cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study

The ARBRE Study is an observational prospective trial aimed at investigating the impact of the therapy initiation with INTIs on brain outcomes according to the time of therapy initiation. Three study arms are considered: 1) Early treated HIV-1 infected patients (\<3 months since estimated date of infection), 2) Regularly treated HIV-1 infected patients (\>6 months since estimated date of infection), 3) Matched seronegative control group. Study assessments will be performed at baseline, 1 month and 12 months. Study assessments will comprise comprehensive evaluation of brain outcomes. They will include cognitive functioning, neuroimaging parameters, and functional outcomes.

Randomized patients will receive LA CAB+RPV administration in the hospital (standard of care) or out-of- hospital administration every 2 months (M2, M4, M6, M8,M10, M12). Medical visits, rutinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline, M1 (if patient has not previously receiving LA CAB+RPV), M6 and M12.

Eligibility Criteria:
The study criteria for participation in the study will be the following:

Inclusion Criteria:

* Age 18-65 years old
* Voluntary participation.
* Signed written consent.
* Confirmed HIV-1 infection (for arms A and B).
* Intention to initiate therapy with cART containing an INSTI. Specifically, the regimen included raltegravir, elvitegravir or dolutegravir.

Exclusion Criteria:

* Prior diagnosis of opportunistic infection involving CNS.
* Current diagnosis of psychiatric disorder.
* Current or past diagnosis of neurologic disease.
* Inability to develop any of the tasks required for the study.
* Pregnancy.
* History of suboptimal adherence (for arms A and B).
Intraoperative Radiotherapy for Rectal Cancer Using the Photon Radiosurgery System

The investigators would like to test the safety and efficacy of intraoperative radiotherapy (IORT) in rectal cancer using the Photon Radiosurgery System (PRS).

Rectal cancer is usually managed by a combination of surgery and x-ray treatments (radiotherapy). The standard way of delivering radiotherapy is with external 'beams' directed at the tumour site. However, although in rectal cancer these treatments are effective, patients are often troubled by late side effects. An alternative option is to deliver the x-rays at the same time as surgery. This is known as intraoperative radiotherapy, or IORT, and a number of techniques have already been tried. There is a new IORT technology known as the Photon Radiosurgery System (PRS) which we are using to treat breast and brain cancers. Our experience to date has informed us that IORT with this x-ray source is safe and effective. We would like to use the technology to treat rectal cancer and believe that it may improve disease outcomes without the side effects associated with standard radiotherapy. We would also like to study the biological processes that follow radiation. It is not understood why some people are more sensitive to x-ray treatments than others. If we knew the reasons for this then we might be able to individualise treatments.

Eligibility Criteria:
Inclusion Criteria:

* Operable rectal cancer

Exclusion Criteria:

* Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease
Model to Predict Coinfection in Elderly Patients With COVID-19

The goal of this observational study is to learn about the clinical characteristics and construction of a predictive model in elderly COVID-19 patients. The main question it aims to answer is the main clinical characteristics and risk factors of elderly COVID-19 patients. Participants will not be asked to do any other intervening measure.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 65 years old;
* COVID-19 was diagnosed with SARS-CoV-2 reverse transcription-polymerase chain reaction positive or rapid antigen test positive or a clinical diagnosis made by the radiological responsible clinician based on signs, symptoms, or radiology consistent with COVID-19;
* Hospitalization more than one day, including patients in emergency.

Exclusion Criteria:

* Age less than 65 years old;
* Pregnancy;
* Hospitalization less than one day;
* Outpatients;
* Patients with missing or incomplete information.
Performance of the Water-Enema Computed Tomography (WE-CT)

The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen.

The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* WE-TC indication for colon tumor suspicion
* Age \> 18 years

Exclusion Criteria:

* Pregnancy
* Patients under 65 years old and for whom the only WE-TC indication is familial antecedents of colon tumor, without clinical or para-clinical personal signs for this pathology
* Infected sigmoid diverticulosis
* Occlusive syndrome
* Anesthesia contraindications
* Anal incontinence
* Renal insufficiency (creatinine \> 150 micromol/L)
* Iode allergy
* Visceralgine contraindications
* Scania contraindications
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have previously had breast surgery resulting in unacceptable scars
* Subject has chosen to have the breast scars revised
* Subjects must not be pregnant or lactating

Exclusion Criteria:

* Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or lactating
* Participation in another clinical trial within 30 days prior to the start of the study
* Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study
Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade III Furcation Defects (FURC-III-OST)

Teeth with furcation grade III defects will be treated with open flap debridement, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade III defects with open flap debridement.


Eligibility Criteria:
Inclusion Criteria:

* Periodontal disease stage III or IV according to 2018 criteria
* Undergoing periodontal therapy (active or supportive) and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade III with PPD\>4mm, and the furcation fornix must be above a tangential line from the distal to mesial interproximal crestal bone level on bitewing radiographs
* Competent to give consent

Exclusion Criteria:

* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
* Present or past use of bisphosphonate treatment
* Pregnant or nursing subjects
* Patients classified as \> class II according to ASA classification
* Previous surgical therapy of included furcation defects
* Inhability to comprehend and respond to the quality of life questionnaire
* Dental restorations or prosthesis involving the furcation area
* Root fractures or suspected fractures/infractions
* Caries lesoins in the furcation area
* No systemic antibiotic treatment within 3 months prior to intervention
Chronic Post Breast Surgery Pain

The purpose of this study is to learn if paravertebral block (PVB) will reduce chronic pain after surgery. Our hypothesis is that chronic pain from breast surgery as a consequence of central sensitization can be prevented by blocking sensory input to the CNS during surgery and the immediate post-operative period.


Eligibility Criteria:
Inclusion Criteria:

1. Female patient who are ≥ 18 and ≤ 80 years of age.
2. Patient with diagnosis of breast cancer.
3. Patient scheduled for modified radical mastectomy or lumpectomy with axillary node dissection
4. Patient scheduled for one of the above listed surgeries with or without sentinel, partial, or complete axillary lymph node dissection
5. Patients scheduled for one of the aforementioned surgeries with or without immediate or delayed reconstruction.

Exclusion Criteria:

1. Pre-existing peripheral neuropathy
2. Pre-existing chronic pain
3. Bilateral procedure
4. Previous breast surgery, except biopsy
5. Inability to read, write or speak English.
6. Allergy to amide local anesthetics
7. Contraindications to paravertebral nerve block including, but not limited to severe scoliosis of the spine, skin lesion overlying the block area, abnormal coagulation studies (some of these may not be known until after informed consent is obtained)
8. Pregnancy
9. Emergency surgery
10. Previous recipients of peripheral nerve block.
11. Medical professional whose experience includes caring for patients who have had peripheral nerve blocks.
The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are:

* how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the GI and systemic/brain interface?
* how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).

This single-site comparison study will be performed on 100 participants, 45 to 70 years of age, who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with the irritable bowel syndrome (IBS), according to the Rome IV criteria. In this study, we will evaluate using the i3.1 probiotic compared to placebo. This is a randomized, placebo-controlled trial with four study arms that will include 25 participants per arm: Individuals with ME/CFS with and without IBS, who will take either the active medication i3.1 or placebo.

Eligibility Criteria:
Inclusion Criteria: eligible if all of the following apply:

* Meets IOM ME/CFS case definition criteria,
* Co-morbid IBS: meets RomeIV criteria for alternating or diarrhea-predominant IBS as reported during screening (technically diagnosed by a physician),
* Able to provide consent to study,
* Patients of childbearing potential must practice effective contraception during the study and be willing to continue contraception for at least six months after the intervention,
* agrees to participate in online surveys and follow-up visits.

Exclusion Criteria: ineligible if any of the following apply:

* Probiotics in the past eight weeks,
* Antibiotics in the past eight weeks,
* Pregnancy or lactating women,
* Medical conditions including short bowel syndrome, celiac disease, biliary disease, pancreatitis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), severe cardiovascular, neurological condition, or liver failure,
* Gastrointestinal surgery within six months of study entry,
* History of psychiatric disorder, alcohol or illicit drug abuse.
Evaluation of Root Resorption During the Correction of Deep Bite With the Help of Laser Irradiation

This study aims to investigate the effectiveness of low-level laser in reducing the resorption of the roots of the upper incisors. Participants will be recruited from patients who will attend the Department of Orthodontics and Dentofacial Orthopaedics at Damascus University. The study sample will consist of 30 patients with a deep bite who will be randomly distributed equally into two groups, 15 patients in each group, average age: 22.37±3.38 years. Mini-implants will apply between the roots of the maxillary central and lateral incisor at both sides with a loading force of 40 g on each end by using a nickel-titanium spring extending from the head of the mini-implants to a wire welded to it with two hooks. A low-level laser (Ga-Al-As) will be used with 808 nm wavelength in continuous mode, 250 milli-Watt power output, 4 Joules/point energy density, 16 s per point in the experimental group. It will be applied on the day of intrusion, then on days 3,7, and 14 of the first month, and then every 15 days starting from the second month until the end of the intrusion. In addition to adjusting the force gauge every 4 weeks until the end of the intrusion stage and reaching normal coverage will be activated every 4 weeks in both groups until normal overbite was reached.

Several studies have indicated the effectiveness of the LLLT in accelerating orthodontic movement, but studies that have evaluated the role of this laser in reducing the risk of OIIRR have been limited. Moreover, the effects of laser in reducing root resorption have been studied with different types of orthodontic movements such as en masse anterior retraction, canine retraction, and tilting of the premolars before extraction, but they have not been studied with the intrusion movement

Eligibility Criteria:
Inclusion Criteria:

1. overbite \> 4 mm
2. Class I or II molar and canine relationship malocclusion
3. maxillary anterior crowding \< 2 mm
4. maxillary incisors positioned below the functional occlusal plane
5. incisor display of 2-3 mm or more at rest
6. the facial growth pattern is normal or horizontal.

Exclusion Criteria:

1. the maxillary incisors had a history of any trauma or endodontic treatment
2. increased inclination of the maxillary incisors towards the labial
3. the subject had any systemic disease
4. the patient exhibited poor oral hygiene
25-G Vitrectomy With Ranibizumab or Triamcinolone Acetonide on PDR in China-Randomized Clinical Trial

Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic patients. Operation is an efficient method to treat PDR. Anti-vascular endothelial growth factor (anti-VEGF) can be used as an adjuvant therapy which can make operation more easy.

Proliferative diabetic retinopathy(PDR) is the leading cause of visual loss in diabetic patients. The operation indication includes non-absorbed vitreous haemorrhage, dense bleeding in front of the macular, proliferative vitreoretinopathy traction macular, tractional retinal detachment combined break, severe progressive fiber vascular proliferation and vitreous haemorrhage combined with early iris neovascularization.

Due to VEGF levels rise in vitreous cavity of PDR patients, some inflammatory cytokines involved in, make easy bleeding during surgery and heavier inflammatory reaction postoperation,thus affecting the curative effect of the operation.

Ranibizumab as angiogenesis inhibitors, has widely applied in the treatment of age-related macular degeneration, won the recognition of ophthalmologists.

Some scholars try to expand the application in diabetic macular edema, also obtained the good curative effect.Some scholars also applied the angiogenesis inhibitors to the diabetes retinopathy before surgery in the hope to reduce the occurrence of intraoperative bleeding.Compared with bevacizumab, the short half-life of lucentis, and thus reduce the inhibition of VEGF system risk.

In this project, the investigators will inject lucentis into vitreous cavity before surgery of PDR, and observe the effect and complications of the operation, compared with triamcinolone acetonide group(the control group); At the same time the cytokines level of VEGF, pigment epithelium-derived factor (PEDF), epidermal growth factor (EGF), Transforming Growth Factor-beta (TGF-beta), interleukin 6 (IL - 6) and interleukin 8 (IL - 8) will be detected before and after pretreatment with lucentis or triamcinolone acetonide, and the cytokines concentration change will be compared between two groups, the mechanism of PDR will be further clarified and theoretical basis for looking for treatment strategies will be a set.

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes mellitus with Diabetic Retinopathy
* Vitreous hemorrhage/Proliferation of retinal/Tractional detachment of retina

Exclusion Criteria:

* Fasting blood-glucose more than 8mmol/ml
* Subjects who have operation on vitreous before
* Accompany with other ophthalmology diseases except cataract
* History of vitrectomy surgery in the study eye
* Previous subfoveal focal laser photocoagulation in the study eye
* Previous participation in a clinical trial (for either eye)
* Previous subfoveal focal laser photocoagulation in the study eye
* Other diseases cannot afford Vitrectomy
Multimedia Information and Pre-operative Anxiety

The aim of this study is to investigate a possible reduction in pre-operative anxiety in patients undergoing major elective surgery, by providing multimedia information regarding the patient pathway to and from the Operating Theatre.

To determine whether multimedia information reduces the level of pre-operative anxiety in patients undergoing major elective surgery. To evaluate the efficacy of a video, showing the patient pathway to and from the Operating Theatre, compared with standard information, a written leaflet, about the operating room experience and environment.

Eligibility Criteria:
Inclusion Criteria:

Adult patients undergoing major elective surgery, never previously undergoing surgery as an adult (\>18) and admitted to hospital at least one day before the scheduled surgery.

Exclusion Criteria:

* Patients unable to give consent.
* Patients not able to watch the video.
* Patients admitted the same day of the planned surgery.
* Patients not at the first experience of surgery as an adult (\>18).
To Explore the Anti-oxidative Effects and Inflammation Effects of Soy Protein to Renal Function of End Stage Diabetes Nephropathy Patients

This study investigated the beneficial effects of soybean on the renal function, oxidative stress, and inflammatory responses in patients with end-stage diabetic nephropathy (DN).

DN outpatients were recruited from Tung's Taichung MetroHarbor Hospital (Taichung City, Taiwan). They were randomly separated into two groups; one group was given soy protein drink and the other group was given casein drink for 4 months. The blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged from 40 to 75 years and were at DN stage 4 or 5 were enrolled in this study.

Exclusion Criteria:

* The exclusion criteria were having hemodialysis, lactose intolerance, gastrointestinal (GI) tract dysfunction, liver disease, acute metabolic acidosis or ketoacidosis, in acute infection, severe dehydration, alcohol abuse, addictive drug abuse, cancer in recent 5 years, being involved in another trial in past 1 month, had operation in the past 4 months, or had compliance lower than 90% in the first month of study.
Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM

Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes.

Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.


Eligibility Criteria:
Inclusion Criteria:

* known history of type 2 DM for longer than 3 months
* age between 18-64 year old,
* treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.

Exclusion Criteria:

* subjects with hyperglycemia without any known history of DM
* presence of diabetic ketoacidosis (DKA)
* patients admitted to intensive care unit (ICU)
* subjects expected to undergo surgery during the hospitalization course
* patients with clinically relevant hepatic disease impaired renal function (serum creatinine ≥ 3.0 mg/dL) systemic infections pregnancy patients on medications known to interfere with the blood glucose level (either increasing or decreasing
Study With Two Coenzyme Q10 Products

The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products

The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products will include 35 subjects who will test two different coenzyme Q10 products. Plasma concentration of coenzyme Q10 will be measured.

Eligibility Criteria:
Inclusion Criteria:

* subject informed consent form
* aged between 50 and 65 years old
* body mass for women 70± 5 kg and for men 85± 5 kg
* non-smoking
* healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
* absence of any prescribed medication during the study
* willing to avoid a consumption of any food supplements at least 2 weeks before and during the study

Exclusion Criteria:

* cardio-vascular diseases, diabetes, neurodegenerative diseases, gastrointestinal disorders, pregnancy, breast-feeding
* intake of any food supplements within two week of the beginning of the study
* drug or alcohol abuse