cyrilzakka/clinical-trials huggingface dataset:
Bioaerosol Sampling Device (BSD) Clinical Study

The goal of this clinical trial is to learn about the bioaerosol sampling device (BSD) and how it can sample patient bioaerosols (breath) and patient's nares for the detection of COVID-19 viral particles in patients seeking to be tested for COVID-19.

SARS-CoV-2, the virus which causes COVID-19, is transmissible through bioaerosols. Routine accessible, non-invasive, sensitive testing could play a role in reducing the spread of the disease and controlling the current and future pandemics. The Bioaerosol Sampling Device may offer both comfort and the potential to increase the ability to detect patients earlier in the infection cycle than a swab. The primary objective of the research is to generate BSD performance data with detection by RT-PCR and at-home molecular and antigen assays, compared to nasal swab comparator detected by EUA or 510k cleared RT-PCR.

Eligibility Criteria:
Inclusion Criteria:

Any patient 5 years or older who wants to be tested Patients may be symptomatic or asymptomatic based on CDC guidelines Patients may be suspected of having COVID-19 based on CDC guidelines Patient's COVID-19 status should be unknown Patients younger than 12 should be assisted by an adult

Exclusion Criteria:

Unable to self-consent Concurrent enrollment in other trials involving same-day nasal cavity sampling

Contraindication to nasal sampling as performed according to the clinical site policies and procedures, including:

Unable to tolerate Nasal Swab Sampling History of perforation of the nasal septum or prone to nosebleed Head or facial injury/surgery within the past 6 months On anticoagulant therapy including anti-platelet therapy Nasal or nasal aspirate and nasal wash performed as standard of care.
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory Indian postmenopausal women with osteoporosis
* greater than 5 years postmenopausal
* aged 55 to 75 years old
* absolute bone mineral density value consistent with a T-score less than -2.5 and greater than - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than or equal to -4.0 are at very high risk for fracture and will be excluded.

Exclusion Criteria:

* previous or current metabolic bone disease, Paget's or Cushing's disease, or hyperprolactinemia
* current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria
* rheumatoid arthritis
* cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal
* medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates
* medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists
* malignancy within 5 years except certain resected types
* malabsorption syndrome or gastrointestinal disorders associated with malabsorption
* abnormal calcium level
* vitamin D deficiency
* any laboratory abnormality that will prevent the subject from completing the study or interferes with interpretation of study results
* oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery
* any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures
* any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results
* known to have tested positive for HIV
* less than two lumbar vertebrae evaluable for DXA measurements
* height, weight, or girth that may preclude accurate DXA measurements
* drug or alcohol abuse within 12 months that interferes with understanding or completing the study
* known sensitivity to mammalian cell-derived drug products
* use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s)
Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)

The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.

Systematic pelvic and paraaortic lymphadenectomy is commonly performed in ovarian cancer patients. However, in early ovarian cancer systematic lymphadenectomy can be an unnecessary procedure which can cause perioperative morbidity and mortality. In the other hand, initially diagnosed early stage ovarian cancer can be upstaged after staging surgery with systematic lymphadenectomy. For preventing unnecessary lymphadenectomy in early ovarian cancer, sentinel lymph node procedure may be an alternative which can prevent major complications without missing the real stage of the disease.

Aim of our study is to assess the feasibility and accuracy of lymph node evaluation with sentinel lymph node technique in early ovarian cancer patients. Pelvic and paraaortic spaces will be evaluated for the sentinel lymph nodes after the injection of the tracers in infundibulopelvic and utero-ovarian ligaments. Than routine systematic pelvic and paraaortic lymphadenectomy will be performed with the routine practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Early stage ovarian cancer

Exclusion Criteria:

* Patient who had been administrated chemotherapy prior to surgery
* Patients who had diagnosed with malignancy other than ovarian cancer.
* Patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery.
* Patients who have allergy for the tracers.
Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes

This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not.

This will be done through:

1. Measuring bone changes around the implant by cone beam
2. Measuring change in bone density around the implants

B- Evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.

Twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. The Patients were divided into three groups (n=8), For the first group; immediately after extraction, PRF alone was added into the extraction socket prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion. For the third Group; PRF + Bone powder are inserted into the extraction site before implant insertion. A conebeam CT was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. In vitro experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization and osteogenic differentiation will be done. The cells were divided into two groups one control group and the other statin group. Osteogenic markers were measured in both groups and statistical analysis performed

Eligibility Criteria:
Inclusion Criteria:

* Badly Broken Down Tooth requiring extraction
* Medically Free
* Any other procedures or surgeries were performed 6 months earlier

Exclusion Criteria:

* patients with systemic diseases affecting bone quality or resorption
* temporomandibular joint dysfunction
* severe attrition or parafunctional habits
* patients undergoing radiotherapy or chemotherapy
* heavy smokers
* vulnerable groups like psychologically unstable patients.
Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have multiple myeloma.

OBJECTIVES: I. Evaluate the complete and partial response in multiple myeloma patients receiving peripheral blood stem cells supported by high dose carmustine and melphalan followed by consolidation therapy with cyclophosphamide/dexamethasone/etoposide/cisplatin (DCEP) and paclitaxel/cisplatin. II. Evaluate the incidence of early death in comparison with historical data in this patient population. III. Evaluate the feasibility of chemotherapy with DCEP and paclitaxel/cisplatin following autotransplantation in these patients.

OUTLINE: Patients receive carmustine IV over 2 hours on day -2, followed by melphalan IV over 20 minutes on day -1. Patients receive intravenous CD34 peripheral blood stem cells on day 0. At 3 months and 9 months, patients with adequate hematologic counts receive cyclophosphamide IV, oral dexamethasone, etoposide IV, and cisplatin IV for 4 days. At 6 and 12 months after autotransplantation, patients with adequate peripheral blood counts and creatinine receive oral dexamethasone on days 1-4, paclitaxel IV over 6 hours on day 2, and cisplatin IV over 24 hours on day 3. Patients are followed every 6 weeks to 3 months until death.

PROJECTED ACCRUAL: Approximately 24-63 patients will be accrued for this study within 2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven multiple myeloma with no greater than 12 months of prior therapy Bone marrow plasmacytosis at least 30% or protein criteria present No obvious myelodysplastic changes in the bone marrow No CNS disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 (3-4 acceptable if based solely on bone pain) Life expectancy: Not specified Hematopoietic: CD34+ at least 4 million/kg Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: LVEF greater than 50% Pulmonary: FEV1 or FVC at least 50% of predicted DLCO at least 50% of predicted Patients unable to complete pulmonary function tests must have a CT scan of the chest and acceptable arterial blood gases of PO2 greater than 70 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active infection requiring IV antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Prior steroid therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified
Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Don gu Bougou, Mali

There are about 300-500 million cases of malaria worldwide each year, with 2-3 million deaths. Plasmodium falciparum, one of four types of malaria, is responsible for most of these deaths. Because of increasing resistance of this parasite to drugs and of mosquitoes to insecticides, a vaccine would be valuable in the fight against malaria.

Don gu bougou, Mali, is an area of seasonal malaria transmission that is being investigated as a possible suitable site for testing investigational malaria vaccines. The goal of this study is to characterize the population of this site in terms of common hematologic (blood) and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials. The study will also assess the prevalence of preexisting medical conditions that might affect assessments of vaccine safety and efficacy. Also, the natural immunity to antigens in the investigational malaria vaccines will be determined.

Don gu bougou, Mali, was chosen because of its high malaria rates. Data will be collected at four time-points. At least 50 individuals will be recruited from each of the following age groups: 6 months-5 years; 6-10 years; 11-15 years; and 16-45 years. Village-wide consent will be obtained and about 25 of the 111 family compounds will be randomly selected. Individual consent will also be obtained.

Enrolled volunteers will undergo a baseline medical history and physical examination. Blood will be collected for various tests, and, for women of childbearing age, urine pregnancy tests will be administered.

At each of three followup visits, a brief medical history and physical exam will be conducted. Blood will be drawn for tests. Also, blood, urine, and/or stool tests not done at baseline will be done at one of the followup visits.

Doneguebougou, Mali, is an area of seasonal malaria transmission that is being investigated as a suitable site for testing investigational malaria vaccines. The overall goal of this study is to characterize the population of this site in terms of common hematologic and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials, as well as in terms of preexisting medical conditions and preexisting immunity to potential malaria vaccine antigens, both of which might impact on the assessment of vaccine safety and efficacy. The development of high quality laboratory proficiency to assess these parameters in Mali will also be achieved by this study.

Eligibility Criteria:
* INCLUSION CRITERIA:

Males or females aged 6 months to 45 years.

Resident of Doneguebougou at the start of the study, and intent to remain a resident for the duration of the study.

Willingness to participate in the study as evidenced by the completed informed consent document.

EXCLUSION CRITERIA:

Clinical evidence of acute life-threatening illness requiring immediate medical care.
RUSSE / Russian Spiriva® Safety & Efficacy Study

At the moment, there is hardly any structured safety and efficacy data collection on Tiotropium in Russia. Therefore, the objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation capsules) delivered by HandiHaler®, in a national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8 weeks.

The objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation capsules) delivered by HandiHaler®, in national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 8 weeks.

Study Hypothesis:

Primary interest is given to observe change from baseline in post-dose FEV1 after 8 weeks.

Comparison(s):

The objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 mcg tiotropium inhalation capsules) delivered by HandiHaler®, in national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. 40 years and older male and female ambulatory outpatients being seen in a participating physicians office for routine care
2. Patients not previously treated with the Tiotropium
3. Patients with clinical diagnosis of all stages of Chronic Obstructive Pulmonary Disease according to the current National Guidelines / 2004
4. Current smokers or ex-smokers with a smoking history of \>=10 pack years

Exclusion Criteria:

1. Uncooperative patients as judged by the physician,
2. Patients that have any condition which, according to the participating physicians opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation,
3. Patients with history of known preexisting or concomitant non-obstructive lung disease (e.g., sarcoidosis, tuberculosis, lung cancer),
4. Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems,
5. Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva®'s Russian package insert, such as:
6. Patients with known narrow-angle glaucoma,
7. Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction,
8. Patient with known moderate to severe renal impairment (creatinine clearance less than 50 ml/min),
9. Patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium or to any component of this product,
10. Pregnant or nursing women.
Stem Cells for Treating Critical Ischemia

Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots

About 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.This procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed

Eligibility Criteria:
Inclusion Criteria:

* Fontaine's classification grade 3 and 4 patients

Exclusion Criteria:

* Record of cancer in the last 5 years
* Over 80 years
* Diabetic retinopathy
Effectiveness of a Protocol of Specific Activation.

In football, knee is the joint that suffers the most severe injuries. Sometimes, this is produced by poor pre-activation of the musculature that is responsible for knee stability and central stability.

OBJETIVE: Study the efficacy of specific gluteus medius and core activation protocol in knee stability in youth football players.

A randomized, longitudinal clinical trial with a blinded and prospective evaluator will be carried out, in which the knee stability will be evaluated with the following tests: Y-balance test and Flamingo balance test. The measurements will be made before and after the intervention. The study will be carried out with patients evaluated by a specialist in Traumatology and will be randomly divided by a system of numerical tables through a computer program between the experimental and control groups. The control group will perform a typical warm-up of competitive football; and the experimental one will do this above, added to a specific activation of gluteus medius and core. Dynamic stability (Y-balance test) and postural and static stability (Flamingo balance test) will be measured before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Perform soccer sports practice, at least 3 times a week at a competitive level.

Exclusion Criteria:

* Subjects with a knee surgery.
* Patients who are injured at the time of the study.
Safety, Tolerability and PK of a Single iv Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Volunteers

The objective of the study is to investigate safety, tolerability, and pharmacokinetics of XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Age ≥ 18 to ≤ 45 years
* BP: 100 - 150 mm Hg systolic, 50 - 95 mm Hg diastolic and pulse rate: 50 - 100 bpm.
* Body mass index between 18.5 and 30.0 kg/m2 and body weight in the 50 - 100 kg range.
* Are able to communicate and co-operate with the Investigator and his/her staff
* Healthy on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings
* Written informed consent obtained
* Male subjects with partners of childbearing potential have to use adequate contraception during, and for at least the four weeks after administration of study medication.

Exclusion Criteria:

* Heavy smokers, i.e. more than 10 cigarettes per day
* Participation in a clinical trial during the previous 4 weeks
* Loss of 500 mL blood or more during the 3 month period before the screening visit of the study
* Existence of any surgical or medical condition which might relevantly interfere with the subject safety, the distribution, metabolism or excretion of the drug or the study assessments, i.e. impaired renal or hepatic function, diabetes mellitus, thyroid function abnormalities including abnormal thyroid hormone values in the Screening evaluation, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
* History of alcohol or drug abuse in the last 3 years.
* Positive results of the drug Screening.
* Clinically significant abnormal laboratory values at the Screening or baseline evaluation.
* A history of any serious adverse reaction or hypersensitivity to any drug or other medicines
* Presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis which requires no treatment may be tolerated).
* Positive results from serology examination for HBV, HCV, HIV or tuberculosis
* History of serious mental disorders.
* Need of any prescription medication within 30 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug or anticipated need for any concomitant medication during the study.
* Volunteers who are unwilling to comply with the provisions of this protocol
* Symptoms of a significant (upon Investigator's medical judgment) somatic or mental illness in the two week period preceding drug administration.