louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04211753: Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Emotional Crisis in Borderline Personality Disorder
Official title: Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Self-managing Emotional Crises in People With Borderline Personality Disorder: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline personality disorder
Mobile app
Crisis intervention
Effectiveness
Security
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effectiveness and security of a mobile App (beta version) for self-managing emotional crisis in a pragmatic randomized controlled trial with 80 patients with borderline personality disorder (40 patients with treatment as usual, TAU) versus 40 patients with TAU plus the mobile App)


Eligibility criteria: Inclusion Criteria:

* DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of borderline personalidad disorder (BPD)
* Aged 18-60 yeats old

Exclusion Criteria:

* Comorbidity with mental retardation
* Comorbidity with psychotic disorder
* Comorbidity with antisocial personality
* Comorbidity with autism spectrum disorder

Primary outcomes:
measure: Number of psychiatric.emergencies and hospitalizations
timeFrame: 9-month
measure: smartphone addiction
timeFrame: 9-month
Secondary outcomes:
Other outcomes:
Locations:
city: Mataro
country: Spain
facility: Consorci Sanitari del Maresme
state: Barcelona
Study officials:
affiliation: Consorci Sanitari del Maresme
name: Pere Clave
role: STUDY_DIRECTOR
References:
Clinical trial NCT01496053: Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
Official title: Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ulcerative Colitis
Crohn's Disease
Inflammatory Bowel Disease
Keywords: Cytokine levels in blood
Calprotectin in feces
Clinical symptom score.
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: ImmunoPharma AS
First posted: 2011-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in patients with ulcerative colitis (UC) and Crohn's disease (CD), experience clinical, biochemical and genetical improvement in their disease.

A prospective randomised study comparing the mushroom extract with placebo.


Eligibility criteria: Inclusion Criteria:

* moderate disease

Exclusion Criteria:

* serious disease,
* biological treatment,
* pregnancy.

Primary outcomes:
measure: Reduction in biochemical blood parameters (pro-inflammatory cytokines)
timeFrame: 21 days
Secondary outcomes:
measure: Reduction of calprotectin in feces.
timeFrame: 21 days
measure: Clinical symptom score.
timeFrame: 21 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ulleval
Study officials:
affiliation: Ullevaal University Hospital
name: Egil Johnson, MD. Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of the Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSanTM, on Symptoms, Fatigue and Quality of Life in Patients with Crohn's Disease in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Jul 14;11(7):e0159288. doi: 10.1371/journal.pone.0159288. eCollection 2016.
citation: Therkelsen SP, Hetland G, Lyberg T, Lygren I, Johnson E. Effect of a Medicinal Agaricus blazei Murill-Based Mushroom Extract, AndoSan, on Symptoms, Fatigue and Quality of Life in Patients with Ulcerative Colitis in a Randomized Single-Blinded Placebo Controlled Study. PLoS One. 2016 Mar 2;11(3):e0150191. doi: 10.1371/journal.pone.0150191. eCollection 2016.
Clinical trial NCT04348253: Danish Multicenter Scapholunate Ligament Study
Official title: Reconstruction of Chronic Scapholunate Ligament Injuries in the Wrist: A Randomized Controlled Trial Comparing The Berger Capsulodesis and Three-Ligament-Tenodesis (3LT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ligament Injury
Wrist Sprain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized trial
Primary purpose: TREATMENT

Brief summary: Comparison of two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. A randomized multicenter study.

Detailed description: This multicentre study aim to compare two surgical techniques commonly used for reconstruction of the scapholunate (SL) ligament. The investigators compare patient reported, clinical and radiological outcomes up to 10 years after treatment of complete dynamic or static but reducible SL ligament lesions. The participants are randomized to two treatments. Effect parameters before and after intervention are compared between groups.

Eligibility criteria: Inclusion Criteria:

* Age 18-60 years (both included).
* Symptomatic SL instability (VAS score ³3, QDASH score ³ 20).
* \> 6 weeks since symptomatic hand trauma (chronic SL lesions).
* SL gapping on radiographic stress views or SL gapping (³2mm) on static PA views.
* Complete SL ligament lesion confirmed by wrist arthroscopy

Exclusion Criteria:

* Geissler grade 1-3 SLL injury (evaluated by arthroscopy).
* Concomitant complete luno-triquetral (LT) ligament injury (evaluated by arthroscopy).
* Lesion of TFCC leading to DRUJ instability (evaluated by arthroscopy).
* Radiocarpal or midcarpal arthritis evaluated by arthroscopy.
* Previous fracture in carpus or intraarticular radius fracture with step off (³2 mm), disposing to posttraumatic arthritis.
* Adverse effects after extra articular radial fractures (dorsal angulation ³10 grader).
* Peroperatively non-reducible scaphoid flexion/SL gap.
* Terminal illness or severe medical illness: ASA score higher than or equal to 3.

Primary outcomes:
measure: The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)
timeFrame: At all follow-ups (0-10 years)
Secondary outcomes:
measure: Grip-strength
timeFrame: At all follow-ups (0-10 years)
measure: SL angle
timeFrame: At all follow-ups (0-10 years)
measure: The Patient-Rated Wrist Evaluation (PRWE) score
timeFrame: At all follow-ups (0-10 years)
measure: Wrist motion
timeFrame: At all follow-ups (0-10 years)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Holstebro
country: Denmark
facility: Hospital Unit Vest
Study officials:
affiliation: Hospitalsenheden Vest
name: Janni K Thillemann, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175953: Short-term Caregiver Psychotherapy
Official title: Psychotherapeutical Short-term Intervention for Caregivers of Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Caregiver Burden of People With Dementia
Keywords: caregiver burden
stress
depression
dementia
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: German Center for Neurodegenerative Diseases (DZNE)
First posted: 2014-06-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to test the feasibility (pilot part) and efficacy (phase IIa part) of a specifically on the needs of caregivers of people with dementia composed new short-term psychotherapeutical intervention.

Detailed description: This prospective study will be offered to caregivers from the out patient clinic of the Department of Psychosomatic Medicine of the University Rostock Medical Center. In a first pilot study with 10 participants without control group, we tested the feasability and acceptance of the program (completed 2/2015). From 4/2015 a phase IIa study started with 10 participants in the intervention group and 10 in the control groups (will be organized by waiting list). The program consists of two modules of caregiver education followed by ten psychotherapeutic group modules. Duration of each module is planned to be 90 minutes including a relaxation exercise at the end of each module. Primary outcomes are the feasibility, acceptance and the effect on caregiver burden.

Eligibility criteria: Inclusion Criteria:

* caregiver of a person with dementia
* willing to participate in all 12 modules of the program

Exclusion Criteria:

* current psychotherapy or antidepressive medication for less than 6 month
* major depression

Primary outcomes:
measure: Change in perceived self-efficacy directly and 3 month after psychotherapeutical intervention and reduction of symptoms of depression
timeFrame: before intervention, 0 and 3 month after end of intervention
Secondary outcomes:
measure: reduction of perceived burden of care
timeFrame: before intervention, 0 and 3 month after end of intervention
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock
state: MV
Study officials:
References:
citation: Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
citation: Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK.
citation: Weissman MM, Sholomskas D, Pottenger M, Prusoff BA, Locke BZ. Assessing depressive symptoms in five psychiatric populations: a validation study. Am J Epidemiol. 1977 Sep;106(3):203-14. doi: 10.1093/oxfordjournals.aje.a112455.
Clinical trial NCT01168453: Changes in Anatomical Landmark Locations
Official title: Changes in the Relationship Between the Right Internal Jugular Vein and Anatomical Landmark After Head Rotation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Intubation
Keywords: jugular vein
anatomy
ultrasonography
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery under general anesthesia with endotracheal intubation, were enrolled in the study between May 2009 and February 2010.

Brief summary: This study was performed to ultrasonographically demonstrate the changes in relationship between the right internal jugular vein (IJV) and an anatomical landmark in two different head positions: neutral and rotational.

Detailed description: Background: This study was performed to ultrasonographically demonstrate the changes in relationship between the right IJV and an anatomical landmark in two different head positions: neutral and rotational.

Methods: One hundred patients scheduled for elective surgery under general anesthesia with endotracheal intubation were enrolled in this study. The patients were placed in the supine position with a neutral head position and without a pillow. The apex of the triangle formed by the sternal and clavicular heads of the sternocleidomastoid muscle and clavicle was marked (anatomical landmark point: AL point). The ultrasonography of the neck anatomy was performed, and a mark was placed at the central point of the IJV to the skin (ultrasonography point: US point). The other investigator measured the distances from the AL point to the US point (AL-US distance). The patient's head was then turned 30° to the left; the same procedure was repeated and the AL-US distance was again measured. The changes in AL-US distance were calculated.

Eligibility criteria: Inclusion Criteria:

* 100 patients weighing 40 - 100 kg and with heights of 140 - 190 cm

Exclusion Criteria:

* a history of neck surgery or trauma involving the neck, previous IJV-related interventions (e.g., venous catheterization), limitation of neck movement, and a body mass index ≥ 30.

Primary outcomes:
measure: anatomical landmark point (AL) - ultrasonography point (US) distance(the distances from the AL point to the US point )
timeFrame: within 5 minutes after itubation
Secondary outcomes:
measure: The average depth of the right IJV
timeFrame: within 5 minutes after intubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
Study officials:
affiliation: Soonchuhyang University Hospital
name: Sun Young Park, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02519153: Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) as Medical Expulsive Therapy in Distal Ureteral Stones
Official title: Role of Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) in Management of Distal Ureteral Stone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ureteral Stone
Urolithiasis
Keywords: Phosphodiesterase 5 Inhibitors
PDE5i
Sildinafil
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urolithiasis is one of the most common urological diseases. The risk of urolithiasis is estimated to be between 5% and 12% all over the world with increased incidence in male rather than female (2:1) respectively . Ureteral stones account for 20% from all urinary tract stones, more than 70% of the ureteral stones found in the lower third of the ureter . The incidence of urinary stones has been increasing day by day. Medical expulsive therapy (MET) of ureteral stones is the investigators' concern in this study. Stone location, size, number, ureteral spasm, mucosal edema or inflammation and ureteral anatomy are the factors affecting passage of the ureteral stones. So, MET is based on mechanism that stone passage is facilitated by the relaxation of ureteral smooth muscle , increasing hydrostatic pressure proximal to the stone and decreasing exciting edema . There are many oral medication could be used as MET such as adrenergic blockers, calcium channel blockers, prostaglandin synthesis inhibitors, glyceryl trinitrate and steroid treatment . Calcium-channel blockers and adrenergic α-antagonists are the main that has been proposed to enhance stone passage as expulsive medical therapy. Cyclic nucleotides are degraded by phosphodiesterases enzymes (PDEs). So using of PDE inhibtors may play role in relaxation of smooth muscle of the ureter. A study was done for evaluation of three PDE5 inhibtors, sildenafil , vardenafil and tadalafil, they found that PDE5 inhibitors can reverse the tension of isolated human ureteral smooth muscle via cGMP-mediated pathways.


Eligibility criteria: Inclusion Criteria:

1. Male Patient aged from 18-65 years.
2. Lower third ureteric stones at or below sacro-iliac joint .
3. Stone size rang from 5- 10 mm.
4. Unilateral ureteric stone

Exclusion Criteria:

1. Patients who had recurrent fever.
2. Patient underwent ESWL.
3. Patient with rising serum creatinine \> 2mg/dl.
4. Patient with history of uretero-vesical reimplantation.
5. Stone larger than 10 mm

Primary outcomes:
measure: the percentage of passage of lower ureteric stones.
timeFrame: one year
Secondary outcomes:
measure: number of patient need for analgesic treatment during their medical expulsive tharpy
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05462353: Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
Official title: A Phase II, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Keywords: Non-alcoholic Fatty Liver Disease
NASH
ASC41
Phase II
THR-β
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults with Nonalcoholic Steatohepatitis (NASH).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years old at screening.
* Presence of ≥ 7.5% steatosis on screening MRI-PDFF read centrally by a radiologist and performed either during the screening period or within 6 months prior to the first visit.
* HbA1c ≤ 9.5%.
* Normal or minimally abnormal renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m\^2

Exclusion Criteria:

* Presence or history of cirrhosis or evidence of decompensated liver disease (e.g., ascites, variceal bleeding) or hepatocellular carcinoma.
* History or presence of other concomitant liver disease as assessed by the investigator or determined by laboratory findings.
* Uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c of \> 9.5% within 60 days prior to enrollment.
* Change in anti-diabetic therapy within 6 months prior to qualifying liver biopsy.

Primary outcomes:
measure: To evaluate the effect of ASC41 compared with placebo in noncirrhotic subjects with NASH by a histological change.
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: The incidence, type and severity of AEs/SAEs were assessed by CTCAE v5.0 to assess the safety and tolerability of ASC41 compared to placebo
timeFrame: 24 and 52 weeks
measure: Change from baseline in hepatic fat fraction assessed by MRI-PDFF
timeFrame: 24 and 52 weeks
measure: To evaluate the effect of ASC41 compared with placebo on serum lipids (cholesterol, HDL-C, LDL-C, triglycerides, Lp(a), VLDL)
timeFrame: 12, 24 and 52 weeks
measure: Plasma pharmacokinetics - Peak Plasma Concentration (Cmax)
timeFrame: 1 and 15 Days
measure: Plasma pharmacokinetics - Area under the plasma drug concentration versus time curve( AUC0-t_, AUC0-∞)
timeFrame: 1 and 15 Days
measure: Plasma pharmacokinetics - The amount of time that a drug is present at the maximum concentration in serum(Tmax)
timeFrame: 1 and 15 Days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The affiliated Hospital of Hangzhou Normal University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06190353: Development, Acceptability and Preliminary Efficacy of an Internet-Based Self-Help Program
Official title: Development, Acceptability and Preliminary Efficacy of an Internet-Based Self-Help Program Using Acceptance and Commitment Therapy for Coping With Burnout Among Healthcare Workers: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Keywords: Burnout
Acceptance and Commitment Therapy
Web-based Intervention
Healthcare Workers
Lead sponsor: CanSagligi Foundation
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a parallel two arms pilot randomized controlled study
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate acceptability and initial effectiveness of an internet-based self-help program utilizing Acceptance and Commitment Therapy specifically for healthcare workers, intending to address burnout.

Detailed description: This pilot study is a randomized controlled trial of two parallel groups. The study will comprise of an intervention and a wait-list control group. The intention of this study is to evaluate the acceptability and preliminary efficacy of an internet-based self-help program with minimal telephone support utilizing Acceptance and Commitment Therapy for alleviating burnout among healthcare workers.

Eligibility criteria: Inclusion Criteria:

* Currently employed in the healthcare field as a doctor, nurse, technician, pharmacist or other healthcare profession for a minimum of six months.
* Proficiency in using computer and email.
* Experiencing symptoms of burnout related to the workplace.

Exclusion Criteria:

* Currently prescribed psychotropic medication.
* Currently undergoing psychotherapy.
* Presently experiencing thoughts of suicide or self-mutilation.

Primary outcomes:
measure: Burnout Assessment Tool
timeFrame: At baseline and 4 weeks
measure: Valued Living Questionnaire (VLQ)
timeFrame: At baseline and 4 weeks
Secondary outcomes:
measure: Acceptance and Action Questionnaire-2 (AAQ-2)
timeFrame: At baseline and 4 weeks
measure: System Usability Scale (SUS)
timeFrame: 4 weeks
measure: Attendance rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: CanSagligi Foundation
state: Uskudar
Study officials:
affiliation: CanSagligi Foundation Center for Contextual Behavioral Science
name: Ahmet Nalbant, MD
role: PRINCIPAL_INVESTIGATOR
References: