cyrilzakka/clinical-trials huggingface dataset:
Surgical Intervention for Refractory Granulomatous Lobular Mastitis

Granulomatous lobular mastitis (GLM) belongs to a group of benign diseases, which is mainly treated with glucocorticoids and surgical treatment. Nowadays, in China, surgical treatment has gradually become the mainstream, but the timing and the extent of surgery are still controversial, and different literatures report that the recurrence rate after surgery is 20-50%. Empirical lesion resection is generally used. We believe that the main reason for the high recurrence rate is the incomplete removal of the breast lesions. Because GLM is often characterized with microabscesses formation, empirical resection is likely to have residual lesions that are not visible to the naked eye. In order to reduce the postoperative recurrence rate and protect the breast appearance as much as possible, we propose a surgical plan : granulomatous lobular mastitis "lesion removal + whole breast exploration and flushing + one-stage microplastic surgery". The purpose of this study was to compare this surgical scheme of granulomatous lobular mastitis with existing surgical schemes, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients, and standardize GLM surgical schemes.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older with granulomatous lobular mastitis
* Patients without surgical treatment;
* Extensive lesions involving two or more quadrants of the breast, or accompanied by abscess, sinus fistula formation, skin rupture and other complex lesions;
* Patients volunteered to participate in the study after informed consent.

Exclusion Criteria:

* Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
* Patients who chose conservative treatment and did not receive surgical treatment
* Combined with other basic diseases, unable to tolerate surgery
* Patients in pregnancy.
Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma Beyond Milan/UCSF Criteria Who Underwent Liver Transplantation

Hepatocellular carcinoma (HCC) is the second commonest cause of cancer death worldwide. Liver transplantation (LT) is the best curative treatment of HCC meeting Milan/UCSF criteria. Milan (solitary tumour \<5cm, or up to 3 tumours, each \<3cm) and University of California San Francisco (UCSF) criteria (solitary tumour ≤6.5cm, up to 3 tumours with none \>4.5cm, and total tumour diameter ≤8cm) provide the benchmark requirements for LT, at which a 5-year survival of \>70% and recurrence rate ranging from 5-15% can be achieved.

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC. Neo-adjuvant TAI for the HCC patients with beyond criteria serving as a down-staging method for the advanced HCC to meet Milan/UCSF criteria，and qualify for LT.

This study is to compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan/UCSF Criteria HCC who underwent LT.


Eligibility Criteria:
Inclusion Criteria:

1. older than 18 years old and younger than 75 years listed for liver transplant;
2. ECOG PS≤1;
3. Child-Pugh Stage A or B
4. Proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
5. Not previous treated for tumor;
6. The tumor was diagnosed beyond Milan criteria or University of San Francisco criteria for LT
7. No distant metastasis;
8. The lab test could meet:

   Neutrophil count≥2.0×109/L; Hemoglobin≥100g/L; Platelet count≥75×109/L; Serum albumin≥35g/L; Total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; Serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
9. Sign up consent.

Exclusion Criteria:

1. Cannot tolerate TAI or LT;
2. Distant metastasis exits;
3. Known history of other malignancy;
4. Be allergic to related drugs;
5. Be treated before (interferon included);
6. Known history of HIV infection;
7. Known history of drug or alcohol abuse;
8. Have GI hemorrhage or cardiac/brain vascular events within 30 days;
9. Pregnancy.
Vasopressin to Prevent Hypotension During Beach Chair Surgery

Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia. The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are evaluated during surgery in BCP.

Patients undergoing shoulder surgery in BCP under general anaesthesia are randomly allocated to receive i.v. normal saline (control group) or AVP 0.05 or 0.07 U kg-1 (AVP group, n = 15 each) 2 min before moving into BCP. Mean arterial pressure (MAP), heart rate (HR), jugular venous bulb oxygen saturation (SjvO2) and regional cerebral tissue oxygen saturation (SctO2) are measured before (pre-sitting in supine position) and after patients assumed BCP.

Eligibility Criteria:
Inclusion Criteria: elective arthroscopic shoulder surgery under general anesthesia in beach chair position

Exclusion Criteria: preexisting cerebrovascular diseases, history of orthostatic hypotension, age less than 18 yr, and the American Society of Anesthesiologists physical status IV or V
The Effects of Synaquell on Brain Function of Ice Hockey Players

This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth ice hockey players.

This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players over the course of an entire season. The repeated measure design will compare pre- and post-season objective brain health parameters, including quantitated EEG (Neurocatch), blood biomarkers and a rapid number naming test (King Devick).

Eligibility Criteria:
Inclusion Criteria:

* Fluent English speakers
* Medically cleared to play ice hockey

Exclusion Criteria:

* An allergy to the ingredients of SynaquellTM or the placebo
* Clinically documented hearing issues,
* In-ear hearing aid or cochlear implant
* Implanted pacemaker or defibrillator
* Metal or plastic implants in skull
* Lack of verbal fluency in the English language
* History of seizures
* Allergy to rubbing alcohol or EEG gel
Characteristics of Hypophosphatasia in Adult Patients in Rheumatology

With hypophosphatasia still being frequently overlooked and misdiagnosed, the primary aim of this prospective observational study is to determine the prevalence of hypophosphatasia in adult patients in rheumatology, and beyond that to establish an algorithm that promotes early hypophosphatasia detection in clinical practice.

Hypophosphatasia (HPP) is a rare genetic disorder (1-3/300,000 severe cases in Europe) caused by one or more mutations in the alkaline phosphatase (ALP) gene. Hypomineralization results in symptoms such as arthralgias, insufficiency fractures, and poor dental status beginning in childhood. A fatal outcome is conceivable in circumstances of early infancy first presentation. In consistency with the musculoskeletal complaint pattern, HPP is far more common in the rheumatology patient population than in the general population.

However, HPP is still frequently misdiagnosed as some other form of bone disease (e.g., rickets, osteomalacia, or osteoporosis). Therefore, implementation of a clinically applicable algorithm for early hypophosphatasia detection is needed.

The primary aim of this prospective observational study is to determine the prevalence of hypophosphatasia in adult patients in rheumatology. Moreover, a further goal is to establish an algorithm that reliably separates adult HPP patients from other, rheumatologic and bone diseases.

Eligibility Criteria:
Inclusion Criteria:

* Written Informed consent
* Age \> 18 years
* Clinical suspicion of hypophosphatasia
* Evidence of a pathological ALP value within the clinical routine screening

Exclusion Criteria:

* Failure to meet the inclusion criteria listed above
Effect of Action Observation Training on Gait Variables and Global Cognitive Functions

This study will investigate the effect of Action Observation Teaining (AOT) on gait variables and global cognitive functions in older adults with mild cognitive impairment (MCI).

The specific objectives are 1) to compare gait variables and global cognitive functions among the AOT with gait training, gait training, and control groups at before training, after training, and follow up and 2) to compare gait variables and global cognitive functions among before training, after training, and follow up in each of the groups.

Participants in this study will be older adults recruiting from the Physical Therapy Center of Mahidol University, Siriraj hospital, and community at Phuttamonthon area (n = 39).

They will be diagnosed as a MCI, using core clinical criteria of the National Institute on Aging and the Alzheimer's Association by a physiotherapist. Prior to participate in the study, participants will be informed the details of the study and sign the informed consent. All participants will be recorded the demographic data and will be assessed visual acuity, hearing, sensation and muscle strength of lower extremity, balance, gait variables, and global cognitive function.

Participants who pass the criteria will be randomly assigned to either the AOT with gait training group (n = 13), the gait training group (n = 13), and the control group (n = 13) by stratified randomization.

Gait variables will be collected by the Force Distribution Measurement platform during walking at comfortable speed (single task) and during counting backwards from 100 by sevens (dual tasks). Global cognitive function will be assessed by the Montral Cognitve Assessment (MoCA).

All varaibles will be assessed 3 times which will be at before training, after 4-week of training, and 4-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60-80 years old.
* Having subjective evidence of cognitive decline from patients, or from closely informants, or from a clinicians.
* Having objective evidence of cognitive decline, deﬁned by using a Montreal Cognitive Assessment (MoCA) 18-24 points.
* Independent function in daily life
* Independent walking without using gait aids.
* Having fall risk, defined by the fall risk threshold (gait velocity \< 1 m/s in walking while counting backwards from 100 by sevens).
* Able to understand Thai language and follow study protocol.

Exclusion Criteria:

* Having history of stroke or heart attack or Parkinsonism symptoms.
* The presence of major depression disorder deﬁned by a Patient Health Questionnaire-9 \> 9 points.
* Diagnosis as dementia by neurologists.
* Any cardiac or respiratory disease that could cause gait limiting.
* Musculoskeletal disorder that affected gait performance.
* Balance disorder in assessment day, such as vertigo and dizziness.
* Visual acuity with a glasses worse than 6/15 (metric system) in both their eyes.
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).

This study is a prospective, single-arm (non-randomized), post-market study which will enroll up to 25 subjects. Intravascular Ultrasound (IVUS) imaging and angiography will be used to assess procedural outcomes in patients who have symptomatic peripheral artery disease who are treated with the Sponsor's OAS and adjunctive balloon angioplasty. An independent IVUS Core Lab will be used to provide adjudicated analyses for IVUS outcomes. In clinic follow-up visits will be performed at 2 weeks, 6 months and at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject's age ≥ 18 years
* Subject is an acceptable candidate for percutaneous intervention using the Sponsor's OAS in accordance with its labeled indications and instructions for use
* Target lesion(s) located in a superficial femoral artery (SFA), popliteal (POP) or tibioperoneal trunk (TPT)
* Tight lesions (\>70% stenosis)
* Lesions less than 110 mm in length
* Artery with the vessel \< 6.5 mm in diameter
* Subject is willing and able to sign an approved informed consent form
* Subject is willing and able to attend follow-up visits

Exclusion Criteria:

* Uncontrolled allergy to nitinol, stainless-steel or other stent materials or to contrast agent
* Unable to take appropriate antiplatelet therapy
* Subject has no distal run-off
* Interventional treatment is intended for in-stent restenosis at the peripheral vascular site
* Subject has history of coagulopathy or hypercoagulable disorder, is undergoing hemodialysis or has impaired renal function (Cr \> 2.5 mg/dl) at the time of treatment
* Female subject who is pregnant or nursing a child
* Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Sponsor's OAS
Origins and Impact of EDS in Connective Tissues and Skin

Ehlers-Danlos Syndrome (EDS) is an inherited disease of collagen, found in connective tissues, such as skin. EDS patients suffer from joint and skin problems (skin hyperextensibility, joint hypermobility) along with a large range of other disorders, including, delayed wound healing with atrophic scarring, easy bruising, tissue fragility, gastrointestinal and gum problems. There are many different types of EDS, with different mechanisms of action, and not all of these are well understood. This study will used advanced microscopy techniques called atomic force microscopy (AFM) and scanning electron microscopy (SEM) to analyse the changes in collagen as a result of EDS, compared to normal collagen. These changes will be viewed at the micron and nanoscale level (between 1,000 to 100,000 x magnification), and will focus on the differences in collagen construction through a process called cross-linking. These changes could potentially help clinicians understand the root cause of EDS symptoms, and provide a deeper knowledge of cross-linking disorders in collagen. Increasing our knowledge of how collagen is affected in EDS patients, may lead to improved treatment options for patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18+) patients requiring elective surgery as part of their treatment plan who fulfil the Brighton criteria for Joint Hypermobility Syndrome (JHS)/EDS hypermobility type with significant joint hypermobility (Beighton score of 6 and above) and /or have evidence of significant connective tissue weakness, or rectal/vaginal prolapse

Exclusion Criteria:

* Patients with insufficient ability in English to give informed consent, if a translator is not present.
* Patients with severe developmental disorders, precluding their consent for research
Biosimilar Retacrit® in the Treatment of Chemotherapy-induced Anaemia in Oncology and Haematology

The aim of this study is to describe, in a real-life context, the impact of an epoetin alpha biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to concomitant iron supplementation.

This is a longitudinal, observational, prospective, multicentre, cohort study, conducted on a representative sample of public and/or private hospital-based oncologists and haematologists practicing in Metropolitan France.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, aged 18 years and older, seen by the oncologist or hematologist for chemotherapy.
* Patients for whom the oncologist or hematologist has decided the initiation of an epoetin alpha biosimilar treatment (Retacrit®) for anemia.
* Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion Criteria:

* Patients with hemoglobin concentrations \>11 g/dL.
* Patients who have been transfused within the previous month.
* Patients who are hypersensitive to erythropoietin or one of its excipients.
* Patients participating or having participated in the previous month in a clinical trial in the field of anaemia in oncology.
* Patients refusing to participate in the observational study.
IRIS- DESyne X2 in the IRIS-DES Registry

This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Intervention with DeSyne X2 drug-eluting coronary stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with DeSyne X2 drug-eluting coronary stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock
Preoperative Hyperthermia in Major Abdominal Surgery Patients

The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age 18 - 75
* Open abdominal, curative cancer surgery \> 2 h

Exclusion Criteria:

* Pregnancy
* Chronic cortisone treatment
* Ongoing chemotherapy
* Acute infections, septic surgery
* Palliative surgery (e.g. debulking only)
Buyang Huanwu Decoction and Normal Tension Glaucoma

The goal of this clinical trial is to test Buyang Huanwu Decoction in normal intra-ocular pressure glaucoma. The main question to answer is: the effect of Buyang Huanwu Decoction and its safety in patients with normal intra-ocular pressure glaucoma.

Participants will take 3 grams of Buyang Huanwu Decoction or placebo for 12 weeks.

Researchers will compare treatment group and placebo group to see if the visual acuity, visual field would be improved.

There is currently no active and effective treatment for normal intra-ocular pressure glaucoma, and glaucoma patients often affect the optic nerve and cause visual acuity and visual field damage. Studies have found that glaucoma patients have less blood flow to the optic nerve, retina and choroid than normal people. Buyang Huanwu Decoction has the functions of invigorating qi, promoting blood circulation and dredging collaterals, and is often used in the treatment of stroke. Therefore, the purpose of this study is to investigate the effect of Buyang Huanwu Decoction on visual acuity, visual field and its safety in patients with normal intra-ocular pressure glaucoma. This study is designed as a randomized, double-blind, controlled clinical trial. A total of 60 subjects with normal intra-ocular pressure glaucoma were randomly divided into: 1) treatment group (30 subjects), oral administration of Buyang Huanwu Decoction (3 grams), two times in a day after breakfast and dinner, for 12 consecutive weeks; 2) control group (30 subjects), the same method as the treatment group, but taking Buyang Huanwu Decoction placebo (90% starch and 10% Buyang Huanwu Decoction). Primary outcome was changes in visual acuity, visual field, and optic nerve fiber layer, and secondary outcome was changes in quality of life scale scores.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of normal tension glaucoma for at least 3 months.
* Using less than 1 medicine for glaucoma.
* Without any eye disease other than normal tension glaucoma.
* Writing the Informed Consent Form by themselves.

Exclusion Criteria:

* With other chronic diseases, such as diabetes, hypertension, cancer.
* With polypharmacy.
* Had glaucoma surgery or myopia laser surgery before the study.
* With mental disease and could not finish the study.
* Allergic to Buyang Huanwu Decoction.
* Pregnancy or lactation.
Prospective Data Analysis of the Development of Hypernatremia in Intensive Care Unit

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. The main mechanism is an imbalance between sodium and total body water. Consequently, this poses multiple factors to play a role in the development of hypernatremia. multifactorial. Previous studies focused on predictors in the development of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and salt balance or renal replacement therapy is lacking. Few studies investigated the recovery of hypernatremia, which showed that correction of hypernatremia can reduce the associated mortality risk.

This study aims to provide better insight in the development and recovery of hypernatremia through the collection of detailed information on the input and output of fluids and salts in a larger group of patients than studied before.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>17 years old
* Admitted \>48 hours in ICU

Exclusion Criteria:

- Expected discharge same day as day of inclusion