louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06622993: Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders
Official title: Effectiveness of the SKILLS Program in the Management of Psychiatric Disorders: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychiatric Disorders
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 60
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: SUPPORTIVE_CARE

Brief summary: Epidemiological studies show that one person in eight suffers from at least one psychiatric disorder. Mental health is therefore a major public health issue, and care for these disorders must continue to be improved.

The management of mental disorders has long followed the traditional categorical approach of developing a treatment for a given disorder. However, researchers have recently pointed out the limits of this approach in the field of mental health. They highlight the large number of co-morbidities, the existence of aspecific disorders and the intra-diagnostic heterogeneity of patients. These factors have led them to develop a transdiagnostic approach, which focuses on the mechanisms common to the various disorders in order to treat them at the same time and thus reduce the cost of treatment.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years of age
* Have at least one diagnosis of a psychiatric disorder
* Be able to carry out psychotherapy sessions
* Have been on stable psychiatric medication for 30 days
* Written informed consent obtained from the participant
* Be affiliated to a social security scheme or equivalent

Exclusion Criteria:

* Cognitive deficits marked by a score above the 10th percentile for one or more tests in the assessment history.
* Persons deprived of liberty by judicial or administrative decision; Persons under legal protection: guardianship or curatorship
* Presence of a severe depressive episode
* Be engaged in psychotherapeutic work elsewhere
* Presence of a state of excessive deficit, making psychotherapy impossible
* Presence of psychic decompensation (e.g. delusions) making psychotherapy impossible

Primary outcomes:
measure: Evolution in Symptom Checklist Scale (SCL 90) scores between randomization and Month 3
timeFrame: At the randomisation and Month 3
Secondary outcomes:
measure: Evolution of Transdiagnostic Skills Scale (T2S) score
timeFrame: At randomisation, Month 3 and Month 6
measure: Evolution of Symptomatic Transdiagnostic Test (S2T) score
timeFrame: At randomisation, Month 3 and Month 6
measure: Evolution of Hosptital Anxiety Depression Scalre (HADS) score
timeFrame: At randomisation, Month 3 and Month 6
measure: Evolution of Satisfaction with Life Scale (SWLS) score
timeFrame: At randomisation, Month 3 and Month 6
measure: Cumulative quantity of psychotropic treatment taken by patients (in mg)
timeFrame: At randomisation, Month 3 and Month 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02845193: Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial
Official title: Effect of A Novel (Modified Grayson) Technique for Nasoalveolar Molding and Taping on Parents' Satisfaction and Short Term Treatment Outcomes in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 63
Sex: ALL
Minimum age (years): 7
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.

Detailed description: In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome.

Eligibility criteria: Inclusion Criteria:

1. Infants with age range from 7 - 30 days.
2. Unilateral complete cleft lip and alveolus.
3. Presence of unilateral cleft palate.
4. Medically free subjects.
5. Both males and females.

Exclusion Criteria:

1. Patients older than 30 days.
2. Syndromic patients with other defects in addition to cleft lip and palate.
3. Patients with bilateral cleft lip and palate.
4. Incomplete Cleft lip.
5. Medically compromised patients.

Primary outcomes:
measure: Parents' satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Nasal Esthetics: a- Nostril height
timeFrame: 3 months
measure: Nasal Esthetics: b- Nostril width
timeFrame: 3 months
measure: Nasal Esthetics: c- Nasal sill height
timeFrame: 3 months
measure: Nasal Esthetics: d- Nostril area
timeFrame: 3 months
measure: Interlabial gap
timeFrame: 3 months
measure: Maxillary Arch Dimension
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT03518593: Evaluation of NICHE Programme Activities in Kenya
Official title: Evaluation of NICHE (Nutritional Improvements Through Cash and Health Education) Programme Activities in Kitui and Machakos, Kenya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Growth Disorders
Malnutrition
Lead sponsor: Kimetrica LLC
Sponsor class: INDUSTRY
Collaborators: name: UNICEF
name: European Commission
First posted: 2018-05-08
Enrollment: 800
Sex: ALL
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the impact of additional cash and nutritional counselling on nutrition outcomes in pregnant women and children up to the age of two years in CT-OVC (cash transfer- orphan and vulnerable children) households in Kitui and Machakos counties of Kenya. The control arm households will receive their normal CT-OVC cash payment and the intervention arm will receive an additional cash payment and nutritional counselling.


Eligibility criteria: Inclusion Criteria:

* Pregnant women and children aged up to 23 months of age in households receiving CT-OVC cash transfers in Kitui and Machakos counties of Kenya

Exclusion Criteria:

* not residing in CT-OVC households

Primary outcomes:
measure: Stunting
timeFrame: 8-15 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kimetrica LLC
name: Helen Guyatt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04242693: Mobile Goal-setting Intervention to Improve Vegetable Intake Among Young College Students
Official title: Effectiveness of Self-Monitoring and Goal Setting on Improving Consumption of Red/Orange Vegetables Among Undergraduate Students: A Pre-Posttest Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to either an experimental or a control group after they completed a preliminary questionnaire.
Primary purpose: PREVENTION

Brief summary: This study used a two-group pre-posttest experimental design. After completing a background survey, participants used their smartphones to uploaded photos and/or descriptions of their meals to an online platform for three days. In addition, those in the intervention group were asked to use a checklist to count the number of times they ate red/orange vegetables and to set a goal to eat one more time the next day. The dependent variable was a measure of eating behavior-an estimate (number of times/day) of red/orange vegetable intake on that day based on review of uploaded photos and descriptions. Those in the intervention group, who were asked to use a checklist to count their red/orange vegetable intake and set a goal to eat one more the next day, improved their vegetable intake.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and above
* Undergraduate at the university
* Currently lived in a dorm
* Owned a smartphone
* Had internet access on their smartphone

Exclusion Criteria:

* Already part of a study to change their eating behaviors

Primary outcomes:
measure: Red/orange vegetable intake
timeFrame: Three days
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Susan E Middlestadt, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06270693: hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis
Official title: Effect of Endodontic Treatment on Serum High Sensitivity C-reactive Protein and Complete Hemogram Indices in Patients With Cardiovascular Disease With and Without Apical Periodontitis: A Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Apical Periodontitis
Coronary Artery Disease
Keywords: apical periodontitis
coronary artery disease
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure.

Detailed description: Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure. Systemic inflammatory burden is assessed before and after endodontic treatment.

Eligibility criteria: Inclusion Criteria:

* Coronary artery disease patients with and without chronic pulp exposure

Exclusion Criteria:

* Other systemic diseases
* Antibiotics for More than 1 month
* Smoking
* Analgesics more than 1 week

Primary outcomes:
measure: Serum hsCRP
timeFrame: 12 months
measure: complete hemogram indices
timeFrame: 12 months
Secondary outcomes:
measure: Periapical index SCORE CHANGE
timeFrame: 12 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
affiliation: Post Graduate Institute Of Dental Sciences,Rohtak
name: DR SANJAY TEWARI, MDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04263493: Delayed Loading Following Repair of a Ruptured Achilles Tendon
Official title: Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Achilles Tendon Surgery
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 48
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: The purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year.

The investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with a traumatic, complete mid-substance Achilles tendon
* No contraindications for MRI
* Presented within 14 days from injury
* Adult (18 to 60 years)
* Understand Danish
* Manage transport to/from the hospital on their own

Exclusion Criteria:

* Other injuries affecting their lower limb functions
* Prior Achilles tendon Rupture
* Smoking
* Systemic diseases influencing tendon healing
* Anticoagulation treatment
* Inability to follow rehabilitation or complete follow-ups
* Immunosuppressive treatment including systematic corticosteroid treatment

Primary outcomes:
measure: Heel-rise test
timeFrame: One-year follow-up
Secondary outcomes:
measure: Tendon length and cross-sectional area
timeFrame: 1 week, 3 months, 6 months and 1 year
measure: The Achilles tendon rupture score (ATRS)
timeFrame: Recall before injury and 1 year
measure: Muscle fascicle length and doppler activity in the tendon
timeFrame: 2 weeks, 3 months, 6 months and 1 year
measure: Isokinetic plantar flexion muscle strength
timeFrame: 1 year
measure: Physical activity level
timeFrame: Recall before injury and 1 year
measure: Heel-rise work
timeFrame: 6 months and 1 year
measure: The Achilles tendon resting angle (ATRA)
timeFrame: 2 weeks, 3 months, 6 months and 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Institute of Sportsmedicine
name: Peter Magnusson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04030793: Individualized Transcranial Direct Current Stimulation for Gait Function in Healthy Subjects
Official title: Individualized Transcranial Direct Current Stimulation for Gait Function in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Adults
Healthy Aging
Keywords: Brain Stimulation
Transcranial direct current stimulation
Motor function
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 19
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the effects of individualized brain stimulation based on simulation and conventional brain stimulation in healthy adults.


Eligibility criteria: Inclusion Criteria:

• Healthy adult men and women without history of central nervous system disease and abnormalities

Exclusion Criteria:

* Under 18 years old, 75 years old or older
* A person who has inserted a metal object in a skull
* A person with complete occlusion of the carotid artery
* A person with epilepsy
* Pregnant and lactating women
* Who is not eligible for the test

Primary outcomes:
measure: Changes in cortical activation
timeFrame: Change from baseline (before stimulation) after stimulation during 30 min
Secondary outcomes:
measure: 10 meter walk test (10MWT)
timeFrame: Before stimulation (baseline); After strimulation during 30 min
measure: Timed Up and Go test (TUG)
timeFrame: Before stimulation (baseline); After strimulation during 30 min
measure: Gait analysis using surface electromyograph
timeFrame: Before stimulation (baseline); After strimulation during 30 min
measure: Gait analysis using motion analysis system
timeFrame: Before stimulation (baseline); After strimulation during 30 min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01647893: Phase 1 Single Dose Escalation Study of CTB-001
Official title: A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: HLB Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 33
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects


Eligibility criteria: Inclusion Criteria:

* Adult males aged 20 to 40 years at screening.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
* History of known hypersensitivity to drugs including CTB-001

Primary outcomes:
measure: Safety
timeFrame: Up to 7 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul,
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03596411: The Detection of Barrett's Esophagus by Gastrointestinal Endoscopy Prevents Esophageal Carcinoma in Morbid Obese After Sleeve Gastrectomy
Official title: Refleeve : A Retrospective Study to Evaluate the Prevalence of the Barett's Esophagus by Gastro-osephagal Endoscopy in Morbid Obese Patients Treated by Sleeve Gastrectomy and the Advantage of the Systematic Detection in the Prevention of Esophageal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Reflux
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gastroesophagal reflux disease (GERD) in morbid obese after sleeve gastrectomy

Brief summary: Severe Gastroesophageal reflux disease (GERD) leading to a chronic aggression of esophagus mucosa, called Barrett's esophagus is a main complication of Sleeve gastrectomy for morbid obesity. Barrett's esophagus is considered as a early stage of neoplastic transformation to adenocarcinoma. Since this last years, six european bariatric centers have adopted the policy to realize endoscopy before and five years or more after sleeve gastrectomy. Investigators worked out a database comprizing the Endoscopic features and patient characteristics. Refleeve projet aim to analyse the long term follow-up datas of 100 patients, evaluate the prevalence of Barret's esophagus and investigate the advantage of the systemetic detection to prevent esophagus adenocarcinomas.


Eligibility criteria: Inclusion Criteria:

* Patients who had had SG with a minimum follow-up of 5 years, without signs of Barrett's esophagus before SG;
* An upper GI endoscopy before the SG;
* An upper GI endoscopy indicating that no Barrett's esophagus was present at the time of the SG;
* An upper GI endoscopy done with the scope of searching for the endoscopic anomalies of the Barrett's esophagus according to the international guidelines for the diagnosis of Barrett's esophagus 9.
* Endoscopic biopsies according to the international guidelines for the diagnosis of Barrett's esophagus 9.

Exclusion Criteria:

* SG as a conversional procedure from another bariatric procedure such as the gastric banding;
* No upper GI endoscopy before the SG
* Barrett's esophagus before the SG;
* A second procedure after the SG such as the conversion to Roux-en-Y gastric bypass or duodenal switch;
* An upper GI endoscopy done not following the international guidelines for the diagnosis of Barrett's esophagus9.

Primary outcomes:
measure: Sleeve gastrectomy
timeFrame: 5 years
Secondary outcomes:
measure: Obesity related comorbidity
timeFrame: 5 years
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes Maritimes
Study officials:
affiliation: Chirurgie Digestive, CHU de Nice
name: IANNELLI Antonio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07007611: The Role of Surgical Resection AND Stereotactic Radiosurgery in Primary Central Nervous System -Diffuse Large B Cell Lymphoma
Official title: The Role of Surgical Resection AND Stereotactic Radiosurgery in PCNS-DLBCL: A Retrospective Analysis of Clinical Benefits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Central Nervous System Diffusing Large Cell Lymphoma
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective analysis was conducted on data from patients diagnosed with primary central nervous system diffuse large B-cell lymphoma (PCNS-DLBCL) at Nanfang Hospital between December 2006 and December 2023. A total of 76 patients were included in this study, with follow-up continuing until July 2024.

Brief summary: The objective of this observational study is to understand the long-term impact of surgery and gamma knife treatment on primary central diffuse large B-cell lymphoma. The main questions it aims to answer are:

Can surgery and gamma knife prolong the survival period of patients with primary central diffuse large B-cell lymphoma? Participants who have already incorporated surgery and gamma knife as part of the routine medical care for patients with primary central diffuse large B-cell lymphoma will answer questions about survival period within 5 years.


Eligibility criteria: Inclusion Criteria:

pathologically confirmed PCNS-DLBCL complete clinical records detailing treatment methods and surgical approaches.

Exclusion Criteria:

incomplete systemic treatment data loss to follow-up after initial contact prior receipt of whole-brain radiotherapy.

Primary outcomes:
measure: Overall survival
timeFrame: December 2006 and December 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: