cyrilzakka/clinical-trials huggingface dataset:
ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)

This is a Post-Authorization Safety Surveillance (PASS) study designed to collect data on the safety and effectiveness of ADVATE reconstituted in 2 mL Sterile water for injection (SWFI) during routine clinical practice in children until 12 years of age. This surveillance study is a post-licensure commitment for ADVATE reconstituted in 2 mL SWFI.


Eligibility Criteria:
Inclusion Criteria:

* Severe or moderately severe hemophilia A (baseline Factor VIII (FVIII) ≤ 2%)
* ≤12 years of age
* Participant's legally authorized representative(s) has provided written informed consent
* Participant is prescribed ADVATE and will only receive ADVATE reconstituted in 2 mL sterile water for injection (SWFI)
* Documented history of prior exposure to ADVATE
* Documented evidence of negative inhibitor test result during ≤10 EDs prior to study entry

Exclusion Criteria:

* Known hypersensitivity to the active substance or to any of the excipients
* Known allergic reaction to mouse or hamster proteins
* Participant has a requirement for a major surgical procedure at the time of enrollment
* Participant has no prior exposure to a FVIII concentrate
* Participant currently being treated with an immune tolerance induction (ITI) regimen
* Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand disease)
* Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device or PASS registry during the course of this study
Urine Alkalinisation to Prevent AKI in COVID-19

The aim is to explore the feasibility and safety of urine alkalinisation in critically ill patients with COVID-19.

Severe acute kidney injury appears to a major part of the SARS-CoV-2 syndrome. Preventing early acute kidney injury may reduce severe AKI as the disease progresses. Urine alkalinisation to prevent binding of SARS-COV-2 to renal tubular epithelial cells is a novel concept that could be used to design other therapies to reduce viral binding. Showing feasibility with this safe and available strategy could be the first step toward other related efforts.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Covid-19 positive
* Admission to Critical Care Unit
* Bladder catheter in situ
* Central line in place (including PICC line)
* Age ≥18y
* Written informed consent to participate in the study

Exclusion Criteria:

* Stage 3 AKI (as defined by KDIGO criteria)
* Chronic kidney disease stage 4 or 5
* Contraindications to NaHCO3 therapy (e.g. risk of serious drug interaction, systemic metabolic alkalosis, congestive heart failure)
* Urine pH \> 7.0
* Serum sodium \>150mmol/L
* Blood pressure \>180/100mgHg
* Severe hypokalaemia (K\<3.0mmol/L)
* Inability to grant informed consent
* Severe hypocalcaemia (Cai \<0.8 mmol/L)
* Pregnant or lactating and breast-feeding women
* Unwilling to use contraception
* Patient is on a medication that may interact with sodium bicarbonate
Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule.

Subjects will receive the following treatments in a crossover design:

Treatment A (Reference): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;

Treatment B (Test): One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;

Descriptive statistics will be calculated for PK parameters including Cmax, Tmax, AUC0-t, and AUC0-inf.

Eligibility Criteria:
Inclusion Criteria:

* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs;
* Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable form of contraception
* BMI of 18.5 to 32.0 kg/m2, inclusive

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* Pregnancy, lactation, or breastfeeding
Efficacy of Magnesium and Alpha Lipoic Acid Supplementation in Reducing Premature Uterine Contractions

To evaluate whether a combined supplementation of magnesium and lipoic acid is able to significantly reduce the incidence of uterine contractions and related episodes of hospitalization in pregnant women.

Primary prevention of preterm labor is based on the early identification of risk factors and on appropriate treatments. Although several drugs are currently used, the identification of effective and safe agents able to improve both maternal and fetal health is still warranted.

In this study the efficacy a formulation based on magnesium and alpha-lipoic acid has been compared with placebo to evaluate the incidence of reduction of preterm delivery.

Three hundred pregnant women at 14-34 weeks of gestation were enrolled and randomly divided to receive a daily single tablet containing magnesium and alpha-lipoic acid supplement or placebo until delivery.

Eligibility Criteria:
Inclusion Criteria:

* 14-34 weeks of gestation

Exclusion Criteria:

* Preexisting diabetes mellitus
* Systolic blood pressure \>140mm Hg
* Cancer
* lupus
* hepatitis
* HIV/AIDS
* Diagnosed alcohol or chemical dependency
Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients

This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.


Eligibility Criteria:
* Patients scheduled to undergo liver transplantation
* Patients able to read and understand consent document (if patient is unable to provide an informed consent, the Legally Authorized Representative will be ask to consent on behalf of the patient).
* SVR lower than 500 dynes-sec/cm-5 intraoperatively (this criterion must be met after consent intraoperatively)
PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPF

This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). The purpose of this study is to find out how much of the study drug gets into the brain and lung, and what the side effects and blood levels of the study drug are in healthy volunteers and patients.

Participants will:

* Take a single dose of the study drug
* Give many samples of blood and urine
* Have multiple PET scans


Eligibility Criteria:
Main Inclusion Criteria

* All parts: male volunteers or female volunteers of non-childbearing potential; agree to follow the contraception requirements of the trial, and able to give fully informed written consent.
* Part A: normotensive volunteers, deemed healthy on the basis of a clinical history, medical examinations, ECG, vital signs, and laboratory tests of blood and urine.
* Part B: volunteers with a diagnosis of PPMS or SPMS by a neurologist, according to the 2017 Revised McDonald Criteria.
* Part C: volunteers with a diagnosis of IPF by a pulmonologist, according to the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline, within 7 years before screening.

Main Exclusion Criteria

* Positive tests for hepatitis B and C, human immunodeficiency virus (HIV)
* Severe adverse reaction to any drug; sensitivity to trial medication
* Drug or alcohol abuse
* Smoking or use of tobacco or nicotine-containing products from 7 days before screening, until the final visit
* Use of a prescription medicine (except hormone replacement therapy \[HRT\] in women, and medications for participants with PrMS and IPF at the discretion of the investigator), or any substance known to interact with cytochrome p450 (CYP)3A enzymes (including St. John's wort and foodstuffs such as grapefruit juice) during the 28 days before the first dose of PIPE-791
* Use of any other over-the-counter medicine, with the exception of acetaminophen (paracetamol) during the 7 days before the first dose of PIPE-791, or received vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), during the 7 days before screening
* Participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the 3 months before the baseline PET scan
* Vital signs or ECGs outside the acceptable range at screening
* Clinically relevant abnormal findings at the screening assessments, including C-SSRS and MRI (Parts A \[brain PET imaging arm\] and B only)
* Acute or chronic illness (except PrMS and IPF in Parts B and C, respectively)
* Clinically relevant abnormal medical history or concurrent medical condition
* Possibility that volunteer will not cooperate
* Contraindications to MRI (Parts A \[brain PET imaging arm\] and B only), computed tomography (CT), PET, or arterial cannulation procedures
* Significant exposure to research-related radiation or other radiation exposure (exceeding 10 mSv when added to exposure from this study) within the previous 12 months
Assessment of Professional Practices in Muscle Rehabilitation of Chronic Hemodialysis

Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of a muscle strengthening program (training against resistance vs endurance training by elliptical bike) during a observational period (12 weeks per program) on frailty, risk of falling, muscle strength and mass, endurance, physical activity, quality of dialysis, nutritional status and neuromuscular sensitivity.


Eligibility Criteria:
Inclusion criteria:

* Chronic Kidney Disease patient on dialysis (stage 5D) for more than 3 months
* Age \> 18 years old
* Stable clinical condition
* Absence of musculoskeletal disorders

Exclusion criteria:

* Cardiovascular contraindication
* Amputation of lower limb not allowing use of elliptical bike
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)

This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.

The primary double-blind study of raltegravir versus placebo was extended to 156 weeks and was followed by an open-label raltegravir phase in which continuing participants from both the raltegravir and placebo groups received open-label raltegravir for an additional 84 weeks for a maximum duration of up to 240 weeks. Participants who had viral failure after Week 16 may have received open-label raltegravir until Week 240.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be HIV positive with HIV RNA values that are within ranges required by the study
* Patient must have documented failure of certain antiretroviral therapy
* Patient must be on the same antiretroviral therapy for at least the past two months

Exclusion Criteria:

* Patient less than 16 years old
* Additional study criteria will be discussed and identified by the study doctor
Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening

This phase I study investigates how well a health service program called Witness CARES Services works in increasing access and adherence to colorectal cancer screening in patients who have not undergone a colorectal screening in the past year. Providing patients with navigational and screening services via Witness CARES Services may improve access to and adherence levels of colorectal screening.

PRIMARY OBJECTIVES:

I. Test the feasibility of Witness CARES (WC) Services to achieve colorectal carcinoma (CRC) screening for non-adherent Medicaid clients.

II. Develop an algorithm for predicting CRC screening outcomes following intervention services.

OUTLINE:

Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy receive navigator assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test receive navigator assistance by facilitating fecal tests.

After completion of study, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are non-adherent to CRC screening over the past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years)
* Medicaid or Medicaid/Medicare subscribers
* Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but will only be eligible for services to obtain fecal immunochemical tests (FIT) through the New York State (NYS) Cancer Services Program

Exclusion Criteria:

* Any participants from the lists of gaps in care clients from insurance or primary care practices who report having had a colonoscopy in the past 9 years (or having positive findings such as polyps, 5 years) or having completed some type of fecal test for CRC will be excluded
* Participants under 50 will be excluded unless they have been deemed high risk by their physician, and have a prescription for CRC screening
* Participants symptomatic for CRC will be excluded from the study
The Effectiveness of High-dose Intravenous Vitamin c With Very Low Carbohydrate Diet for Terminal Colon Cancer Patients

The purpose is to evaluate the effectiveness of high dose intravenous vitamin C (IVC) therapy plus very low carbohydrate diet (VLCD) for stage IV colon cancer (with KRAS and BRAF mutation ) with or without chemotherapy.

High dose IVC induces pro-oxidant effects, inhibits energy metabolism, acts as cytotoxic effect, and induces cancer cell apoptosis and necrosis. The recent advance in Warburg effect makes a new direction in high dose IVC therapy. The Warburg effect is the enhanced conversion of glucose to lactate observed in tumor cells, even in the presence of normal levels of oxygen. Converting glucose to lactate, rather than metabolizing it through oxidative phosphorylation in the mitochondria, is far less efficient as less ATP is generated per unit of glucose metabolized. Therefore, a high rate of glucose uptake is required to meet increased energy needs to support rapid tumor progression..

Vitamin C shares very similar structure with glucose. The high-dose IVC gets accessibility to glucose transporter, with competition to glucose. Having a reduced level of blood sugar seems to be a necessary parameter to increase IVC's anticancer effectiveness. VLCD with high dose IVC showed effectiveness in case series.

The investigator's project is a single-centered, clinical trial (pilot study) for stage IV colon cancer patients with or without chemotherapy. The experimental group will receive high dose vitamin C 75 or 100g (with blood vitamin C level \> 350 mg/dl) in 1000 ml distilled water in 2-hour infusion, twice per week for 12 weeks. Then maintenance dose is 75-100 g once per 2 weeks for 12 weeks. Very low carbohydrate diet will be executed for the first 12 weeks. The control group will be matched for age, sex and chemotherapy and target therapy medication. The control group will receive usual care. The primary outcome will be the response rate by computerized tomography (CT) of the chest, abdomen and pelvis at 12 weeks and 24 weeks. The secondary outcome will be the improvement of tumor markers (CEA and Ca199).

This is the first clinical trial of IVC therapy with VLCD for stage IV colon cancer in Taiwan and in the world. This innovation will give us a primitive answer on the effectiveness of IVC therapy with VLCD for cancers. Vitamin C is a cheap and harmless therapy. The study result will open a door for alternative cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* stage IV colon cancer
* with KRAS and BRAF mutation

Exclusion Criteria:

* G-6-PD deficiency,
* metastatic kidney disease,
* obstructive uropathy,
* nephrotic syndrome,
* under other alternative medicine treatment or intravenous vitamin treatment,
* pregnant or lactating women,
* impaired renal function with a serum creatinine ≥ 132.6µmol/L(1.5 mg/dL)
* significant fluid retention(pleural effusion, ascites, lower leg edema),
* terminal heart failure,
* incapability to make decision,
Prevention of Human Papillomavirus (HPV) Infection in Paediatric Kidney and Liver Transplant Recipients and in Paediatric Patients With Advanced Chronic Kidney Disease

Due to their immunosuppressive therapy, solid-organ transplant (SOT) recipients bear a 10 to 100 times higher risk of human papillomavirus (HPV)-associated malignancies than healthy individuals. The objectives of this observational, non-interventional multi-national, multi-centre research project are to gain an insight into current HPV vaccination strategies and to investigate the immune response to different routinely administered HPV vaccines in European paediatric SOT candidates and immunocompromised transplant recipients, enabling patients at risk of vaccination failure to be identified.


Eligibility Criteria:
Inclusion Criteria:

* Paediatric Kidney and/or Liver transplant recipients
* Paediatric patients with CKD
* Who receive HPV vaccination according to country-specific vaccine schedule

Exclusion Criteria:

* No HPV vaccination according to country-specific vaccine schedule
* No written informed consent
Analgesic and Subjective Effects of Terpenes

The purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of THC.

The overall aim of this placebo-controlled study is to examine dose-dependent analgesia, intoxication, abuse liability, and pharmacokinetics of ecologically relevant doses of vaporized myrcene and beta-caryophyllene administered alone or with vaporized THC.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female aged 21-55 years
* Report non-medical use of cannabis 1-7 days per week over the 1 month prior to screening
* Not currently seeking treatment for cannabis use
* Urine test positive for recent cannabis use
* Have a Body Mass Index from 18.5 - 34kg/m2.
* Able to perform all study procedures
* Must be using a contraceptive method (hormonal or barrier methods)

Exclusion Criteria:

* Meeting DSM-V criteria for any substance use disorder other than nicotine, caffeine, or mild CUD
* Report using other illicit drugs in the prior 4 weeks
* • If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures.
* Current licit use of cannabis primarily for medical purposes, prescription analgesics, or any medications that may affect study outcomes
* Current pain
* Pregnancy is exclusionary due to the possible effects of the study medication on fetal development.
* History of an allergic reaction or adverse reaction to cannabis is exclusionary.
* History of respiratory illness or current respiratory illness
* History of seizure disorder or current seizure disorder
* Insensitivity to the cold water stimulus of the Cold Pressor Test
* Currently enrolled in another research protocol
* Current major Axis 1 disorders (mood, anxiety, or psychotic disorder)
* Not using a contraceptive method (hormonal or barrier methods)
* The evaluating physician reviews all medical assessments along with medical history. Any disorders that might make cannabis administration hazardous are exclusionary.
Treatment of Hepatocellular Carcinoma With Tetrathiomolybdate

Hepatocellular carcinoma (HCC) is a deadly tumor for which the incidence is increasing in the United States, primarily due to prevalence of hepatitis C infection. An important aspect of the development of HCC is that it occurs in patients who have underlying cirrhosis of the liver, thereby limiting the therapeutic options. There is potential curative treatment for these patients, such as resection of the tumor lesion and liver transplantation, but these treatments are feasible in a small percent of patients only. Furthermore, the majority of the patients with HCC are also not candidates for palliative treatments such as percutaneous ablation of the tumor, chemotherapy or radiation. Additionally, it has been shown that these palliative treatment modalities do not alter survival, and are associated with significant risks. Therefore, there are no treatment options for most patients with HCC. A new theory has emerged in the fight against cancer through inhibition of angiogenesis (development of new blood vessels). The hypothesis being that if there is no blood supply "feeding" the tumor cells cannot divide or survive. One such approach, pioneered in this institution by Drs. George Brewer and Sofia Merajver, is the anticopper approach using the medication tetrathiomolybdate (TM). By creating a mild copper deficiency state, several pathways required for angiogenesis are inhibited. They performed a Phase I trial in which patients with metastatic cancer were treated with TM resulting in decrease tumor vascularity. TM had excellent safety profile in this patient population. HCC is well known to be a hypervascular tumor. An antiangiogenesis approach might provide a novel treatment for this HCC. This is a pilot study of 10 patients with HCC who are not candidates for curative surgical therapy with resection or liver transplantation, nor for ablative techniques. Patients seen in the General Liver clinic and Liver Transplant clinic who have an overall good performance status, with an expected survival of more than 6 months will be enrolled. After an initial evaluation, they will be given 120 mg/day of TM in divided doses for one year. The size and vascularity of the tumor will be evaluated by magnetic resonance imaging (MRI). The primary outcome of this study is to prevent tumor progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients with definite diagnosis of HCC based on a Dynamic MRI revealing a vascular mass in the liver and histologic confirmation of HCC.
* Patients who are not candidates for surgical resection, OLT or radiofrequency ablation.
* Patients with no prior treatment for HCC.
* Patients with extrahepatic spread and/or vascular invasion are permissible.