cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.

OBJECTIVES:

* To investigate the association between biomarkers (HPV tumor status and ERCC1 expression) and clinical outcomes in a population of patients with recurrent or metastatic head and neck cancer.
* To develop the ability to select patients likely to respond to therapy and to avoid treatment with ineffective therapies, especially since these therapies have substantial toxicity.
* To estimate response and survival rates of HPV-negative and -positive patients in each study. (exploratory)

OUTLINE: Tumor HPV status is determined by in situ hybridization (ISH) and all samples also undergo immunostaining for p16. ERCC1 expression is evaluated with AQUA, a quantitative IHC analysis.

Samples are classified into two categories based on their biomarker status: HPV tumor status (negative versus positive), and ERCC1 expression level (low versus high).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tissue specimens from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301

  * Stage III, IV, or recurrent disease
  * Squamous cell disease
  * Any of the following diagnoses:

    * Lip and oral cavity
    * Oropharynx
    * Hypopharynx
    * Larynx
    * Paranasal sinus and nasal cavity
    * Squamous neck cancer
    * Salivary gland

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The Effects of Isotonic and Hypertonic Saline Infusion on Renal Biomarkers in Healthy Young Subjects

The kidneys have numerous salt and water channels and play a major role in the regulation of sodium and water. We do not know how these channels work in certain water and sodium accumulating medical conditions.

The purpose of this study is to identify and measure the activity in the water and sodium channels by measuring urine biomarkers/proteins in young healthy subjects.

25 healthy subjects from age 18-45 are recruited.

Subjects will be examined on three examination days. Four days prior to the examination days the subjects will consume a standard diet based on the amount of sodium and calories.

On the examination day subjects are randomised to an infusion with either isotonic saline 23 ml/kg, hypertonic saline 7 ml/kg or glucose 23 ml/kg for a period of 50 minutes.

Renal function is measured by renal clearance of 51Cr-EDTA, urinary sodium, potassium and creatinine.

Urinary NCC, NKCC and ENAC will be measured to evaluate the activity of sodium channels in the nephron.

Eligibility Criteria:
Inclusion Criteria:

* healthy males and females
* age 18-45
* BMI range 18,5-30,0 kg/m2

Exclusion Criteria:

* hypertension (ie ambulatory BP \>130 mmHg systolic or/and \>80 mmHg diastolic)
* history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic disease.
* alcohol abuse
* drug abuse
* smoking
* pregnancy or nursing
* blood donation within a month prior to examination
* Medical treatment apart from oral contraception
Local Injection of Steroid VS.Glucose 5% in Carpal Tunnel Syndrome

To assess pain relief and quality of life among patients with carpal tunnel syndrome after local steroid vs. glucose 5% injection.

Carpal tunnel syndrome (CTS) is the most prevalent type of peripheral nerve entrapment involving compression of the median nerve in the carpal tunnel. 1 This condition is more common in females than in males. CTS may be unilateral or bilateral. It is a significant cause of morbidity and poor quality of life in those patients. There is deterioration in functional outcomes and maybe psychologically as well. The severity of CTS varied from mild to moderate to severe. Its signs and symptoms include numbness along with the median nerve distribution of the hand, pain, atrophy of muscles, handgrip weakness, etc. Mild or moderate cases are usually seeking conservative treatment like electrotherapeutic modalities, manual therapy interventions, oral supplements and medications, and wrist immobilizations such as splints. Severe cases are likely to go toward surgery. But most patients with CTS are reluctant to take the surgical choice, mainly because of financial issues and secondary complications. Therefore, the evaluation of the effectiveness of the non-surgical (conservative) therapies should be a major concern, as they are cost-effective and lacks secondary complications. Much research has been conducted to see the efficacy of various conservative therapies.

-study method: We are going to carry out a double-blinded randomized, case-controlled study on 52 patients who are randomly chosen and categorized them into 2 groups, 26 patients each. we planned to inject steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in (group 1) and to inject 10 ml glucose 5% into the carpal tunnel for the other group (group 2).. All injections will be under sonographic guidance. Neurophysiology, U/S, pain scales, and quality of life scales studies will be performed for these two groups before treatment and after 12 weeks of injection. The patients will be followed up for 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. female or male patient \> 18y
2. mild to moderate cases of carpal tunnel syndrome according to Bland's Neurophysiological Grading Scale for Patients with CTS
3. clear consent to participate in the study

Exclusion Criteria:

1. age younger than 18y.
2. severe cases of CTS.
3. systemic diseases cause CTS .
C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection

This is an open-label, single arm trial in which patient who have ongoing antibody mediated rejection of a kidney transplant deemed refractory to maximal medical therapy are given the complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing antibody mediated injury. A maximum of 5 patients will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant with acute antibody mediated rejection refractory to standard therapy

Exclusion Criteria:

* Patients with known intolerance of or anaphylaxis to Berinert
Particle Sizing of Masticated Tree Nuts - Pistachios and Brazils

The investigators want to understand how oral processing (chewing) of nuts affects particle size and the presence of lipid (fat) on the cut surfaces.

The main objective of the study is to:

Measure the size of nut particles that have been chewed sufficiently to be swallowed.

The secondary objective of this study is to:

Measure any changes in lipid content due to chewing and compare it to a prediction from a theoretical model.

The investigators have developed a theoretical model for determining the release of nutrients from plant foods, specifically lipid (fat) from almonds. The model has been used to calculate the amount of lipid released from chewed almonds. The model shows that only about 10% of the lipid is immediately released. The investigators require information on the particle size distribution (number of particles of each size) for other chewed nuts to calculate the amount of lipid released for other nuts. This will allow us to check the validity of our model for other foods.


Eligibility Criteria:
Inclusion Criteria:

* Must be generally healthy
* Must have eaten nuts within the last month with no adverse effects

Exclusion Criteria:

* Must not be allergic to nuts of any kind
* Must not have any teeth missing (apart from unerupted wisdom teeth)
* Must not have bleeding gums
* Must not have had dental treatment (other than checkups) in the last 3 months
* Must not be currently suffering from any infectious disease that may be passed on via saliva e.g. Glandular fever, flu
Injection of Dorsal Scapular n at Different Levels, Dose it Make Difference?

Dorsal scapular nerve (DSN) entrapment syndrome is an under-recognized cause of neck and shoulder pain. DSN injuries can be the origin of a well-defined chronic pain syndrome, often referred to as DSN syndrome. DSN syndrome is often characterized by a dull ache along the medial border of the scapula.

Dorsal scapular nerve syndrome typically presents with a weakness of the levator scapulae and the rhomboid muscles, and results in a winged scapula. A winged scapula is where the scapula protrudes from the patient's back and can affect the ability to lift objects or pull and push. The winging of the scapula seen with dorsal scapular nerve syndrome is not as severe as seen as injury or paralysis of the serratus anterior muscle.

Dorsal scapular nerve entrapment is a very under-recognized cause of neck and shoulder pain. The scapular winging may be subtle, and the symptoms are easily mistaken for other problems. A careful history and physical exam, along with a high index of suspicion, are necessary for accurate diagnosis and therefore appropriate treatment. Injection of the dorsal scapular nerve under ultrasound guidance can be diagnostic as well as therapeutic.

Eligibility Criteria:
Inclusion Criteria:

* scapular pain

Exclusion Criteria:

* cervical radiculopathy
Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Through prospective registration and follow-up, this study will collect data of patients with intracranial/carotid stenosis, including clinical information, neuropsychological scales, multimodal magnetic resonance images. The investigators aim to analyze clinical and imaging characteristics of patients with cognitive impairment related to intracranial/carotid stenosis, in order to achieve early identification of cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 40 years
* ≥ 50% stenosis in unilateral intracranial / carotid artery
* Written informed consent available

Exclusion Criteria:

* Previous history of major head trauma and any intracranial surgery
* Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
* Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
* Severe loss of vision, hearing, or communicative ability

Exit Criteria:

* Not meet the inclusion criteria
* For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
* Any adverse or serious adverse events during the study period judged by investigator
Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%

The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.


Eligibility Criteria:
Inclusion Criteria:

* Must be male or female and at least 18 years of age.
* Female patients must be on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
* Ability to provide informed consent
* Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand
* AK should be confirmed by histopathology of one of the AK's prior to inclusion

Exclusion Criteria:

* location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma
* undergone Cosmetic or therapeutic procedures
* use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1
* use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 1.
* treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1
* treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy within 2cm of the treatment area in the 8 weeks prior to visit 1
* use of systemic retinoids
* those who are currently participating in any other interventional clinical trial
* females who are pregnant or are breastfeeding
* those known or suspected of not being able to comply with the requirements of the protocol or provide consent
Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.

Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.

This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.


Eligibility Criteria:
Inclusion Criteria:

* in labor
* labor pain \>3 on visual analog scale (VAS)

Exclusion Criteria:

* cardiovascular disease
* preeclampsia
* diabetes mel-litus
* thyroid disease
* current (outpatient) opioid medication
* recent and / or current use of cocaine
* seizure disorder
* psychiatric disease
* body mass index \>35
* preterm labor (\<37 weeks pregnant)
* known allergies to any of the three study substances
Patients With Asymptomatic Hyperuricemia Have Stronger Local Inflammatory Response and Worse Outcome After Total Knee Arthroplasty

We identify all patients who had undergone primary total knee arthroplsty(TKA) from April 1, 2015, to March 30, 2016. Patients are grouped by uric acid level. The knee society score(KSS score) and the hospital for special surgery knee score (HSS score) before the surgery and 6 years after the surgery will be collected. Also the clinical data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* patients who had undergone primary TKA from April 1, 2015, to March 30, 2016

Exclusion Criteria:

* (1) infection, (2) rheumatoid arthritis, (3) ankylosing spondylitis, (4) revision surgery, (5) patients with unicondylar knee replacement, (6) patients who have been diagnosed with gout or previous gouty symptoms, and (7) patients combined with preoperative redness or swelling.
Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function

Randomized, controlled, double-blind intervention study of four parallel branches depending on the product consumed, to analyze the efficacy of an Omega-3 based product on the mobility and functionality of the evaluated joint.

The duration of the study will be 60 days (8 weeks). Each day they will have to consume the product under investigation. Subjects who meet the selection criteria will be randomized into each of the study groups (A, B, C o D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary regarding pain and concomitant medication.

They will make a total of two visits to the research laboratory and will perform the tests pre-established in the protocol. In addition, a follow-up telephone call will be made after 30 days of consume. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (age: 40-75 YO).
* Subjects must have persistent knee pain with a baseline VAS pain assessment score of at least 30 mm.
* Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.

Exclusion Criteria:

* Serious or terminal illnesses.
* Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.
* Subjects who are currently consuming or have consumed in the last two months any Omega-3 based supplement and/or supplement based on the botanical ingredient under investigation.
* Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
* Subjects with a body mass index above 32.
* Subjects with known allergy to any of the study components.
* Pregnant or lactating women.
* Inability to understand informed consent.
Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation

The purpose of this study is to determine whether transcranial cathodal direct current stimulation (tDCS) delivered over the cerebellum can improve essential tremor.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 65 years
* Important essential tremor (bilateral postural and/or action tremor since more than one year)
* Normal physical and neurological examination, except for essential tremor
* Insufficient efficiency of usual essential tremor's treatment
* No treatment altering the cortical excitability
* Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential
* mini-mental status score \>24

Exclusion Criteria:

* Age \< 18 years and \> 65 years
* Current neurological or psychiatric illness other than essential tremor
* Individual who is on medication which is known to lower seizure threshold
* Previous history of seizure, loss of conciousness or current active epilepsy
* Contraindication for MRI or TMS study
* Intake of antiepileptic medications for essential tremor (barbiturates, gabapentine, topiramate, clonazepam), within the 7 days preceeding the first visit
* alcohol intake within the 24 hours preceeding the first visit
* Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
* Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide an informed consent
* Simultaneous participation in another clinical trial
* Patients who are not enrolled at social security
Maraviroc in Rheumatoid Arthritis

The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients.

Following a planned interim analysis in the POC component on 21 August 2008 by the internal DMC (Data Monitoring Committee) of study A4001056, the trial was discontinued due to lack of efficacy. All participating investigators/country offices and monitors were notified on 22 August 2008 to cease patient enrollment. The DMC indicated that maraviroc was well tolerated in the Rheumatoid Arthritis patients and there were no safety concerns in the study. The termination date of this trial was 07 October 2008 when the last patient last visit occurred.

Eligibility Criteria:
Inclusion Criteria:

* Must be legal age of consent
* Must have active rheumatoid arthritis based upon the American College of Rheumatology (ACR) 1987 (Revised Criteria); minimum disease criteria required for entry into the efficacy component of the study
* Must meet ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III
* Must be receiving methotrexate for at least 12 weeks duration and on a stable dose for 4 weeks.

Exclusion Criteria:

* Diagnosed with any other inflammatory arthritis or a secondary non-inflammatory arthritis that would interfere with disease activity assessments.
* Subject receiving prior treatment with certain medications for rheumatoid arthritis
* Tuberculosis and/or a positive tuberculin reaction
* Significant trauma or major surgery within 2 months
* History of alcohol and/or drug abuse outside of a defined period of abstinence
* History of or a finding at screening of postural hypotension
* Any condition that would affect the oral absorption of the drug
* History of cancer and in remission less than 3 years or Grade III-IV congestive heart failure
* Having an infection of human immunodeficiency virus (HIV), Hepatitis B or C or evidence of any active infection
* Abnormalities of clinical or laboratory assessments completed at the screening visit such as elevated liver enzymes, decreased hemoglobin or an abnormal ECG
* Having a positive chemokine receptor 5 (CCR5) delta 32 mutation
* Requiring the use of certain medications
* Lactating or pregnant women or subjects have reproductive potential unwilling to use an adequate method of birth control
* Chronic or recent serious or life-threatening infection; severe , progressive and/or uncontrollable renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease within 12 weeks of the first dose.
Neural Gliding Exercise for Low Back Pain

Low back pain is a very common problem that causes pain, disability, gait and balance problems. Neurodynamic techniques is used for treatment of low back pain. The aim of the study is comparing the effects of electrotherapy and neural mobilization techniques on pain, functionality, gait and balance.

There are many physiotherapy modalities in the treatment of low back pain (LBP). Electrotherapy procedures, manual therapy techniques, kinesiotherapy and specific exercises are among those that are frequently used. In neural mobilization techniques, which began to gain popularity in 1990s, neural tissue and the surrounding structures are glided or tensioned to mobilize them. Neural mobilization is thought to have a positive effect on symptoms by inducing intraneural circulation, axoplasmic flow, and neural visco-elasticity and sensitivity associated with the connective tissue. There are studies in which this modality has yielded therapeutic success in terms of both pain and functionality, particularly in lumbar region and lower limb disorders where neural mechanosensitivity is increased.

Eligibility Criteria:
Inclusion Criteria:

* Subjects scoring below 70 degrees in the straight leg raise test
* received no physiotherapy until at least 6 months before initial evaluation

Exclusion Criteria:

* subjects who were unable to walk independently,
* who had systemic diseases besides LBP,
* who underwent spinal and lower limb surgery,
* who scored above 70 degrees in the straight leg raise test,
* used analgesics within 48 hours before initial evaluation were excluded.