cyrilzakka/clinical-trials huggingface dataset:
Technology-enabled Management Versus Usual Care for Blood Pressure

Two arm parallel randomized clinical trial

Patients will be randomized 1:1 to receive mobile technology intervention versus usual care. Half of patients from a clinician team will receive the intervention and half will receive usual care. We aim to recruit at least 200 patients, 100 in each arm.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-90 yrs.
* Smartphone ownership
* Office SBP: ≥ 140 mm Hg
* ≤ 2 current anti-HTN meds
* Able to add or dose-increase at least 2 of the following classes of medications: ACE-I/ARB, diuretic, calcium channel blocker, beta-blocker, mineralocorticoid receptor antagonists (i.e., at least 2 classes are available for addition or dose- increases after excluding intolerant medications and medications currently at maximum dose)
* English or Spanish-speakers

Exclusion Criteria:

* Heart failure with reduced ejection fraction (EF \< 40%)
* ESRD (GFR \<15)
* Renal replacement therapy
* Pregnant
* Myocardial infarction or stroke within preceding 6 months
* Hospitalization for hypertensive emergency or malignant hypertension within preceding 6 months
* Prior solid organ transplantation
* At the clinical discretion of the investigators
* Enrolled in another clinical study
Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis

Primary objective:

Efficacy of pioglitazone (45 mg/day) as add-on therapy to standard therapy with riluzole in patients with ALS compared to placebo in terms of survival (mortality defined exclusively as death).

This is a prospective, multicentre, randomised, stratified, parallel-group, double-blind trial comparing placebo with 45 mg pioglitazone as add-on therapy to 100 mg riluzole in ALS in 220 enrolled patients. For entry, the El Escorial Criteria for diagnosis will be used. The duration of treatment will be 18 months. The primary endpoint will be subjected to a confirmatory analyses. Secondary variables will be incidence of tracheotomy or non-invasive ventilation, ALS Functional Rating Scale, Quality of life and safety variables.


Eligibility Criteria:
Inclusion Criteria:

* possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
* disease duration more than 6 months and less than 3 years
* best-sitting FVC between 50% and 95% of predicted normal
* continuously treated with 100 mg riluzole daily, for at least one month
* onset of progression weakness within 36 months prior to study
* women of childbearing age be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test
* capable of thoroughly understanding all information given and giving full informed consent according to GCP

Exclusion Criteria:

* previous participation in another clinical study within the preceding three months
* tracheotomy or assisted ventilation of any type during the preceding three months
* gastrostomy
* any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
* presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
* confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT more than 1.5 upper limit of normal)
* renal insufficiency (serum creatinine more than 2.26 mg/dl)
* evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
* known hypersensitivity to any component of the study drugs
* likely to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of an emergency
* other antidiabetics
* heart failure or heart failure in the patients history (NYHA I to IV)
* history of macular oedema
* treatment with thiazolidinediones within 3 months prior to screening
* known or suspected history of alcohol and/or drug abuse
* treatment with gemfibrozil within 3 months prior to screening
Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects

Study design:

This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.

Primary objective:

to study the safety and tolerability of HM10660A, including immunogenicity, as compared to PEG-interferon alpha-2a

Secondary objective:

to study the pharmacokinetics and pharmacodynamics of HM10660A as compared to PEG-interferon alpha-2a

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 45 Years, Inclusive
* BMI: 18.0 - 28.0 kg/m2
* Are Non-smokers or Smoker of Fewer Than 5 Cigarettes Per Day as Determined by History

Exclusion Criteria:

* Mental Handicap
* Evidence of Clinically Relevant Pathology
* History of Type 1 Diabetes or Thyroid Disease
Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma

This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year. We may also collect blood from the relatives of these patients and normal volunteers in order to characterize the genetic basis, if any, of our patients' disorders.

This is an open label study to determine the effects of the administration of Interferon-gamma on the clinical condition and immune function of patients with severe, treatment refractory non-tuberculosis mycobacterial infections. The study drug (interferon gamma) will be administered subcutaneously three times a week at 0.05 mg/m(2) for one year. We may also collect blood from the relatives of these patients and normal volunteers in order to characterize the genetic basis, if any, of our patients' disorders.

Eligibility Criteria:
Demonstrated non-tuberculous mycobacterial infection, either disseminated or pulmonary.

Received medical treatment for at least 3 months without improvement.

Preserved renal, hepatic and hematologic function.

Negative pregnancy urine and effective contraceptive.

Age range greater than 5.

No secondary immunodeficiency such as HIV or malignancy.

Not currently receiving cytotoxic therapy within the past 3 months.

Not pregnant or lactating.

No seizure disorders.

No known symptomatic cardiac disease.
The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects

The objective of the study is to evaluate the pharmacokinetics of lovastatin and lovastatin acid of four 600 mg LipoCol Forte capsules compared to that of one 20 mg lovastatin Tablet after single oral administration in healthy subjects.

This study is two-ways crossover design. The subjects will receive a dose of four 600 mg LipoCol Forte Capsules or 20 mg Mevacor Tablet in fasted state in the morning. There is a minimum of a 6-days washout period before crossover of treatments.

Each subject will be admitted before administration of the investigational product in each period. Study responsible personnel will give the subjects a single tablet or four capsules in fasted state in the morning. The blood samples will be drawn prior to the dosing, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after the dosing.

Observations will be conducted up to 12 hours after the dosing. If no particular health abnormalities are observed in each period, the subjects will be discharged on 12 hours after the dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be at the age of 20-40 years old and be able to sign informed consent prior to study.
2. Body weight must be above 45 kilograms (kg) and within -20 to +20% of ideal body weight.
3. No clinically significant abnormalities were judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.

Exclusion Criteria:

1. Use of any prescription medication, over-the-counter medications or vitamins within 14 days prior to dosing.
2. Participation in any clinical investigation within 2 months prior to dosing or longer as required by local regulation.
3. Donation or loss of more than 500 milliliter (mL) blood within 3 months prior to dosing.
4. Presence of liver disease (Glutamic Oxaloacetic Transaminase (GOT), Glutamic Pyruvic Transaminase (GPT) or Total-bilirubin greater than 2-fold normal values) or renal disease (blood urea nitrogen (BUN) or creatinine greater than 1.5-fold normal values).
5. Creatine kinase (CK) value greater than 1.5-fold normal value.
6. A known hypersensitivity to statins or their analogs.
7. Permanent confinement to an institution.
8. Individuals are judged by the investigator or co-investigator to be undesirable as subjects for other reasons.
Evaluation of an Antithrombotic Therapeutic Strategy in Pregnant Women

The venous thromboembolism is one of the first causes of maternal mortality. Until 2003, only a few recommendations were available on the optimal use of antithrombotic therapy as a preventive measure against thromboembolism in pregnant women. In this study, we propose :

1. To gather the experts who took part in the French consensus conference and the local experts to create a score in accordance with the national and international consensus and to give some precise therapeutic strategies.
2. To evaluate the discriminant, feasible and useful character of this new score by a prospective multicentric study including 2000 pregnant women with a risk of thromboembolism or placental vascular pathology who will benefit from therapeutic strategies defined by the new score.

   .

Purpose : To create a score inspired by our first experience i.e. simple, standardized and quickly usable in day-to-day practice to individualize antithrombotics prescription to women at risk.

Eligibility Criteria:
Inclusion Criteria:

* multiparous or primiparous parturients followed in one of the participating centers
* Presenting at least one risk factor of venous thromboembolic pathology and/or placental vascular pathology

Exclusion Criteria:

* parturient that can't be followed
* unknown familial or personal previous history
* Parturient with a contraindication to use of the treatment recommended by the therapeutic strategy
Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia

The aim of our study was to compare the recovery of smell in people suffering posttraumatic olfactory impairment following a systematic olfactory rehabilitation performed by occupational therapists to natural recovery in a control posttraumatic group of patients.

Forty participants started the study: 20 for the control group and 20 for the treatment group. The mean of the time span between the traumatic event and the first visit in the rehabilitation group was longer than 22 months, time enough to wait any kind of spontaneous recovery.

In order to establish correct comparisons, the investigators analyzed whether both groups of participants (control group and treatment group) were homogeneous or not regarding the age, gender, time span between the traumatic event and the first visit to the office, brain damage and loss of conscience. Investigators administered visual analogic scale (VAS), CCCRC olfactory test and quality of life questionnaire (RSDI) to both groups at the beginning of the study and 12 months late

Eligibility Criteria:
Inclusion Criteria:

* Olfactory loss participants from institution to the Smell \& Tast Office, Otorhinolaryngology Unit, Hospital Universitario Fundación Alcorcón.

All participants provided written informed consent

Exclusion Criteria:

* No sign informed consent
Impact of Fibroblast Growth Factor 23 (FGF-23) and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients

The present study will examine whether serum FGF-23 and serum phosphate at baseline of kidney transplant recipients can predict progression of allograft dysfunction at 3 years and all-cause mortality at 5 years.


Eligibility Criteria:
Inclusion Criteria:

* at least one year post-transplantation
* no more than 10% increase in serum creatinine for the past 3 months

Exclusion Criteria:

* refuse to participate in the study
* any acute illnesses
Social Media for Colorectal Cancer Screening

Using social media for health promotion is an innovative and emerging approach but remains relatively unexplored in cancer screening. Uptake of colorectal cancer (CRC) screening remains low and standard methods of reaching out are expensive with limited impact. The objective of this study is to conduct a cluster randomized controlled trial (RCT) to test the effectiveness of social media messages for CRC screening on screening intention (primary outcome). The results of this trial will be of interest to Ontario Health and are likely to be taken up by other screening programs looking for innovative and novel ways to increase screening participation. The study results will be easily translatable identifying the most compelling CRC screening messages while the approach can easily be translated to other cancer disease sites with screening programs.

The investigators will conduct a cluster randomized controlled trial (RCT) in Facebook users (aged 50+) in Ontario. Randomization will be done at the level of the forward sortation area (FSA) - the first three characters of the postal code. All FSAs in Ontario will be randomized to one of six study arms - users assigned to each arm will receive one of the social media messages or no message (control). If users click on the message, a webpage with further information on screening will appear and participants will be asked to indicate intention to get screened for CRC. The primary outcome will be intention to screen and secondary outcomes will include other engagement metrics such as reach, cost-per-click, click-through rates, number of likes, number of impressions, and post comments.

This study will inform the feasibility of using social media for CRC screening and identify the most compelling CRC screening messages for the screen-eligible population.

Eligibility Criteria:
Inclusion Criteria:

* Facebook users in Ontario who are between 55-64 years of age
Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline of the median nerve could offer symptoms and clinical improvement

Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

* patient refusal infection at the site of intervention
* local anesthetic allergy
Peripheral Optics in Myopia and Orthokeratology

The primary objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles.

Apart from being effective in reducing low to moderate myopia, orthokeratology has been shown to have potential in retarding myopic progression. The central cornea is flattened and peripheral optics altered in orthokeratology and it has been suggested that orthokeratology slows myopic progression through the alteration of peripheral optics. The aim of the current study is to investigate the changes in peripheral refraction and aberration in children wearing orthokeratology (study group) and single-vision spectacles (control group).

Eligibility Criteria:
Inclusion Criteria:

* Myopia (refractive sphere): \> 0.50D and ≤ 6.00D
* Astigmatism: with-the-rule astigmatism (axes 180 +/- 30) ≤ 1.50D; astigmatism of other axes ≤ 0.50D
* Spherical equivalent (SE): \> 0.50D and ≤ 6.75D (myopia)
* Best corrected monocular visual acuity: equal to or better than 6/7.5 in Snellen scale
* Willingness to wear contact lenses or spectacles on a daily basis
* Availability for follow-up for at least 2 years

Exclusion Criteria:

* Strabismus at distance or near
* Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex)
* Prior experience with the use of rigid lenses (including orthokeratology)
* Prior experience with myopic control treatment (e.g. refractive therapy or progressive spectacles)
* Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
* Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
Growth and Tolerance of Cow Milk-Based Infant Formulas

This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.


Eligibility Criteria:
Inclusion Criteria:

* Singleton, 12-16 days of age at randomization
* Term infant with birth weight of minimum of 2500 g
* Solely formula fed
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* History of underlying metabolic or chronic disease or immunocompromised
* Acute infection
* Feeding difficulties or formula intolerance
TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction

Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-45 years old with artificial reproductive needs
* Liver function (ALT) \<40U/L for male and \<30 for female
* HBV-DNA\> 10e+5
* HBVeAg +
* History\> 0.5 years

Exclusion Criteria:

* Cirrhosis
* Combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver
* Liver or other parts of malignancies
* Bilirubin\> 17.1
* GGT\> 2ULN
* Liver transplant patients
* combined HCV, HDV, HIV infection
* A history of anti-HBV drug resistance
* History of habitual abortion
* previous fetal malformation history
* CRP\> 3.0ng / ml
* Uncontrolled hypertension
* Proteinuria or Calculated creatinine clearance \< 70 mL/min
* Heart failure or acute coronary syndrome
* Coagulopathy
* Drug or alcohol addiction
* Hyperlipidemia LDL\> 4.6 or TG\> 2.0
* Alphafetoprotein \> 50 ng/mL
* Received interferon (pegylated or not) therapy within 6 months of the screening visit
* Evidence of hepatocellular carcinoma
* Received solid organ or bone marrow transplantation
* Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents
* Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
Clinical Outcomes of Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine

Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal dosages, and a lower dosage of the drug might be used with an effect equal to higher dosage not buffered. Clinical data are needed to confirm these anecdotal data. No data exist comparing buffered local anesthetics at lower drug concentrations to current dosages commonly used in dental and oral surgical procedures

Specific Aims:

Compare clinical depths of pulpal anesthesia (cold, Electronic Pulp Test) for mandibular molar, and canine teeth at 30 minute intervals post injection for mandibular block anesthesia with buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine.

Hypotheses:

No differences exist in anesthetic depth for pulpal anesthesia after intraoral injection for mandibular block anesthesia between buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2% lidocaine with 1/100,000 epinephrine.

Study Time Frame: 6 months Month One: Recruit 24 volunteers as subjects. Prepare case-books. Months Two-Three: Clinical Study, Months Four-Five: Analyze data Month Six: Prepare Abstracts, Papers Methods: Blinded, Randomized Clinical Design Recruit subjects with Institutional Review Board approved consent at UNC Subjects will serve as their own controls in a cross-over AB/BA study design which is uniform within sequences, uniform within periods, and balanced Randomized subjects to be injected orally for mandibular block (inferior alveolar, lingual, buccal nerves) alternatively with 4cc of buffered 1% lidocaine with 1/100,000 epinephrine and 4cc non-buffered of 2% lidocaine with 1/100,000 epinephrine.

Assessment: pre, and post-anesthetic administration for pulpal anesthesia with cold, Electronic Pulp Test: Mandibular molar, canine at 30 minute intervals Inclusion Criteria: Age 18-30 years, American Society Anesthesiologists (ASA) I Exclusion Criteria Allergy to lidocaine class of anesthetic drugs, Local anesthetic drug past week Current symptoms teeth or oral mucosa. SAS will be used for database management and statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 years, ASA I

Exclusion Criteria:

* Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week Current symptoms teeth or oral mucosa