cyrilzakka/clinical-trials huggingface dataset:
Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer

Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.

The major aim of this project is to conduct a prospective, randomized phase III clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone.

Gemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. According to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.

I). Study end points Primary end point: Patient survival, including overall survival and progression-free survival.

Secondary end points:

1. Acute toxicity during treatment
2. Tumor response rates
3. Sites of recurrence
4. Long-term complications and quality of life II). Design of study

An open-label, prospective randomized trial with two treatment arms:

* Arm I: Patients receive CCRT with weekly cisplatin only.
* Arm II: Patients receive CCRT with cisplatin plus gemcitabine. III). Study population 1) Number of subjects: A total of 172 patients (86 per treatment arm) will be accrued for this study within 4 years.

Conduct of study

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary squamous cell carcinoma of the uterine cervix.
* Previously untreated disease.
* Clinical FIGO stage III-IVa or pelvic/para-aortic lymph node positive by PET examination.
* No known metastases to supraclavicular nodes or other organs outside the radiotherapy field.
* Ages eligible: 35 years - 70 years.
* Patients must have adequate bone marrow, pulmonary, liver and renal function documented before radiotherapy. WBC \> 3000/mm3, platelet \> 100,000/mm3, serum transaminases (GOT, GPT) \< 60 IU/ml, total bilirubin \< 1.5mg%, creatinine \< 1.4mg% (creatinine clearance \> 60 ml/min).
* Performance status 0 or 1 (see Appendix I).
* The interval between RT and randomization is not greater than 3 weeks.
* Patients must have signed informed consent to participate this study.

Exclusion Criteria:

* Age \> 70 or \< 35
* Medical or psychological condition that would preclude treatment.
* Previous chemotherapy or pelvic RT.
* Small cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
* Patient unreliable for treatment completion and follow-up.
Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke

The specific aims of this study will be to:

1. investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy (MT) versus a control intervention on motor and functional outcomes of stroke patients.
2. compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG).
3. determine the correlations between neural activation changes and clinical outcomes after AOT and MT.
4. identify who are the potential good responders to AOT and MT.

In this 3-year study project, the investigators will design a comparative, randomized controlled trial to (1) investigate the treatment efficacy of AOT, MT versus a control intervention on motor and functional outcomes of stroke patients, (2) compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes after AOT and MT, and (4) identify who are the potential good responders to AOT and MT. An estimated total of 90 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (a total of 15 sessions). Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up. For the MEG study, the investigators anticipate to recruit 12 to 15 patients in each group. The patients can still participate in this study to receive treatments and clinical evaluations even if they do not meet the MEG eligibility criteria or are not willing to participate in the MEG study.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed as having a unilateral stroke
2. 1 to 6 months after stroke onset
3. from 20 to 80 years of age
4. a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
5. able to follow the study instructions (measured by the Montreal Cognitive Assessment)
6. capable of participating in therapy and assessment sessions

Exclusion Criteria:

1. patients with global or receptive aphasia
2. severe neglect
3. major medical problems, or comorbidities that influenced UE usage or caused severe pain
Home Use of Dual-light Photodynamic Therapy for Chronic Periodontitis

This early-stage research is designed to determine the efficacy of the Lumoral method in chronic periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque.

The Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy. The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Periodontal disease stage I-III, according to criteria the American Academy of Periodontology (AAP) with at least 2 mm interdental CAL in the site of greatest loss.
* Age of 18- 85 years
* Presence of ≥20 teeth, including implants
* Agreement to participate in the study and to sign a written consent form
* Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

Exclusion Criteria:

* Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
* Removable major prosthesis or major orthodontic appliance
* Pregnancy or lactation
* Use of antibiotics within 2 weeks prior the study
* A need for immediate antimicrobial treatment for periodontitis
Respiratory Variations for Predicting Fluid Responsiveness

Hypovolemia and acute circulatory failure affects more than 60% of patients hospitalized in intensive care or resuscitation. The volume expansion (VE) by fluid replacement therapy is the first treatment improve circulatory function. However, too much VE can be harmful. So, the use of dynamic predictive indicators of fluid responsiveness is recommended in patients with sepsis.In patients with spontaneous ventilation, few studies have evaluated these parameters. In mechanical ventilation, indices based on the respiratory variation of the diameters of vena cava have been studied and validated to predict the response to VE. However there is no similar study in spontaneously breathing patients without ventilatory support. The investigators hypothesize that the respiratory variations in the IVC diameters and femoral artery flow during standardized respiratory cycles are predictive factors of fluid responsiveness in spontaneously breathing patients with sepsis, acute circulatory failure, and regular cardiac rhythm.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of the intensive care units of the Lille university-hospital and of the Valenciennes general hospital.
* Age greater than or equal to 18.
* Patient insured
* Spontaneous breathing without ventilatory support or intubation or tracheotomy.
* Regular cardiac rhythm
* Prescription by the physician in charge of the patients of a 500 mL volume expansion in less than 30 minutes.
* Patients with sepsis with at least one sign of acute circulatory failure:

  * Tachycardia with heart rate\> 100/min
  * systolic blood pressure \<90mmHg or a decrease \>40mmHg in previously hypertense patient
  * Oliguria \<0.5ml/kg/hour for at least one hour
  * skin mottling

Exclusion Criteria:

* high-grade aortic insufficiency
* transthoracic echogenicity unsuitable for measuring the stroke volume or inferior vena cava diameters
* clinical signs of active exhalation
* clinical or ultrasonographic evidence of pulmonary edema due to heart failure
* pregnancy
* abdominal compartment syndrome
* Irregular cardiac rhythm
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications

Examination of therapeutical effects of different types of armsleeves in treating lymphatic diseases after breast cancer surgery during maintenance phase

1. thesis:

   - all types should be equal regarding volume reduction
2. thesis: armsleeves manufactured with microfibre yarn are expected to be

   * better in wearing comfort and
   * better in handling features.

1. thesis:

   * measuring of arm volume by "inverse water-volumetry" (see later)
   * measuring of circumference cD
   * measuring of circumference cG
   * photodocumentation in 2 positions(during each round)
2. thesis

   * questionaire for patients

     * in the beginning
     * after 1 week
     * after 2 weeks (at the end of a wearing period)
   * questionaire for study nurse (at the end of a wearing period)

Eligibility Criteria:
Inclusion Criteria:

* women with a secondary arm-lymphedema for at least 3 months
* willingness to wear compression arm-sleeves for at least 12 hours per day
* maintenance phase, where no significant further reduction of arm-volume can be achieved
* lymphedema in stadium 1 or 2
* age: at least 18 years
* signed consent form by the patient
* sufficient knowledge in national language

Exclusion Criteria:

* edema not completely reduced to "maintenance phase"
* immobilized patient
* acute deep vein thrombosis in arm
* directly after arm-vein-thrombosis
* acute arm erysipelas
* malignant edema
* existent lipedema
* arterial occlusion
* distinctive neuropathy in upper limbs
* neurinoma in upper limbs
* chronic pain after plastic surgery in upper limbs, shoulder or breast
* change in drug treatment, that can influence edema situation during the study
* pregnant women
* breast giving mothers
* not signed consent form
* participation in a second clinical trial
A Study to Evaluate the Efficacy and Safety of Vytorin Versus Standard Treatment of Other Statins in Moderate, Moderately High and High Risk Participants (MK-0653A-406)

This study will evaluate and compare the effectiveness of MK-0653 (Vytorin) to current standard treatment with other statins for the treatment of dyslipidemia in moderate, moderately-high and high-risk participants.


Eligibility Criteria:
Inclusion Criteria:

* Low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL
* Either treatment naïve (no previous treatment with lipid-lowering medication) or if previously treated with lipid-lowering medication, must complete a wash-out 6 weeks prior to enrollment

Exclusion Criteria:

* LDL-C level ≥ 190 mg/dL
* Hypersensitivity or intolerance to Vytorin, ezetimibe or simvastatin
* Taking other lipid lowering agent except statins. (i.e. fenofibrate, niacin, ezetimibe, etc)
* Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
* Currently participating in or has previously participated in a study within 30 days
* Congestive heart failure defined by New York Heart Association (NYHA) Class III or IV within previous 6 months
* Uncontrolled cardiac arrhythmias or recent significant electrocardiogram (ECG) changes
* Unstable angina pectoris
* Myocardial infarction, coronary artery bypass surgery, or angioplasty within previous 3 months
* Unstable or severe peripheral artery disease within previous 3 months
* Uncontrolled hypertension (treated or untreated)
* Type 1 or Type 2 diabetes mellitus that is poorly controlled or recently diagnosed (within previous 3 months)
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
* Serious cerebrovascular disorder (ischemic stroke or cerebral hemorrhage) within the previous 6 months
* Received treatment with systemic corticosteroids, any cyclical hormones

within previous 8 weeks
Diet, Genetics, and CVD Risk Factor Response in Blacks

To test the hypothesis that the responsiveness of major and emerging cardiovascular disease risk factors to changes in diet composition clusters within families depending on genetic susceptibility factors.

BACKGROUND:

Reduction in risk of cardiovascular disease (CVD) through dietary change has considerable potential for a beneficial impact on public health. On a population basis, moderation of both lipid profiles and blood pressure can be accomplished readily with a prudent diet. Nevertheless, individual response to dietary impact on CVD risk factors varies widely, presumably as a result of genetic differences. In particular, Blacks who constitute a subpopulation with documented increased risk of morbidity and mortality from CVD would disproportionately benefit from interventions designed to maximize the impact of dietary change tailored to individual genetic makeup. Therefore, study of the influence of diet on CVD risk factors, along with enhanced understanding of the genetic components involved, would greatly potentiate chronic disease interventions.

The study is conducted in response to a Request for Applications issued in October, 2001 on the Interaction of Genes and the Environment in Shaping Risk Factors for Heart, Lung, Blood, and Sleep Disorders.

DESIGN NARRATIVE:

Two-generational family lines will be identified in Blacks with elevated low density lipoprotein-C (LDLC) in probands. The population will be fed a controlled diet contrasting an established heart healthy regimen with a typical American one. Concomitant rigorous genetic, anthropometric, and behavioral evaluation will provide data with which to analyze individual differences in response to consistent dietary intake. In Specific Aim 1, Black, two-generational, families will be recruited and provided interventional diets designed to reduce (or not) LDL-C and blood pressure. In Specific Aim 2, non-genetic predictors of CVD risk factor response will be identified through extensive assessments of baseline behavioral characteristics, anthropometric features, and metabolic factors. In Specific Aim 3, the underlying genetic factors that predispose to response (or the lack of) to dietary interventions will be identified through the examination of polymorphisms in candidate genes and the identification of susceptibility loci by linkage analyses. In Specific Aim 4, interactions between diet, CVD risk factor response and genetic factors will be dissected through measures of potential mediating metabolic pathways.

Eligibility Criteria:
No eligibility criteria
Patients' Sleep at the Intensive Care Unit

The primary objective of this study is to evaluate patient-nurse reliability and agreement of the Richards-Campbell sleep questionnaire (RCSQ) in a population of medical intensive care unit patients.

The main instrument of this research is the Richards Campbell Sleeping Questionnaire (RCSQ) regarding patients' overnight sleep quality. This questionnaire is given to complete to eligible patients between 7 am and 10 am. The same questionnaire is given to the night-shift nurse between 7 am and 7:30 am, who was taking care of that particular patient overnight. This RCQS assessment is based solely on each nurse´s perception of the patient´s sleep quality last night. Neither the nurse nor the patient know each other´s RCSQ response.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients
* Age 18 years and older
* Glasgow coma scale 15

Exclusion Criteria:

* Age \< 18 years
* Glasgow coma scale \< 15
Evaluation of the Impact of a Personalized Program of Adapted Physical Activates in Patients With Parkinson Disease

Our study aims to compare the effects of a standard care plan to one using adapted physical activity in patients with Parkinson Disease. Using actigraphy as an evaluation measure will allow the collection of quantitative and objective data related to activity in contrast to questionnaires which are more subjective and dependent on self-representation. In addition, the evaluation of the caregiver's actigraphy and hardship (Zarit scale) will provide interesting data from this population.


Eligibility Criteria:
Inclusion Criteria:

* The patient and their carer have given their free and informed consent and signed the consent form
* The patient must be insured of the beneficiary of an insurance policy
* The patient is available for the 6 month follow-up
* The patient is between 40 and 80 years old
* The patient has experienced symptoms of Parkinson Disease for at least 5 years and is in a stable state (no medical event or change of treatment in at least 1 month)
* The functional impact and duration of fluctuations is ≥3 (MDS UPDRS)
* The patient can walk autonomously, including using a technical aid
* The patient does not have any regular physical activity excluding physiotherapy sessions
* The patient has daily help from a caregiver

Exclusion Criteria:

* The subject and/or their caregiver is participating in another study
* The subject and/or their caregiver is in a period of exclusion determined by a previous study
* The patients is under judicial protection or state guardianship
* It proves impossible to give the patient and/or the caregiver clear information
* The patients and/or the caregiver reuses to sign the consent form
* The patient is pregnant or breast feeding
* The patient has anxiety or depression (Score HAD≥ 11/14), cardiac or respiratory failure (stress test), vesico-sphincter problems preventing normal practice of a physical activity, a contraindication to adapted physical activities
* The patient cannot walk
* Muscular tremor preventing the actigraphy measurement. Outside normal range values for UPDRS measures of: 3.15) postural tremor of the hands; 3.16) action tremor of the hands; 3.17) amplitude of rest tremor
Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure

This study investigates the effects of aerobic, resistance, inspiratory training modalities outcomes in functional capacity and quality of life of heart failure (HF) patients, aiming for the 'optimum' (greek, αριστος=aristos) training program for HF patients.

Heart failure is a clinical syndrome characterized by symptoms of dyspnea, exercise intolerance and decreased quality of life. A weakness in both inspiratory and peripheral muscles is also reported. Aerobic training (AT) improves the functional status of HF patients (level of evidence IA). Additional benefits of inspiratory muscle training (IMT) and/or resistance training (RT) when combined with aerobic training (AT) in HF symptoms have also been found.

Four exercise groups will be studied in order to identify the optimum exercise program I. Aerobic-Resistance-Inspiratory training (ARIS) group II. Aerobic Training-Resistance Training (AT/RT) group III. Aerobic training-Inspiratory Muscle Training (AT/IMT) group IV. Aerobic Training (AT) group

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure (from New York Heart Association (NYHA) functional class II to NYHA III)
* Left ventricular ejection fraction below or equal to 35%

Exclusion Criteria:

* Uncontrolled arrhythmia
* Pulmonary oedema or pulmonary congestion in the last 30 days
* Cognitive, neurological or orthopaedic limitations
* Respiratory infection during 30 days before the start of the study
* Pulmonary limitations (e.g COPD)
Heart Failure Registry

The purpose of this registry is to compile a large clinical database on the medical management of patients hospitalized with acute heart failure, using information collected from acute care hospitals across the United States.

ADHERE is a phase IV, multicenter, observational, open-label registry of the management of patients treated in the hospital for acute heart failure (HF) in the United States. The target population consists of patients admitted to an acute care hospital who are treated actively for acute heart failure, where acute HF is defined as new-onset HF with decompensation; or chronic HF with decompensation. Patient eligibility is based upon the presence of an acute HF diagnosis and is not tied to the use of any specific therapeutic agent or regimen. Collect data on the episode of hospital care beginning with the point of initial care in the hospital and/or emergency department and ending with the patient's discharge, transfer out of the hospital, or in-hospital death.

N/A

Eligibility Criteria:
Inclusion Criteria:

* Received or is eligible to receive a principal hospital discharge diagnosis of HF or decompensated HF is present as determined clinically by the patient care team

Exclusion Criteria:

* Heart Failure is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode