louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02579915: Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC)
Official title: Phase 2 Randomized Controlled Trial of Attention and Interpretation Modification (AIM) for Anxiety Disorders in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Mclean Hospital
name: Memorial Hospital of Rhode Island
name: National Institute of Mental Health (NIMH)
First posted: 2015-10-20
Enrollment: 40
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 the study is to develop a personalized, user-friendly computerized treatment for anxiety disorders linked to primary care. The computerized treatment is a type of Cognitive Bias Modification, which targets attention and interpretation biases known to maintain anxiety disorders.

Detailed description: The primary goals of our 3-year, 2-phase project are to develop AIM for primary care linkage and assess its feasibility and acceptability. This protocol description only pertains to Phase 2 (Randomized Controlled Trial).

42 primary care patients with primary Generalized Anxiety Disorder, Social Anxiety Disorder, and/or Panic Disorder (with or without Agoraphobia) will be randomly assigned to the AIM treatment or to a symptom tracking control group. Full assessments will occur pre- and post-treatment and 3-months follow-up. A mid-treatment assessment will include measures of cognitive biases and the primary outcome. Weekly measures of anxiety and depression will be collected, as will feedback from patients and PCPs about the research and delivery procedures.

Eligibility criteria: Inclusion Criteria:

Study site patient Age ≥18 Primary diagnosis of Generalized anxiety disorder (GAD), Social Phobia (SP), and/or panic disorder with or without agoraphobia (PD/A) At least moderate anxiety severity (GAD-7 score \> 10) English-speaking If on psychopharmacotherapy, stable dose for 3 months; to minimize learning effects, patients taking benzodiazepines will complete AIM prior to their first dose of the day No current psychotherapy No current severe psychiatric symptoms requiring immediate attention (e.g., imminent suicidality, psychosis)

Primary outcomes:
measure: Hamilton Anxiety Rating Scale
timeFrame: 6-8 weeks after first treatment session
Secondary outcomes:
measure: 7-item Generalized Anxiety Disorder Scale
timeFrame: 6-8 weeks after first treatment session
measure: Patient Health Questionnaire-9
timeFrame: 6-8 weeks after first treatment session
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Family Care Center at Memorial Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Brown University
name: Risa B Weisberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Medical School/McLean Hospital
name: Courtney Beard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02609815: Initial Combination of Gemigliptin and Metformin on Microbiota Change
Official title: Effect of INitial Combination Therapy With GEmigliptin and Metformin on Microbiota Change and Glycemic Control in patientS With Type 2 DIabetes aNd ObEsity (INTESTINE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 20
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 investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2 diabetes.

Detailed description: Obese type 2 diabetes patients who were not treated with anti-diabetic medication within 6 weeks, were randomly assigned to gemigliptin/metformin or sulphonylurea/metformin. After 24 week treatment, gut microbiota composition change, glucose lowering effect, body weight, and gut hormones were compared between two groups.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Drug naive (no anti-diabetic medication within 6 weeks)
* HbA1c \>= 7.5%
* BMI \>= 25.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes
* DKA, HHS
* history of hypersensitivity to sulphonylurea, metformin or DPP-4 inhibitor
* Gestational diabetes mellitus
* Serum Cr \>1.5 mg/dL (male), \>1.4mg/dL (female)
* Abnormal liver function test
* Anti-obesity medication within 3 months
* Gastrointestinal motility drug, laxatives within 3 months
* History of major gastrointestinal surgery

Primary outcomes:
measure: gut microbiota composition change from baseline
timeFrame: 24 weeks
Secondary outcomes:
measure: HbA1c change
timeFrame: 24 weeks
Other outcomes:
measure: Body composition
timeFrame: 24 weeks
measure: Beta-cell function
timeFrame: 24 weeks
measure: GLP-1
timeFrame: 24 weeks
measure: GIP
timeFrame: 24 weeks
measure: PYY
timeFrame: 24 weeks
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Tae Jung Oh
role: STUDY_DIRECTOR
References:
Clinical trial NCT03567915: Ultrasound Assessment of Gastric Emptying of Korean Meals: Rice and Noodle
Official title: Ultrasound Assessment of Gastric Emptying of Korean Meals in Healthy Volunteer: Rice and Noodle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoperative Fasting
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult healthy volunteers

Brief summary: The investigators evaluate gastric emptying time of common Korean meals (rice, noodles) in healthy volunteers.

Detailed description: The investigators assess the gastric volume and contents of healthy volunteers at 4, 5, 6, 7, 8 hours after eating common Korean meal (rice or noodle) using a ultrasonography.

Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers

Exclusion Criteria:

* History of gastrectomy
* Anatomical abnormalities or mass of stomach

Primary outcomes:
measure: Gastric emptying time
timeFrame: 1 hour
Secondary outcomes:
measure: Incidence of full stomach
timeFrame: At 4, 5, 6, 7, and 8 hours after eating a meal.
measure: Cross sectional area of the stomach
timeFrame: At 4, 5, 6, 7, and 8 hours after eating a meal.
measure: Gastric volume
timeFrame: At 4, 5, 6, 7, and 8 hours after eating a meal.
measure: Type of gastric contents
timeFrame: At 4, 5, 6, 7, and 8 hours after eating a meal.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04305015: Postoperative Benefits of Intraoperative Nociception Level (NOL) Titration - Pilot
Official title: Postoperative Benefits of Intraoperative NOL Titration - Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nociceptive Pain
Keywords: NOL
Nociception
Lead sponsor: Medasense Biometrics Ltd
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NOL-Guided analgesia vs. Routine Management
Primary purpose: TREATMENT

Brief summary: Previous work has shown that NOL (Medasense, Ramat Gan, Israel) accurately quantifies nociception during general anesthesia. Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the post anesthesia care unit (PACU). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.


Eligibility criteria: Inclusion Criteria:

1. Adults having major non-cardiac surgery expected to last ≥2 hours;
2. American Society of Anesthesiologists physical status 1-3;
3. Age 21-85 years old;
4. Planned endotracheal intubation

Exclusion Criteria:

1. Planned neuraxial or regional block;
2. Local anesthetic infiltration at surgical field;
3. Clinician preference for an opioid other than, or in addition to, fentanyl;
4. Non-sinus heart rhythm;
5. Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea;
6. Lack of English language fluency;
7. Routine user of psychoactive drugs other than opioids;
8. Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
9. Intracranial surgery
10. BMI \> 40

Primary outcomes:
measure: PACU pain score
timeFrame: 60 minutes during recovery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland clinic
state: Ohio
Study officials:
References:
Clinical trial NCT01695915: Diurnal Variation in Rectal Diameter
Official title: Diurnal Variation in Rectal Diameter Measured by Transabdominal Ultrasound in Healthy and Constipated Children.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Keywords: constipation
children
healthy
rectal diameter
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2012-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Constipated children are recruited from the outpatient clinic at Kolding pediatric department. A list of patients which have been given the diagnose constipation are drawn from the computer and reviewed. Children between 4-12 years who fulfill the Rome III criteria of constipation and have been taking PEG maintenance treatment at least 1 month, are contacted by telephone for possible participation in the study.

Healthy participants without constipation or other diseases affecting the gastrointestinal tract were recruited among the employees of the Department of Pediatrics at Kolding Hospital.

Written informed consent was obtained from both parents before any procedures were initiated.

Brief summary: The purpose of the study is to determine the diurnal variation of rectal diameter in healthy and constipated children using transabdominal ultrasound.


Eligibility criteria: Constipated Inclusion Criteria:

* Children from 4 to 12 years with previously diagnosed simple constipation defined by ROME III criteria, which at inclusion is in maintenance therapy with PEG + E and has been in treatment for at least 1 month.

Exclusion Criteria:

* Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
* Children receiving drugs known to affect bowel function during a 2 month period before initiation besides laxatives.

Healthy inclusion Criteria:

* Children between 4 and 12 years of age.

Healthy exclusion Criteria:

* Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
* Children receiving drugs known to affect bowel function during a 2 month period before initiation.
* Children with a previous history of constipation, fecal incontinence and / or urinary tract infections.

Primary outcomes:
measure: Rectal diameter
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Pediatric department, Kolding Hospital
Study officials:
affiliation: Kolding Sygehus
name: Line Modin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kolding Sygehus
name: Marianne Jakobsen, MD, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02178215: Effect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients
Official title: Effect of Holly Mangrove Shower Gel Containing Acanthus Ebracteatus Vahl. on Skin Barrier Function in Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
skin barrier function
transepidermal water loss
skin pH
stratum corneum hydration
sebum
wrinkle
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 30
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: Atopic dermatitis is a chronic intermittent inflammatory skin disease. Currently, there are many cosmeceutical skin products in which their major action affects skin hydration and skin barrier function. In addition, there are some herbal medication remedies used for the treatment of skin diseases based on the knowledge of Thai traditional medicine. Patients with pruritic rash symptoms who attended the Center of Applied Thai Traditional Medicine, Siriraj Hospital, were prescribed the Holly Mangrove Shower Gel to use and on the follow-up appointment showed significant improvement. Nevertheless, the knowledge of using this herbal medication for treating pruritic skin rash so far has been categorized as folk wisdom and not been confirmed by any clinical-trial study on its efficacy and mechanism of action.

Research teams chose Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl to act as adjunctive for treating atopic dermatitis. Thus, for the purpose of studying the efficacy of Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl in improving the skin barrier function in atopic dermatitis.

Detailed description: The investigators team research with patients by separate patients into 2 groups and compare among each other. In the first group use placebo, the other group use Holly Mangrove Shower Gel. To compare outcomes, the investigators will measure transepidermal water loss, stratum corneum hydration, skin pH, sebum and wrinkles after using studied gel.

Eligibility criteria: Inclusion Criteria:

* Age 18 years old or above
* Diagnosed as atopic dermatitis (Hanafin and Rajka criteria)
* No active dermatitis within 2 weeks

Exclusion Criteria:

* Pregnancy or lactation
* Any other skin diseases on forearms

Primary outcomes:
measure: Improvement of skin barrier function
timeFrame: baseline, 2 week
Secondary outcomes:
measure: Reduction of severity of pruritus
timeFrame: baseline, 2 week
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital Mahidol Univeristy
Study officials:
affiliation: Mahidol University
name: Papapit Tuchinda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06366815: phenotypeS in Non Ambulant Duchenne Muscular Dystrophy
Official title: Characterizing Phenothypes in Non Ambulant Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Duchenne Muscular Dystrophy
Natural History
Motor Function; Retardation
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 250
Sex: MALE
Minimum age (years): 8
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population expected to be enrolled will include almost 250 patients affected from Duchenne Muscular Dystrophy with a confirmed genetic diagnosis and that have lost the ability to walk indipendently for more than 10 meters.

Brief summary: The aims of the study are to prospectively collect information on several aspects of function in non-ambulant DMD patients by using a structured battery of tests including motor, respiratory and cardiac function

Detailed description: The aims of the study are to prospectively collect information on several aspects of function in non-ambulant DMD patients by using a structured battery of tests including motor, respiratory and cardiac function, to retrospectively review similar information on the data collected in the last decade and to establish the effect of steroids after loss of ambulation on different aspects of function.

We also aim to use this integrated approach to identify patterns of severity and progression, the most appropriate outcome measures and endpoints in each group and possible genotype/phenotype correlations.

Eligibility criteria: Inclusion Criteria:

* Children with genetically confirmed diagnosis of Duchenne Muscular Dystrophy will be included in the study. We will include all Duchenne Muscular Dystrophy boys who have lost the ability to walk independently.
* All patients in whom consent can be obtained will be enrolled with no exclusion criteria.

Exclusion Criteria:

* Patients lacking genetic confirmation of Duchenne Muscular Dystrophy
* Patients still able to walk for more than 10 meters.

Primary outcomes:
measure: motor function
timeFrame: 24 months
measure: respiratory function
timeFrame: 24 months
measure: cardiac function
timeFrame: 24 months
Secondary outcomes:
measure: identify patterns of severity and of progression related to differnt genotypes
timeFrame: 24 months
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS Eugenio Medea - Ass. "La Nostra Famiglia"
state: Lc
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Marika Pane
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03696615: Kettlebell Swings & Low Back Pressure Pain Threshold
Official title: Short Term Effects of Kettlebell Swings on Low Back Pain Pressure Threshold in Healthy Young Adults Utilizing a Tabata Protocol Format.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: high-intensity
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a high intensity kettlebell workout, utilizing a Tabata protocol format, can decrease objective measures of pain pressure threshold in subjects without low back pain. The results of the study could have implications for the use of high intensity kettlebell workouts in the rehabilitation of patients with low back pain.

Detailed description: The kettlebell swing is a full body, posterior-chain focused, ballistic exercise shown to register large recruitment of the gluteal muscles, which are frequently weak in a patients suffering from low back pain. The Tabata protocol is a high-intensity training protocol in which subjects perform 20 seconds of all out effort (i.e. as many swings as possible), followed by 10 seconds of rest, repeated for a total of eight rounds. The rapid contraction-relaxation cycles utilized in the kettlebell swing are theorized to aid in the pumping out of muscle metabolites in the low back musculature, thus providing potential relief of chronic low back pain.

Eligibility criteria: Inclusion Criteria:

* Those subjects between the ages of 18 and 45
* No current low back pain or pre-existing injuries that may be currently affecting them
* No positive response on the Health History questionnaire and PAR-Q.

Exclusion Criteria:

* Current low back pain
* Pre-existing injuries currently affecting the subject
* Positive response on the Health History Questionnaire or PAR-Q
* We will also be excluding minors and prisoners from this study.

Primary outcomes:
measure: Pressure measured in kilopascals
timeFrame: 1 minute post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: William J Hanney, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05325515: The Effect of Effervescent Alendronate on Bone Turnover
Official title: The Effect of Effervescent and Buffered Alendronate on Bone Turnover Compared to Conventional Alendronate: A Randomized Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteopenia or Osteoporosis
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 64
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 study arms in which participants are allocated by randomization 1:1. Randomixation is performed in 8 blocks of 8.
Primary purpose: TREATMENT

Brief summary: 64 postmenopausal women are randomized to treatment with either effervescent and buffered alendronate or conventional alendronate -both 70mg weekly for 16 weeks to see if bone turnover is suppressed to the same extent as in the conventional formulation with the effervescent form.

Detailed description: Alendronate is mainstay in the treatment of osteoporosis but is often discontinued due to gastro-intestinal side-effects. These side effects are believed to be caused by a low gastric pH induced by the drug. Effervescent and buffered alendronate is a new formulation that increases gastric pH and thereby decreases risk of side effects but the clinical effect of the drug is not fully elucidated. In the present study 64 postmenopausal women with a bone mineral density T-score \< -1 are randomized 1:1 to open label treatment with effervescent and buffered alendronate or conventional alendronate 70 mg weekly for 16 weeks. The primary end-point is change in the bone resorption marker "carboxy-terminal collagen crosslinks" from baseline to 16 weeks. The decrease in the two groups is compared using non-inferiority statistics. Secondary end-points include change in the bone formation marker "propeptide of type 1 procollagen", rate of change in the two bone markers and occurence of side effects.

Eligibility criteria: Inclusion Criteria:

* 2 years since last menstrual bleeding
* Bone mineral density T-score \< -1 at either lumbar spine or hip
* CTx \> 0.42 µg/L

Exclusion Criteria:

* Ever treatment for osteoporosis
* Indication for teriparatide treatment
* Treatment with oral systemic glucocorticoids within last 12 months
* Rheumatoid arthritis
* Inflammatory bowel disease
* Untreated thyroid disease
* Primary hyperparathyroidism
* Diabetes mellitus
* eGFR \< 60 mL/min
* Cancer within last 2 years except basal cell carcinoma of the skin
* Hormone therapy
* Unstable liver disease
* Contraindications for alendronate
* Major gastrointestinal disease within 12 months (eg. esophagitis, ulcer, major surgery).
* Vitamin D \< 50nmol/L

Primary outcomes:
measure: CTx
timeFrame: baseline to week 16
Secondary outcomes:
measure: P1NP
timeFrame: baseline to week 16
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
Study officials:
References: