cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain

The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).

The aim of the present study is to compare patients' satisfaction with pain medication during the first 7 first postoperative days following elective hallux valgus surgery in general anaesthesia between etoricoxib and diclofenac in a prospective randomised double-blind study design.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) physiological class 1-2 patients
* aged 18-65 years
* scheduled for elective hallux valgus surgery in general anesthesia

Exclusion Criteria:

* NSAID allergy
* liver disease
* renal disease
* uncontrolled cardiovascular disease
* Lithium therapy
* chronic pain
* regular analgesia use
Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients

This research is a study that compares the administration of calcitriol with the outcomes of COVID-19 patients

This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients, hospitalized patients, and patients aged 18-60 years

Exclusion Criteria:

* pregnancy
Study of Vitamin D Fortification of Milk and Oil

It is a two-year longitudinal effectiveness study. A comparative study with a case-control design. Study will be conducted in Pune city. A total of up to 100 families (50 families per group) will be recruited. The test group will consist of families consuming fortified milk and oil and the control group will consist of families consuming non fortified milk and oil. Individuals between the age 5-18 years, 18-50 years and more than 50 years will be enrolled. Families which intend to stay in the city for the next 2 years, willing to continue with the same brand of milk and oil for the next 2 years, children living with their biological parents and families willing to sign consent form, will be enrolled in the study. Individuals having chronic illnesses likely to affect vitamin D concentrations and those allergic to milk will be excluded.

Study design: A two-year longitudinal effectiveness study Sample selection: Hundred families will be selected for this study, 50 in each group.

For the test group, people/families buying the standardized milk habitually will be identified and offered the study, an ethics approval would be obtained before commencing the study. After a consent is signed, a home visit will be made and family will be given information about the study.

Individuals from families who consume standardized fortified milk + fortified oil will be offered the study. The control group will consist of families consuming unfortified milk and oil. Thus, families habitually consuming unfortified milk and oil (from 'ghanas') will be offered the study.

Eligibility Criteria:
Inclusion Criteria: Age between 5 to 80 years at the time of enrolment, Intention to stay in the city for the next two years, Families willing to continue with same brand of oil and milk for next two years after enrolment, Children living with their biological mothers/parents, Families willing to sign a consent form.

Exclusion Criteria: History of illness involving calcium or bone metabolism, including stones of the urinary tract, Currently taking vitamin D supplements as treatment of any disease, Receiving immunosuppressive therapy (oral corticosteroids, chemotherapy) during the previous year, Known history of lactose intolerance or other contra-indications or a version to milk intake, Known hypercalcemia or hypercalciuria, Diabetes mellitus or past/current history of renal stones, and any known systemic, endocrine or metabolic disorder, Medications known to interact with vitamin D metabolism (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs), Hypersensitivity or allergy to any of the components used in nonfortified or fortified milk or oil, Any other reason which in the opinion of a Principal Investigator would interfere with the study shall be excluded.
Colesevelam, Lipids And Sugars, South Asian Canadian Trial

To evaluate the effect of colesevelam on LDL levels and A1c in high-risk , dysglycemic South Asians (with diabetes, and/or with CAD and concomitant metabolic syndrome) whose LDL remains above target despite optimal statin use.

This is a prospective, non-controlled, open label, multicenter trial of colesevelam in Canadian South Asian adults at high cardiovascular risk.

1. 15-20 clinical sites from Ontario, Quebec, Manitoba and British Columbia will be selected from CCRN's network of primary care physicians and cardiologists to identify patients having stable type 2 diabetes or documented stable CAD with metabolic syndrome who are on maximally tolerated statin therapy, with LDL \>2.0 mmol/L or non-HDL \> 2.6 mmol/L.
2. Following informed consent, patients will be screened at baseline for HbA1c, fasting blood glucose, lipid profile, renal function and liver enzymes.
3. Baseline demographics, CAD and diabetes documentation and concurrent drug therapy will be collected.
4. 250 eligible patients will receive a physician prescription of colesevelam (Lodalis) 625 mg tablets (3 tablets taken twice daily) for 24 weeks.
5. Physicians will be requested not to change lipid or diabetes therapy over the 24 week course of the trial.
6. Patients will be contacted at 2 and 12 weeks (visit 3 and 4) via a phone call to assess adherence to the prescribed therapy, review other concurrent medications and assess for any adverse events.
7. The week 24 visit (study visit 5) will include collection of fasting blood work as per screening visit, review of concurrent drug therapy and a final assessment for any adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of South Asian ethnicity; self-declared, at least 3 of 4 grandparents born in a South Asian country (i.e. India, Pakistan, Bangladesh, Sri Lanka, Nepal and Bhutan)
* Either Diabetes, or Coronary artery disease with metabolic syndrome
* Currently receiving maximally tolerated dose of statin therapy (at least Atorvastatin 20 mg or Rosuvastatin 10 mg)
* LDL \>2.0 mmol/L or non-HDL \>2.6 mmol/L
* Patient is willing to provide written consent
* Age ≥ 18 years

Exclusion Criteria:

* Receiving lipid-lowering agents, other than statins or ezetimibe
* Any changes made to current lipid lowering therapy in the last 12 weeks
* Uncontrolled diabetes (HbA1c \>0.10)
* TG \> 5.0 mmol/L
* Significant hepatic or renal disease (ALT \> 2x ULN or eGFR \< 30 mL/min/1.73 m²)
* Ongoing participation in any randomized clinical trial
Cytochrome P450 2E1 and Iron Overload

The aim of the study is to determine, in patients presenting hepatic iron overload (genetic haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged from 18 to 70 years
* Hepatic iron overload measured by magnetic resonance imaging \[MRI\] (\> 36 µmol/g and \< 200 µmol/L)
* Homozygosity for the C282Y mutation of the HFE or dysmetabolic iron overload syndrome (DIOS) based on the presence of at least one of these following metabolic abnormalities:
* Overweight: BMI \> 25 kg/m2
* Waist/hip circumference (cm) \> 0.90
* Diabetes mellitus (fasting blood glucose level \>1.25g/L or blood glucose level after 2 hours \> 2g/L) or glucose intolerance (fasting blood glucose level between 1.10 and 1.25g/L)
* Total cholesterolemia \> 6.2 mmol/L or HDL-Cholesterol \< 0.9 mmol/L
* TG\>= 1.7 mmol
* Written informed consent

Non-Inclusion Criteria:

* Consumption of alcohol \> 50 g/day and of any CYP2E1 inhibitor substances
* Smoker \> 5 cigarets/day
* History of blood donation or venesection
* Other causes of iron overload: aceruloplasminaemia, haematological disorder (abnormal blood counting), late cutaneous porphyria (cutaneous bullous disorders and photosensibilisation) , martial treatment, repeated transfusions.
* Inflammatory syndrome (CRP \> 3ng/ml)
Intrathecal Pump Refills at Home

The aim of this pilot study is to evaluate the feasibility, safety and effectiveness of intrathecal pump refill procedures at home. It is our hypothesis that a refill at home will be safe, effectiveness and feasible, as is demonstrated in The Netherlands, and preferred by patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient receives intrathecal drug therapy
* Patient is at least 18 years old
* Native French-or Dutch speaking persons.

Exclusion Criteria:

* Patients \< 18 years old.
* No native Dutch or French speaking persons.
Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

Study S187.3.003 (NCT00360568) is a Phase 3, 12-month, open-label, multicenter continuation treatment study of the safety, tolerability, and efficacy of levodopa-carbidopa intestinal gel (LCIG) in the treatment of participants with levodopa-responsive Parkinson's disease (PD) with persistent motor fluctuations despite optimized treatment with available PD medications. All participants received LCIG.

Only participants who completed 12 weeks of double-blind, double-dummy treatment in Study S187.3.001 or S187.3.002 (NCT00357994/ NCT00660387) qualified for enrollment in this 12-month continuation treatment study.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease (PD) according to United Kingdon Parkinson's Disease Society (UKPDS) Brain Bank Criteria
* Levodopa-responsive with severe motor fluctuations
* Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and continue to meet the inclusion criteria for the preceding study

Exclusion Criteria:

* Patients with medically relevant abnormal findings (labs, electrocardiogram \[ECG\], physical examination, adverse events, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387)
Accelerated Intermittent Theta-Burst Stimulation Ameliorate Major Depressive Disorder by Regulating CAMKII Pathway

Major depressive disorder(MDD) is a complex and heterogeneous mental disorder. Repeated transcranial magnetic stimulation (rTMS), as a non-invasive neuroregulatory technique, has shown a promising function in the treatment of depression. Theta-burst transcranial magnetic stimulation (TBS) model significantly shortened the duration of physical therapy treatment, and iTBS under the accelerated model (The latter is referred to as aiTBS)showed promising therapeutic effect. However, whether aiTBS has a better and faster curative effect in the first untreated or recurrent unmedicated MDD patients and the mechanism of its alleviation of depressive symptoms remains unclarified. This project intends to verify changes in CAMKII levels, CAMKII molecules and GABA receptors in brain-derived exosomes in normal controls and patients who received sham, aiTBS and high-frequency (10Hz) stimulation respectively. Neuroimaging and TMS-EEG were used to pinpoint the target of stimulation and to record the changes of brain waves before and after treatment in real time. To clarify the neurobiological mechanism of aiTBS rapidly improving depression, and to provide a new strong evidence for clinical transcranial magnetic stimulation for accurate treatment of MDD patients.


Eligibility Criteria:
Inclusion Criteria:

* Sign a written informed consent to participate in the trial and receive treatment;
* Major depressive disorder diagnosis;
* Hamilton depression scale (HAMD - 24) 24 total score 20 points or more;
* First episode or recurrence of depression patients, not taking psychiatric drugs;
* The han nationality, right-handed;
* Junior high school or above;

Exclusion Criteria:

* Other organic mental disorders and mental retardation and other severe mental disorders;
* Infection, trauma, and autoimmune diseases or other possible interference test evaluation of disease;
* Alcohol and drug dependence or is being treated for a hormone drugs patients;
* Craniocerebral injury;
* Seizure or a family history of epilepsy;
* Pregnancy and lactation women;
* All landowners had a metal and MRI contraindications or MRI examination revealed abnormal brain structure.
Safety, Tolerability, and Pharmacokinetics of SPL84 in Healthy Volunteers

This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SPL84 single ascending doses (SAD) in healthy volunteers (HV)


Eligibility Criteria:
Key Inclusion Criteria:

* Male adults 18 to 50 years old
* Considered healthy based on medical history, physical examination, 12-lead ECG and clinical laboratory results
* Body Mass Index (BMI) 19.0-30.0 kg/m2
* Subjects who have no difficulties in receiving drugs by inhalation

Key Exclusion Criteria:

* A major surgical procedure or significant traumatic injury within 28 days prior to study intervention administration
* Recent diagnosis of lung disease (\< 12 weeks from planned enrollment)
* Any acute illness (e.g. acute infection) within 48 hours prior to the study intervention administration, which is considered of clinical significance by the Investigator.
* Chronic respiratory disease including but not limited to obstructive airway disease such as asthma or chronic obstructive pulmonary disease (COPD); restrictive disease such as idiopathic pulmonary fibrosis (IPF); or pulmonary vascular disease such as pulmonary arterial hypertension (PAH).
* History of adverse reactions during aerosol delivery of any medicinal product.
* Total body weight ≤50 kg at screening.
* Abnormal forced expiratory volume at one second (FEV1) at screening.
* Oxygen saturation ≤95% at screening.
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP) and bilirubin (total and direct) above upper limit of normal (ULN) at screening and clinically significant
* Supine systolic blood pressure \<90 or \>140 mmHg, supine diastolic blood pressure \<50 or \>90 mmHg, heart rate \<45 or \>100 beats per minute (bpm), or elevated body temperature (\>38ºC) at screening
* Clinically significant ECG abnormalities at screening
* Positive for SARS-CoV-19 at screening or Day -1 (baseline).
* Positive serology tests for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening.
* Positive urine drug, tobacco, and breath alcohol test result at screening or Day -1 (baseline).
* Use of any prescription or over-the-counter (OTC) medications, including vitamins and herbal or dietary supplements within 14 days prior to dosing.
* Subjects who have received any vaccines within 4 weeks prior to study intervention administration.
* History or current drug/alcohol abuse (excluding use of medicinal cannabis for pain management).
* History of smoking or vaping within 180 days (6 months) of screening
Genetic Study of Families With High Frequency of Hodgkin Lymphoma

Hodgkin lymphoma (HL) is a relatively rare disorder with known familiar aggregation (i.e. HL in more than one child, or parent and child). Because affected individuals in familial HL are genetically related, the existence of such families has long been considered as evidence in support of a genetic basis of HL susceptibility. However, it is largely unknown which genetic variations are responsible for recurring HL in families. Because the effects of genetic variants are likely to be strong in familial HL, identification of such variations will potentially reveal biological pathways critical to the pathogenesis of HL.

PRIMARY OBJECTIVE:

* To perform genome-wide sequencing of families with recurring Hodgkin lymphoma cases (affected as well as non-affected family members) to identify potential disease-causing germline genetic variations.

SECONDARY OBJECTIVE:

* To describe demographic and clinical features of the affected families.

This study entails a clinical interview and submission of a peripheral blood or saliva sample for non-tumor DNA. Participants diagnosed with HL at outside institutions will be requested to sign a release form to allow the outside institution to send their pathology report confirming their HL diagnosis. If available, previously banked tumor tissue samples will be utilized to assess genetic alterations related to HL. Detailed history will be obtained (e.g., demographics, environmental exposures, cancer risk factors, and family pedigree) to facilitate the analysis of phenotype-genotype correlations, taking into account potential confounding factors.

Investigators will examine the germline and possibly the tumor DNA of each individual participant and use the data from all participants to determine if a gene change is related to HL.

Eligibility Criteria:
Inclusion Criteria:

* Patient with HL diagnosed ≤ 21 years of age with a first-degree relative also diagnosed with HL.
* Family members of the patient, either affected or unaffected by a malignancy who agree to participate in the study.
* Research participant or legal guardian, as appropriate, must provide informed consent for this protocol.

Exclusion Criteria:

* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens

The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 18 years of age and no more than 39 years of age.
* The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
* The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
* Any cylinder power must be ≤ -0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Proton-Pump Inhibitors (PPI) Treatment

The primary objective of the study is to describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(using GerdQ questionnaire). The secondary objectives are: to measure the response at the current treatment after a 4-week period of systematic treatment and to identify the percentage of patients which require alterations of their treatment (GerdQ questionnaire)


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Patients known or newly diagnosed with GERD or patients with typical symptoms of GERD- heartburn, regurgitation (in the last case, GerdQ sum score should be ≥8, in the absence of PPI treatment)

Exclusion Criteria:

* Any symptoms at visit 1 suggesting a need for further investigation, judged by the Investigator (alarm symptoms).The alarm symptoms suggesting complicated disease are: dysphagia, odynophagia, bleeding, weight loss without intention or anemia.
* Previous participation in the present study
Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs

The goal of this study was to explore the safety and efficacy of hyperbaric oxygen in the treatment of peripheral neuropathy due to paclitaxel analogues


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed breast cancer by pathology
2. Age 18-60 years
3. ECOG 0-2
4. CIPN patients with NCI-CTCAE grade 1 or higher after treatment with paclitaxel-based drugs

Exclusion Criteria:

1. Patients with contraindications to hyperbaric oxygen i. Untreated pneumothorax. ii. concomitant administration of disulfiram. iii. concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. iv. premature and/or low body mass newborns.

   iv. Premature and/or low body mass neonates.
2. Other cancers
Pragmatic Research eXamining Inpatient Symptoms

Many hospitalized patients experience pain during their hospital stay, and less than half report adequate pain relief. Common treatments for pain include opioid medications, which have associated side effects and complications. Research has shown that acupuncture is effective for surgical, postoperative and cancer-related pain, nausea, and vomiting. More research is needed on the effectiveness of adding acupuncture to routine care for hospitalized patients. The objective of this study is to examine the effectiveness of acupuncture delivered in a "real-world" setting according to the principles of traditional Chinese medicine among hospitalized patients to manage pain and other symptoms. 250 hospitalized participants will be randomized in a 1 to 1 ratio to receive either 1) usual care or 2) usual care with acupuncture offered (125 in each group). The primary outcome measure will be change in daily pain intensity. Data on other symptoms, such as nausea, vomiting, anxiety, and depression, as well as functionality and quality of life will be collected in person, on a web-based survey, or via telephone follow-up. The aims of the study are to examine the effectiveness of acupuncture to manage pain and other symptoms among hospitalized patients; to evaluate the impact of acupuncture on patient satisfaction among hospitalized patients; and to estimate costs and cost-effectiveness of acupuncture among a subset of hospitalized patients.

The investigators hypothesize that compared to hospitalized patients receiving usual care alone, hospitalized patients receiving acupuncture will have:

1. decreased pain severity
2. higher patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Admitted to Mt Zion Hospital for a minimum anticipated length of stay for at least 4 days
* Aged 18 or older
* In a ward included in the roll out of the Osher Center's acupuncture program at Mt Zion

Exclusion Criteria:

* Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction, severe depression, patients in the intensive care unit)
* Acupuncture contraindication (e.g., sepsis, endocarditis)
* Inability to consent or complete surveys (e.g., cognitive or communication impairment)