cyrilzakka/clinical-trials huggingface dataset:
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA detected at screening
* Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
* Classification as treatment naïve or treatment experienced. Approximately 20% may be treatment-experienced.
* Cirrhosis determination (approximately 20% may have cirrhosis)
* Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day 1 prior to enrollment.
* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol
* Lactating females must agree to discontinue nursing before the study drug is administered
* Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Key Exclusion Criteria:

* Current or prior history of any of the following:

  * Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
  * Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
  * Liver transplantation
  * Hepatocellular carcinoma (HCC) (as determined by appropriate imaging at screening for those with cirrhosis) or current malignancy for which the patient is receiving treatment or which may interfere with individual's treatment, assessment or compliance with the protocol.
* Screening laboratory parameters outside of defined threshold
* Prior exposure to HCV NS5A inhibitor
* Pregnant or nursing female
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Use of any prohibited concomitant medications as described in study protocol
* Known hypersensitivity to VEL, SOF, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contrast-enhanced Diffusion-weighted MRI to Detect Liver Metastases in Patients With Pancreatic Cancer

Given the dismal prognosis of pancreatic cancer, detecting liver metastases early can avoid inappropriate therapy with the associated substantial risks, long-term hospital admissions and high costs, but without survival benefit. The current standard of diagnostic workup with contrast-enhanced CT (CECT) has a poor sensitivity (38-76%) for the detection of liver metastases. As more sophisticated and expensive treatment options emerge, better staging of pancreatic cancer is needed to avoid unnecessary procedures and select the most appropriate treatment strategy. New imaging modalities are available, but their value in staging of pancreatic cancer has not been evaluated yet. Therefore prospective imaging studies are necessary.

The main aim of this study is to determine the diagnostic accuracy of contrast-enhanced diffusion-weighted MRI (CE-DW-MRI) in the detection of liver metastases in patients with pancreatic cancer compared to a reference standard of histopathology and follow up imaging.

The study is an international, multicenter prospective cohort study (inclusion of patients until 138 patients with liver metastases are included, with a total maximum of 465 patients). Patients with pancreatic cancer will undergo additional CE-DW-MRI within two weeks from the CECT. CECT and CE-DW-MRI will be read independently by two radiologists. Suspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Pancreatic resection will be pursued in patients without proven liver or distant metastases. Patients with locally advanced or metastatic disease will be offered palliative treatment. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* clinical suspicion of pancreatic cancer
* written (signed and dated) informed consent

Exclusion Criteria:

* previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, ablation therapy)
* concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years
* contra-indications to undergo CT (due to e.g. extreme claustrophobia, untreatable contrast allergy, renal function impairment)
* contra-indications to undergo MRI (due to e.g. claustrophobia, untreatable contrast allergy, or not MRI compatible medical devices)
* insufficient command of the Dutch language to be able to understand the patient information or fill in the questionnaires
* pregnancy
Hereditary Paraganglioma: Evaluation of Screening Methods to Detect Tumors in SDH Positive Carriers

Hereditary paraganglioma -due to SDH (SDHD, SDHB, SDHC) germline mutations- causes paragangliomas and pheochromocytomas. Presymptomatic genetic testing should be offered to all first-degree relatives if an SDH mutation is detected in an index case with paraganglioma or pheochromocytoma. The main objective of our national clinical research project is to test different screening methods to detect presymptomatic tumors in order to establish guidelines for the work-up and the follow-up of SDH mutation carriers.


Eligibility Criteria:
Inclusion Criteria: identification of an SDH (SDHD, SDHD, SDHC) germline mutation
Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results

This randomized non-inferiority study will evaluate self-directed scalable electronic health platform (eHealth) methods for communicating Alzheimer's gene and biomarker results compared to videoconference telehealth disclosure with healthcare providers, as well as characterize the impacts of learning this information on the participant.

This is a randomized trial to evaluate self-directed scalable eHealth methods for communicating Alzheimer's gene and biomarker results, as well as characterize the clinical impacts of learning this information on the participant. All participants in the study will be randomized to receive their Alzheimer's gene and biomarker results either via person-mediated telehealth videoconference visit with a healthcare provider or by eHealth platform. A permuted block design will be used for randomization, and we will stratify by sex and apolipoprotein E (APOE) genotype.

Participants randomized to the eHealth arm will be offered either the ADWebPortal or ADChatbot but can switch between platforms or schedule a virtual appointment to speak with a healthcare provider at any point. Use of the pre-disclosure education platforms will be tracked. A HIPAA compliant telehealth application will be used for the person-mediated telehealth videoconference visits and sessions will be recorded.

Potential participants will be identified from the GeneMatch program. Study management and participation will be decentralized. Confirmation of eligibility and consent of potential participants will be completed remotely by a decentralized study team. Procedures requiring physical attendance (e.g., blood draw) will be completed remotely using mobile health services.

Eligibility Criteria:
Inclusion Criteria:

* Access to the internet and an internet-enabled device.
* Participant is able to provide informed consent as shown by correctly answering questions administered by the study coordinator during the electronic consenting process that assess understanding of consent form content.
* Participant is willing and has the ability to fully comply with study procedures defined in this protocol.
* Written and spoken fluency in the English.
* Participant agrees to undergo a blood draw for collection of a blood sample for future testing and repository storage.

Exclusion Criteria:

* Participant reports prior knowledge of APOE genotype.
* Lack of psychological readiness to receive AD gene and biomarker information as indicated by:

  1. obtaining a score of 10 or greater on the Patient Health Questionnaire - 9 (PHQ-9) AND/OR
  2. responding yes on any of the suicidal ideation questions extracted from the abbreviated Columbia Suicide Severity Scale (C-SSRS) or AD Specific Suicidality Questions.
* Presence of current major psychiatric illness, e.g., psychosis, bipolar disorder, PTSD
* Communication difficulties such as:

  1. Uncorrected or uncompensated hearing and/or vision impairment.
  2. Uncorrected or uncompensated speech defects.
Effect of PEEP on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure

We aim to determine the level of intraoperative PEEP that optimizes lung compliance without causing a rise in subdural pressure and if we can utilize optic nerve sheath diameter measurement as an indicator for ICP while optimizing lung compliance during supratentorial tumor surgeries.

Application of positive end-expiratory pressure (PEEP) during general anesthesia minimizes ventilation/perfusion mismatch, intraoperative atelectasis and postoperative pulmonary complications. PEEP application in intracranial surgeries is usually avoided due to the risk of raised intracranial pressure (ICP) leading to decreased cerebral perfusion pressure (CPP). Several studies examine the effects of PEEP on subdural pressure and CPP however none examine how lung compliance is affected at the same time. Ultrasound-guided measurement of optic nerve sheath diameter (ONSD) is an indirect indicator of raised ICP and there is limited literature on the correlation of ONSD and ICP during intracranial surgery. In this study, we aim to determine the level of intraoperative PEEP that optimizes lung compliance without causing a rise in subdural pressure and if we can utilize ONSD measurement as an indicator for ICP while optimizing lung compliance during supratentorial tumor surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Supratentorial tumor
* Elective surgery
* American Society of Anesthesiologist Class I, II or III

Exclusion Criteria:

* Midline shift more than 5 mm determined by intracranial imaging
* Initial subdural pressure higher than 20 mmHg
* Requiring intravenous mannitol or hypertonic saline treatment before dural opening
* Congestive heart failure
* Pulmonary hypertension
* Sepsis
* Hypovolemia
* Obstructive or restrictive lung disease
SOLFAMU Study of Nasal Brushing Collected OLFActory MUcosa Samples in the Diagnosis of Human Encephalopathies

Encephalopathies are a group of central nervous system (CNS) affection with heterogeneous etiology. Several causes have been recognized including neurodegenerative, vascular, infectious, autoimmune, toxic or allergic affections or secondary to systemic disorders. While 30-50% of acute encephalitis remains without etiological definition, definitive criteria for neurodegenerative diseases are usually unavailable in vivo and possible or probable definitions are used. The Olfactory mucosa (OM) is the part of the nasal mucosa that carries the specialized sensory organ for the modality of smell; the olfactory epithelium is composed of five principal cell types including olfactory receptor neurons. A sample of OM may be collected through a rhinoscopy-guided brushing: it is well-accepted by patients, not-contraindicated in patients with raised intracranial pressure and associated with almost no side-effects. Nasal brushing has recently been proposed for the in vivo diagnosis of Creutzfeldt-Jakob disease (CJD).

Aims of the project are:

1. Training of ear throat and nose (ETN), Infectious disease (ID) and neurology (NEU) specialists in the technique of nasal brushing;
2. Conducting a prospective study comparing the use of nasal brushing with gold-standard criteria in the diagnosis of Encephalopathies;
3. Increasing the diagnostic and prognostic power in the diagnosis of encephalopathies.

A prospective, case control, multicentric study enrolling 400 patients and 100 controls (patients with nasal stenosis undergoing rhinoscopy for clinical reasons). Patients will be diagnosed and followed according to international guidelines and local clinical practice. Cerebrospinal fluid and magnetic resonance imaging will be used, where indicated, for the diagnosis according to the clinical or radiological suspect.


Eligibility Criteria:
Inclusion criteria for cases:

* age\>18 years;
* signing a written informed consent (by the patients or his/her legal representant);
* clinical suspect of encephalopathy (acute or subacute) including acute encephalitis, neurodegenerative disorders and HIV-associated neurocognitive disorders.

Inclusion criteria for controls:

* age\>18 years;
* signing a written informed consent (by the patients or his/her legal representant); • clinical indication for rhinoscopy for stenotic disease of nasal sept or turbinates.

Exclusion criteria:

* Nasal anatomical abnormalities precluding the execution of nasal brushing;
* Serious general conditions and/or comorbidities in patients for whom nasal brushing may be a risk factor precipitating their pre-existing condition;
* Anti-coagulant treatment.
Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies

The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies.

Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point.

Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged ≥ 18 years.
* Pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva.
* Eligible to undergo brachytherapy treatment as an outpatient procedure.
* Able to read and understand English and/or Spanish.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
* Willing to participate in either the Reiki therapy or standard of care arm regardless of treatment assignment.

Exclusion Criteria:

* Prior brachytherapy treatment for a gynecological malignancy.
* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women

A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the vascular endothelium.

PCOS (cases) and non-PCOS (controls) pregnant women were enrolled. Cases will be randomized in four treatment groups: metformin plus placebo (group A1), metformin plus folic acid (group A2), placebo plus folic acid (group A3), placebo alone (group A4). Controls will not received any treatment (group B). Clinical and biochemical assessment (including serum markers of implantation), Doppler velocimetry of the uterine arteries, and trophoblastic invasion at histological and immunohistochemical evaluation.

Changes in clinical and biochemical data under treatment, pattern of Doppler velocimetry at the uterine arteries, and trophoblastic invasion were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy
* PCOS

Exclusion Criteria:

* Risk factors for pregnancy complications
* Severe obesity
Eating Frequency Study

The purpose of this study is to examine the influence of two Eating Frequency prescriptions, meal (energy intake occurring during three meals per day) and grazing (energy intake occurring every two to three hours per day), on consumption during an ad libitum meal consumed at the end of the day, overall daily energy intake, and ratio of energy intake to energy expenditure. It is hypothesized that the grazing condition will produce lower consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio of energy intake to energy expenditure than the meal condition.

20 men and women of healthy weight will participate in this study. The complete study design will be a 2 x 2 mixed factorial design, with the between-subject factor of order and a within-subject factor of eating condition (meal or grazing). Depending upon the eating condition, participants will be provided with a morning meal and an afternoon meal (meal) or two small meals and three snacks to be consumed every 2-3 hours (grazing). The types of foods and amount of foods provided to participants will be identical in each condition; the only difference in the conditions is the time spacing during the day when the foods are consumed. The primary dependent variable will be amount, both grams and energy, of food consumed during an ad libitum meal consumed in the evening at the completion of the meal condition, overall daily energy intake, and ratio of daily energy intake to energy expenditure. It is hypothesized that the grazing condition will produce lower consumption during an evening ad libitum meal, lower daily energy intake, and a lower ratio of energy intake to energy expenditure than the meal condition.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 35 years
* body mass index (BMI) between 18.5 and 24.9 kg/m2
* no history of overweight or obesity
* unrestrained eater (\<12 on Three Factor Eating Questionnaire \[TFEQ\])
* regularly participate in at least 150 minutes of moderate-intense physical activity per week over the previous 4 weeks

Exclusion Criteria:

* currently taking medication that affects appetite or food intake
* have a medical condition affecting eating or currently following a therapeutic diet
* are currently participating in a weight loss program and/or taking weight loss medication
* have gained or lost \> 5% of body weight during the past 6 months
* diagnosed with type 1 or 2 diabetes
* have had bariatric surgery
* report disliking foods used in the investigation (scoring a 1 or 2 on a 5-point Likert scale)
* report having allergies to foods used in the investigation
* currently smoke
* report binge eating
* are graduate students in the Department of Nutrition
* are pregnant, lactating, \< 6 months post-partum.
Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients

This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part.

Once the MTD has been defined, the MTD expansion part will be opened for enrollment.


Eligibility Criteria:
Inclusion Criteria:

All patients:

* Histologically-confirmed advanced solid tumors
* Progressive, recurrent unresectable disease
* World Health Organization (WHO) Performance status ≤ 2
* No history of primary brain tumor or brain metastases

MTD Expansion part:

* Histologically-confirmed advanced solid tumors
* Progressive, recurrent unresectable disease
* World Health Organization (WHO) Performance status ≤ 2
* No history of primary brain tumor; no brain metastases unless asymptomatic and clinically stable for ≥ 3 months
* Patients with genetic or molecular alteration of the PI3K pathway

Exclusion Criteria:

* Prior treatment with a PI3K inhibitor
* History of or active major depressive episode, bipolar disorder, schizophrenia, or history of suicidal attempt or ideation
* No clinically manifest diabetes mellitus (treated and/or with clinical signs)
* No acute or chronic renal disease
* No acute or chronic liver disease
* No acute or chronic pancreatitis
* No unresolved diarrhea
* No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
* No acute myocardial infarction or unstable angina pectoris within the past 3 months
* Not pregnant or nursing and fertile patients must use barrier contraceptives

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis

The main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.


Eligibility Criteria:
Inclusion Criteria:

* male/female, 18-75 years old, inclusive
* diagnosis of adult-onset RA
* had active disease
* had received methotrexate
* on a stable dose of folic acid

Exclusion Criteria:

* contraindication for methotrexate or anti-TNF
Detection of Celiac Disease in Patients With Hypothyroidism

The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. It also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.

This study is looking at whether hypothyroid patients who require above 125 mcg/day (or \>1.5mcg/kg/day) of levothyroxine are more likely to have celiac disease than those who require smaller doses. It also looks to see if the prevalence of celiac disease in hypothyroid patients who require elevated doses of levothyroxine is high enough to warrant screening in that population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy.

Exclusion Criteria:

* Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease.