cyrilzakka/clinical-trials huggingface dataset:
A Study To Investigate If MRI Scanning Is Effective At Seeing What Hayfever Drugs Do In Nasal Passage.

The purpose of this study is to establish whether MRI scanning is a sensitive measure of the effects of existing drug treatments on nasal dimensions following challenge with intranasal allergen in subjects with hayfever. If successful this technique could be applied to increase confidence for internal decision making and ultimately may be used to assess how effective a new drug treatment is.


Eligibility Criteria:
Inclusion Criteria:

* A medically diagnosed hay fever patient who is otherwise healthy.
* Aged 18 to 60 years.
* Body mass index less than 30 kg/m² with weight range of 50kg (females 45kg) to 100kg.
* A positive skin prick test (wheal = 3mm) for grass pollen at or within 12 months of starting the study and/or a positive RAST (= class 2) for grass pollen at or within 12 months of starting the study.
* Baseline FEV1 = 80% predicted and a baseline FEV1/FVC = 70% predicted (using standard predicted guidelines).
* Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
* Available to complete all study measurements.

Exclusion Criteria:

* Pregnant or nursing females.
* Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
* On examination the subject is found to have any nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, or nasopharyngeal surgery.
* Recent (within 3 weeks) or ongoing chest infection which in the physician responsible opinion renders the subject unsuitable for participation in the study.
* The subject has a history or current evidence of perennial rhinitis, sinusitis, or any other condition potentially or directly involving the nasal cavity, sinuses or nasopharynx.
* A history of any medical condition that would not allow the use of pseudoephedrine (e.g. hypertension, diabetes mellitus, ischaemic heart disease, raised intraocular pressure, hyperthyroidism, benign prostatic hyperplasia) or cetirizine (eg. antihistamine hypersensitivity).
* Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
* The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge.
* The subject has a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
* The subject has participated in another study during the previous 3 months.
* The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, oral contraceptives and herbal remedies.
* The subject regularly, or on average, drinks more than 4 units of alcohol per day - where 1 unit = ½ pint of beer (284mL), or 1 glass of wine (125mL), or 1 measure of spirit (25mL).
* The subject smokes more than 5 cigarettes per day.
* The subject has a history of porphyria.
Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA)
* Must have active RA
* Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
* All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration

Exclusion Criteria:

* Both Rheumatoid factor and anti-CCP negative
* Prior treatment with any B-cell depleting therapy
* Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit
* History of or current inflammatory joint disease other than RA
* Neuropathies or neurovasculopathies that might interfere with pain evaluation
* Complications of RA or other disease
* Any other autoimmune disease other than RA
* Acute or chronic infection
* Clinically significant disease requiring
Study of Intensive Care Unit (ICU)-Acquired Weakness (Handgrip Strength Study)

To better understand ICU-acquired weakness in patients requiring mechanical ventilation in the Intensive Care Unit.

We have generated the hypothesis that handgrip strength can be used to develop our understanding of the effects of critical illness on peripheral muscle strength.

To begin to develop this hypothesis, a better understanding of the determinants of handgrip strength needs to be developed. As a result we propose to perform a prospective observational study examining the clinical factors that are associated with handgrip strength. Several clinical factors are known to be associated with increased risk of developing ICUAP while hospitalized: multiple organ failure, severe sepsis, female gender and treatments like steroids. As many of these risk factors are not modifiable, the opportunity to intervene is unclear. However, by attempting to better describe the spectrum of strength deficits experienced by critically ill patients we may better be able to dissect and prevent ICUAP.

Eligibility Criteria:
Inclusion Criteria:

* • Adult patients admitted to the Medical ICU

  * Age ≥ 18 years of age at ICU admit.
  * Requiring mechanical ventilation for at least 24 hours

Exclusion Criteria:

* • Moribund or in the process of withdrawal of life support

  * Patient, family or physicians not in favor of continued support until awakening.
  * Profound neurologic injury associated with little or no chance of awakening.
  * Active consideration of a diagnosis of brain death by treating physicians.
  * Known history of chronic neurological disease resulting in muscle weakness in more than two limbs.
  * Inability to perform handgrip dynamometry prior to acute illness.
  * Subject is a Non-english speaker
  * Subject or surrogate unable to provide informed consent.
  * ICU stay of greater than 24 hours within the last thirty days or at any point during the current hospitalization
  * Greater than seven days of hospital care prior to hospital admission.
  * Greater than five days since inclusion criteria met.
Clinical Outcomes of Patients With Clostridium Difficile Associated Disease Attributable to Diverse tcdC Genotypes

The purpose of the study is to establish the clinical disease outcomes and features of CDAD associated with variant tcdC genotypes. Two hypotheses are to be tested in this study:

1. Severe CDAD and tcdC truncation:

   Severe CDAD (defined by death and/or colectomy or secondary endpoints) is associated with severe truncations (\> 6 amino acid residues) in TcdC, a negative regulator of toxin A/B production.
2. Disease in low risk populations (patients never exposed to health care facilities and/or patients who never received antibiotics) of any severity is attributable to strains of C. difficile with severe tcdC truncation.

The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), date of specimen collection, presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 6 months of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, past medical history and outcomes. We will collect information retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have confirmed CDAD, confirmed by testing at UPMC's clinical microbiology lab in March 1, 2001- December 31, 2005 for C. difficile by stool toxin test with subsequent positive culture for the organism from inpatients/outpatients at UPMC Presbyterian-Montefiore, from WPIC inpatient units, from ER visits at the Presbyterian University Hospital emergency department, and from clinics closely affiliated with UPMC Presbyterian (medical and surgical clinics in Falk Clinic, the 9 South Montefiore internal medicine clinic, the geriatrics clinic in Montefiore, and the digestive disorders center (GI clinic on 3rd floor of PUH).
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease

The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The pharmacokinetics of TA-650 is also examined.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease.
* Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight).
* Patients with a fever of 37.5ºC or higher axillary temperature at the time of enrollment.
* Patients to whom the study drug can be administered by day 8 of disease.

Exclusion Criteria:

* Patients who have received vaccination with Bacille Calmette-Guérin (BCG) vaccine within 6 months before the enrollment.
* Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization.
* Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections.
* Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B.
* Patients confirmed to have HIV infection, or patients with a family history of HIV infection.
* Patients who have a history of receiving treatment with infliximab or other biological products.
* Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent.
Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary symptomatic uterine prolapse
* ≥ 18 years of age
* Considering pelvic reconstructive surgery

Exclusion Criteria:

* Unwillingness to be randomized to one of two surgical approaches
* Pregnant or planning to maintain their future fertility
* Unable to have general anesthesia
* Currently undergoing chemotherapy OR has current or history of pelvic radiation
* Previous adverse reaction to synthetic mesh
* Recent history of abnormal paps (past 10 years)
* Cervical or uterine cancers
* Previous hysterectomy
* Previous central vault or uterine prolapse repair
* Uterus ≥ 14 weeks size
* Uterine cancer
* History of significant pelvic adhesive disease
* Elongated cervix (length D to C \> 6cm)
* Fibroid ≥ 7cm
* Post menopausal with enlarged uterus
A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.

To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma or ocular hypertension.

Pharmacokinetics and Safety

Eligibility Criteria:
Inclusion Criteria:

* This study will enroll pediatric and adult subjects with glaucoma or ocular hypertension receiving treatment with latanoprost in either one or both eyes for at least two weeks.
* The pediatric subjects will be grouped by age (0 to \<3 years, 3 to \<12 years, 12 to 18 years).

Exclusion Criteria:

* Ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the screening visit.
* History of ocular trauma or surgery in either eye within 14-days of the screening visit.
* Use of continuous wear contact lenses.
Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth

This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) "vaping", while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults ("youth"). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.

We will examine the influence of nicotine form and concentration, and e-liquid flavor on youth vaping behavior, nicotine uptake, abuse liability, toxicant exposure, and acute cardiovascular and pulmonary effects. Participants will complete 9 vaping sessions. Each vaping session will include a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. During the first session, participants will use their own e-cig and e-liquid; for the following 8 sessions, participants will vape a study-provided e-cig and e-liquid.

Eligibility Criteria:
Inclusion Criteria:

* A current exclusive e-cigarette user (\>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine)
* 21-25 years old
* Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
* Willing to complete five, 6 hour lab visits
* Able to read and speak English
* Willing to provide informed consent

Exclusion Criteria:

* Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
* History of cardiac event or distress within the past 3 months
* Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding
* Use of other tobacco products \> 5 days in the past month
* Current marijuana use \> 5 times per month
* Currently engaging in a vaping cessation attempt
* Ohio State University (OSU) verifies study project 2 current membership/past participation
Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

The aim of this study was to determine whether inverted ILM peeling technique could contribute to high reattachment and closure rates after vitrectomy in patients with myopic macular hole retinal detachment (MHRD) in comparison to no ILM peeling.

This retrospective study will include 40 patients presenting by myopic macular hole retinal detachment. Exclusion criteria will include history of trauma, choroidal neovascularization, and the presence of a peripheral retinal break or proliferative vitreoretinopathy before the initial surgery.

Subjects will be divided into 2 groups; Group 1 will include 20 patients that were treated by vitrectomy without ILM peeling and postoperative gas or silicone oil tamponade with or without cataract surgery.

Group 2 will include 20 patients that were treated by vitrectomy with ILMflap technique and postoperative gas or silicone oil tamponade with or without cataract surgery.


Eligibility Criteria:
Inclusion Criteria: macular hole retinal detachment in high myopic eyes.

-

Exclusion Criteria:

* eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded.
Laryngeal Mask, Video Laryngoscopy

LMA insertion provide an intact airway for many surgeries during general anesthesia . LMA insertion technique was defined when it was first produced by Archie Brain . Accordingly, it is recommended to advance the device to the level where resistance is felt blindly. However, placing LMA may not always be smooth and uncomplicated. Thus, gas leaks may occur and intragastric pressure increase may occur due to gastric insufflation. To overcome these difficulties, the placement of the LMA under direct vision using a laryngoscope has been described in several studies . Previous studies have shown that the reliability of the laryngeal mask can be demonstrated by the oropharyngeal cuff leak test . In addition, the classification of the image of the laryngeal structures mediated by fiberoptic imaging and vocal cords from the LMA gives us information about the availability of effective positive pressure ventilation.

LMA insertion provide an intact airway for many surgeries during general anesthesia . LMA insertion technique was defined when it was first produced by Archie Brain . Accordingly, it is recommended to advance the device to the level where resistance is felt blindly. However, placing LMA may not always be smooth and uncomplicated. Thus, gas leaks may occur and intragastric pressure increase may occur due to gastric insufflation. To overcome these difficulties, the placement of the LMA under direct vision using a laryngoscope has been described in several studies . Previous studies have shown that the reliability of the laryngeal mask can be demonstrated by the oropharyngeal cuff leak test . In addition, the classification of the image of the laryngeal structures mediated by fiberoptic imaging and vocal cords from the LMA gives us information about the availability of effective positive pressure ventilation.In cases where difficulties are found in laryngeal mask placement, using direct laryngoscope or videosingoscope, placement is frequently applied in anesthesia practice. Kim GW et al investigated LMA placement with direct laryngoscope. However, there is no study investigating the effectiveness of videongoscopes. Videoingoscopes have wide viewing angles through their cameras located at the blade tips. For this reason, we think that it will be advantageous in placing a laryngeal mask.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-65 years old
* ASA1,2,3 group patients
* Patients undergoing general anesthesia Patients scheduled for elective surgery

Exclusion Criteria:

* The patient's refusal to participate in the study
* Contraindication for placement of the laryngeal mask
Effects of Virtual Reality Based Training on Posture Stability in Parkinson's Disease

The present study is to examine the effects of a virtual reality based balance training using the Kinect sensor on postural stability and functional balance in individuals with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Hoehn and Yahr stages I through III
* A score of more than or equal to 24 on the mini-mental state examination
* Stable medication usage
* Freedom from any other problems that might affect training

Exclusion Criteria:

* Unstable medical conditions
* Histories of other diseases known to interfere with participation in the study
Evaluation of Different Methods to Measure Muscle Mass and Strength in a Population With Class II/III Obesity

Rationale: Weight loss therapies should aim to reduce fat mass while preserving both muscle mass and muscle strength. Consequently, there is a need for validated methods to measure muscle mass and strength. Current methods are either expensive and require trained technicians, or have not been validated in populations with class II/III obesity (BMI \> 35 kg/m2). In our previous studies (MUST-MOP and MUSCLE study), we have validated the use of ultrasound (US) for the measurement of lean mass (a proxy for muscle mass) in a population with obesity. These studies showed that the use of US for the measurement of lean mass was feasible, reliable and valid. The aim of the current study is to validate the use of US for the measurement of lean mass after weight loss in a population of bariatric surgery patients.

Objective: Primary objective: To assess the validity of US to measure lean mass after weight loss in a population of bariatric surgery patients.

Secondary Objectives:

* To assess de differences in lean mass between DXA and US in this study compared to the MUSCLE-study.
* To assess how the lean mass has changed after bariatric surgery and the effects of lean mass on total weight loss and resolution of comorbidities
* To assess whether the change in lean mass has an effect on serum levels of markers for muscle mass.

Study design: This study is an observational follow-up study of the MUSCLE study and will take place in the Centre Obesity Northern-Netherlands (CON) at the Medical Centre Leeuwarden (MCL).

Study population: The population will consists of participants, who have participated in the MUSCLE study and have received bariatric surgery at the CON / MCL.

Main study parameters/endpoints: The main parameters of this study are: lean mass measured by DXA and US. The main endpoint of this study is the validity of the US measurement of lean mass compared to DXA.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no direct benefits for the participants. However, the results of this study can help to further validate the ultrasound as a cheaper and more accessible method to measure muscle mass. This can potentially be used in standard clinical care to assess muscle mass of patients during weight loss.

• The additional time investment: during first year follow-up appointment approximately 30 minutes.

The risks of most test are minor, even the small amount of radiation exposure, which means the risks and burden of this study outweigh the potentially obtainable knowledge.


Eligibility Criteria:
Inclusion Criteria:

* Participation MUSCLE study
* ±1 year after bariatric surgery

Exclusion Criteria:

* Inability to communicate in either Dutch or English
* Weight over 204 kilograms (due to limitations of the DXA)
* Pregnancy
* Pacemaker