cyrilzakka/clinical-trials huggingface dataset:
Concurrent Training and Prediabetes Control

Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Interested in improving health and fitness.

Exclusion Criteria:

* Cardiovascular contraindications to exercise,
* History of stroke, asthma or chronic obstructive pulmonary disease,
* Muscle-skeletal disorders, and
* Smoking.
* A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.
The United Kingdom National Registry for Myotonic Dystrophy

Myotonic dystrophy (dystrophia myotonica - DM) exists in two forms, usually referred to as DM1 (type 1) and DM2 (type 2). Both conditions are genetic disorders but each affects a different gene. DM1 is the most common adult-onset muscular dystrophy, and is thought to affect at least 1 in 8,000 people worldwide.

The aim is to facilitate a questionnaire based research study in order to better characterise and understand the disease in the UK. By maintaining a national registry this will help identify potential participants eligible for clinical trials in the future.

The UK DM Patient Registry (https://www.dm-registry.org/uk/) aims to recruit any individual, from anywhere within the United Kingdom, with a diagnosis of myotonic dystrophy. Participants may be referred to the registry by health care professionals, or genetic testing/laboratory centres who are aware of the registry. Alternatively, a participant may have discovered the registry via promotional activities or by their own online searches. After completing the consent process, participants are able to enter information on to the registry platform (note all forms are also available offline as well). This is an ongoing database and all participants will invited to update their information on an annual basis.

The registry is sponsored by Muscular Dystrophy UK, Cure-DM and the Myotonic Dystrophy Support Group.

The database is divided into two main sections:

1. Mandatory items (demographic information, clinical diagnosis, genetic test result, current best motor function and wheelchair use) and
2. Highly encouraged items (severity of muscle symptoms, cardiac status, respiratory function, digestion, cataracts, and fatigue, ethnic origin and data on involvement with other registries)

The database is designed to be self reporting, however where specialised clinical or genetic information is required, the neuromuscular specialist in charge of the participants care can be invited to provide some additional information. The participant is able to select a health care provider from a pre-populated list at registration stage, if they wish to (optional feature). This information is included in the patient information and consent.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a confirmed Myotonic Dystrophy diagnosis (or pending diagnosis) are eligible for inclusion. Diagnosis will be confirmed via genetic testing results

Exclusion Criteria:

* There are no exclusion criteria for the registry
EMG Control Assistance Virtual Reality Interface Coupled With Cerebellar-iTBS for Arm Recovery After Stroke (ERICA)

The investigators hypothesize that a myoelectric (EMG) controlled VR interface allows for effective upper limb motor recovery of stroke patients. EMG control offers the possibility to alter visual feedback according to the recorded muscle activity in real-time. By manipulating the motion of a virtual hand associated with the recorded muscle patterns, assistance can be provided to stroke patients by correcting the error between the actual (dysfunctional) and a reference (functional) muscle pattern. Thus, through such an assistive EMG control algorithm, patients will be able to perform reaching movements with the virtual hand despite their motor impairment. By gradually reducing assistance, it is hypothesized that the salient error in the task space provided as visual feedback will systematically change the muscle patterns, thereby driving adaptation of the dysfunctional muscle patterns, enhancing motor recovery. Moreover, due to its relevant role in motor learning, it is expected that cerebellar stimulation will favor the underlying processes of adapting cerebello-cortical plasticity involved in motor learning. Therefore, it is hypothesized that an assistive EMG control algorithm in combination with cerebellar transcranial magnetic stimulation will further enhance upper limb recovery.

Theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression. Theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability.

Eligibility Criteria:
Inclusion Criteria:

* First ever ischemic stroke with mild to moderate motor impairment of upper limb;
* Left or right sub-cortical or cortical lesion of the middle cerebral artery;
* Age\>18, \<80 years;
* No visuospatial, cognitive, or attention deficits;
* Fugl-Meyer score\<56.

Exclusion Criteria:

* History of seizures;
* Treatment with Benzodiazepines, Baclofen;
* Pregnancy status;
* Intracranial metal implant;
* Cardiac pace-maker;
* Orthopedic upper limb limitation;
* Upper limb pain;
* Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study.
The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids

This study aims to assess the safety and efficacy of Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery for the treatment of Hypertrophic scars and Keloids.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers without underlying disease
* Patient with keloid age more than 6 months and keloid thickness more than 1 mm.

Exclusion Criteria:

* Dermatitis or infection on treatment area
* Suspected cancer on treatment area
* Immunocompromised host
* Pregnancy or lactating woman
* Recieved corticosteroid injection within 2 months
Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer

RATIONALE: Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with stage III or stage IV prostate cancer.

OBJECTIVES:

* Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in combination with total androgen blockade in patients with localized, regional or metastatic adenocarcinoma of the prostate by determining the proportion of patients who experience an objective tumor response.
* Evaluate the adverse effects of and tolerance to this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 capsules orally 6-7 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Concurrently, patients continue hormonal therapy with flutamide, leuprolide, or bicalutamide at the same dose as before beginning antineoplaston therapy.

Tumors are measured every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven localized, regional, or metastatic adenocarcinoma of the prostate
* Progressive disease during prior hormonal therapy (both antiandrogen and gonadotropin-releasing hormone) and must continue hormonal therapy
* Measurable tumors or tumor markers
* Bone metastases allowed

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 3 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* No hepatic failure
* Bilirubin no greater than 2.5 mg/dL
* SGOT no greater than 2 times normal

Renal:

* No chronic renal failure
* BUN less than 60 mg/dL
* Creatinine no greater than 2.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
* Blood ammonia normal

Cardiovascular:

* No severe heart disease

Pulmonary:

* No severe lung disease

Other:

* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No serious active infections or fever
* No other prior or concurrent second malignancy within the past 2 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior biologic therapy and recovered

Chemotherapy:

* At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered

Surgery:

* Not specified

Other:

* At least 4 weeks since prior investigational clinical trial
* No other concurrent treatment for metastatic prostate cancer
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population

The purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian population.

Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye.

Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months.

This study will be conducted in Australia.

Eligibility Criteria:
Key Inclusion Criteria:

* Planned bilateral cataract removal followed by posterior chamber IOL implantation with PanOptix Toric (TFNT30, TFNT40, TFNT50, or TFNT60);
* Calculated target residual refractive error within ±0.50 diopter (D) of emmetropia within the commercially available IOL Power Range in both operative eyes;
* Preoperative regular corneal keratometric astigmatism with predicted residual refractive astigmatism ≤ 0.50 diopter (D) in both operative eyes;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Preoperative irregular astigmatism;
* Clinically significant corneal abnormalities;
* Glaucoma;
* History of or current retinal disease; anterior or posterior segment inflammation;
* Other planned ocular surgical procedures including, but not limited to, limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK);
* Other protocol-defined exclusion criteria may apply.
Left Atrial Enlargement: A Crucial Indicator for Identifying Atrial Fibrillation in Patients With Hypertension

Based on the data of inpatients with hypertension and a cross-sectional study with a large sample size, this study aims to find the early warning value of the left anteroposterior atrial diameter for the possible occurrence of atrial fibrillation in patients with hypertension, and compare the advantages and disadvantages of the above two methods for the early warning of the risk of atrial fibrillation in patients with hypertension, so as to achieve the purpose of early identification of high-risk groups that may develop atrial fibrillation.

Background Left atrial enlargement resulting from hypertension is closely linked to the development and persistence of atrial fibrillation (AF). The newly proposed staging recognizes AF as disease continuum, which makes us aware that AF prevention should focus on the Pre-AF stage, and atrial enlargement is one of the important manifestations in this stage. Previous scoring systems, such as CHA2DS2-VASc and C2HEST, along with the recently highlighted left atrial diameter (LAD), have been significant tools for predicting AF occurrence. However, a comprehensive assessment of their utility is currently lacking.

Purpose This study aims to explore the role of left atrial size in identifying atrial fibrillation (AF) among hospitalized hypertensives, and to compare its recognition effectiveness with previous scoring systems.

Methods The investigators conducted a cross-sectional analysis within hospitalized hypertensives. The discovery, internal and external validation datasets were established. The eXtreme Gradient Boosting (XGBoost) was employed to identify key variables related to AF occurrence, which were ranked based on their importance scores. To gauge the predictive prowess of LAD regarding AF occurrence, the investigators plotted the receiver operating characteristic curve (ROC) and calculated the area under the curve (AUC). This enabled us to pinpoint the LAD cutoff value corresponding to the maximum Youden index, indicative of susceptibility to AF. Subsequently, Youden index determined the optimal cutoff value from the ROC curve. Delong's test compared the identification abilities of different tools within the same dataset. Logistic regression analysis assessed the correlation between clinical variables and left atrial size.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of primary hypertension using the current or past medical history.
* Availability of one or more complete ECG and 24h holter data.
* Availability of complete echocardiogram data in the current hospitalization.

Exclusion Criteria:

* Patients under 18 years of age.
* Cases with incomplete or unidentifiable results from extracted data.
Protective Effect of CoQ10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiovascular Surgery (PANDA V)

Cardiovascular diseases are the leading causes of death and prescription drug use. Research on certain dietary supplements looks promising as a way to help reduce risk factors. Previous studies showed that CoQ10 levels were decreased in cardiovascular patients and worsening of mitochondrial dysfunction was observed. The overall objective of this study is to determine if supplementing with CoQ10 can reduce inflammatory risk factors in adults with cardiac surgery, independent of other dietary or physical activity changes.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women
* Who receive cardiovascular surgery
* Agree to participate in the surgery and sign the informed consent form

Exclusion Criteria:

* Pregnant or planning on getting pregnant during the study
* Contain a minimum of 2 traits of metabolic syndrome
* Refused to participate in the surgery and refused informed consent
Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)

This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.


Eligibility Criteria:
Inclusion Criteria:

* 19 years of age or greater
* diagnosis of recurrent acute rhinosinusitis
* suitable candidate for office-based procedure
* willing and able to read and sign informed consent and remain compliant with protocol and study procedures
* able to read and understand English

Exclusion Criteria:

* diagnosis of chronic rhinosinusitis
* prior sinus surgery
* physician determined need for ancillary procedures
* known immune deficiency, ciliary dysfunction and/or autoimmune disease
* clinically significant illness that may interfere with evaluation of the study
* participation in clinical studies 6 months prior to study participation
* pregnant or lactating females
Adipokines in Obese Adolescents With Insulin Resistance

The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).

The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of disability and/or premature death.

The current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR, dyslipidemia, and inflammatory processes, are perpetuated.

Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have observed decreases in IR, decreases in weight, and improvements in lipid metabolism.

Adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered to be a risk marker for the development of cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Obesity defined as Body Mass Index (BMI) ≥ percentile 95
* Tanner stage ≥ 2
* Insulin resistance defined as Basal insulin \> 15 µU/mL or Homeostasis Model Assessment index (HOMA) \> 4.5
* Patients' parents signed written consents when they and their adolescent children agreed to enroll

Exclusion Criteria:

* Glucose intolerance
* Diabetes mellitus (type 1 or 2)
* Anemia (Hb \< 10 g/dL)
* Plasma creatinine \> 1.4 mg/dL
* Abnormal hepatic function
* Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
* History of lactic acidosis
Mulligan Sustained Natural Apophyseal Glides Versus McKenzie Method in Patients With Non-Specific Chronic Low Back Pain

Low back pain (LBP) is the most frequent complaint encountered in clinical practice. Exercises and manual therapy prescription are common physical therapy treatments prescribed for the patients presenting with chronic low back pain. The interventions will establish the future direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research

A variety of treatment interventions, modalities and techniques are used in physical therapy management of non-specific low back pain including manual therapy, exercises, neural mobilizations, stretching soft tissue techniques and dry needling etc. Out of these more recent literature supports manual therapy, self exercises, patient counseling and awareness have been recommended in back pain management guidelines, in the United States and is also frequently used in clinical practice in various countries.

Despite multiple theoretical frame works proposing the role of SNAGs and MDT mobilizations and exercises respectively, the literature on the true mechanism of direct or indirect physiological effects of these on performance or performance-related outcomes is vague and lacks justifiable procedural rigor.

The results of this study will provide information regarding the direction for practitioners in choosing the manual therapy or repeated exercises as effective prescription and provide a basis for future research.

Eligibility Criteria:
Inclusion Criteria:

* Patients of Both genders
* Adult patents between the 20 to 45 years of age with chronic non-specific low back pain.
* Pain intensity of at least 3 or greater on 0-10 Numeric Rating Scale.
* Modified Low Back Pain Disability Questionnaire score equal to or greater than 20%.

Exclusion Criteria:

* Serious underlying pathology with red flags.
* Patients having contraindication to physical exercises.
* Females with high parity.
* Pregnant or lactating females.
* Patients who participated in any type of rehabilitative training or exercise program for back pain in last 1 month.
* Spinal deformity or Spinal stenosis.
* History of fall or trauma to spine in last one year.
* History of spinal, abdominal or hip surgery.
* Signs of nerve root compression with sensory, motor or deep tendon reflexes deficit.
* Serious underlying pathology with red flags.
* Systemic disease e.g., cardiovascular, metabolic or central nervous system.
* Osteopenia, osteoporosis.
* Medication's history (steroids, immunosuppressants, chemotherapy)
* Limb length discrepancy.
Bactiseal Catheter Safety Registry in China

Research Purpose: This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman \& Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman \& Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

This study was designed to be single arm, multi-center, and retrospective. A total of 50 patients would be retrospectively enrolled. Information would be collected on adverse events of subjects enrolled within one year after the implantation of the Bactiseal Catheter from August 07, 2018 to Novemver 30, 2020.

The following information would be collected from subjects' medical records or hospitals' databases (if any):

1. General condition of the subjects
2. Intraoperative condition and catheter implantation
3. Information on the shunt product
4. Adverse events of subjects within one year after the operation and classification of the adverse events
5. Relevant examinations in case of postoperative infection
6. Other adverse event-related information (except anticipated adverse events)

Eligibility Criteria:
Inclusion Criteria:

* The informed consent was exempted by the Ethics Committee of a research center. Either a subject or his/her legal representative signed the informed consent form (ICF) prior to enrollment.
* A subject had an indication suitable to use Bactiseal Catheter.
* A subject received a hydrocephalus shunt at least one year ago.

Exclusion Criteria:

* A subject didn't have an indication suitable to use the product.
* A subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing, rifampicin, and clindamycin.
* According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
* A subject was simultaneously implanted with another shunt system different from Bactiseal Catheter.
* A subject had a contraindication of the shunt operation.
* A subject had uncorrected coagulopathy or any bleeding disorder.