cyrilzakka/clinical-trials huggingface dataset:
A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis

This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.

The protocol requires all participants to be treated with Avonex and in addition patients will be blindly assigned to either a group who receive Topamax or a placebo control. Repeated neurological and clinical examinations are performed with laboratory tests to determine any possible adverse drug effects. The scaled neurologic examinations (EDSS and MSFC) and brain MRI's are done at regular intervals to evaluate possible treatment effects.

Eligibility Criteria:
Inclusion Criteria:

Relapsing-remitting multiple sclerosis

-

Exclusion Criteria:

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -
Efficacy of Different Oral Rehydration Solutions on the Hydration Status of Healthy Males

Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Most individuals drink less than their sweat losses during activity, while some individuals overdrink and develop a sodium deficiency. Water and electrolyte balance must be restored as part of the recovery process after any activity that causes sweating. Plain water causes a decrease in plasma sodium concentration and osmolality, which reduces the desire to drink and increases urine production. Unless the volume ingested exceeds the loss, individuals are in net negative fluid balance throughout the recovery period due to urinary losses. When sodium and potassium are added to rehydration fluids, urine production is reduced in the hours following rehydration. Rehydration is only possible if a volume of fluid equal to or greater than the amount lost through sweat is consumed, together with adequate electrolytes. The two test products for this study, are novel hydration beverage formulas. They are an electrolyte drink mixture with five essential vitamins and three times more electrolytes than typical sports beverages. The test products create an osmotic force that permits water to be supplied to the bloodstream sooner in the digestive system by using a specific ratio of sodium, glucose, and potassium. This randomized, placebo-controlled, semi-blind, crossover study will evaluate the effects of the test products on rehydration in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males 18-35 years old at the time of screening. Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part in the study. Participants must be able to read and understand study instructions and any other relevant study documents. Willing to following the lifestyle and dietary restrictions as detailed in the Information Sheet for study.

Exclusion Criteria:

* A history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder. Consumption other nutritional supplements, performance enhancing drugs, and non-steroidal anti-inflammatory drugs (NSAIDs) during the clinical. Participant has any medical condition which alters fluid balance in the body as confirmed by a health history questionnaire. Following a dietary pattern which may alter our findings (e.g., low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting etc.). Women are excluded due to the variability of fluid retention during the menstrual cycle. Participant is not currently enrolled in another clinical study. Participant is consuming any medication which may alter fluid retention such as diuretics. The participant is an employee of the Sponsor.
Mobile Monitoring of Fracture Healing

The objective of this study is to develop methods for using forces measured on circular external fixators to predict the state of individual patient's healing of severe tibial fractures and defects.

Patients receiving external fixators for tibial fractures and defects will be recruited. Normal struts on the device will be substituted with similar but instrumented struts which enable force measurement. During clinical visits, forces in the fixator, plus foot forces, will be measured during ambulation. Changes in force measurements across treatment and bone healing will be analyzed.

Severe fractures in the lower limb are associated with high energy trauma in both civilian and military patients,and are sometimes treated with external fixation devices to stabilize the bone until healing has occurred. The devices are kept on the patient for up to a year or more at significant cost, intrusiveness, and risk of infection. The clinician must decide when to remove the device such that adequate healing has occurred and the bone will not re-fracture, but healing rates are variable and x-rays can be misleading. The clinician must also identify when a patient is starting to progress poorly and an early revision surgery is needed to prevent further complications.

The investigators' goal is to develop novel approaches for instrumenting and collecting mechanical data from orthopaedic braces and devices, and identifying new methodologies for interpreting this large volume of functional data for optimizing personalized treatment. The present study is focused on external fixators. Strain gauges will be adhered to the fixators so that fixator forces can be measured during clinical visits. In this pilot study the investigators will develop methods to predict healing based on these measured forces.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 80 years of age
2. Patients scheduled to undergo or currently undergoing treatment at Hershey Medical Center for tibia fracture and/or defect using a circular external fixator including Ilizarov and Taylor Spatial Frame types.
3. Ability to perform study procedures including ambulation (with assistance device if needed)

Exclusion Criteria:

1. External fixator design that cannot be suitably instrumented for force measurements due to space constraints or other issues
2. Axially stable fracture
3. Inability to understand English
4. Inability to provide informed consent
5. Difficulty maintaining follow-up
Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

The purpose of this study is to compare the wound closure outcomes of subjects receiving diabetic foot ulcer treatment with and without the use of Biovance®.


Eligibility Criteria:
Inclusion Criteria:

* The subject has:

  1. been diagnosed with Diabetes Mellitus (insulin or non-insulin dependent) and peripheral neuropathy (loss of protective sensation) in affected foot
  2. a HbA1c of less than 10% assessed within last 12 weeks
  3. a full-thickness diabetic neuropathic foot ulcer that is free from tunnels/sinus tracks, necrotic tissue, exposed bone and/or tendon, and osteomyelitis post debridement (Wagner 1 or 2; Appendix I)
  4. one (target) diabetic neuropathic foot ulcer of less than 12 months duration that has an area that measures ≥ 1.5 and ≤ 10 cm2 post debridement (max length x max width) at screening that is on any surface and part of the foot (fore-, mid- or hind-foot) with an etiology related to loss of protective sensation in that foot.
  5. a target ulcer that closed \<30% during the 2 week run-in period (2 weeks management with SOC following signature of informed consent prior to potential randomization)
  6. sufficient arterial supply to affected foot tested within the past 60 days

Exclusion Criteria:

* The subject has:

  1. ulcers of non-diabetic etiology on the study foot
  2. a target ulcer clinically infected or has underlying osteomyelitis at time of study treatment initiation
  3. clinical evidence of gangrene on any part of the affected foot
  4. a target ulcer with exposed bone or tendon
  5. any malignancy or a neoplasm at the target ulcer site
  6. active Charcot Foot or Charcot Foot that is unable to be offloaded (stable, non-active Charcot deformity that is able to be offloaded is acceptable)
  7. more than 3 ulcers on the study foot, including the target ulcer, and all other ulcers must be at least 3 cm removed from the target ulcer
  8. any significant comorbid disease that may interfere with wound healing
  9. received chemotherapy, radiotherapy, immunosuppressant or corticosteroid (greater than 10 mg prednisone-equivalent per day) within the past 30 days.
  10. had the diabetic foot ulcer treated with an experimental drug/biologic/device, or a live-cell therapy (experimental or marketed), or active moist wound healing therapy within 30 days of randomization day
Impact of Spa Treatments on the Consumption of Care in Children

Children represent 1.2% of the spa population in France. Spa treatments, including climatic stays, are mainly prescribed for children in the context of respiratory, otorhinolaryngology and dermatological conditions. The benefits after spa treatments are the improvement of the symptoms of the pathology, the quality of life and in particular the reduction of drug exposures.

Few authors have recently investigated the impact of spa treatments on the health of children and society, while care has changed significantly in recent years. Moreover, no real-life study of a large sample of children seems to have been conducted in this area. The present study plan to conduct a pharmacoepidemiology study on medico-administrative databases of the "observational study" type, in real life.


Eligibility Criteria:
Inclusion Criteria:

* Children living in France at the time of the study
* 'POMME' cohort : children included at birth and 'EGB' cohort : children from birth to 15 years-old

Exclusion Criteria:
Heparin-Induced Thrombocytopenia Score Card Study

Main Research Question:

Can two new types of test, one called the 4T's score and the other called a rapid assay, help doctors correctly identify which patients are unlikely to have heparin-induced thrombocytopenia (HIT)?

HIT is a severe allergic reaction to the blood thinner heparin. This allergic reaction can lead to heart attacks, strokes, limb amputations, and death. Because heparin is one of the most commonly used drugs in the hospital setting, it is very important that the investigators are able to correctly identify who can safely continue to take heparin and who cannot.

It can be very difficult to diagnose HIT because it can look like many other medical conditions and the best laboratory tests for HIT are difficult to run and only available at specialized centres.

It would be very helpful if doctors had tests they could use that would tell them quickly and accurately which patients with symptoms that look like HIT really do have HIT (and require urgent treatment with another type of blood thinner) and which patients are very unlikely to have HIT (and could continue to take heparin safely). In this study, the investigators will compare the 4T's score (a scoring system that assigns "points" to the presence or absence of specific clinical features) and a rapid laboratory test with the old laboratory test to find out if one or both of these types of tests are useful for telling doctors which patients have HIT and which patients don't have HIT.


Eligibility Criteria:
Inclusion Criteria:

* Suspected heparin-induced thrombocytopenia

Exclusion Criteria:

* Unable to give consent
* Unable to provide a blood sample
* Previous entered in study
Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)

Participants in the study group will receive a single bolus of Sugammadex (4.0mg/kg) prior to extubation. In the post-anesthesia care unit (PACU), a blinded safety-assessor will use the visual analog scale to clinically assess post-operative pain. Post-operative nausea and vomiting (PONV) will be assessed using a PONV rating scale every 30 minutes until PACU discharge. All patients will be monitored with continuous pulse-oximetry.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for open ventral hernia repair or open colectomy
* ASA class I-III
* 18 years and older
* Subjects with a body mass index (BMI) of \<45kg/m2 and weight less than 150kg
* Subjects who have given written informed consent

Exclusion Criteria:

* Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker
* Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
* Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance \< 30 mL.min-1
* Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction
* Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia;
* Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins or Rocuronium or any of its excipients
* Subjects who have a contraindication to, Rocuronium or Sugammadex
* Female subjects who are pregnant
* Morbidly obese subjects with a BMI \> 45 kg/m2 or weight more than 150 kg
Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy

Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. In our study, the investigators propose to examine the effect of low-dose IV versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses. Our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.


Eligibility Criteria:
Inclusion Criteria:

* Patients having ambulatory arthroscopic shoulder surgery under ultrasound-guided interscalene block (rotator cuffs, acromioplasties, stabilizations, labral repairs, etc.)
* Age 18-70 years

Exclusion Criteria:

* Contraindication to interscalene block
* Known allergy/sensitivity to any study medications
* Having taken daily steroids for 10 days or longer anytime during the past year
* Body mass index \<18 or \>40
* History of uncontrolled nausea and vomiting with opioids or severe post-op nausea and vomiting (to prevent any need for higher doses of IV dexamethasone)
* Non-English speaking
* Revision procedures
* Additional procedures (e.g., removal of hardware, procedures involving other areas, etc.)
* Planned open procedures
* History of diabetes
* Arthroscopic irrigation and debridement secondary to infection
* Peripheral neuropathies affecting the operative extremity
* Having taken opiates daily for 10 days or longer immediately preceding surgery, 3 times a week for greater than 3 months anytime in the past year, or currently taking for anything other than shoulder pain
Flexible Endoscopy Biopsies for Submucous Tumors With a New Drill Instrument

The purpose of this study is to determine whether the newly constructed CE (Conformité Européenne) marked drill biopsy instrument for flexible endoscopes can make possible representative biopsies of the increasing numbers of submucosal tumours in the gastrointestinal tract. The amount of submucous tissue ( micrograms and in % of all the biopsy) harvested with the new drill biopsy instrument used in flexible endoscopy investigations is measured in the study and compared to the amount of submucous tissue harvested with the existing biopsy forceps.

Background: With the existing biopsy instruments for flexible endoscopy it's only possible to achieve superficial biopsies comprising the mucosa and very seldom some small fragments of the submucosa. It is, however, increasingly important to get biopsies from the submucous tissues because the tumors that are on the increase more than any other in the stomach is the GIST (GastroIntestinal Stroma Tumours) that grows in the submucosa. Cytology is not enough for a reliable diagnosis and to often not representative. Furthermore there is a well-known risk for tract seeding when sampling through the abdominal wall with a fine needle instrument.

The investigators have invented a new biopsy instrument for flexible endoscopy that is a drill within a cylinder that can be used for biopsies of the submucous tissues, for instance GIST-tumours, see www.BIBBInstruments.com.

Hypothesis: Will it be possible to achieve representative submucous tissue from the gastrointestinal tract with the newly constructed drill biopsy instrument for flexible endoscopy. The investigators hypothesize that the amount of tissue harvested with the new drill biopsy instrument will give significantly more amount of tissue to evaluate for the pathologist than the existing biopsy forceps.

Method: Ten patients with tumours in the submucosa of the stomach are examined with a gastroscope. The investigator decides where the first biopsy should be taken and randomly the investigator blindly get the new drill instrument or the conventional biopsy forceps and take the biopsy on the decided localization. The next site of the tumour is decided and again blindly the investigator get one of the two biopsy instruments according to a previously decided scheme. Six biopsies (three with each of the two biopsy tools) in every patient are harvested in ten patients. With altogether 30 specimen for each biopsy instrument and a difference of 1/3 which is a low calculated difference 10 patients as above will give a 80 % Power (Chi-2 = 5.40, p = 0.02\*). The amount of submucous tissue harvested with the two biopsy instruments are measured in microgram and as percentage of all the biopsy and compared. The quality of the specimens are also calculated.

Eligibility Criteria:
Inclusion Criteria:

* Submucous gastrointestinal tumours

Exclusion Criteria:

* No gastrointestinal submucous tumor
* Submucosal hemangioma
Development of Countermeasures Against Adverse Metabolic Effects of Shift Work

The goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.

Shift work is associated with circadian misalignment and an increased risk for the development diabetes, obesity, and cardiovascular disease. This research will determine whether changing the feeding schedule can prevent metabolic alterations that can lead to the abovementioned disorders. This research will provide mechanistic insight and may provide a novel therapeutic approach against the increased risk for diabetes, obesity, and cardiovascular disease among shift workers.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5 and 29.9 kgm-2
* Healthy adults with regular sleep-wake timing
* Non-smokers
* Completion of medical and psychological screening tests
* Able to spend 14 consecutive days in the sleep laboratory

Exclusion Criteria:

* BMI \<18.5 or \> 29.9 kgm-2
* History of neurological or psychiatric disorder
* History of sleep disorder or regular use of sleep-promoting medication
* Current prescription, herbal, or over-the-counter medication use
* Traveling across 2 or more time zones within past 3 months
* Donating blood within past 8 weeks
* Worked night or rotating shift work within past 3 years
* Hearing impairment
* Drug or alcohol dependency
Animal Assisted Therapy in a Pediatric Setting

The primary purpose for this study is to determine if children who receive Occupational Therapy while they are an inpatient in the hospital will be more motivated to participate in therapy as well as increase the amount of time they will work during that particular session when a therapy dog is present during their sessions. The investigators will also be collecting data regarding a child's heart rate and blood pressure prior to the session starting and ending to determine if having a therapy dog present also helps relax a child.

The primary objective of this study is to evaluate if a patient in the pediatric acute care setting receiving Occupational Therapy (OT) services in adjunct with animal assisted therapy (AAT) are more motivated to actively participate in the therapy session for a longer period of time.

Methods:

Thirty inpatients will be recruited to participate in this study. This study will utilize a randomized crossover study design where the patients act as their own control. The treatment period for hospitalized patients will include an on off pattern of incorporating AAT into their OT session. Patients' participation of therapy will be assessed with a participation scale (see Figure 2) and the OT session time. Patients will be evaluated for OT and the therapist will determine goals based on functional status and needs of the particular patient. Goals will be determined by providing a functional evaluation based upon Occupational Therapists clinical observation, developmental standards and current functional level of the patient.

Patients who are potential candidates for this study will be hospitalized at Children's Hospitals and Clinics of Minnesota on the St. Paul campus. All inpatients stated to have decreased functional skills that have been referred by a physician to OT will be invited to participate this study.

Patients have a difficult time participating in various therapies due to emotional stress, anxiety, and feeling uncomfortable with the hospital environment. Limited studies have demonstrated the value of AAT used in conjunction with OT for children, regardless of diagnosis within the hospital setting. Results of this study can justify the use of this valuable therapy not only for the selected population, but also for other disciplines such as physical and speech therapy.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient Occupational Therapy Referrals
* Ages 0-21 years

Exclusion Criteria:

* Patients who are uncomfortable with dogs
* Patients who exhibits violent behavior
* Animal Allergies
* Patients are unable to work with a dog
* Patients who exhibit severe cognitive delays