cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy

To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 9 years to 16 years, inclusive, being scheduled to undergo elective colonoscopy
* Subjects must have had 3 or more spontaneous bowel movements per week for 1 month prior to the colonoscopy
* Female subjects of childbearing potential must undergo a pregnancy test at screening and again at randomization

Exclusion Criteria:

* Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
* Hospitalized for inflammatory bowel disease
* Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic surgical procedures
* Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo obstruction, hypomotility syndrome, colon resection)
* Ascites
* Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
* Upper gastrointestinal surgery (gastric resection, gastric banding, gastric bypass)
* Significant cardiovascular disease as determined by the investigator
* If subject has a history of renal insufficiency, serum creatinine and potassium must be within normal limits
* Any clinically significant laboratory value at screening, including pre- existing electrolyte abnormality, based on clinical history
* Hypersensitivity to active ingredients
Snuff-box Deep Palmar Arch Artery Versus Radial Angiography

Angiography is a common diagnostic and therapeutic procedure in patients with acute coronary syndrome (ACS). The complications are variable between mild self-limited complications to severe life-threatening complications which need early interventions.

New angiographic methods are associated with variable complications. Death, myocardial infarction, and stroke are among major angiography complications. In addition, some local complications including bleeding at the site of insertion, infection, arteriovenous fistula, pseudoaneurysm, and thrombosis is reported after angiography.

Radial and femoral methods are common angiographic methods. Its shown that radial method is associated with less complications and patients need shorter duration of hospitalization.

Radial artery thrombosis is common complication of radial angiography. However, the prevalence is between 5 to 19 percent but often it is not clinically important. Risk of ischemia due to thrombosis is low because of blood flow in radial and ulnar and collaterals. In patients with incomplete palmar arch this is important and may cause ischemia.

The aim of this study is to compare the outcomes of coronary angiography using Snuff-box deep palmar arch artery and radial artery in patients attending angiography center of Shahid Mohammadi hospital in Bandar Abbas in 2017.


Eligibility Criteria:
Inclusion Criteria:

* indication of coronary artery angiography confirmed by a cardiologist
* Accepting to sign the written informed consent

Exclusion Criteria:

* No follow up visit after one-month period
Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group.

Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.


Eligibility Criteria:
Inclusion Criteria:

* evidence of asphyxiation, defined by 5-minute Apgar score ≤ 5;
* evidence of HIE, defined by UCB pH \<7.15 or base excess ≤ 10mM;
* subjects with HIE confirmed by clinical features and initial investigations;
* subjects with evidence of anemia, defined by hematocrit \< 40% or hemoglobin ≤ 13g/dL within the first 96 hours of life;
* obtain the informed consent from parents

Exclusion Criteria:

* congestive cardiac failure;
* microcephaly, anencephaly, encephalocele, or other abnormality
* conjoint twins;
* chromosomal disorders
* fetal alcohol syndrome
* spinal bifida or other neural tube defects
* subjects have other neurological deficit conditions
* polycythemia
* congenital hematological malignancy
* investigator decision
PROTeIn-rich Meals to Control Glucose

The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.

Overweight individual with prediabetes and non-insulin treated type 2 diabetes will be recruited for the study. The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake - a high-protein (HP) breakfast and a high-carb (HC) dinner (HP/HC intervention) vs. a HC breakfast and a HP dinner (HC/HP intervention) - divided by a 4-week wash-out phase. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10E%protein, 60%E carbs, and 30%E fat.

Eligibility Criteria:
Inclusion Criteria:

* Prediabetes (fasting blood sugar 100-125 mg/dl)
* Diabetes type 2 (fasting blood sugar \&gt;126 mg/dl)
* Overweight and obesity (BMI 25-50 kg/m2)

Exclusion Criteria:

* Other diabetes types
* Insulin treatment
* Shift work
* Weight changes \&gt;5% within past 3 months
* Systemic glucocorticoid therapy
* Systemic infections
* Severe anemia
* High blood pressure (\&gt;180/110 mmHg)
* Endocrinologic, liver and heart disorders
* Immune diseases
* Thyroid dysfunction
* Heart attack or stroke
* Cancer in the last 2 years
* Eating disorders, food intolerance/allergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases
* Hereditary or acquired coagulation disorders
* Non-interruptible intake of blood thinners (anticoagulants)
* Specific diets, intermittent fasting
* Pregnancy or breastfeeding
* Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.


Eligibility Criteria:
Inclusion Criteria:

* All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study.
* Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold).

Exclusion Criteria:

* Emergent patients
* Patients with proven diverticular abscess and colonic fistulas are excluded
* Patients with planned open surgery are excluded.
Digital Obturators in Maxillectomy Cases

Using Digital approach to treat patients with maxillofacial defects without surgical intervention

Evaluating digital dental and maxillofacial obturators to artifitially close maxillofacial defects in paients with oral cancer and patients with mucormycosis fungal post covid infection.

Craeting Digitized database for all patients included in the study.

Recording casses with post covid infection in specific period.

Eligibility Criteria:
Inclusion Criteria:

-

All participants in this study will be selected according to the following criteria:

* Patients with maxillary defects Class I and class II Aramany Classification with completely healed tissues.
* Patients' age ranging from 20 to 70 years old.
* Nearly intact mandibular arch.

Exclusion Criteria:

-

Participants with the following criteria will be excluded from the study:

* Physical or mental instability.
* Completely edentulous patients.
* Patients presenting allergy to materials being used.
* Patients lacking compliance to maintain acceptable oral hygiene.
* Patients taking radiotherapy
A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar

The study will provide safety and efficacy information among patients receiving daclatasvir. It will describe daclatasvir prescribing patterns and provide a clinical profile of patients receiving the treatment in KSA, UAE, and Qatar.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients greater than or equal to 18 years of age
* Diagnosed with chronic hepatitis C
* Ended treatment with daclatasvir-containing regimen no later than 01-Oct-2015

Exclusion Criteria:

* Use of a daclatasvir-containing regimen in a clinical trial setting

Other protocol defined inclusion/exclusion criteria could apply
Study on the Risk of Allergy-like Reactions After Intra-arterial or Intra-venous Injection of the Marketed X-ray Contrast Medium Iopromid

Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients. It is known that Iopromide may cause allergy-like reactions after being injected. With this study researchers want to find out, if the risk of severe allergy-like reactions is lower, when Iopromide will be injected into an artery, compared to the risk after an injection of Iopromid into a vein. To find this out data from four trials on Iopromide that are already completed will be combined and newly analyzed. The database used for this analysis will contain data from more than 150,000 patients.


Eligibility Criteria:
The study population consists of patients who received a contrast enhanced x-ray examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.
Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals

The aim of this study is to evaluate and optimize entry criteria for the proposed programme for early detection of lung cancer in the Czech Republic.

An estimated 3200 high-risk (age 55-74 years, \>30 pack-years) asymptomatic individuals will undergo baseline low-dose chest CT (LDCT) and a follow-up LDCT at 1 year. Patients with poor performance status (PS) 2-4, history of malignancy in the past 10 years, chest CT in the past 1 year, bodyweight \>140kg will not be included.

The patients will fill out a questionnaire with basic data, including smoking history (pack-years), history of previous malignancy, CT imaging of the thorax, and will undergo spirometry.

Outcomes of the study include:

* optimization of entry criteria, optimization of timing of a follow-up LDCT and management of the patients, proposal of quality assurance indicators
* influence of screening on the stage of lung cancer at the time of the diagnosis and life-years lost
* cost-effectiveness of the screening program
* evaluation of the diagnostic yield for secondary findings (pulmonary fibrosis, cardiovascular risk)


Eligibility Criteria:
Inclusion Criteria:

* Age 55-74 years
* Smoking: \>= 30 pack-years, smoker or ex-smoker \<15 years
* Performance status (0-1) - can climb at least one floor without any difficulty or pause

Exclusion Criteria:

* Body weight above 140 kg
* Malignant disease within the last 10 years (except non-melanoma skin cancer).
* Chest CT less than one year ago
* Clinical signs suspicious of lung cancer (weight loss, new cough, hemoptysis)
Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects

The purpose of this study is to evaluate the Pharmacokinetics (PK) and safety and tolerability of etanercept, 25 and 50 mg, administered as a single dose to healthy male Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy male Chinese subjects, ages 18 to 45. BMI in the range of 18 to 30 kg/m2 and weight greater than or equal to 50 kg.

Exclusion Criteria:

Active tuberculosis (TB) or history of TB. Serious infection (associated with hospitalization and/or antibiotics) within 1 month before study drug administration.

History of protein drug hypersensitivity.
The Effect of Metformin Treatment on Thyroid Hormone Metabolism in Euthyroid Patients With Type 2 Diabetes Mellitus

Aim: To investigate the effects of metformin treatment on thyroid hormone metabolism in euthyroid patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* The patients included in this study were the ones who were newly diagnosed with type 2 diabetes mellitus

Exclusion Criteria:

* Presence of thyroid disorders, positive thyroid autoantibodies and usage of medications affecting thyroid hormones such as amiodarone, lithium were accepted as exclusion criterions
Incidence of Hypoglycaemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring

Certain groups of patients with Type 2 Diabetes Mellitus (T2DM) appear to have higher risk of hypoglycaemia. Periodic use of Continuous Glucose Monitoring (CGM), has been suggested as a method to detect hypoglycaemia events in certain subgroups of patients with high risk of hypoglycaemia.

The aim of the present study is to contribute to the identification of subgroups of T2DM patients with high risk of hypoglycemia events, based on periodic use of Continuous Glucose Monitoring (CGM).

Some studies successfully achieved standard glycemic targets without increased hypoglycaemia in older adults and other groups of patients with high risk of hypoglycaemia events.

However these trials usually exclude adults with poor health and comorbidities, when they support the concept that intensive strategies for selected individuals can be effective and safe. The compendium of results from these and other published analyses suggests that although some patients may benefit from tighter targets, many are unable to reach these targets, and aggressive therapy may be harmful to some patients without the benefit of reducing complications.

Although avoidance of hypoglycaemia is a critical treatment strategy, overall glucose control remains an important goal. The present treatment guidelines fail to locate the proper subgroup of patients with Type 2 Diabetes Mellitus (T2DM), that could be benefited of glycemic control balanced with the adverse effects of glucose-lowering medications and a patient's age, overall health status, and functional and intellectual capacity. The aim of the present study is to contribute to the identification of subgroups of T2DM patients with high risk of hypoglycemia events, based on periodic use of Continuous Glucose Monitoring (CGM).

Eligibility Criteria:
Inclusion Criteria:

* being older than 40 years of age
* having type 2 diabetes for at least 1 year
* being on insulin therapy for at least 3 months before recruitment
* having the ability to perform self-monitoring
* being able to wear a CGM system during 2 weeks
* having a stable metabolic situation, defined as having no need to add new treatments or make any changes in insulin dosage of more than 10% in the preceding 2 months

Exclusion Criteria:

* Having severe hearing or vision problems or any other acute or chronic condition that would limit the ability of the user to participate in the study
* Being institutionalised or person not capable of giving consent
* Pregnancy
Implementing Advance Care Planning Conversation Tools in Family Practice

This study evaluates the use of advance care planning conversation tools with patients attending their family doctor's office. Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions.

Structured tools are helpful for advance care planning. Tools have been developed to help with advance care planning because it is a process which has multiple steps and people involved. This study will help health care teams in primary care learn to use the tools with frail or older seriously ill patients and will evaluate the perceptions of patients, family members and health care providers, as well as the impact of having the discussions on subsequent health care interactions the patient has.

Patients complete tools about their values and wishes, and a health care provider uses a structured discussion tool to talk about the patient's health condition and future wishes. The patient's family member/substitute decision-maker is encouraged to attend and be part of the discussions.

Eligibility Criteria:
Inclusion Criteria:

* age 60 or older
* chronic condition that may reduce life expectancy as per physician's clinical judgement
* able to communicate verbally in English and read English

Exclusion Criteria:

* unable to communicate verbally in English
* unable to read English
* cognitively unable to give informed consent (e.g. memory problems) as judged by referring physician or research assistant
Skin Sensitization Test (Modified Draize-95 Test)

Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for a Blue Non Sterile Powder Free Nitrile Examination Gloves. To evaluate whether residual chemical additives at a level that may induce type IV allergy in the unsensitized general user population are present in a finished rubber containing medical device.

1. To evaluate whether residual chemical additives at a level that may induce Type IV allergy in the unsensitized general user population are present in a finished rubber containing medical device.
2. To meet requirements for claim: This product demonstrated reduced potential for sensitizing users to chemical additives as described in Guidance for Industry and FDA Staff - Medical Glove Guidance Manual9. Supporting Test Data: A negative skin sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be aged 18 and 65 years, inclusive;
* Subjects who have not participated in other voluntary testing for at least 30 days;
* Subjects must be capable of understanding and following directions.
* Female subjects must produce a negative urine pregnancy test prior to the initiation and also at the completion of the tiral.

Exclusion Criteria:

* Subjects who are in ill health;
* Subjects who are taking medication, other than birth control, which could influence the purpose, integrity or outcome of the tiral;
* Subjects who have used topical or systemic corticosteriods, anti-inflammatories, antihistamines or antibiotics within 2 weeks prior to trial initiationor during their participation on this tiral;
* Femable subjects who are pregnant as evidenced by a urine pregnancy test, planning to become pregnant or lactaticn during the tiral;
* Subjects who have a history of adverse reactions to cosmetics, OTC drugs, or other personal care products;
* Subjects who introduce the use of any new cosmetic, toiletry or personal care products during the trial;
* Subjects with any visible skin disease that might be confuesd with skin reactions caused by the test material;
* Subjects with any knowledge or indication of existing Type IV allergy (delayed hypersensitivity) to natural rubber chemical additives;
* Subjects with a history of frequent irritation; or
* Subjects who have received endogenious or exogenious immunosuppressive treatment (r prolonged exposure to sun).
Chronic Pain After Thoracotomy, an Incidence Study

This is an investigation on the frequency of chronic pain after thoracotomy for lung cancer. Factors relating to the development of chronic pain are investigated. Questionnaire survey.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and give consent
* Can read
* Residing in Denmark

Exclusion Criteria:

* Unable to understand the written information in Danish
* Abuse (Medicine, Drugs, Alcohol)
* Severe psychiatric Illness
* Conflicting neurological disease
Domperidone in Refractory Gastroparesis

The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 and older
* Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
* Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
* Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

  * Increased prolactin levels
  * Breast changes
  * Extrapyramidal side effects
  * Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

Exclusion Criteria:

* History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
* Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc\>450 milliseconds for males, QTc\>470 milliseconds for females)
* Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
* Gastrointestinal hemorrhage or obstruction.
* Presence of a prolactinoma (prolactin-releasing pituitary tumor).
* Pregnant or breast feedings female.
* Known allergy to domperidone
Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy

Bell's palsy, also called idiopathic facial paralysis, is a common cause of unilateral facial paralysis. It is one of the most common neurological disorders of the cranial nerves.

Bell's palsy is an alarming condition of rapid onset, which paralyzes half of the facial muscles. Kabat rehabilitation is a manual resistance technique that promotes a basic pattern of movement through facilitation, inhibition, and resistance of a group of muscles. It increases the functioning and power of facial muscles while Mime therapy results in immediate improvement of function and integrity of facial muscles. It also mitigates synkinesis in Bell's palsy. Both techniques are easy to apply. They are clinically important techniques that are easily understood by patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age group 25-50 years.
2. Both male and female.
3. Unilateral bell's paralysis.
4. Not congenital in origin.
5. Sub-acute and chronic cases.

Exclusion Criteria:

1. Other neurological deficits include epilepsy and Alzheimer's disease.
2. Traumatic onset.
3. Surgical reconstruction (nerve or muscle reconstruction).
4. Mental and psychological disorders i.e., schizophrenia, bipolar disorders.
5. Skin diseases (eczema, urticarial) as electrical stimulation may affect the results.
6. Any contraindications for massage like sunburn, bruising, or cuts.