cyrilzakka/clinical-trials huggingface dataset:
Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control, obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show that Chlorogenic acid has an excellent potential for the control of glucose as well as insulin secretion and insulin sensitivity.

A randomized, double-blind, placebo-controlled clinical trial was carried out in 30 patients with a diagnosis of impaired glucose tolerance in accordance with the American Diabetes Association criteria. The patients received 400 mg capsules of Chlorogenic acid or placebo, three times daily 1/ 2 hour before meals for 90 days. Before and after intervention the investigators evaluated: 2 hours plasma glucose, glycated hemoglobin (A1C), triglycerides, high-density lipoprotein, fasting glucose and blood pressure body weight, body mass index, waist circumference, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 30.0-34.99 kg / m2.
* Diagnosis of IGT (OGTT Values between 140mg / dl and 199mg / dl.
* Written informed consent.
* Body weight stable over the last 3 months.
* Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.
* Women who are not contemplated get pregnant within the next 6 months.

Exclusion Criteria:

* Women pregnant or breastfeeding.
* Physical or mental disability that makes it impossible to perform the intervention.
* Diagnosis of Hypertension or heart failure.
* Smokers.
* Untreated thyroid disease.
* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).
* Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.
* Diagnosis of renal disease or creatinine \> 1.5 mg / dl.
* Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.
* Total Cholesterol ≥ 280 mg/dL.
* Triglycerids ≥ 300 mg/dL.
* Known allergy to calcined magnesia or Chorogenic acid.
A Study of Drug-Induced Kidney Disease

The purpose of this study is to identify incidence of Chinese herb nephropathy in a medical center

This is a retrospective study, by computer screening, chart review and phone survey to find herbal nephropathy and determine the cause-relationship.

Using ICD-9-CM code as a tool to screen the newly diagnosed ESRD in NTUH computer data base, and divided patients into those with underlying disease(s) that cause the renal failure and those without.

Eligibility Criteria:
Inclusion Criteria:

* patient who was newly diagnosed as end stage renal disease who need dialysis

Exclusion Criteria:

* started dialysis before 2000
Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE)

This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive);
* Diagnosed with atopic dermatitis;
* Suffering from chronic pruritus;
* Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

* Chronic pruritus due to condition other than atopic dermatitis (AD);
* A positive test for drugs of abuse at the screening or evaluation visits;
* Exposure to any investigational medication in the past 8 weeks
Delirium Reduction With Ramelteon

The overall purpose of this study is to identify a medication that might treat and/or prevent delirium in intensive care unit (ICU). Currently, there is no proven medical therapy for prevention or treatment of delirium. Ramelteon is a medication approved for insomnia. We hypothesize that ramelteon may help regulate the day/night cycle and decrease ICU delirium.

Melatonin is an endogenous hormone that regulates the sleep-wake cycle along with several other physiological functions. It is reported that melatonin secretion may be impaired in ICU patients, and there is some question whether this may be a contributing factor to delirium occurrence. Ramelteon is a melatonin agonist with three to six times increased affinity for MT1 and MT2 receptors versus melatonin. It is FDA approved for the treatment of insomnia, and some studies suggested some benefit with ramelteon for delirium prevention. There is limited prospective research data assessing the efficacy of ramelteon for delirium treatment. The goal of this study therefore is to assess the efficacy of ramelteon versus placebo on the prevention and treatment of delirium in ICU patients.

Eligibility Criteria:
Inclusion Criteria:

* Medical or surgical ICU patient
* Ability to take oral or nasogastric tube within 48 hours of admission to ICU
* Expected ICU length of stay and life expectancy at least 48 hours
* Patient or POA capable of signing informed consent within 48 hours of ICU admission

Exclusion Criteria:

* Past medical history includes cirrhosis
* Active alcohol withdrawal
* Patients taking fluvoxamine prior to admission
* Self-reported hypersensitivity to ramelteon
* Incarcerated patients
* Pregnant patients
* Patients with acute neurological conditions including brain abscess, head bleed, meningitis
* Patients who are transferred from an outside hospital where they have resided for greater than 4 days
* Non-English speaking patients
* Hearing-impaired patients requiring sign language for communication
* Visually-impaired patients
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa

The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).

The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.

Eligibility Criteria:
Inclusion Criteria:

* Aged 30 to 80 years, inclusive, at time of Parkinson's disease diagnosis
* Idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity
* Parkinson's disease impairment warranting treatment with a levodopa formulation according to the investigator's assessment

Exclusion Criteria:

* History, signs or symptoms suggesting the diagnosis of atypical or secondary Parkinsonism due to drugs, metabolic disorders, encephalitis or other neurodegenerative diseases
* History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, tissue transplant)
* Diagnosis of Parkinson's disease for more than 5 years prior to Screening
* Previous use of levodopa in any formulation, entacapone or tolcapone for more than 30 days or anytime within 4 weeks (28 days) prior to baseline
* Use of a dopamine agonist within 4 weeks (28 days) prior to baseline
Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).

High sugar (glucose) is common after surgery, even in patients who do not have diabetes. High glucose contributes to severe hospital complications and even death. Insulin infusions appear to reduce this risk, but are generally only continued for a few days after surgery. In this study, we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). 90 patients who have undergone recent open heart surgery and are requiring an insulin infusion will be enrolled. They will be randomly assigned to one of three doses of detemir, which consists of 50%, 65%, or 80% of the total daily insulin infusion requirement in the fasting state. Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested. It is expected that the high dose group will achieve superior glycemic control without excessive hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus
* post-cardiothoracic surgery
* requiring an insulin infusion of at least 1 unit/hour
* Age 18-75

Exclusion Criteria:

* Glucocorticoids
* total parenteral nutrition (TPN) or tube feeds
* Pregnancy
* Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected
* Expected length of stay less than 48 hours following cessation of the insulin drip
* Patients using subcutaneous insulin pumps
* Diabetic ketoacidosis
* End-stage renal disease
* End-stage liver disease
* Coma
* Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
* Unable to give consent in English
Observational Study on the Treatment of Trigeminal Neuralgia by Radiosurgery

This study aims to evaluate the outcome of patient treated by radiosurgery on LINAC with high dose rate for classical trigeminal neuralgia

This retrospective and prospective case-series hospital-based study will be conducted in all patients with trigeminal neuralgia treated by radiosurgery on LINAC at the Centre Hospitalier Princesse Grace from april 2018 to january 2028. Patients will be treated with frameless technic and receive 90 Gy delivered with high dose rate on the intra cisternal portion of the trigeminal nerve.

Eligibility Criteria:
Inclusion Criteria:

* Classical trigeminal neuralgia according the International Classification of Headache Disorders
* Trigeminal neuralgia resistant to the maximum tolerated medical therapy, with pain intensity according to the Barrow Neurological Institute (BNI) score IV or V.
* Patients aged \> 18

Exclusion Criteria:

* Patients suffering from secondary Trigeminal neuralgia (tumour in the cerebellopontine angle, arteriovenous malformation or multiple sclerosis)
* Previous history of radiosurgery procedure
The Effects of the Pilgrimage in the Way of Saint James on Mental Health and Well-being (ULTREYA)

Objectives: This study aims to evaluate the effects of pilgrimage to Santiago de Compostela on mood, satisfaction with life, happiness, ability to pay attention to the present moment and the capacity to make choices in a more conscious and values-oriented way. Other personal aspects that could be related to the effects of the Camino and that may also mediate some of its effects (e.g., personal reasons for walking, socialization along the Camino, number of days walked, physical pain associated with walking, previous pilgrimages to Santiago, etc.) will be also assessed.

Methods: This is a naturalistic study with a 3-month follow-up. Voluntary participation of pilgrims doing one of the "Way of Saint James" routes will be requested. Participants will be asked to complete an online questionnaire with sociodemographic data and outcome measures (e.g. mindfulness, satisfaction with life, depression, stress, anxiety) before starting the Camino, at the end of the Camino and 3 months later. These evaluations will help us discover the effects of the Camino de Santiago on mental health and well-being in the short- and mid-term.

For more information (and/or to participate), go to: http://estudiocamino.org/


Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 years old)
* Willing to go on pilgrimage in the Way of Saint James
* With or without previous experience in this pilgrimage
* Walking or cycling in the pilgrimage
* Finishing or not at "Santiago de Compostela"
* Ability to understand and read Spanish or English
* With internet access (via PC or smatphone)
* With signed informed consent to participate in the present study

Exclusion Criteria:

* Not walking for 4 or more days
* With incomplete baseline data
* With baseline/post assessments \>1 month previous starting/ending the pilgrimage
Clinical Experience Investigation of Symbicort Turbuhaler as Maintenance Therapy and Reliever Therapy

The purpose of the investigation is to confirm the safety of patients receiving Symbicort Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing actual use.

Symbicort Turbuhaler 30/60 Clinical Experience Investigation for treatment with Symbicort as maintenance therapy and as needed in response to symptoms

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period
Recombinant BNP on Heart and Renal Function in Acute Heart Failure

The purpose of this study is to evaluate the efficacy and safety of recombinant human B-type natriuretic peptide (rhBNP) on heart and renal function in patients with acute decompensated heart failure (ADHF) and acute renal injury (AKI).

Patients with acute decompensated heart failure (ADHF) and acute renal injury (AKI) will be randomized to receive standard of care with or without additional rhBNP.

Clinical heart function, LVEF, SCr, GFR and other laboratory parameters will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* acute heart failure with acute renal injury

Exclusion Criteria:

* not tolerate to rhBNP
Oral Fluid Volume Expansion

When subjected to fluid loss or fluid deficiency irrespective of disease or environmental factors it is discussed how to rehydrate or how to hydrate prophylactic.

In medical care it is common to give infusions. However it has increasingly become common to hydrate the patient through the mouth even early after bowel surgery. Moreover it is more simple to provide energy the natural way.

Which fluid to give, depends on several factors such as possibility to drink, the volume and emptying of the stomach as well as the fluid absorption in the bowel.

The provided fluid can also influence this process depending on temperature, osmolality/tonicity and composition (carbohydrates or salts).

In this study we wish to study the speed with which the provided fluid is absorbed by the bowels and how fast the fluid is distributed to the different body compartments depending on it's composition.

The three fluids will be either tap water, high sodium chloride and a carbohydrate rich fluid.

The healthy volunteer starts the study by voiding. Then he/she lies down for 30 minutes. A blood sample is drawn and thereafter the healthy volunteer ingests one of the three fluids. Blood samples are drawn 10 times during the following two hours. Finally the healthy volunteer is asked to void and the voided urine is measured. The hemoglobin concentrations are used to calculate the blood volume expansion with volume kinetic methods.

The process is repeated another two times with the two remaining fluids.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer
* 18 to 50 years old

Exclusion Criteria:

* medication
* any chronical disease
Spinal Morphine Provides an Effective Pain Control in Patients Undergoing Transurethral Resection of Prostate Gland

Pain after transurethral resection of prostate is considered mild to moderate severity from detrusor muscle spasm and traction from urinary catheter. Numerous pain relieve methods have been studied including spinal opioids, spinal anesthesia with local anesthetic and dexmedetomidine, periprostatic nerve blockade with bupivacaine and mixing of prilocaine with distilled water irrigation while undergoing a procedure. Most of patients having this procedure are in elderly period, thus many anesthetists avoided spinal morphine which may cause respiratory depressant effect postoperatively. Although previous studies showed effectiveness of spinal morphine 25-200 mcg, some patients suffered from neuraxial opioid side effects.

The aim of this study is to demonstrate efficacy of local anesthetic with intrathecal morphine 50 mcg providing pain relieve after transurethral resection of prostate compare to spinal anesthesia with sole local anesthetic.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* Undergoing transurethral resection of prostate gland

Exclusion Criteria:

* Contraindication for spinal anesthesia for any reasons eg. infection, bleeding disorder
* Refuse spinal anesthesia
* Allergic to study drugs
* History of cerebrovascular disease or stroke
An Investigation of the Dose-dependent Vascualr Effects of (-)-Epicatechin in Healthy Men

Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 \& 1.0 mg/kg BW) in healthy men.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index 20-27.5 kg/m2
* Normal blood pressure at screening (\< 150/90)
* Non-smoker
* Non-vegetarian
* 'Normal - low' chocolate consumer (\<2 potions per week)
* 'Normal - low' coffee/ tea drinker (\<3 cups per day)
* Regular exercise routine
* Signed consent form

Exclusion Criteria:

* Haemoglobin (anaemia marker) \< 125 g/l
* Gamma GT (liver enzymes) \> 80 IU/l
* Cholesterol \> 6.5 mmol/l
* Suffered a myocardial infarction or stroke in the last 12 months
* Suffers from any cardiovascular or metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
* Suffers from any blood-clotting disorder, and/or takes supporting medication
* Any dietary restrictions or on a weight reducing diet
* On any lipid-modifying or blood pressure lowering medication
* Consuming any specific vitamin/ herbal supplements or fish oils
Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm

The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.

This study will be run in 2 parts. The first part involves applying escalating concentrations of the new vehicle formulations containing ingenol mebutate to AKs on the forearms. Reactions and safety will be compared to Picato® (a registered and marketed ingenol mebutate gel) to ascertain if the new vehicle formulations are at least as safe and effective as Picato® . The purpose of part 2 is to select the concentration in the "new formulation" that produces this same, if not better response, as Picato® and with a similar or better safety profile.

Eligibility Criteria:
Inclusion Criteria:

* Must be male or female and at least 18 years of age.
* Female patients must be of non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception.
* Ability to provide informed consent.

Exclusion Criteria:

* location of the selected treatment area within 5cm of an incompletely healed wound or within 5cm of a suspected basal cell carcinoma or squamous cell carcinoma
* undergone Cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit
* presence of sunburn within the selected treatment areas
* use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to the treatment visit
* previous enrolment in this clinical trial
* prior treatment with ingenol mebutate on the forearms
* use of topical moisturisers/creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to the treatment visit
* treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of the treatment visit
* treatment with 5-FU, imiquimod, diclofenac,or photodynamic therapy within 2 cm of the treatment area in the 8 weeks prior to the treatment visit
* use of systemic retinoids
* those who are currently participating in any other clinical trial
* females who are pregnant or are breastfeeding
* those known or suspected or not being able to comply with the requirements of the protocol or provide consent
Validation Study of Sleep Tracking Devices

In this study, a two-part recursive convolutional neural networks model was developed, extracting features for each epoch window independently from before and after sleep onset (epoch encoder), and then trained in the context of long-term relationships in the sleep process (sequence encoder), using an approach similar to human expert classification based on information from single-channel forehead EEG and PPG (IR, Green, Red). The classification is based on guidelines from the American Academy of Sleep Medicine and calculated six parameters: total sleep duration (TST), wake (W), N1, N2, N3, and REM.

The validation study of the developed model and the device was conducted at the Sleep Disorders Centre of the Istanbul Medical Faculty using concurrent polysomnographic data from 305 male and female patients aged 18 to 65 years.


Eligibility Criteria:
Inclusion Criteria:

* Participants suffering from sleep disorders
* Participants sent to PSG test by neurologists, pulmonologists, psychiatrists, and otolaryngologists

Exclusion Criteria:

* Anyone who has been diagnosed as having a contagious skin disease
* Participants who do not have consent to have an additional device in their forehead area
* Incomplete of sleep measurement
Identification of Endometriosis and Migraine Criteria in Women With the Comorbidity of Both Conditions in Comparison With Women Who Only Suffer From Endometriosis - A Pilot Study

Patients with both, migraine and endometriosis, present the case-group, while women with endometriosis without migraine serve as controls. The primary endpoint is endometriosis stage confirmed by laparascopy compared to the control group. Further points to compare between groups are infertility, dysmenorrhea, dyschezia, dyspareunia, number of operations, family history with first-degree relatives, and age of first symptoms for both conditions and age at first operation.

Secondary endpoints to evaluate in percentages within the migraine group are migraine frequency, migraine aura/non-aura, age at migraine start, hormonal migraine, family history, treatment response, response to prophylactic agents, localization, types of aura and triggers. Other medical conditions and comorbidities like depression will be noted as well as response to Dienogest treatment.

In the questionnaire we will ask 62 Questions overall. The Questions for endometriosis are based on a questionnaire from the world endometriosis research foundation and to evaluate the severity of the migraine we will use the MIDAS (Migraine Disability Assessment) questionnaire (8).


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women aged 18-55 years, at time of operation
* Endometriosis confirmed with surgery and histologic staging (Report of the surgery available)
* For the cases migraine needs to be confirmed during the interview according to the IHS criteria.

Exclusion Criteria:

• Inability to perform the interview (insufficient knowledge of language, psychological disorder, dementia)