cyrilzakka/clinical-trials huggingface dataset:
Systemic Pharmacokinetics of BOL-303224-A

This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* must be at least 18 years of age, any race
* must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes
* women of childbearing potential must utilize reliable contraceptive methods and have a negative pregnancy test

Exclusion Criteria:

* Pregnant or nursing women
* known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication
* use of any antibiotic within 72 hours of enrollment
* participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study
Study of Protein Translocation in Patients With Beta-Oxidation Disorders

OBJECTIVES:

I. Characterize inheritance patterns of mutations in patients with beta-oxidation disorders.

PROTOCOL OUTLINE:

Patients undergo clinical and molecular analysis of beta-oxidation enzyme metabolism. The evaluation includes a urinary metabolite profile, and DNA and familial studies.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Beta-oxidation disorder, including: Medium-chain acyl-coenzyme A dehydrogenase deficiency Long-chain 3-hydroxyacyl coenzyme A dehydrogenase deficiency Very-long-chain acyl-coenzyme A dehydrogenase deficiency Short-chain 3-hydroxyacyl coenzyme A dehydrogenase deficiency Long-chain 3-ketoacyl-coenzyme A thiolase deficiency Trifunctional protein deficiency Patient age: 1 day and over
A Sedation/Cognition/EEG Study Using AZD6280 and Comparator

The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on sleepiness, concentration and brain activity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 18 to 55 years (inclusive) on Day 1.
* Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Clinically significant illness within 2 weeks before the study start.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
An Expanded Access Program of Emicizumab in Participants With Hemophilia A With Inhibitors

This open-label, multicenter expanded access program (EAP) is designed to provide emicizumab to eligible participants with hemophilia A with factor VIII (FVIII) inhibitors before it is commercially available in the United States for the indication of hemophilia A with FVIII inhibitors. Discontinuation may occur earlier if participant or physician decides to discontinue treatment or the sponsor discontinues emicizumab clinical development.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is \[i.e.\], greater than or equal to \[\>/=\] 5 Bethesda Units)
* History of treatment with episodic or prophylactic bypassing agents for at least the last 24 weeks
* \>/=6 (if on an episodic bypassing agent regimen) or \>/=2 (if on a prophylactic bypassing agent regimen) bleeds within 24 weeks prior to screening
* Currently using recombinant activated factor VII (rFVIIa) or are willing to switch to rFVIIa as primary bypassing agent for the treatment of breakthrough bleeds
* Adequate hematologic function, defined as platelet count \>/= 100,000 per microliters (mcL) and hemoglobin \>/=8 grams per deciliter (g/dL) at screening
* Adequate hepatic and renal function

Exclusion Criteria:

* Inherited or acquired bleeding disorder other than hemophilia A
* Ongoing (or plan to receive during the study) immune tolerance induction (ITI) therapy or prophylaxis with FVIII with the exception of participants who have received a treatment regimen of FVIII prophylaxis with concurrent bypassing agent prophylaxis
* Treatment for thromboembolic disease within 12 months before Day 1 (with the exception of previous catheter-associated thrombosis for which antithrombotic treatment is not currently ongoing) or current signs of thromboembolic disease
* Other conditions (example \[e.g.\], certain autoimmune diseases) that may increase the risk of bleeding or thrombosis
* High risk for thrombotic microangiopathy (TMA), in the investigator's judgment
* History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
* Use of systemic immunomodulators (e.g., interferon or rituximab) at enrollment or planned use during the study, with the exception of antiretroviral therapy
* Treatment with any of the following: An investigational drug to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug administration before Day 1; A non-hemophilia-related investigational drug within the last 30 days or 5 half-lives before Day 1, whichever is longer; An investigational drug concurrently
* Any serious medical condition, treatment, or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in the study
Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma

Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of the 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection.

Funding Source: FDA OOPD

Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer and 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits were scheduled to occur during the 3 weeks prior to the standard of care tumor resection. After the surgery, subjects were followed for 6 months for disease recurrence.

Ten subjects were enrolled in the study. Up to 21 additional subjects could have been enrolled in Stage 2, if safety and efficacy endpoints were not met. The dose was not changed. All subjects were followed for 6 months post-surgery for disease recurrence.

During and at the conclusion of the treatment period, subjects were monitored for local and systemic safety, tumor response due to the treatment, and systemic drug exposure.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed T1 (\<2 cm) or T2 (\>2 cm but \< or = 4 cm) squamous cell carcinoma (SCC) of the lip or oral cavity (anterior 2/3 of the tongue, floor of mouth, lower and upper gingiva, salivary gland, hard palate, and buccal mucosa).
2. Tumor must be easily accessible, with no evidence of infection or active bleeding, encroaching major vessels or clinical evidence of neural invasion. Not previously irradiated.
3. Tumors must be amenable to surgical resection no later than 21 days post Visit 1.
4. Clinically or radiologically measurable tumor.
5. ECOG Performance Status of \< or =2.
6. Adequate renal function as demonstrated by renal creatinine clearance.
7. Adequate organ function as assessed by safety labs.
8. Agree to use effective contraception for 30 days after the last dose of study drug.
9. Absence of any serious medical conditions that would impair the subject's ability to participate.
10. Willing and able to provide written informed consent.
11. Able to return to the study site for treatment and follow-up visits as defined in the protocol.

Exclusion Criteria:

1. Known distal metastasis of the SCC of the oral cavity.
2. Systemic chemotherapy for the treatment of SCC of the head and neck less than 2 years prior to screening.
3. Concurrent documented malignancy, with the exception of localized SCC of the skin.
4. Exposure to any investigational agent within 3 months prior to screening.
5. Known allergy or hypersensitivity to platinum-containing agents.
6. Active, uncontrolled infection requiring systemic therapy.
7. Known or suspected pregnancy, planned pregnancy or lactation.
The Use of Repetitive Magnetic Stimulation for Strength Training of the Quadriceps Muscle

We intend to use repetitive magnetic stimulation to the quadriceps muscle to try to improve strength and improve the metabolic function of the muscle.

Quadriceps strength is reduced in COPD. Increasing quadriceps strength is one of the goals of pulmonary rehabilitation yet some patients with severe COPD are unable to exercise with sufficient intensity, due to breathlessness, to achieve a true training benefit.

Transcutaneous electrical stimulation of the femoral nerve has been shown to improve quadriceps muscle strength, muscle mass, and performance in patients with severe COPD. Magnetic stimulation may be preferred because it offers the opportunity to train the whole muscle and because it is painless. In this pilot study we are investigating whether repetitive magnetic stimulation camn increase the strength of the quadriceps muscle and whether it confers any change in structure or metabolism of the muscle itself.

Eligibility Criteria:
Inclusion Criteria:

Chronic Obstructive Pulmonary Disease

Exclusion Criteria:

Aspirin therapy Cardiac Pacemaker

-
Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations

Parts 1 and 2:

Subjects take 1 dose of various formulations of the study product, and provide samples for pharmacokinetic (PK) analysis after each, with at least 7 days between doses.

Part 3:

Subjects take 2-4 doses of study product or placebo for 6 days, plus 1 additional dose, and provides samples for PK analysis.

Parts 1 and 2:

Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight and receive the study product in the morning of Day 1 in a non-randomized manner. Subjects will remain onsite until 24 h post-dose and will return to the clinical unit at 36 and 48 h post-dose to provide a sample for PK analysis.

There will be at least a 7-day washout between regimens. Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing well-being.

Part 3:

Subjects will be admitted to the clinic on the day before dosing (Day -1). Subjects will fast overnight (for Day 1 and Day 7) and receive the study product or placebo on a once, twice, or three times a day regimen in a randomized, double-blind manner. Subjects will remain onsite until 24 h after the final dose (Day 7), leaving the clinic on the morning of Day 8 and returning at 36 and 48 h post last-dose to provide a sample for PK analysis.

Subject will be telephoned 3-5 days after the final dose to ensure his/her ongoing well-being.

Eligibility Criteria:
Inclusion Criteria:

* negative for urinary cotinine
* normal test values for liver function
* provide informed consent

Exclusion Criteria:

* clinically significant abnormal biochemistry, hematology, or urinalysis, as judged by the investigator
Can Pelvic Floor Muscle Training Reduce my Prolapse

Purpose The aim of this study is to examine if a structured pelvic floor muscle training combined with lifestyle advice with can improve pelvic organ prolapse (POP) symptoms more than structured lifestyle advice programme alone.

Background Pelvic organ prolapse (POP) is a common condition among adult women and almost one in ten women experience symptoms caused by POP. The key symptom of POP is seeing or feeling a bulge in the vaginal opening but POP often gives other symptoms, such as pain, difficulty emptying the bladder or the bowel, incontinence and sexual problems such as dyspareunia.

A majority of women with POP will be offered reconstructive surgery but the risk of reoperations is substantial and surgery may cause new symptoms. In one out of four women surgery does not relieve symptoms and the women have been exposed to unnecessary risk of complications.

It is therefore important to evaluate the effect of conservative treatments for POP. New studies have shown that pelvic floor muscle training offered in combination with lifestyle advice has a significant on POP symptoms and objective measures of POP compared to a lifestyle advice leaflet alone.

No studies have compared the effect of a combined pelvic floor muscle training and lifestyle advice programme with a structured programme of lifestyle advice and hypothetically the structured lifestyle advice programme could have a substantial effect on its own. Our hypothesis is that the pelvic floor muscle training is a vital component of a conservative treatment for POP.

Methods In this single-blind randomised controlled study women with POP will randomised to either a programme of structured pelvic floor muscle training combined with lifestyle advice or a structured lifestyle advice programme alone. Both groups will receive the same lifestyle advices through six (separate) lectures within 12 weeks. The training group will be examined and individually instructed in pelvic floor muscle training before the intervention starts and they will, in continuation with their lifestyle lectures, perform pelvic floor muscle training as group training


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age female reporting bothersome symptoms of any type of POP
* Newly referred to the hospital clinic
* Prolapse ≥II POP-Q
* Understand and write Danish

Exclusion Criteria:

* Instruction in pelvic floor muscle training within the last two years
* Dementia
* Pregnancy or less than one year postnatal
* Disorders that can affect ability to participate in the intervention such as neurological or psychiatric disorders
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography

The study is to compare the performance of a CPAP (continuous positive airway pressure) device to a clinical polysomnography (PSG) in identifying breathing events in patients with obstructive sleep apnea.

Purpose: The purpose of this study was to compare the AED algorithm used in a PAP device with manually scored events on PSG. The PAP device was modified to produce a square wave voltage output identifying when apneas, hypopneas, and snoring events were detected. Recording this event signal on the PSG performed with the patient using the PAP device allowed an event-by-event comparison between manually scored PSG events and AED events. In addition, the AHI, AI, and HI derived from the manually scored PSG were compared with the respective measures reported by the PAP device used during the PSG.

Study Objectives: Compare automatic event detection (AED) of respiratory events using a positive airway pressure (PAP) device with manual scoring of polysomnography (PSG) during PAP treatment of obstructive sleep apnea (OSA).

Design: Prospective PSGs of patients using a PAP device.

Setting: Six academic and private sleep disorders centers.

Interventions: A signal generated by the PAP device identifying the AED of respiratory events based on airflow was recorded during PSG.

Eligibility Criteria:
Inclusion Criteria:

1. Age 21-75
2. Diagnosis of OSAHS with a baseline AHI ≥ 15 events/hr of sleep assessed January 01, 2007 or later
3. CPAP prescription of 8cm of H20 or higher
4. Able and willing to provide written informed consent
5. Native English speaker

Exclusion Criteria:

1. Participation in another interventional research study within the last 30 days
2. Major medical or psychiatric condition that would interfere with the demands of the study and adherence to PAP. Examples include unstable cardiovascular disease (Class III / IV CHF), neuromuscular disease, cancer, and renal failure.
3. Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe continuous positive airway pressure (COPD) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\> 45 mmHg) while awake, or subjects requiring continuous oxygen therapy.
4. Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
5. Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
6. Presence of untreated or poorly managed,non-OSAHS related sleep disorders:

   1. moderate to severe periodic limb movements(≥ 30/hr with symptoms or arousals)
   2. arousals associated with periodic limb movements \> 10 per hour or
   3. anyone experiencing chronic and severe insomnia.
7. Consumption of ethanol immediately prior to the research PSG
Nutritional Status Assessment of Pediatric Cystic Fibrosis Patients and Effect of Nutrition Education on Nutritional Status

The goal of this clinical trial is to to assess the nutritional status of children diagnosed with cystic fibrosis between the ages of 2-14, to determine the changes in the nutrition education given to the mothers of the patients on the nutritional status of the children and the nutritional knowledge of the mothers, and to compare them with the control group.. The main questions it aims to answer are:

1. Will be better the nutritional status of children of mothers in the education group will be better compared to the control group?
2. Will the macro and micronutrient Recommended Dietary Allowance (RDA) and diet quality of children with cystic fibrosis in education group increase after nutrition education?
3. Will the nutrition knowledge test scores of mothers of children with cystic fibrosis in education group on "Nutrition in Cystic Fibrosis" increase after nutrition education?

Mothers of children diagnosed with cystic fibrosis will participate in the study as a result of the call of the Cystic Fibrosis Association in Turkey. Mothers participating in the study will be divided into 2 groups. While the mothers in the first group will be given nutrition education 3 times a week, 1 hour a day, no education session will be given to the mothers in the control group. The nutritional status and nutrient consumption of children in the training group and the control group will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Mothers included in the research must have responded to the KIFDER (Cystic Fibrosis Association in Turkey) call.
* Children of mothers included in the research must have been officially diagnosed with cystic fibrosis.
* Mothers included in the research mustn't receive any nutrition education beforehand.
* Children of mothers included in the research mustn't be regularly followed by a dietitian.

Exclusion Criteria:

* Children of mothers included in the research mustn't have a feeding tube.
* Children of mothers included in the research mustn't be diagnosed with any other disease known to affect growth.
Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With STEMI Undergoing Primary PCI

Therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg vs. ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic resonance imaging (CE-MRI) in STEMI patients undergoing primary PCI.

All STEMI patients will be loaded with dual oral antiplatelet therapy of 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID. The duty interventional cardiologists will be responsible for patient randomization based on a pre-defined randomization chart. As it is a usual practice in Taiwan for door-to-balloon time to be within 90 minutes, we hence do not expect any impact on study results due to D2B time variation.

All STEMI patients will receive loading dose of dual oral antiplatelet therapy with 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID.

The primary variable is to compare myocardial salvage index (in %) as assessed by CE-MRI between 300-mg clopidogrel group and ticargrelor group. Enzymatic infarct size will also be assessed, and two methods will be used to decide that. The first is cardiac troponinI 72 hours after pain onset , while the other is peak CK level after pain onset. Sampling timing of CK will be judged by the caring physicians.

The secondary objectives include: myocardial infarct size (% of LV mass), the extent of MVO, the number of segments with \>75% of infarct transmurality.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Adult patients aged 20 years or older
3. STEMI within 12 hours of onset, defined as:presence of chest pain for \>30 minutes and \<12 hours after symptom onset; ST-segment elevation \>1 mm in ≥2 contiguous leads or presumably a new-onset left bundle-branch block on electrocardiogram.
4. STEMI patients planned for PPCI

Exclusion Criteria:

1. STEMI \> 12 h of onset
2. History of renal dysfunction requiring dialysis
3. Evidence of malignant diseases
4. Unwillingness to give out consent
5. Contraindicated for ticagrelor or clopidogrel
One Year Clinical Evaluation of Pressed BioHPP Polyether Ether Ketone (PEEK)-Based Versus Zirconia-Based Single Crowns

The clinical performance (using the modified Ryge criteria) and patient satisfaction ( using VAS questionnaire) of pressed BioHPP PEEK based posterior single crowns compared to zirconia based crowns are questionable as the peek is considered as a new material and need to be tested for future clinical application.

The study is held to evaluate the clinical performance (using the modified Ryge criteria) and patient satisfaction ( using VAS questionnaire) of pressed BioHPP PEEK based posterior single crowns compared to zirconia based crowns after one year follow-up. Patients requiring posterior single crowns are collected. After teeth preparation to receive single full coverage crowns, secondary impressions were taken. The patients were divided randomly into two groups ;one group will receive pressed BioHPP PEEK single crowns (the intervention) and the other group will receive veneered zirconia single crowns (the control). Fracture of restorations (1ry outcome) using modified Ryge criteria and the marginal adaptation (2ry outcome) using modified Ryge criteria and finally the patient satisfaction (3ry outcome) using a questionnaire, all outcomes will be evaluated every 2 months with total period of follow-up of one year.

Eligibility Criteria:
Inclusion Criteria:

1. From 18-50 years old, be able to read and sign the informed consent document.
2. Have no active periodontal or pulpal diseases, have teeth with good restorations
3. Psychologically and physically able to withstand conventional dental procedures
4. Patients with teeth problems indicated for single posterior crowns:

   1. Badly decayed teeth
   2. Teeth restored with large filling restorations
   3. Endodontically treated teeth
   4. Malformed teeth
   5. Malposed teeth (Tilted, over-erupted, rotated, etc.)
   6. Spacing between posterior teeth
5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

1. Patient less than 18 or more than 50 years
2. Patient with active resistant periodontal diseases
3. Patients with poor oral hygiene and uncooperative patients
4. Pregnant women
5. Patients in the growth stage with partially erupted teeth
6. Psychiatric problems or unrealistic expectations
7. Lack of opposing dentition in the area of interest
8. Failed endodotically treated teeth; short or overextended, narrow, missed canal, ledge or perforated teeth (even if no clear symptoms for failure)