cyrilzakka/clinical-trials huggingface dataset:
Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism

Secondary hyperparathyroidism (SHPT), which is frequently associated with chronic kidney disease, leads to problems such as bone pain, fractures, and cardiovascular issues, thereby affecting patients' quality of life. This clinical trial is designed to compare the efficacy of thermal ablation and surgical treatment for SHPT. Parameters including parathyroid hormone levels, serum calcium and phosphorus levels, SHPT-related symptoms (for example, bone pain, muscle weakness), and complication occurrence will be monitored. The advantages involve enabling better treatment decisions for patients, enhancing patients' quality of life, and alleviating the burden on families, in addition to augmenting the clinical knowledge of healthcare providers. However, both treatments carry risks. Thermal ablation may have problems like incomplete ablation, local tissue damage, and blood parameter changes. Surgical risks comprise bleeding, infection, adjacent tissue damage (such as the recurrent laryngeal nerve), and hypoparathyroidism. The investigators will strive to minimize these risks. This trial is of great significance for SHPT treatment, and the investigators welcome participants to contribute to the advancement of medical science in this area.


Eligibility Criteria:
Inclusion Criteria:

* persistent serum iPTH (intact parathyroid hormone) levels \> 800 pg/mL；
* resistance to calcimimetics, vitamin D, and its analogs, with ineffective conventional internal medicine comprehensive treatment；
* severe bone pain, osteoporosis, muscle pain, ectopic soft tissue calcification, or other factors affecting quality of life；
* imaging examinations indicating the presence of at least one enlarged parathyroid gland

Exclusion Criteria:

* severe bleeding tendency or coagulation disorders, severe cardiopulmonary abnormalities, and abnormal vital signs such as severe hypertension, arrhythmias, and anemia
Comparison Evaluation of Blood Glucose Meter Systems

The purpose of this study was to evaluate the performance of one investigational Bayer Blood Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring Systems from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some blood samples were glycolyzed to lower the glucose levels.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* 18 years of age or older
* Willing to complete all study procedures

Exclusion Criteria:

* Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
* Hemophilia or any other bleeding disorder
* Pregnancy
Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma

This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared to cumulative doses of Proventil as an active control in subjects with mild to moderate asthma

This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary pharmacodynamics (PD) of cumulative doses of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI) compared to cumulative doses of Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) as an active control in subjects with mild to moderate asthma.

Eligibility Criteria:
Inclusion Criteria:

* Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis
* Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy
* Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society \[ATS\]/European Respiratory Society \[ERS\] acceptability/repeatability criteria
* Pre-bronchodilator FEV1 of ≥50 to \<80% predicted normal value after withholding SABA ≥6 hours
* Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1 of ≥15%
* Only 2 reversibility testing attempts are allowed

Exclusion Criteria:

* Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
* Oral corticosteroid use (any dose) within 6 weeks
* Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol
* Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana)
* Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
* Historical or current evidence of a clinically significant disease
* Cancer not in complete remission for at least 5 years
* Hospitalized for psychiatric disorder or attempted suicide within 1 year
* Unable to abstain from protocol-defined prohibited medications during the study
A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit

Hospitalized adult patients suffer from sleep deprivation, which has been associated with multiple negative consequences, both in short and in the long term. Many factors have been attributed to poor sleep quality, including excessive noise, inappropriate lighting, interactions with the healthcare team, administration of drugs, patients' symptoms, among others. There is scarce evidence reporting multicomponent interventions aimed at ensuring and improving sleep quality in hospitalized patients. The following before-after, randomized controlled trial will evaluate and determine the feasibility, acceptability and effectivity of a multicomponent intervention in improving sleep quality and reducing the consequences of poor sleep in a psychiatric intensive care unit (PICU). The intervention is comprised of changes in health personnel habits, improvements in the PICU environment, patient's psychoeducation and continuous sleep and activity monitoring through a validated wearable device.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in the last 72 hours.
* Capacity to consent
* Approval by treating physician

Exclusion Criteria:

* Active psychosis
* Active eating disorder
* Delirium
* Major cognitive disorder
Mannitol-induced Release of Copeptin in Healthy Adults and Patients With Polyuria-Polydipsia Syndrome (MARS Study)

The aims of this study are to investigate whether mannitol stimulates copeptin (part 1: proof-of-concept) and whether the copeptin levels upon mannitol infusion differ in primary polydipsia and arginine vasopressin deficiency (part 2: pilot study).

Diagnosing polyuria-polydipsia syndrome, which includes arginine vasopressin (AVP) deficiency (AVP-D, formerly central diabetes insipidus) and primary polydipsia (PP), is challenging but essential. Currently, the most accurate test currently involves measuring copeptin after osmotic stimulation with hypertonic saline, but this test is rarely used due to the need for close sodium monitoring and the discomfort it can cause.

Mannitol has been shown to stimulate AVP release, but no study has tested copeptin levels after mannitol stimulation in healthy adults or patients with AVP-D or PP.

This single-center study is conducted in two consecutive parts. Part 1 is a double-blind, randomized cross-over proof-of-concept study in healthy adults to investigate if mannitol infusion stimulates copeptin release. Part 2 is an open-label, single arm case-control pilot study in adults with diagnosed PP or AVP-D to see if copeptin levels after mannitol stimulation differ in PP and AVP-D.

The results of this study aim to demonstrate if mannitol infusion has the potential to be used as an alternative to hypertonic saline infusion.

Eligibility Criteria:
Inclusion Criteria:

Part 1: Proof of Concept in Healthy adults

* Age ≥ 18 years
* Healthy with no medication except hormonal contraception

Part 2: Pilot Study in Patients with primary polydipsia (PP) or arginine vasopressin deficiency (AVP-D)

* Age ≥ 18 years
* Evidence of polyuria \> 40-50 ml/kg body weight per 24 hours and polydipsia \> 3 Liter per 24 hours or regular desmopressin medication corresponding to a diagnosis of PP or AVP-D

Exclusion Criteria:

Part 1: Proof of Concept in Healthy adults

* Participation in a trial with investigational drugs within 30 days
* Evidence of disordered drinking habits and diuresis defined as polyuria \> 40-50 ml/kg body weight per 24 hours and polydipsia \> 3 Liter per 24 hours.
* Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1,73 m2
* Glucose \> 11.1 mmol/L corresponding to the diagnosis of an uncontrolled diabetes mellitus
* History of urinary tract obstruction
* Problems with urination
* Pregnancy or breastfeeding
* Multiple allergies (≥ 3)
* Evidence of acute illness

Part 2: Pilot Study in Patients with PP or AVP-D

* Participation in a trial with investigational drugs within 30 days
* Pregnancy or breastfeeding
* Evidence of acute illness
* eGFR \< 60 ml/min/1,73 m2
* Glucose \> 11.1 mmol/L corresponding to the diagnosis of uncontrolled diabetes mellitus
* History of urinary tract obstruction
* Problems with urination
* Therapy with diuretics
* Multiple allergies (≥ 3)
Study to Assess the Effect of AZD4831 on the Pharmacokinetics (Drug Behavior in the Body) of Midazolam

The study is an open-label, fixed-sequence, cross-over study conducted at a single Clinical Unit to assess the pharmacokinetics (PK) of midazolam in healthy male and female (non-childbearing potential) subjects when administered alone and in combination with AZD4831 after multiple doses (once daily) of AZD4831 for 10 consecutive days.

The study will consist of 2 treatment periods and will comprise:

* A Screening period of maximum 28 days;
* Treatment Period 1 and Treatment Period 2:

Treatment Period 1: Midazolam only (Day 1). Treatment Period 2: AZD4831 only (Days 2 to 10, once daily dosing) and AZD4831 plus midazolam (Day 11).

- A final Follow-up Visit after the last administration of investigational medicinal product (IMP) (Day 20 \[± 1 day\]).

Each subject will be involved in the study for approximately 7 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects with suitable veins for cannulation or repeated venepuncture.
* Males must be willing to use appropriate contraception methods.
* Females must not be lactating and must be of non-childbearing potential, confirmed at Screening.
* Have a body mass index between 18.5 and 30 kg/m\^2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive) at Screening.

Exclusion Criteria:

* History of any clinically significant disease or disorder.
* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* A positive Corona Virus Disease 2019 test at Screening or admission to the Clinical Unit on Day -1.
* Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results.
* Any clinically significant abnormal findings in vital signs.
* clinically significant abnormalities on 12-lead electrocardiogram.
* Any positive result at the Screening Visit for Hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
* Known or suspected history of drug abuse in the last 2 years.
* Current smokers or those who have smoked or used nicotine products within the 3 months prior to the Screening Visit.
* Known or suspected history of alcohol or drug abuse.
* Use of any prescribed or non-prescribed medication.
* Subjects with acute pulmonary insufficiency, marked neuromuscular respiratory weakness, obsessional states, phobic states, sleep apnoea syndrome, or unstable myasthenia gravis.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigatoror history of hypersensitivity to drugs with a similar chemical structure or class to AZD4831 or midazolam.
* History or ongoing allergy/hypersensitivity to drugs(including but not limited to rash, angioedema, acute urticaria).
* Subjects who, in the opinion of the Investigator, have any clinically significant skin condition.
Improvement in Endothelial Dysfunction After Initiation of Anti-arrhythmic Therapy in Atrial Fibrillation Patients

This is a prospective, observational study that will examine endothelial dysfunction in atrial fibrillation before and after treatment with anti-arrhythmic agents and the extent to which baseline endothelial dysfunction improves after treatment.

This will be a prospective, observational study and roughly 60 patients will be recruited based on strict inclusion/exclusion criteria. Goal population includes adult patients with a diagnosis of paroxysmal or persistent atrial fibrillation seen in the electrophysiology clinic and admitted to the UPMC Presbyterian electrophysiology service for initiation of anti-arrhythmic medications.

The primary goal of the study will be to evaluate the degree of endothelial function recovery seen after initiating anti-arrhythmic medical therapy. We will assess genetic markers, arterial stiffness and vasodilation in response to acetylcholine iontophoresis, nitroprusside iontophoresis, local thermal hyperemia and reactive hyperemia. Laser speckle contrast imaging will be employed to evaluate the microvasculature. SphygmoCor (arterial tonometry) will be used to assess macrovasculature. Testing will be performed at baseline prior to the 1st dose of anti- arrhythmic therapy and repeated again 1-3 months later at outpatient follow-up visit. Additionally, follow-up phone calls or office visits will take place at 6 and 12 months after the initial data collection visit to document recurrence rate of atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-75 years of age) with paroxysmal or persistent atrial fibrillation
* Patients who recovered from prior tachycardia induced cardiomyopathy will be allowed to enroll in the study.

Exclusion Criteria:

Exclusion criteria will include:

* age \>75 years
* history of cardiomyopathy
* history of severe cardiac valvular disease
* history of coronary artery disease
* pulmonary artery hypertension
* congenital heart disease
* history of stroke
* chronic hypoxia
* recent worsening or flare up of obstructive or restrictive lung disease
* liver cirrhosis
* stage three or worse chronic kidney disease
* any major trauma or surgery within the preceding 3 months
* uncontrolled hyperthyroidism
* uncontrolled hypertension
* uncontrolled diabetes mellitus
* active malignancy
* poorly controlled connective tissue disease
* any acute or chronic inflammatory or infectious disease
* Patients who are already on class I or class III antiarrhythmic agents will be excluded from the study
* Patients on non-dihydropyridine calcium channel blockers and beta blockers will not be excluded from the study, as these agents are not considered anti-arrhythmics and are not hypothesized to affect endothelial function.
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months


Eligibility Criteria:
Inclusion Criteria:

* History of gout
* Occurrence of ≥ 2 self-reported gout flares in the last 12 months
* Body weight no less than 50 kg
* Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL
* Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
* Serum creatinine must be \< 3.0 mg/dL and estimated CLcr ≥ 30 mL/min

Exclusion Criteria:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* Pregnant or breastfeeding
* History of symptomatic kidney stones within the past 6 months
Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis

This is an add-on, randomized, open label, clinical trial that evaluates the use of quadriceps electrostimulation as an additional retraining procedure in patients suffering from cystic fibrosis.

Cystic fibrosis is an autosomal recessive genetic disease due to a mutation of the CFTR protein gene. The CFTR protein transports chloride ions (Cl-) across cell membranes in the lungs, pancreas, digestive tract, reproductive tract, and skin.

CFTR mutation mainly leads to a dysfunction of the pulmonary system and pancreas exocrine function.

Several studies showed that cystic fibrosis commonly induces a reduction of effort tolerance, peripheral muscular strength and work capacity.

Patients suffering from cystic fibrosis with a high endurance capacity have a lower risk of poor prognosis. Those with a severe dyspnea have a higher benefit with a force training or a combined force and endurance training than with endurance training alone.

We propose to study the effect of a quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer, in patients with cystic fibrosis associated with severe pulmonary dysfunction, to enhance their muscular performance and increase their adherence to the cycloergometer retraining program.

This is a randomized trial with two groups:

Group A: experimental group, twenty patients. Six weeks with electrostimulation program followed by six weeks under a cycloergometer program.

Group B: control group, twenty patients. Six weeks with their usual physical activity followed by six weeks with a cycloergometer program.

The Randomization is stratified on expiratory volume per second. The size of randomization blocks is random because of the open design.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Patient suffering from cystic fibrosis
* Patient has at least three measures of maximum expiratory volume per second \<= 45% of the theory among the 6 last measures performed
* Affiliation to French social security
* Capacity to consent

Exclusion Criteria:

* Pregnant women
* Contraindication to application of magnetic field
* Pacemaker
* History of neurosurgical intervention
* Presence of metallic particles near the stimulation site.
Accuracy of Dental Movements Using Clear Aligners Treatment: a Single-center Prospective Observational Study

The aim of the present prospective observational study is to evaluate the accuracy of dental movements in the three planes of space, assessing the correspondence between the virtual planned movements and the clinical outcomes achieved using thermoformed or 3D printed orthodontic aligners. The study will include patients who are candidates for aligner orthodontics treatment. After having acquired the standard initial diagnostic data (clinical examination, intra- and extra-oral photographs, intra- and extra-oral scans, orthopantomography and lateral-lateral teleradiography of the skull), the digital impressions of the arches will be used to plan the dental movements necessary for correction of malocclusion.

The aligners will then be designed using orthodontic CAD software and realized using a thermoformed and direct 3D printing process.

All patients will be treated following current recommendations relating to the orthodontic treatments in question. After delivery of the aligners, during each check-up, intra-oral and extra-oral scans will be acquired to evaluate the actual position of the teeth and, using special software will be compare the virtually designed position with tooth with the clinical outcomes. Any discrepancies will be recorded and statistically analyzed.There are no additional invasive procedures. Intra- and extra-oral scans will be acquired regularly to monitor the extent of tooth movement over time.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 65 years
2. Good general health
3. Presence of a dental/skeletal malocclusion
4. Permanent dentition with second molars completely erupted in the arch
5. Correct tooth shape, with sufficient height of the clinical crowns
6. Good compliance during treatment

Exclusion Criteria:

1. Systemic diseases or pharmacological therapy with drugs that can affect orthodontic movement
2. Orofacial malformations or syndromes
3. Periodontal disease
4. Smoke
5. Pregnancy
6. Signs and/or symptoms of temporomandibular disorders
7. Absence of teeth (except for third molars)
8. Dental Implants
Periodontal Infection and Systemic Inflammation in Renal Patients

The purpose of this study is to examine the role of gum disease in affecting the long term prognosis of renal patients. This disease if untreated causes inflammatory response throughout the body. If the subject has gum disease, he/she will be randomly assigned to one of the two treatment groups. The study investigates what happens to inflammatory markers in blood and saliva after you are treated for gum disease.

The main goal of this project was to explore the contribution of chronic periodontitis to systemic inflammation in Chronic Kidney Disease (CKD). To achieve this goal, the project had two specific objectives:

1. a) To compare the prevalence of periodontal infection between CKD and non-CKD populations and b) to explore the association between the presence of periodontal infection and the uremic status of CKD patients.
2. a) To assess the levels of systemic inflammatory markers, IL-6 and CRP in the presence or absence of periodontal infection in CKD and b) to compare the serum IL-6 and CRP levels in response to periodontal intervention.

Eligibility Criteria:
Inclusion Criteria:

* dental subjects with periodontitis,
* at least 10 teeth
* no periodontal (gum) treatment for the last year,
* no antibiotic for the last 4 months,
* no vascular access infection.

Exclusion Criteria:

* smokers
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography

The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects participating in prior FMSU protocol with known clinical status

Exclusion Criteria:

* Subjects with unkown clinical status
* Subjects not truthed in prior FMSU study