cyrilzakka/clinical-trials huggingface dataset:
Changes in Heart Rate Variability And Heart Rate/Activity Slope After Hospitalization for Acute Exacerbations of COPD

The purpose of this study is to observe the variation in time between heart beats and how heart rate changes during activity evolve after hospitalization for an exacerbation of COPD.

The investigators will place a monitoring patch that continuously records electrocardiogram and activity. Participants will switch this patch every 7 days for a total of 28 days. From these data the investigators will observe how heart rate variability and heart rate responses to exercise evolve after hospitalization for an exacerbation of COPD.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. At least moderate COPD by Global Initiative for Chronic Obstructive Lung Disease spirometry criteria (FEV1/FVC \< 0.7 and FEV1 \< 80% predicted)
3. 10 pack year smoking history
4. Hospitalized with one or more of:

   1. increased dyspnea
   2. increased sputum
   3. change in sputum character
5. Treated with corticosteroids and/or antibiotics for respiratory indications
6. Age \> 40 years old

Exclusion Criteria:

1. Discharging home on hospice
2. Inability to follow trial protocols
3. Pacemaker
4. Allergy to a component of the adhesive patches
5. Breastfeeding
6. Permanent/continuous atrial fibrillation
Metformin in Safety and Efficacy in Gouty Patients

The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients


Eligibility Criteria:
Inclusion Criteria:

* Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology/European League Against Rheumatism criteria of gout.

Exclusion Criteria:

* Systemic disorders such as cardiovascular, neurological, coronary artery disease.
* Hypertension, hyperlipidemia, diabetes mellitus, active infections.
* Other inflammatory or autoimmune diseases.
* Patients on biologics,
* Cases with hypersensitivity to metformin and those with impaired liver and kidney functions.
Analgesic Effect of Morphine Added to Transverses Abdominis Plane Block

Postoperative pain is a condition that increases morbidity and mortality. Therefore, multimodal analgesia techniques with fascial plan blocks are frequently used.TAP block provides analgesia in the anterior abdominal wall by applying local anesthetic to the fascia between the internal oblique and transversus abdominis muscle. Opioids can be added to local anesthetics to increase the quality and duration of analgesia. The investigators aim is comparasion of TAP block with bupivacaine added morphine and TAP block with bupivacaine plus intramuscular morphine effects on postoperative pain score, total opioid consumption and systemic effects in lower abdominal surgery

At the end of the operation, patients will be randomly divided into 2 groups as Group I (Intramuskuler) and Group T (TAP block). The blocks will be administered under general anesthesia in supine position by same anesthesiologist. Group I (Intramuskuler) will be applied 20 ml of %0.25 bupivacaine between the internal oblique and transversus abdominis muscle and 0.1 mg/kg (ideal body weight) morphine to be performed intramuscular. Group T will be applied 20 ml of %0.25 bupivacaine and 0.1 mg/kg morphine (ideal body weight) between the internal oblique and transversus abdominis muscle. At the end of the operation, the patients with a Modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. All patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time. In the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 1st and 6th, 12th and 24th hours. Visual pain scores (VAS) in rest and movement, hemodynamic values, morphine consumption, nausea-vomiting score, itching, ramsey sedation scale, length of hospital stay and postoperative complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Lower abdominal gynecological surgery

Exclusion Criteria:

* Patients with a known allergy to the study drugs,
* Significant cardiac, respiratory, renal or hepatic diseases,
* Bleeding diathesis
* Those with psychiatric illnesses that would interfere with perception and assessment of pain were excluded from this study.
Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke

The purpose of this trial was to evaluate the benefits of combination motor learning training and brain computer interface training for restoring arm function in people with stroke. Our aim was to determine whether the surface-acquired brain signal (electroencephalography (EEG)) can feasibly be used as a neural feedback system to drive more normal motor function in stroke survivors.

The financial burden and human suffering are devastating after stroke due to the lack of rehabilitation protocols that can restore normal brain and motor function. Conventional treatment does not restore normal motor function to many stroke survivors. The majority of available treatments are directed at the peripheral nervous system (arms/legs). Since stroke occurs in the brain and results in brain damage and dysfunction, a more direct approach may be to re-train the brain by directly treating the activation of brain signals that control movement.

The purposes of this study are to determine if motor learning, functional electrical stimulation (FES), and brain computer interface (BCI) training are beneficial for restoring arm function in people who have had a stroke, and to determine if the surface-acquired brain signal \[electroencephalography (EEG)\] can be re-trained to provide more normal motor function in stroke survivors. The primary purpose of this study is to determine the efficacy of the motor learning tasks in stroke recovery.

In the study, scientists will use two different and complimentary brain signal training components to restore more normal motor control of a motor task (elbow, wrist, or finger movement task). Specifically targeting, invoking, and training the surface-acquired EEG brain signal, and integrating brain signal training into motor learning training of upper limb motor tasks, may result in greater motor restoration when compared to a comprehensive motor learning intervention without EEG brain signal training.

Eight people who had a stroke were enrolled in the experimental group. They received brain signal training and comprehensive motor learning based therapy.

An additional 5 healthy adults were enrolled in order to study their ability to acquire brain signal control and the characteristics of their brain signal during the tasks that the stroke participants attempted.

Eligibility Criteria:
Inclusion Criteria:

* medically stable and \>/= 6 months post stroke
* difficulty using upper limb for functional tasks
* \>21 years old

Exclusion Criteria:

* chronic, progressive medical condition (i.e. Parkinson's disease)
S-32 PG 242 Short Stem

The data of calibrated CT-scans will be used for the Finite Element Analysis (FEA) analysis for SMR Short Stem in identified hospitals in EU and US as developers of the project and for further research, upon subject acceptance.

In particular, the Quantitative Computer Tomography (QTC)/Finite Element Analysis (FEA) model of the assembly consisting of the shoulder and the orthopaedic implant allows detailed analyses including:

* assessment of micromotion at the bone-implant interface, to predict osseointegration;
* comparison of strains/stresses between the intact bone tissue and the bone with the implant in order to predict the stress shielding phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects (males and/or females) must be ≥ 18 years of age

  2. Subjects are willing and able to provide written informed consent for collection of the data; if a patient has already completed and performed the calibrated CT-scans as per standard clinical practice, the subject may be contacted to offer participation in the study.

  3. Adult patients who will undergo noncontrast CT scanning of the shoulder as part of routine preoperative planning for shoulder arthroplasty will be eligible to participate in the study and receive a calibrated CT scan of the shoulder. The decision to undergo CT scan will be made independently of study participation; only patients who require a CT scan of the shoulder for clinically necessary reasons are eligible to participate.

Exclusion Criteria:

* 1. Pregnancy or lactation; 2. Subjects who have fracture of the affected shoulder; 3. Subjects who have had prior surgery on the affected shoulder that resulted in metal implants, including but not limited to:
* Partial or total shoulder joint replacement;
* Open reduction internal fixation of fracture;
* Prior rotator cuff repair with metal implants; 4. Local or systemic infection; 5. Persistent acute or chronic osteomyelitis; 6. Focal vascular or neurologic diseases affecting the concerned limb; 7. Metabolic disorders or systemic diseases that substantially affect bone quality, including the following:
* Renal osteodystrophy
* Osteoporosis
* Osteomalacia
* Osteopetrosis 8. Bone tumors involving the shoulder girdle; 9. Local or disseminated neoplastic diseases; 10. Severe deformity including malunion, nonunion, excessive bone loss that would result in improper virtual implant positioning;
Botulinum Toxin for the Treatment of Depression

Depression is frequently accompanied by a specific sad facial expression. This expression is in part mediated by the same muscle activity that produces frown lines. Based on the assumption that there is a positive feedback between depressed mood and the correspondent facial muscle activity (facial feedback) the investigators will conduct a randomized controlled pilot study in which the investigators will apply a classical cosmetic treatment of frown lines with injections of botulinum toxin to depressed patients who did not sufficiently respond to antidepressant medication. The investigators hypothesize that this treatment will contribute to the amelioration of depressive symptoms in these patients. This hypothesis is supported by a previous open case series in which remission of depression was reported after such treatment (Finzi and Wasserman, 2006).


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate depression (Ham-D \>=15)
* Therapy with one antidepressant for at least four weeks
* at least moderate frown line

Exclusion Criteria:

* Bipolar depression
* Psychiatric comorbidity
* Severe somatic comorbidity
* Pregnancy
* Peculiarities at the injection site
* Psychiatric medication other than one antidepressant
* Specific psychotherapy
* Previous application of botulinum toxin
* Medication interfering with botulinum toxin
Shanghai Cohort Study of Diabetic Eye Disease

To describe the design, methodology and baseline characteristics of the Shanghai Cohort study of Diabetic Eye disease (SCODE) study, a community-based study to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai.

The Shanghai Cohort study of Diabetic Eye disease (SCODE) was a three-year community-based study to carry out a regular ocular health screening and epidemiological analysis for diabetic eye disease in the approximately 8,000 middle-aged and elderly people with diabetes in Shanghai. Through this study, we hope to understand the prevalence, epidemic trend and the features of risk factors distribution on diabetic eye disease, especially on DR.

Meanwhile, our aims also included estimating the ocular fundus changes and visual impairment associated with different grade of DR. Furthermore, the aim of the present study was to investigate the association between serum and urine biochemical parameters and DR.

Eligibility Criteria:
Inclusion Criteria:

* Adults with diabetes aged 35 years and above; under archives management; residing in Shanghai.

Exclusion Criteria:

* All the study participants have difficulties of mobility or communication.
Dietary Supplements and Aging Muscle

The purpose of this study is to determine whether older adults (ages 65-89) who consume the dietary supplement Juven (Abbott Laboratories) versus placebo for 6 months will demonstrate increases in fat-free mass, muscle volume,and physical function.


Eligibility Criteria:
Inclusion Criteria:

* Ages 65-89
* Ambulatory

Exclusion Criteria:

* Cognitive impairment
* History of renal or hepatic disease
* History of hypotension
* History of peripheral artery disease
* Uncontrolled hypertension
* Uncontrolled diabetes
* Self-reported claustrophobia
* Current smoker
* Steroid or androgen use with the previous 3 months
* Individuals with pacemakers and defibrillators
Efficacy Study of Homeopathic Medicines in Treatment of Allergic Rhinitis and/or Induced Bronchial Asthma

The purpose of this study is to test whether individualized homeopathic medicines can produce any significant effect beyond placebo in treatment of allergic rhinitis and/or induced bronchial asthma

A prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial is being conducted on 100 participants (subjects 50, control 50) suffering from allergic rhinitis and/or induced bronchial asthma since March 1, 2012 at Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Government of West Bengal. This trial is aimed at exploring the efficacy of homeopathic medicines in comparison with placebo in reducing serum interleukin 10, 13 and immunoglobulin E measured at timeline of 1 year of treatment and absolute eosinophil count every 4 months up to 1 year. Matching for independent and consequent variables will be done to test for bias. Parametric or non-parametric tests will be employed as per distribution of data at the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Age between 5 and 65 years
* Both sexes
* Atopic: reactive to allergens with positive skin prick test (SPT) results and/or eosinophilia
* More than 1 year history of allergic rhinitis and/or induced bronchial asthma

Exclusion Criteria:

* Nasal abnormalities causing obstruction, e.g. nasal polyp(s), deviated septum etc.
* Previous homoeopathic immunotherapy for allergic rhinitis
* Allergen avoidance in past 6 weeks
* Away from usual environment for more than 1 week during trial
* Severe asthma cases as detected clinically
* Respiratory infection
* Severe concomitant disease
* Pregnancy, breast feeding, or likelihood of pregnancy
* Oral or parenteral steroids and/or decongestant in past 6 months
* Conventional desensitization in past 3 months
The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients

Diabetes is a highly atherogenic disease. Pomegranate juice has impressive antioxidant properties. It has been proven to decrease oxidant stress and to cause the regression of atherosclerotic plaques in hypercholestrolemic and diabetic patients.Furthermore it has been proven to potentiate the biologic activity of the enzyme paraoxonase 1 which is very important in preventing atherosclerosis. The study will try to prove that a polyphenolic extract from pomegranate (POMx) has the same desired effects.


Eligibility Criteria:
Inclusion Criteria:

* Males
* HBA1C\>7%
* Drug therapy given for DM

Exclusion Criteria:

* Age\<18
* Inclusion in another study
Brain Activation Patterns in Schizophrenia After Computerized Cognitive Skills Training

This project is a novel exploratory research project to investigate changes in activation patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who received a 12-week computerized cognitive remediation (CRT) program. The hypothesis is that patients receiving CRT will show greater increase in activation patterns in the brain as compared to controls, and the degree of brain activation will correlate with improvements in working memory.

Abnormalities in the domains of attention, working memory (WM) and information processing are important features of schizophrenia. There is growing literature that cognitive remediation therapy (CRT) can produce modest improvements in cognitive functioning in schizophrenia, suggesting that systematic efforts at improving cognitive functioning are feasible. Cognitive improvement after CRT may correlate with changes in brain activation patterns in specific areas.

After screening, patients are randomized to a 12 week trial of CRT using COGPACK (Marker Software), or to a 12-week control condition. All patients attend 3 weekly 1-hour laboratory sessions, with 1 discussion session per week.

Patients continue their antipsychotic treatment with a typical or atypical antipsychotic during the CRT and 4 weeks prior to enrollment in the study (Phase A). Following Phase A they receive baseline evaluations, including an cognitive activation task (N-back visual-letter task) while being scanned for fMRI , MATRICS neuropsychological test battery, and psychiatric, social functioning, and symptoms assessment.

Patients then enter Phase B with randomization to control or CRT for 12 weeks (36 laboratory sessions). Upon successful completion of 36 sessions, endpoint evaluations include an N-back task while fMRI scan, MATRICS, psychiatric, and social functional assessments.

All baseline and endpoint fMRI scans are conducted at the Center for Advanced Brain Imaging (CABI) at Nathan Kline Institute for Psychiatric Research.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient status
* Age 18 - 55
* Male gender (females are enrolled but will not be scanned)
* DSM-IV diagnosis of schizophrenia (all subtypes) and schizoaffective disorder
* illness duration \> 5 years
* MMSE score \> 24 (inclusive) at screening
* Stable dose of oral atypical antipsychotic for at least 4 weeks prior to study entry
* Total PANSS score \> 60 at screening
* Capacity and willingness to give written informed consent
* Patients deemed not ready to be discharged within the next 12 weeks

Exclusion Criteria:

* Inability to read or speak English
* Documented disease of the central nervous system
* History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation)
* Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary, or hematological conditions; HIV positive
* Any medical condition rendering the subject unable to receive an fMRI scan
Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery

This study will compare the incidence of post-op infection after sinus surgery using conventional post-op oral antibiotics to the incidence of infection after sinus surgery when a bio-resorbable antibiotic soaked nasal sponge is used in the nasal cavity in lieu of post-op oral antibiotics. The nasal sponge is a routine nasal dressing used after sinus surgery and will therefore be placed in all patients.

Sinusitis affects 37 million people each year making it one of the most common health problems in the United States. It has a large impact in direct healthcare expenditures, significant loss of workplace productivity and a greater impact on quality of life than diabetes or congestive heart failure.

The most frequently used treatments are medications and/or Functional Endoscopic Sinus Surgery(FESS). 100 subjects undergoing ESS will participate, randomized into two groups, treatment and control. All subjects will have a Nasopore sponge placed into the middle meatus of the nose at the end of the procedure(The sponge is FDA approved and commonly used. Subjects in the treatment group will receive a Nasopore sponge soaked in Bacitracin solution. These subjects will not receive oral antibiotics post-operatively. The control group subjects will have a saline soaked Nasopore sponge laced during surgery and will receive routine oral antibiotics post-operatively. The hypothesis is that subjects who receive the antibiotic soaked nasal sponge in lieu of saline soaked nasal sponge will have infection rates comparable to those who receive systemic antibiotics, but because they will not receive systemic antibiotics, the treated group will have fewer side effects and the cost to treat them will be less.

Eligibility Criteria:
Inclusion Criteria:

* Subjects requiring Endoscopic Sinus Surgery

Exclusion Criteria:

* Pediatric subjects \<18 years
Repeatability and Reproducibility of Skin Test Endpoint Titration

This study will examine the within-tester repeatability and between-tester reproducibility of skin test endpoint titrations performed in those with allergic sensitivities.

Participants will be recruited from the local community. Participants with a previous history of skin prick testing in our lab will not be required to undergo preliminary skin prick testing, as the allergen to be used for skin prick titrations is known. New participants will undergo skin prick testing. The procedures for skin prick testing and skin test endpoint (STE) titration will be guided by the AllerGen CIC Allergen Skin Titration by Epicutaneous Method (Prick) Standard Operating Procedure. Different allergen extracts for the skin prick test or different doubling doses of an allergen in duplicate for the STE will be applied to the forearm, pricked with a lancet, and assessed ten minutes later by measuring the wheal sizes produced. The study will require three visits to the lab (i.e. three testers), each separated by one week and lasting roughly 30 minutes. Each visit will entail the duplicate STE procedure performed by a different tester. If a participant is new to the lab, they will undergo skin prick testing during their first lab visit prior to undergoing the skin prick titration and so, their first study visit may last up to one hour.

Eligibility Criteria:
Inclusion Criteria:

* must have allergic sensitivities confirmed by a skin prick test (or historically) to at least one of the study allergens

Exclusion Criteria:

* skin condition on the forearms
* if there is a situation where interpretation of skin reactions would be difficult (e.g. sleeve tattoos, scarring)
* regular use of anti-histamines (assessed on a case-by-case basis)