cyrilzakka/clinical-trials huggingface dataset:
Rectal Bacteriotherapy, Fecal Microbiota Transplantation or Oral Vancomycin Treatment of Recurrent Clostridium Difficile Infections

The purpose of the study is to investigate if treatment with fecal microbiota transplantation or rectal bacteriotherapy is superior to standard vancomycin in patients with recurrent Clostridium Difficile infections.

Clostridium difficile infection (CDI) is the most common nosocomial infection in the western world. CDI is associated with high morbidity and mortality and is a great burden for the health care system leading Center of Disease Control and Prevention (CDC) to identify it as one of three most important/urgent threats to public health.

Despite antimicrobial treatment of CDI, 20% of the patients have recurrence of CDI. Due to a dysbiosis in the gut microbiota the antimicrobial treatment seems to be less effective.

Fecal microbiota transplantation (FMT) is an alternative treatment for recurrent CDI. Studies have shown a cure rate up to 90% in patients with recurrent CDI. One alternative to FMT is rectal bacteriotherapy (RBT) which is a standardized bacterial culture made in the laboratory consisting of 12 different bacteria. RBT has never been investigated in a clinical trial.

The project is a randomized controlled trial including 450 patients with recurrent CDI will be, after accepting participation, allocated to receive vancomycin alone or vancomycin followed by either FMT or RBT. The patients will be followed up for 180 days. Cure is defined as resolution of CDI symptoms 90 days after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Verified recurrent CDI with symptoms of CDI and microbiological verification (PCR).
* Previously treated for CDI with at least 10 days of vancomycin or metronidazole.
* Be able to read and understand Danish.

Exclusion Criteria:

* Life expectancy \< 3 months.
* Allergy toward vancomycin
* Other infection in the GI tract with clinical symptoms similar to CDI.
* Other illness in the GI tract with clinical symptoms similar to CDI.
* Use of antibiotics for more than 14 days treating other infections
* Planning pregnancy, pregnancy or breast feeding.
* Severe immune suppression which makes FMT/RBT relatively contraindicated
Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy

The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered.

No additional details provided

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Subject must be able to understand the potential risks and benefits associated with the study.
* Baseline systolic blood pressure ≥ 90 mm Hg at the time of enrollment.
* Clinical symptoms of dyspnea and laboratory admission BNP levels \> 500 pg/mL.
* Neither pregnant or breastfeeding at the time of enrollment.
* Authorization of patient's enrollment by patient's medical provider.

Exclusion Criteria:

* \<18 years of age
* Denies written informed consent
* Pregnant or lactating.
* Baseline systolic BP \< 90 mmHg or cardiogenic shock
* No symptoms of congestion or admission BNP \< 500 pg/mL
* Known allergy to E.coli-derived products, or any history of anaphylactic reactions to nesiritide.
* Receiving dialysis at the time of enrollment.
* Serum creatinine \> 2.5 mg/dL at the time of enrollment.
Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.

The study population will exist of patients with a histological diagnosis of NSCLC, stage T1, T2 or T3NO who are not fit for or who refuse surgery. A prospective data analysis will be performed on tumor response, potential acute and late toxicity and survival. A radiotherapy dose of 4x15Gy or 3x 20Gy will be given over 2 weeks with dynamic 3D-conformal arc therapy (Novalis TM)


Eligibility Criteria:
Inclusion Criteria:

1. Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
2. Maximal tumor diameter of 6 cm
3. Only T3 lesions based upon thoracic wall involvement
4. Informed consent is required
5. Life expectancy of at least 6 months
6. Age \> 18 y.
7. Karnofsky score ≥ 70 or ECOG score ≤ 1
8. Inoperable patients or patients refusing surgery
9. Patients with measurable lesion (according to RECIST criteria)

Exclusion Criteria:

1. Diagnosis of small cell lung cancer
2. Lymph node involvement
3. Prior radiotherapy or chemotherapy for lung cancer
4. Pregnant or lactating women
5. Known allergy for CT contrast
6. No FDG-PET
7. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
8. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.
A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)

A study to evaluate biomarkers of cancer (context-specific sensitizers) in the skin of participants already receiving cytotoxic therapy. Additional blood and urine samples will be collected for phosphorylated Histone 2AX (γH2AX) and renal toxicity biomarker testing, respectively.


Eligibility Criteria:
Inclusion Criteria:

Participant has solid tumor that will be treated with one of the following treatments:

* Gemcitabine monotherapy
* Cisplatin monotherapy
* Carboplatin monotherapy
* Gemcitabine and cisplatin combination therapy
* Gemcitabine and erlotinib combination therapy
* Gemcitabine and carboplatin combination therapy
* Cisplatin and vinorelbine combination therapy
* Cisplatin and pemetrexed combination therapy
* Carboplatin and vinorelbine combination therapy
* Carboplatin and pemetrexed combination therapy

Exclusion Criteria:

* Participant has had recent cancer treatments including chemotherapy or radiation
* Participant has been in an investigational study within the last 30 days
* Participant has a history of drug or alcohol abuse
* Participant is Human Immunodeficiency Virus (HIV) positive or has a history of Hepatitis B or C
The Role of Stem Cells on Immune Cells in the Development of Cardiovascular Diseases

An observational pilot proof-of-principle study. 15 patients with significant coronary artery disease and 15 matched controls. To investigate whether long-term activation of the innate immune system, named 'trained innate immunity', occurs at the level of the bone marrow progenitor cells in patients with significant coronary artery disease and whether this correlates with the proinflammatory phenotype of monocytes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤75 years
* With or without significant coronary artery disease on CCTA
* Written informed consent

Exclusion Criteria:

* Chronic infections
* Diabetes mellitus
* Medical history of any disease associated with immune deficiency
* Clinically significant infections within 3 months prior to study entry
* Recent hospital admission or surgery with general anaesthesia
* Known chronic kidney or liver disease
* Previous vaccination within 3 months prior to study entry
* Inability to personally provide written informed consent
* Inability to undergo PET-CT scanning
* Chronic use of anti-inflammatory drugs such as NSAIDs
* History of haematological malignant disease
* Documented bleeding diathesis or thrombocytopenia
* Pregnancy
Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity

The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation.

Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Patient with breast cancer for whom adjuvant chemotherapy has been administered; maintenance treatments (e.g. Trastuzumab, hormone therapy) are eligible,
* Maximum 2 years after completion of adjuvant treatment,
* Patients who have cognitive complaints at inclusion (answer yes to the question: 'Since your cancer treatment, have you had any difficulties with memory, concentration, etc.?)
* Patients planning to return to work or who have returned to work in the past year,
* Signature of informed consent prior to any specific procedure relating to the study,
* Patient affiliated to a social security system.

Exclusion Criteria:

* Patients suffering from illnesses or conditions that impair their ability to understand, follow and/or comply with study procedures,
* Patients with personality disorders and/or psychiatric pathology,
* Patients deprived of their liberty or placed under the authority of a guardian,
* Pregnant women
Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Type 2 Diabetes Mellitus (T2DM)

The purpose of this study is to assess the safety and tolerability of JNJ-64565111 in adult Men and Women (of non-child bearing potential) with Type 2 Diabetes Mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus (T2DM) at least 3 months prior to Screening
* On a stable treatment regimen at least 3 months prior to Screening of (1) diet and exercise, or (2) metformin monotherapy (at a dose of at least 1,000 milligram (mg) per day)
* Blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and between 60 and 100 mmHg diastolic, inclusive at Screening (sitting) and Day -2 (supine). If blood pressure is out of range, up to 2 repeated assessments are permitted
* HbA1c greater than or equal to 6.5% and less than 8.5% at Screening
* Females of non-childbearing potential

Exclusion Criteria:

* History of, or currently active, significant illness or medical disorders, including cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), hematological disease (example, von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders, neoplastic disease, skin disorder, renal disorder, or any other illness that the Principal Investigator (PI) considers should exclude the participant or that could interfere with the interpretation of the study results
* Previous surgical treatment for obesity (example, gastric bypass, gastric banding)
* History of diabetic neuropathy with signs of gastroparesis and/or known proliferative retinopathy or maculopathy
* History or current diagnosis of acute or chronic pancreatitis
* History of an invasive cardiovascular surgical procedure including, but not limited to, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI)
IL-6 in Exercise-Induced Anorexia

This study investigates the effect of high intensity exercise, with and without the inflammation inhibitor, ibuprofen, on plasma levels of IL-6 and other selective biomarkers of inflammation and appetite on food intake and subjective ratings of appetite in normal-weight boys.


Eligibility Criteria:
Inclusion Criteria:

* 13-18 yrs, healthy, male

Exclusion Criteria:

* female, heamatophobia, following a diete, diagnosed with diabetes or other metabolic diseases, scoring ≥11 on an Eating Habit Questionnaire
Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy

The goal of this interventional clinical trial is to assess anatomical and functional outcomes of methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery in patients with advanced proliferative diabetic retinopathy.

The main questions it aims to answer are:

1. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery decrease the post operative vitreoretinal proliferation after vitrectomy in patients with advanced proliferative diabetic retinopathy?
2. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery improve post operative functional outcome after vitrectomy in patients with advanced proliferative diabetic retinopathy?

Researchers will compare the anatomical and functional outcomes after vitrectomy in patients with advanced proliferative diabetic retinopathy without using methotrexate.

Tractional macular detachment (TMD) or macula threatening tractional retinal detachment (TRD) and combined tractional-rhegmatogenous retinal detachment (TRD/RRD) are considered as important indications for vitreoretinal intervention.

Although a growing number of eyes with TMD and TRD/RRD are successfully treated with a single procedure, retinal re-detachment associated with fibrovascular proliferation or proliferative vitreoretinopathy (PVR) is still a major cause of failure of the surgery.

Previous studies have shown increased expression of inflammatory cytokines and growth factors in both proliferative diabetic retinopathy (PDR) and PVR.

Methotrexate (MTX) is an anti-neoplastic and anti-inflammatory agent used to treat a variety of malignancies and rheumatologic diseases.

In ophthalmology, systemic and intraocular MTX has been successfully used for indeterminate uveitis, sarcoid uveitis and intraocular lymphoma.

MTX has been recently found to inhibit PVR by stopping cellular proliferation and promoting organized apoptosis. MTX has also been found to be effective in lowering the incidence of PVR when used as an adjunct in irrigation fluid during vitrectomy for retinal detachment.

Eligibility Criteria:
Inclusion Criteria:

- Patients with diabetic tractional macular detachment or combined tractional- rhegmatogenous retinal detachment

Exclusion Criteria:

* Previous vitreoretinal surgery.
* Pregnant or lactating female.
* Co-existing pathology that might induce PVR such as penetrating ocular trauma or uveitis, co-existing congenital anomalies or hereditary vitreoretinopathies
Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer

This is a multi-national, multi-center, open-label, single-arm extension study for the prolongation of bone metastasis-free survival in men with hormone-refractory (androgen independent) prostate cancer. Patients currently participating in the phase 3 study 20050147 (NCT00286091) will be offered this study if a positive benefit:risk compared with placebo is determined in the 20050147 study. The primary endpoint of the 20050147 study is bone metastases-free survival determined by the time to first occurrence of bone metastases (either symptomatic or asymptomatic) or death from any cause. Participants will receive open-label denosumab administered once every 4 weeks (Q4W) subcutaneously (SC) until they developed a bone metastasis or for up to 3 years, whichever comes first.


Eligibility Criteria:
Inclusion Criteria:

* Subjects currently undergoing every 4 weeks scheduled assessments in the phase 3 study 20050147
* Subjects must sign the informed consent before any study specific procedures are performed

Exclusion Criteria:

* Developed sensitivity to mammalian cell derived drug products during the 20050147 study
* Currently receiving any unapproved investigational product other than denosumab
* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
Efficacy and Time Dependent Effects of tDCS Combined With MT for Rehabilitation After Subacute and Chronic Stroke

This project is designed to investigate the intervention effects and time dependent effects of combining tDCS and MT in patients with subacute and chronic stroke.

This project is also designed to investigate the optimal application timing of tDCS in combination with MT in patients with subacute and chronic stroke. Patients with subacute and chronic stroke will be recruited and randomized into one of the 3 groups: sequentially apply tDCS and MT group (SEQ), apply tDCS concurrently with MT group (CON), and MT with sham tDCS group (SHAM). All participants will receive 40 minutes of MT followed by 30 minutes of functional task training. For the participants in the SEQ group, 20 minutes of tDCS will be applied prior to MT, while tDCS will be applied concurrently with MT for the first 20 minutes in the CON group. As for the SHAM group, tDCS electrodes will be placed on the scalp without actual current output. The interventions will be carried out 90 minutes per day, 5 days per week, for 4 weeks. Behavioral outcomes will be assessed by blinded evaluators before, after, and 3 months post intervention. To study the possible interaction of treatment group and time of outcome evaluations, group (SEQ vs. CON vs. SHAM groups) × time (pretest vs. posttest vs. follow-up) repeated measures ANOVA will be performed. Additionally, the partial eta square (η2) will be calculated to determine the effect size of interest.

Eligibility Criteria:
Inclusion Criteria:

1. experienced a first-ever unilateral stroke with stroke onset ≥ 1 week;
2. UE-FMA score between 18 and 56
3. able to follow instructions to perform the tasks (Mini Mental State Examination ≥ 24)

Exclusion Criteria:

1. Participants are currently involved in other rehabilitation or drug research trial(s);
2. have neurological or psychological disorders other than stroke;
3. have joint contracture or excessive spasticity of the paretic upper limb that prohibits them performing the tasks;
4. received Botulinum toxin injections 3 months prior to enrollment
5. have unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;
6. have contradictions to tDCS including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body
7. have a history of drug or alcohol abuse, skin lesions on the electrode sites, brain tumor, brain injury, arteriovenous malformation (AVM), had brain surgery, other brain diseases (such as intracranial hypertension or cerebral edema), or being not suitable for using tDCS by the physician's assessment.
Psychological Resilience and Psychological Well-being of Intensive Care Nurses

Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on the psychological resilience and well-being of intensive care nurses.

Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test.

Hypotheses: H1: The resilience level scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the nurses in the control group.

H2: Nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase their well-being level scores compared to the nurses in the control group.

H3: The psychological resilience level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores.

H4: The well-being level posttest and follow-up scores of the nurses in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.


Eligibility Criteria:
Inclusion Criteria:

* Having Having a working time of at least 6 months in the intensive care unit,
* No barriers to accessing technology for participation in the online training program,
* Absence of a communication barrier related to vision and hearing

Exclusion Criteria:

* Working in the intensive care unit for less than 6 months
* Working in the intensive care unit due to temporary assignment
Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies.

The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.

60 patients with narcolepsy with or without cataplexy will be included.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of narcolepsy with or without cataplexy
* patients need to free of or discontinue psychostimulant medications for at least 14 days,
* patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
* patients must have adequate support to comply with the entire study requirements

Exclusion Criteria:

* Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
* Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
* Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
* Current or recent history of a substance abuse or dependence disorder including alcohol abuse
A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy

The aim of this clinic trial is to testify the efficacy of using new and noninvasive therapy, called simultaneous "Magnetic and Oxygen Treatment along Meridians and Collaterals" (MOMC), to treat Bell's Palsy.

Between June 1998 and January 2005, a total of 3002 subjects with BP were evaluated, 882 patients fulfilled the inclusion criteria and entered the study.

Patients were randomly assigned to either the prednisone-valacyclovir group(group 1) or the magnetic-oxygen group(group 2) . Among the 882 patients completing the study,825 patients in group 1 received prednisone, given as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days. 57 patients in group 2 received magnetic-oxygen treatment:MOMC treatment was given as daily 20 min section for 10 days with 2\~3 days of intermission between;Oxygen therapy was given simultaneously at a flow rate of 2\~3.0 L / min for the same duration during all acupuncture sections.

Clinical evaluation for the severity of paralysis was performed immediately before and after the treatment using the facial nerve grading (FNG) scores of House and Brackmann system.

Eligibility Criteria:
Inclusion Criteria:

1. Only patients with complete (or nearly complete) non-recurrent facial paralysis (grade 5-6/6) for more than 1 months
2. the first time to onset the disease
3. on one side of the face paralysis
4. willing to finish the whole observation period
5. with written consent form signed by themselves.

Exclusion Criteria:

1. facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
2. facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
3. patient with Hunt's syndrome
4. pregnant women or women in lactation
5. patients are participating other clinical research