cyrilzakka/clinical-trials huggingface dataset:
Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis

Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reduce the long term damage to their lungs from infection. This would typically be with a two week course of intravenous antibiotics each time they have a chest infection (typically three to four times a year).

The most effective and commonly used antibiotic in most cases is tobramycin. If this cannot be used because of previous side effects, allergy or a resistant infection then colomycin or amikacin are usually used. Each of these antibiotics are known to be toxic to both the kidneys and ear. As patients are living longer (into their forties), the total amount of these antibiotics they are receiving over their lifetime is increasing. This is now leading to increased complications such as kidney damage and hearing loss. Because of this, the investigators need to look at methods to accurately quantify damage and reduce potential kidney and hearing damage.

The investigators intend to quantify kidney damage by measuring new protein markers within the urine and blood that signify kidney damage before more conventional and currently available methods are able to.In those patients treated with intravenous tobramycin the investigators will also look at an alternative method used to calculate the most appropriate dose of antibiotic for each participant. This dosing method is called 'area under the curve or AUC' dose monitoring. This method currently in clinical use in other countries is thought to more accurately reflect the most appropriate dose for each participant and thus reduce the chance of kidney and hearing problems. This 'AUC' method requires two rather than one dose level to be checked each time a dose calculation is made. Participants receiving tobramycin will be randomised to receive dosing by this method or the investigators' currently used method of 'trough' monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF\*
* Able to give written informed consent
* Pulmonary exacerbation requiring IV tobramycin, amikacin or colistin based on the decision of the treating physician

Exclusion Criteria:

* Known allergy or adverse reaction to proposed antibiotic (tobramycin, amikacin or colistin)
* Pregnancy (if found to be pregnant during the study the participant will be immediately withdrawn)
* Continuation of nebulised aminoglycoside or colistin during IV treatment
* Use or intended use of NSAIDS
Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

In this study, the researchers investigate the feasibility of using rapid cine MR imaging to provide both offline and online soft-tissue-based image guidance. Such images will provide a significantly more complete picture of the spatial and temporal changes in thoracic anatomy. This more complete information will lay the groundwork for better radiotherapy planning and dose delivery in the presence of respiratory motion.

Rapid MRI scans from Stage I-IV non-small-cell lung cancer (NSCLC) patients will be acquired. MR acquisition will be performed without extrinsically administered contrast, using a balanced turbo field echo (TFE) sequence and commercially available coils.

Eligibility Criteria:
Inclusion Criteria:

* AJCC Stage I, II, III or IV non-small-cell lung cancer to be treated using radiotherapy will be eligible for this study.
* Any types and amounts of prior therapy will be allowed for this study.
* Subjects must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.
* Ability to understand and the willingness to sign a written informed consent document.
* Able to tolerate supine position
* ECOG performance status of 3 or less

Exclusion Criteria:

* MRI-incompatible metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers
* Women who are pregnant or trying to get pregnant
* Pain in supine position
Bone Marrow Adiposity and Fragility Fractures in Postmenopausal Women

The purpose is to determine in a case-control study if an association exist between bone marrow adiposity and fragility fractures in post-menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* post-menopausal women : 50-90 years old
* Group 1 (cases) : occurence of incident major osteoporotic fracture less than 12 months
* Group 2 (controls) : no history of fragility fracture

Exclusion Criteria:

* Implants that are contraindicated for the magnetic resonance (MR) examination.
* Implants that might create a health risk or other problem during an MR exam include: 1) cardiac pacemaker or implantable defibrillator, 2) catheter that has metal components that may pose a risk of a burn injury, 3) a ferromagnetic metal clip placed to prevent bleeding from an intracranial aneurysm, 4) an implanted medication pump (such as that used to deliver insulin or a pain-relieving drug), and 5) a cochlear implant.
* body mass index \[BMI\] \>38 kg/m2, weight \>140 kg
* Disease or current use of medications known to affect bone density, including oral glucocorticoids, treatments for osteoporosis (bisphosphonates, raloxifene, calcitonin, or PTH), hormone therapy.
* Chronic kidney disease with DFG \<30 ml/mn
Propofol to Reduce the Incidence of Postanesthetic Emergence Agitation in Pediatric Patients Under General Anesthesia

This study aimed to know the effectivity of 0.5 mg/kg propofol in the end of anesthesia to reduce the incidence of postanesthetic emergence agitation in pediatric patients under general inhalation anesthesia

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups; propofol and control. Non-invasive blood pressure monitor, electrocardiogram (ECG), pulse-oxymetry, and capnograph were set on the subjects in the operation room. Induction and maintenance of anesthesia will use sevoflurane. Mechanical ventilation will be given to maintaining end-tidal carbon dioxide 35 to 40 mmHg. After surgery, patient will be given intravenously 15mg/kg acetaminophen, 0.05mg/kg neostigmine, and 0.02 mg/kg atropine. Patient will also be given propofol 0.5 mg/kg on propofol group while no propofol will be given on control group. 30 minutes after patient was admitted to post-anesthesia care unit, patient will be evaluated for emergence agitation using Aono scale and Pediatric Anesthesia Emergence Delirium scale. The incidence of emergence agitation, hypotension, and desaturation will be treated accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing non-emergency surgery with general anesthesia
* Patient using sevoflurane as anesthetic agent
* Patient aged 1 - 5 years old
* American Society of Anesthesiologists (ASA) physical status 1 - 2
* Patient family signed the informed consent to be included in the study

Exclusion Criteria:

* Patient that will undergo ophthalmologic and otorhinolaryngologic surgery
* Patient that will require post operation stay in Intensive Care Unit
* Patient with psychological and neurological problem
* Patient with developmental delay
* Patient using sedative drugs
* Patient with allergy to propofol
* Patient or patient family with history of malignant hyperthermia
* Patient with difficulty on intubation and ventilation
* Patient with cardiovascular disease
* Patient with hemodynamic instability
Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1C greater than 7.5% and less than or equal to 11.0%
* Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months

Exclusion Criteria:

* Previous acute treatment with insulin for more than 7 days.
* Treatment with OAD(s) which does not adhere to the approval labeling.
* Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.
A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

Robotic technology has been used for laparoscopic hysterectomies for over 10 years. Mayo Clinic Arizona has used robotics in Gynecology for the last 10 years with well over 500 procedures performed. Similar to the laparoscopic approach, small incisions are utilized with the robotic approach. Robotic instruments differ from laparoscopic instruments in that the tips of the instruments can rotate more like the human wrist. The instruments are attached to the robotic arms which are controlled by your surgeon. The surgeon is seated at the surgeon's console which is located 12 feet from the patient while the surgical assistant is at your bedside assisting in the procedure.

This study is being done to compare the procedure times and results after laparoscopic hysterectomies to laparoscopic hysterectomies performed with robotic assistance.


Eligibility Criteria:
Inclusion Criteria:

- All subjects eligible for a laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy, and with or without appendectomy will be recruited.

Exclusion Criteria:

- Patients with malignant disease, pregnancy, gynecologic infection, or requiring procedure on an emergent basis.
A577-nm Pro -Yellow Laser In Treatment of Striae Rubra

Stretch marks or striae are common skin condition occurring in both genders, but they are more prevalent among women. These are linear dermal scars that are accompanied by epidermal atrophy. They usually occur frequently in numerous physiological and pathological conditions, such as adolescent growth, pregnancy, obesity, Cushing disease, Marfan syndrome, and long-term systemic or topical steroid use. Decreased expression of collagen and fibronectin genes has also been associated with striae.

The pro-yellow laser systems can be used in a wide range of indications such as facial erythema, facial telangiectasia, port wine stain nevus, rosacea, poikilo derma civatte, and Becker's nevus

Some of these indications are clinical lesions in the vascular pattern; some are related to the factors that trigger vascularity, such as vascular endothelial growth factor (VEGF) in etiopathogenesis


Eligibility Criteria:
Inclusion Criteria:

* .Patients diagnosed with striae rubera. .Age groups: at any age. .Sex : ( females).

  * Co-operative patient

Exclusion Criteria:

* Pregnancy .

  * Patient using drugs exacerbating stria as topical or systemic steroid, and patients using other forms of treatment for stria as topical tretinoin, emollients, glycolic acid peel and laser, because that might affect the result of our study.
  * Stria Alba.
  * Skin infection (viral, bacterial or parasitic).
  * Immunosuppressed patients or with history of malignancy or radiation therapy and chronic debilitating diseases and Cushing syndrome.
  * Hypersensitivity to light and intak of photosensitizing drugs.
Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study

COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population.

The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns).

Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.


Eligibility Criteria:
Inclusion Criteria:

* Living in the city of Marseille
* Being homeless
* Be over 18 years of age

Exclusion Criteria:

* Persons under guardianship
* Persons who refused to sign the research consent
The Study of Association Between Intradialysis Sodium Balance and Clinical Outcomes in Chronic Hemodialysis Patients

The purpose of this study is to determine whether the change of serum and dialysate sodium level during hemodialysis can influence on blood pressure and intradialytic weight gain in chronic hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* age 20 years or more
* hemodialysis vintage over 3 months
* dialyzed for 4 hours three times per week
* hemodialysis adequacy (Kt/V) over 1.2

Exclusion Criteria:

* diagnosed with chronic hepatitis or infection
TACE-HAIC Combined With TKIs and Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma With PVTT

Hepatocellular carcinoma (HCC) is characterized with vascular invasion, particularly of the portal vein, resulting in portal vein tumor thrombus (PVTT) in 10%-40% of HCC patients at the time of HCC diagnosis. The prognosis of these patients is extremely poor.Treatment efficacy and safety using a combined therapy (TACE-HAIC combined with TKIs and PD-1 inhibitors) were compared with TACE alone in treatment of HCC patients with PVTT.


Eligibility Criteria:
Inclusion Criteria:

* (a) HCC patients with PVTT (Vp1-4) treated by TACE, or the combination therapy (TACE-HAIC combined with TKIs or an PD-1 inhibitors) as initial treatment; (b) age between 18 and 75 years; (c) Child-Pugh A or B liver function; (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1; (e) adequate hematologic blood counts (white blood cell count \>3ⅹ109/L, absolute neutrophil count \>1.5ⅹ109/L, platelet count \>10ⅹ109/L, hemoglobin concentration \>85 g/L); (f) no extrahepatic metastasis.

Exclusion Criteria:

* (a) severe underlying cardiac, pulmonary, or renal diseases; (b) history of a second primary malignant tumor; (c) incomplete medical data; (d) loss to follow-up.
A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer

This is a Phase III, randomized, double blind, multicenter, active comparator, parallel two arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1706 to EU Avastin® in patients with previously untreated advanced non-squamous non-small cell lung cancer (nsNSCLC) to demonstrate clinical equivalence of BAT1706 and EU Avastin®.


Eligibility Criteria:
Inclusion Criteria:

1. Stage IV nsNSCLC or recurrent disease (any Stage at initial diagnosis) no longer amenable to curative surgery or local therapy (histologically or cytologically confirmed).
2. No prior systemic therapy for metastatic disease. Prior systemic therapy and/or radiotherapy for locally advanced disease is permitted if completed ≥ 6 months prior to randomization.
3. Tumors without activating EGFR or ALK mutation. Patients with unknown mutation status or known activating EGFR or ALK mutation may be included provided the corresponding targeted agent is not available and chemotherapy is the standard of care of the study center.
4. At least one measurable target lesion according to RECIST 1.1 (Appendix 13.4) as confirmed by CIR; bone only and brain-only metastases are not allowed. Lesions previously treated with radiotherapy are non-target lesion.
5. Eastern Cooperative Oncology Group performance status of 0 or 1 and life expectancy \> 3 months based on Investigator's judgment.

Exclusion Criteria:

1. Diagnosis of small cell carcinoma of the lung, mixed predominant squamous cell carcinoma of the lung, NSCLC not otherwise specified.
2. Tumor cavitation, tumor invading into large blood vessels or close to large vessels with an increased risk of bleeding, according to Investigator's judgment.
3. Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGFR, including Avastin®.
4. Prior systemic therapy for metastatic disease.
5. Prior systemic anticancer therapy, or radiotherapy for locally advanced nsNSCLC if completed \< 6 months prior to screening.
6. Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of the skin or pre invasive cancer of the cervix.
Person Centered Nurse Led Atrial Fibrillation Care

The aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with AF. Secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics.

The aim of the study is to evaluate the effect of a person-centred nurse-led outpatient clinic on health related quality of life, for persons with AF. Secondary outcomes are effects on anxiety, depression, illness perception, symtom burden, life style and health economics.

We plan a randomized controlled trial comparing person centred nurse led care vs. standard care. A sample size of 100 persons per group will be recruited.

Data will be collected through questionnaires, medical records, interviews.

Eligibility Criteria:
Inclusion Criteria:

* patients aged \> 18 years with diagnosis of atrial fibrillation, referred for follow up after atrial fibrillation, able to provide informed consent and able and willing to fill in questionnaires.

Exclusion Criteria:

* Atrial flutter diagnosis, Severe heart failure (corresponding to NYHA IIIB and NYHA IV), Cardiac surgery \< 3 month prior to hospitalization for atrial fibrillation, planned surgical procedures (catheter ablation, cardiac surgery), Atrial fibrillation in connection with acute coronary syndrome or infection, not able to fill in questionnaires.
Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study

Changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia and 5-min reperfusion) has not been well documented. In previous studies, there was difference in changes in microcirculation, such as recovery slope and occlusion slope, between healthy subjects and cardiac surgery patients. Moreover, the occlusion slope, which reflects local tissue oxygen consumption during ischemic period, is anticipated to decrease during repeated ischemia-reperfusion cycle by its protecting effect, however there has not been well-conducted study. The purpose of the study is to evaluate the changes in microcirculation measured by tissue oxygen saturation during ischemic conditioning between healthy volunteers and cardiac surgery patients.

Subjects who are male healthy volunteers (aged 20-45) or who are scheduled to receive cardiac surgery (aged 20-80) will undergo ischemic conditioning, consisting of 4 cycles of 5-min ischemia with pressure of 200 mmHg on upper extremity followed by 5-min reperfusion with no pressure. During ischemic conditioning, changes in tissue microcirculation (baseline tissue saturation, occlusion slope during ischemia, and recovery slope during reperfusion) will be observed using tissue oxygen saturation sensor attached to the thenar muscle of the hand. For cardiac surgery patients, the study will be conducted before anesthesia induction on the surgery day to exclude any potential effect of anesthetics.

Eligibility Criteria:
\<Healthy volunteers\>

Inclusion Criteria:

* Age 20-45
* No underlying chronic disease
* Male volunteer

Exclusion Criteria:

* Under taking prescription drugs
* Taking herbal medicines within 2 weeks
* Baseline systolic blood pressure \> 150 mmHg or diastolic pressure \> 100 mmHg
* Body mass index \< 18 kg/m\^2 or \> 30 kg/m\^2
* Vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours
* Any abnormalities on upper extremities
* Do not consent to participate

\<Cardiac surgery patients\>

Inclusion Criteria:

* Age 20-80
* Scheduled for cardiac surgery

Exclusion Criteria:

* Baseline systolic blood pressure \> 150 mmHg or diastolic pressure \> 100 mmHg
* Body mass index \< 18 kg/m\^2 or \> 30 kg/m\^2
* Uncontrolled diabetes
* Under taking beta-blockers
* Severe renal dysfunction, chronic kidney disease, on hemodialysis
* Any abnormalities on upper extremities (i.e, AV fistula on arms)
* Peripheral vascular disease, peripheral neuropathy, coagulopathy
* Vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours
* Pregnant
* Emergency surgery
* Do not consent to participate
Association Between Lipid Profiles and Cardiovascular Events

KORLIPID (Study on the Association between Lipid Profiles and Cardiovascular Events) registry enrolled 4234339 subjects who underwent general health check-ups provided by National Health Insurance Service in 2009.

Subjects who underwent general health check-ups provided by National Health Insurance Service in 2009 were included in KORLIPID study. Demographic data, anthropometric data and medical information from general health check-ups were collected. In addition, medical records in National Health Insurance Service between 2002 and 2018 were also collected.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who underwent general health check-ups in 2009

Exclusion Criteria:

* Age less than 30 years
* Age 75 years or more
Natalizumab Temporary Discontinuation Study

This study evaluates the discontinuation of natalizumab either immediately or tapered off in the treatment of multiple sclerosis. Half of the fifty (50) participants will discontinue natalizumab immediately and the other half will taper off the drug, having two additional infusions, one at six weeks- and one at eight weeks-post discontinuation.

Natalizumab is a pharmaceutical intervention used in the management of multiple sclerosis.

The decision to discontinue natalizumab therapy is often raised in patients defined as high-risk for PML despite good clinical efficacy. During the therapy cessation period following large phase III trials, a return to the prestudy disease activity was reached by four months post-discontinuation. Shorter therapy was associated with a trend for a more severe disease activity pointing to a possible 'rebound' effect after natalizumab discontinuation.

This study focuses on two different approaches: an immediate versus a step-wise/tapered down natalizumab discontinuation protocol, both with reinstitution of a different disease modifying therapy (DMT) within 1-6 months from the last natalizumab infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patient with relapsing-remitting or relapsing-progressive (relapsing-remitting with incomplete recovery and secondary progressive with superimposed relapses) MS according to the McDonald criteria who have been on natalizumab therapy for at least 12 months
* Age 18-65
* Have EDSS scores less than or equal to 7.0
* Positive John Cunningham (JC) virus antibody results at screening
* Signed informed consent
* None of the exclusion criteria

Exclusion Criteria:

* Patients not willing or able to personally provide informed consent (subjects with cognitive impairment that effects the ability to provide informed consent for participation)
* Patients with active disease per clinical and MRI evaluation at baseline
* Patients with renal disease that precludes having an MRI with gadolinium contrast