cyrilzakka/clinical-trials huggingface dataset:
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study II

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

To study the effects of oral ethanol (target BAC of \~0.04g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized cannabis (\~450 mg cannabis plant material at a THC concentration of \~1.7%; roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 21 to 55 years of age (extremes included).
* Occasional current cannabis users.
* Experience with drinking 2 or more standard drinks of alcohol at least once in lifetime.
* Able to provide informed consent.

Exclusion Criteria:

* Cannabis naïve.
* Alcohol naïve.
* Positive pregnancy screen
* Hearing deficits.
Novel Porcine Dermal Matrix in the Treatment of Multiple Adjacent Gingival Recessions

The aim of this study was to assess the clinical efficacy of the acellular porcine derived collagen matrix (PADM) in comparison with connective tissue graft (SCTG ) in the treatment of multiple adjacent gingival recessions (MAGR). The primary objectives of the study were to evaluate mean and complete roots coverage. Additionally, the secondary objective was to evaluate and compare the clinical effectiveness of PADM and SCTG for the treatment of MAGR defects applying modified coronally advanced tunnel technique (MCAT).

Treatment of multiple adjacent gingival recessions (MAGR) still presents a challenge for the clinician. The management of soft tissues becomes more complicated and the wound healing may be compromised by a variety of factors.

According to the available medical databases, predictable root coverage is possible for multiple-tooth recession defects using subepithelial connective tissue graft (SCTG) procedures. However, alternative materials to SCTG are supported by evidence of varying strength, with the need for additional research to confirm their performance and success rate. Because of that, the aim of this study was to assess the clinical efficacy of the acellular porcine derived collagen matrix (PADM) in comparison with connective tissue graft (SCTG ) in the treatment of multiple adjacent gingival recessions (MAGR).

This study is a randomised controlled clinical trial of 12 months duration. Sixteen patients with a total of 81 MAGR Miller's Class I or II were enrolled in this study. Recessions were randomly treated with PADM and SCTG, combined with a modified coronally advanced tunnel technique (MCAT). Several parameters, such as gingival recession coverage (RC), keratinized tissue width (KTW), keratinized tissue thickness (KTT) and clinical attachment level (CAL) were recorded at baseline and one year postoperatively. Healing index (HI) was registered on 1st, 2nd, and 3rd-week post-surgery in order to estimate healing events.

Eligibility Criteria:
Inclusion Criteria:

1. At least two multiple maxillaries or mandibular Miller's Class I and II recession, more than \>2mm defects together with similar contralateral lesions
2. No active periodontal disease with PD\>4mm
3. Absence of the radiographic signs of periapical infection on the teeth to be treated or on the adjacent teeth
4. A full mouth plaque index \<20% and gingival index \< 1

Exclusion Criteria:

1. The inflammatory periodontal disease/ Untreated periodontal conditions
2. Previous surgical attempt to correct gingival recession
3. Pregnant or breastfeeding women
4. Systemic diseases with compromised healing potential or infectious diseases
Pilot to Examine Risk and Feasibility of Remote Management of BP From Childhood Into Early Adulthood

Hypertension is an increasingly common problem in children, especially among those who are obese or with diabetes and chronic kidney disease. This study is a pilot randomized controlled trial designed to test whether improved blood pressure control can be achieved with the use of remote home blood pressure monitoring in children with uncontrolled blood pressure.

Hypertension is an increasingly common problem in children, especially among those who are obese or with diabetes and chronic kidney disease. This study is a pilot randomized controlled trial designed to test whether improved blood pressure control can be achieved with the use of remote home blood pressure monitoring in children with uncontrolled blood pressure. Study investigators will randomize 60 children who have elevated BP (defined as receipt of ≥1 anti-hypertensive agent or office SBP ≥90th percentile) to either home BP monitoring with a home SBP target of \< 90th percentile or less than 120 mm Hg, which ever is lower (intervention group) versus usual care group in 2:1 ratio. This study aims to (1) compare the safety of BP lowering in intervention versus usual care patients, (2) determine the efficacy of the intervention and provide estimates for the refinement of sample size determination for an eventual full-scale trial, and (3) assess the feasibility and acceptability of the intervention, recruitment rates, and barriers to trial completion.

Eligibility Criteria:
Inclusion Criteria:

* must be receiving at least one anti-hypertensive agent or have an office SBP ≥120 mmHg or \>90th percentile for age, sex or height at the time of the screening visit
* have a mid-arm circumference between 22-37cm (BP cuff size limitation)
* able to provide consent to participate in our study
* able to use smartphones, or able to use any phone to call or text our study personnel with home BP readings. If participant does not have a smartphone, they will be allowed to call, text, or e-mail home BP readings on a weekly basis instead.

Exclusion Criteria:

We will exclude those who:

* are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents
* are marginally housed, due to concerns regarding routine follow-up
* are actively participating in a different interventional trial that may affect blood pressure
* are unwilling to consent to participate
* institutionalized individuals or prisoners
* are actively abusing illicit drugs or alcohol
* have a history of poor or doubtful compliance (e.g., frequently missed appointments)
* have office SBP \>170 mmHg
* are already taking ≥5 anti-hypertensive medications (any classes, including diuretics)
* have cognitive impairment prohibiting participation in the study
Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study

Monocentric interventional prospective study to evaluate the prevalence of sarcopenia in adults with type 1 diabetes (T1DM) and to evaluate the association between diabetic neuropathy and sarcopenia in subjects with T1DM; to evaluate the prevalence of dynapenia in adults with T1DM and its association with diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 50-80 years, both sexes
2. Diagnosis of T1DM for at least 10 years, in both multiple daily injections of insulin (MDI) and continuous subcutaneous insulin infusion (CSII)
3. Informed consent before any study activity
4. Ability to fully perform all protocol activities

Exclusion Criteria:

1. Previous diagnosis of T2DM
2. Previous diagnosis of dementia
3. Presence of heart failure (NYHA class III and IV)
4. Presence of muscular disease
5. Diagnosis of neurodegenerative disease (e.g. multiple sclerosis, Parkinson's disease)
6. eGFR evaluated through CKD-EPI formula \<20 ml/min /1.73m2 , estimated on previous creatinine dosage
7. Previous history of stroke or cerebrovascular disease
8. Diagnosis of coeliac disease
9. Diagnosis of chronic inflammatory bowel disease
10. Untreated hypothyroidism or hyperthyroidism or not well controlled hypothyroidism or hyperthyroidism with current therapy (TSH \>5 or TSH \<0.15)
11. Alcohol abuse or consumption of more than 14 alcoholic units weekly
12. Active cancer or therapy
13. Pregnancy
14. Primary hyperparathyroidism
15. Corticosteroid and/or estrogen-progestogen therapy for at least 12 months in medical history
16. On going treatment with antiretroviral therapy
17. On going treatment with immunosuppressive therapy, e.g. cyclosporine, tacrolimus
18. On going treatment with anti-epileptic drugs
Susan G. Komen's ShareForCures

ShareForCures (SFC) is a community-based participatory research registry, and its prime objective is to engage participants representative of the United States breast cancer patient population -including minoritized and historically marginalized people, persons, or communities-to ensure the data researchers use to study breast cancer is as diverse as the people touched by this disease. In doing so, researchers will have a better understanding of breast cancer, and everyone can potentially benefit from scientific advances and improvements in care.

ShareForCures (SFC) will be a people-powered, data-driven breast cancer registry that will provide a way for individuals from diverse backgrounds to participate in research and enable participants' data to be used for breast cancer research. The overarching goal of SFC is to create a robust research resource comprised of clinical, biological, socio-behavioral, and other data from up to 200,000 people with breast cancer-including minoritized and historically marginalized people, persons, or communities-to ensure the data, researchers use to study breast cancer, is as diverse as the people touched by this disease. In doing so, researchers will have a better understanding of breast cancer and everyone can potentially benefit from scientific advances and improvements in care.

Eligibility Criteria:
Inclusion Criteria:

* Individuals must be at least 18 years old. (Individuals in Alabama and Nebraska must be over 19 and individuals in Mississippi and Pennsylvania must be over 21 to participate).
* Individuals must have been diagnosed with cancer originating (or is suspected to originate) from the breast.
* Individuals must be currently residing in the United States or a territory of the United States.
* Individuals must be able to read and understand English.

Exclusion Criteria:

* Individuals under the age of 18 years. (Individuals in Alabama and Nebraska under 19 and individuals in Mississippi and Pennsylvania under 21 are not eligible to participate).
* Individuals without a diagnosis of breast cancer.
* Individuals who are not residing in the United States or a territory of the United States.
* Individuals unable to read and understand English.
Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects

The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
* Diagnosis of a PID disorder as defined by World Health Organization criteria (IUIS Scientific Committee, Primary immunodeficiency diseases. Report of an IUIS Scientific Committee. Clin Exp Immunol. 1999) for which the subject has been receiving a regular regimen of IV immunoglobulin infusions every 21 ± 3 days or 28 ± 3 days or a regular SC immunoglobulin treatment at 1 to 2 week intervals over a period of at least 3 months pre-study at a dose of 300-800 mg/kg BW/4 weeks
* Subjects are aged 2 years or older
* Subjects have a serum trough level of IgG \> 4.5 g/L at the last documented determination
* A negative serum pregnancy test for any female subject who is of childbearing potential
* Female subjects of childbearing potential agree to practice birth control measures for the duration of the study

Exclusion Criteria:

* Subjects positive at enrollment for one or more of the following: Hepatitis B surface antigen (HBsAg), PCR for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1
* Subjects with levels of alanine amino transferase (ALT) or aspartate amino transferase (AST) \> 2.5 times the upper limit of normal for the testing laboratory
* Subjects with neutropenia (defined as an absolute neutrophil count \[ANC\] \<= 500/mm3)
* Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender
* Subjects with a malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident)
* Subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome, severe lung disease)
* Subjects with anemia that would preclude phlebotomy for laboratory studies
* Subjects who received any blood or blood product other than an IGIV, SC immunoglobulin, immune serum globulin (ISG) preparation, or albumin within the 6 months prior to study enrollment
* Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SC immunoglobulin and/or ISG infusions
* Subjects with IgA deficiency and known anti IgA antibodies
* Subjects receiving antibiotic therapy for the treatment of infection within 7 days prior to enrollment
* Subjects participating in another clinical study involving an investigational product or device within 28 days prior to study enrollment
* Subjects with bleeding disorders or who are on anti-coagulation therapy
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION904

The purpose of this study is to assess the safety and tolerability of ION904.

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study of ION904 in up to 72 participants. Following a Screening Period of up to 28 days, eligible healthy participants will be randomized to treatment and receive a single, subcutaneous (SC) dose of the assigned study drug. Participants will be followed for up to 13 weeks after dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Must be healthy males, or females of non-childbearing potential, aged 18 to 65 at the time of informed consent
2. Females must be either surgically sterile or post-menopausal; males must be abstinent, surgically sterile, or if engaged in sexual relations with a woman of childbearing potential, a highly effective contraceptive method must be used from the time of signing the informed consent form until at least 13 weeks after the last dose of Study Drug or the healthy participant must be abstinent through this time period
3. Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) for at least 24 hours prior to study visits
4. Body mass index (BMI) requirements between 18 and 35 kg/m\^2

Exclusion Criteria:

1. Clinically significant abnormalities in medical history or physical examination
2. Uncontrolled arterial hypertension
3. Active infection with human immunodeficiency virus (HIV), hepatitis C or hepatitis B or prior treatment for hepatitis C
4. Treatment with another investigational drug, biological agent, or device within 1 month of Screening
5. History of bleeding diathesis or coagulopathy
6. Regular use of alcohol within 6 months prior to screening, or use of soft drugs within 3 months prior to Screening, or hard drugs within 1 year prior to Screening, or positive urine drug screen at Screening
7. History of any severe (e.g., anaphylaxis) drug allergies
8. History of hypersensitivity to other antisense oligonucleotides (ASOs)
9. Concomitant medication restrictions: over-the-counter or prescription medications within 14 days, prior to dosing on Day 1. Accepted exceptions are:

   * Acetaminophen (paracetamol) up to 2 grams per day (g/d) or ibuprofen up to 2.4 g/day taken sporadically for analgesia
   * Thyroid hormone replacement therapy provided participant is stable on replacement therapy (and participant is euthyroid)
   * Other possible exceptions must be reviewed and acknowledged by the Investigator in consultation with Sponsor's Medical Monitor
10. Blood donation of 50 to 499 mL within 30 days of Screening or of \> 499 mL within 60 days of Screening
Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema

A multicenter, randomized, double-blind, parallel-controlled phase I trial comparing the safety, pharmacokinetics and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose in patients with diabetic macular edema (DME).

This is a multi-center, randomized, double-blind, parallel controlled Phase I clinical trial.

The primary objective is to compare the safety of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.

The secondary objectives are to comparing the pharmacokinetic profile, immunogenicity and efficacy of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.

Eligibility Criteria:
Main inclusion criteria：

1. Diagnosed with type 1 or type 2 diabetes with HbA1c ≤ 11.0%;
2. Use ETDRS chart BCVA ≥ 19 letters and ≤ 73 letters (approximately equivalent to Snellen chart equivalent 20/40 to 20/400);
3. Central retinal thickness (CRT) ≥ 300 μm, (using spectral domain optical coherence tomography);
4. BCVA ≥ 24 letters in the non-study eye (approximately 20/320 equivalent on the Snellen chart).

Main exclusion criteria:

1. with proliferative diabetic retinopathy (PDR), excluding inactive, fibrotic PDR;
2. Vitreous hemorrhage within 30 days before the first administration;
3. Structural retinal damage involving the fovea (such as retinal pigment epithelium (RPE) atrophy, retinal fibrosis, laser scarring, dense hard exudates), or the investigator believes that the study eye has other factors that may hinder vision after macular edema subsides increased retinal damage;
4. Existing ophthalmic conditions other than diabetic retinopathy that cause macular edema or vision changes (such as retinal vein occlusion (RVO), choroidal neovascularization, retinal detachment, macular hole, macular retinal traction, epiretinal membrane, etc.) ;
5. There are iris neovascularization;
6. Uncontrolled glaucoma (defined as intraocular pressure ≥ 25mmHg after anti-glaucoma drug treatment) or glaucoma-causing cup/optic disc ratio of the study eye \>0.8 or previous glaucoma filtering surgery (such as trabeculae); excision, sclerectomy, etc.);
7. The investigator believes that the cataract may affect the judgment of the examination or test results, or requires surgical treatment during the test;
8. Aphakia (excluding intraocular lens) or posterior capsule defect (except for YAG laser posterior capsulotomy after intraocular lens implantation within 30 days);
9. History of vitrectomy.
Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects

The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 5.6 mmol/L (≥ 100 mg/dL) and \< 7.0 mmol/L (\< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is \< 5.7%)
* Age: 25-70 years
* Body mass index 19-35 kg/m2
* Current Non-smoker
* Availability and presence in the study units for approx. 3.5 hours/ week for 2 times.
* Signed informed consent form
* No changes in food habits or physical activity 3 months prior to screening and during the study
* If applicable, stable intake of chronic medication of at least 4 weeks

Exclusion Criteria:

* Subjects with diagnosed Type 2-Diabetes with medical treatment
* Presence of disease or drug(s) influencing digestion and absorption of nutrients
* Intake of medications known to affect glucose tolerance, e.g., diabetic medication SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
* Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator's opinion would impact patient safety
* Severe liver or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST \>3 x ULN)
* Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
* Known inflammatory or malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
* Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
* Major medical or surgical event requiring hospitalization within the previous 3 months
* Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids, omega-3 fatty acids
* Intake of antibiotics within 4 weeks before the test days
* Known alcohol abuse or drug abuse
* Pregnant or breast-feeding women
* Weight loss intervention or recent body weight change \>5 kg during last 3 months
* Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
* Blood donation within 4 weeks prior to Visit 1 or during the study
* Anticipating any planned changes in lifestyle for the duration of the study
* Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study
* Subject unable to co-operate adequately
Antithrombotic Management of Acute Mesenteric Ischaemia

Guidelines on the acute and long-term pharmacological treatment of acute mesenteric ischaemia (AMI) recommend the use of thrombolytic, antiplatelet or anticoagulant therapy depending on the aetiology of AMI and the use of stenting but only few details are given on the choice of the drug, dose and duration of treatment. Besides, recommendations are mainly based on data on coronary, cerebral and other peripheral artery diseases and do also not take into account the altered drug absorption in patients with short bowel syndrome, in which AMI can result.This case-based survey will inform us on the current international clinical practice of long-term antithrombotic management of AMI.


Eligibility Criteria:
Inclusion Criteria:

* gastro-enterologist or cardiologist with expertise in treating SBS patients resulting from AMI

Exclusion Criteria:

* none
Effect of the Extract of the Flour Fermented With Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose

The purpose of the present study is to evaluate the effect of the extract of the flour fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level in subjects with prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose 110-125 mg/dL

Exclusion Criteria:

* Taking anti-diabetic drugs
* Taking drugs or functional food that may affect blood glucose level
* Pregnant or nursing a child
* Participation in any clinical trial within 90 days of the commencement of the trial
* Renal or hepatic dysfunction
* Heart disease
* History of severe disease and/or major surgery