louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03332381: Attention Training Technique and Mindful Self-Compassion
Official title: A Randomized Controlled Trial Comparing the Attention Training Technique and Mindful Self-Compassion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Stress, Psychological
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: The design of the study is a randomized controlled trial. A total of 80 students with self-reported symptoms of stress/anxiety/depression will be invited to take part in a 3-session course consisting of either attention training or self-compassion/mindfulness based meditation. Attention training involves modifying metacognitive control and enhancing attention flexibility so that people can refrain from responding to intrusions with extended processing. Self-compassion involves not avoiding painful or distressing feelings. Instead these experiences are held in awareness with kindness, understanding, and a sense of shared humanity.


Eligibility criteria: Inclusion Criteria:

* self reported symptoms of stress/anxiety/depression

Exclusion Criteria:

-

Primary outcomes:
measure: Change in symptoms of depression as assessed with the Patient Health Questionnaire-9
timeFrame: Baseline, immediately after last session, 6 months after intervention
measure: Change in symptoms of anxiety as assessed with the Generalized Anxiety Disorder-7 scale
timeFrame: Baseline, immediately after last session, 6 months after intervention
Secondary outcomes:
measure: Changes in self-compassion as assessed by the Self-Compassion Scale Short Form
timeFrame: Baseline, immediately after last session, 6 months after intervention
measure: Changes in the attention flexibility subscale of the Detached Mindfulness Questionnaire
timeFrame: Baseline, immediately after last session, 6 months after intervention
measure: Changes in mindfulness as assessed with The Five Facet Mindfulness Questionnaire
timeFrame: Baseline, immediately after last session, 6 months after intervention
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Psykologisk Institutt, Dragvoll
Study officials:
affiliation: Norwegian University of Science and Technology
name: Magne Flaten, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT03364881: Anatomical Classifications of Henle's Trunk
Official title: Multicenter Clinical Trial of Anatomical Classifications of Henle's Trunk in Laparoscopic Right Hemi-colectomy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mesenteric Vein
Colorectal Surgery
Henle's Trunk
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is a prospective study，and based on the number of branches, the anticipant populations of this study is 500.

Brief summary: Right colon has complicated anatomy which is surrounded by important organs. The variations of vessels are more frequent than in left colon, which contribute to the difficulty of surgery. Among the variations, Henle's trunk is more obvious that makes it the commonest cause of bleeding during operation. Several veins can be found to conjoin the Henle's trunk, among which ASPDV and REGV are the two common tributaries while RCV,MCV,SRCV may vary from people to people. As a result, a better understanding of the anatomical classification of Henle's trunk is a must during operation. However, existing studies of Henle's trunk are very rare and often single-centered with minimal samples.In order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of Henle's trunk and the surgical outcome of each type.


Eligibility criteria: Inclusion Criteria:

1. Patients who undergoing laparoscopic right hemi-colectomy with D3 lymphadenectomy
2. Pathology: adenocarcinoma or high-grade intraepithelial neoplasia proven by colonoscopic biopsy.
3. Localization: tumor located between cecum and proximal 1/3 portion of transverse colon.
4. Patients have to be aware of the aim of the trial, and have signed the informed consent.

Exclusion Criteria:

1. History of any gastrointestinal surgery.
2. Patients with ileus, perforation, bleeding and any other conditions required of emergent surgery.

Primary outcomes:
measure: classifications of Henle's trunk
timeFrame: 2 yeas
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospttal
state: Sahgnhai
Study officials:
References:
Clinical trial NCT01915381: Improving Adherence Healthy Lifestyle With a Smartphone Application Based on Adults With Intellectual Disabilities
Official title: Improving Adherence Healthy Lifestyle on a Smartphone Based on Complementation Adults With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Keywords: Intellectual disability
mHealth
App
Physical activity
Adherence
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: AIM: Improve adherence to physical activity in people with Intellectual disabilities with a Smartphone Application DESIGN: Randomized controlled trial SUBJECTS OF THE STUDY: People with intellectual disabilities in Occupational Center ( ASPROMANIS) INTERVENTION: DATA ANALYSIS: descriptive statistics, measuring central tendency and dispersion of the variables study. Inferential statistics will be made between intervention of key variables and outcome


Eligibility criteria: Inclusion Criteria:

* Participants were can write and read to ask scales
* Participant were able to use an Smartphone

Exclusion Criteria:

* Physical illness that prevent physical activity

Primary outcomes:
measure: International Physical activity Questionnaire
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Barthel index
timeFrame: baseline; 8; 18 and 28 weeks
measure: Social Support and Self efficacy SS/SE AID
timeFrame: baseline; 8; 18 and 28 weeks
measure: FunFitness
timeFrame: baseline; 8,18 and 28 weeks
measure: Internatioanl Physical Activity Questionnaire (IPAQ)
timeFrame: Changes from 8 weeks during follow up 18 and 28 weeks
Other outcomes:
Locations:
city: Torremolinos
country: Spain
facility: Patronato Municipal de deportes de Torremolinos
state: Malaga
Study officials:
affiliation: University of Malaga
name: Antonio I Cuesta Vargas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perez-Cruzado D, Cuesta-Vargas AI. Improving Adherence Physical Activity with a Smartphone Application Based on Adults with Intellectual Disabilities (APPCOID). BMC Public Health. 2013 Dec 13;13:1173. doi: 10.1186/1471-2458-13-1173.
Clinical trial NCT05333081: Glycemic Index of Italian Rice Varieties
Official title: Determination of the Glycemic Index of 25 Italian Rice Varieties
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glycemic Index
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The service commissioned by the National Rice Authority required the evaluation of the Glycemic Index of 25 varieties of rice. As a reference, both for the comparison and for the calculation of the Glycemic Index, glucose was used, which clearly has characteristics of greater uniformity than white bread and was preferred because it is better suited to be used as a standard of measurement. In accordance with the ISO 26642 standard, a panel of selected volunteers (consisting of 10 subjects), healthy, not suffering from diabetes or other pathologies of glucose metabolism, were included in the study. As per protocol, the changes in glycaemia of all the subjects involved were evaluated after the intake of glucose (50g), as a standard food, and of rice (50g of available carbohydrates), taking into account the carbohydrate content of each variety. to determine the amount of rice to be fed. The test of each food was carried out for a maximum time of 120 minutes, by carrying out repeated measurements of the glycaemia of all subjects at a distance of 0, 15, 30, 45, 60, 90 and 120 minutes from the administration of the sample in order to obtain a glycemic curve for each sample considered.

From the analysis of the area underlying the glycemic curve of each variety, it was possible to determine the Glycemic Index.


Eligibility criteria: Inclusion Criteria:

* no known foood allergy or intolerance
* no medications to affect glucose tolerance

Exclusion Criteria:

* Diabetes mellitus or insulin disorders
* major event or surgical procedure requiring hospitalization within the preceding 3 months
* disease or drugs that influcence digestion and absorbtion of nutrients
* the use of steroids, protease inhibitors or antipsychotics

Primary outcomes:
measure: Evaluation of glucose response
timeFrame: From baseline to 120 min after rice consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona
Study officials:
References:
Clinical trial NCT02486081: Development and Application-Smart Football for Movement Evaluation and Training in the Special Education Population
Official title: Assistive Device Design, Development and Application-Smart Football for Movement Evaluation and Training in the Special Education Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intellectual Disability
Keywords: Assistive device
the disabled
special education
movement analysis
system development
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 10
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: children with intellectual disabilities

Brief summary: Children with disabilities are frequently ignored by the general population, hence the development of movement evaluation and training devices for use in special education settings are relatively overlooked. Usually the performance of these children is not stable and contains variations. Hence in order to get a complete picture of their sport performance, simply measuring movement time and distance is definitely not representative. With the rising attention from government regarding fitness and social participation of the disabled in recent years, developing a special-designed individual evaluation \& training plan is of great importance. To achieve this goal, a device which is able to record the complete process of movement, and contains algorithm that can pick up the movement characteristics of children with disabilities is needed. The purpose of this study is to design and develop a smart soccer ball system for use in children with intellectual disabilities(ID), and to compare the performance between children with ID and the typically developed.


Eligibility criteria: Inclusion Criteria:

1. Intellectual disabilities (ID) group:

   * children with mild to moderate intellectual disabilities.
   * able to walk independently
   * can follow simple commands
2. Typical developed children:

   * age-matched TD children

Exclusion Criteria:

1. fracture or receive orthopedic surgery within six months.
2. Participate in regular soccer training.

Primary outcomes:
measure: acceleration (in m/sec square)
timeFrame: one week
measure: distance completed (in meters)
timeFrame: one week
measure: time (in second)
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: TaoYuan
country: Taiwan
facility: National TaoYuan Special School
city: Taoyuan
country: Taiwan
facility: Chang Gung Univ.
Study officials:
References:
Clinical trial NCT02582281: Non Touch Technique for IUD Insertion
Official title: The Non Touch Technique for Intrauterine Device Insertion, a Single Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contraception
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The non touch technique is a modification of the traditional intrauterine device insertion technique. It abolishes the use of Allis and uterine sounding.


Eligibility criteria: Inclusion Criteria:

* Females desiring contraception with the use of IUD

Exclusion Criteria:

* Are pregnant or think they may be pregnant
* Septic pregnancy or abortion
* Have unexplained abnormal vaginal bleeding
* Have untreated cervical cancer
* Have malignant gestational trophoblastic disease
* Have uterine cancer
* Have uterine abnormalities
* Have or may have had a pelvic infection within the past three months
* Have or may have any sexually transmitted disease
* Have pelvic tuberculosis
* Are postpartum between 48 hours and 4 weeks
* Have benign gestational trophoblastic disease
* Have ovarian cancer
* Have AIDS (unless clinically well on anti-retroviral therapy)

Primary outcomes:
measure: degree of pain during IUD insertion
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina M Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05868681: Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability
Official title: Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Instability, Joint
Keywords: Ankle instability
Stabilometry
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to evaluate post-operatively the postural control through the Delos system with the Riva method of patients already treated surgically of external capsulo-ligament reconstruction due to ankle instability.

Detailed description: The patients will then be divided into two control groups: one group will undergo reconditioning through the Delos system and one group will undergo standard rehabilitation treatment.

Primary outcome: improvement of joint stability and postoperative proprioception after reconditioning with the Delos system.

Secondary outcomes: improvement of performance indicators and reduction of disability and satisfaction and assessment of long-term ankle stability after reconditioning with Delos system.

Eligibility criteria: Inclusion Criteria:

* patients already undergoing surgery and with at least 4 months of follow-up;
* patients of both sexes aged between 18-40 years;
* patients who have given their informed written consent to participate in the study;
* patients who have given the willingness to reach the Hospital to carry out the checks.

Exclusion Criteria:

* patients with BMI\> 30 kg / m2;
* patients with rheumatoid arthritis;
* patients with chronic inflammatory joint diseases;
* patients with pre-existing deambulation kinematics abnormalities (amputations, neuro- muscular diseases, polio, hip dysplasias);
* patients with Severe arthrosis of the ankle (Kellgren-Lawrence\> 3);
* patients with Severe knee arthritis (Kellgren-Lawrence\> 3);
* patients with severe postural instability;
* patients with cognitive impairments;
* patients with concomitant neurological diseases.

Primary outcomes:
measure: Static and Dynamic Stability Index
timeFrame: 5 weeks from the start of rehabilitation treatment
Secondary outcomes:
measure: Personal perception of the patient
timeFrame: 5 weeks from the start of rehabilitation treatment
measure: Clinical test
timeFrame: 5 weeks from the start of rehabilitation treatment
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopedic Institute (IOR)
Study officials:
References:
Clinical trial NCT02541981: Natural Course for Renal Function After Heart Transplantation
Official title: Natural Course for Renal Function After Heart Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Creatinine Clearance Quantitative Trait Locus
Keywords: Heart transplant
renal insufficiency
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 500
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: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: heart transplantation

Brief summary: The outcome of heart transplantation has improved by years. The renal dysfunction is a major complication after heart transplantation.The natural course of renal function following orthotopic heart transplant is not clear in Taiwan. A retrospective study was conducted on patients who received a heart transplant at National Taiwan University Hospital between 1987 and 2015.

Detailed description: The investigators conducted a retrospective cohort study of patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015 . Clinical data were obtained and a retrospective chart review, and were collected up to 10 years .

Data was collected from medical records and the heart transplant electronic database including: demographic parameters such as age and gender; etiology of heart failure; the presence of any of the following comorbidities: history of smoking, diabetes, hypertension, peripheral vascular disease and previous sternotomy; pre-transplant cholesterol levels; the use of any of the following pretransplant hemodynamic support measures:intravenous inotropes, intra-aortic balloon pump and ventricular assist device;creatinine levels; listing status according to the UNOS classification; waiting time; heart ischemic time;immunosuppression drug levels(cyclosporine,prograft or certican) and development of end stage renal disease requiring onset of dialysis therapy.

Creatinine levels and GFRwere collected before transplantation and then the closest level to every month after heart transplant.

The clinical outcomes of interest analyzed in this study included the development of post-transplant end stage renal disease and death.

Eligibility criteria: This study included patients with a first HTx performed at NTUH between1987 and 2015.

Patients were excluded if their first HTx was a combined transplant involving a KTx, they had renal replacement therapy prior to their HTx.

Primary outcomes:
measure: Natural course for renal function (ex blood creatine leveal ,eGFR) after heart transplantation
timeFrame: patients who received a first heart transplant at the NTUH(Taiwan) between 1987 and 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Professor , School of Nursing, National Taiwan University
name: Chen Cheryl Chia-Hui, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04738981: Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT
Official title: Efficacy and Safety of UC-MSCS for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT: A Multicenter, Randomized, Open-label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Graft Vs Host Disease
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
name: Third Military Medical University
name: Sun Yat-sen University
First posted: 2021-02-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for steroid-resistant aGVHD.

Detailed description: A total of 130 patients with steroid-resistant aGVHD after allo-HSCT are enrolled in this multicenter, randomized, controlled trial. Patients were randomized to UC-MSC + anti-CD25 monoclonal antibodies (mAb) group and anti-CD25 mAb group. The complete response (CR) rate after 4 weeks of treatment in the two groups will be compared. Adverse events are also recorded throughout the study.

Eligibility criteria: Inclusion Criteria:

* 1.Confirmed diagnosed steroid-resistant aGVHD after allo-HSCT. 2. Neutrophile granulocyte (ANC) ≥ 0.5 x 10\^9/L. 3. Creatinine below 2 times normal upper limit . 4. Willing and able to sign written informed consent.

Exclusion Criteria:

- 1. Untoleratation of the treatment. 2. Primary disease are not effectively controlled or are progressing. 3. Active infection (Bacteria, fungi, viruses ). 4. Combined with dysfunction of multiple organ. 5. Female patients who are nursing or pregnant, or who contemplate pregnancy during the study period.

6. Patients who are deemed unsuitable for the study by the investigator.

Primary outcomes:
measure: Rate of complete remission
timeFrame: 4 weeks after treatment
Secondary outcomes:
measure: Overall survival
timeFrame: At the end of Week 4 / 8 / 12 / 24 / 52.
measure: Rate of partial remission
timeFrame: 4 weeks after treatment
measure: Infusion toxicity
timeFrame: From the beginning of to four hours after every infusion of UC-MSC
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Insititute of Hematology, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital, Peking University Insititute of Hematology
name: Xiaohui Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References: