cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™.

The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.


Eligibility Criteria:
Inclusion Criteria:

* a healthy male or female, 12 to 18 months of age at the time of vaccination, who received at least one dose of either pneumococcal conjugate vaccine or Prevenar™ during study 105553 and with written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

* use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up).
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before vaccination up to Visit 2.
* Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of study 105553. Children with a history of seizures or neurological disease, allergic disease, immunosuppressive or immunodeficient condition.
Multi-centre, Open-label, First-in-man Study With Mucopad HA

The device´s intended use is to treat defects and/or lesions of the oral mucosa, e.g. oral mucositis.To prove safety of the device in terms of clinical results.

This is an multi-centre, open-label, first-in-man prospective study.

Up to 60 patients in total will be involved in the open-label trial of new medical device - Mucopad HA. Eligible patients will be undergoing treatment with the device for up to 10 weeks, after which it is expected that there should be significant improvement in the healing process of oral mucositis after radiotherapy. It is considered as an improvement when there is a significant reduction or complete resolution of the mucositis. Mucositis will be assessed as a WHO scale.

Quality of life will be assessed by Oral Mucositis Daily Questionnaire (OMDQ) provided by FACIT. The FACIT and all related works are owned and copyrighted by, and the intellectual property of David Cella, Ph.D. Permission for use of the OMDQ questionnaire is obtained by contacting Dr. Cella at information@facit.org.

List of investigational sites is in appendix 7.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Oral Mucositis after radiotherapy of grade I - IV according to WHO
* Patient willing and able to provide the written consent
* Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study

Exclusion Criteria:

* Age \< 18 years
* Pregnant or lactating women
* Patients in terminal stage of living
* Patients with known hypersensitivity or allergy to any of the substances contained in Medical Device
* Alcohol or drug abuse
Imaging Methods for the Diagnosis of Non-melanoma Skin Cancer and Its Precursors

Prospective, unicentric study that examines if imaging devices like total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy as an addition to clinical examination lead to a benefit for patients in the diagnosis of non-melanoma skin cancer and their precursors

250 patients with lesions that are suspicious for non-melanoma skin cancer that had not yet had a biopsy, are randomized in 2 groups. The intervention group is examined with total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy; the control group is examined with dermoscopy only. The aim of the study is to investigate whether these methods improve the early detection of non-melanoma skin cancer and their precursors. Examined are not only the differences in management of the lesions (excision, biopsy, local treatment or no treatment) and the diagnostic accuracy of the devices.

Eligibility Criteria:
Inclusion Criteria:

* Patients with 1 or more lesions suspicious for non-melanoma skin cancer that had not yet had a biopsy or diagnostic excision of the lesions

Exclusion Criteria:

* Patients with non-melanoma skin cancer that has already been examined with a punch biopsy or diagnostic excision
* Patients younger than 18 years
* Patients that are incapable of giving consent
Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking

The study is designed to evaluate the use of electromagnetic tracking in femoral derotation osteotomies. The goal is to raise the precision of the surgical procedure in order to improve the outcome in short- and long term. The electromagnetic tracking system is evaluated against a base line CT scan serving as reference standard.

Internal rotation gait is a common deformity in children, especially in those with spastic diplegia. The treatment includes soft tissue and bony correction. Especially the bony procedures e.g. femoral derotation osteotomies have proven to be effective both in short term and long term evaluation. Nonetheless there is still a relevant number of patients that suffer from over- or under-correction and recurrence over time. The reasons are diverse and include false measurement of the derotation in OR.

The study now evaluates electromagnetic tracking for femoral derotation to improve these results.

The patients are recruited from the outpatients department and included if they meet the criteria.

A baseline rotational CT scan and a 3-D-gait analysis are performed and the derotation measured with the EMT system in OR. The results of the measurement is invisible and unknown to the surgeon as the system unit is controlled by a technician.

The surgical procedure follows standard rules and does not need alterations because of the study.

After the operation a second rotational CT scan is performed and the derotation precisely evaluated by two raters and later compared to the results of the electromagnetic tracking system.

Eligibility Criteria:
Inclusion Criteria:

* functionally impairing internal rotation gait and indication for supracondylar derotation osteotomy (Evidence of falling because of internal rotation gait, abnormally increased femoral anteversion, confirmation of internal rotation gait in gait kinematics of hip rotation and foot progression angle and a mid point shift in the clinical examination).

Exclusion Criteria:

* severe mental retardation and inability to undertake the CT scan
Muscles Strength and Gait Parameteres After TKA

Total Knee Arthroplasty (TKA) is actually the most effective treatment option for patients with end-stage osteoarthritis (OA). However, nearly 20% of patients who underwent TKA remain unsatisfied with their clinical outcome. Investigating modifiable factors that limit knee functioning following TKA we may notice the significance of lower limb muscles strength. Gait pattern is also affected by OA, as arthritic knee joint cannot provide proper range of motion (ROM) and stability.Therefore any deviation in biomechanics should be noticed and analyzed. After TKA patients' physical function may change, but the study should be conducted to prove whether it improves or not. Patient-reported outcome defined by OKS (Oxford Knee Score) and FJS (Forgotten Joint Score) questionnaires will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* III° or IV° grade knee osteoarthritis
* Age over 50
* Patients with signed consent

Exclusion Criteria:

* Undergone total hip replacement
* Previous femur fracture in anamnesis
* Undergone corrective osteotomy
* Active/ Chronic neoplastic disease
* Significant deformation of lower limb axis
* Mental disorders
* Muscular disorders
Application of NGS Technique in Precise Diagnosis of Infectious Diseases

Infectious disease leads to deaths that accounted for more than 25% of all causes of human mortality. But the traditional microbiological diagnostic methods such as specimen culture are sometimes time-consuming, and have limited sensitivity. And some bacteria, anaerobes and viruses may be difficult to cultivate and isolation. Therefore, the accurate identification and rapid classification of pathogenic microorganisms is very important for the patient's precise diagnosis and timely treatment.

Small-scale studies on the diagnostic efficacy and prognosis of infection in the next generation have been shown to provide early diagnosis and targeted medication guidance for bloodstream infections and respiratory infections, but the larger-scale validation of next-generation sequencing Technology in the diagnosis and treatment of infectious diseases in the human body is relatively rare.

The purpose of this study is to provide rapid etiological diagnosis of patients by means of next-generation sequencing, to change the way of treatment of patients under the existing traditional pathogen detection by means of accurate description of pathogens and monitoring their dynamic changes, and to provide patients with more accurate treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients are highly suspected of fever of unknown origin
* Patients are highly suspected of bloodstream infection
* Patients are highly suspected of respiratory infections
* Patients are highly suspected of central nervous system infection

Exclusion Criteria:

* Patients diagnosed as non-infectious diseases such as cancer and autoimmune diseases;
Are Portable Lactate Monitoring Devices Accurate in Patients with Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?

The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, in a population of patients with glycogen storage disease type 1a.

The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type 1a.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed/confirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia (ICD 10 code: E74.01).
* Connecticut Children's Emergency Department visit and/or admission to Connecticut Children's during time study is active
* For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document
* For adults: Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients with Glycogen storage disease unspecified 74.00, or Ib
* Patients not meeting inclusion criteria
Effects of Ping-Shuai-Gong and Arm-Swing-Exercise

Ping Shuai Gong (PSG) and Arm Swing Exercise (ASE) are two similar exercise with different arm-swinging strategies. This study is plan to explore the relationship between characteristics of arm-swinging movement and skin blood flow during exercise.

With the development of an aging society, the health and social systems of the elderly population have become issues that cannot be ignored. Due to the features of low difficulty and small space requirements, Ping Shuai Gong (PSG) and Arm Swing Exercise (ASE) become very popular within the older population. These physical activities have been proved to show advancement in cardiovascular and physical functions. Hence, this study is design to explores the health effects of two different arm-swinging strategies, and to explore the relationship between characteristics of arm-swinging movement and skin blood flow during exercise.

40 elderly people over 60 years old who have no regular exercise habits were divided into PSG group and ASE group, and each group was given two months of exercise training (at least 24 times of exercise, 30 minutes totally within one day). PSG group was asked to perform PSG exercises (actions were synchronized with the hands raised to shoulder height and then swinging down and back, with two squatting movements at the fifth time). ASE group was asked to perform ASE exercises (actions were to raise both hands synchronously to a 30-degree bend and then 60-degree shoulder extension, and to control the stability of the upper body when swinging arms).

Evaluation procedures of the pretraining evaluation and post-training evaluation are exactly the same.

Eligibility Criteria:
Inclusion Criteria:

age over 60 able to stand unassisted for at least 30 minutes able to understand and follow the instructions no good exercise habits (frequency \> 3 times / wk.), intensity (rated perceived exertion \> 12/20), time \> 30 min.) for at least 3 months able to attend the experiment for 2 months

Exclusion Criteria:

uncontrolled cardiovascular disease severe arrhythmia peripheral artery disease respiratory system diseasehemodialysis patients unresolved upper or lower extremity injury
Hepatic and Portal Vein Transection by Vascular Stapler in Open Living Donor Hepatectomy

To enhance donor safety in living donor liver transplantation (LDLT), the use of vascular staplers for the division of the right portal and hepatic veins in patients undergoing right lobe liver donation has been introduced. This study examines the application of vascular staplers in LDLT and assesses the subsequent feasibility and safety outcomes for donors.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open living donor hepatectomy
* Age ≥ 18 years, ≤ 80 years
* Written informed consent

Exclusion Criteria:

* None.
A Phase I Study to Evaluate LIFE-001

The goal of this clinical trial is to learn if LIFE-001 is safe and tolerable for healthy adult volunteers.

Participants will attend the site where dosing will be done subcutaneously via direct staff administration and they can only participate in one of the following cohorts:

Single Ascending Dose (SAD) Cohorts 1-6: Screening/baseline period of up to 28 days with a 6-day inpatient say and total duration up to 51 days. Single ascending doses of LIFE-001 between 10mg and 300mg or placebo (Day 1) administered under fasting conditions. Increases will be based on safety and tolerability at each dose level.

Multiple Ascending Dose (MAD) Cohorts 1-4: Screening/baseline period of up to 28 days with two 6-day inpatient says and total duration up to 91 days. Four doses of LIFE-001 between 50mg and 300mg or placebo on Days 1, 8, 15 and 22 administered under fasting conditions.

Exact dose of LIFE-001 for SAD Cohorts 2-6 and MAD will be based on safety, tolerability and pharmacokinetic data from preceding cohorts. After all participants have complete Day 8 (SAD) or Day 29 (MAD), a safety review committee (SRC) will determine if the next dose level cohort will be initiated.

Eligibility Criteria:
Inclusion Criteria:

* Female or male between the ages of 18 and 65 years, inclusive
* Medically healthy (without significant medical issues, e.g. high blood pressure)
* Must provide written informed consent

Exclusion Criteria:

* Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant's safety or interfere with the absorption, distribution or excretion of the study drug
* Any abnormal ECG findings, laboratory value or physical examination findings
* Positive ethanol, drug screen or cotinine test
* Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 7 days
* Use of any experimental or investigational device within 30 days
* Donation or loss of 500 mL or more of blood within 30 weeks and/or donation of plasma within 30 days
Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects

This single centre, open-label, non-randomised, single period, single-dose study in healthy male subjects was designed and conducted to assess the mass balance recovery, PK, metabolite profile and metabolite identification of SJP-0008.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
* Must be willing and able to communicate and participate in the whole study
* Must have regular bowel movements
* Must provide written informed consent
* Must agree to adhere to the contraception requirements of the protocol

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
* Subjects who are, or are immediate family members of, a study site or sponsor employee
* Subjects who report to have previously received SJP-0008
* Evidence of current SARS-CoV-2 infection
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week
* A confirmed positive alcohol breath test at screening or admission
* Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months
* Subjects with pregnant or lactating partners
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study

Other protocol-defined exclusion criteria may apply
Dietary Management of Gestational Diabetes

eMOM is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. The comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. The recruited women (n=60) have been diagnosed with gestational diabetes mellitus, and are of Caucasian origin. Of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy Nordic foods. The study has two two-week study periods that are carried out on approximately gestational weeks 24-28 (period I) and 34-36 (period II). Continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. At the beginning of the study, before study period I, the participants are randomized to either one of the intervention diets. The first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. After the wash-out period, the participants receive three days' worth of food according to the other diet. After the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. To ensure the diet is followed, the participants gets at least three personal face-to-face counseling sessions, phone calls, mobile reminders, recipes and food items. After delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.


Eligibility Criteria:
Inclusion Criteria:

- Gestational diabetes at enrollment

Exclusion Criteria:

* Gestational weeks exceed 28+6
* Multiple pregnancy
* Food allergies or restrictions (other than lactose intolerance)
* Mother's or father's ethnic background other than Caucasian
* Type 1 or type 2 diabetes
* Medication which affects glucose metabolism
* Cholesterol medication
* Drug or alcohol abuse
* Psychiatric illness which affects participation in the study
* Factors hampering communication (e.g. lack of Finnish skills)
Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)

Prospective multicenter cross-sectional study evaluating ultrasound of the main salivary glands (2 parotid and 2 submandibular) in patients with Sjögren's disease compared with patients with other connective diseases (rheumatoid arthritis (RA), lupus, scleroderma) and control patients (patient with dry syndrome without the above-mentioned autoimmune disease).

This is a non-interventional study involving patients who are routinely monitored for their disease, and who typically benefit from ultrasound of the parotid and submandibular salivary glands as part of their dry mouth syndrome. Recruitment will be facilitated by the fact that these will be "general population" patients with Sjögren's disease, lupus, RA, scleroderma with dry syndrome, and control patient.

The study will be conducted over a single visit, including a clinical examination and an ultrasound scan. Ultrasound will not be blinded to the clinic, so we will need only one examiner per center.

This is a study in routine care, with no additional costs and no expected constraints. The examination will be carried out as part of their routine follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Patients fulfilling Sjogren criteria (2012 and 2016 American-European criteria) or Lupus according to ACR 2019 criteria or RA according to ACR/EULAR 2010 criteria or scleroderma according to ACR-EULAR 2013 classification criteria or control patient (patient with dry syndrome felt without pre-cited autoimmune disease).

Exclusion Criteria:

* Uncooperative patient who has refused to participate in the study.
* Patients unable to understand the protocol, under guardianship or curatorship.
* Patients not affiliated to the French Social Security system.
Comparative Effectiveness of Stress Tests

The primary objective of this project is to demonstrate that a new approach to cardiac stress imaging that combines treadmill exercise with cardiac magnetic resonance (CMR) provides valuable clinical information in a cost-effective manner.


Eligibility Criteria:
Inclusion Criteria:

* any patient referred for stress SPECT
* known or suspected ischemic heart disease
* ability to perform adequate treadmill stress

Exclusion Criteria:

* any contraindication to MRI (e.g. ferromagnetic foreign body, cerebral aneurysm clip, pacemaker/ICD, severe claustrophobia)
* renal insufficiency (GFR \< 40)
* known allergy to gadolinium-based contrast or iodinated contrast (because of the research CTA in patients not referred for cath after 2 weeks)