cyrilzakka/clinical-trials huggingface dataset:
Autoset T Versus CPAP Therapy, a Comparison of Titration and Therapy

Part 1.Comparison of manual pressure titration in laboratory of sleep disorders with Autoset T APAP device from Resmed. Hypothesis: There is no difference in efficiency between manual and automatical titration.

Part 2. Comparison of CPAP and APAP therapy in the home while 3 month by Questionaire and device data.

Hypothesis: There is a difference in compliance and efficiency between CPAP and APAP mode.

A cross over, simple blind study design has been created for a controlled trial to compare pressure titration and therapy with the Autoset T device.

Part 1: After a baseline polysomnography (PSG) a selected group of patients with obstructive sleep apnea will be titrated in two more nights in a sleep lab under APAP mode and CPAP mode. We compare the sleep quality and the AHI, oxygen saturation, leakage.

Part 2: Over a time range of 12 weeks the patients got two kinds of therapy modes at home: CPAP and APAP (each six weeks. We compare the objective and subjective therapy by compliance, device data, Epworth sleepiness scale, Pittsburgh Sleep Quality Index (PSQI, german version).

Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 80 years

Exclusion Criteria:

* pregnancy
* insomnia
* consumption of soporifics
* pulmonal or cardial diseases
* operation advised by ear, nose and throat specialist
* missing linguistic skills in german
Clinical Practice Guideline for Neonatal Extravasation Injury

This study is aimed to evaluate the effectiveness of an evidence-based clinical practice guideline in the prevention and management of neonatal extravasation injury, and to examine the change in nurses' knowledge of and adherence to the guideline.

A study with controlled before-and-after design was conducted. The clinical practice guideline was developed and a multifaceted educational program was delivered for nurses. Neonatal outcomes were collected at baseline and after completion of the intervention. The changes in nurses' level of knowledge and adherence to the guideline were also measured.

Eligibility Criteria:
Inclusion Criteria:

* Neonates who were admitted for intravenous medication or infusion therapy, and
* Neonates whose parents were equal to or over 18 years old and able to communicate in Chinese or English.

Exclusion Criteria:

* Neonates who were born with congenital dermatological problems such as ichthyosis and epidermolysis bullosa.
Prehabilitation and Rehabilitation in PAD

To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.

Peripheral artery disease (PAD) is a form of cardiovascular disease that affects the arteries supplying blood flow to the legs. The prevalence of PAD is increasing rapidly in the United States. When PAD is severe, it can cause pain with movement and limit a person's ability to walk or perform their normal daily activities. With severe PAD, a procedure is often performed in which an artery is held open with a small tube called a stent.

Programs of exercise-based rehabilitation have been shown to greatly help these patients in terms of the pain they experience with walking, their ability to perform daily activities or those required by work, and improved quality of life. There is also a newer form of therapy, called prehabilitation, which has been shown to have important benefits for patients with PAD. Prehabilitation involves four to six weeks of exercise therapy and lifestyle recommendations before undergoing a stent procedure. Prehabilitation helps patients improve exercise tolerance and make lifestyle changes that improve risk factors before the procedure. Those who participate in prehabilitation programs have fewer complications with the stent procedure, spend fewer days in the hospital, and have a better ability to exercise and return to work more quickly.

Although the benefits of prehabilitation and rehabilitation are well established, most doctors neglect to recommend these treatments to their patients who undergo a stent procedure for PAD. The research team will study the impact of prehabilitation, rehabilitation or both forms of therapy. The results will likely encourage more doctors to recommend the best option for their patients, and possibly to recommend both prehabilitation and rehabilitation among patients who are having a stent procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female adult diagnosed with peripheral artery disease (PAD)
* Experiencing leg pain while walking
* Scheduled to have a stent for PAD
* Able to perform exercise safely
* Postmenopausal and not of child bearing capacity

Exclusion Criteria:

* Medically unstable patients
* Recent MI within 3 months
* Malignancy
* Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)
* Alcoholism or other recreational drug use
Virtual Reality and Pain Perception During Exercises for Patients With Chronic Non-specific Low Back Pain

Immersion in a virtual reality environment has been shown to reduce pain during a variety of painful medical procedures, such as wound care for burn patients and dental care. Often, serious games are used to distract patients from this painful procedures. Recently, serious games have also been developed for patients with low back pain. Because patients with low back pain frequently experience pain during exercises, the investigators hypothesize that exercising with serious games can reduce the pain intensity and the time spent thinking of pain during exercises. To test this hypothesis, the investigators will conduct a randomized controlled trial where two groups will be compared: the experimental group will perform one session of exercises with serious games, while the control group will perform one session of the same exercises without the serious games.


Eligibility Criteria:
Inclusion Criteria:

* Chronic non-specific low back pain, with or without referred pain to the legs
* Age 18-65
* Able to understand Dutch
* A minimum pain intensity of 3/10 on the numeric pain rating scale at the time of the test
* Being familiar with pelvic tilt exercises

Exclusion Criteria:

* Spinal surgery in the past
* Pregnancy
* Serious underlying pathologies (e.g. multiple sclerosis, tumors,...)
* Signs or symptoms of nerve root involvement
* Known skin-allergy for tape
Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders

To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.

Secondary Objective: To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.

Duration:

Estimation for Recruitment: 12 months Estimation for Procedure/Trial: 1 visit with an overnight observation Estimation for Subject Follow Up: 7 days, 14 days, 28 days, 90 days, and 180 days, post ablation, with ultrasound of the bilateral submandibular glands at 28 days and 180 days post ablation Total Expected Duration for Clinical Trial: 2 years


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent and assent (as appropriate) obtained from the subject/caregiver who opted voluntarily to participate in the procedure
2. Male or female 2 to 65 years of age
3. Confirmed diagnosis of sialorrhea as documented in their medical record
4. Clinically stable with no significant changes in health status in the 2 weeks before the ablation
5. Patients diagnosed with cerebral palsy, or other neurological impairment documented in their medical record

Exclusion Criteria:

1. Open sores/ulcers on skin overlying the submandibular glands
2. Contraindications to surgery/general anesthesia e.g; coagulopathies, life threatening arrhythmias
3. Upper respiratory airway obstruction, e.g: severe dystonia
4. History of previous local surgery
5. Any congenital abnormalities that may preclude cryoablation, such as vascular abnormalities or atypical size/location
6. Patients that have received salivary gland Botulinum toxin injections within the prior 3 months
7. Subjects unlikely to complete the study as determined by the principle investigator
Pharmacokinetics of Metformin Intolerance

Pharmacokinetic study of metformin intolerance

This pharmacokinetic study recruited white European individuals with type 2 diabetes, who had previously been exposed to metformin and met the criteria for tolerance or intolerance. Intolerance was defined as previous exposure to metformin (maximum of 1000mg once daily for up to 8 weeks) but discontinued treatment with patient reported or documentation of gastrointestinal upset, leading to discontinuation (Criterion 1). Alternatively, intolerance was defined as inability to increase metformin dose above 500mg without experiencing gastrointestinal side-effects, despite having an HbA1c \>53mmol/mol (Criterion 2). Tolerant individuals were defined as those taking 2000mg metformin daily in divided doses, with no side effects. Ten tolerant and ten intolerant individuals were recruited.

Participants gave written consent. They attended the research centre fasted from midnight. A baseline blood test was taken before a single dose of oral metformin was administered at 0900, with further bloods taken at 11 time points over the following 24 hours. A 24 hour urine collection was completed.

Blood samples were analysed for plasma metformin, and serum lactate concentrations.

Eligibility Criteria:
Inclusion Criteria:

* White European
* Type 2 diabetes
* Meet criteria for tolerance or intolerance as described

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \<60
* Cognitive impairment
* Pregnancy
* Concurrent treatment with: acarbose, cephalexin, cimetidine, pyrimethamine, or tyrosine kinase inhibitors
* History of gastric bypass
* Evidence of slowed gastric or intestinal motility
Analysis of Drug-drug Interaction Alert Based on Multicenter Clinical Database

The doctor's overridden rate for Drug-drug interaction (DDI) alert systems was 85-95% in foreign and there was more than 90% overridden rate in Taiwan. Why DDI alerts systems which spent much time and money to establish could not use medicinal information to increase drug safety? One of the reasons which induced to override was that health care thought there were too much DDI alerts and high false alerts.

The difference between DDI alert systems from pharmacists to confirm drug-drug interaction was that pharmacists not only confirmed ordering drug at the same time but also checked the other drug information such as frequency, rote and refill etc. Therefore, DDI alert systems which were established by drug code alone would induce a lot of false alerts.

In order to study how much false alert rate in drug-drug interactions, this research selected most common drug-drug interaction which was antacids and antibiotics. Antacids were most self-payment so this research needed to analyze ROCDR (Establishing a Multi-Center, Longitudinal, Research-Oriented Clinical Data Repository for Clinical Research). The aim was to study how many drug-drug interactions and false alerts from antacids and antibiotics and analyze the difference in different department. Finally, proposing advice and assessment for building drug-drug interaction alerts system to strength drug information system and increase drug safety.


Eligibility Criteria:
Inclusion Criteria:

* Select DDI rules: antacids and antibiotics
* Database: ROCDR (multicenter clinical database)
* The pharmacists defined six rules which were based on medical knowledge for true alerts or false-alert.

  1. True alert: Rule 1 and Rule 2
  2. "False-alert": Rule 3 or Rule 4
  3. "Other" (Unable to determine): Rule 5 or Rule 6

Exclusion Criteria:

* N/A
A Study to Investigate the Receptor Occupancy of SK-1405 in Healthy, Caucasian, Male Subjects

The primary objective is to confirm the target receptor occupancy of SK-1405 and to correlate receptor occupancy with SK-1405 dose and plasma concentration.

The secondary objective is to assess the safety and tolerability of SK-1405 in healthy, Caucasian, male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent to participate in this study, as confirmed by signing the informed consent document(s).
* Adult Caucasian male aged ≥20 and ≤50 years.
* Body Mass Index (BMI) of ≥ 20 and ≤ 30 kg/m2.
* Height ≤ 190 cm.
* Subject is a non-smoker or has not smoked in the past 6 months.
* Subject is considered to be in good health in the opinion of the investigator.
* Subject's pre-study clinical laboratory findings are within normal range.
* Subject must be willing and able to comply with all protocol requirements.

Exclusion Criteria:

* Use of prohibited medications as described in the study protocol.
* Current known or suspected history of drug/solvent abuse.
* Current known or suspected history of alcohol abuse or currently drinks in excess of 21 units per week.
* Subjects who have consumed caffeine containing products within 24 hours prior to baseline PET-CT.
* Any concurrent medical, surgical, or psychiatric condition that may affect the subject's ability to meet all protocol requirements during the study duration and/or any significant illness in the investigator's opinion in the 4 weeks before screening.
* Participation in any other clinical study with an investigational drug/device within three months prior to the first day of dosing and after enrolment in the current study.
* Subject has a positive result of HIV screen, hepatitis B screen or hepatitis C screen.
* Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
* Subject has donated 500 mL or more of blood within the three months prior to screening.
* History of neurological conditions.
* Participation in a research study or other radiation exposure which in conjunction with this study would result in additional ionisation radiation exposure exceeding 10 mSv within the last year.
* A contraindication for MRI, including but not limited to, MRI-incompatible pacemakers, recent metallic implants, foreign body in the eye, or other indications as assessed by a standard pre-MRI questionnaire, that preclude the subject undergoing MRI scans.
* Subject has claustrophobia.
* Subjects who have consumed Saint John's wort, red wine, Seville oranges, grapefruit or grapefruit juice within 7 days prior to dosing.
* Subject has a partner who is either pregnant or breastfeeding for the duration of the study.
Effect of Fasting Versus Feeding on the Bone Metabolic Response to Running

This study examined changes in bone metabolism (markers of bone turnover, calcium metabolism) with a bout of acute treadmill running preceded by either a single, mixed meal or an overnight fast.

Ten physically active males aged 28 ± 4 y (mean ± 1SD) completed two, counterbalanced, 8 d trials. After 3 d on a standardised diet, participants performed 60 min of treadmill running at 65% VO2max on Day 4 following an overnight fast (FAST) or a standardised breakfast (FED). Blood samples were collected at baseline, before exercise, during exercise, for 3h after exercise and on four consecutive follow-up days (FU1-FU4). Plasma/serum were analysed for β CTX, P1NP, OC, bone ALP, PTH, ACa, PO4, OPG, cortisol, leptin and ghrelin.

Eligibility Criteria:
Inclusion Criteria:

* history of weight bearing exercise
* fasting vitamin D concentration of \>30 nmol•L-1 and/or a fasting parathyroid hormone (PTH) concentration of \<6.9 pmol•L-1.

Exclusion Criteria:

* smokers
* suffered a bone fracture in the previous 12 months
* musculoskeletal injury
* condition/medication known to affect bone metabolism
Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, who is at least 18 years of age or older.
* A clinical diagnosis of rosacea.
* A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
* A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
* A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

Exclusion Criteria:

* Three (3) or more facial inflammatory lesions.
* Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
* Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.
* Intraocular pressure (IOP) measurement less than 10 mm Hg.
Exenatide for Myocardial Protection During Reperfusion Study

This study aims to assess the effect of exenatide on myocardial injury in patients undergoing emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction or heart attack (STEMI).

This is a Phase II randomized, double-blind, placebo-controlled study of patients with STEMI. Those who agree to participate will be immediately randomized to one of two groups: a 24-h infusion of exenatide; or a 24 h infusion of placebo. We will assess the ability of exenatide to reduce ischemic injury. This study will serve as safety evaluation study as well as a pilot for a larger multicentre trial powered for clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Admission for primary PCI for STEMI, with enrollment within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥1mm in 2 or more limb leads, or ≥2mm in 2 or more precordial leads, or new onset LBBB) associated with acute chest pain or an elevation of cardiac enzymes.
* Antegrade TIMI 0 or 1 prior to PCI in the infarct-related artery
* Age ≥18 years

Exclusion Criteria:

* Symptomatic hypoglycemia (serum glucose \<3.3 µmol/L; 60 mg/dl)
* Diabetes mellitus requiring insulin therapy
* Diabetic ketoacidosis
* Coronary anatomy warranting emergent coronary artery bypass graft surgery
* Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation)
* Need for hemodialysis
* Malignancy, HIV, or central nervous system disorder
* Cardiopulmonary resuscitation \>15 min and compromised level of consciousness.
* Cardiogenic shock
* Current participation in any research study involving investigational drugs or devices
* Inability to give informed consent
* Inability to safely undergo cMRI (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant, severe claustrophobia)
* Women of childbearing potential who are known to be pregnant or lactating or who have a positive pregnancy test on admission
* History of pancreatitis
* Known end stage renal failure or known eGFR \<30 mL/min
* Currently taking exenatide (Byetta, Bydureon), liraglutide (Victoza), or any other GLP-1 agonist
Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation \< 80%.


Eligibility Criteria:
Inclusion Criteria:

* preterm infant \< 29 weeks gestation
* at least 8 hypoxemic events during 8 hours
* requires supplemental oxygen to achieve high SpO2 target range
* parental consent given

Exclusion Criteria:

* congenital life-threatening malformation
* fatal outcome expected
* airway malformation
* higher grade intraventricular bleeding (grade III or IV according to LA Papile)
* posthaemorrhagic hydrocephalus
* life-threatening disease at the time of study entry
Evaluation of Side Effects and Relative Activity of Two Chemotherapy Regimens in the Treatment Soft Tissue Sarcoma

The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

The purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.

Ifosfamide and Doxorubicin, given in combination, are recognized as a standard of care for some types of sarcoma. Both gemcitabine and docetaxel are approved by the US Food and Drug Administration (FDA) for the treatment of some cancers (cancers of the pancreas, lung) because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms. However, neither gemcitabine or docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma.

Eligibility Criteria:
Inclusion Criteria:

* no evidence of metastasis
* soft tissue sarcoma
* intermediate or high histologic grade
* greater than 5 cm
* Zubrod performance status 1 or better
* age 10 or older

Exclusion Criteria:

* clear cell, alveolar soft part, Ewing's rhabdosarcoma, undifferentiated small cell or Kaposi's
* prior chemotherapy
* nephrectomy
* active unstable angina pectoris
* concurrent therapy
Twin Block Appliance in Incremental Versus Maximum Bite Advancement in Skeletal Class II

The aim of this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance

* Patients will be clinically and radio-graphically examined for eligibility
* Eligible patients will be randomly assigned to one of two groups:

  * Control Group: Twin Block Appliance fabricated to Maximum Bite Advancement group
  * Intervention Group: Twin Block Appliance fabricated for Incremental Bite Advancement group
* Records will be taken and impressions will be made and poured. In the control group, bite registration will be made with maximum mandibular advancement. In the intervention group, bite registration is made to habitual bite to make a modified twin block.
* Patients will be recalled every 6 weeks for 8 months for monitoring and reactivation of the appliance.

Eligibility Criteria:
Inclusion Criteria:

* Growing Female Patient
* Skeletal Class II Malocclusion due to deficient mandible
* Overjet of 7 to 10 mm
* Short or normal vertical facial pattern
* No previous orthodontic nor orthopedic treatment

Exclusion Criteria:

* Syndromes or Chronic Illness
* Skeletal Class II Malocclusion due to excessive maxilla
* Vertical skeletal growth pattern
* Habits