cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Study of DS-8500a in Patients With Type 2 Diabetes

The objective of this study is to evaluate the efficacy and safety of DS-8500a compared with placebo in Japanese patients with Type 2 Diabetes Mellitus.

The objective of this study is to evaluate the efficacy and safety of DS-8500a 10 mg and 75 mg administered orally, once daily, for 28 days, compared with placebo, in Japanese patients with Type 2 Diabetes Mellitus in a double-blind, placebo-controlled parallel-group design. The primary endpoint is the change in 24-hour weighted mean glucose at day 28 from baseline. The safety, pharmacokinetics, and pharmacodynamics of DS-8500a will be evaluated as well.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 20 years at the time of informed consent
* Japanese patients with type 2 diabetes
* Patients who have HbA1c ≥ 7.0% and \< 10.0% if untreated with antidiabetic agent.
* Patients who have HbA1c ≥ 6.5% and \< 9.5% if treated with antidiabetic agent.

Exclusion Criteria:

* Patients aged ≥ 70 years at the time of informed consent
* Patients with a history of type 1 diabetes or diabetic ketoacidosis
* Patients receiving or requiring treatment with insulin
* Patients with a body mass index (BMI) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2
* Patients with an estimated glomerular filtration rate (eGFR), \< 45 mL/min per 1.73 m2
* Patients with fasting plasma glucose ≥ 240 mg/dL
Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany

In Germany nearly half of the population present elevated values of blood pressure, with - as a result of lifestyle factors and a growing average age - further increasing numbers.

Consequences of arterial hypertension may be cardiovascular diseases, cerebrovascular events, and renal insufficiency. Thus, hypertension therapy focuses on the reduction of these complications.

The aims of the 3A-registry are the characterization of outpatients with hypertension, their diagnostic procedures and medical treatment (esp. with renin inhibitors), therapy compliance and success, clinical events, and an assessment of overall guideline adherence in the treatment of these patients.

Patients fulfilling the relevant criteria are enrolled and followed up by their general practitioner or medical specialist.


Eligibility Criteria:
Inclusion Criteria:

* treatment as outpatient
* arterial hypertension
* treatment with a renin inhibitor, ACE inhibitor, ARB, or without RAS blockade
* informed consent

Exclusion Criteria:

* foreseeable difficulties to perform follow up
Non Invasive Arrhythmia Detection in Hospital Settings

This is a prospective, single center, non-randomized study to evaluate the arrhythmia detection performance during ventricular events.

The system will continuously monitor the patient's cardiac activity which will be compared to standard telemetry system.

Eligibility Criteria:
Inclusion Criteria:

* Is female or male, 18 years of age or older
* Undergoing ICD implant with ventricular arrhythmia induction OR undergoing EP study with ventricular arrhythmia induction

Exclusion Criteria:

* Is participating in another clinical study that may confound the results of this study
Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome

OBJECTIVES: I. Determine whether the time period between randomization and endpoint is longer in the short term pimozide therapy or longer term therapy in patients with Tourette syndrome.

II. Determine whether tic severity, medication side effects, academic performance and psychosocial functioning are better in the short term pimozide therapy or longer term pimozide therapy.

PROTOCOL OUTLINE: This is a combined open label and double blind randomized study.

Patients receive pimozide (open label) orally until a stable level of tic control is achieved and remains unchanged for at least 1 month.

Then, patients are randomized to one of two possible double blind treatments. In the short term pimozide group, patients receive pimozide over 2 weeks. Then, pimozide is gradually replaced by an inactive placebo within the following 10 weeks.

Patients in the long term pimozide group receive pimozide. Patients continue treatment for 12 months or until a worsening of tics or behavioral symptoms are present for which an increased dosage is required.

Patients who do not experience an exacerbation of tics requiring an increase in dosage are followed for 1 year from the date of entry.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- DSM-III-R criteria for Tourette syndrome Chronic motor tic disorder with tics sufficiently severe to require neuroleptic therapy --Prior/Concurrent Therapy-- No clonidine for at least 2 weeks or any neuroleptic (e.g., haloperidol, pimozide) within 3 months prior to study Stable dosage of other medications (e.g., antiobsessional, stimulant) for at least 3 months prior to and during study required
Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy

Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children. Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10 (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has shown significant health benefits in adult patients with cardiovascular disease, it is worth studying water-soluble coenzyme Q10 supplements to evaluate their potential role as complementary therapy for PDCM. The purpose of this study is to explore the potential role of water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months water-soluble ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will assess the quality of life of PDCM patients by questionnaire. Through this study, we expect to demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac function and reduce inflammation, and further reduce the rate of heart transplantation and increase quality of life in PDCM.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric dilated cardiomyopathy defined as left ventricular ejection fraction ≤ 40 % by cardiac echo examination.

Exclusion Criteria:

* Hypertension
* Arrhythmia
* Congenital heart defects
* Acute myocarditis
* Pregnant and lactating teens
* Antioxidant vitamins users
A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF
* FEV1 ≥ 40% predicted normal
* Stable CF lung disease
* Non-pregnant, non-lactating females

Exclusion Criteria:

* Significant unstable co-morbidities within 28 days of screening as judged by the Investigator.
* Has received an investigational drug within the past 30 days
Motivators and Barriers to Physical Activity in Knee Osteoarthritis Patients: a Qualitative Study

This study sought to better identify the motivators and barriers to osteoarthritic patients practising regular physical activity. This is a crucial step towards enabling each health professional to adapt their therapy recommendations, while taking into account the patient's overall lifestyle.

The qualitative research design is well-suited to this type of issue. This choice was justified by need to investigate and understand the actions from the participants' point of view. This exploratory method, conducted in the form of individual interviews and focus groups, enabled us to document the personal experiences, practices, and personal history of each individual

Eligibility Criteria:
Inclusion Criteria:

* symptomatic knee osteoarthritis

Exclusion Criteria:

-
A Study to Assess the Safety and Effectiveness of SJP-0035 for the Treatment of Patients With Dry Eye Disease

A double-masked, randomized, multi-center, placebo-controlled, parallel-group study in adult patients with Dry Eye Disease (DED). Patients will be randomly assigned to receive either SJP-0035 0.001% or placebo

There are currently no approved products available anywhere worldwide for the treatment of Dry Eye Disease (DED) that directly affect the corneal epithelium. This study will evaluate the safety and efficacy of SJP-0035 0.001%, compared with a placebo, on corneal healing. Patients meeting the requirements of the inclusion/exclusion criteria will administer 1 drop of the study drug/placebo 4 times per day for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (ICF).
* Has Dry Eye Disease (DED) with moderate to severe corneal fluorescein staining in both eyes.
* Has blurred vision caused by DED in both eyes.
* Women of childbearing potential must have negative serum pregnancy test results at Screening and Randomization and agree to use effective contraception throughout the study; post-menopausal women must have negative serum pregnancy test results at Screening and Randomization.
* Male participants must agree to use an acceptable form of contraception (i.e. a condom plus spermicide) and to refrain from sperm donation throughout the study.

Exclusion Criteria:

* Has any corneal stromal or endothelial abnormalities in either eye.
* Has any active or chronic allergic, bacterial or viral infection of ocular adnexa and eye structures in either eye.
* Has had eye surgery (including cataract, vitreous or eyelid surgery) in either eye within the last 28 days prior to first dose of study drug.
* Has had refractive surgery (including eye surface laser surgery) in either eye within the last 180 days prior to first dose of study drug.
* Has used any eye medication in either eye within 14 days prior to first dose of study drug, or is anticipated to require such medications during the study. Preservative-free artificial tears may be used up to 72 hours prior to the first dose in either eye.
* Is a contact lens wearer and cannot discontinue use in both eyes from Screening through the duration of the study.
* Has previously received SJP-0035 (study drug) in either eye.
* Currently has punctal occlusions, of any type, inserted into both superior and inferior puncta in either eye at Screening through the duration of the study.

Other protocol-defined inclusion/exclusion criteria could apply.
A Trial Assessing the Effectiveness of Text Messages in Improving Continuation of Birth Control

This study is a randomized controlled trial assessing the effectiveness in a series of educational text messages in improving continuation of a birth control method in comparison to the 'standard counseling', when girls initiate a new method of birth control. Girls aged 15-19 year olds who are attending for a reproductive health visit and who own a working cell phone will be approached and asked if they would like to participate. Following completion of a baseline questionnaire and consultation for initiation of a new birth control method they will be randomized to receive either the intervention or standard counseling.

If randomized to the intervention they will receive 3 messages per week for the initial 3 weeks, 2 messages per week for the following 5 weeks and then one message per week thereafter. Messages will be tailored to the birth control method the participant has initiated. At 4 months all participants will be contacted via telephone and asked to complete a questionnaire regarding continuation of use.

Hypothesis. A personalized text messaging program providing trustworthy, reliable information and support to female adolescents initiating a birth control method, will improve adherence and correct use of the method and so reduce unwanted pregnancies.

Methods. Female adolescents aged 15-19 year olds attending Mount Sinai Adolescent Health Center (MSAHC) for initiating a birth control method will be asked if they are interested in participating in the trial.

The Intervention Group. Upon initiation of a birth control method patients will be signed up to the text messaging platform. Via this program they will receive personalized messages regarding their chosen method of birth control. Participants will receive 3 messages during the initial 3 weeks, 2 messages per week in weeks 4-8 and then one message a week thereafter for a period of 12 months. They will be signed up for reminders to take/change their method (as appropriate) and have access to a Healthcare Provider to ask questions via text message that they may have regarding their method. Participants will be reminded (via text message) to attend the clinic for a birth control refill (if necessary) at 3, 6, 9 and 12 months.

The Control Group. Participants randomized in to the control group will have standard care. This is the usual counseling by the Health Care Provider or Health Educator. Patients in the intervention arm will also receive this standard care.

Eligibility Criteria:
Inclusion Criteria:

* female
* Aged 15-19 years old
* English speaking
* owner of a working cell phone
* patient must be wanting to start a birth control method and not have been on a method for preceding 3 months
* no contra indications to initiating a birth control method

Exclusion Criteria:

* male
* younger than 15 years old, older than 19 years old
* already on a birth control method
* Not English speaking
* No working cell phone in possession
Safety and Clinical and Virologic Outcomes in CKD Patients Treated With Nirmatrelvir-ritonavir

Nirmatrelvir-ritonavir is approved for coronavirus disease 2019 (COVID-19) but not initially recommended in patients with severe renal impairment. Increasing observational data have shown the feasibility of dose-adjusted nirmatrelvir-ritonavir administration in patients with estimated glomerular filtration rate lower than 30 ml/min/1.73 m\^2. The study is planned to assess the safety, clinical and virologic outcomes of early oral nirmatrevir-ritonavir treatment of COVID-19 in patients with stage 4 and 5 chronic kidney disease.

The objectives of the study are to evaluate the safety and clinical and virologic outcomes of dose-adjusted nirmatrelvir-ritonavir in patients with eGFR lower than 30 ml/min/1.73 m\^2. Patients with eGFR greater than 30 ml/min/1.73 m2 and prescribed nirmatrelvir-ritonavir will be used for comparison.

In the single-centre study, patients with stage 4 and 5 chronic kidney disease prescribed early treatment dose-adjusted nirmatrelvir-ritonavir will be assessed for the primary endponts of adverse events during or after treatment with nirmatrelvir-ritonavir (starting on or before day 30), serious adverse events and adverse events leading to discontinuation of nirmatrelvir-ritonavir.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and above.
* COVID-19 infection and symptom onset no more than 5 days, with or without prior vaccination.
* WHO CPS 1-4
* Indicated for nirmatrelvir-ritonavir treatment

Exclusion Criteria:

* Patients cannot swallow capsules or adhere to protocol.
* Severe COVID-19 disease, including patients who require oxygen supplement therapy
* Significant hypersensitivity to nirmatrelvir, ritonavir, or any component of the formulation
* Patients require co-administration of drugs that are highly dependent on CYP3A4 for clearance and cannot be omitted during the treatment period
Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CAD

Exercise training in patients with coronary artery disease is able to correct several risk factors. Furthermore endothelial function can be improved.

There are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary collaterals. This might be due to technique of collateral measurement. Therefore we conduct a study were coronary blod flow before and after 4 weeks of exercise training were measured.


Eligibility Criteria:
Inclusion Criteria:

* stable CAD
* min.1 coronary artery stenosis \>50%
* patient is symptomatic ( CCS 1-3)or has documented myocardial ischemia during stress test
* angina threshold \>75 Watt
* informed consent

Exclusion Criteria:

* Age \<18 oder \>75
* akut coronary syndrome within 2 weeks
* LV-EF \< 40 %
* significant valve diseases
* reduced patient compliance
* muscular disorder
* bronchial asthma or COLD stadium III and IV
Experimental Evaluation of the Virtual Eggs Test on Stroke Participants

The study protocol focuses on evaluating the Virtual Eggs Test (VET) as a tool for assessing hand dexterity and grip strength control in post-stroke patients. The study aims to validate the reliability and concurrent validity of the VET, comparing its outcomes with established tests like the Nine Hole Peg Test (NHPT), the Motricity Index, the Semmes-Weinstein Monofilament Test (SWMT), and the Abilhand-ULA questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Age: Participants of both sexes and any ethnicity, aged 18 to 85 years.
* Post-stroke patients:

  * Participants who have experienced a first ischemic or hemorrhagic stroke.
  * Participants must be in the sub-acute phase (between 2 weeks and 6 months after the stroke) or the chronic phase (more than 6 months after the stroke).
  * Sufficient motor capabilities to perform motor tasks.
* Cognitive and language capabilities: Participants must have sufficient cognitive and language abilities to understand the experiment and follow instructions.
* Informed consent: Participants must provide signed informed consent after being fully informed about the study.

Exclusion Criteria:

* Visual or oculomotor impairments: Participants with significant visual or eye movement disorders.
* Comorbidities/disabilities:

  * Participants with conditions such as multiple sclerosis, Parkinson's disease, muscle tone disorders, or malignant neoplasms, which may interfere with the ability to understand or perform the protocol.
  * Cardiopulmonary or circulatory pathologies.
* Pregnancy or breastfeeding.
* Psychiatric comorbidities.
* Language barriers: Participants unable to adequately understand the Italian language.
* Lack of collaboration: Participants who cannot cooperate sufficiently with the study requirements.
* Substance use: Consumption of alcohol or diuretics before the tests.
* Motor function criteria:

  * Participants with a Motricity Index score of \&lt;19 for the pinch grip item.
  * A total upper limb Motricity Index score of \&lt;57.
  * Participants with a fixed contracture of the affected limb (Modified Ashworth Scale = 4).
Impact of Early Antibiotics on Non-Traumatic Out of Hospital Cardiac Arrest (OHCA)

Specific Aim : The specific aim is to conduct a randomized prospective clinical trial to determine whether no antibiotics in OHCA patients in the ED with very low likelihood of infection is non-inferior to early antibiotic treatment. Hypothesis a: 28-day all-cause mortality will be non-inferior in OHCA patients with very low likelihood of infection who do not receive antibiotic therapy compared with those who receive early antibiotic therapy Hypothesis b: There will be no difference in subsequent incidence of proven infections in the no antibiotics vs, early antibiotics groups Hypothesis c: There will be no difference in the length of ICU stay and overall hospital stay in the early antibiotics vs. no antibiotics groups

As above

Eligibility Criteria:
Inclusion Criteria:

* ● Adults aged \>18 years, presenting to HGH ED after out-of-hospital cardiac arrest

  * Patients with low likelihood of infection as per the definitions provided above
  * Ability to obtain informed consent from the subjects or their next of kin/family member/legal surrogate in case of incapacitation due to sedation, mechanical ventilation, etc. In case the next of kin is not available, an independent physician who is not a part of the investigative team will complete and sign the checklist as per HMC Policy "RES 11026_Appendix 6.5". (see section 4.1.3 for details) A member of the investigative team and a witness will also sign this form before the potential subject is enrolled in the study.

Exclusion Criteria:

* Patients who have clear evidence of infection, as defined by criteria for the study.

  * Patients who have received antibiotics within the last 1 week prior to admission.
  * Patients with malignancy, except those who have been cured or in complete remission.
  * Females with known pregnancy.
  * Known immunocompromised states (including HIV/AIDS, transplant recipients on immunosuppressant drugs, long-term \[\> 3 weeks of prednisone \>5mg/day equivalent\] steroid therapy).
  * Patients on immunologic disease modifying agents (commonly known as "biologics")
  * Patients considered "brain-dead" or "vegetative state"
  * Patients transferred from another hospital, long term care facility or institution
  * Neutropenia (total WBC \<1,500/mm3 or absolute neutrophil count of \<1,000/mm3)
Effect of Modified 45-degree Head-up Tilt Position in Cesarean Operation to the Success of Spinal Anesthesia

The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated.

180 patients in ASA I-II risk group between the ages of 18-50 will be included in the study.The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated. Anatomical features of height, weight, block application of the patients will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* caesarean section
* 18-50 years old
* ASA I-II risk

Exclusion Criteria:

* heart failure
* patient's refusal
* thrombocytopenia
* coagulation disorder
* heart valve diseases