cyrilzakka/clinical-trials huggingface dataset:
Team Approach to Polypharmacy Evaluation and Reduction (Pharmacy)

In an aging population, most seniors suffer from multiple chronic conditions. When the number of medications taken is ≥5 (polypharmacy), the burden of taking multiple concurrent medications can do more harm than good. Seniors take an average of 7 regular medications and studies link polypharmacy with adverse effects on morbidity, function and health service use. However, it is not clear to what extent these are reversible if medication burden is reduced.

This trial will test the effects on medication numbers and patient health outcomes of an intervention to polypharmacy. This study will test a program focused on medication reduction number and dose. Prioritizing medications according to the patient's preference as reducing the dose also reduces the risk of drug side effects.

Patients, aged 70 years of age or older and taking ≥5 medications will receive the TAPER program. The program involves information gathering from the patient, including systematically seeking patients priorities and preferences, medication review with the pharmacist and then a consultation with the family doctor. The intervention is focused on discontinuing/reducing the dose of medications where possible using a 'pause and monitor' framework to assess the need for restart. An electronic program that detects drug adverse effects and flags potentially inappropriate medications will be integrated into an electronic clinical pathway incorporating monitoring and follow-up systems.

This study will examine whether implementing a deprescribing care pathway with community pharmacists as point-of-entry can signal improvements in prescribing and patient health outcomes in older adults with polypharmacy.

This study uses a single-arm, longitudinal cohort feasibility design. Patients will receive the intervention following baseline data collection. Initial baseline data collection from the patient will include information on demographics, medications, and illness characteristics. The patient will then attend an appointment with a pharmacist to review medications appropriate for discontinuation/dose reduction, after which the patient will meet with their family physician to discuss patient preferences for discontinuation/dose reduction. Both health care providers will have access to TaperMD, a web-based program linked to evidence and tools to support reduction in polypharmacy. Follow-up research assessments will take place at one week, 3 months and 6 months (study end). Outcome assessments and a semi-structured interview will take place at the 6 month appointment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years of age or older
* Patient must have a family doctor
* Participating family doctor as most responsible provider
* Currently taking 5 or more long-term medications
* Has not had a recent comprehensive medication review
* Patient willing to try discontinuation

Exclusion Criteria:

* English language or cognitive skills inadequate to understand and respond to rating scales
* Terminal illness or other circumstance precluding 6 month study period
Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes

This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD in adolescents. In addition, successful treatment of CFRD with repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and will not have a negative impact upon quality of life.

This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD. This hypothesis will be tested using the following aims:

Specific Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon blood glucose (BG) and insulin excursion during an oral glucose tolerance test.

Specific Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon BG as measured by continuous glucose monitoring, fasting BG, 2-hour post-prandial BG, hemoglobin A1C, and serum fructosamine.

Secondary Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon weight, body mass index, and lean body mass in adolescents with new-onset CFRD.

Secondary Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon pulmonary function in adolescents with new-onset CFRD.

Secondary Aim 3: To determine the effect of three months of repaglinide and insulin treatment upon quality of life in new-onset CFRD.

Eligibility Criteria:
Inclusion Criteria:

Cystic Fibrosis, Blood glucose concerning for diabetes -

Exclusion Criteria:

Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1\<40%

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Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)

In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724).

In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724)

These participants will have annual follow-up visits at Months 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 after immunization. The primary objective of this trial will be to evaluate persistence of antibodies annually from 1 to 10 years after the single immunization with VLA1553. The secondary objective is to evaluate long-term safety 6 months to 2 years after the single immunization with VLA1553.

Eligibility Criteria:
Inclusion Criteria:

* Individual participated in the VLA1553-301 clinical trial;
* Participant has an understanding of the trial and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any trial-related procedures;
* Participant had immunogenicity blood samples taken at baseline (Visit 1) and either Day 29 (Visit 3), Day 85 (Visit 4) or Day 180 (Visit 5) in Trial VLA1553-301 and was negative for neutralizing antibodies at baseline

Exclusion Criteria:

* Participant presents with clinical conditions representing a contraindication to blood draws;
* Participant has donated blood or use of blood products prior 30 days of immunogenicity sampling;
* Participant has received an active drug with potential immunosuppressive action or investigational drug or device within a period of 30 days prior a trial visit;
* Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
* Participant has any condition that, in the opinion of the Investigator, may compromise the participant's well-being, might interfere with evaluation of trial endpoints, or would limit the participant's ability to complete the trial;
* Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
* Participant is a member of the team conducting the trial or in a dependent relationship with one of the trial team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the trial.
Acute Kidney Injury in Patients With Sickle Cell Disease

Patients with sickle cell disease may be at risk for acute kidney injury (AKI)during sickle cell crisis (pain or acute chest syndrome). This study will evaluate the role of hemolysis during SCD crisis on the development of AKI and the role for monitoring urine biomarkers during an admission for crisis and during well clinic follow-up.

Patients admitted to the hospital for acute chest syndrome or vaso-occlusive pain events may consent to participate in this study. Patients will consent to daily blood and urine collection during their hospitalization and during well clinic visits.

Each AM, participants will have blood and urine collected, processed, and strored for future analysis of hemolytic markers and biomarkers of kidney injury. Patients will also have strict urine output recorded. Acute kidney injury (AKI) will be defined by the current KDIGO definition based on either a rise in serum creatinine or decline in urine output. Patient medical course will be reviewed to determine interventions and outcomes of their admission based on the development of AKI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HbSS or SB0 thalassemia admitted for vaso-occlusive pain crisis or acute chest syndrome
* Able to sign informed consent

Exclusion Criteria:

-
A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery

The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during laparoscopic bariatric surgery. The goal of the study will be achieved by assessing the device performance and by reporting of peri- and postoperative complications in a prospectively maintained database.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age at registry entry.
* Patient and investigator signed and dated the informed consent form prior to the index-procedure.
* Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities.
* Patient has a BMI ≥ 40 kg/m2.
* Patient is eligible for laparoscopic bariatric surgery.

Exclusion Criteria:

* Patient is unable / unwilling to provide informed consent.
* Patient has a history of bariatric surgery.
* Patient is unable to comply with the registry protocol or proposed follow-up visits.
* Patient has a contra-indication for laparoscopic bariatric surgery.
Prevalence of Obstructive Sleep Apnea (OSA) and the Association With Cognitive Impairment

The study is aimed to carry out an epidemiology study investigating the prevalence of obstructive sleep apnea (OSA) and the association with cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Have stability of at least 4 weeks on permitted medications (i.e. medications known not to affect sleep architecture or circadian rhythms).

Exclusion Criteria:

* Suspected dementia or a score of \<24 on the mini-mental state examination
* A diagnosis of neurological disorders (e.g. Parkinson's Disease, Epilepsy, Multiple Sclerosis)
* Psychiatric disorders including current major depression; bipolar disorder; schizophrenia
* Other known clinically significant sleep disorders (e.g. narcolepsy)
* Been currently receiving CPAP or bi-level pressure for OSA
A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions

The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL Tablets, 1000 mg under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Implication of Two Doses of O2-O3 Upon the Pain Alleviation in Patients With Low Back Pain

Low back pain is very common problem, variable modalities have been introduced to control such problem. One of the emerging modalities is the ozone - oxygen (O2-O3 ) mixture that could reduce the herniation disk size and inflammation.

Intervertebral disc herniation is the most common problem which induces low back pain LBP. The number of patients seek surgical and or alternative therapy increases. The rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative.

Epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. However, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular.

Ozone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .

Eligibility Criteria:
Inclusion Criteria:

* All patients Suffered radicular leg pain and some reported additional back pain.
* All patients are non-responsive to conservative treatment modalities with VAS more than 7.

Exclusion criteria

* presence of bleeding disorder
* local infection
* uncontrolled or degenerative spine disease
* pregnancy
* multilevel disk involvement
* patient refusal.
Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial

The study is focused on skin of color participants who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also referred to as eczema, is a condition that causes the skin to become itchy, dry, and cracked.

From the previous studies on the study drug, it is seen that the study drug has an acceptable safety and effectiveness in participants with atopic dermatitis.

The aim of this study is to get additional information on the safety and effectiveness of the study drug, particularly the information on aspects of atopic dermatitis in skin of color participants.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in your blood at different times
* How much the study drug improves quality of life and mental health


Eligibility Criteria:
Key Inclusion Criteria:

1. Skin of color, defined as Fitzpatrick skin type ≥4 at screening visit
2. Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequately controlled with topical AD medications, as defined in protocol
3. Has applied a stable dose of topical emollient (moisturizer) twice daily as per physician recommendation starting at screening visit

Key Exclusion Criteria:

1. Self-reported Caucasian or White race
2. Adolescent body weight less than 30 kg at screening
3. Prior use of dupilumab within 6 months of screening
4. Concomitant skin diseases or other pigmentary disorder that could confound AD assessments
5. Current or prior use, within 12 weeks before the screening visit, of phototherapy or tanning beds
6. Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
7. Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 7 days prior to baseline
8. Planned or anticipated use of any prohibited medications and procedures, as defined in protocol
9. Has received a COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study drug

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
A Study of the Effect of Itraconazole and Phenytoin on MK-1084 in Healthy Adults (MK-1084-008)

The goal of this study is to learn what happens to MK-1084 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of MK-1084 when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* History of cancer (malignancy)
* Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Part 1 Only:

- History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome)

Pat 2 Only:

- History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions
E-cigarette Harm Reduction Among PLWHA in South Africa

The purpose of this pilot randomized controlled trial study aims to address the unmet need for feasible and efficacious strategies for reducing combustible cigarette (CC) use among people living with HIV/AIDS (PLWHA) in South Africa, which has the potential to significantly improve the health and long-term survival of PLWHA CC smokers. Using the proposed intervention, based on the Information-Motivation-Behavioral Skills (IMB), and a simultaneous embedded mixed methods approach, the investigators will evaluate a telehealth program targeting CC harm reduction, comparing E-cigarettes (EC) to nicotine replacement therapy (NRT) that is enhanced by integrating ecological momentary intervention (EMI) texting. As such, this proposal will significantly build research capacity in South Africa to conduct telehealth tobacco treatment interventions using innovative EMI approaches enhancing participants' engagement, as well as state-of-the art evaluation approaches.


Eligibility Criteria:
Inclusion Criteria:

* Adult PLWHA CC smokers;
* Speaks Afrikaans, or Xhosa, or English;
* reports daily CC smoking (≥ 5 CPD);
* Owns any type of mobile phone;
* interested in reducing CC smoking but not necessarily trying to quit;
* Receives HIV/AIDS care in one of the eight selected clinics follow-up rates.

Exclusion Criteria:

* are pregnant or breastfeeding;
* unable to provide consent;
* used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo);
* currently engaged in an attempt to quit CC smoking;
* current major depressive or manic episode, current psychotic disorder, past-year suicide attempt, or current suicidal ideation with plan or intent. plan or intent.
Effects of Isometric Exercises on Balance, Heart Rate, Pulse Ox and Blood Pressure

Determine the effects repeated isometric exercises have on balance, blood pressure, heart rate and pulse ox. Another outcome measure will be a mental speed test (how quickly a subject can process information and make decisions based upon that information).

Subjects will complete a mental speed test and will undergo Computerized Dynamic Posturography (CDP) testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally. Immediately prior to the CDP testing, subjects will have their heart rate, blood pressure and pulse Ox measured. These will constitute the baseline information.

Subjects will then be divided into two groups: the isometric exercise group (they will be instructed to perform specific isometric exercises three times a week, for the next 8 weeks) and the control group (no exercises will be prescribe to them).

The same testing procedure indicated above will be followed at the end of the 8 weeks. The mental speed test, CDP testing, heart rate, blood pressure and pulse Ox will constitute the follow-up information.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Any pathology preventing the subject to safely perform the isometric exercises (the clinician enrolling the subjects will make the decision)
Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery

An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE


Eligibility Criteria:
Inclusion criteria:

Patients of 18 years of age or above undergoing elective total hip or knee replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria:

All patients who should not be treated with Pradaxa 220 mg according to the European Summary of Product Characteristics (SPC): age of \> 75 years, renal impairment (creatinine clearance \<50 ml/min), patients with concomitant therapy of amiodarone, elevated liver enzymes \> 2 upper limit of normal (ULN) and/or hepatic impairment or liver disease expected to have any impact on survival, anaesthesia with post operative indwelling epidural catheters, hypersensitivity to dabigatran etexilate or to any of the excipients, active clinically significant bleeding, organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis except for the above included patients groups, concomitant treatment with quinidine
Neurostimulation for Dysphagia in Parkinson's Disease

This study will explore the effects of 3 different neurostimulation methods on swallowing function in patients with dysphagia secondary to Parkinson's Disease

The aim of this study is to assess 3 novel neuromodulation approaches - namely, pharyngeal stimulation, high frequency (5Hz) repetitive transcranial magnetic stimulation and low frequency (1Hz) repetitive transcranial magnetic stimulation on swallowing function in patients with dysphagia after Parkinson's Disease. A total of 66 patients are planned to be recruited, randomised to one of the 3 technologies or a sham treatment. A single treatment will be given and the effects will be assessed with a barium exam called videofluoroscopy within the 1st hour after the treatment. In addition, some measures of brain function will be recorded, before and after the treatments using single pulse transcranial magnetic stimulation.

Eligibility Criteria:
Inclusion Criteria:

Confirmed Parkinson's Disease with dysphagia

Exclusion Criteria:

Contraindications to magnetic stimulation, such as pacemakers, significant neuroleptic medications, pregnancy Other causes for dysphagia Unable to give informed written consent