cyrilzakka/clinical-trials huggingface dataset:
A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)

This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 in healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Subject is less than or equal to 75 years of age
* Subject is a postmenopausal female
* Subject is within 30% of ideal body weight
* Subject is judged to be in good health
* Subject is a nonsmoker
* Subject is willing to avoid excessive alcohol consumption for the duration of the study
* Subject is willing to avoid strenuous physical activity for the duration of the study
* Subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study

Exclusion Criteria:

* Subject has a history of multiple/severe allergies to foods or drugs
* Subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study
* Subject has a history of major GI abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases
* Subject has a history of bone disease or treatment with bisphosphonates
* Subject has an infection/condition that would suppress the immune system, including HIV
* Subject has a history of chronic/active hepatic (liver) disease, including Hepatitis B and C
* Subject regularly uses illegal drugs
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day
* Subject requires use of any prescription or non-prescription medications during the study
* Part I only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; Glucocorticoid treatment; Vitamin A greater than 10,000 U/day, vitamin D greater than 2000 U/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.
The Relationship Between Superior Vena Cava Flow and Intraventricular Hemorrhage in Preterm Infants

The aim of the study was to evaluate the relationship between superior vena cava (SVC) flow measurements within the first 24 hours of life and development of intraventricular hemorrhage in preterm born infants.

A prospective, observational cohort study was carried out on newborns that fulfill the eligibility criteria and delivered at the Alexandria University Maternity Hospital (AUMH).

The Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital with total admissions of approximately 2100 newborn per year of which approximately more than 50% are admitted due to prematurity and its complications.

The study was carried out in 3 phases:

1. First phase: Enrollment and selection phase.
2. Second phase: Monitoring and Evaluation phase.
3. Third phase: Statistical analysis of the data

Eligibility Criteria:
Inclusion Criteria:

* Newborns with very low birth weight (≤1500 g) or ≤ 32 weeks gestation who were admitted to neonatal intensive care unit in the first day of life.

Exclusion Criteria:

* Newborns (more than 32 weeks of gestation
* Newborns with birth weight more than 1500 g.
* Newborns with congenital heart diseases excluding (patent ductus arteriosus and patent foramen ovale)
* Newborns with major congenital malformations.
* Newborns with birth trauma especially basal skull/temporal bone fractures that require hospitalization
An Exploratory Clinical Study to Investigate the Effect of autoSTEM-OA and alloSTEM-OA in Participants With Knee Osteoarthritis

A phase 1 exploratory clinical study to investigate safety, tolerance and efficacy of a single intra-articular injection of autoSTEM-OA or alloSTEM-OA in participants with mild to moderate knee osteoarthritis


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male or female, aged 18 - 60 years (both inclusive) at the time of informed consent.
3. Joint pain ≥ 30mm on 100mm VAS at screening
4. Grade 2-3 Kellgren Lawrence OA on radiograph with no full-thickness lesion \>1 cm in any dimension by x-ray
5. Failure of minimum 2 nonoperative therapies (oral pain medications, physical therapy, corticosteroid injection, or viscosupplementation injection)
6. Body mass index (BMI) within the range 18 - 35 kg/m2 (both inclusive)
7. Minimum 200 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs as judged by the investigator.
8. Agree to donate cells to alloSTEM-OA participants.
9. Fulfils eligibility criteria for allogeneic cell- and tissue donors.
10. Speaks and reads Danish or English

Exclusion Criteria:

1. Active tobacco use, or use of other nicotine substitutes
2. Active cancer or still in follow-up (5 years)
3. Rheumatologic disease
4. Avascular disease
5. Severe bone deformity
6. Previous infection of the knee joint
7. Pes anserine bursitis
8. pain attributed to diffuse edema
9. pain attributed to displaced meniscal tear or osteochondritis
10. Neurogenic or vascular claudication
11. Bleeding disorders
12. Chemotherapy
13. Radiation therapy to the leg or adipose harvested site
14. Knee injections within 3 months of treatment
15. Unable to discontinue the following drugs 7 days before injections (prescription pain medication, anticoagulation medicine (including ibuprofen), thrombolytics, antiplatelet medication)
16. Use of oral glucocorticoids.
17. Female who is pregnant, breast-feeding or intends to become pregnant within 1-year after the treatment, or is of child-bearing potential and not using highly effective contraceptive method.
18. Known chronic disease associated with metabolism malfunction or poor healing.
19. Allergy towards necessary anaesthesia
20. Varus/valgus malalignment \>5°
21. Isolated patellofemoral arthrosis
Study to Analyse Difference in Bioavailability Between MP29-02 and Fluticasone Propionate

The aim of this study is to investigate and to compare the bioavailability of MP29-02 and fluticasone propionate in nasal tissue after nasal application. This may provide a rational basis for the use of 1 puff per nostril dosage regimen of the drugs. Clinical experience has demonstrated the efficacy of the twice-daily treatment; however, so far, no data are available on the local tissue concentrations of MP29-02 after topical application.

The study will be a single-centre, two-treatment half-side comparative open-label trial; all subjects will receive Dymista® or Flixonase Aqua in one nostril each.

Nasal tissue samples will be obtained from 24 patients. Subjects will be selected based on the subjects plan to undergo septoplasty, septorhinoplasty, or functional endoscopic sinus surgery. Subjects with different diagnoses can be added in the study: non-allergic rhinitis, allergic rhinits, chronic sinusitis and nasal polyposis. The number of subjects is based on a previous experiment where the presence of fluticasone propionate was tested on human nasal mucosal surface and in human nasal tissue after nasal application (Bonsmann, 2001).

Eligibility Criteria:
Inclusion Criteria:

* - Male and female patients
* Age: 18 - 70 years (included)
* Subjects who need to undergo septoplasty, septorhinoplasty or functional endoscopic sinus surgery unrelated to this study
* Willing and able to provide informed consent

Exclusion Criteria:

* - Patients who are member of the staff or relatives thereof directly involved in the conduct of the protocol
* Participant in any other trial during the last 30 days
* Previous treatment with Dymista or any other topical corticosteroid spray or drops within the last month before the operation
* Previous treatment with systemic corticosteroid in the last 2 months before operation
* Previous treatment with anti-histaminics 7 days before operation
* Pregnant or breast feeding women
* Allergic for one of the compounds azelastinehydrochloride or fluticasonpropionate
* Significant co-morbidity (for instance, but not limited to):

  * Glaucoma, cataracts, and increased intraocular pressure.
  * Subjects with active or quiescent tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex
  * Subjects with severe liver disease
* Use of prohibited concomitant medication

  * Potent inhibitors of cytochrome P450 (CYP) 3A4
  * Ritonavir
* Patients unwilling or unable to attend the proposed visit schedule
* Patients suspected or known not to be trustworthy or who are likely not to comply with the study directives
Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm

The purpose of this study is to determine whether pretarsal and preseptal techniques of Botulinum toxin type A injection have any effect on tear functions.

Botulinum toxin type A has been used for hemifacial spasm since 1986. of Botulinum toxin type A can be subcutaneously injected at pretarsal or preseptal portion of orbicularis muscle. Blepharoptosis has been reported less frequently with pretarsal technique, however dry eye was noticed in one patient treated with pretarsal botulinum toxin type A for cosmetic purpose.

Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed with hemifacial spasm

Exclusion Criteria:

* previous history of botulinum toxin treatment for hemifacial spasm
* ocular surface disorders
* tear disorders
* evidence of infection at or around eyelids
* pregnant woman
* other neurologic disease, i.e. OMG
* coagulopathy or treatment with thrombolytic agent
* treatment with aminoglycosides, chloroquine, hydroxychloroquine
Reproducibility of Interactive Cariogram Software Versus Manual Caries Risk Assessment Form

Reproducibility of Interactive Cariogram Software versus Manual Caries Risk Assessment Form on Clinician Decision: observational study

A main factor for planning any preventive program is to accurately assess a person's risk of developing a caries. Dental caries is a multifactorial disease and is affected by several factors, such as the patient's general health and diet, the amount and type of bacteria present in the oral cavity, salivary factors and exposure to fluoride.

Thus, caries risk assessment approaches should take into account risk implications from various factors that influence carious activity Many caries risk assessment models had been developed to assess the caries for certain individual, this study will be carried out to measure the reproducibility between CAMBRA and cariogram model to evaluate if one of them is enough to be used as they give the same result or not

Eligibility Criteria:
Inclusion Criteria:

* Patients should be in range of 18-40 years old. Patient should have good periodontal health

Exclusion Criteria:

* Patient below 18 years and above 40 years old Patient with periodontally affected teeth and mobility. Patient with multiple extraction
Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients

The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.

Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at an initial dose of 20 mg/kg orally once per day. Patient transfusion history and at least three complete blood count (CBC) values must be available for the 12 weeks prior to study registration for patients with MDS and chronic iron overload from blood transfusions.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with low or intermediate (INT-1) risk MDS
* Patients can be EITHER naïve to iron chelation OR have had prior treatment with deferoxamine (DFO).
* Age greater than or equal to 18 years
* Availability of transfusion records for the 12 weeks prior to registration
* A lifetime minimum of 30 previous packed red blood cell transfusions
* Availability of at least three CBC values (pretransfusion) during the 12 weeks prior to registration
* Serum Ferritin:

For entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year.

Serum ferritin ≥ 1000 ng/mL at screening via the central lab.

* Life expectancy ≥ 6 months
* Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)
* Able to provide written informed consent

Exclusion Criteria:

* Serum creatinine above the upper limit of normal
* Alanine aminotransferase (ALT) \> 500 U/L during screening
* Clinical or laboratory evidence of active Hepatitis B or C
* Urinary protein/creatinine ratio \> 0.5 mg/mg
* History of HIV positive test result (ELISA or Western blot)
* Eastern Cooperative Oncology Group (ECOG) Performance Status \> 2
* Patients with uncontrolled systemic hypertension
* Unstable cardiac disease not controlled by standard medical therapy
* Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation
* Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment
* Pregnancy or breast feeding
* Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days
* Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug
* History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative
The Canada Lymph Node Score: A Feasibility Randomized Controlled Trial

For patients diagnosed with early stage Non-Small Cell Lung Cancer (NSCLC) on preoperative computerized tomography (CT) and positron emission tomography (PET) scans, surgical resection is usually the preferred method of treatment. However, to be eligible for surgery, current guidelines require that the cancer has not spread to the lymph nodes in the chest cavity. To evaluate these lymph nodes, the standard of care is to undergo an endobronchial ultrasound (EBUS) procedure, where all the visible lymph nodes in the chest are biopsied (sampled) with a needle. Unfortunately, these biopsies are often inconclusive, especially in patients who have no evidence of mediastinal lymph node spread on pre-operative imaging. Currently, the standard of care mandates that inconclusive biopsies should be repeated, either through another EBUS, or through more invasive procedures. Repeat inconclusive biopsies are oftentimes inconclusive as well; leading to a vicious cycle of inconclusive results, a delay in treatment, morbidity for the patient, and increased costs to the healthcare system. To circumvent this issue, the investigators have developed, validated and published a 4-point score, the Canada Lymph Node Score (CLNS), which uses four features observed during EBUS to predict whether the cancer has spread to the lymph nodes or not. Research has demonstrated that lymph nodes which appear benign on both CT and PET scan that also have a CLNS of ≤1/4 are almost certainly benign. As such, it is believed that these "triple normal" lymph do not require biopsy (or repeat biopsy).

The investigators are challenging the current standard of care in lung cancer, which mandates that all the lymph nodes in the chest need to be biopsied (i.e. Systematic Sampling) before surgery, by proposing that triple normal lymph nodes can be omitted, and only those with cancer potential should be biopsied (i.e. Targeted Sampling).To prove this hypothesis, a randomized controlled trial comparing Systematic Sampling to Targeted Sampling is required. A feasibility trial is proposed to determine whether this large-scale randomized trial will be possible.


Eligibility Criteria:
Inclusion Criteria:

* Referred to have EBUS for staging of confirmed or suspected NSCLC
* Completed both a CT and PET scans
* cN0-cN1 disease indicated on CT and PET scans

Exclusion Criteria:

* Patients with cN0 disease, peripheral tumours and tumours \< 2 cm in diameter (they do not require staging)
* Evidence of cN2 disease or higher on CT and PET scan
A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

To evaluate the clinical efficacy and safety in patients with mild or moderate community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as mild or moderate in severity by the classification of pneumonia "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy (established in 2000)".

Exclusion Criteria:

* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases. ("Severe" assessed by the Severity of underlying diseases and complications of "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections (draft)" by the Japan Society of Chemotherapy (1997)).
Ultrasling Quadrant Versus Bledsoe ARC Shoulder Brace

Shoulder orthoses are an essential component of both, postoperative care as well as a range of conservative treatment concepts, and thus influence the functional outcome of a wide spectrum of glenohumeral pathologies. Therefore it is important to look at them in greater detail.

A new concept, designed by DJO Global in the "Ultrasling Quadrant®" orthosis now immobilizes only the glenohumeral joint, while giving the possibility of elbow movement. It also allows multiple settings concerning the position of the glenohumeral joint like internal rotation as well as neutral or external rotation. It is yet to be seen how these changes will influence the outcome of therapy as well as how they will change the patient's perception of the orthosis and its wearing comfort. Therefore it is planned to be compared to another multifunctional shoulder brace already established on the domestic and international market, the BledsoeARC® brace.

The primary objective is to assess if one of the investigated shoulder braces Ultrasling Quadrant® or Bledsoe Arc® is perceived by patients who received shoulder surgery as superior in terms of higher wearing comfort when worn during the post-operative immobilization period.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (18 years or older)
* Presence of one of the following defined shoulder pathologies with the corresponding surgical treatment:
* Patients with isolated supraspinatus repairs in double row technique with or without biceps Treatment
* Recurrent anterior instability without significant bone loss and arthroscopic Bankart repairs with three anchors
* Rockwood Type V injury treated with arthroscopic-assisted low-profile TightRope Repair plus AC-Cerclage
* Patients with rotator cuff arthropathy treated by reverse shoulder prosthesis
* Signed Informed Consent to participate in the study

Exclusion Criteria:

* Non-tolerance of one of the braces (e.g. allergy to textile component)
* Presence of concurrent pathology of the contralateral arm , that interferes with the immobilizing treatment
* Presence of another physical disability or health disorder (e.g. psychological disorders, dementia, ...) that make the handling of the braces more difficult or impossible
* Patient perceived as being at risk of poor study compliance
* Occurrence of an intra-operative adverse event likely to influence the post-operative immobilization and its evaluation
* Inability to understand and speak German
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Alternative Delivery of Dose Adjustment For Normal Eating (DAFNE) Trial in Patients With Type 1 Diabetes

The best format for the delivery of structured education for adults with Type 1 diabetes is unclear. Currently some hospitals invite their patients to attend a 5 day outpatient course run over one week (Dose Adjustment For Normal Eating (DAFNE)). Other centres offer 1 day a week for 3 to 5 weeks. We aim to find out whether or not the benefit of benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility.

The DAFNE (Dose Adjustment for Normal Eating) course is a 1-week structured education course teaching skills in insulin use and dietary freedom to individuals with Type 1 diabetes. At the moment, we do not understand enough about why some people get more out of the DAFNE programmes than others. Currently DAFNE is always taught over 1 week. We aim to find out whether or not the benefit of DAFNE is the same whether it is delivered over 5 consecutive days, or one day a week for 5 consecutive weeks. If the benefits are the same then it would mean that the course could routinely be offered to patients in either format, thus allowing more patient choice and flexibility. At present there have been no RCTs to address

Approximately 170 people will take part in this study over the next 2 years. Half the people who participate will be allocated to attend a DAFNE course over 5 consecutive days, and the other halfwill attend one day a week for 5 consecutive weeks. We will perform routine biomedical assessments as part of the DAFNE programme and normal diabetes care (e.g. HbA1c (a measure of long-term blood glucose control), weight, blood pressure, blood biochemistry), and ask patients to recall hypoglycaemic (low blood sugar) events. We will also ask participants to fill in some research questionnaires, they will take 45-60 minutes to fill in each time. They will include questions about their diabetes, quality of life, well-being and diabetes knowledge. These assessments will be made at 3 time points; baseline, 6 and 12 months.

The main outcome measure is change in HbA1c, with the other biomedical and psychosocial parameters being of secondary importance. These evaluations will help us develop the DAFNE programme further and inform us how best to deliver the course in the future.

Eligibility Criteria:
Inclusion Criteria:

* adults with Type 1 diabetes for at least 6 months
* HbA1c \<12%
* willing to undertake intensive insulin therapy

Exclusion Criteria:

* severe diabetic complications (making group education difficult)
* inability to communicate in English
* strong preference for on attending a one week course or one day a week for 5 consecutive weeks
* inability to give informed consent
The Risks of Percutaneous Native Kidney Biopsy in Italy: a Prospective Cohort Study

The estimates risks and benefits of the percutaneous kidney biopsy have been reported mainly from retrospective studies. So far no prospective multicentre studies has been designed to identify rates of biopsy related complications. The aim of this prospective multicentre study was to evaluate safety and complication events related to biopsies on native kidney in Italy.

Kidney biopsies performed in 54 italian nephrology centres from 2012 to 2020 were included.

Primary outcome of the study was any major complication, such as haemoglobin decrease more than 2 g/dL, macroematuria, gross ematoma, blood transfusion, artero-venous fistula, invasive intervention, pain, symptomatic hypotension, and/or rapid serum creatinine increase.

Centre and individual patient risk predictors were analysed using multivariate logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* adult or pediatric patients with a kidney disease
* informed Consent

Exclusion Criteria:

* patient with a transplanted kidney