cyrilzakka/clinical-trials huggingface dataset:
Snoring Intervention Via Elevoplasty in a Non-surgical Clinical Environment

Single Group Compared to Baseline, Non-Randomized, Multi-Center, Prospective Safety \& Efficacy Study

Evaluate the safety and efficacy of the Zelegent, Inc. Elevo™ Kit Snoring Intervention Device (a minimally invasive, barbed, absorbable suture implant) in the reduction of simple snoring through subjective evaluation of snoring and objective snoring sound analysis.

The Zelegent, Inc. Elevo™ Kit Snoring Intervention Device is intended to reduce or eliminate simple snoring in the target patient population via minimally invasive implantation of specialized barbed, absorbable sutures in the soft palate for the purpose of stiffening by way of shortening and lifting the soft palate thereby addressing the root cause of snoring.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 22 years (no maximum age)
* Has consistent Bed/Sleep Partner willing to provide Co-Participant Informed Consent
* Apnea Hypopnea Index (AHI) of \< 15 verified by polysomnogram (PSG) or by SNAP® Diagnostics Home Sleep Study (HSS)
* Has basic computer literacy (e.g., email) and home internet access or smartphone
* Chronic, simple snoring (verified by Bed/Sleep Partner)
* No prior surgical treatment for snoring
* Bed/Sleep Partner willing and capable of providing Informed Consent

Exclusion Criteria:

* Age \< 22 years
* Has no consistent Bed/Sleep Partner
* Apnea Hypopnea Index (AHI) \> 15 indicative of Obstructive Sleep Apnea
* Intermittent or occasional snoring
* Body Mass Index (BMI) \> 32 kg/m2
* Modified Mallampati 3 or 4
* Tonsil Grade 3 or 4+
* Significant nasal obstruction
* Previous palatal surgery
* Current cigarette smoker
* Known history of coronary artery disease or stroke
* Chronic obstructive pulmonary disease (COPD)
* Diabetes (Type I or Type II) non-controlled by medical management
* Major depression or non-controlled psychiatric illness
* Drug or alcohol abuse
* Untreated or poorly controlled hypertension
* Anticoagulation therapy
* History of bleeding or clotting disorder
* Pregnant Female
International EXPAND Heart Pivotal Trial

To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation


Eligibility Criteria:
Inclusion Criteria:

* Registered male or female primary Heart transplant candidate
* Age ≥18 years old

Exclusion Criteria:

* Prior solid organ or bone marrow transplant
* Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
* Multi-organ transplant
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).

Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6 and 10 AM, on two separate days at approximately the same time of day, following an appropriate washout of current androgen replacement therapy.
2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary hypogonadal (congenital or acquired).
3. Naïve to androgen replacement or has discontinued current treatment and completed adequate washout of prior androgen therapy. Washout must be completed prior to collection of baseline serum T samples to determine study eligibility.

Exclusion Criteria:

1. History of significant sensitivity or allergy to androgens, or product excipients.
2. Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up.
3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).
4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.
5. Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis
6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus antibodies (HIV Ab).
7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
8. History of any clinically significant illness, infection, or surgical procedure within 1 month prior to study drug administration.
9. History of stroke or myocardial infarction within the past 5 years.
10. History of or current or suspected prostate or breast cancer.
11. History of untreated and severe obstructive sleep apnea.
12. History of long QT syndrome (QTc \> 450) or unexplained sudden death in a first degree relative (parent, sibling, or child).
Physiological Effects of High-flow Nasal Cannula During Exercise

The high-flow nasal cannula (HFNC) has increased its evidence in patients during pulmonary rehabilitation. These studies hypothesize that the physiological effects of HFNC (positive expiratory pressure, anatomical dead space lavage, thermo-humidification) lead to an increase in exercise time. This is believed to be due to improvements that the device can generate in the respiratory system and muscles. However, the physiological effects of HFNC on respiratory effort and distribution of pulmonary ventilation during exercise are unknown. The aim of this study is to determine the acute effect of high flow nasal cannula on the distribution of pulmonary ventilation and respiratory effort during physical exercise in healthy subjects.

A randomized, cross-over clinical trial in which either HFNC or Sham may be used as an adjunct on a cycle ergometer in random order will be performed to compare the respiratory effort and distribution of pulmonary ventilation continuously. Measurements will be taken in a warm-up, exercise, and recovery phase for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults volunteers
* Physically inactive (according to World Health Organization criteria).

Exclusion Criteria:

* Refusal to participate
* Smokers
* History of acute cardiorespiratory or musculoskeletal disease during the last year (including COVID-19 when hospitalization or supplemental oxygen was required without any other disease)
* Any neuromuscular or cardiovascular or condition that limits test performance.
* Contraindication for esophageal catheter installation (recent epistaxis, severe coagulopathy, among other).
Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty

This study aimed to discover the biomechanics of gait pattern adaptation in patients after a total knee replacement.

The first hypothesis of the project was that center-of-pressure manipulation at the foot during dynamic loading is capable of changing the forces, torques and muscle activation patterns of the lower limb.

The second hypothesis of the project was that patient-specific center-of-pressure manipulation at the foot combined with repetitive perturbation training over time will improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain, quality of life and energy consumption in patients after a total knee replacement.

This study is a randomized prospective controlled study of patients after total knee arthroplasty. Patients will be recruited to the study and divided randomly into an experimental and control group. Both groups will match in terms of gender, age, pathology and clinical assessment. In addition to the intervention of the present study, all patients, whether in the experimental or control group, will carry out the usual physical therapy exercises for total knee arthroplasty as directed by their physician. The patients will be recruited and evaluated prior to surgery and for a follow-up period after surgery.

After surgery, patients in the experimental group will be fitted with a customized biomechanical device worn on the feet (Apos System, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel). The device is calibrated personally to each patient. By calibrating the device, the center-of-pressure of the foot can be manipulated during all phases of the gait cycle. The device is capable of inducing controlled perturbation during gait. The immediate effects of the device will be evaluated using center-of-pressure measurements, three-dimensional gait analyses and surface electromyography. The patients are instructed to walk with the device according to a therapy protocol (AposTherapy). Patients will be evaluated for changes in gait via three-dimensional gait analyses, muscle activation pattern changes via surface electromyography, pain, quality of life and energy consumption.

The patients in the control group will carry out the same walking exercises as the experimental group, but without the biomechanical intervention device (placebo walking shoe). The patients will be evaluated with the same tools over time as with the experimental group.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for first total knee arthroplasty due to end-stage knee osteoarthritis
* Ambulatory and active patients that can participate in gait analysis

Exclusion Criteria:

* Prior joint surgery of either lower extremity, with the exception of arthroscopy
* Unsteady gait
* Back pain
* Neurological, pulmonary or cardiovascular pathologies or risks that may affect long-term performance
* Inability to understand or comply with the treatment protocol
Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70
* Schizophrenia, schizoaffective disorder or bipolar disorder
* Smoke an average of at least 10 cigarettes per day for at least 1 year
* Breath carbon monoxide (CO) levels \>8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip \> 2)

Exclusion Criteria:

* Pregnant or nursing
* Seeking treatment for smoking
* Medical contraindications
Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.

OBJECTIVES: I. Assess the feasibility and efficacy of intermediate dose cytarabine plus idarubicin followed by low dose cytarabine in patients with relapsed acute myelogenous leukemia.

OUTLINE: This is a multicenter study. Patients receive intermediate dose cytarabine IV over 2 hours twice a day on days 1-5, idarubicin IV over 24 hours on days 1, 3, and 5, and low dose cytarabine IV over 24 hours on days 6-15. If patients achieve complete remission by day 35, this regimen is repeated once. If patients achieve partial remission by day 35, this regimen is repeated, except with an additional day of idarubicin on day 7. If these patients then achieve complete remission by day 70, the regimen is repeated. Patients may then undergo stem cell transplantation within 6 months of achieving complete remission. Patients who have an HLA identical sibling available receive an allogeneic transplant; others receive an autologous transplant. Patients are followed monthly for 1 year, every 3 months for 3 years, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 24-60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: First bone marrow relapse of primary acute myelogenous leukemia (AML), all subtypes except M3 OR First bone marrow relapse of secondary AML that occurred after other malignancies, but cured, or after alkylating agents and/or radiotherapy, or after myelodysplastic syndrome No previously untreated AML or second or subsequent relapse of AML No isolated extramedullar localization of AML Must have achieved a first complete remission No leukemias after other myeloproliferative diseases

PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN AST no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No cardiac contraindications to anthracycline chemotherapy Ventricular ejection fraction at least 45% Other: No uncontrolled infection No concurrent severe neurological or psychiatric disease No other progressive malignant nonhematological disease

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic or autologous bone marrow or peripheral stem cell transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study

Recently, a new software program for anesthesia has been developed, called Smart Pilot View. This program monitors the patient, the anesthetic drugs given, and the calculated depth of the anesthesia. The purpose of this study is to determine whether the use of this program improves the quality of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* General anesthesia
* American Society of Anesthesiologists Physical Status: I - III
* Age 18 to 90 years

Exclusion Criteria:

* Combined regional and general anesthesia
* Expected surgery duration \< 30 minutes
* Central nervous system (CNS) diseases (dementia, cerebrovascular accident, seizures, psychiatric diseases)
* Regular intake of CNS active drugs (benzodiazepines, antidepressants, antipsychotics, anticonvulsants)
* Heart surgery on cardio-pulmonary bypass
* Relevant hepatic disease (Child B or higher)
* BMI \>35
* Overt signs of alcohol abuse
* Contraindications or allergies to drugs used in the study
Brinzolamide for the Treatment of Chronic Central Serous Chorioretinopathy

Examine the efficacy of brinzolamide for the treatment of central serous chorioretinopathy

Brinzolamide is a carbonic anhydrase inhibitor. Previously, carbonic anhydrase inhibitors have been shown to be effective for the treatment of macular edema when administered orally, also for central serous chorioretinopathy. However, this treatment carries the risk of severe side effects.

The goal of this study is to examine the efficacy of the topical form of treatment of carbonic anhydrase inhibitors in patients with chronic, non-resolving, central serous chorioretinopathy.

Eligibility Criteria:
Inclusion Criteria:

* Central serous chorioretinopathy (CSC) affecting the fovea, non-resolving after 4 months of follow-up
* Optical coherence tomography (OCT) shows foveal subretinal fluid
* Fluorescein angiography and indocyanine green confirm the diagnosis

Exclusion Criteria:

* Any other ophthalmic condition that may lead to subretinal fluid
* Choroidal neovascularization
* Myopia \> -6D
* Previous treatment for CSC in the past 6 months
* Known allergy to fluorescein or indocyanin green
* Known allergy for brinzolamide
* Pregnancy, breast feeding
DIFFERENT SARS-COV-2 VARIANTS' EFFECT ON THE COURSE OF COVID-19 IN ESTONIAN CHILDREN

The study focuses on Estonian children under 18 who had COVID-19 from 27.02.2020 to 01.03.2023. The main aim is to find out the risk factors for severe COVID-19 in children. In order to do that the study includes their demographic data, vaccination status, and details about the severity of illness, such as hospitalization and long-term effects of COVID-19.

Data is collected for all children under 18 years old in Estonia who were diagnosed with COVID-19 between 27.02.2020 and 01.03.2024 (either with the ICD-10 codes U07.1/U07.2 and/or a positive SARS-CoV-2 test. The following data is collected for each patient: age at the time of COVID-19 diagnosis, gender, place of residence, and COVID-19 vaccination status.

In order to assess the severity of the disease, the following data is collected for each case: hospitalization due to COVID-19, length of hospitalization, need for intensive care, need for mechanical ventilation, fatal outcomes, and occurrence of long-term sequelae (post-COVID-19 condition and pediatric systemic inflammatory response syndrome). Additionally, data on any comorbid chronic and acute diseases of the children in the study group is collected. The outcome measures are compared across five different SARS-CoV-2 VOC periods: original, Alpha, Delta, Omicron BA.1/BA.2 and Omicron BA.4/BA.5.

Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 positivity or COVID-19 diagnosis (ICD-10 codes U07.1, U07.2)
* COVID-19 diagnosis in the following time period: 27/Feb/2020 to 01/Mar/2023

Exclusion Criteria:

* age above 18 years
A Prospective Cohort Study Comparing AI Prediction Model With Imaging Assessment to Diagnose Lymph Node Metastasis in Cervical Cancer

The goal of this prospective cohort study is to learn whether artificial intelligence multimodal fusion prediction models are effective in diagnosing pelvic lymph node metastasis in cervical cancer. The main question it aims to answer is: can artificial intelligence multimodal fusion prediction models improve the accuracy of preoperative diagnosis of pelvic lymph node metastasis in cervical cancer? The researchers compared the AI multimodal fusion prediction model with traditional imaging physician assessments to see if the prediction model could yield more accurate lymph node metastasis determinations. Participants will undergo pelvic MRI after pathologically confirming a diagnosis of cervical cancer, and the results will be used to determine pelvic lymph node metastasis status by the predictive model and the imaging physician, respectively. Subsequent pathology results after surgical lymph node clearance will be used as the gold standard to determine the accuracy of the two preoperative lymph node diagnostic modalities.


Eligibility Criteria:
Inclusion criteria:

1. patients with preoperative diagnosis of invasive cervical cancer stage I-III, with any type of pathology, and patients who underwent radical/modified radical cervical cancer surgery + pelvic lymph node dissection in our hospital or sub-center;
2. Age ≥18 years and ≤80 years;
3. patients who underwent preoperative pelvic MRI (plain/enhanced) imaging in our hospital or sub-centers.

Exclusion criteria:

1. patients during pregnancy or lactation, patients with abortion within 42 days;
2. patients who are undergoing or have undergone preoperative neoadjuvant chemotherapy or radiotherapy for this cervical cancer;
3. Patients with other malignant tumors within 5 years;
4. Combination of other underlying diseases that may lead to enlarged pelvic lymph nodes;
5. patients whose preoperative pelvic MRI date is more than 1 month from the day of surgery;
6. poor quality imaging images that are unrecognizable.
A Study to Investigate the Safety and Effect of the Study Drug (FE 204205) in Patients With Cirrhotic Portal Hypertension

The purpose of this trial is to investigate safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) after intravenous (IV) administration of FE 204205 in patients with cirrhotic portal hypertension.

The trial aimed to evaluate the safety, tolerability, PK and PD of IV FE 204205 in cirrhotic patients with portal hypertension and was planned in 2 parts:

Part 1 of the trial was open-label where six subjects were planned to receive three ascending doses of FE 204205, given as infusion over 2 hours on three consecutive days.

Part 2 was planned as a randomised, placebo-controlled, double-blind investigation evaluating the effects of a single dose of FE 204205 on portal haemodynamics in 20 subjects who would have received either the maximum tolerated dose (as defined in Part 1) of FE 204205 (n=16) or placebo (n=4).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed evidence of cirrhosis
* From medical history anticipated hepatic venous pressure gradient greater than equal to (≥)12 mmHg

Exclusion Criteria:

* Co-existing disease e.g. significant organ failure and decompensated cirrhosis
* Type 1 hepatorenal syndrome
* Acute-on-chronic liver failure
* Hepatic encephalopathy ≥grade 2
* Hepatocellular carcinoma
* History of underlying chronic heart disease
* Use of vasopressin or terlipressin within 7 days prior to dosing
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 years or above at the time of signing the informed consent
* Diagnosed with type 2 diabetes \>=30 days before screening
* HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening
* Body mass index (BMI) \>=23 kilograms per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
* Renal impairment with estimated Glomerular Filtration Rate less than 30 milliliter per minute per 1.73 square meter (ml/min/1.73 m\^2) as determined by central laboratory at screening
* Treatment with any medication for the indication of diabetes or obesity within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
* History of use of any injectable therapy for diabetes or obesity. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination