cyrilzakka/clinical-trials huggingface dataset:
Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation

This randomized clinical study investigates the efficiency of plasma rich in growth factors (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after the performance of lateral sinus floor elevation.

The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone formation regardless the type of bone graft.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients requiring implant prostheses oral rehabilitation.
* Patients with insufficient residual height in posterior maxilla requiring a sinus lift procedure to insert the implants

Exclusion Criteria:

* Not having complete the informed consent form.
* Sinusitis.
* Alcoholism.
* Suffering severe haematological disorder or disease.
* Be undergoing or having received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and / or anticoagulants, 30 days prior to the study inclusion.
* In usual treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs.
* Background of chronic hepatitis or liver cirrhosis.
* Diabetes mellitus with poor metabolic control (glycosylated hemoglobin above 9%)
* Patients undergoing dialysis.
* Presence of malignant tumors, hemangiomas or angiomas in the extraction area.
* History of ischemic heart disease in the last year.
* Pregnancy or intention to become pregnant during the study follow-up period.
* Metabolic bone disease
* Patients taking bisphosphonates drugs both orally and intravenously.
* In general, any inability to participate in the study
Remote Limb Ischemic Conditioning to Enhance Learning and Muscle Strength in Healthy Young Adults

The purpose of this research study is to determine if remote limb ischemic conditioning (RLIC) can enhance learning of a motor (balance) and an ecologically valid, complex cognitive-motor (driving) task, and increase skeletal muscle strength in neurologically-intact young adults.

Ischemic conditioning is an endogenous phenomenon in which exposing a target organ or tissue to one or more brief episodes of ischemia results in protection of that organ against subsequent ischemia. The effects of ischemic conditioning are not confined within an organ but can be can be transferred from one organ to another, a technique called remote ischemic conditioning. A clinically feasible method for this is remote limb ischemic conditioning (RLIC), where episodes of ischemia and perfusion are induced with a blood pressure cuff placed on the arm.

The overall goal of this line of work is to use ischemic conditioning to enhance learning and outcomes in persons with neurologic injuries. Two previous studies have shown that remote limb ischemic conditioning (RLIC) can enhance learning a motor task in healthy young adults. The current study extends that work to determine if RLIC enhances muscle strength training and a complex cognitive-motor task (simulated driving). This Phase I study will yield the necessary information to design and execute subsequent trials in neurologic patient populations.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults between the age of 18 and 40 years
2. Visual acuity of 20/20 with corrected vision

Exclusion Criteria:

1. History of neurological condition (i.e. stroke, Alzheimer's disease, Parkinson's disease), Attention Deficit Hyperactivity Disorder (ADHD), depression, bipolar disorder, balance impairment, or vestibular disorder
2. History of severe motion sickness, moderate to severe motion sickness or nausea on oculo-motor components of Simulator sickness questionnaire, inability to ride a car, boat, train or airplane due to motion sickness
3. Recent wrist, hand or forearm injury that would currently prevent ability to lift weights
4. History of lower extremity condition, injury, or surgery that would currently impair ability to stand or balance
5. Any extremity soft tissue, orthopedic, or vascular injury (i.e. peripheral vascular disease) which may contraindicate RLIC
6. Any cognitive, sensory, or communication problem that would prevent completion of the study
7. History of or current sleep apnea
8. Current intensive weight lifting or interval training exercise
9. Current substance abuse or dependence
10. Unwillingness to travel for all study visits
Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)

Type 1 diabetes (T1D) is still associated with tremendous morbidity and premature mortality.

Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. Unfortunately, there is presently no permanent cure for diabetes. Whole pancreas or islet cell transplantation is available only to a very limited number of patients and necessitates potential lifelong immunosuppressive therapy. Autologous stem cell transplants have been used successfully for ALL (acute lymphoblastic leukemia), AML (acute myeloblastic leukemia) and for the treatment of a variety of cancers including breast cancer and neuroblastomas, and more recently for the treatment of autoimmune disorders such as multiple sclerosis (MS), lupus-like disease, and rheumatic disorders. Recently it was shown that bone marrow-derived stems cells transplanted into diabetic mice led to reduced hyperglycemia within 7 days after transplantation and was sustained until they were sacrificed at 35 days post-transplantation. The investigators' goal is to transfuse autologous umbilical cord blood into 23 children (Germany 10 and 20 Controls) with T1D in an attempt to regenerate pancreatic islet insulin producing beta cells and improve blood glucose control. As secondary goals, the investigators aim to track the migration of transfused cord blood stem and study the potential changes in metabolism/immune function leading to islet regeneration.


Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of T1D and have stored umbilical cord blood (10 patients sought) at the cord bank Vita 34.
* TID diagnosis will be defined as having a clear history of polydipsia, polyphagia, polyuria, and weight loss consistent with a clinical diagnosis, diagnosis will mot be based solely upon the presence of autoantibodies.
* Cord blood meets all selection and testing criteria (see below).
* Normal screening values for CBC, Renal function and electrolytes (BMP).
* Willing to comply with intensive diabetes management
* Not younger than 1 year of age

Exclusion Criteria:

* Have complicating medical issues that would interfere with blood drawing or monitoring.
* Require chronic use of steroids or other immunosuppressive agents for other conditions.
* Cord Blood with viability \< 50%.
* Positive infectious disease markers from mothers blood or cord at time of collection (See below for details).
* Any evidence of illness on planned infusion date (i.e. fever \>38.5 C, vomiting, diarrhea, wheezing, or crackles).
The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells

To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury

The purpose of this study is to evaluate the safety and effect of infusions of autologous (the patient's own)umbilical cord blood stem cells in newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood stem cells for the Gunagdong Cord Blood Bank,or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood stem cells if an adequate number of cells that meet Guangdong Cord Blood Bank Quality standards are available in the first 14 postnatal days. Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months. MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.

Eligibility Criteria:
Inclusion Criteria:

* Mothers must have consented for cord blood collection at delivery
* cord blood must be available for extraction of stem cells.

  -\>28 weeks gestation,\<37weeks gestation
* cord or neonatal pH\<7.0 or base deficit\>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
* either a 10 minute Apgar \< 5 or continued need for ventilation.
* All infants must have signs of encephalopathy within 6 hours of age.

Exclusion Criteria:

* Presence of known chromosomal anomaly.
* Presence of major congenital anomalies.
* Severe intrauterine growth restriction (weight \<1800g)
* Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
* Parents refuse consent.
* Attending neonatologist refuses consent.
* Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.
Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance

The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: Healthy non-treatment seeking adults (age 18 to 60, N = 40) who report
* (a) infrequent cannabis use defined as at least one reported use in the past year with a negative THC urine toxicology at baseline, or
* (b) report frequent cannabis use defined as \> 5 days per week for \> 1 year with a positive THC urine toxicology at baseline.

These criteria were selected to target individuals with low and high-frequency cannabis use in order to examine the direct effect of tolerance on study outcome measures.

Exclusion Criteria:

* (1) meet DSM-V criteria for substance use disorders other than tobacco, cannabis, or caffeine,
* (2) are currently receiving or interested in immediately receiving behavioral treatment or medication for cannabis cessation,
* (3) current use of any medications that could affect study outcomes,
* (4) test positive for drugs of abuse (other than cannabis) and/or breath alcohol test at study admission,
* (5) have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity,
* (6) are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding,
* (7) have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina), or (8) are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114

A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114.

This is a first-in-human (FIH), Phase 1a, multicenter, open-label, single-arm dose-escalation study of AK114 to evaluate the safety, tolerability, PK, pharmacodynamics, antitumor activity and immunogenicity in adult subjects with advanced or metastatic solid tumors. The study is comprised of dose escalation phase. Approximately 30 subjects will be treated in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent
2. Age ≥ 18
3. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor
4. Subject must have at least one measurable lesion according to RECIST v1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1
6. At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated
7. Available archived tumor tissue sample (block or a minimum of 10 unstained slides of formalin-fixed paraffin-embedded tissues) to allow for correlative biomarker studies
8. Subjects may opt to provide two fresh biopsy samples (pretreatment and on treatment), where clinically appropriate
9. Adequate organ function
10. Use acceptable method of contraception from screening, and must agree to continue for 120 days after the final dose of investigational product

Exclusion Criteria:

1. History of severe hypersensitivity reactions to other monoclonal antibodies
2. History or concurrent gastrointestinal perforation, surgery and wound healing complications, hemorrhage events
3. Patients with clinically significant cardiovascular disease
4. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of investigational product administration
5. Active or prior documented autoimmune disease within the past 2 years
6. History of primary immunodeficiency
7. History of organ transplant or hematopoietic stem cell that requires use of immunosuppressive medications
8. Known allergy or reaction to any component of the investigational product formulation.
9. History of interstitial lung disease or noninfectious pneumonitis except for those induced by radiation therapies.
10. Prior treatment with canakinumab.
EEG-Guided Sedation in ERCP Procedures

Patients undergoing ERCP have a wide range from patients with poor general condition and septicaemia findings to outpatients who come as day patients without any other additional disease. Rapid deterioration in vital signs may be encountered especially during sedation. In this patient group, it is important to titrate the anaesthetic agent at appropriate doses and to adjust the dose according to the patient.

The aim of the study is to optimise the level of sedation using 4-channel electroencephalography (EEG) in these patients, thus providing balanced anaesthesia and rapid recovery in this already challenging patient group.

Volunteers in the ASA (American Society of Anaesthesiology) I-II-III risk group, aged between 18-65 years, of both sexes, who will undergo ERCP procedure under elective conditions with routine preoperative examination will be included. Before the procedure, the study and all possible risks will be explained to all patients and informed consent will be obtained. Patient's age, weight, ASA value, chronic diseases will be recorded before the procedure. Patients will be divided into two groups. All patients will be routinely monitorised for ECG, non-invasive arterial blood pressure, SpO2, respiratory rate, end-tidal CO2 measurement. These values will be noted at five minute intervals. All patients will receive oxygen at 2 L/min through a nasal cannula. In the case group, in addition to routine monitoring, PSI value measurement will be performed by applying PSI electrodes after wiping the forehead with an alcohol sponge and drying it. All patients will be induced with Propofol at a dose of 1 mg/kg and maintained by infusion at a dose of 50-150 mcg/kg/min according to the patient's need. All procedures will be performed by a single gastroenterologist. In addition, an assessment will be made every five minutes according to the Ramsey Sedation Scale (RSS). An RSS of 2-3 is considered as light sedation and 4 as deep sedation. The duration of the procedure, duration of anaesthesia, total amount of anaesthetic given, time to awakening from anaesthesia (time until Ramsey Score: 1), recovery time (time until Aldrete Score: 10) will be noted.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II-III risk score
* Volunteer patients
* Patients aged 18-65 years of both sexes undergoing elective ERCP procedure

Exclusion Criteria:

* Patient reluctance
* Being under 18 years of age
* Being over 65 years of age
* ASA risk score of 4 and above 4
* Pregnant women
* Those with neurological conditions
* Patients with difficult airways
* Obesity (BMI\>30)
SmartTarget: BIOPSY

The purpose of this study is to determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer.

The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform.

An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre.

SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy.

This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget


Eligibility Criteria:
Inclusion Criteria:

* Previous TRUS biopsy with clinical indication for repeat biopsy
* Discrete lesion on mpMRI scoring 3, 4 or 5 on PI-RADs scale
* An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
* Signed informed consent

Exclusion Criteria:

* Men who have taken any form of hormones (except 5-alpha reductase inhibitors) within the last 6 months
* Men with an irreversible coagulopathy predisposing to bleeding
* Men who are unability to undergo transrectal ultrasonography
* Men who have had previous radiation therapy to the pelvis
* Men who have had HIFU, cryosurgery, thermal, irreversible electroporation, photodynamic, photothermal therapy, or microwave therapy to the prostate. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality is permitted
* Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
* Men who are unable to give informed consent
Cardioprotective Effects of Freeze Dried Grape Powder on Blood Pressure and Plasma Lipids/Lipoproteins

Whole food-based dietary interventions have the potential to promote cardiometabolic health via multiple mechanisms, including improvements in blood pressure, bad cholesterol, and other markers of metabolic health. Previous research suggests that grapes have the potential to promote optimal cardiometabolic function by reducing LDL-C, but it remains unclear whether there is a dose-response relationship. Moreover, few studies have evaluated effects on vascular health following daily grape consumption. We propose to examine the effects of 6-8 weeks of supplementation with freeze dried grape powder (69 g/d; \~three ¾ cup servings) compared to a control powder without grapes on: 1) bad cholesterol and blood pressure and 2) other measures of cardiometabolic health, including glucose and insulin. We will enroll overweight (BMI 25-36 kg/m2) but otherwise healthy adults with moderately elevated LDL-C (\>115 mg/dL for women and \>130 mg/dL for men) and/or blood pressure of120-159/80-99 mm Hg. This will optimize the potential for observing significant changes in these measures of health. We will recruit 20 eligible participants with the expectation that at least 15 will complete the study. The placebo-controlled, crossover study design will allow for a direct comparison of effects within the same participant. We anticipate that the bioactive components of grapes will promote cardiometabolic health via changes in LDL-C and blood pressure. Results from the proposed study would help to clarify how daily grape consumption might promote health and would provide further support for incorporating whole, unprocessed fruit in a healthy dietary pattern.


Eligibility Criteria:
Inclusion Criteria:

* BMI of 25-36 kg/m2
* At least one of the following:

  * LDL-C above 115 mg/dL (women) or above 130 mg/dL (men)
  * Systolic blood pressure of 120-159 mmHg
  * Diastolic blood pressure of 80-99 mmHg

Exclusion Criteria:

* Allergies to grapes
* History of CVD, blood pressure ≥ 160/100 mmHg, kidney disease, diabetes, or inflammatory diseases such as GI disorders and rheumatoid arthritis
* Use of medications/supplements for elevated lipids, blood pressure, or glucose
* Chronic use of non-steroidal anti-inflammatory or immunosuppressant drugs
* Conditions requiring chronic use of steroids
Two-level ESPB in Total Knee Arthroplasty

Effect of two-level ESPB in Total Knee Arthroplasty

Knee arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for total hip arthroplasty
* patients aged \>65 and \<100 years
* patients able to provide informed consent
* patients able to reliably report symptoms to the research team

Exclusion Criteria:

* inability to provide first-party consent due to cognitive impairment or a language barrier