cyrilzakka/clinical-trials huggingface dataset:
Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.


Eligibility Criteria:
Inclusion Criteria:

The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria

1. Patients with FEV1.0/FVC (Forced vital capacity) of \<= 70% in the screening test and whose symptoms are stable
2. Patients aged \>= 40 years or older
3. Patients must be able to understand the patient information form

Exclusion Criteria:

1. Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
2. Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
3. Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
4. Patients with glaucoma
5. Patients who have prostatic hypertrophy
6. Patients with hypersensitivity to anticholinergic drugs
7. Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
8. Women who are pregnant or who may become pregnant, or nursing women
9. Patients who are judged by the investigator as inappropriate as the subjects of the study
Utilization of Somatic Tissue Oxygen Saturation Monitoring in Pregnant Women

The purpose of this study is to compare 3 methods of assessing endothelial function in healthy female volunteers and pregnant women with and without pregnancy induced hypertension. The methods under comparison are simultaneous tissue oxygen saturation (StO2), EndoPAT and Sphygmocor (pregnant women only). 35 participants (15 healthy, 10 pregnant normal blood pressure, 10 pregnant with hypertension) will be enrolled.

In both normotensive women and others with pregnancy induced hypertension, in previous research simultaneous tissue oxygen saturation (StO2) were measured in both forearms, with a blood pressure cuff above the tissue oximetry probe on one side.

StO2 values were continuously monitored on each side during unilateral blood pressure (BP) cuff inflation (to suprasystolic pressure for 3 min), and then during deflation. Despite similarity in the forearm StO2 decline observed with cuff inflation in all women, the rise following cuff deflation - indicative of reactive hyperemia - appeared reduced in hypertensive patients, suggesting a relationship with impaired endothelial reserve.

Eligibility Criteria:
Inclusion Criteria:

Non-pregnant group:

1. \> 18 years of age
2. Male or female

Pregnant group:

1. \> 18 years of age
2. Pregnant women \> 20 weeks
3. Diagnosis of Pre-eclampsia characterized as Systolic BP \> 140 mmHg, diastolic BP \> 90 mmHg after 20 weeks of gestation accompanied by new onset of proteinuria.
4. Normotensive, not meeting criteria in #3

Exclusion Criteria:

Non-pregnant group:

1. Raynaud's Disease
2. Adhesive tape allergy
3. Recent Myocardial Infarction (\< 3 months)
4. Congestive Heart Failure

Pregnant group:

1. Raynaud's Disease
2. Adhesive tape allergy
3. Recent Myocardial Infarction (\< 3 months)
4. Congestive Heart Failure
5. Hemodynamically unstable (SBP \< 90 mmHg)
6. Fetal distress
The Role of Macrophage Activation in Lung Injury Following Ozone Exposure

The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. The exposure visits will be at least 2 weeks apart. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.

Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5 study visits. A physical exam to determine eligibility will be done at the first study visit. If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits, at least 2 weeks apart. One exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood and exhaled breath samples will also be collected at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Vaccinated against COVID-19

Exclusion Criteria:

* Cardiovascular disease
* Respiratory disease
* Recent (within 4 weeks) respiratory or COVID-19 symptoms
* Diabetes
* Pregnancy
* HIV Infection
* History of smoking within the past 5 years.
* Orthopedic or rheumatologic conditions which would interfere with cycle use
* Inability to produce a sputum plug at screening
* Daily use of antioxidant supplements, excluding those in a multivitamin. These supplements include Vitamin C or E, selenium, beta-carotene, lycopene, lutein, zeaxanthin and ginkgo biloba. Supplements taken less frequently but at least once a week will be reviewed by the principal investigator for eligibility determination.
Oral Vasopressin Modulates Neural Responses to Looming Visual Stimuli: An Eye-tracking Study

The main aim of the present study is to investigate the effects of orally administered vasopressin (AVP) on the perception of time-to-collision of threatening and non-threatening stimuli by combining a validated looming fear eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design.

Animal models and initial findings in humans suggest a role of the AVP signaling system in socio-emotional processes. At the same time, the visual system's remarkable ability to perceive and interpret impending threats, notably through the "looming" phenomenon- a distinct pattern of optical expansion on the retina as objects approach, theoretically allows for precise estimation of the time-to-collision (TTC). It was recently demonstrated that the affective content of looming stimuli influences perceived TTC, with threatening objects judged as approaching sooner than non-threatening objects, hinting at a nuanced interaction between emotional valence and temporal perception. Within this context the present study aims to validate the effects of orally administered on the perception of time-to-collision of threatening and non-threatening stimuli. To this end, healthy individuals will undergo a double-blind, between-subjects, placebo-controlled pharmaco-eye-tracking experiment and receive a single oral dose of vasopressin (20 IU) or placebo before performing a looming visual stimuli task 45 minutes after administration. The task paradigm will encompass threatening (butterfly, rabbit) and non-threatening (spider, snake) stimuli

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent.
* Normal or corrected-normal version

Exclusion Criteria:

* History of neuropsychiatric diseases.
* History of cardiac disease, including arrhythmias, aortic stenosis, or congestive heart failure; history of syncope or unexplained loss of consciousness.
* History of hepatic diseases, including cholestasis, biliary obstructive disease, or severe liver dysfunction.
* History of renal diseases, including renal stones or renal failure.
* History of hyponatremia(Serum sodium \<135mmol/L) or hyperkalemia (Serum potassium\>5.5mmol/L); history of diabetes mellitus or diabetes insipidus
* Known hypersensitivity or allergic reaction to any medication or hormone; strong allergic reaction to food.
* Infections such as COVID-19 or influenza, or unexplained fever.
* Subjects with hypertension (BP ≥130/80mmHg) or hypotension (BP ≤ 90/60mmHg).
* History of alcohol or drug abuse; smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day); smoker using e-cigarettes.
A Bioequivalence Study of Two Different PEG-rhGH Preparations.

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged ≥18 years old and≤45 years old;
* The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
* Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion Criteria:

* Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing;
* Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators;
* Subjects with severe infection, severe trauma, or major surgery prior to screening;
* Subjects who have received blood transfusions, had blood donors, or lost blood before screening;
* Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
* Subjects who have participated in clinical trials for medication or medical device prior to screening;etc.
Screening, Brief Intervention, and Referral to Treatment for Drug Use

Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive, integrated public health approach to identify and deliver a spectrum of early detection and intervention services for substance use in general medical care settings. These settings, such as emergency department visits, offer a potential "teachable moment" because patients may have perceptions of vulnerability about their health, and therefore be particularly receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT is effective in reducing alcohol use at varying levels of severity in a myriad of health care settings including primary care, emergency departments, and trauma centers. Although the SBIRT approach has shown promise for alcohol, relatively little is known about its effectiveness for adult illicit drug use specifically.

This will be among the first studies to rigorously test the SBIRT approach for drug use. It will evaluate the effectiveness of SBIRT for drug use and related factors for 700 multi-ethnic ED patients using a two-group randomized repeated-measures design in which biologically-validated drug use abstinence and related outcomes of an intervention group are compared to those of an attention-placebo control group. Over a 14-month period, bilingual/bicultural Health Educators recruited participants who reported past 30-day illicit drug use in excess of risky alcohol use from the waiting areas of two large hospital's ED and trauma units. Following consent procedures and standardized baseline assessments, Health Educators randomly assigned participants to one of the two conditions. The intervention group received "Life Shift," an SBIRT drug use intervention matched to the participant's drug use risk level. The control group received the same type and quantity of intervention in an unrelated area-Driving and Traffic Safety ("Shift Gears" program), also matched to their driving/traffic risk level. A 6-month face-to-face follow-up visit by trained measurement technicians blind to the participant's assigned condition collected standardized self-report past 30-day drug use measures (ASI-Lite)and hair samples for validating self-reported abstinence. Additional outcome variables are changes in the frequency of drug use, functional status measures (i.e., medical problems, psychiatric problems, and alcohol use), and health care utilization.


Eligibility Criteria:
Inclusion Criteria:

* 18 or over
* speak English or Spanish
* competent to give consent and interact
* drug use risk higher than alcohol use risk

Exclusion Criteria:

* under 18
* non english or spanish speaker
* no telephone where one can be reached
* too injured/sick to participate
* alcohol use risk higher than drug use risk
Surgical Management Of Gastroschisis

The investigators aim to analyze the management of children born with gastroschisis between January 2009 and December 2023, i.e. to evaluate post-operative follow-up, hospitalization costs, the risk of post-operative umbilical hernia, and the parents' and the child's appreciation of the scar.

Gastroschisis is an abdominal wall anomaly that affects 3 in 10,000 live births, and in over 90% of cases is diagnosed before birth. In fetuses with gastroschisis, the intestine protrudes through a defect in the abdominal wall, usually to the right of the umbilical cord. Although the survival rate of live newborns with gastroschisis is over 90%, the risk of intrauterine fetal death is still 7.5 times higher than in the normal population, and gastroschisis can cause significant morbidity during the neonatal period.

The scientific literature suggests multiple options for each stage in the care of children with gastroschisis, both pre- and postnatally. Heterogeneity of practice exists even within the same geographical area, and deserves to be analyzed.

In this context, the investigators wish to analyze the management of children born with gastroschisis between January 2009 and December 2023, i.e. to evaluate post-operative follow-up, hospitalization costs, the risk of post-operative umbilical hernia, and the parents' and the child's appreciation of the scar.

Eligibility Criteria:
Inclusion Criteria:

* Patients born with gastroschisis between January 2009 and December 2023

Exclusion Criteria:

* Patients born with gastroschisis before January 2009 or after December 2023 Patients without gastroschisis
MolecuLightDX Measurement Feature Clinical Validation

This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.

The study compares the accuracy of wound measurements (area, length, and width) obtained using the ruler (standard of care) method and the MolecuLightDX device with a ground truth measurement (reference standard) derived from an expert panel.

Eligibility Criteria:
Inclusion Criteria:

* Willing to consent
* Willing to comply with all study procedures and availability for the duration of the study
* Male or female, aged over 22 years old
* Presented with diabetic foot ulcers, venous, arterial and pressure ulcers
* Wound size is greater than 0.5 cm2
* The wound has well-defined wound borders

Exclusion Criteria:

* Circumferential wound
* Wound without clearly defined wound borders
* Wound located in a difficult to reach/measure location
* Any contra-indication to routine wound care and/or monitoring
* Wounds with a length greater than 18.5cm or a width greater than 13.5cm.
* Tunneled or undermined wounds
Injection Site Pain Comparison of Excipient Solutions

The purpose of this study is to investigate different solutions used to inject drugs under the skin. The solutions used in the study do not contain the drugs they will be used for, but they do contain excipients, which are inactive substances added to drug solutions to ensure the stability (shelf life and correct activity) of the drug product. The excipients are considered 'inactive substances' compared to the drug, but they may cause an undesirable effect at the injection site in the form of pain. However, their pain-causing potential has never been tested in a systematic way. The purpose of the study is to determine if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 12 different study products. These study products are excipient solutions, which are substances in medications next to the active substance. None of the 12 products include active medication. This study will be performed in 108 healthy male and female volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 69 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) equal to or above 25.0 and below 30.0 kg/m\^2.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the Investigator.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant within 1 week of Day 2 or is of childbearing potential and not using highly effective contraceptive methods.
* Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
* Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
* Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication (when not used in the abdominal area), contraceptives or occasional use of paracetamol (not allowed within 24 hours prior to Trial Product administration), within 14 days prior to Day 1.
* Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
* Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research centre.
* Use of tobacco and nicotine products, defined as any of the below:
* Smoking more than 1 cigarette or the equivalent per day on average.
* Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period.
* Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the trial requirements.
Renal PK Study of LC350189

This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189.


Eligibility Criteria:
Inclusion Criteria

* The subject has a BMI of 18 to 40 kg/m2, inclusive, at screening.
* The subject is able to provide written informed consent.

For healthy subjects only : The subject has normal renal function as determined by eGFR and calculated using the MDRD formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.

For subjects with renal impairment only

: The subject has mild, moderate, or severe renal impairment as determined by eGFR and calculated using the MDRD formula.

Exclusion Criteria

* The subject has a history or clinical manifestations of a significant neurological, cardiovascular, endocrine, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
* The subject has nephrotic syndrome, defined as serum albumin \<3.0 g/dL and urine protein/creatinine ratio \>350 mg/mmol (as an estimate of approximate proteinuria of \>3.5 g/day) at screening.
Effectiveness of Ergonomic Training and Exercise in Automotive Factory Workers With Nonspecific Chronic Low Back Pain

This study compares the effectiveness of ergonomic training and exercise in automotive factory workers with chronic low back pain of unknown cause.

The study was planned as a randomized controlled study. Workers between the ages of 18-60 who have back pain and work in an automotive factory in Galway, Ireland will be included in the study. Participants will be divided into two groups. The factory workers included in the study will be divided into a study group and a control group using a simple random method. Randomization will be done using the sealed envelope method. The study group will be given stretching and strengthening exercises along with ergonomics training. The control group will be given only ergonomics training. The exercises they will do and the ergonomics training will be explained to the participants individually and supported with a brochure. The participants will be asked to do the given exercises 3 days a week and continue for 12 weeks. The given exercises will be followed up with an exercise follow-up chart. In order to collect data on the sociodemographic characteristics of the participants, a personal information form will be prepared by the researcher and the participants will be asked to fill it out. In order to collect data from the participants; Visual Analog Scale will be used to collect information about pain, International Physical Activity Questionnaire to collect information about physical activity levels, Pittsburgh Sleep Quality Questionnaire to determine sleep quality, Oswestry Low Back Pain Scale for functionality assessment, Manual Muscle Testing to determine muscle strength. These questionnaires will be repeated before starting the study and at the end of the study. The data to be obtained will be evaluated using SPSS 24 package program.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18-60 years old
* Having worked in the same factory for at least 2 years
* Working full time
* Having complained of back pain for at least 3 months
* visual analog scale\>4, pain 4 and above on visual analog scale

Exclusion Criteria

* Being under 18 years old or over 60 years old
* Having worked for less than 2 years
* Working part time
* Having complained of back pain for less than 3 months
* visual analog scale Presence of psychological problems
* Using sleeping pills
* Having undergone surgical intervention in the last 6 months