cyrilzakka/clinical-trials huggingface dataset:
Probiotic Intervention With Elderly Subjects

The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.

The study objective is to evaluate the effect of a probiotic Lactobacillus strain in lowering the levels of Clostridium difficile in the intestine of elderly subjects. In addition, the nutritional and general health status will be assessed using validated health related questionnaires. Bowel function and prevalence of infections will be followed throughout the intervention period. The study population consists of elderly home inhabitants. The study will be conducted as a double-blind placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* elderly subjects
* no acute infection at recruitment

Exclusion Criteria:

* antibiotic treatment 1 month prior to beginning of study
* less than 6 month life expectancy
Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
* 18 to 85 years of age (inclusive)
* If female, and of child-bearing potential, is using an acceptable form of birth control.
* Negative serum pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
* Subjects with inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
* Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days.
* Subjects with uncontrolled hypertension.
* Subjects taking antibiotics within 7 days of colonoscopy.
* Subjects with severe renal, hepatic or cardiac insufficiency.
* Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.
* Subjects undergoing insulin therapy for any indication.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects undergoing colonoscopy for foreign body removal and/or decompression.
* Subjects taking tricyclic antidepressants.
* Subjects using drugs of abuse, including abused prescription medications.
* Subjects who are withdrawing from alcohol or benzodiazepines.
Reduction of Antibiotic Therapy by Biomakers in Patients With CAP Episodes (REDUCE Study)

The purpose of this study is to evaluate two different treatment strategies in patients admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be effective in reducing the length of antibiotic treatment.


Eligibility Criteria:
Inclusion Criteria:

Male and female patients with a diagnosis of CAP and all criteria listed below:

1. Age 18 or above, no upper age limit will be employed.
2. Patients must require hospitalisation.
3. Clinical presentation of an acute illness with one or more of the following symptoms:

   1. Temperature ≥ 38.0 ⁰C (100.4°F)
   2. Dyspnoea
   3. Cough (with or without expectoration of sputum)
   4. Chest pain
   5. Malaise or fatigue
   6. Myalgia
   7. Gastro-intestinal symptoms
   8. Rales, rhonchi or wheezing
   9. Egophony or bronchial breath sounds
4. New consolidation(s) on the chest radiograph.
5. Written informed consent obtained.
6. (Pre-event) Life expectancy \> 30 days

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. (Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants).
2. Active neoplastic disease.
3. Obstruction pneumonia (e.g. from lung cancer).
4. Aspiration pneumonia.
5. Pneumonia that developed within 8 days after hospital discharge.
6. Unable and/or unlikely to comprehend and/or follow the protocol.
7. Pregnant and/or lactating women.
8. Other infection that requires treatment with antibiotics
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics

This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.


Eligibility Criteria:
Inclusion Criteria:

* Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening
* Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
* Ability to perform spirometry
* Demonstrate 12% airways reversibility

Exclusion Criteria:

* Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
* Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases
The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age (either gender and any race);
* Reported history of dry eye for at least 6 months prior to Visit 1;
* Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
* Eye drop use within 2 hours of Visit 1;
* Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1;
* Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;
* Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
* Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1
Extracorporeal Membrane Oxygenation (ECMO): Blood Cells

The objective of the study is to predict outcomes of patients on extracorporeal membrane oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to clinical outcomes using data collected in the ECMO Registry at Spectrum Health.


Eligibility Criteria:
ECMO group:

Inclusion Criteria:

* Greater than or equal to 18 years of age
* Subject presents to the CTICU at Butterworth Campus, Spectrum Health and is critically ill in the ICU needing ECMO therapy.

Exclusion Criteria:

* Subject is less than 18 years of age
* Known prisoner

Control Subjects:

Inclusion Criteria

* Greater than 18 years of age
* Without any known cardiovascular, lung, or autoimmune disease.

Exclusion Criteria:

* Less than or equal to 18 years of age
* Known cardiovascular, lung, or autoimmune disease
Phase II Study of Pallidotomy for Parkinson Disease

OBJECTIVES:

I. Evaluate the safety and efficacy of pallidotomy immediately following 3 preoperative assessments vs. delayed pallidotomy following 6 months of standard medical therapy in patients with Parkinson disease.

PROTOCOL OUTLINE: This is a randomized study. One group of patients undergoes the surgical procedure pallidotomy, a precise lesioning of brain cells in the globus pallidus.

The other group receives standard medical care for 6 months followed by a pallidotomy.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Idiopathic Parkinson disease Hoehn and Yahr stage III or worse during "off" periods

Responsive to levodopa by history or exam Sub-optimal clinical response to maximal medication Medication optimized for at least 4 weeks prior to entry

No atypical or secondary disease, e.g.:

* No history of cerebrovascular accident
* No cerebellar involvement
* No severe brain atrophy on magnetic resonance imaging

No Mattis Dementia Rating Scale score less than 116

No dementia meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria

No Hamilton Depression Rating Scale score greater than 10

No Hamilton Anxiety Scale score greater than 14

--Patient Characteristics--

Other: No medical contraindication to surgery, e.g.:

* Diabetes
* Cardiopulmonary disease
Development of a Screening Tool for Difficult Embryo Transfers

This study aims to investigate the accuracy of a proposed screening tool in identifying difficult embryo transfers (ETs) without doing a mock ET.

So far there has never been a screening tool to identify difficult ETs without doing a mock ET. This is a prospective, longitudinal study including at least 200 ETs. All women undergo a speculum examination at the time of transvaginal oocyte pick-up (OPU), the screening questionnaire will be filled by the Physician doing the OPU procedure. On the day of real ET, the Physician doing the ET will be blinded for the screening result, and fill a second questionnaire after the ET. Combined with the Embryologist recorded parameters, this second questionnaire will be used to categorize ETs as difficult or normal. Participants will NOT undergo any procedures beyond their routine treatment. Once the targeted number of participants are recruited, the questionnaires will be matched to see the accuracy of the screening questionnaire to identify difficult ETs.

Identification of difficult ETs with a non-invasive, free of cost questionnaire can enable selective mock transfers and facilitate the real ET for patients, who would otherwise be only recognized on the day of real ET, after their embryos have been already thawed for transfer.

Eligibility Criteria:
Inclusion Criteria:

* All women undergoing an ET is eligible.

Exclusion Criteria:

* No exclusion criteria, women can participate with multiple ET procedures.
A Trial of Adding Lung Protective Strategies to Existing Enhanced Recovery After Surgery (ERAS) Protocols and Its Effects on Improving Post-Operative Lung Function

The objective of this study is to determine whether the addition of lung protective strategies to existing enhanced recovery after surgery (ERAS) protocols for colorectal surgeries and hepatobiliary surgeries will improve post-operative lung function.


Eligibility Criteria:
Inclusion Criteria:

* All subjects going for scheduled colorectal or hepatobiliary surgery at the MUSC ART hospital who would normally be utilizing the existing ERAS protocols
* English speaking
* Able to give informed consent
* Ages 18 years and older

Exclusion Criteria:

* Emergency cases
* Pregnant subjects-confirmed by pre-operative urine pregnancy test
* Subjects with unique lung pathologies including, but not limited to: advanced pulmonary fibrosis, lung transplantation recipients, end stage COPD, pulmonary Hypertension
* Subjects on home O2
Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis

Patients with portal vein thrombosis, who have chronic liver diseases especially liver cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06 or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis.

The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and 21 days after administration in comparison with the placebo group.


Eligibility Criteria:
Inclusion Criteria:

Inpatients or outpatients meet the criteria (1)-(4) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.

1. Patients who the serum level of AT-III is 70% or less
2. Patients with portal vein thrombosis detected by ultrasonography
3. Patients who have more than 50% of the thrombus lumen occupancy
4. Patients who are older than 20 years at the time of consent

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study beforehand.

1. Patients with tumor embolus in portal vein
2. Patients with an ongoing hepatic intra-arterial chemotherapy such as implantable reservoir system
3. Patients with hepatocellular cancer of more than 3 cm in diameter or more than four hepatocellular cancers
4. Patients with residual or chronic portal vein thrombosis
5. Patients with advanced liver disease (Child-Pugh score 11 or more)
6. Patients with bleeding tendency
7. Patients who had an anticoagulation therapy (intravenous or subcutaneous dose) or hemostasis with an enzymatic hemostatic agent in the period between 7 days before contrast enhanced CT of pre-dose and the day acquired written informed consent
8. Patients who had an anticoagulation therapy (oral dose) in the period between 7 days before contrast enhanced CT of pre-dose and the day acquired written informed consent
9. Patients with a history of shock or hypersensitivity to NPB-06
10. Patients with inappropriate to contrast agents

    * A history of allergy of iodine or X-ray contrast agent
    * Complication of serious thyroid disease
    * Reduced renal function
11. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
12. Patients who have received NPB-06
13. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
14. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance

study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment

This is a prospective clinical trial conducted on 20 preterm neonates \< 37 weeks of gestation, admitted in NICU, maternity hospital, Ain Shams University. They were assessed for gastroesophageal reflux disease and investigated using ph-MII for detection of reflux episodes and they were given Smecta 3gm/day for 7 days at least as a food thickener and then ph-MII repeated to assess the response

Eligibility Criteria:
Inclusion Criteria:

* • Newborns free of any congenital anomalies or inborn errors of metabolism

  * Infants had signs of reflux like:

    1. Typical or atypical crying and/or irritability
    2. Apparent life-threatening event
    3. Poor appetite; weight loss or poor growth (failure to thrive)
    4. Vomiting
    5. Bronchopulmonary dysplasia
    6. Wheezing, stridor
    7. Recurrent pneumonitis
    8. Sandifer syndrome (ie, posturing with opisthotonus or torticollis)

Exclusion Criteria:

* • Newborns with GIT anomalies as trans-esophageal fistula, hiatus hernia and other GIT anomalies causing reflux.

  * Patients with Hirshsprung disease or delayed passage of meconium.
  * History of NEC in the baby.
A Phase II Study of Adjuvant Use of Anti-Epidermal Growth Factor Receptor EGFR-425 in High Grade Gliomas

Data from the wistar institute indicated that this anti-body labeled with iodine-125 would localized in the tumor cells of high grade gliomas of the brain. the project combines surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase II trial in this disease entity.

This is an open-label Phase II study of postoperative radiation therapy followed by Iodine-125 radiolabeled anti-epidermal-growth-factor-receptor monoclonal antibody (125I-MAB 425) derived from cell cultures for high grade malignant gliomas. Each subject will receive postoperative radiation therapy followed by 6.4 mg of 50 mCi labeled 125I-MAB 425 by injection. This dosing regimen will be given three times generally within a two-week period (days one, eight and 15 of therapy) for a total dose of 19.2 mg of 150 mCi labeled 125I-MAB 425 for each course of therapy. The main objective of this study is to determine if the addition of 125I-MAB 425 to postoperative radiotherapy, with or without change, prolongs absolute survival compared to historical control (postoperative radiation therapy alone) in subjects with histologically proven high grade gliomas. The primary efficacy variable is absolute survival and the secondary target variable will be time to progression of the tumor. Multiple courses will be considered based on the subject's clinical status.

Eligibility Criteria:
Inclusion Criteria:

* all cases above 18 years of age

Exclusion Criteria:
Dietary Intake Modifications to Protect Against Changes in Bone Metabolism

Bone loss is not only a well-documented effect of spaceflight on astronauts, but also a condition that affects millions of men and women on Earth each year. Many countermeasures to bone loss have been proposed, and many have been evaluated to some degree. To date, those showing potential have focused on either exercise or pharmacological interventions, but none have targeted dietary intake alone as a factor to predict or minimize bone loss during spaceflight. The investigators proposed to document how the ratio of acid precursors to base precursors in the diet is related to directional changes in markers of bone resorption and formation during flight and recovery from flight. There is a high likelihood for success in predicting the extent of bone loss from dietary intake patterns of astronauts during spaceflight, given that this concept is strongly anchored in data obtained from ground-based experiments in our laboratory and others. The notion of manipulating diet to minimize bone loss could also have significant social and economic impacts for NASA and for the general public - especially given the increasing trends for diets that are high in animal protein and low in fruits and vegetables. The results of the proposed experiments will lead to development of a dietary countermeasure for bone loss consisting of a balanced diet with no associated risks for side effects that might be present with pharmaceuticals or supplements, no requirement for payload mass, and no additional crew time necessary during flight.


Eligibility Criteria:
Inclusion Criteria:

* Astronauts flying on long-duration (3-6 months) spaceflights

Exclusion Criteria:

* Non-astronauts
Accuracy of Pulp Sensibility Test on Teeth With Deep Periodontal Pocket

The aim of this study is to evaluate the accuracy of pulp test in teeth presenting with deep periodontal pocket. The null hypothesis is no significant effect of periodontitis on the accuracy of pulp test.

The aim of this study is to evaluate the accuracy of pulp test in teeth presenting with deep periodontal pocket.

All patients who need root canal treatment would be screened to determine the periodontal condition for possible involvement in this study. They would be grouped into two groups, normal and periodontitis Group.

Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice and electric pulp tester (EPT). Similar or adjacent teeth with no caries, restorations, or a history of the previous injury will be used as controls for that patient.

Upon accessing the tooth, no bleeding was counted as necrotic and any presence of blood was counted as a vital pulp

Eligibility Criteria:
Inclusion Criteria:

* Patients from 18 to 40 years old.
* Periodontitis grade II, III and IV
* Non-traumatized teeth.
* No prior non-surgical root canal treatment (NS RCT).

Exclusion Criteria:

* Periodontitis grade I.
* Patients with medically compromising conditions (ASA III and above).
* Trauma within the last six months.
* Partially necrotic pulps.
* Previously endodontically treated or initiation of treatment will be excluded.
Prevalence and Characteristics of Intimate Partner Violence Against Individuals Seeking Hematological Consultations

Intimate violence against individuals, which is particularly marked among women, is one of the most widespread human rights violations in the world.

The Women Abuse Screening Tool (WAST) self-questionnaire is a screening tool validated in French.

Our preliminary data describing the association between intimate violence against women and the first attack of unexplained venous thromboembolic disease, show a significant frequency of positive responses to the WAST among women attending a biological hematology consultation at the CHU de Nîmes, for reasons of hemostasis disorders (8% out of the first 200 cases).

The study authors wish to establish the prevalence of this situation among patients presenting to the CHU de Nîmes for hematological exploration and management. They hypothesize that the prevalence of violence against individuals seen in Hematology consultations is higher among individuals with hemostasis pathologies (hemorrhagic and thrombotic pathologies) than those with cellular pathologies, and higher among women than men.


Eligibility Criteria:
Inclusion Criteria:

* Currently in a relationship or has been in one in the last 12 months, regardless of the length of the relationship
* Willing to complete the anonymous WAST self-questionnaire
* able to read and understand French
* Outpatient consultant at Nîmes University Hospital in one of the following departments:

  * Biological hematology consultation
  * Clinical hematology consultation
  * Vascular medicine consultation

Exclusion Criteria:

* Individuals under court protection, guardianship or curatorship
* Individuals unable to read and understand French
* Individuals who have already completed the WAST questionnaire during the study period
* Individuals unable to get away from their partner during the consultation to complete the questionnaire in isolation