cyrilzakka/clinical-trials huggingface dataset:
Addition of Lactobacillus to Metronidazole in Treatment of CDAD

The purpose of this study is to determine whether dietary supplementation with Lactobacillus GG will reduce the rate of failure or relapse following treatment of CDAD with metronidazole.

Clostridium difficile associated disease (CDAD), which nearly always follows antibiotic therapy, has become increasingly common and important in American hospitals, causing substantial morbidity and mortality. Metronidazole is the recommended treatment for this condition. We have recently reported (Clin Infect Dis, June 2005) that treatment with metronidazole is associated with a 22% rate of failure and 28% rate of relapse. No other medication has been shown to be more effective. There is a substantial theory and some limited data to suggest that dietary supplementation with non-pathogenic normal bowel bacteria will benefit these patients. Lactobacillus GG is the best-standardized and the most extensively studied of these agents.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together with a positive fecal assay for Clostridium difficile toxin

Exclusion Criteria:

* Patients who are unable to take oral medications and those with underlying gastrointestinal disease or colonostomy will be excluded.
* Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines will be excluded because these drugs are active against Lactobacillus.
Smoking Cessation for Hospital Employees With Low Education.

The aim of this trial is to develop a new tailored smoking cessation program for smokers with low education. Smokers are involved in design of the intervention. The effect of the intervention is then tested in a randomised controlled trial. Half of workplaces will be offered the intervention and the other half will be control group, not receiving any offer.

The target group of this trial is smokers with low education working in hospitals in the Capital Region of Denmark.

The aim is to develop a new tailored smoking cessation program for and together with smokers with low education. We selected following seven positions/occupations as proxy for low socioeconomic status: cleaner, porter, kitchen staff, social and health care assistant, service assistant, technical staff and medial secretary.

In first step the investigators perform focus group interviews with the target group to identify wishes and barriers. In next step the investigators design the new tailored smoking cessation program together with smokers with low education.

Then the investigators test the effect of the smoking cessation program in a randomised controlled trial. All hospitals in the Capital Region of Denmark except one are included (the last hospital is situated on a remote island). Half of the hospitals are randomised to be intervention group and the other half is control group. Recruitment will be by written invitations, posters and primarily by peer-recruitment (smokers with low education who are ambassadors for the project at the work places). Posters and written invitations show photos of the ambassadors in the target group and their statements; why they have decided to quit smoking.

The group-based smoking cessation intervention is designed with guidance from the anchor persons. There is no moralizing or disease-focusing, few written materials and a lot of drawings and humor. The intervention will be in small groups (4-6 persons), with six sessions (á 1½-2 hours) taking place at the workplace during working time. All counsellors are ex-smokers. Stress-management is included at each session. We offer free nicotine products or varenicline by choice, for up to 12 weeks. Nicotine replacement therapy is always based on the patch and combined with inhaler or mouth spray p.n. Nicotine gum is not offered.

The investigators measure validated abstinence rates at each session and 6 months after last session.

Main end-point is smoking rates after 12 months in intervention hospitals compared with smoking rates in control hospitals.

Eligibility Criteria:
Inclusion Criteria: employee with low education working in an intervention hospital in the Capital Region of Denmark.

We selected following seven positions/occupations as proxy for low socioeconomic status: cleaner, porter, kitchen staff, social and health care assistant, service assistant, technical staff and medial secretary.

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Exclusion Criteria:

* does not speak Danish
Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars

In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® VOLUME, and then will return for follow-up assessments 2, 4, 24, and 36 weeks after the treatment. A touch-up treatment may be done 2 weeks after the treatment if deemed appropriate by the Investigator.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Presence of a defect, which in the opinion of the Investigator can be corrected by a dermal filler, and is caused by: ° Facial lipoatrophy of moderate severity, or

  * Morphological asymmetry of the face, or
  * One or more debilitating scars on the face
* Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation
* Willingness to take part in the clinical investigation as evidenced by a personally signed informed consent.

Exclusion Criteria:

* Pregnancy, breastfeeding, or unwillingness to use contraception throughout the clinical investigation (for women of child-bearing potential only)
* History of allergic reaction or hypersensitivity to hyaluronic acid
* History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
* Presence of silicone implant or other non-absorbable tissue filler in the area targeted for intervention, or pre-treatment with any hyaluronic acid filler within the last six months
* Presence of infectious, inflammatory, or proliferative lesions in the area targeted for intervention
* Treatment with anticoagulant or antiplatelet drugs
* Any disease or condition which, in the Investigator's opinion, represents a safety risk for participation in the study
* Current participation in another clinical trial, or previous treatment with any investigational drug/device within 30 days prior to enrolment
* Institutionalized persons with legally limited civil rights
Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients

The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving standard care for the treatment of skin rash.

Of the 100 subjects who will participate in this study, 50 will be in the extensive treatment group and 50 will be in the standard care group. Subjects in the extensive treatment group will use Doxycycline capsule, 100 mg, taken twice daily, sunscreen SPF 30 or higher, moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen, hydrocortisone 1% cream applied to the face, hands, feet, neck, back, and chest each evening.

Subjects will start taking the capsule and applying the creams three days prior to beginning cetuximab therapy. They will continue this regimen of taking the capsule and applying the creams for 8 weeks. If they develop severe skin rash as a result of cetuximab therapy, the study doctor may decide to reduce the amount of the dose of cetuximab that they receive or prescribe other medicines according to standard treatment recommendations, just as he/she would if the subject was not participating in this study. Subjects will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.

The standard care group will not receive preventive treatment, but they will be allowed to use sunscreen and moisturizer if desired. They, too, will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.

If a subject is assigned to this group and they develop a severe skin rash, the study doctor will treat their rash according to standard treatment recommendations, which may include Hydrocortisone 1% cream, Doxycycline capsules or other medications.

There will be a follow-Up period for both extensive treatment and standard care groups. At 6 months, 12 months, 18 months and 24 months, after the end of the subject's 8 week study treatment period, they will be contacted by telephone or discussed during their routine clinic visit.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Diagnosis of colorectal or head and neck cancer
3. Receipt of at least one dose of cetuximab during the study time period

Exclusion Criteria:

1. Prior cetuximab treatment within the 6 months of study initiation
2. Current treatment with tyrosine kinase inhibitors
3. Patients who are pregnant or incarcerated
Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer

The results of previous studies suggest further development of \[18F\]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of \[18F\]EF5 intratumor distribution using repeated pretreatment PET/CT scans.

All patients will undergo normal diagnostic and staging procedures, including a conventional 18F-FDG PET/CT scan for the purpose of RT or surgical planning. In addition to that, an 18F-EF5 PET/CT scan will be performed on a separate day. The patients receive intravenous injection of 250-350 MBq of \[18F\]EF5. After that, a venous blood sample will be obtained for measurement of plasma radioactivity. A low-dose CT (helical) will be performed for attenuation correction and anatomical reference. After that, a PET scan will be performed (starting at 3 h after injection). The second 18F-EF5 scan will be performed in a similar way 4-7 days after the first scan. A representative histologic sample of primary tumor is pre-condition for study and an effort is made to store part of fresh histologic material in liquid nitrogen for later use in immunohistochemical analysis.

Patients are scheduled to undergo preoperative or definitive chemoradiotherapy using current clinical standards after completion of the current protocol. Follow-up information (event-free survival and overall survival) will be gathered.

Eligibility Criteria:
Inclusion Criteria:

* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
* Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck
* Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm
* Patients with nodal neck metastases of head and neck cancer are eligible
* Mental status: Patients must be able to understand the meaning of the study
* The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
* Patient, if female, must not be pregnant or lactating at the time of the study

Exclusion Criteria:

* Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease.
* Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer.
* Patient must not have an uncontrolled serious infection
* Patients with organ metastases in liver, bone, brain or lung.
An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.

The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma detection of head trauma patients


Eligibility Criteria:
Inclusion Criteria:

The patients within 12 hours after head injury, visiting the Emergency Department of the National Taiwan University Hospital, and receiving computed tomography of head were enrolled.

Exclusion Criteria:

1. The patients over 12 hours after head injury, visiting the Emergency Department of the NTUH, and receiving computed tomography of head were excluded.
2. Patients with massive scalp laceration or hematoma were excluded. -
Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

The purpose of this study is to evaluate blood clots after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and inflammation;comparation of the effect and safety between different anticoagulation after Percutaneous ASD Repair; explore propose an optimal anticoagulation plan.

Atrial septal defect (ASD) is a common clinical congenital heart disease. It is estimated that the congenital heart disease increase in children by about 15 million annual in China , of which ASD accounted for 10% to 15%. Secundum ASD is the most common clinical type of ASD, of which about 70% is suited to tanscatheter close.With the cardiac catheterization advancing and the devices developing in recent years ,the method has gradually replaced open-chest surgical repair to the person with Secundum ASD. At present, the most widely used device is Amplatzer occluder. With the wide ues of the occlur,there has gradually emerged occluder thrombosis after closure.there are much different methods to antiplatelet and anticoagulation，not only in China but also in the world.so we perfom the study to evaluating the blood clotting after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and inflammation;comparation of the effect and safety between different anticoagulation after Percutaneous ASD Repair; explore propose an optimal anticoagulation plan.

Eligibility Criteria:
Inclusion Criteria:

* Age≥3 years
* Diameter of defect≥5mm and increasing volume load of right heart
* ≤36 mm secondary left to right shunt
* The distance between defective edge and coronaria venosus sinus, inferior caval vein, superior vena and pulmonary vein≥ 5 mm, between artrial-ventricular valve≥7 mm
* The diameter of defect\>Occluder
* No other cardiac anomalies need surgery intervention

Exclusion Criteria:

* Hypertension
* Coronary artery disease
* Diabetes
* Atrial fibrillation and oral contraceptive medication
* Aspro, clopidogrel and warfarin in 2 weeks.
Single Dose Enteral Tranexamic Acid in Critically Ill Patients

The premise of this study is that enteral tranexamic acid will help to maintain small bowel integrity, which is often compromised by critical illness due to inadequate cardiovascular perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease morbidity in critically ill patients.

The primary objective of this study is to provide preliminary efficacy and safety data on the enteral administration of a one-time dose of tranexamic acid to critically ill patients for the reduction of morbidity at 28 days after enrollment in the study.

Secondary objectives of this study are to determine the efficacy of administration of enteral tranexamic acid in reducing intensive care unit (ICU) and hospital length-of-stay, as well and mortality and morbidity at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients admitted to ICU within 48 hours of onset of illness
* Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)

Exclusion Criteria:

* primary admitting diagnosis of cancer
* primary admitting diagnosis of acute congestive heart failure
* primary admitting diagnosis of chronic obstructive pulmonary disease (COPD)
* primary admitting diagnosis of acute myocardial infarction or unstable cardiac arrythmia
* primary admitting diagnosis of amyotrophic lateral sclerosis (ALS) or other non-infectious disease
* primary admitting diagnosis of post-operative neurosurgical procedure
* known hypersensitivity to tranexamic acid
* acquired disturbances of color vision
* hematuria cause by disease of the renal parenchyma
* active thromboembolic disease such as deep venous thrombosis or pulmonary embolism
* patients with known clotting disorders or other known bleeding disorders
* recent (within 3 months) or active cerebrovascular bleed
* pregnancy
* inability to take study medicine (i.e., ileus with \> 500ml stomach residuals, NPO status)
* patients excluded at the discretion of the treating physician
A Dietary Supplement Examined for Anti-ageing Effects

dietary supplement for healthy ageing


Eligibility Criteria:
Inclusion Criteria: Healthy Adults -

Exclusion Criteria: Diseases deemed to be unable to participate in the study

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Evaluation of the Safety and Effectiveness of Aceclidine/Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia

To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.


Eligibility Criteria:
Inclusion Criteria:

Subjects MUST:

1. Be able and willing to provide written informed consent and sign Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
2. Be able and willing to follow all instructions and attend study visits;
3. Be 45-75 years of age of either sex and any race or ethnicity at Visit 1;
4. Have +1.00 to -4.00 diopter (D) of sphere (so that SE results in myopia no more severe than -4.00 SE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
5. Have up to 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
6. Be presbyopic as determined at Visit 1

Exclusion Criteria:

Subjects must NOT:

1. Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy;
2. Have known contraindications or sensitivity to the use of any of the study medications(s) or their components;
3. Have an active ocular infection at Visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
4. Have moderate or severe dry eye determined by total corneal fluorescein staining at Visit 1;
5. Have clinically significant abnormal lens findings (e.g., cataract) including early lens changes and/or any evidence of a media opacity in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1;
Exploratory/Proof of Principle Microbiota Study

This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Eligibility Criteria:
Inclusion Criteria:

* Singleton, 1-7 days of age at registration or randomization
* Term infant with appropriate birth weight for gestational age
* Either solely formula fed or exclusively receiving mother's own breast milk
* Signed Informed Consent and Protected Health Information

Exclusion Criteria:

* Caesarean delivery
* Infant was born from a mother with Type 1 diabetes
* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or history of formula or human milk intolerance
* Signs of acute infection of current use of antibiotics
Sleep Improvement Intervention for Hospitalized Antepartum Patients

This project seeks to further study the effects of a hospital-based protocol for improving sleep in high-risk antepartum patients as piloted by Lee and Gay (2017).


Eligibility Criteria:
Inclusion Criteria:

* speak, read, and write English
* medically stable
* 20 weeks' gestation or greater
* viable fetus
* hospitalized at least 24 hours

Exclusion Criteria:

* Do not speak, read, and write English
* Medically unstable
* Less than 20 weeks' gestation
* Nonviable fetus
* Hospitalized less than 24 hours
Comparing the "Snifing Position" , "Simple Head Extension" and "Neutral Position"

The simple head extension is recommended for optimization of glottic visualization during Nasotracheal intubation via fiberoptic bronchoscope (FOB) . However, no study confirmed its superiority over"snifing position" and "Neutral Position". In a prospective, randomized study, the authors compared the snifing position , simple head extension and "Neutral Position" in Nasotracheal intubation via fiberoptic bronchoscope.

The study included ninety patients with anticipated difficult airways. The snifing position was obtained by placement of a 7-cm cushion under the head of the patient; the extension head position was obtained by placement of a 7-cm cushion under the shoulder; the neutral position with the occiput close to the operating table. The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group). Randomization (1:1:1) was based on the codes generated by Excel software, which were kept in sequentially numbered opaque envelopes until the began of study.

Eligibility Criteria:
Inclusion Criteria:

• ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.

Exclusion Criteria:

* • ASA class IV or V

  * Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
Depression and Self-care in Heart Failure

The purpose of the study is to test whether Cognitive Behavior Therapy (CBT) plus heart failure self-care education is superior to "usual care" for depression.

Comorbid depression is common in heart failure, but little is known about how to treat it. This randomized, controlled, efficacy trial will compare cognitive behavior therapy (CBT) to usual care (UC) for depression in heart failure. CBT will be integrated with an intervention to improve heart failure self-care, because depression and inadequate self-care are thought to be interrelated problems. It will also be integrated with clinical attention to primary caregiver stress. Basic heart failure education will be provided to all participants.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association Class I, II, or III Heart Failure (Clinically diagnosed at least 3 months ago)
* Meets the DSM-IV criteria for a current major depressive episode, or for current minor depression with a past history of at least one major depressive episode.
* PHQ-9 score of 10 or greater plus 2 or 3 on question 1 or 2 over the last 2 weeks including today

Exclusion Criteria:

* Less than 30 years old
* Current ETOH / drug abuse
* Bipolar disorder, schizophrenia, or other psychotic disorder
* Communication barrier
* Dementia
* Currently in competing research protocol
* High risk for suicide
* Insurmountable logistical barriers to laboratory assessment visits
* Major mobility-limiting physical disability
* Poor 1 year prognosis not r/t heart failure
* Hospitalized for heart failure or acute coronary syndrome in last month
* Initiated antidepressant therapy in the past 4 weeks
* Current non-study psychotherapy for depression or other psychiatric problem