cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Effects of Food on the Pharmacokinetics of Fadanafil in Healthy Subjects

The purpose of this study is to evaluate the effect of high fat meal on the pharmacokinetics of single oral fadanafil tablet 100mg in healthy subjects.

Fadanafil is a selective phosphodiesterase (PDE5) inhibitor. The proposed Phase 1b trial is a single center, randomized, open-label, two-period crossover study in approximately 14 Chinese healthy adult male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects 18-45 years old, inclusive.
* Body weight ≥50kg and Body Mass Index: 19.0\~26.0 kg/m2, inclusive
* The vital signs (body temperature, systolic and diastolic blood pressure, heart rate and respiration) were in the normal range, and the normal value range of each vital sign was: (1) body temperature (underarm) 36.3 \~ 37.2 ℃; (2) 90mmHg ≤ systolic blood pressure \< 140mmHg; (3) 60mmhg ≤ diastolic blood pressure \< 90mmHg; (4) 50th / min ≤ heart rate ≤ 90th / min.
* Before the test, a comprehensive physical examination, laboratory examination and other auxiliary examinations were carried out, and the results were normal or abnormal but of no clinical significance. The ECG QTcF \< 450 ms.
* Subjects should be willing to take appropriate contraceptive measures during the period of taking the study drug and within 6 months after discontinuation to avoid pregnancy of their partners.
* Subjects understand and will comply with the study procedure, participated voluntarily and signed the informed consent.

Exclusion Criteria:

* Subjects who have a history of clinical significant drug allergy (especially those who are known or suspected to have a history of allergy to any PDE-5 inhibitor or its components) or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or severe allergic constitution.
* History of clinically significant ECG abnormality or family history of long QT syndrome (grandparents, parents, brothers and sisters).
* Subjects with severe systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular diseases or mental disorders.
* Subjects with concominant diseases that may affect drug absorption, distribution, metabolism, excretion and safety evaluation, or reduce compliance.
* The test results of human immunodeficiency virus (HIV) antibody or hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or syphilis are positive.
* Subjects who have used over-the-counter drugs, health products, Chinese herbal medicine or traditional Chinese medicine within 2 weeks before screening, or who are taking foods that affect CYP3A4, such as grapefruit or drinks containing grapefruit (except those who occasionally take paracetamol orally, but the total maximum dose cannot exceed 1g, and the drug is not allowed to take orally within 48 hours prio to first dose).
* Subjects who had used any prescription drugs (especially CYP3A4 inhibitors, nitrates, α receptor blockers, drugs potential to cause QT interval prolongation, etc.) within 4 weeks before screening.
Benzonatate Dose Tolerance Study

This is a single-center, randomized, third party blind, placebo controlled, dose escalation study of benzonatate following single dose administration. The primary oobjective is to assess the safety and tolerability of increasing oral doses of benzonatate following single dose administration in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, or clinical laboratory tests.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into this study.
GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.

Study Design:

Eligibility Criteria:
Inclusion criteria:

* EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations
* Age \>= 18 years
* No diagnostic or therapeutic measures beyond routine clinical practice are required
* Patients for whom the treating physician has decided to initiate treatment with GIOTRIF
* Written informed consent prior inclusion

Exclusion criteria:

* Contraindication for Afatinib according to the Summary of Product characteristics
* Participation in another clinical study until 30 days after end of treatment
* Prior systemic chemotherapy (Neo-/adjuvant therapy is permitted)
* Previous treatment with an EGFR-tyrosine kinase inhibitor
* Patients not willing or not able to fill in quality of life questionnaires
* Patients with missing or impaired legal capacity
* Pregnancy
Immediate Effect of Plantar Vibration on Fall Risk and Postural Stability

The aim of this study; To determine the immediate effect on fall risk and postural stability of vibration applied to the plantar region in stroke patients.

Kırıkkale University Faculty of Medicine Physical Therapy will be hospitalized in the USA clinic and volunteers will be involved in stroke rehabilitation. The patients who meet the inclusion criteria and who are excluded from the exclusion criteria will be randomized according to the order of arrival and will be divided into two groups as the vibration group and the placebo group.Patients will be taken to the placebo and vibration group respectively in order of arrival. If the next patient falls outside the inclusion criteria of the study, randomization will be applied to the next patient. The vibration group, one session in supine position will be applied to both sides of the soles of the feet under the soles of the feet for 5 minutes with a 15-100 Hz frequency CE certified vibration device. In the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.

Eligibility Criteria:
Inclusion Criteria:

* Cognitive and non-communication problems
* Volunteer to join the work
* Those with less than 150 kilos
* Spasticity according to a Modified Scale Ashworth 2 and 3 patients treated with Botox
* Patients at least 8 weeks after stroke diagnosis

Exclusion Criteria:

* People who are not stable due to vital signs
* Open wounds under the soles of the feet
* Being spastic at the level that will block the base touch
* Pathological conditions affecting lower limb sense (diabetic peripheral neuropathy, post- fracture surgery)
* 20 seconds independent standing
* Mini Mental Test score below 24
* Multiple sclerosis, Parkinson's disease, etc.
* Those with vision problems
* Patients with thoracolumbar surgery
* Patients with spinal canal stenosis
A Comparison Between The Analgesic Efficacy of Adductor Canal Block Alone and Adductor Canal With IPACK (Interspace Between Popliteal Artery and Capsule of the Knee) Block for Knee Surgeries

A comparison between The analgesic efficacy of adductor canal block alone and adductor canal with IPACK (interspace between popliteal artery and capsule of the knee) block for knee surgeries


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing knee surgery i.e. arthroscopy, total knee replacement, ACL repair.
* ASA physical status I to III
* Sex (males and females)
* Age 21-70 years.

Exclusion Criteria:

* Hypersensitivity to local anesthetics. Preexisting peripheral neuropathy. Infection near site of infections e.g. osteomyelitis, septic knee joint. Etc. Patient refusal. PAny contraindications for spinal anesthesia. ( eg: coagulopathy, use of anticoagulants
Traumatic Optic Neuropathy Treatment Trial 2

After introducing intravenous erythropoietin (EPO) as an option for treatment of patients with indirect traumatic optic neuropathy in 2011 and publishing non inferiority trial in Oct.2017), TONTT2 is aiming to find out the best dose and timing of EPO administration in this group of patients.

Patients with TON will be visited. After being eligible to enter the study and obtaining informed consent, they will be randomly assigned into 3 groups of different total dose of intravenous administration of EPO to which patients and outcome assessors will be masked. They will be assessed at different follow up time periods with the last follow up of at least 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Having indirect traumatic optic neuropathy(with normal eye and fundus exam)
2. Trauma to treatment interval of 3 weeks and less
3. Age of 7 years and more

Exclusion Criteria:

1. Direct optic neuropathy,
2. Glaucoma,
3. Any retinopathy
4. Globe laceration
5. Age under 7
6. Hypertension,
7. Polycythemia,
8. Creatinin more than 3 mg/dl,
9. Sensitivity to EPO
10. Patients who have received any other form of treatment for their traumatic optic neuropathy
Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section

Chronic post-surgical pain is a problem that has historically been underestimated. Over the last few years there has been a search for strategies to both predict and prevent its occurrence in patients undergoing surgery. The Gendolcat index is the only predictive model that uses only objective pre-surgical variables to assess the risk of suffering chronic post-surgical pain. However, it is only validated for the following surgeries: thoracotomy, hysterectomy and open inguinal hernia. Our aim is to test whether the Gendolcat model is also valid for cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent elective caesarean section.
* Patients who have previously signed the informed consent form.

Exclusion Criteria

* Urgent cesarean section.
* Patients with severe psychiatric pathology.
* Patients who require a different surgical approach than usual.
* Patients who refuse to take part in the study and/or to sign the informed consent form.

informed consent.

- Patients with a high language barrier.
The DefiPace Study

Prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery.

The DefiPace registry is designed in two phases

1. to document the standard of care in 50 patients with atrial fibrillation (AF)
2. to assess the treatment and outcomes of patients with post-operative atrial fibrilllation using low-energy cardioversion and subsequent bi-atrial pacing in clinical practice in 100 patients

Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery)

* Data regarding standard of care post-operative pacing and treatment of POAF, if applicable, will be collected from time of surgery until discharge
* No use of an external bi-atrial pacing device
* No use of Defipace
* In-hospital data will be collected for all patients
* Patients that developed POAF (n=50) will be followed-up with a phone call 30 days after surgery.

Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation

* In-hospital data will be collected for all patients
* Use of the DefiPace system for the treatment (low-energy cardioversion) and post-operative prevention (bi-atrial pacing) of POAF will be documented (n=100). These patients will be followed-up with a phone call 30 days after surgery

Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled to undergo elective open chest cardiac surgery (bypass and / or valve surgery)
* Patient is at least 18 years old
* Patient with isolated bypass surgery is at least 70 years old
* Patient with valve surgery is at least 60 years old
* Patient provides written informed consent prior to the procedure
* Phase B only: patient is scheduled for TMA implantation during the elective cardiac surgery and is potentially eligible for DefiPace use

Exclusion Criteria:

* Clinical history of either permanent, persistend or paroxysmal atrial fibrillation
* Permanent pacemaker/defibrillator, other intra-cardiac active implanted electronic devices
* Minimally-invasive surgery
* Recent stroke within the last 3 months
* A history of or current endocarditis
* Pregnacy at the time of surgery
Investigation of the Acute Effect of Novel Olive Oil on Postprandial Oxidative Stress Biomarkers (BioliveCT)

The purpose of this study was the investigation of the hypothesis that the enhancement of a refined olive oil with orange peel extract, may improve the postprandial lipidemic, glycemic profile and blood oxidative status, of volunteers with high cardiometabolic risk, due to increased content of bioactive compounds (polyphenols, carotenoids etc.).

In a randomized, acute, single-blinded and cross-over study, participated 21 volunteers with high cardiometabolic risk, aged 30-65, were randomized and divided into two groups. The first group consumed a meal of mashed potatoes with added refined olive oil, rich in fat and carbohydrates (300g, control meal), while the second group consumed mashed potatoes with added olive oil, enhanced with 10% w/w orange peel extract (functional meal). After a one-week washout period, the volunteers were crossed over and consumed the meals in reverse. Blood samples were withdrawn in a fasting state, 30, 90 and 180 min after meal consumption. Plasma Total Antioxidant Capacity (FRAP), serum lipid levels \[Total, High-Density Lipoprotein (HDL-) and Low-Density Lipoprotein (LDL-) cholesterol and triglycerides\], glucose and uric acid were determined at each time point using a biochemical analyzer (Roche Cobas c111).

Eligibility Criteria:
Inclusion Criteria:

* Age from 30 to 65 years
* Completion of at least 3 of the following parameters:

  * Hypertension (Systolic pressure ≥ 140mm Hydrargyrum or diastolic pressure ≥ 90mm Hydrargyrum or taking antihypertensive treatment)
  * High levels of LDL-cholesterol (≥130mg/dL)
  * High serum triglycerides (≥150mg/dL)
  * Waist circumference \>102cm for men and \>98cm for women
  * Family history (Myocardial infarction or sudden death in a 1st degree relative \<55 years old)
  * High fasting glucose (100-125 mg/dL)

Exclusion Criteria:

* Diabetes or antidiabetic treatment
* Age \<45 and \>65 years
* Malignancies
* Liver disease
A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures

This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal \[GI\], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.

The primary objective of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 Curved Jaw and Generator G11 devices when used per the instructions for use.

Eligibility Criteria:
Inclusion Criteria:

1. Primary laparoscopic or open procedure (upper gastrointestinal, lower gastrointestinal, or gynecological) where at least one vessel is planned to be transected by the ENSEAL X1 Curved Jaw device per the instructions for use;
2. Willingness to give consent and comply with all study-related evaluations and visit schedule; and
3. At least 18 years of age.

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation; or
2. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
Oral Versus Parental Progesterone in the Management of Preterm Labor

Preterm birth, defined as delivery at less than 37 weeks gestation, complicates approximately 12% of pregnancies in the United States

Preterm delivery has been, and remains, the most important challenge to modern obstetrics. In 2009, 13 million babies were born preterm, 11 million in Africa and Asia and 500,000 in the USA, The highest rates of preterm birth are in Africa (11.9%) and North America (10.6%)


Eligibility Criteria:
Inclusion Criteria:

1. Past history of one or more spontaneous preterm labor.
2. Singleton pregnancy.
3. Pregnancy of less than 20 weeks of gestation

Exclusion Criteria:

1. Women on tocolytic drugs .
2. Underwent cervical cerclage in this pregnancy .
3. Multiple gestations .
4. Major fetal congenital malformations .
5. Pregnancy 0f more than 20 weeks gestation .
Coffee Against Obstipation in Intensive Care Treatment

Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit (ICU) patients.

Critically ill patients requiring ventilator support frequently suffer from obstipation. We hypothesize that coffee, administered either orally or rectally, might stimulate bowel movement.

Eligibility Criteria:
Inclusion Criteria:

* admission to the medical intensive care unit of the Dept. of Gastroenterology at the university hospital heidelberg
* requires ventilator support for an anticipated more than 72 hours
* age older than 18 years

Exclusion Criteria:

* pregnancy
* known allergy to coffee
* mechanical ileus
* presence of enterostoma
The Impact of Dosimeter on Measurement of Airway Responsiveness to Methacholine

To determine whether there is a difference in two different breathing tests used to detect asthma. Hypothesis: The Digidoser delivers less methacholine to the airways and will result in a higher PC20 than the value determined by the Rosenthal Dosimeter.

Bronchoprovocation with methacholine is used to confirm the diagnosis of asthma. The procedure involves inhaling methacholine through a nebulizer attached to a dosimeter that delivers a precise volume of methacholine. The endpoint of the test is the provocational concentration that produces a 20% decrease in FEV1 (PC20). To standardize the procedure, the American Thoracic Society (ATS) recommends that the nebulizer output be calibrated to deliver an output of 0.9 ± 0.09 mL/min.

The Rosenthal Dosimeter and the KoKo Digidoser are two commonly used dosimeters. In an attempt to follow the ATS guideline we discovered that the nebulizer output was lower with the KoKo Digidoser and could not be calibrated. However, it is unclear whether the apparent lower output is a result of the Digidoser delivering less solution or that the ATS method of determining output is not applicable to this dosimeter. To answer this question, we propose to determine the methacholine PC20 in subjects with asthma using the two dosimeters. It is our hypothesis that the Digidoser delivers less methacholine and thus will produce a higher PC20 than the Rosenthal Dosimeter.

Twelve nonsmoking subjects with mild asthma will be selected on the basis of \> 18 years of age, a baseline FEV1 of \> 60% predicted and a screening PC20 of \< 8mg/ml. Subjects will be randomized to perform a methacholine challenge with the Digidoser and the Rosenthal Dosimeter on two different days in an unblinded, crossover manner. The geometric mean PC20 with each dosimeter will be compared with a paired t test. The results of this study will indicate whether the Digidoser has the potential of causing false negative test results or whether the ATS method of determining output should not be used with this dosimeter.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking male or female \>18 years of age, with a previous diagnosis of asthma.
* Women of child bearing age must not be pregnant or nursing and be using an acceptable method of contraception.
* Screening FEV1 \> 70% of predicted for height, age, sex, and race when bronchodilators are withheld for appropriate intervals.
* At least a 20% decrease in FEV1 after inhaling ≤ 8 mg/ml of methacholine (i.e., a PC20 FEV1 ≤8 mg/ml) using the KoKo Digidoser system.
* Ability to perform ATS-acceptable and reproducible spirometry.

Exclusion Criteria:

* Cigarette smoking in past year or \> 10 pack year smoking history.
* Respiratory tract infection within the last four weeks.
* History of severe asthma attack requiring hospitalization in the previous 12 months.
* Short course of oral corticosteroids in the past 3 weeks.
* Inability to withhold caffeinated beverages for 12 hours or medications for appropriate intervals prior to each methacholine challenge.
* If female, a positive urine β-HCG test.
Chronic Pain Management After Herniorraphy

Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered as the most frequent complication after inguinal hernia surgery. The primary objective of this randomised double-blind placebo-controlled trial is to investigate whether pregabalin reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.


Eligibility Criteria:
Inclusion Criteria:

1. History of unilateral inguinal herniotomy
2. Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score
3. Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area
4. Duration pain ≥ 3 months
5. Medial or lateral inguinal hernia
6. Age ≥ 18 years
7. VAS score ≥ 40 mm on Vas scale on which they indicate 'how unpleasant or disturbing the worst pain was that they had today'
8. Grade III or IV pain and discomfort on the 4-point pain and discomfort scale
9. Informed consent (addendum V)

Exclusion Criteria:

1. Participation in another trial
2. Age \< 18 years
3. Cognitive disfunction
4. Patient is unable to speak Dutch
5. Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
6. Patient classified as American Society of Anaesthesiologist Class 4
7. Renal impairment
Efficacy of Peripheral Magnetic Stimulation Compare to Dry Needling in Myofascial Pain Syndrome

Compare efficiency between repetitive peripheral magnetic stimulation and dry needling in patient with upper trapezius myofascial pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with myofascial pain syndrome at unilateral upper trapezius muscle and had pain score (Visual analog scale) at least 4

Exclusion Criteria:

* Patients with signs and/or symptoms of neurological deficit
* Patients with history of cervical hernia, cervical radiculopathy, cervical myelopathy, fibromyalgia, whiplash spondylosis and cervical spinal stenosis.
* Patients who received physical therapy/injection/surgery at neck or pain area in last 6 months.
* Patients with abnormal coagulopathy and/or currently use anticoagulant medicine.
* Patients with cardiac device.
* Patients with history of aneurysm clip procedure, stent-coils procedure or cochlear implant surgery.
* Pregnancy