cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer.

OBJECTIVES:

* Determine the locoregional control rates, time to failure, need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus.
* Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation, organ function and quality of life parameters.
* Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring.

OUTLINE: Patients receive concomitant chemoradiotherapy with curative intent. Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure.

The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5. Fluorouracil is given IV on days 0-4. Radiation therapy BID is given on days 1-6. Cycles repeat every 14 days for a total of 5 cycles.

The disease will be reevaluated 4-6 weeks after completion of all treatment, every 3 months for 1 year, then yearly.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed diagnosis of carcinoma
* Stage II-III (T2, T3, N0 or T1-3, N1) carcinoma of head and neck, including: oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus
* No N2 or N3
* Measurable disease is not required

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Zubrod 0-3

Life expectancy:

* Anticipated survival is 3-4 years (median)

Hematopoietic:

* WBC count at least 3.5/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* Not specified

Pulmonary:

* Not specified

Other:

* No infection or severe medical illness
* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy

Surgery:

* No prior surgery
Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders

Evaluate some Inflammatory markers \[IL-6, IL-8, TNF_alpha\] in children with autism spectrum disorder

several studies have suggested a correlation between ASD and abnormal immune activation (9) For instance, there is a high incidence of autistic subjects in families with other autoimmune disorders such as celiac disease and rheumatoid arthritis, suggesting a potential role for immune dysfunction in the pathophysiology of ASD High levels of IL-6 in the brain could determine alterations of synapse formation, dendritic spine development, and neuronal circuit balance \[13\], while in plasma they have been associated with increased stereotypical behaviors and with regressive forms of ASD

Eligibility Criteria:
Inclusion Criteria:

* 50 patients aged 3_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)

Exclusion Criteria:

* : Asperger syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), chronic seizures and recent infection and patients with congenital anomalies
Re-craniotomy and Complications After Elective Neurosurgery

This study is a prospective cohort study to find the incidence of re-craniotomy and predictive factors. The secondary outcomes are to find the incidence of major non-neurological complications and predictive factors.

Demographic data include age, gender, preoperative neurological assessment, diagnosis, operation, surgical position, ASA physical status, dexamethasone requirement, anticonvulsant therapy, airway assessment, and blood component reservation.

Intraoperative information contain anesthetic technique, total dosage of propofol, fentanyl, and other anesthetic agents, total blood loss, types and amount of fluid replacement, volume of blood transfusion, latest body temperature, and the ability of safe extubation.

Postoperative complications will be categorized in to general conditions, neurological complications, and systemic problems. General conditions such as on endotracheal tube overnight and postoperative blood transfusion. Neurological complications include worsen increased ICP, intracranial hematoma, seizures, newly-developed motor deficit, cranial nerve palsy, CSF rhinorrhea, and emergency re-craniotomy. Systemic problems are hypothermia, electrolyte imbalance, anemia, hypertension, and hyperglycemia. Postoperative nausea and vomiting and the rescued anti-emetic drugs will be recorded. Postoperative anti-epileptic drug (AED) and pain medication will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for elective craniotomy during 2017-2019
* Patients who are planned for general anesthesia
* Patients have read the study information and signed in the consent form

Exclusion Criteria:

* Patients who are unable to understand and sign in the consent form
* Patients who are scheduled for minor surgical procedures such as ventriculostomy and VP-shunt
Walking for Stress Reduction

The effectiveness of a mindfulness walking program is tested in subjects with a high level of subjectively perceived stress.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between 18 and 65 years
* Increased level of stress (visual analog scale \>40 mm (0-100))

Exclusion Criteria:

* Regular walking training in the last 6 weeks
* Medical therapy with psychopharmacological drugs
* Regular mindfulness based meditations/exercises in the last 6 weeks
* CAM therapies against stress in the last 6 weeks
* medium or severe chronic diseases
* Stress due to chronic diseases
* Acute disease at inclusion
* Not being able to walk
A Study of RG7667 in Healthy Volunteers

This randomized, double-blind, placebo-controlled study will evaluate the safety and pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomized in cohorts to receive either single/multiple doses of RG7667 intravenously or placebo. Anticipated time on study treatment is up to 57 days with a 12-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, 18 to 55 years of age, inclusive
* Body mass index 18.0 to 31.0 kg/m2, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and laboratory values, as deemed by the Investigator

Exclusion Criteria:

* History of malignancy, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ
* History of severe bacterial, fungal, or parasitic infections (more than 2 hospitalizations within 1 year or more than 2 courses of iv antibiotics within 1 year)
* Pregnant, lactating, or planned pregnancy within 6 months of Screening
* Positive for hepatitis B, hepatitis C or HIV infection
* Exposure to any investigational biological agent within 90 days prior to the Screening evaluation or received any other investigational treatment 30 days prior to the Screening evaluation (or within 5 half-lives of the investigational agent, whichever is greater)
* History of alcoholism or drug addiction within 1 year of Screening
* Positive urine test for selected drugs of abuse at Screening and Check-in (Day -1); positive breathalyzer test for alcohol at Check-in
* Use of prescription drugs within 14 days prior to Day 1 or during the study, except for hormonal contraceptives or hormone replacement therapy
* Use of over-the-counter (OTC) medication within 7 days prior to Day 1 or during the study. Medications such as acetaminophen and ibuprofen and routinely-taken dietary supplements, including vitamins and herbal supplements are allowed at the discretion of the investigator and Sponsor.
* Donation of plasma within 7 days prior to Day 1. Donation or loss of blood of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to Day 1.
* Lack of peripheral venous access
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin

This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects

This study is a double-blind, three-arm, parallel group, single-dose study. A total of 141 subjects will be enrolled; 47 subjects in each of the 3 arms of the clinical study. In each arm, all subjects will receive a single dose (5 mg/kg) of either CT-P16, EU-approved Avastin, or US-licensed Avastin by intravenous (IV) infusion for 90 min (±5 min) on Day 1 followed by 15 weeks during which the PK, safety, and immunogenicity measurements will be made. The randomization will be stratified by body weight and site.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 19 and 55 years, both inclusive
* Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 (both inclusive) and a body weight ≥ 50 kg

Exclusion Criteria:

* Subject is a female.
* Clinically significant allergic reactions, hypersensitivity
* A disease classed as significant by the Investigator
* Non-healing wound, ulcer, bone fracture, a major surgical procedure, significant traumatic injury
* Any malignancy
* Undergone treatment with an investigational drug or participated in another clinical trial
* Plans to father a child or donates sperms
Systemic Transthyretin Amyloidosis: Carpal Tunnel Syndrome in a Portuguese Population

Systemic transthyretin amyloidosis is an aging-related disorder. It is usually associated with cardiac disease but also extends to other organs. Recent studies found that idiopathic carpal tunnel syndrome patients may have amyloid deposition in tenosynovial tissue. The main aims of this project are the characterization of the association between idiopathic carpal tunnel syndrome and transthyretin amyloidosis and its evaluation as a predictive factor of cardiac amyloidosis


Eligibility Criteria:
Inclusion Criteria:

. Patients aged ≥ 60 years old with symptomatic idiopathic carpal tunnel syndrome or other hand surgery indications.

Exclusion Criteria:

. Diabetes mellitus, hypothyroidism, hemodialysis, rheumatoid arthritis, and other inflammatory arthropathies, multiple myeloma, gout, chondrocalcinosis, Colles fracture, space-occupying lesions, and infectious synovitis.
Effects of Substance P on Headache Induction in Healthy Individuals

Substance P is a signaling molecule that has been implicated in the pathogenesis of headache. This study aims to ascertain whether administration of substance P can induce headache in healthy adults.

Substance P is a vasoactive signaling molecule that belongs to the tachykinin family of peptides. It is expressed in multiple cells, including primary afferents of the trigeminal ganglion that innervate the meninges and its arteries. The best-known function of substance P is its role in pain transmission, and several lines of evidence has implicated substance P in the pathogenesis of headache. This study aims to ascertain whether intravenous infusion of substance P induces headache in healthy individuals who have no past or current history of primary or secondary headache disorder, except for infrequent episodic tension-type headache. For this purpose, we will conduct a randomized, double-blind, placebo-controlled, 2-way crossover trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years of age upon entry into screening
* A body weight of 50 to 100 kg
* Provision of informed consent prior to initiation of any study-specific activities/procedures.

Exclusion Criteria:

* Any history of a primary or secondary headache disorder, except for infrequent episodic tensiontype headache
* Any first-degree relatives with a history of a primary headache disorder, except for infrequent episodic tension-type headache
* Any history of moderate to severe traumatic brain injury
* Any history of cardiovascular disease, including cerebrovascular diseases
* Any history of pulmonary disease
* Any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. This includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
* Female subjects of childbearing potential with a positive pregnancy test during any study visit
* Cardiovascular disease of any kind, including cerebrovascular diseases
* Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
* Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
* Abnormalities on the electrocardiogram that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
* Daily use of any medication other than contraceptives
* Intake of any medication other than contraceptives within 48 hours of infusion start
* Intake of caffeine, nicotine, and alcohol within 12 hours of infusion start
* Headache of any intensity within 48 hours of infusion start
Effect of Thoracic Epidural Analgesia for Thoracotomy on the Occurrence of AF

Thoracic epidural anesthesia and analgesia for patients undergoing lung resection can reduce the occurrence of AF if it is continued for six postoperative days instead of just three.

THEA is considered a very effective technique of providing intra and post-operative analgesia for thoracic surgical procedure and it seems that can also be effective in reducing the incidence of postoperative AF in patients undergoing lung resection. Nevertheless the timing of stopping the epidural analgesia and its further substitution with other therapies, remains unclear.

In this study patients who are scheduled for lung resection surgery will undergo the surgery under combined general anesthesia with volatile anesthetics and thoracic epidural anesthesia.

Immediately after surgery the patients will be divided into two groups:

* those who will receive thoracic epidural analgesia for 6 days
* those who will receive thoracic epidural analgesia for 3 days and will then switch to intravenous morphine for another 3 days

All the patients will be monitored daily for arrythmias

Eligibility Criteria:
Inclusion Criteria:

* lung resection
* pneumonectomy

Exclusion Criteria:

* Patient refusal
* AF (present or in the past
* contraindications for epidural catheter placement
Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP

The aim of the work was to find out the effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy.

The significance of this study is that there was paucity of literature in finding the comparative effects of sensorimotor training and constraint induced movement therapy on upper extremity function in children with hemiplegic cerebral palsy. The aim is to find out the effects of sensorimotor training on motor functioning of the upper extremity in comparison of constraint induced movement therapy.

Eligibility Criteria:
Inclusion Criteria:

* subjects who were fully oriented
* children diagnosed with hemiplegic cerebral palsy
* no history of intramuscular botulinum injections past one year

Exclusion Criteria:

* children with epilepsy
* gross deformity of upper limb
* children with contractures
Immunological Measurement of Aspartate/Alanine Aminotransferase

Previous reports have suggested that ALT-immunoglobulin complex was increased according to the severity of the liver disease, and high concentration of mAST and this might indicate a severely damaged liver. Immunoassay might be useful as a screening method in the differ-ential diagnosis of liver fibrosis according to patients. In this study, the efficacy of immunoas-say in the prediction of liver fibrosis in patients with chronic hepatitis B (CHB) was evaluated.

Enzymatic analysis of aspartate/alanine aminotransferase (AST/ALT) does not exactly represent the progression of liver fibrosis. Immunoassay for the AST (cytoplasmic \[c\] AST/mitochondrial \[m\] AST) and ALT (ALT1/ALT2) have been suggested as one of the alternatives for the enzy-matic analysis. We evaluated the efficacy of immunoassay in predicting liver fibrosis and in-flammation. A total of 219 patients with chronic hepatitis B (CHB) who underwent hepatic ve-nous pressure gradient (HVPG) and liver biopsy before antiviral therapy were recruited. Serum samples were prepared from blood during HVPG. The liver function test including enzymatic AST/ALT and immunological cAST, mAST, ALT1 and ALT2 were checked with sandwich ELI-SA immunoassay with fluorescence labeled monoclonal antibodies, and were compared with the METAVIR stage of live fibrosis and the Knodell grade of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* patients with CHB, who simultaneously underwent HVPG and liver biopsy for the routine check-up prior to antiviral treatment, were prospectively recruited.

Exclusion Criteria:

* Patients were selected according to inclusion criteria with CHB and then excluded according to exclusion criteria: i. they had other cause with liver disease: ii. decompensated cirrhosis and re-ceived antiviral treatment within the previous 6 months. iii. malignancy
Safety/Efficacy of Antibiotic Steroid Combination in Treatment of Blepharitis and/or Keratitis and/or Conjunctivitis

Safety and efficacy of antibiotic steroid combination compared with individual administration in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis and/or conjunctivitis).

Antibiotic/steroid combination compared to individuals components 8 days of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of blepharitis and/or keratitis and/or bacterial conjunctivitis

Exclusion Criteria:

* Uncontrolled glaucoma or intraocular hypertension
* Wear contact lens during the study
* Patients with sight in a single eye
* Suspicious of viral, fungic infection
* Use of any other ophthalmic drugs during the study
* Use of immunosuppressant therapy
* Known or suspected allergy or hypersensibility to any component of study medication
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury

In this study the following hypotheses will be tested:

Electrical stimulation of the gluteal muscle (buttocks) leads to

1. an increase in the thickness of the gluteal muscle
2. a decrease in the thickness of the fat of the buttock area
3. a change in the distribution of the middle and maximal seating pressure to a more consistent pressure
4. an increase in well-being of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Duration of palsy: minimum two years after traumatic or non-traumatic spinal cord injury
* Level of lesion: T 10 to L 5, AIS A, classified by the American Spinal Injury Association (AISA)

Exclusion Criteria:

* Acute decubitus in the stimulated area
* Arteriosclerosis
* Less than three months after flap surgery or after decubitus in the stimulated area
* Infections or skin eczema in the stimulated area
The Predictors of ICU Admission of oPRES

The purpose of this study is to explore the predictors of ICU admission of obstetric posterior reversible encephalopathy syndrome.

The investigators retrospectively collected data (General information, clinical data, biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman diagnosed with PRES to explore the predictors of ICU admission during 2012 to 2021.Then, the investigators grouped all the patients into ICU group and Non-ICU group according to ICU admission or not.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant Women were diagnosed of PRES.
2. all patients provided written informed consent

Exclusion Criteria:

1. patients combined with other neurological disorders
2. patients combined with mental illness
Pulsed-dye Laser Treatment Prior to Surgical Excision

This prospective pilot study will investigate whether use of a pulsed dye laser (PDL) prior to surgical excision can improve the appearance and symptoms of scars. The primary outcome measurement for the study is the quality of the scar in areas pre-treated with PDL vs. control (cryogen spray only). For this study, subjects who are scheduled for a dermatologic surgical excision will have half of the surgical area pre-treated with PDL and the other half pre-treated with cryogen spray.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with ages between 18 and 65 years, who are scheduled for a dermatologic surgical excision
* Subjects requiring surgical excisions for any condition
* Subjects with any Fitzpatrick skin type
* Willingness to participate in the study
* Willingness to receive experimental treatment
* Informed consent agreement signed by the subject
* Willingness to follow the follow-up schedule
* Willingness to not use any other scar treatments during the study period (i.e scar massage, over-the-counter silicone pads, intralesional steroid of 5-fluorouracil injections, laser treatments)

Exclusion Criteria:

* Pregnancy
* Prior scar in area to be treated
* Known photoallergy to visible light (i.e polymorphous light eruption)
* Subject is unable to comply with treatment or follow-up visits
* Subject with a history of being on photosensitive medications for the past 3 months (thiazides \[used to treat high blood pressure\], tetracyclines, fluoroquinolones griseofulvin or sulfonamides \[used to treat infections\], sulfonylureas \[used to treat diabetes\], calcium channel blockers \[used to treat hypertension\], phenothiazines \[used to treat serious emotional problems\]).
* Known autoimmune disease (some autoimmune diseases can lead to sensitivity to light, such as lupus erythematosus)
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device
Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence

The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older

  * Undergoing a lung biopsy procedure with Ion System
  * Have peripheral pulmonary lesion (5th bronchial generation or higher)
  * Willingness to participate as demonstrated by signing the informed consent

Exclusion Criteria:

* Unable to provide informed consent

  * Presence of bilateral nodules intended to be biopsied during procedure
  * The presence of medical conditions contraindicating general anesthesia or bronchoscopic biopsy
  * Vulnerable population (e.g., prisoners, mentally disabled)