louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06296784: An E-health Psychoeducation for People With Bipolar Disorders
Official title: An E-health Psychoeducation Program to Manage Symptoms During COVID-19 Pandemic for People With Bipolar Disorders: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Psychoeducation
COVID-19 Pandemic
Keywords: Bipolar Disorder
Psychoeducation
COVID-19 Pandemic
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Alessandra Perra
First posted: 2024-03-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open-label cross-over randomized controlled trial (two arms)
Primary purpose: TREATMENT

Brief summary: This study aims to present data on the improvement of Quality of life (QoL), biological rhythms, anxiety, depressive symptoms and the correlations between QoL and biorhythms following an e-health psychoeducational intervention for Bipolar Disoirder (BD) during Covid-19 pandemic

Detailed description: Biological rhythms significantly impact individuals' quality of life (QoL). During the COVID-19 pandemic, social rhythm dysregulation was identified as a contributing factor to relapses in Bipolar Disorder (BD). This trial aims to present data on the efficacy of an e-health psychoeducational intervention for BD in improving anxiety, depressive symptoms, QoL, biological rhythms, and the correlations between QoL and biorhythms.

This study employs a cross-over randomized controlled trial design. Inclusion criteria include a diagnosis of BD according to Diagnostic and Statistical Manual of mental disorders (DSM-V) criteria, age over 18, and obtaining informed consent.

The intervention consists of e-health psychoeducation aimed at reducing distress levels associated with the Covid-19 pandemic and the implemented restrictive measures (lockdown). The focus is on strategies to manage the dysregulation of biological rhythms, with one session per week over two months. Each session lasts approximately an hour and a half and is conducted by a team comprising psychologists, psychiatric rehabilitation technicians, and professional health educators.

Eligibility criteria: Inclusion Criteria:

* diagnosis of BD according to DSM-V, over 18 years old

Exclusion Criteria:

* do not have bipolar disorder, refusal to participate in the study

Primary outcomes:
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
measure: Hamilton Depression Rating Scale (HDRS21)
timeFrame: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
measure: Short Form Health Survey (SF-12)
timeFrame: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
measure: Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN)
timeFrame: T0 (0 weeks); T1 (8 weeks); T2 (16 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: San Giovanni di Dio Hospital
state: CA
Study officials:
References:
Clinical trial NCT01347684: Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
Official title: Assessing the Effectiveness of Two Treatment Strategies for Tension-type Headache
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Tension-type Headache
Keywords: headache
elavil
splints
physical therapy
behavioral therapy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in temporomandibular disorder (TMD) patients.

Detailed description: The primary aim of the pilot data proposal is to compare usual care (medications) versus multi-disciplinary treatment in TMD patients with episodic or chronic tension-type headache (TTH) with pericranial tenderness involving the temporalis muscle at reducing the intensity of TTH pain at 1 and 6 months. The hypothesis is that a team approach will reduce the intensity of headache more than usual care in this group of patients.

Eligibility criteria: Inclusion Criteria:

Fifty consecutive subjects (Age 18 to 65) will be included when they fulfill the diagnostic criteria for episodic or chronic TTH with pericranial muscle tenderness3 and TMD including myofascial pain involving the temporalis muscle -

Exclusion Criteria:

Exclusion criteria, assessed by review of medical history, include:

* systemic rheumatic disease
* widespread pain
* pregnancy
* concurrent use of tricyclic antidepressants, steroids, anti-inflammatories, muscle relaxants, or narcotics
* major psychiatric disease
* any medical contraindications

Primary outcomes:
measure: Change from baseline of headache intensity of pain using pain scale of 1-10
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota School of Dentistry
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Eric L Schiffman, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03370484: Calcium and Gut Hormones
Official title: The Effect of Calcium Ingestion on Gut Hormone Secretion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Rodent evidence suggests that calcium may stimulate gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the calcium ingestion stimulates gut hormone availability in humans.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women age between 18-65 yrs.
* Able to consume provided supplement.
* Weight stable for the past 3 month (no change within 3%)

Exclusion Criteria:

* Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease
* Not between the ages of 18-65 years
* A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)
* Taking medications that may influence your metabolism
* Plans to change your lifestyle (diet and/or physical activity) during the study period
* Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions.
* Current smoker

Primary outcomes:
measure: Postprandial plasma GLP-1 area under the curve (mmol/L x 120 min).
timeFrame: 120 min
Secondary outcomes:
measure: Postprandial plasma GIP area under the curve (mmol/L x 120 min)
timeFrame: 120 min
measure: Postprandial plasma PYY area under the curve (mmol/L x 120 min)
timeFrame: 120 min
measure: Subjective ratings of appetite (au)
timeFrame: 120 min
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
Study officials:
References:
citation: Chen YC, Smith HA, Hengist A, Chrzanowski-Smith OJ, Mikkelsen UR, Carroll HA, Betts JA, Thompson D, Saunders J, Gonzalez JT. Co-ingestion of whey protein hydrolysate with milk minerals rich in calcium potently stimulates glucagon-like peptide-1 secretion: an RCT in healthy adults. Eur J Nutr. 2020 Sep;59(6):2449-2462. doi: 10.1007/s00394-019-02092-4. Epub 2019 Sep 17.
Clinical trial NCT01719484: Functional MRI of Stress in Obesity
Official title: Functional Magnetic Resonance Imaging of Stress in Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 obese subjects and 30 matched healthy controls will be recruited for this study.

Brief summary: To examine the influence of obesity on brain activation during food cue, stress, and neutral relaxing conditions

Detailed description: Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with food cues, stress and neutral/relaxing imagery

Eligibility criteria: Inclusion Criteria:

1. Between ages 18-50 years old.
2. Able to read and write.
3. negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use.
4. WOMEN: have a regular menstrual cycle.
5. BMI: 30 \< BMI \< 35 for obese subjects (upper limit of 35 selected given our experience with heavier individuals fitting comfortably in the fMRI scanner) and 18.5 \< BMI \<25 for normal weight subjects (Institute, 2006)

Exclusion Criteria:

1. any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with exception of nicotine dependence) as determined by SCID interview;
2. Regular use of any psychoactive drugs including anxiolytics and antidepressants.
3. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders.
5. Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).

Primary outcomes:
measure: No outcome measures for this study, this is an imaging study only
timeFrame: Upon study completion
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Marc N Potenza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02465684: Effect of Tourniquet on UKA
Official title: The Role of a Thigh Tourniquet in Unicondylar Knee Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tourniquets
Arthroplasty
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Medical University Linz, Austria
First posted: 2015-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like operating time, blood loss, quality of prosthesis fixation in the bone, adverse events, radiographic result, clinical score outcome, easy of rehabilitation etc. It is not appropriate to rely on findings from the field of total knee arthroplasty.

It is the aim of the current study, to clarify the role of a thigh tourniquet during UKA with regard to component fixation quality, component positioning and sizing, clinical outcome and rehabilitation process.

Patients scheduled for routine UKA implantation due to osteoarthritis or osteonecrosis in the medial compartment will be considered for participation.

Patients are then randomized for surgery with or without tourniquet. After an anteromedial Quad-Sparing approach the UKA procedure itself is then carried out, as suggested by the manufacturer. For both groups puls lavage and meticulous drying is applied before cementing.

The following outcome parameters are assessed: 1)radiographic cement mantle thickness, 2)component position \& sizing, 3)diolucencies, 4)score outcome and 5)parameters of early Rehab.


Eligibility criteria: Inclusion Criteria:

* waiting list for unicondylar knee arthroplasty

Exclusion Criteria:

* failed upper tibial osteotomy,
* insufficiency of the collateral or anterior cruciate ligaments,
* a fixed varus or valgus deformity (not passively correctable) above 15°,
* a flexion deformity greater than 15° and 5) rheumatoid arthritis. In addition - with regard to the scope of the current study - further exclusion criteria will be
* intake of medicinal anticoagulation prior to surgery
* liver dysfunction / coagulation dysfunction
* peripheral arterial obstructive disease.

Primary outcomes:
measure: cement mantle thickness
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01164384: A Phase 1b, Single Center, Clinical Study to Investigate the Safety and Biological Responses to Baminercept in Patients With Chronic HCV Hepatitis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic HCV Hepatitis C
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: PD Dr. rer. nat. Mathias Heikenwälder
First posted: 2010-07-16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Erstes Safety Trial mit Baminercept in chronischen HCV Patienten. Untersuchung des potentiell antiviralen, antiinflammatorischen Effekts sowie Modulation der hepatischen Gen-Expression.

10 Patienten, open label, 10 Wochen Therapie. Sequentielles Enrollement der ersten 4 Patienten.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria: Informed consent Age 18-60 years Chronic HCV infection Non responder (to Peg-IFN alpha2/Ribavirin containing therapy) Elevated ALT Liver biopsy at screening without sings of (pre-)cirrhosis Compensated liver function Absolute neutrophil count \> 1500 / mm3 at screening Hemoglobin \> 10 g/dL at screening Calculated creatinine clearance of \> 60 cc/min at screening Normal TSH at screening

Exclusion criteria: HBV infection Evidence for concomitant liver disease other than HCV hepatitis Evidence for a HCC Alpha-fetoprotein \>20ng/ml Autoimmune Disease ANA \> 1/320, documented in the last 6 months HIV 1/2 infection ALT and AST \>3x ULN, alkaline phosphatase \>2,5x ULN Known hypersensitivity or allergy to Baminercept Other clinically significant concomitant disease states Known or suspected non-compliance to study protocol, drug or alcohol abuse Infections other than HCV hepatitis Clinically important chest x-ray abnormality at screening Body mass index (BMI) \> 30kg/m2 Concomitant systemic immunosuppressive/-modulating therapy Treatment with anticoagulants Receipt of live vaccine within 4 weeks prior to study start Symptomatic hypogammaglobulinemia with history of recurrent infections Subjects with a history of malignant disease Treatment with other investigational products or participation in an interventional clinical trial within the last 3 months Pregnancy or Breastfeeding Inability or refusal to practice a safe contraception

Primary outcomes:
measure: Sicherheit
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT03239184: Bioinformation Therapy for Pancreatic Cancer
Official title: Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Unresectable Pancreatic Cancer
Keywords: Cancer ablation
Life information rehabilitation therapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shengxin Biotechnology Institute, Beijing
First posted: 2017-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable pancreatic cancer.

Detailed description: By enrolling patients with unresectable pancreatic cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length \> 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02469584: Small Stitch Study
Official title: Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Vaginal Wall Prolapse
Keywords: prolapse
anterior colporrhaphy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a "standard procedure", its exact steps are not well standardized.

We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the strength and durability of AC

Objectives

The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair.

Detailed description: A prospective case series evaluation of SSTAC following the recommendations of IDEAL-Collaboration (www.ideal-collaboration.net) will be performed. The newly developed procedure will be tested in a group of 10 patients, who equals stage 2a in the development and innovation of surgical innovations. In this stage safety and technical success is the main outcome. As technical modifications may be common during stage 2a and their nature and timing should be meticulously recorded, the videotaping during all surgical procedures will be performed.

Eligibility criteria: Inclusion Criteria:

* women older than 18 years of age
* Able to read, understand and sign informed consent
* symptomatic cystocele described as Points Aa or Ba \>= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q)

Exclusion Criteria:

* previous urogynecological operation
* gynecologic malignancy
* planned concomitant incontinence operation
* other contraindications for surgery
* pregnancy
* systemic glucocorticoid treatment
* contraindication for the surgery

Primary outcomes:
measure: the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
timeFrame: 4-6 weeks, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Engelbert Hanzal, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01597284: Oral Therapies in Oncology: Cognitive Function and Compliance
Official title: Oral Therapies in Oncology: Cognitive Function and Compliance
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Oral Therapies
Cancer
Cognitive Function
Compliance
Keywords: Oral therapies
Cancer
cognitive function
compliance
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2012-05-14
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient treated for cancer by a first prescription of exclusive oral therapy (chemotherapy and / or targeted therapy)

Brief summary: The investigators propose to evaluate the compliance of oral cancer therapies, particularly the possible link between this observance and cognitive function of patients at initiation of treatment. To our knowledge, this study will be among the first conducted on the issue in France and is an innovative approach in the management of cancer patients. The inclusion of cognitive dysfunction is part of a comprehensive approach to improving the quality of life and fully meets the objectives of both plans cancer, including those of the axis "Living during and after cancer" highlighted in the Cancer Plan


Eligibility criteria: Inclusion Criteria:

* Age over 18 years,
* Patients treated with a first prescription of exclusive oral therapy (chemotherapy and/or targeted therapy) as part of a cancer,
* Patients who begin treatment with ZYTIGA ® (abiraterone acetate) are incluables,
* Patients with asymptomatic brain metastases are incluables,
* Lack of personality disorders and psychiatric illness scalable,
* Knowledge of spoken and written French,
* Having signed the informed consent of study participation.

Exclusion Criteria:

* Pathology psychiatric
* Refusal to participate,
* Patient unable to respond to cognitive tests, - Documented use of drugs,
* Heavy drinking, - Cancer primitive central nervous system, - Participation in a clinical trial.

Primary outcomes:
measure: Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment.
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
affiliation: Centre François Baclesse
name: JOLY Florence, PhD
role: PRINCIPAL_INVESTIGATOR
References: