louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04351659: Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
Official title: Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: SARS-CoV-2
Coronavirus disease
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Singapore General Hospital
name: National University Hospital, Singapore
First posted: 2020-04-17
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential donors are those who have recovered from COVID-19 and are willing to donate blood for other COVID-19 patients.

Brief summary: The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously for the treatment of severe SARS-CoV-2 infections.

Detailed description: A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine or specific treatment has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients.

The aim of this protocol is to demonstrate the feasibility of preparing SARS-CoV-2 specific T cells from convalescent donors for urgent clinical use. The specific hypothesis is that SARS-CoV-2 specific T cells can be isolated from the blood of convalescent donors rapidly and efficiently using SARS-CoV-2 specific peptides and an automated medical device for emergent treatment of severe COVID-19 disease.

A minimum of 8 convalescent donors will be recruited from Singapore to attain HLA sharing with at least 90% of the general population.

Eligibility criteria: Inclusion Criteria:

* Age 21 to 65
* Had a history of COVID-19 with documented positive test for SARS-CoV-2 in the past
* Has recovered from COVID-19 and is now suitable for blood donation, fulfilling all standard blood donor criteria
* Negative test for SARS-CoV-2 currently

Exclusion Criteria:

* Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.

Primary outcomes:
measure: Success rate in production of SARS-CoV-2 specific T cells from convalescent donor
timeFrame: Two weeks (The expected duration of donor participation is 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: KK Hospital, SingHealth, Duke-NUS
name: Wing Hang Leung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01973959: Information Transfer During Postoperative Handovers in the Post-anaesthesia Care Unit
Official title: Quality of Postoperative Patient Handover in the Post-anaesthesia Care Unit: A Prospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Information Transfer During Postoperative Handovers
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who undergo surgery (general surgery, neurosurgery, ophthalmic surgery, orthopaedics, plastic surgery, trauma surgery, thoracic surgery).

Brief summary: Anaesthesiology plays a key role in promoting safe perioperative care. This includes the perioperative phase in the post-anaesthesia care unit (PACU) where problems with incomplete information transfer may have a negative impact on patient safety and can lead to patient harm. The objective of this study is to analyse information transfer during postoperative handovers in the PACU.

With a self-developed checklist information transfer during postoperative handovers will be documented and subsequently compared with patient information in anaesthesia records.


Eligibility criteria: Inclusion Criteria:

* All patients transferred to the PACU after surgery

Exclusion Criteria:

* Age \< 18 years
* patients who have surgery under local anaesthesia or in standby
* patients who are transferred to the surgical intensive care unit (SICU) after surgery

Primary outcomes:
measure: Quantity of Information Loss during Postoperative Handovers in the PACU
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Krankenhaus Köln-Merheim, Departement of Anaesthesiology and Intensive Care Medicine
state: Nordrhein-Westfalen
Study officials:
References:
Clinical trial NCT05643859: Impact of Dietary Fiber Supplementation on Colonic Microbiome
Official title: Changes in Colonic Microbiome With Fiber Supplementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Colorectal Neoplasm
Non-Neoplastic Anal Disorder
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial tests whether daily fiber supplementation will change the mucosal microbiome of the colon. The microbiome are microorganisms that live in the human gut. They serve a vital role in maintaining health. Certain microbial strains are associated with the growth of colon polyps, which eventually could go on to form colon cancer. Giving dietary fiber supplements may help prevent precancerous polyps from ever developing.

Detailed description: PRIMARY OBJECTIVE:

I. To identify how diet, specifically fiber supplementation, alters the microbiome of the colonic mucosa.

OUTLINE:

Patients receive dietary fiber orally (PO) once daily (QD) for 28 days. Patients may undergo standard of care proctoscopy or anoscopy with biopsy on study and at follow up or may undergo standard of care colonoscopy on study. All patients also undergo collection of blood samples on study and at follow up.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Ability to understand and the willingness to sign a written informed consent document
* Patients who present with a chief complaint of a benign anorectal pathology including hemorrhoids, anal fissures, and anal fistulas without underlying conditions such as colorectal cancer or Crohn's disease or are undergoing a standard of care colonoscopy procedure

Exclusion Criteria:

* Patients with an active malignancy, Crohn's disease, ulcerative colitis, and immunosuppressed patients
* Patients with hereditary colon cancer syndrome including Lynch syndrome or Familial Adenomatous Polyposis (FAP)
* Patients with a prior history of total or partial colon resection
* Colorectal pathology, such cancer or proctitis, after initial study scope

Primary outcomes:
measure: Change in microbiome colonic mucosa: taxa abundance
timeFrame: Baseline and post-supplementation, up to 40 days
measure: Change in microbiome colonic mucosa: microbiome diversity
timeFrame: Baseline and post-supplementation, up to 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Vassiliki L Tsikitis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04897659: Left Bundle Branch Block (LBBB) After IntuityTM
Official title: Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve Replacement: Incidence, Long-term Prognostic and Predictive Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year.

Brief summary: This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis.

It was an observational, retrospective and single-center study. Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent RD-AVR with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. Incidence, prognosis and predictive factors of new-onset of persistent LBBB were evaluated.


Eligibility criteria: Inclusion Criteria:

* rapid-deployment aortic valve replacement (RD-AVR) with the Edwards Intuity™ bioprosthesis for severe aortic valve stenosis
* between July 2012 and May 2018

Exclusion Criteria:

* preoperative permanent pacemaker or defibrillator,
* complete intraventricular conductive disorder defined by a QRS width ≥ 120 ms.
* absence of patient's authorization for anonymous publication of their clinical data for research purposes.

Primary outcomes:
measure: Incidence of NOP-LBBB (new onset of persistent left bundle branch block)
timeFrame: at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
Clinical trial NCT06887959: A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries
Official title: A Phase 4, Open-label, Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine As Part of Multimodal Therapy for Acute Pain After Laparoscopic Procedures of the Intraperitoneal or Retroperitoneal Cavities or Arthroscopic Orthopedic Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness, safety, and tolerability of SUZ for acute pain after laparoscopic procedures of the intraperitoneal or retroperitoneal cavities or arthroscopic orthopedic procedures.


Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m\^2)
* Scheduled to undergo a procedure that is in one of the following categories that would typically be treated with opioid therapy for at least 72 hours postoperatively such as

  * Laparoscopic intraperitoneal or retroperitoneal procedure
  * Arthroscopic orthopedic procedure

Key Exclusion Criteria:

-Participated in previous study with Suzetrigine or received Journavx

Other protocol defined Inclusion/Exclusion criteria will apply.

Primary outcomes:
measure: Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) for Pain Control at the End of Treatment
timeFrame: From Day 3 up to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Baltimore
country: United States
facility: MedStar
state: Maryland
city: Las Vegas
country: United States
facility: Oasis Clinical Research
state: Nevada
city: Camden
country: United States
facility: Cooper University HealthCare (CUH)
state: New Jersey
city: Charlotte
country: United States
facility: OrthoCarolina - Hip & Knee Center
state: North Carolina
city: Durham
country: United States
facility: Eximia Research-Durham
state: North Carolina
city: Morehead City
country: United States
facility: West Clinical Research
state: North Carolina
city: Wilmington
country: United States
facility: Seaside Clinical Research Institute
state: North Carolina
city: Bellaire
country: United States
facility: HD Research LLC | First Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Village
state: Texas
city: Norfolk
country: United States
facility: Tidewater Clinical Research
state: Virginia
Study officials:
References:
Clinical trial NCT01414959: Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients
Official title: Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Abdominal Infection
Urinary Tract Infection
Keywords: intensive care patient
intubation
(please change wording as you like!)
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 16
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: intubated patients, intensive care

Brief summary: The investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients.

Detailed description: Methods: microdialysis, blood sampling, bronchoalveolar lavage

Eligibility criteria: Inclusion Criteria:

* endotracheal intubation; pneumonia or complicated abdominal infection or complicated urinary tract infection

Exclusion Criteria:

* allergy to doripenem, hemodialysis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Med. Univ. of Vienna
Study officials:
affiliation: Medical Universit of Vienna
name: Markus Zeitlinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05532059: Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
Official title: A Phase Ⅱ, Open Label, Single-center Study of Lenvatinib and Tirelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Cholangiocarcinoma
Keywords: Lenvatinib; Gemcitabine and Cisplatin; Tislelizumab; Cholangiocarcinoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery. As more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced CCA. Cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of T cells. Tyrosine kinase inhibitors (TKI) can reduce the expression of PD-L1 and inhibit Treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment. Therefore,we aim to investigate the safety and efficacy of lenvatinib, tislelizumab combined with gemcitabine plus cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
* the world health organization (WHO)/ECOG physical state (PS) to 0 or 1.
* at least 1 RECIST 1.1 standard target lesions.
* not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.
* adequate organ and bone marrow function, defined as follows: 9.0 g/dL or higher hemoglobin; neutrophil count 1.5 x 109 / L; platelet count 100 x 109 / L.

Exclusion Criteria:

* Active or previously documented autoimmune disease or inflammatory disease.
* Uncontrolled complications.
* History of other primary malignancies.
* Active infection.
* Women who are pregnant or breastfeeding.

Primary outcomes:
measure: objective remission rate (ORR)
timeFrame: 4 cycle treatment (each cycle is 21 days)
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: From date of randomization until the date of first documented progression, assessed up to 60 months
measure: Overall survival time (OS)
timeFrame: From date of randomization until the date of death from any cause, assessed up to 60 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT03650959: Optimizing Resource Utilization During Proficiency-based Training of Suturing Skills to Medical Students
Official title: Optimizing Resource Utilization During Proficiency-Based Training of Suturing Skills to Medical Students: a Randomized Controlled Trial of Faculty-Led, Peer Tutor-Led, and Computer Augmented Methods of Teaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education, Medical
Sutures
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evidence favours teaching procedural skills to medical students using a proficiency-based rather than time-based approach. Basic suturing skills can be taught through faculty-led, peer tutor-led, and computer augmented approaches. One method has yet to be identified as superior in terms of educational outcomes, resource utilization, and participant perspectives.

Pre-clerkship medical students were randomized to: faculty, peer tutor, or computer augmented learning. Participants practiced suturing through their randomized method until they reached targeted proficiency defined using hand motion analysis (HMA). Proficiency was defined as a score of the average plus a standard deviation of five surgeons' HMA for two of three consecutive sutures using appropriate technique.

The primary outcome was the number of stitches placed to achieve proficiency. The secondary outcomes were the number of sutures used, time, and costs incurred. Learning curves were constructed. Participants' perceptions were assessed using a follow-up survey.


Eligibility criteria: Inclusion Criteria:

* Second year, pre-clerkship medical students

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of stitched laid to reach proficiency
timeFrame: Five days
Secondary outcomes:
measure: Number of sutures used to reach proficiency
timeFrame: Five days
measure: Minutes to reach proficiency
timeFrame: Five days
measure: Individual costs to reach proficiency
timeFrame: Five days
Other outcomes:
measure: Learning curves
timeFrame: Five days
measure: Student preferences
timeFrame: Five days
Locations:
city: Kingston
country: Canada
facility: Queen's Unviersity
state: Ontario
Study officials:
References:
Clinical trial NCT05194059: 'Activity Pacing' in PLWH With Fatigue Symptoms.
Official title: ActiPacMAN: 'Activity Pacing' in PLWH With Fatigue Symptoms. Monitoring Through the Combined Use of Actigraphy and Mobile App Notifications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical activity helps to improve health and prevent chronic diseases. However, the fatigue usually hampers the training and execution of physical exercises, especially in people with chronic fatigue syndromes (CFCs), such as persons living with HIV (PLWH). We hypothesize that the "activity pacing", i.e. the strategy to optimize daily physical activity into manageable exercises in a way that should not exacerbate fatigue symptoms, may help a progressive improvement in physical activity of a group of PLWH with fatigue symptoms. Motivation and adherence to exercise will be monitored through the use of digital supports.


Eligibility criteria: Inclusion Criteria:

* of age ≥18 years;
* either sedentary or already practicing mild/moderate physical activity (at least 150 minutes of moderate-intensity physical activity throughout the week);
* able to sign the informed consent.

Exclusion Criteria:

The study will exclude HIV+ individuals:

* with any HIV-related disease requiring hospitalization in the 6 weeks before enrolment;
* with medical conditions (e.g. neurologic, muscular-skeletal, cardiovascular diseases) contraindicating non agonistic exercise, as established by a sport medicine specialist;
* currently abusing of substance or alcohol;
* already performing physical activity at higher level than the current WHO recommendations (30 minutes of moderate activity 5 times a week).

Primary outcomes:
measure: Activity pacing improvement
timeFrame: 16 week
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Department of Infectious Diseases
Study officials:
References: