cyrilzakka/clinical-trials huggingface dataset:
Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.


Eligibility Criteria:
Inclusion Criteria:

* accepted informed consent
* preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
* patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage)

Exclusion Criteria:

* rejected informed consent
* patients not fit to surgery (according to the general health condition and the clinical tumor stage)
* pregnant women
Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.

The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations and dosing regimens on high-risk cervical human papillomavirus infection in women.

Cervical cancer is caused by infection with specific genotypes of the human papillomavirus referred to as oncogenic or high-risk human papillomavirus. Current epidemiologic evidence suggests that 80% of sexually active women will become infected during their lifetime with human papillomavirus and 50% of these infections will be due to high-risk human papillomavirus. With US annual rates of cervical cancer now in the range of 13,000/year, a very substantial number of women are left with uncertainty regarding whether their infection will clear spontaneously or progress to cancer.

Subjects participating in this study were required to visit the clinic for approximately 15 or 16 visits, and maintain a diary of self-dosing and menstruation cycles. The total time of participation in this study was approximately 27 months.

Eligibility Criteria:
Inclusion Criteria:

* Willing to be on acceptable method of birth control
* Have a Pap smear result of LSIL or ASCUS
* Is high risk HPV positive

Exclusion Criteria:

* No evidence of high-grade disease or glandular abnormalities,
* Complete visualization of all lesion margins and the transformation zone,
* No uncontrolled significant medical illness or sexually transmitted infections,
* Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.
Ciprofol vs Propofol for Reducing Hypoxia Incidence in ERCP

Intravenous anesthesia has been widely used in endoscopic retrograde cholangiopancreatography (ERCP). In the past decade, many practices have been carried out under the propofol-based monitored anesthesia care without endotracheal intubation in patients undergoing ERCP.

Ciprofol is a newly developed intravenous anesthetic with a potency 4-5 times than that of propofol. Ciprofol seems a promising anesthetic agent for intravenous anesthesia but the evidence supported its application in ERCP is still limited.

This is a prospective, randomized, double-blind trial comparing the incidence of hypoxia in the propofol versus ciprofol intravenous Anesthesia. A total 136 patients will be recruited and randomly assigned to either the propofol or the ciprofol group. The primary outcome is the proportion of patients experiencing hypoxia. The secondary outcomes include: the incidence of hypotension in perioperative period; the incidence of conversion from intravenous anesthesia to general anesthesia; sedation-related procedure interruption; carbon dioxide( CO2) accumulation during operation; Patients' satisfaction with anesthesia and postoperative recovery / VAS score / incidence of nausea and vomiting; the incidence of intraoperative and postoperative adverse events, such as adverse excretion, severe hypoxemia, severe circulatory dysfunction; length of stay and mortality within 30 days after operation.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing ERCP, ASA I-III
* normal renal function
* BMI ≥ 18kg/m 2 and ≤ 30kg/m 2

Exclusion Criteria:

* Previous serious cerebrovascular accidents and other neurological diseases
* mental diseases, long-term use of drugs that affect the function of the central nervous system, benzodiazepines or opioids
* history of anesthetic allergy
* preoperative hypotension or preoperative SpO2 \< 90%, or chronic respiratory failure
* patients suspected of having difficult airways
* screening for drug addiction and alcohol abuse within the first 3 months (\> = 6standarddrinks/day)
* patients diagnosed with severe cardiopulmonary disease, or respiratory or respiratory diseases such as sleep apnea syndrome;
* bradycardia or atrioventricular block.
* participate in other clinical trials within 4 weeks;
* cognitive or communication abnormalities determined by the researchers;
* emergent and critical conditions during the operation;
* other conditions that the researchers believe are not suitable to participate in the study.
Extinction Learning in Adults With Tourette Syndrome

Aversive sensory phenomena such as premonitory urges play a central role in the behavioral treatment model of tics. Extinction learning and extinction recall are learning processes implicated within this model, but are still understudied for individuals with Tourette syndrome (TS). This study examines extinction learning and extinction recall in adults with TS using an experimental task. This study will also explore the relationship between extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes with behavior therapy. Findings from this investigation will be used to update the behavioral treatment model, which serves as the basis for evidence-based behavioral interventions.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old,
* Have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 13 (\>9 for youth with motor or vocal tics only)
* Have not received more than 4 previous sessions of HRT
* Be fluent in English
* Medication free or on a stable dose of psychiatric medication for 8 weeks prior to enrollment.

Exclusion Criteria:

* An inability to complete rating scales
* An inability to attend study visits
Multiparas Attitude to Outpatient Cesarean Section

The main purpose of this study is to explore multiparas attitude to outpatient care after a planned cesarean section.

This qualitative study should provide information about:

* Multiparas reflections in relation to prefer inpatient care after a planned cesarean section
* Womens anticipation of having inpatient care after cesarean section
* The womens experiences in relation to a planned cesarean birth and the first postnatal weeks

Eligibility Criteria:
Inclusion Criteria:

* Planned elective cesarean section of multiparous women
* Singleton pregnancy
* Age of at least 18
* Gestational age between 37 and 42 weeks

Exclusion Criteria:

* Lack of consent
* Women with no or little understanding of Danish and ability to speak Danish.
* Allergies to medicine included in the pain management regimes
* Expected maternal or neonatal complications after delivery
* Birth weight of less than 2500 grams
Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions

Patients with a diagnosis of solid pancreatic lesions evidenced by imaging studies (CT, MRI) and who undergo endoscopic ultrasound-guided biopsy will be selected. Biopsies will be taken using modified tip needles (FNB) three different methods (capillary by suction, capillary without suction and wet suction).

From the results obtained from the pathology service, 3 variables will be assessed; Cellularity, blood contamination and suitability for a diagnosis.

EUS-BAAF procedure The procedure will be performed with a linear echoendoscope (PENTAX 3.8 EG-3870 UTK) and a HITACHI HI VISION Avius ultrasound processor, after deep sedation by the anesthesiology service. BAF Acquire # 22 needles (Boston Scientific, Malborough, MA) will be used. 3 passes will be made to the tumor, each pass will consist of 10-15 movements of the needle back and forth in a fan within the solid lesion, under complete ultrasound control (ESGE 2017- Gastrointest Endoscopy Clin N Am 22 (2012) 155 -167). Doppler will be used to avoid any vascular structure in the path of the needle.

The passes will be in three different ways to compare.

1. Capillary with suction (puncture with gradual withdrawal of the stylet, applying dry suction with a 10 ml air vacuum syringe after removing the stylet)
2. Capillary without suction (puncture with removal of the stylet gradually, without suction after removing the stylet)
3. Moist suction (Before the puncture, the stylet is removed from the needle and irrigated with 1-2 ml saline solution to replace the air column with liquid, then the solid lesion is punctured and suction is placed with a vacuum syringe of 10 ml of air)

The quality of the biopsy will be evaluated by the pathologist independently and without knowing how the sample was obtained.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Any gender.
* Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.

Exclusion Criteria:

* That no lesion in the pancreas is identified by EUS.
* Pancreatic lesions with a cystic component.
* Alteration of coagulation parameters (INR\> 1.5, Platelets \<50,000 / mm3) or having taken antiplatelet agents or oral anticoagulants one week prior to the biopsy.
* History of acute pancreatitis in the last 4 weeks.
* Pregnant
* Refusal or inability to sign informed consent
Acute Effects of an Oral Fat Load on Skeletal Muscle and Hepatic Insulin Sensitivity

The development of type 2 diabetes is based on a combination of insulin resistance and beta cell dysfunction. In the last years, elevated FFA were recognized as a key players in the pathogenesis of insulin resistance and type 2 diabetes.

The study compares the acute effects of an oral lipid bolus on insulin sensitivity and hepatic glucose metabolism in healthy humans.

A dysregulation of lipid metabolism with increased levels of free fatty acids (FFA) represents one key mechanism in the pathogenesis of insulin resistance, which contributes to the development of type 2 diabetes (T2D). In most cases, dyslipidemia is related to obesity and the metabolic syndrome. Not only skeletal muscle glucose uptake, but also hepatic glucose fluxes are altered in insulin resistant states. In obese and T2D subjects, rates of gluconeogenesis (GNG) are increased, but in obese normoglycemic subjects endogenous glucose production (EGP) remains constant because of downregulation of glycogenolysis (GL). However, in T2D subjects, both GNG and GL are elevated, contributing to fasting and postprandial hyperglycemia. Therefore, elevated GNG rates may represent an early event in the pathophysiology of insulin resistance and T2D.

Preliminary studies of our institute show that intravenous lipid infusion with subsequent elevation of FFA results in increased GNG rates without alteration of EGP in lean, non-diabetic subjects. In another recent study we investigated the effects of an oral fat load on hepatic insulin sensitivity. As expected, we did not find any alterations in EGP; however, rates of GNG and GL have not been assessed.

The aim of this study is to analyze the effects of an oral fat load with transiently elevated levels of circulating lipids on hepatic glucose fluxes, especially GNG and GL, to elucidate the role of dietary fat in the induction of insulin resistance in healthy humans.

In this randomized, controlled cross-over study, effects of oral palm oil and canola oil ingestion will be investigated in young, healthy lean subjects. Hepatic glucose fluxes will be assessed by two independent methods, in vivo magnet resonance spectroscopy (MRS) and the deuterated water/acetaminophen method, which also allows for the determination of glycogen cycling rates. Furthermore, hepatic phosphorus metabolites and liver fat content will be monitored by MRS.

Eligibility Criteria:
Inclusion Criteria:

* healthy male and female subjects
* age 20-40
* BMI 20-25 kg/m2

Exclusion Criteria:

* hyperlipidemia
* smoking
* pregnancy
* allergy against paracetamol/palm oil/canola oil
* contraindication for MRI investigations
* anaemia
* taking drugs influencing lipid or glucose metabolism, the immune system or antihypertensive treatment
* M. Meulengracht
* Hepatitis/HIV
* chronic diseases
A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease

This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization. Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep. There will be a screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of informed consent, concomitant medication review, adverse event review, pill counts, vital signs (including supine blood pressure), and outcome measurements. Telephone visits will include review of informed consent, concomitant medication review, and adverse event review.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease
* Have normal kidney function (determined at screening visit by blood sample analysis), and no active medical diagnoses associated with fatigue
* No orthostatic symptoms (i.e. light headedness, blurred vision, and/or muscle weakness)
* No objective orthostasis (significant drop in blood pressure when standing)
* No supine hypertension (high blood pressure while laying down) judged to be of clinical significance by the investigator
* Well-controlled depression
* Stable dopaminergic medication regimen for 6 weeks prior to screening
* No concurrent use of fludrocortisone, midodrine, or other medications that may raise blood pressure
* PD Fatigue Scale Score of 50 or above

Exclusion Criteria:

* Diagnosis of Atypical Parkinsonism (having symptoms that mimic PD without a PD diagnosis)
* Prior Intolerance of droxidopa
* SNRI or TCA class (both antidepressant) medications (irrespective of indication)
* Use of activating agents (amantadine, modafinil, methylphenidate and related stimulants)
* Significant cardiac disease history
* Significant kidney disease history, or creatinine (a chemical found in the blood) greater than 1.5 mg/dl at baseline
* Poorly controlled depression
* Women who are pregnant or breastfeeding
* Significant history of Gastro Intestinal disease that may interfere with absorption (gastric bypass, inflammatory bowel disease)
Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin Conditions and Inflammatory Related Factors

To assess a resveratrol formula on improvement of skin conditions and inflammatory cytokines in blood


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
* Subjects who have large spots (area \>3 square centimeter) or abnormal acne.
Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients.

Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.

Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of at least 3 months
* ECOG performance status of 0 to 1

  • In sexually-active patients, willingness to use 2 effective methods of contraception
* Adequate hematological and organ function, confirmed by lab values
* Tumor tissue must be available for prospective determination of FGFR2b overexpression

  * Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment
  * Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
  * Measurable disease as defined by RECIST version 1.1

Exclusion Criteria:

* Untreated or symptomatic central nervous system (CNS) metastases
* Impaired cardiac function or clinically significant cardiac disease

  - Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs \</=14 days (\</=28 days for patients in Korea) prior to first dose of FPA144
* Ongoing acute adverse effects from prior anticancer or investigational therapy \> NCI CTCAE Grade 1
* Retinal disease or a history of retinal disease or detachment
* Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea
* Major surgical procedures are not allowed ≤28 days prior to FPA144 administration
* Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study

  - Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
* Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate
* History of prior malignancy except:
* a) Curatively treated non-melanoma skin cancer or
* b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or
* c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect
* Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway
MRI Biomarkers in ALS

Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Increasing age is an important risk factor for developing ALS; thus, the societal impact of this devastating disease will become more profound as the population ages. A significant hurdle to finding effective treatment has been an inability to accurately measure brain degeneration in humans. Advanced magnetic resonance imaging (MRI) techniques hold promise in this respect, and may assist in aiding diagnosis and the efficient testing of new drugs.

Different MRI features of brain degeneration will be measured in a large sample of patients with ALS. The study will operate within the Canadian ALS Neuroimaging Consortium (CALSNIC). CALSNIC is a clinical research platform comprised of ALS clinics with standardized clinical and neuroimaging protocols.

This study will use advanced Magnetic Resonance Imaging (MRI) techniques to measure brain changes in ALS and related neurological conditions. Results from cognitive and neurological tests will be compared to the MRI. It is believed that these techniques will reveal changes in the brain that will help us understand normal brain function and the symptoms of neurological diseases as seen in ALS, as well to provide an objective measurement of degeneration (which is called a biomarker). This could improve not only the process by which new drugs for the treatment of neurological diseases are evaluated, but also how health care professionals address the needs of patients with these diseases.

Furthermore, a biomarker may give insight into the biological factors related to the diverse and variable clinical features amongst different patients.

Subjects will be recruited from ALS clinics that are a part of the Canadian ALS Neuroimaging Consortium (CALSNIC). Patients will have a diagnosis of ALS, PLS, PMA, or FTD. Healthy controls will be age and gender matched to patients. Subjects will visit their respective sites to undergo a clinical evaluation and an MRI. Follow up visits will occur at approximately 3-6 month intervals. Most subjects will have 2 follow up visits; more visits may occur for subjects who are physically able to continue in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be adults with a diagnosis of motor neuron disease (MND), including those with ALS, PLS, and PMA, and as well frontotemporal dementia (FTD) without motor neuron signs.
* Healthy controls over the age of 40 will also be recruited and will be age- and gender-matched to patients.

Exclusion Criteria:

* Subjects with other psychiatric/CNS illnesses such as Major Depressive Disorder, Schizophrenia, and Bipolar disorder, and those with significant head injury.
* Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body, or significant claustrophobia that could affect the ability to have an MRI scan.

These exclusion criteria will also apply to controls.
Intra-Corporeal Anastomosis Result in Quicker Return of Bowel Function/Earlier Discharge

Adult patients who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.

The purpose of this trial is to investigate whether minimally invasive right colectomies done with an intra-corporeal anastomosis result in quicker return of bowel function and earlier discharge. The primary endpoint of this study will be return of bowel function as measured by passage of flatus and bowel motions. The secondary endpoints will be inpatient length of stay, incision length, postoperative narcotic use, surgical site infection (superficial, deep and organ-space), perioperative morbidity and operating room charges.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are those over 18 years of age who are regularly scheduled to undergo a right hemicolectomy via a minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis. Right colectomy will be defined as removal of the ascending colon, ligation of the ileocolic artery and vein, +/- removal of the terminal ileum, +/- removal of the proximal transverse colon, and +/- removal of the right branch of the middle colic artery and vein.

Exclusion Criteria:

* Pregnant women
* Additional colon resection is planned (i.e. left colectomy or proctectomy)
* Vulnerable populations such as prisoners or adults unable to give consent
* If the scheduled surgery is planned at Butterworth hospital (as to standardize the nursing care received postoperatively)
* Emergent cases

Patients will be excluded from the study intra-operatively if:

* The procedure is converted to an open resection
* If a loop ileostomy is performed in addition to the right colectomy