cyrilzakka/clinical-trials huggingface dataset:
Infant Transition From Car Bed to Car Safety Seat

This research study has been developed to obtain preliminary information about safe timing of the transition of infants from car beds to car seats, and to find out if initial failure of the car seat challenge is associated with small jaw size or increased respiratory illness.

Studies show that car seats can directly reduce injury in motor vehicle accidents. Unfortunately, some premature and term infants have trouble breathing from the semi-upright seating position in car seats. As a result, the American Academy of Pediatrics recommends car seat challenge testing for at-risk infants, including all children born at less than 37 weeks gestation and other high risk newborns such as those with a history of breathing problems and/or low tone. Infants who fail the car seat test are discharged home in car beds. However, guidelines regarding timing of repeat car seat testing or safe transition back to a car seat are currently unavailable.

At present there is no system for continued evaluation of infants sent home in car beds. In addition, it is not known when it is safe to transition infants from their car bed to a car seat. Infants transitioned too early may still have breathing problems and those transitioned too late may be at risk for injury in the event of a crash. Due to these reasons it is important to find out when it is safe to transition infants from the car bed to a car seat

Moreover, it has recently been shown that some infants with apparent life threatening events (ALTE), have a smaller jaw size than their peers that did not have an ALTE. ALTEs can occur when infants are in their car seats. No studies have been found that looked to see if infants with breathing problems in their car seats also have small jaws. Furthermore no studies have looked to see if infants who fail their initial car seat challenge are at greater risk for respiratory illness during their first year of life.

Eligibility Criteria:
Inclusion Criteria:

* All infants who visit Children's Hospital Boston, Center for Healthy Infant Lung Development for follow up car seat testing

Exclusion Criteria:

* None
Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

Patients with refractory ventricular extrasystoles or tachycardia not eligible for catheter ablation will receive single fraction stereotactic body radiation therapy (cardiac radiosurgery) with 25 Gy.

Investigators initiated this study to demonstrate that in at least 70% of the patients the planned cardiac radiosurgery may be performed without any interruption or treatment related interventional events within the first 30 days after treatment.

Primary endpoint: 30-day post-intervention safety defined as presence of both, radiosurgery delivery of the planned dose to the intended target area, and no possibly treatment related serious adverse events in the first 30 days after treatment.

Secondary endpoints: evaluated at 1 year

* Changes in ventricular tachycardia episodes and ICD shocks
* Changes in antiarrhythmic medication due to treatment effects
* Occurrence of possibly treatment related adverse events in the first year after treatment
* Changes in patient-reported quality of life
* Overall survival
* Safety profile

Eligibility Criteria:
Inclusion Criteria:

* Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
* Age \> 18 years
* either

  1. Recurring symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). At least 3 episodes within the 3 months prior to inclusion or
  2. induction of symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). Induction triggered by ICD or during electrophysiology studies (EPS) or both, a) and b)
* Refractory to antiarrhythmic combination therapy
* Beside the cardiac conditions: No competing illness that would additionally limit the life expectancy to less than 6 months
* No prior radiation therapy in the thorax area
* No pregnancy and no active breastfeeding
* Ability to consent and consent to study participation

Exclusion Criteria:

* ICD electrode malfunction of ICD readings outside reference range
* Lack of evidence of a myocardial scar (Computer tomography or magnetic resonance tomography for MRI-capable ICD aggregates or electrophysiological measurement)
* No possible induction of symptomatic monomorphic ventricular tachycardia non-persistent or persistent with delivery of ICD therapies such as antitachycardic pacing or shock
* Contraindication to radiosurgery (e.g. precise target volume definition not possible due to image artifacts created from a left ventricular assist device (LVAD))
* Inability to consent or missing or withdrawn consent
Screen to Prevent: Using Digital Health to Improve HIV Screening and Prevention

The goal of this interrupted time series quasi-experimental design study is to implement universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old adolescents visiting the pediatric emergency department (ED). The main question\[s\] it aims to answer are:

1. What is the uptake, reach and effectiveness of universally offered, opt-out HIV screening across pediatric EDs after implementing an adapted version of a tablet-based screening process?
2. What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will

   1. Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history
   2. Have the opportunity to opt-out of clinician-ordered HIV testing
   3. Patients meeting CDC criteria for HIV PrEP will be given the opportunity to enroll in the digital health PrEP linkage platform and followed for 3 months after enrollment.

Using a previously developed tablet-based, broad scale gonorrhea and chlamydia screening process, the investigators will adapt, refine, and test this process with the aim of increasing universally offered, opt-out HIV screening in the pediatric ED through electronic integration of patient reported data for provision of clinical decision support for HIV screening and identification of PrEP candidacy. The investigators will then use mHealth to link patients to PrEP services. The goal of this study is to (1) adapt, refine, and test this previously implemented multi-center, ED-based, screening study with a goal of increasing universally offered, opt-out HIV screening among adolescents in the pediatric ED and (2) link at-risk adolescents to PrEP services and preventive care. This will be accomplished through a network of children's hospital EDs (Pediatric Emergency Care Applied Research Network or PECARN). This research will contribute to the evidence base for creating clinically effective and sustainable HIV screening programs that can be successfully implemented into the clinical workflow of the ED. It will also improve identification and linkage to PrEP care for at risk adolescents using mHealth strategies by first identifying adolescents and young adults (AYA) who are PrEP candidates based on their responses to a computerized sexual health screen (cSHS) and subsequently (1) providing clinical decision support to providers via the electronic health record and (2) direct text messaging from the cSHS to PrEP candidates providing educational content and connecting youth to a PrEP navigator. This intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support.

Eligibility Criteria:
Inclusion Criteria:

* All patients 15-21 years of age visiting a pediatric emergency department.

Exclusion Criteria:

* Unable to understand English
* Critically ill
* Cognitively impaired
* Altered mental status
Purastat Prevention Delayed Bleeding Duodenum

PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. In this study the efficacy of PuraStat in reducing delayed bleeding following duodenal endoscopic mucosal resection (EMR) will be assessed. PuraStat will be applied to the EMR defect after the resection. The presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (EGD) performed 1 day after the duodenal EMR. Furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of PuraStat application will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Duodenal non-ampullary mucosal lesion ≥ 10 mm
* ≥ 18y of age
* Informed consent obtained

Exclusion Criteria:

* Ampulloma
* Submucosal lesion
* Lesion \< 10 mm
* \>1 lesion resected
* Active use of anticoagulant or antithrombotic medication other than aspirin
* Known clotting disorder
* Inability to give informed consent
* \< 18y of age
PD-L1 Expression in Lung Cancer

This study will measure PD-L1 expression in metastatic NSCLC (primary tumour and metastatic lesions) using \[99mTc\]-NM-01 SPECT/CT and compare to PD-L1 percentage expression determined by immunohistochemistry (IHC).

A non-blinded, single centre, single interventional arm Phase II diagnostic imaging study.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above
* Patients with histopathology confirmed untreated metastatic NSCLC scheduled for systemic anti-cancer therapy
* ECOG status ≤ 1
* Willingness and ability to comply with scheduled study visits and tests

Exclusion Criteria:

* Pregnant or breast-feeding women
* Concomitant uncontrolled medical conditions as per Investigator assessment
* \> 3 months between IHC PD-L1 and study recruitment
* Significant abnormality of haematology (one or more of: Hb ≤ 90g/L, absolute neutrophil count (ANC) ≤1.5 x109/L, platelet count ≤75 x109/L)
* Significant abnormality of renal function (defined as Cockcroft-Gault calculated creatinine clearance ≤30 mL/min)
* Significant abnormality of liver function (one or more of: AST or ALT ≥2.5x ULN or ≥ 5x ULN if patient has liver metastases; total bilirubin ≥1.5xULN. In the case of patients with Gilbert's syndrome then direct bilirubin must be confirmed as ≤ ULN)
* Significant cardiovascular disease, including New York Heart Association (NYHA) heart failure ≥Class III, myocardial infarction within 3 months of enrolment, unstable arrhythmia or unstable angina
* History of uncontrolled allergic reactions and/or have hypersensitivity to anti-PD-L1 monoclonal antibodies, kanamycin A or aminoglycoside therapies, or other excipients that may induce hypersensitivity
Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting

The aim of this study is to compare negative pressure wound therapy to traditional care after split-thickness skin grafting in patients aged over 18.

Split-thickness skin grafting (STSG) is one of the most commonly used techniques in reconstructive plastic surgery and dermatology. Skin grafts are being used to cover skin defects caused by multiple etiologies. Traditionally, patients are immobilized in bed or in wheelchair for up to five days after surgery. Long immobilization decreases patients overall ability to function and increases the length of the stay in hospital. Negative pressure wound therapy (NPWT) have been used successfully in treatment of acute, chronic and diabetic ulcers. It is proposed that NPWT increases capillary blood flow, decreases bacterial contamination, seroma formation and swelling. Using NPWT on split-thickness skin grafts after burns is well documented. It increases skin graft take ratio and speeds up healing. Aim of this study is to compare NPWT to traditional treatment after STSG for any indication in patients aged 18 to 99. This is a two-arm, multicenter, randomized prospective trial with 160 patients.

Eligibility Criteria:
Inclusion Criteria:

* Wound requiring skin graft surgery
* Voluntary

Exclusion Criteria:

* Not voluntary
* Size of wound exceeding 15x15cm or 5x20cm
* Previous skin graft operation to the same wound
* Inability to co-operate
* Wound depth over 1.5cm
* Multiple wounds requiring skin grafting
* Active infection in wound
* Active osteomyelitis in region of wound
* Flap reconstruction of the wound
* Region of wound not suitable for negative pressure wound therapy (for example toes, foot sole)
Total-Body Irradiation, Busulfan, and Interferon Alfa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Multiple Myeloma

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of total-body irradiation, busulfan, and interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating patients with multiple myeloma.

OBJECTIVES: I. Evaluate the effects of total marrow irradiation and busulfan followed by allogeneic peripheral blood stem cell or marrow transplantation on the outcomes of treatment related mortality, response, relapse, survival, and event free survival for patients with advanced multiple myeloma.

OUTLINE: Peripheral blood stem cell (PBSC) or bone marrow (BM) collection and infusion are performed according to standard practice. Patients undergo total marrow irradiation (TMI) bid for 3 days. Busulfan is administered every 6 hours on days -6 to -3. PBSC or BM is infused on day 0. Interferon alfa is administered subcutaneously on Mondays, Wednesdays, and Fridays beginning on day 80. Interferon therapy may continue in the absence of graft versus host disease or disease progression. Patients are followed on days 56 and 84, then every 6 months for 2 years, and annually thereafter.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued over 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically diagnosed stage II or III multiple myeloma Stage I multiple myeloma progressing on conventional therapy HLA matched donor Related - ages 18-65 Unrelated - ages 18-55

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No significant hepatic disease Bilirubin no greater than 2 mg/dL Renal: Creatinine clearance at least 40 mL/min Calcium no greater than 15 mg/dL Cardiovascular: No significant cardiac disease Ejection fraction at least 40% Pulmonary: No significant pulmonary disease FEV1 at least 50% OR DLCO at least 50% Other: No obesity Chest wall no greater than 3 cm thick No pendulous breasts HIV negative

PRIOR CONCURRENT THERAPY: Must have received prior conventional therapy for stage I disease
Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis

Among knee degenerative osteoarthritis patients aged 50 or older, it will prove the therapeutic effect and safety of Nexsphere-F embolization for patients who need additional treatment because pain is not controlled even if conventional treatments are taken.

This clinical trial is a single arm, single center, open label, and pilot clinical trial to prove the performance and safety of Nexsphere-F in patients over the age of 50 who need additional treatment because pain is not controlled even after conventional treatments are taken.

Since consent cannot be obtained during surgery from a subject who meets the inclusion and exclusion criteria, a written consent is obtained in advance between four weeks before the procedure and the day. As one of the usual orthopedic evaluations, baseline MRI will be performed and WORMS will be evaluated. In addition, the WOMAC score and the VAS score will be measured before the procedure and used as a baseline for evaluation variables. Since it is a pilot study to evaluate the validity, all subjects will undergo a Transcatheter Arterial Micro-Embolization (TAME).

Eligibility Criteria:
Inclusion Criteria:

* Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria in accordance with ACR guidelines and X-ray findings used within 12 months
* VAS score exceeding 50mm
* An adult male and female over 50 years of age
* Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks
* A person who agrees to maintain existing medication treatments during the clinical trial period but does not receive additional medication or new conservative treatments for knee osteoarthritis pain management.

Exclusion Criteria:

* A locally infected patient
* A person whose life expectancy is less than six months
* A person with symptoms of lower extremities that are considered secondary to atherosclerosis or arterial vascular disease (ex: claudication ischemic rest pain)
* A person diagnosed with rheumatism or infectious arthritis
* A person who has undergone knee arthroplasty
* A person who has not had knee microfracture surgery for more than 10 years
* INR 2.5 or less than 30,000 platelets
* Anaphylaxis-causing iodine allergy
* Patients with renal dysfunction or impaired renal function who have been diagnosed with less than 45 GFR (eGFR) within the last 60 days
* Those who have a taboo on MR videos
* Pregnant women
* Other cases where it is deemed inappropriate to participate in this clinical trial at the discretion of the researcher
Bupropion and Restless Legs Syndrome

The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).

Adult patients with moderate to severe RLS will be recruited for the study. Those on medications which treat RLS will be asked to discontinue the medications for two weeks prior to beginning the study. All participants will be screened with Beck Depression Inventory, International Restless Legs Syndrome Study Group (IRLSSG) severity scale, and Clinical Global Impression of Improvement (CGI-I) scale. An ordinal scale (i.e. rate symptoms from 1-8) will also be obtained. Participants will be randomized to a placebo or medication group. Those in the medication group will be given 150 mg of bupropion at night for six weeks. Others will receive similar-appearing placebo. Participants will be called at the end of weeks one, two, four and five to assess symptom severity based on IRLSSG scale, and to determine if they are experiencing any adverse effects. At three weeks and six weeks, participants will return to the clinic to complete all four of the initial forms, the Beck Depression Inventory, IRLSSG severity scale, ordinal scale, and CGI-I.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Restless Legs Syndrome
* Severity Scale score 15 or higher

Exclusion Criteria:

* History of seizures
* History of alcohol use greater than 2 drinks per day or occasional binges of 5 or more drinks per day
* Suicidal thoughts/ideations
* Inability to return for follow up appointments at 3 and 6 weeks
* Lack of access to telephone
* Eating disorder
* Age less than 18
* Pregnancy
* Unwillingness or inability to discontinue any RLS medications
Assessment of Quality of Life in Hemophiliac Patients

Hemophilia is an X-linked congenital bleeding disorder caused by deficiency of coagulation factor VIII (in hemophilia A) or factor IX (in hemophilia B).

The deficiency is the result of mutations of the respective clotting factor genes.

Hemophilia is rare, with only about 1 instance in every 10,000 births (or 1 in 5,000 male births) for hemophilia A and 1 in 50,000 births for hemophilia B.

According to the World Federation of Hemophilia, 400 000 people worldwide \& 5,307 people in Egypt are suffering from hemophilia.

Hemophilia A is more common than hemophilia B, representing 80-85 % of the total hemophilia population.

Signs and symptoms of hemophilia vary according to the level of clotting factors, mild, moderate and sever.

* Unexplained excessive bleeding from cuts or injuries
* Epistaxis without a known cause
* Many large or deep bruises
* Hamoarthritis
* Hematuria and Melena.
* Intracranial hemorrhage and death
* In infants, unexplained irritability

it is subjective representation of health, including not only physical,mental and social, but also emotional and everyday life dimensions in terms of well-being. Several definitions of QoL have been provided, the definition of the WHO viewing QoL as 'individuals perceptions of their position in life in the context of culture and value systems in which they live and in relation to their goals, expectation standards and concerns'

Eligibility Criteria:
Inclusion Criteria:

* - Hemophilia A \& B
* Different age groups (pediatric - adolescence - adult )
* Home or hospitalized treatment
* complications such as joint swelling , spontaneous bleeding, etc....

Exclusion Criteria:

- 1- Other causes of bleeding tendency such as liver failure, DIC, anticoagulant drugs, etc..

2- Diseases that affect joints such as osteoarthritis, SLE , etc.. 3- Mentally retarded patients.
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia

The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.


Eligibility Criteria:
Inclusion Criteria:

* DSM-5 primary diagnosis of schizophrenia.
* Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician.
* PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2).
* CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2).

Exclusion Criteria:

* Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
* Diagnosis of intellectual disability (IQ \< 70).
* Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1.