cyrilzakka/clinical-trials huggingface dataset:
Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)

The Computer-Assisted Self-administration of Ethanol (CASE)will be administered twice, at the ages 18 and 20, in a prospective study of 80 adolescents living in the Dresden area. The sample will be recruited for a differential family history of alcoholism (FHA) and gender, with inventories of alcohol use disorder (AUD) symptoms and personal recent drinking history (RDH) obtained prior to each CASE session.


Eligibility Criteria:
Inclusion Criteria:

* (a) male and female Caucasian volunteers aged 18 years/0 months to 19 years/11 months;
* (b) written informed consent by the subject;
* (c) habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval;
* (d) at least one prior experience of alcohol intoxication
* (e) being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms;
* (f) effective contraception in female participants;
* (g) consenting to abstain from any illegal substance use for 2 weeks prior to participation;
* (h) living within 15 km (9.5 miles) from downtown Dresden;
* (i) sufficient information concerning alcohol use in both parents and in at least four second-degree relatives

Exclusion Criteria:

* (a) prior medical treatment due to alcohol use;
* (b) current or prior history of any serious disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse;
* (c) current history of Axis-I psychiatric illness, including premenstrual dysphoric disorder;
* (d) current or prior history of alcohol-induced flushing reactions;
* (e) positive urine screen for cannabinoids, cocaine, amphetamines, opiates, or benzodiazepines;
* (f) light or non-drinkers: averaging less than 2 standard drinks per week in the preceding two months;
* (g) intention to become pregnant
* (h) pregnancy or positive urine pregnancy screening or breast-feeding;
* (i) any alcohol intake on the test day or the day before;
* (k) use of medications known to interact with alcohol within 2 weeks of the study;
* (l) positive hepatitis or HIV at screening, provided the subject consented to these tests
Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction

In the district areas of Norway patients with acute myocardial infarction with ST-elevation, are treated with thrombolysis. An increasing part of them receives thrombolysis before arrival to the local hospital.Usually these patients have been sent to an invasive center if thrombolysis fails or the patient gets ischemic symptoms during the stay.

This study will compare this strategy against immediate transportation to an invasive center after the patient has received thrombolysis.


Eligibility Criteria:
Inclusion Criteria:

* Duration of painless than 6 hours.
* ST-segment elevation of at least 0.1 mV in two or more extremity leads or at least 0.2 mV in two or more precordial leads.
* The patient is getting thrombolysis.
* Time to reach an invasive center is more than 1 hour.
* Age 18-75 years.

Exclusion Criteria:

* Known serious renal failure (creatinin \> 250 mmol/l)
* Pregnancy
* Cardiogenic chock
* Life threatening arrythmias
* Other serious diseases with life expectancy less than 1 year.
* Inability to perform an informed consent
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies

The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.

Although cord blood is considered as an alternative donor source for allogeneic hematopoietic stem cell transplantation, its procedure has yet to be standardized. Recently, a single institute result of cord blood transplantation for adult patients with hematologic malignancies have been reported by Takahashi et al (Blood 2004:104;3813-3820), in which the survival was significantly better than that of bone marrow transplantation from unrelated donor. The purpose of this study was to reevaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies using the same transplant procedures in a multi-institutional setting.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome
* Lack of HLA-identical or 1 locus mismatched related donor
* Age over 20, and under 55
* Performance status 0 or 1
* No moderate or sever organ dysfunction (liver, kidney, heart, lungs)
* No anti-HLA antibody
* Informed consent was obtained

Exclusion Criteria:

* Uncontrollable diabetes
* Uncontrollable hypertension
* Active infection
* TPHA, HBs-Ag, HCV-Ab positive
* HTLV-I, HIV positive
WeExPAnd: PrEP Demonstration Project Among Women At Risk for HIV Infection - Preexposure Prophylaxis (PrEP)

The objective of this application is to increase PrEP uptake among AA women vulnerable to HIV acquisition in the rural South, specifically those seeking care at Federally Qualified Healthcare Centers (FQHC) in rural Alabama.

The investigators will use a mixed-methods approach to adapt and pilot test a patient-provider communication tool from the CDC PrEP toolkit that focuses on the first three steps of the PrEP cascade (e.g., recognizing HIV risk, identifying as a PrEP candidate, and interested in PrEP) to increase PrEP uptake via referrals to local PrEP clinics.

The investigators propose: (1) to explore the HIV risk perceptions of AA women with recent PrEP use, AA women who are candidates for PrEP, and providers and identify preferences around patient-provider communication about HIV risk and PrEP services that address the needs of AA women.

(2A) To systematically adapt a patient-provider communication tool to increase PrEP uptake at two FQHCs in rural Alabama, using an iterative implementation process; and (2B). To assess the feasibility, acceptability, and preliminary impact of the patient-provider communication intervention on PrEP uptake among AA women and their providers in a pilot pre-/post-intervention design.

As part of aim 2B), the investigators will also systematically document and evaluate reasons for declining a PrEP referral, reasons for incomplete referrals, reasons for failing to initiate PrEP after a successful referral, and ongoing PrEP use at 3 months and 12 months post PrEP initiation among our sample.

Eligibility Criteria:
Inclusion/Exclusion Criteria

Patients

* Cisgender
* HIV-uninfected women
* Age 18 years or older
* English speaking
* Report sexual activity or anticipate sexual activity within 6 months

Providers

* Physicians, nurse practitioners, physician assistants, nurses, medical assistants, social workers/counselors or other potential/actual PrEP service providers
* English speaking
Effect of Anesthetic Conditions on Stapling Thickness and Quality

the excluded stomach during sleeve gastrectomy can be investigated post removal outside the patient. During stapling it is common to reduce systolic arterial blood pressure (SAP) below 100 mmHg to reduce peritoneal perfusion and have better compression. Higher intra abdominal pressures reduce also the peritoneal and mucosal perfusion and might help to improve stapling compression. Stapling compression can be evaluated by measuring stapling thickness and compare it with stomach wall thickness or by measuring leaks during leak test or better outside the patient on the excised stomach with a bursting pressure.

Patients are randomized to two groups: group standard perfusion means that the SAP is kept between 100 and 140 mmHg by adapting depth of anesthesia, by level of post expiratory pressure or by giving vasoconstriction.

low perfusion group means that

1. systolic blood pressure is kept below 100 mmHg from the first linear staple till the last by using a Clevidipine infusion to regulate the blood pressure accurate just below 100 mmHg for a short time while needed.
2. goal directed fluid therapy using 100 ml/h fluid intravenous and extra load of fluid if pulse pressure variation \> 20 %
3. increase intra abdominal pressure (IAP) up to 20 mmHg inly during stapling and return to minimum IAP needed to achieve 3 liter workspace.

The resected stomach is removed and analyzed outside the body before throwing away:

Eligibility Criteria:
Inclusion Criteria:

* primary sleeve gastrectomy

Exclusion Criteria:

* allergy to one of the drugs used intra operative
* liver, renal, cardiac or lung disease with limited function
Impact of Fingolimod Adherence on Outcomes

This study was a retrospective observational claims data study of commercial and Medicare Advantage with Part D (MAPD) patients initiating fingolimod.

The study sample comprised commercial and MAPD enrollees who initiated fingolimod treatment during the identification period of 01 January 2012 through 10 May 2018. The date of the first fingolimod pharmacy claim during the identification period was the index date.

All patients were continuously enrolled in the health plan for 24 months. The 6-month pre-index period, ending the day before the index date, was used to assess patients' clinical characteristics (e.g., comorbid conditions and MS symptoms). The 18-month post-index period started on the index date. The first 6 months of the post-index period (initiation period) were used to assess MS symptoms and adherence. Months 7 - 18 of the post-index period (post-initiation period) were used to measure adherence and outcomes. The 24-month observation period for each patient comprised the 6-month pre-index and 18-month post-index periods.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old during year of index date with valid gender and geographic information
* Continuous enrollment (CE) in the health plan with medical and pharmacy benefits for ≥6 months (180ii days) before the index date (pre-index period)
* CE with medical and pharmacy benefits for ≥18 months (540 days) beginning on the index date (post-index period)

  * All patients had uniform 6-month pre-index and 18-month post-index periods
* ≥1 medical claim with an MS diagnosis codei in any position during the pre-or post-index periods
* ≥1 claim for fingolimod after the index date (i.e., from index date +1 to 539 days post-index)

  * By requiring ≥1 medical claim with an MS diagnosis code and ≥2 claims with an NDC for fingolimod, the inclusion criteria essentially incorporated the preferred/overall best performing MS case-finding definition validated by Culpepper et al. The criteria for that definition required at least 3 separate encounters from any of the following: MS-related ambulatory visits, MS-related inpatient stays, and DMT claims during a 12-month period. Slightly higher accuracy was found when a 24-month period was used.

Exclusion Criteria:

•≥1 pharmacy or medical claim for any MS DMT during the pre-index period
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.

The purpose of the study is to evaluate the effectiveness of low level laser on radiotherapy induced xerostomia to improve oral function and decrease oral complication due to hyposalivation and thus enhancing survival.

In this part of the study, the materials and methods will be presented under the following headings: subjects, equipment, procedures of the study and the statistical procedures.

1. Subjects:

   Sixty patients who have head and neck cancer (oral cavity, pharynx, larynx, or occult primary tumor) submitted to conventional 3D radiotherapy, with irradiation fields necessarily encompassing all major salivary glands. The total dose ranged from 66 to 70 Gy, given in fractions of 2 Gy/day selected randomly from Nuclear medicine department, Oncology institute, Mansoura University.

   These patients will be divided randomly into two groups of equal number, thirty patients for each group.

   Group A: (Laser group) This group of patients composes of thirty patients who will receive GaAlAs laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions (Fernanda A. S.G. et al., 2016).

   Group B :( Control group) This group of patients composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec (Bozana Loncar, D.M.D. et al., 2010) .

   The criteria of Patients selection :
2. Equipment used:

1-Therapeutic equipment: Laser therapy will be performed with an GaAlAs laser

2- Evaluation tools:

* Unstimulated and stimulated saivery flow rate.
* Salivery immunoglobin A (sIgA) concentration in unstimulated saliva
* The 11-item modified Xerostomia Inventory-Dutch questionnaire version 22.

Eligibility Criteria:
Inclusion Criteria:

* - Age range between 25-55 years.
* All patients included in the study established HNC and will receive radiotherapy encompassing major salivary glands accompanied or not by surgery.
* All patients enrolled to the study will have their informed consent.
* Both genders will participate in the study.
* All the patients were examined medically by oncologist

Exclusion Criteria:

* - Diabetes mellitus,
* Autoimmune diseases as sjorgen syndrome by established diagnosis criteria.
* Infectious diseases
* Collagen diseases, as were those with incipient tumors (stage T1 or T2) limited to the larynx, as well as those with trismus (reduced mouth opening capacity) due to surgical sequelae.
* xerostomic drugs (antiretroviral medications, antihistamines, anticholinergics, antihypertensives, decongestants, narcotic analgesics, tricyclic antidepressants)
Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination
* Use of any prescribed or non-prescribed medication
Assessing Fever Rates in Children Ages 24 to 59 Months After Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccines (IIV) Using Text Messaging for U.S. Influenza Vaccines in 2012-2013 & 2013-2014

In this study, the investigators will prospectively assess fever rates in 24-59 month old patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or live attenuated influenza vaccine (LAIV). Children in one of three study sites who receive these vaccines as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed for an eleven day period starting on the day of vaccine administration via a series text messages to their parents.


Eligibility Criteria:
Inclusion Criteria:

1. are 24 through 59 months of age,
2. have a visit at a study site anytime during the study period,
3. receive first dose LAIV or IIV in the season,
4. the parent has a cell phone with text messaging capabilities, and
5. the parent speaks English or Spanish.

Exclusion criteria:

1. any chronic medical condition in the child that precludes receipt of LAIV (except for history of asthma or a wheezing episode within the past 12 months noted in the medical record),
2. currently on oral or other systemic steroids or used in the past month,
3. currently on inhaled steroids or used in the past 2 weeks,
4. presence of fever \>=100.4 at time of vaccination,
5. administration of any antipyretic in the 6-hour period prior to vaccination,
6. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
7. parent only speaks a language other than English or Spanish,
8. parent's inability to read text messages,
9. child receiving the second dose of influenza vaccine in the current season.
Examining Persistence in Smokers With Schizophrenia

All participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.

This study is a non-randomized trial of a new psychosocial treatment for smoking cessation (for smokers with schizophrenia) that is based on cognitive behavioral therapy for smoking cessation - a commonly used approach. Participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18 - 64 years old
* Must indicate commitment to quitting smoking in the next 30 days
* Must smoke at least 5 cigarettes per day for past 6-months
* Expired breath carbon monoxide (CO) \> 5 to ensure daily cigarette use
* Must score \< 8 (or \<7 for women) on the Alcohol Use Disorders Identification Test
* Must score less than 3 on the 6-month Drug Abuse Screening Test-10
* Must provide a negative urine drug screen for cannabis, cocaine, opiates, or
* methamphetamine (Note: Participants with a positive screen for opiates may
* participate with proof of prescription for opiates.)
* Must have a diagnosis of Schizophrenia or Schizoaffective Disorder on Structured Clinical Interview
* Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen including a stable antipsychotic dose for 8 weeks

Exclusion Criteria:

* Must not be currently receiving tobacco dependence treatment counseling
* Must not currently be taking varenicline (Chantix)
* Must not be taking bupropion (Zyban/Wellbutrin) to quit smoking
* Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days.
* Must not report unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days
* Must not be pregnant, breastfeeding, or planning on becoming pregnant in the next 4-months. Women who can become pregnant may be included if using effective birth control
* Must not have pending legal matters with potential to result in jail time
* Must not be planning on moving outside local area in next 3-months
Study to Assess Safety and Tolerability of Multiple Doses of EO2002

The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.


Eligibility Criteria:
Inclusion Criteria:

All ocular criteria apply to the study eye unless otherwise noted.

1. Age ≥ 18 years.
2. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
3. Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.

Key Exclusion Criteria:

All ocular criteria apply to the study eye unless otherwise noted.

1. Other corneal disease
2. Anterior chamber intraocular lens
3. Sutured or scleral-fixated intraocular lens.
4. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
5. History of refractive surgery.
6. History of Vitrectomy
7. Descemet membrane detachment.
8. History of uveitis or other ocular inflammatory disease.
9. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
10. IOP \>21 or \<7 mm Hg
11. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.

11. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).

13. Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.

14. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.

15. Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.
Influence of Umbilical Cord Clamping Time in the Newborn

This study compares two umbilical cord clamping times; the early one, up to a minute (ECC) and the late or delayed one, when the cord stop beating (DCC). The additional blood volume delivered to the newborn from the placenta - placental transference - by delaying umbilical cord ligation, increases the contribution of neonatal iron with increased iron stores in the infant, without increasing neonatal morbidity.

It is an intervention study without drugs administration with a longitudinal, prospective comparison and correlational design.

Patients are recruited by simple random sampling to one of the two intervention groups:

Group 1-ECC: Early clamping of the umbilical cord (before the first minute of life).

Group 2-DCC: Delayed clamping of the umbilical cord (when it stops beating).

Eligibility Criteria:
Inclusion Criteria:

- neonates with a gestational age of 35 to 42 weeks and born through normal vaginal delivery.

Exclusion Criteria:

* monochorionic multiples
* incarcerated mothers
* placenta previa
* concern for abruptions
* Rh sensitization
* hydrops
* congenital anomalies
* the obstetrician declining to perform the intervention