cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment

That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment in patients with tumors that are moving with respiration like breast or lung cancers. The use of a High Frequency Percussive Ventilation system leads to the cessation of respiratory motions while administering radiotherapy (RT) to tumors which allows a reduction of the amount of irradiated normal tissues and which potentially decrease radiation-induced collateral damages.

Primary objective :

Demonstrate the clinical benefit of the HFPV coupled to thoracic radiotherapy in 2 distinct and frequent clinical situations :

1. Tomotherapy for lung and left breast tumors. The investigators assume that the volume of irradiated healthy tissue will be much less when using HFPV as compared to free breathing during tomotherapy sessions .
2. In comparison with Active Breathing Control (ABC system). The investigators assume that the HFPV will lead to breathing motions cessation the same way as the ABC system, but will abrogate pause times when administrating the radiotherapy. This will shorten the radiotherapy sessions for lung patients treated with stereotaxis and for breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer eligible for tomotherapy or linear accelerator with ABC system
* lung cancer eligible for curative tomotherapy and with a significant breathing movements amplitude
* lung cancer eligible for ablative stereotaxis
* WHO 0 or 1

Exclusion Criteria:

* patients requiring oxygen or not able to lie on the back (dyspnea)
* pulmonary functions altered
* cardiac insufficiency
* patient not able to breathe with the High Frequency Ventilation System
* risk of pneumothorax when experiencing High Frequency Ventilation
Multi-Compression Spot Mammography

In this study, participants, who are scheduled to have a breast biopsy, will have several extra spot mammogram images taken of the suspicious area. These images will be acquired with varying levels of compression. The images will then be analyzed to determine whether the type of lesion (malignant or benign) can be determined from the image data alone. The biopsy results will be used as a gold standard to determine the true malignancy status


Eligibility Criteria:
Inclusion Criteria:

* Women 45 years and older
* Women with suspicious mammography findings requiring a biopsy

Exclusion Criteria:

* Men
* Pregnant women
Prospective Evaluation of Stereotactic Body Radiotherapy for Metastatic Prostate Cancer

The investigators aim to test the safety and feasibility of prostate gland stereotactic body radiotherapy (SBRT) plus best systemic therapy in newly diagnosed metastatic prostate cancer.

The investigators and other investigators have previously documented the safety and efficacy of definitive intent stereotactic body radiotherapy (SBRT) in the treatment of localized prostate cancer.

In the metastatic setting for multiple malignancies, improved survival rates and disease outcomes have been shown with definitive treatment of the primary disease site. This concept of "cytoreductive" surgery or decreasing the primary tumor burden is now considered the standard of care for metastatic colon, ovarian, renal cell, and some breast carcinomas (plus post-surgery irradiation).

With new guidelines and declining rates of PSA screening, the incidence of newly diagnosed metastatic prostate cancer is expected to increase. A recent population-based study has concluded significant improvements in the definitive treatment of the local prostate cancer in the stage IV setting with either radical prostatectomy or conventional prostate radiation treatments/brachytherapy. To our knowledge, one prospective phase II trial is currently accruing patients to best systemic therapy or best systemic therapy (BST) plus definitive treatment with either radical prostatectomy or conventionally fractionated radiation therapy

The investigators hypothesize that the addition of primary disease SBRT to best systemic therapy for newly diagnosed metastatic prostate cancer would be associated with an acceptable safety profile, quality of life, disease progression, and overall survival. The addition of SBRT to best systemic therapy is also expected to be better-received for stage IV patients (with relatively limited prognosis), vs. fully fractionated radiation therapy, brachytherapy, or radical prostatectomy. The above endpoints would initially be tested in a prospective phase II multi-institutional trial and in comparison with historical controls.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed, adenocarcinoma of the prostate
* Clinical Stage T1b - T4, NX-0-1, M1
* Any Gleason score
* PSA\<1000
* ECOG Performance Status 0-2
* No prior prostate radiation or other definitive therapy

Exclusion Criteria:

* Prior prostatectomy or cryotherapy of the prostate
* Prior radiotherapy to the prostate or lower pelvis
* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
* Chemotherapy for a malignancy in the last 5 years
* History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
Lung Ultrasound Assisting Weaning in Difficult-to-wean Patients

Daily lung ultrasound can help weaning from mechanical ventilation in difficult-to-wean adult patients. In this randomized trial, standardized lung ultrasound will be performed daily asssociated with standardized interventions aiming to decrease the total time in mechanical ventilation.

This trial will be performed in two intensive care units (ICUs). After randomization, all patients in the intervention group will undergo daily lung ultrasounds before the next spontaneous breathing trial. The results from the lung ultrasound will indicate specific interventions to facilitate weaning:

* No sign of lung sliding (ultrasound finding suggestive of pleural movement): prompt evaluation for pneumothorax or mainstream intubation will be indicated;
* normal lung ultrasound (ultrasound A profile): the patient will be evaluated for deep vein thrombosis / pulmonary embolism and/or for reversible airway obstruction (e.g. uncontrolled asthma or COPD \[Chronic Obstructive Pulmonary Disease\] exacerbation)- followed by appropriate treatment. If the patient has COPD, non invasive mechanical ventilation must be used as mode of discontinuing mechanical ventilation;
* lung ultrasound shows pulmonary edema (ultrasound B profile): cardiogenic pulmonary edema will be differentiated from acute Respiratory Distress Syndrome (ARDS) - followed by appropriate treatment (e.g. a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial);
* lung ultrasound shows asymmetrical patterns (ultrasound AB profile or Pulmonary Consolidation): the possibility of an uncontrolled infection will be investigated;
* presence of simple pleural effusion: diuretics will be indicated (for a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial) or thoracocentesis at description of the assistant team;
* presence of complex pleural effusion: other image exam will be performed, and will be evaluated by the surgical team.

Eligibility Criteria:
Inclusion Criteria:

* Difficult to Wean;
* 1 failure in the spontaneous breathing trial or 1 extubation failure
* Adult patients (over 18 years old);

Exclusion Criteria:

* Palliative Care;
* Life expectancy under 90 days;
* COPD Gold IV, Cirrhosis Child C, Metastatic Cancer with low performance, etc
* Other weaning method than institutional protocol
Ultrasonographic Muscles and Fascia Measurement With Myofascial Pain Syndrome

Pathologies in the trapezius muscle and rhomboid muscle are important in the course and treatment of the disease in patients with myofascial pain syndrome.

In this study, the role of the thickness of these muscles and the shift during movement in the activity and diagnosis of the disease in myofascial pain syndrome will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* myofascial pain syndrome

Exclusion Criteria:

* Cervical radiculopathy
* Fibromyalgia
* Shoulder joint disease,
* Peripheral and central nervous system disease
* Polyneuropathy,
* Inflammatory rheumatic disease,
* Malignancy
Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients.

: High level of fetal haemoglobin (Hb F) decreases sickle cell anaemia (SCA) severity and leads to improved survival. Butyrate proved to increase HbF production in vivo and in vitro studies. Nonetheless, its short half-life limited its utilization in clinical practice. Gum Arabic (GA) is edible, dried, gummy exudate from Acacia Senegal tree. GA fermentation by colonic bacteria increases serum butyrate concentrations. The investigators hypothesized regular intake of GA will increase serum butyrate level. The latter will induce fetal hemoglobin production and ameliorate patients' symptoms. 47 patients hemoglobin SS aged 5-42 years, on regular follow up in Military hospital were recruited from April 2014 to January 2015 Patients received dose of G A 30g/day for 12 weeks. Hb F, complete blood count and Erythropoietin level were measured. The main outcome of interest was the level of HbF after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. over 5 year old
2. less t5han 50
3. diagnosed with homozygous sickle cell anemia by Hb electrophoresis

Exclusion Criteria:

1. patients received blood transfusion within the last three months or admitted to the hospital within 2 weeks because of Sickle cell anemia -related events or crisis.
A Single Group Study to Evaluate the Efficacy of Bye Bye Bloat Capsules in Relieving Bloating and Promoting Healthy Digestion.

This virtual single-group study aims to evaluate the efficacy of Bye Bye Bloat Capsules in relieving hormonal and food-related bloating and promoting healthy digestion. The study will last 4 weeks, involving 40 female participants aged 18+ who will take two capsules after meals and during times of bloating. Measurements and questionnaires will be completed at Baseline, first use, Week 2, and Week 4.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18+
* Self-reported concerns with bloating after eating
* Issues with hormonal bloating
* Generally healthy without uncontrolled chronic diseases
* Willing to avoid using digestive health remedies and other oral supplements during the study

Exclusion Criteria:

* Pre-existing chronic conditions preventing adherence to the protocol
* Undergoing procedures related to digestive health
* Started new medications or supplements targeting digestive health in the past 3 months
* Severe allergic reactions requiring an Epi-Pen
* Pregnant, breastfeeding, or attempting to conceive
* Unwilling to follow the study protocol
* Recent surgeries or planned surgeries during the study
* Diagnosed gastrointestinal disorders
* Recent changes in hormonal birth control use
Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry

Since psychiatry is still too often confronted with a dichotomy between psyche and soma, the assessment of pain and anxiety at RMI is still rarely done (Willer et al., 1982). The objective of this exploratory study is to evaluate the influence of pharmacological factors (type of injected molecules, injection frequency, injection site, treatment duration, treatment dose, time since last injection) and individual about the pain perceived when injecting antipsychotic therapy (diagnosis, sex, age, weight, duration of illness, level of anxiety, psychiatric and somatic comorbidity, insight). In the future, this study will develop a suitable procedure to limit pain and anxiety during RMI. Taking these dimensions into account will probably allow a better compliance of patients for this type of care, and thus a decrease in the number of relapses in the long term.


Eligibility Criteria:
Inclusion Criteria:

* Patients (Males, Females)
* Over the age of 18
* Hospitalized or outpatient
* Patient affiliated with social security, State Medical Aid (AME)
* With prescription of antipsychotic delay by intramuscular injection
* French language mastered
* Given oral consent to pass the self-assessment scales

Exclusion Criteria:

* Patients on long-term analgesic treatment, daily
* Patients with chronic pain with or without analgesic treatment
* Patient not communicating
* Pregnant woman, parturint and nursing mother
* Person deprived of liberty by judicial or administrative decision
* Minor and person subject to legal protection: guardianship or curatorship
Moderate-dose Cyclophosphamide for Childhood Acquired Aplastic Anemia

Severe aplastic anemia (SAA)is characterized by the depletion of hematopoietic precursors associated with life-threatening complications. High-dose cyclophosphamide has been found to yield a complete response (CR) in adults and children with SAA.However, the optimal dosage of cyclophosphamide for patients in childhood remains unclear. So we explore the ideal dosage of cyclophosphamide for the treatment of children with SAA.

Tisdale et al. (2000,2002) attempted to compare immunosuppression using ATG/CSA with high-dose cyclophosphamide (50 mg/kg/d for 4 consecutive days) plus CSA in a randomized trial of newly diagnosed adults with SAA. Both groups received CSA as part of the treatment regimen. However, the trial was terminated prematurely due to excessive morbidity among the patients treated in the cyclophosphamide arm. They documented that invasive fungal infections were severe among the cyclophosphamide group. Between January 2008 through May 2009, in our department, nine pediatric patients with a diagnosis of SAA were enrolled a study with lower dose of cyclophosphamide with 30mg/kg/day for 4 consecutive days and combination with CSA, this study shows promise for children with severe aplastic anemia.Now we want explore the dosage of cyclophosphamide.

Eligibility Criteria:
Inclusion Criteria:

* Acquired Childhood Severe Aplastic Anemia (SAA)

Exclusion Criteria:

* not Childhood and Acquired Severe Aplastic Anemia
Effectiveness of Flu Vaccination and Burden of Illness Among Community-dwelling Elderly With Influenza Like Illness in Brazil

The purpose of this research study is to estimate how many elderly people who have symptoms that look like influenza (i.e. an influenza-like illness) actually have the disease and how effective influenza vaccines are in preventing influenza in elderly people. The study will also examine the severity of the disease (e.g. how long are people ill, were there any complications) and how it affects everyday life (e.g. cost, medications, care by family members).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female \>= 65 years of age.
* Written informed consent obtained from the subject.
* Presenting within the first 72 hours of an influenza-like illness. Influenza-like illness is defined as the presence of:

  * Fever measured by the patient or physician and at least one of the following symptoms:
  * Sore throat.
  * Coryza (runny nose) and/or nasal congestion.
  * Cough.
* Availability to be followed up by phone or in person after an interval of approximately 14 - 21 days.

Exclusion Criteria:

* Receipt of any experimental influenza vaccine within 6 months of the onset of the influenza-like illness.
* Terminal stage of disease.
* Subjects living in a nursing home.
* Use of any investigational or non-registered product planned during the study period.
* Subjects who have already been enrolled in this study.
Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate

CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis


Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis
* Incomplete response to methotrexate

Exclusion Criteria:

* Must not be on biologic therapies
* No recent infections
Antrum Size, Glucagon-like Peptide 1 Levels and Glycemic Control After Sleeve Gastrectomy in Morbid Obese Diabetic Adolescents

Childhood obesity can adversely affect every organ and often has serious consequences. Compare the effect of transection at 2cm vs at 5cm from the pylorus during laparoscopic sleeve gastrectomy on the postoperative weight loss, glucagon-like peptide 1 levels and the glycemic control in morbid obese diabetic adolescents.

This was a retrospective sub-analysis included 18 type 2 diabetic morbidly obese adolescents of both genders from a larger study (performed on 67 patients between December 2014 and December 2015) conducted at pediatric surgery unit, surgical department, Egypt. They were divided in 2 groups, done by 2 surgeons, group A (8 patients) the first stable line was at 2 cm from the pylorus, and group B (10 patients) at 5 cm from the pylorus.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent, children (more than 12 years or less than 20 years), with BMI of at least 40 kg/m2, or 35 kg/m2 with an associated co-morbidity (e.g. hypertension, diabetes, dyslipidemia, obstructive sleep apnea, left ventricular hypertrophy, nonalcoholic steatohepatitis, orthopedic problems). Those with failure to achieve clinically significant weight loss (10% of baseline body weight) despite strict participation for at least 6 months in a formal weight management program were included in the study.

Exclusion Criteria:

* Adults, children (less than 12 years or more than 20 years) or their family who do not understand risks and benefits of the intervention, adolescents who are not autonomously motivated to consider operation, those have unrealistic expectations for results of the surgical intervention, or their parents, families or patients who cannot strictly comply with the postoperative nutritional recommendations and long-term medical and nutritional monitoring, presence of a medically correctable cause of obesity (relative contraindication), existence of a medical, psychiatric, or cognitive condition as attention deficit hyperkinetic disorders (ADHD) which may impair the ability of patient to assent to surgery or to adhere to postoperative dietary and medication regimen (relative contraindication), illicit substance abuses in preceding year, lactating, pregnant, or plans for pregnancy in upcoming 2 years and patients refuse to participate were excluded.
A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain

To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain


Eligibility Criteria:
Inclusion Criteria

* Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months
* Patients required daily opioid medication to treat their chronic osteoarthritis pain

Exclusion Criteria

* Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain
* History drug or alcohol abuse
* Fibromyalgia
* Patients who have major depression or anxiety
* Women who are pregnant or breast feeding
Cerebral Pharmacodynamic Effects of 5-HT1B Receptor Stimulation

The purpose of this study is to show that PET-MR imaging can be used for obtaining a pharmacodynamic profile of drugs. By using the 5-HT1B receptor as target we also aim to find effect areas and sizes of the 5-HT1B receptor agonist sumatriptan.

Recent technological advances in multimodal imaging have enabled the simultaneous acquisition of magnetic resonance imaging (MRI) and PET data. Whereas functional MRI (fMRI) provides excellent spatio-temporal resolution for localizing changes in brain activity, PET offers high sensitivity and neurochemical specificity. Together, PET and MRI measures have the potential to help clarify the neurochemical basis of changes in fMRI signal induced by selective exogenous ligands or endogenous neurotransmitter.

In the present study we will target the 5-HT1B receptor for which a selective radioligand exist (11C-AZ10419369). The receptor can be stimulated with the agonist sumatriptan, which is used for alleviating migraine attacks. The mechanism of action of sumatriptan is not precisely known and it is unknown to what degree sumatriptan crosses the blood-brain barrier and exerts its effect in the parenchyma. In this study we can determine the blood brain barrier penetration of sumatriptan and thereby evaluate Effect sizes, distribution of signal changes, and correlation between the occupancy at the 5-HT1B receptor in the parenchyma (measured by changes in BPND) and the hemodynamic response (measured by changes in CBF).

Ahead of the main study a pilot study will be conducted in which increasing doses of sumatriptan will be tested in the same subject to obtain a dose-response curve. At the same time side effects will be observed and scored. This serves to find the dose with maximum effect size but minimal side effects, which can then be used in the main study for all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Age 18-60

Exclusion Criteria:

* Primary psychiatric disease (DSM IV Axis I or WHO ICD-10 diagnostic classification).
* Present or former neurological diseases,
* Severe somatic disease
* Medication that can interfere with the test results.
* Doesn't speak Danish fluently or is severely, visually or hearing impaired.
* Information regarding former learning disabilities.
* Pregnancy at the time of the scanning
* Breast feeding
* MR-scanner incompatibility (metal in soft tissue)
* Alcohol or drug abuse
* Allergy to ingredients in used drugs
* Participation in experiments with radioactivity (\>10 mSv) within the last year or considerable work-related exposure to radioactivity.