cyrilzakka/clinical-trials huggingface dataset:
Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT

Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with cerebral palsy, having a significantly effect on their mobility and quality of life. There is much controversy about what is the most appropriate treatment of spasticity The objective of the present study is to evaluate the effects of radial extracorporeal shock wave therapy (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with cerebral palsy

The number needed of patients is 70 (35 per group). Leaving a period of washout between one therapy and the other

Outcome Measures:

The primary outcome will be to measure spasticity with passive range of motion of the foot (pROM) by muscular extensibility and its traction reflex using goniometryIt will be assessed at baseline before the treatment, as well as after 3 weeks, 2 months, 3 months, after the washout period (3months), 3 months and 3 weeks, 5 months and 6 months, when the end the intervention.

Secondary outcome includes: 1) Pain will be assessed with Visual Analog Scale (VAS) after the first application of each therapy. 2) Ascertain if the type of Gross Motor Functional Classification System (GMFCS) has an influence on the improvement of these two treatments; 3) Assess whether infiltration of Botulinum Toxin in other muscle groups have influence on the results of study; and 4) Undergo a qualitative registration to know the perception and experience that patient/family will have during this study, through a satisfaction questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age between 5 and 55 years
* Any level of GMFCS (Gross Motor Function Classification System)
* The patient consent to participate in the study
* Diagnosis of spastic cerebral palsy
* Triceps Surae spasticity in them.
* The dynamic foot deformity.
* Extensibility between 0 ° and 20 ° in dorsal flexion passive way.
* Do not be diagnosed important cutaneous alterations.

Exclusion Criteria:

* Associate neuromuscular disease.
* Surgical Intervention to augment the balance articulate and / or reduce the spasticity in the last six months.
* Fixed foot deformity.
* Etiology of factors:

or genetic bone disorders / disturbances soft parts. Position with anomalies or alterations in soft parts or bone alterations (mechanical).

* Unable to follow the treatment.
* Allergy to botulinum toxin.
Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer

This is an open-label, single arm, two-stage Simon Design study for women with LuminalB/HER-2 Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.

The primary objective of the trial is to evaluate of the efficacy and safety of Nanoparticle Albumin-Bound Paclitaxel Combined with Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer.

The primary endpoint of the study is to assess Pathological complete response rate（pCR）using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

The total number of patients to be included in this study is 78 patients.

The duration of the study, from first patient visit to last patient visit will be approximately 12 months.


Eligibility Criteria:
Inclusion Criteria:

* 1.Age: from 18 to 70 years old, female.
* 2.Has histologically or cytologically confirmed unilateral primary invasive breast cancer with a clinical stage of T2-4NanyM0.
* 3.Immunohistochemical detection of ER+, PR+, HER-2 negative (if HER2 expression is 2+ patients need to be confirmed by in situ hybridization to detect no HER-2 gene amplification) and Ki-67 expression \>20% of patients;
* 4.At least one measurable objective lesion according to RECIST 1.1 criteria.
* 5.ECOG performance status of 0-1.
* 6.Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 90 g/L.
* 7.Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal. AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with Gilbert's syndrome.
* 8.Has good compliance with the planned treatment, understand the study process and sign written informed consent.

Exclusion Criteria:

* 1.Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiation therapy.
* 2.Patients with grade II or higher heart disease scored by the New York Heart Association (NYHA).
* 3.Severe systemic infection, or with other serious diseases.
* 4.Patients with known hypersensitivity or intolerance to chemotherapeutic agents or their excipients.
* 5.Other malignancies have occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin carcinoma.
* 6.Pregnant or lactating, and who refuse to take appropriate contraception during the course of this trial.
* 7.Have participated in other study studies within 30 days prior to the first dose of study drug.
* 8.Patients who, in the opinion of the Investigator, are not suitable for participation in the study.
Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been a world health issue during the last months, affecting mostly countries with a high metabolic risk, like Mexico. Patients with type 2 diabetes (T2D) have an increased risk of any kind of infection as well as an increased mortality risk. Hyperglycemia has been established as an important predictor of mortality in patients with T2D and SARS-CoV-2. The standard treatment of hyperglycemia in hospitalized patients has been basen on insulin schemes, but recently evidence suggest the utility of some other drugs, reducing the risk of hypoglucemia and increasing the probability of a proper metabolic control. The goal of this study is to compare the utility of dipeptidyl peptidase-4 inhibitor (DPP4i) as a combination with insulin on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 and hyperglycemia.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been a world health issue during the last months, affecting mostly countries with a high metabolic risk, like Mexico. Patients with type 2 diabetes (T2D) have an increased risk of any kind of infection as well as an increased mortality risk. Hyperglycemia has been established as an important predictor of mortality in patients with T2D and SARS-CoV-2. The standard treatment of hyperglycemia in hospitalized patients has been basen on insulin schemes, but recently evidence suggest the utility of some other drugs, reducing the risk of hypoglucemia and increasing the probability of a proper metabolic control. DPP4 enzyme has an ubiquitous distribution and has been considered as a pro-inflammatory enzyme, considering that DPP4 inhibitors could have and anti-inflammatory effect, as it has been shown in different works. The goal os this study is to compare the utility of DPP4 inhibitor as a combination with insulin on metabolic control and prognosis in hospitalized patients with SARS-CoV-2 and hyperglycemia. For this purpose we will randomize patients with SARS-CoV-2 and hyperglycemia to receive either the combination of DPP4i + insulin or insulin alone and will follow al algorithm treatment to define metabolic control as well as prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with confirmed infection by SARS-CoV-2
* Hyperglycemia higher than 140 mg/dl
* Patients accepting oral medications
* Both sex
* Older than 18 years of age
* Patients who accept to participate in the study and sign the consent form

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy
* Hyperosmolar hyperglycemic state or diabetic ketoacidosis
Surgical Start Time and Prognosis

Surgical start times significantly impacted mortality, morbidity, and resource utilization, particularly in high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients who underwent non-cardiac surgery

Exclusion Criteria:

* Emergency surgeries
* Cadaver surgeries
* Transplantation surgeries
* Patients with incomplete or missing data, such as follow-up information, operation start times, or laboratory values
Cardiovascular Reactivity to Physical Stress

It is well-accepted that an exaggerated blood pressure (BP) response to physical stress has a prognostic value, indicating a higher cardiovascular risk (e.g., sudden cardiac death, myocardial infarction, future hypertension, and left ventricular hypertrophy). However, there is a limited understanding of the underlying mechanisms and therapuetic strategies modulating this response. Therefore, this pilot project aims to explore whether one session of low-volume high-intensity interval training (low-volume HIIT) or combined intermittent heat and cold bath (sauna+cold bath) can decrease BP responses to physical stress. Furthermore, the secondary goal is to investigate whether one brief session learning about positive stress expectations magnifies the decrease in BP following low-volume HIIT and sauna+ cold bath.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 to 50 years
* Non-smoker.
* Non-obese (\<30 kg/m2).
* Able to walk on a treadmill and cycle on a stationary bike without problems.
* No or little (frequency \< 2 times per month) experience swimming with sauna and cold water.
* Proficient in Norwegian and able to provide informed consent.

Exclusion Criteria:

* Current or previous regular smoker
* Addictions to alcohol or illegal drugs
* Diagnosed with cardiovascular, respiratory, metabolic, or autoimmune diseases
* Taking prescription medication with known cardiovascular effects
* Judgment by a medical provider that exercise, heat therapy, or hydrotherapy poses an undue burden or risk.
* Cognitive or psychiatric impairment
* Lack of proficiency in Norwegian language oral or writing skills that will hamper the ability to participate in the interventions and fill out questionnaires.
The Association Between Different Monocyte Subsets and Coronary Collateral Development

Collateral growth and coronary angiogenesis are chronic adaptations to myocardial ischemia. Collateralization helps to restore blood flow and as a result salvages myocardium in severely ischemic myocardial regions. Thus, good collateral development in patients with severe coronary artery disease (CAD) improves ventricular function and prognosis (1-3).

However, coronary collateral development is different among patients even with similar degrees of coronary artery stenosis. Several factors, such as diabetes mellitus (4) and duration of myocardial ischemic symptoms (5) have been reported to effect coronary collateral development. At the cellular level, inflammatory cells, especially monocytes have an important role in collateralization. In a series of experimental studies with animals, it has been shown that monocytes are important elements for development of collateral vessels (6-7). In a recent study, it has been demonstrated that increased circulating monocyte count is related to good collateral development in patients with stable coronary artery disease (8).

Monocytes in human blood are heterogeneous and can be classified into two subsets according to the presence or absence of the FcγRIII receptor CD16 (9): CD14++CD16- monocytes characterized by high level expression of the CD14 cell surface receptor but no expression of CD16 receptor, and CD14+CD16+ monocytes characterized by the co-expression of CD16 receptor with either high or low level expression of the CD14 receptor. These subsets differ in function and response to several cytokines.

Our aim in this study was to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development.


Eligibility Criteria:
Inclusion Criteria:

* \> 95% stenosis of at least one major coronary artery in their first coronary angiogram

Exclusion Criteria:

* previous percutaneous or surgical revascularization history
* evidence of ongoing infection and inflammation
* known malignancy and chronic kidney disease (serum creatinine \> 1.5 mg/dl
* diabetic patients
Effects of 100% Medical Grade Manuka Honey on Tympanic Membrane Reconstruction Healing.

Throughout history, honey has been recognized for its healing properties. The use of honey for its medicinal properties dates back to 2200 BCE.

The purpose of this clinical trial is to learn about the healing effects of 100% medical grade Manuka honey in participants with Chronic Suppurative Otitis Media of the mucosal type.

The main question it aims to answer is: Can 100% Manuka honey given at the time of Tympanoplasty improve the re-epithelialization (healing process) of the tympanic membrane compared to controls?

Participants in the intervention group will receive a wound dressing of 100% medical grade Manuka honey after reconstructive surgery of the tympanic membrane.

Researchers will compare the intervention group to the control group to see healing process.

The aim of the present study is to conduct a randomized clinical trial to compare the effect of 100% sterile Manuka honey on re-epithelialization of the tympanic membrane post Tympanoplasty compared to the control group. The investigation will involve 64 participants with Chronic Suppurative Otitis Media of the mucosal type, who will be randomly put into two groups (intervention or control), where the intervention group will receive a dressing of 100% sterile Manuka honey during surgery. Results of this study will inform practitioners as to the potential benefits of 100% sterile Manuka honey on the re-epithelialization of the tympanic membrane.

Eligibility Criteria:
Inclusion Criteria:

* Participants of 18 - 45 years of age.
* Participants with Chronic Suppurative Otitis Media of the mucosal type.
* Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

* Participants who previously received surgical therapy for Chronic Suppurative Otitis Media or have recurrent or residual disease.
* Participants with anatomical pathology results showing and/or suspecting a tumor.
Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.

Pegteograstim is a novel monoPEGylated recombinant human G-CSF. In this prospective study, the incidence of febrile neutropenia during four cycles of dose dense (DD) doxorubicin/cyclophosphamide (AC) with pegtoegrastim support is being investigated.

The primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of DD AC with pegteograstim support (8 weeks).

Patients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks).

A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).

Clinical, hematological, and biochemical assessments were done before the start of each cycle.

Adverse events (AEs) were graded using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE version 4.03).

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of a primary breast cancer (stage I-III)
* Age \> 18 years of age and Age \< 66 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1
* Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy
* Adequate organ functions

  1. ANC ≥1500 cells/mm3
  2. PLT ≥100,000 cells/mm3
  3. CCr ≥50 mL/min, or Serum Cr \<1.5 x (upper limit of normal, ULN)
  4. Total bilirubin ≤1.5 x ULN
  5. AST (SGOT) ≤2.5 x ULN
  6. ALT (SGPT) ≤2.5 x ULN

Exclusion Criteria:

* Previous chemotherapy history
* Previous bone marrow transplantation history
* Sickle cell anemia
* Radiation therapy within 4 weeks from enrollment
* Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment
* Clinically significant systemic illness (serious infection, liver, kidney, heart disease)
* Pregnant, breast feeding women
Bodyweight Interval Exercise in the Fed Versus Fasted State

The purpose of this study is to investigate the effects of a single session of at-home bodyweight interval exercise, performed in the fasted or fed state, on postprandial glycemic management, post-exercise fat oxidation, and overall perceptions of appetite in recreationally active females. This is a remote/online study and does not involve any visits to the laboratory.

Following the acquisition of informed consent via videoconferencing, eligibility to participate in the study will be determined using questionnaires. If inclusion criteria is met, participants will undergo virtual exercise familiarization by following a pre-recorded instructional video.

Eligible participants will be assigned, in a random order, to two metabolic trials at least 3 days apart in the follicular phase of the same menstrual cycle. These visits will be online with an investigator on videoconferencing. The two trials involve: 1) Exercise followed by breakfast; and 2) Breakfast followed by exercise.

Various outcomes will be measured throughout the metabolic trials including: blood sugar, fat oxidation and appetite. All research tools needed to acquire these methods will be delivered to participants' place of residence.

Eligibility Criteria:
Inclusion Criteria:

* Females 18-35 years
* Recreationally active (complete \<150 min of exercise 1-3 days per week) and not training for any specific sport
* Experiencing monthly menstrual periods (eumenorrheic)
* Are not currently on oral contraceptives, or are taking triphasic oral contraceptives
* Body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2
* Regular consumption of a breakfast meal (solid and liquid meals apply) most (≥ 4) days of the week
* Have a device compatible for use with study applications (e.g., smart phone)

Exclusion Criteria:

* Inability to safely perform physical activity as determined by the Get Active Questionnaire
* Not willing to consume the standardized test drink before and after exercise
* Sensitive to meal timing around exercise (e.g., gastrointestinal issues if exercise performed 10 min after the start of meal consumption or if a meal is consumed 5 min after exercise)
* Inability to adhere to pre-trial protocol guidelines (e.g., caffeine or alcohol restrictions)
* Physical limitations for bodyweight exercise
* Are on monophasic or biphasic oral contraceptives
* Regular tobacco or cannabis use (e.g., recreational and/or medical cannabis, cigarettes, e-cigarettes, vape pens, JUUL)
* Regular use of drugs that may alter metabolism (e.g., corticosteroids, nSAIDs)
* Diagnosed medical condition under the care of care of a physician (e.g., type 2 diabetes, cardiovascular disease) Currently enrolled in a course with Dr. Gillen
Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury

Braces have been used o treat stable (not requiring surgery) burst fractures with much success. Recently questions have been raised in regards to the importance of the brace. Some studies have results that suggest a brace is not important in having a good outcome. However, this has never been proven. This study is being conducted to see whether or not wearing a brace is important to having a good outcome.

The purpose of this study is to prospectively compare the outcome between patients randomly assigned to a thoracolumbosacral orthosis (TLSO) treatment group or no orthosis (NO) treatment group, for the management of an acute AO type A3 thoracolumbar fracture.

Eligibility Criteria:
Inclusion Criteria:

* AO A3 burst fracture between T10 and L3 with associated kyphotic deformity \<35 degrees
* neurologically intact or isolated nerve root deficit
* age 16-60 years
* enrollment within 3 days of injury

Exclusion Criteria:

* neurological deficit
* can not comply with brace wearing (pregnancy/body mass index \>40)
* mobilized with or without a brace prior to recruitment
* suffered a pathologic or open fracture
* alcohol or drug abusers
* had previous injury or surgery to the thoracolumbar region
* unable to complete the questionnaires
Anatomical Resection in Colorectal Liver Metastases Patients

The type of liver resection (anatomical resection, AR or nonanatomical resection, NAR) for colorectal liver metastases (CRLM) is subject to debate. The debate may persist because some certain prognostic factors, associated with aggressive biological behavior of tumor, have been overlooked. The aim of our study was to investigate the characteristics of patients who would benefit more from anatomical resection for colorectal liver metastases.

729 patients who underwent hepatic resection of CRLM were retrospectively collected from June 2012and May 2019. Treatment effects between AR and NAR were compared in full subgroup analyses. Tumor relapse-free survival (RFS) was evaluated by a stratified log-rank test and summarized with the use of Kaplan-Meier and Cox proportional hazards methods.

Eligibility Criteria:
Inclusion Criteria:

(1)Age 18-79 years;(2) Histologically proven colorectal adenocarcinoma;

Exclusion Criteria:

(1) the histologic type of tumor was not called adenocarcinoma; (2) peritoneal metastasis; (3) number of liver metastasis \>3; (4) simultaneous anatomical and nonanatomical resections; (5) R2 resection; (6) history of previous hepatectomy; (7) incomplete data. The rest of patients were divided into 2 groups: patients undergoing an AR, and patients undergoing a NAR.
Effects of the Use of Occlusal Splint on the Postural Balance of Individuals With Temporomandibular Disorder

To investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder. The research group consists of 49 patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old, both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD questionnaire and magnetic resonance imaging of the temporomandibular joints. The research is a randomized, controlled, prospective clinical study with intervention. Postural equilibrium will be evaluated by means of a force plate. In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation about therapeutic exercises. After 12 weeks, the groups were re-evaluated. The results will be analyzed by categorical data using absolute and relative frequencies as well as continuous data using average, median, standard deviation, 25 and 75 percentiles, besides minimum and maximum values; comparison between the times by non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of significance of 0.05.

approved 06/29/2011

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic Criteria Temporomandibular Disorders and dentate subjects

Exclusion Criteria:

* Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects