cyrilzakka/clinical-trials huggingface dataset:
Effect of Front-of-Pack Labels in Ethiopia

Ethiopia is experiencing the type of rapid food system transformation that leads to a double burden of malnutrition and increased non-communicable diseases. Front-of-pack labels on packaged foods are an emerging public health strategy with the potential to address non-communicable diseases by discouraging the purchase and consumption of products with high levels of nutrients of public health concern. The aim of this study is to evaluate and compare the effectiveness of front-of-pack labeling systems to reduce the intent to purchase unhealthy foods among adults in Ethiopia. The study will recruit approximately 1200 adults using a street-intercept methodology. Participants will be randomized to 1 of 4 arms to complete a survey in which the presence and type of front-of-pack label differs across survey arms and asked to rate participants' intent to purchase unhealthy packaged foods.

In 2017, cardiovascular disease was the leading age-standardized cause of death in Ethiopia. The national prevalence of hypertension in Ethiopia in 2015 is estimated to be 16% (Gebreyes et al. 2018). Urban diets are rapidly changing, but not becoming healthier (Wolle et al. 2020). Diet quality remains poor: only 2.4% of the national population meets the WHO recommendation of five servings of fruit and vegetables per day. The mean estimated salt intake of 8.3 g/day exceeds the WHO maximum recommended intake (Challa et al. 2017). Processed foods are penetrating the market at a rapid pace (Melesse et al. 2019; Stuckler et al. 2012). Increasing income has increased demand for convenience foods (Minten et al. 2018). Ethiopia is experiencing the type of rapid food system transformation that leads to a double burden of malnutrition and increased non-communicable diseases (Popkin 2017).

Front-of-pack labels on packaged foods are an emerging public health strategy with the potential to address non-communicable diseases by discouraging the purchase and consumption of products with high levels of nutrients of public health concern (Croker et al. 2020). However, front-of-pack labels have not been tested in the Ethiopian context. Additionally, there are multiple types of front-of-pack labeling systems in use around the world, such as Multiple Traffic Light/Guideline Daily Amounts, the Nutri-Score system, and nutrient-specific warning labels.

Therefore, the study aims to to evaluate and compare the effectiveness of front-of-pack labeling systems to reduce the intent to purchase unhealthy foods among adults in Ethiopia. The study will recruit approximately 1200 adults using a street-intercept methodology. Participants will be randomized to 1 of 4 arms to complete a survey in which the presence and type of front-of-pack label differs across survey arms and asked to rate participants' intent to purchase unhealthy packaged foods.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Purchase foods outside of the household

Exclusion Criteria:

* Age \<18 years
* Do not purchase foods outside of the household
* Unable to complete the survey protocol
Hawthorn Extract Randomized Blinded Chronic Heart Failure (HERB CHF) Trial

To determine the effect of hawthorn extract 450 mg bid vs. placebo, in addition to standard medical therapy in ambulatory patients with NYHA class II to IV chronic heart failure on submaximal exercise as measured by the 6-minute walk test

See Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory individuals 18 years and older who had been diagnosed with CHF (NYHA functional classes II-IV) for \> 3 months
* Left ventricular ejection fraction (LVEF) of ≤ 40 percent
* Receiving indicated standard therapy (if not contraindicated or intolerant for \> 3 months) defined as a diuretic, an ACE-inhibitor or an angiotensin receptor blocker (ARB) and a beta-blocke
* Patients with NYHA class III or IV symptoms were also required to receive spironolactone. Doses of these drugs had to be stable for ≥ 3 months, except for diuretics, for which ≥ 1 month of stability was required.

Exclusion Criteria:

* Hemodynamically severe uncorrected primary valvular disease
* Active myocarditis
* Hypertrophic cardiomyopathy
* Restrictive cardiomyopathy
* Myocardial infarction, stroke, unstable angina, coronary artery bypass graft surgery, valvular surgery, or angioplasty \< 3 months before randomization
* Symptomatic or sustained ventricular tachycardia not controlled by antiarrhythmic drugs or an implantable cardioverter-defibrillator
* Any condition other than heart failure that would be expected to limit exercise (e.g., angina, peripheral vascular disease, pulmonary disease, arthritis, or an orthopedic problem severe enough to limit exercise)
* Nursing mothers, pregnant women and those planning a pregnancy during the study period
Deprescribing for Older Adults After Hospital Discharge in Home Health Care

The purpose of this study is to examine the feasibility of providing a medication optimization program to improve patient health outcomes during the transition from hospital to home. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations.


Eligibility Criteria:
Patient Inclusion Criteria:

* 65 years of age and older
* currently hospitalized or having been hospitalized in the previous 2 weeks
* having a discharge disposition of home with a referral to receive HHC services from URMHC, or currently receiving HHC services from URMHC
* taking more than 10 regular medications daily
* having a primary care provider who is in the URMC system
* Ability to self-consent
* English-speaking

Patient Exclusion Criteria:

* end-of-life prognosis in the following 6 months
* currently receiving hospice care, end-of-life care, or palliative care
* conditions that impact the receipt of the intervention, such as severe cognitive impairment that interferes with the subject's ability to communicate with interventionists;
* substantial difficulties in hearing, vision, and verbal expression that disable the participant from communicating effectively while receiving the HomeMed intervention
Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.

Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic patients. The aim of this study is to examine glucose metabolic outcome in acromegalic patients with and without histologically verified prolactin and growth hormone (GH) co-secreting adenomas. The study population include 79 patients who have all undergone surgical treatment for acromegaly.

Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic patients. The aim of this study is to examine glucose metabolic outcome in acromegalic patients with and without histologically verified prolactin and growth hormone (GH) co-secreting adenomas. 79 patients who have all undergone surgical treatment for acromegaly are included. Clinical and biochemical baseline data are collected from medical records. Patients are divided into two groups based on histopathological evaluation of pituitary adenomas;

1. pure GH secreting adenomas or
2. GH and prolactin co-secreting adenomas.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acromegaly, and treated at the department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Denmark (tertiary referral hospital), surgical treatment of acromegaly

Exclusion Criteria:

* no surgical treatment performed
Effect of Topical Trimebutine on Pain After Hemorrhoidectomy

Trimebutine acts through smooth muscle relaxation. It is presumed that the topical application of trimebutine after hemorrhoidectomy may help relieve pain after the procedure by relaxing the internal anal sphincter spasm.

A randomized trial will be carried out to investigate the effect of trimebutine on pain after Milligan-Morgan hemorrhoidectomy. Trimebutine relaxes the internal anal sphincter spasm which usually occurs after excisional hemorrhoidectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders aging between 18-70 years with grade III/VI internal hemorrhoids will be included

Exclusion Criteria:

* Patients with grade I/II internal hemorrhoids or external hemorrhoids.
* Patients with associated anorectal pathology such as anal fissure, anal fistula, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases.\\
* Patients with recurrent hemorrhoids after previous surgery.
Efficacy and Safety of Glucosanol in Maintaining Body Weight

To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
* Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
* BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
* Expressed desire for weight maintenance
* Accustomed to 3 main meals per day
* Commitment to avoid the use of other weight loss products during study
* Females' agreement to use appropriate birth control methods during the active study period
* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

* Known sensitivity to the ingredients of the device (Phaseolus vulgaris or members of the Fabaceae family)
* History of diabetes mellitus • Fasting blood glucose more than 7 mmol/L
* History or clinical signs of endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
* Clinically relevant excursions of safety parameter
* Current use of anti-depressants
* Presence of acute or chronic gastrointestinal disease (e.g. IBD, coeliac disease, pancreatitis)
* Uncontrolled hypertension (more than 160/110 mm Hg)
* Stenosis in the GI tract
* Bariatric surgery
* Abdominal surgery within the last 6 months prior to enrollment
* History of eating disorders like bulimia, anorexia nervosa within the past 12 months
* Other serious organ or systemic diseases such as cancer
* Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals
* Pregnancy or nursing
* Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
* More than 3 hours strenuous sport activity per week
* History of abuse of drugs, alcohol or medication
* Smoking cessation within 6 months prior to enrolment
* Inability to comply due to language difficulties
* Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
Metabonomics Fingerprinting of Multiple Trauma

The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics methodology and advanced mathematics tools.

Metabonomics is a set of measurements of the dynamic metabolic responses of living systems to stimuli or modifications. This field of study developed from the application of nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry as tools for the study of complex biofluids. Metabonomics is one of the emerging fields of systemic biology researches concerned with the high-throughput identification, quantification and characterization of small molecule metabolites. A metabonomics fingerprinting can be defined as the complete complement of all small molecule (\<1500 Da) metabolites found in a specific cell, body fluid, organ or organism.

Severe poly trauma involves complex injuries that consist of multiple pathological mechanisms involving cytotoxic, oxidation stress and immune-endocrine. The complexity of the pathological physiology and biochemistry process are determined not only by the initial mechanical assault, but also by secondary processes including abnormality of inflammation regulation, ischemia, anoxia, free-radical formation, and immune dysfunction that occur over hours and days following the injury. For the clinical perspective, one of the key difficulties is to identify the most at-risk patients who could develop multiple organ failures and consequently death.

This study aims to establish the dynamics of NMR-based metabonomics fingerprinting of severe multi-trauma patients in order to provide a possible multiple organs failure (MOF) or death event prediction.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-50 years
* Poly trauma
* Injury Severity Score (ISS)\>16 and Acute Physiology And Chronic Health Evaluation(APACHE)II\>10

Exclusion Criteria:

* With comorbidity (Diabetes,Hyperthyroidism or primary organ dysfunction )
* Pregnancy
Panobinostat With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes. Panobinostat has shown effects against cancer in laboratory studies. However, it is not known if it will show the same activity in humans. Panobinostat has been given to participants with various types of cancers, including DLBCL, in previous research studies. In this study panobinostat will be given with the the antibody rituximab, which is FDA approved to be given with chemotherapy in DLBCL.

Study treatment will be given in 4 week periods called cycles. Panobinostat will be taken orally on Monday, Wednesday, and Friday of each week. Rituximab will be given as an intravenous infusion weekly during Cycle 1 and then once per month on day 1 of subsequent cycles. Subjects can receive up to 6 cycles of treatment. Blood draws and 2 EKGs (electrocardiograms) will be done weekly in Cycle 1 and then once in each cycle. PET/CT (Positron Emission Tomography/Computed Tomography) scans will be done every 2 months.

If disease has not progressed after 6 cycles on combination of panobinostat and rituximab, subjects may continue on panobinostat alone for up to 6 additional months.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory DLBCL
* More than 1 line of prior chemotherapy

Exclusion Criteria:

* Currently receiving anticancer therapy or investigational agents
* Major surgery within last 4 weeks
* Known leptomeningeal or brain metastases
* Known HIV infection
* Uncontrolled fungal, bacterial, viral or other infection
* History of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 3 years
* Hepatitis B or C positive
* GI disease
* Pregnant or breastfeeding
* Prior treatment with an HDAC inhibitor including valproic acid
The Role of Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis

The aim of this study is to evaluate the efficacy and safety of rheolytic thrombectomy in restoring venous patency DVT, periprocedural complications and development of PTS after tratment of iliofemoral DVT.

Deep venous thrombosis (DVT) is a common disease affecting approximately 0.1% of the world population.1 The incidence of DVT steadily increases as the patient gets older. One-third of patients with DVT may develop pulmonary embolism (PE)2. DVT can significantly influence the quality of life of patients, and it represents an important clinical and economic disease burden on health-care systems.

Over the years, different options for DVT treatment have been introduced to restore patency, save valve function, and reduce the occurrence of post-thrombotic syndrome (PTS).

The conventional treatment of acute DVT aims to prevent thrombus propagation and to reduce the risks of PE and DVT recurrence5. However, this treatment is ineffective at reducing thrombus burden and consequently does not prevent PTS. Recent advances in catheter-based interventions have led to the development of a variety of minimally invasive endovascular strategies to remove venous thrombus.

Lower-extremity DVT, especially proximal or iliofemoral DVT, has been demonstrated to confer the greatest risk for complications such as pulmonary embolism, thrombosis recurrence, and post- thrombotic syndrome. Most practice guidelines recommend early clot removal for patients with iliofemoral DVT who have symptoms less than 14 days in duration, good functional ability, and acceptable life expectancy and who are at low risk for bleeding complications.

Removal of clot can be achieved by using catheter-directed thrombolysis (CDT) or pharmacomechanical.Use of CDT is limited because of the lengthy procedure/hospitalization time and intensive care unit (ICU) stays required for the procedure11. pharmacomechanical was developed to address the limitations of CDT by combining catheter-based and mechanical technology to fragment and/or aspirate thrombus in addition to delivering a thrombolytic drug throughout the thrombus.

Percutaneous rheolytic thrombectomy (RT) technique is highly effective at clearing thrombus, which preserves venous valve function and prevents subsequent PTS. The use of RT to treat DVT may reduce long-term morbidity in DVT patients by restoring the patency of the veins and preventing pulmonary embolism.

Eligibility Criteria:
Inclusion Criteria:

Acute IF DVT

life expectancy more than 1 year

Exclusion Criteria:

* Recurrence of DVT Chronic DVT The catheter cannot be used in vessels smaller than 6mm. Patients have contraindications for endovascular procedures Patients cannot tolerate contrast media In patients with lesions that cannot be accessed with the guide wire Pregnancy History of pelvic surgery with left iliac vein injury or pelvic radioactive therapy
Urinary Concentration After Salmeterol

The purpose of the project is to investigate urine concentration after inhalation of salmeterol. This will be examined following acute physical activity under both normal conditions and heated conditions.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Age 18-40
* Physically active \>5 hours a week
* Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

* Active smoker currently or within the past 5 years
* Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
* Chronic or acute illness deemed by the responsible study physician to affect the test parameters
* Deviation from the study protocol
* Lean mass index \>21 kg/m²
* Pregnancy
* Smoker
* Blood donation during the past 3 months
Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole

To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

* Normal, healthy gastrointestinal tract (no small bowel mucosal breaks at Day 14 according to endoscopic data
* No history of GI ulcers, bleeding or surgery, or complete or partial stenosis of the small intestine
* Willing not to drink any alcohol during study period

Exclusion Criteria:

Exclusion criteria:

* Has established delayed gastric emptying or diabetic gastroparesis
* Has active gastroesophageal reflux disease or requires anti-ulcer medications
* Has taken aspirin or nonsteroidal antinflammatory drugs (ibuprofen, naproxen) more than 3 times per week within 2 weeks prior to the screening visit; aspirin for cardiovascular prophylaxis is restricted
Analgesic Efficacy of Intravenous Hyoscine-N-Butylbromide (HNB) in Abdominal Colic Associated With Acute Gastroenteritis

This study aims to assess the analgesic efficacy and safety of intravenous 20 mg Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with acute gastroenteritis in the emergency department.

Acute gastroenteritis is a frequent cause of emergency department (ED) presentation. Mainstays of ED treatment are rehydration and antiemetics when needed. Since crampy abdominal pain accompanies (diarrhea) acute gastroenteritis in 67-90% of patients, emergency physicians may have to deal with spasmodic colics in these patients.

Hyoscine-N-butylbromide (HNB), is an anticholinergic agent which has been in use as an antispasmodic agent for sixty years all over the world. It has been studied and revealed various efficacy for several conditions (e.g; biliary colic, renal colic, endoscopic interventions, radiologic interventions, during labor, nonspecific abdominal pain and irritable bowel syndrome).

HNB is commonly used for symptomatic relief of abdominal cramps associated with acute gastroenteritis in the EDs, whereas the literature lacks evidence regarding its efficacy and safety for this condition.

The aim of this study is to assess the analgesic efficacy and safety of intravenous 20 mg hyoscine-n-butylbromide versus placebo in patients with abdominal colic associated with acute gastroenteritis in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Presenting to the emergency department with abdominal cramps associated with acute gastroenteritis
* The pain intensity score upon screening is at least 20 mm on visual analog scale
* Patients who agree to participate and sign the informed consent

Exclusion Criteria:

* Patients younger than 18 years
* Pain of \> 7 days
* Use of any analgesic within 6 hours of ED presentation
* Concomitant medication with spasmolytics, anticholinergics, drugs affecting gastrointestinal motility such as metoclopramide, loperamide, opioid analgesics
* Patients who were administered dopamine antagonists before screening
* Documented or self-reported hypersensitivity to hyoscine-n-butylbromide
* Confirmed or suspected pregnancy
* Breastfeeding
* Glaucoma
* Myasthenia gravis
* Benign prostatic hyperplasia or urinary obstruction
* Any suspected other cause of acute abdominal pain
* Peritonism
* Mechanical stenosis of the gastrointestinal tract, paralytic ileus, megacolon
* Previous intestinal resection
* History of inflammatory bowel disease
* Tachyarrhythmia
* Severe dehydration requiring fluid resuscitation immediately
* Unable to consent
* Refused to participate