cyrilzakka/clinical-trials huggingface dataset:
Dinaciclib in Treating Patients With Stage IV Melanoma

This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib.

SECONDARY OBJECTIVES:

I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease.

III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma.

OUTLINE: This is a multicenter study.

Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed malignant melanoma

  * Stage IV disease
  * Cutaneous or mucosal origin
  * Melanoma of unknown primary allowed
  * No ocular melanoma
* Measurable or non-measurable disease
* No prior or concurrent brain metastases as confirmed by CT scan or MRI
* Zubrod performance status 0-1
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (including patients with hepatic metastases)
* SGOT or SGPT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases)
* Serum creatinine ≤ 1.5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
* No prior therapy with a cyclin-dependent kinase inhibitor
* At least 14 days since prior radiotherapy
* At least 28 days since prior systemic chemotherapy
* At least 28 days since prior adjuvant systemic therapy
* At least 28 days since prior surgery
* No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to ≤ grade 1
* Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy

  * Therapy for stage IV resected free-of-disease will be considered adjuvant therapy
* Prior radiotherapy allowed provided any side effects have resolved to ≤ grade 1
* Prior surgery (for both the primary and stage IV disease) allowed provided side effects have resolved to ≤ grade 1
* No other concurrent or planned non-study treatment (including chemotherapy, hormonal therapy, biologic therapy, or radiotherapy)
* No concurrent CYP3A4 inhibitors or inducers
* No concurrent grapefruit or grapefruit juice
Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease

Investigate the nephroprotective effect of Activated Charcoal and Probiotic in limiting the progression of renal impairment in patients with chronic kidney disease and improving of renal function test and phosphate level.

Condition or disease:

chronic kidney disease

Chronic kidney disease (CKD) is characterized by a gradual decrease in the glomerular filtration rate (GFR) and proteinuria. CKD is a global health problem, and its incidence has been increasing. The estimated global prevalence of CKD is 8-14%. When kidney function deteriorates gradually, many metabolites accumulate in the body. These accumulated substances, termed as uremic toxins (UTs), can result in adverse pathophysiological outcomes. UTs can affect multiple organs and cause renal fibrosis, vascular calcification, anemia, peripheral arterial disease, adynamic bone disease, adipocyte dysfunction with insulin resistance, impaired immune system, and uremic pruritus.

The pathophysiological mechanisms through which UTs cause multiple organ damage are complex and not completely understood. These mechanisms may include inflammation, reactive oxidative stress, cellular transdifferentiation, impaired mitochondria function, intestinal barrier destruction, and changes in intestinal microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age more than 18 years old;
* Patients with CKD;
* Both genders will be included.

Exclusion Criteria:

* Patient with age less than 18 years old;
* Inability or rejection to take activated charcoal or probiotic;
* Clinically unstable;
* Pregnant;
* Unlikely to adhere to study procedure (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism).
Etanercept Plus UVB-311nm Phototherapy in Psoriasis

Etanercept, a biological antipsoriatic drug with anti-tumor-necrosis factor (TNF) activity has been approved for the treatment of moderate to severe psoriasis. However, in a substantial portion of cases etanercept does not induce reduction in psoriasis area and severity index (PASI) of 75% or greater, now being considered as gold standard for treatment efficacy. In this study the researchers aim to determine in a randomized half-side comparison, whether additional narrowband UVB-311nm phototherapy accelerates and improves the therapeutic efficacy of etanercept.

Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater qualify for the study. Etanercept is continued and UVB-311nm phototherapy is added at 6 weeks or thereafter on a randomized body half (left or right; head exempt) 3 x per week until complete response (defined as reduction in PASI to \< 3) for a maximum of another 6 weeks (until week 12). PASI score and patient disease score is assessed weekly; patient life quality score at week 0, 6, and 12; all scores at follow-up visits at month 3, 6, and 12. Paired statistical testing (T-test or Wilcoxon) for differences in PASI and patient disease and life quality scores is done; Fischer exact test is applied to determine differences in complete remission, PASI reduction \> 90%, \> 75%, and/or 50% between body sites.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe psoriasis who have received a standard dose of etanercept (50 mg or 25 mg s.c. twice weekly) for at least 6 weeks without a PASI reduction of 75% or greater

Exclusion Criteria:

* Pregnancy or lactation
* Presence of or history of malignant skin tumors
* Dysplastic melanocytic nevus syndrome
* Antinuclear antibodies (ds-DNA, Ro/SSA, La/SSB)
* Autoimmune disorders such as Lupus erythematosus or Dermatomyositis
* Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
* General poor health status
Molecular Response After Concurrent Exercise With Low Glycogen

This is a randomized, counterbalanced crossover design, in which 14 male subjects will complete two experimental trials. Each trial will be separated by a minimum of at least 12 days (range: 12-30 days). The study aims to investigate the effects of low glycogen availability on skeletal muscle molecular response after a concurrent exercise day.

Two experimental exercise trials; a low carbohydrate (= LOW) and a high carbohydrate (= HIGH) trial. During both experimental days subjects will complete an continues submaximal cycling bout in the morning followed by a resistance exercise session in the early afternoon. During the LOW trial subjects will receive a low carbohydrate mixed meal, during the HIGH trial subjects will be provided with a high carbohydrate meal. In addition, on both experimental days subjects will receive adequate protein beverages. Lastly, protein will be provided post resistance exercise.

Eligibility Criteria:
Inclusion Criteria:

* Male gender between 18 and 30 years of age
* BMI between 18.5 - 25 kg/m2
* Participating in regular exercise training (at least 1 exercise session, and a maximum of 3 exercise session per week)
* Used to different types of exercise (endurance, resistance and/or concurrent)
* Willing to give blood samples
* Willing to give muscle biopsies
* No use of antibiotics during the study or in the past month
* No drug use
* Suitable veins for blood withdrawal
* Registered by a general-practitioner
* Consumption of alcohol beverages is less than 21 per week
* No blood donor during the study
* No vegetarian and willing to eat meat during the experimental days
* Able to be present and participate at both test days and pre testing moments
* Not employed, or intern, or working on thesis at the department of Human Nutrition at Wageningen University
* Not participating in another scientific study (except EetMeetWeet)
* Able to participate during the experimental days en pre tests
* Able to speak Dutch

Exclusion Criteria:

* Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease, gluten intolerance)
* Systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg
* Use of medications known to interfere with gene expression in the muscles (i.e. statins, fenofibrate)
* Use of antithrombotic therapy (marcoumar, sintromitis).
* Diagnosed diabetes mellitus type 1 or 2
* (Chronic) injuries of the locomotor system that can interfere with the intervention
Effectiveness of Using Interactive Consulting System to Enhance Decision Aids of COVID-19 Vaccination

To evaluate the performance of an interactive chatbot and assess its effectiveness for enhancing informed decisions made by cataract patients.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged over 18 years who have been resident in the selected study district for more than six months;
* Willing to participate the study and provide informed consent.

Exclusion Criteria:

* Having ocular, hearing or mental disorders precluding reading or telephone interview.
A Phase III Trial of e-TNS for the Acute Treatment of Migraine

The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device.

The main objective of this study is to have Phase III evidences of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having randomized, double-blind, sham-controlled data of the efficacy and safety of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine-associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 65 on the day of signing the informed consent form
2. ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine, with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
3. Migraine onset before the age of 50
4. Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening
5. Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent
6. Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events reporting form)

Exclusion Criteria:

1. Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
2. Patient has more than 15 headache days per month
3. Patient having received supraorbital nerve blocks in the prior 4 months
4. Patient having received Botox treatment in the prior 4 months
5. Modification of a migraine prophylaxis treatment in the previous 3 months
6. Diagnosis of other primary headache disorders, except rare (\< 4) tension-type headaches per month
7. Diagnosis of secondary headache disorders including Medication Overuse Headache (MOH)
8. Patient abusing opioids or user of recreational or illicit drugs or having had a recent history (within the last year) of drug or alcohol abuse or dependence
9. Implanted metallic or electronic device in the head
10. Cardiac pacemaker or implanted or wearable defibrillator
11. Patient having had a previous experience with the Cefaly® device
12. Migraine Aura without headache
13. Patient is currently participating or has participated in a study with an investigational compound or device in the last 30 days before the screening visit (Visit 1)
14. Patient not having the ability to use appropriately the device and/or to perform himself/herself or bear the first 20-minute stimulation session during the training test session at the study site
Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation

Bilateral Lung transplantation (LUTX) is performed in selected patients with end-stage respiratory failure. During surgery, pulmonary arteries are sequentially cross-clamped. This can cause acute heart failure and hemodynamic instability that eventually persist into the postoperative period, leading to the need for prolonged vasoactive support in the postoperative Intensive Care Unit. Levosimendan is a relatively new vasoactive-inotropic drug, with different pharmacodynamic properties.

This observational retrospective cohort study primarily aims 1) to describe the need for prolonged vasoactive support; 2) to evaluate the risk factors for prolonged vasoactive support; 3) to assess the impact of prolonged vasoactive support on outcomes. The secondary aim is to describe the use of Levosimendan in this cohort of patients.


Eligibility Criteria:
Inclusion Criteria:

Intensive Care Unit admission after Double Lung Transplant surgery.

Exclusion Criteria:

1. single Lung Transplantation;
2. re-transplantation.
Assessment of Body Image in Patients With Rheumatoid Arthritis

Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem, function and quality of life.

Methods: Forty-three RA patients and thirty-nine control patients between 18 and 70 years were evaluated. The RA group was made up of individuals with a diagnosis of RA and the control group was made up of individuals from the community, paired for gender, age and body mass index. The patients were assessed with regard to body image (Body dysmorphic disorder examination (BDDE)), self-esteem (Rosenberg self-esteem scale), function (Health assessment questionnaire (HAQ)) and quality of life (Short form-36 (SF-36)).

Eligibility Criteria:
Inclusion Criteria:

* The RA group included patients between 18 and 70 years of age, of either gender, with an established diagnosis of RA based ACR criteria and belonging to functional classes I, II and III. The control group was made up of individuals from the community paired for gender, age and body mass index with RA group.

Exclusion Criteria:

* Individuals with fibromyalgia, neurological disease, psychiatric disorders or other severe co-morbidity were excluded from the study.
Psychiatric Disorder in Anorectal Dyssynergia

1. evaluate psychiatric disorders among patients with anorectal dyssynergia
2. evaluate the effect of delayed diagnosis of anorectal dyssynergia on the quality of the life

Functional constipation is a functional bowel disorder that presents as persistently difficult, infrequent, or seemingly incomplete defecation.

Subjective and objective definitions of constipation include:

(1) straining, hard stools (hard, inspissated stool), unproductive calls ("want to but cannot"), infrequent stools, or incomplete evacuation. (2) \<3 bowel movements per week, daily stool weight \<35 g/day, or straining \>25% of the time Dyssynergia defecation is common and affects up to one half of patients with chronic constipation. This acquired behavioral problem is due to the inability to coordinate the abdominal and pelvic floor muscles to evacuate stool The etiology of dyssynergic defecation is unclear however it was found that the problem began during childhood in 31% of patients, and after a particular event, such as pregnancy, trauma, or back injury in 29% of patients, and there was no cause in 40% of patients.

The first step in making a diagnosis of dyssynergic defecation is to exclude an underlying metabolic or pathologic disorder .A detailed history, prospective stool diaries, and a careful digital rectal examination will not only identify the nature of bowel dysfunction, but also raise the index of suspicion for this evacuation disorder. Anorectal physiology tests and balloon expulsion test are essential for a diagnosis. Newer techniques such as high-resolution manometry and magnetic resonance defecography can provide mechanistic insights.

. anorectal dyssynergia impact quality of life and cause psychiatric problems such as of anxiety, depression, obsessive compulsiveness, psychoticism, and somatization.

So, the investigators aim to evaluate psychiatric disorders among those patients and impact of delayed diagnosis on their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as anorectal dyssynergia with anorectal manometric study

Exclusion Criteria:

* patient with diabetes mellitus ,hypertension ,chronic kidney disease ,and chronic liver disease patients
* patient with neurological disease
* patient with thyroid disease
* patient with past history of psychiatric disorders
* patients with past or current medications or substance induced psychiatric disorders
MicroRNA Expression Profile in Human Vitreous of Patients With Various Vitreoretinal Diseases Requiring Vitrectomy

MicroRNAs are important regulators of many cellular functions but their expression profile in human vitreous is still unclear. Aim of this study is to investigate microRNA expression profile by PCR in human vitreous of patients with various vitreoretinal disorders and compare with that of patients with macular holes which are suggested to be similar to that of healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* any patients undergoing vitrectomy for various vitreoretinal diseases

Exclusion Criteria:

* previously vitrectomized eyes
Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants

Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: \< 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks.

Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.

Eligibility Criteria:
Inclusion Criteria:

The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level \> 10,000 IU/ml.

Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy.

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Exclusion Criteria:Participants with one or more of

* HCV coinfected with hepatitis B virus (HBV)
* human immunodeficiency virus (HIV)
* had any liver disease other than chronic HCV GT4 infection.
* had a history of liver decompensation
* serum a-fetoprotein (AFP) \> 100 ng/ml
* evidence of hepatocellular carcinoma
* major severe illness such as respiratory, renal, heart failure or autoimmune disease
* non-compliance with treatment.
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression

The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed
* The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20
* The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12

Exclusion Criteria:

* Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk
* Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation
* Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug
Genetic and Environmental Risk Factors Related to Esophageal Cancer

RATIONALE: Gathering information about genes, cigarette smoking, and diet may help doctors learn more about risk factors that may cause esophageal cancer.

PURPOSE: This clinical trial is studying genetic and environmental risk factors related to esophageal cancer.

OBJECTIVES:

* Examine the role of several genetically-determined factors in combination with cigarette smoking and diet in the etiology and prevention of esophageal cancer.
* Identify polymorphisms in metabolizing enzymes (e.g., phase I or II metabolism \[GSTM1, GSTT1,CYP1A1, CYP3A5, mEH, NQO1, GSTP1\], DNA repair \[XRCC1, ERCC2\], free-radical formation \[MPO, MnSOD\], inflammatory genes \[ IL1-beta\], metastatic potential \[MMP1\], and cell cycle or tumor suppression \[p21, p53\]) and related path genes of susceptibility for esophageal cancer.

OUTLINE: Blood and tumor tissue samples are collected. DNA purified from these samples is analyzed using DNA-based assays to determine polymorphisms in various related gene pathways.

Patients complete questionnaires concerning environmental, smoking and diet habits.

PROJECTED ACCRUAL: A total of 1,000 tissue samples from patients and healthy participants (750 patients and 250 healthy participants) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of esophageal cancer (patient)

    * Newly diagnosed disease
    * Receiving care at Massachusetts General Hospital, Thoracic Oncology Center
  * Friend or spouse of patient (healthy participants)

PATIENT CHARACTERISTICS:

* No concurrent psychiatric incapacity or dementia

PRIOR CONCURRENT THERAPY:

* Not specified