cyrilzakka/clinical-trials huggingface dataset:
Repeated Low-Level Red-Light Therapy Shortens Axial Length

The purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers.

High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. Repeated low-level red-light (RLRL) therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.

The purpose of this study is to investigate and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in highly myopic children and teenagers aged 8-18 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents/guardians according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, slit lamp, fundus camera and optical coherence tomography/angiography will be measured at 1-, 3-, 6- and 12-month follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of consent.
2. Age: ≥ 8 and ≤ 18 years at enrolment.
3. High myopia: cycloplegic sphere of -6.00 diopters (D) or greater in both eyes.
4. Willing and able to participate in all required activities of the study.
5. The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
6. Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.

Exclusion Criteria:

1. Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
2. Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
3. Strabismus and binocular vision abnormalities in either eye.
4. Previous any intraocular surgery affecting refractive status.
5. Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
Clinical Impact of Parathyroid Autofluorescence Visualization During Thyroid Surgery

This Before-and-after Controlled Study study evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (NIR) during total thyroidectomy (TT).

It compares two groups of consecutive patients who underwent TT associated or not to lymph node dissection (LND) with and without intraoperative use of NIR, by the same surgeon.

Total thyroidectomy (TT) is responsible for postoperative hypocalcemia in 20-30% of patients, which is definitive in 1-4% of operated patients (1).

This complication is mainly due to surgery-induced parathyroid dysfunction, which could be improved by a better intraoperative identification of the parathyroids.

Intraoperative parathyroid auto-fluorescence visualization (without any dye injection) using near infrared light (NIR) is an emerging technique, which allows correct identification of normal parathyroids in almost all cases (2), but the clinical impact of NIR is unknown.

The main objective of this study is to assess the impact of intraoperative use of NIR camera on postoperative hypocalcemia. Secondary objectives are to assess the impact of NIR on the visualization, autotransplantation and inadvertent resection rates during TT.

The investigators compare 2 groups of patients operated by one surgeon during 2 consecutive but distinct periods (before and after the use of NIR) with control groups operated by another surgeon during the same periods. This study is observational since there was no predefined protocol nor sample size calculation of study groups prior to data collection.

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent one-stage total thyroidectomy, associated or not to lymph node dissection (TT +/- LND)

Exclusion Criteria:

* Combined parathyroid and thyroid disease (including patients with enlarged parathyroids incidentally found during surgery and resected)
The Effect of Modified Stepping Trainings in Frailty Elderly With Physical Performance- a Prospective Randomized Controlled Trial

This single-blind, randomized controlled trial compared the effects of modifiled stepping exercise training on flat step and unstable step on the functional outcomes in community-dwelling older adults. The subjects were involved in a step up in 4 directions exercise on each surface, according to their groups, for 50 min/day, 3 days/week, for 6 weeks. The functional outcomes were assessed prior to training, at Week 3, Week 6 after training and 1 months after training.


Eligibility Criteria:
Inclusion Criteria:

* The eligible participants needed ability of independent walking over at least 10 m without any assistive devices, and did not participate in a regular exercise program prior to being involved in the study. Older individuals who presented any signs and symptoms that might affect walking and the ability to participate in the study, such as unstable medical conditions, inflammation in the joints of the lower extremities (with a pain scale of more than 5 out of 10 on a visual analog scale), and having sequelae of neurological deficits, were excluded from the study

Exclusion Criteria:

* people who were initially recruited, those diagnosed with dementia, depression, severe cardiovascular disease, or mental illness were excluded.
Percutaneous Fixation of Acute Scaphoid Fractures

Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw

Aim of the work:

To assessment outcomes of percutaneous Trans-trapezial fixation of acute scaphoid fracture.

Operative Technique:

Anesthesia: carried out under general anesthesia or brachial plexus block and under tourniquet control.

Position: supine. Approach: Percutaneous Trans-trapezial fixation of acute Scaphoid fracture. Recording any intraoperative complication that may affect the result.

Postoperative Follow Up:

Short arm circular cast including the thumb will be applied. After 3 weeks, cast will be removed and exercises will start.

Eligibility Criteria:
Inclusion Criteria:

* - Acute stable non displaced waist fracture (A2).
* Acute unstable oblique distal third (B1).
* Acute unstable displaced waist (B2).
* Acute un stable fracture dislocation (B4).
* Acute un stable comminuted fracture (B5).

Exclusion Criteria:

* - Acute stable fracture tubercle (A1).
* Acute unstable fracture proximal pole (B3).
* Delayed union fracture (C).
* Established non-union fracture includes fibrous (D1) and sclerotic (D2).
* Bilateral fractures because of possible interference with postoperative grip strength measurement.
Dopamine Transporter Scintigraphy Imaging (DAT-Imaging) in Patients With Lewy Body Dementia

The study is designed to determine the diagnostic efficacy of the visual assessment of SPECT scans in differentiating between probable dementia with Lewy Bodies (DLB) and non-DLB dementia subjects determined by the clinical diagnosis of an independent expert consensus panel used as the standard of truth.

GEHC had decided notto provide this detail

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be adults between 55 to 90 years of age with an established diagnosis for dementia in accordance with DSM-IV criteria and have to fulfil at least one of the following: The ICC criteria for probable and possible DLB, the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer Disease and Related Disorders Association (NINCDS-ADRDA) for Alzheimer's Disease (AD), or the National Institute of Neurological and Communicative Disorders and Association Internationale Pour la Recherche et l'Enseignement en Neurosciences (NINCS-AIREN) for Vascular Dementia (VaD).

Exclusion Criteria:

* Subjects are not eligible if they have a Mini Mental State Examination (MMSE) score of \<10 and use medication known or suspected to interact with the striatal uptake DaTSCAN to the dopamine transporter.
* Furthermore subjects are not eligible if they were diagnosed with idiopathic Parkinson's Disease (PD), with persistent severe depression, normal pressure hydrocephalus, multiple system atrophy, cortico-basal degeneration or Huntington's Chorea Disease.
Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women

Intervention studying the effect of a low-carbohydrate/high-fat (LCHF) diet as well as on bout of exercise in combination with either a normal diet or a LCHF diet, in relation to glucose metabolism, insulin sensitivity, lipid profile and body composition.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Normal weight
* BMI between 18.5 and 25
* Moderately trained

Exclusion Criteria:

* Smokers/tobacco users
* pregnancy
* familial cardio-vascular-disease
* diabetes or reduced glucose tolerance
* under- or overweight (BMI under 18.5 or over 25)
* top athletes
Oral Language in Children With Down Syndrome

The objective of this research is to verify the language of children with Down syndrome concerning lexical, syntactic and semantic aspects using MLU. The hypothesis is that children with Down syndrome will present low performance, regarding not only the quantitative measures as MLU-m, MLU-w, GM-1 and GM-2, but also regarding the qualitative aspects of their production, when compared to children with typical development.

One of the alternatives to observe and assess language development and language disorders is to analyze spontaneous language samples, which allos the identification of qualitative and quantitative aspects. The analysis involves the MLU-morphemes, MLU-words and words classes. All words produced are analyzed, including interjections, adverbs and adjectives.Word classes with grammatical characteristics present lower averages, as prepositions and conjunctions. Reference parameters are the ones of the spoken language. The objective assessment with qualitative and quantitative data may help the speech and language pathologist/therapist to determine therapeutic guidelines to each patient.

Eligibility Criteria:
Inclusion Criteria:

* genetic diagnosis of Down syndrome
* good health conditions
* normal results on audiologic evaluation
* pediatric and ear, nose and throat periodic check ups.
* attend speech-language therapy at the Speech Language Pathology Laboratory in Syndromes and Sensorimotor Deficits (SLPL-SSD) of the School of Medicine of the University of São Paulo.

Exclusion Criteria:

* submission to long term hospitalizations due to heart diseases and major respiratory airway infections, that may interfere in the child's global development
* presence of visual or auditory important deficits
Effects of the Proprioceptive Neuromuscular Facilitation for Promoting Muscular Irradiation

This study aims to evaluate the effects of Proprioceptive Neuromuscular Facilitation (PNF) patterns delivered to the upper limb, lower limb and trunk for promoting motor irradiation to the contralateral lower limb.


Eligibility Criteria:
Inclusion Criteria:

* right-handed
* sedentary
* healthy
* body mass index between 18.5 - 24.9 kg/m2

Exclusion Criteria:

* having any injuries that prevented the implementation of the proposed activities
* being pregnant
Learning Theory Patient Education for Anticoagulants

The goal of this study is to test the feasibility of a randomized control trial evaluating the educational tool for anticoagulated patients.

Participants will be randomized to use new educational materials or current existing educational materials and answer survey questions.

Eligible patients will be randomized using stratified block randomization to control for the type of anticoagulant (warfarin vs. DOAC) and status (naïve vs. experienced) to either the education intervention from Aim 2 or standard of care Data will be collected via online surveys before the intervention, immediately after, and then 3 months after the intervention.

Patients at the University of Utah Thrombosis Clinic will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* initiating (naïve) or currently taking (experienced) oral anticoagulants with an anticipated treatment duration of at least three months
* Experienced patients will be eligible if they score less than 75% on the Anticoagulation Knowledge Test

Exclusion Criteria:

* Deficits in cognitive abilities, sensory input, or language significant enough to impede their use of the education tool and/or provision of written informed consent
The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients

The purpose of this study is to determine whether a specifically designed multispecies probiotic decreases visceral hypersensitivity in IBS-patient (defined by an increased pain tolerance threshold). Moreover, the effect on general symptom scores and inflammatory and microbiological parameters will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of IBS according to the Rome III criteria
* Increased visceral perception according to barostat measurements, defined as a pain tolerance threshold at smaller than or equal to 23 mmHg
* Age between 18 and 65 years
* BMI between 18.5 and 30 kg/m2

Exclusion Criteria:

* Known gastro-intestinal diseases
* Major abdominal surgery
* Previous radiotherapy, chemotherapy
* Clinical significant systemic diseases
* Critically ill patients or patients suffering from severe acute pancreatitis
* Patients with organs failure
* Patients receiving enteral feeding
* Excessive alcohol intake (greater than 15 consumptions per week)
* (planned) pregnancy or lactation
* Use of pre-, probiotics in the month before and during the study
* Use of antibiotics in the two months before and during the study
* Use of anti-diarrhoea medication, anti-laxatives or anti-acid medication in the two weeks before and during the study
* Use of anti depressives (especially SSRI's) in the month before and during the study
* Use of other medication if less then one month on stable dosage
PARP Inhibitor With CDK4/ 6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

This study is a prospective, open-label, phase III clinical study for patients with HR+/HER2- advanced breast cancer.

Patients with SNF3 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate the efficacy of PARP inhibitor in SNF3 subtype of HR+/HER2- advanced breast cancer in randomized controlled phase III clinical studies with larger sample size.

Eligibility Criteria:
Inclusion Criteria:

* Females ≥18 years and ≤ 75 years old;
* Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER \> 10% tumor cell positive is defined as ER positive, PR \> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
* Subtype of similarity network fusion-3 (SNF-3) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
* Has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /L; platelet count \> 75x10ˆ9 /L, hemoglobin \> 9g/dL;
* Patients had received no previous chemotherapy or targeted therapy for metastatic disease
* Has adequate liver function and kidney function: serum creatinine
* ECOG score ≤ 2 and life expectancy ≥ 3 months;
* Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.

Exclusion Criteria:

* Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
* Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
* Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
* is pregnant or breast feeding;
* Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 y.o.
* Histologically proven in situ and invasive ductal or lobular breast recurrence
* Prior history of whole breast/chest wall radiation therapy
* Disease span ≤ 3 cm, unifocal
* No nodal disease (N0)
* No evidence of metastatic disease (M0)
* Time from initial BCT should be ≥ 1 year
* Patients have refused the standard of care of mastectomy
* Skin distance of ≥ 0.8 cm between applicator and skin

Exclusion Criteria:

* Multifocal and/or multicenter recurrence

  * N1-3 status: Regional cytological or histologically proven node recurrence
  * M1 status: Metastatic disease
  * cT4 (Skin or muscle involvement) or Paget's disease of the nipple
  * Patients undergoing mastectomy
  * Patients undergoing neoadjuvant systemic therapy
  * Connective tissue disease or scleroderma, contraindicating radiotherapy
VAC Regimen for AML Patients Who Failed to Response to VA Regimen

Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.

Venetoclax and azacitidine has become the standard first-line treatment for elderly/unsuitable AML patients who can't tolerate for intense chemotherapy.

However, a proportion of patients who were not able to achieve remission after failing to VA regimen and then were given the second cycle, and their rate of achieving remission was even lower. Chidamide down-regulates the expression of MCL and is expected to improve the remission rate further in combination with VA regimen.

Eligibility Criteria:
Inclusion Criteria:

Patients with AML who are not suitable for intensive chemotherapy according to the WHO diagnosis: age ≥60 years or age \<60 years but fulfil the following criteria;

1. Age 18 to 59 years;
2. Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;
3. Expected survival time ≥3 months;
4. Or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (A) Presence of a cardiac history of congestive heart failure, or ejection fraction ≤ 50%, or presence of chronic stable angina; (B) Lung carbon monoxide diffusing capacity (DLCO) ≤ 65%, or first forced expiratory volume (FEV1) ≤ 65%; (C) Moderate hepatic impairment with total bilirubin \> 1.5 to ≤ 3.0 x upper limit of normal (ULN); (D) Creatinine clearance ≥ 30 mL/min to \< 45 mL/min;
5. Not received radiotherapy, treatment regimens other than the VA regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment;
6. Other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable;
7. Ability to understand and willingness to sign the informed consent for this trial;
8. The patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy.

Exclusion Criteria:

1. Patients with a history of myeloproliferative neoplasms (MPN), including myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic leukemia (CML) with or without BCR-ABL1 translocation, and AML or acute promyelocytic leukemia (APL) with BCR-ABL1 translocation;
2. Patients with FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued);
3. Patients with less than 50% reduction of blasts after VA regimen;
4. Patients with active CNS involvement;
5. With prior treatment with chidamide;
6. Clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage;
7. Pregnant or lactating women;
8. Participation in any other clinical trial within 3 months prior to VAC regimen;
9. With other malignant tumours;
10. With uncontrolled mental disorders;
11. Any other condition that, in the opinion of the investigator, makes it inappropriate to participate in this trial.
Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

The purpose of this study is to determine whether terlipressin is safe and effective in the treatment of patients with hepatorenal syndrome (HRS) type 1 when compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Chronic, or acute liver disease
* Rapidly progressive reduction in renal function, e.g. doubling of serum creatinine to \>2.5 mg/dL in less than two weeks.
* No sustained improvement in renal function after diuretic withdrawal and plasma volume expansion
* Proteinuria \<500 mg per day
* No evidence of granular casts in urinalysis or ultrasonographic evidence of obstructive uropathy or parenchymal renal disease

Exclusion Criteria:

* Ongoing shock
* Uncontrolled bacterial infection
* Current significant fluid losses
* Current or recent treatment with nephrotoxic drugs (e.g. NSAIDs or aminoglycosides within 4 weeks)
* Acute liver disease due to factors known to be also directly nephrotoxic (e.g. acetaminophen overdose)
* Confirmed pregnancy
* Severe cardiovascular disease
* Evidence of intrinsic or parenchymal renal disease (e.g. acute tubular necrosis)
* Participation in other clinical studies within 30 days