cyrilzakka/clinical-trials huggingface dataset:
Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France

The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France

This is a multicenter, observational and non-interventional study in PMO patients who receive Prolia® (60 mg subcutaneous \[SC\]) in France. Patients in the study will be enrolled in 2 waves, each targeting specific aspects of the overall study objectives. The first wave will enroll approximately 500 patients who will be followed for approximately 30 months from the first injection. Patients enrolled in this wave will provide descriptive data on persistence to Prolia® as well as a description of the characteristics of patients being prescribed Prolia®, information regarding Prolia® prescription and administration, procedures pertaining to Prolia® and safety.

The second wave will enroll approximately 250 patients and will only provide a cross-sectional description of the characteristics of patients being prescribed Prolia.

Around 2000 specialists in rheumatology and 9000 general practitioners will be randomly selected from a list of rheumatologists whether in hospital or private practice nationwide and a list of general practitioners managing patients with osteoporosis.

In all, 300 physicians initially interested to participate are expected, from which about 180 physicians will be qualified to participate. One-hundred and ten physicians will be initiated.

There are no procedures or changes to the routine clinical management of patients participating in the study. Baseline characteristics will be described for patients enrolling in both waves 1 and 2. Patients enrolling in wave 1 will be followed for approximately 30 months from the date of first injection in the study. It is anticipated that patients will return to the site. Clinical information obtained for routine clinical practice will be recorded where available, including Prolia administration, previous and current therapies, medical history (including fracture), ADRs, SADRs and co-morbidities.The study is descriptive in nature, and no formal hypothesis will be tested. In general, data summaries will be presented by wave and by subgroups of interest.

Eligibility Criteria:
Inclusion Criteria:

* post menopausal osteoporosis women in whom a decision has been made to treat with Prolia in the last 4 weeks
* received their first prescription of Prolia in the last 4 weeks
* patient has provided informed consent before enrolling in the study

Exclusion Criteria:

* patients participating in ongoing or previous Denosumab clinical trials
Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders

Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.

The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will treat those participants no worse than when compared to its predecessor device, the BiPAP autoSV Advanced™, with respect to:

• Apnea-Hypopnea Index (AHI)

Eligibility Criteria:
Inclusion Criteria:

* Age 21-80
* Ability to provide consent
* Documentation of medical stability by investigator
* Subjects who currently have been on Positive Airway Pressure (PAP) therapy for ≥ 4 weeks and who previously had a Continuous Positive Airway Pressure (CPAP) titration with CAI ≥ 5.

OR Subjects who currently have been on PAP therapy for ≥ 4 weeks and who had a diagnostic study done, with a CAI ≥ 5, and were prescribed PAP therapy without a CPAP titration.

* Agreement to undergo a full-night, in-lab research CPAP Titration
* Agreement to undergo two full-night, in-lab therapy research Polysomnography (PSG) on BiPAP autoSV devices

Exclusion Criteria:

* Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease, neuromuscular disease, daytime hypercapnia, cancer, or renal failure.
* Systolic blood pressure \< 80 mm Hg at Baseline Visit.
* Participants in whom PAP therapy is otherwise medically contraindicated.
* Participants who are unwilling to wear CPAP
* Currently prescribed oxygen therapy (as needed, nocturnal, or continuous
* Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
* Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
* Participants with untreated, non-obstructive Sleep Apnea (OSA)/ Complex Sleep Apnea (CSA) sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index \> 15).
Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1

The primary objective of this study was to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession (MAGR) in recession type one (RT1)

this study was conducted to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession

Eligibility Criteria:
Inclusion Criteria:

* Presence of RT1 GRs of the maxillary or mandibular arch in the esthetic zone with a GR depth ≥2 mm,
* patients \>18 years old,
* Full mouth plaque index score \<20%
* Systemically and periodontally healthy patients.

Exclusion Criteria:

* Smokers
* Patients with periodontitis stage III and IV were previous surgical treatment of GR,
* Pregnant or breastfeeding women; P
* Patients with para-functional habits or any source of occlusal trauma.
Bioequivalency Study of Zidovudine Under Fed Conditions

The objective of this study was to assess the bioequivalence of Roxane's zidovudine 300 mg tablet compared to GlaxoSmithKline's Retrovir® 300 mg tablet under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Participation in a clinical trial within 30 days prior to study initiation.
* Positive blood screen for HIV or Hepatitis B and C.
* History of allergic or adverse responses to zidovudine.
Surgiscreen Registration

The purpose of this study is to assess the consistency of the results of irregular antibody screening with Surgiscreen （investigational reagent) and Serascan Diana 3 (control reagent), and the consistency of the results of irregular antibody screening with investigational reagent on serum and plasma from same patients.


Eligibility Criteria:
Inclusion Criteria:

* Serum or plasma samples left after routine clinical testing;
* Blood sample of the same day, or blood samples stored at 2-8°C for 3 days after collection, or serum or plasma samples stored at -20°C for those separated 3 days after collection.

Exclusion Criteria:

* Samples with severe hemolysis, jaundice or chyle-like samples;
* Small sample size insufficient for completing the testing;
* Samples not collected and processed upon the requirements of the instructions.
LongVentKids Study

Scientific advances, population growth, lower mortality, and increasing complexity of diseases have boosted up the number of patients requiring prolonged breathing assistance with mechanical ventilators in the pediatric intensive care units (PICU) in many parts of the developed world. Previous studies also suggest that there is a small group of children who actually need such a high level of support for extended periods of time, utilizing a lot of human and technical resources. We defined children with prolonged mechanical ventilation (PMV) if they required supports with a breathing machine for more than 14 days. We propose an international point prevalence study of children requiring PMV in PICU. We will conduct the study in multiple centers in several different regions, including North and South America, Europe, and Asian countries, with a strong relationship with local physician colleagues. Practice for patients requiring PMV will be examined including the type and size of local PICU, admission and discharge policies, and patient and treatment modalities administered to such patients, types of professionals looking after patients in PMV, types of health care. We anticipate a high variability in practices suggesting a need to further standardize the management of PMV.. Specifically, as an immediate consequence, by comparing and understanding the differences in patient demographics, practice details among PICUs in regards to the background factors of local PICUs and their patients, practitioners will share their way of dealing with such patients. In that way, this study will support the need to generate guidelines and lead to patient care improvement in PICUs.


Eligibility Criteria:
Inclusion Criteria:

Patients who are ventilated \>14 consecutive days (after 37 weeks postmenstrual post-conception age)\*

* including for more than 6 hours per day including on InMV and NIV duration
* patient who have had and short interruptions (\<48hours) of ventilation during the weaning process as the same episode of ventilation can be included.
* InMV can be administered through an endotracheal tube or a tracheostomy tube.
* NIV can be managed through a nasal, full-face, total facial mask, or helmet.
* Patient on HFNC will be included as on respiratory support if they have a proper or a nasal cannula (that allows \>=1 liters/kg/min (LPM) and \>4LPM).
* We define nasal oxygen supply \<1 L/kg/min as non-NIV practice.

Exclusion Criteria:

* Age \>18 years
* Already included in this study
* No consent if required
* Brain death
* Premature children not yet at 37 weeks gestational age.
PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Patients with SNF3 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate efficacy of PARP inhibitor in SNF3 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Eligibility Criteria:
Inclusion Criteria:

* Females ≥18 years and ≤ 75 years old;
* Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER\> 10% tumor cell positive is defined as ER positive, PR\> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
* Subtype of similarity network fusion-3 (SNF-3) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
* Has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /L; platelet count \> 75x10ˆ9 /L, hemoglobin \> 9g/dL;
* Patients had received no previous chemotherapy or targeted therapy for metastatic disease
* Has adequate liver function and kidney function: serum creatinine
* ECOG score ≤ 2 and life expectancy ≥ 3 months;
* Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.

Exclusion Criteria:

* Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
* Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
* Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
* is pregnant or breast feeding;
* Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
Mindfulness-Based Cognitive Behavior Therapy for Bipolar Disorder

The purpose of the study is to investigate the efficacy of mindfulness-based cognitive-behavior therapy (MBCT) for improvement of symptoms associated with bipolar disorder, by comparing MBCT to supportive psychotherapy. Patients who participate in this study will be randomly assigned to receive either

1. state of the art group MBCT, or
2. supportive group psychotherapy (which is considered part of the standard care available to patients at MGH).

We will conduct a randomized controlled trial of group MBCT (n=30) vs. SP (n=30) and compare the benefits and durability of MBCT vs. SP for decreasing symptoms in DSM-IV bipolar individuals over a 12-week period adjunctive to mood stabilizing medications coupled with individual-therapy sessions. We will also conduct follow-up assessments at 3, 6, 9, and 12 months after the active phase of the study. Subjects in the MBCT group will receive group therapy sessions of standardized yoga-meditation based exercises enhanced by psychoeducation and relapse prevention for bipolar disorder. Subjects in the SP group will receive support for coping with the symptoms of bipolar disorder, as well as psychoeducation about bipolar disorder. The focus of SP is on reflecting and expressing feelings about current life issues. Patients are supported and comforted when coping with difficult situations, depression, mood swings, or anger. We will assess mood, cognitive and psychosocial functioning before and after treatment for participants in both groups. Finally, we will investigate the functional neuroanatomy associated with memory impairment, attention, and mindful breathing in subjects with bipolar disorder as a predictor of treatment response using functional Magnetic Resonance Imaging (fMRI).

Eligibility Criteria:
Inclusion Criteria:

* MINI diagnostic criteria for any bipolar disorder (type I, type II, and NOS)
* Written informed consent
* Men or women aged 18-65
* No episodes of mania in the previous 4 weeks.
* Able to read and understand English.

Exclusion Criteria:

* Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
* History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc).
* History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
* Patients who have untreated hypothyroidism.
* Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment.
The Role of Renal Progenitors and Polyploid Tubular Cell Response in Glomerular and Tubular Diseases

Renal progenitors are a subset of parietal epithelial cells (PECs) localized at the urinary pole of Bowman's capsule. Experimental models of podocyte damage showed that PECs can potentially regenerate lost podocytes by migrating from Bowman's capsule to the glomerular tuft, acquiring the morphological and functional features of mature podocytes. Podocyte loss and damage, as well as the inability of PECs to replace lost podocytes, lead to glomerular scarring and chronic kidney disease (CKD) progression.

In addition, the investigators of the present study and others have recently demonstrated the existence of a specific subpopulation of tubular cells in the human kidney with a high potential for regeneration and resistance to death, thus acting as tubular progenitors. These cells are involved in tubular response to damage during acute kidney injury (AKI) trough endoreplication (polyploidization).

Kidney biopsy is the cornerstone of diagnosis in many kidney diseases leading to CKD and AKI, allowing unambiguous diagnosis in some cases and presumptive diagnosis of ongoing disease in others. Very recently, super resolution imaging techniques proved to maintain current diagnostic standards while allowing to study morphological features of pathophysiological mechanisms of glomerular and tubular diseases.

The rationale of this project is to study the role of renal progenitors (PECs and tubular progenitors) in the pathogenesis of CKD and AKI trough super resolution imaging applied to human renal biopsies, to the aim of identifying relevant connections with clinical data and markers of damage and/or disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients with glomerular diseases undergoing renal biopsy (e.g., rapidly progressive glomerulonephritis, minimal change disease, focal segmental glomerulosclerosis, diabetic nephropathy, lupus nephritis, membranous nephropathy, IgA nephropathy, etc)
* Patients with AKI, regardless of the nature of the damage (septal, ischemic, toxic, or unknown).
* Signed informed consent form

Exclusion Criteria:

* Sample insufficient and/or unavailable
Effects of Buprenorphine and Naloxone in Opiate Addicts - 4

The purpose of this study is to evaluate the behavioral and physiological effects of buprenorphine and naloxone, both alone and in combination.


Eligibility Criteria:
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Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.

The primary objective of the study is to determine whether a Medication Event Monitoring System (MEMS®) cap with a liquid crystal display (LCD) reader (a "smart" cap) along with additional patient counseling intervention (Arm 3) can improve adherence to dimethyl fumarate (DMF) treatment in Multiple Sclerosis (MS) patients as compared to a MEMS cap without an LCD reader (a "standard" cap) and no patient counseling intervention (standard of care, Arm 1) at Month 12.

The secondary objectives of this study in this study population are: to determine if data display on a smart MEMS cap with an LCD reader (Arm 2) can improve adherence as compared to a standard MEMS cap without an LCD reader (Arm 1) at Month 12; to determine whether the addition of patient counseling intervention based on MEMS data (Arm 3), or data display from a MEMS cap with an LCD reader (Arm 2) can improve adherence compared to standard MEMS cap without an LCD reader (Arm 1) at Month 6; to assess persistence and compliance at Months 6 and 12 for all arms; to assess the association between adherence and patient- reported outcomes (PROs) for all arms including Multiple Sclerosis Impact Scale (MSIS-29), and the Work Productivity and Activity Impairment Questionnaire (WPAI): MS v2.0.


Eligibility Criteria:
Key Inclusion Criteria:

* The candidate is a DMF-naïve patient
* Have a diagnosis of relapsing forms of MS and satisfy the approved therapeutic indication for DMF
* Have a recent (i.e., within the previous 6 months) complete blood count with results that do not preclude the patient's participation in the study, in the judgment of the Investigator

Key Exclusion Criteria:

* Have comorbid conditions that preclude participation in the study, as determined by the Investigator
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity
* Are participating, planning to participate, or have participated in the Tecfidera QuickStart Program

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care

This observational cross-sectional study will assess the impact of hypothyroidism on tear production and tear film stability. Conducted at DHQ Hospital dera ghazi khan over six months, the study will recruit 71 participants aged 20-60 years using a non-probability convenience sampling method. Patients with confirmed hypothyroidism will undergo tear assessment through the Schirmer I test, Tear Breakup Time (TBUT) test, and Ocular Surface Disease Index (OSDI) questionnaire. The Schirmer test will measure tear production, while TBUT will assess tear film stability.

Ocular surface staining and tear osmolarity will further evaluate ocular health. Patients with systemic conditions affecting tear production, such as diabetes or rheumatoid arthritis, will be excluded. The collected data will be analyzed to determine the relationship between hypothyroidism and dry eye symptoms, aiding in better management of ocular health in hypothyroid patients. The study aims to provide valuable insights into the association between thyroid dysfunction and tear film abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-60 years.
* Confirmed diagnosis of hypothyroidism with thyroid function tests.
* No prior history of ocular surgery or significant ocular pathology.

Exclusion Criteria:

* Use of systemic medications affecting tear production (e.g., antihistamines, diuretics).
* Other systemic conditions (e.g., diabetes, rheumatoid arthritis).
* Pregnancy or lactation
Probiotic S. Salivarius K12 for the Prevention of Upper Respiratory Tract Infection in Nursery-age Children

The purpose of this retrospective study is to assess the treatment benefits of probiotic Streptococcus salivarius K12 for the prevention of recurrent bacterial and viral infections of the pharynx, tonsils and ears in children under 3 years of age.

Recurrent bacterial and viral infections of the pharynx, tonsils and ears are a problem that can affect children of all ages. The persistence of these infections can lead to an overuse of drugs such as antibiotics, antipyretics and anti-inflammatories, with the possible consequent presence of side effects and above all an increase in antibiotic resistance, a global public health issue.

In search at reducing the use of antibiotics and antivirals, there is currently a great scientific interest in probiotic therapies for the oral cavity infection.

The aim of this retrospective, controlled, multicenter, non-profit study is to evaluate the efficacy and safety of the administration of Streptococcus salivarius K12 in pediatric patients attending the 1st or 2nd year of nursery school (\< 3 years of age ), in the prophylaxis of the most common bacterial or viral respiratory infections, assessing the consequent reduction in the use of antibiotics, antivirals or other therapies compared to children.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children attending the 1st or 2nd year of nursery (under aged 3 years)
* Treated with probiotic Streptococcus salivarius K12 (1 billion CFU) for 90 continuous days
* Children not treated with probiotic Streptococcus salivarius K12

Exclusion Criteria:

* Children with underlying health condition