louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05235984: Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors
Official title: Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Sleep Disorder
Keywords: apnea
apnoea
sleep
Lead sponsor: Firstbeat Technologies Oy
Sponsor class: INDUSTRY
Collaborators: name: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
First posted: 2022-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group will be recruited from occupational health care patients who have been earlier admitted by Mehiläinen for a PG study at KNF-laboratoriot.

Brief summary: In this study the feasibility of detecting sleep apnoeas with unobtrusive wearable sensors and sounds recorded with a smartphone is studied by making an overnight recording to patients with high probability of sleep apnoeas. The data acquired with the aforementioned devices is: ECG, acceleration, bioimpedance of thorax and processed and raw audio. In data analysis phase it will be studied which combinations of these signals would enable detecting sleep apnoeas with high enough sensitivity and specificity when compared to a night polygraphy reference (Nox T3 device using airflow, breathing movements, audio, position, movement, oxygen saturation, pulse and leg EMG).


Eligibility criteria: Inclusion Criteria:

* High a priori probability for SA based on previous PG findings, BMI, and ESS and medical history
* Clinical reason i.e. potential benefit of repeating the PG due to e.g. technical challenges in the previous PG and/or unclear findings or diagnosis. Participation may be offered also in cases where first PG is diagnostic. In these cases accuracy of sleep apnoea grading will be improved.
* Adequate Finnish language skills to comprehend study-related instructions and questionnaires. The study materials are available only in Finnish.
* Signed written informed consent

Exclusion Criteria:

* Medical history of a major cardiovascular event (myocardial infarction, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), stroke, or transient ischemic attack) within the previous 6 months
* Use of cardiac pacemaker or history of atrial fibrillation

Primary outcomes:
measure: The sensitivity and specificity of apnoea detection using the Screenbeat technology
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: KNF-Laboratoriot Oy
state: Southern Finland
Study officials:
affiliation: Neurophysiologist at HUS (Hospital district of Helsinki and Uusimaa) and at KNF-Laboratoriot Oy
name: Juha K Heiskala, LM, DSc
role: STUDY_DIRECTOR
affiliation: CTO at Firstbeat Technologies and Associate Professor at Tampere University
name: Ilkka Korhonen, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02141984: Surveillance of Humira in Korean JIA Patients
Official title: Post-Marketing Surveillance of Humira Injection in Korean JIA Patients Under the New-Drug Re-examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyarticular Juvenile Idiopathic Arthritis
Keywords: Korean regulatory required Postmarketing Surveillance
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 28
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General hospital

Brief summary: Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, underlying diseases and complications especially in regard to purified protein derivative (PPD) skin test, and chest X-ray. At routine visits for Humira Injection administration, which will occur according to usual medical practice, concomitant medication information and adverse events information will be collected for up to 70 days after the last administration of Humira.


Eligibility criteria: Inclusion Criteria:

* Patients from 2 years of age who were diagnosed with polyarticular juvenile idiopathic arthritis (JIA) or patients from 6 years of age who were diagnosed with enthesitis-related arthritis (ERA).
* Polyarticular juvenile idiopathic arthritis (JIA) patients for whom the response to previous disease-modifying anti rheumatic drug therapy has been inadequate
* Patients who give written authorization form to use their personal and health data from legal parents or representative.
* Physician will refer to the product market authorization (label) for inclusion criteria.

Exclusion Criteria:

* Patients with known hypersensitivity to Humira or any of its excipients.
* Patients who is participating on other clinical trials.
* Physician will refer to the product market authorization (label) for exclusion criteria.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)
Secondary outcomes:
measure: Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment
timeFrame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
measure: Physician's Global Assessment of the Disease
timeFrame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
measure: Parent's Global Assessment for Effectiveness
timeFrame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie korea
name: Eunjung Gu, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01928784: Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study
Official title: Radial Extracorporeal Shock Wave Therapy on Chronic Low Back Pain: a Prospective Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
extracorporeal shock wave therapy
Trigger Points
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2013-08-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective study is to explore the pain-alleviating effect of low-energy extracorporeal shock wave therapy(ESWT) in patients with chronic low back pain.

Detailed description: 26 patients who suffered from persistent symptoms for more than 3 months are going to be treated with DOLORCLAST radial extracorporeal shock wave(EMS, Swiss). Patients are assigned to two groups according to the exist of specific pain spot. Group I(have specific pain spot) received a total of 2000 impulses of 2.5 Bar; group II(controls, no specific pain spot) 4000 impulses of 2.5 Bar. Patients is going to be treated once. The efficacy of therapy is going to be evaluated by VAS scale before and after the treatment.

Eligibility criteria: Inclusion Criteria:

* Symptom of low back pain during last 4 weeks
* Low back pain history for more than 3 months

Exclusion Criteria:

* Have lower limbs radiating pain beyond knee joints
* Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases
* Spinal surgical history
* Severe heart, lung, liver, kidney disease or high blood pressure
* With cardiac pacemaker
* Coagulopathy or thrombosis
* Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months
* Mental illnesses or none cooperation
* Pregnancy

Primary outcomes:
measure: Change in Visual analogue scale scores(VAS) of patients before and after therapy
timeFrame: baseline, 1 hour after therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
Study officials:
affiliation: Beijing Jishuitan Hospital
name: Yajun Liu, MD
role: STUDY_DIRECTOR
affiliation: Beijing Jishuitan Hospital
name: Yan An, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
citation: Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010 Jun;10(6):514-29. doi: 10.1016/j.spinee.2010.03.032.
Clinical trial NCT06573502: Platelet Rich Plasma Combined with Platelet Rich Fibrin in Management of Temporomandibular Joint Osteoarthritis
Official title: Assessment of Platelet Rich Plasma with Injectable Platelet Rich Fibrin VS Platelet Rich Plasma Vs Platelet Rich Fibrin in Management of Temporomandibular Joint Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studying effectiveness of prp with prf comparing with prp or prf for mangement of tmj osteoarthritis as result in pain and mandibular movement in adult pt

Detailed description: 45 pt assigned for the study , divided in to three gruops to comparing new combination of prp with prf in management of TMJ OA

Eligibility criteria: Inclusion Criteria:

Adult pt with OA

Exclusion Criteria:

Medicaly compromised

Primary outcomes:
measure: Pain severty
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Hassan Ab Ghany, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04725279: Usefulness of Rehabilitation in Patients With Cervical Imbalance
Official title: Usefulness of Rehabilitation in Patients With Cervical Imbalance. Use of Stabilometric Platform and Motion Sensors. (Provisional Title)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Cervical Vertigo
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Using the data obtained in a study carried out at the Hospital of Alcañiz (Teruel, Spain) between February and July 2019, with a stabilometric platform and with movement sensors, the investigators want to demonstrate that the rehabilitation works in those patients with vertigo or dizziness of cervical origin. For this, the data obtained from that sample, which was of 67 patients, will be analyzed in a pre-post rehabilitation treatment study, objectifying whether the patients improved or not, both in terms of imbalance and cervical pain, if any.

Detailed description: Using the data obtained in a study carried out at the Hospital of Alcañiz (Teruel, Spain) between February and July 2019, with a stabilometric platform and with movement sensors, the investigators want to demonstrate that the rehabilitation works in those patients with vertigo or dizziness of cervical origin. For this, the data obtained from that sample, which was of 67 patients, will be analyzed in a pre-post rehabilitation treatment study, objectifying whether the patients improved or not, both in terms of imbalance and cervical pain, if any. The 67 patients attended the rehabilitation consultation where, after taking the anamnesis, they began to perform balance tests with a stabilometric platform and those patients with associated neck pain, with cervical motion sensors. Treatment with conventional physiotherapy, electrotherapy or exercises at home was prescribed as appropriate to each one. 3 months later, the patients were examined again in consultation, using a new anamnesis, the platform and the sensors. With the data obtained in said field work, carried out in 2019, the present study aims to analyze the usefulness of rehabilitation treatment in vertigo.

Eligibility criteria: Inclusion Criteria:

* Present vertigo of vestibular, neurological or cervical cause.
* The last episode of vertigo occurred less than a year ago.

Exclusion Criteria:

* Present acute musculoskeletal pathology in the lower limbs or lumbar spine.
* Present some lower limb amputation.
* Present unresolved visual pathology.
* Being active with anticancer treatment.

Primary outcomes:
measure: Number of patients who improve, worsen or do not present changes after rehabilitation treatment
timeFrame: 3 months passed between the first evaluation and the second.
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Facultad de Ciencias de la Salud
Study officials:
References:
Clinical trial NCT00184184: Registration of Tobacco, Coffee and Substance Use Among Acutely Admitted Psychiatric Patients
Official title: Registration of Tobacco, Coffee and Substance Use Among Acutely Admitted Psychiatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Abuse
Tobacco Use Disorder
Keywords: Emergency Services, Psychiatric
Tobacco use cessation
Coffee use cessation
substance use detection
Substance Abuse Detection
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-09-16
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: This is a study of the registration of tobacco, coffee and substance abuse among acutely admitted psychiatric patients.

Detailed description: We will include all patients acutely admitted to Østmarka Psychiatric Hospital to register this population's use of coffee, tobacco and substances. We will determine whether this differs from other populations, between diagnoses, age, etc.

We will also compare results of substance in immunologic rapid urine tests taken by the nurse at the hospital with substance in urine tested in laboratory with LC/MS (liquid chromatography/mass spectrometry).

Eligibility criteria: Inclusion Criteria:

* All patients acutely admitted to Østmarka Psychiatric Hospital

Exclusion Criteria:

* Dementia
* Serious brain damage

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Østmarka Psychiatric Department, St. Olavs Hospital, University Hospital of Trondheim
Study officials:
affiliation: Norwegian ministry of Education and Research
name: Gunnar Morken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bagoien G, Morken G, Zahlsen K, Aamo T, Spigset O. Evaluation of a urine on-site drugs of abuse screening test in patients admitted to a psychiatric emergency unit. J Clin Psychopharmacol. 2009 Jun;29(3):248-54. doi: 10.1097/JCP.0b013e3181a45e78.
Clinical trial NCT06149884: Micrometastases in Axillary Lymph Nodes in Breast Cancer, Post-neoadjuvant Chemotherapy
Official title: Micrometastases in Axillary Lymph Nodes in Breast Cancer, Post-neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Micrometastases
Neoadjuvant Chemotherapy
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 978
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We conducted a retrospective review of primary breast cancer patients from the breast cancer registries of Gangnam Severance Hospital and Severance Hospital, who underwent surgery following NAC between September 2006 and February 2018. These patients were clinically diagnosed with stage II or III breast cancer and underwent ALND, with or without SLNB. The surgical approach, encompassing either total mastectomy or breast-conserving surgery, was dictated by the number and size of the tumors present. Exclusion criteria comprised of patients who had initial surgery, underwent only SLNB, or presented with de novo stage IV disease.

Brief summary: This study aims to investigate the significance of minimal residual axillary disease following NAC, with a particular focus on micrometastases (ypNmi), in comparison to pathologic lymph node-negative (ypN0) or macrometastases (ypN+). The investigators will further explore the prognostic implications of SLNmi for the prediction of axillary LN status and survival outcomes.

Detailed description: This study aims to investigate the significance of minimal residual axillary disease following NAC, with a particular focus on micrometastases (ypNmi), in comparison to pathologic lymph node-negative (ypN0) or macrometastases (ypN+). The investigators will further explore the prognostic implications of SLNmi for the prediction of axillary LN status and survival outcomes.

Eligibility criteria: Inclusion Criteria:

* Stage II or III primary breast cancer patients
* Patients who performed neoadjuvant chemotherpay
* Patients who underwent axillary lymph node dissection with or without sentinel lymph node biopsy

Exclusion Criteria:

* Patients who performed upfront surgery
* De novo stage IV patients

Primary outcomes:
measure: Recurrence-free survival
timeFrame: the interval from breast cancer diagnosis to the initial recurrence or death upto 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06924684: High-Dose Rosuvastatin Preloading for Enhanced Outcomes in STEMI Patients Undergoing Primary PCI
Official title: Efficacy Of High-Dose Rosuvastatin Preloading Before Primary Percutaneous Coronary Intervention In Patients Suffering From St-Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: ST Elevation (STEMI) Myocardial Infarction
Lead sponsor: Sheikh Zayed Federal Postgraduate Medical Institute
Sponsor class: OTHER
Collaborators: name: Punjab Institute of Cardology
First posted: 2025-04-11
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of high dose rosuvastatin preloading vs placebo before primary PCI in terms of MACE at 30 days


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years Patients undergoing primary angiography

Exclusion Criteria:

* Hemodynamically unstable patients. History or clinical evidence of any co-morbidities. Taking any medications regularly even statins.

Primary outcomes:
measure: Incidence of MACE
timeFrame: 30 days
measure: In-Hospital mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaikh Zayed Hsopital
city: Lahore
country: Pakistan
facility: Punjab Institute of Cardiology
Study officials:
affiliation: Shaikh Zayed Hospital
name: Sohaib Ashraf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03685084: Investigation of AAI101 Safety, Tolerability & PK in Healthy Volunteers
Official title: Phase I, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of AAI101 Administered Intravenously Alone or in Combination With Piperacillin or Cefepime to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Allecra
Sponsor class: INDUSTRY
First posted: 2018-09-26
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: * To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 (SAD \& MAD) in healthy male subjects.
* To assess the safety and tolerability of single and multiple ascending intravenous doses of AAI101 in combination with fixed intravenous doses of piperacillin or cefepime in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Male healthy volunteers aged between 18 and 45 years (inclusive) at screening.
* Body mass index (BMI) of 18.0 to 30.0 Kg/m2 (inclusive) at screening.
* Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings (all results were to be within normal range or considered non-clinically significant by the investigator).
* Non-smoker or smoker of fewer than 10 cigarettes per day as determined by medical history. Had to be able to abstain from smoking during the inpatient stay.
* Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.

Main Exclusion Criteria:

* Any significant cardiovascular (e.g., hypertension), hepatic, renal, respiratory (e.g., childhood asthma), gastrointestinal, endocrine (e.g., diabetes, dyslipidemia), immunologic, hematological, neurologic, or psychiatric disease.
* Acute disease state (e.g., nausea, vomiting, fever, diarrhea) within 7 days before study Day 1.

Primary outcomes:
measure: Safety Profile - Number of Subjects With at Least one Adverse Event
timeFrame: Throughout the period that subjects receive study drug up to 5 days following discontinuation of study treatment
Secondary outcomes:
measure: AAI101 maximum plasma concentration (Cmax)
timeFrame: Up to 24 hours post-dose
measure: AAI101 Clast
timeFrame: Up to 24 hours post-dose
measure: AAI101 AUC(0-t) - AUC(0-8)
timeFrame: Up to 24 hours post-dose
measure: AAI101 half life (t1/2)
timeFrame: Up to 24 hours post-dose
Other outcomes:
Locations:
Study officials:
References: