cyrilzakka/clinical-trials huggingface dataset:
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera

The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl fumarate (DMF) in participants with relapsing forms of Multiple Sclerosis (MS). The secondary objectives of this study are as follows: To evaluate whether montelukast after oral administration of DMF in participants with relapsing forms of MS decreases discontinuations due to GI events and reduces the number of participants taking symptomatic therapies for GI events; To investigate the effect of montelukast on the incidence of flushing events after oral administration of 240 mg DMF in participants with relapsing forms of MS.


Eligibility Criteria:
Key Inclusion Criteria:

* Reside in the United States and have a confirmed diagnosis of a relapsing form of MS and satisfy the therapeutic indication as described in the local label
* As perceived by the Investigator, have the ability to comply with all requirements of the study protocol and to operate the eDiary required to record GI-related events
* Female participants of childbearing potential who are not surgically sterile must practice effective contraception during their participation in the study and be willing and able to continue contraception for 30 days after they complete or withdraw from the study. All men must practice effective contraception, and they should not donate sperm throughout the study and for at least 90 days after their last dose of study treatment.

Key Exclusion Criteria:

* History of significant GI disease (for example, irritable bowel disease, peptic ulcer disease, history of major GI surgery, eosinophilic GI disease, or food allergies)
* Chronic use (≥7 consecutive days) of bismuth subsalicylate, simethicone, calcium carbonate, loperamide, proton-pump inhibitors, or ondansetron within 1 month prior to the Screening Visit
* Use of the following medications: montelukast, immunotherapy, mast cell stabilizers, or parenteral, inhaled, or oral steroids up to 1 month prior to the Screening Visit. Use of these medications is also not permitted for the duration of the study (except for the use of montelukast as per study protocol) and will lead to discontinuation
* Have one or more major comorbidities that, in the opinion of the Investigator, may affect the outcome of the study
* History of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical study

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Effect of Prilocaine on Motor Block During Caesarean Section

To compare the effects of using intrathecal prilocaine combined with fentanyl on duration of motor block versus that of intrathecal bupivacaine combined with fentanyl in elective caesarean section.

The participants in this study will be randomized into two groups based on computer generated numbers using online randomization program (research randomizer). Upon arrival to the operating room, patients will be monitored using electrocardiography, pulse oximetry, and non-invasive blood pressure monitor. The baseline values will be recorded .Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 minutes interval during the procedure and during the PACU stay. An 18G-cannulae will be inserted, and pre-medication drugs will be delivered (metoclopramide 10mg). and 4-8 mL/ kg crystalloid infusion will be initiated . Nasal oxygen 3 L / min will be administered during the whole procedure.

* Group P: patients assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
* Group B: patient assigned to this group will receive intrathecal 10 mg (2 ml) of bupivacaine 5% (sunnypivacaine hyperbaric bupivacaine 20 mg/4ml + 25 ug fentanyl (0.5 ml).

Eligibility Criteria:
Inclusion Criteria:

* Age (18-35)
* ASA II
* Singleton, full term pregnant females.
* Height (1.60-1.90) m.
* BMI \> 35 kg m-2
* Scheduled for elective caesarean section under spinal anesthesia.

Exclusion Criteria:

* Patients requiring general anaesthesia
* Known or suspected coagulopathy (international normalised ratio \> 1.4), thrombocytopenia (platelet count \< 100,000).
* Known peripheral neuropathy, neurological deficits or skeletal deformities.
* Known allergy to prilocaine, bupivacaine , fentanyl.
* Infection at site of injection.
* Patients' refusal to sign informed consent
* Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction less than 50%, heart block and arrhythmias), hypertensive disorders of pregnancy, peripartum bleeding.
Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects

Double-blind randomised, parallel-group, three-arm, multicentre, placebo-controlled study The primary objective is to demonstrate the superiority of the combination of Periactine® (cyproheptadine 8 mg/day or 12 mg/day) and Alpress® (prazosin 5 mg/day or 10 mg/day) over placebo on the reduction of the total alcohol consumption (TAC), in alcohol-dependent patients.

180 patients will be randomised into the two treatment groups (N=60 in the low-dose group and N=60 in the high-dose group) and the placebo group (N=60).


Eligibility Criteria:
Inclusion Criteria:

* Severe alcohol use disorder
* High-risk alcohol consumption

Exclusion Criteria:

* Patient with orthostatic hypotension
* Patient with hypotension
* History of uncontrolled hypertension
* Patient at risk for urinary retention associated with urethroprostatic disorders
* Patient with a clinically-active malignancy
* Patient with a confirmed cirrhosis
* History of bronchial asthma
* History of uncontrolled hyperthyroidism
* History of cardiovascular disease not under control
* Severe psychiatric disorder
* History of alcohol withdrawal syndrome
Smart Phone as a Screening and Evaluation Tool to Identify Knee Valgus During Dynamic Activities

Evidence supports the use of two dimensional video analysis to assess the presence of dynamic knee valgus during generally used screening tasks, however there is limited evidence to support the use of the various smart phone applications as a time and money saving option for clinic use . Subjects that present to the clinic and display dynamic valgus at the knee during the lateral step down test will be given the option to participate in the study. If they consent to the study they will be evaluated with 2-Dimensional video analysis to determine the amount of valgus present at the knee during the lateral step down test. The subject will also have the smart phone attached to their lower leg and the amount of valgus will be concurrently measured by the selected application. The primary objective of this study is to determine the validity of an application on the smart phone to provide an objective measure of dynamic knee valgus. The secondary objective of this study is to determine the possibility of the use of the application as a source of feedback during neuromuscular re-education training in order to decrease or eliminate a subject's dynamic valgus collapse and subsequently decreased their risk for future injury.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate
* ability to perform a single leg squat, drop jump, and single leg drop without pain

Exclusion Criteria:

* lower extremity injury within 6 months prior to testing
* history of lower extremity surgery
* lower extremity weight bearing restrictions
* inability to follow directions
* neoprene/latex allergy
* Adhesive allergy
* Current neurological or developmental condition
* inability to attend follow-up session
* actively receiving Physical Therapy intervention for varus/valgus impairment
* Current pregnancy
Effect of Visceral vs Total Body Fat Reduction in Obese Female With Stress Urinary Incontinence

The aim of this study is to investigate the visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.

compare the effect of visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.

control group: consist of 20 obese women. They will receive Kegel exercises only 3 session/ week for 12 weeks.

Diet group: consist of 20 obese women. They will receive low caloric diet and Kegel exercises 3 session/week for 12 weeks.

Ultrasound cavitation group: consist of 20 obese women. They will receive Kegel exercises 3 session/week and ultrasound cavitation two sessions per week.

Eligibility Criteria:
Inclusion Criteria:

* They will be diagnosed with stress urinary incontinence grade≥ 1
* Their age will range from 35-48 years old.
* Their body mass index will exceed 29.9 kg/m².
* Their hip waist ratio will be more than 0.85 cm.
* They will be multipara \>1.

Exclusion Criteria:

* · Fecal incontinence, urge incontinence, overflow incontinence or functional incontinence or prolapse.

  * Diabetes, asthma, cardiovascular, or renal diseases
  * Taking medication for stress urinary incontinence or hormonal replacement therapy.
  * Gynecological surgeries, or surgeries for obesity.
  * Pregnant women.
Plyometry and Tapping in the Functional Improvement of Non-professional Basketball Players

Introduction. In basketball, the lower extremities have the highest prevalence of injury, regardless of gender and professional category.

Objective. To analyse the efficacy of a physiotherapy intervention using a protocol of plyometric exercises and dry needling in non-professional basketball athletes.

Methods. Randomised clinical study. 20 players will be randomised to an experimental group (plyometric exercises and dry needling of the gastrocnemius muscles) and a control group (plyometric exercises). The intervention will include 8 sessions over 4 weeks. The study variables will be: range of motion in dorsal flexion in loading (Leg Motion®) and unloading (goniometer) and vertical jump (MyJump2®).

Expected results. An intervention of plyometric exercises and dry needling produces significant differences in range of motion and vertical jump in basketball players, compared to the isolated administration of plyometric exercises.


Eligibility Criteria:
Inclusion Criteria:

* Non-professional basketball players who are in competition.
* Subjects over 18 years of age
* Athletes competing in the first men's division of the basketball federation of the Region of Murcia.
* Sign the informed consent document.

Exclusion Criteria:

* Subjects who are injured at the time of data collection.
* Subjects who are unable to attend all training sessions during the duration of the research.
* Athletes with apprehension to dry needling.
Computed Tomography (CT) Perfusion Imaging of Lung Cancer

This is an experimental study of the feasibility and efficacy of CT perfusion (CTP) imaging (CT blood flow measurements) in subjects with non-small cell lung cancer.

Drug/Device Information

1) Contrast

30 cc bolus of a low osmolar, iodinated CT contrast agent, which is FDA approved and used in the clinical CT Imaging procedure.

2) Scanner

The 64 row-multidetector row CT unit (LightSpeed VCT, GE Healthcare, Milwaukee, WI) is FDA approved for clinical CT imaging

Research Design and Methods

1) Primary Endpoint

1. Diagnostic yield of tumor perfusion measurements using a contrast assisted computed tomography technique.

2) Secondary Endpoints

1. Reproducibility of tumor blood flow estimates derived by CT.
2. Assessment of the association between tumor vascularity responses after two cycles of chemotherapy and subsequent best tumor response according to standard anatomic response evaluation criteria (RECIST).
3. Predictive value of tumor blood flow for patient survival, compared to the predictive power of tumor size determinations.

Eligibility Criteria:
Inclusion Criteria:

* Patient with any stage non-small cell lung cancer (NSCLC) who will undergo imaging with CT of the chest with intravenous contrast as standard of care. Other imaging tests will be performed as clinically indicated.
* Patient should be receiving, or planning to receive, or have received systemic therapy (chemotherapy and/or novel agents) treatment with or without radiotherapy. Patients should not be receiving adjuvant or postoperative treatment but neoadjuvant treatment is allowed.
* Histologically or cytologically proven NSCLC.
* At least one measurable primary or other intrathoracic/supraclavicular lesion ≥ 1 cm, according to Response Evaluation Criteria in Solid Tumors (RECIST); this lesion should be either proven to be malignant by biopsy or be considered malignant based on its evolution on previous imaging studies. A scan within 3-6 months prior to registration can be used as the baseline scan.
* Age 18 years or older and ability to provide informed consent.
* Subjects must use medically appropriate contraception if sexually active; women of childbearing potential must not be pregnant or breastfeeding
* Subjects must have normal renal function to participate. Standard laboratory testing to evaluate renal function will be performed prior to administering IV contrast and will be available as standard of care. Renal impairment is defined as a glomerular filtration rate of less than 60 ml/min/1.73 m2 BSA, derived from the patients' serum creatinine concentration.

Exclusion Criteria:

* Subjects of reproductive potential, who are sexually active but unwilling and/or unable to use medically appropriate contraception, or women who are pregnant or breastfeeding;
* Established allergy to iodine containing contrast media
Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease

Evaluation of the effectiveness of three different approaches for the rehabilitation of gait in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).

Gait disorders represent one of principal hallmark of Parkinson's disease (PD). Typically, PD patients demonstrate reduced stride length and walking speed during free ambulation, while double support duration and cadence rate are increased. Gait disorders are generally poorly responsive to dopaminergic treatments and are related to reduced quality of life and augmented risk of falls. Different rehabilitation techniques based on compensatory and learning strategies, which principally exploit the use of cues to bypass the defective basal ganglia and to ameliorate performance through practice, have been demonstrated to be effective in improving gait in patients with PD. Cueing techniques represent the central core for the rehabilitation of parkinsonian gait. In this context, it has been demonstrated that treadmill training can improve gait performance in PD patients. It probably acts as an external cue exerting a normalizing effect on the spatiotemporal gait parameters and leading to an enhanced gait rhythmicity and a reduced gait variability. The use of a treadmill with visual and auditory cues (treadmill-plus) seems to lead to a better improvement in gait parameters when compared to treadmill alone. Recently, the application of virtual reality (VR) has been introduced in the rehabilitation of PD. The use of VR is based on the interaction of the person with a virtual environment with the aim to promote motor learning through enhanced perceptions (visual, auditory, and haptic inputs).

It has been widely demonstrated that a multidisciplinary, intensive, goal-based, motor-cognitive and aerobic treatment (MIRT), specifically designed for PD patients, provide parkinsonians with motor and functional benefits. Nevertheless, the contribution provided by treadmill, treadmill-plus and VR on gait parameters has not been previously addressed within MIRT.

This study aims at investigating the superiority or the non-inferiority of these different devices in improving gait in PD patients in the context of MIRT.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of "probable" idiopathic Parkinson's disease according to Gelb et al (Gelb, 1999);
* Mild to moderate stage of disease (stage 2-3) according to Hoehn \& Yahr scale;
* Ability to walk on treadmill;
* Visual and hearing capacity sufficient to perceive the cues;
* No cognitive impairment (Mini-Mental State Examination score ≥ 26);
* Stable pharmacological treatment since 2 weeks before admission and during rehabilitation;

Exclusion Criteria:

* Diagnosis of atypical or vascular Parkinsonism;
* Occurrence of cardiovascular, orthopaedic, peripheral nerves, musculoskeletal and vestibular disorders which could affect patient's locomotion or balance;
* Neuropsychiatric disturbances;
* Severe dyskinesia;
* Severe freezing of gait;
Smoking Cessation Intervention: Effectiveness in Primary Care

The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.

Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. To have a positive public health impact, a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions. The proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies. This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study. In the proposed research, 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies: patch, lozenge, bupropion, patch+lozenge, and bupropion+lozenge (n = 264/condition). Interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the Wisconsin Tobacco Quit Line. Assessment will be limited to preserve the generalizability of the findings, but select individual differences will be assessed pre-quit to validate algorithms (from Project 1: Efficacy) designed to optimize pharmacotherapy selection for smokers based on gender, level of dependence, and other factors. Smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared. The cost of incorporating tobacco dependence treatment into primary care will also be estimated.

Eligibility Criteria:
Inclusion Criteria:

* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments, Aurora participating clinic patient

Exclusion Criteria:

* Uncontrolled hypertension (systolic \>180mm Hg or diastolic \>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
The Reliability and Validity of the Upper Lip Bite Test to Predict Difficult Laryngoscopy in Korean

Anticipated difficulties at laryngoscopy give time to prepare alternative method and proper management.

Several methods to evaluate the anatomical structures has been used during preoperative period for airway assessment.

Evaluation methods are such as the Mallampati classification, mouth opening, thyromental distance and sternocostal distance.

the Upper Lip Bite test, evaluates the possibility of a patient cover the mucosa of the upper lip by the lower incisor.

The aim of this study was to assess the clinical usefulness of the Upper Lip Bite test(ULBT) in Korean compared to Modified Mallampati classification(MMT).


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing general anesthesia with orotracheal intubation

Exclusion Criteria:

* patient who have facial anomaly , 2. patients who required a rapid sequence induction
Pharmacogenomic Testing to Personalize Supportive Oncology

The purpose of this study is to evaluate pharmacogenomics (PGx) guided drug prescribing for pain and depression in patients with cancer. The investigators aim to understand how PGx testing can be used to improve medication management for pain and depression, and whether PGx-guided prescribing improves these symptoms and quality of life compared to historical controls.

This is a prospective clinical trial of adult cancer patients presenting with pain and depression, newly referred to the Department of Supportive Oncology, and receiving preemptive PGx testing for genes related to supportive care prior to the first clinic visit. Genotyping results will be returned within approximately 4-5 business days. A PGx specialist will provide detailed clinical interpretations to the referring provider and upload a copy of the test results into the subject's medical chart. A consultation note will also be placed in each subject's chart detailing the PGx results. Supportive Oncology clinicians will be instructed to consult a pharmacist to evaluate PGx test results prior to prescribing supportive care therapies, especially pain and depression medications. The number of consults and recommendations will be documented, in addition to test results, demographic data, medical/medication history, ESAS symptom scores, PHQ9 depression scores, and side effects of supportive therapy. The number of ambulatory clinic visits and hospitalizations will be used to estimate health care utilization and costs. Subjects will complete a short survey at the end of the study period regarding their knowledge about PGx, and whether access to PGx information improves satisfaction with care and communication.

Eligibility Criteria:
Inclusion Criteria

* Written informed consent and HIPAA authorization for release of personal health information.
* Completion of ESAS at initial palliative medicine clinic visit, presenting with moderate to high pain (≥ 4/10) and/or depression (≥ 3/10).
* New patients ≥ 18 years of age who have had an initial visit in the Department of Supportive Oncology's palliative medicine clinic with hematologic malignancy or any stage solid tumor malignancy according to the provider.
* Agree to at least one additional palliative medicine clinic visit per protocol.
* Able to provide a buccal sample for PGx testing.

Exclusion Criteria

* Psychiatric illness, social situations, or active/recent (within 30 days) history of illicit substance (e.g. cocaine, heroin) abuse that would limit compliance with study requirements (e.g. clinic visits, medication compliance, etc.) as determined by the Investigator.
* Patients who have had prior multiple visits in palliative medicine clinic.