cyrilzakka/clinical-trials huggingface dataset:
Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity

To evaluate whether a combination regimen of pentoxifylline, ursodeoxycholic acid and enoxaparin provides a protective effect on the liver parenchyma after high dose rate (HDR) brachytherapy.

A preventive effect of pentoxifylline, ursodeoxycholic acid and low dose low molecular weight heparin on pathological processes in healthy tissue after irradiation is described in clinical studies on percutaneous liver irradiation and on bone marrow transplantation. However, data remains inconclusive.

This exploratory study aims at assessing whether a protective effect of the combination of pentoxifylline, ursodeoxycholic acid and enoxaparin can be demonstrated in a limited number of patients with liver metastases of colorectal cancer after HDR brachytherapy.

All patients receive a single fraction CT/MRI-guided HDR-brachytherapy of colorectal liver metastases using Iridium-192 as a standard therapy. The follow-up consists of 4 MRI controls of the abdomen using the hepatocyte-specific contrast agent Gd-EOB-DTPA (Primovist) after 3 days, 6 weeks, 3 months and 6 months as well as blood samples and a questionnaire taken the same time.Within the study, 22 patients are given low dose low molecular weight heparin, pentoxifylline and ursodeoxycholic acid for 8 weeks starting with the preinterventional day. Another 22 patient will receive the standard therapy without the medication. After completion of the follow-up, MRI volume data of the lesion will be acquired and compared to the dosimetric treatment plan. Blood samples are tested for liver-specific and inflammatory laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80
* If female, postmenopausal or surgically sterilized
* Liver metastases from colorectal carcinoma scheduled for a CT/MRI-guided single-fraction interstitial HDR brachytherapy
* Non-cirrhotic liver
* Life expectancy longer than 6 months
* willing and able to undergo all study procedures
* Having voluntarily provided written and fully informed consent

Exclusion Criteria:

* Women who are pregnant, lactating or who are of childbearing potential
* Liver cirrhosis
* Hepatitis B
* Hepatitis C
* Patients being clinically unstable
* Uncooperative, in the investigator's opinion
* Having been previously enrolled in this study
* Participating in another therapy-modulating clinical trial
* Contraindication for MRI
* Contraindication or hypersensitivity to one or more components of Gd-EOB-DTPA, Enoxaparin, Ursodeoxycholic acid and/or Pentoxifylline
* Any prior irradiation therapy of the liver
* Close affiliation with the investigational site; e.g. a close relative of the investigator
* Severe coronary artery disease
* Autoimmune diseases
* Acute bacterial endocarditis
* Active major bleedings and high rish of uncontrolled haemorrhage
* Patients with severe or moderate renal impairment (GFR below 60 mL/min/1.73 m2 according to the MDRD or Cockroft-Gault formula, calculated from a creatinine value obtained within 1 week before each planned Primovist-enhanced MR examination)
CAR-T Long Term Follow Up (LTFU) Study

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

Patients are enrolled following completion or early discontinuation from a Novartis sponsored or supported study of CAR T-Cell treatment. Patients will be followed for 15 years post treatment from the last treatment. They will be monitored for safety and efficacy within the primary treatment protocols for the protocol defined duration. Patients can drop off treatment protocols at any time to enter this long term Follow up study. Patients discontinuing from the primary treatment protocols for any reason will be enrolled in this long term follow up (LTFU). This will allow collecting data on long term safety and efficacy (as applicable) as mandated by the health authorities of all patients treated with CAR-T therapy within the concept of a single protocol.

Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have received a CAR-T therapy and completed or discontinued early from a Novartis sponsored treatment protocol that utilized CAR-T cells or from any CAR-T trial sponsored by the University of Pennsylvania with which Novartis has a contractual agreement to co-develop the CAR technology.
* Patients who have provided informed consent for the long term follow up study prior to their study participation .

Exclusion Criteria:

* There are no specific exclusion criteria for this study.
Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients

The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Part A,Healthy male subjects, aged between ≥20 and ≤40 years.
* Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment

Exclusion Criteria:

* Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP.
* Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator
* Part B, History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease.
* Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation.
Single Ascending-dose Study of the Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Subjects

The primary objective of the study is to assess the safety and tolerability of single ascending doses of subcutaneously (SC) administered REGN1908-1909 in allergic, adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women between the ages of 18 and 55
2. Positive allergen skin prick test
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Exclusion Criteria:

1. Persistent, chronic, or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit
2. Any clinically significant (determined at the investigator's discretion) abnormalities observed during the screening physical examination
3. Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to the screening visit. Patients must be willing to maintain a similar level of exercise for the duration of the study and to refrain from unusually strenuous exercise for the duration of the trial
4. Hospitalization for any reason within 60 days prior to the screening visit
5. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of the investigational drug prior to the screening visit
6. Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
Pharmacodynamic Profile of 'Blackadder' Blackcurrant Juice Effects Upon the Monoamine Axis in Humans

The current study uses a double-blind, placebo-controlled, randomised cross- over design to assess the pharmacodynamics of the platelet MAO-B inhibition, plasma prolactin levels and blood glucose levels after consumption of a single serve of 'Blackadder' blackcurrant juice.

There is emerging evidence which supports health benefits of consuming blackcurrant fruit, including improvements to cognitive performance, modulation of blood flow, regulation of blood glucose and inhibition of enzymes underpinning normal cognitive function. Of particular relevance is our previous demonstration of inhibition of MAO-A and B after consumption of a New Zealand 'Blackadder' blackcurrant juice drink in man.

In an attempt to establish a "therapeutic window" on which future nutritional interventions can be based, the current study will assess the pharmacodynamics of MAO-B inhibition, plasma prolactin levels and venous blood glucose profile following consumption of the 'Blackadder' blackcurrant juice. The trial will utilise a 500mg dose of the 'Blackadder' juice (equivalent to \~100g of fresh fruit) which was shown to have MAO inhibitory effects in our previous report and effects will be measured in a cohort of healthy male adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male
* Aged 18-35
* Non- smoker
* No history of metabolic disease

Exclusion Criteria:

* Diagnosis of blood-borne disease
* Diagnosed history of any psychiatric disorder
* Aged under 18 or over 35 years
* BMI above 30 kg/m2 or below 17 kg/m2,
* Diagnosis of diabetes or current use of prescription or over-the-counter drugs
Acute Pain Caused by Paclitaxel in Patients With Cancer

RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment.

PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with cancer.

OBJECTIVES:

* To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.
* To investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy.
* To perform exome-sequencing analysis and identify genetic variants that predict paclitaxel- induced peripheral neuropathy.
* To identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy).
* To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.

OUTLINE: This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).

Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Planning to receive paclitaxel IV (excluding paclitaxel albumin-stabilized nanoparticle formulation \[nab-paclitaxel\]) according to one of the following dosing schedules:

  * At least 175 mg/m\^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively)
  * 70-90 mg/m\^2 weekly (3 out of 4 weeks allowed)

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Life expectancy \> 6 months
* Able to complete questionnaires (alone or with assistance)
* Willing to provide required biological specimens
* No prior or concurrent peripheral neuropathy (from diabetes or other causes)
* No prior or concurrent fibromyalgia

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones
* No concurrent neutrophil colony-stimulating factor therapy
Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants.

The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients.

Secondary endpoint consist in:

* Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)
* Evaluate the number of sever bleeding event in patient under study treatments compared to the control group
* Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group
* Estimate the stenosis relapse risk in haemophilia patients with arterial STENT
* Estimate the embolic risk of haemophilia patients with atrial fibrillation

Population description:

Haemophilia patients (man, all severity)

Age above 50 years, followed during the last 5 years in one of the study centre


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age above 50 years
* Hemophilia A or B carriers
* Followed within the 5 last years in one of the research center

Exclusion Criteria:

* Jurisdictional prevention procedures
* Other medical condition that might interfere with the bleeding risk (Willebrand's disease, Other coagulation factor deficiencies, haematological malignancies, ...)
* Other drugs that might interfere with the bleeding risk (Serotonin reuptake inhibitors)
* Patient refusal
The Importance of Blastocyst Diamater and Its Correlation to Reproductive Outcomes in PGT-A Cases

Morphometric measurement of blastocyst diameter was taken on the day of trophoectoderm biopsy. PGT-A was done using NGS platform, followed by thawing and transfer of euploid blastocyts. Follow up of the Pregnancy and implantation rates is done and recorded to study the correlation between the diameter and reproductive outcomes of the blastocyst.

Blastocyst morphological grading proposed by Gardner and Schoolcraft including the expansion degree, inner cell mass, and trophoectoderm assessment has proved its importance. Blastocyst expansion degree that can presented in diameter is linked to the blastocyst implantation and overall success.

In order to evaluate the importance of blastocyst diameter in PGT-A cases, measurements will be taken on the day of trophoectoderm biopsy TE (diameter in μm), followed by TE biopsy using flicking technique. Next, PGT-A will be done using NGS platform and results will be confirmed using PGT-ai. Thawing of euploid blastocyst will take place and expansion degree, survival rate will be recorded. Patient will be followed up for the clinical pregnancy and implantation rates.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 18-45 years old
* Male aged 18-60 years old
* ICSI cases having PGT-A for their blastocysts
* Must have their blastocysts cultured in time lapse incubator

Exclusion Criteria:

* Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
* Use of donor oocytes or sperm
* Use of gestational carrier
A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)

A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular Edema.

A Phase 1, Open-Label Safety and Pharmacodynamic Study of RV 001, an Insulin-Like Growth Factor-1 Receptor (IGF-1) Antagonist, Given By IV Infusion in Patients with Diabetic Macular Edema (DME).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus with Hemoglobin A1c \<8.5%
* IGF 1 in serum \> 106 ng/mL
* Women of child-bearing potential must have negative pregnancy test and be willing and able to use two different methods of contraception, one of which must be oral contraceptive or depot formulation. Males must be surgically sterile or agree to use barrier contraception
* Clinically significant DME of less than 12 months duration
* Non-proliferative diabetic retinopathy of moderate severity
* Best corrected electronic ETDRS letter score \< 78 and \> 24

Exclusion Criteria:

* Unstable-uncontrolled diabetes as demonstrated by a change in diabetes medication greater than 15% in the previous 60 days.
* Significant renal disease, myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure
* Blood pressure \> 180/110
* Anti-vascular endothelial growth factor (VEGF) treatment within two months prior to enrollment
* History of pan retinal photocoagulation within four months prior to enrollment
* History of ocular surgery within four months prior to enrollment
* History of systemic treatment with corticosteroids within 3 months prior to enrollment
Intranasal Insulin for Treatment of Alcohol Use Disorder

This is a randomized controlled trial (RCT), within-subject, crossover, double-blind, placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD) (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting, randomized participants will receive a single dose of IN insulin (80IU) or an IN matched placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content (BrAC) to 0.08g/dL.

Aims in this RCT testing the effect of IN insulin, compared to placebo, in individuals with AUD include the following:

AIM 1: to assess the safety, tolerability and acceptability of IN insulin as a pharmacological intervention for AUD. The data collected in this aim will monitor possible adverse events and yield qualitative and quantitative data to finalize the feasibility and acceptability of IN insulin as an AUD pharmacotherapy.

Aim 2 (alcohol-drug interaction): to assess the safety and tolerability of IN insulin when administered with alcohol. The investigators will use a battery of physiological/psychological assessments that measures potential adverse events, alcohol subjective response and alcohol pharmacokinetics endpoints.

Eligibility Criteria:
Inclusion Criteria:

* ≥21 years

  * meet any DSM-5 criteria score for AUD
  * Individuals who, in the last month, have consumed at least the same amount of alcohol that will be administered in the laboratory procedure (i.e. to reach BrAC levels of 0.08g/dl, \~two drinks in one occasion)
  * BrAC=0.00g/dL at each visit
  * good health as confirmed by medical history, physical examination and lab tests
  * willing to adhere to the study procedures
  * understand informed consent and questionnaires in English at an 8th grade level
  * willing to have glucose monitored by finger stick during the laboratory procedures

Exclusion Criteria:

* • female identifying who are breastfeeding or pregnant (assessed by a urine screen)

  * individuals with diabetes
  * history of suicide attempts in the last three years
  * current diagnosis of other substance use disorder (other than nicotine or cannabis)
  * use of drugs (e.g. stimulants/opioids) at each alcohol administration session (by urine tox screen)
  * cannabis intoxication (by clinical assessments)
  * use of medications that may interact with insulin and alcohol (by Micromedex database)
  * hypersensitivity to insulin
  * any nasal disease/congestion that may interfere with intranasal drug absorption;
  * baseline hypoglycemia (blood glucose ≤65mg/dL) or hyperglycemia (blood glucose \>200mg/dL) (by finger stick)
Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees with and Without Prior Exposure to Flavivirus Infections or Vaccination

The goal of this observational study is to learn about the immunity induced by the Qdenga® vaccine in vaccinees.

Participants that will receive the Dengue vaccine as part of their routine before a travel will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years.

This is a non-profit, single-center, drug-based observational study whose primary objective is to characterize dengue-specific humoral and cellular immunity induced by the Qdenga® vaccine in vaccinees.

The study involves the enrollment of all pediatric subjects (age ≥ 4 years) and adults who present themselves at the DITM travel clinic for the administration of the Dengue vaccine; 402 patients are expected to be enrolled and will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years (T4). The samples thus collected will be analyzed for the characterization of innate immunity, the characterization of cellular immunity and the characterization of the humoral response.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes presenting to the DITM to receive the anti-DENV vaccine whether or not they have had a history of prior DENV or other flaviviruses infection or a history of prior vaccination against other flaviviruses. These data will be recorded in the study CRF.
* Age \>= 4 years.
* Signed informed consent.

Exclusion Criteria:

* Age \< 4 years.
* Absence of signed informed consent.