cyrilzakka/clinical-trials huggingface dataset:
An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology

The I-FILE study is a prospective multicenter, multinational observational study where the feasibility of a patient-led registry using home monitoring in patients with pulmonary fibrosis will be evaluated. The aim of the study is to gain more insights in disease behavior in patients with pulmonary fibrosis, so in future patients with progressive disease can be better identified.

Nowadays, identifying disease progression will have direct treatment implications in patients with fibrotic Interstitial lung diseases (F-ILDs). eHealth could be a possible solution for close monitoring and detecting disease progression, at a low burden for patients and healthcare providers. The main aim of the I-FILE study will be to evaluate feasibility of a patient-led registry using home spirometry to monitor disease progression in patients with F-ILD. The secondary aim will be to better validate existing health-related quality of life questionnaires to assess the impact of disease and treatment in these patients.

In total 500 patients with newly diagnosed F-ILD will be included. Patients will perform daily home spirometry in the first three months followed by once weekly measurements with a follow up period of 2 years. In addition, patient-reported outcomes (PROMs) will be completed online every 6 months. Results are encrypted and directly sent to a secured server through the online I-FILE application.

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed patients with F-ILD according to the ATS/ERS criteria by a multidisciplinary ILD team :

* MDT diagnosis ≤ 6 months before inclusion
* Treatment for F-ILD ≤ than 1 month

Exclusion Criteria:

* Not able to speak, read or write in the native language of the country where the patient is included
* Not able to comply to the study protocol, according to the judgement of the investigator and/or patient
* No access to internet
Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination

The objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Reside in a rural area
* No previous dose of a SARS-CoV-2 vaccine
* Speak English
* Able to provide informed consent

Exclusion Criteria:

* A cognitive or other disability that inhibits smart phone use
* Inability to participate because of medical or psychiatric conditions diagnosed by a physician/clinician
* Enrollment in other COVID-19 research; pregnant or lactating
Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain

The purpose of this study is to determine whether rESWT (radial extracorporeal shock wave therapy) combined with supervised exercises will improve function and reduce pain in subacromial shoulder pain compared with supervised exercises alone.


Eligibility Criteria:
Inclusion Criteria:

* Dysfunction or pain on abduction
* Pain on one of two isometric tests (abduction or external rotation)
* Positive Hawkins sign
* Normal passive glenohumeral range of motion

Exclusion Criteria:

* Previous surgery on affected shoulder
* Instability
* Total rupture of the rotator cuff (evaluated clinically or by US)
* Clinical signs of a cervical syndrome
* Infection in the area
* Exclusion criteria cont.
* Patients considered unable to fill out questionnaires or to go through the treatment
* Use of anticoagulant drugs or bleeding disorder
* Pregnancy
* Previous experience of one of the study interventions
* Corticosteroid injection in the past 6 weeks.
* SPADI \< 20
Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens

The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Men and women ≥18 years of age
* Patients with histologically or cytologically documented squamous cell nonsmall-cell lung cancer who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation for locally advanced disease
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Disease progression or recurrence after both a platinum doublet-based chemotherapy regimen and at least 1 additional systemic therapy
* Measurable disease by computed tomography scan/magnetic resonance imaging as per Response Evaluation Criteria in Solid Tumors, volume 1.1

Exclusion Criteria:

* Untreated central nervous system (CNS) metastases. Metastases have been treated and patients neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, patients must have stopped taking corticosteroids or be taking a stable or decreasing dose of ≤10 mg prednisone daily (or equivalent)
* Carcinomatous meningitis
* Active known or suspected autoimmune disease or interstitial lung disease
* Prior treatment on either arm of study CA209-017 or CA184-104
* Prior therapy with anti-Programmed death-1 (anti-PD-1), anti-Programmed cell death ligand 1 (anti-PD-L1), anti-Programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
* A condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug
Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis

Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This close relationship between both diseases is characterized by mutual influence. The presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients.

Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2030, 439 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2011). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetes patients. Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients. Therefore, the aim of the present study is to investigate the effectiveness of antimicrobial photodynamic therapy as adjunct to full-mouth debridement for the treatment of periodontitis in type 2 diabetic patients through a split-mouth randomized triple-blind clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 DM for ≥5 years
* DM treatment with oral hypoglycemic agents or insulin supplementation and diet
* glycated hemoglobin (HbA1c) levels from 6.5% to 11%
* at least 15 teeth (excluding third molars and teeth indicated for extraction)
* moderate to severe generalized chronic periodontitis (Armitage, 1999)
* agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).

Exclusion Criteria:

* medical conditions that required prophylactic antimicrobial coverage
* SRP in the previous 6 months
* antimicrobial therapies in the previous 6 months
* anti-inflammatory therapies in the previous 6 months
* systemic conditions, other than DM, that could affect the progression of chronic periodontitis
* current use of medication that could interfere with periodontal response to treatment
* pregnancy or lactation
* smoking
Availability of Lipid Emulsion to Regional Anesthesia Programs at US Academic Anesthesia Departments

Significant data exists to suggest that lipid emulsion administration in the setting of local anesthetic toxicity has the potential to be life-saving. Unfortunately, a variety of potential barriers exist to routine lipid emulsion administration for those performing regional anesthesia including drug availability, drug cost and drug location. Inadequate training or lack of established protocols also have the potential to negatively impact patient outcomes. A previous study by Toledo et al (Availability of lipid emulsion in United States obstetric units. Anesth Analg 2013;116:406-408.) evaluated lipid emulsion availability on obstetric units and found that it was nearly universally available.

The Accreditation Council for Graduate Medical Education (ACGME) publishes a list of contact information for each anesthesia institution that engages in resident training. Investigators will contact these institutions by phone or email to obtain contact information for their regional anesthesia program director. In the absence of a program director, investigators will send a survey and consent information via email to the faculty physician most involved in regional anesthesia. Survey completion instructions (survey itself to be completed on Qualtrics Survey Hosting Service) and copy of the study consent form will be attached to the initial contact email. The study consent form will contain a description of the study itself. Survey participants will be allowed time to complete their survey in private at their discretion. Non-responders will receive two follow-up emails at one month intervals.


Eligibility Criteria:
Inclusion Criteria:

* Regional Anesthesia Section heads at academic anesthesia institutions.
Investigation of Anthropometric Properties of Babies With Craniosynostosis

Craniosynostosis is a malformation affecting the head and face, in which one or more sutures in the skull are fused prematurely. Premature union of one or more sutures causes changes in the shape of the skull base and dome, resulting in asymmetrical or restricted head and facial enlargement. It has been reported that in craniosynostosis, the bone enlargement is perpendicular to the fused sutures with the counterbalancing expansion. Craniosynostosis usually involves the union of a single cranial suture, but in some cases it has been observed that it may involve more than one suture in the baby's skull. An asymmetrical appearance is observed on the faces of babies, especially an unusual appearance in the form of eyes and skulls. It may present with neurological defects such as hydrocephalus, mental retardation, vision and hearing loss, as well as cosmetic deformities in the skull and facial bones. The general prevalence of craniosynostosis is around 1/2500 births. Generally, in single suture synostoses, there is no clear neurological finding except deformity. In multisuture synostoses there are a wide spectrum of findings such as increased intracranial pressure, hydrocephalus, syringomyelia, Chiari malformation, venous anomalies, ophthalmologic problems, growth retardation and epilepsy. Early diagnosis and treatment provides enough room for the baby's brain to grow and develop. It is thought that by measuring the anthropometric properties of these babies, the course of their development will be examined.

Babies diagnosed with craniosynostosis at birth will be included in this study. The patients will be diagnosed using a combination of physical examination, skull radiographs and 3 dimensional computerized tomography scans.A voluntary consent form will be signed by the parents of all subjects indicating that they are willing to participate in the study. Anthropometric measurements of all subjects will be measured with the Star Scanner device.

Eligibility Criteria:
Inclusion Criteria:

* Being under 2 years old
* Being diagnosed with non-syndromic craniosynostosis
* Agreeing to participate in the study

Exclusion Criteria:

* Having a craniomaxillofacial fracture
* Having a history of surgery
* Having a congenital anomaly that affects growth or development
Combining Data Sources to Identify Effect Moderation for Personalized Mental Health

This work will extend and apply methods for modeling heterogeneous treatment effects when multiple studies are available, with a particular focus on the complexities in mental health research. The methods will be illustrated in examples estimating the effects of medical treatments for major depressive disorder (duloxetine and vortioxetine) using 4 randomized controlled trials (available in the Vivli trials resource) and non-experimental data from the Duke University Health System electronic health record and the Johns Hopkins Health System electronic health record systems.


Eligibility Criteria:
Duke University Health System Electronic Health Record (EHR) System and Johns Hopkins Health System EHR System

Inclusion criteria:

* All patients prescribed any Duloxetine or Vortioxetine in the health systems between 01/01/2015 - 12/31/2021.
* AND from patients with at least 1-year historical EHR data (burn-in period) without prescribing any of the two medications. During the burn-in period, patients should have at least one encounter in the system, and with no encounters during that time frame when they were prescribed Duloxetine or Vortioxetine.
* AND patients age 18-65 years old at baseline.

Exclusion criteria:

- Patients prescribed both Duloxetine and Vortioxetine at baseline would be removed.

4 randomized controlled trials (RCTs)

Inclusion criteria:

* Male or female
* Age 18 years or older
* Major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) classification code 296.3x
* Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 26
* Clinical Global Impression - Severity (CGI-S) scale score ≥ 4
Safety and Efficacy Clinical Study of Severe Hemophilia B Treatment With KL001

This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL001 injection solution in hemophilia B subjects with ≤2 IU/dl residual FIX levels.

This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL001 injection solution in hemophilia B subjects with ≤2 IU/dl residual FIX levels. Nine subjects will be enrolled and administered with three different doses of KL001. Subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of KL001. All subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of KL001 for total 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Male ≥12 years of age.
2. Moderate/severe or severe hemophilia B (baseline FIX activity ≤2% of normal or documented history of FIX activity ≤2%).
3. At least 3 bleeding episodes per year that require on-demand treatment with FIX or are treated with a prophylactic regimen of FIX.
4. At least 100 days exposure history to recombinant or plasma-derived FIX protein products.
5. No neutralizing antibodies to exogenous FIX protein products.
6. Willing and able to comply with study procedures and requirements.

Exclusion Criteria:

1. Suffering from chronic inflammatory muscle disease.
2. Positive in Hepatitis B or Hepatitis C.
3. Infection with HIV-1 or HIV-2 and CD4+T cell count ≤ 200/ μ L.
4. History of thrombosis or susceptibility to thrombosis.
5. Current or previous participation in another gene therapy study.
6. Has any other significant medical condition that the investigator feels would be a risk to the subject or would impede the study.
Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients

The purpose of this study is to investigate the effect of decreasing fluid overload by hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease on intermittent hemodialysis. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.

Obstructive sleep disordered breathing is more prevalent in end stage kidney disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. Despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea, the pathophysiological mechanisms are poorly understood. Recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft and the severity of obstructive sleep apnea. This mechanism was demonstrated in otherwise healthy subjects, in heart failure patients, and in patients with venous insufficiency. We thus suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with hypervolemia, including chronic renal failure.

The purpose of this trial is to investigate the hypothesis that nocturnal rostral fluid ship is linked to overhydration and participates significantly to the severity of obstructive sleep apnea in patients on hemodialysis. The correction of overhydration by hemodialysis should therefore reduce the amount of nocturnally displaced water and consequently lower the severity of obstructive sleep apnea.

The severity of obstructive sleep apnea is measured by two consecutive attended polysomnographies, performed before and after an ambulatory hemodialysis session with fluid removal, whereas overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. The sequence of the two polysomnographies with respect to hemodialysis is randomized, to minimize the first-night effect.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe obstructive sleep apnea syndrome, with an apnea-hypopnea index (AHI) ≥ 15/h
* age ≥ 18 years
* patient with end stage renal disease on chronic intermittent hemodialysis

Exclusion criteria:

* unstable congestive heart failure
* pace-maker
* active psychiatric disease
* amputation of the lower limbs, proximal to the ankle
The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants.

Problems such as poor nutrition, weak sucking, lack of suck-swallow-respiration coordination, low weight gain are among the factors increasing the risk of morbidity in late preterm infants. Early support of sucking and swallowing muscles for the development of suck-swallow coordination can shorten the maturation process and provide early discharge of late preterm infants. The aim of this study is to document kinesiotape technique to support sucking and swallowing muscles for treating nutritional problems and for reducing nutrition risks and accelerating maturation. According to power of analysis of this study, 74 infants planned to assign to kinesiotaping group or control group randomly. In kinesiotaping group, infants feeding performance will be evaluated by measuring the amount of milk invested, maximum heart rate, oxygen saturation, speed of milk intake and counting the number of swallow during feeding. Kinesiotape will be applied to masseter and hyoid muscles 24 hours later after the birth of the infant. Infants will be evaluated before kinesiotape application, 3 hour later and 24 hour later after the application.


Eligibility Criteria:
Inclusion Criteria:

* Infants born in Baskent University Ankara Hospital, age between 34-36.6 weeks.

Exclusion Criteria:

* Infants with multiple kongenital anomaly, hypoxic ischemic encephalopathy, intraventricular and intracranial hemorrhage, necrotizing enterocolitis, tracheoesophageal fistula, diaphragmatic hernia, hydrocephalus, and respiratory distress.
Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee

The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the knee.

Exclusion Criteria:

* No disorders which could interfere with study required assessments.
Genetics and HIV-1 Protease Inhibitors

This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5 (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to people with the normal metabolizing genotype.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 55 years
* Negative HIV screening antibody test
* CYP3A5 expressor status, race, and sex fit an enrollment opening.

Exclusion Criteria:

* Pregnant or breast-feeding
* Medical history of

  * hepatitis B or C,
  * autoimmune disease,
  * active malignancy,
  * kidney disease including nephrolithiasis
* Organ dysfunction manifested by

  * liver transaminases or
  * serum creatinine \>1.25 times the upper limit of normal, or
  * any comprehensive metabolic test (except asymptomatic unconjugated hyperbilirubinemia), blood count, or lipid value \> Grade I according to Division of AIDS (DAIDS) adverse drug event grading system (appendix).
* Medical history of arrhythmias (including atrial fibrillation, atrioventricular block, and/or pacemaker)
* Any QT interval abnormalities or other congenital arrhythmia syndromes on ECG or

  * Any ECG abnormality that in the opinion of the investigators would preclude entry into the study.
* Medical history of any serious heart condition including:

  * congestive heart failure,
  * myopathies,
  * coronary artery disease, or
  * unexplained syncope.
* Medical history of bleeding disorders (i.e., hemophilia)
* Hyperlipidemia
* Any prescription, herbal, recreational, or over-the-counter medication contraindicated with ritonavir or atazanavir including:

  * substrates/inhibitors/inducers of CYP3A/P-gp,
  * cardio-active medication, or
  * medications that alter the acid in the stomach. The study investigators will review each concurrent medication on a case-by-case basis.
* Inability to refrain from grapefruit or grapefruit juice during the study.
* Investigational drugs within the last 30 days.
* Active alcohol / recreational drug abuse,
* Inability to give informed consent.
* A body mass index below 18.5 or above 34.