cyrilzakka/clinical-trials huggingface dataset:
Oxygen Supplementation During Bronchoscopy: High Flow Versus Low Flow Oxygen

In general bronchoscopy is a safe procedure with low rate of complications. Indeed, contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is the case of preexisting decreased blood oxygen levels which may be present in patients requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen drops oxygen supplementation is recommended.

The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula during flexible bronchoscopy.

Consecutive patients referred by their treating physician for bronchoscopy will be offered to take part in the study. Those who wish to participate and give their consent will be randomly assigned into one of two treatment groups (supplemental oxygen given via low flow nasal cannula or via high flow nasal cannula).

Assignment to either treatment arm will not affect in any way the intended purpose of the bronchoscopy. All patients will be closely monitored during the procedure and 2 hours following its completion. Monitoring will be conducted, using strictly non-invasive measures.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo routine bronchoscopy for diagnostic purposes

Exclusion Criteria:

* inability to give an informed consent
* nasal deformities
99Tc-MDP Treatment for Knee Osteoarthritis

Osteoarthritis (OA) of knee is the most common form of arthritis in the world1e, and it has received growing attention in the society because of the increase of old age population, disabled people, and medical expenses from this disease. 99Tc-MDP is effective for rheumatoid arthritis. Therefore, the investigators try to investigate the effects of 99Tc-MDP treatment in patients with osteoarthritis of knee as compared with celecoxib.

The prevalence of osteoarthritis of the knee (OA) is increasing worldwide and this burden will continue to increase owing to aging of the general population 99Tc-MDP is effective for rheumatoid arthritis. Consequent to an increase in incidence is the rise in the number of patients with knee OA who are prone to further deterioration of the knee. It therefore is important to better understand, control, and attempt to prevent further progression of disease in patients with knee OA. Limitations in walking, stair climbing, and squatting are common patient complaints that greatly interfere with activities of daily living and recreation. Currently there is no definite consensus on the standardized management of OA. Oral analgesic and anti-inflammatory agents are perhaps the most commonly prescribed treatments to alleviate knee OA symptoms. The failure of nonsurgical therapies to modify quality of life in knee OA patients is not surprising given their inability to alleviate physical manifestations of OA. Surgical knee OA interventions generally result in good to excellent patient outcomes. However, there are significant barriers to considering surgery, which limits clinical utility.

99Tc-MDP is actually the decay product of 99mTc-MDP (99mTc-methylene diphosphonate, a US Food and Drug Administration-approved radioactive agent widely used for bone scintigraphy). 99Tc-MDP (Chengdu Yunke Pharmaceutical, Sichuan, China) is a kind of anti-inflammatory drug patented in China (patent no. ZL94113006.1). It was approved for production by the State Food and Drug Administration of China in October 1997. 99Tc-MDP has been demonstrated to be safe and effective in the clinical treatment of immune diseases, such as rheumatoid arthritis (RA), ankylosing spondylitis (AS) and certain bone diseases, such as skeletal metastases from cancer in China. 99Tc-MDP also showed clinical effect on knee OA in our practice. Therefore, the investigators try to investigate the effects of 99Tc-MDP treatment in patients with osteoarthritis of knee as compared with celecoxib.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with painful osteoarthritis;
2. The standard uptake value (SUV) of OA related knee greater than 10 on 18F- sodium fluoride bone scan;
3. Participants voluntarily participate in the trial, and signed the informed consent.

Exclusion Criteria:

1. Knee joint replacement;
2. Inflammatory arthritis or joint infection of knee;
3. Nervous joint disease;
4. Fracture of joint;
5. Gout arthritis of the knee;
6. Traumatic arthritis.
The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)

This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function.


Eligibility Criteria:
Inclusion Criteria:

* o 15 ± 3 days of age at randomization, inclusive (day of birth is considered day 0)

  * Singleton birth
  * Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
  * Birth weight of 2500g to 4000g
  * Signed informed consent obtained for infant's participation in the survey
  * Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey
  * APGAR score after 5 minutes of life \> 7
  * Consuming only one source of nutrition
  * Formula-fed infant: Infant consuming infant formula as the sole source of nutrition for 7 consecutive days prior to randomization
  * Breastfed infant: Infant consuming mother's breast milk as the sole source of nutrition for 7 consecutive days prior to registration

Exclusion Criteria:

* Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days
* Diseases jeopardizing intrauterine growth
* Weight at Visit 1 is \<95% of birth weight \[(weight at Visit 1÷birth weight) x 100 \<95%\]
* Infant born from mother suffering from metabolic and/or chronic diseases
* Infant with an acute infection or gastroenteritis at time of randomization or registration
* Infant consuming supplemental foods
* Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization or registration
* Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others
High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures

Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular procedures. The clinical significance of an inadequate response to clopidogrel following percutaneous coronary interventions has been recently recognized.This study was designed to investigate platelet responsiveness to Clopidogrel following endovascular therapy of peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Rutherford 3-6 stage of peripheral arterial disease scheduled to undergo femoropopliteal or and infrapopliteal angioplasty or stenting.
* Patients receiving Clopidogrel per os 75 mg daily at least 1 month prior and 1 year after the procedure.

Exclusion Criteria:

* Acute limb ischemia
* Coagulation disorders
* Known allergy to clopidogrel
* Failure to comply with the antiplatelet treatment protocol
* Aortoiliac disease
Respiratory Training in Low Back Pain

Objective: To determine the effectiveness of bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in patients with low back pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 96 patients with low back pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients with low back pain during 6 weeks

Exclusion Criteria:

* Neural disorders
* Systemic disorders
* Cognitive disorders
Gastrointestinal Implications of Voriconazole Exposure

Voriconazole has better response rates, improved survival and less adverse side effects compared to other drugs for the treatment of invasive fungal infections making it a desirable therapeutic option for children. However, dosing is unpredictable in children and this leads to therapeutic failure. This study aims to understand the physiological differences between children and adults that leads to therapeutic failure of voriconazole in children.

Voriconazole clearance in children (2-12 years old) is 3-fold higher and bioavailability is one half of adult values. An important gap in knowledge exists that explain the mechanisms that result in higher clearance and lower bioavailability of voriconazole and places children at a substantial risk for sub-therapeutic concentrations and treatment failures. Preliminary data suggests that intestinal first-pass metabolism is responsible for the lower bioavailability in children, but not in adults. By inhibiting intestinal metabolism with grapefruit juice, the extent of the effect of intestinal first-pass metabolism on voriconazole pharmacokinetics can be determined. Inpatient children at the Children's Hospital of Philadelphia who are receiving oral voriconazole as standard of care will be enrolled in an open label, cross-over clinical trial to monitor plasma voriconazole levels after voriconazole administration with and without grapefruit juice to inhibit intestinal metabolism of voriconazole. The proposed research will elucidate the role of intestinal metabolism in the reduced oral bioavailability of voriconazole in children, which can be incorporated into a model simulation to guide accurate dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 2-17 years old
2. Receiving oral voriconazole as standard of care and at steady-state concentrations (defined as 72 hours from first-dose or 72 hours with no dose change)
3. Informed Consent/Assent when appropriate

Exclusion Criteria:

1. Allergy or inability to receive the slushy solution, which will be prepared using commercially available frozen grapefruit juice concentrate, cherry syrup, and Sprite.
2. Receiving tacrolimus and/or cyclosporine, which are affected by the furanocoumarins, during study period
3. Suspected or known hepatic dysfunction (defined as liver function tests measured at 3x upper limit of normal within the past 1 month, when measured as standard of care)
4. Receiving renal replacement therapy (example peritoneal dialysis, hemodialysis, continuous veno-venous hemofiltration, continuous veno-venous hemodialysis)
5. Receiving therapy with extracorporeal membrane oxygenation (ECMO)
6. Patients with documented pancytopenia, diarrhea, mucositis, or active infection
Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.

Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. This preparation has been used for treatment of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of malignancy and in gynecological disorders. It does not require a test dose to be given before total dose, nor does it require any premedication. It can be given in a dose of 20mg/kg. The drug has been licensed for use in Europe in 2009. It has been used for treatment of anemia in patients with chronic renal disease, inflammatory bowel disease and in anemia due to malignancies

Eligibility Criteria:
Inclusion Criteria:

* Women within 24-48 hours of delivery with hemoglobin concentration \< 10gm/dl

Exclusion Criteria:

* History of PPH, or significant blood loss in last 24 hours
* History of allergy to iron preparation
* Hemoglobin \< 7gm/dl.
* Sign \& symptoms of cardiac failure
* H/o blood transfusion in last 3 months
* H/O Chronic liver diseases.
* ↑ Creatinine \> 2mg/dl.
Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032)

The purpose of this study is to demonstrate an improvement in physical functional recovery, following administration of Drug for 24 weeks, in patients who have recently experienced a hip fracture. This study will also evaluate the safety and tolerability of Drug.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Patient has had surgery for a unilateral hip fracture, and is considered to be partially or fully weight bearing after the surgery
* Surgical repair of the fracture has occurred no more than 4 days post hip fracture
* Prior to starting the study medication, the patient is enrolled in a rehabilitation program (as an in-patient or as an out-patient)
* Patient is judged to have been able to ambulate independently at home prior to their hip fracture (able to walk indoors in a familiar setting with little or no aid from another person)

Exclusion Criteria:

* Patient has an unstable medical condition
* Patient has a hip fracture that is due to bone pathology other than osteoporosis (e.g., malignancy, or Paget's Disease), or major trauma (e.g. motor vehicle accident).
* Patient has Type I diabetes
* Patient has Type II diabetes with any of conditions;

  1. Patient is currently taking more than one anti-hyperglycemic agent, or is taking a single combination anti-hyperglycemic drug containing more than one anti-hyperglycemic medication
  2. Patient is currently receiving insulin. Note: A short-term course of insulin required for glycemic control post hip fracture surgery is not exclusionary
  3. Patient has diabetic retinopathy
  4. Patient is unwilling or unable to monitor glucose at home
* Patient has been diagnosed with any neuromuscular or neurological disease causing muscle weakness
* Patient has cancer, or had a diagnosis of any malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or adequately treated in situ cervical cancer
* Patient has active carpal tunnel syndrome
* Patient was living in a nursing home prior to the hip fracture (Note: - Patients who were living in an assisted-living facility prior to the hip fracture are eligible for enrollment)
* Patient was permanently wheelchair bound prior to the hip fracture
Medical Trial: Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients

Historically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited. This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested. This data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future rheumatoid arthritis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with rheumatoid arthritis
* Patient has self-identified as planning to enroll in an interventional clinical trial
* Patient is 18 years old

Exclusion Criteria:

* ECOG score of 4
* Patient is pregnant
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
Efficacy of Resveratrol in Depression

Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1) each morning daily for 1 month with primary outcome measures of the score change on depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times over the study period (before, in the middle, after the intervention, and in 2 week follow up).


Eligibility Criteria:
Inclusion Criteria (selectively):

* MDD recurrent or with single episode with melancholic features or dysthymia (DSM-5);
* current depression.

Exclusion Criteria (selectively):

* serious or unstable disease;
* antidepressants intake.
Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC

Trial design:

* Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen.
* Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.
* Randomized 1:1, double-blinded, multi-centre, multi-national (Australia, Bulgaria, Poland, Serbia, Russia, Ukraine and the United Kingdom).
* Dosing regimen:

  * Irinotecan (180 mg/m2) or HA-Irinotecan (180 mg/m2), IV, over 90 minutes, day 1 (in patients \> 75 years of age, the irinotecan and HA-Irinotecan dose in must be reduced to 150 mg/m2).
  * Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
  * 5-fluorouracil (5-FU), 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
  * Repeat every 2 weeks for 8 months.
* Patient accrual over approximately 12-14 months.
* Monitoring to 18 months post-randomization.
* 390 patients.
* Progression Free Survival (PFS) primary endpoint.
* Safety analysis on the initial 20 patients.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer with disease progression after first or second line chemotherapy
* Irinotecan naïve.
* ECOG performance status of 0 or 1.
* Measurable disease, i.e. at least one measurable metastatic lesion (spiral CT or MRI).
* Histological proof of colorectal cancer.
* 18 years of age and older.
* Adequately recovered from and at least 4 weeks after recent surgery or chemotherapy.
* Women of child-bearing potential (WOCBP) and male partners of WOCBP must agree to use adequate contraception.
* Patient consent obtained and signed according to local and/or national ethics.
* CT or MRI scan of chest/abdomen/pelvis within 21 days prior to randomization.
* Hematology done within 14 days prior to randomization.
* Chemistry done within 14 days prior to randomization.

Exclusion Criteria:

* History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \> 5 years.
* Locally advanced or recurrent disease only.
* Unsuitability for irinotecan including known Gilbert's syndrome, active inflammatory bowel disease or chronic diarrhea greater than or equal to grade 2.
* Abdominal or pelvic radiation therapy within the last 12 months.
* Women who are pregnant or breastfeeding.
* Any condition (e.g., psychological, geographical) that would render the protocol treatment dangerous.
* Significant cardiac disease.
* Untreated or symptomatic brain or central nervous system (CNS).
* Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or paracentesis.
* Current partial or complete bowel obstruction.
* Concomitant active infection.
* Enrolled in any other investigational trial, unless treatment in that trial has been discontinued at least 30 days prior to signing the Informed Consent for the ACO-002 study.
Raspberries and Postprandial Metabolism

Raspberries are high in several phytochemicals, vitamin C and B vitamins and have been shown to be potent antioxidants and anti-inflammatory agents. However, human interventional studies reporting the effects of raspberries in obesity, T2DM and associated oxidative stress and inflammation are limited. Aims, objectives and methods:

Aim 1: To assess the effects of raspberries in postprandial glycemia and lipemia following a high-fat fast-food style meal challenge versus control group Objectives: to execute this aim, the investigators will conduct analyses of serum glucose, insulin and lipids (total cholesterol, LDL-cholesterol, triglycerides, VLDL-cholesterol and HDL-cholesterol) at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption. The investigators will also calculate homoeostasis model assessment of insulin resistance (HOMA-IR) at these time points using serum glucose and insulin values.

Aim 2: To assess the effects of raspberries in postprandial vascular functions (blood pressure and artery elasticity) and inflammation following a high-fat fast food style meal challenge versus control group

Objectives: to execute this aim, the investigators will measure C-reactive protein (CRP) and the following parameters of vascular function associated with CVD at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption:

* systolic blood pressure and diastolic blood pressure
* large artery elasticity index and small artery elasticity index
* systemic vascular resistance


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes

Exclusion Criteria:

* not having type 2 diabetes
Comparative Results of Maxillary Deficiency Treatment by Tongue Plate and Facemask in Growing Patients

A new appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a Facemask appliance.

The above method will be compared with traditional one which uses the Facemask in combination with an intra-oral appliance.

Eligibility Criteria:
Inclusion Criteria:

* Growing patients
* Class III with maxillary deficiency

Exclusion Criteria:

* Previous orthodontic treatment
* Un cooperative patients