cyrilzakka/clinical-trials huggingface dataset:
Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement

Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.

Prospective, Double blind, Randomized controlled trial. Male and female subjects, over the age of 18 years. Full thickness rotator cuff tear, requiring surgical repair. Patient undergoes pre- and intra-operative assessment, and once eligibility is confirmed intra-operatively, patient is randomly assigned to receive either a) coblation debridment, or b) mechanical debridement.

Standard post-operative rehab program for all patients. Follow-up occurs at 3, 6, 12, and 24 months post operatively and includes physical exam and patient based outcomes (questionnaires).

Eligibility Criteria:
Inclusion Criteria:

1. The subject has signed the REB approved informed consent form (ICF) specific to this study prior to enrollment
2. The subject has a repairable full thickness rotator cuff tear with an estimated full thickness size \<5cm confirmed with diagnostic MRI in AP or ML dimension and /or ultrasound
3. The subject is independent, ambulatory, and can comply with all post-operative evaluations and visits
4. The subject has persistent pain and functional disability and has failed conservative treatment (e.g. PT, steroid injection, anti-inflammatory) for \> 3 months
5. The subject is at least eighteen (18) years of age and considered to be skeletally mature

Exclusion Criteria:

1. The subject has undergone previous rotator cuff repair surgery to the affected shoulder
2. The subject has a partial thickness rotator cuff tear
3. The subject requires a concomitant labral repair
4. The subject has an irreparable rotator cuff tear
5. The subject is unable or unwilling to undergo MRI scan.
6. The investigator judges the subject unlikely to remain compliant to follow-up.
7. The subject has received an investigational therapy or approved therapy for investigational use within 30 days prior to the surgery
8. The subject is a prisoner, or is known or suspected to be transient
9. The subject's condition represents a worker's compensation case
10. The subject is currently involved in a health-related litigation procedure
11. The subject currently has an acute infection in the area surrounding the surgical site
12. The subject has a major medical illness (life expectancy less than 2 years or unacceptably high operative risk
13. Fatty atrophy \>50% (Goutallier grade 4-5)

INTRA-OPERATIVE EXCLUSIONS:

1. Massive or irreparable rotator cuff tear which cannot be mobilized to the midpoint of the footprint of the rotator cuff on the greater tuberosity
2. Co-existing labral pathology requiring repair with sutures
A Study of Tarceva (Erlotinib) in Combination With Avastin (Bevacizumab) in Patients With Advanced Non-Small Cell Lung Cancer.

This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced (stage IIIb and IV) non-small cell lung cancer;
* measurable disease;
* ECOG PS 0-1.

Exclusion Criteria:

* prior chemotherapy or treatment with another systemic anti-cancer agent;
* radiotherapy within 4 weeks prior to first dose of study treatment;
* CNS metastases;
* other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)

The purpose of this study is to determine the safety and effectiveness of an investigational drug for the treatment of cognitive impairment in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
* Patient has a 6th grade reading level or better and has completed at least 6 years of formal education
* Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout study
* Patient has had a stable living arrangement for at least 3 months prior to study start
* Patient is in general good health based on screening assessments

Exclusion Criteria:

* Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
* Patient has a history of head trauma with loss of consciousness greater than 15 minutes
* Patient has had warfarin treatment, MAO inhibitors, clonazepam, clozapine or St. John's wort within 1 month of screening
* Patient has had ECT treatment within 6 months of screening
* Patient requires treatment with antihistamines or certain other medications listed in the protocol
* Patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within past 5 years
* Patient has a history of alcohol or drug dependence within past year or alcohol or drug abuse within 3 months of screening
Cerebrospinal Fluid Biomarkers of Myotonic Dystrophy

Myotonic dystrophy is associated with central sleep apnea, excessive daytime sleepiness, diminished working memory, impaired visuospatial skills, and deficits in problem-solving skills.

Cerebrospinal fluid (CSF) is a clear, colorless fluid that surrounds and protects the brain.

Changes in the composition of CSF can serve as early indicators of changes in brain activity and function. The purpose of this research is to learn about myotonic dystrophy by examining cerebrospinal fluid and brain activity in participants. The tests will be low risk and are well tolerated. The information that we gather from this study may help us evaluate, prevent, diagnose, treat, and improve our understanding of myotonic dystrophy. Funding Source- FDA OOPD


Eligibility Criteria:
Inclusion Criteria:

* Subjects with DM1 based on genetic testing and/or clinical criteria (some subjects who have positive genetic testing may be asymptomatic, while other subjects who show characteristic clinical features may have declined to have genetic testing done).
* Unaffected subjects are unknown to have myotonic dystropphy or any other muscular dystrophy by history and may have had no genetic testing.
* Clinical indicators of current status, as measured within 30 days of study start: Able to provide informed consent or assent for participation in the study.
* Demographic characteristics (e.g., biologic sex, age): Males and females age 18 years and older.

Exclusion Criteria:

* Medical history of any of the following. State of immunosuppression; pre-existing liver or kidney disease; documented HIV positive; documented hepatitis B and/or C positive.
* Medications and other drugs. Use of anticoagulants within 60 days prior to lumbar puncture and/or blood draw. Use of anti-platelet drugs within 7 days prior to blood draw.
* Contraindications to MRI. The presence of any metal within the body, which would include any medical device containing metal, such as a pacemaker, defibrillator, some heart valves or stents, artificial joint, aneurysm clip, or inner ear device, a history of working with sheet metal, or an injury with metal shrapnel; pregnancy, due to effects of MRI on unborn children.
* Contraindications to Lumbar Puncture. Evidence of increased intracranial pressure or active infection on exam; platelets less than 50,000.
* Other. Inability or unwillingness of the subject to give written informed consent.
Reduced Content of Gluten Diet on Patients With Irritable Bowel Syndrome (Pro.Ali.Fun.)

This study aim to manufacture bread and pasta with an reduced content of gluten and to assess the impact of reducing the daily intake of gluten by 50% in irritable bowel syndrome (IBS) patients. Fungal proteases and selected sourdough lactic acid bacteria will be used for making wheat bread and pasta with a reduced content of gluten (RG) (-50% of traditional products). From a technological point of view, the chemical, structural and sensory features of the RG products approached those of the bread and pasta made with normal level of gluten. The efficacy and safety of new products will be compared to traditional bread and pasta by using a double blind randomized, crossover-controlled trial in IBS patients with persistent gastrointestinal symptoms. Patients will follow two weeks of a GFD diet containing RG bread and pasta and two weeks of GFD diet containing Normal Gluten bread and pasta Symptoms severity will be assessed by Irritable Bowel Syndrome Severity Score (IBS-SS), Visual Analogue Scale (VAS), Hospital Anxiety and Depression Scale (HADS) and Irritable Bowel Syndrome Quality of Life (IBS-QoL).


Eligibility Criteria:
Inclusion Criteria:

1. age above 18 years;
2. having bowel symptoms (altered bowel habit, lower abdominal pain, bloating, or distention suggestive of IBS), as determined by Rome III criteria.
3. Previous exclusion of CD and wheat allergy

Exclusion Criteria:

1. previous GI malignancy and/or surgery;
2. clinically significant cardiovascular, respiratory, endocrine, renal, hematologic or hepatic disease.
3. other clinically significant medical condition; pregnancy or lactation; alcohol abuse; drug addiction; severe neurologic or psychiatric disorders; long-term use of corticosteroids or anti-inflammatory drugs
4. participation in another clinical trial within 6 months before the onset of this trial.

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Comparison Between Interleukin 6 and Procalcitonin in Detecting Sepsis and Incidence of Mortality in Burn ICU Patients

The investigators will compare the efficacy of Interleukin-6 (IL-6) as a better indicator than procalcitonin in burn patients with sepsis or septic shock regarding success of treatment and early ICU discharge.

Interleukin 6 and procalcitonin will be sampled for all patients on days 1, 3, 7, and 10.

Treatment plan will be initiated to all patients according to the burn ICU protocol.

According to the lab results, interleukin 6 and procalcitonin will guide the investigators to take decisions regarding clinical improvement and ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute burn admitted to burn ICU within 24 hours from the burn incidence.
* patients with burn percentage of 25% to 50% of total body surface area
* patients with second to third degree burns
* ASA 1 and ASA 2 patients

Exclusion Criteria:

* Burn percentage more than 50% or less than 25% of total body surface area
* Having autoimmune diseases
* Cancer patients
* ASA 3 and ASA 4 patients
Intraartecular Platelet Rich Plasma for Sacroiliitis

Comparison between the effect of steroids and platelet-rich plasma on low back pain after ultrasound-guided sacroiliac injection to determine any is more effective and of long duration

A prospective randomized controlled study was conducted at the department of anesthesiology Mansoura University Hospital during the period from December 2017 to January 2019 on fifty ASA I-III adult patients, of both sex after approval of IRB (Institutional Review Board) ID number MS17.10.03 \& IRB date 12-11-2017. The patients were randomly allocated into two groups each of 25 patients according to computer-generated random number codes that were placed in sealed envelopes, double blinded, with parallel-group comparison.

Steroid Group (S) (n. 25):- Patients were injected by 4 ml of sterile water containing the methylprednisolone Acetate (Depo-Medrol) per-kg calculated dose (0.5mg/kg up to a lean muscle body weight of 80kg in the painful sacroiliac joint).

Platelet rich plasma Group (P) (n. 25):-Patients received fixed volume of 4 ml platelet-rich plasma in the inflamed painful sacroiliac joint.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients of either sex. 2. ASA I\&III. 3. Age between 18 - 70 years. 4. Chronic lower back pain of sacroiliac origin. 5. Anatomy of the joint can identified by the ultrasonography. Exclusion criteria

  1. Patients with contraindications to sacroiliac injection.
  2. Patients known to be allergic to platelet rich plasma or local anesthetics.
  3. History of immune suppression or immune compromised diseases
  4. Patient below age of 18 as the joint will undergo normal physiological changes.
  5. Patient over 70 years.
  6. Sacroiliac pain of multiple sources.
  7. Preoperative shivering or fever (\>38oc).
  8. Hepatic, renal and heart failure patients.
  9. Patients on; anticoagulants, antiplatelet, and with INR≥1.5.
  10. Exclude corticosteroid injection in the sacroiliac joint at the last three months.
  11. Patient refusal.
Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin

Lung ultrasound (LUS) in combination with a biomarker has not yet been studied. The investigators propose a clinical trial where the primary aims are: 1. To assess whether an algorithm with LUS and procalcitonin (PCT) may be useful for diagnosing bacterial pneumonia; 2. To analyse the sensitivity and specificity of LUS vs chest radiograph (CXR).

Objectives: The general objective is to analyze whether a new algorithm approach of severe pneumonia in pediatric intensive unit (PICU) improves the quality of care. Objectives: 1- To analyze the sensitivity and specificity of lung ultrasound (LUS) compared respect to the chest radiography (CXR) in severe pneumonia and if LUS discriminates between bacterial and viral one. 2- If there is a lower CXR indication. 3- If is possible to reduce the dose of irradiation and costs associated with CXR. 4- To analyze the interobserver agreement of the LUS. 5- determine whether a diagnosis of pneumonia algorithm using LUS and procalcitonin may be useful in directing the indication of antibiotic therapy and / or the duration thereof.

Methodology: clinical, prospective, controlled, randomized, blinded intervention and 3-year trial. Inclusion of children under 18 years, with severe pneumonia, who enter (PICU). Experimental Group 1: pediatrician researcher (PR) will conduct a LUS at admission time, as a first test of lung image; in Group 2, CXR is conduced as first image. Patients will be classified into 3 subgroups, in both branches: a) if PCT is \<1 ng /L and LUS is not suggestive of bacterial pneumonia, no antibiotic will be prescribed; b) if LUS is suggestive of bacterial pneumonia, regardless of the PCT, it will be recommended to start antibiotic therapy; c) If the ultrasound is suggestive of bacterial pneumonia but PCT is\> 1 ng / L, antibiotic therapy will be recommended to cover other causes of infection. The same attitude will be performed, but depending on the CXR instead of the LUS, in group 2. Clinical variables, complementary tests and evolution data will be collected. Statistics by SPPS® 20.0. Informed consent will be requested and the study will be conducted according to the Helsinki Declaration guidelines and Good Clinical Practice.

Eligibility Criteria:
Inclusion Criteria:

* children under 18
* severe pneumonia criteria
* admitted at PICU
* informed consent signed

Exclusion Criteria:

* previous respiratory disease (cystic fibrosis and/or immunosuppression)
* Nosocomial pneumonia development while in charge for community pneumonia.
* Researcher pediatrician has valuated the chest X ray before the PICU admission
* Included in other clinical trial
Prospective Evaluation of a New Approach to Perform an Esophageal Myotomy: the Transesophageal Submucosa Approach

Achalasia is an esophagus motor disability characterized by a lack of relaxation of the lower esophageal sphincter (LES) to deglutition. Myotomy is the gold standard surgical technique allowing to cure this pathology. In this study, investigators are using a new endoluminal technique of myotomy, innovative and less invasive, called POEM (PerOral Endoscopic Myotomy). This technique does not require any cutaneous incision.

Mini-invasive surgery is more and more associated to endoscopy. The practice was initiated by the accession of natural orifice transluminal endoscopic surgery (NOTES). In this context, the introduction of the POEM technique seems to be an original approach and a natural evolution to a new generation of surgical endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Esophagus achalasia
* Confirmed by esophageal manometry
* Requiring surgical care
* No contraindication to general anesthesia
* BMI under 40 kg/m²
* Ability to give an informed consent
* Candidate to elective Heller's myotomy
* Affiliation to a social security system
* Signed and informed consent

Exclusion Criteria:

* Advanced esophageal dilatation (sigmoid megaesophagus)
* Previous mediastinal or esophageal surgery
* Contraindication to esophagogastroduodenoscopy (EGD)
* Contraindication to general anesthesia
* BMI above 40 kg/m²
* Infectious esophagitis (e.g. candidiasis)
* Psychiatric context unsuitable with an experimental protocol
* Allergy to beta-lactam
* Contraindication to endoscopy (esophageal stenosis, suspicion of digestive perforation, state of shock, severe anemia, cardiorespiratory failure or severe metabolic disorders)
* Contraindication to monitored pneumoperitoneum (cardiorespiratory failure or severe metabolic disorders)
* Inability to give an informed consent (emergency situations, misunderstanding...)
* Patient in custody
* Patient under guardianship
* Pregnancy or breastfeeding
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.

Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).

Eligibility Criteria:
Inclusion Criteria:

* Positive clinical history of allergy to Phleum pratense
* Patients of both gender aged from 12 up to 50 years.
* Positive prick test to Phleum pratense allergen extracts
* Specific IgE to Phleum pratense
* Positive clinical history of allergic rhinoconjunctivitis and/or asthma
* Written informed consent.

Exclusion Criteria:

* Use of immunotherapy during the last four years.
* Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
* Treatment with ß-blockers
* Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
* Patients suffering from immune deficiencies
* Patients with serious psychiatric / psychological disturbances
* In addition, the following was considered as exclusion criteria:
* Pregnant or/ in lactation patients
* Patients aspirin intolerance
Study to Investigate the Safety, Tolerability, Biological Effects and Preliminary Pharmacokinetics of Increasing Doses of BIIL 284 BS in Healthy Male Volunteers

The objective of the present study is to obtain information about the safety and tolerability of BIIL 284 BS after repeated dosing, to find the pharmacologically active dose range by determination of the surrogate marker CD 11b (= Mac-1) and to obtain preliminary pharmacokinetic data concerning steady state and accumulation factor


Eligibility Criteria:
Inclusion Criteria:

* All participants are healthy males
* Age range from 21 to 50 years
* Broca-Index: within +- 20% of their normal weight
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give their written informed consent prior to admission to the study

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Volunteers with eosinophilia \> 7 %
* Volunteers who have taken a drug with a long half-life (\>= 24 hours) within at least one month or less than ten half-lives of the respective drug before enrollment in the study
* Volunteers who received any drugs which might influence the results of the trial the week previous to the start of the study
* Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
* Volunteers who smoke
* Volunteers who drink more than 60g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
* Volunteers who have donated blood within the last 4 weeks (\>= 100 mL)
Impact of Bariatric Surgery on Cardiorespiratory Function

Obesity is a growing problem worldwide and its prevention has become one of the leading priorities for the World Health Organisation. Obesity results from chronic imbalance between energy intake and energy expenditure. Although early prevention of obesity is preferable, surgical treatment is often required for severely obese people.

Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight loss following bariatric surgery results in significant improvements in coexisting comorbidities, such as diabetes and hypertension but there is controversy whether bariatric surgery also improves aerobic capacity.

The purpose of this study is to investigate the effects of bariatric surgery on cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric surgery will improve aerobic capacity and result in beneficial lifestyle changes from sedentary to more active.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years to 50 years
* Patients enrolled in the bariatric surgery program of St George's Hospital with BMI \> 40 kg/m2, or 35-40 kg/m2 in the presence of other obesity-related comorbidities such as hypertension or type- 2 diabetes

Exclusion Criteria:

* Locomotor difficulties which would prevent participants from completing the cardiopulmonary exercise testing
* Weight \> 190 kg (due to weight restrictions of equipment used to transfer patients in the event of medical emergencies)
* Cognitive impairment
* Patients unable to follow instructions in English