cyrilzakka/clinical-trials huggingface dataset:
Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn

The goal of this clinical trial is to learn if drug Vardenafil works to treat pulmonary hypertension in newborns, It will also learn about the safety of Vardenafil. The main questions it aims to answer are:

Does Vardenafil lower the pulmonary hypertension in newborns? What medical problems do participants have when taking Vardenafil? Researchers will compare drug Vardenafil to drug Sildenafil to see if drug Vardenafil works better to treat pulmonary hypertension.

Participants will be divided into 2 groups , one group will take oral drug: Vardenafil and the other group will take oral drug: Sildenafil every day.

Pulmonary hypertension will be measured daily until it returns to normal. Keep a diary of the symptoms and any complications

A double blind controlled trial in Children's Hospital Damascus between 5/2023 and 9/2024 on newborns up to 4 d old diagnosed with PPHN, patients were allocated randomly into one of the 2 arms of the study, group Sildenafil and group Vardenafil, both medicines administered orally, management of the patients was the same in both groups except for the investigated drug, pulmonary hypertension and resistance were measured by echo at diagnosis time and every 24 hours later on till normalization of pulmonary pressure, at the end of recruitment data was collected and analyzed to confirm the safety of Vardenafil and compare the efficacy of Vardenafil to Sildenafil

Eligibility Criteria:
Inclusion Criteria:

* Gestation age: 28 weeks or more

Exclusion Criteria:

* Cardiac deformity, inability to administer the drug orally
PREPL in Health and Disease

Evaluation of PREPL activity in healthy controls and known or possible PREPL deficient patients

PREPL is defective in hypotonia cystinuria syndrome and in isolated PREPL deficiency. The investigators have constructed a blood test to evaluate PREPL activity in patients with possible PREPL deficiency.

The study will determine normal values for age (0-18) for PREPL activity in blood.

Also, patients with a clinical phenotype that overlaps with PREPL deficiency (including patients with known primary PREPL deficiency and Prader-Willi syndrome) will be evaluated for PREPL activity in blood.

A last part of the study will involve muscle biopsies during elective anesthesia/surgery for other reasons. There will be 2 groups: patients without signs of PREPL deficiency undergoing surgery (controls) and patients with Prader-Willi syndrome undergoing anesthesia or surgery (patients). The control group will be age-matched to the hypotonia group. In the muscle biopsies, PREPL activity and expression will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* According to group
* Control group: children seen at a postinfectious consultation

Exclusion Criteria:

* Control group: symptoms overlapping with PREPL deficiency, genetic or syndromic disease, atypically developing children
* other groups: contraindication for blood draw
* group with muscle biopsy: contra-indication for muscle biopsy
Early Chemotherapy Intensification in Interim-Positron Emission Tomography (PET) Positive Hodgkin Lymphoma

Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD). Two-year Progression Free Survival of PET-2 positive patients is only 12%, but the optimal treatment for this patient subset is still unknown.

From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early intensification of chemotherapy with BEACOPP \[Bleomycin, Etoposide, Adriamycin (doxorubicin), Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone\](4 escalated + 4 baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The investigators retrospectively recorded and analyzed these data in order to evaluate if this strategy could be of benefit for this subset of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced Hodgkin's lymphoma according to the World Health Organization classification
* Age 16-80
* Not previously treated
* Stage IIB to IVB or stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR \> 50 mm, bulky lesion)
* Written informed consent

Exclusion Criteria:

* Patients aged more than 80
* Concomitant or previously treated neoplastic disorder less than 5 years before the diagnosis of Hodgkin's lymphoma
* Psychiatric disorders
* Uncontrolled infectious disease
* Impaired cardiac (EF \< 50%) or renal (creatinine clearance \< 60 ml/m)function
* Pregnancy and lactation
* Uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
Mesenchymal Stem Cells for Treatment of Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to determine the safety of injecting mesenchymal stem cells through intraspinal delivery for the treatment of ALS.

A single patient safety study for harvesting, expanding ex vivo and injecting autologous mesenchymal stem cells (MSC's) into the subarachnoid space of a patient with amyotrophic lateral sclerosis (ALS). Cells will be isolated from adipose tissue by subcutaneous biopsy and expanded using an FDA-approved protocol. They will then be injected by lumbar puncture into the cerebrospinal fluid. Injection will be completed in the in- patient clinical research unit (CRU). the patient will be followed for two years.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years, if female, must be menopausal or had hysterectomy
* resident and citizen of the United States
* history of a chronic onset of a progressive motor weakness
* able to comply with protocol requirements
* can provide written consent

Exclusion Criteria:

* does not have renal disease (Creatine \> 2.0)
* does not have active systemic disease
* does not have any clinically significant abnormalities on prestudy laboratory evaluation
* does not have any clinically significant medical condition (e.g.,within 6 months of baseline, had a myocardial infarct, angina pectoris, and/or congestive heart failure), that in the opinion of the investigator, would compromise the safety of the patient
* does not have a history of cancer including melanoma with the exception of localized skin cancers (with no evidence of metastasis, significant invasion,or re-occurrence within 3 years of baseline).
* has not used an investigational drug within 30 days of baseline visit
* does not have a tracheostomy
* does not have a Beck's Depression Inventory score \>16
Lung Diffusing Capacity for Nitric Oxide as a Marker of Fibrotic Changes in Idiopathic Interstitial Pneumonias

The diagnosis of idiopathic interstitial pneumonia (IIP) is based on computed tomography (CT) imaging, whereas lung function studies are used for staging and follow up. Lung diffusing capacity for carbon monoxide (DLCO) is generally reduced but weakly correlated with the severity of CT-determined fibrotic process. A possible explanation of this finding is that DLCO is relatively insensitive to changes in alveolar membrane diffusive conductance (DMCO). Lung diffusion capacity for nitric oxide (DLNO) was strongly correlated with CT-determined amount of fibrosis/honeycombing in both usual and non-specific interstitial pneumonias. Moreover. Both DLNO and DMCO were below the lower limit of normality even in patients with small amount of fibrosis. Measurement of DLNO may provide a more reliable assessment of fibrotic changes than DLCO because it better reflects DMCO.

Rationale: Lung diffusing capacity for carbon monoxide (DLCO) is decreased in both usual interstitial pneumonia-idiopathic pulmonary fibrosis (UIP-IPF) and nonspecific interstitial pneumonia (NSIP), but is weakly related to computed tomography (CT)-determined fibrotic changes.

Objectives: To determine whether measurement of lung diffusing capacity for nitric oxide (DLNO) better reflects fibrotic changes than DLCO.

Methods: DLNO and DLCO were measured simultaneously in 30 patients with UIP-IPF and 30 with NSIP. The amount of pulmonary fibrosis was estimated by volumetric analysis of visually bounded areas showing reticular opacities and honeycombing. Alveolar membrane conductance (DMCO) and pulmonary capillary volume (Vc) were calculated.

Eligibility Criteria:
Inclusion Criteria:

* Chest computed tomography (CT) scan diagnosis of either usual interstitial pneumonia-idiopathic pulmonary fibrosis (UIP-IPF) or idiopathic nonspecific interstitial pneumonia (NSIP)

Exclusion Criteria:

* Symptoms/signs or specific serum markers of an underlying autoimmune process
* Previous environmental/occupational exposure to fibrogenic dusts
* Use of fibrogenic medications
Check Yourself Study

The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e., "Check Yourself") to usual care. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services.


Eligibility Criteria:
Inclusion Criteria:

* Eligible individuals will be 13-18 years old who have an appointment to see a provider at a participating clinic and will be able to read and comprehend English.

Exclusion Criteria:

* Individuals will be excluded from the study if:

  * they do not meet age requirements,
  * do not have an appointment at a participating clinic,
  * lack the means to complete follow-up interviews (i.e., has neither telephone not internet access),
  * have a sibling who has/is being enrolled in the study and/or
  * are not able to read or comprehend English.
Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab.

This study will generate patient reported outcomes (PROs) associated with the use of benralizumab as treatment for severe eosinophilic asthma.

Benralizumab was launched in 2018 following regulatory approval in Canada and is now widely available for Canadian patients with severe eosinophilic asthma.

This study is an observational cohort study of patient reported outcomes (PROs) within real-world settings for participants who are prescribed benralizumab for treatment of uncontrolled severe eosinophilic asthma. Patients will be recruited in select clinics across Canada.

Survey data for each participant in the study will be obtained at the following time-points:

* Baseline (Week 0)
* Short-term follow up: 1-, 2-, 4-, and 8-weeks after baseline
* Long-term follow-up: 24- and 56-weeks after baseline

Eligibility Criteria:
The following individuals may be eligible to participate:

* Are enrolled in the benralizumab PSP;
* Are 18 years of age or older;
* Can understand the requirements of the study and provide informed consent to participate in this study;
* Agree to abide by the study protocol and the exclusion criteria and can complete all aspects of the study, including all visits.
* Are benralizumab naïve and have not previously received benralizumab prior to the start of this study

AND

* Suffer from uncontrolled severe eosinophilic asthma meeting at least one of the following:

  1. Has blood eosinophil count ≥ 300 cells/μL AND experienced two or more clinically-significant exacerbations in the past 12 months; OR
  2. Has blood eosinophil count ≥ 150 cells/μL AND are treated chronically with oral corticosteroids (OCS); OR
  3. Sputum eosinophil levels of 3% and higher OR
  4. Have been previously treated with a biologic for severe asthma and previously met the above eosinophil counts (detailed in #1,2, or 3 above) prior to initiation of the previous biologic.

     AND
* ACQ-6 score ≥ 1.5

Exclusion criteria:

Any of the following conditions are cause for exclusion from the study:

* Patients currently enrolled in an interventional clinical study in parallel will be excluded from the study, except for patients who are in parallel documented in a national asthma registry;
* Patients who have previously received benralizumab prior to the start of the study
* Patients currently participating (i.e. have not completed) in any other clinical trial including those with biologic treatment;
* Patients with other documented lung disease other than asthma and not within reimbursed label.
Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)

This non-interventional prospective study is a post-authorization safety study (PASS) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically significant risks associated with the use of vernakalant in real-world clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* To be treated with intravenous vernakalant, independently of this study
* Participant and/or legal guardians willing to provide informed consent and/or informed assent according to local regulations

Exclusion Criteria:

- Enrollment in an investigational drug or device clinical trial in the 30 days prior to study enrolment. Participation in another non-interventional drug or device study or registry is permitted.
Efficacy and Safety of Oral CEP-701 for the Treatment of Patients With Advanced Multiple Myeloma

An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients with Advanced Multiple Myeloma.

An Open-Label Study of the Efficacy and Safety of Oral CEP-701 for the Treatment of Patients with Advanced Multiple Myeloma.

Eligibility Criteria:
Inclusion Criteria:

Patients are included in the study if all of the following criteria are met:

* Histological and cytological confirmation of stage II or III multiple myeloma.
* Relapsed or primary refractory multiple myeloma, after 1 or more courses of standard therapy, and progressive disease.
* ECOG performance status of 0-1.
* Measurable disease as defined by serum M protein of more than 1.0 gm/dl, serum light chain of more than 200 mg/dL, or Bence-Jones proteinuria of more than 200mg/24 hours.
* At least 18 years of age.
* Normal marrow function: ANC\>1.0x10 9/L, platelets\>50X10 9/L An exception is allowed if myelosuppression or thrombocytopenia is secondary to bone marrow plasmacytosis. Growth factor support is allowed.
* Normal organ function: bilirubin \<1.5XULN, AST and ALT\<2XULN, serum creatinine \<2.0 mg/dL.
* Contraceptive measures during participation as appropriate.
* Willing to be able to comply with study procedures and restrictions.
* Signed written informed consent.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

* Nonsecretory disease or plasma cell leukemia (defined as \>2000 circulating plasma cells/uL).
* More than 4 prior courses if anticancer therapy (bisphosphonates are not considered anticancer therapy for this criterion)
* Chemotherapy or radiotherapy within 4 weeks prior to enrollment
* Unresolved adverse events or uncontrolled illness that would be likely to interfere with the objectives of the study.
* Treatment with an investigational drug within 4 weeks of first day of study treatment
* History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free more than 5 years).
* Treatment with potent CYP3A4 inhibitors including cyclosporine, clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole, erythromycin, clarithromycin, and troleandomycin, human immunodeficiency virus (HIV), protease inhibitors, or nefazodone within 1 week (7 days) of the planned 1st day of study treatment.
* Currently receiving warfarin.
* Clinical diagnosis of active gastrointestinal ulceration of melena or hematemesis in the previous 4 weeks.
* Hypersensitivity to CEP701 or any component of CEP701.
* Intolerance of dexamethasone.
* Requirement for HIV protease inhibitor treatment.
CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

The objective of the present proposed study is to discover whether, in the nursery setting, administration of low concentration inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing more regular with less apneic time than that observed with administration of theophylline. The hypothesis to be tested is that inhalation of low concentration CO2 (0.8%) will reduce apnea more effectively and will have fewer adverse side effects than theophylline.

1. To discover whether, in the nursery setting, continuous administration of a low concentration of inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing in preterm infants more regular with less apneic time than that observed with theophylline.
2. To discover whether inhalation of low CO2 decreases apneas, particularly prolonged apneas (\>20 seconds), more effectively than theophylline.
3. To discover whether short term (during hospitalization) and long term (2 years) adverse side effects are less pronounced with CO2 than with theophylline.

Eligibility Criteria:
Inclusion Criteria:

* Infants between 27 and 32 weeks gestational age hospitalized in the neonatal intensive or intermediate care units
* Significant apnea, defined as 5 or more self-resolved apneas, or 2 or more apneas requiring intervention over a 12 hr period

Exclusion Criteria:

* Already on methylxanthine treatment
* On supplemental oxygen, nasal continuous positive airway pressure (CPAP)
* Had major congenital anomalies, sepsis, or other known causes of apnea
Preventing Falls and Disability in Older Adults After Hip Fracture

Patients who have suffered a first hip fracture have a higher risk of falling and sustaining another hip fracture compared with age-matched adults who did not fracture. Although exercise is key to reversing this pattern, there have been very few trials that aimed to improve muscle strength and balance as well as enhance bone health following hip fracture. Therefore, we propose to conduct an RCT that delivers either 12 months of standard care or standard care plus graduated exercise program for older women who have sustained a recent hip fracture.


Eligibility Criteria:
Inclusion Criteria:

* Older community dwelling women who have sustained a first hip fracture
Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process

Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol.

Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. The short, medium and long-term issues of such impact are still debated but some studies have pointed the fact that acute concussion, repetitive concussions, and even "sub-concussive" impacts could major the risk of developing brain diseases and cognitive impairments. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol.

This study will be an epidemiological descriptive and prospective study with a brief questionnaire sent off to any player, above 18 years old, male or female, that had receive a white card during an official match in the French amateur Handball league along two regular season. The results will bring details on how concussion occurs on field and how this protocol is efficient to bring the player to consult a health professional.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Over 18 years old
* Who had received a white card during an official game
* having an email address registered in the FFHB register

Exclusion Criteria:

* Any refusal to participate
* Inability to respond
Efficacy Study of Two Choices of Phototherapy on Itching Skin Diseases

This is a double-blind prospective randomized monocenter study comparing the efficacy of two phototherapy ultraviolet spectra on pruritus (itching) of inflammatory skin diseases. 40 patients per treatment, in total 80 study participants.

In patients with a skin disease and the given indication for a phototherapy with Ultraviolet B narrow-band (UVB narrowband, 311nm) with or without Ultraviolet A (UVA, 320-400 nm), the subjective pruritus levels and clinical severity will be measured before, during and after completion of the 16-week therapy (40 patients per group). Patients will be recruited in the department of dermatology of the University Hospital Zürich in the outpatient clinic. Following oral and written consent, pruritus levels will be measured by a visual analogue scale and a new, detailed pruritus score 2 before start of therapy, every 4 weeks after start as well as after completion of the phototherapy. Phototherapy is to be administered 3 times per week. The study includes 5 study visits and up to 43 treatment visits that include administration of phototherapy only.

A physical examination including clinical scores (Psoriasis Area and Severity Index PASI, Eczema Area and Severity Index EASI, Physician's static global assessment PSGA and Dermatology Dynamics Vector DDV) will be performed at every visit. During the first physical examination the Fitzpatrick-skin type of patient will be recorded, the demographics, the Body Mass Index (BMI), diagnosis, past medical history, co-morbidities, concomitant medication and the number of past UVA/B treatments.

Eligibility Criteria:
Inclusion criteria:

- Pruritic inflammatory diseases such as atopic dermatitis, other types of eczema, psoriasis, prurigo simplex subacuta and others.

Main inclusion criteria:

* Pruritus VAS Score 5 or higher at screening.
* Dermatological indication for a phototherapy with UVB nb / UVA
* Oral and written informed patient consent

Exclusion criteria:

- Patients will be excluded from the study if they fulfill any of the following criteria:

1. Foreseeable interruption of the light therapy for more than 14 days, or interruption of the light therapy for more than 14 days during the study
2. Heightened photosensitivity for UVA or UVB
3. Withdrawal of consent to participate
4. Concomitant participation in another study or having taken part in another clinical study within the last 30 days.