cyrilzakka/clinical-trials huggingface dataset:
Inpatient Rehabilitation and Post-Discharge Outcomes With High Intensity Gait Training (HIGT) of Patients With Stroke

Stroke is a major cause of disability, with 2-3% of Americans reporting stroke related impairments (Tsao 2022). Following stroke, over half of Medicare patients are discharged to post-acute care facilities or receive home-based health care (Tsao 2022). Inpatient rehabilitation guidelines are lacking, with many interventions based on research of patients with chronic stroke. There is great need for randomized clinical trials during the early subacute period (Bernhardt 2017, Jordan 2021).

Clinical practice guidelines recommend high intensity gait training (HIGT) for ambulatory patients with chronic stroke (Hornby 2020). Outpatient HIGT protocols incorporating variable stepping demonstrate equivalent effectiveness to forward stepping protocols (Hornby 2019) and have yielded superior results to lower intensity therapies (Hornby 2019, Hornby 2016). Research suggests that HIGT with variable stepping is feasible during inpatient rehabilitation (Hornby 2015, Moore 2020). Pre-post studies suggest that participation in HIGT during inpatient rehabilitation yields greater improvements in walking without an increase in adverse events. (Moore 2020). Despite this, there are no randomized controlled trials evaluating HIGT in the inpatient setting.

The subacute phase of stroke recovery may be a critical time for neuroplasticity (Dromerick 2021). Not only might rehabilitation interventions be more effective when initiated earlier (Biernaskie 2004, Dromerick 2021) but because inpatient rehabilitation represents the transition from hospital to home, interventions during this timeframe have the potential to improve discharge disposition, enhance quality of life, and reduce utilization of post-discharge services.

In this randomized controlled study, investigators will determine how participation in HIGT during inpatient rehabilitation affects balance, ambulation, and quality of life after 14 and/or 21 days of inpatient rehabilitation, and 8 weeks post-discharge. Investigators will also determine if HIGT reduces health care burden with a cost-effectiveness analysis.


Eligibility Criteria:
Inclusion Criteria:

* adults (≥18 years) recovering from a unilateral cerebral infarct with resultant hemiparesis occurring less than three months prior. Patients must have an expected length of stay of at least 14 days.

Exclusion Criteria:

* are older than 85 years of age have evidence of intracranial hemorrhage on head imaging

  * have had a brainstem, cerebellar or bilateral hemisphere stroke
  * are medically unstable
  * are pregnant
  * have chronic cardiorespiratory disease

    * on oxygen
    * angina
    * unstable arrhythmias
    * ischemic cardiomyopathy (Ejection Fraction \<50%)
  * unable to follow 2 steps commands accurately
  * neurological comorbidities that affect gait

    * Parkinson's
    * severe polyneuropathy
  * unable to walk at least 150 feet premorbid
  * dependent assistance level for transfer from a chair to a bed as assessed by physical therapy.
A Prospective Cohort Study of IgG4RD in China

This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.

Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration.

In this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 18-75 years old with informed consent
* Patients with IgG4-RD:

  1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
  2. elevated serum IgG4 (\>1.35 g/L)
  3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
  4. exclusion of other diseases.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential
* Concurrent severe and/or uncontrolled and/or unstable diseases
* Patient with malignancy
Large Abdominal Hernia Repair With SurgiMend 3.0

The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%. The purpose of this study is to evaluate the rate of hernia recurrence at one year following repair with SurgiMend 3.0, an FDA-cleared novel biologic mesh, the hypothesis being that such rate will be less than 20% at one year, representing a 50% reduction over the historic rate of 40%.


Eligibility Criteria:
Inclusion Criteria:

All three of the following criteria must be present for enrollment into the study:

* Large abdominal hernia
* Inability to close the fascia primarily
* Contra-indication for the use of synthetic mesh
* Age \> 18 years

Exclusion Criteria:

* Use of SurgiMend 3.0 to simply reinforce a complete closure of the fascia performed either primarily or sequentially or by component separation technique
* Inability to close the skin over the SurgiMend 3.0
Predictor of Residual Neuromuscular Blockade in Recovery Room After General Anesthesia

Background When general anesthesia was performed, neuromuscular blocking agents (NMBAs) are frequently used for facilitate tracheal intubation and keep patient still and relax during surgery. Unfortunately, residual neuromuscular blockade are important complication.

There are many factors that affect neuromuscular blockade and may prolong effect of NMBAs which we already know about that such as body temperature, drugs, some kind of diseases. However there are no recent studies that mention about other factors. The purpose of this study is to find out other factors that affect NMBAs effect to improve patient safety.

Methods The study is a prospective, non-randomized, blinded, observational study.

222 patients will be included in this study and will be performed general anesthesia. Anesthetic technique and agent which are used depend on regular staff. Information of patient will be collected are age, sex, weight, height, ASA classification, anesthetic technique, anesthetic and surgical time, amount of inhalation agent, amount of NMBAs, amount of opioids and reversal agents.

After anesthesia finish, patient will be brought to recovery room and Train Of Four watch® will be placed and record Train Of Four ratio by this research staff. Train Of Four ratio \< 0.9 will be defined as there is residual neuromuscular blockade in this patient.

All patients will be divided into 2 groups: residual blockade group(patient who have train of four \<0.9 after surgery) and no residual blockade group(patient who have train of four \>0.9). All factor of each group will be compared between. Statistical will be analyzed to find significant factor which affect neuromuscular blockade.

study about residual neuromuscular blockade

Eligibility Criteria:
Inclusion Criteria:

* - age ≥ 18 years
* American society of anesthesiologist class I-III
* patient who are schedule for intraabdominal surgery, orthopedic surgery and gynecologic surgery under general anesthesia and use neuromuscular blocking agents (NMBAs)

Exclusion Criteria:

* - patients who have myasthenia gravis, myotonia, muscular dystrophy, upper motor neuron lesion
* patients who have drug which influence neuromuscular action such as oral muscle relaxant, anticonvulsants, magnesium sulfate
* Body temperature \>37.8 or \< 36 degree Celsius before operation
Exercise to Boost Response to Checkpoint Blockade Immunotherapy

30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles


Eligibility Criteria:
* Inclusion Criteria:
* Age ≥ 18 years
* Able to read and speak English fluently
* Capable of giving informed consent
* Reported ability to complete 20-30 minutes moderate exercise per positive response to "can you currently walk unaided for six minutes or more?".
* Scheduled for first-time checkpoint blockade immunotherapy with FDA-approved drugs, including avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab in the absence of other therapies (e.g. targeted therapy)
* Melanoma patients (adjuvant setting)
* Melanoma patients (neoadjuvant setting)
* cuSCC patients (neoadjuvant setting)
* Merkel cell carcinoma patients (neoadjuvant setting)

Participants may also be required to have a full COVID vaccination series; the most up-to-date best practice guidelines for research at Moffitt Cancer Center will dictate the need for such a vaccination series.

Exclusion Criteria:

* Presence of medical conditions, such as severe cardiovascular disease for which an exercise intervention may not be warranted.
* Presence of major postoperative complications for which an exercise intervention may not be warranted.
Impact of Machine Learning-based Clinician Decision Support Algorithms in Perioperative Care

Predicting surgical risks are important to patients and clinicians for shared decision making process and management plan. The study team aim to conduct a hybrid type 1 effectiveness implementation study design. A Randomized Controlled Trial where participants undergoing surgery In Singapore General Hospital (SGH) will be allocated in 1:1 ratio to CARES-guided (unblinded to risk level) or to unguided (blinded to risk level) groups. All participants undergoing elective surgeries in SGH will be considered eligible for enrolment into the study. For elective surgeries, the participants will mainly be recruited from Pre-admission Centre. The outcome of this study will help patients and clinicians make better decisions together. Firstly, the deployment of the CARES model in a live clinical environment could potentially reduce postoperative complications and improve the quality of surgical care provision. The findings from this study would allow fine-tuning of CARES as well as further deployment of additional risk models for specific complications other than Mortality and ICU stay. This in turn would translate to better health for the surgical population and improved cost-effectiveness. This is significant as the surgical population is expected to continuously grow due to improved access to care, better technologies and the aging population. Secondly, IMAGINATIVE will be instrumental in improving our understanding of the deployment strategies for AI/ML predictive models in healthcare. Models such as CARES could be the standard of care in the future if proven to improve the health outcomes of patients. As model deployments are costly and can be disruptive to the EMR processes, this study would be the initial spark for future deployment and health services research focusing on improving the value of these model deployments.


Eligibility Criteria:
Inclusion Criteria:

1. Patients \>=21 Years old
2. Patients going for elective surgery

For semi-structured interview:

1. Any clinician or nurse that used CARES during the research trial

Exclusion Criteria:

1. Patients with reduced mental capacity
2. Patients who are unable to give consent
Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist

Novel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of NOAC treatment (NOAC-ICH).

Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There is no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of bleeding conditions other than ICH.


Eligibility Criteria:
Inclusion Criteria:

* Acute intracerebral hemorrhage (symptom onset \<12h)
* Prior treatment with a novel direct oral anticoagulant (apixaban, dabigatran, edoxaban or rivaroxaban; last intake \<48hours or proven NOAC activity by relevant coagulation assays)
* Age \>18 years, No upper age limit
* Informed consent has been received in accordance to local ethics committee requirements

Exclusion Criteria:

* Severe pre-morbid disability (modified Rankin scale \>4)
* Anticoagulation with Vitamin K antagonists (VKA) (recent intake)
* Secondary intracerebral hemorrhage (e.g. arteriovenous malformation (AVM), tumor, trauma) Note it is not necessary for investigators to exclude underlying structural abnormality prior to enrolment, but where an underlying structural abnormality is already known, these patients should not be recruited.
* Glasgow coma scale \<5
* pregnancy
* Planned neurosurgical hematoma evacuation within 24 hours (before follow-up imaging)
* Pulmonary embolism/deep vein thrombosis within the last 2 weeks.
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function

This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening.
* Subjects must have a body mass index (BMI) between 18 and 40 kg/m2 to participate at screening.
* Female subject must be of non-childbearing potential, i.e. surgically sterile at least 6 months prior to screening with supportive clinical documentation OR post-menopausal must have no regular menstrual bleeding for at least 12 months prior to inclusion. Menopause will be confirmed by a plasma FSH level of \>40 IU/L
* Male subjects must agree to practice 2 highly effective methods of birth control at least one method must be barrier technique.

Additional Inclusion Criteria for Healthy Subjects Only:

* In good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening; subjects without diseases/conditions
* Matched with a hepatic impaired patient (mild, moderate or severe, as applicable) using the following criteria: sex, age ±10 years and body mass index (BMI)± 10 kilograms

Additional Inclusion Criteria for Hepatic Impaired Subjects Only:

* History of cirrhosis with supportive documentation (ultrasonography, computed tomography scan, liver biopsy, magnetic resonance imaging, clinical laboratory tests results or physical signs consistent with a clinical diagnosis of liver cirrhosis.
* Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment.
* Blood pressure of 90 to 155 mmHg (systolic) and 50 to 100 mmHg (diastolic).
* Otherwise considered healthy in general as determined by physical examination findings and laboratory assessments within normal limits.

Exclusion Criteria:

* Subjects with a clinically relevant history or presence of any clinically significant disease.
* History of drug or alcohol abuse within the 12 months prior to dosing.
* A positive human immunodeficiency virus (HIV) Type 1 or 2 test result at screening.
* History of blood donation of 500 mL or more of blood within 2 months prior to screening
* A positive tuberculosis test result.

Additional Exclusion Criteria for Hepatic Impaired Subjects Only:

* Received a liver transplant
* Acute or exacerbating hepatitis
* Active Stage 3 or 4 hepatic encephalopathy
* Previously diagnosed with hepatocellular carcinoma, or a history of cholestatic liver disease or biliary sepsis within the past 2 years.
* Additional Exclusion Criteria for Healthy Subjects Only: A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of any clinically significant chronic and/or active hepatic disease.
Assessment of a New Food Product in Metabolically at Risk Children

The current study conducted will lend toward the optimization of the development of a food product that will promote a shift towards improved metabolic health. Specifically, this trial will determine the optimal level of protein needed to elicit positive changes in markers of inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular function, and the relationship of these changes to the metabolome in school aged children (9 - 13 years of age).

Each participant will be asked to participate in a screening and 2 study intervention visits. Each intervention visit will include anthropometric measures, complete the education component, vascular function tests, and a blood draw and spot urine. The screening visit will confirm the child's eligibility for study enrollment and will serve to acclimate the child to the vascular function, and physical activity measurements. The remaining 2 visits will be scheduled 4 weeks apart. The participants will also be provided and asked to wear a physical activity monitor, which in addition to tracking physical activity, will also be used to incorporate a nutrition education program. The parent/guardian will be asked to help with providing the child the daily food product and to help their child fill out the compliance log. Volunteers will also be sought for stool and saliva collection.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female 9-13 years old
* Subject is willing and able to comply with the study protocols
* Subject is willing to consume the test products
* Access to a smart phone or tablet at least 1x / week; and willing to download a free applications associated with the study

Exclusion Criteria:

* Allergies or intolerances to peas, legumes, pulses, soy, dairy or wheat/gluten
* Under current medical supervision
* Tanner Score = 4
* Non-English speaking
* Current participation in a daily exercise routine of moderate or high intensity
* Self-reported presence of disease, a history of serious illness, or who are currently under acute medical care.
* Currently taking prescription drugs or supplements
* Any supplement use, including multi-vitamin/ mineral, herbal, plant or botanical, fish oil, and oil supplements.
* Self-reported malabsorption or gastrointestinal issues
* Current enrollee in a clinical research study.
B/F/TAF Ease of Swallowability Trial

The trial will assess the tolerability and swallowability of a STR placebo of B/F/TAF as compared to DTG/ABC/3TC placebo STR in healthy individuals and HIV antiretroviral naïve patients. The study team will evaluate the ease of swallow and patient's tolerance of the medication formulation, an important, yet often overlooked aspect of ART adherence, with the potential for significant impact on patient's outcomes.

The study will plan to recruit 50 volunteers who will be randomized to receive Placebo A (B/F/TAF) or Placebo B (DTG/ABC/3TC). Randomization will ensure that the patients will have equal opportunity to try either placebo tablet first to avoid bias. Randomization will be done by an investigator not evaluating or providing the questionnaires to the patient. Participants will complete a questionnaire regarding what medications they take and what factors they consider affect their ease to swallow pills or tablets. The participants will be administered one of the placebo tablet with the research investigator present and will complete a questionnaire immediately following the first placebo dose. A study timeout for 15-30 minutes will be done following completion of the questionnaires. After which, participants will take the second placebo tablet and complete the final questionnaires.

The primary comparison will be between the placebo tablets A and B for tolerability, ease of swallow and participant preference. The investigators estimate that the sample size needed to detect a difference of at least 1 point in a 5 point Likert scale will be 50 patients with a standard deviation of 2 points, with \>90% power.

Eligibility Criteria:
Inclusion Criteria:

1. HIV seronegative or seropositive treatment naïve adult over 18 years of age, currently in stable condition, ambulatory and able to swallow tablets or pills.
2. Patients able to provide informed consent and remain in clinic for at least 2 hours.
3. Study participants able to complete the study questionnaires.
4. No known history of allergies to any of the placebo components.

Exclusion Criteria:

1. Patients with known dysphagia or motility disorders leading to difficulty swallowing liquids, food or medications.
2. Patients allergic to any component of the placebo tablets.
3. Children under the age of 18 years.
4. Adults unable to provide informed consent.
5. Female patients known to be pregnant.
6. HIV seropositive patients on antiretroviral therapy or with prior history of antiretroviral therapy.
Cross-Over Multicentre Study in Adolescents

The main objective of this study is to evaluate the effects of two diets with different glycemic index and fibre content on glucose metabolism and plasma lipid profile of 80 adolescents in 4 European centres.

Secondary objectives are to evaluate the effects of the two standardized diets on selected hormones and variables linked to inflammatory status.


Eligibility Criteria:
Inclusion Criteria:

* Age 13-16 yrs
* Written informed consent
* Menstrual cycle for at least 6 months
* Overweight

Exclusion Criteria:

* Taking part simultaneously in another research trial
* Involvement in physical training (\>4 h/week of vigorous physical activity)
* Any dietary treatment in the previous two months
* Body weight changes \> 3 kg in the previous two months
* Gastrointestinal diseases, irritable bowel syndrome, or positive history for recurrent gastrointestinal symptoms such as nausea, vomiting, bloating, epigastric pain, abdominal pain, abdominal discomfort, flatulence, severe constipation
* Kidney diseases
* Type 1 or type 2 diabetes
* Thyroid or other hormonal diseases
* Other secondary causes (including illnesses) of hyperlipidemia or altered glucose metabolism
* Severe hyperlipidemia (total cholesterol \> 300 mg/dL or triglycerides \>300 mg/dL)
* Severe hypertension
* Positive history for eating disorders
* Any regular drug treatment
* Any food allergy and intolerance