louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03480659: Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC
Official title: Breast Cancer Screening Using DNA Methylation Changes in Circulated Tumor, PBMC and T-cells DNA.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Breast Cancer Female
Lead sponsor: HKGepitherapeutics
Sponsor class: INDUSTRY
Collaborators: name: Kazakh Research Institute of Oncology & Radiology
name: Montreal EpiTerapia Inc.
name: Canada-Kazakhstan EpiTerapia Inc.
First posted: 2018-03-29
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be assigned an ID that will be kept confidential according to hospital regulations. IDs will be randomized so that identity will not be revealed except to the approved hospital personnel. Methylation data will be returned to the hospital for follow up of progression of disease and for assessing early prediction of progression of Breast cancer and will be entered into the data base. Other clinical follow up data will be entered into the electronic data base. All data will be captured in case report form

Brief summary: A central challenge in the fight against breast cancer is how to detect disease in a noninvasive manner before it is detectable by imaging methods. Although inroads have been made with more sensitive imaging techniques for earlier detection of breast cancer, these techniques are limited by the size of lesion that could be detected. Alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of breast cancer are urgently needed.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histological confirmed breast cancer subtypes (DCIS and invasive)

Exclusion Criteria:

* Pregnant women
* Minors (subjects less than 18 years of age)
* Prisoners
* Patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C
* Patients having other than one cancer
* Subjects unable to consent for themselves

Primary outcomes:
measure: DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of breast cancer
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh Institute of Oncology and Radiology
Study officials:
References:
Clinical trial NCT03099759: Vitamin D Raising and Maintaining Blood Serum 25(OH)D3 Levels
Official title: Effectiveness of Various Vitamin D Protocols on Raising and Maintaining Blood Serum 25(OH)D3 Levels Over a Three Month Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D Dosing Regimens
Blood Serum 25(OH)D3 Levels
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Brentwood Foundation
First posted: 2017-04-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Analyze the amount of change in blood serum Vitamin D levels in patients of 3 different dosing groups and how their levels change over a 3 month period of time.

Detailed description: Vitamin D has shown multiple health benefits specifically in regards to bone healing. To the investigators knowledge there are currently no protocols for Vitamin D supplementation in the Orthopedic community for patients recovering from fractures. The investigators study will monitor 3 different groups of volunteers taking various Vitamin D regimens and how participants blood serum 25(OH)D3 levels are effected throughout a 3 month period. The 3 groups will include: 1) 100,000 units D2 once on day one, 2) 100,000 units D2 taken once a week x 12 weeks, 3) 50,000 units D2 x 10 days, then 2000 units D3 taken daily for the remainder of the study period. There will be 15-20 volunteers randomly assigned to each of the 3 groups. The investigators will have each volunteer from the 3 groups have blood drawn a total of 4 times throughout the course of this study: prior to the study, week 2, week 6, and week 12. From these results the investigators will determine which protocol most effectively raises and maintains vitamin D levels in the volunteers through this 3 month period. The investigators will also use this data to determine which protocol is not only most cost efficient but also easiest to follow by individuals. The investigators are hoping that this study may help finally develop a universal orthopedic protocol for vitamin D supplementation in patients recovering from fractures.

Eligibility criteria: Inclusion Criteria:

* Low Vitamin D level

Exclusion Criteria:

* Normal Vitamin D level, already taking Vitamin D, any form of steroids, weight-loss drugs, anti-tuberculosis drugs, high blood pressure drugs, high cholesterol drugs, endocrine disease, being treated for any form of cancer.

Primary outcomes:
measure: Vitamin D
timeFrame: Three Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Damien Billow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04105959: A Study to Investigate the Effects of RIST4721 on the Inflammatory Response in Healthy Male Subjects Using a Blister Model
Official title: A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Response
Lead sponsor: Aristea Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 32
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: A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model


Eligibility criteria: Inclusion Criteria:

* Subject is male, with Fitzpatrick skin types 1 to 3
* Subject is aged between 18 to 55 years, inclusive
* Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
* Healthy as determined by a responsible physician, based on medical evaluation
* Must be willing to use birth control as indicated

Exclusion Criteria:

* Subject is known to have immune deficiency or is immunocompromised
* Subject has had a recent acute infection or chronic infection
* Subject has a known or suspected allergy or contraindications to cantharidin (blister induction method), RIST4721 or any component of the study drug
* Clinically relevant history of abnormal physical or mental health (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder)

Primary outcomes:
measure: Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo
timeFrame: Blister formation to Hour 24
measure: Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo
timeFrame: Blister formation to Hour 30
measure: Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo
timeFrame: Blister formation to Hour 36
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
References:
Clinical trial NCT05730959: Sacral Nerve Modulation in IPAA Patients With Poor Function
Official title: Sacral Nerve Modulation in IPAA Patients With Poor Function
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stoma Malfunction
Keywords: IPAA (Ileal Pouch-Anal Anastomosis)
SNM (Sacral Nerve Modultion)
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: IPAA patients with poor functional outcome where no obvious reason can be detected are identified from our patient registry. These patients are offered a sacral nerve modulation test period of three weeks. They will then be scored on function and physiological testing will be done by a Barostat. After a another 14 days without stimulation the tests will be repeated. Those who respond positively will be offered permanent implantation of the Device..


Eligibility criteria: Inclusion Criteria:

* UC With IPAA
* Bad functional outcome

Exclusion Criteria:

* Established treatable cause of malfunction

Primary outcomes:
measure: Øresland Score
timeFrame: 12 months
Secondary outcomes:
measure: Bowel physiology
timeFrame: At inclusion and at 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Oslo
name: Tom Oresland, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00731159: Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment
Official title: Sperm Capacitation Assay as a Tool to Predict Sperm Potential to Fertilize in IVF Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sperm Capacitation
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring IVF within the "routine" work of an IVF Unit

Brief summary: Our aim is to evaluate the potential of a new laboratory method that measure sperm capacitation to predict fertilization of oocytes in patients that undergo IVF treatments

Detailed description: Capacitation is a physiologic process in which the sperm acquire the potential to fertilize oocytes. Capacitation can be measured, but the available technics are expensive, inaccurate and complex. A new method to evaluate sperm capacitation was developed in Bar Ilan University, Israel. We intend to measure the capacitation of semen that is used for fertilizing human oocytes in patients treated at the IVF unit at Assaf Harofeh Medical Center.By this, to evaluate the potential of the new method to predict human oocyte fertilization.If the method will be found valuable, it will enable to develop new drugs/methods that may improve sperm capacitation and by this to improve oocyte fertilization leading to more embryos, pregnancies and deliveries.

Eligibility criteria: Inclusion Criteria:

* Patients requiring IVF within the "routine" work of an IVF Unit
* normo-responding woman
* non ICSI cycles

Exclusion Criteria:

* Patients undergoing ICSI only cycle
* Low responders-less than 8 oocytes
* Male patients with low semen volume

Primary outcomes:
measure: Fertilization rate of human oocytes in thr "routine" IVF Laboratory work
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaacov
country: Israel
facility: Assaf Harofeh MC
state: Zerifin
Study officials:
References:
Clinical trial NCT06156059: Oral Bedtime Melatonin in Critically Ill Patients
Official title: Oral Bedtime Melatonin in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Septic Shock
Stroke Hemorrhagic
Strokes Thrombotic
Cardiac Arrest
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: Universidad Complutense de Madrid
First posted: 2023-12-05
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized
Primary purpose: TREATMENT

Brief summary: Oxidative stress is one of the main mechanisms causing harm in severe infection with septic shock, ischemia-reperfusion injury in resuscitated cardiac arrest and ischemic and hemorrhagic stroke.

Melatonin is a potent scavenger of the mediators of oxidative stress, oxygen and nitrogen-reactive species, which directly injure cell structures like walls and DNA and thus cause organ dysfunction.

In a previous study we have observed that high-dose oral bedtime melatonin (OBM) is associated with improved organ function in severe Covid-19 patients

Detailed description: This is a double-blind randomized, adaptive trial in the 4 indications mentioned above giving 100 mg of OBM or placebo.

Interim analyses with pre-specified stopping rules will be performed in each sub-study for specific outcome variables collected at scheduled timelines.

Comparative organ dysfunction score (Sequential Organ Failure Evaluation-SOFA) will be done at baseline, 7, 14, and 30 days and mortality evaluated at 30 and 90 days.

For the 3 study groups enrolling stroke and resuscitated cardiac arrest patients, the modified Rankin score and the CVC (Glasgow) at 30 and 90 days will be compared.

Eligibility criteria: Inclusion Criteria:

* ICU stay \>5 days

Exclusion Criteria:

* ominous prognosis

Primary outcomes:
measure: Mortality at 90 days
timeFrame: Inclusion to 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00927459: Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol
Official title: A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO-040201 in Male and Female Subjects With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypercholesterolemia
Keywords: cholesterol
coronary artery disease
Lead sponsor: Arbutus Biopharma Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. A maximum of 32 subjects is planned for enrollment in this study.


Eligibility criteria: Inclusion Criteria:

* Fasting, stable LDL-C ≥ 160 mg/dL
* Fasting, stable triglyceride \< 400 mg/dL
* BMI between 22 and 35 kg/m2, inclusive
* Females must be of non-child bearing potential
* Males of reproductive potential must agree to practice effective contraception throughout the study and for 3 months following infusion

Exclusion Criteria:

* Clinically significant endocrine, hematologic, renal, hepatic, pulmonary, uncontrolled psychiatric, or neurologic disease
* Cancer within 5 years prior to screening
* History of congestive heart failure or chronic heart failure
* Uncontrolled cardiac arrhythmias
* History of coronary heart disease
* Clinically significant abnormal baseline ECG
* History of additional risk factors for torsades de pointes
* Hepatitis B, C, or HIV positive
* Current diagnosis or known history of liver disease
* A marked baseline prolongation of QT/QTc interval
* Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or a creatine phosphokinase (CPK) \>3 x upper limit of normal (ULN) at screening
* Alanine aminotransferase, AST, GGT, or total bilirubin \>2 x ULN at screening
* Serum creatinine \> 1.5 mg/dL
* Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on 2 occasions during screening
* Concomitant use of medications that prolongs the QT/QTc interval
* Treatment with lipid lowering therapy within 30 days prior to screening
* Use of investigational drug within 3 months prior to screening

Primary outcomes:
measure: Safety and tolerability of PRO-040201
timeFrame: 29 days
Secondary outcomes:
measure: Pharmacokinetics of PRO-040201 in Humans
timeFrame: 48 hours
measure: Pharmacodynamics of PRO-040201 in Humans
timeFrame: 29 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology Unit
state: Ohio
Study officials:
affiliation: Medpace Clinical Pharmacology Unit
name: Douglas Logan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00289159: Multimodal MRI in Multiple Sclerosis (MS): Reliability and Follow Up
Official title: Follow Up by Multimodal MRI of a Cohort of Patients With Early Remitting Multiple Sclerosis (REPROMMS Study).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: aged 18-50
remitting evolution
less than two years of evolution
MS patients
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2006-02-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To determine wether multimodal MRI (conventinal T1 and T2 sequences, diffusion, magnetization transfer, spectroscopy) is reproducible; to follow up a cohort of patients with early remmittent MS after treatment with interferon.


Eligibility criteria: Inclusion Criteria:

* MS patients according to Poser's criteria
* Remitting evolution (less than two years of evolution)
* Aged 18-50
* Immunomodulatory treatment indicated

Exclusion Criteria:

* Unable to perform MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Ayman Tourbah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01613859: Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)
Official title: Measurement of Cardiac Output and Intravascular Volume Status in Critically Ill Children Using an Ultrasound Dilution Method (COstatus)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-06-07
Enrollment: 9
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric Patients (under 21 years of age) in the ICU

Brief summary: Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is an integral part of hemodynamic monitoring of critically ill patients whether it is done directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies to support the cardiovascular system in critically ill children with multi organ dysfunction. Because of the side effects involved in measuring cardiac output directly, intensive monitoring of patients is currently limited to an integrated assessment of tissue perfusion, oxygen delivery and cellular health both at regional and global levels. Currently available methods of measuring CO have their limitations and complications, and are not used routinely for bedside monitoring. Therefore, the investigators propose to use a newly developed method, termed COstatus for the monitoring of CO in patients admitted to PICU.


Eligibility criteria: Inclusion Criteria:

1. Patients under 21 years
2. Presence of compensated or decompensated shock irrespective of etiology
3. Presence of an existing peripheral arterial and central venous catheters

Exclusion Criteria:

1. Patients allergic to heparin

Primary outcomes:
measure: Comparing CO and other clinical markers in Pediatric ICU
timeFrame: During patients stay in ICU with insitu catheter, expected average 3-4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Children's Hospital, University of Florida
state: Florida
Study officials:
affiliation: Shands Children's Hospital, University of Florida
name: Jai Udassi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
Clinical trial NCT06196359: Assessing Function and Pain After Total Knee Arthroplasty With Combined Femoral and Popliteal Nerve Block
Official title: Assessing Function and Pain After Total Knee Arthroplasty With Combined Femoral and Popliteal Nerve Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Total Knee Replacement
Total Knee Replacement Surgery
Arthritis Knee
Rehabilitation
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Western Galilee Hospital-Nahariya
First posted: 2024-01-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this interventional study is to examine whether a pain management technique of combined femoral and popliteal nerve block is effective in total knee arthroplasty patients. The main questions it aims to answer are:

Are there differences in postoperative outcomes? Does the nerve block, age, preoperative quadriceps muscle strength and Oxford Knee Score of the patient predict early functional ability? Participants underwent total knee arthroplasty and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative variables a predictors of early functional ability. Further research is required to refine postoperative pain management strategies.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Electively assigned for primary knee replacement surgery.
* The American Society of Anesthesiologists physical status score 1-3.

Exclusion Criteria:

* Revision surgery.
* Patients suffering from chronic pain syndrome or chronic opioid use.
* Patients with previous neurological deficits in the lower extremities.
* A cognitive state that does not allow signing of consent or understanding simple instructions.

Primary outcomes:
measure: Timed up & go Test
timeFrame: First day after surgery and third or fourth day after surgery
measure: Numeric Pain Rating Scale
timeFrame: up to four days after surgery
measure: Quadriceps Muscle Strength
timeFrame: A 1 day before the surgery, first day after the surgery and third or fourth day after the surgery .
Secondary outcomes:
measure: Elderly Mobility Scale
timeFrame: First day after the surgery and third or fourth day after the surgery
measure: 5 Times Sit to Stand Test
timeFrame: First day after the surgery and third or fourth day after the surgery
measure: Hospitalization Duration
timeFrame: At discharge (assessed up to day 10)
measure: Surgery Duration
timeFrame: During the surgery
measure: Consumption of Analgesics
timeFrame: At discharge (assessed up to day 10)
measure: Occurrence of Falls
timeFrame: At discharge (assessed up to day 10)
measure: Oxford Knee Score Questionnaire
timeFrame: A 1 day before the surgery
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Galilee Medical Centre
Study officials:
References: