cyrilzakka/clinical-trials huggingface dataset:
The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial

The "Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity" (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design.

Objective: The aim of this study is to assess whether HBOT reduces pain, and improves physical functioning and QoL in breast cancer patients with late radiation toxicity.

Study design: Randomized controlled trial, nested within the prospective UMBRELLA breast cancer cohort according to the TWiC's design. UMBRELLA is a prospective cohort study including all breast cancer patients visiting the University Medical Center (UMC) Utrecht department of Radiotherapy. In total 120 patients will be randomized in a ratio of 2:1.

Study population: Breast cancer patients participating in the UMBRELLA cohort who have given informed consent to be invited for future research (e.g. cmRCT's), and who have reported symptoms of late radiation toxicity.

Intervention: Eligible patients will be referred to the HBO center for a standard HBO treatment. HBOT consists of 30-40 treatment sessions (1 session per day during 5 days per week). During the hyperbaric oxygen (HBO) sessions patients breath in 100% oxygen during 4 times 20 minutes in a hyperbaric chamber.

Main study parameters/endpoints: The primary endpoint of this study is patient reported breast/chest wall pain. Secondary endpoints are: physical functioning, QoL cosmetic outcome, physician reported pain and radiation toxicity (according to CTCAE criteria version 4.03, tissue oxygenation previous to HBOT and after HBOT and side-effects of HBOT.

Eligibility Criteria:
Inclusion Criteria:

* Self reported pain grade 3-4 (on a scale of 1-4) as assessed by the late radiation toxicity questionnaire;
* Participation \>12 months in the UMBRELLA cohort;
* Previous treatment with radiotherapy for breast cancer;
* Completed surgery and (neo)adjuvant systemic therapy except adjuvant endocrine therapy, for breast cancer.

Exclusion Criteria:

* Poor responder to questionnaires (i.e. return of ≤ 2 UMBRELLA questionnaires);
* Previous HBOT;
* Contra-indications for HBOT (e.g. (severe) chronic obstructive pulmonary disease (COPD) or asthma, pacemaker, morbid obesity, epilepsy in medical history, severe heart failure);
* Current metastatic disease or recurrent breast cancer.

Additional exclusions criteria based on screening visit:

* Inability to follow schedule of all consecutive HBO treatments (e.g. due to scheduled holidays \> 2 days);
* Not meeting criteria for HBOT (e.g. due to complaints similar to late radiation toxicity, not caused by radiotherapy).
An Observational Study of the Safety of Topiramate in Adults and Children With Epilepsy

The purpose of this observational study is to evaluate the safety of topiramate in adults and children with epilepsy (or seizures) who have not received or have not responded to treatment with previous antiepileptic medication.

Topiramate is a medication that is approved for the treatment of seizures. In accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is a multi-center, open-label observational safety study to collect information regarding the dosage, tolerability and effectiveness of topiramate in adults and children with epilepsy (or seizures). Patients who have not received previous treatment for epilepsy or for whom previous treatment was ineffective or intolerable will receive 6 months of treatment with topiramate. Topiramate will be given at low doses initially and gradually increased as needed for each patient to control seizure activity. Safety evaluations (incidence of adverse events and laboratory tests) and assessment of patient health status will be performed throughout the study. Effectiveness will be evaluated by recording the frequency of seizures occurring during the study. Patient and physician satisfaction with topiramate treatment will also be recorded. At the end of the study, the treating physician may continue treatment with topiramate in responding patients as appropriate. The study hypothesis is that topiramate will be effective in achieving and maintaining control of seizure activity and is well-tolerated. Observational study - No investigational drug administered.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have not received previous treatment with antiepileptic medications or patients who did not respond to previous treatment with antiepileptic medications, defined as a lack of effectiveness of the medication(s), or the inability to take the medication(s) due to adverse effects

Exclusion Criteria:

* Patients not suffering from epilepsy, whose seizures are due to other causes including disease, exposure to harmful substances, active infection or tumor and are manageable
* Patients with a hypersensitivity to topiramate or to some of its components
* Patients who should not take Topiramate for reasons listed in its approved Summary of Product Characteristics (printed information about a medication that describes its actions, side effects and intended patients)
* Patients who are uncooperative or for whom obtaining compliance with study visit schedules and procedures and information required by the study would be difficult
Single Dose Study of PF-06815345 in Healthy Subjects

The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and female of non-childbearing potential;
* Age of 18-55, inclusive;
* Body Mass Index 17.5-34.9 kg/m2, inclusive;
* Body weight \>50 kg;
* Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Exclusion Criteria:

- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Effects of Vitamin D Supplementation in Muscle Strength and Balance Training

Introduction: In Brazil, a person who is sixty years old or more is considered elderly. The incidence of osteoporosis and osteopenia has been increasing, as have fractures resulting from falls. Vitamin D deficiency can cause muscular atrophy in type II fibers (fast contraction and strength), which can increase the risk of falls. The aging process produces reduction in the ability of postural control system to maintain postural balance, which may increase postural instability and consequently increase the elderly risk to falls. Objective: To evaluate if vitamin D supplementation associated with regular exercise in vulnerable older women improves muscle strength and postural balance in 12 weeks. Methods: This will be a randomized prospective clinical trial, double blind, placebo-controlled intervention. Will be part of the study 40 elderly women vulnerable, who meet the inclusion criteria and that will be coming from the community through calls made by radio and social network. The volunteer will undergoing to blood test, body composition and bone mineral density, Mini Mental State Examination, Geriatric Depressive Scale, Falls Efficacy Scale, WHOQOL-OLD and WHOQOL-BREF instruments, functional capacity tests (MiniBEST, Time up and Go, Chair Rising Test, Six-minute walk test), muscular strength assessment (isokinetic dynamometry, handgrip and 1RM test) and postural balance (AccSway force platform for static postural balance and NeuroCom's Balance Master for dynamic postural balance) before and after 12 weeks of intervention with vitamin D supplementation and resistance and postural balance exercise. The intervention that will be perform during the 12 weeks with a progressive resistance training program.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 60 years;
2. Osteoporosis or osteopenia (bone mineral density lower than -1.5 standard deviations of the T-score);
3. Present hypovitaminosis D (\<30 nmol / L);
4. Do not practice regular resistance exercise;
5. Can not have an injury in lower limbs at least on the last three months,;
6. Be able to perform independent gait without climbing for at least 100 meters;
7. Be independent in your daily life activities;
8. Do not present restrictions for the practice of resistance exercises, including having performed a recent exercise test (maximum 6 months);
9. Do not use medications such as estrogen's, diuretics, to improve bone mass;
10. Do not use dietary supplements with vitamin D;
11. Do not present hyperparathyroidism, diabetes, uncontrolled hypertension, hyperprolactinemia, hypercalciuria, renal lithiasis or elevated serum calcium.
Contingency Management for Cannabis Use for Persons With HIV

The purpose of this study is to determine the feasibility and impact of 28-days of monitored abstinence from cannabis use on symptoms of depression and anxiety, pain, sleep, cannabis use withdrawal, HIV viral load and biomarkers of systemic inflammation among PLWH and who use cannabis regularly (weekly or more often). This will be a single arm pilot feasibility trial involving a contingency management program to induce cannabis abstinence. Specifically, the contingency management program will provide motivational (monetary) incentives to participants who achieve biochemically verified cannabis abstinence. Over the 28-days of this pilot feasibility trial, participants will attend seven study visits. During these visits, participants will complete survey questionnaires to assess sociodemographic, psychosocial, and behavioral factors. In addition, participants will provide blood and urine specimens for testing and quantitation of HIV viral load, biomarkers of systemic inflammation and for the detection of cannabis and other drugs of abuse.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive (confirmed via HIV medication or relevant HIV labs in subject's name)
* Self-report of cannabis use at least once per week in the 6-month period prior to consent
* Provide a positive urine toxicology (UTOX) screen for cannabis
* Not seeking treatment for cannabis use
* Willing to stop using cannabis for 28 days and attend eight study visits over six weeks.
* Ability and willingness to provide inform consent
* English fluency

Exclusion Criteria:

* Currently receiving treatment for cannabis or other drug use disorder
* Diagnosed or receiving treatment for a current major depressive or anxiety disorder
* Diagnosed with any current alcohol or substance use disorder (excluding nicotine) using the Structured Clinical Interview for Clinical Disorders (SCID) Interview (22)
* Positive UTOX screen for opioids
* Having a medical, psychiatric, occupational, or other condition that, in the judgment of the study physician, would make participation difficult or unsafe.
Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain

This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.

Adult patients were given two MRI exams, one after injection of ProHance (0.1 mmol/kg) and one after injection of Gadovist/Gadavist (0.1 mmol/kg). The exams were performed with identical equipment and imaging parameters with the order of the two exams randomized and 2-14 days between the first and the second MRI exam. Image data was evaluated by 3 expert neuroradiologist blinded to the agent administered and patient clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Are scheduled to undergo MRI
* Are willing to undergo two MRI procedures within 14 days
* Have confirmed or are highly suspected of brain disease likely to enhance as determined by the following:
* Clinical/neurological symptomatology;
* Diagnostic testing, such as CT or previous MRI examinations; or
* Have had previous brain surgery and are to be evaluated for recurrence.

Exclusion Criteria:

* Are pregnant or lactating females. Exclude the possibility of pregnancy:
* by testing on site at the institution within 24 hours prior to the start of each investigational product administration; or
* by history (i.e., tubal ligation or hysterectomy); or
* post menopausal with a minimum of 1 year without menses
* Have any known allergy to one or more of the ingredients in the investigational products, or have a history of hypersensitivity to any metals
* Have congestive heart failure (class IV according to the classification of the New York Heart Association; see Appendix A)
* Have suffered a stroke within a year
* Have received or are scheduled to receive any other contrast medium in the 24 hours preceding through the 24 hours following Exam 1, and in the 24 hours preceding through the 24 hours following Exam 2
* Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 hours post-administration of the second investigational product.
* Have moderate-to-severe renal impairment, defined as a GFR/eGFR \< 45 mL/min.
* Have been previously entered into this study
* Have received or are scheduled for one of the following:
* Surgery within three weeks prior to the first examination or between the two examinations
* Initiation of steroid therapy between the two examinations
* Radiosurgery between the two examinations
* Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field.
* Are suffering from severe claustrophobia
A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 and \<70 years of age at initiation of treatment
* Body weight between 50 kg and 125 kg at baseline
* Chronic hepatitis C, genotype 1
* Chronic liver disease consistent with HCV infection
* Compensated liver disease (Child-Pugh Grade A)

Exclusion Criteria:

* Pregnant or lactating women, and male partners of pregnant women
* Chronic hepatitis C, genotype 2, 3, 4, 5 or 6
* Previous treatment with interferon or ribavirin
* Positive for hepatitis A, hepatitis B or HIV infection
* History or evidence of a medical condition associated with liver disease other than chronic hepatitis C
* Decompensated liver disease and/or liver disease Child-Pugh classification \>6
* Hepatocellular carcinoma
* History or evidence of esophageal bleeding
* Hemoglobinopathy, or any other cause for possible hemolysis
* Hb \<11 g/dL in women, \<12 g/L in males
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass

The aim of the planned study is to assess the prophylactic effect of intraoperative administration of a single dose of methylprednisolone 2 (mg/kg) in decreasing the incidence of postoperative acute kidney injury after cardiac surgeries with cardiopulmonary bypass.

Patients undergoing any type of elective cardiac surgical procedure requiring CPB will be randomly assigned into one of the following groups

1. Placebo group / Control group will receives normal saline as a placebo after the induction of anesthesia and before initiating CPB.
2. Methylprednisolone group / Interventional group receives a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.

Measurements:

Primary outcome:

Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.

Secondary outcome:

1. Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl) for 7 days,
2. Duration of ICU stay,
3. Length of hospital stay (LOS),
4. Incidence of wound infection,
5. Incidence of peptic ulcer,
6. Incidence of sepsis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years.
2. Sex: Both sexes.
3. Patients with American Society of Anesthesiologists (ASA) score III-IV.
4. Patients scheduled for any kind of elective cardiac surgical procedure requiring cardiopulmonary bypass (e.g., coronary artery bypass grafting (CABG), valve repair/replacement, or combined procedures (

Exclusion Criteria:

1. Declining to give written informed consent.
2. History of allergy to the medications used in the study.
3. Diabetic patients with HbA1C \>6.5
4. Moderate to severe hepatic diseases (Child B-C)
5. Hepatic dysfunction: INR \> 1.5, serum albumin \< 2.9 g%.
6. Renal dysfunction (serum Creatinine level \>1.3 mg/dl, or GFR \< 80 ml/min./1.73/m2
7. Patients with a recent history of AKI.
8. Patients undergoing urgent cardiac surgery.
9. Patients undergoing cardiac surgeries with deep hypothermic total circulatory arrest.
10. Planned off-pump procedure.
11. Any cardiac surgery exceeds 45 minutes on Aortic cross clamp.
12. Patients requiring high doses of inotropes and/or vasopressors intraoperative or postoperative (high-dose dopamine is defined as peak doses of \>15 μg/kg/min, high-dose norepinephrine is defined as peak dose \>0.1 μg/kg/min, high-dose epinephrine is defined as peak dose \>0.1 μg/kg/min)
13. Delayed extubation for more than 6 hours postoperative.
14. Patients developed postoperative complications as (septic shock and bleeding)
Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.

This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.

FirstSense Medical, LLC is a medical device company which has developed a breast cancer screening device, the Sentinel BreastScan II \[SBS II\]. This radiation free device is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr. Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data with a reported 95% sensitivity and 91% specificity. The SBS II examination will take approximately 7 minutes.

This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging. Currently, mammography is one of the standards of care in screening for visible signs of breast cancer. Breast thermology is the analysis of the heat signature data from an examined breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to participate. All scientific data revealed in this protocol will be used for the specific objectives of the study. The SBS II is a non-significant risk device. There is no contact with the subject during the entire procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, over the age of 18 years of age.
* Asymptomatic women or women who are being screened for breast abnormality.
* Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
* Not pregnant or breast feeding.
* Signed Informed consent.

Exclusion Criteria:

* Subject does not meet inclusion criteria, noted above.
* Use of 100 mg or more of niacin by tablet or niacin patch within the last 24 hours.
* Use of nitroglycerin within the last 24 hours.
* Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
* Subject must not have had a mammogram, breast ultrasound, or breast exam within the last 72 hours prior to the SBS II.
A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects

IBI128 (Tigulixostat) is a novel non-purine selective inhibitor of xanthine oxidase (XO). The XO inhibitors lower uric acid concentrations in serum by inhibiting the production of uric acid.

This ia a randomized, open label, multicenter, parallel-group, positive-controlled, dose finding, and Phase II study to assess efficacy and safety of IBI128 in chinese gout subjects.


Eligibility Criteria:
Inclusion criteria:

1. Participants must be aged between 18 and 75 years old (inclusive, as of the time of signing the informed consent form), with no gender restrictions;
2. Body Mass Index (BMI) should fall within the range of 18.0 to 40.0 kg/m² (including both ends of the range);
3. Subjects must meet the 2015 ACR/EULAR classification criteria for the diagnosis of gout (refer to Appendix 4);
4. At the screening stage, subjects must have a blood uric acid level of ≥480 μmol/L;
5. Subjects must voluntarily sign the informed consent form and agree to strictly adhere to the requirements outlined in this protocol.

Exclusion criteria (brief):

1. History of allergy to any component of Tigulixostat;
2. Previous allergy or intolerance to Febuxostat;
3. Subjects who have taken uric acid lowering medications within 2 weeks prior to screening;
4. Subjects who experienced an acute gout flare-up within 4 weeks prior to screening or immediately before the first dose administration;
5. Subjects considered to have secondary gout (elevated serum uric acid due to causes other than renal insufficiency);
6. Subjects with a history of xanthinuria.
Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery

The purpose of this study is to determine therapeutic benefits by local anesthetic technique for breast cancer.

Experimental and clinical studies have shown that surgical trauma and stress affects the immune system including both the innate and adaptive immune responses.

The break of immune homeostasis might enhance tumor growth and spread. Minimal invasive surgical procedures have been shown to be beneficial to patients in terms of preserving better systemic immune function. Impaired cellular immunity after general anesthesia has significant undesirable effects on tumor surveillance after breast surgery. The local block technique might avoid the surgery inducing neuroendocrine, metabolic, and cytokine responses, which will offer some advantages from better preservation of early postoperative cellular immune function and attenuate disturbance in the inflammatory mediators. Our research will focus on the effects of local block anesthesia on mediators that may be important in inflammatory response, tumor cell dissemination, deposition, and propagation in the early postoperative period. As importantly, local block method is not only a safe procedure but also reduces the need for post operative opioids and prevents nausea following breast cancer which can result in markedly reduced hospital stay and health costs. It is plausible that inhibition of the surgical responses by local block anesthesia may attenuate perioperative tumor enhancing factors and/or potential beneficial actions of lidocaine infiltration combined with propofol sedation per se in anticancer effect to have better cancer control.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven breast cancer Scheduled for mastectomy and axillary node dissection in a single procedure.

Exclusion Criteria:

* previous surgery within the preceding 2 wk those other than ASA physical status I or II any contraindication to either local anesthesia or opioid analgesia