cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization

The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.

This study is a single-arm, open-label, multicenter study of RLYB212 in HPA-1b/b pregnant participants at higher risk for the occurrence of HPA-1a alloimmunization and FNAIT. A laboratory testing paradigm will be applied at screening to identify women at higher risk for HPA-1a alloimmunization. Study IPA2202 is comprised of three phases: a two-part screening phase, an antenatal treatment phase, and a postpartum follow-up phase. Study duration for each participant is anticipated to be \~44 weeks, inclusive of the screening visits through the Week 10 postpartum visit.

Eligibility Criteria:
Inclusion Criteria:

Pregnant women who present at Gestational Week 6 or after and confirmed to be: HPA-1b/b (HPA-1a negative), HLA-DRB3\*01:01 positive, Anti-HPA-1a alloantibody negative, Carrying an HPA-1a/b (HPA-1a positive) fetus

Exclusion Criteria:

* Prior history of HPA-1a related fetal and neonatal alloimmune thrombocytopenia
* Multiple pregnancy (more than 1 fetus)
* Prior history of platelet transfusion or other blood transfusions
* Known sensitivity and/or immediate hypersensitivity to any components of RLYB212 or its formulation
* Any co-morbid medical or obstetric condition(s), laboratory abnormality, concomitant treatment, or other reason that, in the investigator's opinion, could adversely affect the safety of the participant and/or fetus, impair the assessment of study results, or preclude compliance with the study
SC vs IC Approach for US-guided SC Vein Catheterization

Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.

For IP-ISV cannulation, a linear transducer is placed in the infraclavicular fossa. After obtaining a long-axis view of the axillary vein and distal subclavian vein ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the vein while noticing the lung pleura underneath the vessels.

For IP-SSV cannulation, a short-axis view of the IJV is obtained first. The probe is slid caudally following the IJV until getting the best long-axis view of the SCV. Using an in-plane approach, the needle is inserted at the base of the transducer at a 30° angle and advanced under the long axis under real-time US guidance targeting the SCV.

Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.

For IP -ISV, the Linear transducer is placed perpendicularly and inferior to clavicle. Transverse (short axis) view of subclavian vein (SCV), subclavian artery (SCA) and pleura is first obtained. With SCV centrally positioned, the transducer is rotated 90° clockwise until longitudinal view of subclavian vein is obtained. Pulse-wave Doppler view of the SCV confirms non-pulsatile flow and identifies the vessel. The needle is than inserted in the midpoint of the small footprint transducer using the in-plane approach. The needle is advanced slowly, under real-time US guidance targeting the SCV, taking note of the lung pleura underneath the vessels.

For IP-SSV cannulation, a short-axis view of the IJV is first obtained . The probe is slid caudally following the IJV until the junction of the subclavian vein (SCV) and IJV is reached in the supraclavicular fossa. The probe is then turned slightly and tilted anteriorly to get the best long-axis view of the SCV and the brachiocephalic vein .

Using an in-plane approach, the needle attached to a syringe is inserted at the base of the transducer at a 30° angle and advanced strictly under the long axis of the US probe from lateral to medial. The needle point is then guided.

In both groups, catheterization was done through Seldinger technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in intensive care unit requiring a central venous catheter (CVC)

Exclusion Criteria:

* Major blood coagulation disorders,
* Any thrombotic formations within the vein,
* Congenital or acquired deformity of neck or clavicle
* Cannulation site infection, hematoma and surgery.
Prospective Single-center Study Evaluating the Central Blood Pressure in Renal Transplantation

The renal transplant patient is at high cardiovascular risk compared to the general population. The cardiovascular mortality represents one of the most important causes of late graft loss. Cardiovascular risk prediction tools applied to the general population, however, are caught failing on the population of kidney transplant and tend to underestimate the actual risk.

Central blood pressure is the pressure imposed at large artery (aorta, carotid) and is directly related to the target organ (heart, kidney, brain). Central blood pressure could be a cardiovascular risk factor more robust and powerful than brachial blood pressure.

Central blood pressure may in part explain the increased risk of cardiovascular disease in the population of kidney transplant patients. A cohort of 250 kidney transplant patients will be constituted with a measure of concomitant central hemodynamic monitoring to the annual review will be conducted. The main objective of this study is to describe the central blood pressure measured by oscillometric method in renal transplanted population.


Eligibility Criteria:
Inclusion Criteria:

* Major Patient
* Renal transplant patient

Exclusion Criteria:

* Minor patient
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency

A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Australia, and New Zealand.


Eligibility Criteria:
Inclusion Criteria:

1. Investigator-determined GHD diagnosis prior to the historical initiation of daily hGH therapy.
2. 6 months to 17 years old, inclusive, at Visit 1

   1. If 3 to 17 years old, are taking daily hGH at a dose of ≥ 0.20 mg hGH/kg/week for at least 13 weeks but no more than 130 weeks prior to Visit 1
   2. If ≥ 6 months but \< 3 years old, are either hGH treatment-naïve or are taking daily hGH at a dose of ≥ 0.20mg hGH/kg/week for no more than 130 weeks prior to Visit 1
3. Tanner stage \< 5 at Visit 1
4. Open epiphyses (bone age ≤14.0 years for females or ≤16.0 years for males)
5. Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the IRB/HREC/IEC

Exclusion Criteria:

1. Weight of \< 5.5 kg or \> 80 kg at Visit 1
2. Females of child-bearing potential
3. History of malignant disease
4. Any clinically significant abnormality likely to affect growth or the ability to evaluate growth (eg, chronic diseases or conditions such as renal insufficiency, spinal cord irradiation, hypothyroidism, active celiac disease, malnutrition or psychosocial dwarfism)
5. Poorly-controlled diabetes mellitus (HbA1c \>8.0%) or diabetic complications
6. Known neutralizing antibodies against hGH
7. Major medical conditions, unless approved by Medical Monitor
8. Pregnancy
9. Presence of contraindications to hGH treatment
10. Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver)
11. Participation in any other trial of an investigational agent within 30 days prior to Visit 1
12. Prior exposure to investigational hGH
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For 16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \>= 25 kg/m2
* Body Weight \> 50 kg
* Liver fat (assessed via MRI-PDFF) \>= 8%
* Biopsy-proven NASH - diagnosed in previous 24-months
* Presumed NASH - per Sponsor's definition
* NAFLD with minimal inflammation/fibrosis
* Features of Metabolic Syndrome

Exclusion Criteria:

* Alcohol-induced steatohepatitis or other forms of chronic liver disease
* Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus
* Severe Renal Impairment
* Contraindications for MRI
Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.


Eligibility Criteria:
Inclusion Criteria:

* received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.

Exclusion Criteria:

* Recipients of HLA-identical living-donor renal transplants;
* PRA value \>20% within 30 days of transplant;
* GFR \<40ml/min;
* multi-organ transplant;
Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism

Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. The investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.

Mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. The vascular damage, in turn, contributes to significant cardiovascular morbidity and mortality of end-stage renal disease patients. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. We design an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.

Eligibility Criteria:
Inclusion Criteria:

* plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/L)
* aged 18 or older on peritoneal dialysis for at least three months
* willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* evidence of cancer, active infection or diseases with limited life expectancy
* diseases known to cause hypercalcaemia
* adjusted serum calcium level below 2.1 mmol/L (8.4 mg/dL) after correction for albumin
* participation in another interventional study within last 30 days of randomization
* history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
* patients receiving drugs with a narrow therapeutic index and metabolized by cytochrome P-450 2D6 (which is inhibited by cinacalcet): flecainide, thioridazine and most tricyclic antidepressants
Effectiveness of the Mirror Therapy for Improving Bimanual Performance, Somatosensory Function of the Impaired Upper Limb and Quality of Life in Children With Unilateral Spastic Cerebral Palsy

* Background: Unilateral Spastic Cerebral Palsy (USPC) is caused by an injury in one brain hemisphere in the immature brain, and affects the contralateral side of the body, especially on the upper limb. It induces motor and somatosensory damages, that are closely related to the hand function. Evidence posits mirror therapy to be a therapy with potential effects on bimanual performance and somatosensory function, that may influence on quality of life. The aim of this study is to demonstrate the effectiveness of a motor program with mirror therapy in children with USCP in the improvement of the bimanual performance, the somatosensory function and quality of life compared with the same program without mirror.
* Methods: This study is a Randomised Clinical Trial. The participants are children with USCP aged between 8 and 12 years old classified in levels I and II in Manual Ability Classification System, recruited from Fundació Aspace Catalunya. The eligibility criteria are a) to not have had surgical interventions, botulinum toxin or shock waves 3 months before the study; b) to not be receiving intensive therapies on the upper limb; c) to not have attentional or behavioural difficulties; d) to not have moderate to high intellectual disability; e) to not have non-treated epilepsy; and f) to not have non-corrected visual problems. A total of 22 participants will be recruited for this study, and will be randomised in two groups: control and experimental, through the opaque envelope technique. The experimental group will perform a 5-week motor program consisting of 4 bimanual exercises with mirror therapy, to be done at home 30 minutes a day, 5 days a week, while the control group will perform the same program without the mirror. The assessments will be done by a blinded evaluator and will include bimanual performance (Children's Hand-use Experience Questionnaire), somatosensory function and quality of life (PedsQL™), and will be performed at the beginning, at the end of the intervention and 1-month follow-up.
* Discussion: Favourably results in this study may imply the implementation of a low-cost therapy, suitable to be done at home, and with no contraindications for children with USCP. Moreover, the suitability to be adapted and performed at home could increase the family implication and empowerment, increasing its confidence in the disability process.


Eligibility Criteria:
Inclusion Criteria:

* To have been diagnosed with Unilateral Spastic Cerebral Palsy.
* To be capable of following and understanding rules.

Exclusion Criteria:

* To have had surgical interventions, botulinum toxin or shock waves 3 months before the study;
* To be receiving intensive therapies on the upper limb;
* To have attentional or behavioural difficulties;
* To have moderate to high intellectual disability;
* To have non-treated epilepsy;
* To have non-corrected visual problems
Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study

Although its safety and efficacy in the COVID-19 patient population are still unclear, tocilizumab is one of treatment. Tocilizumab is a U.S. Food and Drug Administration approved IL-6 receptor antagonist widely used to treat CRS secondary to the chimeric antigen receptor T cell. In this study the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.

With this study, the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.

With this study, those with signs of hypoxia and systemic inflammation followed by COVID-19 pneumonia (SpO2 \<90% on room air together with the elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrates on chest radiograph and tocilizumab the patients who received treatment and those who received standard therapy will be compared.

In the study, cases followed up with COVID-19 pneumonia and respiratory failure between March 2020 and March 2021 will be retrospectively evaluated. Tocilizumab was applied as 400 mg - 800 mg iv (depending on weight). A second dose could be given 12-24 h later if the patient's condition had not improved. Primary end point was determined as intensive care mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients were admitted to intensive care unit, diagnosed with COVID-19 pneumonia

Exclusion Criteria:

* Patients who require mechanical ventilation in intensive care admission
* Cases who received tocilizumab after being intubated during follow-up even though they were not intubated at admission
* patients for whom tocilizumab is contraindicated
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression


Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with bipolar I disorder, most resent episode depressed
* Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion Criteria:

* History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
* Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
* Imminent risk of suicide or injury to self, others, or property
Early Smoking Reduction or Cessation by Means of no Nicotine Electronic Cigarette Added to Standard Counselling.

The aim of this study is the evaluation of early smoking reduction or cessation by means of no nicotine electronic cigarette added to standard counselling.

Cigarette smoking is one of the major health problems in the modern world for the impact on morbidity and mortality with devastating effects on cardio-cerebrovascular system and on tumor onset. After years of scientific doubts, today the scientific world agrees to define cigarette smoking not a "vice" but a disease.

The aim is to evaluate the effect of no nicotine electronic cigarette use in patients with cancer or myocardial infarction, smoking at least 10 cigarettes per day for at least 10 years, in addition to counselling activity performed by specialised dedicated medical doctors.

If patient is eligible for this trial, he will be enrolled in this trial and randomized. Randomization will be performed using a web-based procedure. Study participants will be randomized to electronic cigarette added to standard counselling or only standard counselling. A calendar will be given to the patient to remember the dates of visits or telephone counselling. After the first visit patient will be followed every ten days for the first two month through outpatient clinic visits and telephone counselling. After the first two months patient will return at institute for a last outpatient clinic visit at sixth month.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of cancer and recently operated at European Institute of Oncology at Milan (Italy);
* patients with a diagnosis of hematology cancer treated at Foundation "San Raffaele del Monte Tabor" at Milan;
* patient with a recent occurrence of acute myocardial infarction from Monzino Cardiology Centre at Milan;
* age greater than 18 years;
* smokers stable for at least 10 cigarettes per day for at least 10 years.

Exclusion Criteria:

* patients with life expectancy less than 6 months;
* patients who have undertaken structured attempts to stop smoking over the past 3 months.
A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.


Eligibility Criteria:
Inclusion Criteria:

* For a patient enrolling into the HUMIRA treatment group; A pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active CD who has been prescribed Humira therapy according to the routine clinical practice.
* For a patient enrolling into the immunosuppressant therapy treatment group; A pediatric patient between the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with moderately to severely active CD who has been prescribed azathioprine, 6-mercaptopurine or methotrexate.
* Parent or guardian; or patient (if 18 years of age or older at enrollment and rolling over from an AbbVie-sponsored investigational Pediatric CD investigation trial) has voluntarily signed and dated an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) after the nature of the registry has been explained and the patient, patient's parent or legal guardian has had the opportunity to ask questions.

Exclusion Criteria:

* Patients should not be enrolled into the registry if they are currently being treated with any investigational agents or are receiving any investigational procedures.
* Patients should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA.
Translation of an Evidence-Based Fall-Prevention Program Into Rural West Virginia Churches

Falls are the leading cause of death and injuries in adults over age 65 both nationally and in West Virginia. Rurality, age, physical inactivity, and chronic conditions, such as arthritis, are strong risk factors for falls in this population. West Virginia has a higher than average fall rate, the second oldest population, the greatest proportion of inactive adults, and the second highest prevalence of arthritis in the US. Thus, older adults in rural West Virginia are at high risk for falls and in great need of public health fall prevention programs. The Tai Chi: Moving for Better Balance (MFBB) program is a community-based, fall-prevention exercise program for older adults. A waiver of informed consent will be requested to conduct the telephone screenings to determine study eligibility. We will enroll up to 300 people in classes to be held at 20 churches in West Virginia. Classes will be held twice per week for 16 weeks and taught by certified MFBB instructors. Participants will be interviewed by telephone, have a brief physical function ability exam, and complete a questionnaire before starting the exercise class, at the end of the class, and 4 months later. The study is being conducted to answer the following questions: 1) What are the functional improvements of older adults who participate in a 16-week MFBB program; 2) What is the rate of falls for those adults; 3) What is the rate and severity of those fall-related injuries of the MFBB participants? The purpose of the study is to: 1) implement a 16-week intervention of MFBB with a 16-week follow-up, in older adults in churches in rural West Virginia; 2) describe functional and fall/injury outcomes. Ultimately, we will translate an efficacious and effective fall-prevention intervention into a new setting.


Eligibility Criteria:
Inclusion Criteria:

* Aged 55 years or older

Exclusion Criteria:

* None