louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06731283: Evaluation of Serological Markers of Vitiligo Activity
Official title: Evaluation of Serological Markers of Vitiligo Activity
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vitiligo
Keywords: biomarker
vitiligo
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Dermatology Department of Hospital de Clínicas de Porto Alegre

Brief summary: The goal of this case-control study is to evaluate the possible applicability of CXCL10, CXCL9, CCL20, and homocysteine as biomarkers of disease activity in vitiligo patients and to compare the levels of these markers with those in healthy controls.

Detailed description: The diagnosis and prognosis assessment in patients with vitiligo are essentially clinical. There are still no validated and established serological markers to objectively assist in defining disease activity. Objective: To evaluate the potential use of the biomarkers CXCL9, CXCL10, CCL20, S100B, and homocysteine to identify disease activity in vitiligo, comparing their values with controls. Methods: A case-control study using previously collected peripheral blood samples from patients aged 18 years or older with a diagnosis of vitiligo and from controls without the disease. The project was approved by the institution's ethics committee. Tests were conducted using ELISA and Luminex kits to measure CXCL9, CXCL10, CCL20, and S100B. For homocysteine, the chemiluminescence method was used.

Eligibility criteria: Inclusion Criteria:

* Vitiligo
* Older than 18 years

Exclusion Criteria:

* Not having diagnosis of vitiligo
* Less than 18 years

Primary outcomes:
measure: Biomarkers levels
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Tania Cestari, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01581983: Mindfulness Meditation Format Pilot Study
Official title: Mindfulness Meditation Format Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Posttraumatic Stress Disorder
Depression
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 8
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess feasibility of an internet and individual format of mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression symptoms

Detailed description: Internet and individual formats of mindfulness meditation have not been previously evaluated. In order establish feasibility of such formats a pilot study is need. The current study will randomize up to 20 people with PTSD and depression symptoms and evaluate changes in PTSD and depression symptoms from before to after the internet and individual mindfulness meditation interventions.

Eligibility criteria: Inclusion Criteria:

* Good general health
* Age 25-65
* Access to internet
* PTSD symptoms (score \>14 on PTSD screen)
* Depression symptoms (endorsement of one question on depression screen)
* Stable on medications six weeks prior to the study
* Willing to be stable on medications during study

Exclusion Criteria:

* Significant potentially life-limiting acute medical illness
* Risk for suicide
* \>2 drinks/day of alcohol and street drug use besides marijuana
* Current daily meditation practice

Primary outcomes:
measure: Posttraumatic Stress Disorder Checklist
timeFrame: Change from baseline to week 7.
measure: Beck Depression Inventory
timeFrame: Change from Baseline to Week 7
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT04659083: How NAVA Works in Preterm Infants With Irregular Respiratory Efforts
Official title: How NAVA Works in Preterm Infants With Irregular Respiratory Efforts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infants
Neurally Adjusted Ventilatory Assist
Ventilator Lung; Newborn
Mechanical Ventilation
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
First posted: 2020-12-09
Enrollment: 18
Sex: ALL
Minimum age (years): 0
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We included preterm infants born before 36 weeks of gestation who received at least 24 hours of ventilatory support with invasive or non-invasive NAVA using a Servo-i or Servo-n ventilator (Getinge, Gothenburg, Sweden).

Brief summary: For the infant participating the study, ventilator settings and respiratory variables will be recorded every day and exported to a specific computer using the Servo Record Viewer version 1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Collected data gives the value for peak inspiratory pressure (PIP), expiratory tidal volume (Vt), peak Edi, minimum Edi, measured respiratory rate (RR), neural respiratory rate (nRR) and percentage of backup breaths for each minute. All the ventilator data will be inspected and compared with the event logs recorded automatically from the ventilator, which includes all the alarm notification, mode and setting changes, cables connection and disconnection data. Data during disconnection of the Edi cable, malfunction or dislocation of Edi catheter will be excluded from the analysis. The mean values during each day will be computed for each ventilatory variables. If there is a change in the ventilatory setting parameters, we will choose the one which was applied for longer duration in the 24-hour time period.

The following clinical characteristics will be collected from medical records: gestational age at birth, birth weight, gender, the time and amount of feeding, medication during the study days, desaturation events, bradycardia events, suction time and methods.


Eligibility criteria: Inclusion Criteria:

* babies who receiving respiratory support with neurally adjusted ventilatory assist
* babies with informed consents from their parents

Exclusion Criteria:

* babies using anesthetic agents

Primary outcomes:
measure: the amount of backup breaths by the ventilator
timeFrame: during the respiratory support using NAVA, from day 1 until the end of 36 weeks of postmenstrual age
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital Neonatal Intensive Care Unit
Study officials:
References:
citation: Lee J, Parikka V, Lehtonen L, Soukka H. Backup ventilation during neurally adjusted ventilatory assist in preterm infants. Pediatr Pulmonol. 2021 Oct;56(10):3342-3348. doi: 10.1002/ppul.25583. Epub 2021 Jul 26.
Clinical trial NCT00908583: Desensitization in Kidney Transplantation
Official title: Desensitization for Preformed Anti-HLA Antibodies in Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HLA Sensitization
Keywords: Alloantibody
Desensitization
Kidney Transplantation
Nephrology
Plasma Cells
Translational Research/Science
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2009-05-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine if deletional strategies will provide effective desensitization.

Detailed description: A prospective iterative trial of proteasome inhibitor (PI)-based therapy for reducing HLAantibody (Ab) levels was conducted in five phases differing in bortezomib dosing density and plasmapheresis timing. Phases included 1 or 2 bortezomib cycles (1.3mg/m2,6-8 doses), one rituximab dose and plasmapheresis. HLA Abs were measured by solid phase and flow cytometry (FCM) assays. Immunodominant Ab (iAb) was defined as highest HLA Ab level. Forty-four patients received 52 desensitization courses (7 patients enrolled in multiple phases): Phase 1 (n=20), Phase 2 (n=12), Phase 3 (n=10), Phase 4 (n=5), Phase 5 (n=5).

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65
* Voluntary written informed consent
* Patient on deceased donor wait list with a current or peak cytotoxic or calculated panel reactive antibody (PRA) \> 20%

Exclusion Criteria:

* Myocardial infarction within 6 months
* Patient received investigational drug within 14 days prior to initiation of study treatment
* Serious medical or psychological illness
* Diagnosed with malignancy within three years, except complete research of basal cell carcinoma or squamous cell carcinoma of skin, an insitu malignancy or low risk prostate cancer after curative therapy
* Absolute neutrophil count (ANC) \< 1000
* Receipt of live vaccine within 4 weeks of study entry
* Female subject that is breast feeding

Primary outcomes:
measure: Number of Living Donor Transplant Candidates That Are Transplanted
timeFrame: 1 year post baseline
Secondary outcomes:
measure: Overall Safety of Bortezomib
timeFrame: Study Day 62
measure: Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%
timeFrame: 46 days
measure: Acute Rejection Rate
timeFrame: 6 months post transplant
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: E. Steve Woodle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03043183: Enhanced Recovery After Surgery(ERAS) for Gastric Cancer and Perioperative Nutritional Status
Official title: The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition Disorders
Keywords: gastric cancer
Enhanced recovery after surgery
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into perioperational nutrition support group and conventional pathway group . Inter-group differences were evaluated for nutritional index,clinical recovery index, complications etc.


Eligibility criteria: Inclusion Criteria:

* A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy;
* age 18-75 years;
* pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy;
* normal hematological, renal, hepatic, and cardiac parameters,American Society of Anesthesiology (ASA) score \< III without severe systemic disease;
* no history of treatment with neoadjuvant chemotherapy and/or radiotherapy
* PG-SGA score ≥2，\<9

Exclusion Criteria:

* patients requiring conversion to open gastrectomy
* excessive bleeding (˃ 500 mL);and patients opting out of the study.

Primary outcomes:
measure: complication
timeFrame: 30 days after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03856983: Benefits of Observing Point-light Displays in Postoperative Rehabilitation of the Total Knee Prosthesis.
Official title: Benefits of Observing Point-light Displays in Postoperative Rehabilitation of the Total Knee Prosthesis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Surgery
Rehabilitation
Point Light Display
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The LOARAL project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into two groups: a control group where patients will do standard rehabilitation and an experimental group where patients will do standard rehabilitation associated with the judgement of point-light display. The aim of this study is to validate the use of point-light display for the Rehabilitation of patients with a totalarthroplasty of the knee.


Eligibility criteria: Inclusion Criteria:

* Volunteers over 18 years of age who have undergone knee surgery

Exclusion Criteria:

* Any locomotor condition not due to knee surgery
* Uncorrected visual disturbances
* Comorbidity altering locomotion (history of stroke, neurological condition, inflammatory rheumatism)

Primary outcomes:
measure: Compare the evaluation of the point light display relative to conventional rehabilitation
timeFrame: Rehabilitation during 3 weeks
Secondary outcomes:
measure: Compare the evaluation of the point light display on functional recovery
timeFrame: At the end of the program (3 weeks max)
measure: Compare the evaluation of the point light display on the detection and action recognition
timeFrame: At the end of the program (3 weeks max)
measure: Compare the evaluation of the point light display on the feeling of self-efficacy personal
timeFrame: At the end of the program (3 weeks max)
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT03854383: Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women
Official title: Efficacy of Intravaginal Administration of Isosorbide Mononitrate Together With Misoprostol Versus Misoprostol Alone in Induction of Labor in Postdate Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Induction of Labor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will compare between using isosorbide mononitrate together with misoprostol versus the misoprostol alone in induction of labor in postdate women


Eligibility criteria: Inclusion Criteria:

* age (20-35 yrs)
* single fetus
* gestational age \> 40weeks
* not in labor
* bishop score \< 7
* no medical disorder

Exclusion Criteria:

* Gestational age ≤40 weeks
* patient with a ripe cervix
* rupture of membranes
* suspected chorioamnionitis
* placenta previa
* history of major uterine surgery
* hypertonic uterine pattern
* contraindicated to receive PG
* fetal malpresentation
* multiple pregnancy
* intrauterine growth retardation
* women with any general medical disorder

Primary outcomes:
measure: The duration of induction to active phase interval
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams maternity hospital
Study officials:
References:
Clinical trial NCT02893683: Paris Visual Learning Test: a New French Task for Assess Visual Learning and Memory to Multiple Sclerosis Patients
Official title: Paris Visual Learning Test (PVLT): a New French Task for Assess Visual Learning and Memory to Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Paris Visual Learning Test
visual memory
criterion validity
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multiple sclerosis. The test results will be compared to a database including results of healthy control patients.

Brief summary: Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially memory function.

Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165 healthy volunteers were studied for its normalization.

The main objective of the present study is to assess the validity of PVLT by comparing MS patients' test results to a database including the test results of 280 healthy control subjects, following recommended international standards.


Eligibility criteria: Inclusion Criteria:

* multiple sclerosis
* 20-89 years old

Exclusion Criteria:

* acute inflammatory stage of central nervous system (\< 1 month)
* other neurological or psychiatric disease
* regular drug and/or alcohol consumption
* refusal to participate in the study
* no health insurance coverage
* patient under legal protection

Primary outcomes:
measure: test score
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Anne-Claire VIRET-VILAYPHONH
role: STUDY_DIRECTOR
affiliation: Fondation OPH A de Rothschild
name: Olivier GOUT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092183: An Investigational Drug for the Prevention of Chemotherapy-Induced Nausea and Vomiting (MK-0869-071)
Official title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Breast Neoplasms
Keywords: Chemotherapy-Induced Nausea and Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 866
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This protocol will study an investigational drug treatment plan against standard therapy in the prevention of chemotherapy-induced nausea and vomiting in patients diagnosed with breast cancer who are to be treated with up to 4 cycles of non-cisplatin moderately emetogenic chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin moderately emetogenic chemotherapy.

Exclusion Criteria:

* Patient has a central nervous system malignancy.
* Patient will receive radiation to the abdomen or pelvis.

Primary outcomes:
measure: Emesis and use of rescue medication
measure: Safety and tolerability
Secondary outcomes:
measure: Quality of life
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005 Apr 20;23(12):2822-30. doi: 10.1200/JCO.2005.09.050.
Clinical trial NCT03755583: Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease
Official title: Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Enteral Nutrition
Gastrointestinal Microbiome
Keywords: Exclusive enteral nutrition
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the inflammation results from sustained abnormal immune response towards altered or pathogenic microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in pediatric Crohn's disease(CD). Exclusive enteral nutrion(EEN) has been shown to improve nutritional status and inflammatory markers in pediatric CD. But there is limited data about the effect of EEN on Chinese children with CD. In this study, investigators focused on disease process,nutritional status and gut microbiome of Chinese children with newly-diagnosed CD after EEN treatment.


Eligibility criteria: Inclusion Criteria:

* Pediatric CD patients who were newly diagnosed and being treated with EEN at the Children's Hospital of Fudan University

Exclusion Criteria:

* (1) patients who were administered corticosteroids, immunosuppressive drugs, or biological agents prior to the study; (2) patients who could not finish the daily prescribed volume of formula for any reason; (3) patients who could not attend consecutive follow-up sessions; (4) patients who had received antibiotics or probiotics within 1.5 months prior to the study; and (5) patients who had been given corticosteroids, immunosuppressive drugs, biological agents, antibiotics, or probiotics during the EEN process.

Primary outcomes:
measure: 5-item gut microbiota measure
timeFrame: 0, 2, 6, 8, 12 weeks post-EEN
measure: 2-item Simple Endoscopic Score for CD (SES-CD)
timeFrame: 0, 8, weeks post-EEN
Secondary outcomes:
measure: 5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)
timeFrame: 0, 2, 6, 8, 12 weeks post-EEN
measure: 2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)
timeFrame: 0,8 weeks post-EEN
measure: 5-item weight measure
timeFrame: 0, 2, 6, 8, 12 weeks post-EEN
measure: 5-item height measure
timeFrame: 0, 2, 6, 8, 12 weeks post-EEN
measure: 5-item Fecal Calprotectin
timeFrame: 0, 2, 6, 8, 12 weeks post-EEN
measure: 2-item Insulin-like growth factor-1
timeFrame: 0, 8 weeks post-EEN
measure: 2-item Calcium, vitamin
timeFrame: 0, 8 weeks post-EEN
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
state: Shanghai
Study officials:
References: