cyrilzakka/clinical-trials huggingface dataset:
A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis

This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects and their parents or legal guardians have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study;
2. At the time of signing the informed consent, the subjects were ≥ 6 years old and \< 18 years old, male or female;
3. Have atopic dermatitis at screening.

Exclusion Criteria:

1. Before enrollment, the subjects weighed \< 15kg;
2. Females who are pregnant or lactating and have a positive pregnancy test result;
3. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD;
4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial;
5. Treated with biologics targeting IL-4Rα , or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection;
6. Has malignancy or has a history of malignancy;
7. Hypersensitivity to the study drug or any ingredient in the study drug.
Photogrammetric Scan System for Body Composition Analysis

This observational study evaluates the goodness of the IGOODI photogrammetric scan system in measuring anthropometry and estimating the body composition of 75 healthy subjects, comparing the results with the measurements taken using methods used in clinical practice, including body circumferences and bioimpedance analysis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female gender
* Between the ages of 18 and 85
* Caucasian race
* Cognitively intact
* Acceptance and signing of informed consent
* Height between 120 and 200 cm (included)

Exclusion Criteria:

* Congenital or acquired musculoskeletal deformities of the limbs or trunk
* Implants resulting from cosmetic surgery
* Articular prostheses and/or means of synthesis
* Current oncological or metabolic pathologies
* Photosensitivity
* Epilepsy
* Claustrophobia
* Subjects unable to independently maintain an upright position
* Wearers of pacemakers
Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

Doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. This type of treatment is referred to as neurostimulation. A common form of neurostimulation therapy is spinal cord stimulation (SCS). In this study, researchers want to learn more about how SCS affects pain processing and relieves pain. The researchers will examine multiple forms of SCS in chronic pain patients who are receiving SCS from their own doctors as part of their standard of care. During the study, participants will be asked to complete a variety of evaluations at certain time points.


Eligibility Criteria:
Inclusion criteria:

* Chronic intractable pain of the trunk and/or limbs
* Undergoing SCS as part of standard clinical care for chronic pain management
* Candidates will have been implanted with a commercial SCS device
* Candidates who are 18 years or older and can speak, read, and understand English
* Able to understand study procedures and to comply with them for the entire length of the study
* Must be willing to participate in COVID-19 symptom screening and answer questions about COVID-19 diagnosis 1-3 days before a scheduled visit
* Must be willing to wear a face-covering during all study visits

Exclusion criteria:

* Subjects who are pregnant or nursing
* Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail
* Subjects who are unable or unwilling to cooperate with clinical testing
* Subjects having any impairment, activity or situation that in the judgment of study personnel would prevent satisfactory completion of the study protocol
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent
* Subjects who currently have or tested positive in the last 14 days for COVID-19, or are symptomatic for COVID-19
Does Ultrasound of the Spine Improve Labor Epidurals/Spinal Anesthesia in Obstetric Patients?

The investigators are interested in determining the utility of ultrasound of the spine for labor epidurals or spinal anesthesia for women in labor or having a cesarean delivery. The investigators hypothesized that in women with poor spinal landmarks that the use of ultrasound of the spine will improve the process of placing labor epidurals or spinal anesthetics

Ultrasound has been in use for peripheral regional anesthesia for several years and is becoming more common. It is currently routinely used here at the University of Missouri. Ultrasound for neuraxial anesthesia, however, is less common and is only being done in a few centers.. There have been several case reports of its use in obstetric anesthesia for patients with prior spinal surgery or spinal deformity. There have been even few prospective randomized studies. While its use may have significant advantages, it is not yet clear what those advantages are and in whom it may be most beneficial. The investigators seek to answer the following questions regarding the use of preprocedure ultrasound for neuraxial analgesia/anesthesia in obstetric patients:

* Are there benefits to the use of pre procedure ultrasound for neuraxial analgesia/anesthesia?
* If so, what are the benefits?
* If measurable, to what extent does the patient benefit?
* Do all patients benefit or only a specific subgroup?
* Is there a "cost" to the use of pre procedure ultrasound, i.e. extra time needed to perform the ultrasound exam vs a "savings" with the use of pre procedure ultrasound, i.e., less time to perform the epidural analgesic or spinal anesthetic as a direct result of the use of ultrasound?
* In particular the investigators hypothesize that in patients whose spinal landmarks are not palpable or are barely palpable, ultrasound will be found to be beneficial as determined by metrics described below (see item #6). In patients whose landmarks are prominent or easily palpable pre procedure ultrasound will not be of significant benefit.

Eligibility Criteria:
Inclusion Criteria:

* Women in labor
* Women scheduled for cesarean delivery

Exclusion Criteria:

* Under age 18
* Emergency cesarean deliveries
* Unable to cooperate with ultrasound examination or regional anesthesia
* Advanced labor
* Contraindications to regional anesthesia
* Unable to understand the consent process
Respiration Patterns With Impedance in LINQ

The purpose of the study is to evaluate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor (ICM) as respiratory rate monitor.


Eligibility Criteria:
Inclusion Criteria:

* Suspected arrhythmia Diastolic Heart Failure and/or in Renal Failure.
* Chronic Kidney Disease (CKD) in Stage 5 (GFR = \<15 mL/min).
* Diastolic Heart Failure in class II and class III (class IV to be considered in end stage and non-reversible).
* Willing to sign the informed consent form.
* Greater than 18 years of age.

Exclusion Criteria:

* Enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
* Significant respiratory diseases such as COPD or pulmonary hypertension.
* Frequent arrhythmias, including PVC's.
* Known systolic heart failure.
* Recent infection.
* Allergenic or rejection reaction to materials used in incision/insertion tools, Reveal LINQ™ ICM exterior or incision closure method.
* Active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc).
* Not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin) or any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
* Body conditions that would complicate accurate measurement of respiratory efforts with an external device deployed around the chest.
* Not able to take the postures as necessary for the study protocol and not able to walk continuously for a period of 6 minutes.
* Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms

Observational study aimed at evaluating the incidence of familial AML/MDSs in patients with de novo MDSs or AML with almost one relative affected by hematologic neoplasms and/or other cancers at young age (\< 40 years)

This is a multicenter, retrospective and prospective, observational study aims to collect clinical information on patients with familial AML/MDSs from January 2014 to December 2022. No intervention is expected.

The purpose of this study is to identify and characterize the patients with familial MDSs or AML (i.e. with relatives affected by hematologic neoplasms and/or other cancers at young age (\< 40 years)) or presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to AML/MDSs.

In order to estimate the incidence of familial AML/MDSs, a survey will be sent every year to all participating sites to collect only the number of the all diagnosis of AML/MDS. All patients will be followed until December 2023 in order to have at least 1 year of observation.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years old
* Diagnosis of AML or MDSs from January 2014 to December 2022
* Suspected familiarity for myeloid neoplasm: at least one family member of first or second degree affected by myeloid neoplasm or other hematological malignancy, or by solid tumors with onset at age \< 40 years or presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to AML/MDSs
* Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

* none
HM15136 (efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years with Congenital Hyperinsulinism (CHI)

This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC). HM15136 will be administered once weekly in multiple doses to subjects in multiple age including pediatric to find appropriate exposure-response data.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged ≥2 years with CHI with persistent hypoglycemia despite current SoC treatment according to the investigator's evaluation or documentation
* Stable therapy with SoC medications with or without nutritional supplementation
* Previously undergone near-total pancreatectomy or being treated with a nonsurgical approach, having been evaluated as not eligible for pancreatic surgery
* HbA1c \<7%

Exclusion Criteria:

* Subjects with type 1 or type 2 diabetes mellitus
* Other reasons for hypoglycemia, including but not limited to drug-induced hyperinsulinemic hypoglycemia, etc
* Treatment of CHI with continuous intravenous glucose or glucagon infusion within 3 months prior to screening
* Subjects with current use of any drugs that are known to interfere with the study drug, glucose metabolism, or study procedures (eg, use of systemic glucocorticoids \[excluding topical, intra-articular or ophthalmic application, nasal spray, or inhaled forms\] or insulin)
* Have conditions that could affect glucose levels such as pheochromocytoma, insulinoma, and glucagonoma
Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

This is a multinational, multi center extension study. This study will provide data on the long-term safety, tolerability, and efficacy of imatinib in the treatment of severe pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments
* Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all Study Completion assessments

Exclusion Criteria:

* Patients with a pulmonary capillary wedge pressure \> 15 mmHg at time of Study Completion assessments in core protocol CQTI571A2301. If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place.
* LVEF \< 45%
* Patients with thrombocytopenia, platelet count \< 50E9/L (50E3/µL)
* Patients with uncontrolled systemic arterial hypertension, systolic \> 160 mmHg or diastolic \> 90 mmHg
* Patients with a QTcF \> 450 ms for males and \> 470 ms for females in the absence of right branch bundle block (based on Visit 1 ECG if required to be performed)

Other protocol-defined inclusion/exclusion criteria may apply
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device

This is a Phase IV, open label, case-controlled, observational study to evaluate the age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin (recombinant human growth hormone \[rhGH\]; Nutropin) using NuSpin device compared to historical controls from the national cooperative growth study (NCGS).


Eligibility Criteria:
Inclusion Criteria:

* Bone age less than or equal to (\</=) 8 years (females) or \</= 10 years (males) as determined by x-ray of the left hand and wrist obtained within six months before enrollment
* Prepubertal males and females by physical exam
* Naive to rhGH therapy
* Diagnosis of IGHD or ISS by standard pharmacologic testing and no other discernable etiology for short stature
* Height standard deviation score (Ht SDS) \</= -1.5 (\</= 5th percentile) for IGHD participants; Ht SDS \</= -2.25 (\</= 1.2 percentile) for ISS participants

Exclusion Criteria:

* Short stature etiologies other than IGHD or ISS
* Participants receiving chronic corticosteroid therapy (greater than \[\>\] 3 months) for other medical conditions
* Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated
* Females with turner syndrome
* Any previous rhGH treatment
* Participation in another simultaneous medical investigation or trial
* Pediatric participants with closed epiphyses
* Participants prescribed rhGH doses outside the variance of NCGS control participant dosing
Phaco vs. Phaco-ELT vs. Phaco-Trabectome 12m

This study compares efficacy (i.e. IOP and hypotensive medications) of phaco alone vs. combined phaco plus excimer laser trabeculotomy vs. combined phaco plus trabectome.

Glaucoma is one of the most common reasons for blindness. Usually an elevated drain resistance is the reason, while aqueous humor production is normal. Medical reduction of intraocular pressure (IOP) is first line therapy in most cases. The gold standard of surgical treatment still is trabeculectomy (TE) but TE has a lot of drawbacks. In particular when glaucoma and cataract coexists, the investigators therefore prefer the combined procedure cataract extraction plus excimer laser trabeculotomy (ELT) or plus Trabectome. Indication is cataract and a moderate elevated IOP without medical therapy or a moderate cataract and elevated IOP with medical therapy.

The ELT is performed by an AIDA XeCl-Excimer Laser System (TUI-Laser AG, Germering, 1,2 mJ per burst, burst duration 16 ns, wave length 308 nm, spot diameter 200 µm). 10 foramina were made over 90 degrees of the anterior chamber angle. Trabectome procedure is performed with the Trabectome unit from Neomedix.

* Trial with medical device
* Trial with surgical intervention

Eligibility Criteria:
Inclusion criteria:

* All patients, which had Phaco, Phako/ELT, or Phaco-Trabectome from 01/2008 until 12/2011, where screened 12 month after surgery

Exclusion criteria:

* IOP \>35 mmHg
Comparison of New Contact Lens With Current Marketed Lens

The purpose of this study is to validate the clinical performance of a new contact lens design.

Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

Eligibility Criteria:
Inclusion criteria

A person is eligible for inclusion in the study if he/she:

* Between and 18 and 35 years of age and has full legal capacity to volunteer
* Has had a self-reported oculo-visual examination in the last two years
* Has read and understood the information consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
* Has a Contact Lens Refraction between -1.00D and -6.00D
* Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
* Currently wears soft contact lenses
* Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
* Has clear corneas and no active ocular disease
* Has not worn lenses for at least 12 hours before the first visit

Exclusion Criteria

A person will be excluded from the study if he/she:

* Has never worn contact lenses before
* Is wearing Monovision modality
* Has any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars
* Is aphakic
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study
RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis

The objective of this study was to conduct a randomized, double-blind, double-dummy active controlled trial to determine the efficacy of denosumab in treating sarcopenia with underlying osteoporosis.

Aims:

1. To assess whether receptor activator of nuclear factor-kB ligand (RANKL)-inhibition can treat sarcopenia in osteosarcopenic patients, in terms of appendicular skeletal muscle mass (ASM), handgrip strength, and physical performance.
2. To assess whether RANKL-inhibition improves quality of life, and decreases falls, fractures, hospital admissions and mortality in osteosarcopenic patients.

Eligibility Criteria:
Inclusion Criteria:

* Elderly males or females aged 65 years or older
* diagnosed with osteosarcopenia (sarcopenia diagnosis based on AWGS 2019 guidelines - low appendicular skeletal muscle mass (ASM) by Dual-energy X-ray absorptiometry (DXA) (M:\&amp;lt;7.0kg/m2, F:\&amp;lt;5.4kg/m2) AND low handgrip strength (M:\&amp;lt;28kg, F:\&amp;lt;18kg) OR low physical performance (6-metre walk: \&amp;lt;1.0m/s or 5-time chair stand test ≥ 12 s); osteoporosis diagnosed based on World Health Organization (WHO) criteria with DXA scan T-score ≤ -2.5)
* Willing and able to comply with study protocol including follow-up evaluations.

Exclusion Criteria:

* history of recent fracture i.e., within 3 months
* history of prior anti-osteoporotic drug
* disease or medication affecting bone or muscle metabolism
* Chairbound or bedbound
* Unable to agree for consent
* contraindication to drug i.e., Denosumab or Zoledronic Acid
* Underlying malignancy or disease known to cause cachexia
* severe renal impairment e.g., Creatinine Clearance (CrCl) \&lt; 35ml/min
* moderate to severe liver failure (Child-Pugh Class B or C).
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Non-Hodgkins Lymphoma

This is a phase II, open-label, single-arm, multicenter study to asess the efficacy and safety of JWCAR029 in adult R/R Non-Hodgkins Lymphoma subjects in China.

This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with R/R Non-Hodgkins Lymphoma in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect the patient reported quality of life changes and immune response after JWCAR029 treatment.

There will be two cohorts of cohort A and cohort B. Large B cell lymphoma (LBCL) patients will be enrolled in cohort A and follicular lymphoma patients will be enrolled in cohort B. Two dose levels of 1.0 x 10\^8 CAR+ T cells and 1.5 x 10\^8 CAR+ T cells are adopted in this study in both cohorts, subjects will be randomly assigned into the two dose levels with a 1:1 ratio. All sujects will be followed for 2 years following JWCAR029 infusion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following criteria to participate in the study:

  1. ≥ 18 years old;
  2. Sign on the informed consent;
  3. Subject must have histologically confirmed large B lymphoma or follicular lymphoma;
  4. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  6. Adequate organ function;
  7. Adequate vascular access for leukapheresis procedure;
  8. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
  9. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
  10. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029.

Exclusion Criteria:

1. Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma;
2. History of another primary malignancy that has not been in remission for at least 2 years;
3. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
4. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
5. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
6. Presence of acute or chronic graft-versus-host disease (GVHD);
7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
8. Pregnant or nursing women;
9. Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
11. Received CAR T-cell or other genetically-modified T-cell therapy previously.