louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04408040: Use of Convalescent Plasma for COVID-19
Official title: Use of Convalescent Plasma Collected From Donors Recovered From COVID-19 Virus Disease for Transfusion, as an Empirical and Preemptive Treatment During Viral Pandemic Outbreak
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The plan is to transfuse COVID-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.


Eligibility criteria: Inclusion Criteria:

* Documented COVID-19 infection by nasal pharyngeal sampling
* COVID-19 disease falling into one of the following groups:
* Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure
* Severe disease: tachypnea \>/=30 per min, O2 sats \</=93% at rest, PaO2/FiO2 index \</=300mmHg
* High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI \>/=40, age \>/=65 years
* Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease

Exclusion Criteria:

* History of IgA deficiency
* History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy

Primary outcomes:
measure: Arms 1 & 2: Number of COVID-19 Infected Patients in Severe, High Risk & Health Care Provider Cohorts Who Survive the Infection
timeFrame: 30 days after initial treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
affiliation: Northside Hospital
name: Kent Holland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06932640: Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
Official title: Continuous Assessment of Cerebral Autoregulation in Subarachnoid Hemorrhage (SAH) Patients Using Cerebral Oximetry Index and Hemoglobin Volume Reactivity Index
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2025-04-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurological Intensive Care Unit (NICU) patients

Brief summary: The goal of this observational study is to continuously assess cerebral autoregulation in patients with subarachnoid hemorrhage (SAH) using cerebral oximetry index (COx) and hemoglobin volume reactivity index (HVx). The main question it aims to answer is: Whether optimal perfusion pressure is dynamic and changes with time in patients with SAH, and that autoregulation is disrupted in patients during the course of SAH, contributing to delayed cerebral ischemia (DCI).


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 89 years who are admitted to the Neurological Intensive Care Unit (Neuro ICU) between March 2025 and December 2026 for aneurysmal subarachnoid hemorrhage (SAH).

Exclusion Criteria:

* Patients under 18 years old
* Prisoners
* Pregnant women
* Patients enrolled in concurrent ongoing interventional trial
* Students of UAB
* Employees of UAB
* Patients who undergoes frontal decompression surgery resulting bone flap deficit where NIRS monitoring pads could not be applied.

Primary outcomes:
measure: Change in Lower Limit of Autoregulation (LLA)
timeFrame: 21 days
Secondary outcomes:
measure: Change of delayed cerebral ischemia (DCI) to the average LLA
timeFrame: 21 days
measure: Change in time under LLA
timeFrame: 21 days
measure: Change in dose under LLA
timeFrame: 21 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Weifeng Song, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04631640: Prognostic Model of HCV-related Disease Progression After DAAs
Official title: Prognostic Model of HCV-related Disease Progression After DAAs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HCV
Keywords: HCV
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥18 years old) with chronic HCV infection that were HCV RNA positive and have received DAA therapy were included, former hcv treatment information and sustained virologic response data were collected restropectively, liver-related events including liver-related deaths, HCC, liver decompensation, and liver transplantation were collected restropectively and prospectively.

Brief summary: In this study, the investigator would conduct an ambispective cohort study to build a prediction model of HCV-related disease after DAAs.

Detailed description: The emergence of direct antiviral agents (DAAs) makes it possible to cure HCV, and the sustained virological response (SVR) rate is up to 90% after DAAs therapy. However, the acquisition of SVR does not mean the cure of HCV-related diseases, some patients still developed liver cirrhosis, liver cancer and other diseases after achived SVR by DAAs therapy.In this study the investigator would like to bulid a prediction model of HCV-related disease after DAAs by conducting an ambispective cohort study. The participants of this study would be adult patients (≥18 years old) with chronic HCV infection and have received DAA therapy, the investigator would retrospectively collected DAA therapy-related information, and follow-up all the enrolled participants every 6 months to observe their liver-related disease outcomes (composite liver outcome, including liver-related deaths, hepatocellular carcinoma, liver decompensation, and liver transplantation).

Eligibility criteria: Inclusion Criteria:

* adult patients (≥18 years old) with chronic HCV infection that were HCV RNA positive;
* have received DAA treatment;
* would like to adhere to the follow-up

Exclusion Criteria:

* lack of HCV treatment information;

Primary outcomes:
measure: incidence of composit liver-related events
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Huixin Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01659840: Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders
Official title: Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders - A Double-blind, Randomized, Parallel Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Keywords: laser,
quality of life,
orofacial pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the same efficacy in relieving pain and improving the quality of life of TMD patients

Detailed description: The aim of the present study was to evaluate and compare the efficacy of red (600nm) and infrared (800nm) laser therapy in relieving pain and improving the quality of life of TMD patients.

Eligibility criteria: Inclusion Criteria:

* systemic health;
* Temporomandibular Disorder diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders questionnaire (RDC);
* pain score ≥ 5 on palpation according to a visual and numerical scale (VNS)

Exclusion Criteria:

* participants who made frequent use of analgesics, NSAIDs and antidepressants;
* patients with previously undergone TMD treatment, or suffered facial trauma

Primary outcomes:
measure: pain points of muscle and articulation
timeFrame: 180 days
Secondary outcomes:
measure: Quality of life
timeFrame: 180 days
Other outcomes:
Locations:
city: Diamantina
country: Brazil
facility: Periodontics Clinic, Department of Dentistry
state: Minas Gerais
Study officials:
affiliation: Federal University of the Valleys of Jequitinhonha and Mucuri
name: Olga D Flecha, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370240: Chlorhydrate of Ropivacaine and Breast Cancer Surgery
Official title: Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Neoplasms
Pain,Postoperative
Keywords: Female
Anesthetics,local
Lead sponsor: Institut Curie
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Gustave Roussy, Cancer Campus, Grand Paris
First posted: 2006-08-31
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of ropivacaine) to prevent chronic pain after breast surgery for cancer.

Detailed description: An estimated 20-65% of women treated with breast surgery for breast cancer experience chronic pain in the treated breast. Patients will be randomize between: infiltration with chlorhydrate of ropivacaine at the time of breast surgery for cancer versus placebo.Intra-operative analgesia will be standardized as well as peri-operative pain management.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients treated by conservative surgery with axillary node dissection or treated by mastectomy with or without axillary node dissection or sentinel lymph node biopsy.
* ASA physical status 1, 2 or 3
* With a minimum life expectancy of 2 years
* Written informed consent

Exclusion Criteria:

* Any previous cancer other than breast cancer
* Allergies to local anesthesic and morphine
* Reported history of drug
* Pregnancy
* Homolateral breast surgery during the last 3 years
* Analgesic use pre-operatively
* Renal, pulmonary or liver major dysfunction
* Active malignant disease
* Unable to follow the protocol for any reason

Primary outcomes:
measure: Comparing the frequencies of chronic breast pain 3 months after breast surgery evaluated by the Brief Pain Inventory in the two groups.
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale
timeFrame: 2 hours after surgery
Other outcomes:
Locations:
city: Saint-Cloud
country: France
facility: René Huguenin Center
Study officials:
affiliation: Centre René Huguenin - Saint-Cloud - France
name: Aline H Albi-Feldzer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04345640: The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver.
Official title: The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver - The Pan Asia-Pacific Prospective Multi-centre Observational Study (APCOLIS STUDY)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhoses
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Covid-19 patients with or without liver disease

Brief summary: To address the existing deficiencies in the knowledge regarding liver involvement and spectrum of clinical presentation and the impact of COVID-19 infection in patients of liver disease was planned. The present study will be a hospital based and the cases of confirmed COVID-19 infection will be evaluated in relation to liver involvement irrespective of pre-existing liver disease. The primary objective was to address the clinical presentation, biochemical alteration and outcomes of COVID-19 infection in subjects with chronic hepatitis, cirrhosis in comparison to those having infection in the absence of pre-existing liver disease


Eligibility criteria: Inclusion Criteria:

1. All patients of COVID-19 positive
2. Age 18-70 years

Exclusion Criteria:

1. No Valid consent

Primary outcomes:
measure: Spontaneous recovery or death in both groups
timeFrame: 90 days
Secondary outcomes:
measure: Severity of prior as well as present decompensation in both groups
timeFrame: 90 days
measure: Duration of prior as well as present decompensation in both groups
timeFrame: 90 days
measure: Improvement in severity assessment Indices Model for End Stage Liver Disease (MELD) scores in both groups
timeFrame: 90 days
measure: Improvement in severity assessment Indices Child-Turcotte-Pugh (CTP) scores in both groups
timeFrame: 90 days
measure: Improvement in severity assessment Indices Sequential Organ Failure Assessment (SOFA) scores in both groups
timeFrame: 90 days
measure: Improvement in severity assessment Indices Acute Physiology And Chronic Health Evaluation (APACHE) scores II in both groups
timeFrame: 90 days
measure: Improvement in severity assessment Indices Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF SOFA) scores in both groups.
timeFrame: 90 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT02645240: Predictive Factors of Intestinal Infraction in Acute Mesenteric Ischemia
Official title: Predictive Factors of Intestinal Infraction in Patients With Acute Mesenteric Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mesenteric Ischemia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 97
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to identify several factors that can accurately predict the incident of intestinal infraction in patients with mesenteric vascular occlusion or ischemia.

Detailed description: The study aims to identify several clinical, laboratory, and radiologic factors that can accurately predict the occurrence of intestinal infraction in patients with mesenteric vascular occlusion or ischemia in order to prevent unnecessary surgical intervention in patients with just intestinal ischemia and to hasten intervention in patients with actual intestinal gangrene.

Eligibility criteria: Inclusion Criteria:

* Patients with acute mesenteric Ischemia

Exclusion Criteria:

* Patients with other causes of acute abdomen other than mesenteric Ischemia

Primary outcomes:
measure: Clinical improvement
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura Univesity
name: Sameh H Emile, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03504540: Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PL-AMD)
Official title: Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PLAMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Erythematosus
Lupus Erythematosus, Systemic
Age Related Macular Degeneration
Keywords: Lupus Erythematosus, Systemic
Age Related Macular Degeneration
"Pseudo-drusen-like" deposits
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-04-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lupus, treated or not with APS, with ou without "pseudo-drusen-like" deposits

Brief summary: The rationale of this research is to determine if patients with lupus and presenting retinal "pseudo-drusen-like" deposits have genetic and complement-related similarities with AMD patients.

Based on the results obtained, this study could lead to future research that could better target the treatment of patients with lupus or patients with AMD (Age related Macular Degeneration).

The primary objective is to check if patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits have a different complement profile (functional exploration of complement, complement factors, genetic complement polymorphisms involved in AMD) compared to patients without "pseudo-drusen-like" deposits.


Eligibility criteria: Inclusion Criteria:

* Systemic lupus erythematosus
* Case patients : with "pseudo-drusen-like" deposit
* Control patients : without "pseudo-drusen-like" deposit

Exclusion Criteria:

* Patient under a measure of legal protection

Primary outcomes:
measure: Comparison of AMD genetic polymorphisms between case and control patients
timeFrame: Baseline
measure: Comparison of complement factors between case and control patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Martine MAUGET FAYSSE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02230540: Intermittent Catheterization in Spinal Cord Injured Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.


Eligibility criteria: Inclusion Criteria:

* Has given written informed consent
* Is at least 18 years of age and has full legal capacity
* Is a male
* Has an Spinal Cord Injury diagnosis

Exclusion Criteria:

* Participating in other interventional clinical investigations or have previously participated in this investigation
* Known hypersensitivity toward any of the test products
* Serious abdominal scars
* Symptoms of urinary tract infections

Primary outcomes:
measure: Residual Volume Less Than 100ml
timeFrame: 2-4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Per Bagi
Study officials:
affiliation: Rigshospitalet, Denmark
name: Per Bagi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06477640: Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension
Official title: Home Rehabilitation Improves Cardiac Effort in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension PAH
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: United Therapeutics
name: Mayo Clinic
First posted: 2024-06-27
Enrollment: 50
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 evaluate whether a home rehabilitation program for patients diagnosed with Pulmonary Arterial Hypertension (PAH) will decrease Cardiac Effort (number of heart beats used during 6-minute walk test/walk distance) and improve quality of life. Ultimately, this information could help improve the management of patients with PAH.


Eligibility criteria: Inclusion Criteria:

* Follows at University of Rochester Medical Center Pulmonary Hypertension Clinic.
* Adult patients (\&gt;18 years old) with right heart catheterization confirmed pulmonary hypertension (PAH) on stable vasodilator dosing for at least 30 days. No planned titrations will occur during the 12-week study. If during the study, the treating physician feels it is necessary for safety reasons to adjust dosing, the subject will remain in their assigned group.
* Access to a smart phone or email to receive daily messages. If patients do not have access to either, we will offer a smartphone with cellular service for use during the study to receive daily messages.
* Clinically stable by the investigator (i.e., we will not enroll patients who endorse ongoing improvement or clinical worsening at enrollment).
* The treating investigator (Dr. Lachant or Dr. White) will review the clinical data of an eligible patient and establish them as safe to participate prior to approaching the patient for enrollment (i.e. not in decompensated heart failure or with recurrent pre-syncopal episodes prior to enrollment).

Exclusion Criteria:

* Pregnancy.
* Pulmonary Hypertension Groups 2-5.
* Resting tachycardia \&gt;120 beats/m during screening.
* Inability to walk.
* WHO Functional Class IV
* Lack of access to email or text messaging.
* Inability to follow daily instructions. including the two home 6-minute walk tests during the initial monitoring period. This is to show compliance with the protocol.
* Participating in a self-reported rehabilitation or exercise program.
* Oxygen therapy of more than 6 L/min at rest.
* Principal Investigator discretion

Primary outcomes:
measure: Mean change in cardiac effort
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Mean change in six minutes walk distance
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: