cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety, Tolerability, and Efficacy of MK-8353 in Participants With Advanced Solid Tumors (MK-8353-001)

This study of the safety, tolerability, and efficacy of MK-8353 (formerly SCH 900353) given as single agent oral therapy for participants with advanced solid tumors will be done into two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2 dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to see if MK-8353 is effective as single agent therapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically/histologically confirmed solid tumor (metastatic or locally advanced disease) that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
* Participants of childbearing potential must have negative pregnancy test; females and males must agree to use effective contraception during the course of the trial and for 90 days after stopping study drug.
* For Part 1b and Part 2, participant with metastatic melanoma or metastatic colorectal cancer with at least one measurable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of ≥3 months.
* Adequate organ function.

Exclusion Criteria:

* Unstable or progressing central nervous system (CNS) metastasis unless asymptomatic for 3 months, with no need for steroids or antiseizure medications.
* Active gastrointestinal disease or a disorder or a history of surgery that significantly alters gastrointestinal motility or absorption.
* Has not recovered from previous therapy and had any chemotherapy, biologic, or hormonal therapy within 4 weeks of study enrollment.
* Radiation therapy (except palliative radiation to bone lesions) within 4 weeks of study enrollment.
* More than 3 prior regimens of chemotherapy, biologic therapy, hormonal therapy, or investigational drugs not including adjuvant or neoadjuvant treatments.
* Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic diseases.
* Mean QTcF interval (interval on the electrocardiogram corrected for heart rate using Fridericia's correction) \> 450 msec at baseline.
* Known Human Immunodeficiency Virus (HIV) infection, hepatitis infection, or tuberculosis infection.
* Current participation in any other interventional clinical study.
* History of significant eye disease, including glaucoma, retinopathy, or retinal vein occlusion.
Longitudinal Study on the Neuroprotective and Neurotrophic Effects of Lithium

Thirty subjects with a DSM-IV (Diagnostic and Statistical Manual, fourth version)diagnosis of BPD during a depressive or hypomanic episode will be divided in two groups according to age and time of illness. All patients will receive lithium (flexible therapeutic dose) for 6 weeks and improvement will be evaluated weekly using depression and mania rating scales; this study also objectives to identify state/trait markers and predictors of response.

Mood disorders are the most prevalent psychiatric, presenting chronic course and high morbidity, affecting 10-15% of population. Diverse structural, functional and biochemical cerebral changes described in the pathophysiology of mood disorders, in special Bipolar Disorder (BPD), have been associated with impairments in neuroprotective mechanisms and cellular resilience. However, the clinical relevance of these pathophysiological findings have been rarely addressed. Meanwhile, lithium has been considered the most used mood stabilizer worldwide, showing significant efficacy in the treatment of manic and depressive episodes, as well as in the prevention of suicide and maintenance. Several studies have demonstrated significant neuroprotective and neurotrophic effects induced by lithium treatment in diverse cellular and molecular targets, but again, few is known about the potential association between these cerebral effects and the its therapeutic clinical efficacy induced by this proof of concept agent. The present project aims to investigate brain levels of lithium using magnetic resonance spectroscopy (7Li-MRS) and its association with different markers of neuronal viability such as n-acetyl-aspartate (using 1-hydrogen-MRS), as well as peripheral markers of mitochondrial, endoplasmic reticulum and neurotrophic factors activity, all highly implicated in the pathophysiology of BD. The investigator has been working in this area in the last ten years, in which the last three and a half in the Lab of Molecular Pathophysiology and Experimental Therapeutics, National Institute of Mental Health (NIMH), National Institutes of Health. The candidate is looking forward to establish appropriate structure to develop a "Research Center for the Study of Neuroplasticity and Neuroprotection in Psychiatric Disorders" in the Institute of Psychiatry, University of Sao Paulo, Brazil. Overall, the study on the neuroplasticity-mediated pathophysiological basis of BPD implicated in the clinical presentation and outcome may shed light on the development of new, improved therapeutics for this and other devastating psychiatric disorders.

Eligibility Criteria:
Inclusion Criteria:

* outpatients
* 18-45 yo
* DSM-IV diagnosis of bipolar disorder (BD-I or BD-II)
* current depressive episode based on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders(SCID-I)
* Hamilton Depression Rating Scale Score (HAM-D) ≥18

Exclusion Criteria

* Medical and psychiatric Comorbidity
* more than 5 years of disease duration
* presence of rapid cycling
The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient

Aim:

Dietary Phosphorus Education Program can improve patients' knowledge, attitude and behavior of phosphorus restriction diet to reduce the risk of hyperphosphatemia and malnutrition of hemodialysis patients.

Inclusion criteria:

The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin \< 4.0 mg/dL, or serum phosphate \> 5.0 mg/dL, are eligible for inclusion.

Subjects will be enrolled into this trial after signed informed consent. We expect to recruit 60 subjects. Patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly. We will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions.

Intervention protocol:

At baseline, the investigators collect demography and pre-test KAP questionnaires among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview and record their answers. Dietary Phosphorus Education is a 6-month program and be implemented by dietitians and investigators, including education, nutritional counseling and dietary records monthly.

The first month was intensive weekly education sessions, each 20 to 30 minutes. Second and third month were monthly education sessions, each 20 to 30 minutes. There are total 6 sessions in this trial. The last 3 months will follow-up periods, will collect anthropometry data monthly, biochemistry measurements and 3-day dietary records among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview or phone-interview to complete each dietary record. Investigator collect post-test KAP questionnaires, diet behavior questionnaires and satisfaction questionnaires from subjects in the end of the trial,. If subjects are illiterate then investigators interview subjects and record.

This is a 6-months trial and retrospective study to collect anthropometry, biochemical measurements and 3-day dietary records from control subjects monthly.


Eligibility Criteria:
Inclusion Criteria:

* The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin \< 4.0 mg/dL, or serum phosphate \> 5.0 mg/dL, are eligible for inclusion. Subjects will be enrolled into this trial after signed informed consent. We expect to recruit 60 subjects

Exclusion Criteria:

* Patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly.
* We will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions
Tamoxifen Citrate in Patients With Breast Cancer

RATIONALE: Estrogen can promote growth of endocrine sensitive breast cancer cells. Endocrine therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Pharmacokinetics and -genomics can have an impact on the efficacy of the treatment.

PURPOSE: This phase III trial is studying blood samples to see if the level of active metabolites of tamoxifen can be improved in patients with breast cancer.

OBJECTIVES:

Primary

* To determine how the increase of tamoxifen citrate dose influences the level of its major metabolites in patients with hormone-sensitive breast cancer.

Secondary

* To characterize the population pharmacokinetic profile
* To investigate the role of the other CYPs
* To assess the relation between clinical symptoms and CYP2D6 genotypes and/or active metabolites levels
* To explore the correlation between genotypes/metabolites levels and clinical outcomes in terms of tumor relapse.
* To assess the feasibility, efficacy, and safety of concentration-guided adjustment of tamoxifen citrate dosage.
* To conduct other exploratory analysis based on the eventual new data coming up in the future.

OUTLINE: Patients receive oral tamoxifen citrate (at a dose of 40 mg/day) daily for 4 months in the absence of disease progression or unacceptable toxicity.

Blood samples are collected for PK, genotyping, phenotyping, and further analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Hormone-sensitive breast cancer defined as \> 10% estrogen receptor and/or \> 10% progesterone receptor positivity by immunohistochemistry
* Receiving treatment with tamoxifen citrate and must be eligible for exposure to higher doses

PATIENT CHARACTERISTICS:

* No history of deep venous thrombosis or pulmonary embolism
* No history of endometrial carcinoma
* No known history of vaginal bleeding, endometriosis, endometrial hyperplasia, endometrial hypertrophy, and/or polyps
* Not pregnant or nursing
* No contraindication to tamoxifen citrate treatment
* No known allergy to midazolam or dextromethorphan

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

Primary Objective:

* To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus

Secondary Objectives:

* To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
* To compare the incidence and frequency of hypoglycemic episodes
* To assess the safety and tolerability of the new formulation of insulin glargine

* Up to 4-week screening period;
* 16-week open-label comparative efficacy and safety treatment period;
* 4-week post-treatment safety follow-up period.

Eligibility Criteria:
Inclusion criteria :

* Participants with Type 1 diabetes mellitus

Exclusion criteria:

* HbA1c greater than (\>) 9% (at screening)
* Participants receiving \>0.5 U/kg body weight basal insulin in the last 30 days prior to screening visit
* Participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last 30 days prior to screening visit
* Less than 1 year on any basal plus mealtime insulin
* Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
* Use of an insulin pump in the last 6 months before screening visit;
* Any contraindication to use of insulin glargine as defined in the national product label
* Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening
* Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization
* Initiation of any glucose-lowering agents in the last 3 months before screening visit
* Weight change of greater than equal to (\>=) 5 kg during the last 3 months prior to screening visit
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require laser, surgical treatment or injectable drugs during the study period

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Alleviating Geriatric Inpatients' Medication-related Iatrogenesis

This study will evaluate the MedWise Risk Score™ (MWRS™), a holistic approach to quantifying the risk of a patient's medication regimen. High risk patients will be identified at hospital discharge. Targeted interventions will be made to reduce their MWRS™ with a 30-day follow up. The hypothesis being tested is that a reduction in MWRS™ will lead to reduced 30-day readmission.


Eligibility Criteria:
Inclusion Criteria:

* Hospital admission for at least 48 hours
* Prescribed at least 5 medications at hospital discharge
* Baseline medication risk score of 20 or more

Exclusion Criteria:

* Reside greater than 25 miles from the index facility
* Discharge to hospice
* Discharge against medical advice
* Patient expiration during initial hospitalization
Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement

Reducing Duration of Untreated Psychosis (DUP) is a primary goal for improving long-term outcomes in young people with a first episode of psychosis (FEP). The "standard of FEP care" within the US focuses on targeted provider education regarding signs and symptoms of early psychosis to motivate patient referrals to FEP services, followed by initiation of services within largely clinic-based settings Experience at the Early Diagnosis and Preventive Treatment (EDAPT) FEP specialty program at U.C. Davis in Sacramento has identified two important bottlenecks to reducing DUP, consistent with reports in the literature from other FEP clinics. These are 1) delays in the identification of psychotic symptoms by referral sources, and 2) delays or disruptions of patient engagement in specialty FEP care. Building upon a comprehensive and established referral network of 20 sites across the Sacramento area (schools/universities, ER/inpatient hospitals, outpatient mental health, primary care), the investigators will address delays in patient identification and engagement using a two-phase, cluster randomized design. The investigators will consecutively test the impact of two interventions to reduce DUP, defined in this RFA as time from first onset of psychotic symptoms to engagement in FEP specialty care. To address identification delays, the investigators will examine the use of standard targeted provider education plus novel technology-enhanced screening compared to standard targeted provider education alone, testing the hypothesis that the education plus technology-enhanced screening will identify more patients, earlier in their illness. To address engagement delays, the investigators will compare the use of a mobile community-based, telepsychiatry-enhanced engagement team to standard clinic-based procedures for intake, engagement and initiation of treatment, to test the hypothesis that the mobile approach facilitates earlier and more stable engagement, thereby reducing DUP. The proposed work will provide new specific evidence-based practices for reducing DUP and improving outcomes through specialty care of individuals with a first episode of psychosis.


Eligibility Criteria:
Inclusion criteria:

Meet DSM-IV criteria for a diagnosis of affective or nonaffective psychosis.

Exclusion criteria:

1. Duration of psychosis \> 2 years
2. Current substance dependence
3. Neurological illness or injury leading to psychotic symptoms
4. Only substance induced psychotic symptoms
5. Documented IQ \< 70
6. Lack of English fluency
Peptide Profiles of Women Undergoing Breast Biopsy

This study is being done to learn about blood proteins. We want to see if the blood proteins in women whose biopsies show breast cancer are different from the blood proteins in women whose biopsies do not show breast cancer. The goal of this study is to develop a blood test than can help detect breast cancers when they are very small and easy to cure.

Despite currently available screening techniques, only 63% of breast cancer cases are diagnosed at a localized stage, for which the 5-year survival rate exceeds 95% (1). Advances in breast imaging are occurring, but further efforts to detect breast cancer at an early stage would be beneficial. Recently, new technologies which use mass spectrometric analysis to characterize the overall pattern of peptide expression in the serum or plasma have been developed. Preliminary studies have suggested that peptide profiles can be used to differentiate cancer patients from those without cancer for a variety of malignancies including breast cancer. If mass spectrometric analysis is able to detect differences in peptide profiles between early stage breast cancers and normal controls, this technique could be developed as a screening modality.

The objective of the present study which is entitled "Peptide Profiles of Women Undergoing Breast Biopsy" is to determine whether the diagnosis of malignancy on breast biopsy is associated with a specific serum or plasma peptide profile which can be distinguished from the peptide profile associated with benign diagnoses on breast biopsy. To accomplish this, blood samples will be collected from 500 women undergoing breast biopsy and 100 women with metastatic disease. Samples will be obtained prior to the biopsies and analyzed by mass spectrometry. Residual material will be shared with investigators of the National Cancer Institute Clinical Proteomics Technology Assessment Consortium.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age ≥ or = to 18

Cohort A: Biopsy Cohort:

* Referred by a healthcare provider for breast biopsy
* No prior history of invasive breast cancer OR of ductal carcinoma in situ
* No prior history of other malignancies within 5 years except cervical dysplasia, squamous cell carcinoma of the skin or basal cell carcinoma of the skin Cohort B: Metastatic Disease Cohort - Diagnosis of stage IV breast cancer

Exclusion Criteria:

* Male
* Age \< 18
Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)

The aim of this study is to characterize the pharmacokinetics and safety/tolerability of AFQ056 in children with Fragile X Syndrome(FXS)


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of FXS
* At Screening and first baseline, vital signs, body weight and body mass index (BMI) must be age-specific within normal ranges.

Exclusion Criteria:

* Use of any other investigational drug within 30 days or 5 half-lives (whichever is longer) of the investigational drug prior to screening until end of study visit.
* History of hypersensitivity to AFQ056 or any mGluR antagonist.
* Female patients who are confirmed or suspected to be sexually active.
* History or presence of any clinically significant disease of any major system organ class, within the past 2 years prior to screening including but not limited to psychiatric, neurological, cardiovascular, endocrine, metabolic, renal, or gastrointestinal disorders (except for typical features of FXS).
* Smokers.
* Loss of ≥10% of total blood volume within 8 weeks (or less if required for this age group and/or by local regulation) prior to dosing or longer if required for this age group and/or by local regulation.
* Significant illness that did not completely resolve at least four weeks prior to the first baseline visit.
* Any abnormal laboratory values at screening or first baseline that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject.
* Use of (or use within at least 5 half lives before dosing) concomitant medications that are strong/moderate inhibitors or inducers of CYP1A1/2, CYP2C9/19 or CYP3A4
* History or presence of Hepatitis B/C or HIV at screening
Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients

The objective of this clinical trial is to investigate the impact of implementing a tool for adjusting the level of diagnostic and therapeutic intensity in the clinical practice of physicians attending hospitalized patients.

The goal of this clinical trial is to investigate the impact of a tool for adjusting diagnostic and therapeutic intensity in hospitalized patients. The main question it aims to answer is: Is there a difference in patient mortality when using the aforementioned tool? The participating physicians will be grouped into 4 groups (5 physicians each). Each group will progressively (every 3 months) incorporate the use of the aforementioned tool into their usual clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Physician belonging to the non-surgical medical area.
* Routine clinical activity on a hospital ward caring for hospitalized patients.

Exclusion Criteria:

* Physician belonging to the Oncology-Hematology/Palliative Care Hospitalization Unit.
* Refusal to participate in the study.
Biobank for Inflammatory Chronic Diseases and Osteoporosis

The aim of this study is to constitute a biobank for patients followed in the Rheumatology center of Toulouse University Hospital for a chronic inflammatory rheumatism including rheumatoid arthritis (RA), spondyloarthritis(SpA), and psoriatic arthritis (PsA) or a chronic bone disease including osteoporosis in order to identify biomarkers associated with therapeutic response.

Biologic ant targeted synthetic disease modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) have greatly improved the prognosis of chronic inflammatory diseases. To date, many bDMARDs and tsDMARDs targeting different immunologic mechanisms are available to treat RA, SpA or PsA. However, the choice of the treatment and its mechanism of action is based on physician decision and experience. Indeed, predictive clinical and biological factors associated with therapeutic response that could help the physician to make his/her choice are lacking. The aim of BIOTOUL is to collect and store biologic samples in patients with RA, SpA or PsA who begin a new bDMARD or tsDMARD. This biobank will permit to study several biomarkers and assess the association between such markers and response to therapy.

Furthermore, osteoporosis is a chronic disease leading to fractures and disability. Several ant-osteoporotic drugs are now available and biomarker(s) that would help the physician to choose the best therapeutic sequence are lacking. BIOTOUL will also include patients with osteoporosis to identify biomarkers associated with severity and response to anti-osteoporotic treatments.

Eligibility Criteria:
Inclusion Criteria:

* Chronic inflammatory rheumatism including RA, SpA or PsA or patients with primary or secondary osteoporosis
* With National Health Assurance
* Able to consent to the study

Exclusion Criteria:

* Pregnancy or breastfeeding
* Not able to give a consent
* Severe anemia (Hb\<10g/L)