cyrilzakka/clinical-trials huggingface dataset:
Controlled Clinical Trial of Traditional Chinese Medicine Mouthrinse

Traditional Chinese medicine (TCM) has been seen as the predominant way of treating disease in China over three thousand years. Certain TCM have scientifically proved to have anti-bacterial property. Patients having orthodontic treatment have higher risks of caries and gum diseases. The purpose of this study was to determine whether the use of TCM Mouthrinses in addition to toothbrushing and flossing has an added benefit for orthodontic patients in maintaining proper oral health.

The aim of this study was to investigate the effects of a Traditional Chinese medicine (TCM) mouthrinse on gingival health and microbial profiles in orthodontic patients. This six-month randomized, single-blinded, parallel controlled clinical trial consists of 90 patients with fixed appliance treatment. The subjects were allocated to (1) negative-control group: oral hygiene instruction (OHI) alone; (2) positive-control group: OHI plus an EO mouthrinse (Listerine®)(3) test group: OHI plus the TCM mouthrinse (5% Fructus mume extract). Clinical examinations included Plaque Index (PI), Bleeding Index (BI) and Modified Gingival Index (MGI). Salivary microbial quantifications included total aerobic and anaerobic bacteria, Streptococci and Lactobacilli counts. Clinical and microbiological examinations were conducted at baseline, 3 and 6 months (T1, T2 and T3).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have at less 20 permanent teeth
* Subjects who have a healthy systemic condition
* Subjects with age range 13-35.
* Subjects who are no-smoker;
* Subjects who haven't taken antibiotic medicine within a 2 week period prior
* Subjects who do not currently undergo any medication or will undergo any medication in next six months
* Subjects who have not dental diseases that required ongoing treatment, which would confound the evaluation of result
* Subjects who are competent in giving consents
* Subjects who are not pregnant or lactating women
* Subjects who do not report teeth sensitivity
* Subjects who are not allergic to ethanol
* Subjects presented a minimum level of pre-existing gingivitis (MGI\>1) but without peridontitis.(probing depth\>4mm)
Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft

The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the renal graft

Focal and segmental glomerulosclerosis (FSGS) is resistant to treatment with immunosuppressants and after transplant, 40% of such patients have recurrences in renal allograft. The purpose of this trial was to use Total Lymphoid Irradiation (TLI) plus mycophenolate mofetil (MMF), cyclosporine A (CsA) and prednisone (PRED) to prevent recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients (age \> 18 years)
* Biopsy-proven primary FSGS
* End-stage renal failure at presentation or prior allograft loss due to recurrent FSGS.
* Signed the informed consent before entering in the study.

Exclusion Criteria:

* Age \< or equal 18 years
* No biopsy-proven FSGS
* Without living donor to perform the transplant
* No signed the informed consent
5 Fraction Stereotactic Body Radiation Therapy for Oligometastases Regimen, for Extra-Cranial Oligometastases

This is a prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule.

The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.

Endpoints are to describe: the proportion of patients with local control for the index site at 1 year; the number of index lesion(s) with local control at 1 year; acute and late AEs related to SBRT; time to local progression for the index site; time to distant disease progression; symptom and QoL profile; median survival.

Eligibility Criteria:
Inclusion Criteria:

* Any solid tumors are eligible. Lymphoma, myeloma and germ cell tumors are excluded.
* Histological confirmation of neoplastic disease either from original primary or metastatic sites is required.
* Radiological diagnosis of oligometastastic metastatic disease is accepted if considered clinically acceptable. Histological confirmation is not mandatory.
* Oligometastatic disease, maximum of 5 lesions.
* At least one lesion is suitable for stereotactic body radiotherapy
* All known sites of disease have plans for local ablative management (see section management plan for definitions) within 3 months
* ECOG ≤ 2
* At least 18 yrs old

Exclusion Criteria:

* Previous radiotherapy to the intended treatment site
* Patient cannot tolerate physical set up required for SBRT
* Active bowel obstruction, if treating abdominal/pelvic site
* Chemotherapy within 2 weeks of intended radiation therapy
* Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
* Pregnancy
A Study to Evaluate the Safety and Therapeutic Effects of Transplantation of MNV-BM-BLD in Pediatric Patients With Pearson Syndrome

Mitochondrial diseases are a genetically heterogeneous group of disorders caused by mutations or deletions in mitochondrial DNA (mtDNA) displaying a wide range of severity and phenotypes. These diseases may be inherited from the mother (mitochondrial inheritance) or non-inherited. The latter are ultra-rare pediatric diseases caused by a mutation or deletion of mtDNA, which develop into a systemic multi organ disease and eventually death. MNV-BM-BLD is a therapeutic process for enrichment of patient's peripheral hematopoietic stem cells with normal and healthy mitochondria derived from donor blood cells. The process, called mitochondria augmentation therapy, aims to reduce the symptoms of mitochondrial diseases.


Eligibility Criteria:
Inclusion Criteria

1. Patient diagnosed with Pearson Syndrome, as verified by molecular identification of a defect in the mitochondrial DNA.
2. Normal maternal mitochondria as verified by mtDNA sequencing.
3. Males and females between 3 years or older and up to 18th birthday.
4. Patient is transfusion independent.
5. Patient has at least one of the following systematic involvements:

   1. High baseline lactate levels
   2. Episodes of metabolic crisis in the last year before pre-screening
   3. Renal failure (not dependent on dialysis) or evidence of proximal tubulopathy
   4. Growth retardation or failure to thrive

Exclusion Criteria

1. Absence of detectable mitochondria mutation or deletion.
2. Patient or patient's mother have a positive test for microbiologic
3. Patient is unable to undergo leukapheresis.
4. Patient suffers from chronic severe infection, malignant disease or any other disease or condition that may risk the patient or interfere with the ability to interpret the study results.
5. Patient has been treated previously with any cell or gene therapy.
6. Patient has participated in another clinical treatment trial or received other experimental medications outside of a clinical trial within 1 month prior to start of this study.
Efficacy of Various Aerobic Exercises on Abdominal Obesity in Women With Metabolic Syndrome.

Objective: To show metabolic and hormonal responses and effects on abdominal obesity of aerobic exercise in different intensity and duration and detraining period in women with metabolic syndrome.

Objective: To show metabolic and hormonal responses and effects on abdominal obesity of aerobic exercise in different intensity and duration and detraining period in women with metabolic syndrome.

Methods: Fifty-one women with metabolic syndrome were divided into three groups: 12 weekly sessions of high intensity supervised treadmill group, respectively, at % 70 of maximum oxygen consumption (group I, n=17), low intensity supervised treadmill group, respectively at % 50 of maximum oxygen consumption (group II, n=17) and walking at low intensity, respectively at % 50 of maximum oxygen consumption with ECEPEDO pedometer (group III, n=17). Target heart rate (HR) corresponding to values of 50-70 % VO2max were determined by the submaximal treadmill test. Group 1 and 2 were instructed walking at their target HR on a treadmill. The number of steps taken in a minute corresponding to target HR was determined by a criterion pedometer and group 3 was instructed walking in this step range recorded to ECE PEDO giving audible feedback. Participants were evaluated by weight, BMI, waist circumference (WC), blood sugar, LDL, HDL and triglyceride; viseral fat, trunk fat and waist circumference by bioelectrical impedance device (VIScan); ergospirometric VO2max at baseline, 12-week and 4-week detraining period.

Eligibility Criteria:
Inclusion Criteria:

* eligible participants who meet the criteria for inclusion were women with metabolic syndrome diagnosis according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria and were 25-65 years old.
* Participants were well communicative, motivated and willing to participate in the study.

Exclusion Criteria:

* The exclusion criteria were presence of uncontrolled hypertension, type 2 diabetes mellitus, atherosclerotic heart disease, using drugs to affect thyroid, lipids metabolism and insulin sensitization, musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function.
Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury

Patients with Septic AKI will be randomized in three arms, group PFD 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive PFD 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days, all receive conventional treatment KDIGO guides. We analyze the recovery of renal function as a primary objective.

Septic acute kidney injury (AKI) is the most common cause of AKI in the world, there is no specific treatment for this pathology; the pathophysiology is related to inflammatory pathway and strategies that modulate this are potentially useful. The Pirfenidone (PDF) is an anti-fibrotic and anti-inflammatory treatment, in animal models has shown a beneficial effect on the recovery of renal function immediately after administrated. The investigators propose a triple blind clinical trial,in which septic AKI patients will be randomized in three arms, all receive conventional treatment KDIGO guides, groupPDF 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days. The Investigators analyze the recovery of renal function as a primary objective, as a secondary objectives clinical variables associated with renal recovery, biochemical variables, inflammatory, molecular variables and measurement of PDF in blood will be analyzed. Patients will be follow-up for 7 days and 28 days after randomization.

Eligibility Criteria:
Inclusion Criteria:

. sepsis

* AKI by serum creatinine, according to the KDIGO guide 2012 Acute Kidney Injury • acute on Chronic kidney disease (baseline creatinine \<2 mg / dL)

Exclusion Criteria:

* Chronic kidney disease stage 3b, 4 or 5 (basal serum creatinine \> 2mg/dl) known and / or sharpened.

  * chronic dialysis (peritoneal dialysis or hemodialysis)
  * History of AKI and / or RRT in the last three months
  * Pregnancy AKI by other causes other than sepsis
iCanWork: A Randomized Controlled Trial

The aim of this study is to evaluate the effectiveness of the iCanWork intervention in assisting cancer survivors (CS) to return to work (RTW) and its impact on their health-related quality of life (QoL), health service utilization, RTW readiness, time to RTW, and work capacity.

The iCanWork intervention comprises several elements related to health and work, taken from the latest reviews that recommend a remote and individual intervention, led by a vocational rehabilitation counsellor (VRC), experts in assisting RTW for CS. The intervention includes 6 sessions with a VRC and 1-4 sessions with an occupational therapist (OT). A total of 270 CS will be recruited into 2 groups (intervention or control). The duration of this study is 24 months. Study participants will complete electronic questionnaires measuring study variables at baseline before randomization and at 6-month, 12-month, 18-month, and 24-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with cancer (all types) treated with curative intent and of working age (between 18 and 65 at the time of diagnosis)
* gainfully employed at the time of diagnosis (full or part-time, including students)
* still on sick leave, including long-term disability leave, but for less than 2 years
* has not started to return to work, since stopping due to cancer
* can read and understand English or French
* reside in Canada.

Exclusion Criteria:

- If the cancer survivor's physicians consider returning to work unwise, such as due to a metastatic cancer diagnosis
Palliative Thoracic ImmunoRT

The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment.
2. Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10).
3. Receiving or planned to receive nivolumab or pembrolizumab
4. Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks
5. Age 18 or older
6. ECOG Performance Status 0-2
7. Life expectancy greater than 3 months
8. Able and willing to provide informed consent
9. Able to complete patient reported outcome questionnaires

Exclusion Criteria:

1. Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia
2. Previous history of thoracic radiotherapy with an overlapping field
3. Previous history of checkpoint inhibitor related pneumonitis or esophagitis
4. Pregnancy
Study of the QUadratus Lumborum Bloc in Total Hip ARthroplasty: Efficacy and Safety

The purpose of this prospective research study is to determine the best way to manage post-operative pain after a total hip arthroplasty. Currently, there is no standard of care for managing post-operative pain in these patients. The quadratus lumborum block (QLB) first described by Blanco in 2007, is a promising technique in this indication: recently, there is a growing evidence for the use of the QLB as an alternative technique for pain management after hip surgery.

A sample size of 100 patients (50 per group) was calculated based on 20% reduction in morphine consumption with 0.05% significance and a power of 0.8.

After ethical committee approval, eligible patients scheduled to have a fast-track total hip arthroplasty are screened during preoperative evaluation clinic. Informed written consent will be obtained from all patients during pre-anesthesia visit the day before surgery (J-1). Consenting patients will be randomized the day of surgery (J0) to undergo QLB with ropivacaine ("ropivacaine group") or normal saline ("saline group").

Before general anesthesia, all patients will have a needle-insertion posterior to the quadratus lumborum muscle avec injection of either ropivacaine in the "ropivacaine group" or normal saline in the "saline group".

After general anesthesia induction, dexamethasone and ketamine will be given to all patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Classification Status (ASA) I to III
* Age ≥ 18 years
* Scheduled for fast-track total hip arthroplasty
* Written informed consent
* Patient covered by health insurance Exclusion Criteria
* Protected patients or patients incapable of giving written informed consent
* Pregnant or breastfeeding woman
* Vulnerable adult
* Contraindication for fast-track surgery
* Inability to comprehend or participate in pain scoring scales
* Allergy to study drugs
* Severe coagulopathy
* Chronic kidney disease with glomerular filtration rate (GFR) ≤ 30 mL/min (estimated by the Cockcroft \& Gault formula)
* Chronic pain (treated by nonsteroidal anti-inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants)
* Peripheral neuropathy
Brain Uptrain to Improve Learning and Development

The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age. All caregivers of infants in this study will receive shared reading training. Half of the caregivers will be trained in an additional coach-led caregiver-implemented early literacy and numeracy program. Information related to infant development will be collected from parent surveys, medical records, and questionnaires and assessments.

This study will test the hypothesis that in term or late preterm infants who are discharged home from the newborn nursery, a coach-led caregiver-implemented early literacy and developmental program in addition to shared reading, compared with shared reading alone, will increase the Ages and Stages Questionnaire® score at 24 months. This will be a double blind randomized controlled trial with 1:1 parallel allocation using stratified permuted block design. Randomization will be stratified by gestational age (≥ 35 to \<38 weeks and ≥ 38 weeks). Randomization of twins and higher orders (when eligible) will be to the same group. Term and late preterm infants ≥ 35 weeks' gestation admitted to the newborn nursery are eligible for inclusion if they are being discharged home. We will exclude infants admitted to the NICU, infants with a known syndrome or major malformation, infants in DHR custody, infants enrolled in a competing study, and infants of families with a primary language other than English or Spanish. All study participants will receive shared reading information at scheduled well-child checks. Caregivers of infants in the intervention group will receive additional coach-led caregiver-implemented early literacy and developmental program. We will complete an ASQ-3 online or by telephone at 12 months, 24 months, and 36 months. We will also measure early literacy at 3 years, 4 years, and 5 years. The primary outcome will be the ASQ-3 scores at 24 months.

Eligibility Criteria:
Inclusion Criteria: inborn at UAB, delivered at more than 35 weeks' gestation, planned for discharge home after initial hospitalization.

-

Exclusion Criteria: a major malformation, a known syndrome, admitted to the NICU, in DHR custody, enrolled in a competing study, and family's primary language is other than English or Spanish.

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Analgesic Effect of Gabapentin in Total Knee Arthroplasty (TKA)

Pain is a major problem after TKA. Gabapentin may reduce acute postoperative pain. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic.

Pain is a major problem after TKA. Studies indicate that Gabapentin may reduce acute postoperative pain. However, the optimal dose is unknown and there is constant controversy on analgesic versus side-effects. The investigators therefore investigate the effect of Gabapentin as a perioperative analgesic in a dose-related manner and with a sample-size allowing evaluation of side-effects.

Eligibility Criteria:
Inclusion Criteria:

* Primary, unilateral total knee arthroplasty (TKA)
* Age 50-85 years
* Ethnic Danes

Exclusion Criteria:

* Treatment with gabapentins, systemic glucocorticoids, opioids, anxiolytic agents, antiepileptics or antidepressive agents (last 4 weeks)
* History of depression or mania
* History of alcohol or drug abuse
* History of malignancy
* History of epilepsia
* BMI \> 40
* Disease affecting central or peripheral nerve function
* History of dementia
* History of renal insufficiency
* Allergy to Gabapentin
* Women with menstruation (last 2 years)
The ICE WATCHMAN Trial

The aim of this multi-center study will be to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance. By eliminating the need for general anesthesia, the hope is to show a reduction in procedural time, decrease use of supplemental invasive procedures (central venous line, invasive arterial pressure monitoring and transesophageal echocardiography) and quicker patient recovery time. This approach can decrease healthcare resource utilization and safely simplify left atrial appendage closure with the WATCHMAN device.

The study will be a prospective, non-randomized multicenter registry of 100 patients undergoing LAA closure with the WATCHMAN device (possibly with WATCHMAN FLX when approved) utilizing an intra-procedural ICE probe under moderate sedation. The primary feasibility endpoint will be ability to successfully implant the WATCHMAN device. Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak \<5 mm) as assessed by a core lab interpretation of the TEE 45 days post-implant. The primary safety endpoint will be a composite of major complications (major bleeding \[intracranial bleeding, or bleeding requiring blood transfusion\], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death). Additional measured end points will be: freedom from conversion to general anesthesia and/or standard TEE during implant, the incidence and the size of iatrogenic atrial septal defect on 45 day TEE. The ICE procedural images will also be collected and analyzed by an independent committee composed of non-implanting interventionalist, and an imaging specialist. The images will be graded in quality as optimal (TEE equivalent), acceptable (adequate but not as detailed as TEE), and inadequate. This prospective study, along with its endpoints will be registered in clinicaltrials.gov.

Eligibility Criteria:
Inclusion Criteria:

* The patients is eligible to undergo WATCHMAN device implant procedure
* The patient is eligible for short term anticoagulation therapy
* Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s)
* Ability to give informed consent for the procedure
* The patient is able and willing to undergo the procedure under moderate sedation
* The patient is able and willing to return for required 45-day TEE.

Exclusion Criteria:

* Patient has contraindication for short term anticoagulation
* The patient has history of a hypercoagulable state per medical record documentation
* Pregnancy or planning to get pregnant during the investigation.