cyrilzakka/clinical-trials huggingface dataset:
Periorbital Massage for Nausea and Vomiting After Laparoscopic Surgery

Laparoscopic cholecystectomy is one of the commonly used surgical treatment methods for gallbladder diseases. However, many patients experience significant nausea and vomiting after laparoscopic cholecystectomy. It is observed that approximately 20% to 30% of patients experience postoperative nausea and vomiting as the most common complaint after laparoscopic cholecystectomy. This study aims to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.

This study aimed to investigate the effectiveness of periorbital massage in postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. One group received periorbital massage, while the other group did not receive massage.

Eligibility Criteria:
Inclusion Criteria:

Those who have laparoscopic cholecystectomy surgery under general anesthesia,

* Those between the ages of 18-70,
* Those who do not have a psychiatric disease,
* Those who understand what they read and volunteer patients,
* Those who do not have a hearing or speech problem,

Exclusion Criteria:

* Patients undergoing emergency surgery,

  * Patients with psychiatric disorders
  * Patients who have taken another antiemetic drug within 24 hours before surgery
A Pharmacokinetic Study of Sevoflurane Inhalation in Burn ICU Patients

Comparing a pharmacokinetic model of a short sevoflurane sedation in burn ICU patients with control ICU patients.

Prospective clinical study in ICU with sedated ventilated patients with sevoflurane with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride) comparing burn and non burn ICU patients

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ventilated requiring invasive procedure in ICU

  * Stable respiratory and hemodynamic conditions
  * Consent of patients or family
  * Arterial line
  * Burn patients : burn area between 20 and 50% (3rd degree) OR non burn patients

Exclusion Criteria:

* BMI \<30

  * Sevoflurane anaphylaxia
Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate steady state pharmacokinetics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Currently on a multiple dose insulin regimen
* HbA1c maximum 12.0%
* BMI (body mass index) below 35 kg/m\^2
* Able and willing to perform self-blood glucose monitoring (SBGM)

Exclusion Criteria:

* Treatment with insulin aspart within the last 14 days prior to this trial
* The receipt of any investigational drug within the last 30 days prior to this trial
* Total daily insulin dose at least 1.8 U/kg
* A history of drug abuse or alcohol dependence within the last 5 years
* Impaired hepatic function
* Impaired renal function
* Blood donation within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory
* Cardiac disease
* Severe, uncontrolled hypertension
Reversal of the Neurological Deficit in Acute Stroke With the Signal of Efficacy Trial of Auto BPAP to Limit Damage From Suspected Sleep Apnea

Although the negative impact of sleep apnea on the clinical course of acute ischemic stroke (AIS) is well known, data regarding non-invasive ventilation in acute patients are scarce. Several studies showed its tolerability, safety and signals-of-efficacy, yet no controlled randomized sequential phase studies currently exist that aim to establish the efficacy of early non-invasive ventilation in AIS patients. The main hypothesis for this study is that early non-invasive ventilation with automated bilevel positive airway pressure (auto-BPAP) positively affects short-term clinical outcomes in AIS patients. This is a multicenter, prospective, randomized, controlled, third rater-blinded, parallel-group trial. Patients with AIS with proximal arterial obstruction and clinically suspected sleep apnea will be randomized to standard or standard stroke care plus auto-BPAP. Auto-BPAP will be initiated within 24 hours from stroke onset and performed for a maximum of 48 hours during diurnal and nocturnal sleep. Patients will undergo cardiorespiratory polygraphy between day 3 and 5 to assess sleep apnea. The primary endpoint is any early neurological improvement on the NIHSS at 72 hours from randomization. Safety, tolerability, short-term and 3 months functional outcomes are assessed as secondary endpoints by un-blinded and blinded observers respectively. This study will provide data to power a subsequent phase III study.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 - 80 years;
* Clinical suspicion of an AIS (measurable or fluctuating neurological deficit with a National Institutes of Health Stroke Scale \[NIHSS\] ≥ 4 points) within 24 hours from symptom-onset;
* Extracranial (internal carotid artery) or intracranial (internal carotid artery; middle/anterior/posterior cerebral arteries) ≥ 50% stenosis, near-occlusion or occlusion diagnosed by ultrasound, computed tomography angiography (CTA) or magnetic resonance angiography (MRA), corresponding to acute neurological deficit;
* High-risk of having sleep apnea (classified by the Berlin sleep apnea questionnaire); or history of known sleep apnea; or witnessed repetitive apnea episodes during sleep or somnolence during hospitalization;
* Written informed consent by participants; alternatively by proxy or two physicians when not obtainable by patient or proxy (according to local regulations).

Exclusion Criteria:

* Perceived course towards the malignant middle cerebral artery infarction;
* Immediate or perceived need for intubation;
* Known sleep apnea currently on non-invasive ventilatory treatment;
* Standard contraindications for non-invasive ventilatory treatment;
* Pre-morbid modified Rankin scale (mRS) score ≥ 3;
* Severe comorbidities (i.e., severe heart failure, severe obstructive lung disease, active malignant disease, severe dementia);
* Pregnant and breast feeding women;
* Participation in another clinical trial other than standard-of-care registry.
Bioequivalence of Telmisartan/ HCTZ Fixed Dose Combination Compared With Its Monocomponents in Healthy Male Volunteers II

Study to investigate the bioequivalence of 80 mg telmisartan/12.5 mg hydrochlorothiazide (HCTZ) fixed dose combination compared with its monocomponents


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, physical finding, physical examination (measurements of height and body weight), vital signs (blood pressure, pulse rate), 12- lead ECG, clinical laboratory tests (including gastric acid (GA) test)
   * No finding of clinical relevance
   * No evidence of a clinically relevant concomitant disease
2. Age ≥ 20 years and Age ≤ 35 years
3. Body weight ≥ 50 kg
4. Body mass index (BMI) ≥ 17.6 kg/m2 and BMI ≤ 25.0 kg/m2
5. Signed and dated written informed consent prior to admission to the study

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. Chronic or relevant acute infections
6. History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
7. Positive result for hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV), syphilitic test or human immunodeficiency virus (HIV) antigen-antibody test
8. Intake of drugs with a long half-life (≥ 24 hours) within at least 1 month prior to administration or within a period of 10 or less half-lives of the respective drugs during the trial
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
10. Participation in another trial with an investigational drug within 4 months prior to administration or during the trial
11. Smoker (20 or more cigarettes/day)
12. Inability to refrain from smoking during hospitalization
13. Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
14. Drug abuse
15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
16. Excessive physical activities (within one week prior to administration or during the trial)
17. Any laboratory value outside the reference range that was of clinical relevance
18. Inability to comply with dietary regimen of study centre
19. Any other volunteers whom the investigator or sub investigator did not allow to participate in this study
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
* Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
* A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
* Written informed consent obtained from the parent or guardian of the subject
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
* Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
* Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament for Analgesia After Open Liver Surgery

This is a prospective, randomized, controlled, noninferiority trial for evaluating the efficacy of ultrasound-guided anterior quadratus lumborum block at the lateral supra-arcuate ligament versus thoracic epidural analgesia after open liver surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years
* ASA I-III
* Open liver surgery

Exclusion Criteria:

* Contraindication to nerve block or epidural puncture
* Chronic use of opioids or NSAIDs
* Refused to participate in the study
A Study of Two Dosage Forms of LY2886721 in Healthy Participants

The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Information about any side effects that may occur will also be collected. Each participant may be involved in the study for approximately 7 weeks.

This study requires 4 periods. In each period, participants will receive LY2886721 as a tablet or capsule, with or without food and water. There is a 7 day washout between each period.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2), inclusive, at screening
* At least 4 participants who are greater than 55 years of age
* Male participants: Agree to use a reliable method of birth control and not donate sperm during the study and for 3 months following the last dose of the investigational product
* Female participants: Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy, hysterectomy, or both) confirmed by medical history, or postmenopausal females, as determined by medical history and physical examination (spontaneous amenorrhea for 6 to 12 months and a follicle stimulating hormone \[FSH\] level greater than 40 milli-international units per milliliter \[mIU/mL\])
* Have venous access sufficient to allow for blood sampling as per the protocol

Exclusion Criteria:

* Are currently enrolled in, have completed, or discontinued within the last 30 days from a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product
* Have known allergies to LY2886721, related compounds, or any components of the formulation
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Have a significantly abnormal blood pressure as determined by the investigator
* Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis B or C and/or positive hepatitis B or C antibody
* Have a history of, or current, significant ophthalmologic disease
* Show evidence of significant active neuropsychiatric disease or history of suicide attempt
Multifactorial Approach to Emergent Cerclage

Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.

The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.


Eligibility Criteria:
Inclusion Criteria:

* GA 16+0 to 23+6 weeks
* Singleton gestation
* Presence of cervical dilation as diagnosed on digital examination
* Intact membranes

Exclusion Criteria:

* Age \<18 years
* Allergy to NSAIDs
* Renal disease
* Allergy to penicillins AND clindamycin
* Currently on antibiotics or indomethacin for any reason
* HIV positive
* Pregnancies complicated by fetal congenital anomalies
* Preterm premature rupture of membranes
* Fever of 100.4 degrees Fahrenheit or higher
* Any patient having received a therapeutic cerclage during the current pregnancy
Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia

ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia) is a prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to demonstrate the safety and effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT) using an endocardial approach.


Eligibility Criteria:
Pre-Electrophysiology Study Inclusion Criteria:

* Supraventricular tachycardia (SVT) compatible with atrioventricular nodal reentrant tachycardia (AVNRT), documented by ECG, TTM, Holter or event monitor

Pre-Electrophysiology Study Exclusion Criteria:

* History of sustained (≥30 seconds) of ventricular tachycardia
* Atrial tachycardia or other arrhythmia that could be confused with AVNRT
* Reversible cause of SVT
* History of previous AVNRT ablation
* Therapy with amiodarone within last 90 days
* Unstable angina/myocardial infarction/open heart surgery in past 60 days
* New York Heart Association (NYHA) Classification III or IV currently or within the past 90 days
* Implantable cardiac rhythm device
* Atrioventricular block (first degree (PR interval ≥ 220ms), second degree, or third degree) or left bundle branch block
* Stroke or transient ischemic attack within the past 180 days
* Life expectancy less than 12 months
* Female known to be pregnant
* Unable/unwilling to give informed consent
* Unable/unwilling to comply with follow-up visits and study requirements
* Less than 18 years of age
* Active systemic infection
* Cryoglobulinemia
* Other conditions where the manipulation of the catheter would be unsafe (for example, intracardiac mural thrombus)
* Participating in a concurrent clinical study that may confound the results of this study

Post-Electrophysiology Study Inclusion Criteria:

* Subject must have one electrophysiology study documented inducible sustained (greater than or equal to 15 seconds) supraventricular tachycardia that is classified as AVNRT.

Post-Electrophysiology Study Exclusion Criteria:

* Presence of a second inducible arrhythmia that could be confused with AVNRT during follow-up or will likely result in ablation within the next 6 months
* Presence of inducible sustained ventricular tachycardia or fibrillation
* Presence of an accessory pathway
* Presence of abnormal conduction or refractoriness parameters of the atrioventricular conduction system.
* Indication for a pacemaker, defibrillator or cardiac resynchronization therapy (CRT)
Executive Functions and Reinforcement Sensitivity in Women With Obsessive Compulsive Symptoms

Methods: The study population consisted of all adult women living in Sabzevar city (Iran). Using cluster sampling, 365 women were selected as the study sample. Participants completed Obsessive-Compulsive Inventory, Sensitivity to Punishment and Sensitivity to Reward Questionnaire - Revised and Clarified (SPSRQ-RC) as well as Behavior Rating Inventory of Executive Function (BRIEF). Data analysis was conducted using correlation and regression tests.


Eligibility Criteria:
Inclusion Criteria:

having age between 18 to 54, be female, be literacy,

Exclusion Criteria:

be male, be illiteracy, having psychotic disorders
Use of Topotecan in Patients With Refractory Acute Leukemia

The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).

Eligibility Criteria:
Inclusion Criteria:

Patients in the following disease categories will be considered eligible for this study:

* Any acute leukemia beyond an initial attempt to induce a remission or after relapse
* Chronic Myelogenous Leukemia in Blast Phase
* Refractory Multiple Myeloma
* Refractory non-Hodgkin's and Hodgkin's Lymphoma
* Patients must be more than 14 days beyond prior myelotoxic chemotherapy
* Several other eligibility criteria apply.

Exclusion Criteria:

* None
Neuromarker S-100B as Diagnostic Tool

The hypothesis of this study is to find evidence if there is an influence of spine surgery on the serum levels of two proteins secreted from neuronal cells.

The question, if there is an effect on the cerebrospinal system during spine surgery, which can be traced by monitoring serum levels of neuromarkers is not yet answered. This study has its background from other studies on patients with traumatic brain injury (TBI), in whom elevated serum levels of the two neuromarkers S-100B and NSE are associated with injury severity, neuronal damage, brain, tissue damage, and outcome. Patients undergoing spine surgery with or without pre-existing traumatic neurologic symptoms are planned to be the study cohort. Pre- and postoperatively the serum levels of S-100B and NSE are obtained and are statistically compared with patients undergoing other types of bone-related surgery.

Eligibility Criteria:
Inclusion Criteria:

* spine fracture

Exclusion Criteria:

* additional traumatic brain injury
* fractures of the long bones
* polytrauma
* severely injured patients
A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity

This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity.

This study is a Phase 2, randomized, double-blind, placebo-controlled, multi-center study in adult participants with obesity. Approximately 70 participants will be randomized in a 1:1 ratio to GLY-200 (2.0 g, twice daily) or placebo (twice daily). There will be a ≤ 28-day screening period. Dosing will occur for 16 weeks. Clinic visits will occur at Screening, Week 0 (Day 1), and Weeks 1, 2, 4, 6, 8, 12, 16, and 17 \[End of Study (EOS)\] or Early Termination (ET). Phone visits will occur at Week 3, 10, and 14.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥ 18 and ≤ 70 years old at the time of screening
* BMI ≥ 32 and ≤ 40 kg/m² at screening

Exclusion Criteria:

* Known history of any form of diabetes mellitus, or HbA1c ≥6.5% (48 mmol/mol)
* Participants who have had an increase or decrease in body weight more than 5% within the last 3 months
* Treated with any prescription medication or procedure that promotes weight loss or weight gain in the last 6 months
* Use of any drug treatment that affects gastric pH
* Use of any drug treatment that affects gastrointestinal motility
* Diagnosis or treatment of any symptomatic or structural abnormality of the GI tract or active disease within 12 months
* Clinically significant symptoms (as determined by the Investigator) of nausea, vomiting, bloating, diarrhea, flatulence, constipation, or abdominal pain in the last 30 days