cyrilzakka/clinical-trials huggingface dataset:
ApneaLink Air Home Sleep Testing (HST) Device Validation Study

This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.

The current gold standard for sleep disordered breathing (SDB) diagnosis is in-laboratory polysomnography (PSG). A barrier of acceptance of Home Sleep Apnea Testing (HSAT) devices as a diagnostic test is their inability to accurately measure total sleep time (TST). A novel algorithm developed by ResMed, Ltd. allows the AL device to accurately calculate TST, however, this algorithm has not yet been validated.

The ApneaLink Air (AL) device is a type III HSAT device. The device is capable of recording up to four channels of data including: flow and snore via a nasal cannula attached to a pressure transducer, a respiratory effort belt, a pulse oximeter to measure pulse and oxygen saturation, and an actigraphy monitor to measure TST along with flow. The AL device has been validated against PSG for AHI, and Cheyne-Stoke respiration detection . Further validation of the effort belt is necessary to determine the accuracy of the AL ability to differentiate between obstructive and central apneic events.

Eligibility Criteria:
Inclusion Criteria:

* Participant is 18 years of age or older
* Participant is willing to provide informed consent
* Participant is willing to participate in all study related procedures

Exclusion Criteria:

* Unable to cease positive airway pressure (PAP) therapy during PSG (if currently using)
* Requires use of oxygen therapy during sleep
* Diagnosis of uncontrolled clinically relevant sleep disorder (e.g., untreated insomnia or restless leg syndrome)
* Pregnant
* Participant is unsuitable to participate in the study in the opinion of the investigator
Effect of Topical Aqueous Suppressants on Intraocular Gas Duration Following Pars Plana Vitrectomy

The purpose of this study is to see if glaucoma eye drops (dorzolamide-timolol) have any effect on the duration of an intraocular gas bubble following pars plana vitrectomy.

At the end of some retinal surgeries, a gas bubble is placed in the eye. In surgeries for retinal detachment, this gas bubble helps to keep the tear(s) in the retina sealed up while the eye is healing and prevent the retina from re-detaching. In macular hole surgeries (a defect in the center part of the retina), the gas bubble helps to seal up this hole in the center part of the retina. The gas bubble (sulfur hexafluoride) will slowly disappear from the eye over the course of approximately 2 weeks.

In some cases, the gas bubble disappears more quickly than the surgeon would wish. Several eye drops are currently available which help to lower the eye pressure in conditions such as glaucoma where the eye pressure is unacceptably elevated and is causing or may cause vision loss. These drops have been shown to keep the eye pressure controlled after surgery with injection of a gas bubble in the eye. However, little is known about the effect of these drops on the duration of the gas bubble. The goal of this study is to see if these glaucoma eye drops have any effect on the amount of time the gas bubble remains in the eye.

After surgery with a gas bubble (sulfur hexafluoride) is completed, patients will be randomly assigned (like a flip of a coin) to receive a glaucoma drop (dorzolamide-timolol) or no glaucoma drop. These drops are currently available from pharmacies with a prescription and are not "experimental." However, the use of these drops in this protocol is not to treat glaucoma but represents an "off-label" use. Patients assigned to receive a glaucoma drop will be provided with the medication. All patients will receive the standard post-operative drops regardless of which group they are assigned to. Patients will be taken care of before and after the surgery like any other patient undergoing this procedure. The investigators expect that you will be enrolled in this study for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for pars plana vitrectomy with intraocular gas tamponade with sulfur hexafluoride (e.g., retinal detachment, macular hole, other condition at the discretion of the investigator).
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

* Prior trabeculectomy or tube shunt surgery.
* Current use of topical aqueous suppressants or other glaucoma medications.
* Aphakia or presence of anterior chamber intraocular lens implant.
* Known allergy or contraindication to sulfa or beta-blocker use (e.g., asthma, chronic obstructive pulmonary disease, bradycardia).
Influence on Food Liking of Adding Spices to Replace Sugar Using CLT

This study aims to reduce the amount of sugar in a particular food item and add spices to see if the food liking of that item rates as high or higher in a post meal survey. Through taste testing of the menu items (using sequential monadic CLT methodology) the investigators will determine an opinion of the participants. Results of these surveys will determine whether participants enjoy the reduced sugar options as much as their full sugar counterparts.

The investigators will compare the overall consumer acceptability of each of three test items (tea, oatmeal and apple crisp) across the three test conditions using central location test (CLT) and cross-over design. The three test conditions for each test item will be (1) Full sugar ("FS"), (2) reduced sugar (and calorie) with no added spice ("RS") and (3) reduced sugar (and calorie) plus spice ("RSS"). The two reduced sugar items will be matched for calories. Subjects will be provided the test items using sequential monadic CLT methodology (Central Location Test methodology which involves product evaluation after a brief exposure (one sample-subject contact) under standardized conditions whereby subjects are given each of the 3 recipes of each test item (e.g., oatmeal with full sugar, oatmeal with reduced sugar, oatmeal with reduced plus spice) back to back (all within one sitting) in a random order. The investigators are interested in using the sequential monadic CLT methodology and having subjects taste all 3 recipes of each item in one sitting which is a commonly used test modality for sensory studies.

Eligibility Criteria:
Inclusion Criteria:

-ages 18-65

Exclusion Criteria:

* diagnosed taste or sensory disorder
* known eating disorder
* allergies to test food/ingredients
* medical conditions that may adversely affect taste (ie: dysgeusia)
* inability to complete protocol or to participate in all three taste testing sessions
* personal dietary restrictions towards test items
* dislike of the particular food items to be served in taste tests
* subjects who do not consume foods or beverages that contain sugar or to which they have added sugar will be excluded
* subjects who have not consumed or would not be willing to consume hot tea, oatmeal or baked apple products will be excluded
* subjects who are pregnant or trying to become pregnant will be excluded
Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.

Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined.

Retrospective evaluation of clinical and functional results and survivorship of total knee replacement and total hip replacement, both isolated or combined.

Evaluation performed 1, 2, 5, 10 and 15 years after surgery

Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years
* Patients underwent total knee or hip replacement, both isolated or combined with other surgical procedures

Exclusion criteria

- Patients underwent other types of knee or hip replacement
Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

Graft rejection has traditionally been one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used for an extended period after transplant surgery. The purpose of this study is to compare the efficacy and side effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea transplant) surgery.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Male or female patient who had endothelial keratoplasty procedure within the past 1 to 7 weeks
* Patient is able and willing to administer eye drops
* Patient is able to comprehend and has signed the Informed Consent form.
* Patient is likely to complete the one-year course of the study

Exclusion Criteria:

* A history of a previous rejection episode in the study eye
* A patient exhibiting intraocular inflammation
* A patient with a known sensitivity to any of the ingredients in the study medications
* A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
* A patient with abnormal eyelid function.
* A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis.
* Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled.
* A patient with a history of non-compliance with using prescribed medication.
* A patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study.
* Patients who are pregnant or planning to become pregnant within the duration of the study
A Retrospective Non-interventional Study to Evaluate the Use of Seroquel Extended Release (XR) and Immediate Release (IR) in the Clinical Practice of Inpatients With Schizophrenia

The primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary antipsychotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia.
* At least one dose of Seroquel XR or Seroquel IR during the study period (1st of July 2009 - 30th of September 2010).
* Hospitalization due to psychotic symptoms at any time during the study period (1st of July 2009 - 30th of September 2010) and with admission and discharge dates available.

Exclusion Criteria:

* Participation in a clinical trial during the study period.
* Treatment in forensic care according to LRV ("Lagen om Rättspsykiatrisk Vård").
Horner's SD After Thoracic Epidural Block

This study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy. The incidence was 1.36% and the mechanism of Horner's syndrome was cephalic spread of the local anesthetic.

Transient Horner's syndrome has been recognized rare complication of epidural anesthesia and the incidence is not exactly well-known in thoracic epidural anesthesia. Therefore, this study prospectively evaluates the incidence of Horner's syndrome after thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy.

Six hundred thirty three Patients, who scheduled for mastectomy with/without breast reconstruction, were eligible for this prospective observational study from September 2010 to December 2013. Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine 15mL followed by sedation consisting of propofol without muscle relaxation. After the operation, thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h. At 1 hour, 2hour, 1 day, 2 day and 3 day after the operation, postoperative surveillance consisted of the occurrence of symptoms of Horner's syndrome (miosis, ptosis, and hyperemia) were performed by anesthesiologists.

Eligibility Criteria:
Inclusion Criteria:

* Patients, who scheduled for mastectomy with/without breast reconstruction

Exclusion Criteria:

* The patients who had more than one abnormal preoperative clotting parameter either clinical signs of potential bleeding disorders suggested by bruising
* Petechiae, or ecchymosis, or anatomic or neurologic abnormalities
* That is, significant scoliosis or kyphosis, radyculopathy or ptosis
* Unsuccessful catheter placement (impossible to insert a catheter at two vertebral levels)
* Unsuccessful epidural anesthesia (not checkable sensory block)
* Dural perforation or intravascular catheterization
Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer

Though brain metastases are a risk in all patients with breast cancer, those with HER-2 overexpression are at significantly greater risk. One series estimated a 30% incidence of brain metastases in this population, while another study found an incidence of approximately 40%. Traditional systemic therapies do not cross the blood brain barrier to any significant degree or at all, but radiation treatment can be effective in the treatment of intracranial metastases.

The rationale for PCI is that the brain is a sanctuary site where cancer cells can remain inaccessible to chemotheraphy and agents such as trastuzumab due to the blood brain barrier, which prevents potentially harmful chemicals such as chemotherapy agents and antibodies such as trastuzumab from reaching the brain. Decreasing the incidence of brain metastasis with acceptable effects on neurocognitive function would be a significant improvement in the care of patients with MBC.

Eligibility Criteria:
Inclusion Criteria:

* Female with HER2-positive disease
* 18 years of age or older
* ECOG greater or equal to 2
* Life expectancy greater or equal to 6 months
* Able to complete self administered quality of life evaluations and neurocognitive testing
* Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study
* Women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit and must use highly effective birth control during study
* Signed informed consent form

Exclusion Criteria:

* Current malignancy in the brain, as determined by screening MRI/CT done no more then 6 weeks prior to study treatment with PCI
* Chemo or radiation planned during the period when patients will receive study treatment with PCI
* Prior radiotherapy of the brain
* Prior stroke or brain hemorrhage in the 6 months prior to screening
* History of neurological/psychiatric disorders, including psychotic disorders or demential, or any other reason, which may affect neurocognitive assessment
* Inadequate renal function
* Other known previous or concomitant serious illness or medical condition that may interfere with participation in the study
Assessment of the Efficacy of Rosuvastatin in Patient Groups With a Dissimilar Risk Profile in an Observational Study (HEROS)

In an observational multi-centre study (HEROS), the effects of starting treatment with rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement, in patients with a dissimilar high-risk profile who had not been treated with cholesterol lowering drugs at least in the past three months. Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied.


Eligibility Criteria:
Inclusion Criteria:

* patients who had not been treated with cholesterol lowering drugs at least in the past three months, with an LDL-C 3.2 mmol/l.
* According to the advise of the CBO, and could be included in one of the following risk groups: secondary prevention, DM or primary prevention.
* The general practice investigator made the decision to start treatment with rosuvastatin irrespective of study participation.
* Patient approved to place anonymous results at the disposal of AstraZeneca

Exclusion Criteria:

* Patients with symptoms of myalgia, myopathy or liver function insufficiency (including raised serum transaminases) which bear a causal relation to the treatment with statins, patients with familiar dyslipidemia and/or patients with contra-indications for treatment with rosuvastatin
Implementation of Therapy Together

The goal of this clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. The main question\[s\] it aims to answer are:

* Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care?
* Is it feasible to implement the Therapy Together program within the standard care, early intervention framework?

Participants will participate in an 8-week pediatric constraint-induced movement therapy program. Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.

A randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 yrs 11 mo) with unilateral cerebral palsy (or at risk for developing cerebral palsy) and caregivers comparing Therapy Together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of Therapy Together within early intervention.

Therapy Together Program:

The Therapy Together program includes caregiver education and coaching on implementing therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to improve arm/hand function. The child and caregiver complete 8 sessions with their therapist. The therapist is trained to educate the caregiver on the Therapy Together program, demonstrate how to engage the child in therapeutic activities, and observe the caregiver implement the program during each weekly session. The first 7 intervention visits focus on constraint-induced movement therapy (CIMT) and the final intervention visit focuses on bimanual therapy (use of two hands).

Eligibility Criteria:
Inclusion Criteria:

* at risk for developing cerebral palsy or have been diagnosed with cerebral palsy
* children ages 3 months to 5 years 11 months
* present with asymmetric hand use
* present with a unilateral upper limb impairment
* able to visually attend to objects
* demonstrate an interest in objects
* attempt to reach for or grasp objects with the impaired upper extremity

Exclusion Criteria:

* uncontrolled epilepsy
* significant visual impairment
* severe behavioral problems
* inability to complete the assessment protocol.
Dry Eye Response to Interval Exercise and Mediterranean Diet

in the recent times, dry eye was found to be correlated sedentary life style, obesity, hypertension. So, changing the sedentary lifestyle is recommended

older patient who will complain from dry eye will be collected. it is planned to recruit 60 elderly (with obesity and hypertension) to be distributed into group 1 (this group will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet) and group 2 (this group will receive only 3-time interval exercise per the week, applied for 30 min with high intensity). Every group will contain 30 elderly

Eligibility Criteria:
Inclusion Criteria:

* elderly patients with dry eye complaints
* the patients will be obese and hypertensives

Exclusion Criteria:

* heart or respiration problems
* other diagnosed eye or systemic diseases
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis

OBJECTIVES: I. Determine whether high-dose intravenous immune globulin (IVIG) is more effective than placebo in restoring neurologic function (muscle strength) in patients with multiple sclerosis.

II. Determine the time to recovery following IVIG.

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are treated with intravenous immune globulin or placebo. In the absence of a hypersensitivity reaction to a test dose, a total of 11 doses is administered: daily for 5 days, then every 2 weeks for 12 weeks.

Patients are followed at 3 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinically or laboratory-supported definite multiple sclerosis
* Disease relapsing-remitting or relapsing-progressive (i.e., secondary- progressive)
* Targeted neurologic deficit as follows: 25% or more loss of power in at least 1 limb Severity -1 or greater on Mayo Clinic rating scale OR Between 3+/5 and 4-/5 on Medical Research Clinic muscle power scale
* Documented by Mayo Clinic Department of Neurology as neither progressing nor improving for 4 to 18 months prior to entry No clinical evidence of spontaneous or corticosteroid-induced improvement
* Able to cooperate with isometric strength testing requirements

--Prior/Concurrent Therapy--

* No concurrent experimental drug therapy
* No concurrent intravenous immune globulin At least 3 months since immunosuppressive therapy, e.g., corticosteroids and corticotropin
* At least 3 months since plasma exchange

--Patient Characteristics--

* Hepatic: No coagulation defect, e.g., hyperviscosity syndrome
* Renal: Creatinine no greater than 1.5 times normal
* Cardiovascular: No unstable or advanced ischemic or cerebrovascular disease, e.g.: angina congestive heart failure transient ischemic attack stroke
* Immunologic: No human gamma globulin or albumin sensitivity No hypergammaglobulinemia No known antibody deficiency syndrome, especially IgA deficiency

Other:

* No condition interfering with neurologic exam, e.g.:
* Major amputation
* Deforming arthritis
* Major psychiatric illness
* Superimposed lower motor neuron deficit
* No intellectual impairment precluding study participation
* No pregnant or nursing women
* Adequate contraception required of fertile patients
Clinical Study on Histamine H3 Receptor Occupancy of TS-091 by PET Examination in Healthy Adult Subjects

To evaluate the following items by PET examination in Japanese heathy adult male subjects who received single oral administration of TS-091 in an unblinded manner.

1. Relationship between plasma concentration and H3 receptor-occupancy of TS-091
2. Time course changes in H3 receptor-occupancy of TS-091


Eligibility Criteria:
Inclusion Criteria:

Subjects who met all of the following criteria.

* Age: between ≥20 years and \<40 years at the time of providing written consent for participation in the study.
* Body mass index (BMI): ≥18.5 and \<25.0 on the day of screening test.
* Subject who received a prior explanation on the study and was able to understand its content and capable of providing voluntary written consent for participation in the study.
* Other protocol defined inclusion criteria could apply-

Exclusion Criteria:

Subjects who came under any of the following exclusion criteria.

* Subjects who were considered to have some disease and not healthy by the investigator or subinvestigator according to his medical judgment based on the results of screening test
* Subjects with a drug or food allergy or a history thereof.
* Subjects with a significant allergic disposition (e.g. asthma requiring treatment) or a history thereof.
* Subjects with a history of heparin-induced thrombocytopenia.
* Other protocol defined exclusion criteria could apply