cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Intermediate Cervical Plexus Block

Background: Many thyroidectomy patients suffer from postoperative pain that could delay early hospital discharge and place a significant burden on both the patient and the healthcare team. Bilateral intermediate cervical plexus block (ICPB) provides good analgesia for neck surgery, including thyroidectomy. However, the duration of a single-shot nerve block is usually short. Therefore, adjuvants are used in peripheral nerve blocks.

Objectives: To compare the safety and efficacy of dexmedetomidine versus dexamethasone as adjuvants to bupivacaine in ultrasound-guided intermediate cervical plexus block in patients undergoing total thyroidectomy under general anesthesia.

Patients and Methods: This is a randomized, double-blind, phase four, prospective clinical trial; carried out on 60 patients, who were candidates for total thyroidectomy under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received bilateral ICPB with isobaric bupivacaine plus dexmedetomidine, and group B, received bilateral ICPB with isobaric bupivacaine plus dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 60 years
* Body Mass Index (BMI) ≤ 35 kg/m2

Exclusion Criteria:

* ASA physical status \> II
* Age \< 21 years or \> 50 years
* BMI \> 35 kg/m2
* Bronchial asthma
* Chronic obstructive pulmonary disease
* Restrictive lung diseases
* Sick sinus syndrome
* Sinus bradycardia
* Hypertension
* Chronic hypotension
* Ischemic heart disease
* Coagulopathies
* Hepatic insufficiency
* Renal insufficiency
* Diabetes mellitus
* Peripheral neuropathy
* Thyroid malignancy
* Hyperthyroidism
* Substernal goiter
* Patients on beta-blockers
* Patients using pacemakers
* Alcohol or drug abuse
* Allergy to the study drugs
Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis

A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study

This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of mild to severe scalp psoriasis

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp, defined by an Investigator's Global Assessment (IGA) score of at least 2 at baseline/randomization

Exclusion Criteria:

* Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies during the study (concomitant treatment of body psoriasis with over the counter topical products including emollients, is allowed).
* Patient has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis)
* Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters, including planned extensive exposure to sunlight during the study.
* History of psoriasis unresponsive to topical treatments.
* Current immunosuppression or history of organ transplant.
* Patients who have a history of or current diagnosis of glaucoma.
* Patients who have had surgery on the eyes or eyelids within 1 month before baseline or plan to have eye or eyelid surgery during the study.
* Patients with active infection (including but not limited to bacterial, fungal and viral infection) and/or open wounds on the entire head and neck area.
A Randomized Control Trial Examining Two Treatments for Problem Gambling

Despite evidence of high rates of concurrent substance use and anger problems among problem gamblers, until recently there have been no empirically evaluated treatments for these co-morbid problems. A recent study (Korman, Collins, McMain, \& Skinner, 2005) found that an emotion and behaviour regulation treatment (EBRT) was more effective than a gambling-only treatment-as-usual in engaging clients in treatment and in reducing gambling, anger, and substance use. This study is a replication of Korman et al's study and will compare an emotion and behaviour regulation treatment (EBRT) for problem gambling, anger and substance use to a manualized cognitive behavioural treatment (CBT) for problem gambling.

80 participants will be randomly assigned to either an emotion and behaviour regulation treatment (EBRT) or to a cognitive behavioural treatment (CBT). Randomization will be stratified by the presence of substance dependence disorder. Both treatment conditions will consist of 12 one-hour weekly outpatient individual sessions. Participants will be assessed at baseline, end of treatment, and 3-months, 6-months and 12-months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Problem gambling (PGSI \> 7; c.f., Ferris \& Wynne, 2001)
* Clinically significant anger (STAXI-II anger expression/trait subscale score \>75th percentile and/or Anger Control subscale score \< 25th percentile; c.f., Spielberger, 1999)

Exclusion Criteria:

* Major thought disorders
* Acute manic episode
* High psychopathy
* Severe developmental/cognitive disability
* Outstanding legal charges/sentencing
POSSE Project: A Community-Level Intervention for Black YMSM

Black young men who have sex with men (BYMSM) are at high risk for contracting and transmitting HIV, and represent a priority population for developing effective interventions. Within the House Ball community (HBC), a clandestine subculture of the Black gay community, HIV is highly stigmatized. This stigma, coupled with high HIV prevalence rates and elevated levels of undiagnosed/untreated HIV infection, places BYMSM in HBCs at incredible risk for HIV infection. Community-level interventions that target social norms, behavior, and stigma in the HBC are sorely needed in order to make a broader impact among BYMSM. Building on prior work in the community, this study proposes to launch an innovative Effectiveness-Implementation Hybrid Type 2 trial to examine the effectiveness and implementation of a community-level HIV prevention intervention (called POSSE) based on popular opinion leader (POL) models across two cities with similar HBCs, Chicago and Philadelphia. The proposed study has two specific aims: 1) To determine the effectiveness of a POL intervention, POSSE, to decrease sexual risk behavior (UAI), STIs and HIV stigma among BYMSM in the HBC; and 2) To evaluate the processes, strategies, barriers and facilitators for the implementation of POSSE delivered across two distinct metropolitan areas with high HIV prevalence among BYMSM and similar House Ball Communities. To examine these aims, the investigators will first use social network strategies to identify, screen, and recruit POLs (n=75) from the Philadelphia HBC. The investigators will then gather baseline behavioral and biological (HIV/STI testing) data in both Chicago and Philadelphia (n=100 BYMSM per city) and train the Philadelphia POLs to implement the POSSE intervention. The investigators will conduct an implementation-focused process evaluation to assess fidelity to the POSSE intervention; number, content, spread, and acceptability of risk reduction messages; age appropriateness of the messages; acceptability of the overall intervention; and barriers/facilitators to implementation. Next, the investigators will complete follow-up assessments every 6 months post- intervention in both cities (n=100 BYMSM per city at each assessment point). The investigators will also assess behavior change in those delivering the intervention (POLs) at each assessment point. The investigators will conduct implementation-focused qualitative interviews with POLs (n=15) and community participants (n=30) from Philadelphia. Last, the investigators will implement POSSE in Chicago by repeating the steps outlined above, continuing assessments in both cities, and conducting qualitative interviews in Chicago.


Eligibility Criteria:
Inclusion Criteria:

* self-identified as Black,
* between the ages of 15 - 24 (inclusive), and
* in attendance at a HBC event at the time of the assessment.

Exclusion Criteria:

* intoxicated or otherwise unable to consent at time of enrollment
Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia

Iron overload is well study in Thalassemia patients and it's not only related to blood transfusions, since intestinal iron absorption is also increased in those patients. Sickle cell patients didn't developed significant clinical symptoms and signs of iron overload in spite frequent transfusions. The purpose of this study is to assess the iron overload in Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and laboratory studies including Non Transferrin Binding Iron, Labile Iron and Hepcidin, in order to determine the cardiac and liver iron.


Eligibility Criteria:
Inclusion Criteria:

* All the patients with Sickle Cell Anemia and Sickle Cell Thalassemia that are treated and followed up at the Pediatric Hematology Unit.
Image Quality Assessment for Screening and Diagnostic Mammography

This study is being conducted to determine the image quality of images using a new investigational medical imaging device.


Eligibility Criteria:
Inclusion Criteria:

1. Are women aged 40 years or older (≥40 years old);
2. Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
3. Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
4. Are able to walk without assistive devices;
5. Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and
6. Are willing to provide written informed consent to participate.

Exclusion Criteria:

1. Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
2. Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
3. Are currently lactating;
4. Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
5. If enrolled to the DBT (Digital Breast Tomosynthesis) cohort, have breast implants (breast implants are not exclusionary in the FFDM (Full Field Digital Mammography) cohort).
Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Objective: To investigate the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis.

Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, during each following period, all the parameters were recorded prospectively, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects.

Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea

Second outcome measures: carrying status of IUS


Eligibility Criteria:
Inclusion Criteria:

* Women with regular menses
* Adenomyosis diagnosed via transvaginal ultrasound
* With severe dysmenorrhea (VAS ≥ 7) and/or menorrhea (pictorial chart scores \>100)
* Duration of placement \> 12 months
* Size of uterus by physical examination less than uterus of 12-week pregnancy

Exclusion Criteria:

* Desire for pregnancy or lactation
* With diagnosis of malignancies or precancerous lesions
* Acceptance of laparotomy
* Contraindication of placing levonorgestrel-releasing intrauterine system
A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia

The purpose of this study is to determine the pharmacokinetics (PK), tolerability and safety of brexpiprazole LAI following a single administration in subjects with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients who are between 18 and 64 years of age, inclusive, at the time of informed consent
* Patients with a diagnosis of schizophrenia as defined by the DSM-5® criteria
* Patients who are able to remain at the trial site for the protocol-defined hospitalization period
* Patients with a body mass index \[BMI = body weight (kg) / height (m)2\] of no less than 18.5 kg/m2 and less than 35.0 kg/m2 at screening
* Patients who are able to provide written informed consent (if the patient is a minor or is hospitalized for medical protection, his or her legally acceptable representative must also give informed consent) prior to commencement of any trial procedure and are judged by the investigator or subinvestigator to be able to meet all protocol-defined requirements

Exclusion Criteria:

* Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (eg, schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder) as defined by the DSM-5® criteria. However, this exclusion does not apply to caffeine- or tobacco-related disorders.
* Patients who fail to meet the mandatory washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of the drugs or foods during the trial period
* Patients who have received electroconvulsive therapy (ECT) within 60 days prior to the administration of IMP
* Patients with clinically significant nervous, hepatic, renal, metabolic, blood, immune, cardiovascular, respiratory, or digestive system disorders However, such patients may be enrolled if the condition is mild or well controlled and is considered to not affect safety or PK evaluations.
* Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days prior to the administration of IMP
* Patients with a positive drug test at screening (according to the results from the central laboratory). However, such patients may be enrolled if their condition is not diagnosed as a substance-related or addictive disorder, according to the DSM-5® diagnostic criteria.
Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease

The aim of this study is to investigate if patients hospitalised for medical disease will increase their time spent out of bed during hospitalisation through simple feedback about physical activities from a mobile device.

Physical activity is measured by means of a pair of accelerometers embedded in band aids placed on the thigh and on the chest. The measurement is continuous and data is uploaded to a secure internet-server. Summaries of physical activity (bedrest, sitting, standing, walking) is computed and can be displayed on a mobile device (tablet) through a dedicated application.

The study will be conducted as a controlled cohort study in a large tertiary public hospital in Copenhagen, Denmark. Patients admitted to Department of Respiratory Medicine will be included and will have their physical activity measured during hospitalisation. Half of the cohort will receive visual feedback about the amount of physical activity from a mobile device placed on the bed table.

A total of 108 patients will be included resulting in 6 periods of 18 patients each.


Eligibility Criteria:
Inclusion Criteria:

1. Is admitted to the Department of Respiratory Medicine
2. Has signed informed consent
3. Reads and speaks Danish

Exclusion Criteria:

1. Any condition that, in the opinion of the investigator, makes the person unfit for participation
2. Has allergy towards band aid
A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)

The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.


Eligibility Criteria:
Inclusion Criteria:

* Ability of the participant or his legally authorized representative (e.g., parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations
* Male participants of any age diagnosed with severe hemophilia A (as confirmed from the medical record)
* Currently diagnosed with high titer inhibitors (historical peak greater than or equal to (\>=) 5 Bethesda units per milliliter (BU/mL), according to medical records)
* Previously treated with any plasma-derived or recombinant conventional or Extended Half-Life FVIII

Exclusion Criteria:

* Other coagulation disorder(s) in addition to hemophilia A
* Previous immune tolerance induction (ITI)
* History of hypersensitivity or anaphylaxis associated with any factor VIII (FVIII) administration
* Planned major surgery scheduled during the study unless deferred until after study completion (minor surgery such as tooth extraction or insertion/replacement of central venous access device is allowed)
* Abnormal renal function (serum creatinine \>1.5 milligram per deciliter (mg/dL) or 2 × upper limit of normal (ULN) for participant age based on local laboratory range) as assessed by local laboratory
* Serum alanine aminotransferase or aspartate aminotransferase \> 5 × upper limit of normal (ULN) as assessed by local laboratory
A Study Evaluating Desvenlafaxine Sustained Release (DVS SR) in Adult Female Outpatients With Fibromyalgia

The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.


Eligibility Criteria:
Inclusion Criteria:

- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria

Exclusion Criteria:

* Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation
* Other painful conditions that may confound the diagnosis or assessment of fibromyalgia
* Treatment with other drugs for fibromyalgia with 14 days of study start or during the study
Acarbose and Secondary Prevention After Coronary Stenting

The purpose of this study is to determine whether the intervention for newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome.

Recent studies have demonstrated that newly diagnosed abnormal glucose tolerance (AGT; diabetes mellitus and impaired glucose tolerance) are common among the patients with ischemic heart disease. Several large cohort studies indicate that people with prediabetic conditions, such as impaired glucose tolerance, have a raised risk of future cardiovascular disease. Intervention with acarbose can prevent myocardial infarction and cardiovascular disease in type 2 diabetic and IGT patients. However, the effect of acarbose to secondary prevention of myocardial infarction or cardiovascular events in patients with newly diagnosed AGT after coronary stenting remains unclear. The purpose of the present study is to determine whether the intervention to such abnormalities after coronary stenting will improve the long-term clinical outcome. This is a opened, randomized study to compare acarbose versus a standard lifestyle modification. Patients will have a 1:1 chance of receiving acarbose versus the standard lifestyle modification. There is some research evidence that suggests acarbose may improve clinical outcome in patients with type 2 diabetes and in IGT patients.

Eligibility Criteria:
Inclusion Criteria:

* Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome.
* Abnormal glucose tolerance according to a 75 g oral glucose tolerance test (OGTT).
* HbA1c is less than 6.5%.
* Age is between 20 and 75 years (at time of consent).
* Patients who can give informed consent themselves in writing.

Exclusion Criteria:

* Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome, etc.
* Patients with planned angioplasty.
* Patients with uncontrollable congestive heart failure.
* Less than 6 months since last episode of cerebral infarction.
* Patients who have received medication for diabetes mellitus before.
* AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
* Creatinine exceeding 2 mg/dl.
* Patients with a history of ileus or less than 6 months since celiotomy.
* Pregnant women or those who plan to become pregnant, or are in the lactation period.
* Habitual drinker (more than 100 ml/day of alcohol).
* Patients with a history of gastrectomy.
* Patients for whom it is impossible to follow up for 5 years.
* Any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.
A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation

This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.


Eligibility Criteria:
Inclusion Criteria:

1. BRAF V600 mutation in solid tumor.
2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment.
4. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
5. ECOG performance status of 0-1.
6. Life expectancy ≥ 3 months.
7. Ability to take the medicine orally.
8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Hypersensitivity to study drug ingredients or their analogues.
2. Prior therapy with MEK-inhibitor.
3. Receiving any other anti-cancer therapy at the same time .
4. Active central nervous system (CNS) lesion.
5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.
6. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome；
7. Uncontrolled concomitant diseases or infectious diseases.
8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
9. History of HIV,HCV,HBV infection.
10. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
11. Serum HCG test is positive.
12. Other conditions that increase the risk of study and influence the result.