cyrilzakka/clinical-trials huggingface dataset:
Adaptation of Mattresses Made With Different Materials to Personal Anthropometry Values and Body Postures

Sleep disorders affect 40% of the adult population each year and are often associated with morbidity and mortality (Kripke et al., 2002; F.-Z. Low et al., 2017). Sleep quality plays a vital role in the overall quality of our lives. Therefore, a good sleep helps to create a quality life rhythm. A quality sleep reduces fatigue and increases physical regeneration (Khaleghipour et al., 2015). Poor sleep quality is due to various environmental factors such as temperature, light, noise and bed quality (Lei et al., 2009). It has been reported that 7% of sleep problems are caused by inappropriate mattresses that affect the load on the spine during sleep (F. Z. Low et al., 2017). Body contact pressure is a measure of the distribution of body weight across the body surface in contact with the mattress. A well-designed mattress usually has the ability to minimize high pressure points applied to the body. However, if the bed is not suitable for the person, pressure sores may develop in the body parts where pressure is intense (Cullum et al., 2004). The areas most affected by high pressure are usually the hips, shoulders and back, which can affect sleep quality and result in drowsiness or body stiffness throughout the day (Jacobson et al., 2002). A recent study by Bae and Ko compared the bed positions of hospital beds and found that a head-to-foot angle of 30° is the best position to reduce the likelihood of decubitus ulcers occurring in patients in high-pressure risk areas (Bae \& Ko, 2013). In the light of previous studies, it has been observed that there is no study comparing many bed types designed using different materials for individual-specific postures. Biomechanical comparison of these bedding materials in individuals with different posture types and sleeping in different sleeping positions will allow us to provide new insights into their pressure distribution abilities. The aim of this study is to measure the effect of mattresses made of different mattress materials on body contact pressure profiles in individuals with different postures in various sleeping positions. It will be evaluated using maximum body pressure and pressure distribution as outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in research

Exclusion Criteria:

* Having a history of back, shoulder or neck pain in the last 6 weeks
* Having a surgical operation in the last 8 weeks
TsDCS and Physical Therapy After Incomplete Spinal Cord Injury

The aim of this study is to evaluate the effects of tsDCS combined with physical therapy on the recovery of motor function in adult patients with chronic incomplete spinal cord injury.

A randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions). Active or sham tsDCS will be combined with physical therapy to verify the improvement of motor function in patients with incomplete spinal cord injury. Assessments will be performed before and after therapeutic sessions and at the 30-day follow-up after the intervention, through: (i) ASIA Lower and Upper Extremities Motor Scale (LEMS and UEMS), (ii) ASIA Impairment Scale (AIS), (iii) Ashworth Modified Scale; (iv) the Functional Independence Measure (SCIM-III), and (v) the Patient Global Impression of Change Scale - (PGICS).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of incomplete spinal cord injury by a neurologist
* Diagnosis time greater than 12 months

Exclusion Criteria:

* Patients with additional current neurological diagnoses
* Presence of contraindications for tsDCS
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia.The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Mixed dyslipidemia

Exclusion Criteria:

* Known hypersensitivity to fenofibrates or simvastatin or pravastatin
* Pregnant or lactating women
* Contra-indication to fenofibrate or simvastatin or pravastatin
* Unstable or severe cardiac disease
Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome

The objective of the VALIDE study is to validate that a 25% dose reduction of enoxaparine in patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and hospitalized for an acute coronary syndrome provides at steady state a similar anti Xa level in plasma compared to that obtained in patients without renal failure and receiving the usual dose of 1 mg/kg subcutaneously every 12 hours. 140 per - protocol patients are planned to be included.

Included patients will be those hospitalized for an acute coronary syndrome with indication of enoxaparin treatment. A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min. After the fourth dose, the anti-Xa plasma levels (main endpoint) will be measured at peak (between 3 and 5 hours after dose administration). Residual values of antiXa will also be measured before the fifth dose administration (secondary criteria).

The objective is to demonstrate a bio-equivalence of efficacy on the anti-Xa values obtained in patients with moderate rela failure compared with patients with creatinine clearance higher than 50 ml/min.

Thrombotic and bleeding events will be recorded during hospitalisation. 140 per-protocol evaluable consecutive patients will have to be obtained: 70 with creatinine clearance higher than 50 ml/min and 70 patients with creatinin clearance between 30 and 50 ml/min.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for acute coronary syndrome
* Indication of enoxaparin treatment
* Informed consent

Exclusion Criteria:

* Myocardial infarction with ST elevation
* Inclusion later than 12 hours after the first enoxaparin dose administration
* Creatinine clearance lower than 30 ml/min
* History of thrombopenia induced by heparin
* Platelet count lower than 100.000 / mm3
* Age \< 18
* Pregnancy
* History of hemorrhagic stroke
* Contra-indication to enoxaparin
Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial

The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology-2 (PVC-RAM-2) Trial is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of virtual care with remote automated monitoring (RAM) technology compared to standard care on acute-hospital care during the 45-day follow up after randomization, in adults who have undergone semi-urgent (e.g., oncology), urgent (e.g., hip fracture), or emergency (e.g., ruptured abdominal aortic aneurysm) surgery. Secondary outcomes at 45 days after randomization include 1) days in hospital; 2) index length of hospital stay; 3) hospital re-admission; 4) emergency department visit; 5) medication error detection; 6) medication error correction; and 7) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 45 days. We will also assess optimal management of long-term health by evaluating among self-reported current smokers and those with atherosclerotic disease, whether patients are taking classes of efficacious medications at 45 days post randomization.


Eligibility Criteria:
Inclusion Criteria:

1. are ≥40 years of age;
2. will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and
3. provide informed consent to participate.

Exclusion Criteria:

1. planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery;
2. are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a language barrier or a cognitive, visual, or hearing impairment; or
3. reside in an area without cellular network coverage.
The Effect of a Series of Systemic Cryotherapy Treatments on the Functional State of Patients With Multiple Sclerosis

Multiple sclerosis (Latin: Sclerosis multiplex; MS) is a chronic, inflammatory and degenerative disease of the central nervous system (CNS) characterised by a varied course and symptomatology. The chronic nature of the disease and gradual loss of tissue within the CNS result in increasing neurological deficits and motor failure over time. Due to the characteristics of the symptoms and the chronic course of MS, patients with MS use various forms of physiotherapeutic procedures throughout most of their lives, including especially often whole-body cryotherapy (WBC) treatments. The aim of this study was to assess potential changes in bioelectrical muscle activity during rest and contraction after exposure on 20 series of Whole body cryotherapy (WBC) in patients with multiple sclerosis (MS). Assessment potential relationships between the sEMG parameters and functional state in patients with multiple sclerosis pre and post 20 series of WBC.

Finally, 114 patients with MS participated in the planned procedures of research. The participants were randomly assigned to the two groups, WBC and control. The sample size was 60 in WBC, and 54 in control groups. Testing before and after series of WBC consisted of: clinical assessment of fatigue was performed by the Fatigue Severity Scale (FSS), gait speed using Timed 25 Foot Walk (T25-FW), Hand grip strength (HGS), and surface electromyography (sEMG) of the dominant hand.


Eligibility Criteria:
Inclusion Criteria:

* documented diagnosis of MS,
* functional status classified according to the Expanded Disability Status Scale (EDSS) to a level lower or equal to 0-3
* no contraindications for WBC treatments found in the medical examination
* no other serious chronic diseases identified that may affect the results of the tests carried out
* readiness to participate in daily WBC
* a written statement of volunteers about not using WBC treatments in the last 2 years, and not using other forms of physiotherapeutic and complementary therapies (other than planned in the procedures) for the period of this study.
Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis

The primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of C-reactive protein (CRP).

The secondary objectives are:

* to assess the reduction of systemic inflammation as measured changes in acute phase protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American College of Rheumatology response rate, and morning stiffness duration;
* to assess the effect on pain relief within first 14 days;
* to obtain evidence of the safety and tolerability of SSR150106;
* to document trough plasma levels of SSR150106 and its first metabolite.


Eligibility Criteria:
Inclusion Criteria:

* Either treatment-naïve patients, or those who have discontinued their Rheumatoid Arthritis-directed medication due to intolerability or insufficient efficacy
* At least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min
* C-Reactive Protein \>=1.8 mg/dl confirmed during screening period
* Non-poor Cytochrome P2D6 metabolizer status

Exclusion Criteria:

* Functional Rheumatoid Arthritis class IV
* Fever
* Infections with hepatitis B, or C, or HIV
* Presence or history (\<5 years) of cancer
* Manifest or latent tuberculosis
* Functional abnormalities (including laboratory values) judged as clinically relevant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
An Intervention to Improve Outcomes in Patients With Advanced Cancer

1.) To integrate discharge planning into an intervention provided by advanced practice nurses (APRNs)for patients with advanced cancer, 2.) To evaluate the effects of the intervention, and 3.) To explore the reach, adoption, and implementation of the intervention to facilitate the transition of patients from surgery/biopsy/chemotherapy to medical oncology in a comprehensive cancer center.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of advanced lung, GI, Head \& Neck, and Lung cancers
* post-surgical/or post-biopsy with physician's order for cancer treatment
* age 21 years or older
* lives within 50 of Yale New Haven Hospital
* has 2 or more co-morbid conditions
* has an emotional distress thermometer score of greater than or equal to 4-

Exclusion Criteria:
Impact of Simulation Based Learning on Gender, and Equity Dynamics Among Inter-health Professional Teams

At Mbarara University of Science and Technology and partner sites, the investigators will explore the role of simulation in gender and equity. African societies are largely patriarchal, and this spills over into professional practice and medical education. Simulation methodology is at risk of suffering from a patriarchal dominance. The male dominance has potential to introduce power relationships between men and women learners in a scenario setting and between physicians and nurses. In the presence of such power differentials, the less dominant party could develop a "culture of silence," fail to take decisions on issues that affect them or their patients, fail to talk about these issues and take appropriate action.

To address the challenges of gender and equity: 1) the investigators will teach Advocacy Inquiry (AI) and the ladder of inference (LoI) as conversational strategies for all simulation faculty members to explore participant frames of action and thought processes, 2) the investigators will design and expose participants to simulated scenarios with embedded gender and or inter-professional power differentials, 3) study the effect of AI, the LoI and debriefed gender and equity scenarios on participant engagement strategies during gender and inter-professional conflict situations.

The Ladder of Influence allows facilitators select some data / observation, add interpretation, draw conclusions and take action. Though the Ladder of influence is a powerful approach to exploring situations, its prone to challenges if users jump to conclusions quickly without being curious about what alternative interpretations of the observed data / action could be. AI uses the "show", "think" and "wonder" as a strategy to slow facilitators from jumping up the LoI to draw conclusions before exploring learner perspectives. AI and the LoI in combination encourage self-reflection and good judgment. The investigators will deliberately encourage simulation teams to have both males and females and inter-professional with opportunities for team leaders to vary with both sex and profession.

Eligibility Criteria:
Inclusion Criteria:

* Medical students
* Faculty members in the Faculty of Medicine
* Based at Mbarara University, Lira University, Busitema University, or Muni University

Exclusion Criteria:

* Medical students and faculty outside the participating Universities
* Non-medical students
* Faculty not based in the Faculties of Medicine
Effect of Acupoint Stimulation on Lactate During Cerebral Endovascular Intervention

It is advocated that neuroprotection should be increased before endovascular treatment and that the penumbra should be protected from reperfusion damage after recanalization. Monitoring lactate and pH levels in acute ischemic stroke patients who have had endovascular recanalization can be utilized to predict mortality and morbidity, especially in the first five hours after the procedure. This study aims to observe the effect of acupoint stimulation on lactate level during endovascular recanalization.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* scheduled for cerebral endovascular intervention

Exclusion Criteria:

* American Society of Anesthesiologists status over level three
* history of cerebral vascular intervention
* history of severe neurological disease (stroke, neurological degenerative disease, psychiatric disease)
* severe hepatic or renal dysfunction
* severe glucose disorder or thyroid dysfunction
* contraindications to transcutaneous electrical stimulation (infection or injury of the skin area, implanted electrical devices)
Addressing Help-Seeking Barriers in Developing an Intensive Treatment for Veterans With Panic Disorder

The purpose of this study is to understand some of the reasons why recently deployed veterans decline psychosocial treatment options for panic disorder and to test a brief weekend treatment for panic attacks.

The population of interest for this program includes men and women returning from deployment in Iraq or Afghanistan who are seen in the TRP at the MEDVAMC. The study consists of two parts: PART 1 involves a qualitative investigation of treatment-seeking barriers specific to persons who refuse standard treatments and PART 2 is a pilot intervention to treat panic symptoms in service members who have co-existing PTSD symptoms. PART 1 will include approximately 15 individuals who will be interviewed by a member of the study staff. Patients will be interviewed individually following a semi-structured questionnaire designed to help identify treatment-seeking barriers. PART 2 will include 8 individuals who will be enrolled in an open-trial of a two-day intensive cognitive-behavioral treatment for panic disorder, which will occur over the weekend. No participants will be assigned to a control condition. All activities related to this project including the interviews and intervention will be delivered in either the TRP at the MEDVAMC or at the Houston Center for Quality of Care and Utilization Studies (HCQCUS), a nearby facility.

Eligibility Criteria:
Inclusion Criteria:

1. Veterans;
2. age 18-74;
3. current diagnosis of panic disorder;
4. PTSD symptoms that either meet full diagnostic criteria from the Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) or are at a sub-clinical level. Sub-clinical PTSD is defined as patients who meet either PTSD criteria B and C or B and D, but fail to meet all three;
5. panic disorder and PTSD present for at least 1 month;
6. PART 1 only: patients who are clinically eligible to participate in the study and refuse standard psychosocial treatments (e.g., 12 weeks of cognitive behavioral therapy) for panic disorder.

Exclusion Criteria:

1. Current substance dependence;
2. diagnosed with bipolar disorder or psychosis;
3. current suicidal/homicidal ideation and intent;
4. severe depression (precluding participation in a research study);
5. panic attacks related only to a diagnosis of a specific phobia;
6. medical conditions mimicing anxiety (e.g., mitral valve prolapse);
7. PART 1 only: patients who are clinically eligible for the study and are willing to engage in a minimum of 12 weeks of psychosocial treatment for panic disorder.
Comparison of Two Devices Using Near-infra Red Spectroscopy During a Vascular Occlusion Test

Tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two device, INVOS®(somanetics Corporation, USA ) and InSpectra™ (Hutchinson Technology, USA). Each probes are attached to both thenar muscles and vascular occlusion test (VOT) is performed. The investigators will compare the Invos® data to InSpectra™ to investigate whether tissue oxygen saturation values by INVOS® can substitute for InSpectra™.

Tissue oxygen saturation is non-invasively measured using near-infrared spectroscopy, by two device, INVOS®(somanetics Corporation, USA ) and InSpectra™ (Hutchinson Technology, USA). InSpectra™ was introduced later than INVOS®.

With InSpectra™, clinicians have used a vascular occlusion test (VOT) to evaluate dynamic changes in tissue oxygen saturation during ischemia and reperfusion, and thus, microcirculatory function. There have been little data about VOT using INVOS®, although it is more popular device.

We hypothesized that there would be a difference between the values from INVOS® and InSpectra™. The aim of this study is to evaluate changes in tissue oxygen saturation in the thenar muscle during VOT using INVOS® and comapre it to InSpectra™ in a normal population.

Eligibility Criteria:
Inclusion Criteria:

* healthy subject

Exclusion Criteria:

* age under 18 years old
* with arteriovenous fistula
* with peripheral vessel disease
* taking vasoactive drug
* with a skin ailment
* with HTN, DM
* with diagnosed heart disease
Effect of Different Suture Techniques on Early Healing of Peri-implant Soft Tissue

The purposes of this study are to compare the blood perfusion and early healing of horizontal mattress suture with vertical mattress sutures following open-flap implant surgery. Patients wanting single implant replacement in esthetic area will be recruited. This is a randomized, open-label, controlled clinical trial. Noninvasive procedures will be used to assess the primary and secondary outcomes.

Inclusion Criteria: With sufficient bone width (≥6mm), With mesial-distal distance over 8mm, age over 18, Willing to participate Exclusion Criteria: Patients want multiple adjacent implant replacements in esthetic area, Untreated periodontitis, Smokers, Diabetes mellitus

The overall aim of this study is to compare the microcirculation changes of peri-implant soft tissues following open-flap implant surgery using different suture techniques. Subjects fulfilling the inclusion and exclusion criteria will be invited to participate in the study and randomized to one of the two groups: vertical mattress suture (test group) and horizontal mattress suture (control group) on a 1:1 ratio. A laser Doppler flowmetry machine (LDF) (LW1111, LEA) will be used to measure the tissue perfusion. Assessment will be performed at different time, including: Baseline Assessments (presurgical measurements) - T0; Immediate after anesthesia - T1; Immediate after suture - T2; 1 hour after surgery - T3; 2 hours after surgery - T4; 6 hours after surgery - T5; 24 hours after surgery - T6; 72 hours after surgery - T7; 7 days after surgery - T8; 14 days after surgery - T9; 30 days after surgery - T10. The primary outcome is blood perfusion volume (PU) change during the observation period. And secondary outcomes include blood flow velocity change during the observation period, hemoglobin count change during the observation period, blood oxygen saturation change during the observation period; three-dimensional soft-tissue volumetric changes during the observation period, changes in clinical wound healing score during the observation period, PROMs (VAS).

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 and above
2. Subjects want single implant treatment in esthetic area (premolar to premolar) in maxilla
3. With sufficient bone width (≥6mm)
4. With mesial-distal distance over 8mm
5. Evidence of subject ability to achieve good oral hygiene and control periodontitis in the whole of the dentition (FMPS\<20% and FMBS\<20%)
6. Ability to understand study procedures and to comply with them for the entire length of the study. Ability and willingness to give written informed consent.

Exclusion Criteria:

1. Subjects want multiple adjacent implant treatment
2. Patients with inadequate bone volume where major bone augmentation would be required at implant location.
3. Subjects with untreated periodontitis
4. Current smokers
5. Subjects with diabetes mellitus.
6. Pregnant females
7. Participation in another intervention trial
8. Inability or unwillingness of individual to give written informed consent.