cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients

Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols:

1. an assessment of readiness for decannulation that was based on suctioning frequency
2. an assessment that was based on tracheostomy capping


Eligibility Criteria:
Inclusion Criteria:

* Within three months of onset
* Age≥18 years old
* GCS≥8
* Clinical stability( defined as the absence of fever, sepsis, or active infection and hemodynamic stability)
* Without massive pooling or silent aspiration of saliva, more than one efficient swallow per minute, adequate cough reflex were tested by gently touching the aryepiglottic region with the tip of the endoscope.
* Passing a tracheostomy-tube de-cuff test(de-cuff the tube for 3 days without pulmonary complications.
* Without significant airway stenosis.

Exclusion Criteria:

* Patients with pending diagnostic or therapeutic procedures and were considered by the clinicians to be at risk for neurologic deterioration
* Medical history of severe respiratory system or heart disease
* Neuromuscular disease other than ICU-acquired weakness, or tracheostomy for airway control
* Don't get informed consent from patient or guardian
Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery

This research is being done to determine the resistance across stenosis in the airway.

There is significant utility in objectively measuring airflow as subjects, undergoing endoscopic laryngeal surgery, commonly have difficulties with airflow secondary to their stenosis. Easier and quicker quantification will tailor diagnosis and treatment. In order to obtain an objective measure of airflow in these participants, we will place a 20-gauge angiocatheter needle into the airway. The catheter will be in situ for a short duration during several spontaneous and non-spontaneous breaths. This will be achieved via the existing tracheostomy stoma or percutaneously via the cricothyroid membrane. This technique is commonly used to access the muscles of the larynx, however, the primary purpose will be to measure airflow in this setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older that require outpatient endoscopic laryngeal airway surgery, in the operating room, at a tertiary academic center.

Exclusion Criteria:

* Pregnancy (status will be determined by a urine test as part of standard clinical care in the preoperative setting)
* Patients that are not cleared for surgery by the preoperative evaluation
* Patients with severe laryngotracheal stenosis
* Patients who are morbidly obese (BMI \> 40)
* Patients with lung disease (asthma, COPD)
Longterm Follow-up After Remote Ischemic Preconditioning for Prevention of Contrast-induced Nephropathy

Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial.

Data of the RenPro Trial has been already published. In the present study data of longterm follow up are collected.

Eligibility Criteria:
All patients who participated to the RenPro trial
Stress Reduction During In Vitro Fertilization

The goal of this study is to determine the effect of Healing Touch (HT) on the stress, anxiety, and self-efficacy experiences of women undergoing in vitro fertilization (IVF) in a randomized, controlled design. HT is a gentle, non-invasive form of energy-balancing work that promotes relaxation.

Once enrolled, each participant will be randomized to one of three groups: the Healing Touch (HT) treatment arm, the Desensitization Therapy (DT) arm, or the no-intervention arm.

Subjects in Group 1 will receive three, 45-minute HT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 2 will receive three, 45-minute DT sessions during the first two weeks of their IVF cycle prior to oocyte retrieval. Group 3 will receive no intervention. Subjects in Group 3 will be offered two HT sessions after completing study participation.

All subjects and their partners will be asked to complete the Spielberger State Trait Anxiety Inventory (STAI), the Perceived Stress Scale (PSS) and the Infertility Self-Efficacy Scale (ISES) at three time points: 1) baseline 2) one day prior to oocyte retrieval and 3) 5-7 days post embryo transfer. In addition, subjects in all groups will complete a short pre-study questionnaire to assess expectation of therapeutic effect, and subjects in the two intervention groups will complete a short post-study questionnaire to evaluate their treatment experience. Demographic and pregnancy outcome data will be collected for all subjects.

Eligibility Criteria:
Inclusion Criteria:-Age \<43

* FSH \<= 14
* About to enter an IVF cycle at the Stanford Fertility and Reproductive Medicine Center
* Planning a transfer of their own fresh embryos during this cycle
* Speak and read English fluently
* Not planning to use concomitant energy work interventions (HT, Reiki, QiGong, acupuncture)during the IVF cycle.
Daily Avanafil for Erectile Dysfunction

In this study, the investigators tried to study the effect of daily avanafil on the serum level of endothelial function markers, as well as its impact on the erectile function in males with erectile and endothelial dysfunction by comparing the results with controls who received placebo.

Avanafil is a highly selective and potent oral phosphodiesterase type 5 inhibitor (PDE5-I) . However, its impact on the soluble markers of endothelial function has not been investigated yet. This study was conducted to assess the effect of daily avanafil on the erectile function and endothelial markers' serum level. In this work we recruited males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction. The investigators randomly treated patients with daily oral avanafil and the other patients with placebo. The investigators measured the International Index of Erectile Function -5 score (IIEF- 5) and the serum levels of markers of endothelial function at baseline and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men with clinical diagnosis of erectile dysfunction of any severity.
* Should be associated with systemic disorders indicative of endothelial dysfunction

Exclusion Criteria:

- Erectile dysfunction due to psychogenic causes, hypogonadism, or spinal cord injury.
Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer

The purpose of this study is to collect information on what effects (good or bad) CT-2103 (Xyotax) has on breast cancer as well as any side effects the drug may cause.

* Patients will be given CT-2103 intravenously every 3 weeks. One week after the first dose of CT-2103 a physical exam, blood work and assessment of any side effects will be performed.
* Prior to each injection of CT-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks).
* Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working.
* Additional blood work will be performed once per week after the first two doses of CT-2103.
* The participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of invasive breast cancer, Stage IV disease
* Age greater than 18 years
* At least one measurable target lesion as defined by RECIST that has not been previously treated with local therapy
* HER2-negative breast cancer
* Up to one prior chemotherapy for advanced or metastatic disease
* ECOG performance status 0-1
* Life expectancy \> 12 weeks
* Adequate liver and bone marrow function: AST \< 2.5 x ULN; Bilirubin \< 1.5 x ULN; ANC \> 1,500/ul; platelet count \> 100,000/ul; normal PT and PTT
* At least 2 weeks since prior radiation and recovered from treatment-related toxicity

Exclusion Criteria:

* Prior taxanes for treatment of metastatic disease
* Pregnant of breast-feeding women
* HER2-positive breast cancer
* More than 1 prior chemotherapy regimen for metastatic disease
* Untreated brain metastases
* Concurrent radiotherapy or investigational drug
* Prior bone marrow or stem cell transplant
* History of other malignancy within the last 5 years, not including curatively-treated carcinoma in situ of the cervix or non-melanoma skin cancer
* Uncontrolled infection
* Active bleeding, or history of bleeding requiring transfusion
* Active cardiac disease
* Serious medical or psychiatric illness
Influence of a Modified Ramadan Fasting on Health and Well-being in Healthy Muslims - a Randomised Controlled Trial

In this study the investigators will test the impact of a modified Ramadan Fasting regimen on health and well-being. The 2016 Ramadan is around summer solstice in Germany making it one of the most challenging fasting periods for participating Muslims. The modified Ramadan Fasting consists of educational components around fasting, and advice for nutritional modifications in order to support health and well-being during Ramadan, while the control group will continue to fast as usual. The investigators will measure not only body weight/fat but also include measures of psychological well-being, and spiritual practice, and serum markers for blood lipids, and blood sugar. With this trial the investigators aim to determine, whether such modifications around Ramadan will be beneficial for health and well-being.

see above

Eligibility Criteria:
Inclusion Criteria:

* Healthy Muslims participating in Ramadan Fasting
* No first time fasting

Exclusion Criteria:

* Untreated or malign hypertension
* Eating disorder
* psychological disorder (e.g. depression, schizophrenia, addiction)
* co-morbid disease (e.g. diabetes, cancer, gout)
* pregnancy
* breastfeeding women
* BMI under 20 or above 40
* recently on a diet
A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer

The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.

This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC. The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled into this study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV)
* Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria
* Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel
* Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL
* Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment
* Eastern Cooperative Oncology Group Performance Status less than or equal to 2

Exclusion Criteria:

* Active or uncontrolled autoimmune disease that may require corticosteroid therapy
* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
* Uncontrolled hypertension
* Hemoglobin less than or equal to 9.0 g/dL independent of transfusion
* Has abnormal liver function tests
* Surgery or local prostatic intervention within 30 days of the first dose
Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Not currently on durg therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)

A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with phacoemulsification from 1 January 2014 to 1 October 2015.


Eligibility Criteria:
Inclusion Criteria:

* Eye treated with XEN 45 Gel Stent for primary open angle glaucoma as a standalone procedure or in combination with phacoemulsification
* XEN 45 Gel Stent was implanted between 1 January 2014 and 1 October 2015

Exclusion Criteria

* None
Renal Resistive Index in Septic Shock Patients

Septic shock is a condition of acute circulatory failure and is defined as a process that requires the use of vasopressors to ensure adequate tissue perfusion when hypotension develops. It is mainly characterized by abnormal peripheral vascular resistance; Therefore, improving vascular function and organ damage is crucial in the management of septic shock. Blood flow measurement with Doppler-based renal resistive index (RRI), which can be performed at the bedside, especially in renal abnormalities, is currently accepted as a tool to assess renal perfusion. With this simple, rapid and reproducible technique, the investigators determine RRI by evaluating systolic and diastolic blood velocity from Doppler flow waveforms in the intrarenal arcuate or interlobar arteries. Our aim is to investigate the relationship between renal resistive index (RRI) and global tissue hypoperfusion parameters and clinical outcomes in septic shock patients admitted to the intensive care unit and receiving invasive mechanical ventilator support.

It is planned for patients who are admitted due to septic shock and need invasive mechanical ventilator support, who have a central venous catheter inserted for central venous pressure measurement and advanced monitoring, and who have undergone invasive arterial monitoring for close hemodynamic monitoring. After initial hemodynamic stabilization is achieved, RRI will be calculated by renal ultrasonography within 24 hours. Simultaneously with renal ultrasonography, blood samples will be taken from arterial and central venous catheters, partial arterial oxygen pressure (PaO2), partial arterial carbon dioxide pressure (PaCO2), partial central venous oxygen pressure (PcvO2) and partial central venous carbon dioxide pressure (PcvCO2), arterial Oxygen saturation (SaO2), central venous oxygen saturation (ScvO2), hemoglobin concentration and arterial lactate levels will be recorded. An attempt will be made to gain an idea about the course of the disease by comparing RRI with these global tissue hypoperfusion parameters.

Eligibility Criteria:
Inclusion Criteria:

* Followed up due to sepsis
* In need of intensive care follow-up
* In need of invasive mechanical ventilation
* Sofa score \>2

Exclusion Criteria:

* Hypothermic patients (\<35C)
* with chronic renal failure
* Pregnant women
* Those with renal artery stenosis
* Structural kidney damage
* Patient with previous renal surgery
* Intra-abdominal postoperative surgery patients
* Patients with atrial fibrillation
Testing Mitochondria Activity and Blood Lipid Content of Multiple Sclerosis Patients

Background: Multiple sclerosis (MS) is a complex and multifactorial neurological disease characterized by infiltration of immune cells and progressive damage to myelin and axons. Remyelination, the generation of new myelin in the adult nervous system, is an endogenous repair mechanism that restores function of axons. Neurons require considerable energy for their activities, including synaptic neurotransmission, and hence have significant numbers of mitochondria. Unlike other cell types that are able to utilize glycolysis as an alternative energy source, glycolysis in fully differentiated neurons is basically suppressed to maintain their antioxidant status. This property makes neurons highly vulnerable to ATP deficiency, and may be a factor in the susceptibility of neurons to cell death. Mitochondria provide cellular energy by converting oxygen and nutrients into adenosine triphosphate (ATP); and reflect local metabolic needs and via oxidative phosphorylation. Nervous tissues contain about 70% lipids of their dry weight, and around 40% of these lipids are polyunsaturated fatty acids (PUFAs).

Goal: Understanding the relationship between blood composition, mitochondria role and clinical status.

Here, we will examine expression levels of different fatty acids in the blood and monitor mitochondrial transmembrane potential as marker for the mitochondria general function.

Hypothesis: Remyelination efficiency in MS is likely mediated by many factors, besides reducing inflammation. Remyelination may not be achieved correctly /sufficient in MS patients due to nutrition low content causing mitochondrial dysfunction and/or due to fatty acid molecules deficit unable to create a new myelin layer.

Methods: The study will be authorized by the Ziv Helsinki Committee. Informed consent and questionnaire will obtained from all subjects before study entry. We will examine 120 volunteers in a blind fashion, including 60 MS patients diagnosed by a neurologist based on clinical, laboratory and MRI findings. Patients will be evaluated according to EDSS score. The control group will include 50 age and gender matched healthy volunteers and 10 more patients with unrelated neurological diseases. Inclusion criteria: Age 18-60; Exclusion criteria: Other diseases, pathologies, or immune system disorders. Here, we will examine expression of different fatty acids in the serum and in erythrocyte samples; Monitor mitochondrial transmembrane potential as marker for the mitochondria general function.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60

Exclusion Criteria:

* Other diseases, pathologies, or immune system disorders.
Home Hazard Removal Program to Reduce Falls

This study evaluates the effectiveness and implementation of a home-hazard removal program to reduce falls in older adults through a community program delivered through the aging services network. The investigators will conduct a hybrid effectiveness/implementation trial of 300 older adults at risk for a fall who will be randomized to a home-hazard removal program or usual care and then followed for 12 months. Investigators will look at the number of falls at 6 months and 12 months.

The investigators will randomly select a sample of older adults from the large observational cohort of older adults assessed annually by an Area Agendy on Aging via the National Aging Program Information System (NAPIS). The eligibility criteria include age 65 years or older and self-report of one previous fall or more in the preceding 12 months or self-report as "worried about falling." We will conduct baseline assessments and randomize participants to receive an home hazard removal program or usual care. Outcomes (falls, fall self-efficacy) will be assessed by a blinded rater at baseline and 12 months after intervention. All assessments and study visits will occur in participants' homes.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 65 years or older and self-report of one previous fall or more in the preceding 12 months or self-report as "worried about falling."

Exclusion Criteria:

* Individuals residing in nursing homes or individuals with severe cognitive impairment who are unable to give consent to participate (as determined by a score of greater than 10 on the SBT for memory10).
Effects of Continuous Noninvasive Arterial Pressure Measurement on Anaesthesia

Continuous noninvasive blood pressure monitoring may help to avoid intraoperative Hypotension or Hypertension


Eligibility Criteria:
Inclusion Criteria:

* orthopedic surgery in general anaesthesia
* American Society of Anesthesiologists - Physical Status (ASA) 2 or ASA 3
* arterial Hypertension

Exclusion Criteria:

-invasive blood pressure monitoring required
Effect of HILT vs LLLT in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis

The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy

Plantar heel pain, also known as plantar fasciitis, causes soreness or tenderness of the sole of the foot under the heel, which sometimes extends into the medial arch. Pain associated with the condition may cause substantial disability and poor health-related quality of life. Achilles tendinitis is a common etiology of posterior heel pain that results in significant pain and loss of function. Calf exercise is initial management that may be supported by laser therapy. A treatment possibility high-intensity laser therapy is little explored. High-intensity lasers can deliver more energy deeper into tissue. The hypothesis is that both lasers are effective in treatment of plantar fasciitis or Achilles tendinopathy, but high-intensity laser therapy is more effective.

The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy.

The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2016-07-14 No. BE-2-32). Patients are recruited in out patient clinic of Physical Medicine and Rehabilitation Department in The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos.

Eligibility Criteria:
Inclusion Criteria:

* unilateral painful activity related symptoms from the Achilles region
* tenderness during palpation of Achilles insertion on calcaneus or couple centimeters above
* unilateral plantar heel pain, mainly during the first few steps upon rising in the morning
* tenderness at the insertion site of the plantar fascia o the calcaneus

Exclusion Criteria:

* bilateral heel pain
* other acute pathology (febrile fever, cold. etc.) that require treatment
* other painful conditions that require painkillers (tooth pain, back pain, etc)
* pregnancy
* history of recent trauma or foot surgery
* wounds, infections in treatment area
* impaired sensation in treatment area
* pigmentation changes on the skin in treatment area (tattoo, birthmarks)
* received oral or injected corticosteroids within the last 26 weeks
* diagnosis of systemic inflammatory arthritis (goat, rheumatoid arthritis, etc)
* diagnosis of neurological heel pain (radiculopathy)
* diagnosis of other heel pathology (calcaneal stress fracture, osteomyelitis, plantar fascia neoplasm, plantar fascia rupture, etc)