cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Body Radiation and Monoclonal Antibody to OX40 (MEDI6469) in Breast Cancer Patients With Metastatic Lesions

This study will test the investigational antibody, MEDI6469 (anti-OX40), in combination with stereotactic body radiation in breast cancer patients that have liver or lung metastases and have received systemic therapy and have progressive disease. The investigators hypothesize that SBRT directed at metastatic breast cancer lesions will result in a systemic anti-tumor immune system response. This amplified and directed immune response could result in anti-tumor responses.

Patients will receive one of three different doses of SBRT depending on which cohort they are in. The doses are:

Cohort 1: 15 Gy (central tumors 10 Gy); Cohort 2: 20 Gy (central tumors 15 Gy); Cohort 3: 20 Gy x 2 (central tumors 15 Gy x 2).

In addition, all patients will receive three doses of MEDI6469. MEDI6469 is administered at 0.4 mg/kg IV over 60 minutes using in-line filter on Days 1, 3, and 5.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer with clinical evidence of stage 4 disease
* Measurable disease and at least one lesion in either liver or lung that is amenable to stereotactic body radiation
* One site of disease that will not receive radiation
* Patients with hormone receptor positive breast cancer must have received prior anti-hormonal therapy for metastatic disease and have progressed and patients with hormone receptor negative breast cancer must have received at least one prior chemotherapy regimen and progressed.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
* Women of childbearing potential must have a negative pregnancy test on the day treatment starts and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment.
* Patients must have blood test results within pre-specified range
* No active bleeding
* No clinical coagulopathy (INR \<1.5, PT \<16 seconds, PTT \< 38 seconds) within 28 days
* Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

* Active infection requiring systemic antibiotics.
* Active autoimmune disease as defined by the autoimmune disease assessment tool.
* Previous treatment with mouse monoclonal antibodies
* At least 28 days since prior chemotherapy or monoclonal antibody therapy (trastuzumab or bevacizumab). Patients who have been on hormonal therapy can continue on therapy at the discretion of the investigator. Bisphosphonate therapy is acceptable during study participation.
* Diagnosis of a solid tumor malignancy (excluding non-melanoma skin cancer) within 3 years of enrollment.
* Need for chronic maintenance oral steroids.
* Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife radiosurgery or radiation and stable for at least 4 weeks and off steroids are eligible.
* No metastatic site amenable to SBRT
* Pregnant or lactating women, as treatment involves risks to the embryo or fetus.
* Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
Heat Stress and Physiological Strain of Permeable vs. Impermeable CB Protective Garment

Current protective clothing of any kind, especially the nuclear-biological-chemical (NBC) protective garments, amplify thermal stress because of the inherent properties of the clothing material. High insulation coefficient and low water vapor permeability of the protective cloth limit the ability of sweat to readily evaporate, which consequently result with a significant elevation of body temperature and with excessive body fluid loss (because of inefficient sweating) that might result with significant dehydration.

Combat soldiers require to perform intense physical activities under hostile environmental conditions, including in contaminated areas that need the use of protective garments. The ability to fulfill a mission derives from the soldier's professionalism and from his physiological limits. It is well established that wearing protective garments affect tolerance time (TT) and performance.

To operate in contaminated areas suitable protective garments should be worn. The inherent characteristics of the current protective garments limit, however, the effective working periods with such an ensemble, which is further aggravated in hot climate. Thus, in an attempt to increase TT and enhance work effectiveness, improved protective garments, which result with a lessened heat-stress, are under different stages of development.

The relative influence of air permeability properties, garment weight and garment construction on heat stress and physiological strain will be investigated.

The results will be quantified in terms of body temperatures, heart rate, fluid balance, subjective sensation and the maximum wear time (if necessary extrapolated).


Eligibility Criteria:
Inclusion Criteria:

* Twelve young (20-30 yr) male subjects will voluntarily participate in this study. The potential participants will be informed of the study's nature, purpose and medical risks. Their inclusion in the study requires the medical clearance by the study's physician (CRF) and after having filled out and sign an informed consent form

Exclusion Criteria:

* heart conditions, blood pressure higher than 140/90 mmHg, known diabetes or any skin illness or lesions. Also be excluded are potential participants who were ill during the 2 weeks prior to the study
The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants

Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora.The purpose of this study is to investigate the stool characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting infant formula supplemented with prebiotics and lactoferrin.

Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora as well as the intestinal immune systems. The purpose of this study is to investigate the stool characteristics（including intestinal microbiota） acceptability, and gastrointestinal tolerance in infants fed a starting infant formula supplemented with prebiotics and lactoferrin, and compared these data with infants on exclusively breast feeding.

Eligibility Criteria:
Inclusion Criteria:

* full-term with a birth weight ≥2,500 g
* be in good health
* without symptoms of diarrhea, and had not received antibiotics for at least 1 week before enrollment
* exclusively fed by breast milk or infant formula

Exclusion Criteria:

* preterm infant
* with known diseases or currently taking medication drugs
* mixed feeding
* with symptoms of diarrhea
* received antibiotics within 1 week
Polygraphy at Home for Neuromuscular Patients Under Non-invasive Mechanical Ventilation

The primary objective of the study is to evaluate the feasibility, the quality and the utility of a polygraphic control at home in order to appreciate the efficacy of the night time non-invasive ventilation (allowing to optimize the ventilator settings when the results are not satisfactory).


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years;
* Patient with chronic respiratory insufficiency has just been posed non-invasive ventilation (NIV) in the hospital, according to the latest international recommendations ;
* Affiliation to the social security scheme;
* Patient has signed the informed consent form to participate to the study.

Exclusion Criteria:

* Patient refusal;
* Patient under guardianship;
* Patient under AME scheme;
* Patients living more than 40 km from reference center;
* Patient depending on mechanical ventilation (more than 6 hours daily);
* Rapidly or reversible evolutive neuro-myopathy (Amyotrophic lateral sclerosis, Guillain Barré syndrome, myasthenia).
The Epidemiologic Study of Human Papillomavirus Infection and Related Diseases

primary purpose:Evaluate the prevalence and incidence of HPV infection and related diseases in subjects.

Secondary purpose:Analyze risk factors of HPV infection and related diseases.


Eligibility Criteria:
Inclusion Criteria:

* ages 18 to 55 years;
* residents of the study site;
* at least one sex partner;
* Be able to understand and comply with the request of the protocol.

Exclusion Criteria:

* pregnant;
* has received HPV vaccines.
Cefpodoxime vs Ciprofloxacin for Acute Cystitis

Urinary tract infection (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20s. One of the most common antibiotics used to treat UTIs is ciprofloxacin, usually for a total of three days. However, increasing resistance to this antibiotic has raised concerns about its overuse for cystitis and generated interest in alternative agents. An alternative antibiotic which is approved for use in UTIs is cefpodoxime. However, there are few studies evaluating the efficacy and tolerance of this compound when given in a 3-day regimen as is commonly used for treatment of UTI. The major purpose of this study is to assess the efficacy and tolerance of a 3-day regimen of cefpodoxime versus ciprofloxacin for treatment of acute uncomplicated cystitis.

Procedures subjects will undergo once they have read and signed the consent are:

Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-9 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Nonpregnant females in good general health with symptoms of acute cystitis

Exclusion Criteria:

* Pregnant,lactating, or not regularly contracepting: known anatomic abnormalities of the urinary tract; use of prophylactic antibiotics; history of allergy or intolerance to any of the study drugs; recent (\>2 weeks)exposure to an oral or parenteral antimicrobial; or history of UTI in the previous 1 month
Understanding Ketamine's Dissociative Effects (KD Study)

The purpose of this study is to understand how ketamine brings about dissociative symptoms.

The goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during dissociation in epilepsy patients with stereoEEG.

Eligibility Criteria:
Inclusion Criteria:

* Patient in Stanford Epilepsy Monitoring Unit
* Age \>18 years old.

Exclusion Criteria:

* Lifetime psychotic or bipolar disorder
* Inability to speak, read or understand English
* Pregnant or nursing females
* Prior adverse ketamine response
QOL Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser

The purpose of this study is to see how the look of telangiectasias (small dilated blood vessels) on radiated breast skin when altered by the pulsed dye laser affects a patient's overall well being.

Patients will have a set of treatments with a pulsed dye laser. This is a laser that targets red blood vessels and delivers heat causing the telangiectasias to become smaller and less visible. The laser has been used safely to treat telangiectasias on the skin of patients who received radiation for breast cancer.

Patients in the study will be asked to complete a questionnaire asking how they feel about the telangiectasias, their radiated skin and its effect on their daily lives. The questionnaire will be given at every visit. The improvement in the look of patients' radiated skin will also be compared to answers to the questionnaire. We hope the study will improve our understanding of how patients feel about the long term effects of radiation on their skin.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced breast cancer patients treated with surgery and adjuvant radiation
* Telangiectasias in the radiation field of the treated breast
* Patients 18 years or older

Exclusion Criteria:

* Non English speaking
* Current oral steroid use or receiving daily therapeutic anticoagulation (e.g. Coumadin, Lovenox)
* Breast/s reconstructed with implant in the area of previous radiation
* Pregnancy or lactation
* Previous laser treatment of telangiectasias
* Presence of a sun tan in the area
* Fitzpatrick skin types V, VI
Influenza Vaccination Among the Elderly Individuals

The aims of the study are to a) identify individuals with a poor response to influenza vaccination and b) identify factors associated with a poor response to influenza vaccination.

This is a population-based prospective cohort study. Potential participants, males and females between 65 and 80 years of age, were selected randomly through the resident registration office in Hannover city, Germany and invited with a personalized letter to participate in the study.

Initially, a blood sample (40 ml) will be drawn from each participant (day 0). Furthermore, participants will be vaccinated against influenza with FLUAD 2014/2015. FLUAD is a trivalent, surface antigen, inactivated influenza virus vaccine adjuvanted with MF59C.1. Additional five blood samples will be collected during the study period of four months (at days 3, 7, 21, 70 and 130). Information about current and past infections, chronic diseases and basic sociodemographic data will be collected through a self-administered questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between 65 and 80 years of age

Exclusion Criteria:

* Individuals with a known hypersensitivity to any of the excipients and to eggs, chicken Protein, kanamycin and neomycin sulphate, formaldehyde, and cetyltrimethylammonium bromide
* Individuals, who have an acute infection during the visit at the study Center
* Individuals with cognitive impairment
* Individuals already vaccinated with influenza vaccination in the influenza season 2014/15
Trial of Leptin Administration After Roux-en-Y Gastric Bypass

This is a pilot and feasibility study to examine a novel intervention using leptin in weight-reduced individuals who have undergone bariatric surgery but still remain obese. Leptin, a peptide hormone secreted from adipose tissue, is a regulator of food intake and energy expenditure. Administration of leptin resulted in profound weight reduction in the few reported cases of obese individuals with genetic leptin deficiency. However, most obese people have increased leptin levels. Such individuals are said to be in a "leptin-resistant" state, whereby administration of physiological concentrations of leptin are ineffective at producing significant weight reduction. Roux-en-Y gastric bypass surgery (RYGBP) is more effective than diet alone in producing long-term reduction of body weight. Yet even after surgery there is a plateau in weight loss though the individual may still be obese and have or be at risk for obesity related morbidities. The investigators have shown that plasma leptin levels are significantly lower in women after RYGBP compared with BMI-matched controls. This state of relative hypoleptinemia or leptin insufficiency suggests that post-RYGBP individuals may be in a "leptin-sensitive" state and, thus, would undergo further weight loss when administered doses of leptin that would not normally result in significant weight reduction. This study will examine the effects of leptin administered by self-injection twice per day on body weight and endocrine function. All individuals will received leptin and placebo and different times during the 34 week study period.

Metreleptin will be self-administered by subcutaneous injection at 0.05 mg/kg body weight twice per day (i.e. at 8 am and 8 pm). This dose was chosen because it would not be expected to cause substantial weight loss in an obese non-surgical population, nor should it incur any substantial injection site reactions. Subjects will receive a demonstration of dose preparation and injection in addition to written instructions with visual aides. After the run-in period, subjects will demonstrate their preparation and injection technique. Placebo injections will consist of sterile water equal in volume to that of the metreleptin dose calculated for each individual. Subjects will be instructed to continue with their current level of physical activity. At week 16, each subject will cross-over to the alternate treatment for an additional 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 25-65 years who are 18 months to 15 years Roux-en-Y gastric bypass
* Current BMI of 28-50 kg/m2 and a percent total body weight loss from highest pre-surgical weight of \>20% and \<45%
* Must live in the vicinity of New York City to comply with 11 study visits over 34 weeks
* Must be willing to self-inject study drug twice per day

Exclusion Criteria:

* Diabetes
* History of plastic surgery
Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir in Healthy Male Volunteers

To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of tipranavir/r on BILR 355 BS pharmacokinetics


Eligibility Criteria:
Inclusion Criteria:

* Age ≥19 and \<60 years
* BMI ≥18.5 and BMI ≤29.9 kg/m2
* Ability to give signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local regulations

Exclusion Criteria:

* Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Currently active (symptomatic within the last 30 days) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within one month prior to administration of study drug or during the trial (review with clinical monitor if questionable)
* Use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation (review with clinical monitor if questionable)
* Participation in another trial with an investigational drug within one month prior to administration or during the trial
* Current smoker or smoked within the past 30 days
* Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
* Recent blood donation (more than 100 mL within 56 days prior to administration or during the trial)
* Excessive physical activities (within 1 week prior to study drug administration or during the trial)
* Any laboratory value outside the normal reference range that is of clinical relevance at screening, according to the judgment of the investigator
* Inability to comply with dietary regimen required by the protocol
* Chronic or relevant acute infections
* Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
* HIV-1 infected as defined by a positive HIV ELISA test
A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease

Study BP40410 is an open-label, adaptive multiple-dose clinical study designed to characterize the PK of RO7234292 (RG6042) in plasma and CSF as well as the acute time course and recovery profile of CSF mHTT lowering in response to RO7234292 (RG6042) treatment after intrathecal (IT) administration of RO7234292 (RG6042) to patients with manifest Hungtington's disease (HD).


Eligibility Criteria:
Inclusion Criteria:

* Manifest HD diagnosis
* Independence Scale score of \>=70.
* Genetically confirmed disease by direct deoxyribonucleic acid testing with a cytosine, adenine, and guanine base sequence found in DNA which is translated into glutamine (CAG) age product (CAP) score \> 400.
* Ability to read the words "red," "blue," and "green" in the patient's native language.
* Ability to walk unassisted without a cane or walker and move about without a wheelchair on a daily basis as reviewed at screening and baseline visit.
* Ability to undergo and tolerate MRI scans.

Exclusion Criteria:

* History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and/or change in level of care within 12 months prior to screening.
* Current active psychosis, confusional state, or violent behavior.
* Any serious medical condition or clinically significant laboratory, vital signs, or ECG abnormalities at screening that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study.
* Clinical diagnosis of chronic migraines or history of low pressure headache after lumbar puncture requiring hospitalization or blood patch.
* Treatment with investigational therapy within 4 weeks prior to screening or 5 drug elimination half-lives of investigational therapy, whichever is longer.
* Concurrent or planned concurrent participation in any interventional clinical study, including explicit pharmacological and non-pharmacological interventions. Observational studies are acceptable.
* Unable or unsafe to perform lumbar puncture on the patient.
* Previous lumbar surgery that is likely, in the opinion of the Investigator or surgical team, to make IT catheter insertion or IT injection unduly difficult or hazardous.
* Poor peripheral venous access.
* Scoliosis or spinal deformity making IT injection not feasible in the outpatient setting.
* Preexisting intra-axial or extra-axial lesions as assessed by a centrally read MRI scan during the screening period.
Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder

The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

A growing body of literature indicates the existence of a highly stable, coordinative relation between respiration and oropharyngeal swallowing in healthy adults. The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Respiratory Rhythm Disorder
* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.