cyrilzakka/clinical-trials huggingface dataset:
Suramin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

RATIONALE: Suramin may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining suramin with radiation therapy may be a more effective treatment for glioblastoma multiforme.

PURPOSE: Phase II trial to study the effectiveness of suramin plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

OBJECTIVES: I. Assess the toxicity of suramin administered prior to and concurrent with radiotherapy in patients with newly diagnosed high grade glioblastoma multiforme. II. Evaluate this regimen in terms of survival in this patient population.

OUTLINE: Patients receive suramin IV over 2 hours for initial dose and over 1 hour for subsequent doses daily for 5 days on week 1. Patients receive concurrent radiotherapy daily with suramin IV over 1 hour twice weekly on weeks 2-7. Patients with stable or responsive disease receive a second course of suramin twice weekly on weeks 20-24. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months until disease progression or start of new therapy and then monthly for survival.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme No prior intracranial or intratumoral hemorrhage

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 2 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL No history of a bleeding disorder that would interfere with protocol therapy Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No suspected disseminated intravascular coagulation No history of venous thrombosis requiring coumadin Other: No serious concurrent infection or other medical illness that would prevent compliance No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic agents (e.g., immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, lymphokine activated killer cells, tumor infiltrating lymphocytes, or gene therapy) for brain tumor Chemotherapy: No prior chemotherapy for brain tumor Endocrine therapy: No prior hormonal therapy for brain tumor Prior glucocorticoids allowed Maintenance 5 day stable corticosteroid regimen required postsurgery Radiotherapy: No prior radiotherapy for brain tumor Surgery: Prior surgery for brain tumor allowed if recovered from the immediate post operative period
Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

The objective of this study is to evaluate the safety and tolerability of RNS60 administered intravenously to healthy subjects. 12 subjects will receive RNS60 or placebo at three escalating rates for 48 hours for each rate.


Eligibility Criteria:
Inclusion Criteria:

* Males between 18-55 years
* Minimum body weight of 60 kg
* BMI of 18-32 kg/m2
* Able to execute informed written consent

Exclusion Criteria:

* A chronic or acute disease that might interfere with the evaluation of the safety of RNS60
* Current or prior malignancies (excluding history of treated non-melanoma skin carcinoma)
* Positive viral serology test for HBsAG, Hep C antibody, Hep A IgM, or HIV
* Use of any prescription medications within 2 weeks of the first day of dosing
* Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, GI, endocrine or metabolic
* Treatment with monoclonal antibody therapy within 5 half-lives prior to the first dose of study medication
* Treatment with any investigational drugs or therapies within 30 days (or 5 half-lives, whichever is greater) prior to the first dose of study medication
* Abnormal pre-admission vital signs, physical exam, clinical laboratory, or any safety variable considered clinically significant for this population by the PI
* Subject is considering or has scheduled any surgical procedure during participation in study
* History of alcohol and/or dug abuse within 1 year prior to first dose of study medication
* Subject has donated plasma or blood within 30 days prior to first dose of study medication
* Subject requires treatment with any medications, either prescription or nonprescription, including dietary supplements or herbal medications, within 14 days prior to the first dose of study medication. Exceptions are nonprescription topical medications (that are not systemically absorbed), acetaminophen, or vitamins at recommended daily doses (not mega dose vitamins)
* A positive qualitative urine drug or alcohol test
* Concurrent enrollment in any other clinical trial
* Subject is judged by PI or Medical Monitor to be inappropriate for the study -
* Subject has Gilbert's syndrome
* Subject has estimated creatinine clearance at screening of \<90 mL/min.
Cocoa Flavanol and Coronary Vasomotion Vascular Function in Patients With Coronary Artery Disease

The aim of the present study is to investigate whether the ingestion of a cocoa flavanol-containing drink compared to a flavanol-free drink, improves coronary vasomotion and platelet function in patients with overt coronary artery disease acutely (after 2 hours)


Eligibility Criteria:
Inclusion Criteria:

Patients with coronary artery disease undergoing elective coronary angiography with or without the need of coronary intervention

* Age 20 - 80
* Written obtained informed consent

Exclusion Criteria:

* Acute ST-elevation myocardial infarction
* Acute non-ST-elevation myocardial infarction (enzyme positive)
* Ventricular tachy-arrythmias or AV-Block \>I°
* Renal insufficiency (GFR MDRD \< 30ml/min) or liver disease (ALT or AST \>150 IU)
* Pregnancy
* Known allergy to compounds of cocoa product
* Known allergy to contrast media
* Known allergy to nuts
* Intolerance to coffein and theobromin
* Acute infectious disease
* Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
* Participation in another study within the last month
* Concomitant vitamin supplements and herbal remedies, as well as fruit and tea extracts
* No study visits ± 1 week before Eastern, Christmas and New Year holyday (altered eating habits)
* Extreme eating habits (as assessed by a questionnaire)
* Alcohol or drug abuse
* Lactose intolerance
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

The primary objectives of this study are to evaluate the humoral immunogenicity of mRNA-1010 relative to that of an active comparator against vaccine-matched influenza A and B strains at Day 29, and to evaluate the safety and reactogenicity of mRNA-1010.


Eligibility Criteria:
Inclusion Criteria:

* Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow-up, including all procedures.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.

Exclusion Criteria:

* Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the United States (US) CDC or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening Visit.
* Participant is acutely ill or febrile (temperature ≥38.0℃ \[100.4°F\]) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number.
* Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.
* Participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 180 days prior to the Screening Visit (for corticosteroids, ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, and topical steroids are allowed.
* Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study injection.
* Participant is not aware whether they have received an influenza vaccine in the past 12 months or has received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to Day 1.
* Participant has tested positive for influenza by local health authority-approved testing methods within 180 days prior to the Screening Visit.
* Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

Note: Other inclusion and exclusion criteria may apply.
Immunological Response After Shrimp Oral Immunotherapy Treatment

Oral immunotherapy is effective in desensitized food allergy. Shrimp allergy is increasing in Thailand. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to shrimp, Immunoglobulin G4 and immunoblot analysis in shrimp allergy patients after shrimp oral immunotherapy.

All subject in this study were sensitized to shrimp. All patient was clinically evaluated, with focus on shrimp allergy by medical history, medical examination and gold standard oral food challenge test. Compare oral immunotherapy to shrimp and shrimp avoidance. Blood sample was taken for baseline determination of immunoglobulin E antibodies to shrimp. The primary outcome was the specific immunoglobulin E antibodies to shrimp,Immunoglobulin G4 and immunoblot analysis in case that oral immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 - 40 years old
* History of Immunoglobulin E-mediated shrimp allergy \> 3 episode/year or disturb quality of life
* Positive oral food challenge test for shrimp

Exclusion Criteria:

* History of shrimp anaphylaxis (include cardiovascular or neurological symptoms)
* Shellfish dependent exercise induced anaphylaxis
* History of cardiovascular disease, uncontrolled asthma, severe atopic dermatitis
* History of Beta-blocker, Angiotensin-converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker
Metabolic Availability of Lysine From Wheat in Adult Men

Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. In many of those countries, wheat is the major cereal grain in the diet. The protein in wheat is low in the essential amino acid lysine. Hence wheat protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body.The protein can be complemented by the addition of lentils to augment the low lysine content. However, lentils are prohibitively expensive in some developing countries.

As the human population increases, the world faces the continuous challenge of maximizing a limited food supply. Protein quality (PQ) evaluation of wheat directly in humans would allow us to bridge the gap in knowledge between what is required and how best to provide.The information gathered from this project will provide the first direct experimental data on PQ of wheat protein in humans on which nutrition recommendations can be built.

Each subject will be part of 8 different experimental diets, and randomly assigned to one of the diets every time.

4 reference diet would be based on egg protein composition, 3 wheat diets would have protein from baked wheat bread and 1 mixed meal would comprise of baked wheat bread and lentils.

Each experimental diet will be studied over 3 days: 2 adaptation and 1 study day. The 2 adaptation meals would be consumed at home. On the study day 3, following a 12-h overnight fast, subjects will come to the research unit at The Hospital for Sick Children, Toronto, ON for a period of 7.5 h and consume the diet as 9 hourly meals. The first 3 meals would be consumed at home.

For the duration of all experiments, subjects will consume a daily multivitamin supplement to ensure adequate vitamin intake.

Measurements:

1. Resting energy expenditure (REE) will be measured by open-circuit indirect calorimetry
2. Body composition (fat and fat free mass) will be measured by BIA and Skin Fold.
3. Breath samples will be collected after the 4th and 7th meals.

Eligibility Criteria:
Inclusion Criteria:

* Male, age 18 - 49 yrs
* Healthy, with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes
* Stable Body Weight
* Not on any medications that could affect protein or amino acid metabolism e.g. steroids

Exclusion Criteria:

* Unwillingness to participate or unable to tolerate the diet
* Recent history of weight loss within the last 3 months or on a weight reducing diet
* Inability to tolerate study diets (ex. Allergy to ingredients)
Influence of Food Preferences on the Occurrence of Undernutrition in Treated Patients for Bronchopulmonary Carcinoma Non-small Cell Stage IV

The study will be offered to patients with non-small cell lung carcinoma diagnosed at stage IV and receiving first-line treatment.

The patient will benefit from a complete assessment at inclusion (clinical exam, imagery, biological exam, dietary consultation, test LFQP.

At the end of this 1st evaluation, patients in whom the diagnosis of undernutrition is made will benefit from dietary management with personalized advice that will take into account the symptoms of cancer, the possible side effects of treatments as well as the social environment.

Every two cures, i.e. every 4 to 6 weeks, these examens will be performed until the occurrence of an event (progression of the disease according to the RECIST criteria, death or change of therapeutic line). At the end of these assessments, patients will benefit from dietary management with a readjustment of personalized advice that will take into account the difficulties highlighted during the assessment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage IV non-small cell lung carcinoma with indication for first-line systemic treatment (chemotherapy, immunotherapy or specific treatment, in particular tyrosine kinase inhibitors) according to current French recommendations.
* Age over 18 and under 70
* Patient speaking and reading French fluently
* Affiliation to a social security scheme
* Patient able and willing to follow all study procedures in accordance with the protocol
* Patient having understood, signed and dated the consent form

Exclusion Criteria:

* Patient requiring hospitalization for more than 48 hours for the administration of the first course of treatment
* Patient benefiting from antibiotic therapy for the treatment of an acute infection
* Psychiatric, cognitive or neurological disorders making it impossible to assess food preferences and/or any impossibility to undergo medical monitoring for the trial for geographical, social or psychological reasons.
* Daily alcohol consumption
* Chest radiotherapy treatment
* Pregnant woman, likely to be, or breastfeeding
* Persons deprived of liberty or under guardianship
Modulation of Memory Consolidation in Humans

The goal of the present study is to optimize effects of slow oscillatory transcranial direct current stimulation (so-tDCS) on sleep physiology and memory consolidation in humans by combining computational and experimental human models in an iterative process. The investigator therefore works in cooperation with Prof. Dr. Klaus Obermayer (TU Berlin), who contributes computation models with the aim to mechanistically understand the impact of different perturbations on sleep-related electrophysiological features, and to subsequently optimize so-tDCS parameters for inducing SO and spindle activity.

Sleep plays an active role in long-term consolidation of memories. Specifically, slow oscillations (SO, large amplitude waves \<1 Hz) and sleep spindles (8-15 Hz), that can be measured by electroencephalography (EEG), appear to be critical for declarative memories. According to the "active system consolidation" account, newly encoded memories are reactivated during sleep, accompanied by sharp-wave ripple events (80-100 Hz) in the hippocampus, and redistributed to cortical long-term storage networks through a coordinated dialog between the hippocampus and neocortex. This dialog is supposedly mediated by a particular coupling between cortical SO and thalamo-cortical fast spindles (12-15 Hz), with spindles preferably occurring during SO up-phases, and hippocampal ripples grouped at the troughs of fast spindles. Slow spindles (8-12 Hz) are a separate kind of sleep spindle activity whose function in memory consolidation is less well understood.

Interventions targeting sleep parameters may not only make it possible to beneficially modulate a vital aspect of memory consolidation, i. e., sleep-dependent memory consolidation, but may also help to delineate which specific elements of the neural dynamics during sleep are crucial for successful consolidation.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 50-80 years
* screened as healthy in a structured telephone interview

Exclusion Criteria:

* Mini Mental Status Examination scores below 24
* history of severe untreated medical, neurological, and psychiatric diseases
* sleep disorders
* alcohol or substance abuse
* brain pathologies identified on MRI scan
* intake of medication acting primarily on the central nervous system (e.g., antipsychotics, antidepressants, benzodiazepines, or any type of over-the-counter sleep-inducing drugs such as valerian),
* nonfluent German language abilities.
Energy Expenditure in Golf

Structured exercise and physical activity are well known to not only improve physical fitness, but also alter various health parameters in a positive fashion. To yield health benefits, exercises need to meet certain characteristics e. g. specific levels of intensity or duration.To evaluate intensity levels and therefor possible improvements in physical conditioning in golf the investigators conducted this study with two groups of each 10 subjects. The groups differed in age and skill level (handicap, hcp). Each group went through a exercise session on the driving range (DR) and a 9-hole compeition round of golf. The investigators assessed spirometrical data (breath-by-breath) to evaluate energy expenditure (EE) and intensity levels of physical activity according to the ACSM guidelines.


Eligibility Criteria:
Inclusion Criteria:

* male
* age 18 to 45 y
* Body-Mass-Index: under 30 kg/m2
* Handicapclasses 1,2 und 4
* healthy

Exclusion Criteria:

* contraindication (orthopaedic, cardiologic, etc.) to participating in physical exhausting force and endurance testing and playing golf
* acute or chronical inflammation
* intake of drugs and medication
Effectiveness of Mindfulness-based Internet Intervention Still Me

The aim of the study is to assess the effectiveness of a mindfulness-based internet intervention for post-traumatic stress disorder symptoms.

Intervention is going to take the form of a mindfulness-based internet intervention consisting of eight modules. The themes include awareness and nonjudgment of senses, emotions, and thoughts. These themes were chosen after considering topics that might be the most useful for individuals who experience post-traumatic disorder symptoms. Each module consists of psychoeducation and exercise (audio records mostly) parts. Psychologist can be reached on demand.

The effect of the intervention will be compared against a waiting list control group. Intervention is in Lithuanian.

Eligibility Criteria:
Inclusion Criteria:

* at least 18-years-old;
* understand Lithuanian;
* internet access and device for that;
* at least one traumatic event during lifetime;
* post-traumatic stress disorder symptoms.

Exclusion Criteria:

* an acute case of psychiatric care;
* interpersonal violence;
* alcohol / drug addiction;
* cannot participate.
A Phase II Study of KCT-0809 in Patients With Dry Eye Syndrome

To evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Corneal and conjunctival damage
* Insufficiency of lacrimal secretion
* Ocular symptom

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctual plugs or surgery for occlusion of the lacrimal puncta
A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.

This is a Phase 2, non-comparative, open-label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.

The study includes 2 cohorts, ran in a sequential fashion:

Cohort 1 - AL101 4 mg once weekly (QW) intravenously (IV) Cohort 2 - AL101 6 mg QW IV

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed Adenoid Cystic Carcinoma with known NOTCH 1/2/3/4 activating mutation that is recurrent or metastatic, not amenable to potentially curative surgery or radiotherapy.
2. Evidence of radiographic or clinical disease progression within 6-months of signing informed consent; newly diagnosed metastatic patients will be allowed.
3. Patients must have Formalin-fixed, Paraffin-embedded tissue available .
4. Must have at least 1 target lesion that is measurable for patients with nodal or visceral metastasis.

Exclusion Criteria:

1. Diagnosed with a malignancy other than ACC in the past 2 years.
2. Uncontrolled, Active Infection
3. Gastrointestinal (GI) disease with increased risk of diarrhea \[e.g. inflammatory bowel disease (IBD)\]
4. Symptomatic central nervous system (CNS) metastases.
5. Unstable or severe uncontrolled medical condition
6. Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
7. Abnormal organ and marrow function