cyrilzakka/clinical-trials huggingface dataset:
Probiotics for the Prevention of Antibiotic-Associated Diarrhea

In North America, one of the most common reasons for hospitalization in previously healthy children is for the treatment of infections with antibiotics. This study will determine if, in previously healthy children hospitalized and prescribed intravenous (IV) antibiotics, the co-administration of a probiotic milk product containing good bacteria, is safe and effective for reducing AAD, as compared to a placebo (identical appearing milk product). This will be a two-center, randomized, masked, placebo-controlled clinical trial. The results of this study will help inform clinicians and families on the use of probiotics in the prevention of AAD, a common side effect of antibiotic use among hospitalized children.

A two-centred randomized, multi-blind (i.e. patients, caregivers, data collectors, outcome assessors, data managers and analysts), placebo-controlled clinical trial intended to evaluate the efficacy and safety of Bio-K+ (Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2) in the prevention of AAD in hospitalized children 1 year to 17 years of age administered IV antibiotics.

Eligibility Criteria:
Inclusion Criteria:

1. Participants will be children aged 1 year to 17 years admitted to the General Pediatric inpatient unit at The Hospital for Sick Children (Site 1) or McMaster Children's Hospital (Site 2).
2. Participants will be prescribed IV antibiotics with a planned duration of 1 or more days, and a total course of both IV and oral antibiotics, if applicable, of no more than 28 days.
3. Parent (if parent-report) or patient (if patient-report) is able to communicate in English (read, write, speak).

Exclusion Criteria:

1. Parental or patient (e.g. child \> 12 years old) report of current diarrhea, diarrhea within the last week.
2. Lactose intolerance.
3. Allergies to strawberry, dried citrus pulp, or any other components of the study product.
4. Immuno-compromised patients or those on immunosuppressive agents (e.g. heart or kidney transplant, complex care, sickle cell disease, chemotherapy agents, oral prednisone).
5. Patients with known or potentially compromised gut integrity (e.g. short gut, Inflammatory Bowel Disease, Celiac disease, Irritable Bowel Syndrome, nasogastric, nasojejunal or gastrostomy tube).
6. Children with serious and/or unstable medical conditions (e.g. diabetes, cardiovascular, renal, lung, psychiatric illness, bleeding disorders, etc.).
7. Children admitted to a medical or surgical subspecialty unit.
8. Patients enrolled in another study.
9. Patients previously randomized to this study.
10. Patient is pregnant.
Condylar Inclination Recorded With Modjaw® Device.

In oral rehabilitation, the integration into the digital flow of mandibular movements and the patient's individual reference planes optimizes the functional adaptation of prosthetic elements whose design is computer aided. The innovative Modjaw® device allows you to record and then virtually simulate mandibular movements.

This retrospective study aims to: 1) Test the reliability of the Modjaw® device; 2) Measure the condylar displacements of asymptomatic subjects for the arbitrary programming of simulators.

Kinematic recordings of 22 healthy volunteers (15F / 7H; mean age: 22.2 years) were analyzed. Two recording sessions were carried out within one month of each other, by three different operators; each subject was followed by the same operator during the first (E1) and the second (E2) recording. The values of sagittal condylar inclination (SCI) obtained in opening, protrusion, right-left mediotrusion were calculated at 3 and 5 mm of condylar displacement. The transverse condylar inclination (TCI) was calculated at 4mm.


Eligibility Criteria:
Inclusion criteria : adult ;

Exclusion criteria : temporomandibular disorders (TMD symptom questionnaire)
Effects of Osteopathic Manipulative Treatment of Fascial Restrictions on Body Awareness, Mood, and Proprioception

The purpose of this research is to assess the effects osteopathic manipulative treatment (OMT) of fascial strain patterns on body awareness, proprioception, and mood.


Eligibility Criteria:
Inclusion Criteria:

* Functionally healthy adults that can move all four limbs within normal range of motion.

Exclusion Criteria:

* People with the following conditions may not participate in the study: known bony injuries or fractures, open wounds, abscesses, infections of the soft tissue or bones, malignancies, auto-immune disorders affecting the musculoskeletal system (ex. lupus, rheumatoid arthritis), severe osteoporosis, aortic aneurysm, deep venous thrombosis, history of pulmonary embolism, bleeding disorders, neurovascular compromise, anticoagulation therapy, recent surgery, recent herniated discs, unstable heart conditions, and musculoskeletal strains or sprains, enlarged spleen or liver, mononucleosis, pregnancy, untreated hyperthyroidism.
Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)

This study evaluates the clinical response rate of local steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive local injection combined with topical steroids and the other half will receive topical steroids mono-therapy.

Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.Clinical presentation of IGM can be variable. Some findings may be confused with breast malignancy.

Although IGM as a disease has been known for nearly four decades, no treatment consensus has been reached because of its rarity. Surgical treatment, antibiotics, oral steroids, topical steroids, immunosuppression (methotrexate, mycophenolate mofetil) and close follow up have all been reported to be effective.

Currently,surgical treatment and systemic steroids treatment are most frequently employed. With the consideration of side effects of long term systemic (oral) steroid usage, topical steroids without systemic use were assessed and showed satisfactory curative effect. But there is no data concerning the use of local injection of steroids therapy on IGM.The purpose of this study is to evaluate the effectiveness of steroids local injection on the basis of topical steroids for IGM treatment.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Granulomatous Mastitis
* Require non-surgical treatment

Exclusion Criteria:

* Breast Carcinoma
Effects of Table Tennis for People With Parkinson's Disease

Quasi-experimental, controlled, non-randomised two-arm pilot, with an experimental group (table tennis exercise) and an active control group (cognitive training based on board games).

Quasi-experimental, controlled, non-randomised two-arm pilot, with an experimental group (table tennis exercise) and an active control group (cognitive training based on board games). Interventions in both groups will take place twice a week for 6 weeks (12 sessions in total). The main variables to be assessed will be motor and cognitive. As secondary variables, clinical and daily life aspects will be assessed. As results, it is expected that the experimental group will obtain improvements in motor variables compared to the control group after receiving the interventions. However, improvements in cognitive variables and secondary variables are expected to be similar in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease based on the UK PD Society Brain Bank Criteria
* Stage I to III on the Hoehn and Yahr scale
* Ability to walk for 10 minutes unassisted

Exclusion Criteria:

* Score of under 23 on the Mini-Mental State Examination
* Severe Visual or Auditory deficits
* Cardiovascular conditions that impede physical activity
* Brain surgery
Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls

Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers, including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are side effects. One of the possible long-term side effects of cisplatin is thought to be heart disease. The way that cisplatin causes heart disease is not well understood. One possibility is that cisplatin may damage the inside layer of blood vessels called the endothelium. The purpose of this study is to measure changes in the endothelium that happen when patients with GCT get cisplatin chemotherapy and to compare these changes with a group of patients not receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Cisplatin-Based Chemotherapy Group

* Histologically-proven diagnosis of GCT
* Male
* Age ≥18
* No prior exposure to chemotherapy or radiation
* Planned to receive 3-4 cycles of cisplatin-based chemotherapy

Surgery-Only Group

* Histologically-proven diagnosis of GCT Male
* Age ≥18
* Surgical management of GCT performed less than 90 days before start of study (includes orchiectomy and primary retroperitoneal lymph node dissection (RPLND))
* No prior exposure to chemotherapy or radiation

Exclusion Criteria:

Cisplatin-Based Chemotherapy Group

* Prior exposure to chemotherapy or radiation
* Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease

Surgery-Only Group

* Prior exposure to chemotherapy or radiation
* Planned for non-surgical management with chemotherapy or radiation.
* Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease.
Effect of Nicorandil in Type 2 Diabetic Obese Patients

1. Evaluating the effect of nicorandil on glycemic control of diabetic obese patients treated with sulfonylureas.
2. Investigating the effect of nicorandil on body weight of diabetic obese patients treated with sulfonylureas.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes duration ranged from 1 to 10 years.
* Body mass index (BMI) \>30 Kg/m2.
* The selected patients are treated with sulfonylureas alone.
* The age of selected patient ranged from 18 and 60 years.

Exclusion Criteria:

* Pregnant and lactating females.
* Patients with hypersensitivity to nicorandil.
* Uncontrolled hypertension and its antihypertensive medications
* Severe renal or hepatic disease.
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).

This will be a randomized controlled trial with a limb-load biofeedback training (EXP) group and an attention control standard-of-care (CTL) group (2:1 allocation ratio). Outcomes will be assessed prior to surgery (Week 5), start of the limb-load biofeedback training (Week 24), and one year after surgery (Week 64). This Phase I clinical trial will be among the first randomized controlled rehabilitation trials for people with transfemoral OI prostheses. There is an immediate need to better understand the physical health benefits and factors that contribute to poor outcomes for this population. A critical step in developing rehabilitation guidelines is to identify optimal methods for people to regain active lifestyles, best use their prostheses, and avoid secondary comorbidities. This novel limb-load biofeedback training program will provide the empirical evidence necessary to inform post-OI rehabilitation regimens designed to optimize outcomes. Importantly, data from this trial will also guide intervention refinement as the investigators move toward a Phase II trial.

Eligibility Criteria:
Inclusion Criteria:

* Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes
* ≥ 18 years old
* History of severe socket-related skin or residual limb problems
* Schedule for OI prosthesis implantation surgery

Exclusion Criteria:

* Vascular amputation etiology
* Substance abuse
* Unstable heart condition
* Acute systemic infection
* Cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<24)
* Active cancer treatment
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group performance status( PS) of 0 or 1.
* Left Ventricular Ejection Fraction (LVEF) ≥ 50%

Part 1:

* Advanced/unresectable or metastatic breast cancer or gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.

Part 2a:

* Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
* Treated with ado-trastuzumab emtansine (T-DM1)

Part 2b:

* Advanced gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
* Treated with trastuzumab

Part 2c:

* Advanced breast cancer with HER2 low expression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.

Part 2d:

* Satisfy at least one of the following criteria

  1. Advanced/unresectable or metastatic solid malignant tumor with HER2 expression other than breast cancer and gastric or gastroesophageal junction adenocarcinoma that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
  2. Advanced/unresectable or metastatic tumor with HER2 mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.

Part 2e:

* Advanced breast cancer with HER2 overexpression that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
* Treated with ado-trastuzumab emtansine (T-DM1) (patients with HER2 overexpression only)

Exclusion Criteria:

* Has a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.
* Has a medical history of myocardial infarction or unstable angina.
* Has a QTc prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females.
* Has a medical history of clinically significant lung diseases
Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions

The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.
Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder

The primary aim is to test the efficacy of a new intervention to improve clinical judgment. The investigators focus on the assessment of pediatric bipolar disorder (PBD), a controversial diagnosis with frequent diagnostic errors, by educating mental health professionals in common cognitive pitfalls and training them in recommended de-biasing strategies. The investigators hypothesize that the Treatment group will show higher diagnostic accuracy than the Control condition: Participants receiving the cognitive de-biasing intervention will be less likely to commit faulty heuristics and race/ethnicity bias. Secondary aims include soliciting feedback about whether the skills were useful when diagnosing the vignettes, and whether skills and cases seem clinically realistic.

A randomized controlled trial (RCT) of 100 participants will test the efficacy of a new intervention to improve clinical judgment.

Eligible participants will be licensed or currently supervised by a licensed mental health professional and have experience working with pediatric populations.

Participants will be randomly assigned to either Treatment or Control conditions. All participants receive a 5 minute pre-recorded presentation about mood disorders, then read several case vignettes and respond to questions regarding judgments about probable diagnoses and next clinical actions.

Study administration is Web-based via a secure portal. After answering questions to confirm eligibility and provide informed consent, participants will complete a background questionnaire. The Web software, Qualtrics, will randomize participants to watch a brief presentation on mood disorders (i.e., Control condition) versus the same presentation on mood disorders combined with the intervention (i.e., Treatment condition). The intervention is a 20-minute training on decision-making errors and cognitive de-biasing strategies.

Next, all participants review four clinical vignettes. Using only four vignettes reduces participant burden and maximizes response rate. Qualtrics presents the case vignettes in random orders.

After completing the last vignette and corresponding questions, participants in the treatment condition rate their experience of the intervention. These questions address the secondary study aims: (a) how participants will use these new techniques in their clinical practice; and, (b) how the investigators can tailor the intervention to make it even more user-friendly and appealing to clinical audiences.

Eligibility Criteria:
Inclusion Criteria:

* Participants need to be: (a) licensed or currently supervised by a licensed mental health professional; and, (b) have experience treating child and adolescent patient populations for mental health issues.

Exclusion Criteria:

* Not meeting criterion (a) or (b) above.
Study of Endoscopic Versus Open Surgery for Urinary Reflux

This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical complications, and quality of life measures after ARS.


Eligibility Criteria:
Inclusion Criteria:

* Age \<12 years
* Unilateral or Bilateral Primary VUR
* Grade 2 or 3 (VCUG) or Grade 2 (RNC) VUR in at least 1 ureter
* Recommended for surgical correction of VUR by Urologist

Exclusion Criteria:

* Grade 4 or 5 (VCUG) or Grade 3 (RNC) VUR
* Secondary VUR (neurogenic bladder, exstrophy, or other causes of secondary VUR)
* Ureterocele
* Periureteral diverticulum
* Complete duplication of duplex collecting system on side with VUR
* Prior ARS, either open or endoscopic, regardless of success or failure
* History of other prior urinary tract surgery other than circumcision
* Solitary functional kidney
* Congenital or acquired immunodeficiency
* Chronic renal insufficiency or renal failure
The Efficacy of Two Models of Intensive Upper Limb Training on Quality of Life in Children With Congenital Hemiplegia

This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy

A total of 52 primary schools were screened comprehensively to determine children conforming specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender, affected side) and severity of functional impairment dealing with cognitive /communication, manual ability and mobility were noted. After a comprehensive screening, a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and probability. Children blinded to group allocation were delivered activity-based upper limb training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training, at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3 sessions per week was carried out in the school time (during the art or physical education class), while 2 out of 3 sessions were carried out in rehabilitation centers which the children regularly attend for regular care 2-day weekly. All participating children continued to receive their standard care (90 minutes per week) throughout the study period.

During the 1-month screening period, physical characteristics of participants were described through classification systems including The Communication Function Classification System, The Manual Ability Classification System , and The Gross Motor Function Classification System. Participating children were evaluated before the study entry (T1), immediately postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27 questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of congenital hemiplegia,
* Must be able to grasp objects

Exclusion Criteria:

* Cerebral palsy dependent severe emotional difficulties