louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04353583: Acute Kidney Injury and Acute Kidney Disease in COVID-19
Official title: Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients With Coronavirus Disease 2019 (COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Corona Virus Infection
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 900
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: Hospitalized patients with diagnosed COVID-19

Brief summary: Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19.

Detailed description: Beginning in December 2019, a novel coronavirus, designated as severe acute respiratory distress coronavirus 2 (SARS-CoV-2), has caused an international outbreak of respiratory illness termed coronavirus disease 2019 (COVID-19). Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients show severe kidney abnormalities. Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19.

Eligibility criteria: Inclusion Criteria:

1) Patients with COVID-19 diagnosed by World Health Organisation (WHO) criteria

Exclusion Criteria:

1. Patients aged less than 18 years
2. Patients with stage 4 chronic kidney disease (baseline estimated glomerular filtration rate \<30 ml/min/1.73 m2)
3. Patients receiving maintenance dialysis
4. Recipients of solid-organ transplantation

Primary outcomes:
measure: Incidence of AKI
timeFrame: 30 days post-hospital admission
measure: Cystatin C as indicator of mortality
timeFrame: 30 days post-hospital admission
measure: Cystatin C as indicator of renal disease
timeFrame: 30 days post-hospital admission
measure: Cystatin C as indicator of respiratory illness
timeFrame: 30 days post-hospital admission
measure: Cystatin C as indicator of disease severity
timeFrame: 30 days post-hospital admission
Secondary outcomes:
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University Hospital Giessen and Marburg, Giessen
state: Hessen
Study officials:
affiliation: University Hospital Giessen and Marburg, Giessen
name: Werner Seeger, MD
role: STUDY_DIRECTOR
References:
citation: Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys. Kidney Int. 2020 May;97(5):824-828. doi: 10.1016/j.kint.2020.03.001. Epub 2020 Mar 7. No abstract available.
Clinical trial NCT03403283: Dyslipidemia and Diabetic Retinopathy
Official title: Dyslipidemia and Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Dyslipidemia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2018-01-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ophthalmology and Primary Care Clinics

Brief summary: The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.

Detailed description: The purpose of this study is to determine if the reparative cells of blood vessels, called endothelial progenitor cells (EPC's) are defective in people with diabetes. Diabetic retinopathy (DR) is an eye disease related to diabetes. It can cause blurred vision and possible bleeding in the blood vessels in the back of the eye (retina). Damage to the cells of the blood vessels from DR can cause vision loss or blindness. Even with current treatments, the quality of life for people with DR is much reduced.

Eligibility criteria: Inclusion Criteria:

* Any man or woman
* Greater than 18 years of age
* Diagnosis of diabetes (applies to the Diabetic Arm only) (N=15 Type 1 and N=15 Type
* The subject must be willing and have the ability to cooperate with the protocol. Children will not be eligible because the investigators need to obtain 150 ml of blood and this is in excess of what can be drawn in children.

Exclusion Criteria:

* Female participants must not be pregnant at the time of the blood draw as evident through a dipstick pregnancy test.
* Have retinal abnormalities other than diabetic retinopathy.

Primary outcomes:
measure: Increase in Acid Sphingomyelinase (ASM) Expression and Activity in Bone Marrow-derived Endothelial Progenitor Cells (EPCs)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Maria B Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02059083: Biofeedback for Adolescent Cannabis Use Disorder
Official title: Biofeedback for Adolescent Cannabis Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Adolescent Cannabis Use Disorder
Keywords: adolescent
cannabis
biofeedback
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study are: 1) to estimate the effect size of HRV biofeedback for stress in adolescents undergoing cognitive behavioral therapy (CBT) for cannabis use disorder (primary outcome: Perceived Stress Scale) and 2) to estimate the effect size of HRV biofeedback for cannabis use in adolescents undergoing CBT for cannabis use disorder (primary outcome: number of days used cannabis in the past 30 days).


Eligibility criteria: Inclusion Criteria:

* be between the ages of 13 and 19 years, with a parent or legal guardian available to complete parental assessments, if the participant is a minor
* meet Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-V) criteria for cannabis use disorder by clinical interview;
* be medically healthy;
* be willing to participate in the study intervention and assessments;
* plan to live locally for at least 4 months;
* be able to read English well enough to complete study questionnaires;
* have self-reported cannabis use in the past 28 days;
* have a Perceived Stress Scale score \> 20.

Exclusion Criteria:

* current or past psychosis;
* bipolar I or II disorder;
* the need to take psychotropic medications at any time during the study;
* pregnancy;
* psychiatric or substance use disorder that cannot be managed with outpatient care (e.g. alcohol withdrawal, severe major depressive disorder, significant suicidal ideation); and
* medications known to affect HRV (e.g. albuterol, pseudoephedrine, beta adrenergic blockers).

Primary outcomes:
measure: Change in Perceived Stress Scale
timeFrame: baseline and 16 weeks
Secondary outcomes:
measure: Change in the number of days used marijuana in the past 28 days
timeFrame: baseline and 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Denver Health
name: Christian Thurstone, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00233883: WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV.
Official title: An Open-label Study of the Tolerability of a Subcutaneous Needle-free Injection Device Used to Administer Fuzeon, Compared With the Standard Needle/Syringe Supplied With Commercial Fuzeon in HIV-1 Infected, ARV Treatment-experienced Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Trimeris
First posted: 2005-10-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free injection device used to administer Fuzeon, compared with the standard needle/syringe supplied with commercial Fuzeon. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* male or female patients, \>=18 years of age with HIV-1 infection;
* previously treated with antiretroviral agents.

Exclusion Criteria:

* prior use of Fuzeon or T-1249;
* inability to self-inject;
* active, untreated opportunistic infection.

Primary outcomes:
measure: Composite endpoint (pain, induration, nodules/cysts).
timeFrame: Throughout study
Secondary outcomes:
measure: Steady state C trough
timeFrame: Weekly
measure: Signs and symptoms associated with Fuzeon injections
timeFrame: Throughout study
Other outcomes:
Locations:
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Fort Lauderdale
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: St Louis
country: United States
state: Missouri
city: Winston-salem
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Annandale
country: United States
state: Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Gottlieb M, Thommes JA; WAND Study Team. Short communication safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection. Antivir Ther. 2008;13(5):723-7.
Clinical trial NCT06723483: Results Of Usage Of Bridging Plate In Multi-fragmentary Distal Radius Fracture
Official title: Results of Usage of Bridging Plate in Multi-fragmentary Distal Radius Fracture
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Distal Radius Fractures
Mechanical Complication of Internal Rod Fixation Device
Internal Fixation; Complications
Keywords: bridging plate, distraction plate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: oFirst peak is the young exposed to high energy trauma , fall from a height, polytrauma patients with extensive communition of metaphyseal and articular parts oSecond peak is old (over 60 years),with osteoporotic bone where even minor falls can cause extensive comminution

Brief summary: using a plate as a distraction method bridging the comminution to restore anatomical parameters to treat comminuted distal radius fracture follow-up functional outcomes of the wrist after metal removal

Detailed description: The plate is extended from the floor of the 2end extensor compartment at an intact radius to the 2end metacarpal by dual minimally invasive skin incisions.

One distal over 2end metacarpal and Other proximal over 2end extensor compartment at intact radius application of distal screws 1st, then the traction is done to restore radial length, radial inclination, and volar tilt followed by the application of proximal screws add wires to restore the joint congruity wire removal after 45 days, plate removal after 100 day follow up every 3 months till 1 year post-operative Assess the Functional Outcome Of the wrist joint after metal removal

Eligibility criteria: Inclusion Criteria:

1. Skeletally mature patients
2. presented with multifragmentary distal radius fractures classify type 23-3C according to AO classification
3. articular with or without metaphyseal comminution
4. Very distal fractures 5 )osteoporotic bone fractures

Exclusion Criteria:

1. Dorsal soft tissue defect or tendon injuries
2. Metacarpal fractures (esp 2end MC)
3. open grade 3 fractures

Primary outcomes:
measure: Modified Mayo Wrist Score (MMWS)
timeFrame: Mean follow-up period is 1 year postoperative.
Secondary outcomes:
measure: Wrist Range of Movement
timeFrame: Mean follow-up period is 1 year postoperative.
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Faculty of medicine assuit university
Study officials:
affiliation: assiut university hospitals
name: Waleed Riad Saleh Waleed Riad Saleh Ramadan, preso doctor
role: STUDY_CHAIR
affiliation: assiut university hospitals
name: Yasser Farouk Yasser Mohamed Farouk Fouad Ragheb, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03503383: Evaluation of Psychological Status in Pregnant Women Complaining of Hypertension With Pregnancy
Official title: Evaluation of Mental Health Status in Pregnant Women Complaining of Hypertension With Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension With Pregnancy
Keywords: Hypertension with pregnancy
anxiety
depression
preeclampsia
mental health
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-04-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is comparing between two groups, first group is healthy pregnant women and second group is pregnant women with hypertension . Both groups are assessed for both Anxiety and Depresion disorders.

Brief summary: This study is a case controlled study comparing mental health status and some psychological impacts between two groups of patients first group is pregnant women without any other medical disorder during pregnancy,the second group is pregnant women complaining of hypertension with pregnancy.


Eligibility criteria: Inclusion Criteria:

* pregnant women
* Hypertensive pregnant women for diseased group
* Normal pregnancy with no medical disorders associated in controlled group
* singleton pregnancy
* spontaneous pregnancy
* patients who are not divorced or not widow

Exclusion Criteria:

* non-pregnant women
* any other associated medical disorder with pregnancy rather than Hypertension
* any known psychological or mental disorder prior to pregnancy
* non spontaneous pregnancy as those whom conceived by IVF
* Twin or more pregnancy
* patients who are divorced or widow

Primary outcomes:
measure: Depression Evaluation using Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 months
measure: Anxiety Evaluation using Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minya Health Insurance Hospital
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
affiliation: Zagazig University
name: Mena M Abdalla, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00454883: Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.
Official title: Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Affective Psychosis, Bipolar
Mania
Manic-Depressive Psychosis
Keywords: Safety of ziprasidone, efficacy of ziprasidone, manic episodes in bipolar disorder, mixed episodes in bipolar disorder, schizoaffective disorder.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-02
Enrollment: 379
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: The patients were identified in in- and outpatients settings (university departments, hospital wards, outpatients clinics, daily psychiatric hospitals)

Brief summary: Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

Detailed description: Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Eligibility criteria: Inclusion Criteria:

* Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes

Exclusion Criteria:

* Hypersensitivity to ziprasidone
* prolonged QTc interval
* coadministration with substances that are prolonging the QTc interval
* recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments

Primary outcomes:
measure: Clinical global impression
timeFrame: 3 months
measure: Recording of extrapyramidal symptoms
timeFrame: 3 months
measure: Changes in manic symptoms over course of treatment
timeFrame: 3 months
Secondary outcomes:
measure: Severity of disease
timeFrame: 3 months
measure: Adverse Events
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04415983: Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children
Official title: Study of Novel Triple Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of Nitazoxanide (NTZ) based therapeutic regimens for Helicobacter pylori in children

Detailed description: Study of Novel triple Nitazoxanide (NTZ) based new therapeutic regimens for Helicobacter pylori in children

Eligibility criteria: Inclusion Criteria:

- Positive helicobacter infection.

Exclusion Criteria:

* Previous treatment for H. Pylori.

Primary outcomes:
measure: Number of patients with cured helicobacter infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Pediatrics department - Tanta University
name: Rasha Gamal, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University Faculty of medicine
name: sherief Abd-Elsalam, ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatrics department - Kafr Elsheikh University
name: Abeer Salamah, Lecturer
role: STUDY_DIRECTOR
affiliation: Pediatrics department - Tanta University
name: dina shawky, lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04802083: COVID-19 Soliris Expanded Access Protocol
Official title: SOLIRIS® (Eculizumab) for the Treatment of Participants With Coronavirus Disease 2019 (COVID-19) - An Expanded Access Protocol
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Covid19
Keywords: Soliris
eculizumab
C5 inhibitor
COVID-19
SARS-COV-2
acute lung injury
severe pneumonia
acute respiratory distress syndrome
severe acute respiratory syndrome coronavirus 2
severe acute respiratory syndrome
multi-organ injury
hospitalization
antibodies, monoclonal, humanized
emergency treatment
viral
expanded access
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This protocol provides participants with COVID-19 access to Soliris.

Detailed description: This is an open-label, multicenter, expanded access protocol that will provide access to Soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection with a clinical presentation consistent with COVID-19 associated organ injury, such as acute respiratory distress syndrome, stroke, or acute renal failure. Participants who qualify for emergency treatment (whether in an inpatient or outpatient setting) will be offered the opportunity to receive up to 7 infusions of Soliris over approximately 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. Males or females ≥ 18 years of age and body weight ≥ 40 kg.
2. Confirmed diagnosis of SARS-COV-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test).
3. Willing to receive vaccination against Neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to Day 1.
4. In the opinion of the Investigator, the participant is suitable to be enrolled in the expanded access protocol (EAP), based on the participant's overall clinical condition and the known Soliris benefit/risk profile.

Exclusion Criteria:

1. Unresolved Neisseria meningitidis infection.
2. Known hypersensitivity to murine proteins or to an excipient of Soliris.

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