louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05041764: RNA Sequencing of Individual Versus Wastewater - SARS-CoV2
Official title: A Comparison Between Individual and Wastewater SARS-CoV2 RNA Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection Viral
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2021-09-13
Enrollment: 1409
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: nice population

Brief summary: The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. These values were compared to values measured in wastewater.


Eligibility criteria: Inclusion Criteria:

* whole population tested in Nice during W43 of 2020

Exclusion Criteria:

* none

Primary outcomes:
measure: RTqPCR result
timeFrame: 1 month
measure: SARS-CoV2 sequence
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice Hospital
city: Sophia Antipolis
country: France
facility: Ipmc . Cnrs
Study officials:
References:
Clinical trial NCT01721564: Bosentan and Pulmonary Endothelial Function
Official title: Pulmonary Artery Remodelling With Bosentan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Royal Prince Alfred Hospital, Sydney, Australia
Sponsor class: OTHER
First posted: 2012-11-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.


Eligibility criteria: Inclusion Criteria:

* Pulmonary arterial hypertension; idiopathic and connective tissue disease associated
* Confirmed or invasive haemodynamic:
* Mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury
* Pulmonary capillary wedge pressure less than 15 millimeters of mercury
* No prior pulmonary hypertension specific therapy
* Ability to provide informed consent

Exclusion Criteria:

* Contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, NG-Monomethyl-L-Arginine, L-arginine
* Advanced renal disease
* Previous allergic reaction to contrast agents

Primary outcomes:
measure: Acetylcholine Vascular Reactivity Response
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Intravascular Ultrasound - Pulmonary Artery Wall Thickness
timeFrame: baseline and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: David S Celermajer, MBBS, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04594564: Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Using Delta TT Cup
Official title: Squeaking in Ceramic-on-Ceramic Total Hip Arthroplasty Using Delta TT Cup
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Osteonecrosis of Femoral Head
Femoral Neck Fractures
Rheumatoid Arthritis of Hip
Posttraumatic Arthropathy
Keywords: Total hip arhtroplasty
Squeaking
Dislocation
Ceramic bearings
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: LIMA Korea
First posted: 2020-10-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who undergo THA for their advanced hip disease.

Brief summary: This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup.

Detailed description: This study will evaluate clinical outcome on patients who undergo ceramic on ceramic (CoC) bearing total hip arthroplasty (THA) using Delta TT cup. Specifically the study intends to address the following research topics:

1. The incidence of squeaking after CoC THA using Delta TT cup.
2. The dislocation rate and survival rate of CoC THA using Delta TT cup.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years old
* Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis
* Rheumatoid arthritis
* Post-traumatic arthritis
* Fractures of femoral neck

Exclusion Criteria:

* Local or systemic infection
* Septicaemia
* Persistent acute or chronic osteomyelitis
* Confirmed nerve or muscle lesion compromising hip joint function
* Unstable medical illness
* Rapidly progressive neurological disease

Primary outcomes:
measure: Squeaking
timeFrame: 6 weeks
measure: Squeaking
timeFrame: 3 months
measure: Squeaking
timeFrame: 6 months
measure: Squeaking
timeFrame: 9 months
measure: Squeaking
timeFrame: 12 months
measure: Squeaking
timeFrame: 24 months
Secondary outcomes:
measure: Dislocation
timeFrame: 6 weeks
measure: Dislocation
timeFrame: 3 months
measure: Dislocation
timeFrame: 6 months
measure: Dislocation
timeFrame: 9 months
measure: Dislocation
timeFrame: 12 months
measure: Dislocation
timeFrame: 24 months
Other outcomes:
measure: Range of motion
timeFrame: 24 months
measure: Survivorship of implant
timeFrame: 24 months
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Young-Kyun Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04523064: POST-CABGDM: Empagliflozin in Perioperative CABG
Official title: Empagliflozin for Prevention of Acute Kidney Injury in Patients With Type 2 Diabetes Mellitus Undergoing Extracorporeal On-pump CABG: The POST-CABGDM Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Coronary Artery Disease
Coronary Artery Bypass Surgery
Acute Kidney Injury
Keywords: Diabetes
Coronary artery disease
SGLT2i
CABG
Acute kidney injury
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 155
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: Introduction: Diabetes Mellitus (DM) is a condition known to be associated with coronary artery disease (CAD) and its role as promoter of atherosclerosis is well stablished. The revascularization surgery is commonly indicated to patients with multivessel coronary disease and kidney injury is a prevalent complication in post operation. This work aims to evaluate the impact of a strategy to control Diabetes Mellitus using inhibitors of sodium-glucose cotransporters (ISGLT2) in diabetics patients with assigned myocardial revascularization with cardiopulmonary bypass

Detailed description: Random Prospective Study non-blinded with 144 diabetics patients designated to myocardial revascularization with cardiopulmonary bypass . 72 patients will be randomly set to usual treatment provided by health care service and 72 patients will be randomly assigned treatment based on ISGLT2 (Empaglifozin). Patients will receive treatment as set for 3 months until 3 days prior to surgery. Creatinine levels will be measured immediately after surgery and in the following 3 days in post-op.

To evaluate the possibility to reduce the acute kidney injury in a randomized group treated with therapy based on ISGLT2.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Type 2 diabetes mellitus
* Multivessel CAD documented by coronary angiography with formal indication for CRM.

Exclusion Criteria:

* eGFR \<30mL / min / 1.73m2 or dialysis therapy;
* Inability to sign the informed consent form;
* Contraindication to CABG on pump;
* Need for urgent or emergency CABG;
* Terminal or disabling illness with reduced life expectancy;
* Pregnancy in progress.

Primary outcomes:
measure: Acute kidney injury
timeFrame: 3 months
Secondary outcomes:
measure: Atrial fibrillation
timeFrame: 3 months
measure: Pulmonary infection
timeFrame: 3 months
measure: Infection of surgical site
timeFrame: 3 months
measure: ICU readmission
timeFrame: 3 months
measure: Need for IV insulin
timeFrame: 3 months
measure: Myocardial Infarction Type 5
timeFrame: 3 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo Medical School - The Heart Institute
state: SP
Study officials:
affiliation: Instituto do Coração - Hospital das Clinicas FMUSP
name: Carlos V Serrano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05914064: Gravitas Feeding Tube System Placement Validation in Neonates
Official title: Gravitas Feeding Tube System Placement Validation in Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasogastric Tube
Lead sponsor: Gravitas Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 110
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to validate the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications.


Eligibility criteria: Inclusion Criteria:

* Infants in the Newborn Intensive Care Unit or on the general medical floor requiring a 5-8 Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5-8 Fr Feeding Tube should only be placed if that size is appropriate.
* Age at enrollment: 0 to 18 weeks post-partum. Can be up to 12 weeks preterm (gestational age ≥ 28 weeks).
* Suitable to start enteral (gastric but not post-pyloric) feeding
* Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube.
* Ability to have a legally authorized representative provide informed consent Both neonates on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.

Exclusion Criteria:

* Known major upper airway malformation (e.g. tracheoesophageal fistula)
* Known major GI malformation (e.g. malrotation)
* NPO status - neonate expected to remain NPO/NPG for the following 72 hours
* Has a medical condition that drastically affects gastric acid-secretion (e.g. Zollinger-Ellison Syndrome, congenital achlorhydria, gastrointestinal perforation/leak/obstruction);
* Has had removal of part of the stomach
* Critically ill, facing imminent death
* Neonate on ECMO
* Deemed unsuitable for enrollment in study by the site principal investigator based on the patients' medical history
* Infant needs an MRI in the immediate future (e.g. 6-12h)
* Infant needs post-pyloric feeds (distal to stomach)
* Infant has a basilar skull fracture

Primary outcomes:
measure: Incidence of device and procedure-related adverse events that occur while the feeding tube is within a subject. The number and type of adverse events will be collected.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard (Stanford) Children's Hospital
state: California
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Charlottesville
country: United States
facility: University of Virginia Children's Health
state: Virginia
Study officials:
References:
Clinical trial NCT03798964: The Expression Heparanase in Term and Preterm Placentas
Official title: The Expression Heparanase in Term and Preterm Placentas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-01-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attending our obstetrical unit

Brief summary: Heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM).

This study aims to investigate the association between heparanase expression in the human placenta and preterm birth (PTB) .

The investigators hypothesize that an abnormal placentation causes relative placental ischemia that induces higher rates of heparanase expression.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy

Exclusion Criteria:

* High-risk patients
* Multiple pregnancy
* Significant maternal illness
* Significant fetal anomaly

Primary outcomes:
measure: Heparanase expression
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Rinat Gabbay-Benziv, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01757964: Bacteriotherapy in Pediatric Inflammatory Bowel Disease
Official title: Bacteriotherapy in Pediatric Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
CD
Keywords: Crohns Disease
Ulcerative Colitis
Inflammatory Bowel Disease
IBD
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
First posted: 2012-12-31
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the investigators want to see if Bacteriotherapy (also referred to as stool transplantation) improves the symptoms and decreases inflammation in children with Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis. Additionally, researchers want to learn whether this experimental therapy delays the need for starting additional medications to treat pediatric IBD.


Eligibility criteria: Inclusion Criteria:

* Children ages 12-21 years old with a diagnosis of mild to moderate Ulcerative Colitis or Crohn's Disease
* Willing parent to donate stool for the transplant

Exclusion Criteria:

* Severe Disease
* History of intra-abdominal abscess, intra-abdominal fistula or stricturing
* History of other systemic diseases
* The patient has received TNF inhibitors to treat their IBD within two months of transplant

Primary outcomes:
measure: Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
citation: Suskind DL, Brittnacher MJ, Wahbeh G, Shaffer ML, Hayden HS, Qin X, Singh N, Damman CJ, Hager KR, Nielson H, Miller SI. Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease. Inflamm Bowel Dis. 2015 Mar;21(3):556-63. doi: 10.1097/MIB.0000000000000307.
citation: Suskind DL, Singh N, Nielson H, Wahbeh G. Fecal microbial transplant via nasogastric tube for active pediatric ulcerative colitis. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):27-9. doi: 10.1097/MPG.0000000000000544.
Clinical trial NCT04827264: Safe Return to Play After ACL Reconstruction
Official title: Safe Return to Play Following ACL Reconstruction: Validation of a Return to Play Checklist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL Tear
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 222
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants ages 15-35 who have undergone primary ACL reconstruction at Rothman Orthopaedics

Brief summary: Recent studies report that as few as 44% of athletes undergoing ACL reconstruction were able to return to their prior level of competitive level of sports. Early return may predispose an individual to re-injury including graft re-tear, meniscal tears, chondral injuries, and contralateral knee injuries. Criteria governing clearance to return to sports after ACL reconstruction has been traditionally defined using time from surgery and one or two objective criteria, often solely isokinetic quad/hamstring strength. Several studies have suggested that historical criteria used to assess readiness to return to play (RTP) are insufficient in identifying individuals at risk of a re-injury. They advocate for additional functional and dynamic testing, which may better reflect the complex kinematics required in high level athletic competition.

We previously developed a "Safe Return to Play Following ACL Reconstruction Checklist" based on a systematic review of the literature and expert survey. Seven objective measures were developed as part of the checklist. The checklist is performed by a certified physical therapist trained in these performance tests.

The purpose of this study is to validate the utility of our "Return to Play Checklist" by evaluating our patients prospectively for return to play following ACL reconstruction by comparing a cohort of patient undergoing testing with the checklist versus "clinical judgement."


Eligibility criteria: Inclusion Criteria:

* All patients ages 15-35 undergoing primary ACL reconstruction

Exclusion Criteria:

* patients who are undergoing revision ACL surgery

Primary outcomes:
measure: Return to Play
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00002064: Toxoplasmic Encephalitis in Patients With AIDS. Treatment and Prevention of Relapse
Official title: Toxoplasmic Encephalitis in Patients With AIDS. Treatment and Prevention of Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toxoplasmosis, Cerebral
HIV Infections
Keywords: Sulfonamides
Toxoplasmosis
AIDS-Related Opportunistic Infections
Pyrimethamine
Drug Therapy, Combination
Encephalitis
Acquired Immunodeficiency Syndrome
Clindamycin
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare pyrimethamine and intravenous (IV) clindamycin vs. pyrimethamine and sulfonamides in the treatment of AIDS patients with central nervous system (CNS) Toxoplasma gondii.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* Opportunistic infection (Pneumocystis carinii pneumonia (PCP), cryptococcal meningitis) or other conditions (brain abscess) which would make treatment results difficult to interpret due to concurrent infection, disease, or therapy.

Patients with other opportunistic infections or brain diseases are excluded.

Patients with AIDS and cerebral toxoplasmosis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Med Foundation
state: California
Study officials:
References:
Clinical trial NCT00114764: Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
Official title: A Multicentre, Double-Blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myeloid Leukemia
Keywords: Acute myeloid leukaemia
Pegfilgrastim
Neulasta®
Neutropenia
Induction chemotherapy
Consolidation
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-06-20
Enrollment: 84
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 purpose of this study is to determine if a single dose of pegfilgrastim is able to reduce the time of severe neutropenia in patients receiving induction and consolidation myelosuppressive chemotherapy for de novo acute myeloid leukemia similar to filgrastim.


Eligibility criteria: Inclusion

* Histologically confirmed de novo AML as evidenced by absence of an antecedent hematologic disease of \> 1 months duration, prior chemotherapy, prior radiation therapy or myelodysplastic cytogenetics (as per exclusion criteria)
* Life expectancy, with treatment, \> 3 months
* Age \> 18 years
* ECOG performance status 0, 1 or 2
* Adequate organ function to receive protocol specified chemotherapy

Exclusion

* Subjects in blast transformation of chronic myeloid leukaemia (CML)
* Patients with secondary AML (Received previous chemotherapy or radiotherapy)
* Previous treatment for AML
* Patients with AML FAB type M3 (Acute Promyelocytic Leukemia, APL) or M7
* High risk (Unfavourable) cytogenetics \[(-5/del(5q), -7/del(7q), t(8;21) with del (9q) or complex karyotype, inv(3q), abn 11q23, 20q, 21q, del(9q), t(6;9), t(9;22), abn 17p, complex karyotypes(\>3 abnormalities)\]

Primary outcomes:
measure: Time to recover from severe neutropenia (ANC less that 0.5 X 10^9/L in chemotherapy Induction 1.
timeFrame: Induction cycle 1
Secondary outcomes:
measure: Duration of severe neutropenia during induction chemotherapy
timeFrame: Induction cycle 1
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Sierra J, Szer J, Kassis J, Herrmann R, Lazzarino M, Thomas X, Noga SJ, Baker N, Dansey R, Bosi A. A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: results from a randomized, double-blind, phase 2 trial. BMC Cancer. 2008 Jul 10;8:195. doi: 10.1186/1471-2407-8-195.