cyrilzakka/clinical-trials huggingface dataset:
Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Meibomian gland obstruction
* Dry eye symptoms
* Willingness to comply with study procedures and return for all visits

Exclusion Criteria:

* Ocular surgery, injury, or herpes infection within past 3 months
* Active ocular infection
* Active ocular inflammation or recurrent inflammation within past 3 months
* Moderate to severe allergic conjunctivitis
* Severe eyelid inflammation
* Eyelid abnormalities that affect lid function
* Ocular surface abnormalities that may compromise corneal integrity
* Macular disease
* Systemic disease condition or medication that causes dry eye
* Use of other treatments for meibomian gland dysfunction or dry eye
* Pregnant or nursing women
* Participation in another ophthalmic clinical trial within past 30 days
Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding

The purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal aromatase inhibitor (AI).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age
* Must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer.
* Must have disease progression during treatment with a nonsteroidal AI for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting.
* Must be a postmenopausal female.
* Must have measurable or evaluable disease.

  * Measurable disease is defined as \>=1 lesion with a diameter of \>=10 mm
  * Evaluable disease is defined as bone lesions evaluable by plain X ray, CT scan, or MRI. Lesions identified only by radionuclide bone scan are not allowed.
* One prior chemotherapy regimen for advanced mBC is allowed.
* Prior radiotherapy is allowed.
* Must be able to swallow and retain oral medication.
* ECOG performance status of \<=2
* Required laboratory values

  * Plasma cortisol and adrenocorticotropic hormone (ACTH) levels that are not suggestive of adrenal insufficiency unless on replacement therapy for known adrenal insufficiency.

Exclusion Criteria:

* HER2 overexpressing tumor.
* History of central nervous system (CNS) metastasis.
* Previous treatment with exemestane or treatment with an Hsp90 inhibitor.
* Use of proton pump inhibitors.
* Known history of or positive test result for hepatitis B or C or HIV.
* History of gastrectomy or major surgery to small intestine.
Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects

The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468

Because ACT-541468 appears to be mainly metabolized by CYP3A4, it is deemed of interest to investigate the potential influence of diltiazem, a well-known CYP3A4 inhibitor on the pharmacokinetic profile of ACT-541468.

Safety of the concomitant administration of the two drugs will also be assessed

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening
* Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests

Exclusion Criteria:

* Any contraindication to the study drugs
* History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs
* History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score \< 0
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamics, and Early Postoperative Atelectasis in Laparoscopic Bariatric Surgery

The aim of this study is to evaluate the effectiveness of intraoperative individualized positive end-expiratory pressure (PEEPIND) titration, compared to fixed positive end-expiratory pressure of 5 cmH2O, on oxygenation, hemodynamic variables, and early postoperative complications in obese patients undergoing laparoscopic bariatric surgery.

Obesity is a major health problem, and the incidence is increasing worldwide. So far, the only treatment for morbid obesity with good long-term results is bariatric surgery.

Obese patients have unique respiratory physiology and ventilatory mechanics characteristics. Their lung function is impaired due to the reduction of oxygen reserve, functional residual capacity, and lung compliance. In addition, they frequently present with respiratory comorbidities, which increases the risk of developing postoperative pulmonary complications (PPCs) such as atelectasis especially after procedures under general anesthesia. Atelectasis has been hypothesized as a main cause of postoperative hypoxemia.

To reduce the incidence of atelectasis, positive end-expiratory pressure (PEEP) and recruitment maneuvers are used as a protective lung strategy to improve gas exchange and lung mechanics through reopening collapsed alveoli and maintaining the aeration of lungs. Application of PEEP may also eliminate auto-PEEP without increasing plateau pressure.

Eligibility Criteria:
Inclusion Criteria:

* Age from 21 to 60 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status class I-III
* Patients who are scheduled for elective laparoscopic bariatric surgery under general anesthesia.

Exclusion Criteria:

* Patients who are unwilling to participate in the study
* Actively smokers.
* Patients who had a history of Chronic obstructive pulmonary disease or bronchial asthma.
* Patients who are receiving renal replacement therapy prior to surgery.
* Patients who had a history of heart failure.
* Pregnant.
* Patients who have allergies to any drug used in the study.
Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures

The objective of this study is to evaluate the impact of reduced pump prime on blood transfusions and postoperative complications in patients at high risk of severe hemodilution during CPB.

HYPOTHESIS The use of a new CPB circuit with a smaller internal volume, together with retrograde autologous priming of the lines (RAP) will allow a smaller prime volume and therefore less significant hemodilution on pump.

EXPERIMENTAL DESIGN Overview

Patients will be randomized on the morning of surgery to one of the two study groups in a 1:1 allocation scheme:

1. Low pump prime
2. Standard pump prime Outcomes The primary outcome is the number of units of blood products transfused within the first 24 hours post CPB.


Eligibility Criteria:
Inclusion Criteria:

* \>18 y of age
* Non-emergent complex cardiac surgery (any procedure other than primary isolated CABG)
* Any of the following: Hb \< 120 g/L (Females) or \< 130 g/L (Males)BSA \< 1.6 m2Creatinine Clearance \< 60 mL/min (Cockcroft Gault Equation)

Exclusion Criteria:

* aPTT \>50 s, INR\>1.5
* Plt \< 100,000 x 106
* Preoperative Hemodialysis
* Tight aortic stenosis (Aortic Valve Area \< 1 cm2)
* Tight lesion of the left main coronary artery (\> 60%)
* Use of Aprotinin requested by the Surgical Team
Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference

Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large \[≥ 20 mm\] or multiple \[≥ 3 sized ≥ 15 mm\] CBD stones). And also compared the outcomes with conventional procedure of open surgery.

Gallstones are a very common problem in developed countries. Most patients with gallstones remain asymptomatic throughout their lifetime, but 10 % - 25 % of them may develop biliary pain or complications, with an annual risk of about 2 % - 3 % for symptomatic disease and 1 % - 2 % for major complications. The development of symptomatic disease and complications is mostly related to the migration of stones into the common bile duct (CBD). Common bile duct stones (CBDSs) may be treated by endoscopic retrograde cholangiopancreatography (ERCP) or surgically during cholecystectomy. Removal of common bile duct (CBD) stones can still be difficult in patients with large or multiple stones despite an adequate sphincterotomy. Procedures such as mechanical, extracorporeal, electrohydraulic or laser lithotripsy, and chemical dissolution have been introduced as effective therapeutic interventions for irretrievable CBD stones. However, these techniques have their drawbacks, are not widely available, or are still under clinical evaluation. Several studies have shown that insertion of an endoscopic biliary stent is a safe, effective, and widely available measure. An indwelling stent provides biliary drainage and fragments large stones, thereby reducing the risk of cholangitis and allowing stones to pass spontaneously or rendering them more extractable at a later procedure. Thus, this study intends to shed a light on advances in diagnosis and management in patients with biliary difficult stones.

Eligibility Criteria:
Inclusion Criteria:

1. All cases of difficult common bile duct stones leading to variable occlusion.
2. Patients fit for intervention.
3. Patients informed consent for study.

Exclusion Criteria:

1. Surgically unfit cases according to ASA
2. Locally advanced irresectable cases.
3. Patients refuse consent to participate in the study.
Comparison of Oxygen Saturation Measurements Using Different Glove Colors in Children

The aim of this study was to determine the effect of different colored gloves on oxygen saturation in pediatric patients whose oxygen saturation was measured by pulse oximetry in pediatric emergency department. The population of the study, which is planned as a prospective cohort study, will consist of children between the ages of 3-18 years who underwent oxygen saturation measurements in the pediatric emergency clinic of İzmir Bakırçay University Cigli and Training and Research Hospital between October 2024 and October 2025.

The aim of this study was to determine the effect of different colored gloves on oxygen saturation in pediatric patients who underwent oxygen saturation measurement by pulse oximetry in pediatric emergency department. The population of the study, which is planned as a prospective cohort study, will consist of children aged 3-18 years who underwent oxygen saturation measurements in the pediatric emergency clinic of İzmir Bakırçay University Çiğli and Training and Research Hospital between October 2024 and October 2025. The sample of the study will consist of children who meet the inclusion criteria on the specified dates and whose parents/legal guardians agree to participate in the study. Descriptive Characteristics Form and Oxygen Saturation Measurement Value Record Form will be used for data collection.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 3-18,
* The parent/legal guardian or the child himself/herself agrees to participate in the study,
* Arterial blood gas measurement was performed,

Exclusion Criteria:

* The finger has a skin condition,
* Having nail polish on your fingernails,
* Having a severed finger,
A 72-week Randomized Clinical Trial Comparing the Safety and Efficacy of Three Initial Antiretroviral Regimens -GPO-VIR S (d4T/3TC/NVP) for 24 Weeks Followed by GPO-VIR Z (AZT/3TC/NVP) vs GPO-VIR Z vs TDF/FTC/NVP

This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in with GPO-VIR S followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will be anemia, neuropathy, lipoatrophy and renal function.

GPO-VIR Z is a new combination antiretroviral (ARV) medication that substitutes zidovudine (AZT) for stavudine (d4T) from the original formulation of GPO-VIR S. This new combination should decrease rates of lipoatrophy and neuropathy which are side-effects strongly linked to the use of d4T. However, there is some risk that initiating therapy with an AZT- containing regimen may cause unacceptable rates of anemia. Many Thai physicians have adopted a practice of using 6 months of the stavudine-containing GPO-VIR S as a lead in before introducing AZT-containing GPO-VIR Z in an effort to balance the risks and benefits of these two medications. There are no definitive data, however, that can attest to the benefit of such an approach.

Eligibility Criteria:
Inclusion Criteria:

1. Documented HIV-1 infection
2. Age ≥ 18 years old.
3. Subjects must be naïve to ARV. Individuals with past exposure to ARV associated with pregnancy will be allowed to enroll as long as the exposure is at least 3 months prior to entry.
4. CD4 \< 350 cells/mm3
5. Subject understands the study and is able to sign informed consent

Exclusion Criteria:

1. Evidence of symptomatic persistent symptoms of tingling or numbness of lower extremities and bilateral lower extremity neuropathy on exam at entry. Abnormal exam includes 1) Diminished (compared with the knee) or absent ankle reflexes OR 2) Diminution of either vibration sensation in the legs (defined as perception of vibration for \< 10 seconds at the great toe with a tuning fork initially struck hard enough to be audible) OR 3) Diminution of pin or temperature sensation in lower extremities OR 4) Contact allodynia in the feet.
2. Laboratory values 1) Absolute neutrophil count (ANC) \< 750/mm3 2) Hemoglobin \< 8.0 g/dL 3) ALT (SGPT) \> 5 x ULN 4) Creatinine \> 2 X ULN or \< creatinine clearance \< 30 cc per min by Cockroft-Gault formula
3. Active AIDS-defining opportunistic infection (OI) within 30 days prior to entry. Subjects must be off all acute treatments for OI for at least 14 days prior to entry. Subjects on maintenance or prophylactic therapy for AIDS-related OIs will be eligible.
4. Any immunomodulator, HIV vaccine or investigational therapy within 30 days of study entry
5. Pregnancy or breast-feeding; intent to become pregnant during the course of the study.
6. Presence of any active malignancy.
Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease

The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.

Parkinson's disease is the second most common chronic neurodegenerative disease.At present, researchers focus not only on the motor symptoms of Parkinson's disease, but also on the non-motor symptoms of Parkinson's disease (including mood disorders, sleep disorders, cognitive decline, and autonomic nervous kinetic disorder, etc.).The principle of transcranial magnetic stimulation is based on the electromagnetic principle proposed by Faraday. When an electrifying coil is suspended over the scalp at a certain distance, the magnetic field generated by the coil current and the electric field generated by the magnetic field can reach the skull and directly or indirectly affect the synapses and neurons in the brain.The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.

Eligibility Criteria:
Inclusion Criteria:

* in line with international Movement disorders association (the Movement Disorder Society, MDS) in 2015 the diagnosis of Parkinson's disease diagnosis standard and China standard (2016)
* can cooperate to complete rating scale, the sleep monitoring, imaging and blood test
* have a sleep disorder
* aged 18 to 70 years old
* agree to participate in this experiment, and have signed the informed consent

Exclusion Criteria:

* superposition of diagnosed with Parkinson's syndrome
* secondary diagnosed Parkinson's syndrome
* is equipped with heart pacemakers and other metal implants
* cannot achieve scale assessment
* has significant malignant diseases
* has a history of seizures
Inspiratory Muscle Training Post-Liver Transplant

Individuals with chronic liver disease develop significant muscle wasting that remains post-liver transplant. The transplant surgery additionally challenges respiratory mechanics. Respiratory muscle strength has been measured to be impaired in individuals post liver transplant. This study proposes an 8 week intervention designed to increase respiratory muscle strength and pulmonary function that we hypothesize will correlate to improved functional performance and quality of life post-liver transplant.

Pre-test post-test design, that will randomize subjects into an experimental group that will receive the inspiratory muscle strengthening exercise in addition to usual post-liver transplant care and a control group that will only receive the usual post-transplant care.

Up to 50 subjects will be recruited from the Post-Liver Transplant Outpatient Clinic at the Miami Transplant Institute.

The subjects will have repeated measurements of respiratory muscle strength, pulmonary function, functional mobility performance, and quality of life at baseline, 4 weeks, and 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have undergone liver transplantation for chronic liver disease of any origin other than cancer.

Exclusion Criteria:

1. Severe cardiopulmonary disease such as recent Myocardial infarction, Congestive Heart Failure, Pulmonary edema, Chronic Obstructive Pulmonary Disease, and Asthma,
2. Severe osteoarthritis
3. Blindness
4. Wheelchair bound individuals
5. Individuals with neurological / neuromuscular disorders including but not limited to: cerebral vascular accident, Parkinsonism, Alzheimer's disease, dystonia, multiple sclerosis, and polio.
6. Severe Cognitive impairment where individuals cannot follow commands and are unable to sign informed consent -
Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation

Investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.


Eligibility Criteria:
Inclusion Criteria:

* patients with pulmonary artery catheter after cardiac surgery

Exclusion Criteria:

* minimally invasive surgery
* unstable conditions
* bleeding
* unability to fit cuirass
Pegaferon and Ribavirin for Hepatitis C

The purpose of this study is to evaluate the safety and efficacy of a locally produced 40KD pegylated interferon alpha-2a (Pegaferon) in patients with hepatitis C. 100 patients will be treated using standard guidelines for hepatitis C. Response to treatment and side effects will be recorded.

The product is locally produced and needs to be evaluated in terms of efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C
* Age between 15 and 65

Exclusion Criteria:

* previous treatment for chronic hepatitis C
* co-infection with human immunodeficiency virus or hepatitis B virus
* major thalassemia or hemophilia
* active drug user
* being treated for major depression or psychosis
* decompensated cirrhosis
* serum creatinine \> 1.5 mg/dL
* solid organ transplant
* untreated thyroid disease
* uncontrolled diabetes mellitus
* uncontrolled autoimmune disease
* advanced cardiac or pulmonary disease.
* planning to become pregnant in the next 1.5 years
* patients with inadequate contraception
* not consenting to the study
Follow up Glucose Levels Among Infants of Diabetic Mothers

Infants to diabetic mothers (IDM) are at risk for developing hypoglycemia after birth. Glucose level follow ups are recommended to each IDM. However, there are no recommendations as to how long this follow up should be performed for, nor are there "safe" glucose levels that allow stopping glucose monitoring.

The aim of the study is to retrospectively follow up glucose levels among IDMs in order to find risk factors for developing hypoglycemia and determine time and glucose levels that would permit monitoring cessation.

A retrospective study of 250-300 IDMs, born in a single large medical center. Data will be collected as follows: Gestational age, birth weight, sex, delivery mode, type of maternal diabetes, other maternal diseases, feeding mode. Glucose levels as were recorded according to newborn protocol (1,2,4,6 hours after delivery, and then every 8 hours for total of 48 hours). Data of hypoglycemia treatment, if given, will be collected.

Later we will statistically try to determine the risk factors for developing hypoglycemia and the "safe" time and glucose levels to stop monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Full-term infants, diabetic mothers, Singleton

Exclusion Criteria:

* Preterm infants, multiple pregnancy, congenital malformations, clinically ill at birth.