cyrilzakka/clinical-trials huggingface dataset:
The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients

The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke patients aged 19 to 80 years
* Patients with subacute stroke within 4 weeks of onset
* Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation

Exclusion Criteria:

* Accompanied by an existing serious neurogenic disease
* Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia.
* If there are difficulties in conducting the research
* Any patients who are judged by the investigator to be difficult to participate in this study
* Exclusion criteria for transcranial direct current stimulation:

  i) Patients with implanted medical devices in the body (e.g. pacemakers) ii) When a metal object is inserted in the skull iii) If there is a wound on the skin of the attachment site iv) history of epilepsy v) Pregnant and lactating women
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.

Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

This study was a multi-center, multinational, prospective, single-arm clinical study with a 6-month treatment period. The primary objective was to extend the safety database of patients with CKD who receive i.v. HX575 epoetin alfa treatment and to monitor the adverse event (AE) profile under post-approval conditions.

Eligibility Criteria:
Inclusion Criteria:

* CKD subjects with or without dialysis treatment
* Age over 18 years
* Subjects requiring i.v. ESA treatment
* Subjects likely to remain on i.v. ESA treatment for 6 months
* Provision of informed consent -

Exclusion Criteria:

* Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level
* Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant erythropoietin product
* History of PRCA or aplastic anemia
* History of anti-erythropoietin antibodies
* Uncontrolled hypertension
* Pregnant woman or nursing mother
* Women of childbearing potential do not agree to maintain effective birth control during the study treatment period.
Studies of the Early Meal Phase in Healthy Individuals - Nutrient Absorption and Gastrointestinal Hormone Secretion

To investigate gastrointestinal hormone secretions and nutrient absorption during the early meal phase we will recruit 12 healthy young men. They will be equipped with peripheral intravenous catheters for frequent blood sampling. Participants will be screened and acclimatised to the study situation on visit 1. On visit 2 and 3 participants will in random order ingest an oral glucose solution or a standardised liquid mixed meal over 2-3 min.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40years
* Male
* Normal Haemoglobin concentration
* Informed consent

Exclusion Criteria:

* Diabetes mellitus
* Family history of diabetes mellitus
* intestinal disease (for example inflammatory bowel disease or malabsorption)
* Family history of inflammatory bowel disease
* Previous intestinal resection (except uncomplicated appendicectomy)
* Body mass index (BMI) \> 25 kg/m2
* Tobacco use
* kidney disease (se-creatinine\> 130 µM and/or albuminuria)
* liver disease (ALAT and/or ASAT \>2 × above normal range)
* Heart disease
* Treatment with drugs
* History of constipation
* Conditions with delayed or accelerated gastric emptying
* Latex or other allergies
* Bleeding diathesis
Suicide Risk Prediction in Cancer Patients

Previous studies have found that the suicide risk of cancer patients is influenced by socioeconomic factors, clinical characteristics, and environmental factors. But prediction model with multiple predictors for suicide risk in cancer patients is limited.

The aim of this study is to assess the association of socioeconomic factors, clinical characteristics and meteorological factors with cancer patients' suicide, based on retrospective cohorts, and to establish a suicide risk prediction model with multiple predictors for cancer patients.

Cancer is a serious public health concern, with almost 10 million people dying from cancer in 2020. Previous studies have reported that cancer patients are more likely to die by suicide than the general public, especially in the six months to one year following cancer diagnosis. Since suicide is a result of the interaction of various factors such as socioeconomic factors, clinical characteristics, and environmental factors, it is necessary to construct a multivariate prediction model to predict the suicide risk in cancer patients.

A retrospective cohort of cancer patients based on the Surveillance, Epidemiology, and End Results (SEER) program database was used to assess the association of socioeconomic factors, clinical characteristics and meteorological factors with cancer patients' suicide, and to establish prediction model with multiple predictors for cancer patients. Another retrospective cohort conducted from Shandong Multi-Center Healthcare Big Data Platform (SMCHBDP) was used to verify the predictive ability and generalization ability of the prediction model.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients in SEER database and SMCHBDP

Exclusion Criteria:

1. No certain cause of death
2. Missing area code
3. Lost to follow-up
Joint Health Study

This is a prospective, non-randomized, controlled study to examine whether or not having a higher trough during prophylactic treatment with clotting factor offers better joint protection than the standard trough of 1% Factor IX (FIX or Factor 9). This study will test the hypothesis that an extended half-life (EHL) FIX product with an intended trough of \>10% could offer better protection than previous treatment concentrates. This study also examines whether or not joint damage could be diagnosed earlier using ultrasound images.

This is a prospective, non-randomized, controlled study to examine whether or not having a higher trough during prophylactic treatment with clotting factor offers better joint protection than the standard trough of 1% Factor IX (FIX or Factor 9). This study will test the hypothesis that an extended half-life (EHL) FIX product with an intended trough of \>10% could offer better protection than previous treatment concentrates. This study also examines whether or not joint damage could be diagnosed earlier using ultrasound images. The primary research question is whether EHL rIX with an intended trough level of \>10% will improve the outcome of joint health of elbow, ankle, and knee joints as assessed with ultrasound assessments in patients with severe Hemophilia B.

Depending on their current treatment regimen, subjects will be in one of three groups: 1) on demand, 2) prophylaxis with an intended trough of 1-5%, and 3) prophylaxis with an intended trough of \>10%. Subjects will have four annual study visits over three years: baseline, year 1, year 2, and year 3. At each of these visits, subjects will complete questionnaires, joint assessments, have their blood taken, and have ultrasound images of their joints. The first 10 subjects will also have x-rays and MRIs of their joints for ultrasound validation.

Subjects are encouraged to come in during a painful episode for an examination, assessment, and ultrasound of their joints and to come in again within 1-2 weeks after the painful episode for a repeat examination, assessments, and ultrasound.

This study will be conducted at the Washington Center for Bleeding Disorders (WCBD) at Bloodworks Northwest, Oregon Health \& Science University (OHSU), University of California San Diego (UCSD), University of California Los Angeles (UCLA), and Tulane University (TU). Cumulatively across the five sites, up to 50 participants will be enrolled. Additional sites may be added.

Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia B (FIX \<1%)
* Either on demand or on prophylaxis with rFIX or EHL-rIX products with the intention to stay on the current regimen for the next 3 years
* For Group C, start of this treatment regimen up to 6 months prior is permissible

Exclusion Criteria:

* Other known bleeding disorder
* Other rheumatologic disorder affecting joints
* Other known neuromotor defect (making physical exam difficult)
A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients

This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.


Eligibility Criteria:
Inclusion:

* Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks
* If Patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the HbA1c level\>7.5%.

Exclusion:

* Fasting plasma glucose \>13 mmol/L at screening
* Ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months
* Drug abuse
* Women pregnant or lactating
* Use any rosiglitazone like drug in 3 months
* Use more than one oral antidiabetic agent in 2 months
* Uncontrolled hypertension
* Chronic heart failure
* Anemia
Examining Perceptions of the 24-Hr Movement Guidelines

The main objective of the proposed research is to experimentally test and inform the most effective brand attributes that is to be featured in the forthcoming Canadian 24-Hour Movement Guidelines for Adults. Specifically, there are two main objectives. The first objective is to determine the most preferred tagline associated with the new Guidelines among a sample of Canadian adults. The second objective is to experimentally test if this new attribute fosters stronger perceptions of self-efficacy among an adult sample, when compared to previous threshold-based approaches.


Eligibility Criteria:
Inclusion Criteria:

* between 18-64 years
* Canadian

Exclusion Criteria:

* cannot read/write in English
* already self-reported meeting Guideline recommendations for all three behaviours (physical activity, sedentary behaviour, and sleep)
* self-reported medical condition and/or sleep condition that would prevent individual from meeting the Guideline recommendations
NTX-001 to Repair Peripheral Nerve Transection(s)

The proposed use of NTX-001 for transections of upper extremity and facial peripheral nerves, acutely or planned.

For this expanded access program, there is a case-by-case internal review process conducted by Neuraptive after the respective investigator provides a prospective case narrative for enrollment consideration.

Allowed Sunderland Classifications are IV degree (Seddon's Class II) and V degree (Seddon's Class III). If the case is approved, the investigator can move forward.

Patients who are between twelve (12) and eighty (80) years of age and has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and require surgical treatment. All peripheral nerve repairs including gap repairs (autografts) will be considered for enrollment.

Eligibility Criteria:
Inclusion:

1. The patient has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and requires surgical treatment.

Exclusion:

1. Patients whose nerve repair will occur greater than 48 hours after nerve transection.
2. Patients requiring repair of the intracranial portion of any nerve.
3. Patients requiring a nerve repair involving an allograft or conduit.
4. Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy).
5. Patients who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow-up due to significant muscle atrophy or other morbidity.
6. The patient has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
7. The patient has a known allergy to polyethylene glycol (PEG) or human grade silicone.
Open-label Study of Inhaled RVT-1601 in Preterm Infants

Preterm birth predisposes infants to greater risk for respiratory morbidities and the need for pulmonary care compared to term infants both in the short-term and long-term. In the short-term, preterm birth is a high risk factor for development of bronchopulmonary dysplasia (BPD), the second most common chronic pediatric respiratory disease after asthma. In the long-term, following discharge from the neonatal intensive care unit (NICU) and the hospital, preterm birth carries a high risk for respiratory morbidities (e.g., wheezing, cough, doctor visits, and hospitalizations for respiratory infections) and resource use, which in turn predisposes infants to the development of lung diseases in childhood and adulthood, including airway hyperresponsiveness, asthma, and chronic obstructive pulmonary disease (COPD). There is a significant unmet need for safe and efficacious approaches in the prevention and treatment of respiratory morbidities of prematurity.

The study will be conducted in the neonatal intensive care unit (NICU) in preterm infants to determine safety, tolerability and lung delivery performance of RVT-1601, a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer/face mask.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants between 32 weeks 0 days and 34 weeks 6 days of PMA
* Born between 24 weeks 0 days and 29 weeks 6 days of estimated GA
* Requiring minimal or no respiratory support (i.e., supplemental oxygen with \<2 liters per minute of nasal cannula flow acceptable)
* Body weight appropriate for gestational age
* Written informed consent obtained from at least one of the parents or legal guardians

Exclusion Criteria:

* Requiring invasive or noninvasive respiratory support (e.g., mechanical ventilation, CPAP)
* Clinically unstable (i.e. unable to maintain SpO2 between 90-95 % , escalating respiratory support in the past 24 hours)
* Major congenital anomaly (chromosomal, renal, cardiac, hepatic, neurologic or pulmonary malformations)
* Significant cardiac disorder (i.e., pulmonary hypertension)
* History of major surgical procedure
* Any condition that would preclude receiving study drug or performing any study-related procedures
* Participation in any other investigational drug study
* History of hypersensitivity or intolerance to cromolyn sodium
Fatigue, Depressive Disorders and Insomnia in Adult Patients with Marfan Syndrome and Ehlers-Danlos Syndrome: Survey

The goal of this observational study is to describe and assess the presence of perceived fatigue in subjects with MFS and EDS. the main question it aims to answer through the FSS instrument is:

* The relationship of fatigue with physical and psychological characteristics, the presence of depressive disorders and insomnia.

Marfan syndrome (MFS) and hypermobile Ehlers-Danlos Syndrome (hEDS) are rare diseases of the connective tissue presenting peculiar symptoms as well as high mortality due to complications related to dilatation and dissection of the ascending aorta and great arteries. Life expectancy of patients with MFS and hEDS has improved markedly in the last decades, but still remains lower than that of the general population. Fatigue represent one of the main causes that limit the quality of life in these populations. The Fatigue Severity Scale (FSS) is a questionnaire widely used in populations with chronic diseases and has been previously applied in MFS and hEDS population: indeed, fatigue interferes with activities of daily living and the presence of chronic pain. However, the potential correlations that fatigue may have with different aspects of psychological well-being (i.e. insomnia and depression) were not investigated in MFS and hEDS.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 or greater with clinical and/or genetic diagnosis of Marfan syndrome;
* Subjects aged 18 or greater with clinical and/or genetic diagnosis of hypermobile Ehlers-Danlos syndrome;
* Signed informed consent;
* Ability to speak, read and write in Italian.
Analysis of Four-fragment Fractures of the Proximal Humerus: the Interest of 2D and 3D Imagery and Inter- and Intra-observer Reproducibility

Fractures of the proximal humerus are increasingly frequent, with numbers tripling between the 1970s and the 2000s. Among these fractures, those involving the tuberosities and also the anatomic neck are a therapeutic challenge. For this type of fracture (Neer's four-part fracture) the degree of displacement of the fracture needs to be understood in order to provide suitable treatment and apprehend the risks in its evolution. There is indeed, in this type of fracture, a risk of humeral head ischaemia, which will carry considerable weight in the therapy adopted.

The usual classifications, such as the AO or the Neer classification, have shown their limitations in terms of reproducibility and are not suitable for the prognostic assessment of these four-fragment fractures of the proximal humerus. The radiographic parameters described by Hertel in 2004, on the other hand, seem to be far more relevant to routine clinical practice.

The use of the scanner to improve reproducibility of the classification of these proximal humerus fractures is still controversial. The scanner is the rule to guide therapeutic strategy for complex fractures, although the reproducibility of the different assessment criteria has never been studied.

The aims of the present study were firstly to analyse inter-observer and intra-observer reproducibility for the different criteria proposed by Hertel, using three types of imagery (standard radiographies, 2D and 3D scans) and secondly to assess the relevance of the use of the scanner to improve reproducibility

Eligibility Criteria:
Inclusion Criteria:

* Proximal humerus fracture
* standard radiographs, a 2D scan with axial, sagittal and coronal sections, and high-resolution 3D reconstructions performed in emergency settings when the patient arrived in the care facility
Optimizing Postoperative Cognition the Elderly

This study will recruit surgical patients more than 65 years old. Patients who participate will wear a sticker on their forehead during surgery which monitors their brain waves (electroencephalogram, EEG) and participate in memory testing before and after surgery. Brain wave patterns will be compared between patients who have problems with memory and thinking after surgery and those who do not. The hypothesis is that there will be characteristic brain wave patients for who will go on to have problems with memory and thinking after surgery.

Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai. After informed consent, patients will complete cognitive and tests at least one but not more than 30 days prior to surgery. In the recovery room the Post Anesthesia Recovery Scale (PQRS), and CAM-ICU delirium screening will be administered. Immediate recovery will be recorded using the Postoperative Recovery Scale (PQRS) on postoperative day 1 and 3, and 1 week.

Longterm functional recovery will be measured with the Alzheimer's Disease Research Center (ADRC) Instrumental Activities for Daily Living (IADL-24). Postsurgical complications will be recorded including unplanned ICU admissions, postoperative myocardial infarction and stroke (risk less than 1 % in most cases), wound infection and reoperation. The full cognitive and functional battery will be repeated at 3 months and 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age and older
* having major elective non-cardiac surgery requiring general anesthesia requiring at least a 2 day hospital stay

Exclusion Criteria:

* previous diagnosis of dementia, stroke, cardiac or intracranial surgery
* inability to consent or communicate in English or Spanish
* major uncorrected hearing or vision deficit, Parkinson's disease, or major psychiatric disease which will be determined by phone interview and computer medical records abstracted by the primary investigator.
Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments

The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR.

The objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score \> 15 points) \& safety claims (The expected acceptable revision rate (state of the art with a confidence interval of 95%) is 3% at 3 years, 5% at 5 years, 7% at 7 years and 10% at 10 years).

The endpoint of this study is to validate the expected performance of the HARMONY® Evolution implants with the PMA score at 10 years and to validate the safety claim with the expected acceptable revision rate at 10 years.

The study is prospective, multi-centric, observational, non-comparative, non-randomized and post market. About 264 subjects will be enrolled in this study to evaluate the safety and performance of the HARMONY® Evolution implants.

Patients will be included in the study during 12 months and followed-up during 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of 18 years of age and older
* Each subject who is willing to give informed consent
* Clinically indicated for a Total Hip Replacement
* Women of childbearing age who are not pregnant and do not expect to become pregnant within 12 months. A pregnancy test should be performed for women of childbearing age
* Geographically stable and willing to return to the implanting site for all follow-up visits

Exclusion Criteria:

* Acute or chronic, local or systemic infection
* Muscular, neurological, psychological or vascular deficits
* Poor bone density and quality likely to affect implant stability (severe osteoporosis)
* Any concomitant condition likely to affect implant integration or function
* Allergy or hypersensitivity to any of the materials used

Specific:

• The HARMONY® Evolution Standard stem size 8 shall not be implanted in subjects weighing more than 70 kg.