cyrilzakka/clinical-trials huggingface dataset:
Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1)

To identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of obstructive sleep apnea syndrome (OSAS) with positive airway pressure (PAP) in children with Down's Syndrome (DS).

This is a multi-center outpatient study to be performed at two clinical sites: Children's Hospital of Philadelphia and Cincinnati Children's Hospital. Forty Caregivers of children with DS and OSAS treated with PAP and their children will be enrolled. The study comprises one 30-minute open-ended semi-structured interview per caregiver. The duration of the interview is approximate. It will last up to 30 minutes as some families may want to include more details.

Eligibility Criteria:
Inclusion Criteria -- Patients

* Children with DS and OSAS treated with PAP for at least 6 months
* Children aged between 6 and 17.5 years
* English proficiency

Inclusion Criteria -- Caregivers

* Parent or legal guardian of an eligible patient subject
* English proficiency
* Must live with the patient subject at least 4 nights of the week

Exclusion Criteria -- Patients

* In foster care
* Diagnosed with major illness, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant as these severe diseases may add confounders

Exclusion Criteria -- Caregivers

* Foster parent
Artificial Intelligence-aimed Point-of-care Ultrasound Image Interpretation System

This proposal is for an one-year project. In this project, we aim to investigate the feasibility of using AI for sonographic image interpretation. The main project is responsible for coordination between the two sub-projects and the main project, providing image resources, and using U-Net (Convolutional Networks for Biomedical Image Segmentation) and Transfer Learning to build up the models for image recognition and validating the efficacy of the models. The purpose of Subproject 1 is to develop an image recognition system for dynamic images: pericardial effusion. After building up the model, validating the efficacy and future revision will be done. Subproject 2 comes out an image recognition system for static images: hydronephrosis. After building up the model, validating the efficacy and future revision will be done.

Ultrasound is a non-invasive and non-radiated diagnostic tool in the emergency and critical care settings. In clinical practice, timely interpretation of sonographic images to facilitate decision-making is essential. However, it depends on operators' experience. As usual, it takes time for junior emergency physicians to have good diagnostic accuracy through traditional sonographic education. How to shorten the learning This proposal is for an one-year project. In this project, we aim to investigate the feasibility of using AI for sonographic image interpretation. The main project is responsible for coordination between the two sub-projects and the main project, providing image resources, and using U-Net (Convolutional Networks for Biomedical Image Segmentation) and Transfer Learning to build up the models for image recognition and validating the efficacy of the models. The purpose of Subproject 1 is to develop an image recognition system for dynamic images: pericardial effusion. After building up the model, validating the efficacy and future revision will be done. Subproject 2 comes out an image recognition system for static images: hydronephrosis. After building up the model, validating the efficacy and future revision will be done.

This pioneer study can provide two AI-assisted ultrasound image recognition systems in the real clinical conditions. They can experience of clinical applications and contribute to current medical education. Moreover, it can improve decision-making process and quality of care in the emergency and critical care units. Furthermore, the set-up models can be used in other target ultrasound image recognition in the future.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving echocardiography or renal ultrasound

Exclusion Criteria:

* patients not receiving echocardiography or renal ultrasound
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay

This protocol describes the pivotal accuracy study for the IdentiClone Dx TRG Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC TRG Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from FFPE (Formalin Fixed Paraffin Embedded) samples from individuals with suspected T-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx TRG (FR1/FR2/FR3) Assays - MiSeq (LT Dx TRG-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC TRG Assay on the same sample type.


Eligibility Criteria:
Inclusion Criteria:

1. De-identified, residual FFPE specimens with a minimum of 8 curls
2. Subject Age ≥ 18
3. For suspected clonal positive specimens, FFPE specimens of subjects diagnosed (at the time the specimen was drawn) with T-cell Lymphoproliferative disease with at least one of the following:

   1. ICD10 Codes: C84, C85.8, C85.9, C86.1, C86.2, C86.3, C86.5, 86.6, C91.5, C91.6, C91.0, C91.z, C91.9, C94, C95, C96, or other T-cell lymphoma diagnosis
   2. b. T-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., SNOMED)
   3. Mycosis fungoides or Sézary syndrome sample are acceptable
4. For suspected clonal negative specimens, FFPE specimens of subjects suspected of T-cell lymphoproliferative disease but diagnosed negative for T-cell lymphoproliferative disease. Up to 20% of the negative specimens may be from normal tissue or tissue diagnosed with diseases other than T-cell lymphoproliferative disease

Exclusion Criteria:

1.FFPE specimens that were fixed using formalin substitute (ethanol, methanol, etc.)
Effects of Ingesting Multiple Boluses of Collagen on Muscle & Skin Connective Protein Synthesis in Vivo in Humans

Rationale: Collagen protein is the central structural component of extracellular connective tissues within skeletal muscle, bone, cartilage and skin. Dietary collagen peptides are a promising protein source to deliver the specific amino acid precursors required to support an increase in connective tissue protein synthesis across several tissues (e.g. muscle, skin). However, the digestion and absorption kinetics of multiple boluses of collagen peptides and the subsequent impact on muscle and skin connective tissue protein synthesis rates have not yet been assessed in vivo in humans.

Objective: To assess the impact of ingestion of multiple boluses of collagen peptides on muscle connective and skin protein synthesis in vivo in humans.

Study design: Double-blind, parallel-group, placebo-controlled intervention study.

Study population: 20 healthy young males, aged 18-35 years.

Intervention : Participants will perform unilateral resistance exercise followed by the ingestion of either 100 g of collagen peptides (in boluses) or a non-caloric placebo (flavoured water) drinks, while all drinks will contain vitamin C. Continuous intravenous stable isotope amino acid tracer infusions will be applied, plasma, skin and muscle samples will be collected in order to assess protein synthesis rates in skin and muscle tissue.

Main study parameters/endpoints: Primary study parameters are muscle connective protein synthesis rates. Secondary study parameters are skin and myofibrillar protein synthesis rates, plasma amino acid concentrations and body composition.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-35 years
* Male
* Healthy, recreationally active (participating in recreational sports activities ≥ 1 and ≤ 6 h per week, with a maximum of 2 h resistance-type exercise)
* 18.5 ≤ BMI ≤ 30 kg/m2
* No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).

Exclusion Criteria:

* Female
* Smoking
* Musculoskeletal disorders
* Metabolic disorders
* Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
* Chronic use of gastric acid suppressing medication or anti-coagulants
* Unstable weight over the last three months
* Diagnosed GI tract disorders or diseases
* Blood donation in the past 2 months
Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

Exclusion Criteria:

* A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
* Patient is likely to be greater than 20% noncompliant in taking study medications
* Patients with chronic medical conditions
* Patients with unstable doses of medications
* Pregnant or lactating women, women intending to become pregnant
* Patient is currently receiving prescription therapy with statins or other lipid-altering medications
* Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients

This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records
* History of at least 150 exposure days to other factor IX products
* Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis

Exclusion Criteria:

* Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews
* HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL
* Congenital or acquired coagulation disorders other than haemophilia B
* Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
* Immune modulating or chemotherapeutic medication
Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus

A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.

A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with Type 2 Diabetes Mellitus.

NA-931 is a Quadruple Receptor Agonist for Insulin Like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Gastric Inhibitory Polypeptide (GIP) and Glucagon.

Eligibility Criteria:
Inclusion Criteria:

* Participants 18-65 years old, inclusive
* BMI of 25 - 40, inclusive
* Stable body weight for two months
* Participants must be capable of giving signed informed consent
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
* Willing to comply with contraception requirements

Exclusion Criteria:

* History of significant medical conditions and malignancy
* Uncontrollable hypertension
* History of alcoholism or drug addiction within 1 year prior to Screening
* Current or recent participation in an investigational clinical trial
* Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
Analysis of Gingival Crevicular Fluid

The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.

Gingival crevicular fluid (GCF) is formed when fluid exudes from the vessels of the microcirculation into the inflamed periodontal tissue and into the sulcus or pocket. As the fluid traverses the inflamed tissue, it is thought to pick up enzymes and other molecules that participate in the destructive process, as well as products of cell and tissue degradation. Efforts to develop diagnostic tests based on host factors have been focused almost entirely on analysis of GCF.

The purpose of this study was to investigate and compare GCF interleukin-1β (IL-1β), interleukin-10 (IL-10), interleukin-36γ (IL-36γ) levels in patients with healthy (H), gingivitis (G) and chronic periodontitis (CP) status.

Systemically healthy and non-smokers 80 participants (30 males and 50 females) who were selected from among admitting to Dentistry Faculty of Selcuk University were included in this study. Clinical periodontal parameters were recorded and GCF samples were obtained. Samples were stored in -80 ˚C until analysis with Enzyme-Linked ImmunoSorbent Assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy
* non-smokers,
* presence of at least 20 teeth in the mouth

Exclusion Criteria:

* receiving periodontal therapy in the last 6 months;
* receiving antibiotics or anti-inflammatory drugs in the last 6 months;
* currently pregnant or breastfeeding
* using a removable partial denture and removable or fixed orthodontic appliances.
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.

The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Eligibility Criteria:
Inclusion Criteria: Healthy adults

* Male or female
* Non-smoker
* 18-55 years old
* BMI \> 18.5 and \< 30.0
* With medically acceptable form of contraception (female only).

Exclusion Criteria:

* Any clinically significant abnormality or vital sign abnormalities
* Any abnormal laboratory test
* History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
* Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
* Positive pregnancy test, breastfeeding or lactating
* Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
* Participation in an investigational study within 30 days prior to dosing
* Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of \> 499 mL (within 56 days) prior to dosing.
Eutectic Mixture for Hemorrhoidectomy Postoperative

Assess the efficacy and safety of the topic use of an eutectic mixture of local anesthetics for postoperative pain control of patients submitted to hemorrhoidectomy. Patients will be operated and discharged at the same day in a day hospital clinic. During the fourteen days recovery period, they will apply the study medication to the anal region 4 times daily. The Visual Analog Pain Scale (VAS) will be answered twice daily. Patients will also take 100 mg oral nimesulide twice daily and 50 mg tramadol on demand up to 4 times daily. The tramadol demand will be tabulated. A rescue medication for analgesia will be provided (sodium diclofenac IM).


Eligibility Criteria:
Inclusion criteria: male and female patients, older than 18, having internal hemorrhoid disease grade III or IV with indication of elective surgery, anesthetic risk ASA 1 or 2; able to read and write.

Exclusion criteria: allergy or hypersensitivity to the mixture components, perianal fistulas, fissures, ulcers, infectious and inflammatory processes or tumors to the anal region, chronic diarrhea, megacolon or colonic anatomical deformities, hemorrhoidal thrombosis, gangrene or any condition that changes the indication from elective to urgent, previous surgery to anal-rectal region, history or clinical signs of diabetes mellitis type I or II, pregnancy, intense anxiety or important emotional disorder, participation in any clinical trial within the 3 months preceding the inclusion, investigator´s opinion.
Jumping Exercises Approach in Individuals With Chronic Ankle Instability

The aim of this pilot study is to analyze the effect of a 12-week specific jump training compared with conventional therapy in patients with chronic functional instability of the ankle. It is to be evaluated to what extent the symptoms in of chronic functional instability of the ankle can be influenced in everyday life.

There is a need for;

1. more homogeneous sub- groups with chronic functional instability of the ankle.
2. Studies are needed that older patients (up to 50 years) and also take into account women.
3. In addition, studies should be performed in a clinical environment and also at the same time clinically adapted test can be used as a form measurement.

( Hiller et al. , 2011).

Eligibility Criteria:
Inclusion Criteria:

* Ankle injury more than 6 months ago
* Chronic instability
* Functional instability of the ankle
* Experience with proprioceptive exercises

Exclusion Criteria:

* Foot surgery
* Fresh ankle injury
* Acute foot pain with signs of inflammation
* Mechanical / anatomical ankle instability
* Athletes with regularly jumping exercise (eg volleyball, basketball)
* Taking medications which affect balance and coordination
* Diseases that affect the balance
* Serious diseases such as tumors, infections, neuropathies, severe articular degeneration
* Non-German-speaking patients
Different Positions on the Diffusion and Blockade Effect of Ultrasound-guided Erector Spinae Plane Block

After the completion of erector spinae plane block, the patient maintains different positions to assess the diffusion of local anesthetic and the effect of the block.

Eighty-four patients were selected to undergo CT guided puncture localization of pulmonary nodules under local anesthesia, and the patients were divided into groups using a computer-generated random number in a ratio of 1:1:1. To ensure objectivity, a nurse who was not involved in the study prepared a sealed opaque envelope containing grouping information. Randomly divide patients into three groups: supine position group (S group, 28 patients), prone position group (P group, 28 patients), and lateral position group (L group, 28 patients). The patients underwent ultrasound guided ESPB on the puncture side before CT puncture localization. Ultrasound guided ESPB method: Using an ultrasound high-frequency linear array probe (5-13MHz, Sonosite, USA), the probe is placed parallel to the spine on the surface of the transverse process tip of the seventh thoracic vertebrae. Under ultrasound, the transverse process and spinal muscles are clearly exposed. Then, a short inclined plane puncture needle is used, and the needle is inserted from the head side using in-plane technology. After the needle tip reaches between the transverse process and erector spinae muscles, 1ml of physiological saline is injected using water separation technology to confirm the position of the needle tip, Then inject 30ml of local anesthetic solution (0.75% ropivacaine 15ml+iohexol 15ml). After the block was completed, patients in Group S remained in a supine position; Patients in group L maintained the blocking side above; Patients in Group P maintained a prone position. After 30 minutes of block completion, CT scan and puncture localization were performed, following with 3D reconstruction. The primary outcome was LA-contrast spread to the paravertebral space.The second outcomes were as follow: 1. spread to the neural foramina 2. cranio-caudal spread 3. spread to the epidural space 4. spread to the intercostal space.

Eligibility Criteria:
Inclusion Criteria:

Patients received CT guided puncture localization of pulmonary nodules under local anesthesia

Exclusion Criteria:

1. Allergic to local anesthetic
2. History of opioid abuse
3. Severe skin infection
4. Peripheral neuropathy
5. Dysfunction of blood coagulation
Cyclical Sighing for Pain

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Seeking treatment at the Tallahassee Orthopedic Clinic

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Other unstable illness judged by medical staff to interfere with study involvement.
Avenir Müller Hip Stem Post Market Surveillance Study

This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Avenir Müller Hip Stem.

The objective of this post market surveillance study is to obtain outcome data on the Avenir Müller Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.

This is a multi-centre, retrospective post-market surveillance study involving orthopaedic surgeons skilled in hip surgery. Each case enrolled has received the Avenir Müller Hip Stem for a primary hip arthroplasty. The Avenir Müller Hip Stem is CE marked (European Conformity) and commercially available.

Eligibility Criteria:
Inclusion Criteria:

* Patients able to participate in a follow-up program based upon physical examination and medical history.
* Patients or patient's legal representatives who have given written consent to take part in the study by signing the 'Patient Consent Form'.
* 18 years minimum.
* Male and female.
* Baseline data exist (pre-, peri- and immediate postoperative)

Exclusion Criteria:

* Patients who are unwilling or unable to comply with the follow-up program.
* Known pregnancy.
* Patients who are skeletally immature.