cyrilzakka/clinical-trials huggingface dataset:
Investigating the Influence of Haemolysis on the Potassium Concentration After Capillary Blood Sampling

This is an open, single-centre trial investigating the impact of haemolysis after capillary blood collection to the measured potassium concentration in Plasma healthy subjects. Each subject will have four capillary blood collections on different fingers. Two on the right and two on the left hand. Additionally as a reference a venous blood collection will be conducted.

K@Home_1 a working package of the FFG project "K@Home - potassium home monitoring for patients with heart- and kidney insufficiency". In the project K@Home a potassium measuring system serveable by the patients even of the home monitoring should be developed.

Aim from K@Home is to allow an everyday home monitoring of the potassium value by the development of potassium-test stripe, like with the diabetes patients who supervise their blood sugar level by measurements with glucose-test stripe from a drop of capillary blood from the finger berry and with it the emergencies and hospital admissions to reduce or to prevent. It is fact that haemolysis has a strong influence on the measured potassium concentration. It is likely that by using capillary blood a haemolysis appears and therefore distorted potassium concentrations are measured.

In the study K@Home_1 it is a matter of evaluating, how high the degree of the haemolysis in capillary blood is, and in this fact to what extent leads to wrong potassium values. The results from this study will be a basic component for the sensor development.

After clarification the approval the Informed Consent is signed and the inclusion as well as exclusion criteria (incl. demography, concomitant medication and medical history) or vital parameters (blood pressure, pulse, size, weight), are raised. An urine-pregnancy test is also carried out for the exclusion of a pregnancy in women capable of bearing children. It is not necessary that the subjects seem sober on the study day.

With 22 healthy subjects capillary and venous blood is taken within the scope of one single study round. Blood is taken from the test persons by trained specialist staff of two fingertips of each hand (a total of four fingertips). The capillary blood sampling occurs in 200 µ l Lithium-Heparin Sarsted Microvettes and in each case the first drop of blood is rejected. To guarantee a light blood decrease without strong mechanical pressure, the hands are warmed up before the capillary sampling required with the help of an electric blanket or by warm water roughly on room temperature.

In addition 15 ml blood from the vein of a forearm is taken.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Healthy
* Signed informed consent before any trial-related activities

Exclusion Criteria:

* Severe acute and/or chronic diseases
* Mental incapacity, unwillingness of language barriers precluding adequate understanding or cooperation
* Pregnancy or breastfeeding
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)

This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.


Eligibility Criteria:
Inclusion Criteria :

* Participant is a healthy infant
* Participant has received one dose of monovalent hepatitis B vaccine prior to or at 1 month of age

Exclusion Criteria :

* Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
* Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, or any combination of the above
* Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment
* Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment
* Participant has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)
* Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection
Longitudinal Study of Intra-Uterine Growth Restriction

The investigation will employ a longitudinal approach in which every fetus diagnosed to be SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta over time. These findings will be correlated with neurological and cardiovascular function in the newborn and early childhood. This research initiative should yield diagnostic and therapeutic templates that will improve the quality of life of IUGR babies in addition to providing important information that will better inform current diagnostic practices.

The overarching objective is to serially assess changes in the fetal circulation, heart, and brain with sophisticated ultrasound, MRI (Magnetic Resonance Imaging), and body composition techniques that will provide clues as to how growth restricted babies will tolerate life outside the uterus. Employing a longitudinal study will allow the investigators to correlate perinatal and postnatal outcomes more comprehensively than previous studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed SGA by an ultrasound estimated fetal weight (EFW) of less than the 10th percentile or a fetal abdominal circumference of less than the 5th percentile will be included in the study at the time of their first examination.

Exclusion Criteria:

* Patients \< 18 years of age, and chromosomal anomalies as identified by regular aneuploidy screening.
DDI Study to Investigate Interaction Between Amikacin and POL7080

Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study. Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects. The study consists of an eligibility screening period, up to 3 treatments periods and a follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) subjects between 18 to 55 years of age (inclusive)
* BMI between 18.0-30.0 kg/m2
* Creatinine clearance estimated by Cockroft Gault formula \> 80 mL/min and \< 160 ml/min (for males), or \< 150ml/min (females)
* Non smokers
* Normal audiogram.

Exclusion Criteria:

* History or suspicion of alcohol and/or drug abuse in the last 5 years
* Within 2 months prior to screening: exposure to aminoglycoside antibiotic, chemotherapy, or current use of loop diuretics
* Regular consumption of large amounts of xanthine
* Any medication that inhibits active tubular secretion within 4 weeks prior to first dosing
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
* Any signs of renal impairment
* Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
* Clinically significant abnormal ECG
Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure

Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of the problems described for this procedure has to do with the closure of the vaginal vault, increased surgical time when suture laparoscopically, complications such as dehiscence of the dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare two different techniques for closure of the vaginal vault.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for total laparoscopic hysterectomy without other simultaneous procedures , for benign causes , who were agree to participate in the trial and give their written consent.
* Patients ASA (American Society of Anesthesiologists) 1 and 2
* Patients who are able to communicate by telephone and answer questions

Exclusion Criteria:

* Patients with coagulation disorders, chronic use of corticosteroids, COPD (chronic obstructive pulmonary disease), collagen diseases, diabetes.
* Endometriosis III / IV
* Patients who can not be reached by phone
The RAD-HOME Project: a Pilot Study of Domiciliary Teleradiology

Aim of the study is to assess feasibility and safety of a public territorial radiology service for home hospitalized frail elderly patients whose health conditions discourage the transportation to hospital.


Eligibility Criteria:
Inclusion Criteria:

* immobilization or chairbound,
* need for chest, pelvis/hips, joints, upper and lower limbs, hands and feet X-rays,
* absence of definite delirium at enrollment according to the Confusion Assessment Method, and
* intermediate or high risk of delirium according to the criteria of Inouye.

Exclusion Criteria:

* need of urgent examination (within 24 hours),
* need of X-ray examinations not suitable at home.
Acute Response to Cigarette and E-cigarette Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and E-cigarettes

Electronical cigarettes, also known as "e-cigarettes" are a new phenomenon, which steadily wins more aprobation among smokers. However, there exists no much data concerning the effects of acute exposure to electronic cigarettes vapour on the respiratory system.

The aim of the present study is to evaluate and compare the acute response to electronic and traditional cigarettes in healthy smokers.

The aim of the study is:

* to evaluate the acute response to traditional cigarettes on the respiratory system
* to evaluate the acute response to electronic cigarettes on the respiratory system
* to assess the relationship between the type of smoked cigarettes (traditional vs. electronic) and concentration of markers of airway inflammation released in healthy smokers

Material and methods:

* 29 healthy smokers of traditional cigarettes
* 29 healthy smokers of electronic cigarettes
* 29 healthy, nonsmoking volunteers

After 8 hours of smoking abstinence:

* the spirometry test
* the first collection of the exhaled breath condensate (EBC I)
* smoking a traditional / electronic cigarette
* the second collection of the exhaled breath condensate (EBC II) - one hour after smoking
* the third collection of the exhaled breath condensate (EBC III) - six hours after smoking
* the measurement of biomarkers of oxidative stress in the EBC (isoprostane-8, malondialdehyde MDA, IL-8) and pH of the EBC

Eligibility Criteria:
Inclusion Criteria:

* healthy smokers of traditional cigarettes - min. 1 packyear
* healthy smokers of e-cigarettes - min. 1 year of smoking history
* control group - healthy nonsmoking volunteers without any history of lung disease

Exclusion Criteria:

* age below 18 years
* inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
* any co-morbidities
* respiratory infections at least 6 weeks prior to study enrollment
Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin

LSD (lysergic acid diethylamide) and psilocybin (the active substance in "magic mushrooms") are widely used for recreational purposes. Both substances are also increasingly used in psychiatric and psychological research to induce and investigate alterations in waking consciousness and associated brain functions (functional brain imaging, "model psychosis") . However, it has never been studied whether there are differences in the alterations in mind produced by these two substances. Both LSD and psilocybin are thought to induce hallucinations primarily via stimulation of the 5-HT2A receptor. However, there are differences in the receptor activation profiles between the two substances that may also induce different subjective effects. LSD potently stimulates the 5-HT2A receptor but also 5-HT2B/C, 5-HT1 and D1-3 receptors . Psilocin (the active metabolite of the prodrug psilocybin) also stimulates the 5-HT2A receptor but additionally inhibits the 5-HT transporter. In contrast to LSD, psilocybin has no affinity for D2 receptors. Both substances are used in neuroscience as pharmacological tools. However, there are no modern studies comparing these two substances directly within the same clinical study and research subjects and using validated psychometric tools. Therefore, the investigators will compare the acute effects of LSD, psilocybin and placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 25 and 65 years.
2. Understanding of the German language.
3. Understanding the procedures and the risks that are associated with the study.
4. Participants must be willing to adhere to the protocol and sign the consent form.
5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
6. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
8. Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session.
9. Women of childbearing potential must be willing to use double-barrier birth control
10. Body mass index 18-29 kg/m2.

Exclusion Criteria:

1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder
3. Psychotic disorder in first-degree relatives
4. Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
5. Pregnant or nursing women.
6. Participation in another clinical trial (currently or within the last 30 days)
7. Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
8. Tobacco smoking (\>10 cigarettes/day)
9. Consumption of alcoholic drinks (\>10/week)
10. Bodyweight \< 50 kg
Investigator-Sponsored Protocol - Continued Use of Ibalizumab

This protocol serves to extend the successful treatment for HIV positive patients beyond the endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled "A Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1 (Amended to 24 Week Study)"), for 24 weeks. Ibalizumab may be administered beyond 24 weeks under this protocol as supply permits and patients continue to demonstrate virologic response.

Ibalizumab is to be administered to HIV-infected patients that have responded (defined as a minimum 0.7 log10 decline in HIV-1 viral load from TMB-202 Baseline) on the TMB-202 protocol. In addition to the investigator-selected Optimized Background Regimen, patient(s) will continue to receive the TMB-202 randomized dose of ibalizumab in open-labeled fashion (800mg IV every two weeks or 2000mg IV every four weeks) as per their original drug assignment for the TMB-202 protocol.

Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding and have voluntarily signed the ICF
* Have documented HIV-1 infection
* Have successfully completed Protocol TMB202 (Amendment 2)(Week 16)
* Have had at least a 0.7 log10 decline in HIV-1 RNA from baseline at Week 16 and beyond while in TMB202 and are no longer eligible to participate in TMB-202 due to TMB-202 protocol-defined virologic failure
* Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason
* Are able and willing to comply with all protocol requirements and procedures
* Are 18 years of age or older
* If sexually active, are willing to use an effective method of contraception during the study and for 30days after the last administration of the study drug.

Exclusion Criteria:

* Any active AIDS-defining illness per Category C except for cutaneous Kaposi's sarcoma and wasting due to HIV
* Any significant disease (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
* Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations
* Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation
Lidocaine Spray vs Viscous Lidocaine Solution Plus Lidocaine Spray in Patients Undergoing Non-Sedated EGD

This study aimed to compare the efficacy of lidocaine spray (S) alone versus lidocaine spray combined with lidocaine viscous solution (S+V) in facilitating pharyngeal observation during Non-sedating upper gastrointestinal endoscopy (UGE).

A randomized controlled trial was conducted between July and October 2023 at Sawanpracharak hospital, Thailand. Of 250 patients undergoing UGE, 125 were randomly assigned to group S (lidocaine spray alone) and 125 to group S+V (lidocaine spray plus lidocaine viscous solution). The total dose of lidocaine did not exceed 5 mg/kg in both groups

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for upper gastrointestinal endoscopy:
* Patients who are robust, without chronic illnesses, or with controlled chronic conditions that do not adversely affect the function of any organ (American Society of Anesthesiologists (ASA) physical status classification I-II).

Exclusion Criteria:

* Has a history of receiving painkillers or sleeping pills within 24 hours before the endoscopy.
* Has a history of post-endoscopy nausea and vomiting.
* Patients who have undergone upper gastrointestinal endoscopy previously.
* Has chronic conditions such as epilepsy, vertigo, or mental health disorders.
* Has a history of allergy to anesthesia used in the study.
* Pregnant or currently breastfeeding.
* Refuses to participate in the study.
Rifaximin in Patients With Gastroesophageal Variceal Bleeding

The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection.

However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.

Eligibility Criteria:
Inclusion Criteria:

* 18 y.o. ≤age≤75 y.o.;
* Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N- butyl-cyanoacrylate injection).

Exclusion Criteria:

* age \<18 y.o. or age \> 75 y.o.;
* Never had the variceal bleeding episode before;
* Do not have endoscopic treatment;
* Combined with other malignant tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment);
* Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
* Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics.
* Acute variceal bleeding within 5 days.
* Refuse to participate
Effect of Oral and Intravenous Diltiazem Protocol for Emergency Department Atrial Fibrillation

The primary objective of the study is to reduce hospital admission and decrease time to disposition through establishing an effective treatment protocol for AF and Atrial Flutter in the Emergency Department of Spectrum Health Lakeland. Secondary outcome is to measure if oral diltiazem is an effective HR controlling agent in AF RVR and Flutter.


Eligibility Criteria:
Inclusion Criteria:

* Heart rate \>125
* Systolic BP\>110
* Atrial Fibrillation/Flutter confirmed on ECG.
* Meets observation unit requirements (performs certain ADL's (acts of daily living)
* Age\>18.

Exclusion Criteria:

* Wolf-Parkinson-White syndrome
* ST Elevation Myocardial Infarction
* Pregnant
* Clinical diagnosis of Sepsis,
* Decompensated HF
* allergy to Diltiazem
* provider discretion
* clinical need for cardioversion
Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers

The investigators are doing this research study to find out the effect of T6 Dermatomal Electrical Stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit) on stomach motor activity.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers with BMI ≤34.99 kg/m\^2 residing within 125 miles of Mayo Clinic in Rochester, Minnesota; these will be healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia on diet) disorders.
2. Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of the test day.
3. Subjects must have the ability to provide informed consent before any trial-related activities.
4. Eligible individuals will be asked to avoid taking additional medications and supplements for one week before and after the test day, unless reviewed and approved by the study team.

Exclusion Criteria:

1. Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.
2. Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility.
3. Positive history of spinal cord injury and/or chronic back pain.
4. Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD). If such a dysfunction is identified by a HAD score \>11 on either Anxiety or Depression or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
5. Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxine replacement therapy, low dose analgesia or anti-inflammatory medications (Acetaminophen and Ibuprofen) and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility.
6. Subjects may also be excluded from participation for other factors at the discretion of the principal investigator.