cyrilzakka/clinical-trials huggingface dataset:
Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS

The primary objective is to compare the effectiveness of maintenance therapy initiation with the combination treatment Tiotropium and Olodaterol (Olo+Tio) compared with LABA/ICS combination in COPD as the time to the first COPD exacerbation.

Secondary objectives are to compare patients treated with Tio+Olo and patients treated with LABA/ ICS combination.


Eligibility Criteria:
Inclusion Criteria:

1. At least one prescription for Tio+Olo combined inhaler or a LABA/ICS combined inhaler between 1 January 2013 and 31 March 2019.

   1. The first dispensing of either Tio+Olo or LABA/ICS combined inhaler will be defined as the index date.
   2. For the main analyses, only fixed dose combination (FDC) inhalers will be included. Sensitivity analyses will also accept free combinations of LABA/ICS.
2. At least one diagnosis of COPD at any time prior to the index date.
3. At least one year of continuous medical and pharmacy health plan eligibility prior to the index date will be required to allow a baseline period for the covariates and identification of new use of the study drugs.

Exclusion Criteria:

1. To increase the likelihood of a true diagnosis of COPD, we will exclude:

   1. All patients less than 40 years of age on the index date, and
   2. All patients with a diagnosis of asthma in the year prior to the index date
2. To limit the population to those without severe lung compromise outside of COPD, we will exclude individuals with lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date
3. To restrict the cohort to new users of Tio+Olo or LABA/ICS, we will exclude any individual with use of either Tio+Olo, LABA/ICS, or LABA/LAMA/ICS combination therapy in free or fixed form for at least one year prior to the index date.
Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals

Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the blood and a secondary increase in the iPTH level. This chronic elevation in iPTH can have adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease the absorption of phosphorus present in the normal diet. Some preliminary studies have indicated that the iPTH level may change based on the amount of phosphorus present in a meal prior to any significant absorption of phosphorus. If this is true in hemodialysis patients, then the timing of the administration of phosphate binders in relation to the ingestion of meals needs to be considered

Drugs used will include three phosphate binders already approved and commonly used. Calcium acetate, aluminum hydroxide, and sevelamer (Renagel) will be given on separate occasions in conjunction with a high phosphorus meal. They will be given in standard doses used in the treatment of high phosphorus levels in hemodialysis patients.

The population targeted will included hemodialysis patients with elevated iPTH and phosphorus levels.

The patients will receive up to five separate meals. Four of these will be high phosphorus content meals and one will be a low phosphorus content meal. On up to three occasions with the high phosphorus content meals the patients will ingest one of the three phosphate binders. The meals will be ingested after a twelve-hour overnight fast. Labs will be drawn prior to meal ingestion and then at 15, 30, 60, 120 and 240-minute intervals. The labs will consist of iPTH, phosphorus, calcium, and glucose. A serum albumin level will be obtained with the initial specimen only. The patients will have an iPTH level of at least 200pg/ml and a serum phosphorus level of at least 4.0 mg/dl.

The primary outcome will be the change in the iPTH level in relation to the phosphorus content of the meals. Secondary outcomes will include the change in iPTH level in relation to the various phosphate binders being used.

Eligibility Criteria:
Inclusion criteria:

* Patients 18 years of age or older
* Receiving treatment with hemodialysis for at least 90 days
* Serum iPTH levels greater than 200pg/ml
* Serum phosphorus levels greater than 4.0mg/dl
A Pilot Study of tDCS for Mild Cognitive Impairment

The primary objective of this preliminary study is to investigate whether the transcranial direct current stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment (MCI)

Twenty patients were recruited and randomized to receive either real or sham-tDCS over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients or their legally responsible caregivers were provided with mobile tDCS device, and were instructed to use it at home. 30-minute session of the stimulation were applied everyday in the morning for 12 weeks. The patients were evaluated at baseline, at week 6 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a subjective memory impairment
* Subjects who have Korean version of Mini Mental Status Examination score 24 or more
* Subjects who have SVLT and RCFT delayed recall test scores lower than 1.5SD
* Subjects who have had other cognitive impairments besides memory
* Subjects with late amnestic mild cognitive impairment, verbal and visual memory impairment and multiple domain problem
* Subjects who have Seoul-Instrumental Activities of Daily Living score (S-IADL) of 8 or lower
* Subjects who are right-handed
* Subjects who are able to read and write
* Both subject and legally responsible caregiver have provided informed consent
* According to the latest MRI result, periventricular white matter cap or band is less than 10mm, or the deep white matter hyper-intensity is less than 25 mm

Exclusion Criteria:

* Subjects who have a history of stroke and seizures
* Subjects who have any illnesses that may disturb the patients completing the trials, including stroke, Parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, Huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a transient ischemic attack.
* Subjects who have neurologic problems on physical examination that cause memory disturbances
* Subjects who have a history of DSM-IV Axis I disorders
* Subjects who have extremely sensitive skin
* Subjects who have suffered from the cancer in 3 years
* Subjects who have had a cerebrovascular neurosurgery in medical history
* Subjects who have dyspnea in sitting position
* Subjects who have problems with memory, language and problem-solving for 2 hours after the heart attack.
* Subjects who have a history of drug or alcohol abuse (in the past 5 years)
* Subjects who have a history of mental or emotional disorders (in the past 5 years)
* Subjects who have been lapsed into unconsciousness for an hour because of other reasons than general anesthesia
* Subjects who have a history of hospitalization due to head injury
* Subjects who are unable to read even with glasses
* Subjects who are unable to understand the conversation due to the hearing defect (even with the hearing aid)
Prevention of Rabies With Four Doses of Rabies Vaccine

To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.

* In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days)；
* To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).

Eligibility Criteria:
Inclusion Criteria:

* People aged 10-60；
* Body temperature on the day of enrollment\<37.3℃ (axillary temperature)

Exclusion Criteria:

* Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
* People with congenital or acquired immunodeficiency or other autoimmune diseases；
* Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;
A Study to Determine the Preferred Dose of the Drug, Lisinopril, for Preventing Urinary Toxicity Following Radiotherapy for Prostate Cancer

This study will establish the preferred dose of lisinopril in men with non-metastatic prostate cancer undergoing radiation treatment. This study will also evaluate the effect of lisinopril on urinary symptoms and the impact of lisinopril on biomarkers and their association with urinary symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Have a confirmed diagnosis of adenocarcinoma of the prostate and are candidates for curative-intent external beam radiation (with or without androgen deprivation therapy, ADT) at the Wilmot Cancer Institute Department of Radiation Oncology. Radiotherapy may be either primary, adjuvant or salvage. It may be part of combined treatment with androgen deprivation therapy.
* Be stage M0 based on the standard of care staging imaging
* Be able to read English
* Have the psychological ability and general health that permits completion of the study requirements and required follow up
* Be ≥18 and \< 70 years of age
* Have ECOG performance status of 0 to 2 within 180 days prior to enrollment
* Have adequate renal function with creatinine clearance \> 30 mL/min within 30 days prior to registration
* Have hematologic and hepatic function deemed adequate for planned treatment by the treating investigator within 90 days prior to registration, including:
* hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors
* platelet count ≥100,000/µL independent of transfusion and/or growth factors
* Have a baseline systolic blood pressure of \>130.

Exclusion Criteria:

* Have received prior pelvic radiotherapy
* Be taking lisinopril or other RAS modifying drug within two months prior to registration
* Have had a prior allergic reaction to lisinopril
The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function Failure

Random grouping by computer, divided into two groups, a group of rhubarb treatment group, another group for the placebo group.

Patients were randomly divided into two groups, using rhubarb powder or placebo. Rhubarb is commercially certified rhubarb(Rheum palmatum, Sichuan origin, provided by the pharmacy of my hospital), ground into a powder, over 80 mesh steel mesh, Two days before 6g, three times / day, oral or nasal feeding, two days later reduced to 3g, three times / day, oral or nasal feeding; Another group of patients taking placebo, with the same dose of Rhubarb; The overall course of the two drugs was a week.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-65 year old;
2. Diagnosis: sepsis with gastrointestinal dysfunction (II-III grade AGI); gastrointestinal dysfunction after trauma (II-III AGI);
3. Complete gastrointestinal tract anatomic structure（including the ileum and colon stoma）

Exclusion Criteria:

1. Hemodynamic instability;
2. Underlying diseases: cardiac function III\~IV, chronic liver dysfunction Child-Pugh score \>9 points;
3. Less than 5 days after surgery for stomach and small intestine，less than 7 days after Colonic surgery, Postoperative gastrointestinal leakage;
4. Abdominal Compartment Syndrome;
5. mechanical ileus
6. active gastrointestinal hemorrhage
Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)

The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD).


Eligibility Criteria:
KEY INCLUSION CRITERIA:

Male or female, ages 18 through 75 years will be included in the study. Females should be either of nonchildbearing potential or of childbearing potential. Females of childbearing potential must have negative serum and urine pregnancy tests prior to randomization. Female subjects of childbearing potential must agree to use medically acceptable methods of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Women using hormonal contraceptives must also be using an additional approved method of contraception starting at Visit 1 and throughout the entire study period and for 1 month after the last dose of study drug. Pregnant or lactating females are excluded. Subjects must have a history of heartburn, identified as their main complaint, for 6 months or longer.Subjects must have documentation of a minimum of 5 moderate to severe heartburn episodes, 3 of which occur during the daytime and 1 of which occurs during the nighttime, during the last 7 days before randomization. Subjects must be able to read, write, and understand the language of the symptom dairy.

KEY EXCLUSION CRITERIA:

Subjects will be excluded from the study if they are found to have erosive esophagitis during esophagogastroduodenoscopy (EGD) at Screening, current or a history of esophageal motility disorders, current or a history of Barrett's esophagus, current esophageal strictures or esophagitis (known or suspected to be due to etiology other than GERD such as infection or medications), current or a history of Zollinger-Ellison syndrome and acid hypersecretory conditions, or current gastric or duodenal ulcer. Subjects will be excluded if they are found to have current or a history of cancer, with the exception of fully excised skin basal cell carcinoma, inflammatory bowel disease, a history of esophageal, gastric and duodenal surgery, except simple closure of a perforated ulcer. Subjects will be excluded who require daily use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (\>=20 mg/day prednisone or equivalent), or aspirin (\>325 mg/day). Female subjects will be excluded who are pregnant, lactating, or have a positive B-human gonadotropin test at Screening/Baseline. Subjects will be excluded who are known to be human immunodeficiency virus (HIV) positive, have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial. Subjects who are unwilling to provide informed consent will be excluded.
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2

The wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities. We propose that demonstrating higher rates of compliance and consistent delivery of optimal force, with accelerometer feedback, will provide a superior alternative to whole body vibration and is plausibly more effective at preventing bone loss in postmenopausal women than vibration platforms in the home setting.

The goal of this study is to demonstrate that postmenopausal women will tolerate our device, have high rates of compliance with the study protocol, receive consistently therapeutic levels of vibration and see significant effects on bone turnover based on plasma markers of bone anabolism and catabolism.

The anticipated outcomes from serum draws are an improvement in two bone turnover markers after a 30 minute treatment with the WVD.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Last menstrual period at least one year prior and not more than eight years prior.
3. 19 years of age and older.
4. BMD T-score at or above -2.49 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
5. Ambulatory (can walk or stand without an assistive device for a minimum of 30 minutes).
6. Able to understand spoken and written English.
7. Capable and willing to follow all study-related procedures.

Exclusion Criteria:

1. BMD T-score at or below -2.5 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
2. A 10-year probability of hip fracture of \> 3% or major fracture of \> 20% based on results of DXA using the FRAX tool (see attached).
3. Weight \> 300 lbs.
4. Are currently taking or have taken bisphosphonates within the past 12 months, estrogen replacement therapy, or drugs affecting bone such as tamoxifen or aromatase inhibitors within the past 6 months.
5. Active cancer or cancer treatment.
6. Any change in exercise in the past 3 months.
7. Fractures or major surgery within the past 6 months.
8. Medical Implants (excluding dental implants).
9. Diagnosed with Paget's disease, heart disease, uncontrolled hypertension, renal disease, chronic fatigue syndrome, herniated disc, severe peripheral neuropathy, severe osteoarthritis.
10. Any bleeding disorder or treatment with a blood thinning medication within the last 2 years.
11. Hip circumference is greater than 42 inches
Comparison of Effect of Prolotherapy and Paraffin Waxes for Hand Osteoarthritis

Patients with hand osteoarthritis will be randomized into two groups, paraffin wax and prolotherapy group. Patients will be evaluated before and after treatment , after 2 weeks 4 weeks and 3 months after treatment. Evaluation parameters are visual analog scale, Duruoz hand index scales, grip strength, lateral pinch, two point pinch and three point pinch strengths.

This study is a randomized clinical trial. 40 Patients with hand osteoarthritis will be randomized into 2 groups, paraffin wax and prolotherapy group.Paraffin group patients will be told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in every physical therapy session. Prolotherapy is a nonsurgical regenerative injection technique that introduces small amounts of an irritant solution to the site of painful and degenerated tendon insertions (entheses), joints, ligaments, and in adjacent joint spaces during several treatment sessions to promote growth of normal cells and tissues.Hypertonic dextrose solution is most common used agent. In prolotherapy group, %15 dextrose solution will be applied to medial and lateral aspect of proximal interphalangeal joints (PIJ), distal interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period. Grip strength, lateral pinch, two point pinch, three point pinch strengths, Visual analog scale (VAS), Duruoz Hand Index scales will be assessed before the intervention and after two weeks, 4 weeks and 3 months after intervention .

Eligibility Criteria:
Inclusion Criteria:

* Hand osteoarthritis defined according to American College of Rheumatology criteria
* Older than 40 years

Exclusion Criteria:

* Carpal tunnel syndrome
* De quervain tenosynovitis
* Dupuytren's contracture
* Secondary osteoarthritis due to Rheumatoid arthritis, chondrocalcinosis, Psoriatic arthritis, hemachromatosis
* Trigger finger
Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy

There are a variety of strategies that can be used for education to improve patients' awareness of the electronic capsule endoscopy process at present. The animated images in the animation videos are interesting as the explanations are simple and easy to understand. It is one of the best choices for children's education. A number of studies have shown that animated videos can increase the awareness rate of children's related knowledge, reduce anxiety, improve children's compliance with examinations and operations, and achieve good clinical results. Effective information transmission to children and their family members can increase the children's cognition and may affect the children's compliance with swallowing capsules and the success rate of autonomous swallowing, thereby reducing the time for swallowing capsule endoscopes and increasing capsule endoscopes Complete small bowel examination completion rate. This study aimed to evaluate the impact of animated video education on the success rate of children swallowing capsule endoscopy and analyze the related factors that affect the time for children to swallow capsules autonomously.


Eligibility Criteria:
Inclusion Criteria:

* Have indications for capsule endoscopy;
* Agree to undergo capsule endoscopy;
* Have normal intelligence and can communicate with the operator normally.

Exclusion Criteria:

* Contraindications for capsule endoscopy;
* Previous experience of capsule endoscopy;
* Allergic to polymer materials;
* Persons with mental retardation;
* Those who cannot communicate normally due to diseases or emotions;
* A HAMA scale of 21 or above, which indicates severe anxiety, before the examination
Stationary Bike Study

Investigators will use a stationary bike protocol to investigate whether patients with post concussion syndrome benefit from adding exertion training to a vestibular rehabilitation program.

Investigators examine the effect of aerobic exercise testing and training on individuals with concussion who are currently experiencing symptoms and examine the effect of aerobic exercise in combination with traditional vestibular rehabilitation.

This is a randomized controlled single blind pilot study testing the hypothesis that the combination of aerobic exercise plus vestibular rehabilitation will result in greater reduction of symptoms of dizziness and imbalance compared to vestibular rehabilitation alone.

Eligibility Criteria:
Inclusion Criteria:

1. History of concussion \>14 days, \<6 months
2. One or more of the following symptoms after most recent head injury: headache, dizziness, fatigue, irritability, insomnia, concentration or memory difficulty)
3. Age range - 18-70
4. Access to stationary bicycle
5. Ability to read and write sixth grade English

Exclusion Criteria:

1. Inability to participate in aerobic exercise for any reason
2. Pre-existing or current neurological or autonomic disease including persistent symptoms form previous concussion
3. Major depressive disorder
4. Litigation
5. Increased cardiac risk
6. Currently taking, Beta Blockers, or Anticonvulsants
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples

The goal of this study is to compare several methods for measurement of Chromogranin A in their ability to serve as a marker for disease activity in patients with neuroendocrine tumors.

Further, in a subgroup, we will determine if taking a proton pump inhibitor affects Chromogranin A levels.

Patient group: patients with neuroendocrine tumors (active or inactive) Healthy volunteers

Eligibility Criteria:
Patients:

Inclusion Criteria:

* having neuro-endocrine disease

Exclusion Criteria:

* age below 18 or above 70 years
* prostate cancer
* kidney failure (estimated GF \< 30 mL/Min)
* heart failure
* chronic atrophic gastritis
* pregnancy

Healthy subjects:

Inclusion Criteria:

* healthy

Exclusion Criteria:

* age below 18 or above 70 years
* taking any chronic medication (except OCP)
* prostate cancer
* kidney failure (estimated GFR \< 30 mL/min)
* heart failure
* pheochromocytoma
* islet cell tumors
* medullary thyroid cancer
* essential hypertension
* neurofibromatosis
* use of proton pump inhibitors
* chronic atrophic gastritis
* pregnancy