louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05552014: Study on the Efficacy Mechanism of Natural Psychotherapy for Neurosis
Official title: Research on the Efficacy Mechanism of Natural Psychotherapy for Neurosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: obsessive-compulsive disorder
natural psychotherapy
Lead sponsor: Beijing HuiLongGuan Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder

Detailed description: 1. To evaluate the cognitive function, Cognitive control, emotion and other aspects of neurosis patients, and to understand and master the cognitive behavior indicators of this population.
2. Investigate the pathological mechanism of neurotic patients from the aspects of EEG/fMRI and biology.
3. To investigate the therapeutic effect of natural psychotherapy on cognitive impairment and related mood, sleep and symptom intervention in neurotic patients. In order to achieve the symptoms of neurosis patients, cognitive impairment and related mood and sleep intervention and promotion, while providing a scientific basis for neurosis rehabilitation.

Eligibility criteria: Inclusion Criteria:

* were between 16 and 55 years old;
* were diagnosed with OCD by an experienced psychiatrist utilizing the Structured Clinical Interview for DSM-5 (SCID);
* had an illness duration of at least 12 months;
* were able to participate in the entire trial and face-to-face on-site assessment

Exclusion Criteria:

* pregnant or breastfeeding;
* suffered from organic brain diseases or severe physical illness;
* had a history of substance or alcohol abuse
* were at high risk of suicide

Primary outcomes:
measure: Obsessive-compulsive symptoms
timeFrame: Baseline, week 4, week 8
Secondary outcomes:
measure: Self-reported obsessive-compulsive symptoms
timeFrame: Baseline, week 4, week 8
measure: Cognitive inhibition
timeFrame: Baseline, week 8
measure: Behavioral inhibition
timeFrame: Baseline, week 8
measure: ERP components associated with cognitive function
timeFrame: Baseline, week 8
measure: rest fMRI in Obsessive-compulsive patients
timeFrame: Baseline, week 8
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Mental Health Center
state: Anhui
city: Beijing
country: China
facility: Institute of Psychology, Chinese Academy of Sciences
Study officials:
affiliation: Institute of Psychology, Chinese Academy of Science
name: Xiang Y Zhang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03316014: Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center
Official title: Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child With Adverse Drug Reactions
Keywords: Pediatry; Adverse drug reactions; Pharmacovigilance
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 0 to 17 years inclusive who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne.

Brief summary: Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics.

Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics

Detailed description: Pediatry aged under 18 years accounted for around 22% of the French general population.

Data regarding drug safety from clinical trials are insufficient in this population.

Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics.

Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics.

Eligibility criteria: inclusion criteria:

* Children from 0 to 17 years inclusive
* Who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne

exclusion criteria:

* none

Primary outcomes:
measure: the different type of ADR
timeFrame: 30 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Saint-Martin C, Kanagaratnam L, de Boissieu P, Azzouz B, Abou Taam M, Trenque T. [Adverse drug reactions in pediatrics: Experience of a regional pharmacovigilance center]. Therapie. 2016 Oct;71(5):467-473. doi: 10.1016/j.therap.2016.04.001. Epub 2016 Apr 11. French.
Clinical trial NCT03429114: Emotion Regulation in Binge Eating and Purging Among Adolescents
Official title: Neural Correlates of Emotion Regulation and Executive Function in Binge Eating and Purging Among Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binge Eating
Purging (Eating Disorders)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 47
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female adolescents between ages 14-18.

Brief summary: The study will examine the neural and behavioral correlates of emotion regulation in adolescents engaging in binge eating and/or purging and healthy adolescents. Furthermore, it will look at the influence of executive function on emotion regulation in this population. This study will allow us to gain further understanding of the neural basis of emotion regulation in this age group. Moreover, this study supports the need to develop new treatment approaches based on a better understanding of the brain processes associated with eating disorders.


Eligibility criteria: Inclusion Criteria:

* Female
* Ages 14-18
* with or without current binge eating and/or purging behaviors

Exclusion Criteria:

We exclude patients of clinically significant low weight (\<85% ideal body weight using CDC norms for height, age, and gender) and those with contraindications for MRI (e.g., orthodontia, metallic implants). Participants also will be without evidence of current or past major neurological (e.g., seizures, psychosis, head trauma) or major sensory deficit.

Primary outcomes:
measure: Brain activity during emotion conflict
timeFrame: Baseline
measure: Brain activity during emotion regulation
timeFrame: Baseline
measure: Brain activity during cognitive control and emotion response
timeFrame: Baseline
Secondary outcomes:
measure: Behavioral performance on emotion conflict task
timeFrame: Baseline
measure: Behavioral performance on emotion regulation task
timeFrame: Baseline
measure: Behavioral performance on cognitive control and emotion regulation task
timeFrame: Baseline
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, Department of Psychiatry
state: California
Study officials:
References:
Clinical trial NCT05091255: Cryotherapy in the Treatment of Desmoid Tumors
Official title: Cryotherapy in the Treatment of Desmoid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Desmoid
Keywords: desmoid tumor; cryotherapy
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.


Eligibility criteria: Inclusion Criteria:

* histologic diagnosis of desmoid tumors
* age \> 18 years
* abdominal and extra-abdominal desmoid tumors

Exclusion Criteria:

* contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
* retroperitoneal desmoid tumors
* age \< 18 years

Primary outcomes:
measure: response to treatment
timeFrame: At baseline (time 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Itituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Kujak JL, Liu PT, Johnson GB, Callstrom MR. Early experience with percutaneous cryoablation of extra-abdominal desmoid tumors. Skeletal Radiol. 2010 Feb;39(2):175-82. doi: 10.1007/s00256-009-0801-z. Epub 2009 Sep 21.
citation: Redifer Tremblay K, Lea WB, Neilson JC, King DM, Tutton SM. Percutaneous cryoablation for the treatment of extra-abdominal desmoid tumors. J Surg Oncol. 2019 Sep;120(3):366-375. doi: 10.1002/jso.25597. Epub 2019 Jun 24.
citation: Schmitz JJ, Schmit GD, Atwell TD, Callstrom MR, Kurup AN, Weisbrod AJ, Morris JM. Percutaneous Cryoablation of Extraabdominal Desmoid Tumors: A 10-Year Experience. AJR Am J Roentgenol. 2016 Jul;207(1):190-5. doi: 10.2214/AJR.15.14391. Epub 2016 Apr 11.
Clinical trial NCT00643955: Neuromuscular Characteristics of Individuals With Down Syndrome (DS)
Official title: Neuromuscular Characteristics of Individuals With Down Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Down Syndrome
Keywords: Evaluation of muscle strength and central activation
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Down Snydrome and control subjects without DS

Brief summary: Evaluation of muscle strength and central activation of muscle in individuals with Down Syndrome


Eligibility criteria: Inclusion Criteria:

* 18-45 years old
* good health with no contraindications to exercise
* documented DS (not for control subjects)

Exclusion Criteria:

* contraindications to exercise,
* severe or profound MR
* documented atherosclerotic heart disease
* documented atlantoaxial instability
* uncorrected congenital heart disease
* implanted prosthetic device
* implanted pacemaker

Primary outcomes:
measure: Muscle strength Central activation ratio
timeFrame: One time
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: IHP
state: New York
Study officials:
References:
Clinical trial NCT01530555: Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia
Official title: Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Aplastic Anaemia
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG, Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who are transfusion dependent. To compare the response rate of the combination of rabbit ATG (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®) and CSA; obtained from the EBMT database (comparative study).


Eligibility criteria: Inclusion Criteria:

1. To define aplastic anaemia there must be at least two of the following: (1) haemoglobin \< 10g/dl; (2) platelet count \< 50 x 109/l; (3) neutrophil count \< 1.5 x 109/l, and a hypocellular bone marrow on bone marrow biopsy
2. Time from diagnosis to study registration ≤ 6mths
3. No prior treatment except for haemopoietic growth factors given for no more than 4 weeks, and androgens.
4. Age ≥ 16yrs (≥ 18yrs in Germany in accordance with German law), with no upper age limit.

Exclusion criteria:

1. Eligibility for an HLA-matched sibling donor transplant for SAA patients
2. Prior therapy with ATG or CSA
3. Haematopoeitic growth factors more than 4 weeks before study enrollment
4. Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome
5. Evidence of myelodysplastic disease
6. Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of PNH associated thrombosis or a PNH clone \> 50% by flow cytometry
7. Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
8. Subject is pregnant (e.g. positive HCG test) or is breast feeding
9. Severe uncontrolled infection or unexplained fever \> 38oC
10. Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months

Primary outcomes:
measure: Response
timeFrame: 2 years
Secondary outcomes:
measure: Over all survival
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Ahmed Al Zahrani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02170155: MRI-changes in Morphometry and Cerebro Spinale Fluid (CSF) Flow in Spinal Cord Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Injury
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Foundation Wings For Life
name: Balgrist Foundation
First posted: 2014-06-23
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with spinal cord disorder and CSM

Brief summary: Understanding the onset and progression of spinal cord disorders is an important aim in clinical neurology. An early diagnosis with consequent therapy might prevent the progression of disability. Therefore, we aim to determine structural and dynamic changes in the microstructure of the spinal cord and CSF, and to explore the relationships between the MRI parameters, clinical disability, and electrophysiology.

In some patients that undergo decompressive surgery CSF pressure will be measured invasive perioperative for 24h to find out if functional limitations and structural changes correlate with the spinal pressure and the spinal perfusion when the spinal cord is damaged.


Eligibility criteria: Inclusion Criteria:

* Cervical injury
* Informed consent
* Age 18-80
* CSM

Exclusion Criteria:

* No other neurologic disorder and psychiatric disorder
* Seizure
* MRI incompatibility
* Pregnancy

Primary outcomes:
measure: Morphometric changes and changes in cerebro spinal fluid (CSF) flow and spinal cord movement in patients and control subjects will be correlated to functional deficits and neurophysiological data (regression model analysis).
timeFrame: Each patient will undergo a MRI scan, clinical and electrophysiological examinations at baseline, after 6 months and after 1, 2, 3, 4, and 5 years. Controls will undergo 1 MRI scan and some scan of retest analysis
measure: Assessment of CSF pressure dynamics in the perioperative setting
timeFrame: Perioperative for 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich, Balgrist University Hospital
Study officials:
References:
citation: Zipser CM, Pfender N, Spirig JM, Betz M, Aguirre J, Hupp M, Farshad M, Curt A, Schubert M. Study protocol for an observational study of cerebrospinal fluid pressure in patients with degenerative cervical myelopathy undergoing surgical deCOMPression of the spinal CORD: the COMP-CORD study. BMJ Open. 2020 Sep 21;10(9):e037332. doi: 10.1136/bmjopen-2020-037332.
Clinical trial NCT06834555: Mobile Phone Thermal Imaging Assessment of Incompetent Perforator Veins
Official title: Can Mobile Phone Thermal Imaging Provide an Ambulatory Assessment of Incompetent Perforator Veins?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Venous Disease
Lead sponsor: Guangdong Second Provincial General Hospital
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Chronic venous disease is a common disease of the lower limbs. Severe CVD can lead to lower limb swelling, pigmentation, and repeated skin ulceration, which seriously affects patients' quality of life. About 10.5% to 92.7% of CVD patients with recurrent varicose veins had insufficient perforating veins. Treatment of these IPVs can promote venous ulcer healing and reduce the recurrence rate of venous ulcers. Accurate assessment and positioning of insufficient perforating veins in the lower leg is a key step in developing a personalized treatment strategy. At present, Color Doppler ultrasonography performed in the upright position in combination with the Valsalva maneuver or local pressure of the limb is regarded as the "gold standard" for the diagnosis of perforating veins insufficiency. However, in China, a large number of perforating veins insufficiency are diagnosed by venography. Because the majority of Chinese vascular surgeons are not versatile in vascular ultrasound examination and venous ultrasound protocols vary from institution to institution. A non-functioning valve in an insufficient perforated vein allows blood to flow retrograde from a deep vein to a superficial vein. Some researchers have shown that the venous blood temperature of deep veins is higher than that of superficial veins. Thus, the retrograde flow of "warm blood" from the deep vein to the superficial vein increases the skin temperature located on the insufficient perforated vein. This study tested the feasibility of a smartphone and its compatible portable thermal imaging device as a tool for assessing insufficient perforated vein. The objective is to study the sensitivity and specificity of smartphone thermal imaging in diagnosing and locating the insufficient perforated vein in CVD patients.


Eligibility criteria: Inclusion Criteria:

A diagnosis of CVD by vascular surgeon, classified C0 to C6 according to CEAP (Clinical-Etiology - Anatomy - Pathophysiology) No history of lower extremity surgery The body mass index (BMI) is 18 to 35 kg/m2

Exclusion Criteria:

deep vein thrombosis heart disease peripheral artery disease chronic liver disease chronic kidney disease pregnancy severe obesity (BMI ≥35 kg/m2)

Primary outcomes:
measure: sensitivity and specificity of smartphone thermal imaging in diagnosing and locating the insufficient perforated vein in CVD patients
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05338255: Results of the Application of the Clinical Pathway of Intensified Recovery Surgery for Adults in the Processes of Total Knee and Hip Replacement at the Maz Hospital
Official title: Evaluation of the Clinical Pathway of Intensified Recovery Surgery for Adults in the Processes of Total Knee and Hip Replacement at the Maz Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Knee
Arthropathy of Hip
Keywords: Arthroplasty
Fast-track surgery
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who is attended at MAZ Hospital.

Brief summary: The investigators are going to study all the patients who have undergone surgery at the MAZ hospital from 2019 to the present for knee replacement and hip replacement. The investigators want to analyze the results to see if applying the RICA clinical pathway results are better.


Eligibility criteria: Inclusion Criteria:

* Adults, over 18 years old.
* Diagnosis of moderate-severe gonarthrosis or moderate-severe coxarthrosis.
* Patients who are operated by orthopedic surgeons at MAZ Hospital with knee or hip arthroplasty.
* Between January 2019 and June 2022.
* ASA I-II-III.

Exclusion Criteria:

* ASA IV.
* Minors.

Primary outcomes:
measure: Degree of compliance with the criteria for performing surgery according to the clinical pathway
timeFrame: One month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Silvia Gómez Gómez
Study officials:
References: