cyrilzakka/clinical-trials huggingface dataset:
A Study of Safety, Pharmacokinetics (Including Food Effect) And Pharmacodynamics of RO5545965 in Healthy Volunteers

This randomized, Investigator/Subject-blind, adaptive single-ascending-dose, placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics (including the effect of food), and pharmacodynamics of RO5545965 following oral administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2 doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period of approximately 2 weeks between treatment periods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Male subjects (whether surgically sterilized or not) with female partners of child-bearing potential must use two forms of contraception, one of which must be a barrier method, for the duration of the study and for 77 days after the last dose

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder
* Any condition or disease that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator
* History of clinically significant hypersensitivity or allergic drug reactions
* Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
* Regular smoker (\> 5 cigarettes, \> 1 pipeful or \> 1 cigar per day)
* Positive for hepatitis B, hepatitis C or HIV infection
* Dietary restrictions that would prohibit the consumption of standardized meals
* Participation in an investigational drug or device study within 90 days prior to screening, as calculated from the follow-up from the previous study
Preoperative Anxiety Level, Premedications and General Anaesthetic Proceedings

Although it seems obvious that the high level of preoperative anxiety may affect intraoperative anaesthetic requirements and recovery adversely, there are several contradictory studies about this subject. Furthermore, the effects of anxiolytic premedication are actually disputed: sedative premedication is widely administered but little clinical evidence supports its use.

We want to evaluate the effects of pre-procedure anxiety for propofol needs in patients receiving general anaesthetic procedure. We also want to know if premedication is useful according to the preoperative anxiety level, in order to determine if a sub-group of patients benefit from it.

This study will be carried out in solely at the institute of CHU de Reims, France (Reims Teaching Hospital) from March 2017 to May 2017. Selected patients will be over the age of 18, among those receiving general anaesthesia for surgery. Demographic data and medical history will be collected after written consent. Before the anaesthetic procedure, an APAIS questionnaire (Anxiety evaluation form) will be filled out by each patient.

The medical, anaesthetic and surgical care will not be changed. In the operating room, we will proceed with anaesthetic induction following a medical protocol according to the practice of our hospital (TCI Target Controlled Infusion or manual induction): the propofol infusion or injection is started with an initial effect-site concentration or dose and increased step by step until patients present the clinical en points defined as LOC (loss of consciousness, i.e. no response to a verbal command).

The effect-site concentration of propofol, induction time required for a loss of consciousness (LOC), and preoperative incidents will be recorded by an anaesthetist student nurse and will be recorded in a data book.

After surgery, we will record any secondary effect attributable to premedication.

The day after surgery, patients will be assessed with the EVAN-G questionnaire. Statistical analysis will be done in sub-groups with variance analysis. We will also do multivariate regression analysis according to the type of premedication, demographic data, preoperative variable and preoperative anxiety level. If the number of included patients allows it, we will do propensity score matching for premedication.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* surgery with general anaesthetic, programmed, in emergency or ambulatory
* Cognitive level adequate to submit APAIS - EVANG form
* General anaesthetic induction procedure using propofol

Exclusion Criteria:

* ASA 4 level
* Patient refusal
* pregnancy
* Rapid Sequence Induction (ISR)
* General Anaesthetic induction procedure using another drug than propofol (thiopental - etomidate)
Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?

The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular block throughout the entire surgical procedure followed by sugammadex reversal, would suppress EMG activity and result in improved anesthetic stability by reducing the variability of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the anesthetic drugs propofol and remifentanil required to maintain an adequate level of anesthesia (BIS between 40 and 60).


Eligibility Criteria:
Inclusion Criteria:

* Patients ASA I-III
* Between 18 - 80 years old
* Scheduled for routine cervical surgery
* Minimum duration of surgery is 90 minutes and performed with total intravenous anaesthesia (TIVA) with the hypnotic propofol, the analgesic remifentanil and the neuromuscular relaxant rocuronium
* Patients that are able to and do provide a signed informed consent form

Exclusion Criteria:

* Patients with neuromuscular diseases and severe cardiac and respiratory pathologies
* Contra indication for any of the drugs used
* Not able to complete the baseline PQRS test.
* Indication to perform tracheal intubation using fibroscopy
* Patients who are pregnant or nursing
Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1

The primary purpose of this study is to evaluate the safety, tolerability and effectiveness of encaleret in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).


Eligibility Criteria:
Key Inclusion Criteria:

* Be able to understand and sign a written informed consent or assent form, which must be obtained prior to initiation of study procedures.
* Postmenopausal women are allowed to participate in this study
* Body mass index (BMI) ≥ 18.5 to \< 39 kilograms (kg)/square meter (m\^2)
* Have an activating mutation of the Calcium-sensing receptor (CASR) gene
* Participants being treated with thiazide diuretics may be enrolled if they are willing and able to discontinue thiazides
* Participants being treated with strong Cytochrome P3A4 (CYP3A4) inhibitors should ideally, if clinically appropriate, discontinue these medications during the screening period
* Participants being treated with magnesium or potassium citrate supplements should discontinue such treatment starting on Day -1 during Period 1 and Period 2 and may be asked to discontinue treatment during Period 3

Key Exclusion Criteria:

* History of treatment with parathyroid hormone (PTH) 1-84 or 1-34 within the previous 3 months
* History of hypocalcemic seizure within the past 3 months
* Blood 25-OH Vitamin D level \< 25 nanograms (ng)/milliliter (mL)
* Participants with hemoglobin (Hgb) \< 13 grams (g)/deciliter (dL) for men and \< 12 g/dL for women
* Estimated glomerular filtration rate (eGFR) \< 25 mL/minute/1.73 m\^2 using Chronic Kidney Disease Epidemiology Collaboration (for participants \<18 years old the Schwartz equation will be calculated)
* 12-lead resting electrocardiogram (ECG) with clinically significant abnormalities
* Participants with positive hepatitis B surface antigen (HBsAg), hepatitis A immunoglobulin M (IgM), or human immunodeficiency virus (HIV) viral serology test results at the Screening Visit
* Pregnant or nursing (lactating) women
* History of drug or alcohol dependency within 12 months preceding the Screening Visit
* History of thyroid or parathyroid surgery
* Current participation in other investigational drug studies
* Unwillingness to refrain from blood donation within 12 weeks prior to Screening Visit from the start of the study enrollment through one year after the last dose of the study drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

This study investigates the Breathe Well device to test whether it is superior to the existing treatment standard of the Varian Realtime Position Management (RPM) system in assisting patients with deep inspiration breath hold.

Recent studies have demonstrated an increased risks of cardiac disease in breast cancer radiotherapy patients. For patients diagnosed \<50 years old, the risks for cardiovascular diseases/events were increased by 24-82% comparing left and right breast radiotherapy. The deep inspiration breath hold (DIBH) technique addresses this problem by reducing the heart dose by up to half, thus potentially reducing the increased rate of major coronary events by 20%. Providing patients with visual feedback in addition to audio guidance has been demonstrated to improve the reproducibility of the DIBH technique by 95% and stability by 80%.

Breathe Well is a new audiovisual feedback device that may increase the accuracy and workflow of implementing DIBH for breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Left-sided breast cancer patients (invasive and in situ)
* Supine positioning of the patients.
* Ability to perform a ≥20s breath hold
* \>18 years old
* An ECOG score in the range of 0 to 2
* Able to give written informed consent and willingness to participate and comply with the study
* Patients must be able to read and complete questionnaires in English

Exclusion Criteria:

* Involvement or at risk regional lymph nodes
* Pregnant / lactating women
The Effect of Silver Diamine Fluoride (SDF) on Bacteria Involved in Root or Cervical Carious Lesions

The study will compare bacteria levels in cavities before and after silver diamine fluoride (SDF) treatment.

To assess the effect of silver diamine fluoride (SDF) treatment on microorganisms present in root caries or cervical lesions by collecting microbial deposits before and 1 month after SDF application. Bacterial samples will be collected from 20 adult subjects at the initial visit before application of SDF and one month after. At the 1 month recall, examination for caries arrest will be performed. All 40 bacterial samples will be sent to the Forsyth Institute to verify bacterial composition using HOMINGS technology.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy adult participants 18 years of age and older.
* At least one tooth with active (soft) cavitated lesions of ICDAS score 5 or 6 near the gingival margin (coronal cervical caries at the CEJ or exposed root surfaces with soft active carious lesions exposing dentin).

Exclusion Criteria:

* Adult participants who suffer from serious life-threatening medical diseases that interfere with basic daily self care activities.
* Patients taking antibiotics within the last two weeks.
* Patients using chlorhexidine or fluoride mouth washes within the last two weeks.
* Pregnant or breastfeeding women.
* Teeth with arrested (hard) cervical or root caries lesions.
* Teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are mobile.
TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)

The primary aim of this study is to understand how insomnia contributes to chronic pain in youth. Specifically, the investigators are interested in how insomnia and the treatment of insomnia impact emotional states and the body's ability to efficiently modulate pain, either to increase or decrease pain perception. It is hypothesized that insomnia is associated with increased negative emotional states and impaired pain modulation, which will improve after treatment of insomnia. In this project, the objectives are to 1) evaluate the role of pain modulation as a potential mechanism through which insomnia impacts pain symptoms, and 2) evaluate the role of negative affect as mediators of the impact of insomnia on pain modulation.

Study participation will consist of a baseline assessment, a 5 session (once per week) virtual group cognitive behavioral therapy for insomnia (CBT-I) intervention, and a follow-up assessment. Investigators will also ask teen participants to complete the consensus sleep diary daily for 7 days prior to the baseline and follow up study visits. Assessment visits will consist of two types of assessments, questionnaires and quantitative sensory testing (QST). Participating parents and teens will complete questionnaires (both child and parent report) assessing the child's pain, sleep, and psycho-social variables. QST will assess pain inhibition via conditioned pain modulation (CPM) and pain facilitation via temporal summation (TS).


Eligibility Criteria:
Youth Inclusion Criteria:

* Aged 12 to 17 years.
* Meets criteria for insomnia with or without comorbid chronic musculoskeletal pain.
* Parent/guardian available to provide consent.
* Patient and a primary caregiver are able to independently read and understand English well enough to provide informed consent and complete study procedures.
* Access to email, internet, and audio and video call capabilities.

Parent/Guardian Inclusion Criteria:

* Parent/legal guardian of a child meeting above eligibility criteria
* Able to independently read and understand English well enough to provide informed consent and complete study questionnaires.

Youth Exclusion Criteria:

* History of cardiac or neuromuscular disorder
* Parent-report of child's use of Opioid medications (i.e., fentanyl, morphine, hydromorphone, methadone, hydrocodone, oxycodone) that cannot be discontinued for 7 days prior to study visits.
* Inadequate proficiency in English or a developmental disability that interferes with informed consent/assent or completion of study procedures.
* History of obstructive sleep apnea, restless leg syndrome, or narcolepsy.
* History of bipolar disorder and/or manic episodes
* Diagnosis of epilepsy.
* Currently in foster care or considered a ward of the state.
* History of Raynaud Syndrome.
* Active suicidal ideation, intent or plan in the past month.

Parent Exclusion Criteria:

• Inadequate proficiency in English or a developmental disability that interferes with informed consent or completion of questionnaires.
SMARTCLOTH. Design, Implementation and Study of the Effectiveness and Usability of a Digital Tablecloth for Self-management of Diet in Diabetic Patients.

The objective of this clinical trial is to know the usability and efficacy of SMARTCLOTH for better control and adherence to the dietary patterns recommended to patients with diabetes, both the portion diet system (more common for cases of Diabetes Mellitus type 1 -DM1-), and the plate method (more recommended in cases of Diabetes Mellitus type 2-DM2-). The main questions are:

* Does the use of SMARTCLOTH improve glycemic control in patients with diabetes mellitus?
* Do patients with diabetes mellitus find SMARTCLOTH useful in their daily lives?

The researchers will compare changes over 3 months in variables related to glycemic control in two groups, one using SMARTCLOTH (intervention group) and the other following standard recommendations (control group). To do so, participants will have to:

* Use SMARTCLOTH for 3 months or follow the recommendations they receive from their referring health professionals.
* Come back after three months for a check-up of the chosen variables.
* The experimental group should contact the investigators in case the hardware has any problems.


Eligibility Criteria:
Inclusion Criteria: Subjects with type 1 and 2 diabetes (eligible population) aged between 18 and 70 years with disease progression not exceeding 15 years and HbA1c greater than 7.5.

Exclusion Criteria:

* Degree of dependence (physical or psychological) that makes it impossible for them to perform autonomous self-care of the dietary-nutritional regimen.
* Oncological or autoimmune disease, chronic renal insufficiency, transplant patients and others that alter the values of the result variables or may constitute a confounding factor.
* Other diseases that entail surgical interventions or hospital admissions that make it impossible to follow up the study.
* Patients with complications due to the evolution of the diabetic pathology: retinopathy, nephropathy, polyneuropathy, ischemic heart disease, as well as other micro and macrovascular complications derived from the same and already recorded in the patient.
* Those subjects subjected to specific dietary regimes such as celiac disease, lactose intolerant, etc.
Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We hypothesise that an improvement or even normalisation of this balance may be achieved by the use of vaccines and dietary oats. The combined use of oral typhoid vaccine and cholera/ETEC-vaccine is supposed to stimulate mucosal defence factors, while dietary oats modifies the microbial environment inside the intestinal lumen. Or study aim is to show if such treatment brings symptom relief to patients with ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* ulcerative colitis of at least 4 months duration
* disease activity index score (Walmsley) \>5 and \</=13
* patients taking no ulcerative colitis relevant medicine, or stable doses of aminosalicylates or maximum 10mg prednisolon daily the last 2 weeks before study entry. They must remain on the same dose throughout the study (6 months).
* stool examination negative for enteric pathogens, clostridium difficile toxin and parasites

Exclusion Criteria:

* ulcerative colitis disease activity index \>13
* symptoms of bowel obstruction
* other serious medical condition
* use of any of the study vaccines during the last two years
* use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first vaccine dose, or planned use during study period
* pregnant or planning to become pregnant
* breastfeeding
* chronic administration of prednisolone more than 10mg per day or steroids of equivalent dose the last 2 weeks before the first vaccine dose
* treatment with anti-tumor necrosis factor within 3 months prior to the first vaccine dose
* use of other immunosuppressants or immune modifying drugs within 30 days prior to the first vaccine dose
Preoperative Cognitive Impairment Predicts Postoperative Delirium

Preoperative cognitive impairment (PCI) may increase the incidence of postoperative delirium (POD), yet screening for cognitive impairment is rarely performed. This study hypothesized that Mini-Cog for preoperative cognitive impairment screening predicts postoperative delirium. Elderly patients (65 years or older) attending Henan Provincial People's Hospital during the trial period who required elective thoracic surgery were recruited into the study.

We collected data points on demographics and hospital episodes through the electronic medical record the day before surgery. Cognitive function screening (Mini-Cog; the Mini-mental State Examination, MMSE), depression screening (Patient Health Questionnaire-9, PHQ-9), sleep quality assessment (Pittsburgh Sleep Quality Index, PSQI), and pain assessment (Numeric Rating Scale, NRS) were performed, and the time spent on Mini-Cog test and MMSE assessment was recorded. The Short Confusion Assessment Method (CAM) was administered once per day on postoperative days 1 to 5 to evaluate delirium.

Eligibility Criteria:
Inclusion Criteria:

1. 65 years of age or older,
2. elective thoracic surgery,
3. under general anesthesia.

Exclusion Criteria:

1. history of psychiatric disorders,
2. use of any antipsychotic drugs,
3. ASA score \>3
4. severe visual, hearing, or physical dysfunction unable to complete the scale
5. advanced malignant tumors of the chest with distant metastases to bone, liver, etc.,
6. history of general anesthesia surgery in the last six months.
PET-CT Scans in Healthy Volunteers After Flu Vaccination

This study is being done to learn how previous flu vaccination or previous infection with flu virus affects the immune response to vaccination.

Until recently, all recipients of influenza vaccine received a killed form of virus, typically in the same nondominant arm, each year before flu season. We hypothesize that natural infection, and some forms of vaccination, could allow vaccine induced responses to spread beyond the local lymph nodes near the vaccination site. From a practical perspective, if vaccine induced proliferation of specific immune cells in sites distant from the vaccination site lead to beneficial immune memory, it would suggest vaccination strategies that could be as simple as alternating the injected arm from year to year, or alternating inhaled vs. injected forms of vaccine.

This will be a 4 armed prospective study of individuals receiving unilateral FluShield i.m. Healthy adult volunteers 21-55 will be grouped according to the following criteria: I. Documented history of prior natural infection with influenza A or B within the past 5 years (diagnostic test or high titer hemagglutinin HA Ab in absence of vaccination); II. History of FluMist vaccination within the past 2 years; III. History of TIV (Trivalent (Inactivated) Influenza Vaccine) vaccination, any number of times, but only in a single (e.g., non-dominant) arm. Within one month of screening and baseline blood draws for PBMCs (Peripheral blood mononuclear cells) and Ab (antibody) titers, individuals will receive FluShield injections. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa). The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb).

Upon entering the study, 50cc of heparinized blood and 10 cc of serum will be drawn by antecubital venipuncture. Within 4 weeks of this blood draw, volunteers will receive a standard dose of i.m. TIV (FluShield). Four-seven days later they will have an FDG PET-CT scan performed after an 8 hour fast.

Additional blood draws of 50cc heparinized blood and 10 cc serum will be obtained at 2, 4, and 6 weeks post vaccination, and at 10-12 months post vaccination. After the last blood draw, volunteers will also be asked questions pertaining to flu-like symptoms during the past 10 months.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 21-55 years old.
* Willingness to participate in the study for a full year including multiple blood draws and PET-CT scanning

Exclusion Criteria:

* Diabetes
* Use of systemic steroids
* Pregnancy or unwillingness to practice birth control of some kind through the PET-CT scanning period
* Recent vaccination for other reasons (e.g., traveler's vaccines)
* Significant intercurrent illness that might interfere with vaccination "take" or interpretation of PET-CT scanning (e.g., chemotherapy for cancer)