cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.

The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of serum levels of G-CSF and absolute neutrophil count - ANC).


Eligibility Criteria:
Inclusion Criteria:

* Agree with all study procedures, sign and date back by their own free will, the IC;
* Be between 18 and 50 years, of both sexes;
* Present a body mass index (BMI) greater than or equal to 20 and less than or equal to 28;
* are considered healthy, clinical, psychological and laboratory;
* are female, but they have and maintain a safe method of contraception during the study.

Exclusion Criteria:

* Known hypersensitivity to filgrastim;
* Hypersensitivity to products derived from E. coli;
* fever or infectious disease in the 07 days preceding the first administration;
* Positive serology for hepatitis B or C and HIV;
* Prior treatment with CSFs, interleukins and interferons;
* Participation in a clinical study in the last 12 months;
* Donation or loss of blood in the 03 months preceding the study;
* General anesthesia in the 03 months preceding the study;
* Provide a history of alcohol abuse, drug or drugs;
* Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological, psoriasis, gout, acute myocardial infarction, thyroid or psychiatric disease;
* Pregnant or lactating women.
Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section

Postpartum women with C-section receiving deep and superficial tissue mobilization would have better improvement on pain, lumbopelvic muscle functions, spinal mobility, and posture compare to the superficial tissue mobilization and control group


Eligibility Criteria:
vaginal delivery

Inclusion Criteria:

* Natural birth without C-section scar
* Postpartum more than 6 months
* Without any pain in the lumbopelvic region

C-section

Inclusion Criteria:

* Healed C-section scar \> six months
* Scar with or without pain

Both mode of delivery

Exclusion Criteria:

* Active infection or infectious disease in the pelvis or abdomen
* Pain medications on days of measurements
* Skin irritation and inflammation at the site of the scar
* Currently pregnant or actively trying to get pregnant
* History of radiation to the area
* Any fracture around spine and pelvis
* Any previous gynecologic and obstetric surgery
Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial

The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).


Eligibility Criteria:
Inclusion Criteria:

* preterm infants born at age between 29 and 37 weeks
* osteopathic treatment performed \< 14 days after birth
* preterms born in the same hospital

Exclusion Criteria:

* Gestational age \< 29 weeks
* Gestational age \> 37 weeks
* First OMT performed after 14 days from birth
* genetic disorders
* congenital disorders
* cardiovascular abnormalities
* proven or suspected necrotized enterocolitis with or without gastrointestinal perforation
* proven or suspected abdominal obstruction
* pre/post surgery patients
* pneumoperitoneum
* atelectasis
* Newborn from an HIV seropositive/drug addicted mother
* respiratory disorders
* transferred to/from other hospital
* admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)
Little Cigar Oxidants

Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 6 exposure groups. These include a high oxidant unflavored little cigar exposure condition, a low oxidant unflavored little cigar exposure condition, a high oxidant flavored exposure condition, a low oxidant flavored exposure little cigar exposure condition, their usual cigarette, and a control condition (unlit little cigar). Following the smoking of each product, exhaled breath condensate samples will be collected at baseline, 30, 60, 90, 120 and 150 minutes. Samples will be analyzed for levels of oxidant markers including hydrogen peroxide, 8-isoprostanes, and C-reactive protein, as well as nicotine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN).


Eligibility Criteria:
Inclusion Criteria:

1. Aged 21 and older
2. Daily cigarette smoker (\>= 1 cigarette per day);
3. Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter
4. Able to read and write in English
5. No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days
6. No plan on quitting smoking in the next 3 months
7. Exhaled Carbon Monoxide (CO) measurement of \<= 16 parts per million at baseline
8. Pulmonary Function of 80%-120% determined via Spirometry

Exclusion Criteria:

1. Women who are pregnant and/or nursing or trying to become pregnant
2. Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)
3. Respiratory diseases (e.g., exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV/AIDS, multiple sclerosis symptoms) or any medical disorder/medication that may affect participant safety or biomarker data
4. Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months
Fibromyalgia in Men Suffering From PTSD

Assessing FM and psychiatric state among PTSD, MDD and healthy participants


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without any current or past psychiatric disorder
* Current diagnosis of PTSD
* Current diagnosis of MDD

Exclusion Criteria:

- Psychotic features
Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease

Meniere's disease is a chronic illness that affects a substantial number of patients every year worldwide. The disease is characterized by intermittent episodes of vertigo lasting from minutes to hours, with fluctuating sensorineural hearing loss, tinnitus, and aural pressure. It has recently been suggested that viral etiologies specially Herpes virus might be the underlying reason. The investigators study is a randomized, double- blinded placebo-controlled clinical trial in Amiralam Hospital. In this study the primary objective is to assess efficacy of Acyclovir in control of symptoms in patients with Meniere's disease specially their vertigo attacks. Inclusion criteria would be patient's willingness to participate in the study and follow ups, being 18 years old or older, having at least 2 vertigos per month each at least 20 min, interfering with function, and not on medication for Meniere's disease for at least 3 months before the trial. They should not have any history of allergy to Acyclovir, renal insufficiency or Creatinine above 1.5 mg/dl, hepatic enzymes more than three times normal, serious uncontrolled illness, be pregnant or nursing or have previous surgeries on Endolymphatic Sac. Participants will be randomly placed in 2 different arms getting either Acyclovir 400 mg or placebo (inert ingredient). They will take the medication for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, 6 month intervals.


Eligibility Criteria:
Inclusion Criteria:

1. Patients' willingness to participate in the study
2. Willingness to participate in follow ups
3. Age of 18 or older
4. Having at least 2 vertigos per month each lasting for at least 20 min, severely interfering with function
5. Not on medication for at least 3 months before starting the trial

Exclusion Criteria:

1. History of Allergy to Acyclovir or the drugs in the same category
2. Renal insufficiency or having Creatinine more than 1.5 mg/dl
3. Hepatic enzymes more than 3 times normal
4. Hematocrit less than 30%
5. Thrombocytopenia
6. Having a serious uncontrolled illness
7. Pregnant or nursing ladies
8. Using Probenecid
9. Previous surgeries on Endolymphatic Sac.
Kindness is Lesser Preferable Than Happiness: Investigating Interest in Different Effects of the Loving-kindness and Compassion Meditations

As an initial step, Study 1 intended to compare the interest in different effects of LKCM among a convenient sample of university students. In order to separate different effects and close to application in real setting, the study will measure participants' interest in participating in proposed meditations, each of which aimed to generate one specific effect. The kind attitudes were represented by compassion for others, compassion for oneself, and appreciative joy for others, which were emphasized in the real LKCM trainings. The emotional well-being included increasing positive emotion, decreasing negative emotion and improving peacefulness, which were validated effects of LKCM. Other validated effects were also measured as fillers and used as additional explorations. The core hypothesis was that the interest in meditations on kind attitudes is significantly lower than interest in meditations on emotional well-being.

The current study created a measure called Willingness to Participate in Meditation Trainings (WPMT). Participants rated their willingness to participate in nine meditation trainings that serve different purposes. Each meditation was rated by one item ("if the purpose of meditation training is to xxx, how much are you willing to participate?" where "xxx" indicates the purposes listed below) and was measured with a 100-mm Visual Analogue Scale (0 = totally unwilling to participate, 100 = totally willing to participate).

Study 2 adopted WPMT in a 21-day online LKCM training. This make sure all participants really took part in meditation training, and allowed further exploration on how participants' WPMT were associated with the adherence and effects of training. To be more sensitive for the change during short training, the effects of training used state-like measures and still focused on two aspects: (1) personal happiness (happiness, sadness, peacefulness) which matched emotional well-being, and (2) interpersonal relationship (love, hate, gratitude) which reflected kind attitudes. The core hypotheses were that higher interest in meditations on Emotional Well-being and Kind attitudes predicted increases in personal happiness and interpersonal relationship, respectively.


Eligibility Criteria:
For study 1 Participants were recruited from two universities in Mainland China with the help of university staff. No other eligibility tests were required.

For study 2 Participants with or without religious beliefs or meditation experience could participate in the study. Each person is required to complete a 21-day meditation course.
Ethnic Differences in Iron Absorption (FeGenes)

This study aims to; 1) investigate population differences in iron absorption between East Asians and Northern Europeans; 2) assess population differences in hormonal and biochemical determinants of Fe absorption between East Asians and Northern Europeans; and 3) to investigate genetic contributions to Fe absorption, Fe status and Fe regulatory hormones between East Asians and Northern Europeans.

Detailed description:

This study will utilize a multidisciplinary approach to identify genetic variation in genes that control iron utilization in order to shed light on the genetic basis of population differences in iron status and disease susceptibility with a long-term goal of informing population-specific dietary iron intake recommendations to minimize the risk of chronic diseases. To evaluate iron utilization, we will employ an in vivo, functional approach using an oral stable iron isotope method. Each participant will have genetic ancestry and genotyping evaluated using the Illumina Global Diversity Array-8. Study participants (n=504, aged 18-50 y) will consume 57Fe (as ferrous sulfate) in the fasted state and will then ingest a standardized breakfast and lunch meal. Two weeks after iron dosing, a blood sample will be collected from each participant and the amount of 57Fe incorporated into red blood cells will be measured using magnetic sector thermal ionization mass spectrometry. This project will fundamentally advance our understanding of ethnic differences in nutrient metabolism and iron status. It will also provide information to assist with the long-term goal of reducing the public health burden of Fe-related diseases.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Age between 18- 50y
* Non-smoking
* Not taking vitamin or mineral supplements.
* Females: premenopausal and not pregnant or lactating
* No preexisting medical complications (such as eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis)
* Body mass index (BMI) between 18 - 30 kg/m2.

Exclusion Criteria:

* BMI \<18 or \> 30 kg/m2,
* Age \<18 y or \> 50y,
* Not of Northern European or East Asian ancestry
* Smoking
* Pregnancy, lactating
* Have gastrointestinal disorders/malabsorption diseases/hemoglobinopathies/dietary restrictions/steroid use/ medication use of medications known to impact iron status, iron utilization or inflammatory status
* Take vitamin and mineral supplementations
The Effect of Self-Acupressure Application on Pain, Fatigue and Sleep Quality in Cancer Patients Receiving Chemotherapy

The aim of this study is to examine the effect of Self-Acupressure application on pain, fatigue and sleep quality in cancer patients receiving chemotherapy.

Self-Acupressur application will improve pain, fatigue and sleep quality in cancer patients receiving chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* To have received at least one course of adjuvant chemotherapy before,
* Not having a psychiatric diagnosis,
* Being an early stage cancer patient
* To be able to communicate adequately
* Not having psychiatric problems
* Volunteering to participate in research

Exclusion Criteria:

* None
A Randomized Double Blind, Placebo Controlled Balanced 4-Way Crossover Study To Assess The Efficacy Of Single Oral Doses

The primary aim of this study is to assess how effective PF-00592379 is in restoring penile erections in patients with erectile dysfunction. Patients will attend for 4 treatment visits where they will receive the following in random order; 2 separate doses of PF-00592379, sildenafil 100mg used as a positive control, or placebo (dummy medication). The effect on penile erections will be assessed in the clinic using penile plethysmography (RigiScan PlusTM technique).


Eligibility Criteria:
Inclusion Criteria:

* Erectile dysfunction, previous good response to an oral treatment for erectile dysfunction.

Exclusion Criteria:

* Patients with high blood pressure or certain heart conditions (e.g. angina, heart failure), regardless of whether treated or not.
* Patients on nitrates or alpha-blocker medications.
A Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia

The purpose of this study is to evaluate the pharmacokinetics (study of what the body does to a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.

This is a multicenter (study conducted at multiple sites), open label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel-group (each group of participants will be treated at the same time) study. Approximately, 60 participants will be enrolled in the study. This study will consist of a screening phase (maximum 14 days), an observation phase (92 days), and a follow-up phase (98 days). Participants will be randomly assigned to treatment group A, B, or C. During the observation phase, participants will receive injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in the deltoid muscle or gluteal muscle as applicable on Days 1, 8, 36, and 64 alternating between sides (left/right). Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, injection site reaction, drug-induced extrapyramidal symptoms scale, and visual analog scale which will be evaluated throughout the study. The total study duration for each participant will be approximately 190 days.

Eligibility Criteria:
Inclusion Criteria:- Participants had to have the capability to provide informed consent in writing to participate in the study

* Participants with a diagnosis of schizophrenia in accordance with the diagnostic criteria for Diagnostic and Statistical Manual of Mental Disorders -IV-TR (DSM-IV-TR)
* Participants whose psychiatric symptom is considered stable by the investigator/subinvestigator at the time of giving informed consent
* Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) in the following 9 items at screening: delusion, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility, uncooperativeness, poor impulse control
* Participants with an experience of taking a risperidone formulation or a paliperidone formulation by 8 days before the initial day (Day 1) of the study treatment

Exclusion Criteria:- DSM-IV-TR diagnosis other than schizophrenia

* DSM-IV-TR diagnosis of substance-related disorders within 180 days before the date of screening
* At a risk of suicide or other-injurious behavior as considered by the investigator/subinvestigator , and participants with a history of suicide attempts
* Concurrent condition of Parkinson's disease (except for drug-induced extrapyramidal syndrome) - Concurrent condition or history of symptomatic cerebrovascular accident
Metabolic Effects of Non-nutritive Sweeteners

The purpose of this research study is to examine whether sugar-replacement sweeteners that are currently on the market (ex. Sucralose, which is in Splenda) change how well the body works to control blood sugar.

The investigators of this study have recently found that sucralose, the most commonly used non-nutritive sweetener (NNS), affects the glycemic response to an oral glucose tolerance test (OGTT) and potentiates glucose-stimulated insulin secretion in obese people who are not regular consumers of NNS. However, studies conducted in healthy lean adults, none of which control for previous use of NNS, show that sucralose does not affect glycemic or hormonal responses to the ingestion of glucose or other carbohydrates. Therefore, we do not know a) whether sucralose effects are limited to obese subjects, or are generalizable to lean people when controlling for prior history of NNS consumption, and b) mechanism(s) responsible for the acute effect of sucralose on glucose metabolism as we measured in obese subjects. The aim of this study is to determine the effects of an acute intake of sucralose on the metabolic response to an oral glucose tolerance test in lean and obese people.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30 kg/m2 or BMI ≥ 18 kg/m2 and BMI\<25 kg/m2
* "insulin sensitive": based on the homeostasis model assessment of insulin resistance (HOMA-IR) \<3

Exclusion Criteria:

* BMI ≥ 25 kg/m2 and BMI\<30 kg/m2
* HOMA-IR\>3
* Current smoker or quit smoking less than 6 months ago
* pregnancy or breastfeeding
* subjects who have malabsorptive syndromes, phenylketonuria, inflammatory intestinal disease, liver or kidney diseases, diabetes
* subjects who are taking any medication that might affect metabolism
* anemia
* regular use of non-nutritive sweeteners
Water Homeostasis in Propofol Based Total Intravenous Anesthesia

Previous study reported that propofol binded to glutamate receptors in the hypothalamus and inhibits AVP release mediated by endogenous γ-aminobutyric acid, as well as directly inhibits the regulated calcium currents leading to normal neuronal depolarization and AVP release. However, there is no clinical data demonstrating the mechanism of propofol can induce transient DI by inhibiting the release of AVP from the hypothalamus when applied to humans. Remifentanil, binding to the μ-receptor or partly κ-receptor, have been used in total intravenous anesthesia combined with propofol, also reported inhibiting AVP relaese in both the hypothalamus (κ receptor mediator mechanism) and posterior pituitary (μ receptor mediator mechanism). However, the effects of anesthetics on water homeostasis during surgery have been not well established. Therefore, we aim to investigate the changes of intraoperative water homeostasis, and related hormones and osmolality in patients with propofol based total intravenous anesthesia due to neuromonitoring for spine surgery.

"All patients will get the total intravenous anesthesia with propofol-remifentanil via an effective site-controlled infusion (TCI). For this, TCI continuous infusion pump will be used with Schnider pharmacokinetic model for propofol and Minto pharmacokinetic model for remifentanil. Propofol and remifentanil will be initiated with target effective site concentrations of 3 μg.ml-1 and 3 ng.ml-1, respectively, and controll these concentrations considering patient's consciousness loss and vital signs. And then 0.6 mg kg-1 rocuronium for muscle relaxation will be administered for intubation. Anesthesia will be maintained with BIS level 40-60 and vital signs will not be more than 20% of the baseline or less. In order to prevent the sudden movement of the patient during surgery, rocuronium will be infused continuously about 50% of TOF until the end of intraoperative neuromonitoring.

Eligibility Criteria:
Inclusion Criteria:

* Patients, ASA Classification I-Ⅲ between 20 and 70 years, scheduled the neuromonitoring for spine surgery in department of neurosurgery

Exclusion Criteria:

Taking thiazide/ACEi /ARB for hypertension

* Receiving insulin treatment due to diabetes mellitus
* Diagnosed with kidney disease or GFR \< 60
* Diagnosed with liver disease or AST/ALT \> 100
* Receiving furosemide or mannitol before surgery
* DI was diagnosed before surgery or having polyuria
* Taking lithium or antibiotics that are known to cause DI
* Do not understand Korean language
* Vulnerable subjects who are unable to obtain consent forms