cyrilzakka/clinical-trials huggingface dataset:
PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers

To investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 under Fed Condition in healthy male volunteers

The purpose of this study is to investigate the Pharmacokinetic Properties and Safety after administration of HCP1303 capsule and Co-administration of HGP1201 tablet, HIP1402 capsule under Fed Condition in Healthy Male Volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer, age 19\~55 years
2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
4. Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. History of relevant drug allergies or clinically significant hypersensitivity reaction.
3. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
4. Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
5. SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower than 60mmHg or higher than 100mmHg
6. Subjects who judged ineligible by the investigator.
Ultrasound Assessment of Ventral Hernia Defects

Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using shear wave velocity values measured with ultrasound will identify features of the abdominal wall that differ between healthy volunteers and subjects scheduled to have ventral hernia repair. Through the use of ultrasound including shear wave velocity measurements, the abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia affects abdominal wall elasticity and effect surgical outcomes.

ARFI-SWV Ultrasound holds promise as an inexpensive, noninvasive, point-of-care diagnostic tool for pre-operatively predicting successful hernia repair. The investigators propose to develop and refine a quantitative ultrasound protocol to measure abdominal wall features suitable for predicting successful closure of the midline fascia. ARFI-SWV ultrasound represents a novel and intriguing modality for real time visualization and characterization of changes in the biomechanical properties of diseased musculoskeletal tissues.

In this study, ARFI-SWV ultrasound is hypothesized to preoperatively measure the stiffness in the lateral abdominal wall as an estimation for mobility during hernia repair. Preoperatively evaluating hernia severity through ARFI-SWV ultrasound will be performed to identify mechanical characteristics of the abdominal musculature to predict success of midline fascial re-approximation in hernia patients. The study proposes to compare ultrasound images and associated shear wave velocity measurements between 35 healthy volunteers and 25 subjects undergoing surgical repair for ventral hernia. Subjects with ventral hernia will undergo imaging no earlier than two weeks prior to elective hernia repair and again postoperatively within six months following repair at a standard followup visit. Statistical analysis will determine if there is a significant difference in the abdominal wall stiffness, represented by the ultrasound shear wave velocity measurements, between the healthy subjects and the subjects with ventral hernia. Further analysis will determine if there is any statistically significant relationship between abdominal wall stiffness of subjects with ventral hernia and surgical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* male or female between 20-70 years of age
* healthy volunteer or seeking elective ventral hernia repair

Exclusion Criteria:

* pregnant women
A Study of RO6885247 in Adult and Pediatric Patients With Spinal Muscular Atrophy (MOONFISH)

This multicenter, randomized, double-blind, 12-week, placebo-controlled multiple dose study will investigate the safety and tolerability of RO6885247 in adult and pediatric patients with spinal muscular atrophy (SMA).


Eligibility Criteria:
Inclusion Criteria:

* Males and females, aged 2 to 55 years inclusive or below 7 months inclusive
* Confirmed diagnosis of 5q-autosomal recessive SMA (Types 1 to 3), for patients aged 7 months or below clinical symptoms attributable to type 1 SMA and 2 SMN2 copies
* Able and willing to provide informed consent and to comply with the study protocol. Alternatively, a legally authorized representative must be able to consent for the patient and assent must be given by the subject wherever possible.
* Female patients of childbearing potential and male patients with a female partner of childbearing potential must agree with the required contraceptive methods as defined per protocol.
* For patients aged 7 months or below, Gestational age of 37 to 42 weeks and not considered small for gestational age at birth

Exclusion Criteria:

* Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening
* Concomitant or previous participation in a SMN2-targeting antisense oligonucleotide study within 12 months prior to screening
* Concomitant or previous participation at any time in a gene therapy study
* For patients aged 2-55 years, hospitalization for pulmonary event within the last 2 months or planned at the time of screening
* Surgery for scoliosis in the last 6 months from screening or planned within 6 months from screening
* Unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease
* Clinically relevant ECG abnormalities at screening or baseline; personal or family history (first degree relatives) of congenital long QT syndrome
* Clinically significant abnormalities in laboratory test results at screening
* Any concomitant disease or condition that could interfere with the conduct of the study, or pose an unacceptable risk to the subject in this study
* Use of prohibited medications as per protocol within 90 days prior to randomization. Patients who are on inhaled corticosteroids, administered either through a nebulizer or an inhaler, are allowed.
* Recently initiated treatment (within \<6 months prior to randomization) with oral salbutamol or another beta2-adrenergic agonist taken orally is not allowed. Patients who have been on oral salbutamol (or another beta2-adrenergic agonist) for at least 6 months before randomization are allowed. Use of inhaled beta2-adrenergic agonists is allowed.
* For patients aged 7 months or below, patients requiring invasive ventilation or tracheostomy, presence of non-SMA related morbidities
Examining Physiology and Brain Function in People With the Fragile X Premutation

This study will examine whether individuals with the fragile X genetic premutation are likely to have emotional, social, and memory deficits and how the brain may be involved in these deficits.

FMR1 is a gene associated with fragile X syndrome-the most common cause of mental retardation-and with social, emotional, and cognitive deficits. The chance of developing these deficits depends on the number of times the FMR1 gene is repeated on the X chromosome. Individuals with more than 200 copies of the FMR1 gene have the full fragile X mutation, putting them at most risk for mental retardation. Individuals with between 55 and 200 copies of the FMR1 gene have the fragile X premutation; they are much less likely to develop mental retardation, but they may have subtle social, emotional, and cognitive deficits and their children are more likely to have the full fragile X mutation. A theory, which this study will test, holds that the deficits of people with the fragile X premutation are caused by dysfunction in the limbic system. The limbic system consists of a group of structures in the brain that govern emotions and behavior. This study will examine people with the fragile X premutation to determine whether and to what extent they have emotional, social, and memory deficits. The study will also determine whether changes in fragile X gene function are related to increased deficits and how the brain, and specifically the limbic system, may be involved in these deficits.

Participation in this study will last 2 days. Participants will undergo several hours of testing at a lab on back-to-back days. Testing on the first day will include the following: providing several saliva samples; undergoing neuropsychological testing, in which participants will solve different types of problems and be interviewed about their emotional and social experiences; and undergoing a physical exam and blood draw.

Testing on the second day will include the following: an MRI scan, which will take pictures of the brain both while participants are resting and while they are performing certain tasks; more neuropsychological testing similar to that from the day before; and questionnaires about emotional and social experiences. A family member will also be asked to fill out a questionnaire about the participant. On 2 other days, participants will be asked to collect saliva samples while at their homes and send the samples to the study researchers. In addition, the researchers will keep in contact with participants in case any follow-up is needed over the next few years.

Eligibility Criteria:
Inclusion Criteria:

* Possesses FMR1 premutation or is part of the general population control group
* Normal or corrected vision
* Speaks English

Exclusion Criteria:

* Presence of contraindication for brain MRI, such as having metal in the body
* Presence of a major medical condition, such as kidney, heart, or liver disease
* Presence of a neurological disorder
* Current alcohol or drug abuse or dependence
* History of head trauma
* History of brain infection
* Medication affecting cerebral blood flow
The Impact of Anterior Abdominal Wall Tissue Oxygenation During Pneumoperitoneum of Regional Anesthesia Methods

During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.

The investigators aimed to investigate the effects of regional anesthesia methods administered during laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* Underwent laparoscopic cholecystectomy

Exclusion Criteria:

* Previous surgeon surgeon
* Local anesthetic allergy,
* Bleeding is a diathesis disorder
* Mental impairment,
* Allergic to the drugs used,
* Patients who are not reluctant to participate in the study,
* Presence of infection in the block area,
* Patients whose body mass index is over 30
The Heidelberg Engineering ANTERION Corneal Epithelium Thickness Precision and Agreement Study

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess corneal epithelial thickness parameters with the ANTERION


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 22 years of age
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. With at least one of the following eye status for the corresponding eye population:

   * Normal Cornea
   * Abnormal Cornea: eye with at least one of the following

     a) Keratoconus b) Contact Lens Wearer c) Status Post-Keratorefractive Surgery (at least 30 days between imaging and Keratorefractive Surgery) d) Dry Eye Disease

Exclusion Criteria:

* Exclusion Criteria General

  1. Active infection in either eye
  2. Insufficient corneal reflex, in the study eye
  3. Physical inability to be properly positioned at the study devices or eye exam equipment
* Exclusion Criteria Normal Cornea Group

  4. Abnormal cornea shape or corneal surgery in the study eye

  5. Contact lens wear within 3 months prior to imaging in the study eye

  6. Dry eye disease in the study eye
* Exclusion Criteria Abnormal Cornea Group

  4. For Keratoconus (a):
  * Contact lenses worn within one hour prior to imaging

    5. For Contact Lens Wearer (b):
  * Keratoconus
  * Post-Keratorefractive surgery
  * Contact lenses worn within one hour prior to imaging

    6. For Post-Keratorefractive Surgery (c):
  * Keratoconus
  * Contact lens wear within 3 months prior to imaging in the study eye

    7. For Dry Eye Disease (d):
  * Keratoconus
  * Post-Keratorefractive surgery
  * Contact lens wear within 3 months prior to imaging in the study eye
Evaluation of Ciclo 21® Effect (Levonorgestrel + Ethinyl Estradiol) Compared to Nordette®.

Assessment of the pharmacodynamic profile of the drug Ciclo 21 ®, marketed by União Química Farmacêutica Nacional S / A, compared to the drug Nordette ® Laboratory Wyeth Pharmaceutical Ltda. Through the modulation of hormonal response (inhibition of the pituitary) evidenced by measurement serum LH and FSH for 28 days, as well as by the absence of follicle formation demonstrated by transvaginal ultrasound examinations

secondary objective

* Evaluation of the safety aspects of medicines such as type, frequency and intensity of adverse events between groups during the 28 day trial.

exploratory objective

* Evaluation of the pharmacokinetics of the drug administered through the dosage of serum hormone levonorgestrel and ethinyl estradiol for 28 days.

Eligibility Criteria:
Inclusion Criteria:

1. Comply with all study procedures, sign, initial and date back, of their own free will, the IC;
2. Women aged between 18 and 35 years, regardless of race and class;
3. Make use of safe non-hormonal method of contraception such as tubal ligation, non-hormonal IUDs or condoms, or be hysterectomised or be vasectomized sexual partner;
4. Examination of Beta-HCG negative;
5. with regular menstrual cycles every 24 to 32 days, at least the last three months;
6. present normal Pap test (current or during the past 02 years);
7. Present or vaginal examination found that the changes do not interfere in the study;
8. present levels of FSH, LH, estradiol and TT for the normal menstrual cycle, as well as normal transvaginal sonographic reports.

Exclusion Criteria:

1. Provide a contraindication to the use of steroids;
2. Use regular or prediction of drugs that interfere with the metabolism of the investigational products, such as antibiotics, anticonvulsants, anticoagulants and hypoglycemic drugs;
3. smokers or have stopped smoking less than 12 months;
4. Diabetic;
5. Toxic-dependent;
6. BMI \<18 and\> 25;
7. have made use of topical or systemic sex hormone for at least two months before the start of the study;
8. Background and personal or family history of thrombosis or bleeding disorders or vascular disorders or cardiovascular disease;
9. Laboratory tests, gynecological ultrasound or changed, the medical criteria;
10. Individuals with allergies or rheumatic diseases for which is indicated the use of cortico-steroid medication;
11. carry any endocrine changes, especially pituitary and gonadal and / or who are advised to use hormones;
12. with lesions or abnormalities suspected or confirmed in the gonads.
13. personal or family history of breast cancer or other hormone-dependent breast pathology;
14. with hypertension or diabetes mellitus (for drug interactions between the COC and hypoglycemic agents and antihypertensives);

a) History of nausea with oral use of COCs; p) Any condition that may interfere with the discretion of the investigator in the study data as well as being the measurement of the study be deleterious to the patient.
Determination of Product Thickness Applied on Different Areas of the Face Using a Multispectral Imaging Method

The aim of the study is to determine:

* the thickness of the RV4369A truly applied on different areas of the face after single application of the product determined by a multispectral imaging method.
* the influence of a second application of the product 15 to 30 minutes after the first application on the product thickness determined by multispectral imaging method.
* the influence of the recommendations of use provided to the subjects before application of the product on the product thickness determined by multispectral imaging method .

This study is a monocentric, comparative, open study performed on the face and forearms of healthy adults.

Planning of the visits:

Visit 1: Inclusion visit (D1) Visit 2: End of study visit (D10), a window of +/- 2 days is allowed for this evaluation, \* The theoretical study duration for each subject is 10 days. The maximal study duration for each subject is 12 days.

Eligibility Criteria:
Inclusion Criteria:

* Dry, normal to combination skin
* Phototype I to V inclusive.
* Absence of significant facial hair.

Exclusion Criteria:

Population

* Pregnant, breastfeeding women.
* For men: moustached or bearded.
* Substantial hair on the forearm and face.
* Application of keratolytic or self-tanning products to the face, forearms and arms in the four weeks prior to inclusion.
* With scars or other cutaneous characteristics, sunburn on forearms in the test areas, the size of which is considered incompatible with the study.
* Application of water, cleansing or beauty products to the forearms and arms since the last wash on the evening before inclusion.

Diseases :

* Known history of allergy to any of the investigational product ingredients.
* Known history of allergy to latex.
* Skin lesions or skin disease on the face or on the arms and forearms that may affect test results (seborrheic dermatitis, atopic dermatitis, psoriasis, acne, rosacea, etc.).

Treatments:

* Ongoing local or Oral treatment (retinoids, anti-inflammatory) that may affect test results.
Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health

This study is investigating the effect of a medication called glucagon-like peptide 1 (GLP1) receptor agonists on mental health. GLP1 receptor agonists are a type of medication that are used to treat obesity and type 2 diabetes (T2D). Obesity and T2D are very common health conditions, and research has shown that people living with obesity and T2D are more likely to experience mental health disorders. Some recent research has suggested that GLP1 receptor agonists might help with mental health problems such as depression and binge eating disorder, and the investigators want to expand on this in this study. The investigators will be recruiting patients from community diabetes services, and tier 3 weight management services in South East London. Patients will be eligible if they are starting on GLP1 receptor agonists for the management of either T2D or obesity. The study is a mixed methods, longitudinal observations study with two components - a quantitative and a qualitative aspect. Firstly, the investigators will be interviewing patients before and 12-16 weeks after starting the medication, using short questionnaires which asks participants about different mental health symptoms that they may be experiencing. The investigators will use this information to see if there are any objective changes in mental health after taking GLP1 receptor agonists. Secondly, the investigators will be conducting a longer semi-structured interview after the second set of short questionnaires (at 12-16 weeks after starting GLP1 receptor agonist), asking about patient's experiences of taking the medication and how it has affected their mental health and general wellbeing. The investigators will qualitatively analyse this data to determine the subjective effect of GLP1 receptor agonists on mental health and wellbeing.


Eligibility Criteria:
Inclusion Criteria:

* being commenced on a glucagon-like peptide 1 (GLP1) receptor agonist for management of either for obesity or type 2 diabetes
* least 18 years of age
* able to consent, speak and read in fluent English.

Exclusion Criteria:

* not able to consent, speak and read in fluent English
Physical Activity Intervention in African American Men After Radical Prostatectomy

The purpose of this pilot study is to evaluate the feasibility of recruiting African American prostate cancer survivors to a 12 week physical activity intervention study of three arms (aerobics, resistance training, and usual care) through physician referral and community advertisement strategies. In addition, the investigators will investigate the acceptance rate of the intervention and gather preliminary results on the effect of exercise on African American men's urinary and sexual functions. These data can then be used to refine the intervention and its implementation model, and to inform the submission of a larger grant to the National Institutes of Health.


Eligibility Criteria:
Inclusion Criteria:

* Speaks English
* African American
* Radical prostatectomy for treatment of prostate cancer within the past 12 months
* Cleared by physician to safely participate in a physical exercise program

Exclusion Criteria:

* Does not speak English
* Non-African American
* Previously undergone radiation treatment to the pelvis
* Previously undergone major pelvic surgery
* Known urethral stricture, colostomy, or inability to urinate requiring chronic urinary catheter
Behavioral Assessment of Operated Preschool Children

This study will investigate the behavior of preschool children who had undergone general surgery during early infancy and will correlate the behavioral outcomes with clinical perioperative variables.

Several epidemiologic and observational studies found the relation between surgery in childhood and neurodevelopmental features in later life. However, these studies are criticized for retrospective design, non homogenous population, social confounders, diversity of surgical procedures and anesthetic management.

Monitoring of neurological function has become standard during surgical procedures at risk for neuronal injury (e.g. cardiac surgery). There is also some data on possible predictive value of certain methods of neuromonitoring (such as cerebral near infrared spectroscopy (NIRS)) for neurodevelopmental outcome.

General neonatal/infant surgery and the whole perioperative period carry the risk of significant physiologic disturbances, which may affect cerebral perfusion, oxygenation or metabolism. This study is the continuum of prospective observational trial, which investigated the value of the neuromonitoring measures in neonates and young infants undergoing general surgery. The present study will apply the behavioral assessment of these patients who are now between 2 and 5 years of age.

Eligibility Criteria:
Inclusion Criteria:

* children, who had undergone general surgery for congenital anomalies or disease from birth until 93 days of age at a single University hospital
* general anesthesia with inhalational anesthetic was applied during surgery
* artificial lung ventilation was applied during anesthesia
* NIRS values were recorded throughout anesthesia
* serum concentrations of brain specific proteins were obtained during perioperative period

Exclusion Criteria:

* children, who had undergone cardiac, neurosurgical, ear, nose and throat or eye surgery from birth until 93 days of age
* general anesthesia without tracheal intubation was applied
* local or combined local/general anesthesia was applied