cyrilzakka/clinical-trials huggingface dataset:
Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel and radiation therapy plus chemoprotection with amifostine in treating patients with stage III or stage IV head and neck cancer.

OBJECTIVES:

* Determine the maximum tolerated dose of paclitaxel with amifostine and radiotherapy in patients with stage III or IV head and neck cancer.
* Determine the toxic effects and complications of this regimen in terms of mucositis reduction in these patients.
* Determine the complete response rate and progression-free survival of patients treated with this regimen.
* Determine whether amifostine modulates the plasma pharmacokinetics of paclitaxel in these patients.

OUTLINE: This is a dose-escalation study of paclitaxel with and without amifostine.

Patients receive paclitaxel IV on days 1, 8, 15, 29, 36, and 43 for a total of 3-6 doses. Patients also undergo radiotherapy twice daily for 6 weeks, except for days when paclitaxel is given.

Cohorts of 2-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2-3 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD.

After determination of the MTD for paclitaxel, subsequent patients also receive amifostine IV over 15 minutes on days 1, 8, 29, and 36 and radiotherapy on days 2-5 and 30-33. Determination of the MTD for this drug combination is carried out as with paclitaxel alone.

At 4 to 8 weeks after the last treatment of radiotherapy, patients undergo CT scanning to determine response. Patients with residual masses undergo neck dissection. Patients with complete or partial response at the primary site are followed without surgery.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage III or IV squamous cell head and neck cancer

  * T3-4, N0-3, M0

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance Status:

* ECOG 0-2

Life Expectancy:

* Not specified

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* Bilirubin no greater than 3.0 mg/dL
* SGOT no greater than 3 times upper limit of normal

Renal:

* Creatinine no greater than 3.0 mg/dL

Other:

* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No concurrent beta-adrenergic blocking agents
Vertos Mild - Post Market Patient Outcomes

This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.

Approximately 50 patients at a single center will be enrolled and followed for a period of up to 26 weeks. Adult patients with symptomatic lumbar spinal stenosis who meet the enrollment criteria will be offered the mild procedure as an alternative to surgery or continued standard non-surgical medical management.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic and lumbar spinal stenosis caused by dorsal element hypertrophy
* Prior failure of conservative therapy and Oswestry Disability Index (ODI) \>20%
* Radiologic evidence of lumbar spinal stenosis, ligamentum flavum hypertrophy (typically \>2.5mm),confirmed by pre-op MRI/CT report
* Central canal cross sectional area clearly reduced per MRI/CT report
* If present, anterior listhesis \< or = to 5.0mm (preferred) and deemed stable by the Investigator
* Able to walk at least 10 feet unaided before being limited by pain
* Available to complete 26 weeks of follow up
* A signed Consent Form is obtained from the patient
* Adults 18 years of age or older

Exclusion Criteria:

* Prior surgery at the intended treatment level
* Compound fracture with intraspinal retropulsion contributing to spinal stenosis
* Disabling back or leg pain from causes other than lumbar spinal stenosis
* Disc protrusion or osteophyte formation severe enough to confound study outcome
* Facet hypertrophy severe enough to confound study outcome
* Bleeding disorders and/or current use of anti-coagulants
* Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment
* Epidural steroids with 3 weeks prior to procedure
* Inability of patient to lie prone for any reason with anesthesia support
* Metabolic wound healing pathologies that may be deemed by the Investigator to compromise the study outcomes
* Dementia and/or inability to give informed consent
* Pregnant and/or breastfeeding
* On workman's Compensation or considering litigation associated with back pain
CONFIDENCE Registry

This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.

This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.

Eligibility Criteria:
Inclusion Criteria - Subjects must meet all the following criteria to be included in the registry:

1. Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities,
2. Are females 18 years of age or older at the time of consent,
3. Have been referred for a breast US and are subject to treatment with the Imagio breast imaging system.

Exclusion Criteria - Aligned with the contraindications on the use of the device, subjects who meet any of the following criteria will be excluded from the registry:

1. Are pregnant.
2. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast.
3. Are experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline.
4. Are currently undergoing phototherapy.
5. Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus).
6. Are undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
7. Have previously participated in this registry,
8. Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.
Regional Distribution of Ventilation to Assess Respiratory Muscle Dysfunction

The aim of this study is to better discriminate respiratory muscle dysfunction by comparing the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the conventional tests of respiratory muscle strength. The final objective is to better select in the future the patients who need more specific assessment of diaphragmatic function like "maximal transdiaphragmatic pressure" measurement and "phrenic nerve stimulation".

All patients which had suspected respiratory muscle dysfunction will have usual exploration of the respiratory muscles according to the clinician prescription. These explorations can include :

* Lung volumes in seating and supine position
* Maximal inspiratory and expiratory pressures
* Maximal sniff pressures

And when diaphragmatic dysfunction is suspected :

* Maximal transdiaphragmatic pressure
* Phrenic nerve conduction

These patients will also beneficiate to the determination of volume variations of the upper rib cage, the lower rib cage and the abdominal compartments by using Opto-electronic plethysmography.

Eligibility Criteria:
Inclusion Criteria:

* suspicion of respiratory muscle dysfunction
* indication of diaphragm exploration

Exclusion Criteria:

* acute respiratory failure
Loop Band Validation Study

The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband.

The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband. This wristband (Loop Band) uses optical sensors and spectrometry to measure and estimate vitals as well as a full blood gas panel; comparable to the standard method of an invasive arterial line and pressure transducer. The investigators aim to show equivalence of clinical physiologic outcome measurements with the Loop Band relative to current methods (i.e. arterial lines, etc.). In addition, this study aims to validate this wearable technology as a potential alternative to invasive measurements, to reduce complications, and improve accuracy in regards to patient monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Patient has capacity to consent for the study.
* Anesthetic plan for an arterial line for vital sign monitoring during their surgical procedure.

Exclusion Criteria:

* Active Atrial Fibrillation
* Active C-difficile
* Amputation of the arm at the wrist or above
* The Investigator and/or Clinical Research Nurse will conduct a visual inspection for attributes that may diminish device accuracy. These include but are not limited to: tattoos over the radial artery, burns or heavy scarring over the radial artery, fragile skin, any skin diseases affecting the wrist or arm, Physician discretion-any condition deemed inappropriate that will preclude use of the device.
Effects Multi-Gravitational Suspension-Based Therapy

Background: Multi-gravitational suspension-based therapy (M-Gravity) is a comprehensive discipline based on the principles of non-gravity, which serves to increase the quality of life and holistic health of the individual with the rehabilitation content of non-pressure inversion therapy.

Aims: To examine the effects of M-Gravity exercise on posture, physical fitness, quality of life, depression, and sleep quality in women without regular exercise habits.

Methods: This study was designed as a non-randomized controlled trial. This study included 20 women without regular exercise habits, who participated in the exercise with M-Gravity and 20 women who did not participate in any exercise program, a total of 40 participants. In this study, the investigators planned to evaluate the effects of M-Gravity on women without regular exercise habits. The following outcomes were measured: posture with the New York Posture Assessment Method, the flexibility of the hamstring and pectoral muscles, time is taken to stay in the plank position, depression levels with the Beck Depression Inventory scale, sleep quality is performed with the Pittsburgh Sleep Quality Index, and the Nottingham Health Profile (NHP) questionnaire to measure the perceived health levels of the subjects. The measurement of the contraction force of the deep lumbar muscles is performed with the Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). Two evaluations were made before and after 4 weeks of exercise.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary women

Exclusion Criteria:

* Individuals with a physical, cardiac, or neurological disease that may interfere with our practices and assessments
* Pregnancy and post-natal individuals
* Individuals with scoliosis of 20 degrees or more
* Glaucoma
* Recent surgery (3-6 months waiting period according to surgery)
* Hypertension, exercise in the head-down position can cause an increase in blood pressure and a hypertensive crisis
* Impaired cerebral circulation
* Botox treatment in the last 6 hours
* Spinal fractures
* Severe osteoporosis
* Sequestered disc herniation
* Spinal tumors
* Inflammatory conditions of the spine
* Head injuries
* Previous myocardial infarction
* Vertigo
The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer

Investigation of the possible efficacy and safety of lansoprazole co-administration with neoadjuvant chemotherapy in tumor response in women with breast cancer who will be planned for surgery.

Several studies revealed that PPIs inhibit not only the H+/K+ ATPase in gastric parietal cells, but also the vacuolar H+ ATPase (V-ATPase) overexpressed in tumor cells, the V-ATPase is an ATP-dependent proton pump that transports H+ across both intracellular and plasma membranes to regulate intracellular and extracellular pH.

Co-administration or pretreatment with PPIs could inhibit H+ transport via the V-ATPase in tumor cells, resulting in lower extracellular acidification and intracellular acidic vesicles which increase the sensitivity of the tumor cells to the anticancer agents. Moreover, the low extracellular pH induces an increased activity of drug efflux pumps P-glycoprotein (P-gp), which is closely associated with multi-drug resistance (MDR) of tumors. As a consequence, there remains a lower concentration of chemotherapeutic drugs in tumor cells and reduced cytotoxic efficacy, thus restoring the normal extracellular PH will decrease MDR.

Eligibility Criteria:
Inclusion Criteria:

* Females with age ≥ 18 years old.
* Newly diagnosed breast cancer patients.
* Planned neoadjuvant chemotherapy.

Exclusion Criteria:

* Pregnancy.
* Nursing mothers.
* Active or uncontrolled infection.
* Presence of another malignancies.
* Inadequate blood picture.
* Serum Creatinine more than 1.5 mg /dl.
* AST and ALT more than 2.5 upper limit.
* History of known hypersensitivity to lansoprazole.
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Rectal adenocarcinoma confirmed by histopathology
2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
3. The age is 18-75 years old, no gender limit

3) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1

Exclusion Criteria:

1. History of other malignant tumors;
2. They were allergic to 5-FU, platinum, etc;
3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;
4. After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
5. History of gastrointestinal fistula, perforation or severe ulcer;
6. At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.
Myocardial Performance at Rest and During Exercise in Heart Failure With Preserved Ejection Fraction

This study is being done to study how well the heart contracts and relaxes during exercise. In addition to traditional measures of heart function, we will use a new computer program that may improve understanding of why people feel shortness of breath or fatigue.

Heart failure with preserved ejection fraction is not well understood, although account for nearly half of all heart failure cases. This study aims to collect data about systolic (contracting portion of a heart beat) and diastolic (relaxing portion of a heart beat) dysfunction at rest and during exercise. Participants with normal cardiac function will serve as a control group and compared to participants who are at risk of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* able to exercise on a bicycle

Exclusion Criteria:

* heart arrhythmias,
* severe chronic obstructive pulmonary disease,
* congenital heart abnormalities,
* infiltrative or hypertrophic cardiomyopathy.
A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users

The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.


Eligibility Criteria:
Inclusion Criteria:

* Be in good general physical health
* Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg
* Recreational opioid use experience for non-therapeutic purposes (at \>/= 10 times in lifetime and \>/= 1 in previous 3 months
* Agree to use an approved method of birth control for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Currently pregnant or breastfeeding
* History of or current infection with hepatitis B virus, hepatitis C virus or HIV
* Current or history of any clinically significant medical or psychiatric condition
* Current or history of in the last 2 years of dependence on alcohol or any illicit drugs
* Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
* Have a history of intolerance or hypersensitivity to opioid antagonists, opioid agonists or related drugs (eg, naltrexone, naloxone, oxycodone, morphine)
* Additional criteria may apply
Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Cesarean Section

The purpose of this study is to find the best dose of metaraminol to be used in patients during elective cesarean sections.

The purpose of this study is to determine the effective dose 90% (ED90) of metaraminol to treat hypotension after spinal anesthesia in elective cesarean sections (CS). It is a double-blind study that uses the biased-coin up-down sequential allocation method to determine the ED90 of metaraminol.

Baseline systolic blood pressure (SBP) will be determined by three automated measures 3 minutes apart just before CS. During the period from induction of spinal anesthesia to fetal delivery SBP will be monitored every minute and metaraminol will be administered every time it is lower than baseline value. If SBP falls below 80% of baseline value, the treatment will be considered a failure. An adequate response will be defined as the absence of hypotension during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Elective CS under spinal anesthesia
* Normal singleton pregnancy beyond 36 weeks gestation
* ASA physical status I/II
* Age over 18 years

Exclusion Criteria:

* Patient refusal
* Allergy to metaraminol
* Preexisting or pregnancy-induced hypertension
* Cardiovascular or cerebrovascular disease
* Fetal abnormalities
Phase I Endovenous Administration of Oncolytic Adenovirus ICOVIR-5 in Patients With Advanced or Metastatic Melanoma

The investigators will evaluate the safety of a single endovenous infusion of ICOVIR5 in adults with locally advanced and metastatic melanoma. ICOVIR5 consists in a conditionally replicative or oncolytic adenovirus.


Eligibility Criteria:
Inclusion Criteria:

* Malignant melanoma advanced or metastatic.
* Other than 18 years
* Karnofsky index \> 60 %
* Life expectancy \> 3 months
* ALT/AST \<=2.5 times the upper normal limit
* Creatinine clearance \>= 50 ml/min.
* Bilirubin \<25 umol/l
* Alkaline phosphatase \<= 2.5 time upper normal limit
* Normal bone marrow function: Neutrophils \>=1.5 E9/L, platelets \>= 1E11/L, hemoglobin \>= 100 g/l, Normal prothrombin time and thromboplastin time,
* HIV negative
* Measurable disease
* Signed informed consent.

Exclusion Criteria:

* Geographical, social or psychological conditions that may impair the protocol compliance.
* Active infections or other severe medical status.
* History of liver disease.
* Other or concomitant treatments for melanoma or investigational product.
* Previous participation in studies with adenovirus.
* Virus diseases diagnosed two weeks before inclusion.
* Immunosuppressive concomitant treatments
* Concomitant malignant haematological disease.
* Patients having family members with immunodeficient status or disease
* Patients with Li Fraumeni syndrome or germinal retinoblastoma gene defects.
In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance

Observational: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Study Phase Definition: Phase of investigation, as defined by the US FDA for trials involving investigational new drugs. Select only one.

N/A: for trials without phases Observational Study Design Case-control: group of individuals with specific characteristics (e.g., conditions or exposures) compared to group(s) with different Time Perspective Cross-sectional: observations or measurements made at a single point in time, usually at subject enrollment Biospecimen Retention - select one Samples Without DNA - samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma) Biospecimen Description

Sputum, whole blood, urine, tissue Enrollment

Single group study Number of Groups/Cohorts Definition: Number of study groups/cohorts. Enter 1 for a single-group study. Many observational studies have one group/cohort; case control studies typically have two.

One study group, anticipated samples in the rang of 400-500 samples 8. Arms, Groups and Interventions N/L Group/Cohort Label

Eligibility Criteria:
Inclusion Criteria:

* All patients with infection with MDRs infections will be included

Exclusion Criteria:

* None