cyrilzakka/clinical-trials huggingface dataset:
The Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 600 participants (300 participants per treatment group) with OIC will be randomized at approximately 75 study centers to receive either oral 0.25 mg CB-5945 BID or oral matching placebo BID for the 12-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for clinical response for duration of their study participation. All participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. The clinical study report for this study includes pooled results for studies 5945-OIC-12-02 (NCT01901302) 5945-OIC-12-03 (NCT01901328), and 5945-OIC-12-04 (NCT01901341).

Eligibility Criteria:
Key Inclusion Criteria:

* Is taking a stable daily dose of opioids of ≥ 30 mg morphine equivalent total daily dose (METDD) for chronic non-cancer pain
* Has constipation that is caused by the chronic use of opioids
* Is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from Screening until the last study assessment

Key Exclusion Criteria:

* Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example \[e.g.\], obstruction) or contribute to bowel dysfunction
* Has evidence of intestinal obstruction
* Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening
* Has an active malignancy of any type (participants with a history of successfully treated malignancy \>5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
* Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone)
* Is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)
Glycemic Index and CVD: a Crossover Feeding Study

This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese adults in a 10-day crossover feeding trial.

This study will compare the physiological effects of two isoenergetic, nutrient-controlled diets that differ in glycemic index. The diets will be studied in obese male adults in a 10-day crossover feeding trial. Hypothesis: Obese subjects will show improvements in clinical endpoints associated with risk for diabetes and cardiovascular disease (CVD) after consuming a controlled low (compared to high) glycemic index diet for 10 days. 1º endpoint: insulin sensitivity as measured by the modified Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT). 2º endpoints: CVD risk factors; postprandial studies of oxidative stress; thermic effect of food.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 35 years
* male
* BMI ≥ 27 ≤45 kg/m2
* willingness to refrain from alcohol and caffeinated beverage consumption for duration of study

Exclusion Criteria:

* major medical illness
* an abnormal screening laboratory test
* taking any prescription medications that might affect body weight
* current smoking (1 cigarette during any of the last 7 days)
* consuming special diets
Italian Study on the Cardiovascular Effects of Systolic Blood Pressure Control - CARDIOSIS Study

Multicenter, prospective, randomised, open study comparing the effect of the following two strategies in hypertensive subjects \> 55 years and poorly controlled (systolic blood pressure \>= 150 mmHg) by antihypertensive treatment:

* usual strategy: reduction of systolic blood pressure to below 140 mmHg, independently of diastolic blood pressure levels;
* intensive strategy: reduction of systolic blood pressure to below 130 mmHg, independently of diastolic blood pressure levels.

During the initial run in period two qualifying visits at distance of 7-14 days will be carried out to establish whether blood pressure remains uncontrolled (systolic blood pressure \>=150 mmHg)by current drug treatment. At the end of the second visit eligible patients will be admitted to the study and the following examinations will be carried out: clinical visit, routine laboratory tests, 12-lead ECG. At this point eligible patients will be randomised to one of the two blood pressure goals outlined above.

Subsequent clinical visits will be carried out at 4 month-intervals up to the end of the study (4, 8, 12, 16, 20, 24 months).

Study partially sponsored by: Boehringer Ingelheim, Sanofi-Aventis, Pfizer

Eligibility Criteria:
Inclusion Criteria:

* written informed consent to the study
* age \>= 55 years at randomization. There is no upper age limit
* systolic blood pressure \>= 150 mmHg in 2 visits at distance of 7-14 days, irrespective of diastolic pressure. Duration of treatment before visit 1 must be at least 12 weeks
* at least one additional risk factor including the following:
* current cigarette smoking
* total cholesterol \>= 20 mmg/dl, or High Density Lipoproteins (HDL) \< 40 mg/dl, or Low Density Lipoproteins (LDL) cholesterol \>= 130 mg/dl
* family history of cardiovascular disease in male first degree relative \< 55 years or female first degree relative \< 65 years
* previous TIA or stroke
* previous coronary artery disease
* history of peripheral occlusive arterial disease (claudication intermittens associated with angiographic or echographic evidence of \> 60% stenosis)

Exclusion Criteria:

* diabetes (fasting glucose \> 125 mg/dl in two samples or ongoing diabetic treatment)
* renal failure, defined by a serum creatinine \> 2.0 mg/dl
* chronic atrial fibrillation or flutter
* clinically significant hepatic or hematological disorders, alcoholism, drug addiction
* causes precluding ECG interpretation for LVH: complete right or left bundle block, Wolff-Parkinson-White syndrome, previous Q-wave myocardial infarction
* any disease causing reduced life expectancy
* unwilling to participate
* significant (more than traces of) valvular heart disease
Effect of Specific ACL Injury Prevention Training in Female Handball Players

The anterior Cruciate Ligament (ACL) injuries rates in female handball are high, particularly among adolescents. Therefore, the primary purpose of this randomized control trial is to explore the effects of an 8-week ACL injury prevention program on muscle activation of the medial hamstring muscles during sidecutting in female handball players.

Secondary aims are to evaluate if training effects are age-related (pre-adolescent: 11-13 year old vs. adults: ≥18 years old). The age-related comparisons Include:

1. Medial hamstring muscles activation during sidecutting;
2. Well-known biomechanical ACL injury-risk factors during high risk movements, such as cutting and landing tasks;
3. Cortical and muscular activity and functional connectivity patterns during controlled knee movements;
4. Visuomotor skill learning during a simple task involving the hamstring muscles.


Eligibility Criteria:
Inclusion Criteria:

* Female handball players playing in youth teams from the age group under 13 (11-13 years old) and adult (≥18 - 40 years old) females playing for elite u19 or senior teams in Denmark
* Have minimum 1 year of experience from playing handball
* Mental and physical skills to complete the electrophysiological and biomechanical tests

Exclusion Criteria:

* Girls/women outside the age groups listed above
* Prior surgeries to the lower limbs (e.g. ACL-reconstructions, meniscus lesions)
* Current intake of medications that include antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
* Neurological and/or psychiatric diagnoses
* Pregnant
Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement

Health professions need to prepare for the large increase in the number of older people with OA requiring health services including TJA surgery. Older age and poor physical function influences the postoperative prognosis of TJA. At discharge from hospital after TJA, studies have shown that gait speed can be severely impaired among older patients.

The investigators hypothesize that an exercise program of 6-12 weeks will be beneficial for patients that are undergoing TJA.

More than 300.000 Norwegians above 20 years of age have osteoarthritis (OA) . There has been a significant increase in the prevalence of OA over the decades. In the United States knee OA affects 19% of adults aged 45 years or older. OA is associated with an extensive high economic and personal burden, largely attributable to the effects of disability, comorbid disease, and the expense of treatment.

Given the aging population, the number of total joint arthroplasty procedures (TJA) for hip and knee is likely to increase substantially. In light of poor physical function prior to surgery among older patients and the likelihood of an added decrease during hospitalization and risk of poorer outcome after surgery, it is hypothesised that prehabilitation (preoperative exercise) would improve outcomes after surgery, however evidence for its efficacy is still lacking

Eligibility Criteria:
Inclusion Criteria:

* Participants 70 years or older living at home with residential address in the county of Oslo or Akershus scheduled for elective primary total hip replacement due to end-stage osteoarthritis.
* Harris Hip Score \>60.
* Participants must also be capable in Norwegian and be able to follow exercise sessions.

Exclusion Criteria:

* Patients with known rheumatoid arthritis or medical contraindications or those who are scheduled for revision of hip arthroplasty
* Unable to speak and understand the Norwegian language.
* Patients with neurological disorders affecting gait
* Medical contraindications for exercise
Acidophilus Pearls Fecal Recovery Study

Commercial probiotics can be delivered in numerous forms. The two most common delivery forms are similar to the two product formats to be tested. It has been demonstrated using in vitro testing that probiotic organisms that are unprotected from gastric exposure may not survive that exposure and therefore may not remain viable throughout the rest of the GIT. (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule will survive gastric exposure. It is anticipated that this difference in in vitro gastric survivability will translate to improved digestive tract survivability that can be demonstrated using fecal recovery techniques.

The commercial product to be tested in this clinical trial has been in the market for over 17 years. However, it is not known what effect this commercial product has on the commensal probiotic population in the gut and particularly in the lower bowel where much of probiotic benefits are believed to be largely realized. Also, it is not known what effect the commercial product has on the total commensal microbiota or fecal pH. While commercial probiotic products have been largely aimed at benefits related to improved health, they also have the potential to change overall gut microbiota (probiotics as well as all others) composition and activities. Learning what happens to the overall gut microbiota can be a helpful step in establishing the potential health benefits of the probiotic class of organisms in the test products.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Regular and predictable bowel movement pattern
* Willing to disclose OTC/prescription medications and dietary supplements taken during the study
* Willing to sign comprehensive informed consent form

Exclusion Criteria:

* Digestive disorders
* Use of prescribed medications that affect bowel function or microbiota (antibiotics, pain medications, laxatives)
* Use of dietary supplements/foods that can affect bowel function or microbiota
* Excessive alcohol use
KvaliMed - a Quality Project With Focus on Patients in Antipsychotic Treatment

Rating and registration in KMS database of all patients in anti-psychotic treatment with 8 selected items from PANSS, GAF, 21 selected items from UKU, 3 selected items from TSQM. and measurement of compliance. Frequency of use of rating scales per participating health care professional.


Eligibility Criteria:
Inclusion Criteria:

* All patients where a physician has decided to treat the patient with antipsychotics.
* All patients that are treated within the Danish health care system

Exclusion Criteria:

* Patients that are treated in accordance with "Law concerning freedom deprivation and other compulsion in psychiatry
* Patients that are in judicial measure
Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis

The objective of the study is to determine whether or not inhalation of hypertonic saline will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung function.

Cystic fibrosis lung disease is characterized by mucous retention which favors secondary bacterial infection and inflammation, which leads to lung damage and ultimately respiratory failure. Classically, therapeutic interventions are aimed to improve mucociliary clearance, to reduce both bacterial load and lower airway inflammation.

Hypertonic saline (HS) has been used for the induction of sputum production in all age groups to obtain secretions from the lower respiratory for diagnostic purposes. Hypertonic saline is also used in older children with CF, who do not produce sputum spontaneously, to obtain representative samples for microbiology.

There is evidence from studies in patients with cystic fibrosis that HS can improve mucociliary clearance. The improvement was more impressive in areas that were well ventilated, making it likely that HS will work better in patients with relatively preserved pulmonary function. Newer evidence also suggests that the osmotic effect on the airway surface that was expected to be short lived, may actually persist for longer time periods (up to 8 hours). All these data indicate that HS may be a useful agent in the treatment of CF patients.

As the effect on mucociliary clearance was found to be better in areas with adequate ventilation, it is logical to assume that treatment with HS may be most efficacious when initiated early in the disease process. So far, no data on the tolerability of inhalation of HS are available for infants with cystic fibrosis. However, evidence from infants with AIDS as well as recent studies in infants with bronchiolitis suggest that hypertonic saline can be safely administered by inhalation in infants. Nevertheless, proof of tolerability in CF infants is a prerequisite for longer term studies of HS in this age group. In older children, tolerability has been tested by measuring pulmonary function both before and after inhalation of HS saline. Similar data are not yet available for infants.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cystic fibrosis
* Age 2 months to 2 years
* Routinely scheduled infant pulmonary function test.
* Clinical stability (no respirator tract infection for 4 weeks prior to study

Exclusion Criteria:

* Acute respiratory symptoms
* Wheezing at the time of study
* Supplemental oxygen therapy
* Oxygen saturation \< 95 % on room air
Study of Pioglitazone in Sporadic Inclusion Body Myositis

A study looking at the effect of pioglitazone in skeletal muscle of patients with sporadic inclusion body myositis (sIBM).

This is a 52-week, Phase 1, open-label, single center, proof of concept study of FDA-approved pioglitazone in adult patients with sporadic inclusion body myositis (sIBM). The trial consists of a 4-week screening period;16-week "lead-in" period during which all subjects are observed off-treatment. At Week 16, all subjects will be started on pioglitazone at a dose of 30 mg daily. The dose will be uptitrated to a goal dose of 45 mg daily after 2 weeks; 32-week treatment period with all subjects on 45 mg daily dose of pioglitazone.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* Diagnosis of sporadic inclusion body myositis (sIBM) based on the sIBM Diagnostic Criteria established by the 2010 European Neuromuscular Center.
* Must be able to ambulate at least 20 feet, with or without the use of an assistive device. Patients may not use another person, wall, or furniture for support.
* Must be able to rise from a chair without support from another person or device.
* Premenopausal women must have a negative serum pregnancy test prior to dosing with study medication.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.

Exclusion Criteria:

* A history of diabetes mellitus, or prior or concurrent treatment with any diabetes therapy
* Use of chronic immunosuppressive therapy including corticosteroids or intravenous immune globulin (IVIG) within the past 6 months.
* Use of Vitamin E supplements within the past 3 months
* Creatine kinase (CK) \> 15x the upper limit of normal
* Any condition other than sIBM that causes significant muscle pain, muscle weakness, muscle atrophy, or joint pain. This includes but is not limited to such neurologic and neuromuscular diseases as polymyositis or dermatomyositis, myasthenia gravis, amyotrophic lateral sclerosis, stroke, multiple sclerosis, epilepsy, muscular dystrophy, fibromyalgia, rheumatoid arthritis, spinal cord injury or degenerative disease of the spine. Osteoarthritis is not exclusionary unless it limits the patient's ability to comply with study tasks. Patients with a history of a hip or vertebral fracture within the past year or surgical hip or knee replacement within the past six months will be excluded.
* Patients receiving any medications or substances that are inhibitors or inducers of CYP2C8 are ineligible. These medications include but are not limited to Gemfibrozil, Rifampin, and warfarin.
* Pregnant women
* History of cancer less than five years prior, other than local basal or squamous cell cancer.
* Patient has any medical condition or laboratory finding during screening, which, in the investigator's opinion may interfere with participation, confound the results, or pose any additional risk to the patient.
Study to Assess the Effect of Leucine Along With Resistance Exercise on Muscle Strength and Quality of Life in Elders

The purpose of this study is to determine whether a nutritional supplement with an amino acid called leucine along with resistance exercise are effective in the improvement of muscle strength and quality of life in elderly people.

Physiological aging is accompanied by functional loss and changes in different organs, including the skeletal muscle, with a progressive reduction in muscle mass. This is called physiological sarcopenia of the elderly.

In any population of autonomous individuals over 65 years, a proportion between 3% and 32% depending on age, meets the criteria of the so-called Frailty Syndrome. Frailty is characterized by a decrease in reserves and resistance to aggression, conferring increased vulnerability, disability and poor vital prognosis.

A feature of the Frailty Syndrome is the potential reversibility of many of the elements at the initial stages of frailty. Currently, available treatment for frailty is limited. One of the tools should be the prevention of sarcopenia, where nutritional treatment and exercise have a vital role.

Protein synthesis in aged muscle can be improved by increasing leucine concentration above physiological levels by a higher intake. Regarding exercise, progressive resistance training is one of the interventions that have shown better results in the increase of mass and muscle strength in elderly people.

The hypothesis raises the possibility that an intervention consisting of a leucine supplement along with progressive resistance training, is superior to the same training program and a placebo in improving muscle strength and quality of life in elderly people.

Eligibility Criteria:
Inclusion Criteria:

* Over 70 years of age.
* Subjects capable of doing resistance exercise.

Exclusion Criteria:

* Hospitalized patients.
* Disabled patients (i.e., not being able to exercise).
* Patients that usually train in resistance exercise.
* Patients with chronic renal failure.
* Patients with a fractured extremity during the last 6 months.
* Patients that follow diets with a protein restriction.
* Patients with oral nutritional support, enteral or parenteral nutrition.
* Patients in a low calorie diet to lose weight.
* Patients using pharmacological treatment with anorexigenic effects, anabolic steroids or corticosteroids.
* Patients with cognitive impairment or major psychiatric disorder.
* Non-signed informed consent.
* Any patient not capable to properly follow the treatment or not considered adequate by the researchers.
Effect of Repeated Administration of Liraglutide on Insulinogenic Indices

The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide, on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may change after repeated administration. The effect of liraglutide on insulin release will be tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be performed without medication and repeated 12 hours after first dose of liraglutide and after 3 weeks of treatment with liraglutide.


Eligibility Criteria:
Inclusion Criteria:

* Weight 50-100 kg

Exclusion Criteria:

* Chronic disease
* Concomitant drug use
* Pregnancy or lactation
* Fasting glucose \>6 mmol/L.
Phase 2 Clinical Proof-of-Concept Study of the Cardioprotective Properties of Danegaptide in ST Segment Elevation Myocardial Infarction

This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ST-segment elevation myocardial infarction
* Acute onset of chest pain of \< 12 hours duration

Exclusion Criteria:

* Pregnancy
* Known prior Myocardial Infarction in same area as present STEMI, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure
* Contraindication for cardiac MRI
* Inability to understand information or provide informed consent