louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04932954: Immunohematology in COVID-19 Patients: A Hospital-based Retrospective Cohort Study
Official title: Immunohematology in COVID-19 Patients: A Hospital-based Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Immunohematology
Blood group
COVID-19
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Henan University of Science and Technology
First posted: 2021-06-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients were diagnosed with COVID-19 following the WHO interim guidelines and admitted for treatment in Tongji hospital. The admission dates were January 01 2020 to April 01, 2021. Male or female patients \<18 years of age were excluded.

Brief summary: This is a hospital-based retrospective cohort study and the Immunohematologic characteristics of COVID-19 patients will be investigated systematically.

Detailed description: This is a hospital-based retrospective cohort study and the Immunohematologic characteristics of COVID-19 patients will be investigated systematically. In this study, we will seek to understand the association between SARS-CoV-2 infection and blood groups and explore the Anti-A and Anti-B effects in COVID-19 patients with graded severity. We will analyze the transfusion requirement and the clinical recurrences of COVID-19 patients. The discrepancy of blood group phenotypes in COVID-19 patients with graded severity will be also analyzed on the molecular level. This retrospective cohort study was conducted using electronic health recording data in Tongji Hospital. The clinical characteristics for all eligible patients will be retrieved. The records will be verified to avoid possible bias. Data collection was carried out independently by two investigators and reviewed by two different investigators.

Eligibility criteria: Inclusion Criteria:

* The patients who were diagnosed with COVID-19 following the WHO interim guidelines (https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novelcoronavirus-(ncov)-infection-is-suspected. 2020.)

Exclusion Criteria:

* Male or female patients \<18 years of age

Primary outcomes:
measure: ABO and Rh distribution
timeFrame: 1 year
measure: ABO antibody titers
timeFrame: 1 year
Secondary outcomes:
measure: Transfusion incidence
timeFrame: 1 year
measure: Patients with coagulopathy
timeFrame: 1 year
measure: Leukocyte and neutrophil counts
timeFrame: 1 year
measure: outcomes of SARS-CoV-2 infection
timeFrame: 1 year
measure: Polymorphism of ABO blood group
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT04396054: Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
Official title: Comparison of Double Y-shaped Plates and Lag Screws in Fixation of Anterior Mandibular Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Fractures
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.

Detailed description: This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, selected from those admitted to the Emergency Department of Alexandria University Hospital. Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry, Alexandria University. A written informed consent was signed by patients before the operation.

Patients were divided equally into two groups, each consisting of eight patients. Assignment of each patient into one of either group was done using computer random numbers.

Group 1: underwent open reduction and internal fixation using two lag screws. Group 2: underwent open reduction and internal fixation using double Y-shaped plates.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders
* with age ranging from 25 to 45 years,
* suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)

Exclusion Criteria:

* old fractures,
* infected fractures
* comminuted fractures

Primary outcomes:
measure: progress of fracture healing in the postoperative period
timeFrame: after 6 months
measure: Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04958954: Post-Marketing Safety Study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in the United States
Official title: Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI) Signal Evaluation in HealthVerity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 50000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected from HealthVerity's aggregated medical and pharmacy claims database that represents healthcare utilization for over 140 million participants between 01 December 2017 and the end of the study period (31 December 2022).

Brief summary: The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.

Detailed description: This retrospective observational cohort study will use secondary, de-identified individual-level medical and pharmacy claims data provided by HealthVerity.

Eligibility criteria: Inclusion Criteria:

* Included in a health plan covered by HealthVerity database
* Covered by a health plan during at least 1 period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods), but not necessarily the full period.
* Demonstrate an AESI specified clean period of continuous baseline enrollment or activity before the period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods) during which the participant is covered.

Exclusion Criteria:

None

Primary outcomes:
measure: Number of Participants With Adverse Events of Special Interests (AESIs)
timeFrame: Index date (that is, first day of health plan eligibility within the applicable time period where all study entry criteria are met) through end of data availability or earliest event (maximum of 751 days depending on duration of capture in the database)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Aetion Inc.
state: New York
Study officials:
References:
Clinical trial NCT05222854: Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma"
Official title: Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma" the CONGENIAL Analysis Sub-study of the GR
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gallbladder Carcinoma
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with gallbladder carcinoma

Brief summary: Multicenter German- Registry of Incidental Gallbladder Carcinoma combining clinical real-world data and comprehensive genomic profiling. The registry collects medical data from clinical observation and molecular data derived from archival tumor tissue samples but does not define any medical intervention nor does it evaluate the efficacy or safety of the treatment decision made by the investigator.

Detailed description: In the largest cohort of IGBC patients ever analysed in such a comprehensive approach

* determine the course of patients in this rare kind of cancer
* combine cGP analysis of histological tumor samples with clinical real-life data to get a comprehensive overview on IGBC patients analysed and evaluate data to identify possible further (targeted) treatment possibilities
* analyze potential risk factors associated with gallbladder carcinoma
* assess the frequency of targetable mutations in IGBC

Eligibility criteria: Inclusion Criteria:

Histologically confirmed diagnosis of incidental gallbladder carcinoma

* Patient ≥ 18 years old
* Patient already deceased
* Available tumor tissue (FFPE block)

Exclusion Criteria:

Patient under 18 years of age

Primary outcomes:
measure: overall survival
timeFrame: Through study completion, an average of 2 years
measure: proportion of patients with genomic alterations
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: The proportion of patients with actionable genomic alterations in all patients
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Frankfurter Institut für Klinische Krebsforschung IKF GmbH
Study officials:
affiliation: Institute of clinical cancer research
name: Thorsten Götze, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06425354: Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study
Official title: Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mechanical Power
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 150
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: Patients with AHRF undergoing mechanical ventilation

Brief summary: The aim of this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.

The main questions it aims to answer are:

1. Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation?
2. Is there a difference in terms of cytokine concentration in patients undergoing mechanical power \>17 J/min compared to \<17 J/min?

Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP \<17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays.


Eligibility criteria: Inclusion Criteria:

* Patients with AHRF (P/F \<300 mmHg) undergoing invasive mechanical ventilation within 7 days from the onset of symptoms
* Invasive mechanical ventilation for less than 6 hours
* Evidence of newly developed lung consolidation on chest imaging (X-ray, CT)
* Age ≥18 years

Exclusion Criteria:

* Prior invasive mechanical ventilation during the same hospitalization
* Tracheostomy
* Severe anemia (Hb\<7g/dL)
* Severe neutropenia
* Renal insufficiency or RRT (Renal Replacement Therapy)
* Noradrenaline \>0.5 mcg/kg/min
* Pregnancy
* Extracorporeal circulation (ECCO2R, ECMO)
* Life expectancy \<24 hours as clinically judged
* Lack of consent

Primary outcomes:
measure: Patients who exceed 17 J/min of MP
timeFrame: 4 years
Secondary outcomes:
measure: Inflammatory cytokines
timeFrame: 4 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza University of Rome
Study officials:
References:
Clinical trial NCT03502954: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of ABY-039
Official title: A Phase 1, First-in-human, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Pharmacokinetic Study of ABY 039 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Affibody
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2018-04-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this first-in-human study is to investigate the safety and tolerability of ABY-039 after single and multiple doses in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female subjects between 18 to 55 years of age agreeing to use highly effective methods of contraception
2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, with a weight of at least 50 kg
3. Non-smoker
4. Subjects in good health
5. Subjects with total immunoglobulin G (IgG) \> 10 g/L at Screening

Exclusion Criteria:

1. Subjects who have donated blood in the 3 months prior to Screening, plasma in the 7 days prior to Screening or platelets in the 6 weeks prior to Screening
2. Subjects who have received systemic corticosteroid treatment within 3 months of first dosing
3. Subjects who have a history of significant drug allergy (e.g., anaphylaxis) or any clinically significant allergic condition (excluding non-active hay fever), as determined by the investigator
4. Subjects who are still participating in another clinical study or received last investigational medical product (IMP) dose in a clinical study within the following time period prior to dosing: 3 months or 5 half-lives, whichever is longer
5. History of splenectomy, asthma (exception of resolved childhood asthma), or chronic obstructive pulmonary disease (COPD)
6. Positive for hepatitis A, hepatitis B, hepatitis C virus or antibodies to HIV-1 and/or HIV-2 or a positive QuantiFERON Gold Plus test at Screening
7. Subjects who have received a live vaccination within 3 months prior to Screening or plan to have a live vaccination within 3 months after the last dose of study drug
8. Subject unable or unwilling to comply with the protocol

Primary outcomes:
measure: Number of (related) treatment emergent adverse events of single intravenous (IV) and subcutaneous (SC) infusions/injections, and multiple SC injections
timeFrame: Baseline up-to 11 weeks post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: PAREXEL Early Phase Unit
Study officials:
affiliation: Parexel
name: Muna Albayaty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04721054: Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy
Official title: Thoracic Epidural Versus General Anesthesia for Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Anesthesia
General Anesthesia
Keywords: headache
blood pressure
Lead sponsor: Armed Forces Hospital, Pakistan
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group to be studied for effects of epidural anesthesia and other group for effects of general anesthesia
Primary purpose: OTHER

Brief summary: Eighty two patients planned to undergo elective laparoscopic cholecystectomy were divided into two groups, T and G, randomly. In Group T all patients underwent laparoscopic cholecystectomy under thoracic epidural anesthesia with 12mlof 0.25% bupivacaine and 1% lignocaine plain whereas in group G all patients underwent surgery under general anesthesia. Intra-operative heart rate, mean arterial pressure (MAP) and post operative opioid consumption in first 24hrs were recorded as primary outcomes whereas presence or absence of respiratory complication and duration of hospital stay as secondary outcome.


Eligibility criteria: Inclusion Criteria:

1. patients having ASA statusI-III
2. age more than 18 years,
3. both genders
4. planned to undergo laparoscopic cholecystectomy

Exclusion Criteria:

1. Patients who did not give consent,
2. Allergic to local anesthetic
3. Hemodynamically unstable,
4. Pregnant, full stomach patients

Primary outcomes:
measure: effectiveness of thoracic epidural anesthesia with general anesthesia for Laparoscopic cholecystectomy in terms of change in heart rate during surgery in immediate 24 hours-heart rate.
timeFrame: changes in heart rate at 24 hours of surgery.
measure: effectiveness of thoracic epidural anesthesia with general anesthesia for Laparoscopic cholecystectomy in terms of change in mean arterial blood pressure during surgery in immediate 24 hours-mean arterial blood pressure.
timeFrame: changes in mean arterial pressure at 24 hours of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Military Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT01081054: Hospitalization or Ambulatory Treatment of Acute Diverticulitis
Official title: Randomized Trial Comparing Two Treatment Strategies for Acute Diverticulitis. Hospitalization or Ambulatory Antibiotic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diverticulitis
Keywords: Diverticulitis
Not complicated diverticulitis
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 132
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 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.


Eligibility criteria: Inclusion Criteria:

* Age older than 18 years
* Diagnosis of mild diverticulitis by abdominal computerized tomography
* Signed informed consent

Exclusion Criteria:

* Severe diverticulitis
* Informed consent not signed
* Suspicion of colon cancer
* Pneumoperitoneum
* Intolerance for oral feeding
* Antibiotics for diverticulitis in the last month
* Immunosuppression
* Pregnancy or lactation
* Severe (decompensated) other illness
* Psychological or social problems

Primary outcomes:
measure: Treatment failure
timeFrame: 30 days
Secondary outcomes:
measure: Recurrence, quality of life, costs
timeFrame: 30 days
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari Bellvitge, Colorectal Unit
state: Barcelona
city: Pamplona
country: Spain
facility: Hospital Virgen del Camino
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitari de la Vall d´Hebron
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Valencia
country: Spain
facility: Hospital Clinico Universitario De Valencia
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Sebastiano Biondo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01192854: An Study of Efficacy and Safety of Clevudine
Official title: A Multi-center, Randomized, Double-blind, Positive-control, Phase III Trial of the Efficacy and Safety of Clevudine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Keywords: Clevudine
efficacy
safety
chronic hepatitis B
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B


Eligibility criteria: 1. Patients are between 18 and 65, inclusive.
2. All the male and female reproductive-aged subjects should use reliable and appropriate contraceptive method from the entrance of screening to at least 3 months within the end of study.
3. Hepatitis B virus Early Antigen (HBeAg) positive patient with HBV DNA \>1 x 105 copies/ml, HBeAg negative patient with HBV DNA \>1 x 104 copies/ml within 30 days of baseline.
4. Absolute neutrophil count \> 1500 /mm3.
5. Alpha fetoprotein within normal laboratory limit at screening.
6. Normal electrocardiogram (ECG) or clinically non-significant changes at screening.
7. Able to participate and willing to give written informed consent before starting therapy.
8. Able and willing to comply with study assessments and restrictions.
9. Normal renal function to take Adefovir without any dose modifications; Creatinine clearance must be \>50 ml/min (based on the Cockcroft-Gault equation.

Exclusion criteria

1. Subjects coinfected with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus
2. Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration.
3. Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease.
4. Poorly controlled type I or type 2 diabetes mellitus
5. Donation or loss more than 400 ml blood within 60 days of baseline.
6. Known serious allergies to nucleoside/nucleotide analogs.
7. Subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.

Primary outcomes:
measure: Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.
timeFrame: 48 weeks
measure: Histological response
timeFrame: 48 weeks
Secondary outcomes:
measure: Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay.
timeFrame: 48 weeks
measure: Percent of patients with normalization of alanine aminotransferase (ALT) at week 48
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya hospital
state: Hunan
Study officials:
affiliation: Xiangya Hospital
name: Guoping Yang
role: PRINCIPAL_INVESTIGATOR
References: