cyrilzakka/clinical-trials huggingface dataset:
Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)

The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia.

The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing surgical procedures typically performed under general anesthesia in Japan (thoracic, abdominal, joints, back, and neck), where analgesics and muscle relaxants are concomitantly used. The study is also intended to demonstrate the non-inferiority of desflurane with nitrous oxide to sevoflurane with nitrous oxide in time to awakening/recovery.

Eligibility Criteria:
Inclusion Criteria:

* ASA PS 1-3
* age: older than 19 y and younger than 70 y
* undergoing surgery of the thorax(thoracotomy, thoracotomy plus laparotomy, endoscopy; but excluding cardiovascular),abdomen(laparotomy,endoscopy;but excluding cesarean section), joints (including peripheral vessels), back (spine)or neck (neck, throat)
* willing to be hospitalized for at least 3 days and 2 nights (from the day before surgery to the day after surgery)
* having given written consent

Exclusion Criteria:

* need for spinal subarachnoid, epidural or local anesthesia (except local surface or infiltration anesthesia for catheter insertion or use of local anesthetic for testing before inserting epidural catheter for post-surgical pain)
* contraindication for use of nitrous during surgery
* anticipated need for postoperative transfer to intensive care unit and receive mechanical pulmonary ventilation
* BMI of 30 kg/m2 or more
* serious hepatic, renal, or circulatory disorder (Grade 3 per Notification 80 by MHW, Pharmaceutical Affairs Bureau, Safety Division)
* uncontrollable hypertension (SBP 160 mmHg or higher while on antihypertensive therapy)
* emergency surgery
* history of hypersensitivity to components of sevoflurane, fentanyl, propofol, vecuronium or other anesthetic
* contraindication to sevoflurane, fentanyl, propofol, or vecuronium
* exposure or suspected exposure to inhalational halogenated anesthetic within 3 mo prior to consent
* known or suspected history or family history of malignant hyperthermia
* considered likely to have difficulty in receiving tracheal intubation due to conditions such as brachygnathia, micrognathia, bucked teeth, articular rheumatism or injury of cervical spine/cervical cord
* known or suspected to be pregnant or lactating
* participated in a clinical study within 6 mo prior to consent
* history of drug dependence
* history of epilepsy
* otherwise judged by the investigator to be unsuitable for the study
ED Hypernatremia. Prognostic Factors and Epidemiology.

This study evaluate the 1-month mortality of patients who proceed a blood sample while in the ED with an hypernatremia (\>145 mmol/l). This prospective study will try to show several prognostic factors, and show the epidemiology of hypernatremia in this single center evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Natremia \> 145 mmol/l

Exclusion Criteria:

* Age \< 18 years
* Refusal
Clinical Trails of Photoelectrochemical Immunosensor for Early Diagnosis of Acute Myocardial Infarction

The aim of this prospective randomized controlled clinical trial will evaluate the sensitivity, precision and effectiveness of photoelectrochemical immunosensor for early diagosis of acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Symptoms of chest pain

Exclusion Criteria:

* Patients who will undergo immediate PCI Pregnant
* Lactating women
* Patients with mental disorders
* Patients are using other experimental drugs; Refusal to provide informed.
Evaluation of the Fathers Advancing Communities Together (FACT) Program

The Urban Institute-a nonprofit, nonpartisan research organization-is partnering with Rubicon Programs to conduct a rigorous evaluation of its Fathers Advancing Communities Together (FACT) program. FACT is a multi-faceted program designed to deliver responsible parenting, healthy relationships, and economic stability services on a voluntary basis to low-income fathers in Contra Costa County, California. Urban's evaluation comprised of three key components:

The implementation evaluation will describe FACT program activities and services, including communication and coordination across partners, service delivery mechanisms, and whether and how participants and their families received comprehensive services. Urban will identify a logic model for the program and assess the barriers to and facilitators of program performance. The implementation evaluation will draw from interviews with program staff, partners, and stakeholders, as well as field observations, program and administrative data, and focus groups with FACT participants and their families.

The outcome evaluation will build on the implementation evaluation to determine whether specific program components, their frequency, and their duration, are related to outcomes. Urban will conduct surveys of program participants at the time of their enrollment into the program and one year following their enrollment to explore how participants' self-reported attitudes on various domains are associated with economic self-sufficiency and family functioning. Urban will also use program and administrative data collected by Rubicon and its partners, specifically Rubicon's case management database, to assess participant outcomes.

The impact evaluation will assess to what extent participation in the FACT program is associated with improved outcomes as compared to similarly situated individuals who did not participate in the program. Urban will work with Rubicon's partners to identify individuals living in Contra Costa County who were eligible to participate in the program but, for whatever reason, did not do so. Once a comparison group of fathers has been established, Urban will use individual-level outcome data to determine whether the FACT program has an impact on economic self-sufficiency and family functioning.


Eligibility Criteria:
Inclusion Criteria:

* An individual is eligible for the impact evaluation if the individual is a FACT participant and is a parent with an open child support case in Contra Costa County, CA during the time of their enrollment.
Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.

To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.


Eligibility Criteria:
Inclusion Criteria:

Study participants were individuals with DS and healthy volunteers (HVs).

* Main inclusion criteria for individuals without DS

  * \>=21 and \<= 40 years of age
  * Mini-Mental State Examination (MMSE) \>= 28
  * Clinical Dementia Rating (CDR) of 0
* Main inclusion criteria for individuals with DS

  * \>= 40 years of age

Exclusion Criteria:

* Main exclusion criteria for both groups

  * Unstable medical or psychiatric condition, study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time
Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability

The main goal of this study is to evaluate the effect of taping on postural control during dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the study. Several questionnaires regarding anthropometric data, medical history, activity level and functional status will be filled in by the participants. Postural control will be measured using a force plate and an optoelectronic system to capture lower limb kinematics. Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they have to maintain their balance for 10 seconds after landing. 5 good trials of each movement will be captured. Subjects with CAI will perform these exercises with and without tape. Hypothesis is that subjects with CAI that tape will enhance postural control.


Eligibility Criteria:
Inclusion Criteria:

* a history of at least one ankle sprain which resulted in pain, swelling and stiffness, prohibiting participation in sport-, recreational or other activities for at least 3 weeks
* repeated ankle sprains
* presence of giving way
* feeling of weakness around the ankle
* a decreased functional participation (recreational, competitive or professionally)

Exclusion Criteria:
Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.

Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* prehypertension or Stage 1 hypertension

Exclusion Criteria:

* Type 1 diabetes
* Stage 2 hypertension
* CKD
* recent MI, revascularization, CVA or TIA
Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Aromatic Plants

This randomized, double blind, parallel group study, compared the efficacy of spray containing aromatic essential oils of some herbal plants, against placebo in the treatment of patients with acute viral Laryngitis or Tracheitis.

Study objectives: Primary to demonstrate a hoarseness or cough relief within 20 minutes after first administration of treatment with the spray.

Secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment

This study compared the efficacy of spray containing aromatic essential oils of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, against placebo in the treatment of patients with acute viral Laryngitis or Tracheitis.

In- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of Laryngitis or Tracheitis. The pharmacological and clinical activity of Eucalyptus citriodora, Eucalyptus globulus, Mentha piperita, Origanum syriacum, and Rosmarinus Officinalis, include anti-inflammatory, anti-bacterial and anti-viral activities. Some of these herbs and trees oils have direct activity on the respiratory tract, the coughing reflex and the airflow in the nasal tract.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute viral Laryngitis or viral tracheitis.
* Active disease less than 48 hours
* Patients agree to sign informed consent according to GCP and Israel national regulations.

Exclusion Criteria:

* Acute lower respiratory tract infection.
* C.O.P.D.(Chronic Obstructive Pulmonary Disease)
* Under any antibiotically treatment.
* Asthma disease.
* Under coumadine therapy.
* Hyper sensitivity to Aromatic essential oils.
* Any immuno-suppressive disease
Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy

The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.


Eligibility Criteria:
Inclusion Criteria:

* subjects with a cow's milk allergy
* age between 0 to 36 months

Exclusion Criteria:

* age more than 36 months
* eosinophilic disorders of the gastrointestinal tract,
* food protein induced enterocolitic syndrome,
* concomitant chronic systemic diseases,
* congenital cardiac defects,
* active tuberculosis,
* autoimmune diseases,
* immunodeficiency,
* chronic inflammatory bowel diseases,
* celiac disease,
* cystic fibrosis,
* metabolic diseases,
* lactose intolerance,
* malignancy,
* chronic pulmonary diseases,
* malformations of the gastrointestinal tract.
A Trial on SBRT Versus MWA for Inoperable Colorectal Liver Metastases (CLM)

The trial is designed to perform a rigorous evaluation of efficacy and tolerability of SBRT by means of a randomised, controlled trial in patients affected by inoperable colorectal liver metastases. The chosen comparator is MWA.

The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes.

The trial is a monocentric prospective, randomised controlled, unblinded, parallel-group superiority trial of Stereotactic Body Radiation Therapy (SBRT) versus Microwave Ablation (MWA) for the curative treatment of inoperable colorectal liver metastases. Patients will be randomised on an equal basis to either SBRT or MWA. The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes. The key short-term outcomes will include assessment of local response rate and acute toxicity. Longer-term outcomes will concentrate on oncological aspects of the disease with analysis of disease-free and overall survival and local recurrence rates at 3-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Karnofsky index \>70%
* Histological proven adenocarcinoma of the colon or rectum with radiological (by CT- or MRI) or histological-/cytological verified liver metastases.
* Metastases must be visible on diagnostic- and dose planning CT scans and on ultrasonography.
* The patient should not be suitable for surgical resection due to technical or patient-related conditions. Resectability must be judged by a trained hepatobiliary surgeon and discussed in a multidisciplinary team meeting.
* Presence of 1-3 lesions .
* Diameter ≤ 40 mm.
* All tumors should be feasible for treatment with each of the two modalities, SBRT and MWA
* Adequate liver function: bilirubin \<1.5 mg/dl, alb\> 3.5g/dl, normal PT/PTT except if the patient uses anticoagulants, liver enzymes\<3 times upper limit of normal. No ascites.
* Renal function must be adequate for infusion of iv. contrast for CT-scan.
* Adequate bone marrow function: Hbg³8 g/dl, platelets³100.000 and leucocytes ³2.000/ml.
* Informed consent.
* Extrahepatic disease stable or in response after CT
* No previous abdominal radiation therapy (RT)

Exclusion Criteria:

* Uncontrolled primary tumor or extrahepatic disease
* Previous abdominal radiation therapy (RT) or other local conservative treatment on lesion target.
* Pregnant or breastfeeding patients.
* Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression).
* Previous inclusion in this study.
* Underlying liver cirrhosis (Child-Pugh grade B or C).
* Ascites and/or relevant intra-hepatic biliary tract dilatation.
* Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.
Non Inferiority Trial Investigating Surfactants Administered Via MIST

RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST.

Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.

Babies who require emergent intubation will not be enrolled in the interventions.

Parental Consent will be obtained prior to randomization.

INTERVENTION Infants who on CPAP who reach the threshold of 30% oxygen will be randomized to calfactant (Infasurf), 3ml/kg or poractant alfa (Curosurf), 2.5ml/kg, administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA).

A second dose of calfactant (Infasurf) 3ml/kg or poractant alfa (Curosurf), 1.25ml/kg, will be administered via MIST their fiO2 reaches the threshold of 30% between 6 and 48 hours after the first dose.

No further surfactant should be given in the first 7 days unless the infant reaches the intubation criteria.

POST-INTERVENTION MANAGEMENT Other than the requirement to adhere to intubation criteria in the first week, and in some cases perform a room air trial at 36 weeks corrected gestation, management will be at the discretion of the clinical team.

Titration of CPAP pressure is encouraged, with a permitted maximum of 8 cm H2O. Use of nasal IPPV is allowable for apnea, but discouraged for RDS and should only be after at least one dose of surfactant has been given. Early caffeine therapy is expected.

Criteria for intubation:

Enrolled infants on CPAP will be intubated if:

* FiO2 ≥0.45 for 15 minutes, or if there is unremitting apnea (\> 6 episodes/hour requiring intervention or in the opinion of the treating physician) or persistent respiratory acidosis (pH\<7.25 and pCO2 \>60) on blood gasses at least 30 minutes apart or metabolic acidosis refractory to treatment.
* Need for an anesthetic or an intervention requiring intubation

These criteria apply during the first week of life, and to the first episode of intubation only. If the infant is intubated it is expected that another dose of surfactant will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30

Exclusion Criteria:

* Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
* Infants who require emergent intubation will not be enrolled in the interventions.
Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo

Vitiligo is a chronic disease with an unpredictable clinical course, characterized by the appearance of white macules and patches on the skin and mucous membranes due to the disappearance of melanocytes in the affected area.

It affects approximately 0.5% - 2% of the population worldwide and may occur at any age.

Vitiligo is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin.

The treatment of vitiligo has been a challenge for dermatologists. Recent reports have highlighted darkening of iris, and eyelashes and periocular hyperpigmentation induced by prostaglandin F2α analogues used for the treatment of glaucoma (as travoprost). Extrapolating these findings in the treatment of vitiligo.

The beneficial effect of fractional CO2 laser on vitiligo is postulated to come from the release of cytokines and growth factors that act as mitogens for melanogenesis . The preceding laser also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation.

308 nm excimer laser is a monochromatic, target type treatment and allows the delivery of higher fluences to the lesions and avoids damage to the surrounding normal skin resulting in a faster and more effective pigmentation with minimal side effects.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 12 years.
2. Patients with generalized non-segmental vitiligo.
3. No previous treatment for vitiligo in the last 1 month.
4. Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.

Exclusion Criteria:

1. Patients with sensitivity to travoprost.
2. Patients with photosensitivity.
3. Patients with history or active skin cancer.
4. No other dermatological or systemic diseases.
5. Active infections .
6. Pregnant or lactating females.
Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants

The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, between 18 and 65 years of age, inclusive
* BMI range is 20-35 kg/m2, inclusive for the SAD Module, and 25-35 kg/m2, inclusive for the MAD Module at Screening;
* In good health, determined by no clinically significant findings from medical history, physical exam, 12 lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the PI)
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance