cyrilzakka/clinical-trials huggingface dataset:
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence

* Purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound dehiscence.
* Sample size: 144
* intervention groups:

  * Group A: Acetazolamide administration for 10 days
  * Group B: prone positioning for 10 days
  * Group C: Acetazolamide administration and prone positioning for 10 days
  * Group D: no intervention
* Period of study: Autumn 2012 to the end of winter of 2015

The purpose of this study is to evaluate the effect of Acetazolamide administration and prone positioning following lumbosacral spinal surgery in preventing cerebro-spinal fluid leakage and collection and wound dehissence in children admitted to Children Medical Center of Tehran since Autumn 2012 to the end of winter of 2015.The study is run under 4 categories of intervention:

* Group A: Acetazolamide administration for 10 days
* Group B: prone positioning for 10 days
* Group C: Acetazolamide administration and prone positioning for 10 days
* Group D: no intervention All patients are randomly assigned to these groups and when the patients faced with any of these complications, the protocol changes to Acetazolamide administration and prone positioning and the patient is considered as the failure of the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Untethering surgery for primary tethered cord caused by thick filum
* Lipomyelomeningocele
* Split cord malformation management
* Untethering surgery in uncomplicated Dermal sinus
* Tumors needing intradural management in lumbosacral region
* Having any other disease with similar management technique

Exclusion Criteria:

* Infected dermoid tumors
* Intramedullary abscess
* Myelomeningocele surgery and related reoperation
* Meningocele
* Presence of hydrocephalus
Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome

A prospective assessment of psychological characteristics, quality of life and sexuality in naïve patients.

This project with PCOS patients include an assessment of quality of life and sexuality in naïve patients.

Hypothesizing that PCOS women would show higher rates of psychological alterations, this study is aimed to investigate the association between polycystic ovary syndrome (PCOS) and psychological disturbances, including anger and to analyze whether the biochemical/phenotypical features of PCOS may play a role in the type and severity of psychological disorders.

Eligibility Criteria:
Inclusion Criteria:

PCOS patients without gestational desire who met the following criteria

* Oligomenorrhea (cycles lasting \>35 days) or amenorrhea (no periods in 6 months)
* Hyperandrogenemia/hyperandrogenism Hirsutism Ferriman-Gallwey score \> 12 Obvious acne or pronounced alopecia Androgen levels over normal female range

Exclusion Criteria:

* Prior psychiatric diagnosis
* Current use of psychiatric medications
* Difficulties with language comprehension in case of non-nationals.
* Yatrogenic hirsutism,
* Other endocrine deseases with hyperandrogenism or that may influence the final results Ovarian or adrenal neoplasia Prolactinoma Cushing's syndrome Congenital adrenal hyperplasia Diabetes mellitus Thromboembolic disease
* Patients who had received any drug therapy for hirsutism over the last 6 months
Quality of Life of Colorectal Cancer Screenees in the Period Between Colonoscopy and Next Clinic Visit for Final Report: Does Real-time Endoscopic Optical Diagnosis Improve Their Quality of Life

Colorectal cancer screening program has been proven to reduce colorectal cancer (CRC) mortality and is cost-effective. It has been adopted by most countries in the world, and colonoscopy is regarded as the most accurate test for detecting colorectal neoplasm. After screenees underwent colonoscopy, most endoscopists do not routinely explain the preliminary optical diagnosis to the subjects before they going home, which may cause unnecessary anxiety and may reduce the quality of life of the subjects before acquiring the final results. In recent years, endoscopic optical diagnostic technology has been validated by meta-analysis studies as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer. The real time feature of endoscopic optical diagnosis allows endoscopists to explain the preliminary results confidently to the subjects immediately after colonoscopy, which is expected to reduce the anxiety of the subjects before they acquired the final results and improve their quality of life. We designed a randomized controlled trial to validate whether real-time endoscopic optical diagnosis could decrease the anxiety burden and improve the quality of life for colorectal-cancer screenees after colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who preparing to received screening or surveillance colonoscopy under general anesthesia.
* Patients who preparing to received sedated colonoscopy due to other GI tract related symptoms.

Exclusion Criteria:

* Impaired mental status that could not understand the questionnaire questions.
* Patients with major psychological disorders.
Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis

The primary purpose of this study is to determine whether iloprost inhalation solution is safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial pressure. The secondary purpose is to evaluate the effectiveness of this treatment in subjects with this disease.

While there are no FDA approved therapies for the treatment of IPF, there are therapies that have been shown to be effective in ameliorating the effects of pulmonary hypertension in patients with PAH (pulmonary arterial hypertension), including inhaled iloprost. However, these therapies have not been used extensively in patients with IPF who have pulmonary hypertension as a complication. The potential benefits of treatment of pulmonary hypertension complicating IPF include: improvement in pulmonary hemodynamics, with reduction in pulmonary artery pressure and pulmonary vascular resistance, and increase in cardiac output.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic pulmonary fibrosis according to American Thoracic Society criteria
* Diagnosis of elevated pulmonary pressures
* Six minute walk distance between 50-380
* NYHA functional class II - IV

Exclusion Criteria:

* Pulmonary fibrosis related to a systemic disorder
* Significant chronic obstructive pulmonary disease
* History of thromboembolic disease within the previous year
* Awaiting lung transplantation within next 36 weeks
* Active lung infection
* Survival prognosis of less than 1 year
* Significant left-sided heart failure, active coronary artery disease
* Clinically relevant liver disease
* Concurrent medications: epoprostenol, treprostinil, bosentan, PDE-5 inhibitor, investigational agents
Effectiveness of Pain Neuroscience Education on Clinical and Psychosocial Variables in Chronic Low Back Pain

An educational intervention on the neurophysiology of chronic pain will be provided. The content of the intervention will be identical in the experimental groups (group and individual). The intervention has an active educational approach based on reconceptualizing the maladaptive beliefs that influence the fear-avoidance behavior of the participants through updated contents of the neuroscience of pain.

The effects of the intervention will be compared between the groups and the influence of the social determinants of health on the effects will also be determined.

The investigators hypothesize that there will be significant differences in favor of the group intervention group over the individual intervention groups. Furthermore, the effects will be influenced by the social determinants of health in both experimental groups.


Eligibility Criteria:
Inclusion Criteria:

* non-specific low back pain ≥ 3 months without compromise of any lower limb.
* average pain intensity ≥ 3/10 and ≤8/10 (according to the 0-10 numerical rating scale \[NRS\]) in the last month.

Exclusion Criteria:

* psychiatric, neurological or oncological diseases.
* operated of some lumbar pathology
* chronic low back pain due to a specific cause (lumbar stenosis, herniated disc, spinal deformity, fracture, spondylosis)
* have received any modality of active or passive physical therapy for pain in the last two months,
* previous experiences with PNE
Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmatic Patient's Adherence

The purpose of this Study is to assess the effect of a smartphone application connected to an add-on device system fitted on Pressured Metered Dose Inhaler (PMDI) on adherence to take medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient's written informed consent obtained prior to any study-related procedures
* Male or female patient aged 18 years and above
* Patient with established diagnosis of asthma for at least 6 months
* Patient on maintenance therapy (Fixed dose combination ICS/LABA) with high dose of ICS
* Patient with ACT score \<20 at screening and at randomization
* Non- or ex-smoker who smoked ≤ 10 Pack-years prior to screening
* Patient must have their own Android® or iPhone operating system (IOS) smartphone
* Ability to use the pMDI device correctly

Exclusion Criteria:

* Patient with an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 to 3 month prior to screening
* Patient with a history of near-fatal asthma
* Clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, psychiatric or any other disorder that would put the safety of the subject at risk through participation, or which would affect the analysis
* Patient not able to be compliant with the study requirements.
* Patient with a BMI \> 40
* Patient working on night shifts
* Patient participating in the clinical phase of an interventional trial or have done so within the last 30 days prior to screening.
* Patient who has an already planned major surgery or hospitalization
* Female patient who is pregnant or lactating or who plans to become pregnant in the next 4 months.
* Patient with a history of hypersensitivity to any of the components of Foster pMDI
PICU Admission Lactate and Central Venous Oxymetry Study

Observational multicentre cohort study. Children admitted to a Dutch PICU are studied for lactate levels and ScvO2. Children instrumented with arterial and central venous catheters are included within the first 12 hours after admittance.

Rationale: Hemodynamic therapy in children with circulatory insufficiency requires the use of hemodynamic monitoring parameters including parameters that reflect tissue/organ oxygenation and oxygen utilization. Two parameters are readily available at the bedside that may reflect this: arterial lactate level and central venous oxygen saturation (ScvO2). To date is it unknown if these parameters are useful in guiding treatment of critically ill children. Also it is unknown how often lactate and ScvO2 are abnormal in children admitted to a Dutch PICU or if they are related to each.

Objective: The objective of this study is to find the incidence of a raised lactate level and or a decreased ScvO2, to study their mutual relation and to study the relation between lactate, ScvO2 and outcome parameters in children admitted to a Dutch PICU.

Study design: Observational cohort study

Study population: children admitted to a PICU \<= 16 years

Intervention (if applicable): No intervention

Main study parameters/endpoints: Arterial lactate level, central venous oxygen saturation (ScvO2), arterial blood gas analysis and general hemodynamic variables in the first 24 hours after admission. Parameters for organ dysfunction, severity of illness and outcome parameters like length of PICU stay.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This is a strict observational design. No blood samples are taken for the purpose of this study. No intravascular catheters are inserted for the purpose of this study. No treatment strategy is associated with this study.

Eligibility Criteria:
Inclusion Criteria:

* Al children admitted to a PICU \<= 16 years equipped with an arterial and central venous catheter in situ at admission or inserted within \< 12 hours after admission to the PICU

Exclusion Criteria:

* Patients without an arterial or central venous catheter \> 12 hours after of admission
* Patients with a known underlying metabolic disorder causing an elevated lactate level
* Patients with asthma and therapy (nebulized or intravenous) with salbutamol.
* Patients with an intoxication causing elevated lactate levels
* Premature children (\<38 weeks GA)
* Patients on ECMO
Diffuse Noxious Inhibitory Controls (DNIC): Nociceptive Modulation and Interaction With Neurocognitive Performance in Chronic Pain

Diffuse noxious inhibitory control In order to quantify central sensitization in chronic pain patients, the Diffuse Noxious Inhibitory Control (DNIC) model has been used frequently. DNIC relies on painful conditioning stimulation of one part of the body to inhibit pain in another part, to remove the "noise" and to focus on relevant stimuli.

Earlier studies provided evidence for malfunctioning of DNIC in Fibromyalgia (FM) patients. However, the cause of this impairment is not yet elucidated, and further study is required to unravel the pathophysiology of DNIC in FM.

Hypothalamus-Pituitary-Adrenal (HPA) axis Besides neural mechanisms, also hormonal abnormalities could cause altered pain processing. Cortisol is released in answer to pain to suppress the pain. Given the evidence for hypofunction of the hypothalamic-pituitary-adrenal axis and the lower cortisol release in response to stressors in a proportion of FM patients and in chronic whiplash associated disorders (WAD) patients, the relation between pain and cortisol in these patients may be an interesting topic to consider.

Neurocognitive performance Besides chronic pain, people with chronic WAD and FM suffer from severe concentration difficulties and decreased neurocognitive capabilities (reduced reaction time, short term memory deficits etc. The decreased neurocognitive performance is known to be related to pain severity in various chronic pain populations. It is hypothesized that malfunctioning of descending inhibitory pathways and subsequent chronic pain experience precludes optimal neurocognitive performance.

Objectives The present investigation addresses the (patho)physiological mechanisms of DNIC in chronic pain populations.

1. Firstly, patients with FM, chronic WAD and healthy controls are compared regarding functioning of DNIC, cortisol levels and response and neurocognitive performance (case-control).
2. Secondly, the possible interaction between the functioning of DNIC, cortisol and neurocognitive performance is studied in patients with FM, WAD and healthy control subjects (cross-sectional).
3. Thirdly, to examine whether a fatiguing neurocognitive stressor changes DNIC and cortisol levels in patients with FM, chronic WAD or healthy sedentary control subjects.


Eligibility Criteria:
Inclusion Criteria:

* 30 FM group: comply with the diagnostic criteria for FM as defined by the American College of Rheumatology.
* 30 WAD group: comply with the criteria of the Quebec Task Force (grade I to III)
* 40 healthy pain-free control subjects
* Dutch speaking
* aged between 18 and 65 years.

Exclusion Criteria:

* FM patients reporting a history of a whiplash trauma
* WAD patients fulfilling the diagnostic criteria for FM
* healthy control subjects cannot suffer any pain complaints
* cannot be pregnant or until 1 year postnatal
* asked to stop analgesics 48 hours prior to study participation, not to undertake physical exertion, and to refrain from consuming caffeine, alcohol or nicotine on the day of the experiment.
Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy

Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen side effect. Hydromorphone is a hydrogenated ketone of morphine and approximately 5-10 times more potent. There lacks about efficacy and efficiency of hydromorphone in electrical pump for patient controlled intravenous analgesic (PCIA).


Eligibility Criteria:
Inclusion Criteria:

* 70≥ Age ≥18
* Selective operation lung section with video-assisted thoracic surgery (VATS)
* III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I
* Patients informed and agreed to join the study

Exclusion Criteria:

* Abnormal function of liver and kidney
* Allergic- dependence history of alcohol, opioids and Local anesthetics
* No noncompliance
* Mental disease history，language communication disorder，cicatricial diathesis
* Underweight or overweight（BMI\<18 or \>30)
* Patients not suitable for clinical subjects for other reasons
* Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24 hours before the operation.
* History of previous abnormal anaesthesia
* Women during pregnancy or lactation
Postural Control and Fine Motor Skills in People With Stroke

This study evaluates the relationship between seated posture and fine motor performance in a drawing task in people with stroke and in healthy control subjects.

Current stroke rehabilitation practice guidelines support an interprofessional approach which integrates discipline-specific goals into a comprehensive plan of care. However, there has been a failure to implement interprofessional guidelines into today's stroke rehabilitation clinical practice. Instead it is common that one discipline focuses on recovery of posture, while another discipline focuses on recovery of fine motor skills. The investigators argue that control of the hand is not independent from postural control. In fact, treating them separately ignores the kinematic and muscular linkages connecting the trunk to the hand via the scapula and proximal arm. It also ignores evidence that postural and hand muscles have overlapping cortical representations thus likely have similar neural control networks. Hence, the overall goal of this project is to demonstrate the relationship of posture and fine motor skills to advance stroke rehabilitation.

The study will include two groups, stroke survivors and neurologically healthy controls, and both will perform a tracing task while seated on a backless bench. The task will be performed twice, at baseline and after giving participants cues to improve their posture. Both task repetitions will be performed in a single session on the same day. Kinetic and kinematic data will be collected to evaluate posture, postural stability and fine motor performance. Data collected at baseline will be used to examine the relationship between postural impairments and fine motor deficits. Additionally, we will evaluate the effects of postural cues on body segment alignment, stability and fine motor performance.

Eligibility Criteria:
Stroke survivors:

Inclusion Criteria:

* experienced uni-hemispheric ischemic or hemorrhagic stroke 3 mo - 7 yrs prior
* ability to grasp and hold a stylus for the duration of the experiments
* passive motion throughout the paretic UE within 20° of normal
* dominant side affected

Exclusion Criteria:

* lesion in brainstem or cerebellum
* presence of other neuro-disease impairing motor skills
* unable to understand 3-step directions
* pain, orthopedic condition or impaired corrected vision that would alter reaching

Healthy Controls:

Inclusion Criteria:

* no history of stroke or incomplete spinal cord injury
* no medical, orthopedic, neurological, or uncorrected visual condition that would limit the ability to participate in upper extremity testing

Exclusion Criteria:

* none
The Pneumatic Tourniquet Technique for Endoscopic Radial Artery Harvest; Does it Affect Patient Hemodynamics?

This study aims to investigate the effect of the pneumatic tourniquet technique on the patients' hemodynamics; heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP).

Coronary artery bypass graft surgery (CABG) is the most common cardiac surgical procedure. Radial artery of the non-dominant hand with better ulnar collaterals is preferred over the saphenous vein because of long term patency of the radial artery. Radial artery is the preferred second or third arterial conduits for vessels with sub occlusive stenosis.

There are two techniques of radial artery harvesting; open and endoscopic techniques. Endoscopic radial artery harvesting (ERAH) is increasing and it is possible but the evidence regarding its safety is scarce. ERAH is cosmetically better than the open technique.

ERAH technique is performed after applying a tourniquet over the distal arm proximally to the elbow. Allen test will be done first and if the hand has a good blood supply through the ulnar artery, the tourniquet pressure is increased 75-100 mmHg over the systolic pressure and the tourniquet time is kept under one hour and the left radial artery will be endoscopically harvested.

During the time of tourniquet inflation, there is ischemia of the forearm with subsequent cellular ischemic changes like; cellular acidosis, cellular edema, and activation of cellular apoptosis. On deflating the tourniquet, there is reperfusion of the limb and development of ischemic / reperfusion injury with a subsequent increase of inflammatory mediators and reactive oxygen species (ROS). These changes may be associated with some hemodynamic instability that might be dangerous, especially in patients with ischemic heart disease (IHD).

Eligibility Criteria:
Inclusion Criteria:

* Listed for CABG surgery with the use of ERAH technique.

Exclusion Criteria:

* Emergency CABG surgery.
* CABG plus any other cardiac surgery.
* The use of inopressor drugs before ERAH