cyrilzakka/clinical-trials huggingface dataset:
Rituximab, Bortezomib,Bendamustine , Dexamethasone, Patients With Mantle Cell Lymphoma

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, dexamethasone, and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy together with rituximab and bortezomib may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with bortezomib, doxorubicin, dexamethasone, and chlorambucil works as first-line therapy in treating older patients with stage II, stage III, or stage IV mantle cell lymphoma.

OBJECTIVES:

Primary

* Evaluate the efficacy of rituximab, bortezomib, doxorubicin hydrochloride, dexamethasone, and chlorambucil as first-line therapy in patients with stage II-IV mantle cell lymphoma.

Secondary

* Determine the complete response rate in these patients.
* Determine the efficacy, in terms of complete and overall response, by F18 fludeoxyglucose scan.
* Determine overall, disease-free, and event-free survival of these patients.
* Assess tolerability of this regimen in these patients.
* Evaluate the impact of factors, described in previous protocols, on response to therapy and survival.
* Assess the impact of residual disease in cerebrospinal fluid on survival.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1 (days 1 and 8 of the first course only); bortezomib IV on days 1, 4, 8, and 11; doxorubicin hydrochloride IV continuously over 24 hours on days 1-4; dexamethasone IV on days 1-4; and oral chlorambucil on days 20-29. Treatment repeats every 5 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least 50% response receive 2 additional courses of therapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of mantle cell lymphoma

  * Stage II-IV disease
* No neuromeningeal disease

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* No prior cancer except for carcinoma in situ of the cervix or basal cell skin cancer
* LVEF \> 50%
* HIV-negative
* Hepatitis B- and C-negative
* No hepatocellular, renal, or bone marrow insufficiency unrelated to lymphoma

PRIOR CONCURRENT THERAPY:

* Not specified
Cognitive Control of Language

The cognitive control of speech is central to human social communication. Two frontal brain regions seem to have a critical role: 1) Broca's area (BA) and 2) the mid-cingulate cortex (MCC). Current rehabilitation strategy is clearly based on therapies promoting language performance. However, there is few evidence that rehabilitation strategies based on nonlinguistic aspects of brain function may enhance recovery. Such strategies may benefit from knowledge about the primary -nonlinguistic- function of the BA-MCC network. The aim of LANGUAGE is to identify this primary function. One hypothesis is that, in non-speaking primates, this network is involved in cognitive control of voluntary vocal/orofacial production. Specifically, whereas BA may be responsible for the high-level selection of orofacial and vocal responses during learning, the face motor representation within the MCC may be responsible for performance monitoring, a process inherently required in learning. LANGUAGE aims to test this hypothesis by determining in human the anatomo-functional organization of the BA-MCC network thanks to functional magnetic resonance imaging (fMRI).


Eligibility Criteria:
Inclusion Criteria:

* being able to provide a written consent form
* having a social insurance
* have a normal vision (with or without corrections)
* Right-handed

Exclusion Criteria:

* Subjects with MRI contraindications (e.g. pacemaker, claustrophobia, metal in the body, etc...).
* Subjects must be willing to be advise in case of discovery of brain abnormality.
* History of known neurological or psychiatric illness
* Pregnant or nursing women
* Persons under guardianship, curators or any other administrative or judicial measure of deprivation of rights
Analgesic Effect of Ibuprofen, Paracetamol (Acetaminophen), and Paracetamol (Acetaminophen) Plus Codeine on Acute Pain

The purpose of this placebo controlled clinical trial is to evaluate the dose response relationship of ibuprofen in doses from 400 mg to 800 mg and paracetamol (acetaminophen)in doses from 500 mg to 1000 mg compared with paracetamol (acetaminophen)1000 mg plus codeine 60 mg on acute postoperative pain after surgical removal of impacted third molars.

Acetaminophen (paracetamol) and related aspirin-like drugs have traditionally been used for pain control of minor to moderate postoperative pain. Gradually traditional non-steroidal anti-inflammatory drugs (NSAIDs) have become more popular as analgesics due to assumed superior therapeutic effects and aggressive marketing campaigns orchestrated by the pharmaceutical industry.

Ibuprofen is a widely used analgesic both in non-prescription and prescription doses.

A dose-response relationship for low ibuprofen doses is shown. Evidence of a progressing dose response relationship for moderate (i.e. 400 mg) to higher doses is scarce. A possible analgesic ceiling effect has been suggested for doses above 400 mg, although a correlation between given ibuprofen doses above 400 mg and patient serum levels is shown. However, it may be questioned if the plasma concentration of ibuprofen is an important determinator of analgesic drug efficacy. A higher dose is more likely to influence the duration of analgesic effect rather than the peak analgesic effect.

There are few clinical trials investigating the dose-response relationship of increasing ibuprofen doses and paracetamol doses. To our knowledge no published study has investigated the dose-response relationship of ibuprofen and paracetamol in the same trial with a negative (i.e. placebo) and a positive (i.e. best standard analgesic treatment) control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes referred for surgical removal of impacted third molars, due to symptoms or after being advised to do so by their dentist.
* Persons of both sexes (ASA type I).
* Females who are not pregnant or plan conception.
* Persons who have not used analgesics for 3 days prior to the day of surgery.
* Persons without known active ulcus or gastrointestinal bleeding.
* Persons without any known hypersensitivity for NSAIDs.
* Persons under no other continuous drug treatment than contraceptives.
* Caucasian origin.
* Persons with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars.

Exclusion Criteria:

* Patients with surgery time exceeding 60 minutes
* Peroperative complications such as profuse bleeding or perforation to the maxillary sinus requiring additional drug treatment during or after the surgical removal of the third molar.
* Postoperative complications such as extended bleeding, nausea and regurgitation during the observation period.
* Smoking before taking the test-drug or during the observation period.
Effect of Exercise on Prevention of Weight Gain

The purpose of this study is to examine the dose-response of exercise on prevention of weight gain in overweight adults.


Eligibility Criteria:
Inclusion Criteria:

1. Female or Male
2. 18-55 years of age
3. BMI = 25-29.9 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
2. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
3. Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. However, this will be confirmed with the urine pregnancy test that will be conducted prior to the baseline DEXA.)
4. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
5. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
6. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
7. History of myocardial infarction or valvular disease.
8. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid


Eligibility Criteria:
Inclusion Criteria:

* Patients willing and able to complete the micturition diary correctly
* Patients experiencing frequency of micturition as verified in the diary
* Patients experiencing significant post void residual volume
* OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.

Exclusion Criteria:

* Significant post void residual volume
* Patients with indwelling catheters or practicing intermittent self- catheterization
* Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose
The Health Benefits of Indoor Air Filtration Among Children

This study aims to explore the health benefits of air purifier on the impact of air pollutants on children's health.

From April 2021 to December 2021, researchers conduct a randomized double-blind crossover trial on about 100 healthy children in Jiaozuo City, Henan Province. The children are divided into two groups according to their classes and alternated the use of true or sham purifiers devices, including air purifiers and fresh air ventilation. Air purifiers are installed in the classroom and bedrooms of the children. Fresh air ventilation is installed in the classroom. A total of 4 epidemiological surveys are conducted on the subjects, with an interval of 60 days or more. All participants and research staffs were blinded to the group assignment. In addition, air pollutant exposure monitoring, questionnaire surveys, physical examinations, and biological sample collection are conducted on the research subjects each time. The biological samples are further tested for the concentration levels of related biomarkers such as the respiratory system, cardiovascular system, metabolic system, and nervous system. Furthermore, comprehensive evaluation of children's behavioral ability is also carried out. Ambient PM2.5 and indoor PM2.5 exposure concentrations are monitored in the study.

Eligibility Criteria:
Inclusion Criteria:

* 10 ≤ 12 years old
* Volunteer to participate in this study

Exclusion Criteria:

* Current and past medical history, including asthma, childhood diabetes, childhood hypertension, behavior-related diseases
* Students who plan to transfer or move within six months
* Unable to cooperate with follow-up
Noninvasive Measurement of Sympathetic Nerve Activity in Healthy Volunteers

Activation of the sympathetic nervous system is associated with increased risk of ventricular arrhythmias and sudden cardiac death (SCD). Development of simple, noninvasive, reliable tools to measure sympathetic outflow in human subjects is therefore highly desirable.

Microneurography is the current gold standard measurement technique, whereby multiunit postganglionic sympathetic nerve activity is recorded with tungsten ultrafine microelectrodes inserted selectively into nerve fascicles of the peroneal nerve. Though this technique is considered extremely safe, and has been used successfully for decades in human translational physiology experiments, it has not been adopted for routine clinical assessment due to the requirement for sophisticated equipment and specific technical training and skills. Alternatively, many have adopted heart rate variability as a simple, noninvasive technique for assessing sympathetic nerve activity. However, heart rate variability does not directly measure sympathetic nerve activity, and there is much debate in the literature as to the exact source of sympathetic nerve traffic. For example, many believe it is an accurate reflection of cardiac sympathetic nerve activity, but does not accurately reflect changes in muscle or skin sympathetic nerve activity.

To address these limitations, the investigators have developed a simple, noninvasive technique to measure sympathetic nerve activity using surface electrodes.

Despite its great promise, this new approach has not yet been directly validated. The purpose of this study is therefore to validate this new technique (refered to as EKG-NA) against the current gold standard measurement technique, microneurography.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years of age
* BMI \< 35 kg/m2

Exclusion Criteria:

* History of hypertension, diabetes, pulmonary disease, metabolic disease or heart failure
* Cardiac rhythm disorder, specifically: rhythm other than sinus
* Use of any medications other than common supplements
* Unable to perform handgrip exercise
* Pregnant
Home Therapy With VPRIV in Gaucher's Disease

The purpose of this study is to proof increasing patient satisfaction and preservation of quality of life in patients with Gaucher's Disease receiving their enzyme replacement therapy with VPRIV (Velaglucerase alfa)at their home setting compared to receiving the infusions at the clinic or at doctor's practice.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with a confirmed diagnosis of Gaucher disease type 1
* Age\> 2 years
* patients who have at least 3 infusions (6 weeks) at least 5-year or 5-6 infusions (10-12 weeks) at 2 - to 4-year patients have received VPRIV ® and tolerate well
* The patient is compliant, the previous VPRIV ® infusions were / performed approximately every 2 weeks in the center during office visits
* The patient was already before inclusion in this study for a home infusion therapy and has consented to (or their legal representative)
* The patient / be lawful. Representative has consented in writing to participate in this study.

Exclusion criteria:

• The patient is participating in a clinical trial with a medicinal product
Air Versus Gas Tamponade in Primary Retinal Detachment

Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty.

There is no single surgical plan for management of primary retinal detachment due to upper retinal break, some surgeons prefer scleral buckling over vitrectomy in cases with no traction over the retinal break, others prefer to perform primary pars-plana vitrectomy with either air or gas tamponade.

In this study we aim to compare the results of air and non-expansile gas tamponade in cases with upper retinal detachment with grade a or b proliferative vitreoretinopathy.

Eligibility Criteria:
Inclusion Criteria:

* primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.

Exclusion Criteria:

* cases with combined tractional retinal detachment.
* cases with recurrent retinal detachment.
* cases that are eligible for scleral buckling that have no traction on retinal break.
Vitamin A Kinetics and Mathematical Modeling in American Women

Women were given a vitamin A tracer, and blood was sampled to determine individual and group vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine effects of study length on model outcomes.

This is a longitudinal study in which American women were given an oral, stable isotope tracer of vitamin A, and blood was sampled in a staggered, serial design to determine individual and group vitamin A kinetics. Data were subsequently modeled using compartmental analysis, and study truncation analysis was performed on data to investigate the factor of study duration on resulting vitamin A kinetic models and outputs related to vitamin A metabolism.

Eligibility Criteria:
Inclusion Criteria:

* BMI (18.5 - 24.9 kg/m2)

Exclusion Criteria:

* Smoker
* Pregnant
* Trying to become pregnant
* Lactating
* Weight loss \> 4.5 kg during the past 3 months.
* Actively trying to lose weight
* Inability to refrain from drinking alcohol when requested
* Amenorrhea
* Acute or chronic illness including hepatitis
* Current or previous history of anorexia or bulimia
* Concurrent participation in other studies
* Family member already enrolled in the study
Calisthenic and Neuromuscular Training in Patients With Knee OA.

The aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.

OsteoArthristis (OA) is the most frequent form of arthritis and a leading cause of pain and disability worldwide. OA can affect any synovial joint, although the hip, knee, hand, foot and spine are the most commonly affected sites.

The knee is the most commonly affected joint and knee OA (KOA) represents the leading joint disorder in the world. At present, there is no preventive or curative drug treatment available for KOA.

Physical therapy plays a significant role in treating patients with knee OA. Rehabilitation enables the patient to cope with their daily task independently and mainly focus on self-help and patient-driven treatments rather than on passive therapies delivered by clinicians.

A systemic review was conducted on Comparative Effect of Calisthenics and Proprioceptive Exercises on Pain, Proprioception, Balance and Function in Chronic Osteoarthritis of Knee. According to this study Light intensity Calisthenics exercises are effective and can be recommended as an adjunct to conventional physiotherapy for the patients with Osteoarthritis knee.

Another research was conducted on Efficacy of Neuromuscular Training on Pain, Balance and Function in Patients with Grade I and II Knee Osteoarthritis. The results shows that although conventional exercise program is effective in reducing knee pain, and increasing lower extremity muscle strength and range of motion, adding neuromuscular training (KBA) along with conventional exercise program in rehabilitation leads to higher improvement on balance and function in patient with knee grade I and II osteoarthritis.

A positive effect has been observed in treating patients with both the interventions.

The past research records are evident that therapists have determined individual effects of calisthenics and neuromuscular training for rehabilitation of Knee OA. The evidence for implementation of two protocols for rehabilitation of Knee OA is sparse. So the aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with chronic OA (symptoms for more than 3 months).
2. Subjects willing to participate and take treatment.
3. Grade of 2 to 3 as per Kellegren and Lawrence radiographic classification.

Exclusion Criteria:

1. Subjects having any systemic joint pathologies, inflammatory joint disease (e.g.

   Rheumatoid arthritis, gouty arthritis, psoriatic arthritis).
2. Subjects who had any neurological deficit (paresthesia, sensory loss, radiculopathy, myelopathy any mental illness (Dementia, Alzheimer's, Parkinson disease etc.) that can affect orientation and concentration.
3. Subjects on medication like antidepressants, corticosteroid, and anti-inflammatory medications.
4. Peripheral vascular diseases.
5. Any history of surgery related to lower extremity.
6. Subjects having metal implants in the lower limb
Congestive Heart Failure: Causes of Sudden Worsening

The purpose of the study is to recognize main causes of acute decompensation of chronic congestive heart failure.

Congestive heart failure (CHF) presents a very significant cause of morbidity and mortality. The prevalence of CHF is between 2 and 4% and rises with age (in 70- to 80-year-old people is between 10 and 20%). CHF is the cause of 5% of all acute hospital admissions and accounts for 2% of expenses on health. The most common causes of worsening of the chronic CHF are ischemia, arrhythmias, valvular dysfunction, systemic or pulmonary hypertension, volume overload or fluid retention, high output conditions (infection, anemia, thyrotoxicosis), drugs (NSAIDs, cyclo-oxygenase (COX) inhibitors, thiazolidinediones) and medication nonadherence. The goal of this study is to determine the proportion of various reasons of acute worsening of CHF, using commonly available methods including assessment of serum drug levels.

Eligibility Criteria:
Inclusion Criteria:

* able to provide informed consent
* aged 19 years or more
* history of heart failure of at least one month
* examined or hospitalized for acute dyspnea at rest or with minimal exertion
* clinical signs of fluid overload defined as at least one of following:
* rales
* jugular venous distension
* peripheral edema
* pulmonary congestion on X-ray
* NT-proBNP above 210 pmo/l

Exclusion Criteria:

* none
Efficacy of Pregnenolone in Patients With Schizophrenia

Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. After four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with people who do not take any additional medication.

Pregnenolone is a steroid health supplement which is readily available in health food stores. We are using it in this study at higher doses than you would normally take as a health supplement because preliminary studies have indicated that negative symptoms improve and certain aspects of cognition improve at these doses. We do not require you to stop your existing treatment in order to enter the study. After four months we will test your symptoms and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a follow-up study designed to determine the long-term costs and benefits of taking pregnenolone.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Diagnosis of schizophrenia or schizoaffective disorder
* No new medication for past 3 months and stable dose for past 4 weeks
* SANS (Negative symptom) score of 20 or above

Exclusion Criteria:

* Significant dementia or head trauma.
* Seizure during past year.
* Substance dependence in past 6 months or positive urine drug screen.
* History of hormone-sensitive cancer such as breast, testicular, prostate, ovarian or uterine cancers.
* Steroid metabolism disorder, e.g.Cushings or Addison's disease.
* Taking steroids other than birth control or post-menopausal hormones.
* Women who are pregnant or nursing.