louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03849027: MethOxyflUraNe at moderaTe High AltItudes for PAIN Management
Official title: MethOxyflUraNe at moderaTe High AltItudes for PAIN Management: A Randomised, Double-blind, Cross-over Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: altitude
analgesia
methoxyflurane
wilderness medicine
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomised, controlled, cross-over
Primary purpose: TREATMENT

Brief summary: A randomised, double-blind, cross-over study to assess the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting.

Phase IV, randomised, double-blind, cross-over clinical trial to evaluate the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting, in 24 healthy volunteers

Detailed description: Primary outcome: To assess the analgesic efficacy of inhaled methoxyflurane at moderate high altitudes in a wilderness setting.

Secondary outcomes: To assess the comparative safety and adverse events with inhaled methoxyflurane at moderate high altitudes in a wilderness setting.

Eligibility criteria: Inclusion Criteria:

1. Male or female between 18 and 65 years of age (inclusive).
2. Able to provide informed consent and comply with study-related procedures

Exclusion Criteria:

1. History of diabetes
2. Renal or hepatic disease or impairment (defined as a value exceeding the maximum reference range)
3. Chronic or nociplastic pain
4. Chronic fatigue syndrome
5. Chronic/regular use of analgesic medications
6. Personal or familial history of malignant hyperthermia
7. Personal or familial history of anaesthesia-induced rhabdomyolysis
8. Personal history of anaesthesia volatile-induced hepatitis or drug induced liver injury
9. Recent volatile anaesthesia (within 6 months)
10. History of significant altitude-related illness
11. Significant underlying medical condition which precludes gentle exercise at moderate high altitude (\<2500 m ASL) as determined by the investigators
12. Hypersensitivity to Penthrox/Penthrop®, methoxyflurane or any fluorinated anaesthetic.
13. Concurrent treatment with CYP 2A6 or CYP 2E1 enzyme inducers (such as: phenobarbital, rifampicin, alcohol or isoniazid)
14. Pregnancy

Primary outcomes:
measure: Analgesic effect
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Safety and adverse events
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town Department of Anaesthesia & Perioperative Medicine
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Ross Hofmeyr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06484127: Heterogeneity of Tertiary Lymphoid Structures Predicts Distinct Malignancy and Immune Microenvironment in Prostate Cancer: a Retrospective Cohort Study
Official title: Heterogeneity of Tertiary Lymphoid Structures Predicts Distinct Malignancy and Immune Microenvironment in Prostate Cancer: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients diagnosed with prostate cancer who underwent radical prostatectomy or prostate puncture

Brief summary: The aim of this study was to reveal the predictive value of spatial heterogeneity and maturity difference of tertiary lymphoid structure in pathological sections of prostate cancer patients for clinical features and prognosis. It provides a new idea for the selection of prostate cancer immunotherapy population in the future.


Eligibility criteria: Inclusion Criteria:

1.patients diagnosed with prostate cancer who underwent radical prostatectomy or prostate puncture

Exclusion Criteria:

1. incomplete medical records, inadequate follow-up information, and confirmed non-prostatic acinar adenocarcinoma.

Primary outcomes:
measure: Correlation between the detection of TLS(tertiary lymphoid structure) and clinical features
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT01117727: Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology
Official title: Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2010-05-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research is to develop tools to help people who are paralyzed. These tools are called brain-computer interfaces (BCIs). BCIs would allow a person to use brain signals to operate technology. Specifically this project's goal is to design a BCI to operate a switch.

Detailed description: The investigators want to make a BCI that can be used to operate commercially available technologies for communication, environmental control or computer access. The BCI would replace a switch to let people operate these technologies without moving. However, investigators need people to test the BCI so they can determine how effective it is in replacing a switch.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Able to read text on a computer screen
* Able to understand and remember instructions concerning participation

Exclusion Criteria:

* Unable to give informed consent
* Unable to understand and follow instructions
* Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings
* Known to have photosensitive epilepsy
* Open head lesions or sores

Primary outcomes:
measure: Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning
timeFrame: 8 sessions over 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Direct Brain Interface Project
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jane Huggins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03985527: Janus Feasibility Study
Official title: Transvenous Nerve Stimulation Study (Janus Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea Syndromes
Lead sponsor: Respicardia, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an acute, prospective, non-randomized, single arm IDE feasibility study.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years old
* Subject with moderate to severe central sleep apnea is undergoing a de novo commercial remedē® System implant procedure or other de novo transvenous cardiac implantable device procedure including a pacemaker or an implantable cardiac defibrillator
* Subject is willing and able to give informed consent

Exclusion Criteria:

* Subject is unable or unwilling to participate with study procedures or in the investigator's opinion is medically unstable for the procedure (Medically unstable is defined as when a patient is expected to have worsening health status if additional procedure time is needed)
* Subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the implant)
* Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator
* Subject has body mass index (BMI) \> 40 kg/m2 at the time of implant
* Subject has had prior neck surgery
* Previous or currently implanted upper airway stimulation device
* Subject has had prior oral cavity surgery that may interfere with breathing
* Subject has significant upper airway-related anatomic anomaly
* Subject is enrolled in concurrent study that may confound the results of this study
* Subject is taking muscle relaxant medication unless approved by the site implanter and ZOLL Respicardia clinical staff
* Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue

Primary outcomes:
measure: Changes in respiration and airway physiology
timeFrame: During procedure (immediately post-stimulation)
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Bryn Mawr
country: United States
facility: Bryn Mawr Medical Specialists Association
state: Pennsylvania
Study officials:
affiliation: Respicardia, Inc.
name: Kathy A McPherson, RN, MSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT01029327: Effects of Curcumin on Postprandial Blood Glucose, and Insulin in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2009-12-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects recruited from the population in southern Sweden.

Brief summary: Previous animal studies have shown that extracts of Curcumin lowers blood glucose.

Detailed description: To study the effect of curcumin on postprandial blood glucose and plasma concentrations of insulin in fifteen healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Fifteen healthy subjects without symptoms or a history of gastrointestinal disease, abdominal surgery or diabetes mellitus, were included in this crossover study.

Exclusion Criteria:

* Connective tissue disease or cerebrovascular or endocrine disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Medicine, Malmö University Hospital
Study officials:
References:
citation: Wickenberg J, Ingemansson SL, Hlebowicz J. Effects of Curcuma longa (turmeric) on postprandial plasma glucose and insulin in healthy subjects. Nutr J. 2010 Oct 12;9:43. doi: 10.1186/1475-2891-9-43.
Clinical trial NCT06789627: Oral Health Related Quality of Life in Cad Metallic and Poly Ether Ether Ketone (Peek) Partial Denture Frameworks in Mandibular Kennedy Class I Cases
Official title: Indirect CAD/CAM Removable Partial Denture Frameworks: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Oral Health-Related Quality of Life
Keywords: CAD/CAM
Digital metallic RPD
patient centered outcomes
3D printing
PEEK
OHIP-14
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare CAD Poly ether ether ketone (PEEK) RPD to CAD metallic RPD in treating partial edentulism in terms of Oral health related quality of life


Eligibility criteria: Inclusion Criteria:

* Patients with bilateral free end saddles in the mandible (Kennedy class I) with the last standing abutment second premolar
* Opposing dentition is fully intact or restored to be intact
* Adequate inter-arch space of at least 7mm
* Angle's class I maxilla-mandibular relationship
* Patients with no periodontal disease and good oral hygiene
* Cooperative patients showing motivation to follow-up

Exclusion Criteria:

* Periodontal affection of the abutment teeth
* Skeletal mal-relationship
* Unmotivated patients to maintain adequate oral hygiene and to follow up---- ---- Patients with neuro-mascular disorders
* Systemic disease affecting periodontal health like uncontrolled diabetes

Primary outcomes:
measure: Oral Health Related Quality of Life (OHRQoL)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo University
state: Giza
Study officials:
References:
Clinical trial NCT03773627: MRI Maker of Perioperative Neurocognitive Disorder
Official title: MRI Marker of Postoperative Delirium and Delayed Neurocognitive Recovery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrosis of Femoral Head
Knee Osteoarthritis
Fracture of Lower Limb
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients elder than 60 years old elective to undergo lower limb surgery and conform to the including criteria would be recruited.

Brief summary: Periperative neurocognitive disorder(PND) is consistently associated with increased morbidity and mortality, but its mechanisms remain unclear. Moreover, valid biomarkers for the prediction or diagnosis of the development of delayed neurocognitive recovery in aged patients have not been identified so far. The purpose of this study is trying to find the functional MRI marker of PND.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years
* Spoke proficient Chinese
* Selected to lower limb osteopathic surgery
* Informed consent signed by the patient
* Underwent general anesthesia

Exclusion Criteria:

* Existing cerebral disease, or have a history of neurological and psychiatric diseases including AD, stroke, and psychosis
* Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
* Several audition or vision disorder
* With standard contraindications to MRI examinations
* Unwillingness to comply with the protocol or procedures.

Primary outcomes:
measure: MRI markers of PND before 7th day after surgery
timeFrame: From the day before surgery to the 7th day after surgery
Secondary outcomes:
measure: MRI markers of PND before 12 month after surgery
timeFrame: From the 7th day after surgery to 12 month after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
name: qi lu, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05947773: Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients
Official title: Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Keywords: robotic
stroke
rehabilitation
Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 45
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are conducting a three-group comparative study on stroke patients. The treatment is started in a subacute state and completed in the hospital. The essence of robot-assisted treatments is faster recovery and better learning to walk. The group will do a special walking exercise with a robot. The walking group does the same training, only without robotic assistance. The control group will receive physiotherapy treatments financed by the state. Control examination after 3 weeks.


Eligibility criteria: Inclusion Criteria:

post stroke 6MWT : 120\> minimum after stroke 3 days be a stroke patient first stroke hemiplegia

Exclusion Criteria:

multiple strokes, inability to stand and walk, cognitive function disorder does not reach 50 meters with a minimal walking aid Alcohol Sever heart problem sever demeanor alcoholism drug problems Drug

Primary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 3 weeks (0-5 score, high score better)
Secondary outcomes:
measure: Barthel Index for Activities of Daily Living (ADL)
timeFrame: 3 weeks
measure: Berg Balance Scale
timeFrame: 3 weeks (0-30, high score better)
measure: 10-m maximal walking speed
timeFrame: 3 weeks
measure: 6MWT
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Kaposvár
country: Hungary
facility: Dr. Tollár József
state: Somogy
Study officials:
References:
Clinical trial NCT04257773: International REACH Forgiveness Intervention
Official title: International REACH Forgiveness Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness
Lead sponsor: City University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Stanford University
First posted: 2020-02-06
Enrollment: 4598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Six sites spanning five regions (Hong Kong, Colombia, Indonesia, Ukraine, South Africa) will administer a forgiveness workbook intervention in a randomized design with a stepped, waitlist intervention deployment.

Detailed description: Intervention deployment:

ODO1 X O2 O3 (immediate-treatment \[IT \] group) ODO1 O2 X O3 (delayed-treatment \[DT \] group)

where OD denotes measurement of baseline demographic and personality measures, X denotes deployment of the intervention, and O1, O2, and O3 denote measurements of outcomes.

Eligibility criteria: Inclusion Criteria:

* Must be able to read and comprehend the materials in the workbook
* Must be 18 years old or above
* Have someone in mind they want to forgive

Exclusion Criteria:

* No

Primary outcomes:
measure: Depression (BSI)
timeFrame: 4 months
measure: Anxiety (BSI)
timeFrame: 4 months
measure: Forgiveness (TRIM)
timeFrame: 4 months
Secondary outcomes:
measure: Trait Forgiveness (TSF)
timeFrame: 4 months
measure: Forbearance (FS)
timeFrame: 4 months
measure: Decision to Forgive (DTSF)
timeFrame: 4 months
measure: Flourishing
timeFrame: 4 months
Other outcomes:
Locations:
city: Cordoba
country: Colombia
facility: Universidad del Sinú
city: Depok
country: Indonesia
facility: Universitas Gunadarma
city: Pretoria
country: South Africa
facility: The South African and Africa Chapter of the International Association of Assessing Officers
city: Kyiv
country: Ukraine
facility: Realis Center for Education and Research
city: Kyiv
country: Ukraine
facility: Ukrainian Institute of Arts and Sciences
Study officials:
affiliation: City University of Hong Kong
name: Man Yee Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00710073: Sono-Electro-Magnetic Therapy for Refractory Chronic Pelvic Pain Syndrome
Official title: Sono-Electro-Magnetic Therapy for the Treatment of Chronic Pelvic Pain Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Keywords: Chronic pelvic pain syndrome
Neuromodulation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-07-03
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail.

We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men.


Eligibility criteria: Inclusion Criteria:

* CPSS III
* symptomatic \>3 months
* NIH-CPSI total score =/\>15
* NIH-CPSI pain =/\>8

Exclusion Criteria:

* post void residual \>100mL
* urinary tract infection
* urethral stricture
* age \<18 years

Primary outcomes:
measure: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
timeFrame: before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment
Secondary outcomes:
measure: Pain visual analogue scale
timeFrame: before treatment, after 6 weeks of treatment, if effective also after 12 weeks of treatment
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Urology, Bern University Hospital
Study officials:
affiliation: Department of Urology, University of Bern, 3010 Switzerland
name: Thomas M Kessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03144973: Periodontitis and Upper gi Post-operative Complications
Official title: Meaning of Periodontitis in Post-operative Complications After Upper Gastrointestinal Tract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Surgery--Complications
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All the patients that have upper-gi surgery in our time frame are asked to join in the study
Primary purpose: PREVENTION

Brief summary: Periodontitis is a infection of mouth gingival mucosa and connecting tissue. It has been shown in previous studies to have a effect on the risk of heart diseases getting worse and elevate risk in heart surgery. The investigators are studying periodontitis and how it affects upper gastrointestinal tract patients complication rates and the quality of complications.

Detailed description: Before patricipating patients go to preop, the investigators have them take a mouth rinsing quick-test, periosafe(c), that tells specifically about periodontitis. Participants go to surgery (upper gi) and have a normal operation following our clinics standards and normal follow up. After the investigators analyze the patient data concerning possible complications and do they have relations between the positive periodontitis results. Participants are also given advice about seeing a dentist if positive results are seen, but the operating surgeons do not get to know the mouth rinsing test results.

Eligibility criteria: Inclusion Criteria:

* Need for a upper gi surgery

Exclusion Criteria:

-

Primary outcomes:
measure: meaning of periodontitis in post operative complications
timeFrame: 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki university hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Hanna Seppänen, Phd, Dos
role: PRINCIPAL_INVESTIGATOR
References: