cyrilzakka/clinical-trials huggingface dataset:
Diffusion-Weighted Magnetic Resonance Imaging

Recently, diffusion-weighted (DW) MR imaging has widened its application on various oncologic applications. Especially, it is expected the DW MRI could provide valuable information about early response evaluation after treatment using rapid apparent diffusion coefficient (ADC) value change. It has demonstrated potential usefulness in response evaluation in the liver tumors after treatments such as transarterial chemoembolization (TACE) and radiation therapy (RT). Furthermore, it is a functional imaging technique that does not require a contrast agent, it can be safely used in patients with renal insufficiency or other medical contraindications for contrast agents.

The optimal assessment of early response of RT could provide one of the most important information to prescribe patient and cancer specific RT dose. It might be also important in palliative RT of HCC bone metastasis which is related with painful aggressive mass formation.

This study is performed to evaluate the usefulness of DW MRI in early response evaluation after RT for HCC bone metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Hepatocellular carcinoma
* Spine metastasis
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
* 20 or older age
* informed consent
* consent to birth control during 6 months after treatment

Exclusion Criteria:

* less than 12 weeks of expected survival
* indication of emergency operation
* uncontrolled ascites or encephalopathy
* previous RT field lesion (within in 1 month)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)

This study aims to evaluate the safety, tolerability and PK of repeat dose administration of GSK2618960 in the treatment of pSS. The study will contain two parts, Part I will be open label and Part II will be randomized, double-blind. The minimum duration of Part I \& Part II of the study will be 26 and 32 weeks respectively.


Eligibility Criteria:
Inclusion Criteria:

* Part I and Part II: Male and females aged 18-70
* Part I and Part II: pSS diagnosis according to the American-European Consensus Group Criteria
* Part I and Part II: Documented previous biopsy evidence of salivary gland inflammation consistent with pSS and/or documented history of anti-Ro and/or anti-La antibodies
* Part II: Has any of the following abnormalities at screening: hypergammaglobulinaemia \[serum Immunoglobulin G (IgG) greater than or equal to 16 gram per liter (g/L); Presence of Rheumatoid factor (RF); Anti Nuclear Antibodies (ANA) titer greater than or equal to 320:1.
* Stimulated whole salivary flow greater than 0.1 milliliter per minute (mL/min) at screening.
* Symptomatic oral dryness greater than or equal to 5 out of 10 on Visual Analogue Scale (VAS) scale and/or Schirmer test less than 10 millimeter (mm) at screening.

Exclusion Criteria:

* Part I and II: Secondary Sjögren's Syndrome
* Part I and II: Receiving cyclophosphamide, other biologic, immunosuppressive or immunomodulatory treatments
* Part I and II: Active infections, or history of recurrent infections
* Part I and II: History of significant medical illness
* Part I and II: History of lymphoma
Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer

Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.

The study is a cross-sectional study. A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients.

The study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott).

The gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula.

Correlation between both parameters will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma in Head and Neck
* Getting a cross-sectional imaging of Head and Neck within 2 weeks of collecting serum squamous cell carcinoma antigen

Exclusion Criteria:

* Metastatic disease
* Accompanied Non-Head and Neck squamous cell carcinoma
* Nasopharyngeal, thyroid, salivary, nose and paranasal sinus carcinoma
* Skin disease: eczema, erythrodermic epidermitis, pemphigus, and psoriasis
* Pulmonary disease: tuberculosis, adult respiratory distress syndrome, pulmonary infiltration with eosinophilia, sarcoidosis, and bronchogenic cyst
* Renal failure
* Using antihistamine eye drops
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening

A prospective multicenter interventional study will be conducted to enroll women undergoing routine cervical cancer screening to collect cervical liquid-based cytology (LBC) specimen(s). For all subjects, two cervical specimens will be collected, and one placed into Hologic ThinPrep Pap Test collection kit with PreservCyt Solution (also referred to as ThinPrep specimen) and the other into BD SurePath liquid-based Pap test (also referred to as SurePath specimen). Cytology and HR HPV results will be generated and utilized to determine need for subject referral to colposcopy. Collection of an endocervical curettage (ECC) specimen, and biopsy(ies) if applicable, from women who are referred to colposcopy as a follow up will be conducted according to a standardized protocol. Disease status for each subject will be determined based on cytology, HPV test results, and/or consensus histology review of cervical biopsy specimens.


Eligibility Criteria:
Inclusion Criteria:

Women is eligible if she meets the following:

* Is 25 years of age or older
* Is attending a participating clinic for routine cervical cancer screening following screening guidelines
* Has an intact cervix
* Is willing and able to provide documented informed consent
* Is willing and able to undergo colposcopy, biopsy, and endocervical curettage (ECC) within 12 weeks (≤ 84 days) from the baseline visit, if required
* Is willing and able to allow collection of two cervical cytology specimens

Exclusion Criteria:

A women is ineligible for the study if she meets any of the following criteria:

* Is pregnant at the time of visit or plans to become pregnant within the following 12 weeks
* Has any known medical condition that, in the opinion of the investigator, would result in increased risk of bleeding at biopsy
* Has a known history of excisional or ablative therapy (e.g., LEEP, cone biopsy, cervical laser surgery, or cryotherapy) to the cervix in the last 12 months prior to the baseline visit
* Had a cervical cytology specimen collected within the last 4 months
* Is currently participating in any diagnostic trial for cervical cancer
* Had a complete or partial hysterectomy, either supra cervical or involving removal of the cervix
* Is currently participating or planning to participate in any clinical trial for HPV treatment (for the duration of this study)
* Previous participation in this study
Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting

A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,

In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (PONV).

Eligibility Criteria:
Inclusion Criteria:

Age ≥18 and ≤75 years old; 18 \< BMI≤30kg/m\^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.

expected or agreed to stay in the hospital for 24 hours or more after surgery;

Exclusion Criteria:

diagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;
Neural Correlates of Stress Reduction

This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Right-handed
* Stressed

Exclusion Criteria:

* Lifetime history of schizophrenia or psychosis
* Psychiatric illness
* History of seizure or significant head trauma
* Use of psychotropic medications
* Metallic implants or devices contraindicating magnetic resonance imaging
* Claustrophobia
* Pregnancy
Continuous, Non-invasive Monitoring of Intraoperative Cerebral Perfusion and Oxidative Metabolism (CPOM)

This study uses a CPOM Optical neuromonitor to assess the relationship between brain cytochrome C oxidase, cerebral oxygen saturation and blood pressure during surgery performed under general anesthesia.

During various surgical procedures, blood supply to the brain can be jeopardized either due to interruption of flow as occurs during carotid surgery, or due to inadequate arterial pressure which can occur in settings as diverse as heart surgery or shoulder surgery. This is a prospective observational study of brain oxygen levels, brain metabolism and blood pressure in 50 adult surgical patients under general anesthesia using a CPOM Optical neuromonitor.

This is an observational study. The primary objective of this study is to describe the changes in redox state of brain CCO (reflecting oxidative metabolism), CBFi, and brain tissue oxygen saturation in relation to systemic blood pressure in patients during general anesthesia/cardiopulmonary bypass (CPB). This study represents the first opportunity to assess this combined technology in adult patients and will provide important data to support further investigations in brain-at-risk patients.

These 50 patients will be used to help the investigators to obtain pilot data about the relationship between brain cytochrome C oxidase (bCCO), cerebral oxygen saturation (ScO2), and blood pressure (especially hypotension) using a CPOM device. Cerebral auto regulation indices will also be determined. No intervention will be applied.

Eligibility Criteria:
Inclusion Criteria:

* All adult surgical patients (\>18 year-old) who require general anesthesia for their surgery
* Patients required an arterial line for his/her procedure

Exclusion Criteria:

* Emergency surgery
* Unable to obtain consent
* Condition that preclude the use of CPOM monitor (e.g. skin lesion in the forehead)
Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine

The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated with migraine headaches.

The primary objective for this study is to compare headache relief (defined as a reduction from moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\] or mild \[Grade 1\] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.

Eligibility Criteria:
Inclusion Criteria:

* Men or women, between the ages of 18 to 65 years
* Diagnosis of migraine, with or without aura
* Experiences between 1 and 8 migraine attacks per month for the past 12 months

Exclusion Criteria:

* Inability to distinguish other headaches from migraine
* Experiences headache of any kind at a frequency greater than or equal to 15 days per month
* History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as subjects who have not responded to an adequate dose and duration of treatment
* Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
* Chronic opioid therapy (\>3 consecutive days in the 30 days prior to screening)
Cognitive Complaints in Obstructive Sleep Apnea

The study assesses cognitive complaints in newly diagnosed patients with obstructive sleep apnea with no medical-comorbity affecting cognition. Cognitive complaints will be compared to healthy controls matched on age, sex and educational level. Factors related to cognitive complaints will also be assessed, including anxiety and depressive symptoms, complaints of fatigue and sleepiness, quality of life, psychological coping strategies and objective measures of cognition. Patients starting treatment for sleep apnea (continuous positive airway pressure or mandibular repositioning device) will be reassessed on all measures after 6 months of treatment to study the impact of treatment as usual on cognitive complaints and its related factors.


Eligibility Criteria:
Inclusion Criteria:

* native Dutch speaker
* estimated verbal-IQ of ≥80

Exclusion Criteria:

* other sleep disorder than obstructive sleep apnea
* substance or alcohol abuse (e.g. no more than three units of alcohol per day for males and no more than two units of alcohol per day for females
* diagnosis of a psychiatric disorder
* use of medication effecting cognition
* neurological disease, diabetes mellitus, hypo- or hyperthyroidism or lung disease (as checked by verbal report and medical records)
An Investigation to Test a Prototype Full-face Mask in the Home Setting

This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial.

This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects with OSA (Ethics reference NTY/08/06/064), Auckland District Health Board (ADHB), or WellSleep Centre (Bowen Hospital, Wellington, NZ).

Participants will be on the trial for 21 days ± 6 days, using the prototypes at home for 14 days ± 3 days. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for 7 days ± 3 days prior to mask fitting with the Jupiter trial mask.

Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.

Eligibility Criteria:
Inclusion Criteria

* 18+ years of age
* Diagnosed with OSA by a practicing physician
* Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or experienced (6 months and more)
* Existing full face mask users
* Patients who are able to put on and remove their current mask without gross difficulty relating to an existing condition (e.g. arthritis of the hands).

Exclusion Criteria

* Inability to give informed consent
* Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
* Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or think they may be pregnant
Modulation of Propofol Injection Pain by Rubbing and Distraction

This prospective randomized controlled study will be conducted to evaluate the effects of rubbing and distraction on the incidence and severity of propofol injection pain and compare them with the standard intravenous lidocaine method.

Propofol has become one of the most common anesthetic agents used for sedation, induction, and maintenance of anesthesia because of its unique pharmacological properties. Pain during bolus injection is a major drawback with an incidence as high as 80%-90% in an untreated patient.

One of the most effective factors that alleviate the injection pain involves pretreatment with lidocaine.

Spinal modulation of pain is explained by the melzack gate control theory, it proposed that stimulation of A beta fibers by touch and vibration, modulate the dorsal horn "gate" and therefore the nociceptive input from the periphery could be reduced. (5) Regarding the use of this concept for managing propofol pain, only one study was conducted and revealed that rubbing didn't decrease the incidence but significantly decreased the severity of pain.

Distraction is a method of removing attention; so, it modifies cognitive pain perceptions by altering nociceptive responses and triggering an internal pain-suppressing system. Therefore, it causes a decrease in the activation of areas in the brain (e.g.: thalamus and insula) which contribute significantly to pain perception. we will combine rubbing and distraction, as methods for spinal and supra-spinal pain modulation, to evaluate their effects on propofol injection pain and compare them with the standard intravenous lidocaine method.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex
* American Society Anesthesiologists physical (ASA) status I-II
* age between 18-65 years old
* undergoing elective surgeries under general anesthesia using Propofol for anesthetic induction.

Exclusion Criteria:

* Allergy to experimental drugs
* Abuse of alcohol, analgesia, or sedative antidepressant
* Difficulty in communication
* Chronic pain syndromes, thrombophlebitis, neurological disease, and analgesic administration at the time of the study
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C

The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.

The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.

Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria:

* Insulin-dependent diabetes
* Anemia
* Smoking
* Shift work within the past 1 year
* Drug or alcohol dependency
* Bipolar disorder
* Post traumatic stress disorder (PTSD)
A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent

Acute mountain sickness is a common ailment in people venturing over 2500 m altitude. Pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of acute mountain sickness. There are no randomized controlled trials that have studied protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies regarding this matter.

This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will be randomly assigned for 3 days and participants will be assessed at 3 stations.

This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be the first RCT done in this issue.

The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the incidence and severity of acute mountain sickness.


Eligibility Criteria:
Inclusion Criteria:

* Nepalese national
* Aged 18 to 65
* Travelling directly from Dhunche to Gosainkunda
* Rapid ascent as defined by ascent within 3 days

Exclusion Criteria:

* Use of any drugs for the prevention of altitude sickness or headache
* Current illness
* Current altitude sickness (more than one mild symptom on the Lake Louise Questionnaire (LLQ), or oxygen saturation less than 75%
* Known to be pregnant or cannot exclude the possibility of being pregnant, or have missed menses by over 7 days
* One night within the last 30 days spent at an altitude of 4500 metres or above
* Residents of altitude more than 2500m
* A known drug allergy to sulfonamides.
* Treatment with any of the following in the last 2 days: acetazolamide (Diamox®), steroids (dexamethasone/decadron, prednisone), theophylline or diuretics (Lasix®), ibuprofen/motrin, naprosyn/naproxen, aspirin or acetaminophen.
* Any serious intracranial abnormalities such as history of brain tumours or pseudotumour cerebri
* Known severe uncontrolled headache syndrome
* Diagnosed renal function impairment, diabetes, cirrhosis of liver or liver dysfunction
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)


Eligibility Criteria:
Inclusion Criteria:

* Completion of Study OTX-101-2016-001

Exclusion Criteria:

-
Assessment of Comskil Training Through Videorecording and Patient Surveys

At Memorial Sloan-Kettering Cancer Center the investigators want to provide the best care to their patients. One way to do this is to evaluate the ways that doctors communicate with patients. To this end, the Department of Psychiatry and Behavioral Sciences runs a Communication Skills Training and Research Laboratory. One goal of this laboratory is to evaluate doctor-patient communication and provide training in how to improve the quality of this communication.

Invitation to participate in this pilot project does not mean that a problem with communication has been identified in your doctor's practice. Rather, it is because your doctor and the fellow working with your doctor have agreed to cooperate with us as the investigators develop strategies to train physicians, nurses and other clinical personnel to communicate with cancer patients in as effective and sensitive a manner as possible.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age;
* Able to understand and provide signature on permission form (Appendix II)
* Able to speak and read English

Exclusion Criteria:

* Evidence of cognitive impairment severe enough to preclude giving permission to the study staff, or completing the survey instrument of the study.