cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study

PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of PNEUMOSTEM® in premature infants at high risk for BPD.


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)
* A subject whose gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) \< 28 weeks)
* A subject whose birth weight is between 500g and 1000g, inclusive
* A subject who is intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening
* A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment
* A subject whose parent/guardian can give a written informed consent

Exclusion Criteria:

* A subject who has a congenital heart defect, except for patent ductus arteriosus (PDA), atrial septal defect (ASD) or a small, restrictive ventricular septal defect (VSD)
* A subject who has a serious malformation of the lung such as pulmonary hypoplasia/aplasia congenital diaphragmatic hernia, or other congenital lung anomaly
* A subject who has a chromosomal abnormality (e.g., Trisomy 18, Trisomy 13 or Trisomy 21) or a severe congenital malformation (e.g., hydrocephalus and encephalocele, tracheo-esophageal fistula, abdominal wall defects, and major renal anomalies)
* A subject who has had a severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, HIV, etc.)
* A subject who has evidence of severe sepsis or septic shock due to an active infection at Screening
* A subject who underwent a surgical procedure within 72 hours before study drug administration or who is anticipated to have a surgical procedure within 72 hours before or following study drug administration
* A subject who was administered surfactant within 24 hours before study drug administration
* A subject who has had a bilateral grade 3 or 4 intracranial hemorrhage
* A subject who has active pulmonary hemorrhage or an active air leak syndrome at Screening
* A subject who is currently participating in any other interventional clinical trial
* A subject who is, in the opinion of the Principal Investigator, considered inappropriate for the trial due to any reasons other than those listed above
Efficacy and Safety of 3% Minoxidil Lotion for Chest Hair Enhancement

The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for chest hair enhancement.


Eligibility Criteria:
Inclusion Criteria:

* healthy male

Exclusion Criteria:

* serious underlying diseases
* history of chest/ hair treatment before 6 months
* history of surgery or trauma on chest area.
* history of minoxidil allergy
Validation of New G6PD Point of Care Tests Against Gold Standard Quantitative

This is a laboratory research to evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping.

Radical cure of P. vivax malaria can be achieved using large doses of primaquine which have shown to cause some degree of hemolysis even in subjects who tested normal by the conventional qualitative G6PD tests. Different regimens of drug might be more appropriate in subjects with intermediate G6PD activity which can be currently measured only in well equipped laboratories. Validation of new qualitative and quantitative point-of-care tests is essential to for safe deployment of standard and new radical cure regimens against Plasmodium vivax.

This study will evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping. Patients will be searched from the electronic record database to identify up to 150 patients with the following characteristics: approximately 50 G6PD-deficient men and women (however only a very small percent of deficients are homozygous women) approximately 50 G6PD-heterozygous women with intermediate activity, and approximately 50 G6PD-normal individuals and patients who meet the screening criteria will be contacted at their home by a clinic staff member. The home visitor will explain study details and invite to participate in the study. If the patients express interest in participating, they will be directed to visit the following month at the clinic where they usually receive care.

After signing the informed consent form, two blood samples will be withdrawn; one sample will be taken by finger-stick (200 µl) and one sample (0.5 ml) will be taken by arm venipuncture. The blood from capillary sample will be used to assess G6PD activity using the POC tests, CBC and laboratory based quantitative tests. The venous blood will be used for reference standard quantitative G6PD assays, Hb typing analysis, CBC and buffy-coat will be stored for DNA extraction for G6PD genotyping only; leftover blood will be discarded.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with age ≥ 18 years
* Subjects willing to participate and sign informed consent form
* Male and Female
* Previously tested G6PD deficient, G6PD normal and G6PD intermediate or heterozygous for G6PD variants at SMRU clinic

Exclusion Criteria:

* Patients with severe malaria or other severe or any acute illness
* Patients who received a blood transfusion in the last 3 months
* Patients who received primaquine in the past 1 month (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)
* Patients who have not had a critical illness or received other hemolytic drugs (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)
Social Anxiety Disorder in Medical Students in Sohag University

The study will be done in Sohag University to assess the prevalence and associated factors of Social Anxiety Disorder among undergraduate medical students .

Social anxiety disorder (SAD) is highly prevalent and it's the most common anxiety disorder among all types of anxiety disorders and the third most common psychiatric condition after major depression and alcohol dependence.

Social anxiety disorder (SAD) is characterized by persistent fear/anxiety about one or more social or performance situations in social settings.

SAD had a negative impact on learning ability, educational achievement, professional achievement, quality of life and social relationship \& may lead to substance abuse and depressive disorders.

Eligibility Criteria:
Inclusion Criteria:

* Medical undergraduate students who are still studying for Bachelor of Medicine and Bachelor of Surgery ( M.B.B.Ch ) .

Exclusion Criteria:

* students who will refuse to participate in this study .
Prospective Data Collection of Newly Diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma Cases

Prospective Data Collection of Newly Diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma Cases

Prospective Data Collection of Newly Diagnosed HD and NHL.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma

Exclusion Criteria:

* Patients with diagnosis other than HD and NHL.
The Effect of Combined Speech and Music-therapy on the Speech Characteristics of People With Parkinson's Disease (PD)

Speech and voice disorders are observed in almost 90% of patients with PD during their course of illness. Reduced voice pitch inflections or monotone speech, reduced vocal loudness, prosody disorders, the imprecise articulation of the consonants, hoarseness, and breathy voice is also observed in patients with PD; these symptoms often lead to reduced speech intelligibility. The aim of this study will to investigate the possible changes in the voice and speech features in people with PD after a combined speech and music therapy using Telerehabilitation.

the investigators of this study propose to conduct a pilot randomized, controlled trial in patients with PD to assess the potential effectiveness of a Telerehabilitation intervention that encourage a higher level of speech performance. The investigators hypothesize that patients in the combined treatment group will have more and better improve in the study outcome measures after treatment and 3 month follow up, as compared with patients in speech therapy group and music therapy group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic Parkinson's disease (IPD)
* Patients who are in stages 1-3 according to Hoehn \& Yahr test
* Native language is persian
* The patient or family complains about the person's speech condition
* Adequate vision and hearing
* No history of stroke, head injury, brain surgery, laryngeal diseases such as vocal cord nodules
* No other neurological disorders other than IPD
* Do not use treatment other than medication (such as deep brain stimulation surgery (DBS)
* informed consent

Exclusion Criteria:

* If a patient develops a stroke or other neurological complication during treatment, they are excluded from the treatment
* Lack of cooperation
Optical Coherence Tomography Guided C&D

The purpose of the study is to identify the presence of residual superficial and nodular basal cell carcinoma (BCC) status-post curettage and desiccation (C\&D) by using optical coherence tomography (OCT).


Eligibility Criteria:
Inclusion Criteria:

* Patients of any: age, gender, Fitzpatrick skin type and ethnicity.
* Primary BCC of any type, except aggressive types that fit the criteria for Mohs surgery
* No prior treatment on the lesion within the last 3 months.
* Lesions anywhere except the head, neck and distal extremities.
* Willing and able to sign informed consent

Exclusion Criteria:

* Aggressive BCC types.
* Recurrent tumors.
* Lesion treated within last 3 months.
* Lesions on head and neck (high risk areas)
* Lesions on distal extremities (thin epidermis not preferred for OCT).
* Pregnant women.
* Patients less than 18 years old.
* Prisoners.
* Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol
Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B

The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe hemophilia B (FIX: C ≤2%)
* Previously treated patients (PTPs) with ≥150 documented exposure days
* Age ≥ 12 years (US sites only)

Exclusion Criteria:

* Detectable factor IX inhibitor defined as ≥0.6 Bethesda Units for pooled plasma reported by the local laboratory (family history of inhibitors will not exclude the patient)
* Patient history of factor IX inhibitor replacement therapy
* Patient unable to be off factor IX replacement therapy for at least 5 days without bleeding
Weissella Cibaria JW15 Consumption and NK Cell Activity

A The aim of this study was to investigate the impact of consuming Weissella cibaria (W. cibaria) JW15 supplementation isolated from Kimchi, Korea traditional fermented food, on natural killer (NK) cell activity and circulating levels of cytokines and immunoglobulin (Ig).

A randomized, double-blinded, placebo-controlled study was conducted on 100 nondiabetic subjects. Over an eight-week testing period, the probiotic group consumed 4 capsules (300 mg/capsule) containing 1 x 10\^10 colony-forming units (cfu) of W. cibaria JW15 each day, whereas the placebo group consumed the same product without a probiotic.

Eligibility Criteria:
Inclusion Criteria:

* Nondiabetic (fasting serum glucose concentration \< 126 mg/dL)
* Subjects with 4,000-8,000 leukocyte counts

Exclusion Criteria:

* Constant consumption of any probiotic products
* Taking medicine related to inflammation within one month before screening
* Allergy to probiotics
* Lactose intolerance
* Diabetes
* History/presence of significant metabolic disease
* Acute or chronic disease requiring treatment
* Taking any medications
Evaluation of Human Milk Fortifiers in Preterm Infants

The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.


Eligibility Criteria:
Inclusion Criteria:

* Birth weight of 700 g-1500 g.
* ≤ 32 weeks and 0 days GA at birth.
* Appropriate for GA (AGA).
* Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0).
* Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified.
* Parent(s) agrees to allow infant to receive both human milk and HMF.
* Singleton or twin births only.

Exclusion Criteria:

* Enteral feeding of preterm infant formula or HMF for \> 7 days.
* Expected to be transferred to another facility and will not be able to be followed for at least 15 days.
* Serious congenital abnormalities or underlying disease that may affect growth and development.
* 5 minute APGAR ≤ 4.
* Steroids used at the time of randomization.
* Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).
* Mechanical ventilator dependence.
* Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.
* Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
* Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \<3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \< 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24).
* Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
* Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.
* Participation in another study that has not been approved as a concomitant study by AN.
A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart Failure

The purpose of this study is to investigate the safety, tolerability, pharmacodynamics (how the study medication affects the body) and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of an intravenous administration of JNJ-39588146 or placebo over a 3-hour period in patients with heart failure. The highest tolerated dose received during the first 3 hours of the study will be administered to some patients for an additional 18 hours. There will be up to 3 doses given throughout the administration period over a total of up to 21 hours.

This study will assess the safety, tolerability, pharmacodynamics and pharmacokinetics of JNJ-39588146 or placebo (which looks like the drug being studied but has no active ingredients) in patients with heart failure. This study is being conducted in two parts. Part 1 is a randomized (study drug will be assigned by chance), double-blind (neither the physician nor patient knows the identity of the assigned drug) study of 3 intravenous doses of JNJ-39588146 or placebo administered in 1-hr intervals (for a total of 3 hours) in 60 patients with heart failure. Part 2 is an extended infusion of JNJ-39588146 and placebo that will administer the highest tolerated dose from Part 1 for an additional 18 hours. The entire duration of the infusion could be as long as 21 hours. There is a 1 in 4 chance of getting placebo. The participation period is a maximum of 42 days, including a screening visit, a 2-day in-clinic period and two follow-up visits. For both parts of the study, patients will have a cardiac catheter in place to monitor heart function. Safety evaluations, which will include ECG (electrocardiograph, measuring the electrical currents in the heart), vital signs and monitoring of side-effects will be performed. Additionally, blood and urine samples will be collected for evaluation. Part 1: Patients will receive an intravenous (IV) solution of three different doses of JNJ-39588146 or placebo administered over 1 hour periods for a total of 3 hours. Part 2: Patients participating in the sub study will continue receiving an IV solution for 18 more hours for a total of up to 21 hours of administration.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been diagnosed with heart failure
* Women must be either postmenopausal or have been surgically sterilized at least 6 months ago
* Males must be willing to use an acceptable birth control method for 3 months after the last dose of study medication.

Exclusion Criteria:

* Patients must not have had an heart-assist device or heart transplant or be in imminent need of one
* Patients must not have had an ischemic attack within the last 6 months or a heart attack within the last month
* Patients must not have lung disease or congenital heart failure.
Non-interventional Study -Observe Treatment Efficacy in Maintaining Symptoms Control in Schizophrenia With Seroquel XR

the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Patients will have a diagnosis of schizophrenia , as defined by DSM-IV-TR and their symptoms are controlled with Seroquel XR therapy started approximately 1 month before
* All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.

Exclusion Criteria:

* All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
* As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
Neoadjuvant Combined Endocrine and HER2 Target Therapy in Postmenopausal Women With ER and Her2 Positive Breast Cancer

Cross-talk between epidermal growth factors and the ER occurs at multiple levels and seems to play a crucial role in breast cancer progression and endocrine resistance.Combined HER1/HER2-targeted therapy with aromatase inhibitors for ER-positive and HER-2 positive postmenopausal breast cancer might enhance response and block emergence of endocrine resistant tumor.

1. To evaluate the efficacy of the neoadjuvant combination therapy with letrozole and lapatinib in postmenopausal patients with ER-positive and HER2-positive breast cancer.
2. To assess markers predictive of treatment response and outcome in this setting.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Female patients
* Histologically confirmed invasive breast cancer
* Primary tumor greater than 2cm diameter, measured by sonography
* N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed)
* ER positive (intermediate and strong positive)
* HER2 positive (IHC3+ or FISH positive in case of IHC 2+)
* No evidence of metastasis (M0)
* No prior hormonal, chemotherapy or radiotherapy is allowed
* No breast operation other than biopsy to make diagnosis is allowed
* Postmenopausal women with ECOG Performance Status of 0 or 1
* Postmenopausal, as defined by any of the following:
* At least 55 years of age
* Under 55 years of age and amenorrheic for at least 12 months OR follicle-stimulating hormone (FSH) values ≥ 30 IU/L and estradiol levels ≤ 20 IU/L
* Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months
* Adequate hematopoietic, renal, hepatic function:

Exclusion Criteria:

* Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
* Patients who underwent surgery for breast cancer
* Patients with bilateral invasive breast cancer
* Patients with inflammatory breast cancer (T4d)
* Patients without primary tumor (T0) Inability to perform \[18F\]FES PET imaging due to physical inability, claustrophobia, or other mental illness.
* ER poor disease as defined locally (e.g: Allred score 1-3, H-score\<100)
* Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
* Chronic daily treatment with aspirin (\>325mg/day) or clopidogrel (\>75mg/day)
* Chronic daily treatment with corticosteroids (dose of \>10mg /day ethylprednisolone equivalent)
* Clinically significant cardiovascular disease: CVA/stroke (\<6month prior to enroll), MI (\<6month prior to enroll), unstable angina, NYHA Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication.
* Hormone replacement therapy within 4 weeks of starting treatment
* Known hypersensitivity to any of the study drugs including ditosylate monohydrate salt
* Pregnant or nursing mother (if applicable)