cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers

This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in healthy volunteers

To healthy subjects of forty (40), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.

Reference drug: XELJANZ 5Mg Tablet / Test drug: Chong Kun Dang Tofacitinib Tablet Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subject older than 19 years at the screening
2. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2

   \* BMI = Weight(kg)/ Height(m)2
3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
4. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG, chest X-ray etc.)
5. Women who are not pregnant at physical examination

Exclusion Criteria:

1. Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs, such as drugs or excessive drinking within the 1 month
2. Individuals who had taken any medication within 10 days prior to the first day of dosing
3. Individuals who were deemed to be inappropriate to participate in the study by the investigator
4. Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
5. Individuals who donated whole blood within the 2 months, or blood components within 2 weeks prior to the first dose of the investigational product(s)
6. Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days (only, 4 weeks for women who may be pregnant) after investigational product(s) administration (Double contraception: two or more of the use of condoms, intrauterine contraception, diaphragm, cervical cap, or a sexual partner who had been medically diagnosed infertility)
7. Individuals with hypersensitivity to ingredients used in the investigational product(s)
8. Patients with serious infection (e.g., Sepsis) or active infection including localized infection
9. Patients with active tuberculosis
10. Patients with severe hepatopathy
11. Patients with an absolute neutrophil count (ANC) less than 500 cells/mm3
12. Patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3
13. Patients who have hemoglobin levels less than 8 g/dL
14. Women who are pregnant or may be pregnant or lactating
15. Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
16. Patients with nephropathy (BUN\<8 or BUN\>20 or Creatinine\>1.5)
The Effect of Administering a Small Dose of Glucose During Cesarean Section

The purpose of this study is to investigate the effect of administering a small dose of glucose on the pregnant women and their neonates during cesarean section. We investigate the safety and efficacy of use of a glucose-containing solution for the pregnant women and the neonates.

Rapid infusion of large amount of glucose is associated with fetal hyperglycemia, hyperinsulinemia, and neonatal hypoglycemia. However, the effect of small dose of glucose is unclear. We conducted a pilot study of small dose of glucose. We investigated the effect of a glucose-containing fluid on the blood sugar of the umbilical artery. We found that in the case of no-glucose-containing fluid, there were some cases in which umbilical arterial concentration of glucose was less than 50 mg/dl, which might cause neonatal hypoglycemia. In addition, in the case of 1%-glucose-containing fluid, mean umbilical arterial concentration of glucose was 97 mg/dl.

The purpose of this study is to investigate the effect of administering a small dose of glucose on the pregnant women and their neonates during cesarean section. We investigate the safety and efficacy of use of a glucose-containing solution for the pregnant women and the neonates.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cesarean section who met the criteria of the American Society of Anesthesiologists physical status of 1-2

Exclusion Criteria:

* ASA physical status \>=3, Obesity (BMI\>35), Height\>=175cm, Weight\>=80Kg
Epinastine and Pseudoephedrine Fixed Combination Compared to Separate Administration in Healthy Volunteers

Study to compare the bioavailable fraction of epinastine and pseudoephedrine when administered as a fixed dose combination in tablet form (new pharmaceutical formulation), with that obtained with each of these drugs when administered separately to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes aged between 21 and 45 years
* Non-smoking volunteers
* Volunteers willing to abstain from alcohol
* The volunteers will have to have suspended any drug treatment at least two weeks prior to the start of the study
* Informed consent in writing, signed in time for the start of the study

Exclusion Criteria:

* Women who are pregnant, breast-feeding or receiving hormonal contraceptives
* Volunteers who require drug treatment of any kind of a chronic nature or due to a known addiction
* Volunteers who have taken part in another clinical trial during the preceding four weeks
* Volunteers who have to begin treatment incompatible with this one during the period of the present study (systemic anaesthetics by inhalation, antihypertensives or diuretics used as antihypertensives, beta-adrenergic blockers, CNS (central nervous system) stimulants, digitalis, glycosides, levodopa, monoamine oxidase inhibitors, nitrates, rauwolfia alkaloids, thyroid hormone sympathomimetics)
* Volunteers who do not observe the fasting stipulated in the study or who do not satisfy its requirements with respect to avoiding the ingestion of coffee, tea, cola drinks, etc. during the 24 hours prior to the study
* Volunteers with a history of hepatic or renal disease and disorders of psychiatric origin
* A history of allergy or intolerance with respect to epinastine or pseudoephedrine
* Volunteers who are intolerant of other sympathomimetics (e.g. salbutamol, amphetamine, ephedrine, etc.)
* Non-cooperative volunteers
* Previous participation in this study
* Histories of cardiovascular disease, ischaemic heart disease, hypertension, diabetes mellitus, glaucoma, hyperthyroidism, prostatic hypertrophy
Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer

Primary objective:

To assess response rate. To record the clinical improvement in relation to stage and histopathological grading.

Secondary objective:

To determine progression free survival. To find out overall survival. To evaluate the safety of the study regimen.


Eligibility Criteria:
Inclusion Criteria:

* Performance status Karnofsky index ≥ 60%.
* Early stage as well as advanced/metastatic ovarian cancer proven by abdominal ultrasonography, chest x-ray, Computerized axial tomography scan.
* Histologically: epithelial/germ cell
* Haematology: absolute neutrophil count: ≥2X10\^9/L; Platelet: ≥150X10\^9/L; Haemoglobin: ≥ 10g/dL
* Liver function: total bilirubin: ≤1X UNL (upper normal limit); Aspartate transaminase \& Alanine aminotransferase: ≤2.5 x UNL; Alkaline phosphatase: ≤2.5 UNL
* Renal function: Creatinine: ≤130 µmol/L; If creatinine \> 130 µmol/L, the 24 hour creatinine clearance should be \> 60 ml/min.

Exclusion Criteria:

* Symptomatic peripheral neuropathy \> grade 1 by National Cancer Institute - Common Toxicity Criteria scale
* Uncontrolled diabetes mellitus and uncontrolled hypertension
* Pregnant, or lactating patients(patients of childbearing potential must be using adequate contraception).
* Active infection or other serious underlying medical condition not compatible with program entry eg. congestive heart failure, previous myocardial infarction within 6 months prior to treatment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Characterisation of Gene Variants in the Angiogenic Pathway

Anti-angiogenic targeted therapies are used in a wide range of solid tumors including NSCLC, breast cancer, GISTs, CRC, renal cell carcinoma and hepatocellular carcinoma. Somatic mutations in genes related to tumorigenesis have been associated with treatment response whereas germline gene variants have been associated with tumor risk, prognosis and treatment related toxicity.Study objectives are:

1. To characterise the prevalence and clinicopathological associations of germline and somatic variation in genes involved in the angiogenic pathway in healthy donors and unselected cancer patients
2. To examine the association between angiogenic gene variants and outcome in patients receiving anti-angiogenic therapy

Angiogenesis plays a key role in the process of tumour growth and metastases. Anti-angiogenic targeted therapies are currently used in a wide range of solid tumors including lung, breast, colorectal, kidney and liver cancer. Somatic variants in genes related to tumorigenesis have been associated with treatment response, whereas germline gene variants have been associated with tumor risk, prognosis and treatment related toxicity. In this study we propose to (1) To characterise the prevalence and clinicopathological associations of germline and somatic variation in genes involved in the angiogenic pathway in healthy donors and unselected cancer patients (2) to examine the association between angiogenic gene variants and outcome in patients receiving anti-angiogenic therapy. Genes related to angiogenesis to be characterised include those encoding platelet derived growth factor receptors, vascular endothelial growth factors, vascular endothelial growth factor receptors, K-Ras, B-Raf, and c-kit. Results from this study may (1) identify patients who are more likely to respond to anti-angiogenic targeted therapy, thus maximising drug efficacy and (2) to identify further targets for potential anti-angiogenic drug therapies.

Eligibility Criteria:
Inclusion Criteria:

* Anti-angiogenic targeted therapies are used in a wide range of solid tumors including NSCLC, breast cancer, GISTs, CRC, renal cell carcinoma and hepatocellular carcinoma
The Follow Study of Speech Functions in Preschool Children With Cerebral Palsy: Clinical Measures and Acoustic Analysis

The aims of this study:

1. to investigate the difference in motor speech functions among children with cerebral palsy (CP) of different motor severities.
2. to investigate the longitudinal in motor speech functions at 6 months follow-up phase among children with CP of different motor severities.
3. the correlation between motor severity, personal factors, family factors, language ability and motor speech in children with CP.
4. to identify the variables that can predict motor speech functions in children with CP.

Mental impairment, language and speech disorders are the common associated problems in children with CP. Previous studies focus on language and motor speech dysfunctions in children with CP at school-age child, adolescents and adults. Few literatures identify the determinants for predicted the motor speech performance in these children. It is important issue to follow-up the language and motor speech functions in children with CP. These data will provide clinicians for outcome prediction and goal setting.The aims of this study: (1) to investigate the difference in motor speech functions among children with CP of different motor severities, and(2) to investigate the longitudinal in motor speech functions at 6 months follow-up phase among children with CP of different motor severities, and(3) the correlation between motor severity, personal factors, family factors, language ability and motor speech in children with CP, and(4) to identify the variables that can predict motor speech functions in children with CP.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects between the ages of 4-8 years old children.
2. Subjects which aged 7 years or older should sign a consent form by themself.
3. In line with the assessment, the case must be able to follow simple verbal commands, and can be done in a simple sentence description.
4. were diagnosed with spastic cerebral palsy.

Exclusion Criteria:

1. physiological condition is unstable: Included in three months for surgery or infection and other major diseases
2. there is progressive or degenerative symptoms or diseases (such as degenerative epilepsy), peripheral nerve injury, spinal cord injury.
3. visual perception or hearing problems, after correction difficult communicators.
4. other movement disorders patterns for children with cerebral palsy (athetoid type, offset type, etc.).
Anesthesia on Optic Nerve Sheath Diameter

Different amounts of anesthetic gas can be used in the obstetric gynecological surgery operations to be performed with open method. Researchers aimed to compare the effect of gas changes on intraocular nerve diameter by ultrasonography.

A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* ASA I-II
* Who underwent laparotomic gynecological surgery

Exclusion Criteria:

* Patients with obstructive pulmonary disease
* Patients with decompensated diabetes, those with a fasting period of more than 12 hours -Acute alcohol intoxication
* Chronic alcohol use
* Who refuse to participate in the study
* Who are not cooperative, do not speak Turkish
* Who had known eye disease (glaucoma, retinal detachment), had a previous history of eye surgery,
* Increased intracranial pressure findings (intracranial lesion, previous cerebrovascular diseases
* Body mass index of \> 40kg/m2
* ASA \> III
Families With Substance Use and Psychosis: A Pilot Study

The purpose of this study is to develop and evaluate an intervention that adapts Community Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). The intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (CRAFT-FT). To assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. Data on client relatives with psychosis will be collected for preliminary assessment purposes. Client relatives will not complete the research study intervention.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70.
* Having a relative who:

  1. Is a patient with early course psychosis (DSM-5 schizophrenia, schizoaffective disorder, schizophreniform, psychosis not otherwise specified (NOS), delusional disorder, brief psychotic disorder, major depression with psychosis, and bipolar disorder with psychosis) with first onset in the past 6 years, and
  2. Uses tobacco, alcohol, or cannabis in the past 90 days and/or has no apparent immediate interest in abstinence.
* The person(s) who can best describe the client with psychosis.
* At least 4 days per month contact with the client.
* Access to a computer with internet or mobile phone with video conferencing capabilities.
* Ability to provide written informed consent.
* Speak and read English.

Exclusion Criteria:

* DSM-5 moderate or severe substance use disorder in the past year.
* Lifetime psychotic disorder.
* History of domestic violence with the identified patient (IP).
* Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the treatment plan.

Inclusion Criteria for Client Relatives:

* Ages 18-35.
* First episode psychosis (FEP) onset in the past 6 years with a DSM-5 diagnosis of affective (bipolar disorder or major depressive disorder with psychotic features) or non-affective psychosis (schizophrenia spectrum disorder).

  a. Used tobacco, alcohol, or cannabis within the past 90 days and/or has no apparent immediate interest in abstinence.
* Ability to provide written informed consent.
* Speak/read English

Exclusion Criteria:

* N/A
Evaluate the Safety and Efficacy of Sinocare CGM System Regarding Real Time Glucose Level Monitoring

From Jan 2022 to June 2022, 120 subjects (22-75 years of age, mean ±standard deviation \[SD\] of 53.20 ±14.49 years) with type 1 or type 2 diabetes participated in the study in P.R. China. Subjects wore two sensors in the abdomen which were paired with smart devices running a glucose monitoring mobile application (i3/H3 CGM APP). Subjects were asked to undergo one in-clinic visit (on one of the study days 2, 7-9, or 15) for 7-hour long YSI frequent sampling test (FST) periods, where intravenous (IV) blood samples were drawn every 15 min and analyzed using the YSI 2300 STAT Plus Glucose \& Lactate Analyzer (Yellow Springs Instrument, YSI Life Sciences, Yellow Springs, OH).


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years, male or female;
2. Clinically diagnosed with diabetes;
3. Being willing to wear the investigational device for the duration set according to its service life, and conduct glucose monitoring;
4. Consent to participate in this clinical study, and sign the Informed Consent Form (ICF).

Exclusion Criteria:

1. Disagree to wear the investigational device continuously according to the requirements of the trial;
2. Refuse venous blood collection for 7 consecutive hours (every 15 minutes) on a certain day during the trial;
3. Plan to undergo magnetic resonance imaging (MRI) during the clinical trial;
4. With diffuse subcutaneous nodules at the wearing site of the investigational device;
5. Have a history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within the 6 months prior to screening;
6. With mental disorders, lack of self-control and inability to express clearly;
7. Have participated in any other clinical trial within the past 1 month;
8. Where the investigator thinks not suitable for being enrolled.
The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure

The main objective of this study is to investigate the effect of Prometheus liver support dialysis on intracranial pressure, cerebral metabolism and circulation in patients with acute liver failure.

Acute liver failure (ALF) is a highly mortal medical condition often complicated by multiorgan failure. Apart from severe coagulopathy ALF is characterized by onset of hepatic encephalopathy and in many cases intracranial hypertension (ICH) with the risk of cerebral incarceration. The pathogenesis behind ICH is incompletely understood and the therapeutic options are limited. Prometheus (R) liver support dialysis offers a system that apart from regular high-flux hemodialysis to a certain extent is able of removing albumin-bound substances from the patient - a feature that theoretically could benefit patients with ALF.

In this study we intend to investigate the effect of 6-8 hours of Prometheus (R) liver support dialysis on cerebral metabolism, ICH and cerebral bloodflow (CBF) in patients with ALF. The study is designed as a open, prospective and randomized study, where a control-group treated with 6-8 hours of continuously veno-venous hemodiafiltration (CVVHDF) and standard medical treatment (SMT) is compared to the intervention group treated with Prometheus (R) liver support dialysis and SMT. The study is designed as a cross-over study so that included patients will be treated in both groups in a randomized order.

The primary end-points are treatment effect on intracranial pressure, CBF and cerebral oxidative metabolism (lactate/pyruvate-ratio). We use a intracranial monitoring system from Integra/Camino (R) (United States) in combination with CMA microdialysis system and bedside analyzer (CMA-600) (Stockholm, Sweden).

Eligibility Criteria:
Inclusion Criteria:

* acute liver failure
* and grade II-IV encephalopathy
* and persistent raised arterial ammonia-concentration above 150 micromol/L
* and informed consent from closest relative and general practitioner

Exclusion Criteria:

* withdrawal of informed consent
* severe untreated infection
* active bleeding within 48 hours
* suspicion of malignant liver disease
* severe heart insufficiency or middle artery pressure below 60 mmHg in spite of vasoactive therapy
* pregnant or lactating women
* disseminated intravascular coagulation
* clinical suspicion of cerebral damage
Effects of Playing Pokemon Go on Physical Activity

The purpose of this study was to test the feasibility and preliminary efficacy of playing Pokémon Go to increase daily steps among young adults. The study also aimed to assess people's experience playing the game, identify specific features of the game that users like/dislike, and explore game features that may promote overall well-being.

Study participants were 30 undergraduate students from a State university in California who were 18 years or older, enrolled full-time, non-Pokémon Go players, and were able to walk leisurely. Daily steps were measured for 6 consecutive weeks via the Fitbit Flex 2. Habitual activity was first measured during the first two-weeks. After the 2-week baseline assessment of physical activity and GPS travel patterns, participants were randomized to one of three study conditions for the remaining 4 weeks: (1) "No Play," (2) "Play At Will," or (3) "Goal Oriented Play". The 4-week intervention period was followed by a post-study interview completed within one week from the end of the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled as a full-time undergraduate or graduate student at participating University
* Willingness to be randomized to one of the three study conditions
* Never played or a Novice Player of Pokemon Go (Cannot have previously exceeded Level 5)
* Not currently meeting physical activity guidelines for adults (i.e., 150 minutes per week of moderate-intensity aerobic activity and/or 75 minutes per week of vigorous-intensity aerobic activity). Assessed via the GPAQ questionnaire.

Exclusion Criteria:

- Unable to leisurely walk for 30 minutes consecutively