cyrilzakka/clinical-trials huggingface dataset:
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects

The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.

This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between the ages of 18-45 years
* Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing
* Have signed the informed consent form approved by the IRB

Exclusion Criteria:

* History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and/or excretion of the studydrug, determined by the investigator
* Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis
* Have a history of or current allergic disease
* Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse
* Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine
* Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests
* Pregnant or breastfeeding female subjects
Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma

Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event, especially in newly diagnosed patients and during induction treatment with thalidomide in combination with dexamethasone. This association was mainly heightened during the 3 first months of chemotherapy.

Several coagulation abnormalities have been described. Laboratory tests measuring the overall thrombophilic tendency might be useful to assess thrombosis risk.

The aim of this study is to compare thrombin generation by calibrated automated thrombogram during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.


Eligibility Criteria:
Inclusion Criteria:

* Inscription to medical assurance
* Patients who gave their written consent
* Patients with newly diagnosed Multiple Myeloma required chemotherapy

Exclusion Criteria:

* Patients with renal failure who need to undergo hemodialysis
* Patients with indication for curative anticoagulant therapy
* Patient with 3 month follow-up not possible
* Patient with life expectancy \< 6 month
Mobility and Activity Patterns in Hospitalised Severe Brain Injury

The purpose of this observational study is to quantify physical activity patterns in patients with severe acquired brain injury admitted for in-hospital rehabilitation.

Patients admitted for rehabilitation will be included for two periods of one-week monitorization of physical activity. The investigators will include all patients with moderate to severe brain injury.

This is an observational cross-sectional study including patients 18 years or above. Patients with conditions such as unstable fractures that restricts mobilisation are excluded. Physical activity is measured continuously during rehabilitation at two separate seven-day periods using a body-worn activity tracker. The first period will be initiated in the early phase of rehabilitation (3 days after admission) and the second at the late phase (10 days before discharge).

Baseline variables considered predictors, confounders or modifiers for physical activity will be collected along with registration of variables during the measurement periods and functional outcome variables at discharge.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old

Exclusion Criteria:

* Planned discharge within two weeks
* Fractures of lower extremities, pelvis or spine prohibiting weight-bearing
* Amputation of lower extremities
PREPARE: Patient Centered Perioperative Experience

The purpose of this study is to determine whether an educational video about patients' perioperative experience (period that spans from the time of admission to the hospital to the time of recovery after surgery) will affect the timing of hospital discharge. The researchers will use information collected during this study to create a questionnaire and an educational video related to the patient perioperative experience. The educational video will address patient concerns about the perioperative period and recovery after surgery (post-operative recovery).

All participants in this study will be undergoing a MIS hysterectomy according to their routine care in the Gynecology


Eligibility Criteria:
Inclusion Criteria:

* Woman ≥18 years of age.
* Scheduled to undergo MIS hysterectomy by a gynecologic oncologist at MSK at either Josie Robertston Surgery Center or the main hospital OR completed MIS hysterectomy by a gynecologic oncologist at MSK at either Josie Robertson Surgery Center or the main hospital within 1 month of consent (post-op patients eligible for Phase 1 only). Phase 1 was completed on 3/31/2021).
* Determined to be an appropriate candidate for the AXR program or expected to be discharged within 23 hours after surgery.

Exclusion Criteria:

* Not able to speak and read English.
Safety, Tolerability, Effect of Vildagliptin and How the Body Changes the Blood Level of Vildagliptin in Healthy Chinese Volunteers

The purpose of this study is to assess the safety, tolerability, effect of vildagliptin and how the body changes the blood level of vildagliptin of single and multiple oral doses of vildagliptin in healthy Chinese volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Chinese healthy volunteers age 18 to 45 years of age included
* In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
* All subjects must have both parents of Chinese origin and citizenship and must have been born in China.
* Body mass index (BMI) within the range of 19 to 24 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* Smokers
* Use of any prescription drugs within four (4) weeks prior dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, dietary supplements) within two (2) weeks prior to dosing. Paracetamol (or equivalent in China) is acceptable
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
* Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
* Significant illness within two weeks prior to dosing.
* A past personal or close family medical history of clinically significant cardiac abnormalities
* History of Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease) Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis) Known hypersensitivity or severe adverse event to darifenacin or similar drugs Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. Drug or alcohol abuse within the 12 months prior to dosing.

Other protocol-defined inclusion/exclusion criteria may apply
Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed invasive breast cancer
2. Tumor size of 3cm or less and N0
3. Hormone receptors have been identified as negative
4. HER2 positive confirmed by IHC 3+ or FISH+
5. LVEF \> 50% by echocardiogram or MUGA
6. Adequate EKG
7. No prior treatment for breast cancer
8. PS 0-1
9. Required baseline laboratory data WBC \> 4,000/mm3 and Neut \> 2,000/mm3 PLT \> 100,000/mm3 Hb \> 9.0g/dl AST and ALT \< ULNx2.5 T-Bil \< 1.5mg/dl Serum creatinin \< 1.5mg/dl
10. Written informed consent

Exclusion Criteria:

1. With history of hypersensitivity reaction for important drug in this study
2. With history of invasive breast cancer
3. Bilateral invasive breast cancer
4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
5. Positive for HBs antigen or HCV antibody
6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
7. With severe edema
8. With severe peripheral neuropathy
9. With severe psychiatric disorder
10. Pregnant or nursing women
11. The case that is judged to be unsuitable for this study by physician
A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section

This randomized controlled study will compare narcotic consumption between two groups: patients that receive a perioperative dose of IV acetaminophen versus patients that receive a perioperative dose of oral liquid acetaminophen for scheduled cesarean section.

"Enhanced recovery" is an alternate management protocol described by a multi-modal, evidence based approach to peri-operative care, with the goal of accelerating recovery and return to normal activity after surgery. Results have shown stable pain control with a decrease in narcotic consumption, a quicker return of bowel function, and decreased length of hospital stay and cost with no change in level of patient satisfaction, morbidity, or readmission rate. An aspect of some alternate management protocols is the administration of acetaminophen.

The concentration of acetaminophen in cerebrospinal fluid (CSF) is directly proportional to the analgesic activity of acetaminophen. Acetaminophen relies on a high concentration gradient from the plasma to the CSF in order to passively diffuse into the central nervous system (CNS), its principal site of action. A 2012 study, comparing plasma and CSF pharmacokinetics of intravenous (IV), oral (PO), or rectal (PR) acetaminophen, concluded that IV administration of acetaminophen results in higher plasma and CSF concentration values. Therefore, IV acetaminophen produces better CNS penetration compared to PO or PR methods.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18 or older
* Scheduled to undergo a cesarean section

Exclusion Criteria:

* Existing diagnosis of chronic pain
* Need to undergo a vertical skin incision
* Aspartate Aminotransferase (AST) \> 50, alanine aminotransferase (ALT) \> 70
* Platelets below 80,000 on admission
* Need to undergo general anesthesia
* Tubal ligation at time of Cesarean section
* Prior or known allergy to any of the medications being utilized in this study
Brain Metabolism Observed at 7 Tesla

The goal is to develop methodology to monitor flux in the citric acid cycle in brain via 13C nuclear magnetic resonance (NMR) spectroscopy at 7 Tesla.

The goal is to establish a protocol to 13C-label (from 13C-glucose) several physiological molecules: glucose, lactate, pyruvate and derived compounds. All of these molecules can undergo oxidation in the citric acid cycle. The intent is to study the 13C labeling pattern of these molecules in control and G1D subjects to determine if downstream products (such as 13C bicarbonate or 13C glutamate) due to oxidation in the mitochondria can be detected in brain or in blood by NMR analysis. While inside the instrument, the subjects may also undergo a 7T MR exam to correlate spectroscopy with brain structure.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescents and adults with previously documented diagnosis of Glut1 Deficiency with diagnosis genetically confirmed or confirmed by PET scan of the brain.
2. Ages 16 to 65
3. Persons with dental fillings, dental crowns, and short (max.4 cm) dental retainer wires can be included.

Exclusion Criteria:

1. People or patients with uncontrolled seizure disorder, defined as grand mal (not absence) seizure in the preceding 3 months.
2. Pregnant females will be excluded. A serum or urine pregnancy test will be administered to all females of child bearing potential within 24 hours of administration of the tracer and MRI scan. The pregnancy test will be communicated in person by the study PI. Positive results in subjects 17 years old or younger will be disclosed to parent/guardian only.
3. Subjects with typical implanted orthopedic metal in bone may be considered for inclusion in a 7T scan providing the implant is not within the volume of the radio frequency coil. The PI and the AIRC Medical Director will discuss each case and determine eligibility.
4. Persons with ICD, pacemakers, neurostimulators and other such devices will be excluded.
5. Persons with claustrophobia are excluded.
6. Persons with questionable ferrous implants, bullets, BB's, and shrapnel will be excluded.
7. Subjects who are not fluent in English will be excluded because immediate cooperation and the ability to respond to instructions from the investigators are necessary.
Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

This study is an investigation of the neurologic, immunologic, and rheumatologic markers of Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). PANS is a condition characterized by the abrupt, dramatic onset of obsessive compulsive disorder (OCD) and/or eating restriction accompanied by equally abrupt and severe co-morbid neuropsychiatric symptoms, which include anxiety, emotional lability, depression, irritability, aggression, oppositionality, deterioration in school performance, behavioral (developmental) regression, sensory amplification, movement abnormalities, sleep disturbance, and urinary frequency. PANS is thought to be caused by infection, inflammation, or alternate triggers that is associated with a brain response that leads to these symptoms. The purpose of this study is to examine specific neurologic, immunologic, rheumatologic, and genomic, components in children with the acute-onset of psychiatric symptoms. This research may begin to uncover a much larger story of autoimmune processes that are involved in psychiatric disorders of childhood. By better understanding the etiologic components of psychiatric phenomenon, future treatments may be better targeted to underlying causes.

The investigators will recruit 500 children, 1-18 years old at onset with PANS/PANDAS. They will be treatment naive and within one month of onset/exacerbation. The 500 children with PANS will be gender- and age-matched to 100 healthy children, to allow examination of immunologic, neurologic, genomic, and behavioral differences between these two groups of children.

Eligibility Criteria:
Inclusion Criteria:

* Children with PANS

  1. Age 1-18 at onset of PANS
  2. Diagnosis of PANS: abrupt onset of OCD or food restriction, and at least two of the following associated symptoms: frequent urination, worsening handwriting/cognition, inattention, anorexia, separation anxiety, oppositionality, irritability/rage outbursts, and emotional lability.
  3. Patients must live within 90 miles of Stanford University and have a new onset of PANS illness
  4. Patients must have an established pediatrician within 90 miles of Stanford University for 3 years.
* Healthy Controls

  1. Age 4-18
  2. No psychiatric diagnosis

Exclusion Criteria:

* Any neuropsychiatric illness that may obscure the clear diagnosis of PANS
Prevalence and Risk Factors for Postsurgical Pain After the Open Reduction and Internal Fixation of Lower Limbs.

The objective of this study is to specify the demographic and medical factors that most likely constitute a risk of developing CPSP in the patients with lower limb.

Chronic pain,one of the most frequent causes for patients to seek medical care,is a recognized health problem.Chronic postsurgical pain (CPSP), commonly defined as pain that develops after a surgical procedure and persists at least 3 months, constitutes a widely underdiagnosed and often poorly treated medical problem affecting 10-50% of all postsurgical patients. According to the reports,in the United States alone,1.9 million persons abused or were dependent on prescription opioid analgesics for chronic pain in 2013,contributing to one of the worst public health crises the developed world has recently faced.Here,open reduction and internal fixation（ORIF） of lower limb fractures ,what the investigators focus, is a common surgical procedure in orthopedics and microscopic hand and foot surgery.The removal of the intramedullary nail can relieve anterior knee pain, but in a substantial number of patients, pain persists after nail removal.The most painful daily activities are kneeling and squatting.Therefore, it is increasingly important and urgent to solve the postoperative chronic pain of patients with lower extremity fractures surgery.

The underlying biology of chronic postoperative pain and genetic heritability is complex and not yet fully understood . A common feature of CPSP is that the painful sensations change from the familiar acute postoperative pain to a complex pain syndrome with nonaplastic characteristics，neuropathic characteristics, or both. Preclinical studies have revealed that neuroinflammation is one of pathological hallmarks of CPSP. The transition from acute to chronic pain starts early within the first 2 weeks after nonaplastic by peripheral and central inflammatory processes and activation of spinal glial cells.Repetitive nociception resulting from prolonged inflammatory and neuropathic responses to noxious stimuli causes a cascade of biochemical and structural changes to various pain pathways resulting in sensitization of the peripheral and central nervous system（CNS）. Cytokines and neurotrophic factors have been identified as pivotal mediators involved in neuroimmune activation pathways and cascades in various preclinical chronic pain models.

Although lower limb fracture is one of the most frequently reported triggering CPSP events, few large-scale studies have shown the occurrence of and factors associated with it.The objectives of investigators are to specify the demographic and medical factors that most likely constitute a risk of developing CPSP and to search for potential interventions to reduce the occurrence of CPSP in these limb fracture patients.

Eligibility Criteria:
Inclusion Criteria:

* Underwent surgical repair including fracture of the lower leg, fracture of the foot and fractures involving multiple regions of the lower limbs.

Exclusion Criteria:

* Refusing to participate in this study.
The Experiences of Parents Learning Physiotherapy Techniques for Their Child

The experiences of learning from paediatric physiotherapists were explored through unstructured interviews applying Colazzi's method to interpret the data. In this hermeneutic phenomenological study, six parents responsible for a physiotherapy home programme for their child were selected through convenience sampling. The purpose of this study was to obtain rich and valid information that could be analysed. The phenomenon of their learning experiences was formed and explored, its implications discussed and inferences made in light of current physiotherapy service delivery.


Eligibility Criteria:
Inclusion Criteria:

* parent/main carer of a child with a long term physical condition receiving physiotherapy in the United Kingdom for at least six months.

Exclusion Criteria:

* parents experiencing physiotherapy outside UK practice.
* parents to whom English is not their first language.
* parents under 16 years of age
Pharmacokinetics in Morbid Obesity After Bariatric Surgery

Morbid obesity (MO) is associated with several disorders such as hypertension, type 2 diabetes, dyslipemia and degenerative arthropathy that require pharmacological treatment. Drug bioavailability and metabolism in patients with MO is altered compared to population controls. Bariatric surgery is the gold standard treatment for MO when conventional therapy fails.

Bariatric surgery techniques can modify drug absorption in MO patients. These modifications depend on the drug absorption characteristics and on the bariatric surgery technique used. The changes in weight and body composition caused by BS at middle term can alter drug bioavailability and metabolism. The kinetics of the "normalization" process in patients with MO after bariatric surgery is unknown

Objectives. To analyze the changes in drug metabolism and pharmacokinetics. To establish drug dosing criteria in the post-intervention period in patients with MO after bariatric surgery. To determine the relationship between changes in drug bioavailability and metabolism in MO after bariatric surgery (longitudinal gastrectomy and Y-roux gastric by-pass).

Patients and methods. A prospective study of two cohorts of patients in a program of bariatric surgery (gastric by-pass and sleeve gastrectomy). Study "before and after".

Evaluations. Study on drug metabolism and pharmacokinetics using a modified "karolinska cocktail" (dextromethorphan, caffeine, losartan, omeprazole and paracetamol) before bariatric surgery and at 4 weeks and 6 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults (from 18 to 55 years)
* Morbid Obesity BMI \> 40 or BMI\> 35 plus co-morbidity
* Healthy controls (non-overweight and overweight groups)

Exclusion Criteria:

* Allergy to study drugs
* Liver diseases
NeoFent-I Study; Fentanyl Treatment in Newborn Infants; a Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study

The study will assess the efficacy of fentanyl using a pharmacokinetic/pharmacodynamic (PK/PD) model where the concentration of the drug is related to effect curve (pain score change in response to standardized procedural pain). Further cortical, physiological and biochemical responses to fentanyl will be assessed, elucidating the feasibility before the main study project (NeoOpioid) start.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for analgesia before any of following procedures;

  1. insertion of peripheral IV-catheter
  2. insertion of arterial cannula
  3. insertion of chest tube
  4. other skin breaking procedure.
* Possibility to obtain blood samle after the procedure (indwelling line)
* Infants all gestational ages.
* Postnatal age 0-28 days
* Informed written parental concent

Exclusion Criteria:

* Concurrent or previous opioid administration (72 h interval required)
* Abdominal surgery
* Major chromosomal anomaly
* Neonatal encephalopathy
* Use of muscle relaxant
* Hypothermia treatment after hypoxic-ischemic insult
* Clinical or biochemical evidence of hepatic failure
* Participation in other intervention trial