cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390

The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24 Follow Up Visit in TPL103922 or TPL108390
* Male or female ≥18 years old
* Evidence of chronic HCV infection
* While participating in TPL103922 or TPL108390, discontinued from study drug due to thrombocytopenia
* Appropriate candidate for antiviral therapy with pegylated interferon plus ribavirin
* Platelet count \<75,000
* Fertile males and females must use two forms of effective contraception during treatment and for 24 weeks after treatment
* Ability to understand and comply with the protocol requirements and instructions
* Ability to provide written informed consent

Exclusion Criteria:

* Decompensated liver disease
* Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag, or their ingredients
* History of clinically significant bleeding from oesophageal or gastric varices
* History of arterial or venous thrombosis and two or more of the following risk factors: hereditary thrombophilic disorders; hormone replacement therapy; systemic contraception (containing estrogen); smoking; diabetes; hypercholesterolemia; medication for hypertension or cancer
* Pre-existing cardiac disease (congestive heart failure Grade III/IV) or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
* Evidence of hepatocellular carcinoma
* HIV or Hepatitis B infection
* Therapy with anti-neoplastic or immunomodulatory treatment within six months prior to eltrombopag therapy
* Malignancy diagnosed or treated within the past five years. Except for localized basal or squamous cell carcinoma treated by local excision or malignancies that were adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival.
* Pregnant or nursing women
* Men with a female partner who is pregnant
* History of alcohol/drug abuse or dependence within six months of the study start unless participating in a controlled rehabilitation programme.
* Treatment with an investigational drug or interferon within 30 days or 5 half-lives (whichever is longer) of the screening visit
* History or platelet clumping that prevents reliable measurement of platelet counts
* Evidence of portal vein thrombosis within three months of baseline visit
Incretin-based Therapy in Early Diagnosed Type 1 Diabetes

The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis in OGTT), and treated with insulin.


Eligibility Criteria:
Inclusion Criteria:

* 10-30 years of age
* early diagnosis type 1 diabetes (no symptoms, diagnosis in OGTT)
* not pregnant.

Exclusion Criteria:

* allergic to liraglutide or other ingredients of Victoza®
* diabetic ketoacidosis
* previous treatment in the last three months with any antidiabetic medication other than insulin
* impaired liver or kidney function or on dialysis
* severe heart failure
* severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease
* past or current history of pancreatitis
* serum calcitonin value above normal (\>50 ng/l or ≥3.4pmol/l)
* presence of any chronic metabolic, hematologic or malignant disease
* obesity BMI ≥30
* pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
* breast-feeding
Regulation of Inflammatory Genes in Psoriasis

Psoriasis is a chronic and recurrent skin disorder characterized by marked inflammatory changes in the skin. An extensive cytokine network including generated by activated dendritic cells and T cells mediates the formation of psoriatic lesions. These immune-response parameters can be used as markers in the severity and management of the disease after further in-depth studies.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of psoriasis
* Must be age 19 or older.
* Must be Fitzpatrick skin type I, II, III, IV, V, VI.

Exclusion Criteria:

* Subjects who do not have photosensitive disease and are not on photosensitizing medications.
* Subjects with a history of keloids (who are more likely to develop hypertrophic scars following skin biopsy).
* Subjects who have an allergy to local anesthetics, antibiotics and/or anticoagulants.
* Subjects who are pregnant.
Optimizing Expectations in Cardiac Surgery Patients

The purpose of this study is to evaluate the potential benefit of targeting patients' expectations before coronary artery bypass graft surgery through a brief psychoeducational intervention.

Coronary artery bypass graft surgery (CABG) is an extremely invasive medical intervention.It is postulated that even under these conditions, treatment outcome is substantially determined by non-specific effects, e.g. patient's expectation. Targeting patients' expectations at an early stage might have potential to optimize outcomes after cardiac surgery. The purpose of this research project is to optimize patients' outcome expectations before undergoing cardiac surgery through a brief psycho-educational program. Using a randomized controlled design, 180 patients who are scheduled to undergo elective CABG are randomly assigned either to standard medical information alone, or to an additional expectation manipulation intervention (EMI) during the two weeks before surgery, or to an attention-control group ("supportive therapy"). The main goal is to enhance positive expectations (surgery 'non-specific effects') about favorable outcome through EMI, about coping abilities to deal with adverse events, and to reduce negative expectations and misconceptions. Assessment takes place before and after EMI, 10 days after surgery and 6 months later; same assessment points are used for the 2 control conditions. Primary outcome is disability, which has been shown to be strongly determined by patient's expectation in previous studies. Moreover, psychological and biological predictors and mediators of treatment success are analyzed. A positive result for this expectation intervention would have major implications for clinical practice. In order to optimize treatment outcome, it is not only necessary to improve the treatment-specific procedures (e.g., cardiac surgery) but also to address non-specific factors such as patients' expectations.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled on the elective waiting list for first time coronary artery bypass graft surgery wiht the use of heart-lung-apparatus at the Department of Cardiovascular Surgery, Medical School, University of Marburg
* Sufficient knowledge of German language
* Ability to give informed consent

Exclusion Criteria:

* Emergency surgery
* Presence of a serious comorbid psychiatric condition
* Presence of a life threatening comorbid medical condition
* Current participation in other research
CrossFit's Injuries Study in Grand Nancy Clubs During 2018-2019

CrossFit is a recent sport that has been democratized since the beginning of the 2000's in France. The 3 major studies of CrossFit injuries were conducted in the United States in 2014, Brazil in 2016 and the United States in 2017. They show a discrepancy in terms of injuries average, from 19.4% to 31% in relation to an upsurge in the number of CrossFit practitioners, the specific training or not of the coaches framing this activity, the practice or not in competition. The main locations of these wounds are highlighted at the shoulders, lumbar region and knees. In France, to date, no epidemiological studies have been conducted on this subject.

Hypothesis: High incidence of injuries related to a lack of framing, or bad practice and ignorance of CrossFit practitioners.

Objectives : Estimate the injuries incident due to the CrossFit practice over a 8-month period in an adult population who practice in clubs .

Research, among the anthropometric, sociodemographic, environmental, and the nature and frequency of practice and training sessions, those which are associated with the occurrence of injury in this cohort.


Eligibility Criteria:
Inclusion Criteria:

Men and women

* 18 years and over
* Practicing CrossFit in a club of the Grand Nancy
* Information and non-opposition to research

Exclusion Criteria:

* Opposition to study
Spouse READI (Resilience Education And Deployment Information) Post Deployment Telephone Support Groups

This 12-month study is for spouses or significant others of service members who have returned from Afghanistan or Iraq. This study will determine if participating in a telephone discussion group, offering education, skills building, and support, will help increase post-deployment adjustment. There will be 225 spouses recruited for this study.


Eligibility Criteria:
Inclusion Criteria:

1. have a spouse who participated in a deployment to Iraq and Afghanistan and is at least 1 month post-deployment
2. if not married, must have lived as married for at least one year
3. must be committed to the relationship
4. have a telephone.

Exclusion Criteria:

1. known deployment of spouse in the next six months
2. auditory impairment that would make telephone use difficult.
Early Detection of Chronic Kidney Disease

This retrospective observational study aims to assess the proportion of patients who were appropriately referred from primary care to the nephrology teleconsultation service. The appropriateness of the referral will be determined by the time elapsed between the referral criteria being met and the date of the teleconsultation, as well as by the patient's treatment at the time of referral.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years of age
* Teleconsultation to nephrology from Primary Care in the Garraf region during the period from January to December 2024
* Patients with at least one referral criterion for the nephrology service

Exclusion Criteria:

Participants diagnosed with any of the following conditions:

* Patients with Chronic Kidney Disease previously evaluated by the nephrology service.
* History of requiring renal replacement therapy (hemodialysis, peritoneal dialysis, or kidney transplantation).
* Patients hospitalized within the last 3 months with a diagnosis of kidney failure.
* Patients with a known prior diagnosis of Autosomal Dominant Polycystic Kidney Disease or glomerular diseases.
Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of unknown primary AJCC Stage IIIC or IV (uveal and mucosal melanoma are excluded)
* Presence of NRAS Q61 mutation in tumor tissue prior to randomization as determined by a Novartis designated central laboratory
* Naïve untreated patients or patients who have progressed on or after any number of prior lines of immunotherapy for unresectable locally advanced or metastatic melanoma
* Evidence of at least one measurable lesion as detected by radiological or photographic methods
* Adequate bone marrow, organ function, cardiac and laboratory parameters
* Normal functioning of daily living activities

Exclusion Criteria:

* Any untreated CNS metastases
* Uveal or mucosal melanoma
* History of or current evidence of retinal vein occlusion (RVO) or risk factors of RVO
* Patients with washout period \< 6 weeks from the last dose of ipilimumab or other immunotherapy.
* Previous systemic chemotherapy for unresectable locally advanced or metastatic melanoma.
* History of Gilbert's syndrome
* Prior therapy with a MEK- inhibitor
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Uncontrolled arterial hypertension despite medical treatment
* HIV positive or active Hepatitis A or B
* Impairment of gastrointestinal function
* Patients who have undergone major surgery or radiotherapy ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure;
* Patients with neuromuscular disorders that are associated with elevated CK.
* Pregnant or nursing (lactating) women
* Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

Other protocol-defined inclusion/exclusion criteria may apply
Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
* Has RA greater than or equal to 3 months and less than or equal to 2 years

Exclusion Criteria:

* Received any previous treatment with MTX
* Received any previous treatment with ETN or other tumour necrosis factor antagonist
Game Based Assessment of Emotion-regulation Skills in College Students

The aim of this study will be to investigate the validity of the in-game performance measurements or scores as indicators of students'ER abilities.


Eligibility Criteria:
Inclusion Criteria:

* first year student at Babes-Bolyai University
* internet and PC access to complete the scales and game

Exclusion Criteria:

* no internet or PC access
Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration

This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration

This is a double blinded, placebo controlled study which compose of two arms. The treatment group is the local lidocaine spray application to the cervix with the intravenous opioid. The control group is the the intravenous opioid with the placebo (normal saline) before the manual vacuum aspiration. The outcome is to compare the visual analog pain score during and after procedure.

Eligibility Criteria:
Inclusion Criteria:

* female ageed 20 years to 60 years who have an indication for manual vacuum adpiration under intraveneous analgesia

Exclusion Criteria:

* patient with allergic to lidocaine or history of allergic to lidocaine
* patient with reproductive and urinary infection
* patient with abnormal vital sign
* patient with abnormal kidney and liver function test
Patient Registry of Intrathecal Ziconotide Management(PRIZM)

The objectives of this study are to evaluate the effectiveness, long-term safety, tolerability, satisfaction with treatment, and health-related quality of life (HRQoL) associated with Intrathecal PRIALT use for severe chronic pain of varying etiologies.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age at the time of study entry.
* Patient who has severe chronic pain, whom IT therapy is warranted, and who is intolerant of, or refractory to other treatments, such as systemic analgesics, adjunctive therapies, and/or IT morphine.
* Patient is planned to be initiated on IT PRIALT as the sole agent in the pump at a participated site.
* Patient has not received PRIALT treatment administered continuously via Medtronic SynchroMed® II pump within the past 30 days.
* Patient has a life expectancy \>6 months as determined by the physician.
* Patient is able to read, understand, and voluntarily sign the IRB-approved informed consent document prior to the performance of any study-specific procedures.
* Patient is able to understand and complete required assessments.

Exclusion Criteria:

* Patient has a known hypersensitivity to PRIALT or any of its formulation components.
* Patient has a pre-existing history of psychosis.
* Patient has infection at the microinjection site, uncontrolled bleeding diathesis, or known spinal canal obstruction that impairs circulation of cerebrospinal fluid.
* Patient is being initiated with PRIALT in conjunction with other IT agents.
* Patients with any other concomitant treatment or medical condition that, in the opinion of the clinician, would render IT administration hazardous.
Creatine on Bone Mass in Postmenopausal Women

Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* healthy postmenopausal women
* T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD

Exclusion Criteria:

* drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation)
* low BMI (\< 18.5 Kg/m2).
WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers

This research will test the WeCareAdvisor tool for family caregivers of military veterans with dementia to help caregivers assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management. 60 caregiver-person with dementia dyads will be recruited (30 Treatment Group, 30 Wait-List Control Group).


Eligibility Criteria:
Inclusion Criteria:

Eligible caregivers must:

* Be the primary caregiver of a military veteran with dementia for at least 6 months and planning to remain the primary caregiver for the next 2 months
* Currently living with the person they are caring for (care recipient)
* Comfortable utilizing technology (e.g. computers, tablets, the internet)
* Have access to the internet and a computer or tablet device
* Plans to live in the area for the duration of the study

Care recipients (military veteran living with dementia) must:

* Exhibit at least one or more behavioral symptoms (any behavior at any frequency)
* Receiving psychotropic medication or cognitive enhancers will not exclude the care recipient.
* Have a clinical diagnosis of dementia (any type) per caregiver report.
* Be a military veteran.

Exclusion Criteria:

* Inability to read, speak or understand English
* Lack of regular access to a telephone, internet, technology (tablet or computer)
* Caregiver is unable to use a computer or tablet
* Person with dementia is not a military veteran
Sleep in Hospitalized Children at MSKCC

The investigators want to better understand how children sleep at night at MSKCC, so that the investigators can learn how to improve the sleeping environment.


Eligibility Criteria:
Inclusion Criteria:

* Parent/Patient must provide written consent
* Patient must be between the ages of: Newborn - ≤ 18 years of age
* Patient is expected to be admitted to the Pediatric floor at MSK for at least 2 nights (patients/parents will not be approached for consent on day of admission or day of discharge)
* Patient/parent must be English speaking

Exclusion Criteria:

* Expected length of stay of fewer than 2 nights (for example.: if admitted Monday and discharged Tuesday, patient/parent will not be eligible).
* Patient /Parent unable to complete questionnaire due to education or language barriers.
* Patients admitted to the PICU. (Only children on M9 will be included. It is known that sleep in the PICU is highly disordered; as such, we will be excluding PICU patients from this study).
Long-term Safety of Protopic in Atopic Eczema

Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%

A long-term, multi-centre, open label, non-comparative phase III study in patients with atopic dermatitis. All centres in Europe which have participated or are still participating in the FG-506-06-12, FG-506-06-18 or FG-506-06-19, FG-506-06-22 or FG-506-06-23 studies will be offered a participation in the protocol. Only patients enrolled by those centres for the above mentioned studies, who have received at least one dose of study medication can be enrolled. Tacrolimus ointment 0.1% will be administered until clearance of the skin occurs. Treatment is restarted after signs and symptoms reoccur. Safety will be assessed from adverse events reported by the patient/parent/guardian or observed by the investigator at the site of application and elsewhere. The safety evaluation will include monitoring of routine hematology and serum chemistry parameters at Baseline/Day 1, Week 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and/or at the end of the study (End-of-Study Visit).

Eligibility Criteria:
Inclusion Criteria:

* Every patient who has participated in the FG-506-06-12, FG-506-06-18, FG-506-06-19, FG-506-06-22 or FG-506-06-23 study, and has received at least one dose of study medication
* Patient is likely to benefit from further treatment with Tacrolimus (FK506) ointment in the opinion of the investigator
* Patient has atopic dermatitis with Body surface involvement between 5% and 60% for patients with the age of 2 years to 15 years (not having reached their 16th birthday) and between 5% and 100% for patients with 16 years of age or older

Exclusion Criteria:

* Patient has an infection requiring treatment
* Patient is known to be HIV positive
* Patient has a systemic disease, including cancer or history of cancer or AIDS, which would contraindicate the use of Tacrolimus (FK506) ointment