cyrilzakka/clinical-trials huggingface dataset:
Madrid - Tolerance and Acceptability Study

Tolerance and Acceptability of a gum based thickener.

To evaluate the tolerance and acceptability of AYMES MADRID, in patients that may require modified consistency fluids. Measuring GI tolerance, compliance, convenience and preference.

To obtain data to support an ACBS submissions for AYMES MADRID (to allow for prescription in the community at NHS expense).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) who are able to communicate clearly.
* Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by -Speech and Language Therapist.
* Patients expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks.
* Informed consent obtained from patient or for those without capacity following consultation with carers.

Exclusion Criteria:

* Patients with maize / corn allergy requiring a maize free diet
* Patients with inherited metabolic conditions.
* Patients requiring enteral tube feeding or parenteral nutrition.
* Patients with medical or dietary contraindication to any feed ingredients
* Patients with delayed oral phase of swallowing.
* Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
* Patients with dysphagia not requiring stage 1, 2 or 3 thickened fluids.
* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
* Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study (to prevent over burdening of participants and ensure a period of normalisation between study involvement)
Effects of Acceptance and Commitment Therapy in Primary Health Care

How does education of health personnel with Acceptance and Commitment Therapy affect the extent of medical certificates of sick leave and drug prescriptions in primary health care centers in Kalmar compared with similar centers in Jönköping in which the personnel do not get such therapy?

Five primary health care centers in the County Council of Jönköping who do not get education according to Acceptance and Commitment Therapy (ACT) serve as controls. Six primary health care centers in County Council of Kalmar, with the same total number of listed patients (about 45 000 in total per County Council) in their areas undergo group education according to ACT. Data on medical certificates of sick leave and drug prescriptions are taken from registries (this is routine in primary health care in Sweden) at baseline and after 6, 12 and 24 months in both regions. The personnel at both centers also fill out questionnaires about their own quality of life at baseline and after 12 months. The investigators also plan to interview about 20 subjects on these matters.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* working at the health care center

Exclusion Criteria:

* age less than 18 years
* do not work at the Health care center
Short Sessions of HRV Biofeedback

Remote 5 minute sessions of heart rate variability (HRV) biofeedback will be employed by participants for 5 weeks. Subjects will be followed for a total of 17 weeks. Surveys assessing psychological well being will be completed during the study period. Wearable devices will be worn to monitor HRV response during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Participants were recruited from The Mount Sinai Hospital, Morningside Hospital, Mount Sinai West, Mount Sinai Beth Israel, Mount Sinai Queens, New York Eye and Ear Infirmary, and Mount Sinai Brooklyn.
* Eligible participants were 18 years of age or greater.
* Had an iPhone series 5 or greater.
* Had or were willing to wear an Apple Watch 4 or greater.
* Potential participants were excluded if they had an underlying chronic disease or used a medication that is known to impact autonomic nervous system function.

Exclusion Criteria:

* Underlying chronic diseases including but not limited to:

  * rheumatoid arthritis
  * systemic lupus erythematosus
  * inflammatory bowel disease
* Use of medications that impact heart rate variability including but not limited to:

  * beta-blockers (ie. atenolol, carvedilol, metoprolol, Coreg, Tenormin, Normodyne, Trandate)
  * digoxin
  * calcium channel blockers (ie. Norvasc, amlodipine, Cardene, nicardipine, Procardia, nifedipine, Cardizem, diltiazem)
  * regularly used benzodiazepines
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.
2. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
3. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).
4. Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).

Exclusion Criteria:

Medical Conditions

1. Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening.
2. History of thymectomy within the 12 months prior to screening.
3. History of N meningitidis infection.
4. Use of the following within the time period specified below:

   * IV immunoglobulin within 4 weeks of randomization
   * Use of plasma exchange within 4 weeks of randomization
   * Use of rituximab within 6 months of screening
5. Participants who have received previous treatment with complement inhibitors (for example, eculizumab).
Identifying Novel Biomarkers in Early Rheumatology Patients

Patients new to a rheumatology practice will be asked if they want to consent to their blood sample, medical records, and hand/foot x-rays (with sharp scores) for the analysis and correlation with the diagnosis they will receive from the rheumatologist.

At the end of their first visit new rheumatology patients will be asked for their interest in joining the Inova biomarker study. If yes, the patient will be consented, blood will be drawn for the Inova biomarkers, and x-rays will be sent for sharp scoring. Patients may decline and will not be part of the Inova study. Patients who decline will continue to receive standard of care treatment henceforth.

Patients in the Inova trial will receive a diagnosis from their doctor and are placed into separate cohorts based upon their diagnosis. The Inova biomarker results of each cohort will be cross-correlated with diagnoses, pre-screening tool results. Baseline disease activity and sharp scores will also be correlation variables.

Eligibility Criteria:
Inclusion Criteria:

* Newly referred Arthritis Northwest PLLC
* Age 18 or older

Exclusion Criteria:

* None.
Accuracy of mpMRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in Detection of Prostate Cancer

The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigator inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.

Purpose: In recent years, multiparametric Magnet Resonance Imaging (mpMRI) has been established as a diagnostic imaging technique of the prostate and its assessment standardized with the "prostate imaging - data and reporting system" (PI-RADS v2). The previously established Likert scale from 1 to 5 has been shown to reflect the increasing probability of a carcinoma. Suspicious MRI lesions can be biopsied in a targeted fashion using ultrasound navigation termed fusion biopsy. The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigators inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.

Materials and Methods: This prospective study includes 228 consecutive patients, which underwent a perineal MRI-TRUS-fused prostate biopsy (BiopSee®, MedCom Company) during the period of September 2015 to March 2017 at the cantonal hospital Winterthur due to a suspicious PSA value, a suspicious digital rectal examination or a known prostate cancer under active surveillance. 71 patients were excluded due to lack of PI-RADS v2 diagnosis and / or MRI performed at a different center. Targeted biopsies were performed specifically in the indicated MRI lesions and standardized over the rest of the prostate (system biopsy).

Eligibility Criteria:
Inclusion Criteria:

* Patients with mRI-TRUS Fusion prostate biopsy
* age \> 18y
* elevated PSA
* suspicious DRE (digital rectal examination)
* patients with prostate cancer under active surveillance

Exclusion Criteria:

* age \< 18y
* treated prostate cancer (Radiotherapy, antiandrogens therapy, brachytherapy, HIFU).
Analysis of a Beneficial Effect of Prolonges Topical Steroid Treatment After Low-risk Penetrating Keratoplasty

PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN: Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes (age: 52 \>= 19 years; follow-up: 42 \>= 18months). METHODS: Postoperative treatment started with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6 months. Patients were then randomised into either short-term (stop topical steroid treatment) or long-term treatment (continue steroids once daily until 12 months).

PURPOSE: To assess the impact of duration of topical steroid treatment on the incidence of endothelial graft rejection following normal-risk penetrating keratoplasty (PK). DESIGN: Prospective, institutional, longitudinal, randomized interventional trial including 406 eyes (age: 52 \>= 19 years; follow-up: 42 \>= 18 months). METHODS: Postoperative treatment started with prednisolone acetate 1% eye drops five times daily and was tapered over the first 6 months. Patients were then randomised into either short-term (stop topical steroid treatment) or long-term treatment (continue steroids once daily until 12 months). \<=

Eligibility Criteria:
Inclusion Criteria:

* Low risk keratoplasty

Exclusion Criteria:

* High risk keratoplasty
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults

Primary Objective:

To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine.

Secondary Objectives:

To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 25 years on the day of screening
* Informed consent form signed
* Able to attend all scheduled visits and to comply with all trial procedures
* For a woman, inability to bear a child or negative serum pregnancy test performed at screening (Visit 01)
* Subject entitled to national social security
* Subject registered in the French file of healthy volunteers in clinical trials
* For a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least 3 months prior to screening to 3 months following trial vaccination
* For a woman, inability to bear a child or negative urine pregnancy test.

Exclusion Criteria:

* Previous smallpox vaccination confirmed by vaccination record or typical scar
* Participation in another trial in the 3 months before or during the trial period
* Acute intercurrent or chronic illness during the trial
* Breast-feeding
* Allergy or sensitivity to any known components of vaccinia immune globulin or previous reaction to immunoglobulins or trial vaccine
* Congenital or acquired immunodeficiency or immunosuppressive therapy or any treatment including corticosteroids
* Treatment with antiviral drugs within 1 month before vaccination
* History of organ or bone marrow transplant or skin disorders
* Personal or family history of autoimmune disease or cardiac disease, including cardiac risk factors
* History or current central nervous system disease
* Ongoing acute infectious disease
* Blood or blood-derived products received in the past 6 months
* Any vaccination with a live-attenuated vaccine within the 60 days or other vaccines within 40 days preceding the trial vaccination
* Vaccination planned in the 8 weeks following the trial vaccination
* Planned or foreseeable close contact after vaccination with infants less than 12 months, or with immuno-suppressed persons, pregnant and/or lactating woman, or practice of contact or water sports after vaccination before the crust separates
* Skin wound near the vaccination site
* Apparent lack of personal hygiene
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
* HIV, hepatitis B or hepatitis C seropositivity (screening tests)
* Abnormal lab values for hematological parameters or cardiac enzyme (screening tests)
* Feverish illness (oral temperature \>=37.5°C, rectal equivalent temperature \>=38.0°C) on the day of vaccination.
Efficacy and Safety Study of SHR117887 in Combination With Metformin in Patients With Type 2 Diabetes

SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 2 diabetes mellitus
* Patients have been treated with metformin for at least 8 weeks and be on a stable dose of at least 1500mg daily prior to the screening visit
* HbA1C：≥7.5% and ≤11.0% at screeing visit and at the end of run-in period
* Age:≥20 and ≤70 years
* BMI(body mass index):≥20 and ≤35 kg/m2

Exclusion Criteria:

-
Korean Practice Patterns for Screening PCA(Prostate Cancer)

This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.

This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.

Eligibility Criteria:
Inclusion Criteria:

* Male with PSA more than 2.5ng/ml from 1 Jan 2008 to 31 Dec 2008

Exclusion Criteria:

* Age less than 40 at PSA screening
* History of drug use which can affect level of PSA within 6months before PSA screening
* Subject who participate any other clinical trial
Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)

To collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.


Eligibility Criteria:
Inclusion Criteria:

Male or Female patients who are prescribed voriconazole (VFEND) for deep mycosis on Scedosporisis.

Exclusion Criteria:

Subject who have been prescribed voriconazole (VFEND) for deep mycosis on Aspergillus, Candidasis,Cryptococcal infections not involving Scedosporisis.
Effect of AIDET on Physician-Patient Communication

Patient satisfaction is an important aspect of care and is gaining increasing importance as a measure of Healthcare quality. Tools for improving physician-patient communication are available but have not yet been tested in the Hospital setting. The purpose of this project is to determine if training in AIDET (Acknowledge, Introduce, Duration, Explanation, Thank) communication method improves physician-patient communication. Patient satisfaction data will be compared to historical controls using modified HCAHPS (Hospital Consumer Assessment of Health Plans Survey) as the primary outcome measure. In addition, a validation of delivery of AIDET communication will be accomplished through administration of questionnaires to patients.

This is a process of change study, which will compare HCAHPS patient satisfaction surveys before and after the Hospitalist receives AIDET physician-patient communication training. Once the Hospitalists agree to participate in the study, they will receive AIDET training by a Studor Group certified trainer. Both before and after the training intervention, Hospitalists' use of the AIDET method will be validated by having patients complete anonymous questionnaires during their hospital stay.

All HCAHPS surveys will be conducted by an external patient satisfaction survey vendor, and information will be de-identified both in terms of patient and specific Hospitalist. Validation questionnaires will be distributed by administrative staff, and will also be de-identified both in terms of patient and specific Hospitalist.

Eligibility Criteria:
Inclusion Criteria:

* Physicians: All physicians of the Hospital Medicine Service will be invited to participate

Exclusion Criteria:

* Any invited physicians who refuse to consent
Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy

This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy


Eligibility Criteria:
Inclusion Criteria:

* Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
* Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure \>=90 and \<= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of \>=90 and \<= 100mmHg.
* Patients with Left Ventricular Hypertrophy

Exclusion Criteria:

* Severe hypertension
* Symptomatic heart failure
* History of stroke, heart attack, coronary bypass surgery etc.
* Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients

The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Able and willing to complete all protocol requirements
* Age: 18 years and older
* Histologically confirmed stage III or IV melanoma
* HLA-A\*0201 haplotype
* Expected survival of at least 6 months
* ECOG performance status of 0 or 1
* At least one and no more than 2 previous systemic therapies for metastatic melanoma
* Able to undergo computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan for tumor assessment.
* Lack of response to or progression after most recent systemic therapy for metastatic melanoma.
* Adequate organ and bone marrow functions
* All adverse events (AEs) from prior anticancer therapy have resolved to ≤ Grade 1
* Sexually active males should use adequate contraception throughout the study period and 3 months thereafter.
* Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine.

Exclusion Criteria:

* Pregnant or nursing
* Use of an investigational drug within 30 days before enrollment
* Known or suspected brain metastases
* Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ.
* Major surgery within 4 weeks prior to enrollment.
* Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug.
* Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders.
* Serum tests positive for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV).
* Active autoimmune diseases or severe allergies.
* Known type 1 allergy.
* Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
* Blood donation or loss of \> 400mL within 8 weeks prior to inclusion.
* Hemoglobin (Hb) \< 10g/dL
* Abuse of alcohol or other recreational drugs.
* Previous vaccination with a Melan-A peptide analogue.
Feasibility and Outcomes of Repetitive Radial Approach

The purpose of this study is to assess the feasibility of performing repetitive coronary angiograms via the radial approach

Assessing succes of radial access in patients with prior TRA procedures

Eligibility Criteria:
Inclusion Criteria:

Patients with previous successful radial artery approach scheduled for elective transradial coronary angiography

Exclusion Criteria:

Lack of indication to perform radial approach Abnormal Barbeau test result (type C and D) Presence of radial artery occlusion Previous important trauma of the upper limbs Presence of fistula for renal dialysis Lymphoedema Acute myocardial infarction Refusal to sign the informed consent form