louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02039206: The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease
Official title: The Influence of Deep Repetitive Transcranial Magnetic Stimulation (TMS) on Cerebellar Signs in Patients With Spinocerebellar Ataxia Type 3 (SCA3 - Machado Joseph Disease)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Machado Joseph Disease (SCA3)
Keywords: Machado Joseph disease
Deep TMS
TMS
Transcranial Magnetic Stimulation
SCA3
Magnetic Stimulation
Brainsway
Lead sponsor: Brainsway
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To test the effects of low frequency deep rTMS using the novel HCERMJD-coil on cerebellar deficits in patients with SCA3 and to establish its safety in this population.

Investigator is anticipate that stimulation of the cerebellum with the novel HCERMJD-coil may induce significantly therapeutic effects in patients with SCA3 and will pave the way for establishing a novel and effective treatment for this disorder.


Eligibility criteria: Inclusion Criteria:

* SCA3 patients aged 20 - 80 years, with detectable clinical signs and confirmed genetic diagnosis.

Exclusion Criteria:

1. Patients who have concomitant epilepsy.
2. History of seizure or heat convulsion.
3. Patients on neuroleptics.
4. Patients with dementia (MMSE\<25) or any unstable medical disorder.
5. History or current unstable hypertension.
6. History of head injury or neurosurgical interventions.
7. History of any metal in the head (outside the mouth).
8. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
9. History of frequent or severe headaches.
10. History of migraine.
11. History of hearing loss.
12. History of cochlear implants
13. History of drug abuse or alcoholism.
14. Pregnancy or not using a reliable method of birth control.
15. Participation in current clinical study or clinical study within 30 days prior to this study.

Primary outcomes:
measure: Scale for the Assessment and Rating of Ataxia (SARA)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Health Center
name: Carlos Gordon, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02326506: Evaluation of Drainable Volume Measurements During VA-ELS
Official title: Evaluation of Drainable Volume Measurements and Their Usage for Predicting Optimal Cardiac Support in Patients Supported by Veno-arterial Extracorporeal Life Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Arrest
Keywords: Extracorporeal Membrane Oxygenation
Cardiopulmonary Bypass
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-12-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Veno-arterial extracorporeal life support (VA-ELS) is used to support patients with acute cardiac failure. In that context, sufficient drainable venous volume is crucial for reliable and adequate support. To date, no reliable measurement method exists to monitor drainable volume adequately. Furthermore, it is still unresolved how to diagnose adequate cardiac recovery.

Previous (pre)clinical studies showed that the calculation of the dynamic filling index may provide a valuable parameter to monitor the drainable volume in patients supported by VAELS. In addition, a case report showed that measurement of the dynamic filling index could successfully be used to estimate cardiac recovery in a single patient supported by VA-ELS in the ICU.

This study will assess the dynamic filling index as a representation for drainable volume and cardiac recovery using standard recorded perfusion data in patients supported by VA-ELS


Eligibility criteria: Inclusion Criteria:

* Written informed consent of the relative(s) or legal representative(s)
* Supported by VA-ELS at the ICU
* \>18 years

Exclusion Criteria:

- Pregnancy

Primary outcomes:
measure: TEE results
timeFrame: participants will be followed for the duration of the VA-ELS support, an expected average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
Study officials:
affiliation: Maastricht University Hospital
name: Patrick W. Weerwind, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simons AP, Reesink KD, Lance MD, van der Nagel T, van der Veen FH, Weerwind PW, Maessen JG. Reserve-driven flow control for extracorporeal life support: proof of principle. Perfusion. 2010 Jan;25(1):25-9. doi: 10.1177/0267659109360284. Epub 2010 Jan 29.
citation: Simons AP, Reesink KD, Lance MD, van der Veen FH, de Jong DS, Weerwind PW, Maessen JG. Dynamic filling index: a novel parameter to monitor circulatory filling during minimized extracorporeal bypass. Eur J Cardiothorac Surg. 2009 Aug;36(2):330-4. doi: 10.1016/j.ejcts.2009.03.045. Epub 2009 May 2.
citation: Simons AP, Lance MD, Reesink KD, van der Veen FH, Weerwind PW, Maessen JG. Quantitative assessment of cardiac load-responsiveness during extracorporeal life support: case and rationale. J Cardiothorac Surg. 2010 Apr 27;5:30. doi: 10.1186/1749-8090-5-30.
Clinical trial NCT05352906: Accuracy of Handheld and Non-contact Tonometry
Official title: Accuracy of Handheld and Non-contact Tonometry in Clinical Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Intraocular Pressure
Glaucoma, Suspect
Keywords: Glaucoma
Suspect
Tonometer
Air-puff
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Monitoring the intraocular pressure (IOP) is one of the most important tests used in follow-up among glaucoma suspects and confirmed glaucomatous patients.

Detailed description: In tertiary hospitals, IOP screening is an important tool to confirm glaucomatous eyes. Inaccurate measurements may lead to missed diagnosis or false positive results that may affect patients' quality of life.

There are many devices produced to measure IOP, the commonest one is Goldman contact tonometry, the aim of this study is to compare the results of new developed tonometers to the standard applanation tonometer.

Eligibility criteria: Inclusion Criteria:

* All subjects seeking regular check-up in glaucoma clinic at banha university hospital.
* Glaucoma suspects and glaucomatous patients that visit glaucoma clinic for regular IOP measurements.

Exclusion Criteria:

* Patients that will refuse to measure IOP again with other devices.
* patients with previous corneal surgeries or scar that may alter the measurements of the tonometer s (as previous keratoplasty, trauma or opacities).

Primary outcomes:
measure: Accuracy of air-puff tonometry
timeFrame: Immediately after goldman applanation tonometry test for each eye.
Secondary outcomes:
measure: Accuracy of handheld tonometry
timeFrame: Immediately after goldman applanation tonometry test for each eye.
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy
state: QA
Study officials:
affiliation: Benha University
name: Ahmed A Abdelshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05304806: Effective Volemia in Older Adults With Orthostatic Hypotension
Official title: Effective Volemia in Older Adults With Orthostatic Hypotension, Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthostatic Hypotension
Keywords: older
orthostatic hypotension
volemia
clinical sonography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 70 years, orthostatic hypotension

Brief summary: Clinical and biological assessments of volemia are challenging in older patients as they are more likely to present non-typical signs. Point of care ultrasonography (POCUS) using heart and lung exploration is a relevant tool to assess volemia in adults with little data in older adults.

The primary objective of the study is to evaluate feasibility of positional POCUS in aging patients.

The secondary objectives are to assess the variability of measurements between decubitus and sitting position.

Detailed description: This is a monocentric study. Twenty patients will be enrolled, aged of 70 years and older. POCUS parameters, duration of procedure and measurements will be recorded for each patients.

Eligibility criteria: Inclusion Criteria:

* 70 years and older
* Orthostatic hypotension or venous insufficiency
* Affiliated to a social security or beneficiary

Exclusion Criteria:

* Refusal to participation to the study
* Cognitive disorder
* Unable to keep sitting posture for up to 30 minutes
* Foreign patients under french AME scheme

Primary outcomes:
measure: Duration of recording during positional echography
timeFrame: 3 months
measure: Feasibility of positional echography
timeFrame: 3 months
Secondary outcomes:
measure: Cardiac ultra sound parameters: left ventricle diastolic diameter
timeFrame: 3 months
measure: Cardiac ultra sound parameters: left ventricle ejection fraction
timeFrame: 3 months
measure: Cardiac ultra sound parameters: E and A waves velocity
timeFrame: 3 months
measure: Cardiac ultra sound parameters: Inferior vena cava size and compliance
timeFrame: 3 months
measure: Cardiac ultra sound parameters: left atrial size
timeFrame: 3 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Geriatric medecine department, Ambroise Paré hospital, APHP
Study officials:
affiliation: Geriatric medecine department, Ambroise Paré hospital, APHP
name: Marion Pepin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00685906: AZD6140 Oral Contraceptive Interaction Study
Official title: A Randomised, Double-blind, Two-way Crossover Study to Determine the Effects of Co-administration of AZD6140 and Nordette® (Combination of Levonorgestrel and Ethinyl Estradiol) After Multiple Oral Doses in Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: oral contraceptive
birth control
Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-29
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
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 examine the effect of co-administration of AZD6140 and Nordette® on the blood levels of certain female hormones.


Eligibility criteria: Inclusion Criteria:

* Females who are healthy, non-pregnant, not planning pregnancy within the study period, non-breast-feeding, and pre-menopausal
* Either currently taking Nordette® which was well tolerated for at least two months prior to randomisation with no history of break-through bleeding, or, willing to take Nordette for 2 months prior to receiving the study drug
* Females of child-bearing potential must be willing to use at least 1 additional medically approved non-hormonal barrier contraceptive method (for example, condom or diaphragm) that contains spermicide

Exclusion Criteria:

* History of intolerance (e.g. adverse events) to any oral contraceptive or AZD6140
* History of blood vessel or bleeding conditions that would make the volunteer more prone to bleeding
* History or presence of significant medical problems
* Women who are current smokers

Primary outcomes:
measure: Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®
timeFrame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
Secondary outcomes:
measure: Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette®
timeFrame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
measure: Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette®
timeFrame: At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2.
measure: Safety and tolerability of AZD6140 when co-administered with Nordette®
timeFrame: Screening through completion of the study
Other outcomes:
Locations:
city: Miami
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: AstraZeneca
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
affiliation: SeaView Research
name: Audrey, Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02529306: The Correlation Between Testosterone and Cortisol Level and Inflammatory Markers Levels in Type 2 Diabetic Men.
Official title: The Correlation Between Testosterone and Cortisol Level and Inflammatory Markers Levels in Type 2 Diabetic Men.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetic
Keywords: men
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-08-20
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic men, age 40-55

Brief summary: Many type 2 diabetic men have low serum testosterone levels. Our aim in this trial is to check if there is a correlation between serum or hair testosteron levels and serum or hair cortisol levels in type 2 diabetic men. We'll also examine whether there is a correlation between serum and hair testosterone levels and cortisol levels and serum inflammatory markers.

If such correlation will be found- then it is possible that excess cortisol or an abnormal inflammatory status- may cause the low testosterone levels that seen in type 2 diabetic men.

Detailed description: Eligible participants are type 2 diabetic men who visit our clinic, as part of their routine medical surveillance, and other 10 healthy volunteers (men) as a control group.

All the participants will sign an informed consent form. The study will include 30 type 2 diabetic men, (40-55 years old) and 10 healthily volunteers (same age group).

In addition to routine blood test of blood count, kidney function and liver enzymes will be taken blood samples of total testosterone serum levels, total cortisol serum levels and serum inflammation markers levels, and also a sample of head-hair for cortisol and testosterone levels (1 cm of occipital hair weighing 50 mg).

Optional: from patients who will agree to visit the clinic after 8 hours-fast will be also taken one additional blood sample of fasting glucose, insulin and C-peptide levels, in order to estimate their insulin resistance status, and it's possible correlation to the other measures.

From the 10 healthy volunteers In addition will be taken blood and hair samples of the above parameters, as a control.

Eligibility criteria: Inclusion Criteria:

* men age 40-55
* type 2 diabetic

Exclusion Criteria:

* HIV
* septic disease

Primary outcomes:
measure: Testosterone level
timeFrame: 24 months
measure: Cortisol level
timeFrame: 24 months
measure: C-reactive protein levels
timeFrame: 24 months
measure: Anti Tumor Necrosis Factor alpha
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
Study officials:
References:
Clinical trial NCT01672606: Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea
Official title: Effect of Partial Neuromuscular Blockade by Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea-before and After Three Month CPAP Treatment. A Non-randomized, Non-blinded Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Rocuronium
Neuromuscular Blockade
Hypoxic Ventilatory Response
CPAP
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2012-08-27
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study describe the effect of partial neuromuscular blockade of rocuronium on the acute hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.


Eligibility criteria: Inclusion Criteria:

* Male with diagnosed moderate OSA (AHI 15-30), untreated, but planned for CPAP treatment. Healthy except for OSA and well controlled tablet treated hypertension where the treatment has not been changed during the last 3 month. None smokers. 18-70 years old. BMI \<35.

Exclusion Criteria:

* If they don´t fit the inclusion criteria

Primary outcomes:
measure: Hypoxic ventilatory response
timeFrame: At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
Secondary outcomes:
measure: Hypercarbic ventilatory response
timeFrame: At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
measure: Hypoxic ventilatory response
timeFrame: At diagnosis and after 3 month of CPAP treatment at home
measure: Hypoxic ventilatory response during acute CPAP treatment
timeFrame: At diagnosis and after 3 month of CPAP treatment
measure: Hypercarbic ventilatory response
timeFrame: At diagnosis and after 3 month of CPAP treatment at home
measure: Hypercarbic ventilatory response during acute CPAP treatment
timeFrame: At diagnosis and after 3 month CPAP treatment at home
measure: Upper airway obstruction
timeFrame: At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital and Karolinska Institutet
name: Malin Jonsson Fagerlund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04715906: Project COPE (Coping Options for Parent Empowerment)
Official title: Coping Options for Parent Empowerment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depression
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Children's Trust, Miami FL
First posted: 2021-01-20
Enrollment: 35
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 research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers of children with Autism Spectrum Disorder (ASD) cope with these stressors.


Eligibility criteria: Inclusion Criteria:

1. Must be willing to consent to participate via RedCap
2. Indicate a mild or greater elevation on screening measures of anxiety and/or depression
3. Not meet any exclusion criteria.
4. Lives in Florida
5. Has a child between the ages of 4-13 years who has been diagnosed with ASD
6. Speaks either English or Spanish primarily
7. Has technical capacity to participate in Zoom sessions on a mobile device or preferably a computer

Exclusion Criteria:

1. Severe mental illness (e.g., bipolar disorder, schizophrenia, an intellectual disability, psychosis, alcohol use disorder, substance use disorder) or hospitalization for mental health concerns or suicide attempt. Parents may receive concurrent psychiatric or psychological intervention services but may be excluded if the severity of current mental illness is such that outpatient, weekly group treatment would be considered inappropriate.
2. Parents who report any prior arrest for child endangerment, child abuse or child neglect may also be excluded.
3. Parents who have Moderate or greater risk of suicidal ideation.

Primary outcomes:
measure: Change in Anxiety levels as measured by GAD-7
timeFrame: Baseline, 6 Weeks
measure: Change in depressive symptoms as measured by the PHQ
timeFrame: Baseline, 6 Weeks
Secondary outcomes:
measure: Change in parenting beliefs as measured by the PSOC Scale
timeFrame: Baseline, 6 Weeks
measure: Change in Hope as measured by the State Hope Scale
timeFrame: Baseline, 6 Weeks
measure: Acceptability of Intervention as measured by the Program Feedback Scale
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Jill Ehrenreich-May, PhD
role: PRINCIPAL_INVESTIGATOR
References: