cyrilzakka/clinical-trials huggingface dataset:
SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

SUMMARY:

This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression.

RATIONALE:

Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients.

PURPOSE:

This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.


Eligibility Criteria:
INCLUSION CRITERIA:

Documented B-Cell NHL or mantle cell lymphoma

* CD-20+ tumor
* Indolent NHL: follicular B-cell lymphoma, diffuse small lymphoma, marginal zone lymphoma
* Maximum of three prior chemotherapy regimens
* Age of at least 18 years at Screening Visit (Site specific requirement may differ)

EXCLUSION CRITERIA:

* Refractory to rituximab, defined as progression of disease while being treated with rituximab or progression within 6 months of the last dose of rituximab (when given either as a single agent or in combination)
* Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to any agents administered previously
* Use of investigational agents within 28 days of study
* History of prior high dose chemotherapy with allogeneic stem cell support
* History of prior radioimmunotherapy
Impact of Acute Leg Cycling at Various Intensities on RLS Severity in Persons With MS

The purpose of this study is to evaluate the impact of acute leg cycling conditions at three different intensities versus a control condition condition on symptoms of restless legs syndrome (RLS) in persons with multiple sclerosis (MS). This study includes a proposed sample of 24 participants diagnosed with both MS and RLS that will complete four sessions of supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks.

The aim of this study is to evaluate the impact of acute leg cycling conditions at three different intensities (i.e., light, moderate, and vigorous) versus a control condition (i.e., quiet rest) on symptoms of RLS in persons with MS. This study involves a within-subjects, repeated measures design that includes a proposed sample of 24 participants diagnosed with both MS and RLS. Participants will complete four sessions with supervised exercise or rest conditions in the lab, one session per week, over the course of four weeks. The order of the three conditions will be randomized and counterbalanced and include: (1) leg cycling with no resistance (i.e., light), (2) leg cycling at moderate intensity, (3) leg cycling at vigorous intensity, and (4) seated, quiet rest (i.e., control condition). The primary study outcome includes the objective measure of RLS severity using the Suggested Immobilization Test (SIT) that will be administered immediately before and immediately after each condition (i.e., light, moderate, vigorous, and quiet rest).

Eligibility Criteria:
Inclusion Criteria:

* 18-54 years of age
* Diagnosis of multiple sclerosis
* Has not experienced a relapse in the last 30 days
* Positive screening for restless legs syndrome
* Restless legs syndrome severity of moderate or greater
* Ambulatory with or without an aide

Exclusion Criteria:

* Moderate or high risk for undertaking strenuous or maximal exercise
* Diagnosis of: radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia), renal disease, or diabetes
Preimplantation Genetic Testing in Women of Advanced Maternal Age

The GETSET trial is a prospective randomized trial designed to evaluate the clinical outcomes of incorporating preimplantation genetic testing for aneuploidies (PGT-A) in elective single embryo transfer in women between 35 and 40 years of age.

In this randomized controlled trial, a total of 240 patients divided evenly across the two participating IVF centers will be recruited. Patients will be randomized to a control and to a treatment group, each containing 120 participants.

Only patients with at least one evaluable blastocyst will be randomized. Patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by IVF center.

In the control arm, patients will undergo a single frozen embryo transfer with an untested blastocyst with the best morphology. All other blastocysts with lower morphology will undergo trophectoderm biopsy on day 5, 6 or 7 and will be frozen. PGT-A results of the untransferred embryos will be revealed to the patient AFTER the outcome of the initial ET is known. If the initial transfer results in a non-conception cycle and additional euploid embryos are available for transfer, these cycles will be followed and their outcomes collected.

In the experimental arm, all embryos will be cultured to blastocyst and all viable blastocysts will undergo trophectoderm biopsy and PGT-A. PGT-A will be performed regardless of the number of blastocysts available. Patients will undergo frozen transfer of the single, best quality euploid blastocyst. If the initial transfer results in a non-conception cycle and additional embryos are available for transfer, these cycles will be followed and their outcomes collected until the embryo cohort is exhausted.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF of between 35 and 40 years of age at IVF cycle start
* Utilization of Intracytoplasmic Sperm Injection ICSI
* Utilization of ejaculated or testicular sperm
* Utilization of autologous or donor sperm
* All Controlled Ovarian Hyperstimulation (COH) protocols

Exclusion criteria:

* Patients with anovulatory Polycystic ovarian syndrome (PCOS)
* Utilization of donor oocytes
* Utilization of gestational carrier
* Recurrent Pregnancy Loss (RPL) defined as ≥ 3 consecutive miscarriages
* Recurrent Implantation Failure (RIF) defined as ≥ 3 more failed embryo transfers
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

Eligible participants with screening central laboratory low-density lipoprotein cholesterol (LDL-C) values ≥ 75 mg/dL (1.9 mmol/L) were instructed to follow National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP) Therapeutic Lifestyle Changes (TLC) diet and were assigned to 1 of the following 4 background lipid-lowering therapies for a 4-week stabilization period based upon their screening LDL-C and its distance from the individual's required goal as stipulated by their NCEP ATP III risk category:

1. no drug therapy required - diet alone
2. low dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily (QD)
3. high dose drug therapy required - diet plus atorvastatin 80 mg PO QD
4. maximal drug therapy required - diet plus atorvastatin 80 mg PO QD plus ezetimibe 10 mg PO QD.

If the participant met entry criteria at the end of the lipid stabilization period they were randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52 weeks in addition to their background therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent.
* Fasting LDL-C ≥ 75 mg/dL and meeting the following LDL-C values on background lipid-lowering therapy:

  * \< 100 mg/dL for subjects with diagnosed coronary heart disease (CHD) or CHD risk equivalent
  * \< 130 mg/dL for subjects without diagnosed CHD or CHD risk equivalent
  * OR on maximal background lipid-lowering therapy defined as atorvastatin 80 mg PO QD and ezetimibe 10 mg PO QD
* Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

* New York Heart Association (NYHA) II-IV heart failure, or last known left ventricular ejection fraction \< 30%
* Uncontrolled cardiac arrhythmia
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization, type 1 diabetes, newly diagnosed or poorly controlled type 2 diabetes
* Uncontrolled hypertension
The Impact of Obesity on Maternal and Perinatal Outcomes

Body Mass Index is an index that is commonly used to classify underweight, overweight and obesity in adults. It is defined as the weight in kilograms divided by the square of the height in meters.The growing epidemic of obesity in our society has become a major public health issue where the proportion of overweight and obese among women aged 15-59 have increased from 68 percent in 2008 to 76 percent in 2015


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* single fetus
* gestational age \>28weeks

Exclusion Criteria:

* patient refusal
* multifetal pregnancy
* Medical illness prior to pregnancy.
Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528

This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.

Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.

Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have completed 24 weeks of randomised treatment in study ROP111528(and must have completed the one-week downtitration at the end of treatment/early withdrawal).
2. Subjects must not have a break in medication between completing the downtitration phase for studies ROP111528 and beginning treatment in this extension study.
3. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System).
4. Provide written informed consent for this study.
5. Be willing and able to comply with study procedures.

Exclusion Criteria:

1. Patients with any ongoing clinically significant adverse events at the end of the study ROP111528.
2. Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma).
3. Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the study ROP111528.
4. Subjects with severe dizziness or fainting due to postural hypotension on standing.
5. Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
6. Women who are pregnant or breast-feeding.
7. Use of an investigational drug throughout the treatment period.
Statin Compliance of Patients With Non-insulin-dependent Diabetes

The diabetic population has an increased cardiovascular risk compared to the general population.

Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia.

Many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and as secondary prevention, to avoid recurrence.

However, compliance to these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness.

The purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.

The diabetic population has an increased cardiovascular risk compared to the general population. The mortality of people with diabetes due to ischemic heart disease is multiplied by 2.2, and when is due to cerebrovascular disease by 1.8 compared to those patients without diabetes. Hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) inhibitors, or "statins", are considered as the standard treatment for hypercholesterolemia.

Statins have been shown to be effective in reducing the risk of cardiovascular events, each 1 mmol decrease in LDL cholesterol reduces the risk of cardiovascular events by 21% at 5 years.

Many patients with non-insulin-dependent diabetes are prescribed with statins, both for primary prevention, before the first cardiovascular event, and for secondary prevention, to avoid recurrence.

However, compliance with these drugs may be difficult due to polypharmacy, side effects (myalgia) or tiredness. Indeed, the persistence of statin use, one year after its prescription, is estimated at 70% in the general population. However, there are no data in the French population, and in particular on French diabetic patients for whom the cardiovascular risk is increased compared to the general population.

The purpose of this study is to determine the compliance of diabetic patients with statins searching for important factors which could favor adherence.

Eligibility Criteria:
Inclusion Criteria:

* Major patients
* With non-insulin-dependent diabetes, taking statins for at least 1 month (to assess compliance)
* Hospitalized in the Diabetology Day Hospital of the Saint Philibert Hospital
* In capacity to answer the Girerd test
* Patient who has been informed and not opposed to the study

Exclusion Criteria:

* Patient's refusal to participate in the study
* Patient under guardianship or curatorship
Optimizing Mental Health for Young People at Clinical High Risk for Psychosis (CHR)

This proposal aims to adapt an evidence-based comprehensive psychosocial and mental health support program, the Optimal Health Program (OHP), to improve functioning, reduce distress, and build resiliency in youth who are at clinical risk of developing psychosis (CHR).

The main aims of the studies are 1). To adapt an existing, effective, validated psychological intervention for use in young people with CHR; 2). To evaluate the acceptability of OHP and the feasibility of conducting a clinical trial of OHP in individuals with CHR; 3). To assess the preliminary efficacy of OHP in enhancing resiliency, reducing depression and anxiety, and improving functioning in individuals with CHR in a single-arm exploratory clinical trial.

Participants will be delivered OHP intervention over 12-weeks. Measures will be completed at study entry and repeated immediately post-treatment at 12-weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Be 16-29 years old
2. Being competent and willing to consent to study participation
3. Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) either currently or at some point in the past 3 years.

Exclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
2. Diagnosis of intellectual disability previously documented in the patient chart
3. Severe developmental disorder
4. Acute suicidality requiring immediate intervention
Efficacy and Safety of TC Cream In Treating Patients With Psoriasis Vulgaris

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Controlled, Two-Center, Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of TC cream In Treating Patients with Psoriasis Vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Age of 18-70 years old. Both men and women and members of all races and ethnic groups
* Consistent with diagnostic criteria of stable phase psoriasis vulgaris and have at least two target lesions suitable for evaluation
* Women of childbearing age must be using birth control strategies defined by one of the following: 1) a barrier method (condom) and/or 2) oral contraceptives, during the 8-week study period.
* ISGA score ≥ 2 (at least mild severity)
* BSA (stable stage group): 1%≤ to ≤20%
* Signed a written informed consent document
* No additional exposure to the sun

Exclusion Criteria:

* Subjects in pregnancy, preparing for pregnancy or breast feeding
* History of hyperergic or photosensitivity
* History of complicated cardiovascular diseases, cerebrovascular diseases, severe primary diseases of hepatic, kidney and hematopoietic system, or patients with psychiatric disorders
* History of photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosa
* Within 4 weeks prior to randomizations, patients have taken treatment with following approved or investigational psoriasis therapies on the target lesions:

  * Topical treatments
  * PUVA, UVB or Grenz ray therapy.
  * Any systemic treatments other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, hydroxycarbamide, azathioprine, methotrexate, cyclosporine, other immunosuppressant).
  * Any types of other investigational therapies for psoriasis
* Within 3 months prior to randomizations, patients have taken systemic treatments with retinoids or biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab).
* Planned initiation of, or changes to, concomitant medications that could affect psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the double-blind phase of the study.
* History of allergic reactions attributed to compounds of similar chemical or biologic compositions to Coumarins.
Assistance in Neurosurgery (ExtempoRMN)

The main ambition of this project is to develop, and provide the medical community, an innovative method to analyze extemporaneously, during a neurosurgery operation, excised tissues. This method is based on the analysis of the metabolic profile of excised tissues by the technique of High-Resolution Magic-Angle Spinning (HR-MAS) Nuclear Magnetic Resonance (NMR) spectroscopy. Indeed HRMAS NMR method can provide in a sufficiently short time lapse (currently about 30 minutes but within our project a time lapse of 15 min or even less is ultimately intended), medical information that can complement those obtained by classic histological examination.

Primary purpose:

The main objective of this study is to determine the sensitivity of HRMAS NMR spectroscopy in detecting residual tumor infiltration at the brain resection cavity. The investigators aim to determine the relevance of the metabolic analysis compared to histological analysis during a neurosurgery operation. This involves analyzing excised tissue samples, obtained from the operating rooms of Strasbourg University Hospitals, and Colmar Hospital Center, with no return to neurosurgeon for surgery.

Secondary purposes:

The secondary objectives of the protocol are to investigate the metabolome of different types of brain tumors, in order to find prognostic and diagnostic markers. It consists in detecting metabolomic factors of bad prognosis, and potential marker of good prognosis such as the IDH mutation.


Eligibility Criteria:
Inclusion criteria:

* Male or female
* Age 18 years of age or older at the time of surgery
* Primary brain tumors (gliomas mainly) or epilepsy, for which neurosurgical intervention is programmed
* In the case of brain tumors: primary-lesions or transformation of low-grade gliomas into high-grade gliomas not treated with radiotherapy
* Affiliated with a social security
* Having signed the informed consent
* Having been informed of the results of the medical examination prior

Exclusion criteria:

* Relapse of tumors previously treated with radiotherapy or chemotherapy
* Subject under treatment (radiotherapy or chemotherapy) prior to surgery
* Metastatic lesions (location of the primary lesion outside the central nervous system)
* Inability to give to the subject or his/her family enlightened information (subject in emergency situation, difficulties of understanding...)
* Subject under judicial protection
* Subject under guardianship or curatorship
* Patients' Refusal
Consumer Engagement to Increase Advance Care Planning: Patient Randomization

This is a study of the effect of consumer-directed financial incentives on completion of advance care planning among Medi-Cal patients.

Older adults receiving primary care from one of three clinics contracting with Partnership HealthPlan of California, a multi-county Medi-Cal managed care plan will be mass randomized to receiving educational materials regarding advance care planning with or without a financial reward for completing advance care planning.

Eligibility Criteria:
Inclusion Criteria:

* Partnership HealthPlan of California enrollee
* Receipt of primary care from one of 3 participating clinics (Ole, Petaluma, West County)
* Age \> 65

Exclusion Criteria:

* \> 75
Modeling Impaired Judgement in Cocaine Abusers - 6

The purpose of this study is for the modeling of impaired judgement in cocaine abusers.

The objective of this study is to investigate recognition memory and appreciation of changing contingencies in relation to a response judgement.

Eligibility Criteria:
Inclusion Criteria:

(3 groups)Normal, healthy controls. Recent cocaine experience. Over 6 months since the last cocaine experience.

Exclusion Criteria:

Psychosis or mood disorder. History of seizure, head trauma