louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05653310: Tradipitant for Functional Dyspepsia
Official title: Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Tradipitant for Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Functional Dyspepsia
Keywords: tradipitant
NK-1 antagonist
neurokinin 1 receptor
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2022-12-16
Enrollment: 60
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: BASIC_SCIENCE

Brief summary: To evaluate the effects of tradipitant relative to placebo on gastric motor functions, satiation, and postprandial symptoms in patients with functional dyspepsia.


Eligibility criteria: Inclusion Criteria:

* Able to provide written consent
* Body Mass Index (BMI) of 18-35 kg/m2
* Absence of other diseases which could interfere with interpretation of study results

Exclusion Criteria:

* Current H. pylori infection
* Pregnancy or nursing
* Recent history of Alcohol Use Disorder or Substance Use Disorder

Primary outcomes:
measure: Accommodation gastric volumes measured by single photon emission computed tomography (SPECT)
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Xiao Jing (Iris) Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04563910: Impact of Duration of Untreated Manic Episodes on Clinical Outcome
Official title: Impact of Duration of Untreated Bipolar Disorder (Manic Episodes) on Clinical Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Diagnosed With Bipolar Disorder ( Manic Episodes) and Delayed Diagnosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients recruited from inpatient psychiatric unit at department of neurology and psychiatry, Assiut University Hospitals

Brief summary: The current study is cross sectional retrospective study, included 100 patients were diagnosed as mood disorder bipolar I (manic episodes) according to DSM5, patients recruited from inpatient psychiatric unit at department of Neurology and Psychiatry, Assiut University hospitals The current work is designed to study the effect of duration of untreated bipolar disorder on clinical outcome ( severity , residual symptoms ,duration of hospital admission) and to study factors affecting duration of untreatment in Upper Egypt.

Detailed description: Mood disorder carries a major burden in our country as it represents 15% of inpatients and 20% of outpatients in mental hospitals in Egypt

The current work is designed to study the effect of duration of untreated bipolar disorder on clinical outcome ( severity , residual symptoms ,duration of hospital admission) and to study factors affecting duration of untreatment in Upper Egypt.

The current study is cross sectional retrospective study, included 100 patients were diagnosed as mood disorder bipolar I (manic episodes) according to DSM5, patients recruited from inpatient psychiatric unit at department of Neurology and Psychiatry, Assiut University hospitals

Eligibility criteria: Inclusion Criteria:

* -Age group between 18 to 45 years old.
* Patients diagnosed as mood disorder bipolar I manic episode according to DSM V(2).
* Clearly consenting to participate in the study.

Exclusion Criteria:

* -Mood disorder due to substance abuse.
* Patients in depressive episodes.
* other mental disorders

Primary outcomes:
measure: measure the effect of duration of untreated bipolar disorder on severity (young mania rating scale on admission
timeFrame: one year
Secondary outcomes:
measure: To measure the effect of duration of untreated bipolar disorder (manic episodes) on clinical outcomes (severity, residual symptoms, duration of admission).
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT00536510: Effect of MK0524A on Cholesterol Levels (0524A-048)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Lipid-Altering Efficacy and Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Hyperlipidemia
Keywords: High Cholesterol
Excess lipids
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-27
Enrollment: 646
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: The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.


Eligibility criteria: Inclusion Criteria:

* Patient is male or female between 18 and 70 years of age
* Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

Exclusion Criteria:

* Patient has a history of not being able to take niacin or niacin-containing products
* Patient consumes more than 2 alcoholic beverages per day
* Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
* Patient engages in vigorous exercise or an aggressive diet regimen

Primary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kush D, Kim HS, Hu DY, Liu J, Sirah W, Sapre A, McCrary Sisk C, Paolini JF, Maccubbin D. Lipid-modifying efficacy of extended release niacin/laropiprant in Asian patients with primary hypercholesterolemia or mixed hyperlipidemia. J Clin Lipidol. 2009 May-Jun;3(3):179-86. doi: 10.1016/j.jacl.2009.04.048. Epub 2009 May 3.
Clinical trial NCT03276910: Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
Official title: Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Sports Drug Abuse
Keywords: antidoping
Lead sponsor: Association Athletes For Transparency
Sponsor class: OTHER
Collaborators: name: University of Milan School of Medicine
name: Centre d'Investigation Clinique Lyon (CIC)
name: Ecole Nationale de Ski et d'Alpinisme (ENSA)
name: Partnership for Clean Competition
First posted: 2017-09-08
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 different conditions:

* Eprex 20 UI/kg
* Eprex 50 UI/kg
* Placebo
Primary purpose: TREATMENT

Brief summary: The main objective of this research is to demonstrate the possible use of erythroferrone (ERFE) as a potential marker of recombinant human erythropoietin (rHuEpo) use to be included in the Athlete Biological Passport (PBA) developed by the World Anti-Doping Agency (WADA).


Eligibility criteria: Inclusion Criteria:

* Man between 18 and 49 years old
* Beneficiary of a social protection scheme
* Able to sign informed consent

Exclusion Criteria:

* Hematocrite\>50% or Hemoglobin\> 17d/dl or Ferritin\<30 ug/l
* Hypersensitivity to the active substance or to any of the excipients ofEPREX
* Erythroblastopenia already reported following treatment with erythropoietin
* Uncontrolled hypertension
* Any medication taken as part of a chronic treatment
* Absence of stable or evolutionary pathology without treatment
* History of convulsion or epilepsy
* History of thrombotic vascular events
* Large blood loss due to an accident, pathological condition or other similar situation.
* Donation of blood or blood transfusion within three months prior to inclusion in the protocol.

Primary outcomes:
measure: Erythroferrone
timeFrame: 12 measures in 29 days
Secondary outcomes:
measure: Hbmass
timeFrame: 2 measures in 29 days
Other outcomes:
Locations:
Study officials:
affiliation: Centre d'Investigation Clinique (CIC)
name: Catherine MD CORNU, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05314010: A Study of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Official title: A Multicenter, Phase Ib/III Study to Evaluate the Safety and Efficacy of MIL62 in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neuromyelitis Optica Spectrum Disorder
Lead sponsor: Beijing Mabworks Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 140
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: This study will evaluate the safety and efficacy of MIL62 in patients with Neuromyelitis Optica Spectrum Disorder.


Eligibility criteria: Inclusion Criteria:

1. Patient with NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) with anti-AQP4-IgG seropositive status.
2. Male or female aged 18～60 years.
3. Expanded Disability Status Scale(EDSS) score ≤6.5.
4. A documented history of at least one attack requiring rescue therapy in the last year or two attacks requiring rescue therapy in the last 2 years prior to screening.
5. Subjects who have had a relapse immediately prior to screening must have at least 12 weeks in which their relapse symptoms are stable prior to the first administration.

Exclusion Criteria:

1. CD20+ B cell counts below the lower limit of normal (LLN). Receipt of rituximab or any B-cell depleting agent within the 6 months prior to screening, unless the subject has B-cell counts above the LLN. CD4 T lymphocyte count \<300 cells/μL(CD4：CD8≤1.4).
2. Receipt of tocilizumab, eculizumab within 3 months prior to the first administration.
3. Receipt of any of the following prior to the first administration: Azathioprine,Mycophenolate mofetil,Tacrolimus,Cyclosporin, Methotrexate,Cyclophosphamide,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .
4. Receipt of IVIG, plasmapheresis or blood transfusion within 28 days prior to the first administration.
5. Any live or attenuated vaccine within 28 days prior to the first administration.

Primary outcomes:
measure: Phase 1b: CD19+ B and CD20+ B lymphocyte ratio
timeFrame: Up to 52 weeks
measure: Time to Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ethics Committee of Chinese PLA General Hosptial
state: Beijing
Study officials:
References:
Clinical trial NCT04710810: UCB Stem Cells for Autism Spectrum Disorders
Official title: Transplantation of Human Allogenic Cord Blood Mononuclear Stem Cells in Autism: Safety and Efficacy of the Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autism Spectrum Disorder
Lead sponsor: St. Petersburg Bekhterev Research Psychoneurological Institute
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose. The goals of the study are to assess the safety of the intravenous infusion of umbilical cord blood (UCB) cells in patients with autism and to confirm changes in social/ communicative skills and cognitive functioning after four infusions of ABO/Rh-matched UCB stem cells.

Material and methods. The sample comprises 30 patients (27 males, 3 females) aged between 3 and 11 years with ASD under the care of the National Medical Research Center for Psychiatry and Neurology (Saint-Petersburg, Russia). Participants are randomly assigned to either the control group (14 males, 1 female) or the experimental group (13 males, 2 females). The experimental group receives intravenous injections of UCB cells four times with a two-week gap between injections. The control group receives standard therapy.

The dynamic of cognitive functions and social/communicative skills assess with Checklist for autism spectrum disorders (CASD), Autism treatment evaluation checklist (ATEC), subscales of Wechsler Intelligence Scale for Children (WISC) - "Digit Span", "Picture completion", "Block design", "Coding".


Eligibility criteria: Inclusion Criteria:

* diagnosed ASD by ICD-10 criteria

Exclusion Criteria:

* acute somatic diseases
* indication for surgical (neurosurgical) therapy
* acute or chronic infectious diseases
* history of acute allergic reactions

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events
timeFrame: 24 hours after infusion
measure: Changes in severity of autistic symptoms from baseline at 3d and 6th month (measured by Checklist for Autism Spectrum Disorders (CASD)
timeFrame: at baseline, 3d and 6th month
measure: Changes in severity of autistic symptoms from baseline at 3d and 6th month (measured by Autism Treatment Evaluation Checklist (ATEC)
timeFrame: at baseline, 3d and 6th month
Secondary outcomes:
measure: "Digit Span" subscale of Wechsler Intelligence Scale for Children (WISC)
timeFrame: at baseline, 6th month
measure: "Picture completion" subscale of Wechsler Intelligence Scale for Children (WISC)
timeFrame: at baseline, 6th month
measure: "Block design" subscale of Wechsler Intelligence Scale for Children (WISC)
timeFrame: at baseline, 6th month
measure: "Coding" subscale of Wechsler Intelligence Scale for Children (WISC)
timeFrame: at baseline, 6th month
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: St.-Petersburg Bekhterev Reserach Psychoneurological Institute
state: Санкт-Петербург
Study officials:
References:
Clinical trial NCT02474810: Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol
Official title: Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter Dysfunction Protocol Using Alteplase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Insufficiency
Keywords: central venous catheters
hemodialysis
thrombosis
tissue plasminogen activator
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Central venous catheters (CVCs) are used for vascular access by approximately 56% of our 380 hemodialysis (HD) patients at the Capital Health Renal Program. The major complication of these catheters includes thrombosis and infection. Catheter locking solutions such as recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and prevent clotting of the catheter during HD treatments and during the interdialytic period. Evidence to guide the use of rt-PA is limited. This quality assurance project will compare the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol for rt-PA in HD patients.

Detailed description: The proposed study will be a retrospective cohort study of consecutive HD patients conducted at a HD unit using two catheter dysfunction protocols during January 2013 to Septebmer 2013. In the Intensive Protocol, rt-PA intervention is administered to all catheters based on blood flow and/or line reversal. In the Standard Protocol, rt-PA intervention is administered to all catheters based only on blood flow.

Eligibility criteria: Inclusion Criteria:

* All adults undergoing HD with a tunneled CVC (both newly inserted CVCs as well as pre-existing CVCs) will be included.

Exclusion Criteria:

* Patients were excluded from using the CVC dysfunction protocols if they had a known allergy or intolerance to rt-PA.
* A physician order to proceed with the CVC dysfunction protocols was required if they met one of the following criteria:
* CVC line insertion or exchange within 72 hours;
* any surgery, organ biopsy, obstetrical delivery within 72 hours;
* active bleeding; bleeding disorders; hemoglobin decrease greater than 20 g/L over 2 weeks;
* active pericarditis; arterial puncture within 48 hours;
* bacteremia with positive blood cultures.

Primary outcomes:
measure: Alteplase use
timeFrame: 9 months
Secondary outcomes:
measure: Rate of bacteremia
timeFrame: 9 months
measure: Cost of alteplase
timeFrame: 9 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Capital Health District Authority, Department of Medicine, Division of Nephrology
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Jo-Anne S Wilson, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05681910: Mode of Uterine Extraction in Total Laparoscopic Hysterectomy
Official title: Predictive Factors for Mode of Extraction of the Uterus in Total Laparoscopic Hysterectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hysterectomy
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 200
Sex: FEMALE
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: Clinical data of patients undergoing total laparoscopic hysterectomies for larger uteri with uterus size of 12 gestational weeks (g.w.) or greater between. Inclusion criteria were as follows: (1) patients with uterine myomas or endometrioma; (2) patients who have good physical conditions and have no reproduction requirement; (3) patients with uterine size ≥ 12 weeks of gestation; and (4) patients who receive no hormone therapy in the recent 3 months. Exclusion criteria were as follows: (1) patients who are contraindicated to laparoscopic surgery; (2) patients with uterus size \>16 g.w.; (3) patients with cervical myoma; (4) patients with uterine myoma associated with ovarian lesions; (5) patients with suspicious malignant gynecological disease diagnosed by ultrasound or MRI; and (6) patients with cervical cancer diagnosed by Thinprip cytologic test (TCT) and malignant endometrial lesions diagnosed by diagnostic curettage

Brief summary: Hysterectomy remains the most common major gynecological operation worldwide. It may be carried out by three different routes and its variations: vaginal, abdominal, and laparoscopic.

A large uterus will lead to several surgical difficulties during laparoscopic hysterectomy, such as limited operative field, restrictive instrument range of motion, and difficult removal of the specimen.

The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or uterine morcellation approaches after strict preoperative assessment.


Eligibility criteria: Inclusion Criteria:

* patients undergoing total laparoscopic hysterectomies for larger uteri

Exclusion Criteria:

* oncology

Primary outcomes:
measure: Intraoperative complications
timeFrame: During surgery
measure: Post operative complications
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Section of Obstetrics and Gynecology, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy
Study officials:
References:
Clinical trial NCT03348410: Joint Coordination to Facilitate the Transition From Sick Leave to Employment
Official title: Joint Coordination (GESAM) - Collaboration Project to Facilitate the Transition From Sick Leave to Employment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long Term Sick Leave
Absent-mindedness
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: GESAM is a randomized controlled intervention study that addressed women and men on long-term sick leave in Uppsala County. Participants which are on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance will be offered to participate in an intervention.

Those how give informed consent will be randomly assigned one of the following groups: 1) informing and motivating intervention with insurance officer 2) control group. The main purpose of the study is to facilitate the return to work (preventing a return to the public health insurance) during the project period.


Eligibility criteria: Inclusion Criteria:

* On sick leave
* Risk of losing sick leave compensation

Exclusion Criteria:

* Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)
* Cancer disease

Primary outcomes:
measure: Return to work (RTW)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university
Study officials:
affiliation: Uppsala University
name: Ingrid Anderzén, PHD
role: PRINCIPAL_INVESTIGATOR
References: