cyrilzakka/clinical-trials huggingface dataset:
Personalized Estimation of Doses Delivered During Image Guided Radiation Therapy Tests

In image-guided radiotherapy (IGRT), the repeated and increasingly intensive use of on-board positioning imaging, using 2D or 3D Mega-Volt (MV) or kilo-Volt (kV) imaging devices (cone-beam or CBCT scanners), is leading the international medical community to question the potential impact of these additional doses delivered to the patient, especially in at-risk populations such as children and young adults. The doses delivered to the patient by positioning imaging are still relatively unknown, due to the lack of experimental means and software available in clinical routine to easily and accurately evaluate these doses.

The main objective is to estimate by personalized Monte Carlo calculation the physical doses delivered to the patient's organs by the onboard imaging systems during their radiotherapy treatment. The obtained imaging doses will be compared according to different irradiation scenarios commonly used in clinical routine as well as according to the treated location.

The study will consist of 2 successive steps:

* Step 1 : for a set of patients selected in the clinical centers participating in the study, 3D maps of physical doses delivered to organs by positioning imaging will be calculated based on the patient's CT image used by the treatment planning system (dosimetric calculation performed by Monte Carlo method).
* Step 2/ all the new dosimetric data, average organ doses and dose volume histogram, will be the subject of a more global analysis, which will be returned to the project's clinical partner centers.

Eligibility Criteria:
Inclusion Criteria:

* IGRT (Image Guided Radiation Therapy) treatments considered: lung, pelvic (prostate), breast, ENT and pediatric cancers
* Treatment modalities: linac + daily kV-CBCT (kilo-Volt ConeBeam CBCT) and linac + weekly kV-CBCT + daily 2-Dimensional-kilo-Volt (2D-kV) (adult: lung, prostate, breast, Ear Nose and Throat (ENT); pediatric: neuro, ENT, thorax and abdomen); Cyberknife + daily 2D-kV (adult lung); Tomotherapy + daily MV-CBCT (Mega-Volt ConeBeam CBCT) (adult prostate, breast, ENT; pediatric ENT, thorax and abdomen)

Exclusion Criteria:

* Patient who has undergone a treatment discontinuation or modification (re-planning) of treatment with an impact on the IGRT protocol.
* Patient for which details on the imaging procedures used during treatment or DICOM files (DICOM CT, DICOM RTstruct) are incomplete will not be included
Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia

This prospective, open label, muti-center study evaluates the use of Nano-Pulse Stimulation (NPS) in the treatment of Sebaceous Hyperplasia (SH) lesions less than 2.5mm in size.

The study is designed with each subject serving as his or her own control. A total of up to 75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 1.5-mm x 1.5-mm or 2.5-mm x 2.5-mm tip. All treated lesions will receive at least one NPS treatment and evaluated at 30 days for lesion clearance. Initial lesions scored as Not Clear or Partially Clear may undergo a second NPS treatment. All subjects will have their lesions evaluated at 60 days post-primary or secondary treatment.

Eligibility Criteria:
Inclusion Criteria:

* Males or females
* Presents with at least 2 and up to 5 clinically visible SH lesions
* Understands that 1 lesion will remain untreated to act as a reference
* Lesions must measure no greater than 2.5 x 2.5 at the outside margin
* Wishes to have at least 1 and perhaps 2 NPS treatments to each study lesion
* Selection of the non-treated reference lesion will be randomly identified
* Willing to return for 4 or 5 total study visits at specified intervals over 60 or 90 days
* Agrees to photographic or other image capture methods of both the treated and untreated lesions.
* Agrees to avoid any other treatment to the NPS treated and untreated SH lesions until the end of the NPS study
* Has no evidence of active infection in the designated tissue prior to treatment and reports no infection within 90 days
* Is not allergic to Lidocaine or Lidocaine-like products

Exclusion Criteria:

* Presence of Implantable electronic devices that cannot be removed. e.g., pacemaker or automatic defibrillator
* Taking medications prescribed for cardiac arrhythmia at any time within 6 months prior to exposure to the NPS device
* SH lesions are located within the eye orbit or on the nose
* Active infection or history of infection in designated test area within 90 days prior to study initiation
* Use of oral steroid and/or retinoid use within the last 12 months
* Prior treatment to the identified SH lesions targeted for the study which occurred within 6 months prior to study start
* Is known to be immune-compromised and/or received immunosuppressant therapy within 6 months prior to study start
* Taking blood thinning medications
* Has Insulin dependent diabetes
* Is known to be pregnant or lactating female
Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL

The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proved extranodal NK/T cell lymphoma
* No previous anti-cancer treatment
* Measurable lesion on baseline PET/CT and MRI
* Stage I
* Normal serum LDH level
* Primary tumor invasion (PTI) absence
* ECOG PS 0-1
* Sufficient organ functions

Exclusion Criteria:

* Other mature T- or NK- lymphoma
* Hemophagocytic lymphohistiocytosis
* Primary CNS lymphoma or CNS-involved lymphoma
* History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment
Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.

Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children. Participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. The primary endpoint was fever duration and analysed by intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of Mycoplasma pneumoniae infection
* Lobar pneumonia or pneumoniae with pleural effusion

Exclusion Criteria:

* Immunosuppresant host
* Chronic cardiovascular/pulmonary disease
* Hospital acquired infection
Acupuncture for Relieving Perimenopausal Symptoms

The purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.

* A randomised controlled trial with superiority design
* A total of 220 participants will be included in 3 centers
* 2 arms: acupuncture group and Climen® group

Eligibility Criteria:
Inclusion Criteria:

* Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days.
* Reported relative perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
* Age 40-50 years.
* Not accompanied with conditions that are needed for hormone therapy, e.g., menopause after surgery, active osteoporosis.
* Willing to participate and signing the inform consent.

Exclusion Criteria:

* Had a regular menopausal cycle 3 months before this trial.
* Taking estrogen, selective serotonin reuptake inhibitor(SSRI), soy isoflavone, progesterone, Vitamin E or black cohosh in the 4 weeks before inclusion.
* receiving chemoradiotherapy.
* Agnogenic vaginal bleeding.
* Coagulation defeats, or taking anticoagulant drugs, such as warfarin, heparin, etc.
* Dermal diseases, e.g., eczema, psoriasis.
* Liver or kidney failure.
* Uncontrollable hypertension, diabetes, or thyroid diseases.
* With diabetic neuropathy, malignant cancer and mental diseases (including depression).
* Intend to gestation, in gestation period or lactation period.
* Using sedative or antianxiety drugs.
* With smoking or intemperance problems.
* Using cardiac pacemaker, or joint prosthesis.
* Low compliance.
* Benign tumor in breast.
* Family history of breast cancer.
Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire

The validation of a sleep questionnaire (translated into French from a source questionnaire in English) will provide a reliable and easily administered tool for assessing sleep quality in intensive care, enabling better identification of patients at risk of sleep disorders and other associated complications, in particular ventilatory weaning difficulties.

Sleep disturbance in intensive care is influenced by a number of factors, such as environmental nuisances (noise, light, repeated interruptions), treatments (sedation, analgesia, mechanical ventilation) and the severity of the acute pathology that led to admission. Consequences include alterations to the immune system, neuropsychiatric disorders and impaired functional recovery.

Current management of these disorders remains limited:

* No pharmacological treatment has clearly demonstrated its efficacy on sleep quality in intensive care.
* Interventions aimed at modulating environmental nuisances (reducing noise, reducing light exposure, respecting day/night cycles) have shown limited effects.
* According to the available data, individual devices (eye masks, earplugs) have not significantly improved sleep architecture.

In this context, the Richards-Campbell questionnaire (RCSQ) represents an interesting alternative for subjectively assessing sleep in intensive care patients. This questionnaire, specifically designed for these patients, provides a simple and rapid assessment of sleep disturbances. The validation of a French version of the RCSQ meets a need to standardise assessment practices in France and to gain a better understanding of the factors influencing sleep quality in intensive care.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years
* Hospitalised in intensive care for at least 24 hours
* Able to understand and answer questionnaires
* Unsedated (discontinued for 24 hours) presenting a Richmond Sedation Agitation Scale score between ≥-2 and ≤ +1
* Fluent in French
* Having given oral consent for participation in the study
* Person affiliated to a social security scheme.

Exclusion Criteria:

* Patient refusal
* Person deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship or curatorship)
* Patient unable, for whatever reason, to read, understand or answer the questionnaires (visual problems, psychiatric or cognitive problems, etc.)
* Patient already included in the study or another study evaluating sleep
Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) of 35 percent or less
* New York Heart Association (NYHA) functional Class III at time of screening
* QRS duration less than 120 milliseconds (ms)
* Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months
* Receiving stable optimal medical therapy for heart failure prior to enrollment
* Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL)
* 18 years of age or older
* Willing and able to comply with study procedures
* Expected lifespan greater than 12 months beyond study enrollment as assessed by physician

Exclusion Criteria:

* Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician
* Polyneuropathy
* Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
* Unable to perform an exercise capacity test
* Pregnant or planning to become pregnant during this study
* Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study
* Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days
* Had a heart transplant
* Has complete heart block
* Had Acute Coronary Syndrome within the past 90 days
* Has congenital heart disease with significant hemodynamic shunting
* Has chemotherapy-induced heart failure
* Has reversible cardiomyopathy
* Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area)
* Has diagnosed unstable angina pectoris
* Has unstable coronary artery disease
* Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy
* Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead
* Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater
* Has an existing neurostimulator
Combined Method for Induction of Labor

Induction of labor is performed via the vaginal misorostol 25 ug/ 6 hours and intracervical foley's cather administration and both techniques performed together.


Eligibility Criteria:
Inclusion Criteria:

* females presenting for induction of labor

Exclusion Criteria:

* previous cesarean section
* previous uterine scars e.g. myomectomy
* refusal to participate in the study
The Effect of Multiple Oral Doses of BI 1356 BS on Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of Simvastatin and on the Pharmacokinetics of Its Metabolite Simvastatin Acid in Healthy Male Volunteers

Investigation of the multiple dose pharmacokinetics, safety and tolerability of simvastatin and simvastatin acid with and without concomitant administration of BI 1356 BS


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the following criteria: No findings deviating from normal and of clinical relevance as well as no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests
* Age ≥21 and Age ≤65 years
* BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or-neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs, including herbal products, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
* Not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until one month after the last intake
Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events

The aims of this study are to investigate the effect of eliminating routine GRV monitoring on VAEs in patients receiving MV and early EF, Determine the effect of eliminating routine GRV monitoring on nutritional adequacy in patients receiving MV and early EF and evaluate the effect of eliminating routine GRV monitoring on feeding intolerance in patients receiving enteral feeding.

Early enteral nutrition (EN) is consistently recommended as first line nutrition therapy in critically ill patients since it favorably alters outcome, providing both nutrition and non-nutrition benefits. However, critically ill patients receiving mechanical ventilation (MV) are at risk for regurgitation, pulmonary aspiration, and eventually ventilator-associated pneumonia (VAP). EN may increase these risks when gastrointestinal (GI) dysfunction is present. Gastric residual volume (GRV) is considered a surrogate parameter of GI dysfunction during the progression of enteral feeding in the early phase of critical illness and beyond. About 62% of critically ill patients receive enteral nutrition (EN) and in patients on MV, enteral feeding was connected to a threefold increase in the development of VAP.

A new surveillance definition of ventilator-associated events (VAE) was introduced by the National Healthcare Safety Network (NHSN) in 2013 to identify patients who develop complications of MV. It outlines the various events in a step-by-step fashion, beginning with ventilator-associated complications (VAC), moving on to infectious complications (IVAC), and finally VAP. According to the NHSN, VAEs occur within 9% to 40% of mechanically ventilated patients

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged≥18 years)
* Newly admitted mechanically ventilated patients who are attached to a mechanical ventilator for at least 48 hours.
* Starting enteral nutrition via a nasogastric tube within 36 hours after intubation.

Exclusion Criteria:

* Abdominal surgery within the past month.
* History of esophageal, duodenal, pancreatic, or gastric surgery.
* Bleeding from the esophagus, stomach, or bowel.
* Enteral nutrition via a jejunostomy or gastrostomy.
* Pregnancy
Changes in Arch Parameters After Molar Distalization; Hybrid Hyrax Distalizer Versus Pendulum

this study was to compare the changes in arch parameters after molar distalization; hybrid hyrax distalizer versus Pendulum distalizer using CBCT.

Evaluation of maxillary molar amount of distal movement and the amount of anchorage loss Arch length, arch width, arch depth

Eligibility Criteria:
Inclusion Criteria:

* For group 1(Hybrid hyrax distalizer) Patients suffering maxillary collapse with a skeletal background with unilateral or bilateral posterior crossbite.
* For group 2 (Pendulum distalizer) Patients with skeletal class I or class II malocclusion who needed upper first and second molar distalization for incisor retraction or relieving of the upper arch crowding and minimum or no crowding in lower jaw were selected.
* All Patients had no systemic diseases that may affect bone quality or interfere with orthodontic treatment, periodontal disease and no previous orthodontic treatment.
* Age range was 13 to 17 years.

Exclusion Criteria:

* Missed upper first molar.
* un-cooperative patient
Myocet Plus Endoxan for Older Patients With Breast Cancer

This study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment

Elderly individuals make up a large part of the breast cancer population. When treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Anthracyclines are associated with a cumulative dose-dependent cardiomyopathy with increased rate in patients over the age of 70. Liposomal-encapsulated doxorubicin improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination with cyclophosphamide as first-line therapy for metastatic breast cancer

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic breast adenocarcinoma
* No more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable.
* Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
* Performance status (WHO) 0-2
* Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases)
* Adequate renal function (serum creatinine \<1.5 times the upper normal limit)
* Adequate cardiac function (LVEF within normal limits)
* Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
* No radiation of measurable disease (except brain metastases)
* No progressive brain metastases according to clinical or radiological criteria
* No brain metastases without prior radiation therapy
* Written informed consent

Exclusion Criteria:

* Active infection
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period
* Other invasive malignancy except non-melanoma skin cancer
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women