louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03153306: Importance of the Infusion Rate for the Plasma Expanding Effect of 5% Albumin in the Septic Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sepsis
Keywords: Albumin
Lead sponsor: Hainan People's Hospital
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
First posted: 2017-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Correction of hypovolemia is an important therapeutic measure，Even though there is no consensus regarding infusion rates, a plasma volume (PV) expander is often given at a fast rate to treat a suspected hypovolemia without delay which can be associated with aggravation of adverse interstitial accumulation of macromolecules and fluid, especially in inflammatory conditions such as sepsis.the smallest possible volumes for PV resuscitation to maintain normovolemia should be used to reduce the risk of simultaneous interstitial fluid accumulation. The investigators tested the hypothesis that a slow infusion rate of a PV expander results in better plasma expansion than a fast infusion rate to patients with severe sepsis or septic shock.


Eligibility criteria: Inclusion Criteria:

* admitted to the ICU patients with severe sepsis or septic shock (diagnosis according to the 2012 surviving sepsis campaign guidelines)
* there is low blood pressure (SBP \< 90 or mean arterial pressure(MAP) \< 65 or the systolic blood pressure is decreased 40 mmHg more than the basic level) or lactic acid or greater for 4 mmol/l
* the informed consent

Exclusion Criteria:

* less than 18 years of age
* more than 80 years old
* pregnant women
* albumin allergies
* the dying patients expected lifetime no more than 24 hours)
* patient with myocardial infarction, heart failure
* liver failure
* refused to sign the informed consent

Primary outcomes:
measure: Extravascular lung water (EVLW) before and after fluid resuscitation
timeFrame: 6 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan Provincial People'S Hospital
state: Hainan
Study officials:
References:
Clinical trial NCT04441606: The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies
Official title: The Role of 68Ga-FAPI-04 PET/CT as a Problem Solving Imaging Modality in Various Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Different Types of Cancer
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the suggested study is to assess the added value of 68Ga-FAPI-04 PET/CT over 18F-FDG PET/CT in evaluating the extent of disease in patients with various malignancies, in whom a diagnostic challenge is met, such as inconclusive findings on 18F-FDG PET/CT or other imaging studies, better delineation of tumor extent prior to therapy, and with emphasis on malignancies known to show variable avidity to FDG and at times, no uptake at all. Also patients unable to optimally comply with the required preparation for FDG imaging, such as diabetic patients who struggle in achieving glycemic control.


Eligibility criteria: Inclusion Criteria:

The study population will include up to 50 patients with disease in whom a diagnostic challenge is met, including but not limited to:

1. Inconclusive findings on 18F-FDG PET/CT or other imaging modalities.
2. Better delineation of tumor extent prior to therapy
3. Malignancies known to show variable avidity to FDG and at times, no uptake at all (e.g. Exocrine Pancreatic cancer, Gastric carcinoma, Mucin-producing or Signet-ring carcinoma).
4. Patients unable to optimally comply with the required preparation for FDG imaging.

   * The study population will include only patients treated in Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel, and referred by their attending physicians, of whom are part of the hospital staff.

Exclusion Criteria:

* Age \< 18 years.
* Pregnant females.
* Patients who are reluctant to undergo both FDG and FAPI PET scans.

Primary outcomes:
measure: Patients who preformed 68Ga-FAPI-04 PSMA.
timeFrame: 1 year
measure: Patients who preformed 68Ga-FAPI-04 PSMA and PET/CT FDG.
timeFrame: 1 year
measure: Patients who preformed 68Ga-FAPI-04 PSMA and PET/MRI.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky medial center
Study officials:
References:
Clinical trial NCT07010406: A Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations
Official title: A Phase 1, Open-label, Randomized, 2-part Study to Evaluate the Relative Bioavailability of Povetacicept Formulations and Bioequivalence of Povetacicept Presentations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2025-06-08
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative bioavailability of Povetacicept formulations, bioequivalence of Povetacicept presentations, and safety and tolerability of Povetacicept.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
* A total body weight of more than (\>) 50 kg

Key Exclusion Criteria:

* History of febrile illness that has not fully resolved within 14 days before the dose of study drug.
* Immunization with a live vaccine within 45 days before study drug administration or a non live vaccine within 14 days before study drug administration.

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing to 28 Days (AUC0-28d) of Free Povetacicept
timeFrame: From Day 1 up to Day 30
measure: Maximum Observed Plasma Concentration (Cmax) of Free Povetacicept
timeFrame: From Day 1 up to Day 30
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 31
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01109706: Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.
Official title: Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary syndrome
PCSK9
cardiovascular safety
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-04-23
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both sexes, 18 years old minimum, with an acute coronary syndrome, treated or not with statins, admitted to cardiological intensive care unit.

Brief summary: PCSK9 (Proprotein convertase subtilisin kexin type 9) plays a key role in LDL-cholesterol (LDLC) metabolism by inhibiting LDL receptor (LDLR) at post-transcriptional level. PCSK9 loss of function mutations are associated to decreased LDLC levels and a cardiovascular protection. In this context, the development of pharmacological inhibitors of PCSK9, in association with statins treatment, represents a major therapeutic issue for LDLC modulation. It was previously shown that PCSK9 plasmatic concentration correlated with plasmatic LDLC, TG and glucose concentrations. However, no data are available on predictive value of PCSK9 plasmatic level concerning coronary disease severity.

The main objective of this study is to determine whether plasmatic PCSK9 concentration is linked to coronary damage severity in patients with acute coronary syndrome.


Eligibility criteria: Inclusion criteria:

* more than 18 years old
* Acute coronary syndrome (ST+ or ST-)
* 2 groups of patients: with statin, and without statin treatment

Exclusion criteria:

* Patient who had cancer during the last 5 years or with cancer in progress
* Patient with severe infection in progress
* Hepatic failure (TP\<50%)
* Severe kidney failure
* Patient unable to give his consent to the study

Primary outcomes:
measure: Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9
timeFrame: Day 1, Day 2, Day 3, Day 4
Secondary outcomes:
measure: Correlation between PCSK9 and morbidity/mortality
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: association between PCSK9 and metabolic/inflammatory factors
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: kinetic of PCSK9 for statin-treated patients
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: kinetic of PCSK9 after intensive care
timeFrame: Day 1, Day 2, Day 3, Day 4
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University hospital
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Bertrand Cariou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03860506: Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who Smoke
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single-Dose, 2-Period Crossover Study of the Pharmacodynamics of Orally Administered PSI-697 in Healthy Subjects Who Smoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy subjects who smoke
healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-03-04
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single dose inpatient and outpatient study to test whether an effect on the ability of platelets to stick to white blood cells in subjects who smoke.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12?lead electrocardiogram (ECG).
* Smoker of at least 1 pack or more of cigarettes per day (20 plus or minus 3 cigarettes) for more than 1 year as determined by history.

Exclusion Criteria:

Exclusion Criteria:

* Any diagnosed bleeding disorder.
* Any major surgical procedure within 6 months before study day 1.
* Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study day 1.

Primary outcomes:
measure: reduction of platelet monocyte aggregates
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04422106: Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores
Official title: Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anastomotic Leak
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aim of the work This study aims at; Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leakage with application of scoring scale to assess presence or absence of leakage.


Eligibility criteria: Inclusion Criteria:

* Any patient with intestinal or colonic anastomosis either elective or emergent.

Exclusion Criteria:

* Patients with inflammatory bowel disease will be excluded because this could influence plasma levels of inflammatory biomarkers.
* patients using corticosteroids
* Patients unfit for anaesthesia, those having collagen diseases or hematological disorders.

Primary outcomes:
measure: Early detection and management of intestinal anastomotic leak
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT02485106: Rifaximin Use in Severe Alcoholic Hepatitis
Official title: Effect of Gut Decontamination Using Rifaximin in the Patients With Severe Alcoholic Hepatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Severe Alcoholic Hepatitis
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 170
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effect of decontamination by rifaximin in severe alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be randomly allocated to rifaximin group or control group.


Eligibility criteria: Inclusion Criteria:

* Heavy alcohol drinking within 3 months (Over 40 g/day)
* Maddrey's discriminant function ≥ 32
* AST/ALT ration ≥ 2
* Bilirubin level ≥ 5mg/dL
* Any one of the following additional criteria : hepatic encephalopathy, enlarged, tender liver, or peripheral leucocytosis
* Age : 19-75
* Jaundice within 3 months

Exclusion Criteria:

* Other causes of chronic liver disease (HBV, HCV, or autoimmune hepatitis)
* Antibiotics or probiotics use within 8 weeks
* Drug induced hepatotoxicity
* Acute viral hepatitis (HAV or HEV)
* Hepatic abscess or cholagitis
* Hepatocellular carcinoma of modified UICC stage II, III or IV
* Malignant tumor other than HCC
* Pregnancy
* Severe chronic extrahepatic disease
* Type I hepatorenal syndrome
* Hepatic encephalopathy grade II or IV
* Severe infection

Primary outcomes:
measure: Mortality
timeFrame: 6-month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00004306: Clinical and Molecular Correlations in Spinocerebellar Ataxia Type 10 (SCA10)
Official title: Pathogenic Mechanism of Spinocerebellar Ataxia Type 10 (SCA10)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Ataxia
Keywords: hereditary ataxia
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: The University of Texas Medical Branch, Galveston
First posted: 1999-10-19
Enrollment: 18
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inherited ataxia

Brief summary: OBJECTIVES: I. Clinically evaluate members from families with a dominantly inherited ataxia and collect blood, skin and muscle samples for detailed molecular studies.

II. Perform detailed clinical evaluations on patients with recessively inherited ataxias.

Detailed description: PROTOCOL OUTLINE: Participants undergo a comprehensive clinical and molecular evaluation. Studies include: neurologic evaluation, including magnetic resonance imaging and nerve conduction studies; ophthalmologic exam; audiologic exam, including auditory brain stem evoked response; DNA extraction from blood, skin and muscle; genotype phenotype correlation.

A neuropathologic evaluation is conducted postmortem, when possible.

Eligibility criteria: Inclusion criteria:

Subjects who have the diagnosis of SCA10 and their immediate relatives.

Exclusion criteria:

Children under 3 years of age, pregnant women, prisoners, mentally incapacitated subjects, and subjects who do not give consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
Study officials:
affiliation: University of Texas, Galveston
name: Tetsuo Ashizawa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174406: Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis
Official title: Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Screening
Keywords: Ultrasound
Digital Breast Tomosynthesis
14-119
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 1494
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women scheduled for a WBUS and a FFDM on the same day or within the following 30 days of each other will be identified by the investigators/research staff at MSKCC clinic.

Brief summary: The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.


Eligibility criteria: Inclusion Criteria:

* Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other.

Exclusion Criteria:

* Age \< 30 years old
* Male patients
* Patients with any clinical symptoms (palpable mass, nipple discharge, etc)
* Patients with known cancer
* Patients with any breast surgery or biopsy within 90 days prior to the study
* Patients with breast implants
* Patients pregnant or lactating

Primary outcomes:
measure: estimate the cancer detection rates
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Janice Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04800406: Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.
Official title: Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assess Marginal Bone Height Changes Around Dental Implants
Keywords: Implant surface treatment
Marginal bone height
Cone beam computed tomography
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ten completely edentulous patients aged from 50-60 years
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients participating in this study were rehabilitated by mucosa supported maxillary complete denture and mandibular overdenture supported by two different surface treated implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by ball attachments. The marginal bone height changes around RBM and acid etched surface treated dental implants retaining mandibular complete overdenture were assessed by cone beam computed tomography.


Eligibility criteria: Inclusion Criteria:

* Free from any systemic diseases affecting the bone metabolism.
* Healthy, firm covering mucosa which is free from any signs of Inflammation or ulceration.
* Residual alveolar ridge with adequate height and width.
* Angel's class I classification maxillo - mandibular relationship.
* Sufficient inter arch space

Exclusion Criteria:

* Smoker.
* Patients with parafunction habits (clenching or bruxism).

Primary outcomes:
measure: Marginal Bone height changes
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
state: Dokki
Study officials:
References:
Clinical trial NCT02314806: Gentamicin Versus Clindamycin Versus Normal Saline Lavage in Axilla
Official title: Effect of Gentamicin Versus Clindamycin Versus Normal Saline Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 51
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing lavages with normal saline (Group 1), patients undergoing lavage gentamicin solution (Group 2) and patients undergoing lavage with a clindamycin solution (Group 3). Drainage volume discharge is investigated

Detailed description: The patients undergoing axillary lymph node dissection were randomized into 3 groups: patients undergoing 2 lavages with 500 ml normal saline (Group 1), patients first undergoing lavage with 500 ml normal saline followed by a second lavage with a 500 ml of a gentamicin (240 mg) solution (Group 2) and patients first undergoing lavage with 500 ml normal saline followed by a second lavage with 500ml of a clindamycin (600mg) solution (Group 3). Drainage volume discharge is investigated

Eligibility criteria: Inclusion Criteria:

* diagnosis of breast neoplasms
* plans to undergo an elective ALND of Berg's levels I and II due to axillary metastasis determined preoperatively by core biopsy or evidence of metastasis in the SLNB in the intraoperative or in the differed analysis.

Exclusion Criteria:

* allergy to any of the antibiotic drugs used
* chronic renal failure due to possible toxicity of gentamicin
* patients undergoing a modified radical mastectomy.

Primary outcomes:
measure: Drainage volume discharge
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital General de Elche
name: Jaime Ruiz-Tovar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oller I, Ruiz-Tovar J, Cansado P, Zubiaga L, Calpena R. Effect of Lavage with Gentamicin vs. Clindamycin vs. Physiologic Saline on Drainage Discharge of the Axillary Surgical Bed after Lymph Node Dissection. Surg Infect (Larchmt). 2015 Dec;16(6):781-4. doi: 10.1089/sur.2015.020. Epub 2015 Aug 5.