cyrilzakka/clinical-trials huggingface dataset:
Dementia in Migrants Living in Italy: Promoting a Diversity-sensitive Clinical Approach and Provision of Care

The number of older migrants with cognitive impairment and dementia living in Italy and attending national healthcare services is rapidly increasing. There is a need to develop diversity-sensitive policies and practices to include migrants and people with different cultural values in the public health response to dementia.

Based on the gaps and barriers identified by the ImmiDem study (GR-2016-02364975), the present project aims to:

i) Describe the clinical and sociodemographic characteristics of migrants with cognitive disorders living in Italy, their health outcomes, and their access to healthcare resources; ii) develop and disseminate screening and assessment tools allowing the cross-cultural cognitive examination of individuals with a migration background; iii) raise awareness about dementia among culturally diverse people and train healthcare professionals in how to provide culturally competent care and support for migrants with cognitive disorders.

Eligibility Criteria:
Inclusion Criteria:

* Migrant (person who was not born in Italy) attending an Italian CCDD;
* Presence of a cognitive impairment.

Exclusion Criteria:

* A person without any cognitive impairment.
Mimic Muscle Volume, Central Facial Palsy Severity and Dysphagia

70 stroke patients with central facial paralysis will be included and their demographic data will be questioned and facial nerve thickness, depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.

70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included and their demographic data such as age, gender, marital status, education level, body mass index, stroke etiologies will be questioned and used with the House-Brackmann scale. Involvement levels, facial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated. The data obtained will be correlated with total dysphagia score and facial disability index.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke and presence of unilateral central facial paralysis,
* Agreeing to participate in the study,
* Cognitive competence to understand the test instructions,
* Presence of communication skills to respond to the test instructions.

Exclusion Criteria:

* Presence of previous facial paralysis or a neurological disease other than stroke that will cause central paralysis,
* bilateral involvement
* illiteracy, refusal to participate in the study,
* jaw joint problem,
* surgical intervention in the facial area that will affect ultrasound measurements,
* infected open wound.
Bioequivalency Study of Torsemide Tablets Under Fasting Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Torsemide or any comparable or similar product.
Mobile Health Sleep and Growth Study 2

Investigators seek to determine if an online behavioral economic based intervention can be developed to target increases in childhood time in bed (TIB).

Investigators seek to determine if an online behavioral economic based intervention can be developed to target increases in childhood time in bed (TIB). The primary objectives of this study are to determine if the behavioral economic strategy of compensatory effect leads to the middle time in bed (TIB) target to be most commonly selected, and if the behavioral economic strategies of normative feedback and loss-framed incentives lead to longer TIB and therefore longer total sleep time.Children aged 10-12 who sleep about 7-8 hours per night will wear a FitBit for 11 weeks in order to measure time in bed and total sleep time. Participants will have a time in bed goal to meet each night. Participants will be randomized to one of four study arms and receive text and/or email messaging from the study about sleep hygiene. Some study arms receive additional messaging. The study involves two visits to the Children's Hospital of Philadelphia (CHOP) Roberts Center for Pediatric Research.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 10 to 12 years.
2. Speak, read and write in English.
3. Parental/guardian permission (informed consent) and child assent.
4. Have a computer or a tablet computer with access to the Internet, or own a smart phone with a data and text plan.
5. Parent reported time in bed on school nights between 7-8 hours in bed at night (e.g. 7 hour time in bed: go to bed at 11pm \& get out of bed at 6am).

Exclusion Criteria:

1. Any clinically diagnosed sleep disorder (e.g. sleep apnea).
2. Syndromic obesity.
3. Diagnosed with a psychiatric disorder \[(e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety)\].
4. Diagnosed with an eating disorder.
5. Musculoskeletal or neurological disorder that limits physical movement and activity.
6. Use of medications (prescription or otherwise) known to affect body weight and/or sleep.
Efficacy of a Bilberry-based Probiotic Product on Glucose Tolerance and Insulin Resistance

The impact of a bilberry-based probiotic drink on the postprandial levels of serum glucose and insulin have already been study in the past. The aim of the current study is to evaluate the long term effect of the probiotic bilberry drink on glucose tolerance and insulin resistance in healthy adults and in comparison to a control drink.


Eligibility Criteria:
Inclusion Criteria:

Healthy adults with a BMI between 20-30

Exclusion Criteria:

-
Safety and Efficacy of Addition of Structured Lipids in Starter Formulas

The primary objective of this trial is to demonstrate that infants receiving an infant formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the first 4 months of life, stools that are softer than those of infants receiving a control formula.

Human milk is considered as the golden standard for infant formula. In human milk and infant formula lipids provide about 55% of energy for the infant and represent as such a major nutrient for the baby. The vast majority of the lipids in human milk is composed of triacylglycerols (98% of total lipids) and the remainder percent are phospholipids. Triglycerides are composed of the glycerol backbone to which three fatty acids are bound. In human milk, palmitate (16:0) is the major long chain saturated fatty acid representing 22% to 26% of total fatty acids, esterified to approximately 70% in sn-2 position on the glycerol backbone. Unsaturated fatty acids such as oleic acid (18:1) and linoleic acid (18:2n-6) are preferentially esterified at the 1 and 3 position. In infant formulas the major source of palmitic acid is palm oil or palm olein where palmitate is, however, preferentially in the external 1,3 positions, and mono- and polyunsaturated fatty acids are usually esterified at the 2-position of the triacylgycerol.

The aim of this study is to assess the safety and efficacy of infant formula containing 40% and 50%, respectively, of palmitic acid in sn-2 position.

Eligibility Criteria:
Inclusion Criteria:

* healthy newborn infants
* full term infant (37 - 42 weeks gestation)
* birth weight between 2.5 and 4.5 kg
* singleton birth
* the infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
* having obtained his7her legal representative's informed consent

Exclusion Criteria:

* congenital illness or malformation that may affect normal growth
* significant pre-natal and/or post-natal disease
* hospitalization in the first 14 days of life after the child has left the maternity ward
* receiving antibiotic treatment at time of enrolment
* newborn whose parents/caregivers cannot be expected to comply with treatment
* newborn currently participating in another interventional clinical trial.
Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients

This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.

In the first stage, 13 evaluable patients will be accrued per cohort. Evaluable is defined as: at least one administration of nivolumab and availability of paired biopsies for immunohistochemistry (for induction treatment cohorts pre-induction and pre-nivolumab biopsies).

If there are 1 or no responses observed in these 13 patients, the cohort will be stopped. Otherwise, 21 additional patients will be accrued for a total of 34.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or incurable locally advanced triple negative breast cancer (ER \< 10%, HER2 IHC 0,1+ or 2+ with no amplification)
* Metastatic lesion accessible for histological biopsy
* 18 years or older
* Maximum of three lines of chemotherapy for metastatic disease and with evidence of progression of disease. Treatment with low-dose doxorubicin in the palliative setting is not allowed.
* WHO performance status of 0 or 1
* Measurable or evaluable disease according to RECIST 1.1
* Disease Free Interval (defined as time between first diagnosis or locoregional recurrence and first metastasis) longer than 1 year
* Subjects with brain metastases are eligible if these are not symptomatic and free of progression of at least 4 weeks
* A maximum dosage of 360 mg/m2 of anthracyclines and no previous anthracycline-related cardiac toxicity. In case of radiation in the cardiac area, hypertension, diabetes mellitus or hypercholesterolemia, the left ventricular ejection fraction must be 50% or higher.
* Adequate bone marrow, kidney and liver function

Exclusion Criteria:

* uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris
* known history of leptomeningeal disease localization
* history of having received other anticancer therapies within 2 weeks of start of the study drug
* history of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (\>10 mgl daily prednisone equivalents) or chronic infections.
* prior treatment with immune checkpoint inhibitors.
* active other cancer
* history of uncontrolled serious medical or psychiatric illness
* current pregnancy or breastfeeding
Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema

The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch in children with eczema.

Eczema is characterized by chronic itch. Many children develop a chronic focus (rumination) on their itch. Rumination is a maladaptive method of responding to distress, in which the individual thinks obsessively about the source of distress. The rumination on chronic itch in eczema can have detrimental effects on one's quality of life, as well as induce significant anxiety about when itch will return, how long it will last, and how it will affect physical and social functioning.

Cognitive behavior therapy (CBT) is a frontline treatment for rumination, as it focuses on teaching strategies so that the individual can examine distressing thoughts objectively and determine their validity, replace negative thinking patterns with more adaptive thought patterns, and increase the individual's awareness to their problematic thought patterns. Additionally, CBT helps the individual to implement behavioral strategies to cope with possibly anxiety-inducing situations, such as scratching while trying to go to sleep.

The investigators hypothesize that an Itch CBT intervention is an effective, non-medication-based, easy to implement strategy to improve itch in children with eczema.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe atopic dermatitis \[assessed by Patient Oriented Eczema Measure (POEM)score of \>-8 OR NRS itch score of \>= 4\].
* English speaking.
* Currently receiving treatment at Lurie Children's Hospital for atopic dermatitis.
* Parent or guardian available to participate in protocol.
* Have sufficient technology (e.g., cell phone, computer, tablet, etc.) that can be used to access Zoom conference technology for telemedicine visits.

Exclusion Criteria:

* Inability to comprehend and complete questionnaires.
* History of intellectual disability or psychosis.
Effects of Dry Needling on Neck and Shoulder Pain in Orchestral Musicians: a Prospective Case Series

This study evaluates the effectiveness of Deep dry needling of active myofascial trigger points present in muscles of the neck and shoulder region in orchestral musicians.


Eligibility Criteria:
Inclusion Criteria:

* Orchestral musicians
* Chronic neck or shoulder pain
* Presence of active myofascial trigger points

Exclusion Criteria:

* Fear of needles
* Coagulation disorders
* Pregnancy
Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis

The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.

Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed acute appendicitis

Exclusion Criteria:

* Age less than 7 or more than 75 years old
* Gangrenous appendicitis
* Combined generalized peritonitis
* ASA score more than 3 point
* Pregnant women
* Cases requiring draining tube
The Effect of Slow Stroke Back Massage on Pain and Fatigue in Women With Fibromyalgia

Fibromyalgia syndrome (FM) is defined as a non-inflammatory chronic pain syndrome with widespread pain in the musculoskeletal system, tender points (PINs) on physical examination and no specific laboratory findings. T Sampling was calculated using Power power (G Power 3.1.9.4) analysis. The effect size of the study was calculated based on the mean pain scores and standard deviations of the control and experimental groups taken from the study conducted by Field, et al. (2002). Accordingly, when 25 patients were included in each group, it was determined that the power was 85% at 5% Type I error level. The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes. data will be collected with patient information form, fatigue severity scale and vas.

he research will be conducted experimentally with the aim of evaluating the effects of slow-stroke back massage in patients followed up in the physical therapy and rehabilitation unit with the diagnosis of fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Able to communicate verbally,
* Over 18 years of age,
* no vision and hearing loss
* who have received medical treatment,
* who have never received a slow-stroke back massage before

Exclusion Criteria:

* Initially volunteered to participate in the study, but did not like the application of slow-stroke back massage
* who wants to leave the study for another reason
An Investigation To Determine The Potential Interaction Effect Between GW876008 And Midazolam.

This study will evaluate any effect of single and repeated administration of GW876008 on the metabolism of midazolam in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females.
* Normal ECG.
* Agree to remain in the clinic for the time defined in the protocol.
* Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample.

Exclusion Criteria:

* Any serious medical disorder or condition.
* Any history of an endocrine disorder.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* Active peptic ulcer disease.
* Positive faecal occult blood.
* The subject smokes or has smoked or has used any nicotine-containing products in the last six months.
* Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
INtraoperative Approach With Eventual Clearance of Common bilE Duct by SpyGlass Discover vs Sequential Strategy in Patients With Acute Calculus Cholecystitis and Intermediate/High Risk of Common BiLE Duct Stone

INACCESSIBLE trial is a randomized controlled study that compares two different strategies for the treatment of Acute Calculous Cholecystitiis (ACC) patients with high/intermediate risk of CBDS, according to the score by Khoury T (named Israelian Score, IS). If a patient meets the inclusion and exclusion criteria, (s)he will be randomized to receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures (control group) or ELC + Spyglass cholangiography (study group). The follow-up will be performed after 30 days and 6 months from intervention with an outpatient medical examination


Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of ACC as defined by 2018 Tokyo Guidelines criteria
* have an Israelian Score (IS) for the risk of main bile duct stones of 2 or 3
* be \>18 years old
* onset of symptoms ≤7 days before Emergency Department (ED) admission
* provide signed and dated informed consent form
* be willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

* Pregnancy
* Patients unwilling to undergo follow-up assessments
* Patients diagnosed with concomitant cholangitis or pancreatitis
* Acute cholecystitis not related to a gallstone etiology
* Onset of symptoms \>7 days before ED admission
* Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
* Biliary peritonitis
Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression

The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of major depressive disorder consistent with DSM-IV-TR
* current episode greater than 8 weeks in duration
* Hamilton Depression score \>/- 21
* less than 25% reduction in depression during current episode assessed by ATRQ

Exclusion Criteria:

* Axis diagnosis of other psychiatric disorders
* Experiencing hallucinations, delusions, other psychotic symptomatology
* ECT during current episode
A Study of BGB-11417 in Participants With Myeloid Malignancies

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .


Eligibility Criteria:
Key Inclusion Criteria:

1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:

   * AML, nonacute promyelocytic leukemia
   * MDS
   * MDS/MPN
2. Eastern Cooperative Oncology Group performance status of 0 to 2.
3. Adequate organ function defined as:

   * Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)
   * Adequate liver function
4. Life expectancy of \> 12 weeks.
5. Ability to comply with the requirements of the study.

Key Exclusion Criteria:

1. A diagnosis of acute promyelocytic leukemia.
2. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)
3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
4. Prior therapy with a B-cell lymphoma-2 inhibitor
5. Known central nervous system involvement by leukemia.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically or cytologically confirmed advanced HCC
* No previous systematic treatment for HCC
* Have at least one measurable lesion (in accordance with RECIST v1.1)
* BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
* ECOG-PS score 0 or 1
* Child-Pugh Class: Grade A
* Life Expectancy of at least 12 weeks
* Subjects with HBV infection: HBV DNA\<500 IU/ml or \< 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
* Subjects with HCV-RNA(+) must receive antiviral therapy
* Adequate organ function

Exclusion Criteria:

* Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
* Moderate-to-severe ascites with clinical symptoms
* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Cardiac clinical symptom or disease that is not well controlled
* Hypertension that can not be well controlled through antihypertensive drugs
* Factors to affect oral administration
* History of hepatic encephalopathy
* Previous or current presence of metastasis to central nervous system
* HIV infection
* Combined hepatitis B and hepatitis C co-infection
* Be ready for or previously received organ or allogenic bone marrow transplantation
* Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
* Active known, or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
* Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Severe infection within 4 weeks prior to the start of study treatment
* Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment
* Treatment of other investigational product(s) within 28 days prior to the start of study treatment