cyrilzakka/clinical-trials huggingface dataset:
Glucomannan for Childhood Functional Constipation.

The purpose of this study is to determine whether administration of glucomannan (dietary fiber) is effective in treating functional constipation in children.

Constipation is a common condition in children. In many patients symptoms persist to adulthood and decrease quality of life. The standard treatment, mostly osmotic laxatives such as lactulose or polyethyleneglycols, are often ineffective and may cause adverse events. Therefore, alternative treatment measures are being searched for.

Glucomannan, a water-soluble fiber polysaccharide from the tubers of the Japanese Konjac plant, has been reported to be effective in constipated children. To date, 2 randomized trials were performed.1,2 One evaluated the effect as glucomannan as an adjunct to standard treatment.1 Another was conducted in neurologically impaired children, who constitute a specific population that cannot be compared to patients with functional constipation.2 In both trials, the number of patients was relatively small.

Well-powered, randomized controlled study is required to evaluate clinical effectiveness of glucomannan as a sole treatment in childhood functional constipation.

Eligibility Criteria:
Inclusion Criteria:

* functional constipation diagnosed according to Rome Criteria III (duration of symptoms for at least 2 months prior to study inclusion)
* age 3 to 16 years
* informed consent from parents and/or child

Exclusion Criteria:

* organic cause of defecation disorders (Hirschsprung's disease, spinal anomalies or anorectal pathology; history of gastro-intestinal surgery)
* mental retardation
* metabolic disease (e.g. hypothyroidism)
* irritable bowel syndrome
* intake of medications influencing gastrointestinal motility
Effect of RAS Blockers on CKD Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)

This study evaluates the effect of renin-angiotensin blockers on chronic kidney disease progression in elderly (\>65 years old) patients with non-proteinuric nephropathies. Half of the patients will receive angiotensin converting enzyme inhibitors, while the other half will not receive them. Renal function, proteinuria and cardiovascular events will be follow up during a three year period.

STUDY DESIGN: Open, multicentre, prospective, parallel-group, randomized controlled study comparing the effect of an angiotensin converting enzyme inhibitor (ACEI) vs standard antihypertensive treatment without ACEI, in the progression of renal disease in elderly patients with non-proteinuric 3-4 stage chronic renal disease.

Elderly patients (\> 65 years) with moderate-severe non-proteinuric chronic renal disease (estimated Glomerular Filtrate Rate between 19-59 ml per minute per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration Group equation) and urine-creatinine rate \< 30 mg/g, will be included. They will be randomly assigned in a 1:1 ratio to receive ACEI or standard antihypertensive treatment. Patients will be followed up for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Age \>65 years
* Chronic kidney disease stage 3 or 4 (GFR measured by CKD-EPI 15-59 ml/min/1,73 m2)
* Albumine/creatinine index \< 30 mg/g in simple urine sample or albuminuria \< 30 mg/day in 24-hour urine sample.
* Previous hypertensive treatment::

  1. patients who have not received RAS blockers in the three months prior to inclusion can be included
  2. patients who are receiving RAS blockers could be included after one month washout period

Exclusion Criteria:

* Diabetes mellitus (type 1 or 2)
* Glomerulopathy
* Chronic heart failure or coronary heart disease
* Poorly controlled hypertension (\>160/100 mmHg)
* Monorrenal
* Active malignant neoplasia (except skin cancer different from melanoma). Patients who have been free of malignancy for the last 5 years could be included.
* Chronic symptomatic or not controlled inflammatory disease (eg rheumatoid arthritis, Chron disease, ulcerative colitis or systemic lupus erythematosus)
* Chronic liver disease
* Allergy or intolerance to renin angiotensin system blockers or calcium channel blockers
* Hepatitis B, C or HIV infection
* Immunosuppressive treatment in the 3 months prior to inclusion
* Hospitalization of any cause in the three months prior to inclusion
* Rapidly progressive kidney disease (decline in GFR \>5ml/min/1.73 m2/year)
* Inability to sign the informed consent
Effect of Hearing Aid Labeling on Speech Understanding Measures

New and experienced hearing aid users will be fit with two hearing devices. One will be labeled as an OTC (Over-The-Counter) device, the other will be labeled as a Prescriptive (i.e. professionally fit) device. Both devices will be generically programmed for a mild to moderate hearing loss. An objective speech in noise test will be completed with both devices.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or older with bilateral mild to moderate hearing loss
* Experienced users must have at least 6 months Hearing Aid experience
* New users must have no prior hearing aid experience, defined as never owning their own devices

Exclusion Criteria:

* Self-reported ear related pathology (otorrhea w/in 90 days, dizziness, sudden hearing loss or worsening of hearing w/in 90 days, otalgia)
* Visible deformity of the ear
* Chronic, severe tinnitus
* Unilateral hearing loss
* Cognitive impairment
Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair

The purpose of the study is

1. To compare the recurrence rate of the laparoscopic total extra peritoneal inguinal hernia repair without fixation of the mesh to mesh fixation under spinal anesthesia
2. To test whether non-fixation of mesh leads to less pain compared to the repair when the mesh is fixed.

Hernia repair is one of the most common surgery performed all over the world. The same is true about India. With more than a billion population, the number of hernia patients in India perhaps run in millions. The laparoscopic repair is increasingly becoming popular in India.

Decreased post operative pain and lesser morbidity are the main advantages of Total Extra Peritoneal Repair (TEP) over open hernia repair. Laparoscopic hernia repair is now recommended as the method of choice for bilateral and recurrent inguinal hernias. The disadvantages of TEP are requirement of general anesthesia (GA), need to fix the mesh, seroma formation and difficult learning curve. Fixation of mesh with metal staples, apart from increasing the cost, may lead to new post operative groin pain which even becomes chronic in small percentage of patients. This had led to various studies showing that the non-fixation of mesh is safe, cost effective and lead to no increased risk of hernia recurrence compared to the conventional open hernia repair. Requirement of GA for TEP repair also had several disadvantages compared to regional anesthesia such as significant hemodynamic changes, delayed recovery, post operative nausea and vomiting, increased cost and inability to give anesthesia in high cardio-pulmonary risk patients. Several studies in recent past have demonstrated TEP is feasible and safe in regional anesthesia (epidural or spinal) as well. We earlier reported that TEP repair could be done without fixation of the mesh under regional anesthesia.

This study is a Randomized Controlled Trial (RCT) comparing the outcome of non-fixation of mesh during laparoscopic inguinal hernia repair with fixation of mesh under spinal anesthesia. The end points measured would be the recurrence of the hernia and pain in the post operative period.

Eligibility Criteria:
Inclusion Criteria:

* All reducible inguinal hernias will be included in the study

Exclusion Criteria:

* Irreducible hernia after anesthesia
* Obstructed and strangulated hernias
* Pediatric hernias
* Associated other hernias like ventral hernias
* Unfit for spinal anesthesia
Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis

The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of psoriasis in patients for a period of up to 1 year.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at baseline
* Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5)
* Able to start Enbrel (Etanercept) therapy per the approved product monograph

Exclusion Criteria

* Active infections at the initiation of Enbrel therapy.
* Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
* Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B (UVB) therapy within 2 weeks of study drug initiation.
* Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug initiation and during the study period.
* Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug initiation and during the study period.
* Have received Remicade® (infliximab), Humira® (adalimumab) or Amevive®(alefacept) within 3 months before the initiation of study medication or during the study period.
Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study

This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle implementation on the outcomes of interest. Advancements in the care provided in Pediatric Intensive Care Units (PICUs) have led to fewer deaths in children. These improvements are unfortunately countered by the emergence of side effects of critical illness, known as PICU-acquired complications (PACs). Delirium, muscle weakness, drug dependency and withdrawal are increasingly common. PACs occur because children are often over-sedated and experience long periods of immobilization. PACs delay recovery, increase disability and worsen long-term function and quality-of-life. Although they are preventable, PACs are very common and frequently overlooked by clinicians. This study aims to "liberate"children from critical illness and improve their recovery and functioning after discharge, through an innovative rehabilitation bundle of 8 complementary steps (PICU Liber8) to reduce sedation, allow children to awaken and breathe comfortably, encourage early mobilization, and engage families in their child's care.

This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle.

The objectives are:

1. Primary - Implementation Objectives: to determine the feasibility and resources required to implement PICU Liber8 in 2 PICUs, evaluate strategies for successful bundle adoption. Co-Primary - Process Objectives: to determine the impact of PICU Liber8 on the process of care.
2. Secondary Efficacy: impact on PACs and patient reported outcomes The methods consist of a PICU Liber8 Bundle Implementation Plan (Pronovost's 4 E's Framework), and measurement of the impact of Implementation through Orchestrated Testing (OT).

For successful adoption of the PICU Liber8 bundle, the following are necessary:

1. A context appropriate implementation framework.
2. An implementation team leader.
3. Inter-professional team engagement (i.e. RN, RT, MD, pharmacy, allied health and family).
4. Ability to customize PICU Liber8 to the needs of each site. We will use the Pronovost's implementation framework, which has been shown to facilitate successful bundle adoption and improve the quality of patient care in adult and pediatric ICUs.17-19 This framework has 4 phases: Engage, Educate, Execute and Evaluate.

Eligibility Criteria:
Inclusion criteria: All children admitted to the Pediatric Intensive Care Unit with a minimum of 48h stay in the PICU and more than one organ dysfunction.

Exclusion criteria: as this is an assessment of a quality improvement strategy there are no criteria for excluding participants.
The Effect of Experimental Neck Pain in Healthy Participants

This study investigates if/how an experimentally applied muscle pain/soreness, lasting for some days may affect brain activity, balance, movement patterns, muscle function and pain sensitivity in a healthy population

All included healthy volunteers will participate in test-sessions on 4 separate days over approximately 2 weeks.

During the study participants will be randomised into and either a control group (injection of isotonic saline into a neck muscle) or neck pain group (injection of Nerve Growth Factor (NGF) into a neck muscle).

Alle participants tested with regards to:

Brain activity related to neck muscles will be estimated using TMS Balance will be tested using a force place Body movements will be recorded using 3D tracking Muscle activity will be estimated using electromyography (EMG)

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 18-50 years
* Only for sub-projects 1 and 2: Right-handed
* Able to speak, read and understand Danish and English

Exclusion Criteria:

* Pain from the neck or shoulder area during the past 6 months
* Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session
* Former surgery in neck or shoulder
* Current or previous chronic or recurrent pain condition
* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, musculoskeletal or mental illnesses
* Regular use of analgesics
* Abnormally disrupted sleep in the last 24 hours preceding the experiment
* Lack of ability to cooperate
* Unable to pass the TASS safety screening questionnaire for TMS
Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery

Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until hospital discharge to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Aim1b: Patients using statins preoperatively will be randomized to atorvastatin 80mg or placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Endpoints include glomerular filtration, urine and plasma markers of renal dysfunction, markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium, dialysis, stroke, myocardial infarction, time to extubation, ICU length of stay, and death.


Eligibility Criteria:
Inclusion Criteria:

* open heart surgery

Exclusion Criteria:

* acute coronary syndrome with troponin leak or unrelenting angina
* liver dysfunction (transaminases 2x normal)
* history of myopathy or liver dysfunction on prior statin therapy
* use of potent CYP3A4 inhibitors such as antifungal azoles, macrolide antibiotics, HIV protease inhibitors, and nefazodone.
* pregnancy or breast feeding
* cyclosporine use
* dialysis
* history of kidney transplant
* fibrate users who cannot stop fibrate use.
Muscle Relaxation for Short Procedures

Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium, reversed by low-dose sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), as well as patient satisfaction for these two muscle relaxants.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 yr
* scheduled for elective rigid bronchoscopy

Exclusion Criteria:

* known neuromuscular disease
* significant hepatic or renal dysfunction
* family history of malignant hyperthermia
* known allergy to one of the drugs used in this protocol
* pregnancy or breastfeeding
Sport Climbing With Parkinson's Disease

This controlled interventional study will investigate the effects of a 12-weeks sport climbing course compared to 24 weeks of unsupervised physical exercise on motor symptoms in Parkinson's disease

The primary aim of this study is to evaluate the effects of a 12-week sport climbing course versus unsupervised physical exercise on motor symptoms in patients with Parkinson's disease.

Background: Sport climbing (SC) is known as a whole-body workout, which additionally trains cognitive, mental, and social abilities. In contrast to its public image, SC in a controlled environment using "top-rope" belay, is a safe sport and can be performed at any age and at any level. In the field of neurological rehabilitation, it is already used as "therapeutic SC" for other neurological diseases, such as stroke, multiple sclerosis, depressions etc. but studies on climbing in PD patients are lacking.

Hypothesis: to find significant improvement of motor symptoms in the climbing group compared to the control group as well as biopsychosocial improvements after 6 weeks, 12 weeks, and 6 months after the intervention.

Methods: Effects of SC on motor symptoms in 48 PD patients in total, who will be randomized into a climbing group (n=24) and a control group (n=24) will be evaluated. The climbing group will follow a 12-week 90 min/week climbing trainings course, led by professional climbing instructors.

The control group will receive education/information material of the European physiotherapy guidelines for physical activity recommended by the WHO and will be instructed to follow the recommendation of the guidelines to independently live an active lifestyle and train unsupervised. All patients will be evaluated with clinical assessments at baseline, in between the study period (mid), after completing the 12-weeks study period (post). As additional outcomes, health benefits of SC in PD with a holistic approach, covering biopsychosocial aspects will be investigated. Therefore, non-motoric and motoric parameters will be evaluated, and follow-up assessments 6 months after.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* HY stage 1-3

Exclusion Criteria:

* cognitive impairment
* severe hearing or visual impairment
* severe orthopedic problems
Subjective Memory Complaints' Cognitive Intervention

This study will be divided into two parts: development of the mobile medical application for older adults with subjective memory decline and the intervention application. Start by developing and optimizing the application based on the rapid prototyping model. Then, in accordance with the framework of designing and evaluating complex intervention measures proposed by the Medical Research Council of the United Kingdom, pre-experiments will be carried out to apply the developed application to the actual intervention process to test the intervention effect, feasibility, and other contents of the application.


Eligibility Criteria:
Inclusion Criteria:

* Patients with subjective memory complaints by SMCQ for 6 months and above.
* Individuals age over 60 years (depending on the characteristics of the disease, it can be relaxed to 55 years) are included.
* Older adults owning and being able to use smartphones to access the Internet, or whose caregivers can assist in the completion can also be included.
* Older adults who voluntary participate in the study and provide informed consent are also included.

Exclusion Criteria:

* Older adults diagnosed with cognitive or mild cognitive impairment.
* Older adults diagnosed with other neurological disorders ( cerebrovascular disease, encephalitis, brain tumor, brain trauma, epilepsy, Parkinson 's disease, depression, mania, etc. ), metabolic diseases ( anemia, thyroid dysfunction, folic acid and vitamin B12 deficiency, etc. ), carbon monoxide poisoning and cognitive decline caused by general anesthesia
* Older adults with serious medical and surgical diseases who cannot complete the experiment are also excluded.
Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer

This is a pilot study to test whether there is an association between baseline Vitamin D levels, Vitamin D supplementation and survival in patients with stage III colon and stage II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled. Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly) Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D levels will be checked throughout supplementation then followed for 5 years with occasional Vitamin D testing and surveying in order to collect information on recurrence and survival outcomes.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Willing to stop herbal medications as directed by physician
* Willing to stop current supplemental Vitamin D (Multivitamin with Vitamin D component is acceptable)
* Willing to travel to Legacy Health/OHSU facility if necessary
* Agree to attend study visits outside of standard of care visits, if necessary
* Diagnosed with stage III colon or stage II/III rectal cancer that will receive neoadjuvant or adjuvant chemotherapy but have not yet started
* Baseline serum Vitamin D level below 52 ng/ml

Exclusion Criteria:

* ≤ 18 years of age
* Colon cancer stages I-II and IV or Rectal cancer stage I or IV
* Patients who do not undergo chemotherapy
* Patients with prior chemotherapy for this cancer
* No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease-free for \> 3 years
* Unable to comply with protocol
* Unable to provide written informed consent
* Unwilling or unable to stop oral supplemental Vitamin D
* Patients taking high-dose Vitamin D supplementation (50,000 IU weekly) prior to enrollment
* Patients with Vitamin D levels above 52 ng/ml at baseline testing
* Patients with hypercalcemia and/or any condition resulting in malabsorption
* Investigator does not believe study participation, for any reason, is in the best interest of the patient
Efficacy Study of IL-21 to Treat Metastatic Melanoma

This trial is conducted in Oceania. A phase 2a study to assess the effect on tumor size. At least 14 to a maximum of 40 patients, who have not previously received treatment for their stage IV disease, will be treated for 6 weeks. IL-21 will be administered intravenously.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed surgically incurable metastatic melanoma
* Patients must have measurable disease
* ECOG performance status of 0 or 1
* Expected life expectancy at least 4 months

Exclusion Criteria:

* History of and signs/symptoms of uncontrolled brain metastases or edema.
* Previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.)
* Radiotherapy: Radiation therapy within 4 weeks prior to entering the study.
* Receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.