cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Outcome Trial in Heart Failure (DOT-HF Trial)

The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.

The study was designed with a Control Arm in order to adequately study the effect of early intervention triggered by the OptiVol® Alert and/or SentryCheck™ Monitor/PatientLook™ Indicator and evaluation using OptiVol® Fluid Status Monitoring with Cardiac Compass. OptiVol® Fluid Status Monitoring with Cardiac Compass features are available in the per Clinical Investigational Plan specified Medtronic products (CRT, CRT-D and ICD devices)

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both genders with mild to severe HF as defined as NHYA Class II to IV who also have an indication for device implant according to ESC/AHA guidelines as well as having a HF hospitalization or Emergency Department visit necessitating therapy within the past 12 months and who meet all inclusion criteria and no exclusion criteria, are eligible for this study.

Exclusion Criteria:

* Subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year
* Subject received a coronary artery bypass graft or valve surgery in last 90 days
* Subject with a myocardial infarction (MI) in the last 40 days.
* Subject's life expectancy is less than one year in the opinion of the physician
* Subject has severe Chronic Obstructive Pulmonary Disease (COPD), as determined by physician and documented in medical records
* Subject is listed for valve replacement/valve repair
* Subject has severe, primary pulmonary hypertension as determined by physician and documented in medical records
* Subject with serum creatinine ≥ 2.5 mg/dL measured within 14 days prior to enrolment
* Subject on chronic renal dialysis
* Subject on continuous or uninterrupted (≥ 2 stable infusions per week) infusion (inotropic) therapy for HF
* Subject has complex and uncorrected Congenital Heart Disease
Evaluation of Digital 3D Printed Temporary Removable Partial Denture.

This study aims to compare oral health-related quality of life and retention between digitally- fabricated temporary flexible RDPs and conventionally-fabricated temporary flexible RDPs.


Eligibility Criteria:
Inclusion Criteria:

* Maxillary Class III, modification I partially edentulous patients that enables measuring the retention values intraorally without denture rotation.
* Fully dentulous or partially edentulous opposing mandibular arch.
* Patients that require temporary partial dentures for aesthetic reasons or as an interim denture during mouth rehabilitation treatment or after implant placement.
* Age range (30-55 years).
* Cooperative patients that are willing to attend all follow-up periods.
* Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
* Patients with healthy abutments and healthy periodontium and no more than grade I mobility.

Exclusion Criteria:

* Patients with Parkinson's disease
* Patients with xerostomia.
* Patients with a history of allergy to dentures made of resins.
* Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
* Patients with large irregular bony exostosis.
* Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation.

According to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, inflammatory biomarkers, blood pressure, and arterial oxygen saturation.

The study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo an IHHE session, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The sham group will undergo a 5-cycle protocol with an FiO2 of 21%.

Both groups will follow a 6-week protocol with three weekly sessions (Monday, Wednesday, and Friday).


Eligibility Criteria:
Inclusion Criteria:

* Being over 65 years old.
* Having no previous experience in hypoxic training.
* Engaging in less than 150 minutes of physical activity per week.

Exclusion Criteria:

* Having any pathology that prevents the subject from being independent in terms of walking and functionality.
* Subjects with impaired cognitive abilities.
* Subjects with pulmonary hypertension, decompensated heart or respiratory disease.
* To have or have had cancer
The Effect of Oral Intake of Animal and Plant Proteins on the Metabolism in Healthy Women

The goal of this interventional study is to learn about the effects of different proteins (from animals or plants) on the metabolism in healthy, normal weight women between 18-45 year who are not on hormonal birth-control.

The main questions the study aims to answer are:

1. How do different proteins affect biological markers of the metabolism and which protein has the strongest effect?
2. How are the different proteins digested and taken up from our body?

Participants will drink four different shakes on four different study days in a random order. Three of them contain each a different protein and one does not contain protein. Right before drinking the shake and on 11 timepoints after drinking the shake blood samples will be drawn.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Age: 18-45 years
* Body mass index: 18.5 \< 25 kg/m2
* Signed informed consent

Exclusion Criteria:

* Use of hormonal contraceptives
* Pregnancy or breastfeeding
* Diabetes mellitus or any other metabolic disease that might affect the results of this study
* Gastric surgery that affects digestion and uptake of protein
* Any clinically significant present or past disease/condition and medication which in the investigator's opinion could interfere with the results of the trial
Functionality of Lower Limbs in Patients Who Have Undergone Knee Meniscectomy

Introduction. Meniscal lesions are common and are associated with the development of osteoarthritis of the knee. Work activities that cause mechanical stress can lead to acute or chronic injuries. The surgical treatment for this injury is meniscectomy. Physiotherapy is a widely accepted first-line treatment for patients with meniscus tears.

Objective. To assess the clinical and functional status of patients who have undergone meniscus surgery with and without post-surgical physiotherapy.

Material and method. Multicenter ambispective cohort study. 89 patients who have undergone meniscectomy will be recruited. The primary variable of the study will be functionality (Time Up \& Go), with the prescription of a post-surgical physiotherapy treatment being the dependent variable. The secondary variables, estimated as modifying or confounding, will be range of motion (goniometry), pain intensity (visual analog scale) and kinesiophobia (Tampa scale).


Eligibility Criteria:
Inclusion Criteria:

* Persons aged 20 to 65
* Of both sexes
* With previous meniscectomy surgery in one of the two knees in the last 5 years
* Who sign the informed consent document.

Exclusion Criteria:

* Patients who require technical aids for walking
* Dependent patients for carrying out activities of daily living
* Patients over 65 years of age
* Patients with cognitive impairments that prevent understanding of tests and evaluations
Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-Cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough

This is a randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety and efficacy of ARINA-1 compared to placebo (isotonic saline, 0.9%) in participants with NCFBE. Study participants will receive either study treatment or placebo twice daily for 28 days. Efficacy endpoints will include quality of life, sputum rheological markers, and blood inflammatory markers. Quality of life will be measured using the following tools: Quality of Life-Bronchiectasis (QOL-B) questionnaire, St. George's Respiratory Questionnaire (SGRQ), Chronic Airways Assessment Test (CAAT), and a daily clinical global impression questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NCFBE confirmed by chest CT
* 18-80 years old, inclusive at time of informed consent
* BMI \>18
* Percent predicted FEV1 \> 40%, pre-bronchodilator
* Stable for 90 days with any airway clearance technique (ACT) method(s)
* Stable on standard of care (SOC) therapy for 90 days (includes cycling antibiotics, such as inhaled tobramycin, and long-term macrolide therapy) and not likely, in the opinion of the investigator, to require any changes to therapy during the duration of study participation
* Fully vaccinated for COVID-19 (second dose of a 2-shot regimen or single dose of 1-shot regimen completed \>14 days prior to the screening visit)
* Must be able to produce a sputum sample
* If female and of childbearing potential, must be willing to use contraception for the duration of the study.

Exclusion Criteria

* Positive urine pregnancy test for women of childbearing potential (WOCBP) at screening and baseline visit
* Active exacerbation ≤28 days prior to the baseline visit
* Initiating or changing antibiotic, antiviral, or antifungal therapy ≤ 28 days prior to the baseline visit
* Changing or initiating any vitamin C, glutathione or N-acetyl-cysteine-containing therapy or multivitamin within 30 says prior to the screening visit.
* Positive COVID-19 diagnostic test (PCR or antigen) within 90 days prior to the screening visit.
* Participated in other interventional drug or device studies within 30 days of the screening visit (Note: observational studies are acceptable)
* Significant unstable comorbidities (in the opinion of the site investigator), such as heart failure, cardiovascular disease, diabetes, renal disease, liver disease
* Current tobacco or marijuana smoker (those with active smoking exposure \<180 days prior to the screening visit) (Note: edibles are acceptable)
* Requiring the use of any supplemental oxygen
* Currently on cycled antibiotics (e.g., tobramycin) or have been on a cycled antibiotic regimen within 90 days prior to the screening visit.
* Current diagnosis of non-tuberculous mycobacteria (NTM) requiring antibiotic treatment. (Participants who test positive for NTM but who are not currently on antibiotic therapy are eligible for screening)
Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.

To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.

* Patients will be recruited after written informed consent.
* Adverse events will be coded using Medical Dictionary for regulatory activities (MedDRA).
* Descriptive statistics will be used for all the safety and efficacy variables.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged ≥18 to \<80 years and suffering from exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection
2. Sputum sample collected for culture before starting treatment

Exclusion Criteria:

1. Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception
2. Subjects suffering from cystic fibrosis, active pulmonary mycobacterial infection, end stage chronic obstructive pulmonary disease on long term oxygen therapy, severe uncontrolled asthma, active sarcoidosis and active allergic broncho-pulmonary aspergillosis
3. Current exacerbation of bronchiectasis is associated with lung abscess or empyema
4. Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa
5. Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count \< 200/mm3
6. Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent
Comparing Speedlyte and IV Rehydration Treating Children With Gastroenteritis in a Pediatric Emergency Department (ED)

To compare length of stay (LOS) of pediatric patients in a pediatric emergency room presenting with Gastroenteritis treated with IV rehydration versus oral Speedlyte rehydration.

Gastroenteritis leading to dehydration is very commonly encountered in the pediatric emergency room setting. Oral rehydration therapy (ORT) is the first line therapy recommended by the American Academy of Pediatrics but is seldom used compared to intravenous therapy (IVT). ORT has many advantages including less traumatic to the patient, can be administered by mouth, can be administered at home and less costly compared to IVT. Furthermore, intravenous fluids may present several complications with IV placement such as infiltration, hematoma, air embolism, phlebitis, extravascular injection, intraarterial injection, etc. Speedlyte is a new oral rehydration product with lipophilic absorption which allows for electrolytes to be more readily absorbed compared to other oral rehydration solutions. The liposome encapsulates the salty molecules which is thought to decrease the negative salty taste associated with oral rehydration solutions. In addition, the encapsulation of electrolytes allows for more molecules to be delivered past the stomach acids and absorbed into the body under higher bioavailability due to the lipid shell.

Participants will be randomized into two rehydration groups. One group will receive oral rehydration with the Speedlyte product, the amount will be based on the participant's weight. The other group will receive intravenous rehydration with a normal saline bolus per physician practice, usually in the amount of 20 mL/kg. These interventions can be incorporated into the emergency room practice without undue expense to the setting or placing excessive demands on nursing time as these practices are standard of care in many rehydration cases.

Eligibility Criteria:
Inclusion Criteria:

* 6 mths to 18 years;
* Signs and symptoms of dehydration for less than a week
* Diagnosis of acute gastroenteritis, dehydration, vomiting, and/or diarrhea;
* Patient able to drink from bottle and/or cup;
* Per clinician's judgment, patient needs rehydration with IV solution.

Exclusion Criteria:

* Chronic disease that includes but not limited to TB, HIV, congenital heart disease with hemodynamic consequences, metabolic disease, cerebral palsy, adrenal hyperplasia, renal tubular acidosis, and nephropathy;
* Vomiting due to head trauma;
* Severe hydration;
* Diabetic ketoacidosis;
* Bloody diarrhea;
* Diarrhea for more than a week;
* Malnutrition;
* Burns;
* Pneumonia;
* Meningitis;
* History of seizures;
* Absent bowel sounds;
* Not able to drink from bottle or cup;
* Previous allergic reaction to citrate or other food coloring particles/formulation;
* Parent/legal guardian refusing to participate.
Evaluation of Tolerability, Efficacy and Adherence to Treatment With Wynzora Cream

The primary objective is to assess with the PPQ questionnaire the patient preference for Wynzora compared with therapy carried out previously with Enstilar spray foam. Secondary objectives Assess satisfaction with the treatment. Assess adherence to therapy. Evaluate the impact of various clinical and demographic factors on treatment adherence. Evaluate the efficacy of Wynzora cream therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age, of either sex;
* Patients diagnosed with mild-to-moderate psoriasis (PASI and BSA \&lt;10) requiring monotherapy topical with Wynzora;
* Patients who have stopped treatment with Enstilar foam for any reason for at least 30 days; and
* Patients whose medical records are accessible and record all demographic parameters, anthropometric and clinical parameters during the treatment period
* Signature of written informed consent;

Exclusion Criteria:

* Patients with palmoplantar, inverse, erythrodermic, guttate, and scalp psoriasis.
* Patients who are taking concomitant systemic therapies for psoriasis, such as. cyclosporine, methotrexate, acitretin, phototherapy or biologic therapies.
* Women who are pregnant or planning to become pregnant.
* Patients with disabilities or other motor problems that could complicate self-medication.
The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.

Total hip replacement surgery is one of the most common orthopedic interventions. Proper anaesthesia and adequate analgesia is one of the key interests of attending anaesthetist. Recent studies show that ultrasound guided suprainguinal fascia iliaca compartment block may play a significant role in proper management of pain after these procedures. The aim of this study was to assess the clinical usefulness and compare different methods of anaesthesia for total hip replacement surgery via posterolateral approach.


Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years old
* informed consent to participate in the study
* ASA score I-III
* BMI -19-30kg/m2
* qualified for total hip replacement
* no contraindication to used anesthesia and drugs

Exclusion Criteria:

* contraindications to spinal anesthesia and regional blocks
* previously coexisting chronic pain
* previously opioids intake
* BMI\>30kg/m2
* allergy to drugs using during study
* mental status preventing the usage of patient controlled analgesia pump
Ketone Supplementation, Glucose Control, and Cardiovascular Function

Post-prandial hyperglycemic excursions induce a cascade of deleterious effects on the body, including increased inflammation, production of reactive oxygen species, and impaired cardiovascular function. Ingestion of an exogenous oral ketone supplement blunts hyperglycemia in response to an oral glucose tolerance test. Accordingly, it is hypothesized that exogenous ketone supplement ingestion prior to a meal could be an effective strategy for blunting postprandial hyperglycemia. Therefore, the purpose of this study is to investigate the effect of short-term (14-days) pre-meal exogenous ketone supplementation on glucose control, cardiovascular function, inflammation, and oxidative stress in individuals at an elevated risk of type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Elevated waist circumference (\>102 cm for males, \>88 cm for females) and/or Obesity (BMI \> 30 kg/m2) and/or Diagnoses of prediabetes based on A1C (5.7-6.4%) and/or fasting plasma glucose (5.6-6.9 mmol/l) using ADA criteria

Exclusion Criteria:

* Competitively trained endurance athlete
* Actively attempting to lose weight
* History of mental illness or existing neurological disease(s)
* Previous cardiovascular events (i.e., heart attack, stroke)
* Diagnoses of diabetes
* Hypoglycemia
* Irritable bowel syndrome or inflammatory bowel disease
* Taking medication that may interfere with insulin sensitivity
* Currently following a ketogenic diet or taking ketone supplements
* Unable to commit for 2 separate 14-day trials and unable to follow a controlled diet
Immunological and Cardiovascular Phenotyping of Oocyte-donation Pregnancies

The investigators conduct a study to evaluate the underlying causes of preeclampsia in oocyte-donation pregnancies.

A detailed medical history, questionnaires as well as blood, urine and placental samples will be used to analyse several factors leading to the high risk of preeclampsia in oocyte-donation pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* pregnancy

Exclusion Criteria:

* severe auto immune disorders
What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder

This study evaluates the efficacy and acceptability of two cognitive-behavioural interventions for reassurance seeking behaviour in obsessive-compulsive disorder (OCD), a family accommodation reduction protocol vs. a novel support-seeking protocol. Half of participants will be randomly assigned to participate in the support-seeking intervention, whereas the other half will participate in the family accommodation reduction intervention.

An existing family accommodation reduction intervention to reduce reassurance seeking behaviour in OCD (which represents treatment as usual, or TAU) is being compared to a novel support-seeking intervention to determine which is more efficacious and acceptable to participants.

The TAU protocol asks participants to make an agreement with their significant others to withhold reassurance when it is sought. It is believed that this behaviourally-based intervention encourages extinction of reassurance seeking over time by eliminating reinforcement of the behaviour by significant others.

The support-seeking intervention asks participants to move towards adaptively seeking support from a significant other to manage anxiety or distress rather than seeking reassurance. Significant others are taught to provide support rather than reassurance. It is believed that support-seeking may reduce reassurance seeking behaviour because it helps participants manage the anxiety or distress that underlies the requests for reassurance without interfering with disconfirmatory learning.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OCD
* Engaging in reassurance seeking more than once a day about the same thing
* Willingness to allow the experimenter to contact a significant other from whom the participant seeks reassurance regularly
* Ability to read, write, and communicate in English

Exclusion Criteria:

* Current suicidal ideation/intent
* Current substance abuse
* Psychosis
* Diagnosis of bipolar disorder (I or II)
* If participants are on medication they must be on a stable dose (i.e., have maintained a consistent dose for at least three months) and agree not to change their medication regimen for the duration of the study
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age

The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.


Eligibility Criteria:
Inclusion Criteria:

* healthy females 18 through 40 years of age;
* have provided written informed consent after the nature of the study has been explained;
* are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
* are in good health as determined by: medical history ,physical assessment

Exclusion Criteria:

* unwilling or unable to give written informed consent to participate in the study;
* pregnant (serum pregnancy test)
* unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
* nursing (breastfeeding) mothers