cyrilzakka/clinical-trials huggingface dataset:
Trial of Steroids in Pediatric Acute Lung Injury/ARDS

Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating disorders associated with lung inflammation, low oxygen levels and respiratory failure in children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000 deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in children. In adult patients, use of steroids early in the course of ARDS appears promising. There are no published clinical trials examining the use of steroids for the treatment of ALI/ARDS in children.

Hypothesis:

Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours) and longer than 7 days will have improved clinical outcomes as compared to placebo control group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly increased PaO2/FiO2 ratios.


Eligibility Criteria:
Inclusion Criteria:

1. Between 1 month and 18 years of age; AND
2. Admitted to the PICU with a diagnosis of ALI or ARDS, as defined by:

   1. acute onset of the disease,
   2. PaO2/FiO2 ratio \<300,
   3. evidence of bilateral infiltrates on chest radiography, and
   4. no evidence of cardiac dysfunction; AND
3. Intubated and mechanically ventilated.

Exclusion Criteria:

1. Underlying disease requiring steroids \>0.5mg/kg/day of methylprednisolone (eg. Asthma)
2. HIV positive, or have any other congenital or acquired immunodeficiency;
3. Terminally ill patients or patients on hospice care or if there is a lack of commitment to aggressive intensive care
4. Cytotoxic therapy within the past 3 weeks
5. Major gastrointestinal bleeding within last 1 month
6. Extensive burns (\>20% total body surface area of full- or partial-thickness burns)
7. Known or suspected adrenal insufficiency
8. Vasculitis or diffuse alveolar hemorrhage
9. Bone marrow or lung transplant
10. Disseminated fungal infections
11. Severe chronic liver disease
12. Other conditions with estimated 6-month mortality of 50% or higher
Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Purpose: The purpose of the study is to investigate if treatment with ciprofloxacin for one week followed by therapy with E. Coli Nissle (EcN) for seven weeks can influence disease activity among ulcerative colitis patients with disease flare-ups compared to placebo controls.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease where existing treatments have proven to result in numerous side effects. An important causal factor for the development of the disease is an autoimmune cellular response against bacteria in the colon.

As a possible treatment, manipulation of the bacterial flora has been studied using the probiotic bacterium Escherichia coli Nissle 1917 (EcN). Studies on UC patients have shown that treatment with EcN is equally good at maintaining remission as the standard treatment with mesalazine. Furthermore, treatment with antibiotics such as ciprofloxacin have been studied for treatment of UC and some, but shortlived, effect has been described.

Patients are randomized to one of four treatment-arms: ciprofloxacin-EcN, ciprofloxacin-placebo, placebo-EcN or placebo-placebo.

Disease activity are quantitated with Colitis Activity Index (CAI) and quality of life by the Inflammatory Bowel Disease Questionnaire (IBDQ). Also, dietary interviews to examine the patients' dietary intake are completed and the patients' fecal-calprotectin-concentrations will be measured.

Hundred subjects with ulcerative colitis will be recruited for the study. Standard medical care and therapies will be continued throughout the study

Eligibility Criteria:
Inclusion Criteria:

* Age, \>/=18 years and diagnosed with ulcerative colitis
* CAI score of \>/=6 (active UC)

Exclusion Criteria:

* Pregnant or breastfeeding females
* Known sensitivity to ciprofloxacin
* Subjects who participate in another clinical trial
* Positive stool sample with any enteric pathogens, parasites or Clostridium difficile
* Treatment with systemic corticosteroids or biologic therapy
Adipose Derived Cells for Chronic Obstructive Pulmonary Disease

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed with chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* A prior diagnosis of moderate or severe COPD
* GOLD III and IV
* Age between 18 and 85 years

Exclusion Criteria:

* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* Severe asthma that would contraindicate surgery
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Patients with Alpha-1
* Unwilling and/or not able to give written informed consent.
Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye

The study aims to test the safety of Repetitive Magnetic Stimulation (RMS) treatment for dry eye disease. Patients are asked to undergo a one-time treatment with Epitech Ocular Magnetic Stimulation Device on one eye in the first stage and both eyes sequentially in the second stage of the study. Changes are monitored for over a study period of 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18-80 years old
2. Subjects with moderate to severe dry eye syndrome
3. Subjects able to understand the requirements of the protocol and provide informed consent.

Exclusion Criteria:

1. Eyes with other ocular surface pathology which requires more treatment than eye lubricant and conventional eyelid hygiene
2. A concurrent ocular disease including ocular infection or pterygium.
3. Ocular surgery within the previous 6 months and LASIK within the previous 1 year.
4. Any ocular injury or ocular Herpes infection within past 3 months
5. Anticipated necessity to wear contact lens in the duration of the study.
6. Unstable thyroid disorders (Drugs Tx not stable in the last 3 months).
7. Alcoholism
8. Pregnant or nursing women
9. Documented HIV positive
10. Cardiac pacemakers, cardioverter defibrillators, or neurostimulators, cochlear implants, implanted medication pumps or intracardiac lines, implanted brain electrodes (cortical or deep-brain electrodes)
11. Any Conductive, ferromagnetic or other magnetic - sensitive objects such as aneurysm clips or coils, stents, bullet fragments in the head or neck
12. Significant heart disease or cerebrovascular disease
13. History of epilepsy, dementia, head trauma, increased intracranial pressure, or central nervous system (CNS) tumors.
14. Participation in another ophthalmic clinical trial within past 30 day
15. Any other specified reason as determined by the clinical investigator.
Sensory Cues for Freezing in Parkinson's Disease

The purpose of this study is (1) to determine if patient triggered sensory(auditory, visual and tactile) cues can help treat freezing of gait in Parkinson's disease, and (2) to assess if unexpected (randomized) cues are more effective than anticipated ones.

Freezing of gait (FOG) is defined as a transient halt in motor activity, wherein the patient appears "as if nailed to the floor." It is a common phenomenon in Parkinson's disease (PD), both when medications are at their peak ("on state") and at their lowest effectiveness ("off state"). While "off" FOG often responds to dopaminergic medications, "on" FOG is a difficult to treat, causing significant distress for the patient, and elevating risk of falls and morbidity.

A few small studies have suggested that auditory and visual sensory cues, in the form of continuous stimuli such as a clicking metronome, music, or horizontal lines drawn the floor, may help patients with gait freezing. In this study, we aim to: (1) evaluate if stimuli (including visual, auditory as well as tactile cues) which are present only on patient triggering are effective for FOG in PD; (2) investigate if presentation of unexpected cues, in the form of randomized sensory stimuli, are more effective that anticipated cues.

Participants will include patients diagnosed with PD, stabilized on drug therapy, with adequate vision, hearing, and mentation to respond to cuing, and experiencing "on" FOG. Patients will be evaluated during a single session. A small device which we have developed will be placed around the neck, and emit either repetitive beeping, a flashing line on the floor, or a slight vibration felt over the neck when the patient presses a button on the front panel in response to FOG. Participants will be videotaped walking a 15 m strip with: (1) no cues; (2) auditory cues only; (3) visual cues only; (4) tactile cues only; and (5) randomized cues. The order in which patients receive the cues will be randomized.

A reviewer will watch the videotape with sound off so that they will be blinded to the cues. The Total Time, Freezing Time (duration of walk in which patient experiences freezing, Walking Time (duration of walk during which patient is not experiencing freezing), and Average Duration of Freeze will be recorded for each walk.

Eligibility Criteria:
Inclusion Criteria:

* Currently living in Melbourne, Australia (note that we cannot respond to enquiries from outside of this area)
* Confirmed diagnosis of Parkinson's disease
* Stabilized drug therapy for at least 1 month prior to the study and during
* Hearing and vision - Able to identify lines on floor, hear metronome
* MMSE \>24
* Able to walk independently (with or without a mechanical aid)
* Able to give informed consent

Exclusion Criteria:

* Severe comorbidity (joint problems, neuromuscular disorder affecting mobility)
* Severe dyskinesias
Ovarian Mesial Incision: a New Safe and Fertility-sparing Technique

The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.


Eligibility Criteria:
Inclusion Criteria:

* reproductive age
* pre-operative findings suggestive for benign tumor
* regular menstrual cycles at least six months before surgery

Exclusion Criteria:

* previous pelvic surgery
* known endocrine disease
* estrogen-progestin use before surgery
Expiratory Flow Limitation Assessment

This study intended to assess the expiratory flow limitation (EFL) during tidal breath in patients intubated in intensive care unit (ICU) for moderate or severe acute respiratory distress syndrome (ARDS). EFL is defined as the lack of increase in expiratory flow in response to an increase in alveolar-to-atmospheric pressure gradient. It reflects airway closure. Early studies have been done using the Negative expiratory pressure (NEP) technique, which is no longer available. We proposed in present study a new method, which consists of diverting manually the expiratory flow to the atmosphere by-passing the expiratory valve. We aimed at assessing EFL at positive expiratory pressure (PEP) 5 cmH2O in semi-recumbent then in supine position together with measurement of trans-pulmonary pressure and regional lung ventilation. Higher PEP levels will be tested, namely 10, 15 and a trans-pulmonary PEP of 3 cmH2O, in semi-recumbent position.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or more in age
* moderate to severe ARDS according to the Berlin definition : Intubated (or tracheotomized) and mechanically ventilated in the ICU
* no pregnancy
* informed consent from the next of kin

Exclusion Criteria:

* Contra-indication to PEP \> 5 cmH2O
* extracorporeal membrane oxygenation (ECMO)
* chest tube
* mean arterial pressure \< 65 mmHg
* Contra-indication to oesophageal device
* underlying disease fatal in less than one year
* active therapy limitation
* under guardian
* refusal to participate
* not affiliated to insurance regimen
* speaking barrier of the next of kin
* investigator not available
Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease

The aim of the study is To compare between the effect of both pelvic floor and Pilates exercises on urinary incontinences in COPD patients.

Urinary incontinence (UI) is defined as loss of bladder control and is characterized by the complaint of any involuntary leakage of urine UI is an important individual and social problem, in that it is associated with worse health-related quality of life (HRQoL) in subjects with chronic obstructive pulmonary disease. Although UI is not a life-threatening condition, it is common and can have numerous negative psychological, social, and economical effects. Women with UI in the general population have higher levels of depression, anxiety and stress, poor sleep quality and significantly lower HRQL Additionally, long term UI may result in absence from work, increased healthcare costs, social isolation and physical inactivity which is common from the early stages of the COPD due to dyspnea. Furthermore, inactivity is associated with risk of hospital admissions and is a strong predictor for mortality. The combination of UI and COPD may therefore result in a double risk factor in terms of exercise avoidance and the subsequent negative consequences of inactivity.

As it could be concluded that urinary incontinence is a trouble problem that can change the life of COPD patients and therapy attempts to prevent it or control it will be appreciated, taking in consideration that all people nowadays prefer to choose the most safe method of their conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COPD \& Urinary incontinence
* Stable with moderate to severe COPD
* Their ages will range from fifty years old.
* All patients will be clinically stable.

Exclusion Criteria:

* Gynecologic surgery ( 6 months prior to study)
* Current urinary tract infection
* Uncontrolled Diabetes Mellitus
* Diagnosed with psychiatric or depressive disorder
* Existing arterial aneurysm.
* Clinical signs of unstable cardiac event (eg, congestive heart failure),
* Severe arterial hypertension,
* Neurological disorders that will affect pelvic floor muscles.
* Acute COPD exacerbation within the last 4 weeks.
* Any need for supplemental oxygen.
Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery

RATIONALE: Palliative therapy with octreotide may help patients who have bowel obstruction that cannot be removed by surgery to live longer and more comfortably.

PURPOSE: Phase II trial to study the effectiveness of octreotide as palliative therapy in treating patients who have cancer-related bowel obstruction that cannot be removed by surgery.

OBJECTIVES:

* Determine the effectiveness of octreotide in the palliation of bowel obstruction secondary to cancer.
* Characterize the dose and tolerability of octreotide in this patient population.

OUTLINE: Patients receive octreotide subcutaneously or IV over 24 hours on days 2-5.

Patients who respond well to study may continue octreotide for palliative effects.

PROJECTED ACCRUAL: A total of 9-25 patients will be accrued for this study over 9 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Inoperable bowel obstruction secondary to cancer OR
* Metastatic or primary abdominal cancer
* Patient presents with vomiting
* Percutaneous gastrostomy tube allowed

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-4

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No documented hypersensitivity to octreotide
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior chemotherapy allowed

Endocrine therapy:

* Concurrent steroids allowed

Radiotherapy:

* Prior radiotherapy allowed

Surgery:

* Not specified
Acute Episodes in Chronic Stable Angina: Assessment of the Use of the Coronary Vasodilator Propatyl Nitrate.

This is an open, self-paired study of 200 patients with heart failure who have a diagnosis of chronic stable angina pectoris, who will be treated for 30 days with propatyl nitrate (10mg) . Treatment regimen is 3 sublingual tablets per day, at 8:00 AM, 2:00 PM, and 8:00 PM. The study will include three visits the patient to the study center: Pretreatment / Assessment 1, Assessment 2 after 15 days of treatment, and the Assessment 3 after 30 days of treatment. At each visit, data will be collected on the medical history, physical examination and vital signs, and evaluation of episodes of angina pectoris, as well as the laboratory evaluation of adverse events and the use of concomitant medications.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic stable angina pectoris
* Female subjects post-menopausal or not pregnant and using of contraceptives
* Signature of Informed consent document

Exclusion Criteria:

* Pregnant women or nursing patients , women of childbearing age
* Hypersensitivity or intolerance to any component of the study drug
* Angina pectoris Class IV, according to the Canadian Society of Cardiology
* Clinical diagnosis of severe anemia , glaucoma, head trauma , increased intracranial pressure, cerebral hemorrhage, acute myocardial infarction, congestive heart failure, aortic valve disease
* Recent infarction (within the last 3 months)
* Recent history (within the last 6 months)of angioplasty
* Use of these medicines within 7 days screening : sildenafil citrate and other inhibitors of phosphodiesterase-5 , adrenergic substances
* Significant alteration of any laboratory test (\> 20% above or below the normal range )
* Gastric or intestinal ulcer or intestinal
* Asthma or chronic rhinitis
* Any other condition which in the opinion of the investigator, shall exclude the study of the patient.
Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma

Study of traumatized patients treated in emergency departments of Tours, seeking to optimize the management of trauma pain in an inpatient setting, with the opportunity to integrate inhaled methoxyflurane (Penthrox®) into the arsenal analgesics useful in the analgesic protocol of the Reception and Orientation Nurse.

Intra-hospital, the prevalence of pain is major; this is variable depending on the studies, but permanently above 60%. A study conducted in 2015 in Tours Adult Emergencies showed a prevalence of pain of 66.5% with an average waiting time of 2h28 before receiving an analgesic.

The pain management protocol at the Tours emergency department includes paracetamol for a numerical evaluation scale (EN) \< 3 and tramadol for an EN between 4 and 6. But these therapies have a delay of action too long or are given too late. An improvement in the management of pain in emergency is therefore necessary.

Methoxyflurane (Penthrox®) is a volatile fluoridated analgesic; it offers several benefits: fast over a long period, well tolerated, effective and without interference with other drugs. Despite a misuse in the 70s, it has been used for more than 20 years in Australia and New Zealand. It was granted marketing authorization in 2016 and has been marketed in France since 2017.

It should be noted that this analgesic treatment is already adopted in several hospitals in the region and also in the SAMU 37.

A similar study was conducted in Grenoble but on a different population. The investigators plan to highlight the interest of Penthrox® in the management of monotraumatic pains in the Adult Emergencies of Tours with the intention of modifying the antalgic protocol accordingly to the reception of emergencies.

Eligibility Criteria:
Inclusion Criteria:

* Conscious patient
* Age ≥ 18 years
* Acute pain of monotraumatic origin
* Pain \> 4 on a visual numerical scale

Exclusion Criteria:

* State of shock with unstable hemodynamics (PA \<90/60)
* Suspected or proven trauma to the chest, abdomen or pelvis
* Serious head trauma
* Consciousness disorder with Glasgow score \<15
* Patient who has already received analgesics (with the exception of paracetamol)
* Patient receiving an intravenous approach for analgesia
* Renal or hepatic disorders known
* Hypersensitivity to fluoridated anesthetics or history of malignant hyperthermia in the patient or family
* Pregnant or nursing woman
* Patient under judicial protection
* Non communicating patient or with difficulties of understanding

Exclusion Criteria:

* Intravenous injection for analgesia
A Phase 1 Study of AMG 211 in Participants With Advanced Gastrointestinal Cancer

The purpose of this Phase 1 study is to determine if AMG 211 given as a continous intravenous (IV) infusion is safe and tolerable in adult participants that have advanced gastrointestinal adenocarcinoma. The study will be conducted in multiple sites and test increasing doses of AMG 211. The safety of participants will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests. Efficacy will be assessed by the usual imaging procedures and their interpretation.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent provided
* 18 years or older
* Advanced relapsed/refracted gastrointestinal adenocarcinoma
* At least 1 measurable tumor lesion
* Tumor tissue available or is willing to undergo biopsy of a tumor lesion before the start of treatment
* Adequate hematological, renal, and liver function
* Body weight ≥ 45 kg
* Other inclusion criteria may apply

Exclusion Criteria:

* Malignancy other than gastrointestinal (GI) adenocarcinoma requiring current therapy
* Evidence of uncontrolled systemic disease, active infection, Hepatitis B and/or C, human immunodeficiency virus (HIV), history of cardiac disease, history of significant central nervous system (CNS) disease, history of chronic autoimmune disease (with the exception of stable type 1 diabetes)
* Major surgery within 28 days of study day 1
* Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment in another investigational device or drug study. Other investigational procedures while participating in this study are excluded. Exception to this criterion is the participation in the optional Imaging Study and all procedures related to this study.
* Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for cancer within 14 days prior to study entry and not recovered from treatment
* Unresolved toxicities from prior anti-tumor therapy
* Males or Females of reproductive potential, and unwilling to practice an acceptable method of effective birth control while on study through 30 days after receiving the last dose of study drug
* Females who are pregnant, planning to become pregnant, lactating/breastfeeding or who plan to breastfeed while on study through 30 days after receiving the last dose of study drug
* Other exclusion criteria may apply