cyrilzakka/clinical-trials huggingface dataset:
Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients

This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment.

The experimental arm "APAD": tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment

The experimental program will include:

* 8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week.
* 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment.

The control arm: standard of care

Eligibility Criteria:
Inclusion Criteria:

* Female patient with histologically proven breast cancer
* Age ≥18 years old
* Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + 3 taxanes) followed by radiotherapy
* Satisfactory healing from surgical act on breast and lymph nodes
* Ability to understand the nature, goal and study methodology
* Consent to cooperate for clinical assessments
* Affiliation to a social security regime or beneficiary of equivalent social protection
* Written informed consent provided before any study specific procedures

Exclusion Criteria:

* Metastatic disease
* Any other primary tumor
* Contra-indication to moderate physical activity: Unchecked high blood pressure; family history of sudden death in a first degree relative; not stabilized heart disease; acute or chronic lung disease resulting in dyspnea for moderate effort; uncontrolled diabetes, carrying a stent; other severe pathologies unstabilized, disabled or not indicated to physical practice.
* Contra-indication to adjuvant chemotherapy or radiotherapy
* Pregnancy or breast feeding (according to the recommendations of the usual adjuvant breast cancer)
* Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions
* Legal inability or restricted legal ability
Use of Virtual Reality Goggles During Chemotherapy Infusion to Reduce Anxiety-Related Symptoms

This clinical trial evaluates the use of virtual reality (VR) goggles during chemotherapy infusion to reduce anxiety-related symptoms in patients with head and neck, thoracic, hematologic, and breast cancers. Virtual reality headsets provide the ability for users to explore a simulated, three-dimensional environment with which users can interact. In virtual reality users can play interactive games, enjoy relaxing experiences, and watch immersive videos. The use of VR goggles may help with anxiety management during chemotherapy infusion.

PRIMARY OBJECTIVE:

I. To evaluate the effectiveness of VR therapy in reducing severity of anxiety symptoms during chemotherapy infusion, compared to participants utilizing a smartphone as a control.

SECONDARY OBJECTIVES:

I. To evaluate whether there is a short-term effect of VR use in anxiety levels.

II. To assess participant satisfaction with their chemotherapy infusion experience in the control and treatment groups.

EXPLORATORY OBJECTIVE:

I. To assess participants' reported adverse effects associated with VR headset use.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: Patients use VR during chemotherapy infusion on study.

GROUP 2: Patients use smartphone during chemotherapy infusion on study.

Eligibility Criteria:
Inclusion Criteria:

* English speaking: Ability to interact with virtual reality content may be impacted by inability to understand English; moreover, paper questionnaires will only be provided in English.
* Older than 18 years of age, and younger than 89 years of age. All sexes/gender identities and members of all races and ethnic groups will be included.
* Planned to receive chemotherapy infusion for head and neck, breast, thoracic, and hematologic cancers at the Oregon Health \& Science University (OHSU) South Waterfront Center for Health \& Healing building 2 (there are no restrictions related to prior chemotherapy infusions or other cancer treatments).
* Chemotherapy treatment lasting at least 10 minutes.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Social or psychiatric conditions that may interfere with compliance.
* Reconstruction, incisions, wounds, wound care, or injury that impact the ability to place on the VR headset. This would limit the ability to utilize the VR headset.
* History of seizure or epilepsy.
* History of vertigo or persistent dizziness.
* Use of cardiac pacemaker, requirement for hearing aid on at all times, or have defibrillators.
* Children.
* Pregnant women.
* Decisionally impaired adults.
* Prisoners.
Fully Constrained Acetabular Liner vs. Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip

The purpose of the current study is to investigate whether dual mobility liners are non-inferior til constrained liners regarding the post-operative hip joint dislocation risk following total hip replacement in patients with metastatic bone disease of the hip.

The use of constrained liners in total hip arthroplasty (THA) in patients with metastatic bone disease of the hip (MBD) has increased at our department in recent years to avoid hip dislocation in this high-risk population. Hip surgeons seldom recommend the use of constrained liners in primary surgery due to the risk of polyethylene wear and high revision rates. An alternative to constrained liners are dual mobility cups, which have been shown to decrease the risk of dislocation in other high-risk THA operations such as revision THA and THA in hip fracture patients, while providing the added benefit of a less restricted range of motion of the joint. This study will investigate whether dual mobility cups are non-inferior to constrained liners regarding the post-operative joint dislocation risk in patients with MBD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with metastatic bone disease of the hip defined as bone lesions in the proximal femur because of secondary malignant growth of a primary cancer located elsewhere or bone lesions in the proximal femur due to hematological malignancies
* Determined eligible for total hip arthroplasty for metastatic bone disease of the hip and is planned to undergo surgery at the study site
* Provides informed consent prior to initiation of any study-specific activities/procedures

Exclusion Criteria:

* Previous osteosynthesis or endoprosthetic surgery of the ipsilateral hip
* Pelvic reconstruction of the ipsilateral hip
* Total femoral replacement of the ipsilateral femur
* It is not surgically viable to insert an acetabular cup and/or a femoral stem
* Subject is currently or has previously been enrolled in this study
* Subject is incapable of understanding the patient information or unable to provide informed consent
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.

This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females, defined as one from the next :

  1. Natural menopause \>/=1 year,
  2. Surgical ovariectomy,
  3. Chemotherapy-induced amenorrhoea \>/=2 years.
* Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
* Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
* Patients whose tumour was estrogen receptor positive (ER+).
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients for whom Aromasin® treatment is contraindicated (see SmPC).
* Presence of metastasis or a contra lateral tumour.
* Other adjuvant endocrine therapy.
* Another concomitant antineoplastic treatment
* Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
* The patients are not supposed to participate to any other trial during all the study period.
Mobile Unit Screening of Pathologies Associated With Chronic Diseases - Feasibility

The main objective of this study is to assess the feasibility of standardized screening for comorbidities among patients with one or more of three chronic diseases (diabetes, COPD, atherosclerosis) by a mobile unit at times and localities under-served by health actors.

The investigators secondary objectives include assessing patient and GP satisfaction in relation to the mobile screening team.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has one or more of the following three diseases: (1) chronic obstructive pulmonary disease (COPD); (2) type II diabetes; (3) atherosclerosis.

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* There is a need to take urgent therapeutic care in the opinion of the general practitioner
* The patient has received within the past year, a full examination including Doppler assessment of supra-aortic arteries, abdominal aorta and lower limbs; the patient has received a measure of the ankle-brachial index at the toe.
Questionnaire About Risk Factors of Iron Deficiency Anemia in Pregnancy

Anemia in pregnancy,and especially iron deficiency anemia is both a long standing scholarly interest ,the aim of my research to summarise the risk factors of iron deficiency anemia in pregnancy, especially in Egypt as a less developed country,and suggest recommendations about how to prevent it


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older with established iron deficiency anemia (HB less than 10)
* established intrauterine pregnancy
* women want to participate in the study

Exclusion Criteria:

* anemia due to other causes
* recent blood transfusion in the last 3 months
* women with threatened miscarriage
* women are known to have pathological blood loss (urinary bleeding or GIT bleeding) 5- history of haematological disorder 6- women used iron in the past 3 months
Cardiac Sarcoidosis and FDG-PET

Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the formation of non-caseating granulomas in involved organs. Its cardiac involvement may be potentially fatal. Although endomyocardial biopsy is required for deﬁnitive diagnosis of cardiac sarcoidosis, it is invasive and lacks sensitivity. The specific diagnostic tool for cardiac sarcoidosis is far from satisfactory. Recent studies have revealed that FDG-PET with under fasting conditions is a useful method for identiﬁcation of cardiac sarcoidosis patients. However, to our knowledge, no investigations have been published with regard to FDG quantification for the diagnosis and management of cardiac sarcoidosis by PET.

Fasting FDG-PET will be performed in all subjects. Serum calcium, C-reactive protein (CRP), angiotensin converting enzyme (ACE), lysozyme, and B-type natriuretic peptide (BNP) levels will be measured in all patients. All patients will undergo chest X-ray, resting 12-lead ECG, transthoracic echocardiography, and 3 types of radionucleotide imaging using Tc-99m sestamibi for myocardial perfusion, Ga and FDG for whole-body evaluation. All assessments will be conducted within 2 weeks and no sign indicated any change in disease activity of sarcoidosis. The patients with cardiac involvement will be treated with 30 mg/day of prednisolone orally for the first 4 weeks, then will decrease to a dose of 20 mg/day for the next 4 weeks, and will maintain to a dose of 10 mg/day afterwards.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 35 and 85 years
* Subjects with systemic sarcoidosis
* Subjects with idiopathic sarcoidosis

Exclusion Criteria:

* Subjects with active inflammatory diseases not related to sarcoidosis
* Subjects with coronary artery disease and primary valvular heart diseases
* Subjects with uncontrolled diabetes mellitus or insulin treatment
* Subjects with use of the corticosteroid
* Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease
Stimulation of Diet-Induced Thermogenesis by Cold-Exposure

Human fat tissue is essentially white fat, the main function of which is to store excess energy intake, and to release it when necessary. Brown fat is far less abundant and is present in the body to burn fat (and thus energy) to generate heat to maintain body temperature around 96 degrees. This phenomenon is called thermogenesis. When humans are exposed to cold on a chronic basis, brown fat expands and becomes more active, and consequently burns more energy. The amount of brown fat is higher during winter, and daily short (20 minutes) exposures to cold might be sufficient to induce its activity.

We hypothesized that daily short term (20 minutes) exposure to a cold environment (4 °C) for four weeks increases adaptive BAT-mediated thermogenesis. CIT and DIT will be increased proportionally (the increase in CIT and DIT will be correlated).

This study will have 3 phases:

Phase 1: baseline testing. This phase takes place at the beginning of the study to establish several physical, physiological and metabolic studies and includes measures of height, weight, body composition, sedentary and resting metabolic rate in a metabolic chamber as well as your metabolic and cardiac responses to cold.

Phase 2: cold exposure (treatment) phase. This phase is initiated immediately after phase 1 and will last 4 weeks. Each work day (Monday to Friday) subjects will have to spend 20 minutes in a cold room wearing light clothes.

Phase 3: post-treatment testing. The same physiological and metabolic studies measured at baseline will be repeated over 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Men between the ages of 18-35 years, inclusive
* Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive, with a stable weight (\<2kg variation) within the past 3-6 months
* Non smokers
* On no medication or recreational drugs
* Healthy as assessed by a standard self-reported screening health questionnaire
* Provide written informed consent

Exclusion Criteria:

* Smokers
* Individuals taking any medications
* Individuals taking any stimulants
* Individuals taking beta-blockers
* Individuals with diabetes or impaired fasting glucose as defined by theADA criteria, i.e. fasting plasma glucose concentration ≥ 5.6 mmol/L (100 mg/dl).
* Individuals with chronic alcohol consumption (\> 3 drinks per day) or drug abuse
* Individuals unable to abstain from caffeinated beverage or alcohol the days of study
* Individuals with pacemakers or defibrillators
* Individuals with history of heart disease or history of stroke
* Individuals having a significant recent loss or gain of weight
* Individuals involved in regular (\> 3 times per week), intense competitive sporting activities.
* Individuals involved in intensive exercise activity.
Topical Everolimus in Patients With Tuberous Sclerosis Complex

Tuberous sclerosis complex (TSC) is a rare genetic multisystem disorder characterized by the development of hamartomas in several organs (e.g. brain, heart, kidney, liver, lung), and skin in more than 90% of cases. Facial angiofibromas (FA), present in about 80% of patients, are a stigmatizing hallmark of the disease. Everolimus could be a candidate for use as a topical formulation to treat FA. This adaptive seamless Phase II/III study primary objective is to determine the dose of topical everolimus for treatment of FA and evaluate the efficacy and safety of topical everolimus versus placebo in patients with angiofibromas.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 2 years
* With definite or possible diagnosis of TSC
* With at least 3 FA, diagnosed by a dermatologist
* Patients (or parents or legal guardians) who have provided written informed consent prior to participation in the study
* Willing and able to comply with study requirements
* With negative blood pregnancy test at the screening visit and using effective contraceptive methods for women of childbearing potential, up to 12 weeks after treatment discontinuation
* Covered by national health insurance

Exclusion Criteria:

* Systemic treatment by sirolimus, everolimus, or any other immunosuppressive drug, during the previous 6 months
* Use of topical tacrolimus or sirolimus on the face, during the previous 6 months
* Destructive treatment (laser therapy, surgery, cryotherapy) of facial angiofibromas during the previous 6 months
* Concomitant use of topical treatments that could affect facial erythema (e.g. Brimonidine)
* Known internal organ involvement requiring systemic mTOR inhibitor in the next 6 months
* Immunosuppression (immunosuppressive disease or immunosuppressive treatment)
* Known chronic infectious disease Known hypersensitivity to mTOR inhibitor
* Neutropenia \< 1000/mm3
* Thrombopenia \< 75,000/mm3
* Chronic renal insufficiency (estimated Glomerular Filtration Rate \< 60 mls/min)
* Chronic liver disease (SGOT or SGPT \> 3 times upper normal limit)
* Uncontrolled dyslipidaemia
* Uncontrolled diabetes
* Brest feeding or pregnant women, or women on childbearing age without any effective method of contraception during treatment and up to 12 weeks after treatment discontinuation
* Subjects who, in the Investigator's opinion, are unable or unwilling to comply with the protocol.
Effects of Dexmedetomidine on Respiratory Mechanics and Oxygenation During One Lung Ventilation With Chronic Obstructive Lung Disease

COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary hyperinflation would divert pulmonary blood flow and impair arterial oxygenation. Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as bronchodilator in COPD patients when administered during surgery with the one lung ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to anesthetic agents in COPD patients during the OLV.


Eligibility Criteria:
Inclusion Criteria:

1. Above 40 years of age
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. COPD diagnosed , criteria ( on preop. PFT : FEV1 \< 80%, FEV1 / FVC \< 70% after bronchodilator)
4. thoracic surgical procedure

Exclusion Criteria:

1. severe functional liver or kidney disease
2. diagnosed HF ( NYHA class \>3)
3. arrhythmia or received treatment with antiarrythmic drug .
4. exceed BMI \> 30 kg/ m2
5. bradycardia (HR \<50 bpm)
Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This study will test the safety of Quad Shot radiation therapy using 2 different treatment schedules to find out what effects, if any, this treatment has on people with advanced NSCLC who are receiving systemic therapy for their cancer. The Quad Shot treatment schedule reduces the number of days needed to deliver the radiation treatments, which may be less disruptive to systemic therapy schedules.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer with metastatic disease detected on cross-sectional imaging with a plan for one of the following systemic therapies:

  * Carboplatin/paclitaxel
  * Carboplatin/paclitaxel/pembrolizumab
  * Carboplatin/pemetrexed
  * Carboplatin/pemetrexed/pembrolizumab
  * Pembrolizumab (single agent or in combination with other regimens in this list)
  * Cisplatin/pemetrexed
  * Cisplatin/pemetrexed/pembrolizumab
  * Pemetrexed/pembrolizumab
  * Pemetrexed
  * Nivolumab (single agent or in combination with other regimens in this list)
  * Ipilimumab/nivolumab
  * Carboplatin/etoposide
  * Carboplatin/etoposide/atezolizumab
  * Cisplatin/etoposide
  * Cisplatin/etoposide/atezolizumab
  * Durvalumab (single agent or in combination with other regimens in this list)
  * Atezolizumab (single agent or in combination with other regimens in this list)
* Patients eligible for the systemic therapy regimens notes
* Patients with Stage IV NSCLC who have symptomatic (defined by patient-reported cough, dyspnea, or hemoptysis) or near-symptomatic (determined radiographically to be threatening the airway, esophagus or vasculature) centrally located.
* KPS ≥ 60
* Age ≥ 18 years.
* Able to provide informed consent.
* Patients at reproductive potential must agree to practice an effective contraceptive method.

Exclusion Criteria:

* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
* Serious medical co-morbidities precluding radiotherapy.
* Pregnant or breast-feeding women.