louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01855633: Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke
Official title: Repetitive Transcranial Magnetic Stimulation in Patients With Hemiplegic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Dongtan Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 48
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: Stroke is one of the major causes of death in the World. Many stroke survivors may suffer from long-term sequelae of stroke such as hemiplegia. The effects of rehabilitation therapy are limited. The development of new treatment strategies is essential. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method to stimulate the focal area of the brain for restoring brain function. The aim of this study is to investigate the therapeutic effect of rTMS on the motor recovery in patients with hemiplegic stroke.


Eligibility criteria: Inclusion Criteria:

* stroke patients with motor weakness
* Medical research council (MRC) grade 0-4
* More than 2 weeks after stroke onset
* Age 18 years and older
* Able to provide consent for the protocol

Exclusion Criteria:

* History of previous symptomatic stroke
* pregnant women
* Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), intracardiac lines that may pose a physical hazard during magnetic stimulation will also be excluded
* Patients with history of seizure disorder or epilepsy
* Subjects without the capacity to give informed consent

Primary outcomes:
measure: Keyboard tapping test
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Hwaseong Si
country: Korea, Republic of
facility: Dongtan Sacred Heart Hospital
state: Gyeonggi-Do
Study officials:
References:
Clinical trial NCT01308333: Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia
Official title: Investigation of Chronic Inflammatory Processes in the Respiratory Tract and the Eyes of Male Individuals With X-linked Hypohidrotic Ectodermal Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: X-linked Hypohidrotic Ectodermal Dysplasia
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
Collaborators: name: Edimer Pharmaceuticals
First posted: 2011-03-04
Enrollment: 38
Sex: MALE
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with X-linked hypohidrotic ectodermal dysplasia (XLHED) and healthy controls

Brief summary: X-linked hypohidrotic ectodermal dysplasia (XLHED) is a complex genetic disorder characterized by lack of sweat, sebaceous, submucous, Meibomian and mammary glands, sparse hair and eyebrows, and oligodontia. Insufficient function of the respective glands may lead to chronic inflammatory processes in airways and eyes of the affected individuals. The investigators will quantify sweat glands of XLHED patients, assess chronic conjunctivitis and blepharitis in conjunction with quantitative and/or qualitative alterations of lacrimal fluid in these subjects, evaluate lung function and assess chronic inflammatory processes in the airways by NO measurements. The data should provide a basis for genotype-phenotype correlations.


Eligibility criteria: Inclusion Criteria:

* for patients: X-linked hypohidrotic ectodermal dysplasia caused by mutations in the gene EDA
* written informed consent

Exclusion Criteria:

* acute respiratory disease
* acute allergic problem, e.g. allergic coryza
* implantable electronic devices, e.g. pacemaker

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen, Competence Centre for Children with Ectodermal Dysplasias
state: Bavaria
Study officials:
affiliation: University Hospital Erlangen
name: Holm Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dietz J, Kaercher T, Schneider AT, Zimmermann T, Huttner K, Johnson R, Schneider H. Early respiratory and ocular involvement in X-linked hypohidrotic ectodermal dysplasia. Eur J Pediatr. 2013 Aug;172(8):1023-31. doi: 10.1007/s00431-013-1985-8. Epub 2013 Apr 4.
Clinical trial NCT00920933: Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects
Official title: Double Blind, Placebo Controlled, Parallel Group Study With an Open Label Reference Arm to Assess the Effects of Intravenously Administered AIN457 on Ozone Induced Neutrophilia Compared to Placebo & Oral Corticosteroid in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Ozone challenge
airway neutrophilia
induced sputum
Healthy volunteers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo, or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.


Eligibility criteria: Inclusion criteria:

* Healthy subjects
* Normal sputum neutrophil levels at screening
* Ozone responsive

Exclusion criteria:

* Smokers
* Prior treatment with antibody treatment or immunosuppressive agent
* Presence or history of a major chronic inflammatory autoimmune disease
* History of severe hypersensitivity to any biological agents (antibody or soluble receptor), a history of serious allergic reaction, collagen disease, neurological disease (including demyelinating disease).

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Total neutrophil cell count in 106/mL in induced sputum
timeFrame: Day 16
Secondary outcomes:
measure: Serum total IL-17A
timeFrame: Day 1- Day 120
measure: Percentage neutrophil cell count in induced sputum
timeFrame: Day 16
measure: Safety and tolerability. Safety assessments will include vital signs, electrocardiograms (ECG), spirometry, pulse oximetry, immunogenicity and adverse events (AEs)
timeFrame: Day 1-Day 120
measure: Airway function (FEV1, FVC, and FEF25-75)
timeFrame: 4h, 24h, and 48h after the start of the ozone exposure
measure: Serum AIN457 pharmacokinetics (PK)
timeFrame: Day1-Day 120
Other outcomes:
Locations:
city: Grosshansdorf
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01547533: Study of Benznidazole Transfer Into Breastmilk in Lactating Women With Chagas Disease
Official title: Study of Benznidazole Transfer Into Breastmilk in Lactating Women Treated for Chagas Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chagas Disease
Lactation
Keywords: Chagas disease
lactation
breastmilk
postpartum period
infants
pediatric clinical pharmacology
developmental clinical pharmacology
parasitology
trypanosoma cruzi
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population of young women with Chagas disease referred to our center for evaluation and treatment

Brief summary: The investigators propose to study the transfer of benznidazole into breastmilk from the blood of lactating women who receive the drug for the treatment of Chagas disease. Breastmilk and blood samples will be obtained from these patients at given times after they take the clinically indicated medication, and the concentrations in both matrices will be compared to estimate degree of transfer, which in turn will be used to evaluate potential degree of exposure of infants breastfed by these women. This study will help clarify safety of continuing breastfeeding while receiving treatment with benznidazole for Chagas disease.


Eligibility criteria: Inclusion Criteria:

* Lactating women with Chagas disease, not treated before
* Use of contraception

Exclusion Criteria:

* History of allergy to benznidazole or its excipients
* Pregnancy
* Significant heart involvement (due to Chagas disease)
* Significant systemic diseases that could affect the interpretation of the results in the opinion of the principal investigator

Primary outcomes:
measure: Benznidazole concentration in breastmilk and in plasma
timeFrame: at randomly selected time points during the 30 days of treatment
Secondary outcomes:
measure: incidence of adverse drug reactions in women treated with benznidazole during lactation
timeFrame: throughout the 30 days of treatment
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Parasitology and Chagas Service, Buenos Aires Children´s Hospital Ricardo Gutierrez
Study officials:
affiliation: Buenos Aires Children´s Hospital Ricardo Gutierrez ; CONICET
name: Facundo Garcia Bournissen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Bournissen F, Moroni S, Marson ME, Moscatelli G, Mastrantonio G, Bisio M, Cornou L, Ballering G, Altcheh J. Limited infant exposure to benznidazole through breast milk during maternal treatment for Chagas disease. Arch Dis Child. 2015 Jan;100(1):90-4. doi: 10.1136/archdischild-2014-306358. Epub 2014 Sep 10.
Clinical trial NCT06982833: Trunk Restraint in Multiple Sclerosis
Official title: Investigation of the Effect of Trunk Restraint on Upper Extremity Functionality in Individuals With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Healthy Control
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MS patients and their age-matched healthy control group were evaluated.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examined the effect of trunk restraint on upper extremity functionality in patients with Multiple Sclerosis (MS).The study included 66 MS patients over the age of 18 and 30 healthy individuals. Participants' upper extremity functions were assessed. Their trunks were then restrained and their upper extremity functions were assessed again. The patients' level of disability (EDSS), trunk control (Trunk Impairment Scale - TIS), upper extremity functionality (Nine Hole Peg Test- 9HPT), were evaluated.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Being diagnosed with MS
* Volunteering

Exclusion Criteria:

* Having any additional disease or disorder of the upper extremity or trunk (such as disc herniation, fracture)
* Having any additional neurological disease

Primary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: up to 6 weeks
measure: Trunk Impairment Scale (TIS)
timeFrame: up to 6 weeks
measure: Nine-Hole Peg Test (9HPT)
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Arzucan Toksal
city: Zonguldak
country: Turkey
facility: Zonguldak Bulent Ecevit University
Study officials:
affiliation: Yuksek Ihtisas University
name: Güngör Beyza Özvar Şenöz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsun University
name: Bilge Piri Çınar, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zonguldak Bulent Ecevit University
name: Mustafa Açıkgöz, Assoc. Prof
role: STUDY_DIRECTOR
affiliation: Zonguldak Bulent Ecevit University
name: Nursena Ceylan
role: PRINCIPAL_INVESTIGATOR
affiliation: Zonguldak Bulent Ecevit University
name: Arzucan Toksal Uçar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03358433: Effectiveness of Exercise in the Treatment of Depression
Official title: Effectiveness of Exercise in the Treatment of Depression in Older People as an Alternative to Drugs Antidepressants in Primary Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Primary Care
Exercise
Lead sponsor: Gerencia de Atención Primaria, Albacete
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 312
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to test the non-inferiority of supervised exercise versus antidepressant treatment in reducing depressive symptoms in patients with clinical criteria for depression (according to ICD 10) over a period of 6 months follow-up.

Detailed description: This is a randomized clinical trial in primary care in which a total of 312 patients over 65 years with clinically significant depression will be randomly assigned to an exercise program supervised or receive treatment with antidepressant drugs commonly used in clinical practice. At baseline physical fitness of the participants will be checked, and assessments will be made after 15 days and 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6 month period in which a sports instructor will train patients to perform at least 30 minutes of regular, moderate-intensity activity with a frequency almost daily, including aerobic exercise and strength training, flexibility and balance. In both groups will be evaluated periodically, among other variables, the state of depressive symptoms, level of physical activity, self-rated health, occurrence of adverse effects and adherence to exercise program or antidepressant treatment. The main outcome measure is the reduction of the baseline score on the scales of depressive symptoms (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale).

Eligibility criteria: Inclusion Criteria:

* People with depression

Exclusion Criteria:

* Contraindication to exercise

Primary outcomes:
measure: Improvement in depressive symptoms
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Jesús López-Torres Hidalgo
city: Albacete
country: Spain
Study officials:
affiliation: Centro de Salud Zona VIII de Albacete (Spain)
name: Jesús López-Torres Hidalgo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hidalgo JL, Sotos JR; DEP-EXERCISE Group. Effectiveness of Physical Exercise in Older Adults With Mild to Moderate Depression. Ann Fam Med. 2021 Jul-Aug;19(4):302-309. doi: 10.1370/afm.2670.
citation: Lopez-Torres Hidalgo J; DEP-EXERCISE Group. Effectiveness of physical exercise in the treatment of depression in older adults as an alternative to antidepressant drugs in primary care. BMC Psychiatry. 2019 Jan 14;19(1):21. doi: 10.1186/s12888-018-1982-6.
Clinical trial NCT01201733: Traditional Thai Massage and Brain Electrical Activity
Official title: The Immediate Effect of Traditional Thai Massage on Brain Electrical Activity in Patients With Scapulocostal Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scapulocostal Syndrome
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the immediate effect of traditional Thai massage on brain electrical activity in the patients with scapulocostal syndrome


Eligibility criteria: Inclusion Criteria:

1. Age between 18 - 50 years old
2. The participants have experienced spontaneous scapular pain (VAS ≥ 3) for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and trapezius muscles). Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
3. The participants will be able to follow instructions.
4. Good communication and cooperation.

Exclusion Criteria:

1. A history of the following diseases or disorders:

   * Rotator cuff disease
   * Cervical radiculopathy
   * Degenerative shoulder joint disease
   * Shoulder stiffness
2. Contraindications of traditional Thai massage

   * Contagious skin disease
   * Injury or inflammation of muscle
   * Bone fracture and/or joint dislocation
   * Open wound
   * Uncontrolled hypertension
   * Drug and/or alcohol intoxication

Primary outcomes:
measure: Electroencephalography (EEG):the absolute band power in every frequency band
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University
state: Khon Kaen
Study officials:
References:
citation: Buttagat V, Eungpinichpong W, Kaber D, Chatchawan U, Arayawichanon P. Acute effects of traditional Thai massage on electroencephalogram in patients with scapulocostal syndrome. Complement Ther Med. 2012 Aug;20(4):167-74. doi: 10.1016/j.ctim.2012.02.002. Epub 2012 Mar 2.
Clinical trial NCT04664933: Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)
Official title: Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET): One Single Center, Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Intravascular Thrombosis
Mechanical Thrombectomy
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who received recanalization operation.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. Acute ischemic stroke patients who is eligible for endovascular treatment;
3. Signed informed consent.

Exclusion Criteria:

1. Modified Rankin Score \>2 caused by a history of prior stroke;
2. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<80000/mm3);
3. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
4. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
5. Unsuitable for this clinical studies assessed by researcher.

Primary outcomes:
measure: Proportion of server adverse events
timeFrame: 48 hours
Secondary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 1
timeFrame: 90 days
measure: Proportion of patients with modified Rankin Score 0 to 2
timeFrame: 90 days
measure: Modified Rankin Score
timeFrame: 90 days
measure: Decrease in national institutes of health stroke scale (NIHSS)
timeFrame: 48 hours
measure: Proportion of symptomatic intracranial hemorrhage (sICH)
timeFrame: 48 hours
measure: Proportion of intraparenchymal hemorrhage (PH1 and PH2)
timeFrame: 48 hours
measure: Changes in cerebral edema
timeFrame: 48 hours
Other outcomes:
measure: Differences in serum factors levels and blood gas in diverse vessel region
timeFrame: Hour 0
measure: Changes in serum factors levels
timeFrame: 30 minutes, 24 hours
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References:
Clinical trial NCT01223833: A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitors and Tamoxifen
Official title: A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Arthralgia
Keywords: breast cancer
postmenopausal
aromatase inhibitors
tamoxifen
arthralgia
IGF-I
BMI
grip strength
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 296
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal early breast cancer patients scheduled to start adjuvant hormonal therapy with any of the third generation aromatase inhibitors or tamoxifen in University Hospitals Leuven.

Brief summary: The Logribmet study is a prospective study that evaluate grip strength changes in both hands of postmenopausal women with breast cancer receiving treatment with tamoxifen or an aromatase inhibitor. Patients included in the study will undergo a grip strength measurement and receive a rheumatological questionnaire prior to the start of treatment, then at 3 and 6 months and at year 1 into therapy. Furthermore, BMI will be measured to assess if BMI is a predictor for the decrease in grip strength.

IGF-I, GH and IGFBP-3 serum levels will also be measured at all time points.


Eligibility criteria: Inclusion Criteria:

1. Patients with early breast cancer who are scheduled to receive endocrine therapy with tamoxifen or any of the third-generation aromatase inhibitors, anastrozole, letrozole or exemestane.
2. No major rheumatological disorders such as severe rheumatoid arthritis.
3. Patients must have provided informed consent for participation in this study.

Exclusion Criteria:

1. Concomitant endocrine therapy for breast cancer.
2. Concomitant intake of sex hormone containing drugs such as hormone replacement therapy.

Primary outcomes:
measure: To assess the effect of BMI on loss of grip strength measured by a modified sphygmomanometer with baseline, month 3, month 6 and month 12 measurements.
timeFrame: 1 year
Secondary outcomes:
measure: IGF-I, GH and IGFBP-3 levels
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Patrick Neven, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: