cyrilzakka/clinical-trials huggingface dataset:
Orthostatic, Respiratory, Balance-Intervention

The purpose of this study is to help understand how training breathing muscles will impact balance, blood pressure, and quality of life of participants with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

1. Upper/lower/both extremity weakness or paralysis resulting from SCI with ASIA Impairment Scale (AIS) grades A-C who use a wheelchair as primary means of mobility.
2. ≥1 year post-injury
3. Willingness to participate in the study and provide consent.

Exclusion Criteria:

1. Inability to understand the consent form or consent process
2. Reliance on a mechanical ventilator.
3. Use of Betablockers
4. Inability to travel to The Miami Project for weekly sessions during intervention month
5. Any complication that would limit transfer ability, or compromise supine or sitting tolerance, including but not limited to:

   * Fracture, dislocation, or malformations affecting supine or sitting tolerance.
   * Spinal instability.
   * Pressure ulcers or skin integrity issues on contact surfaces that would prohibit sitting or lying in supine.
6. Individuals who are able to stand independently or with a walker
7. Unresolved deep vein thrombosis (DVT).
8. Hospitalization due to autonomic dysreflexia in the last 3 months.
9. Pregnancy determined by urine testing in sexually active females.
Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema.

To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years) with diabetes
* DME in the study eye (if both eyes have DME both eyes will be included in analysis)
* BCVA minimum of 20/200 (35 letters)
* Central Macular Thickness (CMT) ≥300 µm
* Patients with DME who were treated with Ozurdex at least twice (baseline is before the first Ozurdex injection).
* Follow up of at least 6 months after the last Ozurdex injection given
* Complete records including BCVA (OCT and Fluorescein Angiography (FA) if available) throughout the follow up

Exclusion Criteria:

* Patients with ME not secondary to Diabetes Mellitus (DM).
* Presence of other retinopathies (AMD, RVO) or visually significant ocular morbidity (e.g. advanced glaucoma, corneal opacity)
* Previous ocular trauma or surgery other than cataract extraction
* Intravitreal triamcinolone ≤6 months before baseline
* Intravitreal bevacizumab, ranibizumab, or pegaptanib \<1 months before baseline
* Marked intraocular pressure (IOP) elevation in response to any previous steroid treatment
* Ocular Hypertension (OHT) in the study eye(s)
* IOP \>23 mm Hg without antiglaucoma medication
* IOP \>21 mm Hg with one antiglaucoma medication
* Use of 2 or more antiglaucoma medications
* Glaucoma - Visual Fields (VF) defect \> 4 dB
Chemotherapy Resistance and Sensitivity Testing in Lung Tumors

The purpose of this study is to screen chemotherapy drugs currently used to treat lung cancer and determine the most effective treatment based on results of chemo sensitivity testing on the patients own cancer cells in the laboratory. The results of this screening will not influence the patients treatment.

The chemosensitivity assay will be performed on tissue obtained during the diagnostic fine needle aspiration, core biopsy, or excisional biopsy of the lung lesion. Cancer cells (Bulk of tumor) and Cancer Stem Cells (CSCs) will be isolated and expanded in the laboratory.

The drug screening assay will be used to evaluate the response of the CSCs and of the cancer cells to the various chemotherapy regimens.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed diagnosis of lung cancer

  * undergoing a fine needle aspiration, core biopsy, or excisional biopsy for diagnosis.
* Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
* Patient must be at least 18 years of age
* Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.

Exclusion Criteria:

* Patient pathology shows benign pathology for sample submitted
* Patient is not indicated to receive chemotherapy for their disease
Study of PD-1 Antibody and PARP Inhibitor in Extensive Stage Small Cell Lung Cancer

This is a Phase II, Open, Single-center Study of Camrelizumab and Fluzoparib as Consolidation Treatment for Patients With Extensive stage small cell lung cancer Who Have Not Progressed after first-line treatment


Eligibility Criteria:
Inclusion Criteria:

1. All subjects were required to sign the informed consent before starting the study;
2. Histologically documented Extensive stage small cell lung cancer；
3. ECOG PS 0\~1 ；
4. 18-75 years；
5. According to recist1.1, CR or PR was achieved after 4-6 cycles of first-line etoposide and platinum chemotherapy;
6. .Life expectancy ≥ 3 months；

Exclusion Criteria:

1. Recurrence or distant metastasis of localized small cell lung cancer after chemotherapy or concurrent chemoradiotherapy；
2. Active infection including tuberculosis, HIV, hepatitis B and C；
3. Interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy or active pneumonia with clinical symptoms, or other moderate to severe lung diseases that seriously affect lung function;
4. Severe infection existed, including but not limited to infection complications, bacteremia, severe pneumonia, etc;
5. Symptomatic brain metastasis and cancerous meningitis;
Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg

A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet under Fed and Fasting Conditions in Healthy Volunteers

\[Objectives\]

* Primary: To investigate the food-effect bioavailability of absorption of gemigliptin and dapagliflozin 50/10 mg fixed dose combination film-coated tablet in healthy subjects under fed and fasting conditions
* Secondary: To evaluate safety of investigational product under fed and fasting conditions

Eligibility Criteria:
Inclusion Criteria:

* Male and female, healthy volunteers aged 18-55 years, body mass index between 18.0 to 30.0 kg/m2. All of them should be able to complete the clinical study including the follow-up and capable of providing written informed consent.

Exclusion Criteria:

* History serious hypersensitivity reactions
* History or evidence of clinically significant renal, hepatic, gastrointestinal
* Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
* History about administration of first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period
* History or evidence of family diabetes
* History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
* etc.
A Collaborative Palliative and Leukemia Care Model for Patients With AML and MDS Receiving Non-Intensive Therapy

This research study is evaluating the impact a collaborative palliative care and oncology team will have on end-of-life outcomes, quality of end-of-life care, and the quality of life, symptoms, and mood of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) receiving non-intensive therapy

Frequently people undergoing treatment for AML or MDS experience physical and emotional symptoms during the course of their illness. These can be very distressing to both patients and their caregivers. Patients with AML or MDS receiving non-intensive therapy also often experience a rapid decline in their health status and have a limited prognosis. Despite their limited life-expectancy, they rarely engage in discussion with their clinicians regarding their goals and preferences for care at the end of life. The study doctors want to know if the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these distressing symptoms and have expertise in enhancing communication about prognosis and illness trajectory may improve the overall care of patients with acute leukemia.

This team of clinicians is called the palliative care team and they focus on ways to improve the participant's pain and other symptom management (nausea, fatigue, shortness of breath, anxiety, etc.) and to assist the participant and the participant's caregivers in coping with the emotional and social issues associated with their diagnosis. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness.

The main purpose of this study is to compare two types of care - standard oncology care and standard oncology care with collaborative involvement of palliative care clinicians to see which is better for improving the experience of patients with AML and MDS undergoing treatment.

The purpose of this research study is to find out whether introducing patients undergoing treatment for AML or MDS to the palliative care team can improve their end-of-life communication, understanding of their prognosis, and their physical and psychological symptoms during the course of their illness.

Eligibility Criteria:
Inclusion Criteria:

* Patients with AML receiving non-intensive therapy including hypomethylating agents, single-agent chemotherapy, targeted therapy agents, or single or combination non-intensive agents offered on a clinical trial, including the following populations:

  * Newly diagnosed AML
  * Relapsed AML
  * Primary refractory AML
* The ability to provide informed consent
* The ability to comprehend English or complete questionnaires with minimal assistance of an interpreter

Exclusion Criteria:

* Patients not receiving care at MGH
* Patients receiving intensive chemotherapy (requiring 4-6 week hospitalization)
* Patients receiving supportive care alone
* Major psychiatric illness or co-morbid conditions prohibiting compliance with study procedures
* Patients already receiving palliative care
Changes of Cerebral Glucose Metabolism and After 12 Weeks of Escitalpram Treatment in Panic Disorder

Panic disorder is one of the most prevalent psychiatric disorders and recently abnormal fear network is known to be implicated in the pathophysiology of panic disorder. The fear network involves many brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus. Escitalopram, a highly selective serotonin reuptake inhibitor, is usually effective for panic dis order, but there is little information on how escitalopram affects the fear network.

The specific aim of this study is to test the following hypotheses using 18F-FDG positron emission tomography (PET)

1. Patients with panic disorder will show abnormal activity of the fear network compared to healthy comparison subjects.
2. Patients with panic disorder will show normalized activity of the fear network after 12-weeks of treatment with escitalopram.
3. The changes of fear work after the treatment will be associated with psychological variables and neurohormones.


Eligibility Criteria:
Inclusion Criteria:

* panic disorder
* 20-60 years

Exclusion Criteria:

* history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder. The acceptable score on the 17-item Hamilton Depression Rating Scale at entry into the study will be less than 17.
* patients and volunteers with alcohol dependence and current regular use of benzodiazepines will be excluded. Subjects with current or previous regular use of benzodiazepines will be excluded.
Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT

The primary objective of this study was to assess the sensitization potential of Omeza Collagen Matrix compared to that of a negative control based on a Modified Human Repeat Insult Patch Test.


Eligibility Criteria:
Inclusion Criteria:

* Good general health, as assessed by medical history and brief dermal skin examination of the application site (back);
* Was fully informed of the risks of entering the study and was willing to provide written consent to enter the study;
* Was willing to follow study rules, which included: no sun exposure (for example; no swimming, sunbathing, or tanning beds), avoided activities that would cause excessive sweating, abstained from use of lotions, creams, or oils on the back area;
* Was willing to not change current brand of personal care products such as soaps, body washes, laundry detergents, body sprays, body spritzes, etc. while participating on the study;
* Was willing and able to practice an acceptable measure of contraception (i.e. birth control medication for at least 3 months prior, condom with spermicide or birth control injections,) during the study, if female of childbearing potential. To be considered female of non-childbearing potential, subject must have had a hysterectomy, tubal ligation, or had been post-menopausal for at least 1 year.

Exclusion Criteria:

* Clinically significant skin disease which contraindicated participation, including psoriasis, eczema, atopic dermatitis, and active cancer;
* Asthma that required medication;
* Insulin-dependent diabetes;
* Known immunological disorders such as HIV positive, AIDS and systemic lupus
* erythematosus;
* Treatment for any type of cancer within the last six months;
* Routine use (as defined by using more than 3 days in a week) of any anti-inflammatory drug (e.g., aspirin, ibuprofen, corticosteroids; 81 mg aspirin is acceptable), immunosuppressive drugs, antihistamine medication (steroid nose drops and/or eye drops are acceptable) or over-the-counter pain medication that was ingested in quantities exceeding label instructions;
* Use of topical drugs at patch site;
* Pregnancy, lactation, or planning a pregnancy (confirmed by a urine pregnancy test administered to females of childbearing potential);
* Medical condition which, in the Investigator's judgement, made the subject
* ineligible or placed the subject at undue risk;
* Participation in any patch test for irritation or sensitization within the last four weeks;
* Dermatological aberrations in or around test sites which included sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or any other disfiguration of the test site;
* Confirmed allergy to adhesives, bandages, or ingredients in OmezaTM Collagen Matrix;
* History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax).
Predictors of Early Hematoma Expansion in Patients With Acute Intracerebral Hemorrhage (Clinical and Laboratory Study)

This study aim to develop inflammatory score based on proper integration of several inflammatory markers and investigate whether it was associated with hematoma expansion and poor outcomes in patients with ICH .

Intracerebral hemorrhage(ICH) accounts for approximately a quarter of all stroke subtypes with high mortality and the survi- vors always have varying degrees of residual disability. However, few medical and surgical treatments are clearly beneficial comparing with ischemic stroke. Hematoma expansion, which is a determinant of poor outcomes, occurs in about 30% of ICH patients especially at the early stage. Attenuating hema- toma expansion is a compelling target for ICH treatment, while the outcomes have not been accordingly improved after curbing the growth of hematoma in several clinical trials. It will be more helpful if a predictor can identify the risk of hematoma expansion and poor outcome rapidly and accurately. Thus the antiexpansion treatment to the patients with positive of such predictor is likely to provide clinical benefits.

Eligibility Criteria:
Inclusion Criteria:

* patients having spontaneous ICH aged 18 years or older admitted to a stroke unit within 24 hours After symptom onset .

Exclusion Criteria:

1- patient have secondary ICH (cerebral aneurysm, Moyamoya syndrome, arteriovenous malformation, tumor, trauma or hemorrhagic transformation from brain infarction); (2)patient have primary intraventricular hemorrhage (IVH); (3)patients with historical modified Rankin scale (mRS) score greater than 1 (4) patient refused to be enrolled.
Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity

Researchers are doing this study to compare the effects of drugs approved for long-term weight loss combined with an employer-based weight management program with the effects of the weight management program without drugs for weight loss. If participants agree to be in this study, they will join the Cleveland Clinic Integrated Medical Weight Management Program (WMP). Participants will be assigned by chance (like flipping a coin) to one of two treatment groups: A) Group 1: Cleveland Clinic Integrated Medical WMP + medication for long-term weight loss. B) Group 2: Cleveland Clinic Integrated Medical WMP without medication for weight loss. Participants have an equal chance of being in either of the treatment groups. The total study duration for the individual participants will be approximately one year.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study
* Male or female, age more than or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) more than or equal 30 kg/m\^2
* Enrolled in Cleveland Clinic Employee Health Plan, and expecting to be covered by the Cleveland Clinic Employee Health Plan for the duration of the study

Exclusion Criteria:

* Contraindications to all of the medications approved by the FDA for chronic weight management according to the label
* Previous participation in this study. Participation is defined as signed informed consent
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
* Participation in another clinical trial within 30 days before screening
* Treatment with any medication with the intention of weight loss within 90 days before screening
* Previous or current participation in Cleveland Clinic's Integrated Medical Weight Management Program
* History of (or plans during the study period for) bariatric surgery, or use of minimally-invasive weight loss devices (i.e. Intragastric balloons, lap bands) not removed within 1 year prior to screening
* History of type 1 or type 2 diabetes mellitus
* Hemoglobin A1c (HbA1c) more than or equal to 6.5% at screening or within 90 days prior to randomization
* Any condition, unwillingness or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol
The Effect of 40 Hz Transcranial Stimulation on the Incidence of Emergence Delirium in Children

Emergence delirium is a complex of perceptual deficits and psychomotor agitation most commonly seen in preschool children in the early post-anesthetic period. It increases the risk of bed falls, accidental catheter removal, surgical wound dehiscence, and delayed discharge in children. Exogenous 40 Hz stimulation can improve cognitive functioning. Therefore, the aim of this study was to explore the effect of 40Hz stimulation on the incidence of emergence delirium in children undergoing vascular malformation surgery under sevoflurane anesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Age 3-14 years old
2. ASA classification I or II
3. Proposed vascular malformation surgery under sevoflurane general anesthesia
4. Anesthesia duration\>1h
5. Obtaining informed consent

Exclusion Criteria:

1. Emergency surgery
2. Mental retardation
3. Neurological disorders with manic-like symptoms
4. Presence of severe kidney or liver disease, heart or respiratory disease
5. Autoimmune diseases
6. Vascular malformation of the head and face
7. Significant life changes in the 1 month prior to surgery
My Body is Fit and Fabulous at School Phase II

"My Body is Fit and Fabulous" (MyBFF@school) program was designed specifically for overweight and obese school children in order to help them control their BMI and body fat. MyBFF@school is a multi-faceted obesity intervention program that incorporated physical activity, nutrition and psychology modules.

"My Body is Fit and Fabulous" (MyBFF@school) is a school-based, cluster randomised controlled trial (C-RCT) study that primarily aimed to evaluate the effectiveness of MyBFF@school program on overweight and obese school childrens' BMI for age (BMI z-score) and body fat percentage at 3 and 6 months post intervention. Primary and secondary schools in the central region of Peninsular Malaysia were randomised to either intervention or control school via systematic random sampling method. The selected intervention schools underwent MyBFF@school programme that consisted of physical activity, nutrition and psychology modules, whereas the control schools followed the standard national school curriculum.

Eligibility Criteria:
Inclusion Criteria:

* Give consent
* Overweight and obese students with BMI for age (BMI z-score) more than +1SD based on WHO 2007 Growth Reference
* Age between 9-16 years old

Exclusion Criteria:

* BMI for age below and equal +1SD
* Physical or mental disability
* Medical conditions that prevent him/her to participate in moderate-to-vigorous physical activity
* Co-morbidities that may interfere with the study such as:

  1. diagnosed type 2 diabetes mellitus
  2. hypertension
  3. nephritic syndrome
  4. epilepsy
  5. congenital heart disease
  6. skeletal anomalies
* On steroids
* On anti-epileptic
* On methylphenidate
CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain

The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc, Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.


Eligibility Criteria:
Inclusion Criteria:

* CPSP or TGN/facial pain refractory to other medical treatments
* Pain \> 1 year prior to baseline
* Pain intensity with an average daily VAS score \> 5 demonstrated by 12 ratings across 4 days
* Stable pain medication for \> 1 month prior to baseline

Exclusion Criteria:

* CPSP with important paresis/severe motor deficit in the area of pain
* TGN/facial pain with complete deafferentation pain
* Atypical facial pain, i.e. when objective evidence for neuropathic facial pain syndromes is lacking and when specific psychological and behavioral factors can be identified
* Pain associated with malignant neoplastic disease anywhere in the body or head
* History of epilepsy
* Presence of a deterioration of cognitive functions