cyrilzakka/clinical-trials huggingface dataset:
Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
* Males and females ages 9 years and older at the time of consent.
* Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
* Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
* An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline.
* Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
* Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
* Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
* Subjects in good health as judged by the Investigator.
* Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Key Exclusion Criteria:

* Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
* Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
* Previous treatment with ARQ-154 or ARQ-151.
* Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
* Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
* Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).
* Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.
Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria

This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are candidates to receive both proton beam and sorafenib
2. Patients with tumor burden that exceeds San Francisco criteria

Exclusion Criteria:

1. Patients who are candidates for surgical resection
2. Patients with tumor burden within Milan and/or San Francisco criteria
3. Patients who have contraindication to receive proton
4. Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
5. Patients treated previously by any locoregional treatment
6. Patients with prior liver transplant
7. Patients with child class C
8. Patients with model for end-stage liver disease (MELD) score of \> 25
9. Patients with other comorbid diseases that may impact survival
10. Patients with ongoing alcohol intake
11. Patients with active sepsis
12. Patients with gastrointestinal bleeding within a week
13. Patients unwilling to sign informed consent form
14. Patients with history of noncompliance
Preoperative levosimendán and Hip Fracture

The purpose of this study is to evaluate whether preoperative optimization with levosimendan in heart failure patients undergoing hip fracture surgery improves haemodynamic and tissue perfusion parameters.

Hip fracture is a very predominant entity in elderly patients and it is one of the most frequent cause of admission in a hospital.

Elderly patients undergoing surgery for hip fracture have a high risk of morbidity and mortality in the postoperative. Several studies have shown that there is a high risk of cardiovascular complications in this group of patients and 3-months mortality is 15-20%. One of the causes of this high morbidity and mortality is the high incidence of chronic cardiac failure in this patients. The goal of the present study is to evaluate if the optimization of preoperative cardiac function with levosimendan in patients with left ventricular ejection fraction \< 45% can improve haemodynamic and the tissue perfusion values, and reduce cardiac morbidity and mortality 3 months postoperatively.

Following written consent, the patients with left ventricular ejection fraction \< 45% will be admitted in the resuscitation and anaesthesia room where they will receive a levosimendan intravenous injection undergoing a strict haemodynamic vigilance.

Before the levosimendan intravenous injection the patients firs have an echocardiography to evaluate myocardial function, NT-proBNP. Subsequently, an arterial line is inserted and optimization achieved by using this arterial line connected to a ProAQT sensor system ( PULSION , Edwards). The system uses pulse wave analysis to assess several parameters including: stroke volume index (SVI), cardiac index (CI), systemic vascular resistance index (SVRI), cardiac power index (CPI).The levosimendan will be administered like a continues injection during 24 hours (0,1 mcg/kg/min) without initial dose. Following the optimization the patients will be transferred to the operating room in the next 3 days and will come back to the resuscitation and anaesthesia room where they will stay 24 hours more if there is no any complication.

All the cardiac complications will be documented and follw-up will be done by after 30 days and 3 months postoperative.

The patients will be selected for more than 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients due to undergo urgent of hip fracture.
2. Patients with cardiac failure (EF \< 45 %).
3. Decompensated heart failure.
4. Informed consent provided by the patient.

Exclusion Criteria:

1. \<18 years old
2. Emergency surgery
3. Serious aortic stenosis (\< 1 cm2)
4. Sustained ventricular tachycardia or atrial fibrillation \>140
5. Earlier episodes of "torsades depointes"
6. Systolic blood pressure \< 85 mmHg
7. Serious kidney failure (GFR \< 30 ml/min)
8. Serious liver failure (known class C Child-Pugh score)
9. Allergy levosimendan
AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine

This study is a non-inferiority phase III randomized trial evaluating the effect of intranasal midazolam versus intramuscular loxapine on the rapid tranquilization of agitated patient in emergency department. Intranasal midazolam is safe and may allow a management of extreme agitation state and prevent adverse effects.

This study is a prospective, multicenter, open-label randomized, controlled, parallel-group 2-arm phase III non-inferiority trial. Patients with agitation at emergency department will be randomized to two arms of treatment: one experimental arm with intranasal midazolam 5mg (investigational medicinal product), and one control arm with comparator treatment intramuscular loxapine 100mg. The duration of participation for each patient is at least 28 days (+7 days if follow-up not completed on D28). An endpoint Adjudication Committee will be scheduled.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years;
* Agitated Patient whose somatic or psychiatric aetiology cannot be diagnosed in an emergency situation and who need a sedation in a hospital emergency setting due to the presence of unmanageable agitation with 3 major criteria.

Major criteria :

Agitation Pain Tolerance Tachypnea ( fr \> 20)

And 1 minor criteria among :

Sweating Tactile Hyperthermia Medical care Non compliance Lack of tiring Unusual Strenght Inappropriately clothed, nudity

• Medical insurance The protocol can start if the THREE major inclusion criteria and ONE of the minor inclusion criteria are checked PRESENT and ALL the non-inclusion criteria are checked no.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from randomization into the study:

* Pregnancy
* Prisoners
* Contraindications to intranasal Midazolam or intramuscular Loxapine :

  * Hypersensitivity to benzodiazepines or to any of the excipients (Sodium Chloride, Hydrochloric Acid, Sodium Hydroxide, Water for Injection)
  * Known hypersensitivity to loxapine or to any of the excipients (Polysorbate 80, propylene glycol, 20% v/v hydrochloric acid, water for injections, Nitrogen (Inert gas)
  * Individuals who are in comatose states or have central nervous system (CNS) depression due to alcohol or are taking other depressant drugs
  * Individuals with severe depressive states, spastic diseases, and with Parkinson's disease, except in the case of dyskinesias due to levodopa treatment
  * In combination with dopamine agonists except levodopa (amantadine, bromocriptine, lisuride, pergolide, piribedil, ropinirole, cabergoline, pramipexole, apomorphine) outside the patient with Parkinson's disease
  * Individuals with a history of cerebrovascular accident or epilepsia
  * Individuals in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension;
  * Individuals with severe cardiac decompensation
  * Patients with severe respiratory failure or acute respiratory depression
  * Individuals with acute narrow angle glaucoma.
Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG

Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. The goals of the study are to (1) confirm airway obstruction with endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX sedation alone.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients more than 18 years old with American Society of Anesthesiologists (ASA) classification of I, II, or III.
* Patients undergoing sedation for sleep endoscopy with DEX alone, and possible surgical follow-up.

Exclusion Criteria:

* ASA classification higher than III.
* Any deformities or diseases that may prevent application of SedLine (Masimo Sedation Monitoring) or RAM (Masimo Rainbow Acoustic Monitoring) sensors with a proper fit
* Inability to obtain any physiological, vital, demographics and real time anaesthesia data
* Subjects who have known intolerance to any of the drugs to be used according to the study protocol
* Subjects deemed not suitable for study at the discretion of the Principal Investigator.
Smartphone-based Stress Management Intervention for Employees

Participants were able to use the application the investigators developed for four weeks. With the application, the participants were able to monitor their stress level and life style patterns. The participants were also provided personalized stress management techniques including psychoeducation and cognitive behavioral technique. In 2014, additional relaxation techniques-abdominal breathing, progressive muscular relaxation, and meditation-were incorporated. Participants' mental health status and life style patterns were evaluated at baseline and at 4 weeks. Pre- and post-intervention statuses were compared after adjusting for degrees of life stress factors. Brief encounter psychosocial instrument (BEPSI-K) score and Center for Epidemiologic Studies Depression Scale (CES-D) score were used as primary outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Any employee from three corporations (the Korea Gas Corporation (KOGAS), the Korea District Heating Corporation (KDHC), and the Korea Expressway Corporation (KEC)); any individual who visited the health promotion center for a health checkup at Seoul National University Bundang Hospital

Exclusion Criteria:

* None
Multi-dose Ibuprofen Prophylaxis for IUD-insertion

This study compares the effectiveness of decreasing pain at time of and day after intrauterine device (IUD) insertion when patients take three doses of Ibuprofen versus three doses of placebo.

Ibuprofen is commonly used over the counter and prescribed for pain relief such as menstrual cramps. Intrauterine (IUD) insertion can cause pain during and after the insertion. Currently, studies have found that single dose of Ibuprofen take prior to IUD insertion does decrease pain at time of IUD insertion. This study will examine whether 3 doses of Ibuprofen can decrease pain at time of and 1 day after IUD insertion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Female
* Able to provide informed consent
* English speaking
* Able to provide telephone and address contact information
* Able and willing to receive HIPAA compliant telephone texts and phone messages
* Stable (the same) address and phone number within the last 6 months.

Exclusion Criteria:

* Contraindications to IUD insertion (active pelvic infection, current pregnancy)
* Contraindications to NSAIDs (allergy, history of asthma, history of aspirin allergy, history of kidney disease, history of stomach ulcer, history of active GI bleeding, history of liver disease)
* Not undergoing any other concurrent office procedures
Effect of Aerobic Training Versus Resistance Training on Plasma Homocystiene in Diabetic Patients

The goal of this \[clinical trial\] is to \[ compare \] in \[ diabetic male patients \]. The main question to answer is :

Will be any difference between aerobic exercises and resistance exercises in improving levels of homocysteine, cholesterol and insulin in diabetic patients?

Participants will take their medications and group of them do aerobic exercises and another group do resistance training

40 male diabetic patients diagnosed by type 2 diabetes mellites to evaluate therapeutics outcomes of aerobic exercises versus resistance exercises as a treatment tool on homocysteine, insulin and cholesterol levels in diabetic patients.

The patients will be randomly assigned to two equal (in number) groups:

Group (A) Twenty male patients will receive moderate intensity aerobic exercises in a form of supervised treadmill walking for 30-45 mins performed 3 times/ week for 12 weeks.

Group (B) Twenty male patients will receive resistance training program comprised 30-45 min performed 3 times /week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 1- Their ages will range from 40 -55 years 2- Their body mass indexes will range between (25 to 35 Kg / m²). 3-All patients are diagnosed with type 2 diabetes mellites.
* Diagnostic criteria for type 2 diabetes were: 1) a fasting plasma glucose concentration of 7.0 mmol·L-1 or higher or 2) a plasma glucose concentration of 11.1 mmol·L-1 or higher two hours after an oral glucose challenge. (Punthakee et al.,2018).
* All subjects took oral hypoglycemic drugs but none of them were being treated with insulin when enrolled.

  4- All patients are medically and psychologically stable

Exclusion Criteria:

1. Patients with uncontrolled blood glucose level
2. Patients with unstable cardiovascular conditions (those with a known history of uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure, currently on anticoagulation therapy) were excluded from this study.
3. Patients with severe pulmonary disease (with restrictive lung disease or with obstructive lung disease).
4. Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis or severe osteoarthritis).
5. Patients with BMI \> 35 will be excluded from the study.
The Effects of Glucose/Ischemic Preconditioning on Reperfusion Injury in Deceased-Donor Liver Transplantation

Standard liver retrieval procedures for transplantation from a deceased donor inevitably result in a "reperfusion injury" to the liver tissue. The purpose of this research study is to find out whether treatment of the liver with a "preconditioning" protocol before its removal from the donor will help reduce any of this injury.

The "preconditioning" treatment being tested has two components. Firstly, a solution of glucose+insulin is infused and secondly, blood flow to the liver is stopped briefly (10 minutes) and then resumed. Both strategies, individually, have been shown to reduce liver tissue injury in human studies.

We hypothesize that combining both strategies will have a clinical benefit to patients and will improve liver function following transplant.

Liver transplantation is the only chance of cure for patients with end-stage liver disease. Unfortunately, standard organ preservation results in an ischemic-reperfusion injury (IRI) at the time of graft implantation. Novel strategies have been proposed to decrease reperfusion injury and improve graft function. This study will be the first to combine both strategies in a randomized, prospective trial. The intervention will occur during the retrieval surgery prior to cold preservation. Briefly, a glucose and insulin solution will be infused via the mesenteric vein at a controlled rate. Immediately prior to cross-clamping, blood supply to the liver will be restricted for 10 minutes and then resumed for 10 minutes before beginning cold preservation. All remaining surgical procedures, including the recipient surgery, will be performed by standard techniques. The liver recipient does not directly receive any intervention during this study.

Eligibility Criteria:
Inclusion Criteria:

* Recipient 18 years of age or older
* Recipient with chronic end-stage liver disease
* Deceased donor liver transplant
* Recipient capable of providing written informed consent
* Whole organ graft from donors aged 60 years or older

Exclusion Criteria:

* Fulminant liver failure
* Objection by any other member of the retrieval team
* Split-liver grafts
* Donor that has received total parenteral nutrition within 24hr of organ retrieval Donors from whom the pancreas and/or small bowel are also being retrieved
Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars

This study will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis

After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be taken after explaining the procedure and its associated risks and benefits. Clinical diagnosis of irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either Complete Pulpotomy group or Partial Pulpotomy group. (Mineral Trioxide Aggregate) MTA will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in second appointment.

Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at every 3 months from baseline to 1 year.

Eligibility Criteria:
Inclusion Criteria: Inclusion criteria

* The patient should be ≥18 years of age.
* Restorable molar teeth.
* Tooth should give positive response to pulp sensibility testing.
* Clinical diagnosis of irreversible pulpitis.
* Tooth with probing pocket depth and mobility are within normal limits.
* No signs of pulpal necrosis including sinus tract or swelling.
* Non-contributory medical history

Exclusion Criteria:

* Teeth with immature roots.
* No pulp exposure after caries excavation.
* Bleeding could not be controlled in 6 minutes.
* Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.
TOFO Insulin Combination Trial

Primary Objectives:

To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus.

To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.

Secondary Objectives:

To assess the effects of tofogliflozin in comparison to placebo on:

* Body weight
* Fasting plasma glucose (FPG)
* Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.

The total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.

Eligibility Criteria:
Inclusion criteria:

* Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM).
* Hemoglobin A1c ≥7.5% - ≤10.5% and FPG ≤220 mg/dL.
* Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening.
* Stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening.
* Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen.
* Body mass index (BMI) ≥18.5 kg/m\^2 and \<35.0 kg/m\^2.
* No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.

Exclusion criteria:

* Type 1 diabetes mellitus.
* Pregnancy or lactation.
* Severely uncontrolled glycemic situation.
* History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening.
* History of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months.
* A measured serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of the reference range at the central laboratory test facility.
* Has previously received treatment with the investigational product.
* Has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment.
* Corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical \[skin\] application, eye drops and sprays).
* Patients who are frequently experiencing orthostatic hypotension.
* Required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment:
* Lipid-lowering drug
* Antihypertensive drug
* Thyroid hormone preparation
* Uric acid lowering drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.