cyrilzakka/clinical-trials huggingface dataset:
Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females aged 18-60 years.
2. Normal weight, at least 50 kg.

Exclusion criteria

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
4. Known hypersensitivity to the active substance(s) or the excipient of the drug.
5. Pregnant or lactating females.
Comparison of Hyperemic Efficacy Between Central and Peripheral Adenosine Infusion for Fractional Flow Reserve (FFR) Measurement

The purpose of this study is to evaluate the safety and effectiveness of the peripheral IV continuous infusion without the insertion of central venous vascular access method in the achievement of steady-state maximal coronary hyperemia compared with the central IV continuous infusion method.


Eligibility Criteria:
Inclusion Criteria:

* non -infarct related, patients with moderate coronary artery stenosis
* normal ejection fraction on echocardiogram

Exclusion Criteria:

* infarct-related arteries or clinically unstable state
* collateral blood flow to the target vessel is shown
* atrioventricular block on electrocardiogram
* reduced ejection fraction(\<50%) or left ventricular hypertrophy on echocardiography
* contraindication of adenosine
A Study Comparing Two Forms of Didanosine in HIV-infected Patients

The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe and absorbed by the body as well as the chewable-tablet form of ddI.

Didanosine (ddI) is an anti-HIV drug. The effectiveness of ddI can be lowered by acid in the stomach. To prevent this, patients take antacids with ddI. The coated-capsule form of ddI may replace the need for antacids.

Didanosine, a purine nucleoside analogue, is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. Didanosine is administered orally with antacids to protect it against acid-induced hydrolysis in the stomach. To eliminate the need for using buffers in the ddI formulations, an enteric-coated bead formulation of ddI is being developed.

Patients are randomized to 1 of 2 groups to receive treatment on 2 separate occasions at least 72 hours apart. Group 1 receives the reference formulation of ddI. Group 2 receives the test formulation of ddI. Clinical evaluations, including clinical laboratory tests, are performed periodically during the study and at discharge. Serial blood samples are collected at specific time points over the 12 hours following dosing, and are used for the pharmacokinetic variables CMAX and AUC(INF). Factors used in analysis are sequence, subject within sequence, period, and formulation. Safety is assessed by monitoring adverse effects, vital signs, ECG recordings, and clinical laboratory tests throughout the study.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 cell counts of at least 200 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Any evidence of organ dysfunction.
* Any clinically significant deviations from specified baseline requirements for physical examinations, laboratory tests, or 12-lead electrocardiogram.
A Randomized Study to Establish the Efficacy of Oral Ice Exposure During Oxaliplatin Infusion in Preventing Oral Cold Sensitivity

The main purpose of this study is to evaluate whether exposure to ice chips in the mouth (oral ice chips) during oxaliplatin treatment prevents or reduces symptoms of cold sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥18 years of age will be enrolled.
* Patients must have histologic confirmation of a solid tumor malignancy that will be treated with a regimen that contains full-dose oxaliplatin.
* Patients may be receiving treatment in the neoadjuvant, adjuvant or metastatic setting.
* Patients must be treatment-naïve to platinum-agents at the time of enrollment. Prior treatment with non-platinum agents is permitted.

Exclusion Criteria:

* Any active intraoral infection, including yeast infection (thrush) or active oral herpes simplex virus at the time of enrollment.
* Patients may not have dentures.
* Patients may not have a disorder that may result in altered taste sensation at baseline. This includes but is not limited to: persistent dry mouth.
Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation

The objective of this study is to investigate the effects of personalized, adaptive, current-steering functional electrical stimulation (FES) of the lower leg to improve gait in people with foot drop.

Adaptive, current-steering FES enables precise control over dorsiflexor and evertor muscles, allowing for personalized treatment to correct key foot drop characteristics including dorsiflexion at heel strike and ankle inversion during swing phase. All participants will receive adaptive FES of the dorsiflexors and evertors during back-to-back walking sets. Participants completed up to three walking sets of unstimulated walking (pre-test) followed by lower-leg stimulated walking (post-test). The primary outcome measures include ankle dorsiflexion at heel strike and mean ankle inversion during swing phase. Secondary outcome measures include foot angle at heel strike and single-side heel strike to toe strike time (heel-toe time).

Eligibility Criteria:
Inclusion Criteria:

Adults aged 18-70

* Lower extremity impairment that makes walking difficult or uncomfortable
* Capable of sitting, standing, and walking independently or with assistance
* Able to walk at least 50 feet independently or with assistance
* Able to understand and follow basic instructions in English

Exclusion Criteria:

* Have non-reversible damage to the peripheral nervous system
* Have underlying pre-existing conditions like thrombosis/hemorrhage, severe epilepsy or other seizure disorder, severe atrophy or history of implanted electrical devices
* Have cognitive impairment that would prevent you from fully understanding the study and ability to provide informed consent
* Have lower motor neuron disease or injury that may impair response to stimulation
* Are pregnant
* Are under the age of 18 years old
* Have skin conditions of the affected lower limb, including cuts, burns or lesions
Lupus Cohort--Thrombotic Events and Coronary Artery Disease

To study longitudinally the incidence, pathogenesis, and risk factors for thrombotic events and coronary artery disease in a cohort of patients with systemic lupus erythematosus (SLE).

BACKGROUND:

The Johns Hopkins Lupus Cohort, begun by Dr. Petri in 1987, was a longitudinal study of the incidence and pathogenesis of thrombotic events and coronary artery disease in SLE. The usual natural history of thrombotic events and coronary artery disease is telescoped in SLE, so that patients present with these outcomes in their third and fourth decades.

DESIGN NARRATIVE:

Risk factors addressed in the study included: 1) the hypercoagulable state secondary to antiphospholipid antibodies (the lupus anticoagulant and anticardiolipin antibody); 2) premature atherosclerosis, accelerated by prednisone and hypertension; 3) underlying vascular damage from lupus vasculopathy and vasculitis; 4) co-morbid factors, including obesity, smoking, hyperlipidemia, hypertension, sedentary life style, and family history of coronary artery disease, and 5) other factors, including sex, age, race, immunogenetics, compliance with medication, and socioeconomic status. The Hopkins Cohort Study was uniquely able to focus on these issues, both because of its population, which reflected a broad racial, educational, and socioeconomic background, and because the four years of data accumulated showed promising preliminary results.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Medtronic South Asian Systolic Heart Failure Registry

The purpose of this study is to (a) characterize the current management of patients with systolic heart failure (HF) in South Asia following an educational intervention of current guidelines and delivery of disease management tools and (b) to characterize the effect of current therapy on clinical outcomes in patients managed by tertiary care centers across South Asia. Current therapy includes characterization of the post market performance of any market released Medtronic cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy plus implantable cardiac defibrillator (CRT-D) system for cardiac resynchronization therapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Patient has signed and dated study informed consent. Patients having moderate to severe heart failure (NYHA Class III or IV) EF \< 35% as measured by echo, MUGA, contrast ventriculogram or MRI. QRS duration \> 120 ms.

Exclusion Criteria:

Patient has life expectancy of less than 12 months due to medical conditions other than HF.

* Patient has experienced unstable angina, acute myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months.
* Patient is known to have chronic permanent atrial arrhythmias (i.e., cases of long-standing atrial fibrillation of greater than 1 year, including those in which cardioversion has not been indicated or attempted).
* Patient is enrolled in any concurrent study that would confound the results of this study.
* Patient is pregnant or breastfeeding.
* Patient has a CRT device implanted previously.
* Patient has had a heart transplant.
Lentiviral FVIII Gene Therapy

This study is a Phase I trial using an advanced lentiviral vector to deliver a functional gene for human clotting factor VIII into patients with hemophilia A, to evaluate the safety and efficacy of infusion of lentiviral gene modified autologous stem cells in patients.

Hemophilia A is a genetic bleeding disorder caused by the lack of ability to produce blood-clotting factor VIII (FVIII). Individuals with hemophilia A suffer repeated bleeding episodes, which can cause chronic joint disease and sometimes even death due to the inability for blood to clot efficiently. The current treatment is intravenous infusion of clotting factor concentrates, either prophylactically or in response to bleeding. The procedure is life time long and expensive while still cannot achieve a cure.Gene therapy is a novel technology that has been successfully demonstrated in a number of clinical studies for diseases such as cancer and genetic diseases. In this study, an advanced lentiviral vector system NHP/TYF will be used to deliver a functional FVIII gene to overcome human clotting FVIII gene defect in patients with hemophilia A. This study is a Phase I trial evaluating the safety and efficacy for infusion of gene modified autologous stem cells in patients with hemophilia A.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent and comply with requirements of the study.
2. Males ≥2 years with confirmed diagnosis of hemophilia A (endogenous factor VIII ≤2 IU/dL or ≤2% of normal).
3. A minimum average of 4 bleeding events per year requiring episodic treatment of factor VIII infusions or prophylactic factor VIII infusions.
4. No measurable factor VIII inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor VIII protein.
5. Agree to use reliable barrier contraception until 3 consecutive samples are negative for vector sequences.

Exclusion Criteria:

1. Significant liver dysfunction as defined by abnormal alanine transaminase, bilirubin and alkaline phosphatase.
2. History of inhibitor against factor VIII.
3. Evidence of active hepatitis B or C and currently on antiviral therapy.
4. Have serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm3 (subjects who are HIV+ and stable with CD4 count \>200/mm3 and undetectable viral load are eligible to enroll).
5. Any evidence of active infection or any immunosuppressive disorder.
6. Participated in a gene transfer trial within the last 6 months or in a clinical trial with an investigational drug within the last 12 weeks.
7. Unable or unwilling to comply with study assessments.
Effects of Ashwagandha Extract on Stress Levels

The purpose of this study is to evaluate the efficacy of two proprietary ashwagandha extracts on stress levels, with secondary outcomes of cognition, energy, and sleep, as compared to a placebo.

Participants will take one of two extracts or a placebo every day for 60 days; outcomes of stress, sleep, energy, and cognition will provide information on effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
* Self reported high stress
* Baseline score of above-average stress levels on the NRI-SS
* Biological sex of woman; gender identification of female
* Aged 30 to 59, inclusive
* Good general health as evidenced by medical history and screening
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
* Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

* Pregnancy, trying to conceive, or breastfeeding
* Currently smokes or vapes (i.e., tobacco, flavored items, marijuana, etc.) or has in the past year
* Consumes \> 8 alcoholic beverages in an average week
* Is a primary caretaker for a child younger than 18 months of age
* Currently consumes an ashwagandha supplement or has consumed one regularly (defined as 1x week or more often) within the past 24 months
* Consumes any stress aid, medication, diet, or supplement intended to improve stress in any way
* Current or recent (within 60 days) history of taking thyroid medications, hypertensive drugs, CNS depressants, diabetic medications, benzodiazepines, or immunosuppressants
* Any liver or kidney disorder
* Known allergic reactions to any components of the intervention
* Positive COVID-19 test within 30 days of the study period
* Recent dramatic weight changes (10% change in body weight in the last 6 months)
* Introducing a new investigational drug or other intervention within 60 days before the start of the study
* Introducing a new lifestyle stress-reduction aid (i.e. physical activity, yoga, etc) within 60 days before the start of the study
Limbal Astigmatic Keratotomy to Correct High Degrees of Astigmatism After Phacoemulsification

Compare manually performed Astigmatic Keratotomy to femtosecond laser astigmatic keratotomy to manage corneal astigmatism more than three diopters after phacoemulsification.

create circumferential corneal incisions, following the limbal curvature, at 1-1.5 mm anterior to the limbus, manually and by using femtosecond laser to correct corneal astigmatism more than three diopters after phacoemulsification.

Eligibility Criteria:
Inclusion Criteria:

* Possibility to have informed consent and attendance of all study visits.
* Patients who have undergone conventional phacoemulsification at least one month ago.
* Clear cornea.
* Astigmatism more than 0.5 diopters.

Exclusion Criteria:

* Corneal opacity.
* History of corneal surgery.
* Thin cornea.
* Astigmatism equal to or less than 0.5 diopters.
Pancreatic Cancer Initial Detection Via Liquid Biopsy

The overall rationale of PANCAID is to provide a diagnostic blood test for early diagnosis of pancreatic cancer. With a set of different liquid biopsy methods, it is the aim to measure these markers in well-defined patient cohorts. For the entire series of these studies, the following groups are planned: 1) Histologically proven early-stage pancreatic cancer (e.g. T1a/b and T2 carcinomas \[N0M0\]); 2) Intraductal papillary mucinous neoplasia (IPMN) that were operated with verification of the benign, premalignant or malignant histology; 3) ordinary branched-duct IPMN; 4) individuals at risk (IAR) with and without IPMN, with and without known hereditary cancer gene (e.g. BRCA2); 5) a high risk group of patients with chronic pancreatitis, aged 55-65, who are heavy smokers (≥40 PY), with newly onset diabetes mellitus (NODM).


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of or elevated risk for pancreatic ductal adenocarcinoma (PDAC); intraductal papillary mucinous neoplasias (IPMN); individuals at risk (IAR) for pancreatic cancer

Exclusion Criteria:

* other malignant condition
Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery under extracorporeal circulation. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.

The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery under extracorporeal circulation. Microcirculatory changes during cardiac surgery have been investigated mainly during coronary procedures using the conventional extracorporeal circulation. There is no single study in the literature investigating microcirculatory alterations using a perioperative strategy of "physiologic" perfusion. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.

All patients will follow the same anaesthetic and perfusion protocol. The protocol for the evaluation of microcirculation will be based on:

* Cerebral near-infrared spectroscopy (rScO2) measurements (INVOS, Covidien-Medtronic Inc.).
* NIRS-Based Cerebral Autoregulation Monitoring: Analog arterial blood pressure signals will be digitized and then processed with the digital NIRS signals using a personal computer and a special ICM software (University of Cambridge, Cambridge, UK). Monitoring cerebral autoregulation ensures adequate renal perfusion. Hence, brain can be used not just as a target but also as an index organ indicating adequacy of perfusion.
* Somatic near-infrared spectroscopy (rSsO2) measurements (INVOS, Covidien-Medtronic Inc.).
* Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging (MicroScan, Microvision Medical, Amsterdam, The Netherlands).

All measurements will be performed at the following time points:

T0: after induction of anaesthesia T1: after initiation of cardiopulmonary bypass T2: 10 minutes after cross- clamping the aorta T3: 10 minutes before removing the aortic cross-clamp T4: after weaning from extracorporeal circulation

Eligibility Criteria:
Inclusion Criteria:

* patients aged \> 18 and \< 85 years with coronary artery disease and/or aortic valve disease undergoing open heart surgery with accepted indications

Exclusion Criteria:

* patients undergoing emergency surgery
* patients in preoperative cardiogenic shock with evidence of tissue malperfusion
* patients \> 85 years of age
* patients with severe peripheral vascular disease
MARPE Effect With/Without MOP in Non-growing Patients

This study compares the effect of MARPE (mini-implant assisted rapid palatal expansion) versus MARPE+ MOP (Micro-osteo-perforation) on nasal airway and maxillary transverse deficiency in non-growing patients.

All participants with skeletal transverse deficiency with unilateral or bilateral cross-bite aging 20-25 years were treated by expansion of maxillary arch as a first phase of treatment with one expander screw which was anchored to mini-implants placed in the palatal region (Mini-implant assissted rapid palatal expansion; MARPE). The patient's bone support in the anterior area of the palate was examined on CBCT. Micro-osteoperforation (MOP) was done along of medial palatine raphe in the intervention group. Control-group is the same of the intervention group but without micro-osteo-perforations.

Eligibility Criteria:
Inclusion Criteria:

1. The age ranges from 20-25 years.
2. Post pubertal adolescent
3. Skeletal transverse deficiency with unilateral or bilateral cross-bite
4. Extraction is not indicated in the lower arch.
5. Upper permanent dentition is erupted up to the second molars.
6. Average facial vertical growth pattern.
7. Space deficiency in the upper arch is less than 8 mm

Exclusion Criteria:

1. Diseases and medications those are likely to affect bone biology.
2. Evidence of root resorption.
3. Poor oral hygiene.
4. Previous orthodontic treatment.
5. Evidence of bone loss.
6. Active periodontal disease.
7. Craniofacial congenital anomalies, such as cleft lip and palate.

7. Pregnant females. 8. Presence of oral habits.
Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proved adenocarcinoma (colorectal cancer).
* Age: 20 ≤ at enrollment.
* No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded.
* At least one measurable lesion by RECIST criteria

Exclusion Criteria:

* Serious drug hypersensitivity.
* Prior history of peripheral neuropathy.
* Diarrhea .
* Simultaneously active double cancer.
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Safety.

To prove the safety in normal conditions of use.


Eligibility Criteria:
Inclusion criteria:

* Integral skin test in the region;
* Use of cosmetic product of the same category;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs;
* Atopic antecedent or allergic to cosmetic product;
* Active cutaneous disease in the evaluation area;
* Diseases which cause immunology decrease, such as diabetes and HIV;
* Endocrinal pathologies;
* Intense solar exposure 15 days before the evaluation;
* Treatment until four months before the selection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.