cyrilzakka/clinical-trials huggingface dataset:
Management of Displaced Supracondylar Fractures of the Humerus Using Lateral vs. Crossed K-wires

Completely displaced (Type III) supracondylar fractures of the humerus are treated in the operating room and are held together with pins stuck into the bone. There are two ways of inserting the pins: crossed and laterally. The crossed method is often used because it is thought to be more stable, but this method also carries a risk of hitting the ulnar nerve. It is not known which method is more stable. Our hypothesis is that loss of reduction will be equivalent between the two pinning methods.

Children with type III supracondylar fractures of humerus who meet the study inclusion criteria will be invited to participate in the study by the on call orthopaedic surgeon. All patients will be required to provide informed consent. Patients will then be randomized through a random number software package and will commence immediately after confirmation of inclusion into the study. The fracture is reduced and fixed percutaneously either with crossed or lateral K wires, according to which group the subject was randomized to. Post reduction antero-posterior and lateral radiographs of the elbow are done in the operating room. Above elbow cast is applied. Radiographs are taken at follow-up visits to the clinic. The radiographs are measured to determine loss of reduction between immediate post-op films and films taken immediately prior to pin removal.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients scheduled for closed reduction and K wiring of supracondylar fractures of the humerus under general anaesthesia a
* Type-3 Supracondylar fractures of the humerus.
* Aged 3 to 7 years old
* Consent to participate in the study

Exclusion Criteria:

* Open supracondylar fractures of the humerus
* Children with pre-operative ulnar nerve injury
* Supracondylar fractures with compartment syndrome needing fasciotomy
* Supracondylar fractures needing vascular repair
* Refusal to provide informed consent
Renal Denervation by Iberis MultiElectrode Renal Denervation System in Patients With Primary Hypertension

The purpose of Iberis-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with primary hypertension by using Iberis multielectrode renal denervation system

The purpose was to evaluate 3-month outcomes of RDN for the treatment of primary hypertension in Chinese patients.In a prospective, multi-center study, 216 Chinese patients with primary hypertension would be recruited to undergo RDN by Iberis Multielectrode denervation system. The primary effectiveness endpoint wasReduction in average 24-hour ambulatory systolic blood pressue at 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years
* Primary Hypertension
* Stable medication regimen including 3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and 1) Office SBP ≥150 and ≤180 mmHg, and DBP ≥90 , 2) average 24-hour ambulatory systolic blood pressue and/or DBP ≥135 and ≤170 mmHg
* Main renal arteries with ≥3 mm diameter or with ≥20 mm treatable length (by visual estimation)
* Written informed consent

Exclusion Criteria:

Clinical Exclusion Criteria:

* Known secondary hypertension
* Type 1 diabetes mellitus
* Has an implantable cardioverter defibrillator (ICD) or pacemaker
* Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
* Has hemodynamically significant valvular heart disease
* Pregnant, nursing, or planning to be pregnant
* Any serious medical condition that may adversely affect the safety of the participant or the study
* Currently enrolled in another investigational drug or device trial

  2.Angiographic Exclusion Criteria
* Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
* History of prior renal artery intervention including balloon angioplasty or stenting
* Multiple renal arteries where the main renal artery is estimated to supply \<75% of the kidney
* Main renal arteries with \<3 mm diameter or with \<20 mm treatable length (by visual estimation)
* Renal artery abnormalities
Effects of Progressive Muscle Relaxation Exercises During Pregnancy

Participants were allocated into three groups; the control group, progressive muscle relaxation (PMR) group and relaxation music (RM) group. The PMR and RM programs were explained toall participants, and the first program was tested under the supervision of the researcher. PMR and RM group participants performed the program daily throughout 4 weeks. Severity of RLS with the International Restless Leg Syndrome Scale (IRLSS) and sleep quality with the Pittsburgh Sleep Quality Index (PSQI) were assessed at baseline, 2 and 4 weeks for all the groups.

A CD recorded by the Turkish Psychological Association was provided to explain relaxation techniques to PMR group participants. The CD contains relaxation exercises instructions and there is relaxing music in the background. This CD consists of two parts. The first part(11 minutes) gives short information about the content and how exercises should be done. It consists of information about deep relaxation. In the second part, there are 27 minutes of relaxation exercises accompanied by command with background music.

PMR exercise consists of four stages: stretching-relaxation (1st stage -approximately 20 minutes), autogenic training - only relaxation (2nd stage approximately 10 minutes), deep breathing training-breathing relaxation (3rd stage approximately 3-4 minutes), rapid relaxation (4th stage--a few seconds). In the first stage, the participant was instructed to first stretch and then relax the specified muscle group (hand, forearm, upper arm, forehead, cheek, nose, chin, neck, chest, shoulder, waist, abdomen, stomach, hip, calf, foot) in sequence. The participant was asked to constantly compare the feeling of tension that shehas just experienced with the feeling of relaxation later.

Another CD recorded by the Turkish Psychological Association was provided to RM group participants. It consists of 30 minutes relaxing music only.The participant was asked to just listen to music with without working in a private room.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with RLS by a physician
2. 27 to 34 weeks gestation
3. aged 20 to 35 years
4. able to understand and answer questions in the scale and forms
5. having a CD player

Exclusion Criteria:

* have

  1. vision-hearing problems
  2. chronic disease (hypertension, diabetes mellitus, heart disease, etc.)
  3. any psychiatric diagnosis
  4. multiple pregnancy
  5. rheumatic disease (to avoid difficulties in assessing the severity of RLS)
  6. lumbar hernia and low back pain complaints (to avoid difficulties in assessing the severity of RLS)
  7. varicose veins in the legs (to avoid difficulties in assessing the severity of RLS)
Posture and Mobility Measurements of the Upper Quadrant in Asymptomatic Subjects by Means of a Smartphone

This study aims to investigate posture-mobility associations in the upper quadrant by means of smartphone measurements

One purpose of this study is to measure the magnitude of the thoracic kyphosis, thoracic spine extension, and side-to-side differences in scapular protraction and elbow extension range of motion during the median nerve neurodynamic test through a smartphone (iPhone 4, app Compass, iOS 7.1.1), and to assess the intrarater agreement parameters.

Another purpose is to assess associations between thoracic kyphosis, thoracic spine extension, scapular protraction and the resting length of the pectoralis minor muscle through smartphone, photographs and tape measurements.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Normal mobility in the joints of the upper quadrant

Exclusion Criteria:

* complaints in the upper quadrant over the past 3 months
* significant deformities in the upper quadrant
* leg length discrepancy \> 1.5 cm
Increasing Access to Evidence-Based Care in Integrated Behavioral Health

The purpose of this research is to explore whether a single-session therapy visit may be of interest to patients seeking mental health services in Mayo Clinic's Integrated Behavioral Health program and whether a single-session therapy visit may be helpful in improving mental health. Researchers hope to better understand whether single-session visits could be a helpful option to offer patients in the future.


Eligibility Criteria:
Inclusion Criteria:

* Being a patient currently scheduled for an IBH consultation session at Mayo Clinic Rochester.
* Able to read and speak English.

Exclusion Criteria:

* Individuals diagnosed with psychotic spectrum, Bipolar I and II, or severe substance use disorder and individuals with severe cognitive impairment per chart review will not be eligible and will not be contacted about the study. Individuals must score ≥ 5 on the PHQ-9 and/or GAD-7 but not \>14 on either measure (indicating mild to moderate depression and/or anxiety) and respond \< 2 to Item 9 of the PHQ-9 ("thoughts that you would be better off dead, or thoughts of hurting yourself in some way") to be eligible for the study.
* Patients who are ineligible will remain scheduled for a regular IBH therapy consultation as originally planned.
ProbGut: Probiotics on the Healthy Gut Microbiota

In adults, probiotics have been shown to have no effect on the microbial composition and the beneficial effects are only transient. However, the gut microbiota of young children is less stable and more impressionable. The aim of this study is to examine the effects of probiotics on the developing microbiota in early life and to determine whether a young child's microbiota may be less resilient to probiotic-induced changes and possibly resulting in longer lasting probiotic effects compared to adults.

Probiotics are live microorganisms that have been associated with health benefits. However, probiotic effects have not been shown to persist beyond discontinuation of use in adults. The intake of probiotics during the critical window of gut microbiota development in young children, however, may allow for a longer duration of persistence of probiotic bacteria and more stable changes in microbial composition possibly resulting in stable engraftment of the probiotic strains. This study aims is to examine the effect of a 14-day course of a commercially available probiotic yogurt drink on the composition, diversity, and changes in immune biomarkers (e.g. human beta-defensin-2 and calprotectin) of the gut microbiota of healthy children. As well, to assess whether the probiotic strains persists after discontinuation of intake and whether engraftment occurs. By understanding the impact of probiotics on the gut microbiota, we will better understand the mechanism by which probiotics exert their beneficial effects. This may help guide probiotic selection based on the potential short- and long-term effects on the commensal microbiota.

Eligibility Criteria:
Inclusion Criteria:

1. Participants will be healthy children between 1 to 3 years of age.

   * Participants will be considered healthy on entry into the study if they did not have a history of chronic gastrointestinal issues, including chronic or frequent episodes of diarrhea (\>3 bowel movements/day for 3 consecutive days) during the month prior to enrolment.
2. Mother of participant is able to communicate in English (read, write, speak), as she will be required to provide her personal and medical history.

Exclusion Criteria:

1. Lactose or milk protein intolerance, or strawberry anaphylaxis, or allergies to dried citrus pulp, or any other components of the study product.
2. Immuno-compromised children (e.g. heart or kidney transplant, complex care, sickle cell disease) or those on immunosuppressive agents (e.g. chemotherapy agents, oral prednisone).
3. Children with known or potentially compromised gut integrity (e.g. short gut, Inflammatory Bowel Disease, Celiac, nasogastric, naso-jejunal or gastrostomy tube).
4. Children admitted to a medical or surgical subspecialty unit.
5. Children on antimicrobial therapy within 30 days prior to enrolment.
6. Children on an alternative probiotic within 30 days prior to enrolment.
Observational Study of Kibow Biotics in Dialysis Patients

A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.

Probiotics are increasingly utilized clinically. As their safety and health benefits are established, it is reasonable to anticipate that probiotic bacteria will be incorporated into a growing number of clinical regimens, as a dietary supplement.

Extensive in vitro R\&D investigations in Kibow's laboratories

Bacterial strains studied were a mixture of patented and proprietary strains of Streptococcus thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).

Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University, Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr) levels.

Two independent veterinarians investigated the effect of Kibow Biotics® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA.

Pilot scale studies, double blind, placebo controlled, cross-over studies for six months conducted in 45 patients in USA, Canada, Argentina, and Nigeria demonstrates reduction of BUN (P\>95%) and improved quality of life (P\>95%). Decrease in creatinine and uric acid levels were also observed. However, these studies were based on correlating the age of geriatric cats and dogs with moderate to significant kidney failure to human geriatric conditions. The proposed current study is being reevaluated based on correlating the weight basis of animal to human conditions. Hence, this is a does escalation study on ingestion of 1x (90 billion CFU/day), 2x (180 billion CFU/day), and 3x (270 billion CFU/day) dosages.

Eligibility Criteria:
Inclusion Criteria:

* Currently on hemodialysis
* 18 to 75 years of age
* Willing to give informed consent
* Baseline serum creatinine \>2.5 mg/dL

Exclusion Criteria:

* Pregnant or nursing women
* Refusal to sign the informed consent form
* Documented to have HIV/AIDS/Liver disease
* Active dependency on drugs or alcohol
* Currently on anticoagulant therapy
A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)

The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a complicated urinary tract infection
* Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture
* Patient is indian and 18 years of age or greater.

Exclusion Criteria:

* Patient had a kidney transplant
* Patient had been given antibiotic therapy for condition
* Patient had poor liver function
* Patient has complete obstruction of urinary tract
* Patient has history of serious allergy to antibiotics and multivitamins
* Patient is pregnant
* Patient not likely to respond to 10 to 14 days of antibiotic therapy
* Patient not likely to survive 4 week study period
Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer

RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate-term and long-term effects of surgery and brachytherapy.

PURPOSE: Randomized clinical trial to study quality of life in patients undergoing radical prostatectomy or brachytherapy for stage II prostate cancer.

OBJECTIVES:

* Compare changes in health-related quality of life (HRQOL) in patients with stage II prostate cancer up to 2 years after treatment with radical prostatectomy or brachytherapy.
* Compare the effect of baseline HRQOL, age, and other covariates on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
* Compare the effect of treatment modality on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
* Compare the effects of treatment failure on HRQOL, in terms of disease progression, in these patients.

OUTLINE: Patients are randomized to 1 of 2 arms on ACOSOG-Z0070 (radical prostatectomy vs brachytherapy).

Patients in both arms complete a quality of life questionnaire at baseline, 2 and 6 months after treatment, and then at 1, 2, 4, 7, and 10 years after treatment.

PROJECTED ACCRUAL: A total of 500 patients (250 per group) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate within the past 120 days

  * Stage II disease (T1c-T2a, N0, M0)
* Concurrent enrollment on ACOSOG-Z0070

  * Not yet randomized to an intervention arm (radical prostatectomy or brachytherapy)
* Willing and able to complete heath-related quality of life questionnaires

PATIENT CHARACTERISTICS:

Age

* 75 and under

PRIOR CONCURRENT THERAPY:

Endocrine therapy

* More than 6 months since prior hormonal therapy for prostate cancer
TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry

Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT

Quality Control Registry of a standard treatment with intraoperative radiotherapy during breast conserving surgery with 20 Gy at the applicator surface as an advanced boost followed by a shortened external beam radiotherapy. This is a prospective phase IV study to evaluate real life data of IORT Boost. Study runs in Germany with 13 active centers recruiting. Due to the nature of the study (registry) there is no need for randomization. Inclusion of n = \>1000 patients is planned.

Eligibility Criteria:
Inclusion Criteria:

* Tumor diameter \< 3,5 cm
* Informed consent

Exclusion Criteria:

* No informed consent
* Tumor size \> 3,5 cm
* No indication for a boost
Nicotine TMS EFT Smoking Pilot Study

Prior and recent evidence suggests a role of medial prefrontal cortex (MPFC) in cigarette smoking. Episodic Future Thinking (EFT) has also been shown to be associated with increased delayed discounting and reduced cigarette self administration. In the present study, we will examine whether a single administration of theta-burst transcranial magnetic stimulation (tbTMS) can increase Episodic Future Thinking and delayed discounting while reducing craving for nicotine.

The purpose of this study is to develop theta burst transcranial magnetic stimulation (tbTMS) as a potential treatment for nicotine addiction. Theta burst TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether tbTMS over the forehead can produce a reduction in things that may prompt individuals to want to smoke cigarettes. TMS has been approved by the Food and Drug Administration as an investigational tool as well as a therapy for depression. However, TMS is not approved by the Food and Drug Administration as a treatment for nicotine cravings and other addictions.

This study consists of one consent session and one TMS session. Participants will be asked to complete a series of questionnaires and computer assessments about nicotine both before and after a single tbTMS session.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years of age
2. Smoke at least 10 cigarettes a day (on average)
3. Not be pregnant
4. Meet all criteria on a standardized TMS safety screen (including to but not limited to implanted electronic devices, bullets or metallic fragments above the neck, hair clips that cannot be removed)
5. No barriers to making contact between the TMS coil and the skin (e.g. cornrows that cannot be removed, glasses that the participant is unwilling to remove)

Exclusion Criteria:

1. Report comorbid mental or physical illness (managed or unmanaged)
2. Currently using prescription medication that might affect smoking or nicotine metabolism
3. Using smokeless tobacco or alternative nicotine products
4. History of epilepsy or seizures (other than childhood febrile seizures)
5. History of chronic migraines
A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer.

CDK4/6 inhibitors are approved medicines indicated for the treatment of a kind of advanced/metastatic breast cancer, called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. They are given orally in combination with hormonal therapies.

The purpose of this study is to better understand how the CDK4/6 inhibitors combinations are used in real-life conditions and their clinical impact for the treatment of Canadian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC).

Female patients aged 18 years old or more presenting the following conditions will be selected for the study:

* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
* Diagnosis of ABC/MBC between 01 January 2016 and 01 July 2021
* Treatment with CDK4/6 inhibitor

Information will be collected from one single Canadian institution, on each selected real-life patient treated with CDK4/6 inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
* Diagnosed with ABC/MBC between 01 Jan 2016 and 01 July 2021
* Treatment with CDK4/6 inhibitor

Exclusion Criteria:

* Patient does not have ABC/MBC
* Patient has indicated HR- or HER2+ status
* Patient received a CDK4/6i as part of a clinical trial
Involvement of Lymphocyte Type B in Amyotrophic Lateral Sclerosis (ALS)

The involvement of Lymphocyte type B in Amyotrophic lateral sclerosis (ALS) patients will be compared to lymphocyte in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* ALS patients who could sign ICF.

Exclusion Criteria:

* No ALS patients age less than 18 years.