cyrilzakka/clinical-trials huggingface dataset:
Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)

Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.

This multicenter, study will be run into two parts. Both parts will be run in consecutive age cohorts, starting from the oldest age categories(12 to \< 18 years old) to the youngest (birth to \< 3 months).

* Part A is an open-label, dose finding part to be conducted in at least 24 subjects.
* Part B follows a randomized, assessor-blinded, parallel-group design with vancomycin used as an active comparator. Part B will be conducted in about 176 children.

In both parts, the treatment period will be 10 days and will be followed by a Follow-up period of 28-32 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent by parents or legally authorized representatives (LAR) and assent by the child according to local requirements prior to initiation of any study-mandated procedure.
* Male or female from birth to \< 18 years of age, diagnosed with Clostridium Difficile-associated diarrhea (CDAD).
* Females of childbearing potential must have a negative pregnancy test at screening and must agree to use an adequate and reliable method of contraception.

Key Exclusion Criteria:

* Positive Rotavirus test for subjects \< 5 years.
* Fulminant or life-threatening CDAD.
* More than one previous episode of CDAD in the 3 month period prior to enrollment / randomization.
* Antimicrobial treatment active against CDAD administered within 24 h prior to screening except for metronidazole treatment failures (MTF).
* Subjects with body weight \< 3 kg.
* Inflammatory bowel disease, chronic abdominal pain, or chronic diarrhea of any etiology.
* Fecal microbiota transplant (FMT), immunoglobulin therapy, or any investigational drug to prevent or treat CDAD within 1 month period (or 5 half-lives in case of investigational drug, whichever is longer) prior to enrollment / randomization.
* Monoclonal antibodies against C. difficile within 6 months prior to enrollment / randomization.
* Previous vaccination against C. difficile.
* Known mental disorders.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study, or compliance with the protocol.
A Video Intervention to Decrease Patient Fear of Colonoscopy After a Positive Fecal Immunochemical Test

This clinical trial compares an educational video intervention versus usual care of no video intervention in decreasing patient fear of a colonoscopy procedure after receiving a positive fecal immunochemical test (FIT). The lack of a follow-up colonoscopy after an abnormal FIT result is associated with an increased risk of colorectal cancer mortality, advanced-stage colorectal cancer, among other complications, compared to the completion of a follow-up colonoscopy. An educational video may reduce patient fear and increase knowledge, self-efficacy, and intent to complete a colonoscopy compared to the usual care of no video intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy.

ARM 2: Patients receive usual care and do not watch the educational video.

After completion of study, patients are followed for 12 months after their abnormal FIT result.

Eligibility Criteria:
Inclusion Criteria:

* Age 45-75
* Have an assigned primary care provider in our partnering safety-net health system
* Have a billable primary care encounter between 2019-2022
* Have an abnormal FIT result for colorectal cancer (CRC) screening without a colonoscopy within 1 year
* Ability to communicate in English due to initial videos being available in English

Exclusion Criteria:

* Adults \< age 45 or \> age 75
* Patients who receive care at other University of Washington (UW) medicine sites (non-safety-net patients)
* Individuals without a primary care encounter between 2019-2022
* Individuals whose primary language is not English
Fluid Volume During Fluid Shifts

This study is designed to answer the question of if several non-invasive methods are comparable to the invasive clinical gold standard of radiolabeled albumin in terms of detecting changes in fluid volume.

It is broken into two studies: Aim 1 Study A is designed as a pilot phase to develop the non-techniques, and Aim 2 Study B is comparing these techniques to the gold standard.


Eligibility Criteria:
1. Non-smokers
2. Have a BMI\<30
3. Have no chronic disease
4. Be free of medications with known cardiovascular effects
Telephone-Based Educational Intervention in Improving Communication Between Patients With Stage 0-III Cancer and Their Children

This pilot clinical trial studies the feasibility of a telephone-based educational intervention in improving communication between patients with stage 0-III cancer and their children. An educational program delivered by telephone may help parents talk with their school-age child about their cancer.

PRIMARY OBJECTIVES:

I. Test the feasibility of the recruitment and study protocol.

II. Evaluate the short-term impact of the program on the diagnosed parents' and the parent's perceptions of their children's adjustment using a within group design (pre-posttest design).

III. To compare outcomes from the telephone-delivered program with outcomes obtained from the in-person program (between group design).

OUTLINE:

Participants complete the Enhancing Connections Telephone Program comprising 5, 1 hour educational telephone sessions over 3 months. During session 1, parents receive help defining the child's experience with the cancer as distinct from their own and ways to manage their own cancer-related emotions so that they do not emotionally flood the child. During session 2, parents receive assistance with developing skills to deeply listen and attend to the child's thoughts and feelings, complementing the parent's tendency to be a teacher, not a deep listener, of the child's thoughts, concerns, worries or understandings. During session 3, parents receive additional communication and parenting skills enabling them to initiate difficult cancer-related conversations and also interact with an upset child or one who is not forthcoming. During session 4, parents receive help focusing on and non-judgmentally interpreting the child's ways of coping with the cancer. It includes exercises that assist the parent to relinquish negative assumptions about the child's behavior related to the parent's cancer. Concurrently the session offers the ill parent ways to elicit their child's report of what the parent can do to assist the child cope with the child's cancer-related pressures. During session 5, parents focus on the gains they made in prior sessions and what they have accomplished, in their own words, in parenting their child about the cancer. The session also assists the ill parent to identify available resources that can be used after program completion to maintain the parent's newly acquired gains from the program.

Eligibility Criteria:
Inclusion Criteria:

* Parents will be eligible if they have an initial diagnosis of non-metastatic cancer of any type (stage 0-3), including melanoma, colorectal, cervical, leukemia, lymphoma or breast cancer within the past 7 months
* Read and write English among their languages of choice
* Have ready access to a telephone
* Have a child 5-12 years old living at home who has been told their parent's cancer diagnosis
* The child is living at home and does not have learning challenges
* No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer
Atrial Flutter Ablation in a Real World Population

The "LEONARDO" study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for Atrial Flutter isthmus-dependent (AFL) ablation will be enrolled. Patients can be treated with any market released catheter for ablation. The decision to perform the ablation of AFL will be made based on clinical evaluation of the investigators according to their clinical practice. The study does not require specific surgical techniques. Patient time commitment for the study is approximately 12 months.The study has been designed to describe the italian clinical practice in relation to the approach of AFL ablation. In particular, the investigators will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers.

Catheter ablation of Atrial Flutter has become an accepted alternative to pharmacologic therapy.The current guidelines recommend the catheter ablation at the first episode of AFL (Class IIa) or in any case of recurrent episodes of AFL (Class I). Recent studies have already demonstrated a high degree of procedural efficacy (higher than 90%). However, there are still two main areas of investigation. First, what is the best method to obtain an effective lesion. Second, what is the most reliable method to validate the procedure success.The present study is aimed at investigating these aspects in the current Italian clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing ablation of atrial flutter isthmus-dependent
* Patient able to sign an authorization to use and disclose health information or an Informed Consent.
* Patient available to attend scheduled follow-up visits at the center for at least 12 months

Exclusion Criteria:

* Patient is participating in another clinical study that may have an impact on the study endpoints
DaxibotulinimtoxinA for Treatment of Platysmal Neck Bands

This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.

This clinical investigation is a prospective study consisting of a screening/treatment visit and 5 follow-up visits. A total of 20 patients will be recruited.

Following informed consent and screening, each eligible subject will be photographed. Next, patients will be randomized to receive 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Patients randomized to each group will receive the same dosage injected to each neck band divided over 4 to 5 injection sites (up to 2 anterior and 2 lateral platysmal bands).

After randomization, patients will be treated with either 15 or 20 units per band. After treatment, subjects will be provided with post treatment instructions. Randomization will be conducted by having the patient pick either "15" or "20" out of a box. A total of 10 patients will be randomized to the 15 unit/platysmal band group. Another 10 patients will be randomized to the 20 unit/platysmal band group. The physician will fill out the 5-point Merz Neck Scale at baseline and at each follow-up visit. Photographs will be captured at each visit.

The patient will return at post-treatment weeks 8, 12, 16, 20, and 24. Subjects will fill out FACE-Q Satisfaction with Outcome surveys at each follow-up visit. FACE-Q Appraisal of Neck surveys will be filled out by the patient at the baseline and follow-up visits.

A blinded independent evaluator will evaluate the baseline and post-treatment photographs on Merz Neck Scale after completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* \>30 years old
* Rating of 2, 3, or 4 on 5-point Merz Neck Scale
* No use of any botulinum toxin in the neck for the past 6 months

Exclusion Criteria:

* Pregnancy
* Prior adverse reaction or known hypersensitivity to neuromodulators treatment
* Connective tissue disorder
* Scar in the treatment area
* History of dysphagia and/or neuromuscular disorders (such as but not limited to Amyotrophic Lateral Sclerosis, Multiple sclerosis, Myasthenia Gravis, Lambert-Eaton syndrome, others per PI's discretion)
* Active infection in treatment area
* Active moderate or severe inflammatory disease in treatment area such as atopic dermatitis, psoriasis
* Prior treatment with neuromodulators in treatment area (neck) within the past 6 months
Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients

Nonalcoholic fatty liver disease (NAFLD) is a global public health concern, and the leading cause of chronic liver disease, especially in developed countries. NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. Lifestyle interventions, including dietary modification and exercise, remain the cornerstone of NAFLD treatment. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven NASH and fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Either male or female adult patients (\>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography

Exclusion Criteria:

* Pregnant and/or lactating women
* Excessive alcohol use (defined as an average alcohol intake \> 30 g per day in men and \> 20 g per day in women)
* Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis.
* patients suffering from chronic kidney disease, and hyper/hypoparathyroidism
* Hypersensitivity to carbocistiene.
Amifostine in Treating Women With Ovarian, Peritoneal, Cervical, Fallopian Tube, Uterine, or Endometrial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing the risk of side effects caused by cisplatin and paclitaxel in treating women who have ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer.

OBJECTIVES: I. Determine the efficacy of amifostine in reducing significant peripheral neuropathy in women with ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer treated with cisplatin and paclitaxel. II. Determine the proportion of patients on this regimen who experience significant peripheral neuropathy 3 months after completing chemotherapy. III. Assess the overall toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours, amifostine IV over 10 minutes, and cisplatin IV over 90 minutes. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Neurotoxicity is assessed and vibration perception threshold testing is performed prior to each course of chemotherapy and at 3 months following the last treatment. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 29-59 patients will be accrued for this study within 18-36 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Ovarian, primary peritoneal, cervical, or fallopian tube carcinoma, uterine sarcoma, or endometrial adenocarcinoma for which the proposed treatment is cisplatin plus paclitaxel Must be ineligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No hypertension for which medication cannot be discontinued for 24 hours through the day of each chemotherapy treatment Other: No history of neuropathy (e.g., diabetic neuropathy) No significant infection Prior malignancy allowed if disease free for at least 12 months No physical disabilities precluding vibration perception threshold testing of the upper and lower extremity (e.g., amputation, paraplegia)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for ovarian, primary peritoneal, or fallopian tube carcinoma, uterine sarcoma, or endometrial adenocarcinoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy except for cervical carcinoma Surgery: Not specified
The EXCEL Registry of Patients Requiring ECMO

ECMO is associated with significant costs, risks and requires specialist training and expertise. EXCEL is a novel, high-quality, detailed prospective registry of patients requiring ECMO in Australia and New Zealand. The registry provides information on patient selection, complications, costs and patient reported outcome measures. EXCEL uses the Theoretical Domains Framework to identify evidence-practice gaps and explore barriers and enablers to tailor implementation of evidence

The aim of EXCEL is to generate a bi-national multidisciplinary network of integrated care for patients suffering acute cardiac or respiratory failure or cardiac arrest requiring extracorporeal membrane oxygenation (ECMO) to monitor long term outcomes and identify best practice.

Each year around 130,000 Australians and New Zealanders are admitted to an intensive care unit (ICU). The sickest patients in the ICU who have severe failure of the heart or lungs may require an external machine to oxygenate their blood in addition to a mechanical ventilator. This intervention, called extracorporeal membrane oxygenation (ECMO), involves circulating all of the patient's blood through large cannulae to external machinery every minute. It has the capability of completely replacing a non-functioning heart or lungs for days to weeks on end. These critically ill patients who require ECMO are the sickest in the hospital with only 42% hospital survival. The use of ECMO has doubled in Australia and New Zealand and globally over five years, and in the USA has increased by 433%.

The use of ECMO is associated with significant costs and risks, and it requires specialist training and expertise. In order to prepare for the organisation of these complex interventions in the ICU across regions, the investigators need to have accurate data on patients undergoing ECMO. The investigators monitor and review current practice in ECMO services by providing robust binational registry data to service providers and clinicians with a closed-loop feedback system. EXCEL explores barriers and enablers to evidence-based care in ECMO services and providing a platform to embed clinical trials. The investigators will translate findings with greater capacity, reach, and impact to drive measureable change in practice and improve patient-centred outcomes.

The EXCEL Partnership represents a novel, coordinated effort to create a high-quality, detailed, prospective registry of patients requiring ECMO at ECMO centres. A tailored, detailed ECMO registry (EXCEL) can be used to address specific safety concerns, clinical questions and process of care issues. As a result, EXCEL can be designed and implemented to answer new investigator-initiated, hypothesis-driven clinical questions.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to adult hospitals and receive ECMO in Australia and New Zealand

Nil Exclusion Criteria
A Pharmacogenomics Study of Safety and Efficacy of Enalapril or Enalapril-Folic Acid Therapy in Hypertensive Patients.

Dry cough is the most common adverse reaction of angiotensin converting enzyme, including enalapril, in Chinese population. Clinical observations suggest that the incidence of ACEI-induced dry cough is different between Chinese and other racial groups, however, there is still lack of research data in Chinese. Stroke is the second leading cause of death in the world and leading cause of death in China. Except the known risk factor such as hypertension, high homocysteine level, folic acid deficiency, the impact of genetics should not be ignored.

In this study, we will investigate whether there are specific genotypes which may predict the incidence of (1)enalapril-induced dry cough in Chinese and (2)first stroke in hypertensive patients taking enalapril or enalapril-folic acid therapy, so as to provide a basis for developing guidelines on precision medication in enalapril therapy apply to Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Patients taking enalapril or enalapril-folic acid therapy
* Signed informed consent.

Exclusion Criteria:

* Patients not taking enalapril treated
* Intolerance or unwillingness to blood sample collection.
Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery

To date it is unknown how physical activity levels in adults is limited before and after lumbar spine surgery and if physical activity level is associated with disability and limitations of quality of life. The main objective is to compare physical activity preoperatively and 6 and 12 weeks postoperatively in patients undergoing lumbar spine surgery with norm data. In addition, the investigators will study the association of changes in physical activity, disability and quality of live.

Patients scheduled for planned lumbar spine surgery will be contacted to participate in this study. All outcomes will be assessed within 1 week preoperatively and at 6 and 12 weeks postoperatively. Changes in outcome scores will be detected using analysis of variance. Association of changes in physical activity and changes in secondary outcomes will be detected using stepwise linear regression models.

Eligibility Criteria:
Inclusion Criteria:

* primary lumbar spine surgery
* single or multi level surgery on segments L2 to S1 (e.g. discectomy, decompression, laminectomy, foraminotomy)
* German speaking

Exclusion Criteria:

* stabilisation or fusion surgery or surgery above L2
* previous lumbar spine surgery
* indication: scoliosis, fracture, trauma, infection, tumor
* limited walking ability due to other conditions
* psychiatric conditions or dementia