louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02796053: TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Treatment
Official title: Study to Assess Pharmacodynamics, Clinical Effects, Safety and Pharmacokinetics of TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Concomitant Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: Theramab LLC
Sponsor class: INDUSTRY
First posted: 2016-06-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08 during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled with current therapy.

Detailed description: 1. To assess dynamics of the T-lymphocytes subpopulations in patients peripheral blood during 12 weeks of TAB08 treatment.
2. To assess dynamics of selected cytokines levels in patients peripheral blood during 12 weeks of TAB08 treatment.
3. To assess TAB08 concentrations in patients blood during 12 weeks of TAB08 treatment.
4. To assess frequency, seriousness and severity of adverse events during 12 weeks of TAB08 treatment.
5. To assess changes in PASI, IGA and DLQI during 12 weeks of TAB08 treatment and subsequent 4 weeks follow-up.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Vulgar Psoriasis
* Area of Psoriasis skin damage ≥ 10%
* PASI Score ≥ 12
* Score on IGA scale ≥ 3

Exclusion Criteria:

* Other forms of psoriasis in addition to vulgar
* Prohibited treatment
* Pregnant or nursing women
* Concomitant systemic therapy dosage modification (if any) within 4 weeks before randomization

Primary outcomes:
measure: Change of T-lymphocytes subsets in absolute count (number of cells per mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
timeFrame: 12 weeks
measure: Change of T-lymphocytes subsets (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
timeFrame: 12 weeks
measure: Change of cytokines concentrations (in micrograms/mL) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
timeFrame: 12 weeks
measure: Change of cytokines concentrations (in percent) in peripheral blood at Weeks 2, 3, 4, 8 and 12 comparing to Baseline.
timeFrame: 12 weeks
Secondary outcomes:
measure: TAB08 concentrations in peripheral blood
timeFrame: 12 weeks
measure: Adverse events frequency, seriousness and severity
timeFrame: 16 weeks
measure: Psoriasis Area Severity Index (PASI)
timeFrame: 16 weeks
measure: Investigator Global Assessment (IGA)
timeFrame: 16 weeks
measure: Patient-reported health outcome assessed by Short Form - Dermatology Quality of Life Index (DLQI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Yaroslavl
country: Russian Federation
facility: Clinical Emergency Hospital of Yaroslavl
Study officials:
affiliation: Theramab LLC
name: Daniil Nemenov, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06140953: Benefits of Trimetazidine in MASLD Patients
Official title: Evaluation of Potential Benefits of Trimetazidine in the Management of Patients With Metabolic Associated Steatotic Liver Disease (MASLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Associated Fatty Liver Disease
Keywords: trimetazidine in MASLD
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 60
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: Objective of this study is to determine the clinical benefits of trimetazidine in improvement of MASLD

Detailed description: the study will evaluate the possible benefits of trimetazidine when added to pateints with metabolic associated fatty liver disease

Eligibility criteria: Inclusion Criteria: participants were included if they met MASLD diagnostic criteria, which required imaging-confirmed hepatic steatosis (via abdominal ultrasound and CAP), along with metabolic factors (BMI ≥25 kg/m², diabetes/dysglycemia, blood pressure ≥130/85 mmHg, triglycerides ≥150 mg/dL, or reduced HDL-cholesterol)

Exclusion Criteria: The study excluded those with

* alternative steatosis causes (alcohol intake \>50 g/day women or \>60 g/day men
* drug-induced injury, hepatitis C, Wilson disease).
* Additional exclusion criteria covered ages below 18 years, pregnancy. decompensated cirrhosis, portal hypertension, hepatocellular carcinomas.
* Trimetazidine contraindications (Parkinson's disease, parkinsonian symptoms, tremors, severe renal impairment), patients on statins, sodium glucose transporter 2 inhibitors (SGLT2), glucagon-like peptide 1(GLP1) were among the other exclusion criteria

Primary outcomes:
measure: incidence in mafld
timeFrame: "1 Year "
measure: incidence in mafld
timeFrame: "1 Year "
measure: incidence in mafld
timeFrame: "1 Year "
measure: CAP score and FAST score
timeFrame: 1 year
Secondary outcomes:
measure: incidence of mafld
timeFrame: " 1 Year"
measure: incidence of mafld
timeFrame: "1 Year "
measure: incidence of mafld
timeFrame: "1 year "
measure: incidence of mafld
timeFrame: "1 Year "
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Maha Youssif Fekry
Study officials:
affiliation: Beni-suaf university
name: Hoda m rabea, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06326853: Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models
Official title: Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endocrine Disorders
Adiposity
Pituitary Adenoma
Cushing Syndrome
Acromegaly
Hypopituitarism
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by: Non-secreting pituitary adenomas, Prolactinoma, Cushing's disease, Acromegaly, TSHomas, hypopituirarisms treated with cabergoline, octreotide, lanreotide, pasireotide, pegvisomant, rhGH and/or undergoing surgical therapy (transnasosphenoidal neurosurgical removal of the pituitary tumor. Healthy obese subjects.

Brief summary: The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle/bone tissue


Eligibility criteria: Inclusion Criteria:

Obese patients affected and not by hypothalamic-pituitary diseases

Exclusion Criteria:

1. Minor subjects;
2. Pregnant and/or breastfeeding women;
3. Patients suffering from states of primary and/or acquired immunodeficiencies, and/or serious impairment of general clinical conditions (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacerbated/compensated chronic pathologies);
4. Patients unable to understand and sign the Informed Consent.

Primary outcomes:
measure: Rate of patients with BMI greater than 30 with hypothalamic-pituitary pathologies
timeFrame: retrospective and prospective collection of clinical data between 01/01/2021 and 31/12/2026
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03186053: Sodium Creatine Phosphate in Heart Valve Surgery
Official title: Cardioprotective Effects of Sodium Creatine Phosphate in Valve Surgery: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Valve Diseases
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery

Detailed description: Objective: To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery Methods: 250 patients undergoing valve surgery were randomly divided into experimental group and control group. 5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h). The control group was treated with saline in the same manner. The cTnI level was measured at the corresponding time points. Hemodynamic indexes and postoperative complications were recorded.

Eligibility criteria: Inclusion Criteria:

* valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass(CPB)

Exclusion Criteria:

* thoracoscopic valve surgery
* other organ dysfunction: such as cancer, organ failure, severe anemia, infection
* patients with mental disorders
* coagulopathy, active ulcer, ischemic or hemorrhagic stroke (within 6 months), trauma

Primary outcomes:
measure: serum cardiac troponin I(cTnI)
timeFrame: within 24 hours after aortic declamping
Secondary outcomes:
measure: mortality
timeFrame: within 30 postoperative days
measure: stroke
timeFrame: within 30 postoperative days
measure: blood filtration of kidney failure
timeFrame: within 30 postoperative days
measure: extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support
timeFrame: within 30 postoperative days
measure: mechanical ventilation time
timeFrame: within 30 postoperative days
measure: arrhythmia
timeFrame: within 30 postoperative days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
state: Beijing
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital
Study officials:
affiliation: Department of anesthesiology,Fuwai hospital
name: Guyan WANG, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02811653: Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease
Official title: Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Motor slowing
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 155
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In AD (Alzheimer disease), the anatomic correlates of attention disorders (as evaluated by motor slowing) have not been thoroughly characterized.


Eligibility criteria: Inclusion Criteria:

* Patients

  * Age between 40 and 85
  * French mother tongue
  * Consulting at the Amiens Memory Resource and Research Centre (CMRR) for:
  * MCI, according to Albert et al.'s criteria (Albert et al., 2011)
  * Mild dementia (MMSE\>20) due to AD, according to McKhann's criteria (McKhann et al., 2011).
  * Mild dementia due to LBD, according to McKeith et al.'s criteria (McKeith et al., 2005).
  * Mild dementia due to FTLD, according to Rascovsky et al.'s criteria (Rascovsky et al., 2011).
  * Social security coverage
* Healthy controls

  * Healthy age and gender matched volunteers will be recruited into the study from the general population.

Exclusion Criteria:

* Reading or writing difficulties related to a learning disorder or illiteracy.
* A medical history with a potentially significant impact on cognition (non-corrected thyroid disorders or heart failure):

  * NYHA stage IV dyspnoea.
  * respiratory impairment requiring oxygen therapy.
  * liver impairment.
  * kidney failure, progressing neoplastic disease, or past or present alcohol abuse.
* Past or present neurological disorders other than those having prompted consultation in the Memory Clinic:

  * stroke.
  * meningitis or encephalitis.
  * severe head injury.
  * sensorimotor impairments (sensory, proprioceptive, cerebellar and visual impairments).
  * epilepsy (requiring ongoing treatment),
  * psychiatric disorders (other than treated depression).
  * treatment with psychotropic medications (other than anxiolytics or antidepressant withdrawn or initiated in the previous month). Patients with parkinsonian syndrome were examined in the "on-drug" state.
* Impossibility to perform a neuropsychological evaluation or brain MRI.
* Withdrawal from the study at any time, if desired.
* Pregnancy
* Contra-indication to MRI:

  * nerve stimulators
  * cochlear implants
  * ferromagnetic foreign bodies close to nervous structures in the eye or brain
  * cerebral shunts
  * dental appliances
* Legal guardianship or incarceration.

Primary outcomes:
measure: median SRT (simple reaction time) to a stimulus (in milliseconds)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Daniela ANDRIUTA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06113653: Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis
Official title: Outcomes and Predictors of Mortality Among Preterm Infants With Neonatal Sepsis Admitted in NICU of Assiut University Children's Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neonatal Sepsis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All preterm infants diagnosed with neonatal sepsis

Brief summary: A prospective cross-sectional study of outcomes and predictors of mortality among preterm infants with neonatal sepsis admitted in NICU of Assiut University Children's Hospital

Detailed description: Neonatal sepsis is a clinical syndrome of bacteremia with systemic signs and symptoms of infection in the first 28 days of life. It can also result from viral and fungal invasions of the bloodstream It is one of the events that can occur during neonatal intensive care unit (NICU) admission. It contributes significantly to the morbidity of very preterm (VP: \<32 weeks gestational age) and/or very low birthweight (VLBW: \<1500 g) infants Sepsis is a major cause of neonatal mortality and neurodevelopmental impairment among neonates which results in death and major disability for 39% of those affected even with timely antibiotic treatment .

Globally, it is estimated that more than 1.4 million neonatal deaths annually are the consequence of invasive infections .

Infection-specific mortality varies by geographic region and neonatal risk factors like gestational age and body weight .

It contributes to nearly 30-50% of neonatal deaths in developing countries . The risk of death is highest in the first 24 h of life when more than half of deaths occur and about three-quarters of all neonatal deaths occur within the first week of life.

Eligibility criteria: Inclusion Criteria:

* All preterm infants (\<37 weeks) diagnosed with neonatal sepsis
* Preterm infants aged 0-28 days

Exclusion Criteria:

* Full term infants (\> 37 weeks gestation) -Neonates with congenital anomalies -Neonates diagnosed with metabolic diseases
* Neonates with birth asphyxia

Primary outcomes:
measure: mortality among preterm infants with neonatal sepsis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02666053: A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects
Official title: A Study to Assess the Effect of a High-fat Meal and Increased Gastric pH on the Bioavailability of an Extended-release Formulation of BMS-663068 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2016-01-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent
2. Target population: Healthy males and females.
3. Males and females
4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
5. Women must not be breastfeeding
6. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

1. History of any chronic or acute illness or gastrointestinal disease
2. Any major surgery within 4 weeks of study drug administration
3. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
4. History of allergy to HIV attachment inhibitors, famotidine or high fat meal
5. History of smoking

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Days 1-12
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF)
timeFrame: Days 1-12
Secondary outcomes:
measure: Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation
timeFrame: Days 1-12; for SAEs up to 30 days post discontinuation of dosing
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01178853: Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers
Official title: Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.


Eligibility criteria: Inclusion Criteria:

* Subject is a healthy adult male or female volunteer aged 18 to 45 years, inclusive
* Subject has a body mass index of 18 to 32 kg/m2, inclusive
* Subject is able and willing to abstain from alcohol, grapefruit, caffeine
* Subject has no clinically relevant abnormalities on the basis of medical history, physical examination, and vital signs

Exclusion Criteria:

* Subject has clinically relevant out-of-range prothrombin time (PT), activated partial thromboplastin time, fibrinogen, protein C, or protein S
* Subject has abnormal prolongation of bleeding time at Screening
* Subject has hematuria on urinalysis
* Subject has personal or family history of coagulation or bleeding disorders

Primary outcomes:
measure: Percent Mean Change From Baseline of International Normalized Ratio (INR)
timeFrame: 22 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT03084653: Choosing the Technique for First Abdominal Entry in Laparoscopy
Official title: Choosing the Technique for First Abdominal Entry in Laparoscopy: A Questionnaire-based Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decision-Making
Keywords: Trocar entery
Surgery, Laparoscopic
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-03-21
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Close-ended survey questions were formed and sent to general surgeons by e-mail containing the web address of the survey.

Brief summary: Several techniques for initial abdominal entry in laparoscopy have been introduced in literature. Various guidelines and recommendations are available on this subject, however, compliance to these are controversial. The purpose of this study is to evaluate the rationale and the process of decision making for first entry technique in laparoscopy.

Detailed description: Several methods, i.e., the Veress needle, open approach using the Hasson trocar and direct trocar insertion without insufflation have been described for initial abdominal entry in laparoscopy. On the other hand, relatively new approaches, e.g., the optical or radially expanding trocars did not become common yet. Despite the advantages of laparoscopic surgery, serious complications can be encountered during the initial entry. Development of a complication, e.g., major vascular and intestinal injury, would affect the outcome of the operation and it may result in conversion to the open approach. Because of low incidence of these complications, it is impossible to show any superiority of one approach to another.

In this study, we aimed to analyze the rationale and the process of decision making of a surgeon about initial abdominal entry technique for laparoscopy.

Eligibility criteria: Inclusion Criteria:

* General Surgeons who approve to participate to the study will be included.

Exclusion Criteria:

* Surgical residents will be excluded from the study

Primary outcomes:
measure: Rationale of choice in decision-making of first abdominal trocar entry method.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and Research Hospital
state: Ümraniye
Study officials:
affiliation: Umraniye Education and Research Hospital
name: Fatih Basak
role: PRINCIPAL_INVESTIGATOR
References: