cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly

The purpose of this study is to determine whether Lactobacillus acidophilus/rhamnosus complex is effective in the prevention of antibiotic-associated diarrhea (AAD) in the elderly.

Antibiotic-associated diarrhea (AAD) is a common adverse drug reaction, occurring in 5-35% of patients, and is of significant consequence to hospitalized patients. Patients who develop AAD are more likely to experience a longer hospital stay, incur higher medical costs, and develop other co-morbidities. Clostridium difficile infection (CDI) accounts for approximately 15-25% of AAD cases and is a significant cause of morbidity and mortality in hospitalized geriatric patients.

A preventative measure that has been suggested for AAD and CDI is the use of probiotics. Although probiotics have been used for a wide range of indications, including the prevention and treatment of AAD and CDI, there is lack of data regarding efficacy of these products.

Hospitalized elderly patients are at significant risk of developing AAD and CDI and prevention of AAD and CDI in this population may contribute to a reduction in morbidity, length of hospital stay, medical costs, and potentially mortality.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients over the age of 60 on 4A/B unit at Victoria General Hospital, Victoria BC, and
* Anticipated to receive antibiotics (intravenous or oral) for greater than 72 hours for any indication, and
* Are determined to be competent by the prescriber.

Exclusion Criteria:

* Patients who have been on antibiotics during the past 2 weeks
* Patients who have active diarrhea at enrollment
* Patients who have been diagnosed with CDI within the previous 3 months
* Patients who are lactose intolerant
* Patients who have an underlying chronic GI tract disease (inflammatory bowel disease, irritable bowel syndrome)
* Patients who have an ileostomy or colostomy
* Patients who regularly take probiotics
* Patients who are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last year)
* Patients who have a life-threatening illness
* Patients who cannot take medications by mouth or are tube fed
* Patients who have been on the new antibiotic for more than 72 hours
* Patients who are anticipated to receive the new antibiotic for a duration of less than 72 hours
* Patients who do no give informed consent.
Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

The primary purpose of this protocol is to provide fluconazole for the treatment of individual patients who require therapy for serious or life-threatening systemic fungal infection, who have failed on conventional antifungal therapy or have had unacceptable reactions to conventional antifungal therapy, and who are ineligible for other established fluconazole clinical trial protocols.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole.

A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole.

AMENDED:

* 900207 Open only to unapproved indications and/or age ranges.
* Original design:
* Patients with clinically established serious or life-threatening systemic fungal disease will be considered if conventional fungal therapy is not an acceptable alternative. Unacceptability of conventional therapy is defined as:
* Failure of conventional therapy to control or eradicate infection after appropriate trial(s) of generally accepted regimen(s).
* Serious and unacceptable untoward reaction(s) to conventional antifungal therapy.
* OR A major contraindication to the use of conventional antifungal therapy.
* The patient must be ineligible or have no access to other established fluconazole investigational protocols. The final judgment of patient acceptability for inclusion lies with the Pfizer Clinical Monitor.
Xenogenic Collagen Matrix for the Treatment of Multiple Gingival Recessions

The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding). The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM is not inferior to CTG in terms of recessions reduction and secondary clinical variables, and superior regarding to PROMs.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and able to sign informed consent
* At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment
* A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest
* Available to attend study related procedures (including follow-up visits)

Exclusion Criteria:

* Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
* Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
* Pregnant or nursing women;
* History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
* Furcation involvement in the teeth to be included;
* Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated;
* Presence of fixed or removable prosthesis in the area to be treated
To Test for Photo Allergy Reaction of Sunscreens

The primary objective of this tudy was to evaluate the potential of photoallergy of of sun care products Sun Protection Factor (SPF) 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 application compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.

The secondary objective aims for evaluation of the safety of SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with ultraviolet (UV) A/B irradiation by monitoring adverse events (AEs) throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, aged 18 to 65 with good general health
* Fitzpatrick skin type I IV
* Females (of childbearing potential) on acceptable measure of contraception
* Willing to follow study rules, which include: no sun exposure (for example, no swimming, sunbathing, or tanning beds), avoidance of activities that would cause excessive sweating, no use of lotions, creams, or oils on the back area
* Willing to not change the current brand of personal care products such as soaps, body washes, laundry detergent, body sprays, body spritzes, etc. while participating in the study
A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5 mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18
* Rheumatoid arthritis for 3 months-5 years
* Naive to methotrexate
* If receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior to baseline

Exclusion criteria:

* Rheumatic autoimmune disease or inflammatory joint disease other than RA
* Prior receipt of any biologic therapy for RA
* Concurrent treatment with any DMARD
FORE-SIGHT Tissue Oximeter During Cardiac Surgery

The purpose of this study is to measure cerebral and lower extremity oximetry on patients during cardiac surgery.

The purpose of this research study is to collect data from a tissue oximeter device that measures brain oxygen saturation simultaneous with data from the same device that monitors skeletal muscle during cardiac surgery. This monitoring will allow for continuous, non-invasive, and earlier assessment of perfusion abnormalities/hypoperfusion.

Two sensors from the FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows and two additional sensors will be placed on the leg muscles. Data from the FORE-SIGHT Elite monitor will be recorded in addition to clinical and demographic data, which is standard of care during the procedure, for research purposes to look at factors associated with desaturations.

Eligibility Criteria:
Inclusion Criteria:

* Subjects where cerebral oximetry is monitored during their surgery

Exclusion Criteria:

* Birthmarks, tattoos, or other skin abnormalities that FORE-SIGHT Sensors cannot avoid
A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy

This is a multi-center, open-label, non-interventional, retrospective registry study, with no pre-set statistical assumptions and will not intervene subject's clinical treatment or clinical management.

In the study, the clinical data of the subjects will be retrospectively collected from the electronic health records (EHR) of each research center. The clinical information will be based on the actual medical records of the cases. After the retrospective study time (June 30, 2020), patients will be followed for one-year and two-year survival. Clinical treatment and management will be based on local clinical practices and regulations. This study will record the actual diagnosis and treatment, and will not interfere with any clinical decision.

After subject-out, patients will be followed for one-year and two-year survivals, thus the follow-up consent will be exempted. All patients receiving PD-1 monoclonal antibody in combination with chemotherapy will be visited during the entire study period. At the end of study, investigator will check up on the conditions of patients who withdraw from the study.


Eligibility Criteria:
Inclusion Criteria:

1. Men and woman, aged over 18
2. Cytology or histologically confirmed squamous cell lung cancer
3. Advanced squamous cell lung cancer, Stage IIIb to IV according to AJCC staging (version 8)
4. Patients receiving approved PD-1 mAb in combination with chemotherapy according to their condition
5. Patients receiving PD-1 mAb in combination with chemotherapy for at least one cycle (21 days)
6. Have imaging results with measurable tumor 2 weeks before receiving PD-1 mAb in combination with chemotherapy
7. Able to understand and comply with the requirements of the consent and voluntarily participate in the study

Exclusion Criteria:

1. Patients participating in other clinical studies
2. Severe medical data missing
3. Unable to understand the purpose of the study or not agree with the requirement of the study
4. Malignancies other than squamous cell lung cancer, history of malignancies
5. Unsuitable for the study according to investigator
Nutraceutical Support With Omega-3

Although evidence have clearly proved that intravitreal injection of vascular endothelial growth factor antagonists prevents vision loss and may even improve visual acuity in patients with neovascular AMD, a significant percentage of patients continue to lose visual acuity. Moreover, monthly intravitreal injections represent a burden for society as well as the caregiver.

Combination therapy with either topical 0.1% pranoprofen or nutraceutical support with AREDS2 formula plus omega-3 might act synergistically with intravitreal injection, offering valuable therapeutic support to aflibercept injections in patients requiring long-term treatment.


Eligibility Criteria:
Inclusion Criteria:

* provision of written informed consent and compliance with study assessments for the full duration of the study
* age \> 40 years
* presence of treatment-naïve neovascular AMD

Exclusion Criteria:

* any previous intravitreal treatment
* previous laser treatment in the study eye
* myopia \> 7 diopters in the study eye
* concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma)
* concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal
* known sensitivity to any component of the formulations being investigated.
Fluid Challenges and Microcirculation

The goal of this prospective observational study is to assess the impact of fluid challenge administration on macro and microcirculation in patients situated in the gray zone during a high risk abdominal surgery

Fluid optimization is a key goal in anesthesia. It allows to titrate fluid bolus based on flow variables or dynamic parameters of fluid responsiveness (pulse pressure variation (PPV) or stroke volume variation (SVV)).

When PPV or SVV is above 13%, the patient will usually respond to a bolus of fluid while when PPV or SVV is below 9%, the patient will normally not respond to it. Between 9% and 13%, it is a gray zone where the effect of a fluid bolus is uncertain.

The overall goal of fluid bolus administration is of course to optimize macrocirculation (stroke volume and cardiac output) but also (and probably more importantly) end organ tissue perfusion. However, regional tissue perfusion is not widely monitored during surgery. However, we do have some monitoring tools to assess microcirculation at the bedside.

Investigation of microcirculation in addition to macro circulation may allow clinicians to know if a patient situated in the gray zone may or not increase microcirculation variables while macrocirculation variables are well known to be of little value to predict fluid responsiveness.

The goal of this study is to assess microcirculation variables in patients situated in the gray zone (PPV between 9%-13%), and to assess macro and microcirculation responses to a standardized fluid challenge of 4 ml/kg of a balanced crystalloid solution.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a high-risk abdominal surgery
* Patients equipped with a minimally invasive cardiac output monitoring device in order to optimize fluid administration

Exclusion Criteria:

* Atrial fibrillation
* Ejection fraction \<40%
A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas

This is a Phase 1 dose-escalation study of PRT811, a protein arginine N-methyltransferase (PRMT) 5 inhibitor, in subjects with advanced cancers and high-grade gliomas who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT811.

This is a multicenter, open-label, dose-escalation, dose-expansion Phase 1 study of PRT811, a PRMT5 inhibitor, in subjects with advanced cancers without any approved or available treatment options including solid tumors, CNS lymphoma, and /or high-grade gliomas. The study will consist of 2 parts, a dose escalation part evaluating subjects with advanced solid tumors, CNS lymphoma, and/or high-grade glioma and a cohort expansion part which will evaluate the safety and efficacy of PRT811 in subjects with advanced solid tumors, and glioblastoma multiforme. For subjects, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT811.

Eligibility Criteria:
Inclusion Criteria:

* Malignancies that are refractory to or intolerant of established therapies known to provide clinical benefit for the malignancy in question, or in the opinion of the Investigator, not be a candidate for such therapies
* Subjects must have recovered from the effects of any prior investigational system therapies
* For subjects with recurrent high-grade glioma or GBM, must have biopsy proven evidence (WHO Grade III or IV) and received external bean fractionated radiotherapy and at least 2 cycles of adjuvant temozolomide chemotherapy. Mutant Glioma must comply with biomarker defined enrollment criterias.
* For biomarker-selected solid tumors: must meet enrollment criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
* Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
* Female subjects of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use an effective method of contraception during the trial

Exclusion Criteria:

* Untreated concurrent malignancies or malignancies that have been in complete remission for less than one year
* Treatment with strong inhibitors of CYP3A4 for which there are no therapeutic substitutions
* Inflammatory disorders of the gastrointestinal tract, or subjects with GI malabsorption
* HIV positive; known active hepatitis B or C
* Known hypersensitivity to any of the components of PRT811
Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma

It is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (ORR) of Camrelizumab combined with apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma.


Eligibility Criteria:
Inclusion Criteria:

1. age:18-75 years, male or female.
2. Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
3. Has not received any systematic anti-tumor drug treatment.
4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. ECOG 0-1.
6. Adequate organ function.
7. Life expectancy of greater than 12 weeks.
8. Patient has given written informed consent.

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
6. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
7. Received a live vaccine within 4 weeks of the first dose of study medication.
8. Pregnancy or breast feeding.
9. Decision of unsuitableness by principal investigator or physician-in charge.
Therapeutic Impact of KT Along With BT in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction

This research aimed to determine the impacts of KT and balance exercises in patients with CLBP of SIJ dysfunction.

The study will be based on a two-arm parallel group randomized control design. thirty participants of CLBP of SIJ Dysfunction will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into two groups A and B. Experimental group A will receive the hot pack, Stretching exercise, and Kinesio taping along with balance training (KBT), and group B will receive the hot pack, Stretching exercise, and Balance training (BT) exercise

Eligibility Criteria:
Inclusion Criteria:

* Subjects having chronic (\>3 months) non-specific low back pain (NSLBP) of sacroiliac joint (SIJ) origin
* Age 20-50 years.
* Presence of pain exacerbated as a result of bending laterally or backward.
* Positive results on at least 2 of the pain-provocation tests \[FABER, Posterior shear, and Gaenslen pain provocation tests) and one of the motion palpation tests (ie, Gillet and forward flexion tests) .

Exclusion Criteria:

* past or current history of surgery or major trauma to spine, pelvis, lower limb, chest or abdomen in the past 12 months.
* lower extremity musculoskeletal disorders.

  .localized spinal pathology, congenital anomalies of hip, pelvis or spine that limits mobility -systematic arthropathy, neuropathy or metabolic disorder
* Presence of other causes of LBP such as lumbar discopathy and spinal stenosis discovered via clinical examination and MRI scanning
* pregnancy.
Impact of Sprint Stair Climbing "Snacks" on Markers of Metabolism and Vascular Function

Prolonged sitting has been shown to impair metabolism and vascular function. The overall purpose of this study is to determine if breaking up prolonged (9 hours) of sitting with brief (\~20 second) stair climbing exercise "snacks" can improve markers of metabolic control and vascular health in healthy young male participants and in males or females with overweight/obesity who are at risk of insulin resistance. An additional purpose is to determine if saliva insulin can be used as a valid indicator of blood insulin when measured throughout the day in sedentary and active conditions and when diets with different amounts of carbohydrates are consumed.


Eligibility Criteria:
Lean Group Inclusion Criteria:

Non-smoking

Lean Group Exclusion Criteria:

Diagnosed with diabetes or prediabetes (fasting blood sugar more than 6.0 mmol/l) or any other chronic condition that may impact glucose or insulin levels.

BMI is over 25 kg/m2 Take medications which may affect glucose and insulin levels Allergic to eggs. Smoker Competitive or serious endurance athlete.

Overweight/Obese Group Inclusion Criteria:

Elevated waist circumference (\>102 cm for male and \>88 cm for female)

Overweight/Obese Group Exclusion Criteria:

Diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) Take medications which may affect glucose and insulin levels Allergic to eggs. Smoker Competitive or serious endurance athlete.