cyrilzakka/clinical-trials huggingface dataset:
Pre-workout Supplement Versus Caffeine on Energy Expenditure.

The primary purpose of this study was to examine the acute effects of a multi-ingredient pre-workout supplement versus an ergogenic dose of caffeine (6 mg/kg) on energy expenditure during low-intensity exercise. The effects of these substances on substrate utilization, gas exchange, and psychological factors were also investigated. Twelve males (mean ± SD: age = 22.8 ± 2.4 years) completed three bouts of 60-min of treadmill exercise at 4.8-6.4 km/hr on separate days after consuming a pre-workout supplement, 6 mg/kg of caffeine, or placebo in a randomized fashion. The pre-workout and caffeine supplements resulted in significantly greater energy expenditure (p \< 0.001, p = 0.006, respectively), VO2 (p \< 0.001, p = 0.007, respectively), VCO2 (p = 0.006, p = 0.049, respectively), and VE (p \< 0.001, p = 0.007, respectively), but not rates of fat or carbohydrate oxidation or respiratory exchange ratio compared to placebo (collapsed across condition). In addition, the pre-workout supplement increased feelings of alertness (p = 0.015) and focus (p = 0.005) 30-minutes post-ingestion and decreased feelings of fatigue (p = 0.014) during exercise compared to placebo (collapsed across condition). Thus, the pre-workout supplement increased energy expenditure and measures of gas exchange to the same extent as 6 mg/kg of caffeine with concomitant increased feelings of alertness and focus and decreased feelings of fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Male

Exclusion Criteria:

* history of medical or surgical events, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders;
* use of any medications
* use of nutritional supplements
* habitual use of caffeine (≥1 caffeinated beverage per day)
* participation in another clinical trial or investigation of another investigational product within 30 days prior to screening/enrollment.
Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors

Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that uses a series of short but intense electric pulses delivered by NanoKnife generator through paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis through irreversibly disrupting cellular membrane integrity. This study aimed to investigate the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE） in the treatment of patients with locally advanced tumors in different anatomical position.

This study is a multicenter, open-label trial that aimed to evaluate the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE）in the treatment of patients with locally advanced tumors. Investigators will screen eligible patients and examine them by imaging tests as well as serological examination before and after the IRE procedures to assess the result with the size，blood supply，metabolism of tumors，the change of blood test and treatment-related complications. Big bore multislice spiral CT with thickness 5 cm, 120kilovolt，and 250milliampere，ECG-gated device and anesthesia monitoring equipment were selected during these procedures. Imaging (performed by contrast enhanced CT scan) and serological follow-up was at postoperative day 3 and 1，3，6，12months. The primary endpoint is the effective rate of IRE，and the secondary endpoint is 1-year survival rate and the frequency of adverse events. The response of irreversible electroporation ablation will be assessed according to the different evaluation criterions based on Response Evaluation Criteria in Solid Tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed locally advanced solid tumor.
2. Unresectable tumors or the patient refused surgical therapy.
3. Patients in good health conditions can receive general anesthesia.
4. Patients with good compliance can cooperate with doctors for related tests and the regular follow-up.

Exclusion Criteria:

1. Targeted tissues that metallic wallstents or metallics were implanted.
2. With heart pacemaker or be allergic to contrast medium that can not have related imaging examinations.
3. With bleeding and psychiatric disorders.
4. Severe arrhythmia.
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)

The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia who are not considered to be suitable for standard chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission
* Newly diagnosed Acute Myeloid Leukemia who are not considered suitable for other treatments.

Exclusion Criteria:

* Administration of anticancer agents (other than hydroxyurea) within 2 weeks prior to first dose of study drug, and administration of hydroxyurea within 24 hours prior to first dose of study drug
* Participation in any other trial with an investigational product within the previous 30 days.
* Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations
Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study following core study.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES


Eligibility Criteria:
Inclusion Criteria:

* - Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
* Patients whose guardians have given written informed consent to participation in this study

Exclusion Criteria:

* - Patients who failed in treatment compliance in the core study
* Patients who had a major violation of the protocol in the core study
Sleep Quality in (COPD) Patients (COPD: Chronic Obstructive Pulmonary Disease)

Patients with COPD, in addition to daytime symptoms, may suffer from nocturnal disturbances. The frequency of nocturnal problems has been reported to be higher in COPD than in the general population and it currently affects up to 50% of patients.

The CASIS questionnaire includes 7 questions and it has been recently validated as an objective tool to evaluate nocturnal symptoms in patients with asthma and COPD. The present study aims to study the validity of the CASIS questionnaire as a predictor of sleep quality measured by objective polysomnographic parameters.


Eligibility Criteria:
Inclusion criteria:

Patients with written inform consent to participate in the study and all the following criteria will be selected:

* Age 40-80 years
* Smokers or exsmokers of at least 10 pack-years
* Moderate-to-severe COPD

Exclusion criteria:

* Non-stable COPD. Stability is defined as being exacerbation free and without treatment changes for at least 4 weeks prior to baseline evaluation. The presence of a COPD exacerbation previous to the sleep studies (polysomnography, actigraphy, OSLER test) will lead to an early discontinuation of the patient´s participation in the study.
* Heart failure, asthma, cancer or other major medical illness with known effects on sleep quality.
* Unable to understanding the questionnaires administered in the study.
* Known Obstructive Sleep Apnea, other sleep disorder (narcolepsy, periodic limb movements) or shift work.
* Chronic respiratory failure (PaO2 \<60 mmHg).
* Treatment with sedatives or antidepressants.
Information Provision During Early Gait Training Post Stroke

This study examined the feasibility of using implicit and explicit learning approaches during gait rehabilitation in the early phase following stroke. It was a double blind trial (participants and assessors) using a matched pairs design. Participants were recruited from an acute stroke unit, and were randomised to receive gait rehabilitation over three consecutive days using either an implicit or explicit approach. Guidelines for each were developed empirically, including differences in the amount, timing, and attentional focus of therapists' verbal communication. Sessions were recorded and their content analysed to establish concordance with the guidance. Clinical measures were taken at baseline and 24 hours post intervention using the Berg Balance Scale and the Step Test. Therapists were able to adhere to the guidance. Both approaches were found to be acceptable to both patients and therapists. The findings will be used to design an appropriately powered RCT.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving rehabilitation for their first episode of stroke which resulted in hemiplegia
* Able to give informed consent to take part in the study.
* Currently receiving physiotherapy for the re-education of gait (at minimum is able to stand, weight bear and take one step with assistance of one person).

Exclusion Criteria:

* Patients with a history of:

  * any other neurological conditions including previous stroke
  * any pre-stroke musculoskeletal condition that either: i. limited walking to less than 100 metres and/or ii. resulted in a noticeable gait abnormality and/or iii. required use of a bilateral walking aid (e.g. 2 walking sticks or a walking frame)
* Patients with marked receptive dysphasia (not able to follow 3-stage commands) - confirmed through liaison with multi-disciplinary team, including Speech and Language Therapists where necessary
A Comparative Study on Relieving Postpartum Lumbago with Fire-dragon Cupping Therapy and Acupuncture

Abstract: Objective To compare the effects of fire dragon pot therapy and acupuncture on low back pain, lumbar function, self-efficacy and postpartum depression in patients with postpartum low back pain. Methods From April 2024 to September 2024, 84 postpartum patients with low back pain who met the standard of sodium discharge in Hangzhou area were recruited and divided into acupuncture group (routine acupuncture + core stability training (42 cases) and Huolongcan group (42 cases) according to random number table method. Fire dragon pot + core stability training (42 cases), the two groups each intervention 30 min, once every other day, intervention 3 times. Before and after the intervention, the visual Analogue Scale (VAS) was used to evaluate the degree of low back pain, the Oswestry Disability Index (ODI) was used to evaluate the lumbar function, the pain Self-efficacy questionnaire (PSEQ) was used to evaluate the patients' confidence in effectively coping with pain, and the Edinburgh Postpartum Depression Scale (EPDS) was used to evaluate the postpartum depression. The changes of each index before and after intervention were observed.


Eligibility Criteria:
Inclusion Criteria:

* (1) Postpartum 42 days to 1 year; (2) Visual analogue scale (VAS)\[7\]≥4 points; (3) Have basic reading comprehension ability, be able to fill out questionnaires independently, cooperate with investigation and treatment; (4) Sign informed consent voluntarily.

Exclusion Criteria:

* (1) Tumor, fracture, tuberculosis, bleeding tendency or serious organic disease; (2)Immune system diseases such as ankylosing spondylitis; (3) severe osteoporosis; (4) Patients with Yin deficiency and fire flourishing
A Multi-centre, Prospective Surveillance to Assess Mid-term Performance of the Mpact Cup

This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
* Those presenting with disease that meets the indications for use for Medacta USA implants defined by this study (on-label use).
* Patients must be willing to comply with the pre and post-operative evaluation schedule.

Exclusion Criteria:

* Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study.
Development of Algorithms to Predict Hemodynamic Instability

Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice unexpected deterioration of cardiovascular function remains a serious problem and an important cause of death. Novel perspectives in reflex testing of the autonomic nervous system might be useful to protect some patients from cardiovascular events by detecting cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings is nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is evidence that additional analyses of pulse wave characteristics might be a valuable source of information to generate additional insights into the cardiorespiratory status of the patient. Herein, we aim to develop novel algorithms in order to protect in-hospital patients from cardiovascular events in consequence of hemodynamic instability in the future.

70 datasets from hospitalized patients will be acquired in order to characterize the functional status of the autonomic nervous system as well as hemodynamics during baseline and during standard procedures including physical exercise testing and head-up tilt table testing.

Autonomic reflex testing:

* Heart Rate Characteristics
* Heart Rate Variability
* Heart Rate Turbulence
* Blood Pressure Variability
* Baroreflex Sensitivity
* Hyperoxic Chemoreflex Sensitivity

Hemodynamic Monitoring:

* Heart Rate Trends
* Blood Pressure Trends
* Pulse Wave Characteristics
* Cardiac Output
* Peripheral Vascular Resistance
* Context information

Eligibility Criteria:
Inclusion Criteria:

* hospitalization
* Age \> 17 years

Exclusion Criteria:

* documented diseases of the central nervous system
* impairment of mental health
* age \> 85 years
Comparison of Erector Spina Plan Block and Rhombodid Intercostal Block in Breast Surgery

In this study, the investigators compared ultrasound-guided erector spinae plane (ESP) block and rhomboid intercostal block (RIB) on postoperative analgesic effect in unilateral breast surgery.

After being informed about the study and potential risks, written consent was obtained from all patients.Patients who meet eligibility requirements will be randomized in a 1:1 ratio to erector spinae plane block and rhomboid intercostal block.

Eligibility Criteria:
Inclusion Criteria

* Patients who will undergo unilateral breast-conserving surgery (BCS) or modified radical mastectomy (MRM) with or without axillary lymph node dissection
* Patients undergoing elective surgery
* ASA (American Society of Anesthesiologists) physical status classification I-III

Exclusion Criteria:

* Use of anticoagulants
* Allergy to the medications to be used
* Patients who use analgesic drugs due to a history of chronic pain
* ASA (American Society of Anesthesiologists) physical status classification IV-V
* Patients with psychiatric disorders
* Presence of infection in the area where the block will be applied
* Presence of deformity in the patient's spinal, paraspinal and area where the block will be applied
* The patient does not accept the block application or cannot cooperate with the patient
The Lifestyle Education About Nutrition for Diabetes (Legend) Study

This study is being completed to compare two dietary approaches for participants with type 2 diabetes. This research will test whether a very low-carbohydrate or a plate-method diet better improves outcomes for blood glucose control and body composition for patients with type 2 diabetes that follow one of these approaches for 12 months.

Participants that meet screening and eligibility will be randomized to one of the two diets. In addition to the diet, study specific visits and assessments will be performed at various timepoints.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 diabetes, with current HbA1c \> 6.5% and \< 12% (self-reported and then measured at screening)
* ability to speak English (this is a group-based intervention)
* ability to engage in light physical activity
* willingness to be randomized to either type of diet

Exclusion Criteria:

* unable to provide informed consent
* substance abuse, mental health, cognitive, or medical condition that would, in the opinion of the investigators, make it difficult for the individual to take part in the intervention, may alter key outcomes, or may require important diet modifications and includes conditions such as hypercalcemia or thyroid dysfunction
* pregnant or planning to become pregnant in the next 12 months, or currently breastfeeding (pregnancy and breastfeeding require modifications to the intervention's dietary approaches)
* current use of weight loss medications (this is likely to alter weight outcomes and may alter other measures)
* history of weight loss (bariatric) surgery or plans for bariatric surgery in the next year
* currently enrolled in a weight loss program or have unalterable plans to enroll in one of these programs in the next year
* vegan or vegetarian
* unwilling or unable to participate in study measurements and group classes
* current use of systemic steroids (self-reported in screening survey; oral or IV systemic steroids excluded. Injected steroids may be permitted depending on frequency and timing of injections with regard to lab assessments (minimum of 2 weeks between injection and blood tests))
* weight above 400 pounds (weight limit for dual-energy X-ray absorptiometry (DEXA) scans)
* history of multiple or recent (within the last four years) kidney stones
* currently following a very low-carbohydrate diet
* unwilling to stop an SGLT2 inhibitor medication if the participant were to be randomized to the very low-carbohydrate diet
Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline

The goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in cognitively healthy adults and older adults diagnosed with mild cognitive disorder (MCI). The main questions it aims to answer are:

* whether it is possible to restore various cognitive functions in older adults diagnosed with MCI by delivering theta burst stimulation (TBS), a form of transcranial magnetic stimulation, and
* whether closed-loop TBS is able to induce therapeutic benefits that outperform open-loop TBS.

Participants play a cognitive video game while a brain-computer interface (BCI) analyzes their electroencephalogram (EEG) signals and decodes the presence or absence of the contingent negative variation (CNV) potential, a marker of cognitive control. The BCI triggers TBS when its outputs indicate that the participant is not engaged properly in the video game.

Researchers will compare the effects of sham, closed-loop, and open-loop TBS using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.


Eligibility Criteria:
Inclusion Criteria:

* Cognitively normal younger adults

  1. Ages between 18 to 35 years
  2. Good general health
  3. Normal or corrected vision
  4. Completed elementary school education or able to understand middle school level experiment instructions
* Cognitively normal older adults

  1. Ages between 60 to 90 years
  2. Good general health
  3. Normal or corrected vision
  4. Completed elementary school education or able to understand middle school level experiment instructions
  5. Score of 23 or higher on the Montreal Cognitive Assessment, a brief formal cognitive screening test, which is used to indicate absence of cognitive impairment
* Older adults with mild cognitive impairment (MCI)

  1. Ages between 60 to 90 years
  2. Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria
  3. Good general health
  4. Normal or corrected vision
  5. Completed elementary school education or able to understand middle school level experiment instructions

Exclusion Criteria:

1. Neurological or psychiatric diseases (e.g., personal history of epilepsy/seizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.).
2. Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.)
3. Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.)
4. Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.)
5. Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)
Related Factors of Hp Infection in Physical Examination and Community Population in Hunan Province

This study intends to investigate the prevalence and risk factors of Helicobacter pylori (H. pylori) infection in the population of physical examination centers and communities. The physical examination population from the health management center of the Third Xiangya Hospital and the family-based community residents in Changsha were randomly selected. The H. pylori infection was detected by carbon-13 urea breath test (13C-UBT), and the related factors of H. pylori infection were investigated by questionnaire survey. The study provides supporting evidences to implement family-base H. pylori management to curb its intrafamilial spread. The results have important clinical implications in refinement of eradication strategies and impact on public health policy formulation for related disease prevention.


Eligibility Criteria:
Inclusion Criteria:

1. population aged 4-90 years, no requirement for gender;
2. the physical examination population from the health management center of the Third Xiangya Hospital;
3. the family-based community residents in Changsha City \[families containing two or more family members (living together for more than 10 consecutive months per year) and the family members aged 3 years and above\];

Exclusion Criteria:

1. people with use of antibiotics, bismuth or Chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13C-UBT, or H2 receptor antagonists, PPIs, P-CAB or other drugs affecting H. pylori activity within the previous 2 weeks of 13C-UBT;
2. people with H. pylori treatment within the past 3 months;
3. People who fasted less than 3 hours before 13C-UBT;
4. people with other contraindications to performing 13C-UBT;
5. people living alone in a family;
6. people with incomplete questionnaire information;
7. people with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on;
8. people with mental illness and communication disorders;
9. people deemed unsuitable by the researchers to participate in this project;