cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Men aged 18 years or over and less than or equal to 60 years with a diagnosis of Androgenetic Alopecia grades IIIv to IV in the modified Norwood-Hamilton classification, who have been using minoxidil 5% for at least 3 months and willing to maintain the same style, approximate length and hair color throughout the test.

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Participants with other concomitant dermatological diseases on the scalp, except for mild seborrhoea dermatitis;
* Participants with a history of surgical treatment for hair loss or shaved scalp;
* Participants who used shampoo or topical solution containing ketoconazole, tar, selenium, threonine or steroids in the last 2 weeks;
* Participants who used 5α reductase inhibitors, such as finasteride and dutasteride, in the last 12 months;
* Participants using testosterone replacement therapy (TRT) or using testosterone-containing gel;
* Participants who used micro-infusion of medications on the skin (MMP), microneedling or intradermotherapy on the scalp in the last 3 months;
* Participants who have undergone radiation treatment for the scalp or chemotherapy in the past year;
* Participants with diseases that can affect hair growth;
* Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;
Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye

This study examines the effectiveness of combining Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL) treatments for Mixed Dry Eye, a condition where both tear production and tear quality are compromised. Twenty-five patients received both treatments over a period of six weeks, and their symptoms and tear quality were monitored for three months.

Study Title: Efficacy of Quantum Molecular Resonance Combined with Intense Pulsed Light in Mixed Dry Eye: A Prospective Clinical Study

Purpose of the Study: This study aims to evaluate how well two treatments-Quantum Molecular Resonance (QMR) and Intense Pulsed Light (IPL)-work when used together to treat Mixed Dry Eye (MDE). Mixed Dry Eye is a condition that affects both the quantity and quality of tears, leading to discomfort and vision problems. The goal is to see if combining these treatments can better relieve symptoms and improve tear production and stability.

What is Mixed Dry Eye? Dry Eye Disease is a common condition that can cause symptoms like burning, itching, and blurred vision. Mixed Dry Eye occurs when both the tear production is low, and the tears evaporate too quickly, leading to chronic discomfort.

What are QMR and IPL Treatments?

QMR (Quantum Molecular Resonance): This is a newer technology that uses low-intensity, high-frequency waves to stimulate the cells in the eye. It may help improve tear production and reduce inflammation.

IPL (Intense Pulsed Light): This treatment uses light to heat the skin around the eyes, which helps improve the function of glands that produce the oily layer of tears, preventing tears from evaporating too quickly.

Study Design:

Participants: 25 patients with Mixed Dry Eye Treatment: Participants received 4 sessions of QMR and 3 sessions of IPL over 6 weeks. They were also given tear substitutes to use during the study.

Follow-up: Patients were evaluated at the beginning, and after 1 and 3 months to assess the improvement in their condition.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosed with Mixed Dry Eye (MDE)
* Ocular Surface Disease Index (OSDI) score of 13 or higher
* Non-Invasive Tear Film Break-Up Time (NIBUT) less than 10 seconds
* Lipid Layer Thickness (LLT) less than 75 nm
* Schirmer I Test (ST) without anesthesia less than 5 mm in 5 minutes

Exclusion Criteria:

* Presence of skin conditions that prevent QMR or IPL treatments
* Corneal disorders that affect diagnostic tests, including:
* Active corneal infections
* Corneal dystrophies
* Active ocular allergy
* Previous device-based dry eye treatments, such as:
* Microblepharoexfoliation
* Low-level light therapy
* Vectored thermal pulsation
* Inability to understand or comprehend the informed consent
* Pregnant or lactating women
* Contact lens wearers who do not discontinue lens use at least one week before baseline and follow-up exams
MgSO4 Combined With Rocuronium Priming

Priming with either rocuronium or MgSO4 is known to accelerate the effect of rocuronium on muscle relaxation. The purpose of this study is to define the effect of MgSO4 on the rocuronium-priming.

Acceleration of muscle relaxation is beneficial in rapid-sequence intubation. If MgSO4 combined with priming is efficient in accelerating muscle relaxation, it would be an interesting alternative to rapid-sequence intubation.

Eligibility Criteria:
Inclusion Criteria:

* patients of ASA Ⅰ-Ⅱ
* aged 18\~65
* scheduled to undergo elective surgery under general anesthesia

Exclusion Criteria:

* risk of pulmonary aspiration
* anticipated airway difficulty
* reactive airway disease
* allergic to study drugs
* neuromuscular / cardiovascular/ renal/ hepatic disease
* atrioventricular conduction disturbance
* BMI \< 18.5 or \> 24.9
* chronic treatment with calcium channel blocker
* medications which affect muscle relaxation
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis

This is a study to assess the long-term safety, tolerability, and efficacy of bimekizumab.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have completed all dosing requirements in PS0016 without meeting any withdrawal criteria
* Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives)

Exclusion Criteria:

* Subjects previously participating in this study
* Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study. Note: For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including herpes zoster or hospitalizations) in PS0016, the Medical Monitor must be consulted prior to the subject's entry into PS0018
* Subject has any current sign or symptom that may indicate a medically significant infection
* Subject has current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, tuberculosis (TB), nontuberculous mycobacteria (NTMB),Blastomyces, Aspergillus, or Candidiasis (systemic). Any subject diagnosed with Histoplasmosis, Coccidiodes, Paracoccidioides, Pneumocystis, TB, NTMB, Blastomyces, Aspergillus, or Candidiasis (systemic) during PS0016 is excluded from PS0018 even if treatment has been completed.
* Any subject who meets any withdrawal criteria in the feeder study (PS0016) is excluded from participating in the open-label extension study (PS0018)
Trimetazidine in Myocardial Injury After Percutaneous Coronary Intervention in Patients With Angina and Diabetes

Introduction: Recent studies have suggested that trimetazidine may help reduce myocardial damage following percutaneous coronary intervention. However, the evaluation of the potential of this medication in the reduction of myocardial damage in patients with diabetes mellitus and unstable angina, in a prospective and randomized way, has not yet been described. Objective: The aim of this study was to evaluate the efficacy and safety of the use of trimetazidine versus placebo in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty. Methodology: For this, a unicentric, randomized, double blind and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, drug dose, complications) of patients will be analyzed for safety and effectiveness. Myocardial damage will be measured by means of ultrasensitive Troponin dosages. Expected results: The use of trimetazidine reduces myocardial damage in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women aged\> 18 years.
* Diagnosis of unstable angina with chest pain at least 2 hours after arrival at the emergency unit.
* Measurement of troponin less than the upper limit of the normality of the method.
* Indication of cardiac catheterization and need for percutaneous coronary intervention with uniarterial stent within 24 hours of admission.
* No known allergy to trimetazidine.
* Prior diagnosis of diabetes mellitus under specific treatment.
* ClCr\> 30 mL / min.
* Signed consent form.

Exclusion Criteria:

* Pregnancy.
* Hemodynamic instability (pulmonary congestion / systolic blood pressure less than 90 mmHg).
* SCA with ST elevation or troponin elevation.
* Body mass index greater than 40 kg / m2.
* Use of oral anticoagulant.
* Orotracheal intubation.
* Left ventricular outflow tract obstruction.
* Allergy to iodinated contrast.
* Thoracic trauma in the last 30 days.
* Previous surgical myocardial revascularization.
* Presence of ventricular arrhythmias.
Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants

The purpose of this study is to evaluate whether the pharmacokinetics (body concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when they are administered together


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, Physical Examination, vital signs, 12-lead ECG, and clinical laboratory determinations
* Body mass index (BMI) of 18 to 30 kg/m2
* Men and women, ages 18 to 45 years
* Women of childbearing potential must use acceptable methods of highly effective birth control

Exclusion Criteria:

* History of chronic or recurrent urinary tract infection for females
* History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose transporter type 2 (SGLT2) inhibitors
* Any significant acute or chronic medical illness
* Current or recent gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Prior exposure to saxagliptin or dapagliflozin or related drugs
3-Month Trial Observation of A1c Change

The incidence of type 2 diabetes in long term care facilities has been approximated at 25% with barriers to treatment including untimely access to a specialist and improper/poor adherence to insulin regimes. This 3 month trial will investigate the efficacy of improving overall glycemic control by using an internet blood glucose reporting system to facilitate bi-weekly consultations between long term care facility patients with type 2 diabetes and an endocrinologist.

Purpose: This project will investigate the benefits (as measured by change in the primary outcome measure hemoglobin A1c) of bi-weekly reporting of blood sugar values for patients with type 2 diabetes in long term care facilities.

Hypothesis: Our hypothesis is bi-weekly reporting will result in a reduction in A1c after 3 months.

Justification: Elevated A1c values increase risk of health complications for people with type 2 diabetes.

Objectives: Improved type 2 diabetes management for patients in long term care facilities.

Research Methods: Patients who meet the inclusion / exclusion criteria and are interested in participating in the study will self-identify to the research coordinator. Consent will be done in person with any questions answered. Strips and blood glucose meters will be provided. Blood glucose values and testing frequency will be recorded using the internet reporting system Heath-e-Connect. HbA1c, serum creatinine and demographic data will be collected at 0 and 3 months to determine effect of bi-weekly remote communication of blood glucose with an endocrinologist.

Statistical Analysis: HbAlc values at 0 and 3 months will be compared using an unpaired t-test to measure the effect of the intervention

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes mellitus patients at Point Grey Private Hospital
* Trained in self-blood glucose monitoring
* Willingness to test blood glucose levels a minimum of 3 times daily
* Willingness to be trained on IBGMS

Exclusion Criteria:

* Patients with medical conditions that may affect their study participation or results will be excluded.
* Patients currently being treated with steroid medication
* Patients that have impaired liver function
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state.


Eligibility Criteria:
Inclusion criteria:

1. Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.
2. Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening.
3. Age \>21 and Age \<70 years (male and hysterectomised female patients) Age \>60 and Age \<70 years (postmenopausal female patients)
4. Body Mass Index (BMI) \>18.5 and \<40 kg/m2
5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria:

1. Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)
2. Fasted blood glucose \> 240 mg/dl (\>13.3 mmol/L) on two consecutive days during washout.
3. Glycosylated haemoglobin A1 (HbA1c) \>8.5% at screening
4. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:

   * Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)
   * Renal insufficiency (calculated creatinine clearance \< 80 ml/min/1.73m²)
   * Cardiac insufficiency NYHA II-IV, myocardial infarction, other known cardiovascular diseases including hypertension \> 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA (Transistoric ischaemic attack)
   * Neurological disorders (such as epilepsy) or psychiatric disorders
   * Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections)
   * Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder
5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
7. A history of additional risk factors for TdP (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)
GIOTRIF rPMS in Korean Patients With NSCLC

To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)


Eligibility Criteria:
Inclusion criteria:

1. Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
2. Age = 19 years at enrolment
3. Patients who have signed on the data release consent form

Exclusion criteria:

1. Known hypersensitivity to afatinib or any of its excipients
2. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
3. Patients for whom GIOTRIF® is contraindicated according to the local label
Edoxaban for TIA and Acute Minor Stroke

Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and slightly increase the risk of intracerebral hemorrhage. Recently, edoxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage.

This trial is a randomized, double-blind, multicenter, controlled clinical trial in China. The investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (male or female ≥18 years old)
* Acute nondisabling ischemic stroke (NIHSS ≤3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle
* TIA (neurologic deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with investigational medication within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle
* Informed consent signed

Exclusion Criteria:

* Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major nonischemic brain disease, on baseline head CT or MRI scan
* mRS score \>2 at randomization (premorbid historical assessment)
* NIHSS ≥4 at randomization
* Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state)
* Contraindication to investigational medications
* Thrombolysis for ischemic stroke within preceding 7 days
* History of intracranial hemorrhage
* Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anticoagulation
* Gastrointestinal bleed or major surgery within 3 months
* Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
* TIA or minor stroke induced by angiography or surgery
* Severe noncardiovascular comorbidity with life expectancy \<3 months
* Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test result
* Severe renal failure, defined as Glomerular Filtration Rate (GFR) \<30 ml/min -Severe hepatic insufficiency (Child-Pugh score B to C)
Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye

Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.

The primary goal of this investigation is to determine the relative comfort of an intravitreal injection (same day and the next day) after a preparation utilizing three cotton swabs soaked in 4% lidocaine versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel. Based on the available data, the researchers contend that a preparation based on viscous 3.5% ophthalmic lidocaine gel, which coats the surface and remains in contact with the eye longer, may provide greater anesthesia and result in greater patient comfort than the topical 4% lidocaine, which is part of the standard preparation routinely utilized in the ophthalmology department currently. Secondary outcome measure is the intraocular pressure rise after the injection, and the authors will generate prospective data to study whether softening the eye with cotton swabs prior to the injection lowers post-injection pressure spike.

Eligibility Criteria:
Inclusion Criteria:

* Has required repeat Ranibizumab injections and has had at least 3 injections prior to recruitment
* Informed consent
* Age ≥ 18 years
* Clinical need for a therapeutic ranibizumab intravitreal injection regardless of the medical indication
* Able to understand and read English

Exclusion Criteria:

* Pregnancy (positive pregnancy test)
* Mental disability
* Prisoners
* Patients with fluctuating or impaired decision-making capacity
* Inability to comply with study or follow-up procedures
* Previous reaction to the same drug class
Peripartum Cardiomyopathy in Nigeria Registry

Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality, and Nigeria probably has the highest burden of the disease in the world. Unfortunately, much about the disease including its aetiology, epidemiology and treatment is not yet well described. This will be a prospective, national, multicenter cohort study, conducted in centres in Nigeria. It is expected that approximately 500 patients with PPCM and 500 apparently healthy pregnant women will be recruited over a 6-month period with follow-up at 3-monthly intervals for 18 months.

Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality, and Nigeria probably has the highest burden of the disease in the world. Unfortunately, much about the disease including its aetiology, epidemiology and treatment is not yet well described. This will be a prospective, national, multicenter cohort study, conducted in centres in Nigeria. It is expected that approximately 500 patients with PPCM and 500 apparently healthy pregnant women will be recruited over a 6-month period with follow-up at 3-monthly intervals for 18 months. The objectives of the study are:

i. To describe the burden and demographic, social and clinical characteristics of PPCM in Nigeria.

ii. To describe the ventricular remodelling and outcomes (rehospitalisation rate, cardio-embolic events and survival) of PPCM in Nigeria.

Sub-study:

iii. To study the relationship between selenium deficiency, oxidative stress and PPCM in Nigeria.

iv. To describe the prevalence of selenium deficiency and its relationship with cardiac function in apparently healthy pregnant women in Nigeria.

v. To study the impact of sodium selenite supplementation on cardiac function among selenium deficient PPCM patients who have not recovered left ventricular function at 6 months after the diagnosis.

This will be the largest systematic evaluation of PPCM in Nigeria, and it is hoped that the information will assist in developing locally applicable treatment guidelines, policies and interventions for this seemingly deadly disease.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PPCM
* PPCM patients with HF symptoms at the time of recruitment
* Asymptomatic pregnant women attending antenatal clinic (ANC)
* Sub-study: Open-label randomised Trial: Non-pregnant PPCM patients with all of the following: LVEF \<35% and/or LVEDDi≤33.0 mm/m2 at 6 months postpartum AND selenium deficiency
* Written informed consent

Exclusion Criteria:

* Asymptomatic PPCM patients at the time of recruitment
* PPCM patients who are not expected to survive at least 6 months from recruitment
* Pregnant women with any medical condition other than PPCM
* Subjects who are considered not likely to attend follow up reviews regularly, because of lack of patient's and close relative's phone numbers, or long distance from the study centre, etc
* Refusal or withdrawal of consent