louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05937880: Leflunomide for Henoch-Schonlein Purpura
Official title: Leflunomide for Refractory Skin Henoch-Schonlein Purpura in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Henoch-Schonlein Purpura
Keywords: Leflunomide
Henoch-Schonlein Purpura
Children
Efficacy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Refractory skin Henoch-Schonlein Purpura
Primary purpose: TREATMENT

Brief summary: This study conducted a prospective, multicenter, one-arm clinical trial on the combination of leflunomide and steroid therapy for refractory skin Henoch-Schonlein Purpura in children on the basis of ethical principles. A one-year follow-up was conducted to evaluate the changes in the main indicators (frequency of rash recurrence) and secondary indicators (proportion of kidney damage, proportion of joint involvement, T lymphocyte subpopulations, and inflammatory factors) before and after treatment, Exploring the safety and effectiveness of leflunomide in the treatment of refractory skin type HSP in children, it is expected that leflunomide combined with conventional treatment can improve the remission rate of HSP children's skin purpura and reduce HSP recurrence. The research results are expected to bring new treatment methods and strategies for this group of patients.


Eligibility criteria: Inclusion Criteria:

1. Age ranges from 1 to 18 years old;
2. Patients meet the HSP diagnostic criteria;
3. Refractory skin type HSP: Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or fresh rash still appears, and frequently repeated more than 3 times during hospitalization.
4. Parents or guardians agree to treatment and sign a written informed consent form.

Exclusion Criteria:

1. Individuals who are allergic to leflunomide;
2. Concomitant severe underlying diseases (such as systemic malignancy, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery);
3. Patients with other digestive system diseases;
4. Those who have previously used flumiphene in clinical trials;
5. Excluding purpura caused by drugs, infectious factors, and other autoimmune diseases.
6. Other situations where the researcher deems it inappropriate to participate in the study.

Primary outcomes:
measure: Rash frequency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Weiping Tan, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05101980: Predictors of Atrial Fibrillation Recurrence After Ablation Using PENTARAY Catheter
Official title: Predictors of Atrial Fibrillation Recurrence After Ablation Using PENTARAY Catheter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation Ablation Using PENTARAY Catheter
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with paroxismal AF who are eligible for AF ablation

Brief summary: CARTO represent a new way of 3D electroanaromic mapping for AF which has improved safety and success rate of AF ablation compared with other conventional methods of AF ablation as it provide accurate visualization of atrial anatomy and identification of atrial substrate properties for catheter ablation of atrial arrythmias which ensure good ablation with decreased incidence of recurrence of AF.


Eligibility criteria: Inclusion Criteria:

* Patient with paroxismal AF who are eligible for AF ablation
* Patient resistant to medical treatment

Exclusion Criteria:

* Patient with other types of arrythmias
* Patient with prothetic valves
* Patient with valvular AF

Primary outcomes:
measure: Maintenance of sinus rhythm after successful ablation of atrial fibrillation
timeFrame: 6 months after AF ablation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01564680: Lornoxicam vs. Paracetamol After Lower Abdominal Surgery
Official title: Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Lower abdominal surgery
Paracetamol
Lornoxicam
Morphine
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lower abdominal surgery.

Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol 1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam group). Additionally pain was treated postoperatively using morphine patient-controlled analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours postoperatively.


Eligibility criteria: Inclusion Criteria:

* lower abdominal surgery

Exclusion Criteria:

* body weight more than 150% of their ideal body weight
* history of significant cardiac, pulmonary, renal, hepatic or hematological disease; chronic drug or alcohol abuse; hypersensitivity to any of the studied drugs; bronchial asthma; gastritis or peptic ulcer; and pregnancy
* patients who received any analgesic drug a day before surgery

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: Morphine consumption
timeFrame: 24 hours
measure: Incidence of side-effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Al-Khobar
country: Saudi Arabia
facility: Dammam University, KFHU
state: EP
Study officials:
affiliation: UD
name: Hany A Mowafi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mowafi HA, Elmakarim EA, Ismail S, Al-Mahdy M, El-Saflan AE, Elsaid AS. Intravenous lornoxicam is more effective than paracetamol as a supplemental analgesic after lower abdominal surgery: a randomized controlled trial. World J Surg. 2012 Sep;36(9):2039-44. doi: 10.1007/s00268-012-1649-2.
Clinical trial NCT06708780: Immunotherapy with Autologous Tregs in T1DM
Official title: Clinical Safety and Therapeutic Effects of Autologous Tregs in T1DM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Shanghai Institute of Materia Medica, Chinese Academy of Sciences
First posted: 2024-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 1 diabetes (T1D) is an autoimmune disease characterized by a progressive immune distruction of pancreat beta cells and deterioration of endogenous insulin secretion. Regulatory T cells (Treg) are fuctionally deficient in T1D, leading to the loss of immune tolerance to the islets and the initiation of an autoimmune attack. Previouse studies have revealed the potential theraputic effects of autologous Treg transplantation in T1D. We have modified the preparation protocol for autologous Tregs. The purpose of this study is to assess the safety and effect of autologous Treg therapy in patients with T1D.


Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria of T1DM based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes;
* Aged 8 to 65 years;
* At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L;
* Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.

Exclusion Criteria:

* The condition of diabetic ketoacidosis has not been controlled;
* Severe allergic constitution;
* Known or suspected tumor;
* Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases.
* Suffering from gestational diabetes mellitus, single gene mutation diabetes mellitus, diabetes mellitus caused by pancreatic damage or other secondary diabetes mellitus (such as diabetes mellitus caused by Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
* Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.
* Mental illness, alcohol or drug abuse, unable to cooperate with treatment;
* According to the judgment of the investigator, there are other clinical conditions that may endanger the safety of the subjects.

Primary outcomes:
measure: Number of Participants with adverse events, laboratory abnormalities and other signs of toxicity.
timeFrame: From enrollment to the end of treatment at 1 year
Secondary outcomes:
measure: Therapeutic effects on diabetes-related outcomes
timeFrame: From enrollment to the end of treatment at 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT02985580: Effects of Blueberry Juice Consumption on Cognitive Function in Healthy Older People
Official title: Effects of Blueberry Juice Consumption on Brain Activation and Perfusion in Healthy Older People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Aging
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties, which in rodent models are neuro-protective. The risk of developing dementia is reduced in people habitually consuming high flavonoid intakes, but data from human intervention studies is sparse. We therefore investigated whether 12 weeks of blueberry concentrate supplementation improved cognitive function in healthy elderly via increased brain activation and perfusion.


Eligibility criteria: Inclusion Criteria:

* aged 60-80y
* Addenbrooke's Cognitive Examination III questionnaire \> 88
* Consuming 5 or less portions of fruit per day

Exclusion Criteria:

Addenbrooke's Cognitive Examination III questionnaire \< 88 Contraindications for MRI Consuming more than 5 portions of fruit per day

Primary outcomes:
measure: Brain perfusion
timeFrame: Change from baseline to 12 weeks dietary supplementation
Secondary outcomes:
measure: Brain activation
timeFrame: Change from baseline to 12 weeks dietary supplementation
measure: Cognitive function tests
timeFrame: Change from baseline to 12 weeks dietary supplementation
measure: Blood biomarkers of inflammation
timeFrame: Change from baseline to 12 weeks dietary supplementation
measure: Blood biomarkers of oxidative stress
timeFrame: Change from baseline to 12 weeks dietary supplementation
measure: Blood biomarkers of neurogenesis
timeFrame: Change from baseline to 12 weeks dietary supplementation
Other outcomes:
Locations:
Study officials:
affiliation: University of Exeter
name: Joanna Bowtell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05199480: Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health
Official title: Understanding the Impact of Cartridge-Based Electronic Cigarettes and Generated Aerosols on Cardiopulmonary Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: E-Cig Use
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Over the last decade, e-cigarettes have become increasingly popular, due to their promotion as a healthy alternative to traditional tobacco cigarettes. However, there are large discrepancies of knowledge in understanding how these e-cigarettes affect the user's health. The overall goal of this study is to evaluate the impact of e-cigarettes usage on user's cardiopulmonary health


Eligibility criteria: Inclusion Criteria:

E-Cigarette group:

* 21 years of age or older
* Used e-cigarettes (≥3 times/week for ≥3 months)

Non e-cigarette group

● 21 years of age or older

Exclusion Criteria:

* 20 years old and younger
* Use of cigarettes for 15 days or more in the past 60 days
* Use of other tobacco products (cigars, hookah, smokeless) weekly or more frequently in the past 60 days
* Use of marijuana or any illicit or prescription drugs for non-medical use weekly or more frequently in the past 60 days
* Known allergy to propylene glycol or vegetable glycerin
* Evidence of cardiovascular, pulmonary, renal, hepatic, metabolic, or cerebral diseases
* Disorder or use of medication that affects cardiopulmonary health
* Evidence of pregnancy or current nursing

Primary outcomes:
measure: Change in Peak oxygen consumption (VO2 peak)
timeFrame: Change from baseline to 2 weeks
measure: Change in Expiratory Volume
timeFrame: Change from baseline to 2 weeks
Secondary outcomes:
measure: Change in Skeletal muscle O2 utilization
timeFrame: Change from baseline to 2 weeks
measure: Change in Maximal microvascular dilation
timeFrame: Change from baseline to 2 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Paula Rodriguez Miguelez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00163280: Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis
Official title: Randomised Double-Blind Placebo-Controlled Study of Orally Administered ATL-104 to Assess Safety, Tolerance and Effect on Oral Mucositis in Patients Following Treatment With Chemotherapy and Peripheral Blood Stem Cell Transplant (PBSCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucositis
Keywords: Mucositis
Peripheral blood stem cell transplant
Lead sponsor: Alizyme
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT

Detailed description: Mucositis is a serious side effect of cancer therapy and Peripheral Blood Stem Cell Transplant (PBSCT) which requires appropriate and effective management. Mucositis is a condition in which there is inflammation and ulceration of the mouth, throat and gut caused by damage to the mucosal barrier induced by chemo- and radiotherapy. Symptoms include pain, nausea, abdominal cramping, and vomiting. This study will investigate whether ATL-104, when administered as a swallowable mouthwash, is safe and well tolerated in patients undergoing PBSCT and to investigate its potential to reduce the level of severity of mucositis associated with PBSCT.

Eligibility criteria: Inclusion Criteria:

* Patients with haematological malignancies undergoing chemotherapy in association with PBSCT

Exclusion Criteria:

* Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
* Visible oral disease
* Significantly reduced platelet and neutrophil count

Primary outcomes:
measure: Safety: Adverse events
timeFrame: 28 days post-treatment
measure: Efficacy: Oral mucositis scale
timeFrame: 28 days post-treatment
Secondary outcomes:
measure: Safety: Laboratory monitoring, vital signs, ECG
timeFrame: 28 days post-treatment
measure: Pharmacokinetics of ATL-104
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Addenbrooke's Hospital, Cambridge, UK
name: Robert Marcus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03505580: AMIStem-H Radiological Assessment
Official title: Etude rétrospective et Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la sécurité de l'Implant AMIStem
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Replacement Arthroplasty
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2018-04-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients who undewent total hip arthroplasty with AMIStem-H cementless femoral stem at the investigational sites between April 2009 and April 2012

Brief summary: The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up.

All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice


Eligibility criteria: Inclusion Criteria:

* patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012
* patients bearing an AMIStem-H cementless femoral stem

Exclusion Criteria:

* patients who refuse to give consent for the treatment of data

Primary outcomes:
measure: Presence of radiolucencies
timeFrame: 5 years
Secondary outcomes:
measure: correlation between the presence of radiolucencies and patient/implant characteristics
timeFrame: 5 years, 10 years
measure: evaluation of radiolucent lines progression
timeFrame: 1 years, 10 years
measure: evaluation of radiolucent lines progression
timeFrame: 5 years, 10 years
measure: Record of adverse events
timeFrame: 1, 5 years and 10 years
Other outcomes:
Locations:
city: Bois Guillaume
country: France
facility: Clinique du Cèdre
city: Paris
country: France
facility: Clinique Paris V
Study officials:
References:
Clinical trial NCT02188680: Irritable Bowel Syndrome and Low FODMAP Diet
Official title: Does Irritable Bowel Syndrome Improved by Low FODMAP Diet ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: fructose test
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patients having a syndrome SII would be more intolerant in the fructose than the healthy subjects and would benefit from a fructose diet but also from the fructans which contain some fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after absorption of fructose. However, the eviction of the fructose is sometimes recommended to the patients without having realized beforehand the test of intolerance.

Detailed description: The main objective is to evaluate the efficacy of the FODMAPS diet on IBS symptoms and to correlate the results with the respiratory test

Eligibility criteria: Inclusion Criteria:

* older than 18, patients with IBS, patients with no organic disorders, patients informed and agreed to participate

Exclusion Criteria:

* patients with sclerodermia, diabetes, obesity, anorexia, colo-rectal surgery, patients with small intestinal bacterial overgrowth, pregnancy

Primary outcomes:
measure: Fructose expiration rate (ppm)
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Service de Physiologie Digestive, Urinaire, Respiratoire et Sportive
state: Haute Normandie
Study officials:
affiliation: University Hospital, Rouen
name: Anne-Marie LEROI, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Melchior C, Desprez C, Houivet E, Debeir LA, Bril L, Maccarone M, Grout E, Ducrotte P, Gourcerol G, Leroi AM. Is abnormal 25 g fructose breath test a predictor of symptomatic response to a low fructose diet in irritable bowel syndrome? Clin Nutr. 2020 Apr;39(4):1155-1160. doi: 10.1016/j.clnu.2019.04.031. Epub 2019 May 8.