cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding

This is a prospective, single-blinded, randomized study to evaluate the efficacy and safety of CEGP003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine injection therapy.

CEGP003 is wound dressing solution containing Hydroxyethyl-cellulose and EGF. Epidermal growth factor (EGF) stimulates cell growth and differentiation by binding to its receptor, which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a peptic ulcers bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

Exclusion Criteria:

* Subjects who have a history of malignant tumor in upper gastro-intestinal site
* Subjects with platelet and coagulation dysfunction (PLT \< 50E9/L, INR \> 2)
* Subjects that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 72 hours after the treatment
* Subjects with one or more bleeding sources
* Subjects who are pregnant or breast-feeding
* Subject who are allergic or have a hypersensitive reaction to Hydroxyethyl-cellulose or EGF
* Subjects who have undergone endoscopically therapies within the last 7 days
* Subjects who are considered not suitable for the study by significant disease
* Subjects who are not able to comply with the study requirements
* Subjects who are currently enrolled in another clinical study which can impact the study within 30 days of screening
* Subjects who are considered not suitable for the study by the investigator
A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 1)

The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion).


Eligibility Criteria:
Inclusion Criteria:

* Advanced cancer, excluding cancer in the blood
* Availability of 10 tumor tissue slides

Exclusion:

* Known brain metastases
* Severe nerve damage
* Significant cardiovascular disease
* Inadequate blood counts
* Inadequate liver or kidney function
* Inadequate thyroid function or uncontrolled thyroid disease
Meeting Protein Targets in Critically Ill Patients

This is a retrospective study of protein and energy intake in enterally fed critically ill adult patients before and after the introduction of a very high protein enteral nutrition formula in a single center medical/surgical ICU.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age, mechanically ventilated
* Received enteral nutrition for a minimum of five days during the first week of ICU admission

Exclusion Criteria:

* Received parenteral nutrition during first week of ICU admission
* Acute renal failure not dialyzed
* Hepatic encephalopathy grade 3 or 4
* Intentional underfeeding/trophic feeding - including refeeding syndrome
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-1 and BR1015-2 Under Fasting Conditions

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015 and co-administration of BR1015-1 and BR1015-2 in healthy volunteers under fasting conditions


Eligibility Criteria:
Inclusion Criteria:

* Those weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of consent to 14 days after the last administration and disagrees to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Testing the Contribution of Orbitofrontal Cortex Networks to Reward Identity Learning

This research study examines the contribution of orbitofrontal cortex (OFC) networks to learning reward identity expectations.

This study is designed to examine the contribution of OFC networks to reward identity learning. It will use network-targeted TMS to test whether OFC is necessary for reward identity learning. Healthy human subjects will perform a three-reward reversal learning task after either TMS or sham stimulation while fMRI data are acquired. This is a randomized, within-subject, cross-over study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years old
* Right-handed
* Fluent English speakers

Exclusion Criteria:

* History of significant neurological conditions (e.g., epilepsy, dementia, multiple sclerosis, brain tumors, etc.)
* History of major psychiatric conditions (e.g., general anxiety disorder, depression, schizophrenia, obsessive-compulsive disorder, post-traumatic stress disorder, attention deficit hyperactivity disorder, alcoholism, etc.)
* Significant medical illnesses (e.g., cancer, meningitis, chronic obstructive pulmonary disease, cardiovascular disease, etc.)
* Significant cerebrovascular risk factors (e.g., hypertension, diabetes, elevated cholesterol, etc.)
* Current use of psychoactive medications (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, citalopram, escitalopram, fluoxetine, diazepam, etc.)
* Smell or taste dysfunction
* History of significant allergies requiring hospitalization for treatment
* History of severe asthma requiring hospitalization for treatment
* Habitual smoking
* Magnetic implants (e.g., shunts or stents, aneurysm clips, surgical clips, cochlear implants, metal bone/joint pins, plates and screws, eyelid spring or wires, etc.)
* Electronic devices (e.g., implanted cardiac defibrillator, cardiac pacemaker, deep brain/spinal cord or nerve stimulator, internal electrodes/wires, medication infusion devices, etc.)
* History of metal working without proper eye protection, or injury with metal shrapnel or metal slivers
* Claustrophobia
* Pregnancy
* Predisposition to seizures (e.g., personal history of seizures, family history of seizures epilepsy, pregnancy, alcoholism, etc.)
* Use of medications that increase the likelihood of seizures (e.g., bupropion, citalopram, duloxetine, ketamine, gamma-hydroxybutyrate, etc.)
* History of surgical procedures performed on the brain or spinal cord
* History of severe head trauma followed by loss of consciousness
* History of fainting spells or syncope
* Hearing problems or tinnitus
Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects

Study to evaluate the effect of food and the effect of swallowing capsule whole versus sprinkling on apple sauce on the pharmacokinetics (PK)/bioavailability of palovarotene, and evaluate the effect of palovarotene on the PK of the CYP3A4 substrate midazolam.


Eligibility Criteria:
Key Inclusion Criteria:

* Generally healthy male or female aged 18 to 55 years, inclusive; body mass index (BMI) of 18 to 30 kg/m2 and a body weight of \>50 kg; resting pulse of \>45 bpm and \<100 bpm; systolic and diastolic blood pressure of \<140/90 mmHg

Key Exclusion Criteria:

* a history or current evidence of a clinically significant or uncontrolled disease, disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
* exposure to synthetic oral retinoids or creams containing retinoids in the past 30 days prior to the signature of the informed consent.
* history or presence of silent infections, including positive tests for human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* history of allergy or hypersensitivity to retinoids, gelatin, or lactose
* For the DDI component only, the subject had a history of allergy or hypersensitivity to benzodiazepines, midazolam, cherries, or midazolam formulation excipients
Oxidized Cellulose Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study

This single-blind prospective randomized study was designed to assess the efficacy and safety of the use of Surgicel® compared to the use of conventional surgical procedures (ligatures and bipolar electrocautery alone) to achieve hemostasis in thyroid surgery

patients who require a thyroidectomy will be enrolled after informed consent will begiven. Prior to thyroidectomy, patients will be randomized to two groups: 1) use of conventional surgical procedures to achieve hemostasis,i.e., ligatures and bipolar electrocauterization alone, and 2) use of oxidized cellulose patch (Surgicel©) in addition to classical methods (ligature; bipolar electrocautery). All anticoagulants will be discontinued 10 days prior to the operation, if this will not be possible the patient will be excluded. The investigators will perform the specified procedure in accordance with accepted clinical practice standards. At the end of the thyroidectomy, a meticulous hemostasis will be achieved. Before wound closure, the sealed affiliation envelopes will be opened and 1-2×2 cm oxidized cellulose patch will be placed over the thyroid bed depending on patient randomization. Next, a suction drain will be placed. The drains will be removed when the secretion volume/day will be less than 20 cc.

All operations will be performed under general anesthesia by three head and neck surgeons who had experience in thyroid surgery. Outcome measures will include duration of operation, hemodynamic variables on emergence (blood pressure and heart rate), volume of secretion in the drain, time to removal of wound drain, length of postoperative hospital stay, and incidence of postoperative complications, i.e. hemorrhage, transient hypoparathyroidism, wound infection, seroma, and recurrent laryngeal nerve palsy. Evaluation of the postoperative course and recording of data will be done by one surgeons blinded to the intervention (MA). Follow-up for this study will be ended one month after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients who required a thyroidectomy

Exclusion Criteria:

* Unwilling or unable to consent
* Age \< 18 years
* known allergy to oxidized cellulose
* Inability to discontinue use of anticoagulants 10 days before surgery
* Coagulopathy that could not be corrected
Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients

This prospective randomized controlled trial aims to examine the effect of fascia iliaca compartment block on the postoperative pain and opioid consumption in pediatric patients (3y≤ age \<18y) who will undergo orthopedics surgery (proximal femoral osteotomy).

Patients will be allocated to either the FICB(Fascia iliaca compartment block + IV PCA) group or the control group (no block + IV PCA). Fascia iliaca compartment block will be performed using 0.25% ropivacaine (1mL/kg, MAX 30mL) under ultrasound-guidance at the end of surgery.

The total opioid consumption at 12, and 24 hours after the surgery, and the pain score at 10 min after PACU admin, 1,6,24 hours after the surgery, the total dose of additional rescue analgesia (intravenous ketorolac or nalbuphine) at 12 and 24 hours after the surgery will be recorded.

This prospective randomized controlled trial aims to examine the effect of fascia iliaca compartment block on postoperative pain and opioid consumption in pediatric patients (3y≤ age \<18y) who will undergo orthopedics surgery (proximal femoral osteotomy).

Patients will be allocated to either the FICB(Fascia iliaca compartment block + IV PCA) group or the control group (no block + IV PCA). Fascia iliaca compartment block will be performed using 0.25% ropivacaine (1mL/kg, MAX 30mL) under ultrasound-guidance at the end of surgery.

The total opioid consumption at 12, and 24 hours after the surgery, and the pain score at 10 min after PACU admin, 1,6,24 hours after the surgery, the total dose of additional rescue analgesia (intravenous ketorolac or nalbuphine) at 12 and 24 hours after the surgery will be recorded.

Eligibility Criteria:
Inclusion Criteria:

- 36 children aged between 3 and 18 years who undergo proximal femoral osteotomy

Exclusion Criteria:

* Complex surgery (other than proximal femoral osteotomy)
* Allergy to opioid
* Allergy to local anesthetics
* Disease in heart, lung, kidney, and liver
* Coagulation disorder
* Disease in the central and peripheral nervous system
* Unstable vital sign
* Significant renal impairment (Creatinine\> 3.0 mg/dl)
* Significant hepatic impairment (aspartate transaminase\> 120 unit/L, alanine aminotransferase\> 120 unit/L)
Early Occupational Therapy in Intensive Care: Feasibility of Implementation

The objective of the study is to assess the feasibility of early daily occupational therapy intervention within an interdisciplinary team in an intensive care unit of a Swiss university hospital.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old.
* Hospitalized at SMIA for at least 48 hours.
* Stable patient: hemodynamically stabilized patient (norepinephrine dose \< 15 mcg/min iv), respiratory (P/F ratio \> 150) and neurological (Glasgow Coma Scale \> 8).

Exclusion Criteria:

* contraindication to occupational therapy
Fish Oil and Folate Supplementation During Pregnancy

Pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. Biochemical measures are determined in maternal blood during pregnancy and in cord blood.

Non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* gestation \<20 week at enrollment
* intention to deliver in one of the study centers
* body weight at time of enrollment from 50 kg to 92 kg

Exclusion Criteria:

* serious chronic illness (eg, diabetes, hepatitis)
* use fish oil supplements since the beginning of pregnancy
* use of folate or vitamin B-12 supplements after gestation week 16
Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants

Healthy (non-injured) and concussed college-aged participants will complete two testing sessions that include (1) clinical symptom, balance, and cognitive evaluations and (2) a progressive exercise session to establish symptom exacerbation or maximal exercise capacity. Individuals randomized to the control group will receive no intervention between sessions, while individuals randomized to the intervention group will complete 30 minutes of stationary bike exercise at least 3 days/week.

Healthy and concussed participants will be randomized to ACTIVE training (intervention) or control (no intervention) groups. Participants, regardless of group assignment, will receive clinical symptom, balance, and cognitive evaluations as well as a progressive exercise assessment at study outset. Concussed participants will enroll into the study within three days of injury and study participation will termination following 24 consecutive hours with no reported concussive symptoms. Healthy participants will have arbitrary start dates and will terminate the study 10-14 days later to approximate the general length of concussion recovery and, therefore, make the time between session in the healthy and concussed cohorts as equivalent as possible. Participants in the intervention group will complete stationary cycle ergometer workouts for 30 mins at least 3 days per week between testing sessions. Healthy participants will complete six ACTIVE training sessions, while concussed participants will complete ACTIVE training at least three days per week until asymptomatic. Concussed control participants will follow physician guidelines for rest and activity, while healthy control participants will be asked to follow their typical routines for rest and activity. Participants will repeat the identical testing session assessments prior to study termination.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having a concussion by a physician within three days of study enrollment (concussed participants only)
* Glasgow Coma Scale \>13 (concussed participants only)
* Participants must be active, which is defined as 30 or more minutes of moderate to vigorous physical activity 3 or more days per week. All healthy participants must met this definition and concussed participants should have met this definition prior to injury.
* Good cardiovascular health (subject to approval from study physician)

Exclusion Criteria:

* Recreational drug use over the course of study participation
* Associated injuries (broken bones, etc.) that would limit the ability to successfully complete ACTIVE training
* For healthy participants, no history of concussion within the last year
* For concussed participants, skull fracture or brain bleed at time of the injury
* UNC Varsity athletes
STerOids in COVID-19 Study

At the time of writing (3/4/2020), close to a million people have been infected by the SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths is now called CoVID-19. Currently, there are no effective treatments for the early or late stages of this illness. Governments worldwide have undertaken dramatic interventions to try and reduce the rate of spread of this deadly coronavirus.

Early data from multiple studies in China, where the virus originated, show that severe cases of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This data has been confirmed by the Italian physicians. The investigators think that the widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients with chronic lung disease. Early microbiological data also shows that these corticosteroids are effective at slowing down the rate of coronavirus replication on lung cells.

Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma. This type of medicine is among the top 3 most common medication prescribed around the world. Their safety is well understood, and their potential side effects are mild and reversible.

The investigators propose to test this idea that, in participants early in the course of CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the chances of severe respiratory illness needing hospitalisation. We will also study the effect of this inhaled therapy on symptoms and viral load.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the trial
* Male or Female, aged 18 years or above
* New onset of symptoms suggestive of COVID-19 e.g. new onset cough and/or fever, and/or loss of smell or taste within 7 or fewer days of participant being seen at visit 1
* In the Investigator's opinion, is able and willing to comply with all trial requirements

Exclusion Criteria:

* A known allergy to investigational medicine product (IMP) (budesonide)
* Any known contraindication to any of the IMPs (budesonide)
* Patient currently prescribed inhaled or systemic corticosteroids
* Recent use, within the previous 7 days of inhaled or systemic corticosteroids
* Patient needs hospitalisation at time of study consent
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients

The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications.

A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients


Eligibility Criteria:
Inclusion criteria:

* chronic HCV genotype-1;
* high viral load

Exclusion criteria:

* Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening
* Previous treatment with protease inhibitor