cyrilzakka/clinical-trials huggingface dataset:
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen®

This trial is conducted in Europe. The aim of this trial is to compare Injections with the Medical Device DV3316 Pen-injector versus FlexPen®.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-74 years (both included) at the time of signing informed consent
* T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) (as diagnosed clinically) at least 12 months prior to screening
* Daily self-injection(s) with anti-diabetic drug (insulin or Glucagon-Like Peptide-1 (GLP- 1) analogues) in pen-injector or vial/syringe for at least 12 months
* Caucasians
* Body Mass Index (BMI) at least 18.5 kg/m\^2

Exclusion Criteria:

* Known or suspected hypersensitivity to test placebo solution incl. m-cresol and phenol or related products (placebo)
* Female who is pregnant,, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* Known urticaria factitive or abnormal reactions to mechanical trauma
* Haemophilia and any diseases affecting blood coagulation
* Anti-coagulant or inhibitors of platelet aggregation treatment on the day of the visit
* Intake of any pain-relieving or analgesic drugs on the day of the site visit
* Skin diseases and infections of the skin in the injection site areas (abdomen and thighs)
* Lipodystrophia in the injection site areas (abdomen and thighs)
SENSORY RE-TRAINING IN PATIENTS WITH CHRONIC NECK PAIN

It is known that tactile acuity and proprioceptive sense decrease in patients with chronic neck pain. However, sensory re-training in patients with chronic neck pain has not been given sufficient importance. The effects of proprioceptive and tactile acuity training on pain intensity in patients with chronic neck pain will be compared in this study. Eligible participants will be divided into three groups as follows: Proprioceptive Training Group (PTG), Tactile Acuity Training Group (TAG), and Control Group (CG). The randomization will be performed using the block randomization method to obtain an equal number of participants in the groups. Each participant will be evaluated two times at a 4-week interval. Participants will be evaluated regarding subjective pain intensity by using a Numerical Rating Scale, temporal summation, and conditioned pain modulation using an algometer (JTECH Medical-Algometer Commander, USA). Neck proprioception exercises will be applied to the patients in the PTG at 3 days a week for 4 weeks. Tactile acuity training will be applied to the patients in the TAG 3 days a week for 4 weeks. Between the two assessments, the Control Group will not receive any treatment.


Eligibility Criteria:
Inclusion Criteria:

* to be aged between 20-60 years old
* Pain limited to the posterior of the cervical region.
* Pain that lasts longer than 3 months
* Pain severity of 3 or higher on the Visual Analog Scale

Exclusion Criteria:

* Malignant tumor in any part of the body (no screening will be performed for the presence of tumor and patients diagnosed with tumors before the study will not be included).
* Vertebral fractures
* Fibromyalgia
* chronic fatigue syndrome
* History of surgery in the neck or shoulder area
* Radicular pain
* Neurological deficit of disc pathologies
* Spinal stenosis
* Spondylolisthesis
* Pronounced cervical kyphosis
* Significant scoliosis involving the cervical region
Health Related Quality of Life and Cognitive Function Among Norwegian Dialysis Patients

The purpose of this study is to assess health related quality of life and its predictors among chronic dialysis patients and to assess cognitive function using 3 different tests.

(undergraduate medical student research project; not published)


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney failure
* Active dialysis treatment
* Aged over 18 years
* Able to read and answer the quality of life questionaire

Exclusion Criteria:

-
Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to \<20 year olds with BMI \>85th percentile ( total daily insulin dose \>0.7 units/kg, and HbA1c 7.0%-9.9%).


Eligibility Criteria:
Inclusion Criteria:

1. Meets eligibility criteria of the main study, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828).

Exclusion Criteria:

1. Low hemoglobin or hematocrit as defined by each local institution's rules for insulin clamps or if no institutional requirements a Hematocrit \<30% or hemoglobin \<10 gm/dL
Ultrasound Imaging of Fibrotic Tissue

This project intends to collect the ultrasonic spectrum information of shoulder and knee joint fibrotic tissue, and use machine learning to study the mechanism of fibrosis tissue ultrasound imaging, and then build a model and finally establish the relationship between joint stiffness and fibrosis formation. In this study, the broadband ultrasound imaging method for joint fibrosis has the potential to create a method for ultrasonic localization, staining and evaluation of joint fibrosis, laying the foundation for the research of new conservative treatment methods and surgical positioning for fibrosis, and for reducing the occurrence of joint fibrosis rate, improve joint function of patients, and return to family and society earlier and better


Eligibility Criteria:
Inclusion Criteria:

1. Unilateral shoulder or knee joint stiffness and normal on the opposite side
2. The course of the disease is longer than 3 months
3. Good cognitive function, able to understand the content of this experiment, willing to cooperate with follow-up
4. Over 18 years old, voluntarily participate in this study, and sign the informed consent

Exclusion Criteria:

1. Wound non-healing, joint dislocation or unstable fracture fixation, pseudarthrosis, joint purulent infection and other contraindications for joint range of motion examination
2. There are skin lesions, wounds or allergies to the coupling agent on the joint surface and other conditions that cannot be used for ultrasound examination
Caregivers of Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

Children with esophageal atresia and tracheoesophageal fistula (EA-TEF) may experience feeding and swallowing difficulties, which result in stressful interactions between children and caregivers, and potentially impact the concerns of caregivers. The aim of this study was to assess concerns of caregivers of children with EA-TEF related to feeding-swallowing difficulties.

Children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF) experience some degrees of feeding and swallowing difficulties Feeding and swallowing difficulties cause aspiration-induced recurrent pneumonia, malnutrition, dehydration and stressful interactions with their caregivers. There is lack of knowledge regarding the concerns of caregivers of children with EA-TEF related to feeding and swallowing disorders.Therefore, the aim of this study was to assess concerns of caregivers of children with EA-TEF related to feeding-swallowing difficulties.

Eligibility Criteria:
Inclusion Criteria:

* Having a child with EA-TEF
* Having a child with swallowing disorders aged between 6 months-18 years

Exclusion Criteria:

* Having a child without swallowing disorders
Transplanting Lungs From Uncontrolled Donation After Circulatory Death

The study team developed an uncontrolled donation after circulatory death (uDCD) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (PEEP) and supplemental oxygen. The study will assess lung uDCD program safety by continuous review of operations/clinical records from each case activation and transplantation. Attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (EVLP) performance testing, and lung transplantation. Planned viability assessments also include macroscopic determination, radiology (X-ray), and fiber optic bronchoscopy before initiating EVLP. We expect \~50% of lungs assessed with EVLP will be transplanted to meet sustainability targets. Safety outcomes include the primary outcome, primary graft dysfunction (PGD) grade III at 72 hours, and secondarily survival one year after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients waiting for lung transplants
* Willing to participate in the research study

Exclusion Criteria:

* Unable to be followed for 1 year after transplantation
* Unable to provide written informed consent to participate in the research (or designate a surrogate)
Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.


Eligibility Criteria:
Inclusion Criteria:

* Male/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy.
* Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject.
* Subject used to consume dairy products.
* For female subjects: effective contraceptive methods used.
* Subject having given written consent to take part in the study.

Exclusion Criteria:

* Subject with blood triglycerides levels above 350 mg/dL.
* Subject having experienced any cardiovascular event in the last 6 months.
* Subject having sitosterolemia.
* Subject taking any hypocholesterolemic treatment drugs.
* Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start.
* Diabetic subject (type I and type II).
* Subject smoking strictly more than 10 cigarettes / day.
* Subject with heavy alcohol intake (\> 40 g / day for men ; \> 30 g / day for women).
* Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy.
* Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product).
* Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
* Subject receiving a transplant and under immunosuppressor treatment.
* Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
* Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
* Subject with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product.
* For female subject: pregnancy, breast feeding or intention to be pregnant during the study.
* For female subject: subject likely to change her contraceptive method during the study.
New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT

The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester miscarriage.

* To study the severity and extent of the IUA as assessed by the AFS and ESGE adhesion score in both groups of patients.
* To examine the rate of complications or side effects with the NCH gel.
* To assess the subsequent menstrual history and reproductive outcome in both groups of patients.

There is limited data to evaluate the incidence of IUA after using this NCH gel in patients undergoing surgical evacuation via USG-MVA for the treatment of first-trimester miscarriage. Previous RCT showed a significant reduction in IUA with the use of NCH gel, with IUA detected in only 9.5% of patients with NCH gel applied compared to 24.1% in the control group. However, the group did not involve patients undergoing surgical evacuation by USG-MVA.

Therefore, the objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment of first-trimester miscarriage.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years old or above
* No previous history of IUA/ Asherman's syndrome
* No previous surgical history of EVA or dilatation or curettage or surgical termination of pregnancy or caesarean section
* No previous history of therapeutic hysteroscopic surgeries
* Voluntary informed consent and understanding of study

Exclusion Criteria:

* previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis)
* suspicion of molar pregnancy
* genital tract malformation
* suspicion of active infection or genital tract malignancy or genital tuberculosis
* abnormal blood coagulation
* inability to tolerate pelvic examination known
* suspected intolerance of hypersensitivity to NCH gel or its derivatives
* patient refusal
A First-in-Human Study of LY2409021 in Healthy Participants and Participants With Type 2 Diabetes

The main purpose of this study is to determine the safety of LY2409021 in healthy participants and participants with diabetes. The study drug is given as single oral doses. Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing periods. Side effects will be documented. This study is approximately 9 weeks long, not including screening. Screening is required within 6 weeks prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Must be either a male, or a female who cannot become pregnant, who is either healthy or have type 2 diabetes mellitus (T2DM) but not taking medication for diabetes
* Have an hemoglobin A1c (HbA1c) value of less than or equal to 10% at screening
* Have blood and urine laboratory test results that are acceptable for the study

For healthy participants:

* Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m\^2 inclusive
* Have a fasting blood glucose between 3.0-5.2 millimoles/liter (mmol/L) at screening
* Have plasma glucose, two hours after ingesting an oral 75 g glucose load, less than 7.8 mmol/L

For participants with type 2 diabetes mellitus (T2DM):

* Have a screening body mass index (BMI) of 18.5 to 35 kg/m\^2 inclusive
* Must weigh 45 kg or more at screening
* Have a fasting blood glucose less than 11.1 mmol/L at screening
* Have plasma glucose, two hours after ingesting an oral 75 g glucose load, greater than or equal to 11.1 mmol/L

Exclusion Criteria:

For all participants:

* Have participated in a study with a new drug in the last 30 days
* Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
* Have hypertension requiring more than single-agent therapy, or blood pressure greater than 140/90 millimeters of mercury (mmHg) on monotherapy
* Are allergic to LY2409021 or similar drugs
* Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
* Intend to use other over-the-counter or prescribed medicines during 7 or 14 days respectively before the study, or during the study. Medicines for high cholesterol and high blood pressure are allowed if you have diabetes.
* Have a significant blood disorder and/or donated blood (450 ml or more) in the last 3 months

For participants with T2DM:

* Have signs of having serious problems with diabetes (For example, severe eye problems, poorly healing skin)
* Have a history of being in a coma due to low blood sugar
Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy

Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.


Eligibility Criteria:
Inclusion Criteria:

* Female aged \>18 years old
* Patients that fulfill the indication of mastectomy
* Medium-sized breast volume (Breast weight \< 1500 grams)

Exclusion Criteria:

* Patients who cannot complete the informed consent
* Patients with ASA CLASS \> 3
CT Versus CEUS Findings of Complex Cystic Renal Lesions

Retrospective comparison of complex cystic renal lesions which are found with computed tomography (CT) and were controlled with contrast enhanced ultrasound (CEUS).

All subjects receive an contrast enhanced CT due to different clinical indications. When a complex cystic renal lesion is found an evaluation with CEUS is performed. The CEUS protocol included a native baseline examination of both kidneys. After a bolus injection of 1.5 ml SonoVue (Bracco, Milano, Italy) an examination of the affected kidneys is performed over a time period of at least three minutes. An optional dose will be given when the initial examination is not conclusive, e. g. when the arterial phase is partly missed. When both examinations are done the lesions were classified using the Bosniak classification system and a comparison of both methods will be done.

Eligibility Criteria:
Inclusion Criteria:

* Finding of a complex cystic renal lesion

Exclusion Criteria:

* age \< 18 y, gravity
Peri-articular Nerve Group Block Versus Fascia Iliaca Block on Postoperative Pain After Hip Arthroscopy

The study aims to evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy

In recent decades hip arthroscopy gained popularity and the number of procedures increase every year , due to the widening range of indications, as femoroacetabular impingement, labral tears, chondral injuries, loose bodies, osteonecrosis and septic arthritis Pain after hip arthroscopy due to several factors. divided in two regions. First the intra-articular where pain originates from the joint capsule (capsulotomy), a repaired labrum or bony resection. Outside the joint caused by traction, the portal tracts and extravasation of irrigation , soft tissue swelling.

the hip joint found to be innervated from the femoral nerve for its anterior part, the obturator nerve for its antero-medial part, the sciatic nerve for its posterior part, and the nerve to the quadratus femoris muscle for its postero-medial par

Pericapsular Nerve Group (PENG) Block aims to block the articular branches of the accessory obturator and femoral nerve Also, it could spread to block the obturator nerve and its articular branches the high articular branches from FN and AON are found between the anterior inferior iliac spine(AIIS) and the ilio pubic eminence (IPE), whereas the ON is located close to the inferomedial acetabulum.

The fascia iliaca compartment is a virtual space anteriorly limited by the posterior surface of the fascia iliaca, posteriorly by the iliacus muscle and is cranially in continuation with the space between quadratus lumborum muscle and its fascia . Three important nerves for hip innervation are located in this space, the femoral nerve, obturator nerve and lateral femoral cutaneous nerve

Eligibility Criteria:
Inclusion Criteria:

age 16-60 years old ASA physical status I or II scheduled for hip arthroscopy

Exclusion Criteria:

* pregnancy or breast feeding
* neurological deficits or neuropathy
* opioid addict
* local skin infections, bleeding diathesis, and coagulopathy
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.

The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged 12 to \<15 months or 18 to \<24 months during sentinel-cohort enrollment, Or,12 to \<24 months during expanded-cohort enrollment.
* Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.
* Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

* Previous vaccination with any meningococcal serogroup B vaccine.
* Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
* Contraindication to vaccination with any HAV vaccine or known latex allergy.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* A known or suspected disorder of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B-cell function or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included.
* History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
* Significant neurologic disorder or history of seizure (excluding simple febrile seizure).
* Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.
* Current chronic use of systemic antibiotics.
* Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.
* Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.