louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03012425: Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
Official title: Pilot Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Related Distress Among Cancer Caregivers
Keywords: Cognitive Behavioral Therapy
Acupuncture
17-001
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Hunter College of City University of New York
First posted: 2017-01-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The other aim of this study is to determine which of those two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of cancer patients.


Eligibility criteria: Inclusion Criteria:

* As per self report, age 18 and older
* As per self report, identifying as an informal caregiver to MSKCC patients of any site or stage of cancer
* Score greater than 7 on the Insomnia Severity Index and meet the criteria for Insomnia Disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5) (56) as assessed by the Insomnia Interview Schedule
* In the judgment of the investigators and/or consenting professional, able to read and comprehend English
* In the judgment of the consenting professional cognitively able to provide informed consent

Exclusion Criteria:

* As per self report, participant has another sleep disorder provided that it is not adequately treated (e.g., sleep apnea without CPAP treatment)
* As per self report, participant has major depressive disorder, alcohol or drug dependence and
* As per self report, heavy drinker (regularly having more than 14 alcoholic beverages per week)
* As per self report, engaging in night shift work
* To not obscure cortisol assessment, regular smokers per self report (daily use) will be excluded.
* As per self report significant needle phobia as to prevent participation in acupuncture

Primary outcomes:
measure: number of participants who complete the assessments
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: New York
country: United States
facility: Hunter College
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Allison Applebaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04845425: Analysis of miRNA Expression in Endometrial Cancer
Official title: Identification of miRNAs in Endometrial Cancer as Novel Diagnostic and Prognostic Biomarkers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Keywords: endometrial cancer
miRNA
microRNA
TGCA
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with endometrial cancer

Brief summary: The TCGA project identified four distinct prognostic groups of endometrial carcinoma (EC) based on molecular alterations: (i) the ultramutated subtype that encompasses POLE mutated (POLE) cases; (ii) the hypermutated subtype, characterized by MisMatch Repair deficiency (MMRd); (iii) the copy-number high subtype, with p53 abnormal/mutated features (p53abn); (iv) the copy-number low subtype, known as No Specific Molecular Profile (NSMP). Although the prognostic value of TCGA molecular classification, NSMP carcinomas present a wide variability in molecular alterations and biological aggressiveness. Given that the study aims to evaluate the miRNA expression profile to identify novel potential biomarkers to better stratify the EC patients, taking into account the molecular status


Eligibility criteria: Inclusion Criteria:

* age\>18yo
* histological diagnosis of endometrial cancer
* tumor resection
* patient's informed consent

Exclusion Criteria:

* patients with other neoplasia within the last 5 years

Primary outcomes:
measure: Evaluation of miRNA expression based on the 4 molecular groups
timeFrame: 1 year
Secondary outcomes:
measure: Integration of molecular results with clinico-pathological data
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS- Azienda Ospedaliera-Universitaria di Bologna
state: Bo
Study officials:
affiliation: IRCCS Azienda Ospedaliera-Universitaria di Bologna
name: Anna Myriam Perrone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03133325: A Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine
Official title: A Randomized, Split Arm Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety
Keywords: Hyaluronic Acid, Lidocaine
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-04-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine.

There is a 12-week follow-up period. AEs will be recorded throughout the study.


Eligibility criteria: Inclusion Criteria:

* Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
* Signed and dated informed consent to participate in the study, including photo consent
* Men or non-pregnant, non-breast feeding women aged 18 years or older

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable HA gel
* Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
* Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
* Participation in any other clinical study within 30 days before treatment

Primary outcomes:
measure: The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: CTC
Study officials:
References:
Clinical trial NCT06317025: Design and Development of Multi-modal Intelligent Anesthesia Monitoring System
Official title: Design and Development of Multi-modal Intelligent Anesthesia Monitoring System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anesthesia
Keywords: Anesthesia monitoring
Near infrared reflectance spectroscopy（NIRS）
electroencephalogram（EEG）
multimodal
Age dependent
Machine learning
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 330
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing non-cardiac surgery under general anesthesia in Beijing Chaoyang Hospital, Capital Medical University

Brief summary: This project integrates the characteristics of electroencephalo-graph（EEG）, cerebral oxygen, blood pressure, heart rate, etc., based on nonlinear theory and neural oscillation, large sample data and machine learning theory, to develop a multi-modal monitoring system suitable for domestic patients, taking into account changes in sedation, analgesia, cerebral hemodynamics and other factors, regardless of patient age and type of general anesthesia drugs.


Eligibility criteria: Inclusion Criteria:

1. Age: 0-65 years old
2. ASA: Level I-III
3. Patients undergoing non cardiac surgery under general anesthesia
4. Informed consent of the patient or legal representative

Exclusion Criteria:

1. Previous history of severe neurological disorders
2. History of mental illness and related medication use
3. Individuals who are unable to cooperate in completing cognitive function tests
4. Severe hearing or visual impairment
5. Preoperative delirium in patients
6. Individuals who have experienced severe adverse reactions such as cardiac arrest and cardiopulmonary resuscitation during surgery
7. Those who require neurosurgery, head and facial surgery
8. Individuals who are allergic to EEG and fNIRS electrodes

Primary outcomes:
measure: the depth of anesthesia (too deep or too shallow)
timeFrame: During general anesthesia
Secondary outcomes:
measure: EEG characteristics of loss of consciousness induced by different general anesthesia drugs
timeFrame: During general anesthesia
measure: Characteristics of perioperative neurovascular coupling
timeFrame: Perioperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04243525: Inflammatory Bowel Disease (IBD) Research Registry
Official title: University of Pittsburgh Medical Center (UPMC) Center for Inflammatory Bowel Disease (IBD) Research Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients-subjects (age 18-100 years old) who are receiving or seeking medical care at the Center for Inflammatory Bowel Diseases Clinic at UPMC

Brief summary: Patients seen at the Center for Inflammatory Bowel Disease will be asked to provide their written informed consent (authorization) to allow their identifiable medical record information related to their Inflammatory Bowel Disease to be placed in Center's Research Registry for the purpose of facilitating retrospective research studies directed at Inflammatory Bowel Disease, and the identification and recruitment of potential, eligible subjects for participation in future research studies involving Inflammatory Bowel Disease.

Information obtained from the Inflammatory Bowel Disease Registry will allow a better classification of disease and factors that influence the natural course of disease; which may lead to a better understanding of the pathogenesis of IBD and may permit the development of better therapies and the potential for preventive therapies.


Eligibility criteria: Inclusion Criteria:

All patients age 18 and above seeking medical care at the Center for Inflammatory Bowel Diseases Clinic at UPMC

Exclusion Criteria:

N/A

Primary outcomes:
measure: Number of patients with IBD
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David Binion, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06354725: Effect of Weekly Plyometric Training Frequency on Youth Female Basketball Players: A Comparison of Two vs. Four Sessions
Official title: Effect of Weekly Plyometric Training Frequency on Youth Female Basketball Players: A Comparison of Two vs. Four Sessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Performance
Keywords: physical performance
strength and conditioning
jumps
in-season
Lead sponsor: University of Évora
Sponsor class: OTHER
Collaborators: name: Vytautas Magnus University
First posted: 2024-04-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Players were randomly assigned to a two-times-a-week (2PLYO, n = 15) or four-times-a-week (4PLYO, n = 15) PT (Plyometric Training) group. Both groups performed the same weekly total volume of jumps during PT in addition to regular basketball training and competition. The 2PLYO group performed 240 jumps over two sessions (120 jumps per session), and the 4PLYO group performed 240 jumps over four sessions (60 jumps per session). After the eight-week intervention, all players underwent a one-week detraining period with no PT training while basketball training and competitions continued. Testing was performed at baseline (pre-test), after intervention (post-test), and after the detraining period. Players were assessed for lower body power using jump tests (countermovement jump \[CMJ\], drop-jump \[DJ\] from a 20-cm box, and horizontal jump \[HJ\]; change of direction ability using a planned agility test; and speed using a 20-m sprint and a 5-m split.


Eligibility criteria: Inclusion Criteria:

* Minimum of four basketball training sessions with at least 90-min duration and one competitive game per week.

Exclusion Criteria:

* Musculoskeletal, neurological, or orthopedic injury that may impair their participation.

Primary outcomes:
measure: Horizontal jump
timeFrame: 10 weeks
Secondary outcomes:
measure: CMJ
timeFrame: 10 weeks
Other outcomes:
measure: Drop Jump
timeFrame: 10 weeks
measure: Drop jump (RSI)
timeFrame: 10 weeks
measure: Linear sprint-5m
timeFrame: 10 weeks
measure: Linear sprint-20m
timeFrame: 10 weeks
measure: Change of direction
timeFrame: 10 weeks
Locations:
city: Kaunas
country: Lithuania
facility: Vytutas Magnus University
Study officials:
References:
Clinical trial NCT06051825: Diagnostic Importance of the C-reactive Protein From Blood and Saliva in Children With Acute Appendicitis
Official title: Diagnostic Importance of the Circulating C-reactive Protein in Blood and Saliva in Acute Appendicitis in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Appendicitis
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 5 to 17 years of age, presenting with acute abdominal pain consistent with diagnosis of acute appendicitis, to Emergency Surgery Department at the University Hospital Split

Brief summary: Diagnosing acute appendicitis in children is still a challenge even for experienced clinicians. Failure to recognize this acute condition can result in perforation, with consequent peritonitis, or misdiagnosis can result in negative appendectomies. C-reactive protein in blood can be elavated in children with acute appendicitis. The aim of this research is to compare the diagnostic value of C-reactive protein from the blood and saliva of children with acute appendicitis and to prove wheter the analysis of biomarker from saliva as a minimally invasive procedure can be sufficient for diagnosis.


Eligibility criteria: Inclusion Criteria:

* children with age from 5 to 17 with acute abdominal pain
* children with clinical signs of appendicitis

Exclusion Criteria:

* previous diagnosis of chronic and/or malignant disease
* children wich had previous abdominal surgery
* pregnancy

Primary outcomes:
measure: Level of CRP in blood
timeFrame: 72 hours
Secondary outcomes:
measure: Level of CRP in saliva
timeFrame: 72 hours
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Split
name: Zenon Pogorelić, PhD.Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02285725: Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Primary Osteoarthritis of Knee
Osteoarthritis Knee
Degeneration; Articular Cartilage, Knee
Degenerative Lesion of Articular Cartilage of Knee
Lead sponsor: Bone and Joint Clinic of Baton Rouge
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA).


Eligibility criteria: Inclusion Criteria: MRI-confirmed full-thickness unipolar or bipolar chondral lesion(s) from osteoarthritis.

Exclusion Criteria:

* Inflammatory arthritis
* Body mass index (BMI) greater than 35
* Presence of significant varus or valgus knee instability or unusually stiff knee
* Greater than 50% deviation of the mechanical axis
* Presence of active cardiac disease
* Presence of active pulmonary disease
* Prior septic arthritis of the involved joint
* Presence of active bacterial or Mycobacterial infection
* Presence of a known hypercoagulable state
* Pregnant or lactating females
* Subject known to be positive for hepatitis B, hepatitis C, or HIV
* Known allergy to hyaluronic acid
* Patients who are unable or unwilling to participate fully in post-operative physical therapy
* Patients with a contraindication to MRI scanning
* Any disorder that compromises ability to give consent or comply with study procedures
* Patients who are felt to be at significantly increased risk for elective orthopedic surgery
* Non-ambulatory patients
* Patients with cognitive impairment

Primary outcomes:
measure: Change in International Knee Documentation Committee (IKDC) score
timeFrame: Change from baseline at 5 years post-operatively
Secondary outcomes:
measure: Joint Space Changes
timeFrame: 2 and 5 years post-operatively
measure: MRI appearance of repair cartilage
timeFrame: 2 and 5 years post-operatively
measure: Frequency of adverse events requiring additional procedures
timeFrame: Continuously for 5 years post-operatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04064125: Dermal Cumulative Irritant Patch Study
Official title: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design


Eligibility criteria: Inclusion Criteria:

* Healthy males or females who were 18 years of age or older.
* Were of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema.

Exclusion Criteria:

* Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction.
* Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.

Primary outcomes:
measure: Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool.
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01626625: Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healing of Fracture
Keywords: nonunion
stem cells
autograft
hydroxyapatite
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture.


Eligibility criteria: Inclusion Criteria:

* athropic nonunion fracture of the long bone

Exclusion Criteria:

* immunocompromise,
* active infection,
* pathological fracture,
* ongoing hormonal therapy

Primary outcomes:
measure: healing of fracture
timeFrame: 1 year
Secondary outcomes:
measure: VAS
timeFrame: 1 year
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: RSCM
Study officials:
References: