cyrilzakka/clinical-trials huggingface dataset:
Vivomixx for Prevention of Bone Loss in Women With Breast Cancer Treated With an Aromatase Inhibitor

This study evaluates the efficacy of the probiotic food supplement Vivomixx in the prevention of bone loss occurring in post menopausal women with breast cancer treated with an aromatase inhibitor. Half of the participants will receive Vivomixx while the other half will receive a placebo. The primary endpoint is to assess changes of bone turnover markers during the period of 6 months.

Aromatase inhibitors function to reduce estrogen levels. They are considered first-line treatment for postmenopausal women with estrogen receptor-positive breast cancer. Estrogen depletion leads to significant loss of bone mineral density and an increased fracture risk. One contributing mechanism to "estrogen deficiency associated bone loss" is the increase in systemic and local gut inflammatory responses upon estrogen deficiency. Probiotics have been shown to decrease inflammatory cytokine formation in both the systemic circulation and gut.

Vivomixx is a high potency probiotic medical food designated for the dietary management of inflammatory gut conditions in adults and children and is currently being studied in clinical trials in a wide variety of inflammatory conditions such as asthma and diabetes. In preclinical studies Vivomixx has been shown to protect from estrogen deficient bone loss.

Eligibility Criteria:
Inclusion criteria

1. Age≥ 35 years
2. Breast cancer stages 1-3 (non metastatic)
3. Under treatment with aromatase inhibitors
4. In menopausal status for ≤10y
5. Estrogen receptor positive tumor
6. CTX ≥300 pg/ml

Exclusion criteria

1. Distant metastases
2. Additional active primary malignancy
3. Metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, paget, osteomalacia etc)
4. Glucocorticoid treatment (chronic or high dose \>7.5 mg in the last three months)
5. Bisphosphonate treatment for more than 3 months in the last 2 years
6. Bone densitometry (DXA) T-Score \<-2 unless not a candidate for antiresorptive therapy (unwilling/unable to take treatment)
7. Lactose intolerant subjects
Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH

This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).

Duration: 24 week-intervention Study Group: Four arms

* Control: no intervention
* Rosiglitazone: rosiglitazone (8 mg/day)
* alpha-lipoic acid: alpha-lipoic acid (1800 mg/day)
* Rosiglitazone/alpha-lipoic acid: combination of rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)

Eligibility Criteria:
Inclusion Criteria:

* the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)

Exclusion Criteria:

* alcohol consumption \> 20g/day
* viral hepatitis B and C
* autoimmune hepatitis
* Wilson's disease
* hemochromatosis
* alpha-1 antitrypsin deficiency
* breast-feeding or pregnant females
* subjects planning to become pregnant
* severe comorbid medical conditions (such as severe cardiac, pulmonary, renal or psychological problems)
* those not consenting for the study
A Clinical Study to Assess the Effects of KB295 in Patients With Ulcerative Colitis (UC) on Gut Microbiota Structure and Function

This exploratory, open-label clinical study aims to explore the effects of KB295, a novel glycan, on adult patients with ulcerative colitis (UC) presenting with mild-to-moderate UC symptoms


Eligibility Criteria:
Inclusion Criteria:

* Be male or female, ≥18 and ≤75 years of age
* Confirmed diagnosis of UC (\>6 months) by endoscopy
* Mild-to-moderate UC with at least 4 weeks of UC symptomatology prior to screening
* Stable medication regimen for at least 2 weeks prior to screening, if on medication for UC

Exclusion Criteria:

* Possible or confirmed diagnosis of Crohn's disease or indeterminate disease
* History of isolated distal proctitis
* Use of any antidiarrheal medications within the last 1 week prior to screening
* Antibiotic treatment within the past 28 days prior to screening
* Any non-UC related immunosuppressive medications other than purine analogs. Systemic corticosteroids including prednisone \> 10 mg per day are excluded.
* Major intra-abdominal surgery related to the bowel within 24 weeks prior to the screening period and/or planned invasive surgery/hospitalization during the study
* Major medical comorbidities, or other conditions in the opinion of the PI, that might impact the patient's safety or compliance, or the interpretation of the study results
* Treatment with any other investigational drugs within 28 days prior to the screening visit
Efficacy of SASI Bypass in Super Obese Patients

Although previous studies investigated weight loss and improvement in comorbidities after SASI bypass, patients included in these studies had a BMI less than 50 Kg/m2. Therefore, the aim of the present study was to investigate the outcome of SASI bypass in patients with super obesity to assess the success of this novel bariatric procedure in this challenging group of patients in regards weight loss and improvement in associated comorbid conditions at 12 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Patients included to the present study were adult patients of both genders aging between 18 and 65 years with primary morbid obesity with BMI ≥50 kg/m2 with or without obesity-associated comorbidities such as hypertension, diabetes mellitus (DM), dyslipidemias, and gastroesophageal reflux disease (GERD).

Exclusion Criteria:

* Pregnant women.
* Patients unfit for general anasthesia (ASA 4, 5)
* Endocrine or psychiatric disorders.
* History of previous upper abdmominal laparotomy.
* Alcoholic addiction
* Liver cirrhosis
* Coagulopathy
Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide

This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects.

This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects. Unique subjects will be enrolled into each arm of the study and enrollment will be sequential. The first 20 subjects confirmed to be eligible will be assigned to Arm 1 (digoxin), the next 16 subjects will be assigned to Arm 2 (adefovir) and the next 22 subjects will be assigned to Arm 3 (furosemide). Blood samples for PK analysis will be collected at pre-defined timepoints for each arm throughout the study. Subjects will be on study for up to 80 days, including a 28-day screening period, 7-21 day in clinic period, and a 30-day follow up period post last dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Male or female between 18 and 55 years of age, inclusive, at time of informed consent.
* Body mass index between 18.0 and 30.0 kg/m2, with a minimum body weight of 45 kg for females and 50 kg for males, inclusive.

Exclusion Criteria:

* Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease. History of cancer (except treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
* Positive test results for human immunodeficiency virus (HIV) antibody; Positive test results of hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCVab) within 3 months prior to screening; or positive test results for human immunodeficiency virus antibody (HIVab) at Screening
* Taking any prescription medication or over the counter multi-vitamin supplement, or any non-prescription products (including herbal-containing preparations but excluding acetaminophen) within 14 days prior to Day -1.
Bipolar Research Study Using MR Imaging

In this proposal, the investigators will focus on subcortical gray and white matter structures commonly found to be abnormal in schizophrenia. Thus, the investigators will evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.

There are relatively few studies evaluating brain structure in bipolar disorder (BD), the results of which have been largely inconsistent, both in terms of what abnormalities are present in BD and whether they show any similar abnormalities to those found in schizophrenia. One possibility that might explain the varying degree of reported similarity in structural findings in schizophrenia and BD is that there might be effects of BPD diagnostic subtype associated with brain structure. One viewpoint that contrasts schizophrenia and BD considers psychotic (PBD) to differ from non-psychotic (NPBD) subtypes in terms of shared pathophysiology with schizophrenia. PBD has been reported as being of special interest, as it shares symptomatic overlap with schizophrenia, "runs in families", shares a chromosomal linkage to the 13q13-32 and 22q12 with schizophrenia, shows similar increases in dopamine receptor Bmax induced by \[c-11\] N-methylspiperone positron emission tomography and similar working memory impairments as in schizophrenia. If PBP and NPBP are associated with different forms of brain pathology, then merging the two entities into a single "bipolar group" might obscure relevant anatomic differences if these occur primarily in only one group. In this proposal, the investigators will focus on subcortical gray and white matter structures commonly found to be abnormal in schizophrenia. Thus, the investigators will evaluate the volume and shape of the hippocampus, thalamus and basal ganglia, as well as measures of structural integrity of the corpus callosum and its various subregions.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-30
* diagnosed with Bipolar Disorder

Exclusion Criteria:

* history of head injury
* unstable medical condition
Tourniquet vs. no Tourniquet During High Tibial Osteotomy

The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during high tibial osteotomy.

Tourniquet is widely used in orthopedic surgery, but its effect and safety in high tibial osteotomy have not been studied. This study evaluated the efficacy and safety of tourniquets by comparing different timing of use.Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* 1.Simple knee medial compartment osteoarthritis High tibial osteotomy.
* 2. With varus deformity, medial proximal tibia angle \<85°
* 3. Unilateral High tibial osteotomy
* 4. Informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process

Exclusion Criteria:

* 1.Patients who underwent other knee surgery within 6 months
* 2.Preoperative combined anemia (Hb\<100g/l)
* 3.Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
Emoticare: Serious Game for the Adaptation to the Disease of Adolescents with Type 1 Diabetes Mellitus.

The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. To foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. Such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. Presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges.

The platform integrates new technologies for assessment and intervention. Ecological Momentary Assessment enables real-time evaluation, with data transferred to the technological platform. Artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. Ecological Momentary Intervention is employed for in-context treatments in participants' daily lives and natural environments. A serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. The game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. It addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Diabetes mellitus type 1 (6 months from diagnosis)
* Informed consent by parents/guardians and participants

Exclusion Criteria:

* Diagnosis other than type 1 diabetes mellitus
* No access to internet or new technologies
* Not speaking Spanish
Cervical Ca PROs in Clinical Practice

Concurrent chemo-radiotherapy followed by intracavitary brachytherapy is standard of care for patients with locally advanced cervical cancer. Although curative, this treatment is challenging and leaves a significant proportion of women with severe toxicity, negatively impacting their quality of life. Although most recover over time, a proportion of women do not. Therefore, evaluation of quality of life becomes increasingly more important as cancer specific outcomes improve. One such method is through patient-reported outcomes (PROs), defined as "any report coming directly from the patient about a health condition and its treatment." This prospective multi-institutional study, involving the Princess Margaret (PM), Odette Regional Cancer Centre(ORCC) and Royal Victoria Regional Health Center (RVH), will assess to feasibility and acceptability of integrating a cervical cancer specific PRO measurement tool into clinical practice. Cervical cancer patients coming for follow-up appointments will be asked to complete the EORTC QLQ-CX24, a validated cervical cancer specific PRO questionnaire. At the end of the study period, Feedback Forms will be completed by participating patients and health care providers to obtain their perspectives regarding the feasibility and acceptability of incorporating the instrument into clinical practice. Future directions include designing an electronic platform and expanding its use in cervical cancer clinics provincially and nationally. The data collected should help identify disease-related symptoms, treatment-related toxicities, facilitate patient-physician communication, shared treatment planning and target intervention strategies.


Eligibility Criteria:
Patient Inclusion Criteria:

1. Adult (\> 18 years) English speaking patients
2. Treated with curative intent with chemo-radiotherapy
3. Seen in routine clinic follow-up within 5 years post completion of treatment

Patient Exclusion Criteria:

1. Patients at their anticipated last clinic visit prior to cancer center discharge
2. Patients unable to complete the EORTC QLQ CX-24 questionnaire due to inability to read or write.
3. Non-English speaking patients
4. Patients of the principal investigator. The rationale for this is that patients of the principal investigator who complete the Feedback form may be biased and this may be reflected in the results.

Oncologist Inclusion Criteria:

1. Oncologists who treat cervix cancer
2. Oncologists with at least one consenting patient enrolled in the study

Oncologist Exclusion Criteria:

1) Principal investigator listed on the protocol. The rationale for this is that oncologists who are also investigators on this study may have inherent bias in the study which may be reflected in the results of the Feedback form.
Nerve Stimulator Versus Ultrasound-guided Infraclavicular Block

The investigators compared the postoperative analgesia of nerve stimulator-guided and ultrasound-guided infraclavicular block for upper extremity surgery.

Ultrasound (US)-guided peripheral nerve block has increased in popularity. It has many advantages such as improved success rate, faster onset time, fewer needle passes, shorter performance time, and reduced procedural pain and vascular puncture. However, there is no information about postoperative analgesia.

Therefore, the investigators tested whether ultrasound-guided peripheral nerve block enhanced the postoperative analgesia for upper extremity surgery compared with nerve stimulator (NS) guidance.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class I - III patients scheduled to undergo upper extremity surgery

Exclusion Criteria:

* coagulopathy, severe pulmonary disease, neuropathy, contralateral diaphragmatic paresis, allergy to study medications
Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer

This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.

Rationale: Studies suggest that chemotherapy agents docetaxel, doxorubicin, and cyclophosphamide have some efficacy against different types of breast cancer. However, the optimal sequence in which to administer these treatments remains unknown. The current study assesses two separate sequences of docetaxel, doxorubicin, and cyclophosphamide.

Purpose: This study will evaluate two different combination chemotherapy schedules for patients with axillary node-positive breast cancer. Combination one is docetaxel before doxorubicin and cyclophosphamide. Combination two is docetaxel after doxorubicin and cyclophosphamide. The combination with no dose reductions of docetaxel within 10 weeks will then be tested in a Phase III study. The toxicities of docetaxel will also be assessed in study participants.

Treatment: Patients in this study will receive one of two chemotherapy combination schedules. A computer will randomly assign patients into their treatment group. Group one will receive docetaxel before doxorubicin and cyclophosphamide. Group two will receive docetaxel after doxorubicin and cyclophosphamide.

Patients in group one will receive docetaxel every two weeks for a total of eight weeks. These patients will then be given combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. Patients in group two will receive combination doxorubicin and cyclophosphamide every two weeks for a total of eight weeks. These patients will then be given docetaxel every two weeks for a total of eight weeks.

Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Must have histologically or cytologically confirmed breast cancer
* No metastatic disease
* Prior lumpectomy or mastectomy
* No prior chemotherapy or hormone treatments for breast cancer
* Must have normal organ and marrow function.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Exclusion Criteria:

* Peripheral neuropathy of grade II or higher.
* History or evidence upon physical exam of CNS (central nervous system Diseases)disease.
* History of unstable angina or myocardial infarction within the last six months.
* Pregnant or nursing women.
* Known allergies to polysorbate 80.
* HIV-positive patients.
Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women

The purpose of the study is determine whether the Core Stability Exercise is more effective than the traditional Back School for low back pain (LBP) in women.

The aim of this study is to check what kind of exercises are the best to treat LBP with regard to clinical improvements. The secondary objectives are: to determine which treatment is more effective in improving pain in the fewest sessions possible, to determine the involvement of inflammatory biomarkers in the development of pain and revalue the results after one month of having finishing treatment.

The project is a longitudinal, single-blind and randomized study with two treatment groups:

GROUP 1: Infrared light+ Transcutaneous Electrical Nerve Stimulation (TENS) + Core Stability Exercises.

GROUP 2: Infrared light + Transcutaneous Electrical Nerve Stimulation (TENS) + Traditional Back School.

Duration of treatment: 4 weeks. The participants will performe the exercises in 20 daily sessions (Monday to Friday) guided by a physiotherapist. Following treatment with the physiotherapist, the participants should perform the exercises at home for 4 weeks at a rate of three times per week.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 70 years.
* Diagnosis of back pain from a trauma.
* Untreated pain (except acetaminophen).
* Informed consent.

Exclusion Criteria:

* Algic process in the lumbar spine of infectious, neoplastic, metastasis, osteoporosis, inflammatory arthritis or fractures.
* Cognitive impairment of any etiology.
* Exercise intolerance for any reason.
* Patients who have completed physical therapy in the last 3 months.
* Patients who have received infiltration injections in the last 6 weeks.