louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04761978: Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis
Official title: Effectiveness and Safety of JAK Inhibitors for the Treatment of Moderate-to-severe Atopic Dermatitis in a Real-life French Multicenter Adult Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatitis, Atopic
Keywords: Effectiveness
Safety
JAK inhibitors
Atopic dermatitis
Adults
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients assessed by French members of the Groupe de Recherche sur l'Eczema Atopique.

Brief summary: The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort


Eligibility criteria: Inclusion Criteria:

* Adults
* moderate to severe atopic dermatitis
* treated by JAK inhibitors between december 2020 and september 2021
* inefficiency, loss of efficiency or contra-indication of previous systemic agent, DUPILUMAB or phototherapy
* ineligibility to French ongoing clinical trials

Exclusion Criteria:

* Children
* mild atopic dermatitis
* eligibility to CICLOSPORINE, METHOTREXATE, DUPILUMAB, phototherapy
* eligibility to French ongoing clinical trials
* patients' opposition for the use of their records
* follow up \<3 months

Primary outcomes:
measure: reduction in Eczema Area and Severity Index (EASI)
timeFrame: At 3 months
Secondary outcomes:
measure: SCORing Atopic Dermatitis (SCORAD)
timeFrame: at baseline and at 3 months
measure: Investigator's Global Assessment (IGA)
timeFrame: at baseline and at 3 months
measure: Dermatology Life Quality Index (DLQI)
timeFrame: at baseline and at 3 months
measure: patient-reported pruritus score from 0 to 10
timeFrame: at baseline and at 3 months
measure: patient-reported sleep loss from 0 to 10
timeFrame: at baseline and at 3 months
measure: Adverse effects (biological and clinical)
timeFrame: at baseline and at 3 month
Other outcomes:
Locations:
city: Lisle-sur-Tarn
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Delphine Staumont-Salle, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06176378: A Clinical and Radiographic Evaluation of Low-Level Diode Laser Full Pulpotomy in Vital Permanent Teeth
Official title: A Clinical and Radiographic Evaluation of Low-Level Diode Laser Full Pulpotomy in Vital Permanent Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irreversible Pulpitis
Endodontic Inflammation
Keywords: Full pulpotomy
Low-level Diode Laser
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, patients with symptoms of irreversible pulpitis in mature permanent molars were treated with two pulpotomies techniques after random allocation in either 2 groups: Diode laser pulpotomy and traditional pulpotomy using bioactive materials (retro mineral trioxide aggregate ) with each group.The null hypothesis of the study was there would be no difference in success rate between Diode laser and traditional methods of adult pulpotomy .

Detailed description: In this study, 40 patients with symptoms of irreversible pulpitis in mature permanent 1st and 2nd molars were treated with two pulpotomy techniques after random allocation in either 2 groups: traditional pulpotomy and low-level diode laser pulpotomy. The pulp in each group was capped with Retro MTA . In the traditional pulpotomy group, the coronal pulp was removed by the traditional method while in the low-level diode laser pulpotomy group, the radicular pulp was biostimulated using low-level diode laser beam with parameters (970nm, power .5Watt, duty cycle 50%, and frequency 5H) 10 sec for each pulp stump in non-contact mode. After that, the capping material was prepared as manufacturer's instructions and applied over the pulp stamp, the final restoration was then placed in both groups. Patients were followed up after 6, 12, and 18 months to evaluate success and failure.

Eligibility criteria: Inclusion criteria:

* permanent 1st and 2nd molar
* irreversible pulpitis
* restorable

Exclusion criteria:

* Non-restorable teeth.
* Teeth with buccal restoration.
* Non-vital teeth that are not responsive to thermal stimuli or electric pulp test.
* Presence of swelling or sinus tracts.
* Teeth which showed sensitivity to percussion.
* Teeth with grade Ⅱ and Ⅲ mobility.
* Teeth with immature apices.
* Teeth with internal or external resorption or teeth with periapical pathosis.

Primary outcomes:
measure: Assessment of success or failure
timeFrame: (T1): 1 week postoperative, (T2): after 6 months, (T3): after 12 months, and (T4) after 18 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
Study officials:
References:
Clinical trial NCT04747678: Adverse Effects of Ivermectin Used in Egypt During COVID-19
Official title: Tolerability and Adverse Effects of Using Multiple Doses of Ivermectin in Egypt During Covid 19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Ivermectin Poisoning
Drug Toxicity
Drug Side Effect
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all healthy and diseased people who used ivermectin the last three months either as a treatment or as a prophylaxis with mention of the doses used and the adverse effects experienced during and after the usage

Brief summary: retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt

Detailed description: ivermectin was used in Egypt during the pandemic of covid-19 and it was registered in the MOH protocol that has been published in November 2020 the study will document the adverse effects of many patients used ivermectin as aprophylaxis and as a treatment with multiple dose regimens

Eligibility criteria: Inclusion Criteria:

* all people used ivermectin as a treatment or as a prophylactic in covid 19 pandemic in egypt with explained dose

Exclusion Criteria:

-

Primary outcomes:
measure: all adverse effects will be collected from people used Ivermectin in between September 2020 to December 2020
timeFrame: the data will be collected from February 2021 to march 2021
Secondary outcomes:
measure: all data will be arranged according to time and dose manner
timeFrame: February to match 2021
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Ahmed Mansour
state: Menoufia
Study officials:
References:
Clinical trial NCT02874378: Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients
Official title: Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients: Double-Blinded, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Failure
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative renal function recovery is very important to value the operation quality after kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow rate and perioperative renal function. Some animal experiments have revealed its beneficial effects against ischemia-reperfusion injury (IRI), our goal is therefore to investigate the effectiveness of a recipient treatment with Dexmedetomidine during operation at reducing Cystatin C level and enhancing renal function after kidney transplantation.

Detailed description: Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Dexmedetomidine and 0.9 %NaCl solution will be treated from 10 minutes before anesthesia induction, ending in the last 10 minutes before the operation to complete. Cystatin C level and urine volume (but are not limited to these data) at 1,7,14 days after the transplantation will be recorded. The participation of each patient is scheduled for 14 days.Investigators will research both living and cadaveric kidney transplants.

Eligibility criteria: Inclusion Criteria:

Patients underwent renal transplant in the First Affiliated Hospital of Xi'an Jiaotong University.

Exclusion Criteria:

severe comorbidity history: severe cardiac dysfunction, central nervous system disease, endocrine, and history of mental disorders; alcoholic and long-term use of sedatives and opioids history; drug allergy history.

Primary outcomes:
measure: Cystatin C level
timeFrame: 2 weeks
Secondary outcomes:
measure: average daily urinary volume
timeFrame: 2 weeks
measure: length of hospital stay (LOS)
timeFrame: an expected average of 2 weeks
measure: Wake up time, extubation time,SAS score,PONV
timeFrame: up to 6 hours
measure: total dosage of remifentanil
timeFrame: up to 4 hours
measure: Cr/GFR improvement
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the 1st affiliated hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References:
Clinical trial NCT05856578: Comparing the Efficacy of Mulberry Twig Alkaloid Tablet and Canagliflozin in Patients With Type 2 Diabetes
Official title: Nanjing Medical University, Nanjing First Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet
Canagliflozin
Flash Glucose Monitoring （FGM）
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 60
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: TREATMENT

Brief summary: The aim of the study is to investigate the efficacy and safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Canagliflozin for 12 weeks in individuals with type 2 diabetes mellitus

Detailed description: To compare the clinical efficacy, insulin resistance and blood glucose fluctuation of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Canagliflozin in patients with type 2 diabetes mellitus using FGMS.

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate and be able to sign informed consent prior to the trial.
* Patients with type 2 diabetes, aged 18-75 years old and BMI ≥18.0kg/m2.
* Treatment with one or two hypoglycemic drugs (in combination, the sulfonylureas dose should be less than half of the maximum dose).
* HbA1c : 7.0-9.0%.
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
* Recurrent urinary tract infections.
* Drug abuse and alcohol dependence in the past 5 years.
* Patients with poor compliance and irregular diet and exercise.
* Systemic hormone therapy was used in the last three months.
* Patients with infection and stress within four weeks.
* Patients with pregnancy, lactation or pregnancy intention.
* Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Primary outcomes:
measure: Concentration of FBG, PBG and HbA1c
timeFrame: 12 weeks
measure: Concentration of MBG, TIR, TAR, TBR, MAGE, MBG and LAGE
timeFrame: 12 weeks
Secondary outcomes:
measure: Concentration of C-peptide, Insulin, glucagon and HOMA-IR
timeFrame: 12 weeks
measure: Concentration of the TC, TG, LDL, HDL and FFA
timeFrame: 12 weeks
measure: Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α
timeFrame: 12 weeks
Other outcomes:
measure: Fecal 16S rRNA gene sequencing
timeFrame: 12 weeks
measure: Incidence of hypoglycemia
timeFrame: 12 weeks
Locations:
city: Nanjing
country: China
facility: Jianhua Ma
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Jianhua Ma
role: STUDY_DIRECTOR
References:
Clinical trial NCT00878878: Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
Official title: A Phase 4, Placebo Controlled, Single-blind, Cross-over Safety Study to Evaluate the Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR) as Measured by Right Heart Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Keywords: Pulmonary artery systolic pressure (PASP)
Pulmonary Vascular Resistance (PVR)
Right Heart Catheterization
Pulmonary hemodynamics
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2009-04-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.


Eligibility criteria: Inclusion Criteria:

* Must be already scheduled for left and/or right heart catheterization for clinical reasons.
* Must be in sinus rhythm, without an arrhythmia likely to affect the ability to assess pulmonary hemodynamics by catheterization, as determined by the investigator.
* Women of childbearing potential must be using adequate birth control and have a negative pregnancy test.

Exclusion Criteria:

* History of right-to-left, bi-directional, or transient right-to-left cardiac shunts or diagnosed by color flow Doppler echocardiography during screening.
* Hypersensitivity to Optison, perflutren, blood, blood products, or albumin.
* Female subjects who are nursing mothers.

Primary outcomes:
measure: Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.
timeFrame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
measure: Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.
timeFrame: Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration
Secondary outcomes:
measure: Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.
timeFrame: During the injection and catheterization procedure, and for up to 24 hours post-injection
Other outcomes:
Locations:
city: Elliott City
country: United States
facility: ICON Development Solutions
state: Maryland
Study officials:
affiliation: ICON Development Solutions
name: Christopher Jefferds
role: STUDY_DIRECTOR
References:
Clinical trial NCT06897878: Optimal Number of Pleural Biopsies During Pleuroscopy
Official title: OPTImal Number of Pleural BIOPsies During Pleuroscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Diseases
Keywords: Pleuroscopy
Pleural effusion
Pleural biopsy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients that undergo pleuroscopy for pleural biopsies, excluding those with inability to provide informed consent.

Brief summary: A single-center, non-randomized, prospective observational, pilot study designed to determine what is the optimal number of pleural biopsies to take during pleuroscopy.

Detailed description: After enrollment, participants will undergo pleural biopsies via pleuroscopy. Specimens will be divided into three aliquots (1-3, 4-6, 7-10), which will be sent to pathology. A designated pathologist will evaluate the specimens in each aliquot to determine the number of biopsies required to reach a diagnosis and to obtain sufficient material for biomarker testing (when needed), and determine whether analysis of further aliquots is needed.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients who require pleuroscopies will be enrolled to the study.
* Age ≥ 18

Exclusion Criteria:

- Inability to provide informed consent

Primary outcomes:
measure: Number of pleural biopsies to reach a diagnosis
timeFrame: At week 2 after pleuroscopy
Secondary outcomes:
measure: Number of pleural biopsies required for comprehensive biomarker testing.
timeFrame: At week 4 after pleuroscopy
measure: Number of complications
timeFrame: At week 4 after pleuroscopy
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: MBBS
name: Udit Chaddha
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01567878: Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
Official title: Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylitis, Ankylosing
Keywords: ultrasound
MASEI index
clinical and ultrasound correlation
enthesis ultrasound
articular ultrasound
ankylosing spondylitis ultrasound
radiographic and ultrasound correlation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ankylosing spondylitis healthy subjects

Brief summary: * Evaluate the correlation of ultrasound MASEI index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis.
* Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables.
* Evaluate correlation between articular and enthesis ultrasound exam in this study.
* Compare patients and healthy individuals data, to calculate the ROC curve to estimate predictor value of disease.


Eligibility criteria: Inclusion Criteria:

* Ankylosing spondylitis by the Modified New York Criteria (1984)or ASAS classification (2009)
* Healthy people with no history of joint pain, inflammatory lumbar pain inflammatory disease,
* 18 - 65 years old

Exclusion Criteria:

* Fibromyalgia
* Corticosteroid injection in the last 3 months
* Previous surgery in joint or enthesis of study
* Peripheric neuropathy
* Diabetes mellitus
* Hypothyroidism
* Peripheric venous insufficiency (with edema or ocre dermatitis)

Primary outcomes:
measure: Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects
timeFrame: december
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Suellen Narimatsu
Study officials:
References:
Clinical trial NCT01660178: Profile of Newborn Undergoing Early Stimulation in a Neonatal Intensive Care Unit
Official title: Profile of Newborn Undergoing Early Stimulation in a Neonatal Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Skills Disorders
Keywords: newborns
intensive care unit
early stimulation
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2012-08-08
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: newborns underwent early stimulation in a neonatal ICU

Brief summary: To describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation.

Detailed description: Objective: To describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation.

Methods: It was conducted a descriptive, cross-sectional and analytical study carried out in the General Hospital Dr. Cesar calls, from July to December 2010. The sample consisted of 116 medical records of newborns indicated for the treatment of early stimulation, representing (9.2%). The study excluded seven infants who had some type of congenital malformation. It was used the following variables: weight, sex, gestational age, Apgar score, diagnosis of Respiratory Distress Syndrome and Intracranial Hemorrhage and the use of mechanical ventilation and CPAP.

Eligibility criteria: Inclusion Criteria:

All cases of newborns who were admitted to the NICU and were referred for treatment of early stimulation

Exclusion Criteria:

all records relating to incomplete study variables and newborns who had a congenital malformation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: