) & psychosexual education patient information cards or intervention modality (telephone, in-person or online).
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jeanne Carter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416842: Home Exercise With Wearable Sensors
Official title: Home-based Exercises Using Wearable Motion Sensors for Community-dwelling Stroke Survivors With Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Hemiparesis
Keywords: outpatient
wearable sensors
home exercise
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
Collaborators: name: 4D Motion Sports
First posted: 2018-01-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Repetitious motor therapy has been shown to yield the greatest improvement in motor function in those who suffer hemiplegia because of a neurological impairment. However, motor therapy remains largely clinically based due to the absence of quantitative home-based therapy technology or equipment. With the current lack of accountability, patient adherence to home exercise physical therapy programs is estimated to be as low as 35%. In response, some companies have extended the applications of their motion capture devices to be used for home-based physical therapy. However, the technologies often have not passed their initial stages of development. In contrast, a company named 4D Motion is actively working alongside the Restorative Neurology Clinic at Burke Medical Research Institute to develop a motion capture system tailored to the motor rehabilitation of hemiplegic stroke patients. This device is driven by a user's active range of motion and does not impart electrical or mechanical stimulation to the user. The device does not force the user beyond their active range of motion and does not apply resistance to motion that limits the user's capability. The 4D Motion capture system is only used to record what the patient is doing and to promote adherence to their prescribed physical therapy plan.


Eligibility criteria: Inclusion Criteria:

* Able to follow 1-2 step commands
* Neurological deficit leading to hemiparesis or hemiplegia with a sensorimotor deficit
* Fugl Meyer Upper Extremity Score of at least 20/66

Exclusion Criteria:

* Has a metal implant anywhere on or inside the body
* Fixed contracture or deformity of affected upper extremity
* Individuals with bilateral stroke (i.e. if both arms are affected)
* Unable to tolerate repetitious movement as determined by Likert Scale Rating greater than 5 out of 10

Primary outcomes:
measure: Number of treatment days completed
timeFrame: From day 1 to day 30 of intervention
measure: Change in active range of motion of shoulder, elbow, and wrist
timeFrame: From day 1 to day 30 of intervention
Secondary outcomes:
measure: Change in Fugl Meyer upper extremity assessment
timeFrame: From day 1 to day 30 of intervention
measure: Physical Activity Enjoyment Scale
timeFrame: Day 30 of intervention
measure: System usability survey
timeFrame: Day 30 of intervention
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
Study officials:
References:
Clinical trial NCT02523742: Study of the Hemispheric Specialization for Language in Subjects With Neuropsychiatric Disorders Compared to Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropsychiatric Disorders
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced by a language task were significantly lower in a semantic region of the left hemisphere (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri medium and angular) in schizophrenic patients compared with controls matched for age, sex, level of education and handedness.

Investigators wish to test the hypothesis that functional modification of the hemispherical specialization is specific language and also specific for schizophrenia.


Eligibility criteria: Inclusion Criteria:

* patients under 65 years
* Schizophrenics, bipolar or schizoaffective (DSM IV)
* Patients who signed informed consent

Exclusion Criteria:

* Women with childbearing potential without effective contraception or positive pregnancy test.
* Contra-indications to fMRI

Primary outcomes:
measure: variation in signal (SPM99) during a language task compared to a reference task (rest or Tamil) in fMRI in anatomical regions of interest
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05854342: Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
Official title: Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis Risk
Keywords: bicarbonate-calcium water
Lead sponsor: University of Salerno
Sponsor class: OTHER
Collaborators: name: San Giuseppe Moscati Hospital
First posted: 2023-05-11
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water


Eligibility criteria: Inclusion Criteria:

* Premenopausal women aged ≥40 years
* Menopausal women, period of early menopause 1-10 years

Exclusion Criteria:

* Inclusion in other study protocols
* estrogen-replacement hormone therapy
* osteoporosis therapy
* corticosteroid therapy
* insulin therapy.
* calcium supplementation
* kidney diseases of medium-severe level
* liver diseases of medium-severe level
* severe osteoporosis

Primary outcomes:
measure: calcium (mg/dL)
timeFrame: 0-3-6 month
measure: 25-OH vitamin D (ng/mL)
timeFrame: 0-3-6 month
measure: osteocalcin (ng/mL)
timeFrame: 0-3-6 month
measure: Parathyroid hormone (pg/mL)
timeFrame: 0-3-6 month
Secondary outcomes:
measure: NMR metabolomic profile and applications of Metabolomics in calcium metabolism
timeFrame: 0-3-6 month
Other outcomes:
measure: changes cholesterol total (mg/dL)
timeFrame: 0-3-6 month
measure: changes cholesterol HDL (mg/dL)
timeFrame: 0-3-6 month
measure: changes cholesterol LDL (mg/dL)
timeFrame: 0-3-6 month
measure: changes glycemia (mg/dL)
timeFrame: 0-3-6 month
Locations:
city: Salerno
country: Italy
facility: University of Salerno
Study officials:
References:
citation: Meunier PJ, Jenvrin C, Munoz F, de la Gueronniere V, Garnero P, Menz M. Consumption of a high calcium mineral water lowers biochemical indices of bone remodeling in postmenopausal women with low calcium intake. Osteoporos Int. 2005 Oct;16(10):1203-9. doi: 10.1007/s00198-004-1828-6. Epub 2005 Mar 3.
citation: Wynn E, Krieg MA, Aeschlimann JM, Burckhardt P. Alkaline mineral water lowers bone resorption even in calcium sufficiency: alkaline mineral water and bone metabolism. Bone. 2009 Jan;44(1):120-4. doi: 10.1016/j.bone.2008.09.007. Epub 2008 Sep 26.
Clinical trial NCT06402942: Gamified Occupational Therapy for Adolescents with Duchenne Muscular Dystrophy
Official title: Gamified Occupational Therapy for Adolescents with Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Gamification
Occupational Therapy
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
Collaborators: name: Hacettepe University
First posted: 2024-05-07
Enrollment: 20
Sex: MALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research aims to improve the quality of life, occupational performance, occupational satisfaction and emotional health of young people with Duchenne muscular dystrophy compared to the classical occupational therapy program. The findings are planned to shed light on the development of new and effective strategies in the rehabilitation of adolescents with Duchenne muscular dystrophy.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Duchenne muscular dystrophy
* To be literate in Turkish
* To have scored 27 points or more on the Modified Mini Mental Test
* Having a computer, tablet and internet connection
* Volunteering to participate in the study by their parents and reading and signing the informed consent form

Exclusion Criteria:

* Having a neurological disease other than Duchenne muscular dystrophy and/or another diagnosed neurological disease accompanying Duchenne muscular dystrophy
* Having a cooperation problem that prevents completing the assessments for any reason
* Difficulty understanding and speaking the Turkish language

Primary outcomes:
measure: Demographic information form
timeFrame: At the start of the evaluations
measure: Modified Mini Mental State Test
timeFrame: before and after the eight-week intervention programs
measure: Vignos lower extremity functional scale
timeFrame: before and after the eight-week intervention programs
measure: Brooke upper extremity functional classification scale
timeFrame: before and after the eight-week intervention programs
measure: The Pediatric Quality of Life Inventory 3.0 Neuromuscular Module
timeFrame: before and after the eight-week intervention programs
measure: Canadian Occupational Performance Measure
timeFrame: before and after the eight-week intervention programs
measure: Children's Depression Inventory
timeFrame: before and after the eight-week intervention programs
measure: The Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
timeFrame: before and after the eight-week intervention programs
measure: The Numeric Rating Scale - Pain
timeFrame: before and after the eight-week intervention programs
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Lokman Hekim University
Study officials:
References:
Clinical trial NCT05204342: Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France
Official title: Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France: Surgical Thresholds, Geographical Distance, Age and Therapeutic Sequence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Ovarian or Tubal Cancer
Upfront surgery
surgical thresholds
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 22500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women treated for tubo-ovarian cancer in France between 2012 and 2016

Brief summary: Evaluation of the following prognostic factors in France, based on national quotation data: volume per center, patient age, geographic distance from a clinical center, delay for chemotherapy,Upfront surgery.


Eligibility criteria: Inclusion criteria:

* - Diagnosic of Ovarian or Tubal Cancer C56 et C570
* +/-
* Carcinose péritonéale C786
* Tumueur maligne secondaire de la plèvre C782,
* Tumueur maligne secondaire des ganglions C770 à C779,
* Tumueur maligne secondaire du foie C787,
* Tumueur maligne secondaire du péritoine C786

Exclusion criteria:

* autres causes de :
* Carcinose péritonéale C786
* Tumueur maligne secondaire de la plèvre C782,
* Tumueur maligne secondaire des ganglions C770 à C779,
* Tumueur maligne secondaire du foie C787,
* Tumueur maligne secondaire du péritoine C786

Primary outcomes:
measure: To study the prognostic effect of the volume of activity
timeFrame: at 5 years
measure: Verify that the therapeutic sequence
timeFrame: at 5 years
Secondary outcomes:
measure: Verify that delay in initiation of chemotherapy beyond 4 weeks
timeFrame: at 5 years
measure: Verify that age is a poor prognostic element
timeFrame: at 5 years
measure: Verify that geographic distance
timeFrame: at 5 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Martha DURAES, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03217942: Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
Official title: Spread of Muscle Hyperalgesia and Pain in a Low Dose NGF-induced Pain Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperalgesia
Healthy Subjects
Keywords: Muscle soreness
NGF-induced pain
Pain model
Long-lasting sensitization
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate and determine the time course and distribution on muscle hyperalgesia and muscle pain in a repeated, low dose NGF model. It is hypothesized that low dosages i.m injections of NGF are able to induce mechanical hyperalgesia and muscle soreness in a same manner (effect of duration) as for dosages previously used in NGF studies. Furthermore, it is also speculated if several injections of low dose NGF into the muscle combined are able to course immediate pain sensation and spreading of muscle hypersensitivity.

Detailed description: Effects of pain responses, symptom development and pattern (time course and distribution) following 5 i.m low dose injections of NGF injected into the tibialis anterior muscle will be compared to a high dose i.m injection of NGF injected into the contralateral side in healthy pain-free subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy and pain free volunteers

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, mental illnesses, or psychiatric diseases.
* Past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue)
* Participation in other pain trials throughout the study period
* Lack of ability to cooperate
* Taking any analgesic 24 hours before the injections
* Performing any strenuous leg exercise through out the study period causing sore muscles

Primary outcomes:
measure: Muscle sensitivity
timeFrame: Change from baseline at 3 weeks
Secondary outcomes:
measure: Pressure-induced referred pain
timeFrame: Change from baseline at 3 weeks
measure: Activity-induced muscle soreness
timeFrame: Change from baseline at 3 weeks
measure: Pain intensity
timeFrame: Assessed continuously at 0-5 min during the injections at each leg
measure: Muscle soreness Diary
timeFrame: Change from baseline at 3 weeks
measure: Activity-induced muscle soreness Diary
timeFrame: Change from baseline at 1 week
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Aalborg University
name: Line Bay Sørensen, Ph.d stud.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04031742: A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia
Official title: Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Homozygous Familial Hypercholesterolemia
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-24
Enrollment: 18
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
Intervention model description: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 \[ Time Frame: Baseline and Week 12 \]
Primary purpose: TREATMENT

Brief summary: A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.

Detailed description: This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.

Eligibility criteria: Inclusion Criteria:

1. Males and females ≥ 18 to ≤ 80 years of age
2. Diagnosis of homozygous familial hypercholesterolemia
3. LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
4. Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
5. Bodyweight of ≥ 40 kg at screening

Exclusion Criteria:

1. History of liver transplant
2. Uncontrolled hypertension
3. Moderate to severe renal dysfunction
4. Active liver disease or hepatic dysfunction
5. Known sensitivity to any of the products to be administered during dosing

Primary outcomes:
measure: Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).
timeFrame: Baseline and Week 12
measure: Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline and Week 12
Secondary outcomes:
Other outcomes:
measure: Number of investigational product-related adverse events.
timeFrame: Baseline and Week 12
measure: Number of ADA and Nab.
timeFrame: Baseline and Week 12
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References: