cyrilzakka/clinical-trials huggingface dataset:
Multinational Haemapheresis Vigilance Study

During a seven years period the participating transfusion medicine establishments will report all their non-trivial adverse events (AE) occurring during preparative hemaphereses. Complications may be related to the blood donors, the blood products, the disposables or the apheresis devices. The study hypothesis regarding each participating center is that their procedure-related AE rate is not higher than the respective rate of all other centers in total.

In the scope of this study the participating transfusion medicine establishments obligate themselves to record all significant Adverse Events (AE) related to preparative hemaphereses of healthy donors. All complications (phlebotomy and circulation problems, citrate toxicity, donor compliance, and technical complications) shall be assessed with respect to plasma-, platelet-, leukocyte- (stem cells, granulocytes, monocytes), and red cell aphereses as well as multicomponent aphereses. Study data are recorded by means of an Internet-based hemapheresis vigilance system. Study results will be evaluated according to the advanced standards of the International Haemovigilance Network (IHN). The study contributes to the quality assurance of each single center as it enables the comparison to other transfusion medicine establishments.

Eligibility Criteria:
Inclusion Criteria:

* blood donor standard criteria :
* healthy donor of \> 50 kg
* hemoglobin 125 g/L or 7.8 mmol/L (female donors)
* hemoglobin 135 g/L or 8.4 mmol/L (male donors)
* hemoglobin \> 140 g/L for 2 unit red cell apheresis
* total proteins \>= 60 g/L for plasmapheresis
* platelet count \>= 150 × 10e9/L for platelet apheresis
* blood volume of \> 5 L for 2 unit red cell apheresis
* normal leukocyte count
Early-phase Exercise-based Cardiac Rehabilitation After MI

This study aimed to investigate the effects of early-phase exercise-based supervised cardiac rehabilitation on functional exercise capacity, grip strength, fatigue, sleep quality, and health-related quality of life.

Myocardial infarction (MI) is not only a severe form of coronary heart disease but also a leading cause of death and physical disability, particularly in the rapidly growing elderly population. Although percutaneous coronary interventions reduce mortality, ensuring the recovery and reintegration of discharged patients into society remains an unresolved issue. Cardiac rehabilitation (CR) is beneficial for patients with MI in terms of reducing cardiovascular mortality and hospital readmissions, managing cardiovascular risk factors, and improving aerobic capacity.

CR is a comprehensive intervention tailored to the individual needs of patients diagnosed with heart disease. It includes personalized exercise training, physical activity promotion, health education, cardiovascular risk management, and psychological support. Initial recommendations for CR were limited to low-risk patients following MI. However, over the past two decades, with the accumulation of evidence supporting the benefits of CR, current clinical guidelines now routinely recommend comprehensive CR for a broader range of cardiac diagnoses, including acute coronary syndrome and heart failure with reduced ejection fraction.

Until two decades ago, studies recommended starting CR in the early phase, defined as the second-week post-discharge. However, in the past decade, CR initiation with very low-intensity exercise activity as early as one week after MI onset has been reported as safe and effective. More recently, studies have shown the beneficial effects of terminating bed rest within 12-24 hours and initiating bedside activities. Phase I exercise-based CR has been shown to be effective in improving exercise capacity and preventing recurrent cardiac events. Nonetheless, concerns remain regarding early exercise-based CR due to exercise-induced ischemia after acute MI. While the effects of early rehabilitation initiated post-MI have been investigated in the literature, sufficient evidence has yet to be established.

Eligibility Criteria:
Inclusion Criteria:

* Clinically and medically stable patients with first MI
* Prescribed cardiac rehabilitation by a cardiologist
* Being between 30-65 years old
* having ejection fraction (EF) of more than 20% (i.e. EF≥ 20%)
* being volunteer to participate

Exclusion Criteria:

* having coronary artery bypass graft surgery
* Being diagnosed with chronic renal failure
* Presence of unstable angina
* Atrial fibrillation
* Severe and symptomatic aortic stenosis
* Presence of decompensated heart failure
* Exercise-induced myocardial ischemia,
* Pericardial disease,
* Moderate-to-severe valve disease
* COPD or asthma
* BMI \> 40 kg/m2
* Orthopedic and neurological problems that prevent exercise
INSTRUMENTED-MANUAL PHYSIOTHERAPY VERSUS NONINSTRUMENTED

This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.

Background: There are several therapies currently used to treat myofascial trigger points, including conservative and invasive techniques. It has been shown that conservative techniques including therapeutic massage, stretching, transcutaneal electrical nerve stimulation, spray and stretch, cold laser treatment, and ultrasound are the most applied treatments for myofascial pain syndrome, but no single strategy has proved to be universally successful. Instrumented massage has shown clinical effectiveness on shoulder pain, low back pain, and only one study (case report) on myofascial trigger points. This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.

Methods/Design: The study includes 31 volunteers with myofascial trigger points on right trapezius muscle. Clinical and patient data were obtained from questionnaires, VAS, algometry, sono-myoelastography and myotonometry. Also, physiotherapist grip strength was measured. Subjects were randomly allocated into one of two groups: Instrumented massage or Manual massage. The intervention consisted in a single 20 minutes session of massage on the back and neck by the same therapist, depending of the group, massage was applied manually or instrumented.

Eligibility Criteria:
Inclusion Criteria:

* • To be of legal age.

  * To understand correctly Spanish.
  * To show their approval by signing the informed consent.
  * Suffering from mechanical neck pain

Exclusion Criteria:

-
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.

Exclusion Criteria:

* Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Emergency Surgery

The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after emergency surgery.

The investigators identify all patients treated with emergency surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients Undergoing Emergency Surgery

Exclusion Criteria:

* Patients with incomplete electronic medical record information
Whether Probiotics Use in Neonate and Infant Improve Their Mother's Life Quality

Postpartum depression and poor quality of life during postpartum were an vital issue in recent years. Infant's health condition was thought to be a possible reasons related mother's postpartum quality of life, and functional gastrointestinal disorders such as infantile colic and regurgitation were common problem during infant period. Previous study revealed that probiotics may improve the infant's discomfort caused by functional gastrointestinal disorders. Thus, this study aimed to investigate whether probiotics use in neonate and infant improve their mother's life quality?

This is single blinded intervention study. The investigators will invite mother to participate in the project after giving birth. At week 0, mother who meet the eligibility criteria will be randomized in a single-blind study in a 1:1 ratio to probiotics with Vit. D3 (five drops per day) or Vit. D3 (placebo) (single drop per day) for 90 days. The follow-up will be at the 1, 3 and 6 months all the subjects.

Eligibility Criteria:
\<Participants of neonates\>

Inclusion Criteria :

* Gestational age more than 37 to less than 41 weeks
* Age less than 1 week on entry into the study
* Birth weight adequate for gestational age
* Apgar score of more than 8 at 10 minutes

Exclusion Criteria:

* Congenital disorders and/or clinical or physical alterations at clinical examination
* Antibiotic or probiotic administration before inclusion
* Admission to ICU

\<Participants of neonates' mother\>

Inclusion Criteria:

* Aged between 20-50 and baby included in our study

Exclusion Criteria:

* Diagnosed as psychiatric disease during antepartum period or before pregnancy
Stratifying Risk for Intracerebral Haemorrhage

This study aims to investigates the role of gestational age on the prevalence of coagulation factors and components of the complement system in preterm- (≤32+0 weeks) and term neonates (≥37+0 weeks) and their role for the development of brain hemorrhage.

The occurrence of brain hemorrhage (germinal matrix hemorrhage and intraventricular hemorrhage, GM-IVH) in newborns, especially in preterm infants, is one of the most important prognostic factors for mortality and morbidity (especially for later neurological development) in this collective. The risk of high-grade bleeding in extremely premature infants (22 weeks) is approx. 38% and decreases to approx. 7% by the 28th week. The total frequency of GM-IVH is around 8% in gestational weeks 23 to 31, with each additional gestational week reducing the risk by 3.5%. The etiopathology of brain hemorrhage is complex and involves both environmental and genetic factors. Recent studies particularly suggest an involvement of the immature coagulation system in preterm neonates. Global coagulation parameters, such as the International Normalized Ratio (INR), have already been associated with an increased risk of bleeding, but rarely show fluctuations outside the norm. Furthermore, polymorphisms in the area of individual coagulation factors as well as other inflammatory and vascular individual components of coagulation, are associated with an increased risk of bleeding. Mass spectrometry has long been used for the analysis of biological samples and has developed into an indispensable tool for proteomics research. The study aims to establish the mass spectrometric detection of a total of 125 blood plasma factors containing the individual components of the coagulation system and the complement system. The method enables quantitative detection of the coagulation system with even the smallest sample quantities, so that sampling can be combined with routine measures, particularly in the field of neonatology. This pilot study to compare the compositional differences regarding coagulation factors and the complement system in relation to the gestational age (i.e. preterm ≤32+0 weeks vs. term neonates ≥37+0 weeks).

Eligibility Criteria:
Inclusion Criteria:

* medical indication (newborn screening) and informed consent for blood drawing

Exclusion Criteria:

* clinical evidence of infection
* clinical evidence of hyperbilirubinemia
* Preeclampsia (PE), HELLP-syndrome, intrauterine growth restriction (IUGR) and PE+IUGR
Effects of Vitamin A Supplementation on Intestinal Parasitic Reinfections

Intestinal parasitic infections, malnutrition and iron deficiency anaemia (IDA) are still considered as public health problems in rural Malaysia especially among Orang Asli children. Despite intermittent control programmes, the prevalence of these problems is still high suggesting the need of other control and interventions measures. This randomized double-blind, placebo-controlled trial was carried out among Orang Asli schoolchildren from Sekolah Kebangsaan Betau in Pos Betau, Pahang (200 km northeast Kuala Lumpur) to investigate the effects of vitamin A supplementation on intestinal parasitic reinfections, growth, iron status and educational achievement.

HYPOTHESES

1. Vitamin A supplementation has a negative effect on intestinal parasitic reinfections and the worm burden of infections among Orang Asli schoolchildren in Pos Betau, Kuala Lipis, Pahang.
2. Vitamin A supplementation has a positive effect on growth (weight and height) among Orang Asli schoolchildren.
3. Vitamin A supplementation is effective in improving serum iron status among Orang Asli schoolchildren.
4. Vitamin A supplementation has a positive effect on cognitive function and educational achievement among Orang Asli schoolchildren.

Children from Sekolah Kebangsaan Betau in Pos Betau, Kuala Lipis, Pahang served as the target population for this study.

The selection criteria for study subjects were the following:

* Age 7-12 years (according to birth date in birth certificate).
* Non-menstruating females (age \<13)
* No history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
* No evidence of concomitant severe and/or chronic illness such as acute respiratory tract infections, mental retardation and neurological deficits.
* Consent of parent to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 7-12 years (according to birth date in birth certificate).
* No evidence of concomitant severe and/or chronic illness such as acute respiratory tract infections, mental retardation and neurological deficits.
* Consent of parent to participate in the study.

Exclusion Criteria:

* history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
* menstruating females (age \>13)
Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up

The objective is a 3-year follow-up clinical trial to evaluate longitudinal indicators of periodontal disease (plaque score, bleeding on probing (BOP), and gingival index (GI)) in 58 participants who completed NCT03571958. These participants were randomized to a brief motivational (BMI) test group or a traditional oral hygiene instruction (OHI) group for a 1-year clinical trial from 2018-2020.

In addition, analysis of retrospective data to determine health topics that emerge from the behavior change strategy of BMI compared to traditional OHI by transcription of audio recordings from 2018-2020.


Eligibility Criteria:
Inclusion Criteria:

° Completed all study visits of STUDY00003697 (NCT03571958)

Exclusion Criteria:

* Current smoker or quit smoking within the last year
* Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
* Uncontrolled diabetes (HbA1C \> 7)
* Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS)
* Current use of oral bisphosphonates
* History of IV bisphosphonates
* Require pre-medication or on long-term antibiotics
* Current orthodontic treatment or planning to begin orthodontic treatment during the study
* Unable to comply with the study protocol
Randomized Controlled Trial of Internal Fixation Reconstruction With Stent Screw in the Treatment of Kummell's Disease

This study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (Kummell's disease) are better with the use of stent screw internal fixation and percutaneous bone cement reconstruction technique compared to patients undergoing traditional percutaneous balloon kyphoplasty (BKP) for vertebral augmentation


Eligibility Criteria:
Inclusion Criteria:

* Age 60 or above, gender not specified.
* Must have one to three vertebral segments with vertebral compression fracture (VCF) located between T5 and L5, attributed to underlying primary or secondary osteoporosis rather than cancer.
* All VCFs must exhibit the following radiographic changes: according to Genant's criteria, acute (≤4 months) decrease in anterior, middle, or posterior vertebral height by at least one grade (20-25% reduction in vertebral height, 10-20% reduction in vertebral area) compared to previous X-ray, CT, or MRI results.
* All VCFs for treatment must occur within four months or less.
* All VCFs for treatment must be technically feasible and clinically suitable for BKP or SAIF surgery.
* Pre-treatment back pain NRS score must be ≥ 7 and ineffective with conservative (non-surgical) treatment.
* Pre-treatment Oswestry Disability Index must be ≥ 30 (on a scale of 0-100).
* Patient's life expectancy must be ≥ 12 months.
* Must declare willingness to participate in all post-operative follow-ups.
* Must be capable of understanding the risks and benefits of the study and willing to provide written informed consent.

Exclusion Criteria:

* Vertebral morphology or fracture morphology unsuitable for balloon kyphoplasty. VCF caused by high-energy trauma.
* Asymptomatic VCF or vertebral bodies amenable to prophylactic treatment.
* VCF at the same site associated with primary bone tumors.
* Back pain caused by reasons other than acute fractures. VCF with an estimated fracture time of more than 4 months, based on clinical assessment (radiological evidence and patient history).
* VCF associated with secondary radiculopathy or neurological compromise.
* VCF requiring spinal surgery other than BKP or SAIF.
* Spinal cord compression or vertebral canal injury requiring decompression surgery.
* Combined clinical conditions unsuitable for surgery or affecting subsequent long-term data collection or follow-up.
* Allergy to any component during the surgical procedure (e.g., bone cement, contrast agents).
* Concurrent participation in another clinical study.
* Pregnancy during the study or planning to become pregnant.
The Effects of Vitamin B-6 and Coenzyme Q10 Status on Oxidative Stress, Antioxidant Capacities, and Inflammatory Responses in Patients With Liver Cancer

Carcinoma is the leading cause of worldwide. Hepatocellular carcinoma (HCC) is the second cause of cancer mortality in Taiwan. Vitamin B-6 and coenzyme Q10 has been recognized as antioxidants and anti-inflammatory nutrients in recent clinical studies. The purposes of this study are going to investigate the relation of vitamin B-6 and coenzyme Q10 with the indicators of oxidative stress, antioxidant enzymes activities and the inflammatory markers in patients with stage 1 and stage 2 HCC. The study is designed as an intervention study. The investigators will recruit HCC patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy. HCC subjects are randomly assign to placebo, vitamin B-6 (50 mg/d), coenzyme Q10 (300 mg/d), and vitamin B-6 plus coenzyme Q10 supplements groups. Intervention is going to administration for three months. The concentrations of vitamin B-6, coenzyme Q10, oxidative stress indicators, antioxidant enzymes activities, antioxidant vitamins (vitamin A and E), and inflammatory markers are going to be analyzed. The results would provide more information nutrients for clinical physicians and dietitians for considering suggesting patients with HCC using vitamin B-6 or coenzyme Q10 supplementation to improve their clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

- The HCC patients with stage 1 and stage 2 (n = 150) who are identified by liver biopsy.

Exclusion Criteria:

* age \< 20 years old.
* The patients who had heart, renal, gestational, diabetes, or other metabolic diseases.
* Under the medications which may interfere the vitamin B-6 or coenzyme Q10 concentrations, such as phenobarbital, phenytoin, cycloserine, pyrazinamide, isoniazid, (thio)semicarbazide, hydramitrazine, phenelzine, carbidopa, levodopa, hydralazine, steroids, penicillamine, ,Statin, or Warfarin.
* The women who are during pregnancy or Lactation.
* The women who are taking the oral contraceptives.
* The subjects who are taking the dietary supplements, such as vitamin B-6, coenzyme Q10, or other antioxidant vitamins.
High Intensity Interval Training in Chronic Stroke

Both gait and cardiovascular dysfunction are primary factors limiting community ambulation for stroke individuals. Increased gait variability and asymmetry contributes to a higher risk of falls, leading to reduced physical activity, decreased cardiorespiratory endurance, and increased walking economy and sympathetic nervous system activity, thereby potentially triggering secondary strokes. Previous studies have primarily focused on the significant improvements in walking endurance and speed with high-intensity interval training (HIIT) on a treadmill, leaving a gap in understanding the effects of HIIT on oxygen uptake efficiency slope (OUES) and gait quality for stroke individuals using a stationary bicycle ergometer with exergaming. Therefore, this study aims to investigate the effects of HIIT using a stationary bicycle ergometer on improving cardiorespiratory fitness and gait quality in individuals with chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-69 years
* At least 6 months post-stroke
* Functional Ambulation Category (FAC) ≥ 3
* Mini-Mental State Examination (MMSE) ≥ 24
* Able to walk 10 meters overground with or without assistive devices

Exclusion Criteria:

* Unstable cardiopulmonary conditions within the last 3 months
* Other chronic neurological disorders
* Contraindications to exercise as recommended by the American College of Sports Medicine (ACSM)
* Severe lower limb spasticity (Modified Ashworth Scale \> 2 points)
* Implanted pacemaker or cardioverter defibrillator