louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01005394: Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery
Official title: Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischemic Stroke
Lead sponsor: Nexstim Ltd
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 20-80 years who have suffered a unilateral ischemic stroke and who will undergo motor rehabilitation at the study center will be asked to participate in the study.

Brief summary: The past 10 years of research in persons more than 6 months post stroke have shown certain types of rehabilitation can help "re-wire" the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this re-wiring by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in brain activity during the first 6 months after stroke (to determine how the brain "re-wires"); 2) compare changes in recovery of motor function with changes in brain re-wiring; 3) determine the ability of TMS to "predict" functional outcome in the first 6 months after stroke.

The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure motor threshold (MT), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes at 3 and 6 months.


Eligibility criteria: Inclusion Criteria:

* one sided ischemic stroke confirmed by radiology
* 20-80 years old

Exclusion Criteria:

* hemorrhagic stroke
* brainstem stroke
* cerebellar stroke
* thalamic stroke
* seizure with the recent stroke
* any history of uncontrolled seizure
* history of epilepsy
* pregnancy or planning on getting pregnant during the next year
* MRI incompatibility (e.g. metal implants in body)
* recent history (past year) of alcohol and drug abuse (due to lack of follow up)

Other criteria include TMS exclusions: aneurysm clips, previous surgery over motor cortex, open craniotomy

Primary outcomes:
measure: navigated transcranial magnetic stimulation examination and correlation with motor functional testing
timeFrame: Enrollment, week 2, week 4 , week 12 and week 24 post-stroke
Secondary outcomes:
measure: Safety of navigated transcranial magnetic stimulation examination
timeFrame: each examination
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Drake Rehabilitation Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Kari Dunning, PhD,PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05487794: Effect of Dose Fractionation of Testosterone Cypionate on Transgender Men with Erythrocytosis
Official title: Effect of Dose Fractionation of Testosterone Cypionate on Hematocrit in Transgender Men with Erythrocytosis Secondary to Testosterone Use.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Testosterone
Transsexualism
Hematologic Diseases
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2022-08-04
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A transgender man is someone with a male identity who were born with a vulva and vagina. The acquisition of masculine characters can come from surgery or from the use of testosterone. Despite the benefit of using this hormone in relation to hair development, muscle mass gain and changes in voice timbre, its use can cause an increase in the hematocrit (Ht) level. When erythrocytosis occurs (Ht ≥ 50%), the currently proposed conduct is the suspension of cross-hormonization for 3 months, which has negative effects on the affirmation process. This project aims to assess whether reducing the dose of testosterone cypionate by half (100mg/15d) can mitigate the negative outcomes caused by the suspension with the benefit of reducing the hematocrit level in trans patients who developed erythrocytosis using testosterone. This is a pilot study that will compare the intervention (testosterone cypionate 100 mg, fortnightly) to the suspension of the drug, both for 3 months, with the main outcome being the hematocrit level. Hormonal and biochemical levels and the Hospital Anxiety and Depression scale (HAD) will also be evaluated in patients treated at the Gender Incongruence Outpatient Clinic of the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto.


Eligibility criteria: Inclusion Criteria:

* TM aged between 18 and 40 years in threatmeant with Testosterone Cypionate 200mg/2mL with a diagnosis of erythrocytosis (Ht⩾50%).

Exclusion Criteria:

* TM with polycythemia vera or secondary to other pathologies (chronic kidney disease, severe lung disease, chronic myeloid leukemia, lymphoma, liver diseases and Cushing's syndrome);
* TM in use of hormonal contraceptives or copper IUDs;
* TM with psychiatric conditions such as severe psychotic disorders, severe personality disorders
* Patients with Ht \> 54.

Primary outcomes:
measure: Rate of Erythrocytosis
timeFrame: 3 months
Secondary outcomes:
measure: Efects on lipids and glucose levels
timeFrame: 3 monsths. Blood collection will be carried out in recruitment and 3 months after intervention or control.
measure: Anxiety and Depression Hospital Scale (HAD)
timeFrame: The scale will be applied in recruitment and 3 months after intervention or control.
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Faculdade de Medicina de Ribeirão Preto - FMRP-USP
state: SP
Study officials:
References:
Clinical trial NCT06205394: Improving The Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors, Intended for SGM Study
Official title: Improving the Breast Cancer Care Delivery Model for Sex and Gender Minority Survivors (Intended for SGM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer survivors that self-identify as a member of the sex and gender minority community or partner with an individual of the same sex or gender and breast oncology clinicians recruited through Ohio State University Comprehensive Cancer Center.

Brief summary: This study evaluates Improving the Breast Cancer Care Delivery Model for Sex and Gender Minority (INTENDED for SGM) in identifying the patient, support person and provider barriers to quality care in SGM breast/chest cancer survivors.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the important ways the iCanDecide breast cancer decision aid needs revised for SGM people, and how best to integrate a culturally-relevant tool into clinical practice.

OUTLINE: This is an observational study.

AIM 1: Interview transcripts from SANGRIA study utilized to explore the values, preferences and key considerations for breast cancer treatment decision making in SGM individuals.

AIM 2: Patients are assigned to 1 of 2 groups.

GROUP 1: Cancer survivors participate in a focus group on study.

GROUP 2: Breast cancer clinicians undergo a semi-structured interview on study.

Eligibility criteria: Inclusion Criteria:

* SURVIVORS:

  * Self-identify as a member of the sex and gender minority community or partner with an individual of the same sex or gender
  * Must be a breast cancer survivor, in active treatment or completed active treatment in the last 10 years (not including hormone therapy)
  * Be over age 18
  * English-speaking
  * Received care in the US

BREAST ONCOLOGY CLINICIANS: Physicians, advanced practice providers, nurses, psychologists and social workers will be eligible if they:

* Provide care and/or surgical decision support to individuals diagnosed with early stage breast cancer in the US
* Are English-speaking

Primary outcomes:
measure: Survivor participant feedback, opinions, and preferences for breast cancer care
timeFrame: At completion of study up to 2 years
measure: Clinician participant reports of experiences, opinions, and knowledge of caring for LGBTQ+ people
timeFrame: At completion of study up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Elizabeth K Arthur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05470894: Liver Injury After COVID-19 Vaccination
Official title: APASL Post-COVID-19 Vaccination Liver Injury (APCOVLI Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjects After COVID-19 Vaccination
Lead sponsor: Humanity & Health Medical Group Limited
Sponsor class: OTHER
Collaborators: name: Tokyo University
name: Nihon University School of Medicine
First posted: 2022-07-22
Enrollment: 379
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects after COVID-19 vaccination

Brief summary: The COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is still raging across the world and vaccination is expected to lead us out of this pandemic. Although the efficacy of these vaccines is beyond doubt, safety still remains a concern. Liver injury, such as autoimmune hepatitis (AIH), has been reported after COVID-19 vaccination. The aim of this prospective study is to investigate the spectrum and profile of liver injury after COVID-19 vaccination in Asia-Pacific region and to explore the potential risk factors for the development of liver injury.


Eligibility criteria: Inclusion Criteria:

* Subjects who have received at least one dose of approved COVID-19 vaccine;
* Volunteer to participate in this study.

Exclusion Criteria:

* No valid consent.

Primary outcomes:
measure: Number of subjects with liver injury after COVID-19 vaccination
timeFrame: Within 24 weeks after COVID-19 vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Humanity & Health Medical Group Limited
city: Tokyo
country: Japan
facility: Nihon University School of Medicine
city: Tokyo
country: Japan
facility: Tokyo University
Study officials:
affiliation: Humanity & Health Medical Group
name: George Lau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokyo University
name: Masao Omata, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nihon University School of Medicine
name: Tatsuo Kanda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01191294: Evaluation of a Simulation Training Tool to Identify Lesions Requiring Further Screening for Melanoma
Official title: Development and Evaluation of a Simulation Training Module to Identify Lesions Requiring Further Visual Screen or Skin Biopsy for Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Simulation Model
Mastery Learning Model to Simulation Training for Visual Screening for Melanoma and Skin Biopsy
Keywords: Melanoma
Simulation Training
Medical Students
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-08-30
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The investigators will design a curriculum for visual screening for melanoma and skin biopsy procedure, based on the mastery learning model, using simulators and web-based didactic instruction for medical students and internal medicine residents. This requires having a skin simulation model that presents a range of lesions from benign nevus to atypical nevus to melanoma in a distribution and density that mimics the clinical findings of those with 2 skin tones: fair-skin non- Hispanic white and Hispanic.


Eligibility criteria: Inclusion Criteria:

* Medical student in his primary care clerkship at Northwestern University

Exclusion Criteria:

* Not a medical student in his primary care clerkship at Northwestern University

Primary outcomes:
measure: Simulation curriculum for screening for melanoma
timeFrame: 1 year
Secondary outcomes:
measure: Change in melanoma detection skills
timeFrame: 1 hour
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: June Robinson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Dennis P West, PhD
role: STUDY_DIRECTOR
References:
citation: Jain N, Anderson MJ, Patel P, Blatt H, Davis L, Bierman J, McGaghie W, Brucker JB, Martini M, Robinson JK. Melanoma simulation model: promoting opportunistic screening and patient counseling. JAMA Dermatol. 2013 Jun;149(6):710-6. doi: 10.1001/jamadermatol.2013.2882.
Clinical trial NCT00923494: Effectiveness of Ultrasound (US) Guided Supraclavicular Block
Official title: Effectiveness of Ultrasound Guided Supraclavicular Brachial Plexus Block With 20, 30, or 40 ml of Ropivacaine 0.5%
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Analgesia
Pain
Keywords: Anesthesia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is being done in order to find out if there is any difference in the effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). The investigators want to show if you can have a successful nerve block with less amount of local anesthetic, thus potentially decreasing the risk of side effects.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-64,
* Patients who are ASA I-III, presenting for distal upper extremity surgery. Surgeries to be considered are ORIF of distal upper extremity fractures such as ORIF radius, ORIF ulna, ORIF of any bones in the wrist or hand, and distal upper extremity surgery involving bones or tendons for which postoperative pain is to be expected. No emergency surgeries will be considered.

Exclusion Criteria:

* Emergency surgery,
* Patient or surgeon refusal
* Patients for which peripheral nerve block or study medications are contraindicated,
* Patients on chronic analgesic therapy at home,
* History of nerve injury, neuropathy, or known neurologic injury or illness, or inability to properly describe postoperative pain to investigators (language barrier, psychiatric disorder, dementia).

Primary outcomes:
measure: Onset of analgesia
timeFrame: First 30 minutes
measure: Duration of analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Total analgesic use
timeFrame: First 24 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Jaime Ortiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03158194: Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.
Official title: Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Anxiety
Stress
Asthma
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-subject multiple baseline design.
Primary purpose: TREATMENT

Brief summary: This is a study to develop a protocol on Cognitive behavior therapy (CBT) for asthma-related anxiety that in a consecutive study can be translated to internet-delivered CBT.

Detailed description: Asthma is one of the most common chronic diseases around the world, with a high prevalence of anxiety disorders. Cognitive behaviour therapy (CBT) has been shown to increase psychological well-being for anxiety-related asthma. Our primary aim is to develop a standardized CBT protocol for asthma-related anxiety that can be transferred to internet-delivered CBT. Ten participants will be included in a single-subject multiple baseline design. They will all receive 10-12 sessions of CBT.

Eligibility criteria: Inclusion Criteria:

* asthma diagnosed by a physician
* anxiety or stress related to asthma

Exclusion Criteria:

* severe psychiatric disorder (e.g. psychotic disorder, addiction disorder, suicidal ideation).

Primary outcomes:
measure: Penn State Worry Questionnaire
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Anxiety Sensitivity Index-3
timeFrame: Baseline to 12 weeks
measure: Short Health Anxiety Inventory (SHAI)
timeFrame: Baseline to 12 weeks
measure: Asthma Quality of Life Questionnaire
timeFrame: Baseline to 12 weeks
measure: Asthma control test
timeFrame: Baseline to 12 weeks
measure: Catastrophizing about asthma Scale
timeFrame: Baseline to 12 weeks
measure: Perceived Stress Scale
timeFrame: Baseline to 12 weeks
measure: Patient Health Questionnaire
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
Study officials:
affiliation: Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
name: Catarina Almqvist Malmros, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297660: Neuro-urological Outcome After Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder Neurogenic Dysfunction
Keywords: neurogenic detrusor overactivity
detrusor sphincter dyssynergia
compliance
video urodynamic
spinal cord injury
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ages Eligibility: minimum 18 years old Genders Eligibility: female and male

Brief summary: Most patients with spinal cord injury suffer from bladder dysfunction which may - especially in the long-term - impair renal function. Improved treatment during the last decades improved life expectancy and quality of life. This study evaluates the bladder function in the long-term after spinal cord injury.

Detailed description: Bladder dysfunction is a common consequence of spinal cord injury and depends on the completeness and the level of the lesion. Patients with suprasacral injury usually suffer from neurogenic detrusor overactivity mostly combined with detrusor sphincter dyssynergia. Without adequate treatment, this adverse combination puts the upper urinary tract at risk due to high intravesical pressure often causing vesico-ureteral reflux. Based on improved therapeutic options in the last decades, life expectancy and quality of life constantly increased in spinal cord injury patients. The investigators aim to evaluate the bladder function in the long-term after spinal cord injury.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury for at least 5 years
* Neurogenic lower urinary tract dysfunction
* Written informed consent

Exclusion Criteria:

* Lower urinary tract dysfunction due to other causes than spinal cord injury

Primary outcomes:
measure: Urodynamic evaluation
timeFrame: 5 years after SCI, yearly thereafter (participants are followed until death)
Secondary outcomes:
measure: secondary complications
timeFrame: 5 years after SCI, yearly thereafter (participants are followed until death)
measure: imaging of the upper urinary tract
timeFrame: 5 years after SCI, yearly thereafter (participants are followed until death)
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Jens Wöllner, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01430260: Omnaris Versus Levocetirizine Phase 4 Study
Official title: A Multi-center, Open, Randomized, Three-arm, Parallel-group, Phase IV Study to Compare the Efficacy of Ciclesonide Nasal Spray and Levocetirizine, Alone and in Combination for the Patient With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: efficacy
ciclesonide
levocetirizine
allergic rhinitis
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
Collaborators: name: Takeda
First posted: 2011-09-08
Enrollment: 349
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: This i a comparison of the efficacy ciclesonide nasal spray and levocetirizine, alone and in combination.

Detailed description: randomized, open-label, three arm, parallel group, multi-center study

Eligibility criteria: Inclusion Criteria:

* Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)
* Moderate to severe patient according to ARIA guideline
* To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.
* Subjects who complete the subject diary(S) at least 70%.

Exclusion Criteria:

* Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment
* Hypersensitivity to corticosteroid and/or hydroxyzine
* Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
* A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline
* Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists
* Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (\> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)

Primary outcomes:
measure: rTNSS
timeFrame: 2 weeks
Secondary outcomes:
measure: rTOSS
timeFrame: 2 weeks
measure: TNSS
timeFrame: 2 weeks
measure: PANS
timeFrame: 2 weeks
measure: RQLQ
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: handok pharmaceuticals co. LTD
Study officials:
affiliation: Handok Inc.
name: Moonhwa Park, Doctor
role: STUDY_DIRECTOR
References: