cyrilzakka/clinical-trials huggingface dataset:
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)

The primary objectives of the study are to:

* Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old
* Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers that reflect the status of phosphate homeostasis in children between 1 and 4 years old with XLH


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged ≥1 year and \<5 years
2. Diagnosis of XLH supported by ONE or more of the following

   * Confirmed phosphate regulating gene with homology to endopeptidases located on the X chromosome (PHEX) mutation in the patient or a directly related family member with appropriate X-linked inheritance
   * Serum fibroblast growth factor 23 (FGF23) level \> 30 pg/mL by Kainos assay
3. Biochemical findings associated with XLH including:

   * Serum phosphorus \< 3.0 mg/dL (0.97 mmol/L)
   * Serum creatinine within age-adjusted normal range
4. Radiographic evidence of rickets
5. Willing to provide access to prior medical records for the collection of historical growth, biochemical, and radiographic data and disease history
6. Provide written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures
7. Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule, and comply with the assessments

Exclusion Criteria:

1. Unwilling to stop treatment with oral phosphate and/or pharmacologic vitamin D metabolite or analog (e.g. calcitriol, alfacalcidol) during the screening period and for the duration of the study
2. Presence of nephrocalcinosis on renal ultrasound grade 4 based on the following scale: 0 = Normal, 1 = Faint hyperechogenic rim around the medullary pyramids, 2 = More intense echogenic rim with echoes faintly filling the entire pyramid, 3 = Uniformly intense echoes throughout the pyramid, 4 = Stone formation: solitary focus of echoes at the tip of the pyramid
3. Planned or recommended orthopedic surgery including staples, 8-plates or osteotomy, within the clinical trial period
4. Hypocalcemia or hypercalcemia, defined as serum calcium levels outside the age-adjusted normal limits
5. Presence or history of any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study
6. Presence of a concurrent disease or condition that would interfere with study participation or affect safety
7. History of recurrent infection or predisposition to infection, or of known immunodeficiency
8. Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Ability and willingness to adhere to study regimen
* Completed core study with assigned regimen;

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

* Severe hypercholesterolemia or hypertriglyceridemia.
* Low platelet count.
* Low white blood cell count.
* Positive test for human immunodeficiency virus (HIV).
* Systemic infection requiring active use of IV antibiotics.
* Patients in a critical care setting.
* Use of prohibited medication.
* Use of immunosuppressive agents not utilized in the protocol.
* Hypersensitivity to any of the study drugs or similar drugs.
* Pregnant or nursing (lactating) women
* Women of child-bearing potential not using a highly effective method of birth control.

Other protocol-defined inclusion/exclusion criteria may apply
A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
* At least 1 lesion accessible for biopsy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

* Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
* Participants with active, known or suspected autoimmune disease
* Participants with conditions requiring systemic treatment with either corticosteroids (\> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
* Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

Other protocol defined inclusion/exclusion criteria could apply
Lanadelumab for Treatment of COVID-19 Disease

So far little is very few drugs have demonstrated positive results for treatment of COVID19.

Recently the researchers have shown that the use of icatibant in COVID-19 results in a potent decrease in oxygen use. Yet the effect of the three dosages as according to the label dose was insufficient to maintain the clinical improvement in a small group of patients. The researchers argue that with the use of lanadelumab a more lasting effect can be reached due to its longer half life.


Eligibility Criteria:
Inclusion Criteria:

* Patient is SARS-COV2 positive (PCR)
* Without oxygen a saturation below 90%
* At least 3L/min oxygen dependent
* Patient is 16 years and older

Exclusion Criteria:

* Has previously participated in this study
* Acute myocardial or cerebral ischemic event at time of enrolment
* Receiving ACE or ARB inhibitor or comparable drugs that is specified as an intervention in this domain as a usual medication prior to this hospitalization will exclude a patient from receiving that agent
* A baseline alanine aminotransferase or an aspartate aminotransferase that is more than five times the upper limit of normal
* Patient is known hypersensitive to full human monoclonal antibodies
* Patient is pregnant or breast feeding
Yoga for Seniors

The overall purpose of this study is to deliver a 12-week yoga program to older adults (over 60 years of age) in rural WI who do not have access to yoga programming and examine the effects of the programming on activities of daily living, gait, balance, falls, activity level and social isolation.

Participants will be assigned to immediately begin a 12-week yoga class (2 classes per week for 75 minutes each) or complete a 12-week wait (wait-list control). The measures of interest will be examined at pretest (wait-list only), baseline, posttest and at 3-month follow-up to see what, if any, changes are maintained after completion of the program. All assessment data collections sessions will be conducted on-site at a predetermined site identified by the community partners.

Eligibility Criteria:
Inclusion Criteria:

* Ability to independently ambulate for at least 10 minutes continuously (with or without an assistive device)
* Ability to attend the yoga class for all or most of the 12 weeks
* A previous fall, near-fall or identified fear of falling

Exclusion Criteria:

* No known contraindication for exercise (i.e. a medical doctor has told you not to exercise)
* A resent injury that causes pain during movement
* Current enrollment in another research study or class focused on balance
Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease

The purpose of this study is to describe initiation and use of oxygen therapy among patients with fibrotic Interstitial Lung Disease (ILD) and to assess the impact of oxygen therapy on clinical outcomes among patients with fibrotic ILD.


Eligibility Criteria:
Inclusion criteria:

* ≥2 fibrosing Interstitial Lung Disease (ILD) diagnoses in any position on different dates of service, within 365 days of each other, and in the same continuous enrollment period during the patient identification period. The fibrosing ILD diagnosis date will be defined as the date of the first fibrosing ILD diagnosis. The two fibrosing ILD diagnosis codes can be one of the following combinations:
* 2 fibrosis codes
* 1 fibrosis code \& 1 ILD code that requires fibrosis code
* ≥18 years of age as of the fibrosing ILD diagnosis date
* Continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ILD diagnosis date (pre-ILD baseline period)

Exclusion criteria:

* Fibrosing ILD diagnosis in the 12-month pre-ILD baseline period
* Unknown gender, geographic region, or insurance type
Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery

The goal of this observational study is to learn about the changes in gene expression in blood immune cells in after cardiac surgery with cardiopulmonary bypass.The main question it aims to answer is: What specific gene expression changes predict kidney damage after cardiac surgery with cardiopulmonary bypass. Participants received conventional treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age≥ 18 years old; 2) Cardiopulmonary bypass descending valve replacement (molding), or coronary artery bypass grafting, or macrovascular surgery.

Exclusion Criteria:

* 1) any cognitive or mental impairment that is unable to sign the informed consent form; 2) Have basic immune system and blood system diseases; 3) pregnancy; 4) Receiving radiotherapy and chemotherapy before surgery; 5) Receiving immunosuppressive drugs within six months; 6) Have participated in other interventional clinical trials within 30 days before surgery.

Exit Criteria:

1. Incomplete surgery;
2. Secondary transfer in the operating room;
3. Automatically request to terminate the test.
Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness

This observational study will seek to describe the uses and safety and efficacy outcomes of treprostinil in clinical practice in patients with persistent pulmonary hypertension (PPHN).


Eligibility Criteria:
Inclusion Criteria:

1. Newborn infants who received at least one dose of IV or SC treprostinil as per clinical practice within 5 years from the moment of data collection.
2. Aged up to 44 weeks after conception at treprostinil initiation.
3. Pulmonary hypertension (PH) or suspicion of PH at the moment of treprostinil initiation.
4. Parent(s) or legally authorized representative(s) provides non-opposition consent for the patient participation in the study.
5. Newborn infants affiliated to French social security.

Exclusion Criteria:

* None.
Effect of Video Monitor Size on Adenoma Detection Rate

The goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor.

Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles River Plaza. The two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (NDS 26") used at this facility while the other room will have a larger video monitor (NDS 32"). The ADR achieved by each physician in each room will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit
* Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit

Exclusion Criteria:

* Refusal to participate
Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects with Dry Eye Disease

To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease

The purpose of the study is to demonstrate that a combination of DMSt and RF applied on the periocular skin below the lower eyelids improves eye blink quality in subjects with moderate to severe signs and symptoms of dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to read, understand and sign an Informed Consent Form (ICF)
* 22 or older
* Lower lid laxity, as clinically judged with lower lid DT and the snapback test
* Moderate to severe OSDI (larger or equal to 23)
* TBUT smaller or equal to 5 sec in both eyes

Exclusion Criteria:

* Abnormally high blink rate, as estimated by the study investigator
* Any ocular surgery or eyelid surgery, within 3 months prior to screening
* Blepharoptosis
* Moderate or Severe Floppy Lid Syndrome
* Corneal Dystrophy
* Exophthalmos
* Thyroid Eye Disease
* Ocular Chemical Injury or burn
* Limbal Stem Cell Deficiency
* Facial Nerve Palsy
* Blepharospasm
* Hemifacial Spasm
* Corneal neuropathy
* Pregnant or nursing women
* Participation in a different study
* Any condition revealed whereby the study investigator deems the subject inappropriate for this study
Fisher Wallace Neurostimulation & Depression Study

Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device on Major Depressive Disorder using two 20-minute per day treatment sessions over eight weeks.


Eligibility Criteria:
Inclusion criteria:

* Age greater than or equal to 21
* US resident
* Can receive packages to their home via UPS/Fedex/USPS
* Major Depressive Disorder
* PHQ-8 Score greater than 10 (show some signs of mild to moderate depression)
* PHQ-8 Score less than 20 (given remote study serious depressed should be excluded)
* Read/write English
* have not contemplated suicide in the past year
* not been institutionalized for mental health issues.
* not currently experiencing problems with alcohol or drug abuse
* can commit to not drinking alcohol 4 hours before bedtime for the duration of the study
* can commit to two (2) 20 minute sessions per day for 8 weeks
* has not used a brain stimulation treatment in one year
* no suspected or known history of heart disease
* no pacemaker
* not under medical supervision for other serious medical condition
* not taking opioids
* is a resident of states in which we have licensed medical professionals
Genetics of Women With Lobular Carcinoma in Situ of the Breast

RATIONALE: Gathering information about genetic changes in patients with lobular carcinoma in situ of the breast may help doctors learn more about the disease and find better methods of treatment.

PURPOSE: This clinical trial is studying the genetics of women with lobular carcinoma in situ of the breast.

OBJECTIVES:

Primary

* Identify inherited variation that predisposes women to develop lobular carcinoma in situ (LCIS) of the breast.
* Identify the frequency of these variants and determine the effect they have on tumor risk.
* Determine how worthwhile it would be to test for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.

Secondary

* Analysis of genetic changes within LCIS with the aim of identifying cases of LCIS which may progress to invasive cancer.

OUTLINE: Patients and control participants undergo blood collection. DNA is extracted from blood samples and used to genotype at selected polymorphisms, compare allele frequencies (used to associate alleles with disease) using a genome-wide single nucleotide polymorphism (SNP) screen. Archival tumor samples (if available) from patients are used for DNA-, RNA-, or protein-based analyses.

All participants complete a questionnaire about family history, a brief medical history, and provide epidemiological data to a genetic counselor. Participants identified to be at risk for known hereditary predisposition to cancer will be referred to a clinical genetics service. Individual results of this study are not disclosed to participants.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

PROJECTED ACCRUAL: A total of 2,000 participants (1,000 patients and 1,000 matched controls) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Current or prior diagnosis of lobular carcinoma in situ (LCIS) of the breast, including any of the following cases:

    * Pure LCIS
    * LCIS with subsequent development of invasive breast cancer of any morphological subtype
    * LCIS presenting as an incidental finding together with invasive breast cancer of any morphological subtype
  * Control participant matched for age and ethnicity to each LCIS patient

    * Not affected by LCIS
    * No history of ductal carcinoma in situ of the breast
    * No breast cancer
    * No relative (up to 2nd degree) who has been affected by breast cancer
    * Male or female

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a clinical diagnosis of stable plaque psoriasis

Exclusion Criteria:

* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis
* Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
* Subject has used any phototherapy, photo-chemotherapy or systemic psoriasis therapy within 30 days prior to initiation of treatment
* Subject has used systemic corticosteroids or topical, inhaled, intranasal corticosteroids within 30 days and 14 days, respectively, prior to study screening
* Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to initiation of treatment
* Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to initiation of treatment
* Subject has used emollients/moisturizers on areas to be treated within one day prior to initiation of treatment
* Subject is currently using lithium or Plaquenil (hydroxychloroquine)
* Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized
* Subject is pregnant, nursing or planning a pregnancy during the study period
* Subject is currently enrolled in an investigational drug, biologic or device study
* Subject has received an investigational drug, biologic or an investigational device within 30 days prior to study start
* Subject has been previously enrolled in this study and treated with the test article
* Subject has an irregular sleep schedule or works night shifts
Indications and Outcomes of Endoscopic Ultrasound in Tanta

The aim is to evaluate the initial experience for the indications and outcomes of EUS in Tanta university hospital.

Detection of main causes for referral to EUS in Tanta, Egypt.

Eligibility Criteria:
Inclusion Criteria:

* All cases of gastrointestinal EUS

Exclusion Criteria:

* Missed data
Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment

Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of life and high economic burden. Although a number of conservative therapies have proven to be effective for the management of hand OA, only modest treatment effects were reported for most individual interventions. The aim of the proposed study is to assess the effect of laser therapy on pain, function and force in patients with carpometacarpal osteoarthritis (CMC OA).

A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, were carried out involving patients diagnosis of CMC joint OA grade 1-2 (aged 18 years and above). Both assessor and statistician remained blinded. The research diagnostic criteria for carpometacarpal joint osteoarthritis was used to assess all individuals who agree to participate. All participants were submitted to a clinical examination and X-ray assessment of thumb base to determine carpometacarpal osteoarthritis grade. Based on the clinical and radiological findings, the participants were classified by a rheumatology. Those with CMC OA grade 2-3 were included in the study. The experimental group received laser therapy and control group received a placebo treatment.

The primary outcome measures was pain scores during daily living activities (DLA)- at the base of the thumb measured with VAS (Unidimensional measure of pain: 0-10 (0, no pain and 10, worst pain), and changes in hand function measured using the Quick-Dash questionnaire. Secondary outcome measures included changes in pinch strength. All outcome measures were collected at baseline, immediately following the intervention at 4 weeks and at 12 weeks following the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 diagnosis of CMC joint OA in their dominan hand.
* State 1-2 according to the American College of Rheumatology.
* Pain intensity during activities of daily living (ADLs) of up to 4 of 10 on the visual analog scale (VAS)
* Ability to read or understand the patient information sheets.
* Ability to sign a consent form will be included in the study

Exclusion Criteria:

* Neurologic disorder affecting the upper limb
* Previous treatment for their hand problem in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb
* Had fractures or a significant hand injury or previous surgery to the wrist, thumb or hand
* Finger tenosynovitis.
* Dupuytren disease.
* Psychological treatment.
Environmental Health and Myopia Prevention and Control

Myopia is one of the major causes of low visual acuity during childhood. It is generally more prevalent in urban areas than in rural areas. Current evidence does not address our understanding of the myopia incidence and development and associated risk geographic factors, such as green spaces. Therefore, our study aimed to evaluate the association between geographic factors and myopia base on a population-based large-scaled cohort design.


Eligibility Criteria:
Inclusion Criteria:

* schoolchildren in the 1st to 4th grades

Exclusion Criteria:

* schoolchildren unwilling to participate