cyrilzakka/clinical-trials huggingface dataset:
Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus
* Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
* HbA1c below 10.0%
* Body Mass Index (BMI) \< 30.0 kg/m\^2

Exclusion Criteria:

* Known hypoglycaemia unawareness or recurrent major hypoglycaemia
* Current treatment with total insulin dose of more than 100 U or IU/day
* Current treatment or expected to start treatment with systemic corticosteroid
* Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer \[thiazolidinedione: TZD\]) within the last 12 weeks prior to screening
A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.

This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>=18 years of age
* Patients with confirmed rectal cancer who are subject to surgery and would benefit from pre-operative combined chemo-radiotherapy
* Measurable and/or evaluable lesions according to RECIST criteria
* EOCG performance status 0-1

Exclusion Criteria:

* Prior radiotherapy or chemotherapy for rectal cancer
* Untreated brain metastases or spinal cord compression or primary brain tumors
* Chronic daily treatment with high-dose aspirin (\>325 mg/day) or other medications known to predispose to gastrointestinal ulceration
* Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ.
PiCCO Guided Therapy in Liver Cirrhosis

Prospective comparison of standard therapy in liver cirrhosis versus standard therapy plus intensified hemodynamic monitoring using the PiCCO system.

Patients presenting with advanced liver cirrhosis will receive either standard treatment or standard treatment plus hemodynamic monitoring with the PiCCO device. Fluids and vasoacitve drugs will be administered according to the measurements over a period of 5 days.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis Child-Pugh-Score \> 7
* Ascites \> 500 ml

Exclusion Criteria:

* Coronary heart disease
* Apoplexia \< 6 months ago
* Vasculitis
* Thrombosis
* Arterial occlusive disease \> stadium II
Surgeon Infiltration QL Block Comparison

The purpose of this study is to learn if using a Quadratus Lumborum (QL) plane injection technique (also called a "nerve block") that numbs the nerves going to the abdominal area improve pain control after surgery compared to administration of local anesthetic directly to the surgical incision. The QL block technique uses a numbing solution (local anesthetics) that is injected next to nerves located along muscles in the back to reduce pain. This block will not affect movement in the leg and/or make the legs weak. Some institutions, including Duke, use the QL block for patients having various abdominal surgeries, with the hope of providing good pain relief combined with improved mobility after surgery.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* ASA 1-2 patients undergoing living donor nephrectomy

Exclusion Criteria:

* ASA 3 or 5
* Diagnosis of chronic pain
* Daily chronic opioid use (over 3 months of continuous opioid use)
* Inability to communicate pain scores or need for analgesia
* Infection at the site of block placement
* Pregnant women (as determined by standard of care day-of surgery urine bHCG)
* Intolerance/allergy to local anesthetics
* Weight \<50 kg
* Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course
Teriflunomide Observational Effectiveness Study

The main goal of this investigator-initiated study is to evaluate the effectiveness and efficacy of Teriflunomide in a population of Relapsing Remitting Multiple Sclerosis (RRMS) patients treated in regular practice, over a period of at least two years, in the regular setting of a Multiple Sclerosis Clinic.

Consenting adult RRMS patients, meeting all inclusion criteria and who have been prescribed Teriflunomide by their treating physician will be asked to complete questionnaires on quality of life (QoL), fatigue, and employment.

The study will include 300 participants from three Multiple Sclerosis (MS) Clinics. Disease and magnetic resonance imaging (MRI) activity, blood tests (aspartate aminotransferase (AST), alanine aminotransferase (ALT), complete blood count (CBC)), drug compliance, side effects, toxicity, will be monitored.

MS patients never treated with a disease modifying drug (DMD) and MS patients previously exposed to another DMD will be included. Some would have been on a single medication, while others would have been treated with two or more medications.

The results of the study will provide the patient-perceived global impacts of Teriflunomide on the patient's overall quality of life.

These results will also guide the physician in giving a treatment that will be adapted to the patient's major concerns.

Eligibility Criteria:
Inclusion Criteria:

* Consenting Relapsing Remitting Multiple Sclerosis adults with an Expanded Disability Status Scale (EDSS) score ≤ 5.0 who have been prescribed Teriflunomide and who agree to follow study procedures.

Exclusion Criteria:

* Primary progressive or secondary progressive Multiple Sclerosis without relapses; other diseases that may confound evaluation of outcomes; other exclusion as per product monograph; and women contemplating pregnancy or actually pregnant.
The Degree, Duration and Frequency of Insulin Resistance in Non-operated Patients With Sepsis

Surgery induces insulin resistance lasting for 2-3 weeks. We wanted to elucidate if stress-metabolic, medical conditions carry the same effect.

Background: Insulin resistance is well documented after surgery in a severity positively correlated to the degree of trauma (Thorell et al. 1999; Chambrier et al. 2000). Similar phenomena have been described in severely ill patients in ICU with consequences for the survival (Van den Berghe et al. 2001; The NICE-SUGAR Study Investigators 2009). The documentation, however, is scarce and the extent is unknown in acutely ill patients with sepsis.

Method: Adult, consecutive, non-diabetic patients with elevated CRP, leukocyte counts, SOFA-score of ≥ 2 were monitored with fasting p-C-peptide, blood glucose, CRP, leukocyte count and HOMA-IR at admittance, discharge and at two follow-up visits 2 weeks and 4 weeks after admission. Blood glucose levels were measured continuously during the whole study period with a flash glucose monitor mounted on the patients' upper arm. The diagnosis was sepsis, urosepsis, pneumonia, erysipecosis, bacteremia, infection with unknow focus and covid-19.

Eligibility Criteria:
Inclusion Criteria:

* elevated CRP on acute asdmission
* elevated leukocyte count on admission
* SOFA-score ≥ 2
* diagnosis: bacterial sepsis
* full age and authority

Exclusion Criteria:

* not able to understand the protocol
* not able to co-operate
* diabetes mellitus of any kind
Safety, Tolerability, and Efficacy of BVS857 in Patients With Spinal and Bulbar Muscular Atrophy

The purpose of this study was to determine if BVS857 is safe, tolerable and increases thigh muscle thickness in patients with spinal bulbar and muscular atrophy (SBMA).


Eligibility Criteria:
Key Inclusion Criteria:

* Genetic diagnosis of SBMA with symptomatic muscle weakness
* Able to complete 2 minute timed walk
* Serum IGF-1 level less than or equal to 170 ng/mL

Key Exclusion Criteria:

* Medically treated diabetes mellitus or known history of hypoglycemia
* History of Bell's palsy
* Treatment with systemic steroids \> 10 mg/day (or equivalent dose); androgens or androgen reducing agents; systemic beta agonists; or other muscle anabolic drugs within the previous 3 months
* History of cancer, other than non-melanomatous skin cancer
* Retinopathy
* Papilledema Other protocol defined inclusion/exclusion criteria may apply
The Cedar Project: Impact of mHealth for HIV Prevention Among Young Indigenous People Who Use Illicit Drugs

This study will examine the effect of a culturally-safe two-way supportive text message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in a community-based setting.

The study is nested within The Cedar Project, an ongoing cohort study addressing HIV and Hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia, Canada. Indigenous collaborators and investigators, collectively known as the Cedar Project Partnership, govern the entire research process.

A stratified Zelen pre-randomized design will be used to identify a random selection of cohort members to be offered the Cedar Project mHealth intervention with consent. Participants in the intervention arm will receive a package of supports, including a mobile phone and long-distance plan, weekly two-way supportive text messaging via the WelTel platform, and support from Cedar Advocates. Those drawn from the cohort study population as the comparison group will continue on in the usual Cedar Project study under its existing informed consent with no change whatsoever to their participation in the overall study.

The main outcome is an HIV propensity score, assessed at six months and one year. Secondary outcomes include HIV risk, resilience, access to drug-related services, psychological distress, and connection to culture measured at six months and one year. Primary analysis is by intention to treat.


Eligibility Criteria:
Inclusion Criteria:

* currently enrolled in the Cedar Project
* completed main Cedar Project Baseline questionnaire and attended at least one follow-up visit since 2009
* had not tested positive for HIV
* joined study in Vancouver or Prince George
* alive at initiation of Cedar Project mHealth study
Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant

The effect of using of i-PRF (injectable platelet rich fibrin) on filling the gap of immediate dental implant in the esthetic zone

Grouping the samples: (sixteen patients was recruited from the outpatient clinic of Oral Medicine, Periodontology, Diagnosis and Radiology Department, Faculty of Dentistry, Ain Shams University).

The sixteen patients assigned to group 1 or group 2 will be randomly allocated using flip of a coin into one of the 2 treatment modalities.

Primary objective:

Radiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the immediately placed dental implant and the surrounding bone.

Secondary objective:

Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed dental implant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult patient.
* Age from 20-50 years old
* Patients must be free of any systemic disease which could influence the surgical procedure.
* Tooth involved in the esthetic zone.
* Sufficient hard and soft tissue volume in vertical and buccolingual 6. Natural teeth adjacent to the involved tooth were required to be free from infection.
* Controlled oral hygiene.
* Indication for tooth extraction included;

  * Endodontic failures
  * Untreatable caries\> Non- restorable teeth
  * Vertical root fracture
  * Remaining roots
* The decision to proceed with the implant placement was made after tooth extraction and probing of the extraction socket which revealed:

  * The presence of intact facial bone.
  * Compliance with all requirements in the study and signing the informed consent.

Exclusion Criteria:

* Patient had surgeries in the same site during the last 6 months prior to the surgery.
* Severe vertical bone loss (socket type lll or type lV).
* Presence of acute dento-alveolar infection or periodontal affected of involved tooth.
* Pregnant and lactating females.
* Smokers.
Intraocular Fluid Detection in Endophthalmitis

Endophthalmitis is also called vitreous inflammation. Broadly speaking, it refers to all kinds of serious intraocular inflammation, such as vitreitis, anterior chamber empyema and eye pain caused by intraocular infection, intraocular foreign body, tumor necrosis, severe non infectious uveitis, lens cortex allergy, etc. Clinically, it generally refers to infectious endophthalmitis caused by bacteria, fungi or parasites. According to the different ways of infection, it can be divided into exogenous endophthalmitis and endogenous endophthalmitis. Exogenous endophthalmitis is more common. When inflammation involves sclera or extraocular orbital tissue, it is called "panophthalmia".

Endophthalmitis is a kind of serious intraocular inflammation which can lead to the loss of visual function. Early diagnosis and treatment is the key. Studies have found that the changes of cytokines in aqueous humor are helpful for the diagnosis of endophthalmitis. Okhrvai et al. Also pointed out that the application of PCR can reduce the diagnosis time of endophthalmitis. This study mainly verified the use of molecular biology technology to detect the changes of VCAM, ICAM-1 and other cytokines, bacteria, viruses, fungi, Toxoplasma gondii IgG in patients' intraocular fluid, including aqueous humor and vitreous humor, so as to timely judge the etiology and progress of endophthalmitis, and provide reference for diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* ① Clinical manifestations: eye pain, photophobia and tears, decreased vision, conjunctival congestion and edema, etc. ② Special examination: anterior examination showed conjunctival congestion and edema, postkeratosis, anterior chamber empyema and other inflammatory manifestations. Fundus examination showed vitreous opacity, fundus hemorrhage and white lesions. ③ Laboratory examination: bacteria, viruses, fungi and Toxoplasma gondii were detected in the aqueous humor and vitreous humor of the patients.

Exclusion Criteria:

* 1. With tumor, rheumatoid and other autoimmune diseases. 2. Accompanied by diabetes and other systemic chronic diseases. 3. Patients with retinal and choroidal vascular diseases and history of eye surgery were excluded.
SA Versus SOI Surfaces for Single Implant-supported Crown

The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.

This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.

Eligibility Criteria:
Inclusion Criteria:

* Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.

Exclusion Criteria:

* Patients unable to commit to 5 years follow-up.
* General contraindications to implant surgery.
* Less then 4 mm of keratinised gingiva crestally (at the implant sites).
* Immune-suppressed/compromised patients.
* Patients irradiated in the head and/or neck.
* Uncontrolled diabetes.
* Pregnancy or lactation.
* Untreated periodontal disease.
* Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
* Addiction to alcohol or drugs.
* Psychiatric problems and/or unrealistic expectations.
* Patients with an acute infection or suppuration in the site intended for implant placement.
* Patients needing any form of tissue augmentation at implant placement.
* Immediate post-extractive implants (implants can be placed after a 3-month healing period).
* Patients treated or under treatment with intravenous amino-bisphosphonates.
* Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
* Patients participating in other studies, if the present protocol could not be fully adhered to.
Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

The purpose of this study is to find a safe and tolerable way to improve engraftment after transplant. Research studies have shown that adding nicotinamide riboside to donor cells has the potential to increase blood stem cell numbers and potentially decrease the time to engraftment. Also, nicotinamide riboside, TRU NIAGEN (the study drug) is a type of vitamin B supplement that the general public can get without a prescription and is well tolerated.

This is a single-center, pilot feasibility study of NR supplementation in allogeneic (donor) HCT in which the study team is seeking to obtain preliminary data on any beneficial effect of increasing NAD+ levels in-vivo to facilitate engraftment. Engraftment is defined as the process during which transplanted stem cells begin to grow in the bone marrow and produce new white blood cells, red blood cells, and platelets. It takes about 14 to 24 days for donor cells to engraft after infusion, and the time between which blood counts fall to the time when they recover is a very critical period. Transfusions are frequently required to prevent bleeding and antibiotics are needed to prevent infections during this critical time period. Shortening the time of engraftment decreases these risks and can improve long-term health status.

The primary objectives of this study is to evaluate safety and tolerability of NR supplementation

The secondary objective of this study is to evaluate neutrophil and platelet recovery after HCT

Eligibility Criteria:
Inclusion Criteria:

* All disease indications for allogeneic hematopoietic cell transplantation except for myelofibrosis.
* Subject must meet program eligibility criteria\* for myeloablative conditioning alloHCT and plan to undergo myeloablative conditioning.
* HLA-identical related donor or unrelated human donor source with bone marrow graft.
* Subjects must provide a written informed consent.

Exclusion Criteria:

* History of allergy or intolerance to NR precursor compounds, including niacin or nicotinamide
* Pregnant or breastfeeding women are excluded from this study since allogeneic HCT is a strict contraindication.
* Subjects with uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes

This early feasibility first-in-human study is a prospective single-arm single-center study of Sigi insulin patch pump. After a 1st day and night under medical surveillance during a hotel stay, Sigi system will be evaluated during 15 days at home in adults with type 1 diabetes.

Sigi Insulin Management System (Sigi) is a novel insulin patch pump intended for subcutaneous delivery if insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Sigi is offering superior delivery accuracy and precision, accelerated occlusion detection, wearable patch pump, pre-filled insulin cartridges and smartphone control.

Glycemia is CGM controlled and for safety purposes, CGM data are shared with study medical team during the whole study.

Sigi FIH Study is conducted in a single clinical site in Lausanne University Hospital (CHUV) in Switzerland.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed
* Patients with T1D since more than 1 year
* Adults 18+years
* Patients under sensor augmented pump for at least 6 months
* Hybrid closed-loop users willing to switch to manual mode 15 days before study
* Patients with calculated insulin-to-carb ratio and correction factor
* Patients with total daily insulin above 30 insulin units
* Patients with correction factor below 3.5 mmol/L
* No severe hypoglycemic or ketoacidosis episode requiring third-party intervention within the past 12 months
* Active users of Teflon infusion sets
* Patients willing to use a smartphone interface to use their pump and to answer study questionnaires

Exclusion Criteria:

* Patients with T2D
* Patients with T1D under multiple daily injections
* Patients using Apidra and not willing to switch to NovoRapid / Fiasp / Humalog
* Patients with history of skin diseases (e.g. generalized eczema, plan lichen, psoriasis)
* Patients with known allergy to some insulins
* Clarke's score ≥ 4 (hypoglycemia unawareness)
* Severe late complications of diabetes, like severe neuropathy, non-stabilized proliferative retinopathy, EGF \< 30 mL/min, myocardial infarction or stroke within the last 3 months
* Glycated hemoglobin HbA1c \> 8.5 % at screening visit
* Medications interacting with glucose homeostasis (e.g. steroids)
* Pregnant of breastfeeding women
* Planned operation / MRI / CT requiring removal of infusion pad over the 15 days of the study
* Planned travel over the 15 days of the study
* Persons under guardianship or incapable of judgement