cyrilzakka/clinical-trials huggingface dataset:
Postbiotic MBS and Metformin Combination in Patients With T2DM

The primary objective is to evaluate the effect of MBS treatment in human subjects, and to validate its impact on intestinal flora and diabetes symptoms on diabetic patients undertaking metformin. The scientific data collected will be referenced for future product development.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject who aged from 20 to 70.
2. BMI in between 18.5 and 35 kg/m2 inclusively.
3. Fasting blood sugar ≥ 126 mg/dL, and confirmed diagnosis of type-II diabetes.
4. 30 days prior to the screening visit (V1), HbA1c is steadily maintained in between 7-10% by medication.
5. Prior to the screening visit (V1), subjects have been regularly taken 500-200 mg/day for at least 90 days.

Exclusion Criteria:

1. Pregnant or breastfeeding women or female subjects plan to enter pregnancy during study period.
2. Subjects who are allergic to soy or products containing it.
3. At investigator's discretion, subjects are unlikely to comply with study procedures due to a history of alcohol or drug addiction.
4. Subjects on vegetarian diet or other special diets (eg. Ketogenic or gluten-free diets).
5. Subjects have ongoing participation in another clinical trial that involves the use of investigational drugs, medical devices, dietary supplements, and/or cosmetics.
6. Subject with impaired renal function confirmed by Serum Total Bilirubin ≥ 1.5 upper limit of normal \[ULN\], Aspartate Transaminase/ Alanine Transaminase (AST/ALT) ≥ 2 ULN, Creatinine ≥ 2 ULN or eGFR \<60 mL/min/1.73 m\^2.
7. Subjects who have been diagnosed with malignant tumors within five (5) years before the screening visit (V1) with exception to subjects with topical cancer but show significant recovery following investigator's assessment, such as basal or squamous cell skin cancer, superficial bladder cancer, or prostate or cervix or carcinoma in situ of the breast.
8. 30 days prior to screening visit (V1), subjects have taken antibiotics, synthetic drugs (Sulfonamides, Fluoroquinolone, etc.), anti-fungal or anti-viral medication but not limited to topical forms for use in skin application.
9. Within 14 days prior to screening visit (V1), subjects have taken products or supplements that contain probiotics or prebiotics.
10. Within 14 days prior to screening visit (V1), subjects experience diarrhea caused by gastrointestinal infection (3 times of watery stool within 24 hours).
11. Within14 days prior to screening visit (V1), subjects have taken steroids, immunosuppressant, and/or inflammatory medicines.
12. Subjects took or intend to take medications other than metformin that may affect intestinal flora within 30 days prior to screening visit, during screening period or whole trial period. Examples of this kind of medication include DPP-4 inhibitors, GLP-1 receptor agonists, acarbose, hypoglycemic sulfonamides, thiazolidinediones, SGLT2 inhibitors, and insulin.
Guidance of Ultrasound in Intensive Care to Direct Euvolemia

The purpose of this study is to assess the effectiveness of routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation in reducing acute kidney injury (AKI) incidence and duration in trauma patients in a teaching institution.


Eligibility Criteria:
Inclusion Criteria:

* Injured patients that are admitted to the trauma ICU

Exclusion Criteria:

* Incarceration
* Pregnancy
Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation

The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation.

40 patients were randomly divided in two study groups after radiological and clinical evaluation. Both groups received bone grafting by a xenogeneic bone substitute (BSM, cerabone, botiss biomaterials GmbH, Zossen, Germany) using the lateral approach. In the bony wall group (BW), following piezosurgery the retrieved bony wall was repositioned. In the collagen membrane group (CM), the lateral window was created by rotary instruments, covered via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany). After 6 months, biopsies were taken to analyze both approaches in terms of new bone formation. Duration of treatment, the number of perforations, postoperative patient discomfort were registered. Established histopathological analysis and histomorphometrical measurements to analyze the tissue reactions and the tissue distribution, i.e., the fractions of newly formed bone tissue (NB), of remaining bone substitute material (BSM) and connective tissue (CT), were conducted.

Eligibility Criteria:
Inclusion Criteria:

* at least one missing maxillary premolar or molar
* at least 7 mm crestal bone width confirmed by preoperative ConeBeam Tomography (CBCT)
* maximally 5 mm residual bone height at the sinus floor confirmed by preoperative ConeBeam Tomography (CBCT)
* full mouth plaque and bleeding scores (FMPS and FMBS) \<20%
* satisfactory patient compliance (e.g. to participate in follow-up procedures)
* signed informed consent.

Exclusion Criteria:

* clinically relevant diseases (e.g.: diabetes, rheumatism cancer)
* untreated periodontitis
* systemic steroid use
* bisphosphonate use
* acute or chronic inflammatory processes
* previous endoscopic sinus surgery
* previous sinus floor elevation
* GBR-treatment at the study site
* GTR-treatment at the study site
* tooth removal within 6 weeks prior to surgery
Comparison of Exercise With & Without Bracing in Office Workers With Kyphosis

The study aims to Compare PT and bracing in improving posture, pain, and functionality in patient with kyphosis.

It also assess the additive benefits of combining PT with bracing. It also identify sustainable, non-surgical approaches for managing kyphosis in office

The study focuses on understanding Kyphosis, defined as excessive forward curvature of the thoracic spine, has become increasingly prevalent in modern work environments due to the sedentary nature of desk jobs. Kyphosis, characterized by a rounded upper back or "hunchback" appearance, is a clinical and postural problem with significant physical, functional, and psychosocial implications. Among office workers, the condition is primarily postural, driven by long hours of desk work, inappropriate ergonomic settings, and inadequate postural awareness. The increasing prevalence of kyphosis in this demographic has led to a pressing need for effective nonsurgical management strategies, including physical therapy (PT) and spinal bracing.

Eligibility Criteria:
Inclusion Criteria:

* Office workers diagnosed with Postural Kyphosis
* age limit 30 to 45years
* Experience of upper back or neck pain lasting at least three months
* Spend a minimum of 6 hours per day in a seated position for work.

Exclusion Criteria:

* History of spinal surgery, severe scoliosis, or other significant spinal deformities.

Current engagement in any structured physical therapy program or use of bracing for posture. Any neurological or musculoskeletal disorders impacting posture or movement.
Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum

To examine retrospectively whether transcatheter closure of the interatrial septum leads to myocardial injury and to determine the mechanism.

In a prospective study in adults troponin T (TnT) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (ASD) or patent foramen ovale (PFO).

Eligibility Criteria:
Inclusion Criteria:

* transcatheter ASD and PFO closure at the University Hospital of Lund, Sweden

Exclusion Criteria:

* missing TnT values
Brain Oxygenation-II

The Brain Oxygenation-II study (BOx-II) is a phase-II, multicenter, single-arm clinical trial evaluating interventions based on near-infrared spectroscopy (NIRS) monitoring of cerebral oxygen saturation in extremely premature infants. Enrolled infants will follow a treatment guideline to maintain cerebral oxygen saturation in a target range within the first 72 hours of life. The primary outcomes will include interventions used to maintain cerebral saturation in target range, rates of cerebral hypoxia and systemic hypoxia, and a composite of death or severe brain injury detected on term-equivalent magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

* Infants born with postmenstrual age less than 28 weeks
* Signed informed consent

Exclusion Criteria:

* Missing written parental informed consent
* Decision not to conduct full intensive care support
* No possibility to place cerebral NIRS oximeter within six hours after birth
* Skin integrity insufficient to allow for sensor placement as deemed by a clinician
Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain

Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Even though most of the studies demonstrate efficacy, other studies do not support these observations. Few studies addresses the efficacy of probiotics in children with IBS. The goal of the present study was to determine whether oral administration of the probiotic Lactobacillus GG under randomized, double-blind, placebo-controlled conditions would improve symptoms of children with abdominal pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients were considered for study inclusion, if they were 4 - 12 years of age and had if they had a pain history of at least 12 weeks (which need not be consecutive) in the preceding 12 months suggestive for IBS or FAP with no structural or metabolic abnormalities to explain the symptoms and according to the Rome II diagnostic criteria valid at the time of the design of the study.
* IBS was diagnosed in presence of an abdominal discomfort or pain with at least two of three features:

  * relieved with defecation
  * onset associated with a change in stool frequency
  * onset associated with a change in the form (appearance) of the stool.
* FAP was diagnosed in presence of symptoms of
* Continuous (nearly continuous) abdominal pain
* No or only occasional relation of pain with physiological events (e.g. eating, menses)
* Some loss of daily functioning
* The pain is not feigned (e.g. malingering)
* The patient has insufficient criteria for other functional gastrointestinal disorders that would explain the abdominal pain.

Exclusion Criteria:

* Known concomitant psychiatric, neurological, metabolic, hepatic, renal, infectious, haematological, cardiovascular and pulmonary disease
* Treatment with antibiotics/probiotics in the last 2 months
* A pain history suggestive for functional dyspepsia or aerophagia or abdominal migrain
* Growth failure
* Gastroparesis
* Gastrointestinal obstructions/stricture
* Any disease that may affect bowel motility such as diabetes, connective disease or poorly controlled hypo/hyperthyrodism
* Previous abdominal surgery.
Corin MiniHip and Trinity Cup Clinical Surveillance Study

The aim of the study is to provide long term follow up data on the performance and safety of the Corin MiniHip and Trinity acetabular cup over a 10-year period.

To verify the ten-year clinical and radiographic performance of the Corin MiniHip and Trinity Advanced Bearing Acetabular System when used in patients under normal conditions of use.

To document the safety, evaluate patient satisfaction, quality of life and to determine the survivorship following intervention with the Corin MiniHip and Trinity Advanced Bearing Acetabular System at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or developmental dysplasia of the hip.
* Avascular necrosis of the femoral head
* All subjects must be between the age of 18 and 75 at the time of surgery to take part in this study
* Scheduled for a primary total hip replacement.

Exclusion Criteria:

* Active infection
* Severe Obesity (BMI over 35)
* Pregnancy
* Mental illness
* Grossly distorted anatomy (surgeon's discretion)
* Sepsis
* Osteomyelitis
* Osteomalacia
* Distant foci of infections
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Muscular atrophy or neuromuscular disease
* Allergy to implant material
* Marked bone loss or bone resorption
* Patients without sufficient quantities of synovial fluid to allow for proper lubrication, such as patients with Sjogren's syndrome
* Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock or poor skin coverage around the hip joint which would make the procedure inappropriate
* Any case not described in the inclusion criteria
* Any patient who cannot or will not provide informed consent for participation in the study
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
AVJ Ablation Followed by Resynchronization Therapy in Patients With CHF and AF

The purpose of the study is to determine if the combination of AVJ ablation followed by BiV pacing significantly improves functional status and exercise capacity compared to pharmacologic rate control in patients with chronic AF and depressed ejection fraction, regardless of rate or QRS duration.

* This is a prospective, randomized, double blinded, multicenter study
* Patients meeting all the enrollment criteria are screened at enrollment and randomized to Group 1 (Pharmacological therapy + Single Chamber ICD) or Group 2 (AVJ Ablation + CRT-D)
* Screened patients are implanted with a FDA approved SJM ICD/CRT-D with compatible lead system
* Patients are followed at 1, 3, 6 and 12 months post implant
* Total # of centers - 20 centers
* Sample size - 180 patients

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic permanent AF
* Class I or II indication for ICD
* LVEF ≤ 35% within 6 months
* NYHA class II or III with a history of CHF
* Maximal tolerated drug therapy for CHF and rate control with a stable regimen for ≥ 30 days
* Ability to independently comprehend and complete a QoL questionnaire
* Ability to give informed consent for study participation and willingness and ability to comply with prescribed follow-up tests and scheduled evaluations

Exclusion Criteria:

* Paroxysmal or persistent AF
* Class I indication for pacing (including AVJ ablation for poor rate control)
* Ability to walk ≥ 450 meters in 6 minutes
* Musculoskeletal disorders that prohibit the completion of a 450 meters walk
* NYHA class I or IV at the time of enrollment
* A contraindication to taking Coumadin therapy
* History of myocardial infarction, percutanous coronary intervention, or CABG in the past 30 days
* History of mitral valve surgery
* Prior attempts for cardiac resynchronization therapy
* The presence of an existing coronary sinus lead or epicardial lead
* Life expectancy \< 1year
* Age \< 18 yrs
* Current participation in other clinical studies except registry trials
* Use of calcium channel blockers
* Pregnancy
* Inability to give informed consent
Left Bundle Branch Area Pacing in Patients After TAVR

Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) is a well-established treatment of aortic valve stenosis. Yet, requiry of permanent pacing due to new onset atrio-ventricular conduction block remains a frequent complication. Standard right ventricular pacing (RVP) at high pacing burden may lead to deterioration of left ventricular function. Left-Bundle-Area Pacing (LBBP) is a new, innovative method of physiological ventricular stimulation resulting in narrow, physiological QRS complexes.

In this prospective, randomized, single center clinica trial, patients are included after TAVR and with normal left ventricular function who require pacing due to a higher degree atriao-ventricular block with an anticipated high pacing burden. Patients will be randomized to receive either left bundle branch area pacing (intervention) or right ventricular apical pacing (control).

The results will confirm the feasibility of LBBP in patients following TAVR. Results will further investigate the primary outcome of a clinically relevant QRS narrowing and a combination of exploratory secondary endpoints including clinical outcomes, functional status, laboratory biomarkers, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Successful TAVR implantation for classical (high flow high gradient), symptomatic aortic valve stenosis
* LVEF ≥50%
* Guideline-based indication for pacing due to AV block III°, AV block II°, or symptomatic bradycardic atrial fibrillation with an expecteed ventricular pacing burden \>20%
* Signed informeed conseent to study participation

Exclusion Criteria:

* LVEF \<50%
* Expected pacing burden \<20%
* Pre-existing implanted cardiac device
* Participation in a concurring interventional trial
* age \<18 years
* Current preegnancy
* life expectancy \<6 months
Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects

To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed written informed consent
* Diagnosis of active choroidal neovascularization secondary to wet AMD
* BCVA of 65 to 25 ETDRS letters (20/50 to 20/320) in the study eye
* BCVA of 25 ETDRS letters (20/320) or better in the fellow eye

Exclusion Criteria:

\[Ocular\]

* Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1 and throughout the study
* Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
* Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
* Need for ocular surgery in the study eye during the course of the study
* Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform examinations

\[Non-ocular\]

* Allergy or hypersensitivity to study drug product, fluorescein dye or other study related procedures and medications
* Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study
* Participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study
* Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study
* Unable to comply with study procedures or follow-up visits
Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer

The aim of this study is to investigate urokinase Plasminogen Activator Receptor (uPAR) microexpression in gastroesophageal cancer (adenocarcinomas) both qualitatively and semi-quantitatively and to evaluate if it offers a possibility for future imagining purposes.

* Sections of the tumor tissue will be HE stained.
* Sections of the tumor tissue will be stained with an uPAR antibody for immunohistochemistry.
* Immunohistochemical staining against cytokeratin which colors cancer cells will be made to assist the observer in the evaluation of uPAR microexpression pattern.
* A semiqualitative scale corresponding to the level of uPAR expression will be made.
* Quantitative polymerase chain reaction will be used to validate the immunohistochemistry uPAR expression pattern.
* An electronic scoring system (digital pathology) will be trained to access the expression of uPAR in both tumor- and normal tissue.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old.
* Patients who underwent curatively intended surgery for gastroesophageal cancer
* Patients who underwent surgery after 01-01-2016.

Exclusion Criteria:

* Patients who applied for an exception from medical research at the "National Registry of Tissue Use."
* Patients with other histological subtypes than adenocarcinoma.
ApoB48 Metabolism in Plasma and Interstitial Fluid

Postprandial increases in the levels of atherogenic chylomicron remnant lipoprotein particles have long been considered a presumable risk factor for the development of atherosclerosis with time, also in normolipidemic subjects. apoB-48 (Chylomicron) in blood is a specific marker for intestinal derived lipoproteins. Specific aim: To determine if apoB-48 containing lipoproteins may appear in IC in the postprandial state after a standard meal and investigate the effect fasting and feeding have on levels of lipids, apolipoproteins and the cholesterol component of lipoproteins in IF and plasma.

Methodology: Intercellular fluid will be collected using the cup technique. IF will be collected in intervals corresponding to different periods after food intake. The IF from these different occasions will then be analysed and compared using FPLC and Elisa.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years.
* For the T2D study group: Diagnosed with type 2 diabetes.

Exclusion Criteria:

For subjects with type 2 diabetes:

* Systemic inflammatory disease that requires active treatment
* Thyroid disease that requires active treatment
* Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated
* Treatment with oral glucocorticoids
* Levels of SR, TSH, T4 or Hemoglobin in the blood pronouncedly outside the reference range
* Pregnancy

For healthy controls:

* Registered disease in the health declaration that requires continuous systemic treatment. Exception to the above: well controlled hypertension in which case the subject should not have treatment with more than one antihypertensive drug, the drug must not be an alpha-blocker or beta-blocker or thiazide diuretic
* Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated
* Blood pressure pronouncedly above 140/90
* Blood test results pronouncedly outside the reference range
* Pregnancy