cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing Care in Multiple Clinics Versus Care in a Cardiac, Diabetes and Kidney Care Clinic

The purpose of this study is to assess the benefits of a combined cardiac, kidney, and diabetes clinic versus multiple clinics.

Hypothesis: Attendance at multiple clinics by one individual patient has multiple problems which may be overcome by the introduction of a combined care clinic.

This is a randomized control trial to compare health care resource utilization, and achievement of stated targets of therapy (BP, Hgb, glucose control, use of preventive medications) as well as patient and health care team satisfaction, and longer term patient outcomes in patients with kidney disease who have either or both diabetes and heart disease, and currently attend either a diabetic or heart function clinic (or both) in addition to a kidney care clinic. In addition, we will also establish and refine the specialized cross-disciplinary care model, within a framework in Vancouver, and evaluate its functioning from the perspectives of allied health and medical professionals.

This is a systematic evaluation of health care delivery methods to a complex group of patients, which will serve as a nidus for ongoing research in both health outcomes research, and biomedical research.

The creation of this multifaceted clinic in an organized manner would permit evaluation of all of the components of it, and also demonstrate the importance of collaboration between disciplines and between public health care initiatives and industry partners, who would fund this clinic infrastructure and research components in the initial phase.

Eligibility Criteria:
Inclusion Criteria:

* All patients currently attending or who would be eligible to attend 2 or more of the following clinics: cardiac, diabetic or kidney

Exclusion Criteria:

* Those patients currently attending the diabetic, cardiac or kidney clinics who do not have more than one condition (i.e. who have only one of the diagnoses) or who refuse to sign informed consent
Avidhrt Clinical Equivalence Study

The Avidhrt Clinical Equivalence Study will test and evaluate the equivalency between ECG signals acquired simultaneously using the Avidhrt Sense Lead-1 ECG, and an FDA cleared Lead-12 gel ECG. The Avidhrt Clinical Equivalence Study also includes a sub-study. The Avidhrt Sense Human Factors sub-study will evaluate the usability and efficacy of the user-interface of the Avidhrt Sense device.

This study will test the clinical equivalency of an Avidhrt Sense acquired Lead-I ECG signal and a Lead-I ECG signal obtained from an FDA cleared 12-lead-ECG gel electrode.The Avidhrt Clinical Equivalence study is comprised of study Arm A and Arm B. In Arm A of this study the population is comprised exclusively of subjects with AF, who will be asked to participate in the Clinical Equivalence Study and in the Human Factors Sub-Study. In Arm B of this study the population will consist of all other subjects (no AF), who will be asked to participate in the Clinical Equivalence Study, with the option to enroll and participate in the Human Factors Sub-Study. This is a prospective, parallel-cohort, non-randomized study using an enriched population.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 22 years old at the time of enrollment
* Capable of giving informed consent
* Sufficient manual dexterity to capture an ECG using Avidhrt Sense
* Subjects in the arrhythmia group must have a known history of arrhythmia, and may have an arrhythmia at the time of enrollment based on the screening ECG just before the study recordings are taken.

Exclusion Criteria:

* Cardiac pacemaker or implantable cardioverter-defibrillator
* History of a life-threatening rhythm such as ventricular tachycardia or ventricular fibrillation
* Anti-arrhythmic (rhythm control) medication use (such as amiodarone or flecainide)
* Subjects in the normal controls group should not have any history of arrhythmia and should not be in arrhythmia at the time of enrollment based on the screening ECG
* Subjects with tremors who are unable to stably hold the Avidhrt Sense during a recording without movement
MK0524A Bioequivalence Study (0524A-059)

This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good health
* Subject is willing to follow all study guidelines

Exclusion Criteria:

* Subject has or has a history of any disease or condition that might confound the results of the study or make participation unsafe
Comparing the Effectiveness of Oral Versus Intravenous Pain Medicine for Suction Curettage (D&C)

The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.

The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Undesired pregnancy between 6 0/7-12 6/7 weeks gestation.
* Has already signed consent for pregnancy termination.
* Eligible for IV sedation per clinic protocol.

Exclusion Criteria:

* Under 120 lbs.
* Allergies to any of the drugs being studied.
* Chronic narcotics, barbiturates or benzodiazepine use within the past year.
* History of IV drug use within the last year.
* Inability to give informed consent.
* Does not speak English or Spanish and does not have translator for all study procedures
* Previously participated in study
Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)

Protocol V503-021 is a long-term follow-up study of the V503-001 base study (NCT00543543) to evaluate the safety, immunogenicity, and long-term effectiveness of V503 vaccine in preventing cervical cancer and related precancers caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. Because of the high retention of V503-001 participants from the Nordic countries, and the highly efficient screening and surveillance system there, study V503-021 will evaluate only participants from V503-001 sites in Denmark, Norway, and Sweden. The hypothesis is that V503 vaccine will remain effective for at least 30 years after the start of vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Randomized into the V503-001 (NCT00543543) study from a Denmark, Norway, or Sweden site and participated in the study by receiving either the selected dose formulation of V503 or GARDASIL
* Agrees to allow passive follow-up, analysis of biopsy specimens, future contact from the National Registry Study Centers, and serum collection

Exclusion Criteria:

- There are no exclusion criteria
Tracheal Intubation With Collar Immobilisation : a Comparison of Glidescope and Fastrach

Intubation must be done with utmost care in cervical trauma patients. cervical spine motion must be minimized and intubation must be fast. The aim of this study was to compare the effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients undergoing elective surgery were enrolled in this trial. After standard monitorisation including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were divided into two groups glidescope and fastrach. Rigid collar was placed then patients were intubated with one of these devices. Mask ventilations with or without collar were recorded. insertion times, intubation times of the devices were recorded. Peroperative hemodynamic parameters and postoperative minor complications were also recoded.

inclusion criteria: ASA I-II , 18-60 years of age undergoing elective surgery requiring intubation exclusion criteria:

- pregnancy reflux nonfasted head and neck tumors recent flue in 2 weeks

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* ASA I-II
* requiring intubation
* BMI\<35

Exclusion Criteria:

* less than 18 or higher than 65
* ASA III-IV
* BMI\> 35
* PREGNANT
* head and neck tumors
EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan

A named patient program (NPP) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (T-DXd) treatment. To gain early insights on the use of T-DXd outside of a trial setting, patients with advanced/metastatic HER2+ breast cancer receiving treatment (or previously treated) with T-DXd through the NPP will be invited to participate.

The antibody-drug conjugate T-DXd has been granted conditional approval in the European Union as a single agent for adult patients with unresectable or metastatic HER2+ breast cancer who have previously received ≥2 HER2-based regimens. This was based on data from the Phase II DESTINY-Breast01 trial (NCT03248492).

DS8201-0002-EAP-MA is a real world data (RWD) observational data collection inviting patients with advanced/metastatic HER2+ breast cancer receiving T-DXd through the NPP already to participate to help further understand the usage in a real world clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Participants for whom T-DXd treatment is indicated, according to the summary of product characteristics conditionally approved by the EMA, that are eligible for treatment with T-DXd through the NPP (i.e., those with advanced/metastatic HER2+ breast cancer who have received ≥ 2 prior anti-HER2-based regimens and have documentation of HER2 positive tumour status by a validated method) will be eligible for inclusion to this RWD collection, subject to providing written informed consent to participate.

Exclusion Criteria:

* Any participant who does not meet all inclusion criteria noted above.
United States Pharmacovigilence Retapamulin-Prescribing

Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the United States (US), retapamulin is approved for the treatment of impetigo in persons nine or more months of age and was launched on 12 April 2007. This five-year study is designed to examine use of retapamulin in the pediatric population less than nine months of age. We will conduct an annual assessment of prescription sales claims for retapamulin using the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database. For each year of reporting, the observed frequencies of the exposure, with or without same-day, co-prescribed sales claim of mupirocin, will be identified. The study objectives are to determine the frequency of retapamulin sales in a representative US population stratified by the designated age group and to determine the frequency of same-day sale of the topical agent, mupirocin.

The IHCIS is Health Insurance Portability and Accountability Act (HIPAA) compliant with encrypted member and provider identifiers; date of birth is restricted to year of birth. Based on year of birth and the prescription sales claim date, age at the time of the prescription(s) will be categorized as less than 9 months (definitive) and less than 9 months (uncertain).

Eligibility Criteria:
Inclusion Criteria:

* The study population will consist of all 'eligible members' in the IHCIS database with a valid gender and age record who have at least 1 month enrolment and eligibility of pharmacy benefits.

Exclusion Criteria:

* Membership in IHCIS without a valid gender or age record, enrolment less than 1 month, or ineligibility for pharmacy benefits will be excluded.
A Phase I Study of Hetrombopag Olamine in Healthy Adult Volunteers

Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of increasing platelet count in animal and human. This study is designed in dose escalation fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine.

1. To evaluate safety and tolerability of Hetrombopag Olamine.
2. To investigate pharmacokinetics of Hetrombopag Olamine Under fasting conditions.
3. To obtain pharmacodynamics information of Hetrombopag Olamine on platelet count elevation in healthy volunteers.
4. To determine preliminary regimen for phase II study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be adequately informed of the nature and risks of the study, able to understand the risks associated with the study, and are willing to provide written informed consent prior to screening.
2. Must be a healthy male between the ages of 18 to 45 years, inclusive.
3. Must have a BMI between 19 to 28 kg/m2, inclusive and a total body weight ≥50 kg.
4. Platelet counts must be within the normal range.
5. Subjects must be free of any clinically significant disease based on medical history and physical examination.
6. Clinical laboratory tests (complete blood count \[CBC\], blood chemistries, and urinalysis) must be within the normal limits or clinically acceptable.
7. Must be nonsmokers, defined as not having smoked tobacco or used chewing tobacco or nicotine.
8. Subjects of reproductive potential with partners who are women of childbearing potential, will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 6 months after discontinuing treatment with the investigational product.

Exclusion Criteria:

1. History of hypersensitivity to hetrombopag olamine or its components.
2. History or presence of significant cardiovascular deficient, pulmonary, hepatic, gallbladder or biliary tract, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
3. History of deep vein thrombosis, or any other thromboembolic event.
4. History or presence of conditions that may place the subject at increased risk as determined by the investigator.
5. History of thrombocytopenia or bleeding due to abnormal platelet number or function.
6. History of platelet clumping that prevents reliable measurement of platelet counts.
Patient Report Outcome and Oncological Safety -Oncoplastic and Conventional BCS Cohort

Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic BCS could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as conventional BCS does. However, these studies that focused on patient-reported outcomes and oncological safety were mainly from one institution or of small sample size. The variations across hospitals and regions were not fully analyzed. A multicenter prospective patient report outcome (PROs) and oncological safety will be planned to assess the PROs and safety for Chinese breast cancer patients who will undergo oncoplastic and conventional breast-conserving surgery (OBCS). This study follows the Helsinki Declaration and Chinese rules. All patients will be asked to sign the informed consent and will be followed up 24 months after operations. All data will be collected.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed;
2. Non-metastatic Breast cancer patients confirmed by pathology;
3. Adult (\>18 years old, \<80 years old);
4. Female;
5. Must undergo oncoplastic or conventional breast-conserving surgery;

Exclusion Criteria:

1. Inflammatory breast cancer, Stage IV breast cancer patients;
2. Have other malignant tumors;
3. Pregnancy women;
4. Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients;
5. Refuse breast-conserving surgery.
Hyperhomocysteinemia in Alzheimer's Disease

Alzheimer's disease (AD) is the most common neurodegenerative disease. Age is its main risk factor. AD is a multifactorial disease, combining genetic and environmental risk factors. Autosomal dominant mutations have been identified (PSEN1, PSEN2, APP), leading to earlier and more severe forms of the disease. Other genetic risk factors have been identified, such as the ε4 allele of the APOE gene. . The environment also plays a major role, with the identification of several risk factors such as air pollution or nutritional deficiencies.

AD patients frequently present hyperhomocysteinemia, a consequence of a dysfunction of monocarbon metabolism. Homocysteine is an amino acid involved in the metabolism of methionine and cysteine. High concentrations of homocysteine can be deleterious to the central nervous system.

Most prospective studies have shown that elevated homocysteine is a predictor of undefined cognitive impairment or AD. Other studies have focused on clinical data and, in particular, on cognitive function. For example, a meta-analysis found an inverse correlation between MMSE score and homocysteine level.

Thus, our study seeks to evaluate the impact of hyperhomocysteinemia on the severity and early onset of AD, while knowing the presence or absence of genetic risk factors associated with AD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease
* Positive CSF biomarkers
* age of onset \< 75 years
* already benefited from a previous research of Alzheimer's disease genetic features (PSEN1, PSEN2, APP, APOE)
* already benefited from a previous research of homocysteine cycle (monocarbon metabolism) by complete exome/clinical exome or panel

Exclusion Criteria:

* patient refusal
Teriflunomide Vs. Placebo During Gluten Challenge in Celiac Disease

The investigators will see if the drug teriflunomide (which is in use in other immune disorder (multiple sclerosis)) can inhibit the immune activation in celiac disease patients during a 3 day gluten challenge. This will be measured in a blood sample.

This is a controlled, double-blind, randomised, singlecentre, placebo-controlled, phase IIa proof-of-concept study on effects of the drug on activation and efflux of gluten specific T cells using HLA-DQ:gluten tetramers. The study will be conducted with two treatment groups in the form of a 2:1 parallel group comparison and will serve to compare oral treatment with 14 mg/d teriflunomide vs. placebo in subjects with well-controlled coeliac disease undergoing gluten challenge. The screening period will be up to 8 weeks, followed by a 7-day run-in treatment period with a loading dose of teriflunomide followed by a 6 day therapeutic maintenance dose, an initial 4-week treatment-free follow-up period and a 6 month closing follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18-80
* Willingness to comply with the study procedures and having signed informed, written consent
* Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and/or IgGDGP) and a duodenal biopsy showing villous atrophy graded as Marsh 3
* Positive gene test for HLA-DQ2.5
* Adherence to gluten-free diet

Exclusion Criteria:

* Known intolerance to ingredients of teriflunomide or placebo tablets
* Known intolerance to gluten challenge
* Known intolerance to cholestyramine
* Duration of gluten free diet shorter than six months
* Positive serology (IgA-TG2 below upper level of normal) at screening visit
* Pregnancy or breast-feeding
* Not willing to comply with proper pregnancy control (in females)
* Concomitant medication that interferes with immune activation (e.g. steroids, calcineurin inhibitors, biological treatment for inflammatory bowel disease or other immune disorders, further list is given below)
* Any other medical condition that in the opinion of the principal investigator makes the individual unsuitable for participation
Validation of Hand Held Dynamometer for Assessment of Lower Limb Muscle Strength in Multiple Sclerosis

Evaluate a method of testing the strength of five key lower limb muscle groups using a hand-held strength gauge (dynamometer).

Purpose of this study is to assess the intra-rater and inter-rater reliability of a hand-held dynamometer (HHD) in the assessment of lower limb strength in patients with Multiple Sclerosis.

Also to establish a standardized strength testing procedure for key lower limb muscle groups using a HHD fo research and clinical purposes in Multiple Sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Stable patients with clinically definite Multiple Sclerosis
* No Multiple Sclerosis exacerbation 30 days prior to screening
* No change in disease modifying therapy for 30 day prior to screening

Exclusion Criteria:

* Inflammatory myopathy
* Endocarditis, pericarditis o rother unstable heart disease
* Cardiac surgery or myocardial infarction in the last 3 months
* Decompensated congestive heart failure
* Severe aortic stenosis
* Severe pulmonary hypertension
* Pulmonary embolus or infarction in the last 6 months
* Uncontrolled hypertension by history or by screening or baseline diastolic blood pressure \>170 or systolic blood pressure \>105
* Concomitant neurodegenerative neurological disease such as Amyotrophic Lateral Sclerosis (ALS) Parkinsons or hemiplegic stroke
* females who are pregnant
* Cognitive deficits that would interfere with the subjects's ability to give informed consent or preform study testing
* Painful orthopedic condition affecting the lower limbs
* Any other serious and/or unstable medical condition
Safety of Gadovist in Renally Impaired Patients

Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate (eGFR 30 - 59 ml/min/173m2) or severe (eGFR \< 30 ml/min/1.73m2) renal impairment, scheduled to undergo Gadovist-enhanced MRI

Exclusion Criteria:

* GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Gadovist within 12 months prior to administration of Gadovist
* History of NSF (Nephrogenic Fibrosing Dermopathy)
* Age outside the indicated age range mentioned in national labelling.