louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06891989: Effects of a Mobile App-Based Mindfulness Intervention in Persons with Spinal Cord Injury and Chronic Pain
Official title: Effects of a Mobile App-Based Mindfulness Intervention in Persons with Spinal Cord Injury and Chronic Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-03-24
Enrollment: 282
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: The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.


Eligibility criteria: Inclusion Criteria:

* Traumatic SCI of at least 6 months duration
* Chronic pain \[defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale\]
* Understand spoken and written English sufficiently to provide informed consent, participate in the intervention and complete study surveys

Exclusion Criteria:

* Lack of daily internet access
* inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions about the study
* Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations
* Use of any meditation more than once a week in the last 3 months
* Inability to provide or obtain an email address for registration to the AC intervention and/or communication with study staff
* inability to provide a phone number for communication with study staff

Primary outcomes:
measure: Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS).
timeFrame: baseline , post-intervention (6 weeks after baseline)
Secondary outcomes:
measure: Change in pain interference as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference scale
timeFrame: baseline , post-intervention (6 weeks after baseline)
measure: Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: baseline , post-intervention (6 weeks after baseline)
measure: Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)
timeFrame: baseline , post-intervention (6 weeks after baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Radha Korupolu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03098589: Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)
Official title: Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Adult T-cell Leukemia Lymphoma
Teratogenicity
Myelosuppression
Haemorrhage
Infection
Thromboembolism
Hypersensitivity
Tumor lysis syndrome
Peripheral neuropathy
Ischaemic heart disease
Cardiac failure
Arrhythmia
Renal failure
Interstitial lung disease
Hepatic disorder
Hypothyroidism
Gastrointestinal perforation
Orthostatic hypotension
Convulsion
Somnolence
Confusion
Fatigue
Dizziness
Blurred vision
Second primary cancer
Cataract
Revlimid capsules
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 1149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Among patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as "Adult T-cell Leukemia Lymphoma (ATLL)") who are treated with Revlimid Capsules (hereinafter referred to as "Revlimid", used by both 2.5 mg and 5 mg capsules).

Brief summary: To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

1. Planned registration period 3 years
2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL


Eligibility criteria: Inclusion Criteria:

- Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to approximately 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Iizuka
country: Japan
facility: ASO KK Iizuka Hospital
state: Fukuoka
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00494689: Transcranial and Rapid Magnetic Stimulation for Gait Apraxia Due to Normal Pressure Hydrocephalus and Cerebral Ischemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Walking
Cognitive Function
Keywords: transcranial sonolysis or monitoring
rapid magnetic stimulation
cerebral ischemia
hydrocephalus
Barthel's index
Lead sponsor: Devathasan Neurology Practice Pte Ltd
Sponsor class: OTHER
First posted: 2007-07-02
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: The investigator(neurologist) has published a study in International Congress Series, in the 15th International Conference of Biomagnetism Vancouver Proceedings 2006,and Science Direct website, of 15 patients with brain ischemia and dilated ventricles who improve when treated with transcranial monitoring or low ultrasound wave intensity (milliwatts) and with rapid magnetic stimulation which is also a diagnostic tool routinely used by many neurophysiologists. Before, these patients will progress and may need a brain shunt called Ventriculo-peritoneal shunt. He and collaborators now would like to do a double study as this appears to be a cheap and effective alternative treatment and help patients to walk again.

Detailed description: The transcranial monitoring intensity would be equivalent to the well known CLOTBUST study (\<300mw/sq cm)for one hour, using two probes.

All will be treated as an outpatient and there is no form of infusion or interventional treatment.

The rapid magnetic stimulation is at about 50a/us, 15Hz, 1000 pulses with 10 sec pause for ten days along the skull vault. Informed consent will be obtained. 30 patients will be recruited and sham treatment would be just applying probe without power for transcranial and for magnetic stimulation coil will be angled away. Data will be compiled by a separate blinded investigator and so with the statistics. VP shunt failure patients, which is common, will be included. Barthel's daily living index and standard cognitive tests will be used to assess results.

Eligibility criteria: Inclusion Criteria:

* cerebral ischemia with our without hydrocephalus and gait apraxia

Exclusion Criteria:

* all other conditions which contribute to walking difficulty e.g. bad knees; or spondylosis; parkinson's or paralytic strokes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Devathasan Neurology Practice #11-16 MEMC
city: Singapore
country: Singapore
facility: Devathasan Neurology Practice
Study officials:
affiliation: Freelancer Computer Programmer and data control
name: Weng Kiong Aw Yong, Bsc (QUT)
role: STUDY_CHAIR
References:
citation: Devathasan G, Dinesh D. Rapid magnetic stimulation with sonolysis for gait apraxia due to to normal pressure hyprocephalus and cerebral ischemia. International Congress Series xx (2007)xxx-xxx( in press)
Clinical trial NCT04784689: Host Immune Response to Novel RNA COVID-19 Vaccination
Official title: Host Immune Response to Novel RNA COVID-19 Vaccination in Patients With Cancer (CTMS# 21-0012)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Vaccine
Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mays Cancer Center patients eligible to receive the COVID-19 vaccination.

Brief summary: To determine the antibody response level in patients with cancer to the COVID-19 vaccination.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Must be eligible to receive the COVID19 vaccination by standard and current CDC guidelines. This includes all RNA vaccinations grant EUA status by the FDA
3. Diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as DCIS (Ductal Carcinoma in-situ)
4. Able to provide informed consent
5. Patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation.

Exclusion Criteria:

1. Previously documented COVID infection
2. Previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (Those patients on a trial but known to receive a placebo dose are eligible to enroll)
3. Contraindication to the vaccination based on current CDC guideline such as know allergic reactions that increase risk of having an allergic reaction to a COVID RNA vaccination. This includes but is not limited to:

   * Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components
   * Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol \[PEG\])
   * Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)
4. Pregnant or breastfeeding
5. Unable to comply with study related procedures as determined by the study team.

Primary outcomes:
measure: Antibody response level in patients with cancer to the COVID-19 vaccination.
timeFrame: Pre dose on day 1 (baseline), pre dose on day 21, day 35, 6 months, 12 month and 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Mays Cancer Center, UT Health San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Dimpy Shah, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03183089: Comparative Study of Rohto Dry-Aid® and Systane® Ultra in Patients With Dry Eye
Official title: A Randomized, Single-Center, Comparative Study of Rohto Dry-Aid® and Systane® Ultra in the Management of Tear Film Stability and Visual Function in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Dry Eye
Lead sponsor: The Mentholatum Company
Sponsor class: INDUSTRY
First posted: 2017-06-09
Enrollment: 80
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: The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Provide written informed consent
* Have a reported history of dry eye
* Have a history of use of eye drops for dry eye symptoms
* Ocular discomfort
* Conjunctival redness
* Tear film break up time
* Corneal and Conjunctival Staining

Exclusion Criteria:

* Have any clinically significant slit lamp findings at entry visit
* Be diagnosed with an ongoing ocular infection
* Have any planned ocular and/or lid surgeries over the study period
* Have an uncontrolled systemic disease
* Be a woman who is pregnant, nursing or planning a pregnancy
* Be a woman of childbearing potential who is not using an acceptable means of birth control
* Have a known allergy and/or sensitivity to the test article or its components
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Primary outcomes:
measure: Dry Eye Staining
timeFrame: 28 days
measure: Dry Eye Symptom Questionnaire
timeFrame: 28 days
measure: Tear Film Break Up Time
timeFrame: 28 days
measure: Visual Function Assessment
timeFrame: 28 days
Secondary outcomes:
measure: Drop Comfort Assessment
timeFrame: Day 1
measure: Visual Acuity
timeFrame: 28 Days
measure: Slit-Lamp Biomicroscopy
timeFrame: 28 Days
measure: Adverse Event
timeFrame: 28 Days
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail L Torkildsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02523989: The Relationship Between Arsenic Methylation Capability and Blood Metals in Children With Developmental Delays
Official title: The Relationship Between Genetic Polymorphism of Arsenic Methylation Enzymes, Arsenic Methylation Capability and Blood Metals, and Developmental Delays in Preschool Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Delays
Keywords: arsenic
heavy metal
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 137
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with developmental delays and children with normal development

Brief summary: The purpose of this study is to explore the relationship between arsenic methylation and blood metals in children with developmental delays and its correlation with health related quality of life.

Detailed description: The investigators recruited children with developmental delays and children with normal development from Shin-Kong Ho-Su Memorial Hospital as controls. Information obtained from the interview included socioeconomic and basic demographic characteristics as well as children function, health condition, and quality of life. On the other hand, blood and urine samples of the participants were collected for the analysis of arsenic methylation related enzymes using polymerase chain reaction and restriction fragment length polymorphism. 2 ml blood were digested for the determination of mercury, lead and arsenic. The relationship between arsenic methylation and blood metals in children with developmental delays and its correlation with health related quality of were analyzed.

Eligibility criteria: Study group:

Inclusion Criteria:

* children with developmental delays obtained written informed consent from parents

Exclusion Criteria:

* parents refused for participation of their children to the intervention failed to obtain the written informed consent from parents

Control group:

Inclusion Criteria:

* children with normal development obtained written informed consent from parents

Exclusion Criteria:

* parents refused for participation of their children to the intervention failed to obtain the written informed consent from parents

Primary outcomes:
measure: heavy metal assessment
timeFrame: 3 months
Secondary outcomes:
measure: quality of life
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Visiting staff
name: Ru-Lan Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00544089: Chromosomal and Morphological Structure of Mature and Immature Male Germ Cells and Recognition of IL-18 in Testicular Tissue of Azoospermic Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: azoospermia FISH IL-18 TESTICULAR BIOPSY
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-10-16
Enrollment: 25907
Sex: MALE
Minimum age (years): 22
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: To develop a biotechnological assay which will be able to recognize germ cells of the spermatogenic lineand and to identify the chromosomal and morphological structure of mature and immature male germ cells, in cases of of sperm production disorders(azoospermic patients).

To recognize IL-18 in testicular tissue of azoospermic men compared to control group as it has been suggested that this cytokine may serve as a paracrine defense factor in the male gonad associated to spermatogenesis.

Detailed description: A new biotechnological assay was developed by adapting an existing computerized system which scans cell morphology and chromosomal ploidy in the same cell of hematologic line using digital technology, to recognize germ cells of the testis by their morphology and cytogenetics. Testicular tissues which obtained from 15 men were enzymatically digested and the cells received were fixed on slides. The cells were stained by Giemsa May Grinwald staining and scanned automatically in a bright field for cell morphology. Fluorescence in situ hybridization (FISH) using centromeric probes for chromosomes X, Y and 18 was performed on the same slide after destaining. The cells were automatically scanned and classified according to the ploidy of the chromosome signals. The presence of IL-18 in the same men's testis was examined parallelly, by immunohistochimical staining using specific antibody for human IL-18.

Eligibility criteria: Inclusion Criteria:

* Non-obstructive azoospermic patients

Exclusion Criteria:

* Obstructive azoospermia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Infertility unit, Asaf-Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Canter
name: Raphael Ron-el, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04207489: Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer
Official title: Prospective Registry Study of Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Indocyanine Green
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were to undergo indocyanine green fluorescence imaging for laparoscopicradical operation of colorectal cancer.

Brief summary: Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer

Detailed description: To observe the imaging result of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer, and analyze the relevant factors, so as to guide the submucosal injection of preoperative indocyanine green better.

This study is prospective and observational. In order to analyze the related factors that affect the imaging effect, we enrolled patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical resection for colorectal cancer.

Eligibility criteria: Inclusion Criteria:

* Patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical operation of colorectal cancer.

Exclusion Criteria:

* have simultaneously other cancer

  * have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
  * have gastrointestinal surgery
  * Indocyanine green or iodine allergy
  * the period is too late or the tumor is too large to carry on a laparoscopic surgery.

Primary outcomes:
measure: The imaging effect of indocyanine green
timeFrame: During the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Chang chun
country: China
facility: the First Hospital of Jilin University
state: Ji Lin
Study officials:
affiliation: The First Hospital of Jilin University
name: Dong Yang, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04451889: Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients
Official title: Probe-based Confocal Laser Endomicroscopy in Critically Ill COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Sponsor class: OTHER_GOV
First posted: 2020-06-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study is devoted to the comparative analysis of the data received in patients with COVID-19 lung pathology using the method of probe-based confocal laser endomicroscopy of distal airways and two reference methods: high resolution computed tomography and morphology (in some patients).


Eligibility criteria: Inclusion Criteria:

* Patient Informed Consent;
* the diagnosis of COVID-19 or one of the following lung diseases: chronic obstructive pulmonary disease, pneumonia, solitary nodule, pulmonary sarcoidosis, idiopathic interstitial pneumonia, hypersensitivity pneumonitis, pulmonary vasculitis, pulmonary eosinophilia, hemochromatosis, histiocytosis X, pulmonary lymphangioleiomyomatosis; alveolar proteinosis, other rare lung disease
* high resolution computed tomography scans performed not later than one month before pCLE (for non-COVID-19);
* planned or performed histology (for non-COVID-19)
* Severe respiratory failure,

Exclusion Criteria:

* pregnancy or breast feeding,
* lung bleeding,
* any acute or chronic disease that may be a contraindication to bronchoscopy,
* any diseases of hematopoietic system,
* taking part in other clinical trials

Primary outcomes:
measure: Number of COVID-19 Participants With Notable Differences in the pCLE images in comparison with the pCLE images of non-COVID-19 Participants
timeFrame: up to one year
Secondary outcomes:
measure: Number of Participants With the Correspondence of pCLE Images to High Resolution Computer Tomography and Morphologic Data as a Measure of Specificity and Sensitivity of the Method
timeFrame: up to one year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Research Clinical Center FMBA Russia
Study officials:
affiliation: Federal Research Clinical Center FMBA Russia
name: Olesya Danilevskaya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: