cyrilzakka/clinical-trials huggingface dataset:
Mineral Water for Prevention of Renal Stones

The investigators would like to assess if the intake of high bicarbonate mineral water would not only increase total fluid intake but will also be able to give patients the additional benefit of correcting the urinary abnormalities which may predispose them to stone formation.

The life time risk of developing nephrolithiasis is about 10-15% in the western world, but can be as high as 20-25% in the middle east. Evidence suggests that the incidence and prevalence of kidney stones is increasing globally which represent a significant economic burden. Besides the lack of hydration, the most common metabolic abnormalities associated with calcium stones are hypercalciuria, hypocitraturia and hyperoxaluria. In addition, low urinary pH from consumption of non-dairy animal protein has been associated with reduced urinary citrate and increased uric acid stones which form a nidus for subsequent calcium oxalate precipitates.

Dietary modification is the first line approach in the treatment of idiopathic calcium oxalate (CaOx) nephrolithiasis. General advice includes adequate hydration, avoiding oxalate-rich foods, and consumption of an adequate amount of calcium. Adequate hydration is an easy and effective way of preventing stones. Siener et al found in healthy men, consumption of mineral water rich in magnesium and bicarbonate resulted in favourable changes in urinary pH, magnesium and citrate excretion (inhibitors of CaOx stone formation). Our pilot study in 10 young and healthy surgical residents also revealed similar results after drinking bicarbonate rich mineral water for 1 week.

In this study, the investigators compared the effect of drinking bicarbonate rich mineral water with plain water on urine biochemistry in a prospective randomized study in patients with known CaOx stones. The investigators hypothesize that the intake of bicarbonate rich mineral water, particularly at meal times, reduces stone risk via reduction in urinary oxalate through increased intestinal oxalate binding with dietary calcium. Other potential benefits of mineral water include increased urinary stone inhibitors like magnesium, citrate and alkalinisation of urine.

Eligibility Criteria:
Inclusion Criteria:

* patients with proven Calcium Oxalate (CaOx) stone (CaOx \>50% by infrared spectroscopy) from Jan 2018 to Aug 2019 in Singapore General Hospital
* all stone formers had suffered spontaneous passage or surgical removal of a urinary calculus during the study period.

Exclusion Criteria:

* presence of urinary tract infection
* severe cardiovascular insufficiency
* previously diagnosed causal metabolic disease such as hyperparathyroidism, renal tubular acidosis, primary hyperoxaluria, Wilson's disease, Cushing disease, osteoporosis and malignant diseases.
* pregnant women
* chronic intestinal diseases
* history of previous bowel resection
* participation in competitive sports
Ultrasound-guided Erector Spinae Plane Block Using Catheter for Video-assisted Thoracoscopy

Different modalities ranging from patient controlled analgesia (PCA) to different regional blocks have been used to control postoperative pain after thoracic surgeries. Thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc.

Erector spinae plane block (ESPB) is relatively new regional technique which was described by Forero et al in 2016. Several studies have demonstrated an effective role of ESPB in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper GI laparoscopy. Shim et al in their study showed that ESPB significantly reduced pain score in first 6 hours postoperatively in patients who underwent VATS. The aim of this study is to evaluate the eﬀect of ESPB using catheter on postoperative 24 hours opioid consumption in video-assisted thoracoscopy (VATS)

Video-assisted thoracoscopic surgery (VATS) is more commonly used technique nowadays in thoracic surgery. This technique is associated with lesser postoperative pain, better postoperative pulmonary function, decreased mortality and shorter hospital stay. However, patients can have severe and prolonged postoperative pain following VATS. Homma et al reported that 18.8 % of patients have persistent pain following VATS. Acute postoperative pain is considered to be one of strong predictor of persistent pain postoperatively.

Different modalities ranging from patient controlled analgesia (PCA) to different regional blocks have been used to control postoperative pain after thoracic surgeries. Thoracic epidural analgesia and paravertebral blocks are effective modes of pain relief but have the risks of severe complications and side effects which include severe hypotension, nerve injury or spinal cord injury, vascular injury and pleural injury etc.

Erector spinae plane block (ESPB) is relatively new regional technique which was described by Forero et al in 2016. Several studies have demonstrated an effective role of ESPB in controlling pain for thoraco-abdominal surgeries which include breast surgery, thoracic surgery and upper GI laparoscopy. Shim et al in their study showed that ESPB significantly reduced pain score in first 6 hours postoperatively in patients who underwent VATS. The objective of this study is to investigate the role of ESPB using catheter in reducing opioid requirements in first 24 hours after VATS.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18-70 years, ASA 1 to 3 undergoing video-assisted thoracoscopy

Exclusion Criteria:

* Patient refusal, Contraindication to regional anesthesia, Allergy to local anesthesia, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate PCA, psychiatric disorders or use of psychiatric medications, conversion to open thoracotomy
Mechanism for Exercise to Delay Cardiac Aging

The goal of this clinicaltrial is to assess and compare isokinetic performance, surface electromyography, laboratory parameters, and cardiorespiratory function both before and after engaging in vigorous intermittent lifestyle physical activity(VILPA) within a healthy population.

The main question it aims to answer is:

\[1\] Does VILPA yield effective outcomes?

Throughout the course of the trial, participants will engage in a simulated regimen of vigorous intermittent lifestyle physical activity for a duration of 8 weeks. The efficacy of the exercise protocol will be quantified and evaluated through the utilization of a wearable device.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Adults
2. No exercise habits (more than 3 months)

Exclusion Criteria:

1. Exercising ≥ 3 times per week;
2. the presence of chronic diseases, such as hypertension, hyperglycemic states, etc;
3. have conducted an exercise program in the past three months.
The SHIELD Whole Lung Lavage Study

An observational cohort study that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis.

BACKGROUND: Silicosis is a fatal lung disease caused by inhaling silica particles. Australia is currently facing an epidemic with hundreds of young workers having contracted silicosis from machining engineered stone.

AIMS: To determine the effectiveness and safety of Whole Lung Lavage (WLL) in workers with silicosis due to significant engineered stone exposure.

DESIGN: Participants (30) with silicosis or silica-induced bronchitis who are scheduled to undergo WLL as part of their normal care will be enrolled. They will undergo the following interventions pre and 3 months post WLL, some of which would have been carried out as part of routine standard care:

1. Complex pulmonary function tests (PFTs) - standard care
2. HRCT scan (if not within 6 months of WLL) - standard care
3. Blood tests
4. Cardiopulmonary exercise testing
5. Forced oscillatory technique
6. XV Lung Ventilation Analysis
7. Questionnaires (K-BILD and LCQ)

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged \>=18 years and scheduled for WLL at the study site as part of routine clinical care
* History of exposure to respirable crystalline silica (RCS) while working in an at-risk industry (e.g. stonemasonry, construction, tunnelling, concreting, mining)
* Elimination of workplace exposure to RCS for a minimum of 6 months
* Ground glass nodularity \> extent of solid nodularity on HRCT, as judged by investigator or evidence of silica-induced bronchitis
* Evidence of disease progression within the past 2 years, defined as any of

  * a relative decline in the FVC or FEV1 of at least 5% of the predicted value,
  * worsening of respiratory symptoms
  * increased extent of silicosis on high-resolution CT scan
* Able to understand and sign a written informed consent form (or legally authorised representative)

Exclusion Criteria:

* Ongoing workplace exposure to RCS or removal of workplace exposure of less than 6 months
* Progressive massive fibrosis, defined as areas of confluent fibrosis with diameter \> 10mm on HRCT.
* FEV1 or FVC \< 50% predicted
* DLCO \<50% predicted
* Contraindication to WLL, as judged by the investigator
* Actively or imminently listed for lung transplantation
* Females with a positive pregnancy test at screening or currently breastfeeding
* Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 24 months
* Any condition other than silicosis that, in the opinion of the investigator, is likely to result in the death of the participant within the next 24 months
* Significantly impaired cardiac function
Checklists Resuscitation Emergency Department

The study will systematically evaluate how an emergency manual-a collection of checklists and fact sheets-affects the performance of resuscitation teams during the management of priority one patients in an emergency department.

Simulation-based studies indicate that crisis checklist use improves management of patients with critical conditions in the emergency department (ED). This six-month-long study prospectively evaluates a digital emergency manual-a collection of crisis checklists and fact sheets-during the management of priority 1 patients in the Skåne University Hospital at Lund's ED.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive priority 1 patients managed in the resuscitation room of Skåne University Hospital at Lund's Emergency Department

Exclusion Criteria:

* None
Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures

Subjects enrolled in the SP615, SP756, or SP774 open-label extension (OLE) trials receiving oral SPM 927 for at least 8 weeks and a stable dose of up to 3 antiepileptic medications may participate in a research trial at approximately 30 locations.

Trial objectives include investigating whether iv SPM 927 is safe and well tolerated when given twice daily for a short period of time and identifying the appropriate infusion rate(s).

Subjects will receive SPM 927 as a 30-, 15- or 10- minute infusions twice daily for 2 - 5 days based on notification by the research doctor and subject choice. Subjects will remain on the same stable dose as received in the OLE trial.

Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion.

Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.


Eligibility Criteria:
Inclusion Criteria:

* Partial seizures with or without secondary generalization.

Exclusion Criteria:

* Subject has previously received iv lacosamide.
* Subject meets the withdrawal criteria for the open-label extension trial.
Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia

A multi-center,randomized,double-blind,controlled clinical trial was used to investigate the effectiveness of the treatment of infant iron deficiency anemia by taking ferralia and different contents lactoferrin.

5-9 months old infants with iron deficiency anemia were randomly divided into three groups. On the basis of giving the same dose of ferralia,three different levels lactoferrin infant formula were intervened 3 months respectively,and evaluate the clinical effect.

Eligibility Criteria:
Inclusion Criteria:

* Full term,healthy infants at 37-42 weeks of gestational age
* 5-9 months old infants were diagnose as iron deficiency anemia
* Accepting bottle feeding

Exclusion Criteria:

* Hb\<60 g/L
* Other microcytic, hypochromic anemia
DaVitri: Semi-Automated Vitrificacion Clinical Study

The main objective of this clinical study is to demonstrate the non-inferiority of the semi automated device (DaVitri) developed by Overture Life in the preparation procedures for vitrification of human samples.

Vitrification is a manual technique that is routinely used in assisted reproduction clinics for the cryopreservation of oocytes and embryos in liquid nitrogen at -196oC. There are different methods of vitrification, the most used being the Cryotop of Kitazato. This is a manual process that requires precision and experience to achieve a good result. For this reason, the correct execution of the technique is considered key in in vitro fertilization (IVF) treatments, as it can favor the preservation of fertility and optimize clinical results.

The purpose of the study is to validate the viability of the semi automated vitrification process, to obtain survival rates similar to or superior to manual processes, and also the capacity to provide greater reproducibility in the results.

The semi automatic exchange of vitrification fluids in human oocytes is as efficient as the manual procedure, in terms of survival (85-90%), but with significantly lower variability between technicians and between centers (95% reproducibility), as well as reduced manual processing times.

The initial hypothesis is that semi automated vitrification equals or improves the manual technique, thus introducing a new standardized protocol for clinical use.

Eligibility Criteria:
Inclusion Criteria:

* Donors will be selected according to the clinic's usual inclusion criteria in terms of infectious diseases, genetic diseases, karyotype, etc.

Exclusion Criteria:

* BMI\<18.5 or BMI \>25
* Implantation failure
* Abnormal ovulation cycle
* Endometrial thickness \> 7mm
Frameless Stereotactic Radiosurgery for Intact Brain Metastases

This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
* Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-5 intraparenchymal brain metastases.
* Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease.
* Negative urine or serum pregnancy test done ≤ 14 days prior to CT simulation, for women of child-bearing potential only.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy.
* Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).
* Diagnosis of leptomeningeal disease.
* Prior cranial radiotherapy within 90 days of trial enrollment or prior SRS at any time to any lesion to be treated on protocol
* Chemotherapy (including oral agents and targeted agents) or immunotherapy given within 14 days of SRS. Hormonal therapy is permitted. For Her2+ breast cancer patients, anti-Her2 therapy cannot be given within 14 days of SRS. Patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled.
* Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR\<30, gadolinium allergy).
Effects of Early Exercise Rehabilitation in Severe Burns

BACKGROUND:

Postburn changes in glucose and protein metabolism are at their peak during the acute phase of severe burns. The resulting metabolic derangements lead to substantial muscle wasting, insulin resistance, which ultimately hampers full recovery and reintegration into society.

PURPOSE:

This randomized controlled trial was initiated to investigate the effects of exercise-based rehabilitation on muscle wasting, insulin resistance, and quality of life during the acute phase of severe adult burns.

METHODS:

Severly burned adults (40-80%TBSA) will be recruited from one of China's largest burn centres.

Subjects allocated to the intervention group will undergo a 6-12 week long exercise program in addition to standard care rehabilitation. As part of the exercise program, participants will carry out progressive resistance and aerobic training, initiated as soon as medical safety and patient cooperation allow. Exercise type and dosage will be chosen according to patient status in terms of grafts, mobility, and strength.

The control group will receive standard care rehabilitation only, including passive, assisted, active range of motion exercise, functional exercise, and scar treatment.

The results of this translational research will provide insight into the effects and mechanisms of exercise on both a fundamental and clinical spectrum.

The added exercise intervention is initiated in line with the following readiness criteria, which were checked prior to each training session:

Criteria:

* Cardiorespiratory stability:
* Mean arterial pressure (MAP) 60 - 110 mmHg
* fraction of inspired oxygen (FiO2) \<60%
* partial pressure of oxygen / fraction of inspired oxygen (PaO2/FiO2) \>200
* Respiratory rate \<40 bpm
* Positive end expiratory pressure (PEEP) \<10 cmH2O
* no high inotropic doses (Dopamine \>10 mcg/kg/min or Nor/adrenaline \<0,1 mcg/kg/min)
* Temp. 36 - 38,5°C
* Richmond Agitation Sedation Scale (RASS) -2 - +2
* Medical Doctor clearance
* Medical research council (MRC) score lower limbs ≥3

Accordingly, the post burn starting time differs per enrolled subject.

Exercises are administered as in-bed exercises or out-of-bed exercises, depending on whether subjects are able and allowed to engage in out-of-bed mobility.

Exercise intensity for resistance training is set at 60% peak force based on a weekly peak force measurement by hand-held dynamometry, or on a 3 RM in case of out of bed exercises. Aerobic exercise intensity is set at 50-75% peak Watts determined by a weekly cycle ergometer or treadmill ramp protocol.

Eligibility Criteria:
Inclusion Criteria:

* ≥40 - ≤70 %TBSA
* Burn depth: 2nd deep / 3rd degree

Exclusion Criteria:

* Electrical burn (except flash burns)
* Associated injury: fracture lower limb
* Diabetes Mellitus type 1
* Central neurological/neuromuscular disorders (interfering with assessment/exercise)
* Cognitive / psychological disorders (interfering with cooperation)
* Cardiopulmonary disease (interfering with exercise safety)
* Pregnancy
* Palliative care
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Methotrexate vs Hydroxychloroquine

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://docs.google.com/spreadsheets/d/14HJn7W3NfPFcaowVDniCi9ulLRKRN2fn2jyeJjGgtzc/edit?usp=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2007 to 2017 (end of data availability).

Inclusion Criteria:

* 1. No prior use of methotrexate or hydroxychloroquine anytime prior to cohort entry date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. No prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date
* 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
* 4. Prior history of DMARD use measured anytime prior to cohort entry date
Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery

The aim of this study is to evaluate the effect of power breath device on arterial blood gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery.

No more studies have been done on the effect of IMT by power breath on valvular surgery, So, this study will see the effect of power breath device on arterial blood gases, diaphragmatic excursion and six minute walk test after valve surgery to know enhanced recovery protocols in valvular surgery that accelerate the functional recovery, minimize the length of the hospital stay and decrease cost of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with valve surgery (valve replacement or repair with median sternotomy procedure).
* Age between 25 to 35 years old.
* BMI is between 18.5 to 24.5 kg/m2.

Exclusion Criteria:

The participants will be excluded if they meet one of the following criteria:

* Uncontrolled hypertension (systolic blood pressure\>230 mm Hg and diastolic blood pressure\>120 mm Hg)
* Patients with coronary artery disease or heart failure.
* Need for mechanical ventilation for \>24 h or reintubation.
* Renal and hepatic disorders.
* Infected or unstable sternum.
* patient with pneumothorax after surgery.
* Metabolic disorders.
* Pregnant woman.
* Lactating mother.
* Smokers
* Stroke patient