cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease

The purpose was to evaluate as to whether administration of infliximab of 12 week interval with supplementary VSL#3 is more effective or at least of similar efficacy when compared to conventional administration of infliximab only of 8 week interval.

The purpose of our study was to evaluate if supplementation of VSL#3 can improve treatment outcome for those pediatric Crohn's patients treated with infliximab every 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who were diagnosed with severe Crohn's disease who require infliximab treatment
* confirmed diagnostic of Crohn's disease in clinical, endoscopic and histological findings

Exclusion Criteria:

* patients who has proven to have infliximab antibody
Effects of a Machine Learning-based Lower Limb Exercise Training System for Knee Pain

The study will be a 12-week randomized controlled trial that aims to examine the effects of a machine learning-based lower limb exercise training system for older adults with knee pain. Participants will be randomly allocated to either the machine learning-based lower limb exercise training system group (intervention arm), video-based exercise training system group (intervention arm), or usual care group (control arm). Data will be collected at baseline, and at 4, 8, and 12 weeks after randomization.

Knee pain, often caused by osteoarthritis, is a prevalent musculoskeletal disorder among older adults and significantly reduces physical function and quality of life. Exercise therapy has been shown to be an effective form of treatment for knee pain. However, the traditional delivery of exercise therapy requires that individuals attend clinics to participate in face-to-face exercise sessions, which can be expensive and inconvenient. In recent years, information technologies have been used to support the delivery of exercise programs. The programs have also shown great benefits in improving the management of knee pain. However, it remains a concern that physical therapists are not able to provide the patients with direct and immediate supervision when exercises are taken place remotely at home or in community centers, which can be detrimental to exercise performance and the management of knee pain.

Thus, the research team has developed a machine learning-based exercise training system to provide evidence-based lower limb exercise videos, real-time movement feedback, and tracking of exercise progress for older adults with knee pain. In this study, a proof-of-concept randomized controlled trial will be conducted to examine the effects of the machine learning-based exercise training system, comparing with the effects of video-based exercise training system (providing exercise videos alone but no real-time movement feedback or tracking of exercise progress) and effects of usual care.

Eligibility Criteria:
Inclusion Criteria:

Participants will be recruited if they

* age ≥ 55 years,
* have knee pain, stiffness, or both in one or both knees on most days for at least one month during the past 12 months, or have consulted healthcare professionals with their pain, stiffness, or both in one or both knees during the past 12 months,
* are able to perform the exercises required in physical assessments and exercise training,
* are able to speak and read Chinese,
* are able to provide written informed consent.

Exclusion Criteria:

Individuals will be excluded if they have

* inflammatory arthritis,
* acute trauma,
* malignancy,
* history of knee replacement,
* being on the waiting list for knee surgery,
* physical therapy for knee problems during the past three months,
* intra-articular injection to the knee within six months.
Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne

This is a clinical trial to compare the benefits and possible adverse events of two antibiotic treatments for mild to moderate acne. It is expected that minocycline microgranules will be more effective than lymecycline with a better adverse events profile.


Eligibility Criteria:
Inclusion Criteria:

* Both gender
* 14 to 30 years old
* Mild to moderate acne
* Face localization
* At least 20 non-inflammatory lesions OR
* At least 15 inflammatory lesions OR
* At least 30 total lesions AND
* Less than 5 nodular lesions

Exclusion Criteria:

* Patients younger than 14 or older than 30 years old
* Less than 20 non-inflammatory lesions OR
* Less than 15 inflammatory lesions OR
* Less than 30 total lesions
* Patients with severe acne
* More than 5 nodular lesions OR
* More than 50 inflammatory lesions OR
* More than 125 total lesions
* Pregnant women
* Lactating women
A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia

The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone for hemodynamic stability and quality of sedation in elderly patients under spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 65 years
* ASA physical status class I-II
* the patients who want sedation during elective lower limb surgery under spinal anesthesia

Exclusion Criteria:

* contraindication to spinal anesthesia
* neurologic or cognitive dysfunction
* severe cardiovascular or pulmonary disease
* refusal to participation
Effects of Pulmonary Rehabilitation on Functional and Health Status Measures in Pulmonary Fibrosis

The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis.

The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis. This study reports outcomes of an observational, quasi experimental type of study. A total of 120 participants were recruited: 60 patients formed part of the active group, another 60 patients were enrolled in an inactive group. Each participant was classified according to the modified Medical Research Council dyspnoea scale and placed in one of 5 categories (0 to 4) according to self-perceived breathlessness during daily activities. The following outcomes were measured: Lung function tests including plethysmography and diffusion capacity of carbon monoxide (DLCO), functional tests (6-minute walking test, Dyspnoea Borg Scale) and Health status measures (St George's Respiratory Questionnaire and HAD score).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of Pulmonary Fibrosis
* Patients had to be medically stable to participate in such a programme

Exclusion Criteria:

* Any orthopaedic or neurological condition affecting mobility
* If they required oxygen therapy this had to be used
Pain Evaluation of Venous Cannulation to Predict Postoperative Pain

The investigators have recently reported a relationship between pain induced by peripheral venous cannulation and postoperative pain. The purpose of this study is to validate this method of postoperative pain prediction in a larger cohort subjected to different types of surgery.

* The investigators will study all adult (\>18 years old) patients going through surgery at the site during a defined period of time. Before induction of anesthesia participants will be asked to assess (in VAS units) the pain intensity associated with peripheral venous cannulation. The maximum level of postoperative pain intensity will be recorded in the post-anesthesia care unit.
* After the endpoint of the study, the patient records will be reviewed, and de-identified relevant data be recorded and analyzed in the Statistical Package for the Social Sciences (SPSS) software.
* Sample size assessment: In a previous study patients scoring ≥ 2.0 on venous cannulation assessed their median pain postoperatively at 5.8 VAS units compared with 2.9 in those scoring \< 2.0 - corresponding to a difference in maximum postoperative pain intensity of almost three VAS units. To statistically confirm, with unpaired non-parametric tests, 80 % power (β), and 95% probability (1- α), half of that difference (1.5 VAS units) in pain intensity level between patients scoring above or below 2.0 VAS units, respectively, would require 55 patients in each group subjected to the same kind of surgery. With 4 groups of cases and controls 440 patients would need to be included. As the study is strictly observational, 600 patients will be included to make up for possible missing data.
* Statistics: The Mann-Whitney U- test will be used to compare differences in postoperative pain intensity levels, and the Pearson Chi-square test to compare proportions of patients with moderate or severe postoperative pain, in patients differing in pain scores (above or below 2.0 VAS units) on venous cannulation. Logistic regression analysis will be used to adjust for gender and age and to evaluate the predictive ability of proposed method.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Scheduled for surgery in Halmstad
* Prepared for surgery in the preoperative ward or ward 71 (day-case or direct admittance)

Exclusion Criteria:

* Inability to handle the Visual Analog Scale
* Hospitalized already before surgery
The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power

Several studies suggest fully-automated ventilation to ventilate with a lower amount of MP in unselected ICU patients, patients after cardiac surgery, and patients with and without ARDS. The current study will directly compare the amount of MP in invasively ventilated critically ill patients by calculating MP breath-by-breath, using the various equations proposed in the literature.

Rationale:

Mechanical ventilation can cause ventilator-induced lung injury (VILI). Lung protective ventilation, consisting of a low tidal volume (VT), a low plateau pressure (Pplateau) and a low driving pressure (ΔP) improves survival and shortens duration of ventilation in patients with acute respiratory distress syndrome (ARDS). Lung protective ventilation may also benefit critically ill patients with respiratory failure not caused by ARDS. 'Mechanical Power of ventilation' (MP), the amount of energy per time transferred from the ventilator to the respiratory system, is a summary variable that includes all the components that play a role in VILI. With fully-automated closed-loop ventilation, these components are no longer set by the operator, but under control of the algorithms in the ventilator.

Objective:

To compare MP under INTELLiVENT-adaptive support ventilation (ASV), a fully-automated closed-loop ventilation, with MP under conventional ventilation.

Hypothesis:

INTELLiVENT-ASV compared to conventional ventilation results in a lower MP.

Study design:

National, multicenter, crossover, randomized clinical trial.

Study population:

Invasively ventilated critically ill patients.

Methods:

The ventilator will be randomly switched between INTELLiVENT-ASV for 3 hours and conventional ventilation for 3 hours. The amount of MP is calculated using various equations proposed in the literature.

Study endpoints:

The primary endpoint is the amount of MP with each form of invasive ventilation.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Differences in burden and risks of the two ventilation strategies compared in the current study are not expected. Both modes of ventilation are interchangeably used as part of standard care in the participating centers. No other interventions are performed. Neither the collection of demographic and outcome data, nor the capturing of ventilation characteristics causes harm to patients.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to one of the participating ICUs;
* Receiving invasive ventilation through a standard endotracheal (i.e., oral) tube;
* Expected to be ventilated \> 24 hours; and
* Ventilation is applied by a ventilator that can provide INTELLiVENT-ASV and conventional ventilation.

Exclusion Criteria:

* Age under 18 years;
* No written informed consent;
* Morbidly obese; and
* Any contra-indication for use of INTELLiVENT-ASV
Impact of Weight Loss Induced by Bariatric Surgery or Nutritional Management on Sexual Function in Men With Severe Obesity

Study of the impact of weight loss induced by surgery (interventional group) or optimal nutritional management (control group) on sexual function in men with severe obesity


Eligibility Criteria:
Inclusion Criteria:

* Severe obesity with BMI\> 25 kg / m2

Exclusion Criteria:

* Patient having undergone sterilization
NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia

The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m\^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.

In addition to the details above we will also explore

* the relationship of the post-HD-MTX MRD-levels with the dose of 6MP, TPMT-activity, DNA-6TGN, E-6TGN, E-MeMP, E-MTX, and presence of ASP-antibodies,
* the early development of anti-ASP antibodies during continuous PEG-ASP therapy.

The study could improve the understanding of the pharmacodynamics of the 6MP/HD-MTX interaction in combination with PEG-ASP.

Eligibility Criteria:
Inclusion Criteria:

* B-lineage ALL
* 1-17.9 years
* WBC \<100, clinical remission obtained day 2
* Written consent to participation.

Exclusion Criteria:

* t(9;22)
* Hypodiploidy
* 11q23-aberrations
* TPMT-deficiency
* Intolerance to MTX or 6MP
The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)

To test the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with IBS.

Irritable bowel syndrome (IBS) is a diagnosis in Western Medicine characterized by recurrent abdominal pain associated with disturbance in bowel habit such as diarrhea or constipation. Epidemiological studies showed that 14% of males and 27% of females in the US (white) have symptoms of IBS. In Hong Kong, our survey reported a similar prevalence of this condition among Chinese (13% in males and 21% in females). IBS is one of the most common conditions leading to seeking of medical care. Treatment for IBS has so far been unsatisfactory. Numerous medications have been proposed for IBS; however, none is convincingly effective. A review and critique of published drug trials for IBS from 1966 to 1988 concluded that there was no proof that any western medicine is effective for all IBS patients. With the unsatisfactory treatment response of western medicine, many turned to alternative treatment modalities for IBS. Traditional Chinese medicine is particularly attractive as their effectiveness in treating functional disorders and retaining balance of body functions has been known for centuries. However, there is a lack of convincing clinical data demonstrating the effectiveness of Chinese medicine in this condition. In this study, we sought to determine the efficacy of herbal medicine in relieving symptoms and quality of life of patients with IBS. This is a prospective randomized, double-blinded double placebo-controlled study in patients with non-constipation type IBS. Patients will be randomized to receive either one of three treatment arms: 1. herbal medicine (HM) + placebo western medicine (WM), 2. WM + placebo HM and 3. placebo HM + placebo WH. Each patient will go through an 8-week period of randomized double-blind treatment with either HW, WM or placebo and followed by an 8-week of observation period. The IBS symptom and quality of life will be compared.

Eligibility Criteria:
Inclusion Criteria:

* All patients (aged 18-65) attending the Gastroenterology Clinic of the Prince of Wales Hospital or Hong Kong Baptist University Chinese Medicine clinics for symptoms of IBS will be enrolled in the study.
* IBS is diagnosed by Rome II criteria \[Thompson et al. Gut 2000\]: At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has two of three features: relieved with defecation; and/or onset associated with a change in frequency of stool; and/or onset associated with a change in form (appearance) of stool
* Normal colonic evaluation (colonoscopy or barium enema) in recent 5 years
* Mean score of abdominal discomfort/pain,based on a 5-point scale,at baseline and during the 2-week run-in period
* Informed written consent for participation into study.
* Ethical approval will be obtained from the Clinical Research Ethics Committee of the University
Intrapartum Fever and Histopathological Placental Findings

Intrapartum fever associated with epidural anesthesia is caused by non infectious causes therefore without histological findings


Eligibility Criteria:
Inclusion Criteria:epidural with and without fever

-

Exclusion Criteria:

* Patients with infectious backgroud or prilinged PROM
To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma

To investigate the molecular mechanism of traditional Chinese medicine constitution, the investigators proposed a randomized, double-blind, placebo-controlled, phase II trial to recruit 120 patients with nasopharyngeal cancer. Next generation sequencing, immune repertoire, gut microbiota, traditional Chinese medicine constitution and tongue diagnosis would be examined before/after 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy in this project. The correlation between different examinations would be analyzed to investigate the molecular mechanism of traditional Chinese medicine constitution. Disease survival, recurrence, and quality of life would be also followed up for two years to evaluate the benefit of Danggui BuxueTang.

The basis for academic excellence is the interdisciplinary cooperation. The individualized medicine is the future trends, and the theory of body constitution is the most potential study for the individualized medicine and to research the process and prognosis of disease. Technique of next-generation sequencing (NGS) is also involved to comprehend to the mechanism of the prescriptions under the theory of body constitution.

The nasopharyngeal cancer is a Chinese-specific disease, and radiation therapy has remarkable effect. There are many studies proving that Traditional Chinese medication can relieve the side effect of radiation therapy. The study will combine next-generation sequencing and TCM diagnostic tool, and analyze the transformation of body constitution and the performance of genes related to radiation therapy. The results may reveal the molecular mechanism of TCM constitutions and the benefit of Danggui BuxueTang, and may be used for early screen and prevention to other cancers or diseases. Furthermore, it can help to develop the potential drugs.

The study plans to collect 120 cases within two years. The participants would be divided randomly to the experimental group and control group. The blood sample would be taken for next generation sequencing analysis before the radiation therapy, and after the radiation therapy combined with traditional Chinese medication. The result of samples would be compared with each other to identify "Qi deficiency gene" and "TCM effective gene".

Eligibility Criteria:
Inclusion Criteria:

Patients with pathological diagnosis of nasopharyngeal carcinoma stage II \~ IVa (AJCC eighth edition) preparing to receive concurrent chemoradiotherapy

Exclusion Criteria:

* Pregnant or lactating women
* ECOG PS (ECOG performance status) scores of over 2 points for each day's performance assessment
* Take anticoagulants or antiplatelet agents such as aspirin, warfarin, etc.
* Cannot accept routine treatment, or can not cooperate with the research program
Stress Ball Use on Anxiety

Stress management in dialysis patients plays a key role in reducing these negativities and in maintaining both physical and mental well-being. In dialysis patients, on the other hand, the effectiveness of stress ball use on comfort and stress was evaluated, and no study was found that evaluated its effect on anxiety.

Stress ball is one of the non-pharmacological methods used to distract individuals when they consciously focus on a stimulus. With the squeezing of the ball, the nerves in the hands are stimulated and stimuli are sent to the limbic region of the brain, and these stimuli provide an acupressure effect. At the same time, it is the easiest and cheapest method that allows the mind to get away from stress and maintain the mental well-being of the person.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* On maintenance hemodialysis three times per week for four hours per session
* Able to communicate in Turkish
* Willing to participate to the study

Exclusion Criteria:

* Having any health problems related to the hand/arm to use the stress ball
* Patients who did not want to participate in the study