cyrilzakka/clinical-trials huggingface dataset:
Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans

This study will be collecting data on participants undergoing lower body negative pressure (LBNP) to simulate progressive blood loss. The goal of the study is to collect data to allow for development of an algorithm with machine learning to predict blood pressure responses to hyporvolemia by analyzing the arterial waveforms collected during LBNP.

Death from exsanguination continues to be a major problem in combat casualty care and the care of civilians subjected to trauma. The ability to detect significant blood loss using traditional vital signs (heart rate, blood pressure) is marginal due to a variety of compensatory mechanisms that maintain blood pressure in the face of marked reductions in circulating blood volume. Along these lines, it is critical to develop monitoring devices and algorithms to non-invasively assess central blood volume in humans for the purposes of facilitating more timely interventions. The standard way to simulate hemorrhage in humans is to use Lower Body Negative Pressure (LBNP). In this technique, the lower body of a supine volunteer is enclosed in an airtight container while suction is applied to cause venous pooling in the legs and reduce central blood volume. This technique generates many physiological adaptations that are similar to that observed during blood loss studies in animals and human volunteers. Thus, the purpose of this study is to obtain data for use in developing monitoring technology to detect hemorrhage and other surrogate markers of central blood volume in humans.

Eligibility Criteria:
Inclusion Criteria:

* Non-obese (BMI \< 30)
* Non-smokers
* Free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity
* Women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test
Ketamine + Magnesium for Chronic Cluster Headache (KETALGIA)

Chronic cluster headache (CCH) is a rare primary headache disorder, defined by episodic attacks that occur for more than one year with no remission period or with remission periods lasting \< 3 months (ICHD-3 criteria). In certain cases, CCH patients become drug-resistant and continue to suffer almost daily attacks.

Ketamine appears to be effective in a variety of chronic pain conditions, such as refractory headache, and can show an enhanced analgesic effect when combined with magnesium. A single infusion of ketamine-magnesium combination has been described to reduce attacks in 17 patients with rCCH. The main outcome was a comparison of the number of daily attacks two weeks prior to the infusion and one week after (days 7-8). The number of daily attacks decreased from 4.3±2.4 before treatment to 1.3±1.0 after treatment (p\<0.001). 13/17 had at least 50% response. Thus, the goal of this placebo-controlled study is to try to confirm these findings.

Chronic cluster headache (CCH) is a rare primary headache disorder, defined by episodic attacks that occur for more than one year with no remission period or with remission periods lasting \< 3 months (ICHD-3 criteria). In certain cases, CCH patients become drug-resistant and continue to suffer almost daily attacks.

Ketamine appears to be effective in a variety of chronic pain conditions, such as refractory headache, and can show an enhanced analgesic effect when combined with magnesium. A single infusion of ketamine-magnesium combination has been described to reduce attacks in 17 patients with rCCH. The main outcome was a comparison of the number of daily attacks two weeks prior to the infusion and one week after (days 7-8). The number of daily attacks decreased from 4.3±2.4 before treatment to 1.3±1.0 after treatment (p\<0.001). 13/17 had at least 50% response. Thus, the goal of this placebo-controlled study is to try to confirm these findings.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Chronic cluster headache diagnosis made according to ICHD-3 criteria
* A mean of at least 2 attacks/day during the 14 days before infusion
* Insufficient efficacy or intolerance or contra-indication to the use of the 3 main validated treatments (verapamil, lithium and sub-occipital steroids injections)
* Stable preventive treatment for at least 7 days before infusion

Exclusion Criteria:

* Pregnant or lactating woman
* Contra-indication to ketamine use (uncontrolled high blood pressure, stoke history, severe cardiac failure)
* Ketamine use during the previous year
* Hypersensitivity to the product or their metabolites
* Severe renal insufficiency (creatinine clearance \< 30ml/min)
Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the area of executive functioning. Relatively limited research has focused on interventions for improving neurocognitive outcomes in long-term survivors of ALL. A promising technique for cognitive enhancement is Transcranial Direct Current Stimulation (tDCS) which differs from conventional cognitive remediation approaches in that it directly stimulates specific brain regions responsible for cognitive processes and activates functional networks similar to those activated during cognitive training.

Primary Objective

To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on direct testing of executive function in survivors of ALL.

Secondary Objectives

* To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on patient-reported symptoms of executive dysfunction in survivors of ALL.
* To examine the effects of home-based tDCS paired with remote cognitive training on patterns of regional brain activation as measured by functional magnetic resonance imaging.
* To examine the effects of home-based tDCS paired with remote cognitive training on white matter integrity and structure as measured by diffusion tensor imaging.

Eligible participants will be randomized to receive 1 mA direct current stimulation over the left dorsolateral prefrontal cortex or placebo/sham for 20 minutes. All participants will receive home-based computerized cognitive training. Participants will complete tDCS paired with cognitive training 2 times per week for 6-months.

Eligibility Criteria:
Inclusion Criteria:

* Completed treatment for acute lymphoblastic leukemia (ALL) at SJCRH \< 21 years at diagnosis
* Enrolled on St. Jude Lifetime Cohort Study
* ≥ 5 years post-diagnosis of ALL
* ≥ 2 years post-treatment completion deemed to impact the central nervous system.
* Currently between 18 and 39 years of age
* English language proficiency
* Executive dysfunction defined as having an age-adjusted standard score \<16th percentile on Trail Making Test Part B, Controlled Oral Word association Test, or Digit Span Backward
* Patient-reported executive dysfunction defined as a standard score \>84th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire or the Behavior Rating Scale of Executive Function

Exclusion Criteria:

* Full scale intelligence score \<80
* Currently taking medication intended to treat neurocognitive impairment (e.g. stimulants)
* Participated in a past trial of neurostimulation
* Female who is pregnant or breastfeeding
* History of seizures within the past year
* Implanted medical devices or metal in the head
* History of head injury or a neurodevelopmental disorder (i.e. genetic disorder, hypoxic-ischemic encephalopathy) associated with neurocognitive impairment and unrelated to cancer treatment
* Currently receiving cancer directed therapy
Pyrosequencing of the BRAFV600E Mutation

To investigate the diagnostic efficiency of pyrosequencing for the mutant BRAF allele in ultrasound (US)-guided fine needle aspiration biopsies (FNAB) of thyroid incidentalomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients with thyroid nodule larger than 1 cm, or nodule smaller than 1 cm that required further evaluation because of suspicious ultrasound findings

Exclusion Criteria:

* Patients who refuse participation.
A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of PNH confirmed by flow cytometry with clone size \> 10%.
2. Have not received complement inhibitor therapy;
3. LDH \> 1.5\*ULN at screening.
4. Hemoglobin level \< 10 g/dL at screening.

Exclusion Criteria:

1. Known or suspected hereditary or acquired complement deficiency;
2. Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L);
3. Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;
4. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
5. Positive of HIV, HBsAg or HCVAb.
A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children

Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).

An open, multicentric, post-marketing surveillance study to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals. Poliomyelitis vaccine (inactivated) -PoliorixTM., administered in Korean children as a primary vaccination in healthy subjects aged two to six months or as a booster vaccination in subjects aged four to six years.

Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female child between two and six months of age (primary vaccination) or between four and six years of age (booster vaccination) at the time of vaccination.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards)
* Written informed consent obtained from the parent/ guardian of the subject

Exclusion Criteria:

* At the time of study entry, the contraindications and precautions of use indicated in the Korean Label should be checked and the subject must not be included in the study if there is any contraindication or risk
Ultrasound Guided Bilateral Erector Spinae Plane Block in Caesarean Delivery

Erector Spinae plane block (ESPB) is a regional anesthesia technique described three years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that ESPB could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral low thoracic ESPB in cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

* patients undergoing cesarean section under general anesthesia morbidly obesity, ASA III - IV , infection of the skin at the site of needle puncture area, patients with known allergies to any of the study drugs, coagulopathy, recent use of analgesic drugs
Z-360 in Unresectable Advanced Pancreatic Cancer in Combination With Gemcitabine Treatment

To evaluate the safety of two doses of Z-360 with Gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for PhaseII study


Eligibility Criteria:
Inclusion Criteria:

* Subjects with unresectable locally advanced or metastatic pancreatic cancer
* KPS \> 70%
* Life expectancy of at least 3 months

Exclusion Criteria:

* received previous chemotherapy for the current indication
* received previous radiotherapy for the current indication
* Currently receiving chemotherapy
Fall Prevention Program for Older Adults

The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill.

The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill. The training program will last for 4 weeks. Upon completion, participants will complete a test where a trip is simulated. Those assigned to the intervention group will test one additional time as well.

Eligibility Criteria:
Inclusion Criteria:

* 65-80 yr old,
* normal reflexes and muscle tone

Exclusion Criteria:

* lower extremity fracture or surgery last 5 yrs
* back surgery or disc herniation last 5 yrs
* noticeable gait impairment,
* low back pain,
* decreased disease-related vision,
* dizziness,
* history of heart problems,
* bone mineral density \<.65,
* mini-mental score \<24
Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia

Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells transplantation by intramyocardial multiple precision injection in ischemic heart failure patients.

The increase of prevalence of heart failure in human population requires to develop new and effective methods of treatment. One of them is stem cells transplantation into a myocardial tissue, which cause the improvement of contractility, myocardial remodelling after myocardial infarction (MI), dilated cardiomyopathy, etc. Use of autologous stem cells does not require of immunosuppressive therapy and does not correlate with some ethical problems. Clinical application of mesenchymal stem cells always requires a step of culturing, which is associated with increased risk of contamination Therefore haemopoietic stem cells, endothelial progenitor cells or mononuclear bone marrow cells are often used to be transplant for treatment of heart failure (HF) patients.Using NOGA XP Cardiac Navigation System improves specificity of transplantations, that is decisive.

Eligibility Criteria:
Inclusion Criteria:

* patients with coronary artery disease (CAD) and HF II-III NYHA class
* MI more than 6 months before the study
* LVEF less than 35%
* absence of indication to coronary revascularization
* optimal pharmacological therapy no less than 8 weeks
* heart transplantation is contraindicated
* patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
* patients giving informed consent

Exclusion Criteria:

* acute coronary syndrome
* coronary revascularization less than 6 months
* patients requiring surgical correction of post-MI aneurism
* LV wall thickness less than 5 mm in site of possible injection
* patients with CRT implanted within 3 month before cells injection
* clinically significant associated diseases
Effects of Coffee Consumption on Glucose Metabolism

Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the mechanisms are limited.

This project aims to assess the effects of coffee consumption on glucose metabolism, using stable isotope tracer (13C-glucose) to explain the possible metabolic mechanisms involved on the reduced risk for T2DM.

This is a crossover randomized clinical trial that has been studying 14 male healthy young adults, who were enrolled five treatments: coffee with sugar, coffee without sugar, decaffeinated coffee without sugar and two controls (water with and without sugar).

The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE) was performed. The use of ODILE methodology permits separation of the glucose absorbed and removed from the circulation increasing the accuracy and the effectiveness of glucose uptake and insulin sensitivity (Bluck et al., 2006).

Eligibility Criteria:
Inclusion Criteria:

* Male healthy young adults (18 - 50 years old);
* Body mass index (BMI) between 18.5 - 28.0 kg/m²;
* No weight changes (≥ 5 kg) in the last 3 months;
* Not take any pills/drugs that alter metabolism, appetite and sleep;
* Not have sleep disorders;
* Not have donated blood in the last 3 months;
* Regular breakfast consumption (≥100 kcal ingested up to 2 hours after waking ≥4x/week);
* Being a habitual coffee consumer (≥100mL ≥5x/week).

Exclusion Criteria:

* Diagnosis of anemia, metabolic and heart diseases;
* Previous sudden fainting and convulsions;
* Any drugs and tobacco consumption;
* Consumption of more than 500mg of caffeine / day (5 cups of coffee, tea and cola soft drinks).
Embryo Selection Using Non-invasive Metabolomic Analysis Versus Morphology

Metabolomics was recently introduced in human IVF for non-invasive identification of viable embryos with the highest developmental competence. The investigators intended to investigate if embryo assessment using non-invasive metabolomic profiling leads to increased implantation rates compared to routine morphology evaluation alone.

Metabolomics was recently introduced in human IVF for non-invasive identification of viable embryos with the highest developmental competence. The aim of the present study was to determine whether embryo selection using non-invasive metabolomic profiling as an adjunct to morphology leads to increased implantation rates compared to routine morphology evaluation alone.

Eligibility Criteria:
Inclusion Criteria:

* patients with at least 4 fertilized oocytes

Exclusion Criteria:

* patients with less that 4 fertilized oocytes
Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients - A Three Year Extension

This study is designed to demonstrate that Tysabri is effective in maintaining cognition in MS patients after 5 or more years of continuous treatment.

During a second period of 36 months, the extension study will assess the evolution of cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and a CogState battery of tests.

Tysabri reduces the relapse frequency, slows progression and preserves cognitive function as compared to placebo as per the AFFIRM trial. The benefit on relapse rate and progression appears to be sustained in longer-term studies such as STRATA. In clinical practice however despite a stable EDSS patients often complain of cognitive deterioration.

The investigators' preliminary results from the first pilot study have shown that cognition in Tysabri treated MS patients for two or more years, as measured by the SDMT or Cogstate battery is maintained, including the ability to learn. The investigators' final data will be presented at the American Academy of Neurology (AAN) in 2015.

The Symbol Digit Modalities Test (SDMT) is a sensitive and validated test of cognition in MS. CogState offers a standardized battery of cognitive tests frequently used in clinical research in the fields of dementia and Parkinson's disease. The CogState battery of tests consisting of the Detection test (processing speed), Identification test (attention), One Back test (working memory), International Shopping List test (verbal learning) and the Groton Maze Learning test (reasoning and problem solving) will further confirm and validate the results of the SDMT in MS patients as well as examine other cognitive domains.

The Beck Depression Inventory-II \[Beck 1996\] is a validated and well recognized clinical research tool for depression in the field of multiple sclerosis.

Together the above tests done prospectively can assess the evolution of cognitive function in Tysabri treated MS patients over the longer term.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed the original study and are willing to continue into the extension.

Exclusion Criteria:

* Patients with cognitive decline from causes other than MS (i.e., PML, stroke, sleep apnea, neurodegenerative disorders, brain tumors).
Safety and Efficacy of IDP-122 Lotion When Applied Topically to Subjects With Moderate to Severe Plaque Psoriasis

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% halobetasol propionate) to Ultravate® (halobetasol propionate) Cream, 0.05% in the Treatment of Plaque Psoriasis.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, of any race, at least 18 years of age (inclusive).
* Freely provides both verbal and written informed consent.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Subject is willing to comply with study instructions and return to the clinic for required visits.

Key Exclusion Criteria:

* Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
* Is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
Efficacy of Xenograft Alone or Mixed With Arginyl-Glycyl-Aspartic Acid (RGD) in Horizontal Ridge Augmentation With Split-crest Technique for Implant Placement

The aim of the present study is to evaluate the efficacy of xenograft alone or xenograft mixed with Arginylglycylaspartic acid (RGD) , in horizontal ridge augmentation with split-crest technique, for implant placement.

A comparative study for ridge augmentation procedure, With two groups. First group underwent a surgical ridge splitting procedure with ultrasonic bone surgery and grafting with Xenograft alone and implant placement. Second group underwent a surgical ridge splitting procedure with ultrasonic bone surgery Xenograft mix ed with Arginylglycylaspartic acid (RGD) and implant placement.

Both groups were followed up for 1 and 3 months after loading.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (age 18-30) exhibiting initial insufficiently bone width.
2. Patients with good oral hygiene.
3. Patients must be free from systemic diseases that may influence the outcome of the therapy.
4. Patients with bony horizontal defects alone, Class III \& IV.

Exclusion Criteria:

1. Heavy smokers.
2. Patient treated by immunosuppressive chemotherapy or radio therapy,
3. Allergy to any material or medication used in the study.
4. Pregnant females.