cyrilzakka/clinical-trials huggingface dataset:
Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment

The purpose of this study is to prospectively obtain reliable data on the bleeding and treatment pattern of patients with VWD undergoing on-demand treatment with a VWF-containing product over a period of 6 months. The data obtained will be used as a basis for historical comparisons with the bleeding and treatment pattern obtained from a clinical study on the efficacy of prophylactic treatment with a VWF/FVIII concentrate.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following criteria are eligible for the study:

* Male or female patients aged ≥5.5 years at the time of enrolment
* VWD type 1 (baseline von Willebrand factor activity \[VWF:RCo\], \<30 IU/dL), 2A, 2B, 2M, or 3 according to medical history requiring substitution therapy with a VWF-containing product to control bleeding
* Currently receiving frequent on-demand treatment with a VWF-containing product
* In female patients of child-bearing potential using hormonal contraception, the medication class should remain unchanged for the duration of their study participation
* Voluntarily given, fully informed written and signed consent obtained before collection of any patient data

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

* Patients currently on prophylaxis for VWD (except for perioperative prophylaxis) as well as patients having received treatment once a month for menstrual bleeding, but not for any other bleeds
* Patients whose VWD treatment is planned to be switched from on-demand to prophylactic treatment in the next 6 months
* History, or current suspicion, of VWF or FVIII inhibitors
* Medical history of a thromboembolic event within 6 months before enrolment
* Severe liver or kidney diseases as described in the medical records
* Female patients with an existing or suspected pregnancy or who are breast-feeding at the time of enrolment
* Change in hormonal contraception within 6 months before enrolment
* Cervical or uterine conditions causing abnormal uterine bleeding (including infection or dysplasia)
* Other coagulation disorders or bleeding disorders due to anatomical reasons
* Participation in an interventional clinical study during the 6-month of study period
* Inability to complete the patient diary to reliably evaluate the type, frequency, and treatment of BEs during the 6-month study period
Deep Brain Stimulation in Treatment Resistant Schizophrenia

This study aims at assessing efficacy and safety of Deep Brain Stimulation (DBS) for treatment of patients with treatment resistant schizophrenia, by means of a random, controlled and crossed study.

The first phase of the study will consist of implanting electrodes. Recruited patients will be random to 2 targets: (1) medial prefrontal cortex (mPFC); (2) nucleus accumbens (NAcc). Continuous stimulation will be applied until the patients stabilise clinically. This period is anticipated between 6 and 9 months.

After this stage, the next phase will consist of the crossover study. Those patients who respond to DBS will be randomly distributed in two groups, for a period of 3 months: on stimulation group and off stimulation group. Patients will then be crossed over to the other group for a further 3 months.

Weekly visits during first month after, and fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance.

Patients who complete the study and respond to treatment with DBS will be provided continuing with treatment, and keeping control visits to assess the long-term effectiveness.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged between 18 and 55 years.
2. DSM IV-TR diagnosis of schizophrenia for at least 3 years prior to the screening visit.
3. Determined to be treatment-resistant as demonstrated by:

   1. Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years.
   2. Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks.
   3. Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects.
   4. ECT is contraindicated or have failed to produce a maintained response.
4. Persistence of positive symptoms defined as i) requiring a score of 4 (mild) or more on at least 2 of the next PANSS items: delusions, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above PANSS items.
5. Current CGI score 6 or more
6. Stable antipsychotic treatment for last 2 months.
7. Women of childbearing age using medically approved contraceptive methods.
8. Adequate familiar or social support during all study procedures.

Exclusion Criteria:

1. MRI (Magnetic Resonance Imaging) contraindication to stimulation or contraindications for MRI
2. History of epilepsy or clozapine-induced seizures, where use of anticonvulsants was needed
3. Current suicidal ideation, plan or intent for self-harm during last 2 months.
4. Evidence of global cognitive impairment.
5. Current acute, serious or unstable illnesses.
6. History of substance abuse (other than tobacco or caffeine).
7. Comorbid axis I or II DSM IV-TR disorders.
8. Female patients who are pregnant or breastfeeding.
Inflammation and Obesity-associated Disease

Visceral obesity and adipose inflammation is considered a driving force of obesity-related systemic disease, e.g. cardiometabolic disease, liver cirrhosis and chronic kidney disease (CKD). Inflammatory resolution is actively regulated by specialized pro-resolving mediators (SPMs), including the endogenous eicosanoid LXA4. Impairment of SPMs may underlie development of obesity-related pathology.We hypothesize that obese patients who develop obesity-related disease do so because they suffer from impaired endogenous production of pro-resolving lipids. This will result in aggravated adipose inflammation and fibrosis, which contribute to the systemic pathologies. We thus wish to investigate adipose inflammation and the pro-resolving lipid profile of obese subjects with and without obesity associated metabolic disease. We also aim to investigate whether LXA4, LXB4 and other anti-inflammatory agents (such as AICAR) can alter the phenotype of human adipose macrophages in ex vivo tissue culture. We also investigate basic pathways in inflammatory regulation and obesity related cardiometabolic disease.


Eligibility Criteria:
Inclusion Criteria:

* Obese BMI 35-55 kg/m2
* Lean BMI 18.5-24.9

Exclusion Criteria:

* Medical treatment with NSAIDs, corticosteroid treatment, immune-suppressants.
* Other: smoking, alcohol abuse.
Study of the Effects of Iron on Lung Blood Pressure at High Altitude

Body iron levels may be important in determining how the blood pressure in the lungs changes in response to low oxygen levels. At high altitude, where oxygen levels are low, some patients develop elevated lung blood pressure. The investigators hypothesize that, in high altitude residents with elevated lung blood pressure, iron supplementation will cause a reduction in lung blood pressure.

Pulmonary hypertensive disorders frequently complicate hypoxic lung disease and worsen patient survival.

Hypoxia-induced pulmonary hypertension is also a major cause of morbidity at high altitude. Hypoxia causes pulmonary hypertension through hypoxic pulmonary vasoconstriction and vascular remodelling. These processes are thought to be regulated at least in part by the hypoxia-inducible factor (HIF) family of transcription factors, which coordinate intracellular responses to hypoxia throughout the body.

HIF is regulated through a cellular degradation process that requires iron as an obligate cofactor. In cultured cells HIF degradation is inhibited by reduced iron availability (by chelation with desferrioxamine) and potentiated by iron supplementation. In humans, laboratory experiments lasting eight hours have shown that acute iron supplementation blunts the pulmonary vascular response to hypoxia, while acute iron chelation with desferrioxamine enhances the response.

These findings suggest that iron may also affect the pulmonary vascular response to hypoxia over longer time periods. The purpose of this study, which will take place at high altitude in Kyrgyzstan, is to investigate whether iron supplementation can reduce pulmonary artery pressure in patients with established high altitude pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* High altitude natives, currently resident at high altitude
* Pulmonary hypertension (mean pulmonary artery pressure \> 25 mmHg)
* Pulmonary artery systolic pressure measurable using Doppler echocardiography

Exclusion Criteria:

* Clinical evidence or history of major co-morbidity
* Recent changes to relevant medications, or taking iron/vitamin supplements
'M'-Technique, Guided Imagery, or Standard of Care on Anxiety and Pain Pre- & Post-operatively in Elective Joint Replacement Patients

In the M-TIJRP protocol the investigators will utilize two Integrative Medicine modalities in a randomized, controlled study using either the 'M'-Technique® developed by Jane Buckle, PhD or Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ with nature sounds to determine their effects on a specific group of pre- and post-operative patients, compared to no integrative medicine intervention - considered Standard of Care. A total of 225 patients undergoing surgical hip or knee replacement will participate; one third of the patient population will receive the 'M'-Technique touch intervention, one third will receive Tusek's Guided Imagery intervention delivered by headsets monitored by therapists from our Center for Complementary Medicine (CCM) and one third will comprise the control group, consisting of routine preoperative \& postoperative care without integrated intervention.

Patients will be asked to complete Pain and Anxiety scales at four different timepoints throughout their hospital stay. These will occur at Same Day Surgery (pre-operatively), and Post Operatively Day 0, Day 1 \& Day 2.

Rationale: Patients are often at their most vulnerable just prior to surgery when their stress and anticipation are high and again immediately afterward when their energy is lower and their bodies are trying to accommodate after an invasive procedure. In addition, the patient and his or her family sense a lack of control and feel a rise in anxiety over the possible outcomes. This stress, anxiety, and pain associated with surgery and recovery can increase complication rates and slow recovery times resulting in longer hospital stays.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Be receiving an initial or subsequent elective hip or knee replacement surgery

Exclusion Criteria:

1. Patients with an active infection or open wound in the location of the extremities where the 'M'-Technique will be performed
2. Patients with touch aversion
3. Non-English speaking patients - due to guided imagery recording availability in English only
4. Patients who demonstrate insufficient auditory discrimination as determined by their ability to engage in normal conversation
5. Patients who lack the sensation of being touched on the hands and/or feet
Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma

Objective To evaluate change in same-day pulmonary function testing in pediatric patients receiving OMT compared to those receiving usual care.

Methods For this study, we selected patients utilizing the following inclusion criteria: 1) ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then randomized to either an OMT or a control group. We excluded patients who were experiencing an acute asthma exacerbation. Patients in the OMT group were treated with rib raising and suboccipital release, in addition to standard asthma care, while control group patients received standard care only. A second PFT was performed on both groups at the end of the visit. OMT was performed by multiple osteopathic pediatric residents who were specifically trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1, and FEF 25-75%) were then compared.

Objective To evaluate change in same-day pulmonary function testing in pediatric patients receiving OMT compared to those receiving usual care.

Methods For this study, we selected patients utilizing the following inclusion criteria: 1) ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then randomized to either an OMT or a control group. We excluded patients who were experiencing an acute asthma exacerbation. Patients in the OMT group were treated with rib raising and suboccipital release, in addition to standard asthma care, while control group patients received standard care only. A second PFT was performed on both groups at the end of the visit. OMT was performed by multiple osteopathic pediatric residents who were specifically trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1, and FEF 25-75%) were then compared.

NOTE: The OMTs were done either by our OMM attending at that time (Dr. Wolf) or by residents trained by her for this study (Drs. Jones, Pe, Bryant and Regan,)

Eligibility Criteria:
Inclusion Criteria:

* Age as noted above
* Diagnosis of asthma
* Scheduled for routine asthma care at our clinic
* at least one prior PFT done prior to this visit

Exclusion Criteria:

* Clinical indication for pre- and post-bronchodilator spirometry on day of visit
* albuterol use w/in 8 hours of the visit
* oral steroid use in previous 2 weeks
* diagnosis of asthma exacerbation w/in prior 4 weeks
Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.

Benzodiazepines, levo-dopa/carbidopa, dopamine agonists, anticonvulsants, and opioids have been used with variable success, to treat RLS. Often, RLS patients treated with a benzodiazepine, over the course of several months, develop tolerance to the medication. Also, benzodiazepines can cause confusion or daytime sleepiness and may be addictive. Patients may also develop tolerance to levo-dopa/carbidopa treatment. Because of the short half-life, symptoms may be suppressed for only the first part of the sleep period and then recur later during the night. Rebound has been reported. Worse yet, augmentation, the occurrence of RLS symptoms, often more severe than before treatment began, earlier in the day, may occur in up to 80% of RLS patients treated with levod-dopa/carbidopa. Dopamine agonists, including pergolide, pramipexole, and ropinirole, are effective for some patients but not for others. Common side effects of these drugs include coryza, hypotension, and rash. Of the anticonvulsants, preliminary reports suggest that gabapentin, carbamazepine, and divalproex can suppress RLS symptoms in some patients, especially those with mild RLS. Side effects include sleepiness, ataxia, and weight gain. Opioid treatment for RLS has been described as effective but, aside from the stigma of taking controlled substances regularly, side effects may include nausea, sedation, constipation, and dysequilibrium. Iron supplementation is therapeutic in some patients with iron deficiency and RLS.

Preliminary anecdotal data suggest that topiramate reduces RLS symptoms. Topiramate has several potential mechanisms of action including enhancement of GABA-mediated inhibition, which may account for the observed benefit in patients with RLS.

Topiramate may be a better alternative than the currently available treatments to suppress RLS symptoms. Like gabapentin, it offers the possibility of decreasing RLS symptoms while also diminishing pain, especially in those patients who have limb pain from neuropathy, radiculopathy, or other causes. Unlike gabapentin, topiramate may help overweight patients with RLS lose weight, if anedotal reports on weight reduction with the medication are correct.

Eligibility Criteria:
Inclusion Criteria:

* The symptoms of each subject must meet the diagnostic criteria of the International RLS Study Group
* More than five periodic leg movements per hour recorded during baseline polysomnography (PSG)
* Each subject must discontinue all treatments for RLS and agreed not to take other RLS treatments during the study

Exclusion Criteria:

* Clinically unstable medical problems
* History of nephrolithiasis
* Progressive neurologic disease
* Inadequate therapeutic response from two previous treatment regimens for RLS
* Subjects unable to discontinue medications known to cause or suppress RLS
* Subjects with sleep apnea syndrome
* Subjects consuming daily more than three beverages containing caffeine
Evaluation of an Informative Intervention to the ICU Team About the Presence of Asynchronies in Mechanically Ventilated Patients: Effect Over Incidence Reduction

Mechanical ventilation (MV) if a life-support treatment for critically ill patients that can develop adverse effects. Patient-ventilator asynchronies can be present from the beginning of MV, it can be associated with poor outcome and it can develop clinical changes. The aim of this study is to evaluate if the knowledge of the presence of asynchronies by the healthcare team can help to reduce its incidence, improving outcomes of critically ill patients.

A prospective, single-center, before and after study will be conducted in the ICU of Hospital de Sabadell. The study will have 2 phases: a first observational period where the incidence of asynchronies will be assessed, and a second period where a daily information of the presence of asynchronies to the healthcare team will be done with the aim to reduce the incidence.

A continous record of asynchronies and clinical variables will be done during ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation \< 24 hours.
* \> 18 years-old

Exclusion Criteria:

* \> 24 hours of invasive mechanical ventilation at admission.
* \<48 hours of data collected
* Informed consent not obtained
Development/Testing of SUMMIT: a Tool to Help Patients Manage Pain While Tapering Opioids

There are nearly one million veterans being treated with long-term opioid therapy (LTOT) for chronic pain. Numerous short and long-term harms associated with LTOT and mounting evidence suggest they have modest or no benefit. Yet, currently available resources to support veterans to taper are inadequate. Primary care, where most LTOT in VHA is prescribed, is overburdened and straining to meet the challenge of caring for patients with chronic pain. A scalable, relatively inexpensive tapering intervention to support primary care and/or to extend the reach of resource-intensive specialty clinics would be of great benefit to veterans who are not deriving sufficient benefit from LTOT. As such, the goal of this study is to develop and test an interactive, theory-informed, multi-component mobile website to enable veterans to safely taper opioids while managing their pain.

The investigators will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial of the multicomponent mobile website called SUMMIT. Eligible participants will be randomized to SUMMIT versus a pain monitoring app. Outcome measures will be collected over 9 months.

To ensure rigor and successful future implementation, the investigators will: 1) develop an evidence based program with features proven to maximize engagement and retention; 2) ensure that the program includes mechanisms to address the diverse obstacles veterans report when consider opioid tapering (e.g. fear of pain flares and abandonment by the system); 3) employ a User Centered Design - with meaningful input from veterans and primary care providers throughout the development and testing phases; and 4) adhere to recently published guidelines for mobile health interventions.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for Veterans will be primary care patients who are dispensed 84 consecutive days of a stable dose of opioids (reflecting three consecutive 28-day prescriptions) through primary care and who report stable levels of pain intensity over the past month.

Exclusion Criteria:

Exclusion criteria will be Veterans on liquid methadone or buprenorphine for opioid use disorder (OUD) and those who have transitioned to buprenorphine (transdermal or sublingual) for chronic pain, have hearing or visual impairments (not corrected with hearing aids or glasses), psychiatric conditions, cognitive impairments, or participating in a concurrent pain or opioid-related research study.
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys

The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil \[MMF\] plus steroids versus tacrolimus plus MMF, following induction with daclizumab) in recipients of marginal donor kidneys.

An open, multicentre, randomized, parallel group study to compare in marginal old-for-old renal transplant patients the safety and efficacy of two treatments: sequential mycophenolate mofetil/delayed tacrolimus plus steroids vs tacrolimus plus mycophenolate mofetil, in patients requiring induction with anti-IL2 monoclonal antibody.

Elderly (≥50 years) low risk patients (PRA grade ≤50%, in the previous 6 months) receiving an allograft transplantation of marginal kidney(s) from elderly (\>65 years) donors (old-for-old allocation) will be randomized to one of the following treatment arms:

Arm1: Sequential mycophenolate mofetil/tacrolimus/steroids

Arm2: Tacrolimus/mycophenolate mofetil/steroid one single dose (perioperatively)

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients minimum 60 years of age undergoing a cadaveric kidney transplant
* Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation.
* Donors older than 60 years
* Female patients of child bearing age agree to practice effective birth control during the study.
* Patient has been fully informed and has given written informed consent

Exclusion Criteria:

* Patient has significant, uncontrolled, concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
* Patient has previously received or is receiving an organ transplant other than kidney or a kidney retransplant
* Any pathology or medical condition that can interfere with this protocol study proposal
* Other exclusion criteria apply