louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07006714: Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA)
Official title: Preoperative Single High-Dose Vitamin D for Correcting Deficiency in Hip and Knee Arthroplasty Patients-A Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Osteoarthritis
Vitamin D Deficiency
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 96
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is being conducted to determine whether correcting low levels of vitamin D with a single high-dose supplement reduces complications after the participant's primary TJA.


Eligibility criteria: Inclusion Criteria:

* Serum 25(OH)D \< 30 ng/mL within 2 weeks of surgery.
* Able to provide informed consent.

Exclusion Criteria:

* Follow-up duration \< 90 days anticipated.
* Acute hepatitis, cancer, organ transplant recipients, or dialysis patients.
* Extra vitamin D supplementation within 90 days post-surgery.
* Preoperative serum 25(OH)D ≥ 30 ng/mL.
* Adults unable to consent (excluded).
* Individuals under 18 (excluded).
* Pregnant women (excluded).
* Prisoners (excluded).

Primary outcomes:
measure: Prosthetic joint infection as measured by the Musculoskeletal Infection Society (MSIS) criteria.
timeFrame: Up to 90 days.
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Up to 90 days.
measure: Number of medical complications
timeFrame: Up to 90 days.
measure: Number of readmission rates
timeFrame: Up to 90 days.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Michele D'Apuzzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01601314: Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients
Official title: Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seizures (Incl Subtypes)
Brain Tumor
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the relationship between magnesium sulphate administration and levels of S100B protein in serum of patients undergoing supratentorial brain parenchymal resection.


Eligibility criteria: Inclusion Criteria:

* Male and females older than 18 years.
* Undergoing supratentorial parenchyma resection surgery.
* Capable of collaborate on probes and explorations included in the study.
* Signature the written informed consent form.

Exclusion Criteria:

* Life expectancy less than 12 months due to the suspected histological type of tumour.
* Hypothalamic-pituitary axis illness.
* Presence of Melanoma previously.
* Glomerular filtration rate less than 60 mL/min.
* Thyroid or parathyroid glands pathology.
* Myasthenia gravis.
* Respiratory depression.
* Pregnancy or breastfeeding.

Primary outcomes:
measure: Serum S100B protein
timeFrame: 2 hours after the end of the surgery
Secondary outcomes:
measure: Serum S100B protein
timeFrame: 1 hour before surgery; daily postoperative until day 10.
measure: Serum Specific Neuronal Enolase (SNE)
timeFrame: 1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10
measure: Improvement on Magnetic Resonance Imaging
timeFrame: within the month prior to surgery; early postoperative; 6 months postoperative
measure: Improvement on Neuropsychological Assessment
timeFrame: within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative
measure: Glasgow Outcome Scale
timeFrame: 6 and 12 month postoperative
measure: Mortality
timeFrame: 6 and 12 month postoperative
measure: Apolipoprotein E genotype
timeFrame: 1 hour before surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Neus Fabregas, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05884255: An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
Official title: Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Gastroenteropancreatic Neuroendocrine Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in Subjects With advanced gastrointestinal pancreatic neuroendocrine tumors.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. 18\~75 years old,male or female；
3. ECOG performance status 0 or 1
4. Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors ( GEP-NETs ) of low and medium grade ( G1 or G2 ) confirmed by histopathology ;

Exclusion Criteria:

1. Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks.
2. There are clinical symptoms or diseases of the heart that are not well controlled.
3. Diabetes ( fasting blood glucose \> 2 × ULN ) that cannot be well controlled after optimal medical support treatment.
4. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason

Primary outcomes:
measure: Progression-free survival (PFS) assessed by BICR
timeFrame: up to 1 years follow-up
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: up to 5 years follow-up
measure: Objective Response Rate(ORR)
timeFrame: up to 1 years follow-up
measure: Duration of Overall Response(DoR)
timeFrame: up to 1 years follow-up
measure: Disease Control Rate
timeFrame: up to 1 years follow-up
measure: Incidence and severity of AE and SAE
timeFrame: up to 5 years follow-up
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin University Cancer Institute and Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT00599755: Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)
Official title: A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine and Cisplatin or Carboplatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Non-small Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-01-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Has histologically or cytopathologically confirmed metastatic or locally advanced stage IIIB/IV Non-small cell lung cancer (NSCLC)
* Has measurable disease
* Has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for NSCLC
* Is 18 years of age or older
* Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

* Is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment
* Has untreated brain metastases related to their NSCLC or carcinomatous meningitis
* Abuses drugs or alcohol
* Is pregnant or breastfeeding
* Is Human Immunodeficiency Virus (HIV) positive
* Has active viral hepatitis
* Has hearing loss
* Has poorly controlled diabetes mellitus
* Is allergic to gemcitabine, cisplatin or carboplatin

Primary outcomes:
measure: Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean
timeFrame: Weeks 3 and 6 following chemotherapy
Secondary outcomes:
measure: Repeatability of FDG SUVmean at Baseline
timeFrame: Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy
measure: Change in FDG-PET Uptake From Baseline to Week 3
timeFrame: Baseline and Week 3
measure: Change in FDG-PET Uptake From Week 3 to Week 6
timeFrame: Week 3 and Week 6
measure: Change in FGD-PET Uptake From Baseline to Week 6
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05478655: Predictors of Treatment Failure Pain Among Patients With Mine-explosive Wounds
Official title: Predictors of Treatment Failure Pain Among Patients With Mine-explosive Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Chronic pain, mine-explosive wounds
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 1166
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was carried out on the basis of the National Military Medical Clinical Center "Main Military Clinical Hospital". All patients participated in Operation Joint Forces and received gunshot wounds during combat operations.

A retrospective analysis of disease histories for the period from 2014 to 2021 was carried out. Data collection was carried out at all stages of treatment: medical and nursing brigade, military mobile hospital, military medical clinical center, during rehabilitation, within 12 months of the injury.

Recruitment of patients for the prospective study was carried out in the period from 02.24.2022 to 05.24.2022. Data collection was carried out during the Russian invasion of Ukraine and the offensive on Kyiv.

Brief summary: Mine-explosive wounds in the general structure of combat sanitary losses reach 25%. They are characterized by significant damage resulting in high intensity pain. In patients who received mine-explosive injuries in the conditions of hostilities, such pain has its own unique features. It is necessary to pay more attention to the problem of pain treatment in patients of this category, because about 87.2% of cases have negative results of treatment - it becomes chronic.

Detailed description: The peculiarities of pain in patients with mine-explosive wounds depending on the localization of the wound at the stages of treatment need to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Since in 87.2% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Eligibility criteria: Inclusion Criteria:

* chronic pain, mine-explosive wounds

Exclusion Criteria:

* absence of mine-explosive wounds

Primary outcomes:
measure: visual analog scale
timeFrame: 12 months
measure: Didier Bouhassiraa DN4
timeFrame: 12 months
measure: The Hospital Anxiety and Depression Scale
timeFrame: 12 months
measure: Chaban Quality of Life Scale
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets National Medical University, Ministry of Health of Ukraine
Study officials:
References:
Clinical trial NCT02934555: Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
Official title: Ubiquinol as a Metabolic Resuscitator in Post-Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Arrest
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Kaneka Medical America LLC
First posted: 2016-10-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To study the effects of ubiquinol as a "metabolic resuscitator" in post-cardiac arrest.

Detailed description: Cardiac arrest (CA) occurs in more than 400,000 patients in the United States each year with an estimated mortality of greater than 90%. The majority of patients who are resuscitated from CA will succumb to the neurologic morbidity associated with the post-CA syndrome and ischemic-reperfusion injury. Currently, there are no pharmacologic agents known to offer survival benefit or to prevent devastating neurologic injury in post-CA patients.

A potential therapeutic target following ischemia-reperfusion injury is mitochondrial function in the injured cell and/or reduction of oxygen free radicals. Coenzyme Q10 (CoQ10) is an essential mitochondrial co-factor and free radical scavenger that has been proposed as a neuroprotective agent in various neurodegenerative disorders as well as a cardioprotective agent. CoQ10 have furthermore shown exciting preliminary results as a potential therapy in post-CA.

In order to test the effects of ubiquinol as a "metabolic resuscitator" in post-CA patients and to provide additional preliminary data for a large-scale clinical trial, the investigators are conducting a randomized, double-blind, place-controlled trial of ubiquinol in post-CA patients.

Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years)
* Cardiac arrest defined by cessation of pulse requiring chest compressions
* Not following commands after ROSC
* Admission to the ICU
* Naso/orogastric tube
* Ability to receive enteral medication

Exclusion Criteria:

* Protected populations (pregnant women, prisoners, the intellectual disabled)
* Current CoQ10 supplementation
* Anticipated death within 24 hours
* \> 12 hours from ROSC to estimated randomization
* Jejunostomy tube (J-tube)

Primary outcomes:
measure: Coenzyme Q10 Plasma Levels
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Decreased Neurological Injury
timeFrame: Up to 72 hours
measure: Cellular Oxygen Consumption
timeFrame: At 24 hours
measure: Global Oxygen Consumption
timeFrame: Up to 48 hours
measure: Mortality
timeFrame: At hospital discharge, an average of 14 days
measure: Number of Participants With Favorable Neurological Outcome
timeFrame: At hospital discharge, an average of 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michael W Donnino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00539955: Brief Intervention to Reduce Drinking Among Batterers
Official title: Brief Intervention to Reduce Drinking Among Batterers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intimate Partner Violence
Alcohol Use
Keywords: intimate partner violence
alcohol use
substance use
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Butler Hospital
First posted: 2007-10-05
Enrollment: 253
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this project is to examine whether, relative to standard care, violence and alcohol use outcomes can be improved by a brief, motivationally based adjunct alcohol treatment for men enrolled in batterer intervention programs. We hypothesize that men randomized to also receive the brief alcohol intervention will have better partner violence and alcohol use outcomes than men who are randomized to the batterer intervention program alone.


Eligibility criteria: Inclusion Criteria:

* Participation in a batterer intervention program
* Hazardous drinking

Primary outcomes:
measure: Intimate partner violence Substance use
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: University of Tennessee-Knoxville & Butler Hospital
name: Gregory L. Stuart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: David Strong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stuart GL, McGeary J, Shorey RC, Knopik VS. Genetics moderate alcohol and intimate partner violence treatment outcomes in a randomized controlled trial of hazardous drinking men in batterer intervention programs: A preliminary investigation. J Consult Clin Psychol. 2016 Jul;84(7):592-8. doi: 10.1037/a0040219. Epub 2016 Mar 28.
Clinical trial NCT01254955: Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients
Official title: Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Organ Transplantation
Keywords: 2009 H1N1 influenza vaccine, organ transplant patients
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2010-12-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tranplant patients at the out-patient clinical ward and staff members at the Transplant Institute, Sahlgrenska University Hospital.

Brief summary: Organ transplant patients and staff members at the Transplant Institute have received pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by haemagglutination inhibition according to the clinical guidelines and policy, respectively. This study retrospectively assessed the immune response after vaccination.

Detailed description: A total of 100 organ transplant patients and 36 healthy controls were included in the study. All individuals were vaccinated between October and November 2009 and received 2 doses of Pandemrix. Serum samples were collected at baseline before vaccination and 1 month after the first and second vaccination. Individual hemagglutination-inhibiting serum antibody titers were measured.Frequency of \> 4 -fold increase in antibody titers and seroconversion from non-protective prevaccination titers to protective postvaccination titers were recorded. Adverse events were reported.

Eligibility criteria: Inclusion Criteria:

Cohort number 1:Organ transplant patients who were vaccinated and serum sample drawn at baseline.

Cohort number 2: Staff members who were vaccinated and serum sample drawn at baseline.

Exclusion Criteria:

Cohort number 1: Organ transplant patients who were vaccinated and no serum sample drawn at baseline.

Cohort number 2: Staff members who were vaccinated and no serum sample drawn at baseline.

Primary outcomes:
measure: Frequency of responders in organ transplant patients and controls
Secondary outcomes:
measure: Frequency of >4-fold titre rise in organ transplant patients and controls
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Transplant Institute, Sahlgrenska University Hospital
state: Västra Götaland
Study officials:
References:
citation: Felldin M, Studahl M, Svennerholm B, Friman V. The antibody response to pandemic H1N1 2009 influenza vaccine in adult organ transplant patients. Transpl Int. 2012 Feb;25(2):166-71. doi: 10.1111/j.1432-2277.2011.01391.x. Epub 2011 Nov 26.
Clinical trial NCT05554055: Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (Anti Xa vs ACT-LR in Endovascular Surgery)
Official title: Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Diseases
Arterial Disease
Thrombosis
Keywords: Complex aortic endovascular repair
Arterial recanalization
Deep veinous recanalization
Anti Xa
LR-ACT
Heparin
Endovascular procedures
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-09-26
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: All patients who will undergo an endovascular surgery in the centre.

Brief summary: Activated clotting time (ACT) is currently recommended to monitor high concentrations heparin anticoagulation. ACT-LR was specifically designed to measure the activity of low dose of heparin used during endovascular surgery. The correlation between ACT-LR and Anti Xa activity which is considered as the gold standard seems to be debated.

Few studies in literature had shown controversial results. These studies were conducted in patients who underwent open as endovascular surgery. However, the ACT monitoring is not recommended in open surgery. In addition, heparin administration protocols are not described and specific to each centre.

In this study investigators want to study the correlation between LR-ACT and anti Xa after introducing a heparin protocol during complex endovascular procedures.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 ans
* Weight ≥ 37,5 kg
* Patients operated for
* complex endovascular aortic aneurysm repair
* deep vein recanalization
* complex arterial revascularization (TASC D lesions)
* Patient informed of the study details and who didn't opposed to participate in this research

Exclusion Criteria:

* Known allergy to heparin
* Known hepatic insufficiency with repercussion on coagulation
* Thrombocytopenia
* Known hemostasis disorders
* Anemia defined HB\<8 g/L
* Pregnant women
* Persons deprived of their liberty by a judicial or administrative decision
* Persons subject to psychiatric care
* Persons admitted to a health or social establishment for purposes other than research
* Adults subject to a legal protection measure (guardianship, curatorship)

Primary outcomes:
measure: Correlation between ACT (second) realized in operative room and Anti Xa activity (UI/ml) results provide by the lab.
timeFrame: During surgery - 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de chirurgie vasculaire (U50) Hôpital Louis Pradel - HCL
Study officials:
References: