cyrilzakka/clinical-trials huggingface dataset:
Alcohol Effects on Driving-related Skills of Young Drivers

Given the known driving behavior of Driving Under the Influence of Alcohol and some of its parallel to driving under the influence of cannabis, this supplemental study aims to validate the sensitivity of the primary and secondary outcome measures employed in a cannabis and driving study currently in progress.

This study will examine the effects of an intoxicating dose of alcohol on driving-related skills among young drivers using driving simulator technology.

This study is a double-blind, placebo-controlled mixed design study, including randomized between-subjects comparison of the effects of alcohol intoxication and both between- and within-subjects examination of acute and residual effects at approximately 24 and 48 hours following one-time alcohol administration.

Initial contact with potential participants will be made by telephone, where study personnel will conduct a telephone screen for eligibility. Those telephone screened as eligible will attend CAMH for an eligibility assessment. Enrolled participants will complete four sessions on consecutive days: a practice day, an alcohol administration day, and a 24-hour and 48-hour post-alcohol session.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 19 to 25.
* Reported consumption of at least 1 heavy drinking episode (according to NIAAA criteria of 5 drinks for males and 4 for females within an occasion) in the 6 months prior to eligibility assessment.
* Held a valid class G or G2 Ontario driver's license (or equivalent from another jurisdiction) for at least 12 months.
* Willing to abstain from alcohol use for the duration of the study, and for 48 hours prior to Session 2.
* Provides written and informed consent.

Exclusion Criteria:

* Taking medications or have any medical condition for which alcohol is contraindicated
* Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants).
* Diagnosis of severe medical or psychiatric conditions.
* Meets criteria for current or lifetime Substance Use Disorders (DSM-IV) with the exception of nicotine.
* Meets criteria for Alcohol Dependence (DSM-IV)
* Is pregnant, is trying to become pregnant, or is currently breastfeeding.
* Severe allergic reaction to citrus.
Jail-Based Use of Smoking Cessation Treatment Study

Smoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. People who are incarcerated represent the intersection of multiple high-priority populations (disproportionately African-American, Native American, low-income, homeless, on Medicaid, and suffering from mental illness and substance use disorders). This study examines the impact of a smoking cessation intervention for individuals discharged from jail to the community on smoking abstinence. Participants will be randomized to either 1) guideline-based, in-person smoking cessation counseling during incarceration, telephone counseling after incarceration, and nicotine replacement, or 2) enhanced treatment as usual. This study's findings will be used to develop a larger, multi-site study that is fully powered to measure longer-term health and smoking cessation outcomes.

Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post discharge from jail. During these assessments, seven-day point prevalence abstinence will be bio-verified with exhaled carbon monoxide, and self-reported general health, physical health, mental health, and substance use measures will also be obtained. The analysis is fully powered (i.e., power \> .8) to detect significant between group effects on the primary outcome (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to treat sample and will utilize pre-specified logistic and linear regression models.

Eligibility Criteria:
Inclusion Criteria:

* Use of ≥ 1 cigarette per day prior to incarceration
* Expected release from the Hennepin Adult Detention Center to the community within 90 days
* Age 18-64
* English fluency
* Lives within 20 minutes of Hennepin County Medical Center and has no plans to move away from area for 4 months
* Willing to attempt quitting or reducing smoking at discharge
* Has a telephone
* Cleared for nicotine lozenge safety by jail health care provider and willing to use at discharge

Exclusion Criteria:

* Active tuberculosis
* Current mental health crisis (i.e., currently experiencing significant mania, psychosis, or suicidality)
* Unable to ambulate independently
* Acute medical condition that would impair participant's ability to follow-up for assessments
* Expected discharge to a control institutional setting (e.g., locked state mental health facility or prison)
* Active pregnancy
* Heart attack within the last two weeks
Incidence, Risk Factors, Severity and Prognosis of Necrotizing Enterocolitis in Turkey

Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.

Necrotizing enterocolitis (NEC) is a gastrointestinal system disease characterized by inflammatory necrosis of the intestine mainly seen in premature infants, and continues to be an important cause of mortality and morbidity in neonatal intensive care units all over the world. Although it is more common in premature infants, it is also seen in term babies when the intestine is ischemic. Although the major problem in premature babies is the immaturity of the intestine, many factors contributing to immaturity play a role in the pathogenesis of NEC.

With this study project, which is planned as a national multicenter prospective study, the incidence of necrotizing enterocolitis in newborn infants born in neonatal intensive care units in our country and the risk factors associated with the NEC, especially the detailed feeding history of the patient (when the first feeding is nourished, antibiotics and other treatments that are being used). Most epidemiological data such as the most common stage of the disease, treatment, prognosis, comparison with the data of other countries will provide important information for the neonatal health of our country.

The aim of this study was to determine the factors affecting the emergence of NEC in neonatal intensive care units and to determine the frequency of NEC.

Study Hypothesis: Delayed enteral feeding, intensive use of antibiotics and nutrients other than breast milk increase the incidence of necrotizing enterocolitis.

Eligibility Criteria:
Inclusion Criteria:

* Newborns diagnosed with NEC in neonatal intensive care units

Exclusion Criteria:

* Major congenital anomaly,
* congenital heart disease (except for atrial septal defect, ventricular septal defect, patent ductus arteriosus)
* Chromosomal anomaly
* Inherited metabolic disease
* Hypoxic ischemic encephalopathy
* Newborns who died within the first 48 hours of life
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

This is a multi-center, open-label, Phase I study of obatoclax administered every 2-week or weekly cycles, or as a Prolonged Infusion every 2 to 3 weeks to patients with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML)in Myeloid Blast Phase, Myelofibrosis, Previously-Treated Chronic Lymphocytic Leukemia (CLL), or Aplastic Anemia. Due to the PK/PD sampling schedule Cycle 1 will require overnight hospitalization. For the following cycles treatment may be administered on an outpatient basis but is at the discretion of the investigator. No investigational or commercial agents or therapies other than those described within the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from hematological malignancies are allowed.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmation of AML, MDS, CML in blast phase, myelofibrosis, CLL, or aplastic anemia
* There are no limitations on additional, allowable type and amount of prior therapy as long as acute toxicities have resolved to the allowable grade.
* Must have normal organ functions
* Must be willing to submit to blood sampling for the planned PK and PD analyses.
* Must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

* No other agents or therapies administered for the intent to treat
* Uncontrolled, intercurrent illness
* Pregnant women and women who are breast feeding
Ambulatory Versus Inpatient Initiation of Home Mechanical Ventilation

The purpose of this investigation is to see if outpatient initiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up in patients with amyotrophic lateral sclerosis is non-inferior to initiation during admission to the hospital

The primary hypothesis is that outpatient intiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up is non-inferior to initiation during hospitalization in patients with amyotrophic lateral sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosed with amyotrophic lateral sclerosis
* Indication for start of non-invasive mechanical ventilation

Exclusion Criteria:

* No informed consent
* Does not understand Danish or English
* Indication for invasive mechanical ventilation
* No morning baseline PCO2
* Hospitalization
Efficacy of Zingiber Officinalis (Homoeopathic Medicine) in Treatment of Acne Vulgaris

Acne is one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. As a part of this study, efficacy of Zingiber officinalis will be studied in the treatment of Acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 12 to 25 years of age
* Presence of inflammatory and non-inflammatory lesions
* Able to follow-up according to protocol
* Patients not taking any medication for treatment of Acne in preceding one month.

Exclusion Criteria:

* Acne Conglobata
* Pregnant or Breast feeding females or females having intention of becoming pregnant
* Significant systemic disease
* Any drug/ alcohol addiction
* History of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome
Constraint Induced Movement Therapy on Infantile Hemiplegia

The purpose of this study is to assess the functionality of the affected upper limb in infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Children's Hemiplegia Medical diagnosis.
* Aged between 4 and 8 years.
* Lack of activity of the affected upper extremity.
* Overcoming 10th extension at the metacarpophalangeal and interphalangeal joint.
* Complete the 20 º of wrist extension of the affected upper extremity.
* Adequate cognitive development to understand verbal commands given for the execution of tasks.
* Cooperation in the execution of tasks.

Exclusion Criteria:

* To Have vision problems that prevent them from carrying out the intervention.
* Having significant balance changes that endanger the child fall to bring a restriction in the affected upper limb.
* Submit uncontrolled seizures.
* To Have received botulinum toxin prior to 6 months prior to the intervention.
Study of Karenitecin (BNP1350) in Patients With Brain Tumors

The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.


Eligibility Criteria:
* Confirmed diagnosis of a newly diagnosed glioblastoma multiforme or recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma.
* Evidence of measurable recurrent or residual primary CNS neoplasm.
* An interval of at least 3 weeks between prior surgical resection or 6 weeks between prior radiotherapy or chemotherapy, and enrollment on this protocol unless there is unequivocal evidence of tumor progression after surgery, radiotherapy, or chemotherapy.
* Hematocrit \> 29%, ANC \> 1,500, platelets \> 125,000
* Serum creatinine \< 1.5 mg/dl, BUN \< 25 mg/dl, serum SGOT and bilirubin \< 1.5 times upper limit of normal
* Negative pregnancy test for female patients
Mindfulness Meditation for Epilepsy

In one-third of epileptic patients treated in France, seizures persist despite drug treatment. These so-called "refractory" epilepsies are among the most severe. Only a minority of patients with refractory epilepsy can undergo surgery. The other options available are based on brain or vagus nerve stimulation interventions which clinical effectiveness is still being studied. Alternative therapies are needed both to decrease the frequency of patients' seizures and to improve their quality of life.

The practice of mindfulness meditation has recently been included in the recommendations of the International League Against Epilepsy in order to alleviate anxiety or depression comorbid symptoms.

This study falls within this framework by targeting two aspects of the pathology.

Through the development of standardized protocols, mindfulness meditation has been introduced as a complementary treatment to prevent the relapse of depression, and to reduce stress and improve well-being in many chronic conditions.

Epilepsy, which results from the activity of hyperexcitable circuits, is also associated with a disorganization of the physiological brain networks. Studies in cognitive neuroscience in healthy subjects suggest that meditation induces lasting changes in the physiological networks of attention and default mode and could potentially compensate for dysfunctions of these networks in epileptic patients.

Eligibility Criteria:
Inclusion Criteria:

* For patients :

  * Patients over 16 years of age;
  * Epilepsy refractory to drug treatment according to the consensus criteria of the International League Against Epilepsy ;
  * Affiliated with a health insurance plan;
  * Free, informed and written consent signed by the patient, and parents for patients under the age of 18.
* For healthy subjects :

  * Healthy subjects 16 years of age and older;
  * Affiliated with a health insurance plan;
  * Free, informed and written consent signed by the volunteer, or parents, for volunteers under the age of 18.

Exclusion Criteria:

* For patients :

  * Alcohol Addiction Disorders (assessed by the Mini-International Neuropsychiatric Interview (MINI) scale) ;
  * Patients with psychogenic crises;
  * Treatment with antidepressants;
  * Simultaneous participation in other research that may interfere with the protocol;
  * Persons of legal age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
* For healthy subjects :

  * Psychiatric pathology and/or alcohol addiction disorders (evaluated by the MINI scale) ;
  * Simultaneous participation in other research that may interfere with the protocol;
  * Persons of legal age subject to legal protection (protection of justice, guardianship, trusteeship), persons deprived of liberty.
Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)

This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of Telintra in patients with Low or Intermediate-1 risk MDS. Patients at least 18 years of age presenting with histologically confirmed Low to Intermediate-1 risk MDS with documented significant cytopenia for at least two months by the IWG criteria are eligible.


Eligibility Criteria:
Inclusion Criteria:

* Primary or de novo MDS
* Low or intermediate-1 MDS
* ECOG performance status 0 or 1
* Documented significant anemia with or without neutropenia and/or thrombocytopenia
* Adequate kidney and liver function
* Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry

Exclusion Criteria:

* Prior allogenic bone marrow transplant for MDS
* History of MDS IPSS score greater than 1.0
* Pregnant or lactating women
* Any severe concurrent disease, infection, or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
* Oral steroids e.g. prednisone \>10 mg per day
* History of active hepatitis B or C
* Known history of HIV
Dual-scopic Pancreatic Necrosectomy (DPN)

The LPN procedure is performed under general anesthesia. The transperitoneal access to peripancreatic space is via the gastro-colic ligament and greater omentum, effusion and pus is removed by laparoscopic forceps and suction. Laparoscopic cholecystectomy (LC) is performed during the LPN procedure on patients with indication.

The NPN procedure is followed by the standard retroperitoneal approach. After the catheter is exchanged over a guide wire and serially dilated up from 6F to 24F followed by Seldinger technique, the access track to the necrotic cavity is established. A nephroscope is inserted into the cavity through the track for debridement. Using forceps and suction, the peripancreatic solid necrotic tissue and pus is grasped and removed. A large-bore irrigating drain is left in the cavity, with continuous irrigation by warm normal saline solution at a rate of 100-125 ml/h after surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients ages 18 or above admitted to UPMC with a diagnosis of AP based on at least 2 of the following criteria:(i) abdominal pain characteristic of AP (ii) serum amylase and/or lipase ≥ 3 times the upper limit of normal (iii) characteristic findings of AP on abdominal CT scan will be screened for study enrollment.

Exclusion Criteria:

* Less than 18 years of age
* Pregnant women
* Presence of renal dysfunction (Cr\>1.5mg/dL)
* Pre existing heart dysfunction or NYHA classification score above III
* Coagulation disorder
Effects of Gluten Digestion With ALV003

This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of gluten with ALV003 or with placebo when ingested by CD Subjects.

The primary objective of this study is to compare the effects of gluten treated with ALV003 vs placebo:

* The clinical response by symptom measurement before and after oral challenge
* The immune response measured by ELISPOT testing and serology The secondary objective of the study is to
* Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Well controlled Celiac Disease without flare in symptoms for the past 8 weeks
* History of biopsy proven Celiac Disease
* Able and willing to complete a symptom diary for 3 days prior and through 3 days post gluten challenge
* Been on a gluten free diet for 8 weeks prior to study entry
* Have normal celiac serology (anti- tTG level of \<20 units/mL)

Exclusion Criteria:

* Uncontrolled complications of celiac disease which in the opinion of the Investigator would impact their immune response, or pose an increased risk to the subject. (example: like type 1 diabetes or other autoimmune disease)
* Pregnant or breast feeding women, subjects of childbearing potential to use two methods of contraception
* Concomitant medications such as over the counter digestive enzymes, immunosuppressive therapies, anticoagulants, NSAIDs. Chronic medications for well-controlled chronic conditions are allowed.
* Clinically significant abnormal lab values, as determined by the PI:
* Untreated or active peptic ulcer disease, esophagitis, motility disorders or any gastrointestinal diseases.
* Positive pregnancy test within 7 days prior to study drug administration
* Known allergy or hypersensitivity to E.coli or E.coli derived proteins
Screening for Primary Ciliary Dyskinesia Using Nasal Nitric Oxide

Background: Primary ciliary dyskinesia (PCD) is a rare genetic disease characterised by recurrent respiratory infections and subfertility due to dysfunction of cilia (brushes) of the lining cells. Undiagnosed and untreated it can result in an irreversible crippling chronic lung disease. The diagnosis of PCD is a difficult one and involves the complex assessment of ciliary structure and function. Thus, PCD is under diagnosed and appropriate preventative and symptomatic treatment may be denied in many patients. In addition, the gene responsible for PCD is at present unknown, thus preventing pre-natal diagnosis and genetic counseling.

Working hypothesis and aims: Recently, it has become apparent that the evaluation of nasally expired nitric oxide (NO) constitutes a simple and non-invasive diagnostic method, which discriminates between PCD patients, PCD carriers and healthy controls at high rate of specificity and sensitivity. Testing is simple and last approximately one minute. We have recently identified a unique isolated Druze population with high prevalence of PCD. The high frequency of disease places this closed community at a high risk of undiagnosed PCD.

The aim of this project is to use nasal NO measurement as a screening tool to identify possible undiagnosed cases of PCD and PCD carriers in this high risk Druze population.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary willing to participate

Exclusion Criteria:

* Recent URTI
* Steroids use 2 weeks prior to testing