cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effects of Sharpened Romberg Testing (SRT) in Healthy Subjects

This research study is being done to evaluate the effectiveness of using the sharpened Romberg test to screen for impaired postural control in patients with impaired or altered breathing patterns.

The effects of hypocapnia on the postural system have not previously been adequately investigated. The specific aim of this study is to evaluate the effects of hypocapnia on postural standing balance using the sharpened Romberg test (SRT). There is very little research in this area, even though there is significant clinical relevance, ranging from individuals with conditions affecting ventilation (respiratory conditions, cardiac conditions, concussions, medications, post-surgical states requiring ventilatory support etc). The design of the experiment consists of testing healthy subjects and measuring their standing balance with SRT before and after they deliberately lower their carbon dioxide levels by increased ventilation over 2min. End-tidal CO2 (ETCO2) will be used to estimate the blood carbon dioxide level during the experimental procedures. ETCO2 will be measured using the Masimo, Emma Capnometer device. The device is a measurement tool that reads the end tidal carbon dioxide level on its display. The results will then be compared to the normal pre-hypocapnic SRT to assess how hypocapnia affects standing balance.

Eligibility Criteria:
Inclusion Criteria:

- Research subject conditions that may result in alterations of ventilatory control (capnic status) and balance will be specifically reviewed as criteria for participation.

Exclusion Criteria:

* Current pregnancy in women, alcohol use within the past 3 days prior to the experiment, history of balance problems (e.g., vertigo, neuropathy, central or peripheral vestibular disorders), and musculoskeletal disorders affecting the ability to perform a SRT in participants.
* Patients currently taking carbonic anhydrase inhibitors, opioids, benzodiazepines, hypnotics, first-generation H1 antihistamines, amphetamines, and first-generation antipsychotics.
* Patients with a history of insomnia, sleep apnea, circadian rhythm disturbances, narcolepsy, movement disorders, chronic low blood pressure, fainting spells, multiple concussions, seizure disorders, migraines, severe headaches and panic attacks.
* If the patient took medications known to cause prolonged QTc interval and other cardiac arrhythmias, the researchers will exclude the patient from the study.
A Cross-sectional Study of Covid-19 Pandemic in Zhejiang Province

this study adopted a cross-sectional study, collected the medical history and symptoms of patients infected with Covid-19 through a questionnaire survey, and made statistical analysis, so as to provide better clinical guidance.

Recently, there has been an outbreak of covid-19 in Zhejiang Province. In order to comprehensively understand the condition of patients with covid-19 in Zhejiang Province, this study adopted a cross-sectional study, collected the medical history and symptoms of patients infected with Covid-19 through a questionnaire survey, and made statistical analysis, so as to provide better clinical guidance.

Eligibility Criteria:
Inclusion Criteria:

* A positive nucleic acid test for Covid-19, or a positive antigen test for novel coronavirus, no age limit.

Exclusion Criteria:

* Unable to understand the contents of the questionnaire for various reasons
Evaluation of Limb Health Associated With a Prosthetic Vacuum Socket System

The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.

The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also significantly impact an amputee's limb health. If the prosthesis is not held securely to the amputee's limb, relative movement between the limb and prosthetic interface can cause bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can lead to much more serious health conditions. A positive solution to creating secure and comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists in preventing movement in the socket. The clinical benefits associated with vacuum suspension include volume retention, increased proprioception, secure suspension, and frequently reported observations of wound healing. However, the long term effects of vacuum suspension on circulation remain undetermined or undocumented.

This study examines a vacuum suspension system on the health of the residual limb (amputated limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin of the residual limb.

Eligibility Criteria:
Inclusion Criteria:

* Consenting Adult
* Unilateral lower extremity amputee
* Currently using a liner with prosthesis
* Uses a prosthesis to ambulate
* Ability to read, write and understand English
* Available during regular business hours for appointments

Exclusion Criteria:

* Impaired contra lateral leg
* Uses vacuum suspension with their current prosthesis
* Diagnosis of renal failure
* Smoker
Accuracy of Pulse Oximeters With Profound Hypoxia

The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted by pulse oximeter manufacturers to the FDA for device approval.

The study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary data points to meet the ISO 80601-2-61:2017).

Per FDA guidance, at least 2, or 15% of the subjects will have dark skin.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is male or female, aged ≥18 and \<50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI\>30).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. Subject has diabetes.
5. Subject has a clotting disorder.
6. The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
7. The subject has any other serious systemic illness.
8. The subject is a current smoker.
9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
10. The subject has a history of fainting or vasovagal response.
11. The subject has a history of sensitivity to local anesthesia.
12. The subject has a diagnosis of Raynaud's disease.
13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
14. The subject is pregnant, lactating or trying to get pregnant.
15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Confirmatory Efficacy Trial of a Gluten-Free Diet in a Subgroup of Persons With Schizophrenia Who Have High Levels of IgG Anti-Gliadin Antibodies (AGA IG)

This study purpose is to conduct a confirmatory double-blind randomized controlled trial in an inpatient setting of the effects of a tightly controlled gluten-free diet (GFD) to improve negative symptoms in people with schizophrenia or schizoaffective disorder who have antibodies to gliadin (AGA IgG). As part of the project investigators will also confirm outcomes such as cognitive symptoms, changes in peripheral and central inflammation as well as gut/blood brain barrier permeability.

This study is a randomized double blind clinical trial being funded by NIMH. Investigators will need to enroll 40 cases with AGA IgG positivity in order to present a powered and convincing result about the efficacy of gluten withdrawal in the subpopulation of persons with schizophrenia with elevated AGA IgG levels. Investigators will recruit a minimum 50 to ensure they are well powered without question, and to account for dropouts. Investigators will use a battery of measures of peripheral and central inflammation as well as gut permeability at baseline and endpoint to confirm the relationship of these outcomes to changes in AGA IgG and symptom changes in the clinical trial. Investigators will test negative symptoms as a primary outcome but will test changes in other symptom domains such as positive symptoms. After the completion of the 5 week confirmatory study, investigators will discharge participants and follow them for 8 weeks in their own environment to test the maintenance of the effect following the stringent GFD, and provide education on gluten free shopping, cooking and eating.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV/DSM 5 diagnosis of schizophrenia or schizoaffective disorder
2. Positive for antibodies to gliadin (IgG \> 20 U)
3. SANS total score ≥ 20 and the affective flattening or alogia global item ≥ 3
4. Age 18- 64 years
5. Same antipsychotic for at least 4 weeks
6. Ability to consent determined by a score of 10 or greater on the Evaluation to Sign Consent.

Exclusion Criteria:

1. Persons already on gluten free diets
2. Positivity to tissue transglutaminase (tTg) antibodies or known history of Celiac Disease
3. Pregnant or lactating females
4. Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
5. Meets DSM-5 criteria for alcohol or substance use disorder (other than nicotine) within the last month
6. Gluten ataxia, as measured by the Brief Ataxia Rating Scale

   Additional exclusion for those participating in optional imaging component:
7. Non-removable ferromagnetic metal on or within the body
8. Current claustrophobia
9. Inability to lie supine for 1.5 hours
McMaster Catheterization for Thoracoscopic Surgery Study

It is common practice to insert a Foley catheter into the bladder to drain urine during and after a lung resection. Recently, there has been increasing interest in the potential risks associated with this catheterization, particularly with regard to infection. As thoracic surgery adopts minimally invasive surgical techniques, the need for urinary catheterization during surgery is being questioned since these less invasive surgeries are known to result in less post-operative acute pain, shorter length of stay, and other outcomes that tend to decrease overall anesthetic needs for this patient population. Thus, there is a need to investigate whether patients who have had a minimally invasive lung resection truly need the Foley catheter at all. This will be achieved by assigning patients to either an experimental no-catheter group or the standard of care routine urinary catheter group to determine if patients with no catheter experience different rates of complications. This pilot study will primarily determine if there is a difference in post operative urinary complications between the groups. It is hoped that this study will definitively determine whether a Foley urine catheter is a necessary procedure in the course of a minimally invasive lung resection.

Urinary catheterization is standard practice during and shortly after lung resections. The standard practice is being questioned in an era where unnecessary interventions are being re-considered, particularly since urinary catheterization is not without a risk of adverse events. The study is being done to establish an evidence base to support widespread discontinuation or continuation of this standard practice. Consenting patients will be randomized to either the catheterized or non-catheterized arms. Patient urinary management will be managed as per an a priori-defined protocol that follows St. Joseph's Healthcare Hamilton (SJHH) institutional standards.

Eligibility Criteria:
Inclusion Criteria:

* Must undergo minimally invasive Video-Assisted Thoracoscopic Thoracic Surgery (VATS) or Robotic-Assisted Thoracoscopic Thoracic Surgery (RTS) anatomic pulmonary resection surgery (lobectomy, segmentectomy)
* Must be diagnosed with primary or secondary lung cancer eligible for resection

Exclusion Criteria:

* Patients who are unwilling to comply with study procedures
* Patients who are unable to complete questionnaires with assistance
* Non-VATS/RTS pulmonary resection patients
* Non-anatomic pulmonary resection
* Patients with benign disease
* Patients requiring chronic urinary catheterization
* Patients with contraindications to placement of urinary catheter
Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)

The purpose of this study was to explore in a more documented way the relative potential and efficacy of piracetam 9600 and 4800 mg daily.


Eligibility Criteria:
Inclusion Criteria:

* male/female between 50 and 89 years (inclusive)
* declining cognitive function of at least 3 months duration interfering with complex activities of daily living
* normal basic activities of daily independent living
* Clinical Dementia Rating scale score equal to 0.5
* score at least one point above the lowest possible score on 7 out of 8 tests in the cognitive battery at both Selection Visit and Baseline Visit

Exclusion Criteria:

* general anesthetics within 3 months of selection visit
* history of severe allergic drug reaction(s)
* history of drug or alcohol dependence (DSM IV defined) within the last 12 months
* any drug prescribed to activate cerebral metabolism, taken within 1 week of screening or/and concomitantly
* concomitant intake of anticoagulent medications
* concomitant intake or intake within 1 week before screening of drug that might affect cognitive function or central nervous system
* history of dementia, psychiatric or neurological disorders, mental retardation, learning disabilities and stroke
* current depression
* impaired renal function, thyroid function or neurological degeneration
* any gastrointestinal dysfunction that might interfere with the absorption or elimination of the study drug
* insulin-dependant diabetes mellitus
* bleeding disorders or disturbance in hemostatic function.
Optimal Duration of Antimicrobial Susceptibility Test (AST) Guided Rescue Therapy for Helicobacter Pylori Infection

Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies. However, due to the increasing resistance rates to antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy for persistent H. pylori infection is becoming a grand challenge the investigators have to face.


Eligibility Criteria:
Inclusion Criteria:

* Patients require upper endoscopy owing to persistent H. pylori infection despite one or more treatment attempts.

Exclusion Criteria:

* Age younger than 18 years;
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Known or suspected allergy to study medications;
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Laparascopic Assisted Colonoscopic Polypectomy

Study Objective: To compare the hospital costs between the standard surgical procedure and the Laparascopic Assisted Colonoscopic Polypectomy (LACP) technique for patients with advanced polyps in the colon.

All patients being referred for possible LACP to the Division of Colorectal Surgery at Stony Brook University Medical Center will be randomized in a 1:1 fashion using a computer generated system to undergo either partial colectomy (performed by means of laparoscopy when possible), or LACP for the treatment of advanced polyp(s). Our research assistant will be present in the operating room to record the data.Patients will then undergo standard clinical management while hospitalized at Stony Brook according to the procedure performed.

Eligibility Criteria:
Inclusion Criteria:

* Polyp spanning 2 or more colonic folds
* Polyp \> 20mm
* Polyp spanning greater than 50% of the colonic circumference
* Positive "lift sign" following submucosal injection of saline beneath the polyp
* Difficult location or position of the polyp, thus preventing assurance of complete endoscopic resection.

Exclusion Criteria:

* Polyps with histological evidence of adenocarcinoma
* Polyps in the rectum (\<15cm from anal verge)
* Patients with known inflammatory bowel disease (IBD).
* Patients with known familiar adenomatous polyposis (FAP) syndrome
* Polyps without known histology (i.e. not previously biopsied)
* Polyps with large ulcerations, or those that demonstrate a "non-lift sign" during submucosal injection at the time of colonoscopy; as these are indicators of adenocarcinoma .
* Severe cardio-pulmonary disease, or irreversible coagulopathy, preventing abdominal surgery at an acceptable risk.
* POSSUM predicted mortality score greater than 2%
* Inability to obtain informed consent
* Patients under the age of 18
* Pregnant patients
Prospective Evaluation of Reduced Impedance Noninvasive Cortical Electrostimulation (RINCE) to Reduce Fibromyalgia Effects - Extension Study

The purpose of this open label study is to provide up to 24 active treatments of noninvasive cortical electrostimulation therapy only to those fibromyalgia patients who experienced inadequate pain reduction in a sham controlled double blinded lead in study, NPT-201 (NCT01825954). The therapy will be provided by the NeuroPoint device using the same protocol as that used in active treatment arms of NPT-201. The study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. The study will provide active treatment to those participants who received sham therapy in NPT-201, and will test whether or not additional therapy applications might further improve pain in those participants who previously received active therapy, but did not achieve adequate pain relief.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have successfully completed study NPT-201 and had an inadequate pain response, defined as \<50% reduction in pain from baseline during participation in NPT-201.
* Patient must provide written informed consent and privacy authorization prior to participation in the study.
* Female patients of childbearing potential must be willing to use an acceptable method of birth control for the duration of their study participation. Acceptable birth control includes a vasectomized partner, contraceptives (oral, parenteral, or transdermal), intrauterine device, or double barrier method including condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream. Patients considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or greater than one year post-menopausal, defined as a complete cessation of menstruation for at least one year.
* Patients must be willing to refrain from all excluded therapies for the duration of the study.
* In the opinion of the Investigator, the patient is willing and able to comply with all protocol-specified requirements.

Exclusion Criteria:

* Patient has a current significant psychological or psychiatric disorder (e.g., severe, unstable or poorly controlled depression, severe anxiety or obsessive-compulsive disorder.
* Patient has a score of 2 or 3 on item 9 of the BDI, or, based on the investigator's judgment, the patient is at risk of suicidal ideation or behavior.
* Patient has resumed treatment with duloxetine, milnacipran, pregabalin, gabapentin, sodium oxybate or prohibited narcotics.
* Female patient who is pregnant, planning a pregnancy, or breastfeeding.
* Any anticipated need for surgery that might confound results or interfere with patient's ability to comply with the protocol.
* The occurrence of a major protocol violation during the lead-in study indicating a lack of compliance or other significant concern that precludes the patient's ongoing participation.
Improving Asthma Treatment Using Inhaler Technology

This study will use inhaler technology to observe and feedback overall patterns of medication use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler overuse.

We will also assess whether inhaler technology is patient-friendly and cost effective, whether it helps with treatment decisions in asthma and whether it can help us to predict and prevent asthma attacks.

The SmartTouch™ range of electronic casings will record the use of metered dose inhalers (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by the investigators.

The hypothesis is that employing such technology to measure medication patterns and to help provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma control and exacerbations) in asthma patients with recent asthma attacks in a practical, real-world setting.

We will assess whether electronic inhaler data capture can identify patients requiring more frequent reviews or treatment change and enable proactive self- management.

Using qualitative methods, we will explore participants' attitudes to their asthma management, whether the use of inhaler technology has had an impact on this and whether they found its use acceptable.

Eligibility Criteria:
Inclusion Criteria:

* Use of systemic corticosteroids for worsening asthma (or an increase from baseline dose in patients on long-term oral corticosteroids) in the prior 12 months \[i.e. at least one asthma exacerbation requiring additional systemic corticosteroid in the prior 12 months\] patient reported.
* Doctor's diagnosis of asthma for at least 12 months
* On BTS step 2-5 treatment via MDI \[monitoring devices to be utilised in the study are compatible with MDI inhalers\]
* Use of own internet-enabled and compatible mobile phone

Exclusion Criteria:

* Diagnosis of COPD or onset of symptoms after the age of 40 in patients with ≥10 Pack Year History of smoking
* Other clinically significant coexisting respiratory disease e.g. fibrosis, bronchiectasis
* Patients on maintenance and reliever therapy ('SMART' or 'Fostair® MART')