cyrilzakka/clinical-trials huggingface dataset:
Medical Management of Sleep Disturbance During Opioid Tapering

This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. All participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO and the investigators hypothesize that one or both doses of SUVO will improve total sleep time relative to placebo. Patients will attend a single follow-up session, 5-10 days following discharge.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old and above
* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD with evidence of physical dependence on opioids, and seeking treatment to stop using illicit opioids.
* Provides a urine sample that tests positive for opioids.
* Willing to comply with the study protocol.
* Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation.

Exclusion Criteria:

* Seeking or currently enrolled in methadone or buprenorphine maintenance treatment for OUD
* Pregnant or breast feeding
* Have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification
* Have a known allergy to the study medications
* Past 30-day prescribed use of suvorexant or benzodiazepines for the indication of insomnia
* Current use of a Selective Serotonin Reuptake Inhibitor (SSRI) or Monoamine oxidase (MAO) inhibitor for depression or insomnia, or other medications that are contraindicated with suvorexant
* Current narcolepsy, restless leg syndrome or sleep paralysis
* High risk for current sleep apnea
* Current major depressive disorder
* Past year suicidal behavior
* Severe hepatic or renal impairment

  * Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3x ULN
  * Total bilirubin \>2x Upper Limit of Normal (ULN)
  * Creatinine \>1.5x ULN
* Have circumstances that would interfere with study participation (e.g., impending jail)
Self-Management in Stroke Survivors

This is a feasibility study of using health-IT to promote self-management of risk factors in stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

* Acute Stroke Survivors and their caregivers
* English speaking
* History of hypertension

Exclusion Criteria:

-Cannot use the health-IT system
Evolution of the Lymphocyte Phenotype in Patients with Infection in Intensive Care Unit

Patients admitted for polytrauma, severe neurological injury, post-operative monitoring or sepsis/septic shock present with significant inflammation, leading to immunoparalysis, which is responsible for infection, particularly prolonged infection. A study of their lymphocyte phenotype over time could help explore the phenomenon of immunoparalysis.


Eligibility Criteria:
Inclusion criteria:

* Postoperative esophagectomy surveillance within the last 24 hours.
* Patients with intra-abdominal infection
* Neurological patients with intubation planned for more than 24 hours (subarachnoid hemorrhage with coma, severe head trauma, ischemic or hemorrhagic stroke with coma).
* Polytrauma with intubation planned for more than 24 hours
* Patient aged 18 and over
* Patient with social security coverage

Non-inclusion criteria :

* Hereditary immune deficiency HIV-AIDS
* Malignant hemopathies
* Immunosuppressive treatment other than corticosteroid therapy or chemotherapy
* Patient under legal protection
* Pregnant or breast-feeding women
Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness

The study was a 12-month, multi-centered, quasi-experimental design to assess point-of-care (POCT) screening/monitoring of subjects on antipsychotic agents for metabolic syndrome. Subjects were also randomized to either an Extended Treatment Group (ETG) defined by receiving comprehensive medication management (CMM) pharmacist interventions or a Usual Treatment Group (UTG) receiving no CMM interventions. All subjects were recruited from three community mental health clinic settings in Minnesota.

It is well recognized that patients on antipsychotic agents with mental illness continue to be affected by a severe health disparity due to lack of adequate metabolic monitoring.1-7 A major healthcare concern is the life-expectancy decrease of \~25 years for patients with illnesses such as schizophrenia as compared with the general population. Equally concerning is that patients with severe persistent mental illness (SPMI) continue to have inadequate integration of care between psychiatry and medicine. Because of the difficulty getting patients to primary care or hospital based laboratories, the use of capillary blood, point-of-care tests (POCT) to monitor glucose and lipids in addition to vital signs and other anthropometric measurements in community mental health centers might prove beneficial. It is highly likely that this advanced level of screening in the mental health setting may lead to identifying new metabolic abnormalities or improved treatment with careful monitoring of previously diagnosed metabolic syndrome, diabetes, and/or hypertension in antipsychotic treated patients. It is hypothesized that if metabolic abnormalities are identified; then providing pharmacist CMM consultative services would reduce medication related problems by improving medication adherence, coordination of care between psychiatry and primary care, and outcomes in metabolic indices.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Age 18-64
* Competent to understand and make medical choices independently

Exclusion Criteria:

* Currently or previously seen by a CMM pharmacist
Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream

Participants will have study medicine applied by site staff- delgocitinib cream or vehicle, and then exposed to UV light. The trial is designed to find out if delgocitinib cream can cause skin photoallergy after UV-light exposure in people with healthy skin.

This is a single-centre, randomised, double-blind, vehicle-controlled, within-subject comparison phase 1 trial in Germany.

The trial consists of a screening phase, an induction phase, a rest phase, and a challenge phase. There will be 2 columns of test fields on each participant's back with the 3 treatments in either column for a total of 6 treatments. One column of test fields will be irradiated and the other will not be irradiated. All participants will be exposed to UV-light on skin treated delgocitinib cream or vehicle and on untreated skin on test fields to be irradiated.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy subjects aged 18-64 years (inclusive).
* Fitzpatrick skin type of I, II, or III.

Exclusion Criteria:

* Atopic dermatitis, eczema, psoriasis, acne, dermatitis solaris or suntan that could interfere with the test field evaluation, hyperpigmentation, multiple naevi, tattoos, blemishes, or dense body hair in the range of the test fields.
* Any other skin disease or other visible skin condition noted on physical examination which in the investigator's opinion might interfere with the evaluation of the test field reaction.
* Any history of or presence of cancerous or precancerous skin lesions in general including melanoma, lentigo maligna, basal cell carcinoma, dysplastic naevi or actinic keratoses.
* History of or active or both photo-induced or photo-aggravated disease (e.g. cutaneous or lupus erythematodes, polymorphic light eruptions).
* Use of any topical or systemic medication that could interfere with the trial objective within 2 weeks before randomisation until subject's end of trial.
* Use of drugs that might cause photosensitising or phototoxic reactions within 4 weeks before randomisation until subject's end of trial.
* Foreseeable intensive UV-light exposure to test fields within 4 weeks before randomisation until subject's end of trial (solar or artificial).
Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

Among the different creatinine-based GFR predicting equations, the MDRD equation gives the best prediction in renal transplantation but does not provide the level of accuracy usually seen in renal patients with native kidneys.

Blocking the tubular secretion of creatinine with an oral administration of cimetidine is likely to make creatinine a more accurate marker of GFR.

We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal transplant patients by incorporating into the equation a cimetidine-corrected serum creatinine value.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplantation \> 1 year
* Patient with immunosuppressant treatment of TACROLIMUS (PROGRAF)
* Creatinine clearance \> 30 ml/min/1,73m2 within 3 months before inclusion
* Written informed consent
* Patient affiliated to social insurance

Exclusion Criteria:

* Unstable renal function defined by serum creatinine (J0) \> 25% serum creatinine realised in 3 months
* Treatment: Bactrim, Fansidar, Cimetidine arrow within the week before inclusion
* Contraindication listed in the labeling of Cimetidine arrow
* Last residual rate of Tacrolimus \> 12 ng/ml.
* Treatment : carvedilol, phenytoïn (interaction with cimetidine)
* Serious hepatic insufficiency
Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)

Benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate, places pressure on the urethra and causes urination and bladder problems. Transurethral Resection of the Prostate (TURP) remains the gold standard treatment in most centres for BPH. However, morbidity after TURP is high, especially bleeding requiring blood transfusion and late postoperative bleeding.

Holmium laser enucleation of the prostate (HoLEP) is a safe and effective procedure which has demonstrated comparable results to TURP. HOLEP also offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. The main reason HoLEP has yet to become the new standard for treatment of symptomatic BPH is due the complexity of this procedure as compared to TURP. Furthermore, the HoLEP can be used with the MOSESTM system, a system that allows for more efficiency and ease of use of the HoLEP.

Thulium fiber laser (TFL) enucleation of the prostate is an emerging technology for endoscopic prostate enucleation that is notable for its high wavelength and pulsed mode of action. Recent studies have shown TFL enucleation of the prostate to be a safe and highly efficacious treatment modality for the management of large volume (\> 80 cm3) glands in BPH. Due to its novelty, further studies are needed to broaden the investigators' understanding of the TFL and comprehend the full implications and benefits of this new technology, as well its limitations.

The aim of this study is to whether Thulium Fiber laser enucleation of the prostate (ThuFLEP) and Holmium laser enucleation using MOSES™ (M-HoLEP) have comparable length of hospital stay, as well as intraoperative and postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Males over 50 years of age at the time of enrollment
2. Referred to urology for refractory LUTS or urinary retention secondary to BPH
3. Failed medical (non-surgical) treatment
4. Prostate size on preoperative TRUS of≥80 ml
5. IPSS \>15 and QOL score ≥3 and Qmax \<15 ml/sec
6. Written informed consent to participate in the study
7. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

1. Previous surgical treatment for BPH
2. History of prostate cancer
3. Prostate size \< 80 mL
4. History of urethral stenosis or its management
5. Known or suspected neurogenic bladder
6. Participants with active urinary tract infection until appropriately treated
7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
8. Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent
Evaluation of the Influence of Short Term Fasting Diet on Chemotherapy-induced Toxicities in Breast Cancer Patients

This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy - induced toxicities in breast cancer patients. The study will have an intevention group and a control group. The intervention group will follow a fasting diet of 60 hours (36h prior chemotherapy and 24h after the end of chemotherary), while the control group will follow regular (standard) diet. At the meantime of the chemotherapy cycles, the intervention group will be recommended to follow the Mediterranean diet.

The main questions this study is aiming to answer is whether short term fasting diet influences chemotherary - induced toxicities and if it is easy to be implemented.

This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy - induced toxicities in breast cancer patients. The study will have an intevention group and a control group. The intervention group will follow a fasting diet for 60 hours (36h prior chemotherapy and 24h after the end of chemotherapy), while the control group will follow regular diet. At the meantime of the chemotherapy cycles, the intervention group will be recommended to follow the Mediterranean diet. The patients will be randomized in the two groups. A total of 50 patients is required. Biochemical data, anthropometric measures and grading of toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events, nutritional habits, adherence to the Mediterranean diet (implementation of MedDietScore) will be assessed prior, during and after the intervention, in both groups. Nutritional counseling will be performed by Registered Dietitian, and telephone interviews will be used to record adherence to fasting diet and Mediterranean diet.

The main questions this study is aiming to answer is whether short term fasting diet influences chemotherary - induced toxicities and if it is easy to be implemented.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients with first diagnosis of breast cancer
* no distinct metastasis
* patients will receive at least 4 cycles of adjuvant or neo-adjuvant chemotherapy

Exclusion Criteria:

* BMI\<19kg/m2
* unintentional weight loss of \>3 or \>5 kg the last 3 or 6 months respectively
* medical history of anorexia nervosa, boulimia or any other eating disorders
* renal failure (creatinine \>2mg/dl)
* diabetes mellitus (type I or Insulin dependent type II)
* serious psychiatric disease
* serious cardiovascular disease
* mobility limitations
* being participant in any other study
A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters

The Groshong and Groshong PICC catheters are popular venous access devices because they are maintained with only weekly saline flushes. In a recent study, however, we found an apparent decrease in the rate of withdrawal occlusion in Groshong catheters flushed weekly with heparinized saline. However, a randomized trial is necessary to confirm this impression. In the current study as many as 66 patients will be randomized to each of two treatment arms. The Groshong catheters of one group will be flushed with saline only and the other group with heparinized saline. A comparison will be made between the frequency with which urokinase is used in the two groups to treat withdrawal occlusion during the first three months of catheterization. Groshong catheters using saline flushes will be compared to Groshong catheters using heparinized saline flushes and Groshong PICC catheters using saline flushes will be compared to Groshong PICC catheters using heparinized saline flushes. Data will be analyzed using Fisher's exact test.

The Groshong and Groshong PICC catheters are popular venous access devices because they are maintained with only weekly saline flushes. In a recent study, however, we found an apparent decrease in the rate of withdrawal occlusion in Groshong catheters flushed weekly with heparinized saline. However, a randomized trial is necessary to confirm this impression. In the current study as many as 66 patients will be randomized to each of two treatment arms. The Groshong catheters of one group will be flushed with saline only and the other group with heparinized saline. A comparison will be made between the frequency with which urokinase is used in the two groups to treat withdrawal occlusion during the first three months of catheterization. Groshong catheters using saline flushes will be compared to Groshong catheters using heparinized saline flushes and Groshong PICC catheters using saline flushes will be compared to Groshong PICC catheters using heparinized saline flushes. Data will be analyzed using Fisher's exact test.

Eligibility Criteria:
Adult subjects enrolled in approved protocols of the NCI in the CC or under treatment at the National Naval Medical Center who are planned to have Groshong Catheters used as part of their cancer treatment.

No subjects with a history of allergy to heparin.

No abnormal PT or PTT.

No subjects on anticoagulant therapy.

No history of heparin induced thrombocytopenia.
Assessing Health Related Quality of Life in Hypersensitivity Pneumonitis

The objective of this study is to administer and validate a disease specific health related quality of life (HRQOL) survey for patients with Chronic Hypersensitivity Pneumonitis (CHP).

The objective of this study is to administer and validate a disease-specific health related quality of life (HRQOL) survey for patients with Chronic Hypersensitivity Pneumonitis (CHP). The survey items have been developed and revised from prior qualitative research with CHP patients. Potential participants will be recruited from WCMC, the Pulmonary Fibrosis Foundation (PFF) Registry and outside physician referral for the study. Participants will be asked to sign informed consent. At the initial visit participants will be asked to complete the survey and two additional PROs needed for concurrent validity testing. Participants will then be asked to complete the HRQOL survey under study a second time 2 weeks after the initial visit for test-re-test reliability testing. Pulmonary function testing and six minute walk test results will be collected. Pertinent demographic and clinical information will be collected from the patients and their medical records or registry data (if a PFF Registry participant). All information will be entered into a REDCap database for secure data management and storage. Psychometric testing will be performed on the overall survey instrument and the individual items in order to test validity and reliability. The goal is that the survey developed will be a reliable and valid measurement tool for use in both clinical practice and research settings.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older
2. Understand and sign the informed consent document
3. Documented diagnosis of HP made and confirmed at an ILD center via expert consensus or in multidisciplinary discussion

   a. Diagnosis based upon a minimum of a medical history, physical examination, pulmonary function testing, and computerized tomography (CT) scan. Pathology will be reviewed if available but is not required.
4. HP must be the primary pulmonary disease
5. Anticipated ability to complete follow up survey within 2 weeks of initial survey completion
6. Participants recruited from the PFF registry must have agreed to be contacted for ancillary research studies.

Exclusion Criteria:

1. Non-English Speaking (Patient must be able to speak and read English fluently but it does not have to be their primary language)
2. Inability to complete questionnaire due to cognitive impairment
3. Patients who have not been seen by or communicated with their provider in over 2 years
OUTCOME AND SAFETY OF RECANALIZATION TREATMENTS IN ISCHEMIC STROKE DUE TO ACUTE BASILAR ARTERY OCCLUSION

Rationale: Recently, two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy (EVT) in patients with an acute symptomatic basilar artery occlusion (BAO). However, the high rate of crossover in BEST study and the long-term of recruitment in BASICS study influenced the validity of the results.

Objective: To assess the outcomes and prognostic factors of recanalization therapy in patients with BAO, caused by a CTA/MRA/DSA confirmed occlusion of the basilar artery.

Study design: This is a prospective observational study. Study population: Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTA/MRA/DSA.

Main study parameters/outcomes: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3. The estimate will be adjusted for the known prognostic variables age, time from onset to treatment, stroke severity (NIHSS), PC ASPECT and collateral flow and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known in Vietnam.Various treatments were tried in groups of patients with acute ischemic stroke due to basilar artery occlusion, but evidence based was not cleared previous studies. Therefore, we conduct this study to evaluate the efficacy and safety of recanalization therapies, which included intravenous thrombosis alone, endovascular alone, or bridging IVT and endovascular, in basilar artery occlusion stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms and signs compatible with ischemia in the basilar artery territory.
* Basilar artery occlusion (BAO) confirmed by CTA or MRA or DSA.
* Age 18 years or older
* Patients were treated with one of these among therapies IVT alone, bridging IVT and thrombectomy or thrombectomy alone..

Exclusion Criteria:

* Patients did not agree to enroll.

Imaging exclusion criteria:

* High-density lesion consistent with hemorrhage of any degree
* Significant cerebellar mass effect or acute hydrocephalus