cyrilzakka/clinical-trials huggingface dataset:
Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety

Almost 80% of panic disorder patients report difficulty sleeping. Sleep disturbances in turn may exacerbate underlying anxiety/panic attacks. Moreover, individuals with insomnia (sleep disturbance) are at higher risk of developing a new anxiety disorder. Therefore it is expected that improving sleep quality with medications along with other medications to treat anxiety component of panic disorder might be helpful. However, there is lack of pharmacological studies examining the effects of improving sleep disturbances with medications in panic disorder patients, which is a critical problem for providing optimal care to these patients. The objective of this proposal is to determine the effects of ramelteon (FDA approved for insomnia) on sleep disturbances in Panic disorder patients who are on escitalopram for underlying anxiety.


Eligibility Criteria:
Inclusion Criteria:

* 1) Clinical diagnosis of panic disorder
* 2) Difficulty initiating sleep (subjective sleep latency (SL) of \>30 minutes) for at least 3 times per week in the preceding month.

Exclusion Criteria:

* 1)Patients meeting DSM-IV criteria (as determined by MINI) for a current anxiety disorder (other than panic disorder), or current major depressive disorder that is considered by the investigator to be primary (i.e., causing a higher degree of distress or impairment than panic disorder)., Patients with past history of DSM-IV anxiety disorders or depressive disorder will not be excluded.
* 2) Patients with current psychotic disorder, current bipolar disorder, or substance use disorder (except nicotine dependence) or Subjects with significant suicide risk.
* 3) Candidates with known sensitivity to any selective serotonin reuptake inhibitors (SSRI) will be excluded.
* 4) CNS diseases: Candidates with seizure disorder (other than febrile seizure in early childhood), a history of other neurological disorder, and head trauma will be excluded.
* 5) Cardiovascular and respiratory diseases: Candidates with hypertension (systolic \>130; diastolic \> 85), arrhythmias, coronary artery disease, cardiac pacemakers, COPD, asthma, and other pulmonary diseases will be excluded.
* 6) Primary sleep disorders: Candidates with breathing related sleep disorder, restless leg syndrome, circadian rhythm sleep disorders, narcolepsy, and other major primary sleep disorders will be excluded.
* 7) Systemic diseases: Candidates with other medical problems, such as endocrinopathies, renal or hepatic failure, autoimmune diseases involving the CNS, obesity (BMI \> 30 kg/m2), or a history of pheochromocytoma will not be eligible.
* 8) Consumption of greater than 720 mgs. of caffeine daily.
* 9) History of shift work (11 PM to 7 AM) in the past 6 months.
* 10) Reproductive status: Women candidates who are pregnant (based on urine test) are not eligible. Women of child bearing age will be on birth control methods during the study period.
* 11) Individuals with personality, behavior, or medical disorders likely to interfere with study participation.
The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study

1. Study Hypothesis:

   * The decrease of plasma adrenomedullin (ADM) concentration by ultrafiltration and isovolumetric hemofiltration in patients with acute III and IV Class New York Heart Association Functional(NYHA) heart failure is more pronounced than a standard diuretic treatment and is related with clinical improvement.
2. Outcome Measurements:

To correlate the adrenomedullin plasma levels with clinical treatment, ultrafiltration and hemofiltration related to:

* Brain natriuretic peptide (BNP) level
* angiotensin II level
* sympathetic nervous activity
* oxydative stress
* clinical outcome at the beginning, at discharge and 90 days after randomization.

Testing the hypothesis that adrenomedullin (ADM) is a important peptide in severe heart failure and that is related to clinical condition, we will study the effects of 3 different treatments (clinical usual treatment,ultrafiltration and isovolumetric hemofiltration with diuretics) to participants are followed until discharge to Adrenomedullin level and clinical outcomes,and also their relationship with angiotensin II level, brain natriuretic peptide(BNP), sympathetic nervous system and oxydative stress.

The patients will be randomized in three different treatment group and analyzed in three moments: on the randomization, at discharge and 90 days after randomization(plus or minus 3).

The clinical treatment will be optimized, the ultrafiltration will be done until clinically adequate fluid removal or until hematocrit increased 10% from basal level, and isovolumetric hemofiltration will be done for 8 hours- dose of 35 ml/kg/h in association with diuretic. All this dialytic procedures will be done with PAES membrane- filter HF1400 and automatic machine.

Eligibility Criteria:
Inclusion Criteria:

* more than two item:

  * more than eighteen years of age
  * orthopnea
  * Chest Rx with cardiomegaly and pulmonary infiltration
  * edema
  * diuretic resistance

Exclusion Criteria:

* insulin dependent diabetes
* hepatic cirrhosis
* vascular access problems
* creatinine more than 2,5 mg/dl before acute heart failure
* systemic infection
* aortic stenosis and heart transplantation
* radiologic contrast up to 72 hours prior randomization
* advanced neoplasia
Rhythmic Auditory Stimulation & Gait Training

This study will enroll patients with Multiple Sclerosis and some difficulty with walking. The purpose of this study is to use Rhythmic Auditory Stimulation (RAS) a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve a patient's movements, especially when walking.

Participants will be asked to participate in a walking program (WP) with Rhythmic Auditory Stimulation (RAS), or a WP without RAS.

Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking. The RAS can be delivered at a fixed tempo or interactive tempo.

The device used in this study will deliver an interactive tempo. The equipment will include a mobile device app and sensors that are attached to the participant's shoes. Headphones and smartphones will be required to use the device and will be provided to the study team and kept at the center for this study. The device is designed to use audio cues to facilitate improvements in the participant's walking speed while listening to music.

The overall purpose of this study is to assess the safety and acceptability of interactive RAS music combined with gait training in individuals with MS and walking impairment, and to gather preliminary efficacy data for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS based on 2017 revised McDonald criteria (relapsing or progressive course)
* Performs the T25FW in 8 to 30 seconds (cane(s), walking stick(s), crutch(es), or wheeled walker allowed)

Exclusion Criteria:

* Physical therapy in the past 3 months or immediate need for PT due to safety concerns (e.g. falls)
* Requires at least one seated rest during the 6 MW test
* Treatment with high-dose corticosteroids in the past 2 months or planned during the study period
* Lower extremity botulinum toxin (BT) injections for spasticity in the past 3 months, or planned during the study period
* Initiation of an oral symptomatic therapy which could affect walking in the past 4 weeks (particularly dalfampridine and medications for spasticity)
* Initiation of a new disease-modifying therapy for MS in the past 3 months
* Comorbidity compromising safe participation or affecting walking (e.g. uncontrolled cardiac or respiratory illness, musculoskeletal disorder)
* Severe hearing impairment with or without the use of hearing aids, such that the participant cannot hear the rhythmic music stimulus consistently.

Inability to walk safely to the rhythmic music stimulus during the baseline visit.
Alcohol Labeling Study

This study aims to examine the effects of new front-of-package alcohol warnings on alcohol consumption. Participants will be randomly assigned to either new front-of-package health warnings or control labels. Participants will bring in their own alcohol to weekly study visits and take home the alcohol to consume as usual. Participants will receive study labels on their alcohol containers per their assigned trial arm.

This study aims to determine whether new front-of-package health warnings on alcohol containers lead to less alcohol consumption and improve consumer understanding about the harms of alcohol. We aim to enroll approximately 720 adults ages 21 years and older who report consuming alcohol at least once per week.

After providing informed consent, participants will be randomly assigned to receive new front-of-package health warnings or control labels.

Participants will attend 3 in-person study visits spaced approximately 1 week apart. Participants in the warnings arm will receive a health warning applied to the front of their alcohol containers at each of the weekly visits for a total of 3 unique warnings during the study. Warnings will be applied in counterbalanced order. Participants in the control arm will receive one label during the study.

Participants will report the number of drinks they consumed daily via text message and will complete 4 computer surveys spaced approximately 1 week apart.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 21 years and older
* Not identified as having possible alcohol dependence
* Consumed alcohol at least once per week during the past 4 weeks
* At least half of alcohol consumed each week is from store-bought containers
* Willing to bring 8 days' worth of alcohol to 3 in-person study visits
* Not pregnant, breastfeeding, or trying to get pregnant
* Able to take surveys in English
* Willing to respond to text messages daily for 3 weeks
* Not living in the same household as anyone else in the study

Exclusion Criteria:

- Not living in US
Investigation of Macular Pigment Augmentation on Dark Adaptation

The study will evaluate whether taking a nutritional supplement designed to increase macular pigment in the eye can improve a person's ability to adjust to darkness. Patients will be assigned to take either a placebo or nutritional supplement for 8 months. Vision will be assessed at baseline, 4 months, and 8 months.

The study design is a randomized, double-blinded, placebo-controlled intervention study that will evaluate whether macular pigment augmentation improves the speed of dark adaptation. Two groups of participants will be enrolled, old adults with normal vision and early age-related macular degeneration patients. Macular pigment will be augmented using EyePromise RESTORE (ZeaVision, Inc). EyePromise RESTORE is a nutritional supplement that has been found to increase macular pigment levels in some users. Macular pigment level and the speed of dark adaptation (how fast a person adjusts to the dark) will be assessed at baseline, 4-months, and 8-months. Fundus appearance will be assessed at baseline and 8-months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 60 to 80 years old
* \< +- 4.00 diopters spherical equivalent
* normal eye health or early age-related macular degeneration

Exclusion Criteria:

* neurological conditions that can impair vision
* diabetes
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo

This is a phase II intervention to propose a new melanoma chemoprevention agent. The investigators believe oxidative stress/damage in nevi is a probable indication for melanoma risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate whether administration of NAC around the time of UV exposure will reduce melanoma risk in high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and 2) examine key genetic variants that will identify which individuals are most likely to benefit from chemoprotection.


Eligibility Criteria:
Inclusion Criteria:

* Must have at least 2 nevi (each \>6 mm diameter) not clinically suspicious for melanoma that can be biopsied.
* Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* The patient is a minor (\< 18 years old).
* The patient cannot speak/understand English or Spanish. (NOTE: A Spanish consent form and certified interpreter can be made available if needed)
* The patient is pregnant. (NOTE: All female patients who have not had a hysterectomy and are not post-menopausal (i.e. post-menopausal for 1 year and not of child-bearing potential) will have a urine pregnancy test.)
* The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
* The patient has history of allergic reaction to NAC.
* The patient has history of severe asthma.
* The patient has been taking NAC or any other oral antioxidant.
* The patient has recent history (i.e., 3 months) of sunless tanning (tanning bed) or extensive sunburn.
Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation

The purpose of this study is to evaluate the ability of the T-SPOT.CMV assay to determine immune competence against CMV infection in stem cell transplantation.

To determine the utility of the T-SPOT.CMV assay used before transplantation to determine immune competence against subsequent CMV reactivation and to determine the utility of the T-SPOT.CMV assay used after transplantation to determine immune competence against subsequent CMV reactivation.

In this prospective, non-randomized, observer-blind observational study, up to 200 patients who meet the study's eligibility criteria will be enrolled at up to 20 study centers. Enrollment will be actively managed by the sponsor.

Blood samples will be collected up to 14 days before transplantation, and then at 2-week intervals for the 6 months after the transplant procedure.

Study duration: 15 months: 9 months to enroll all patients, with 6 months (182 days) of participation for each patient.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Patients who will undergo one of the following types of allogeneic transplantation: matched related donor, matched or mismatched unrelated donor, haploidentical, or cord blood.
3. Patients must be seropositive for CMV prior to transplantation, regardless of donor seropositivity.
4. Institutional Review Board (IRB)-approved written Informed Consent and privacy agreement per national regulation (e.g., Health Insurance Portability and Accountability Act \[HIPAA\] for sites in the USA) must be obtained from the patient or the patient's legally authorized representative prior to any study-specific procedures.
5. Patients must be considered suitable for the study by the Investigator.

Exclusion Criteria:

* 1. Patients with a known active CMV reactivation within 1 month prior to enrollment or during the study's pre-transplant screening period.

  2. Patients who have received any antiviral therapy active against CMV other than acyclovir and valacyclovir (i.e., foscarnet, ganciclovir, valganciclovir, or cidofovir) during the month prior to enrollment.

  3. Patients who have previously received or are planning to receive a CMV vaccine.

  4. Patients who are known to be hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) positive.

  5. Patients who are known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.

  6. Patients who are participating in or plan to participate in CMV-related drug or vaccine studies.
Validation of the French Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

Background: Despite current popularity, positive mental health is under researched. This is possibly due to a lack of consensus on appropriate measuresThe Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14 positively phrased Likert-style list of items developed to measure mental well-being. Its validation has been internationally explored. This report presents the French validation of the WEMWBS (F-WEMWBS) in non-clinical and clinical populations.

Methods: Two non-clinical populations comprised of 319 working adults (WORK), and 75 students (STUD), and one clinical population of 121 patients with remitted schizophrenia (PRS) were included in the validation study. Participants completed the F-WEMWBS as well as complementary measures of psychological constructs potentially related to well-being.

Three different populations participated in the study: two non-clinical populations composed of students (STUD), and working adults (WORK) and one clinical population comprised of patients with remitted schizophrenia (PRS). The STUD population was a convenient sample of 75 first year students (51 females and 24 males); with 45 from a School of Business Management and 30 from a medical university. The WORK population was also a convenient sample of 113 (63 females and 256 males) working adults including 217 soldiers from Paris Fire Brigade, 93 nurses and 9 individuals from a research laboratory. The PRS population was comprised of 121 remitted schizophrenia patients (39 females and 82 males) who were all clients of the rehabilitation centre for psychotic disorders (Le Vinatier hospital), situated in Lyon, France.

Eligibility Criteria:
Inclusion Criteria:

* For STUD and WORK, there were two criteria to be included in the study: (i) , not undergoing medical treatment for psychological issues at the time of the study and (ii) and not having been part of a stress management program prior to recruitment for the current study.
* For PRS, there were three criteria to be included in the study: (i) a DSM-IVR diagnosis of schizophrenia as confirmed by the Mini International Neuropsychiatric Interview for DSM-IV (MINI; 14); (ii) age between 18 and 65 years; and (iii) being clinically stable (i.e. not having required hospitalization or increases in medication as a result of an exacerbation of acute symptoms over the previous three months).

Exclusion Criteria:

-
Effect of Pre-warming on Perioperative Hypothermia During HoLEPunder Spinal Anesthesia

Inadvertent perioperative hypothermia is an unintentional drop in core body temperature below 36°C. Intraoperative hypothermia can lead to serious clinical complications such as, myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection. Hypothermia develops easily during surgeries that require irrigation fluid, such as laparoscopic surgery and transurethral resection of the prostate. Although isothermic irrigation fluid was suggested to prevent perioperative hypothermia, it can be difficult to warm a large volume of irrigation fluid.

Re-distribution after induction of anesthesia is the most important cause of perioperative hypothermia. The extent of re-distribution is proportional to the gradient between the core and peripheral compartments. Pre-warming increases the heat content of the peripheral thermal compartment, reducing the gradient for redistribution. Recently, A recent-meta analysis suggested that as a single strategy, preoperative forced air warming had significant benefits than other warming methods. Also, it was reported that only 20 (or even 10) min of pre-warming mostly prevented patients from perioperative hypothermia under general anesthesia. However, few studies have examined whether short time pre-warming can reduce hypothermia due to a large amount of irrigation fluid during surgery under spinal anesthesia.

The purpose of this study is to assess whether the application of preoperative forced air warming set to high temperature (\> 43°C) for brief period can prevent hypothermia or shivering during procedures requiring large volumes of cold irrigation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with ASA physical status I-III, aged 50 - 80 years, undergoing HoLEP under spinal anesthesia

Exclusion Criteria:

* preoperative body temperature of more than 37.2°C preexisting severe cardiovascular, respiratory and endocrinal disease on anticoagulant therapy
Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers of angiogenesis and disease in patients with unresectable malignant mesothelioma treated on clinical trial CALGB-30107.

OBJECTIVES:

* Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin portend a poor prognosis in patients with unresectable malignant mesothelioma treated with vatalanib on protocol CALGB-30107.
* Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin correlate with response or stable disease in these patients.

OUTLINE: Serum samples previously obtained from patients on protocol CALGB-30107 are tested for levels of thrombospondin I serum, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin using enzyme-linked immunosorbent assays (ELISA).

PROJECTED ACCRUAL: A total of 47 specimens will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of malignant mesothelioma

  * Unresectable disease
* Must have received treatment with vatalanib on protocol CALGB-30107

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Dental Health Epidemiology Among Israel Defense Forces (IDF) Recruits

An epidemiological survey for prevalence description of dental morbidity (caries, gingivitis, dental trauma and fluorosis) among Israel Defense Forces (IDF) general recruits. Morbidity measures were collected from 700 recruits at their first day of military service in order to evaluate extent and burden of dental diseases among recruits. The data will enable the military dental services commanders to plan and implement dental services according to the dental needs.

Caries, gingivitis, dental trauma and fluorosis epidemiological measures were collected among IDF recruits in 700 sample using short clinical evaluation without radiographs. water fluoridation ecological data will be obtained from the ministry of health. the results might impact dental services plan, professional manpower system, and the layout of the dental clinics in the IDF. It will give the professionals in the military dental services an evidence based data for planning an accurate primary and secondary prevention programs and an evaluation of dental diseases burden in order to have the "full picture" of recruits dental needs. .

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old.

Exclusion Criteria:

* Chronic bone diseases.
* Mineralization defects