cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women

The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 19 and 30 kg/m²
* Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator)
* Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions

Exclusion Criteria:

* History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease
* Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease).
* History or current alcohol abuse or drug addiction
* Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study
Computer Guided Versus Freehand Dental Implant Surgery

This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap procedures vs. 3D implant design software and specialized surgical templates.

Patients with at least 7 mm of height and 4 mm of breadth in their bones, who needed at least two implants to be restored with a single prosthesis, were recruited one after the other. Patients were randomly assigned to two groups in a parallel group trial design. : Group I: consisted of 6 patients where computer guided dental implant placement and Group II: included six people who had dental implants placed manually. A temporary prosthesis was inserted into the implants right away, and four to six months later, a permanent prosthesis took its place.

Implant failures, marginal bone loss, number of therapy sessions, length of treatment, post-surgical pain and swelling, use of painkillers, surgical time, time needed to resolve problems, and patient satisfaction were among the outcome variables evaluated by a blinded, independent assessor. Patients were tracked for a full year.

Eligibility Criteria:
Inclusion Criteria:

* totally edentulous in one or both arches,
* with at least 7 mm of height and 4 mm of breadth in their bones as assessed by preoperative CBCT scans.
* patients between the ages of 35 and 65 who could give informed permission,
* Implants next to each other required to be positioned at least 3 mm apart from each other and 1.5 mm apart from the tooth.

Exclusion Criteria:

* Patients who have received radiation therapy to the head and neck region within the year prior to implantation,
* those who are receiving intravenous amino bisphosphonates,
* those who have untreated periodontitis,
* those with uncontrolled diabetes,
* pregnant women, or nursing mothers are among the general contraindications to implant surgery.
First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.

This is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.

The cost of performing a percutaneous coronary intervention is very variable since a large number of materials and human resources are considered, with the Stent cost being a fundamental factor; in developing countries, the cost this technology represents an important expense for the patient and the health system; which promotes the development of local technology to support the requirement of these devices.

Ischemic heart disease together with cerebral vascular events is the main cause of, adding 15 million deaths per year. Percutaneous revascularization is the gold standard choice in many of the variants of presentation of ischemic heart disease, the implantation of Stents is the most used method.

Nowadays more and more countries start their own research and development of novel devices in order to reduce cost.

Research question: Is the INC1 Bare Metal Stent safe and effective for the treatment of de novo coronary lesions in humans? Hypothesis: The INC1 Bare-metal Stent is safe and effective for the treatment of de novo coronary lesions in humans

The INC1 Bare metal Stent is a 70uCoCr

Eligibility Criteria:
Inclusion Criteria:

* Both genders.
* From 18 to 75 years
* Stable ischemic heart disease.
* Live less than 300 km from the Institution
* Single coronary artery disease with a single coronary lesion
* Stenosis of 50 to 90% of the lumen of the vessel to be treated.
* Lesions less than 20 mm long
* Reference lumen of the vessel to be treated greater than 2.5mm and less than 4.5mm

Exclusion Criteria:

* Left main disease.
* Lesions greater than 90% of the lumen.
* Non-dilatable lesion with conventional balloons.
* Contraindication for dual antiplatelet therapy.
* Creatinine clearance less than 45ml / min.
* Calcification from moderate to severe.
* Multivessel coronary artery disease.
* Chronic total occlusion.
* Cardiogenic shock or hemodynamic instability.
* Left ventricular ejection fraction less than 30%.
* Valvular disease of moderate to severe.
* Coronary disease in bifurcation.
* Probable or definite presence of thrombus in the lesion.
Effects of Installing Height-adjustable Workstations on Office Workers Workplace Sitting Time and Productivity

The purpose of this study was to look at the effects that height-adjustable workstations on occupational sitting time and workplace productivity in office workers. Participants workplace activity (sitting, standing and walking) and productivity was measured before the installation of the height-adjustable workstations. Workplace activity and productivity were then measured four weeks after the installation of height-adjustable workstations. The results were compared to a control group who received no intervention whilst the intervention had the height-adjustable workstations.

Sedentary behaviour has been found to be ubiquitous within the workplace and due to the negative consequences of sedentary behaviour upon health, research has began to look at ways to reduce and interrupt sedentary behaviour.

Interventions that have introduced height-adjustable workstations into the workplace have been found to reduce sedentary behaviour. Some employees and employers are concerned that using height-adjustable workstations and trying to reduce workplace sedentary behaviour can lead to a loss of workplace productivity.

The present study looked at the effects of installing height-adjustable workstations on occupational sitting time and workplace productivity in desk-based workers. Workplace activity was measured objectively using ActivPal accelerometers and productivity was measured via self-report measures. Measurements took place at baseline and four weeks after receiving the height-adjustable workstation.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 to 65 years,
2. working ≥0.6 full time equivalents,
3. access to a work telephone and desktop computer with internet,
4. not pregnant,
5. no planned absence \>1 week during the trial,
6. not chair-bound or uniquely impaired such that reducing occupational sitting time was not feasible,
7. no pre-existing musculoskeletal disorder.

Exclusion Criteria:

-
Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node.

The purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (SLN) using Indocyanine green (ICG). Moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of SLN during the surgery, and evaluate the diagnosis consistency of the AI technique and pathological examinations for lymph node with and without metastasis.

Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. But identification of metastatic LNs within the fibro-adipose tissue of the fossa axillaris specimen remains a challenge. Recently, indocyanine green (ICG) and methylene blue are commonly used in clinical practice. ICG as a fluorescent dyes, has effectiveness in mapping SLNs during surgery. Surgeons can follow the fluorescence display to detect SLN, and simultaneously capture real-time fluorescent video images. Several other groups has been demonstrated that the usage of ICG fluorescent surgical navigation system to detect SLNs in breast cancer patients is technically feasible. But no study investigate the variability between fluorescent images of breast sentinel lymph node with and without metastasis in the existing paper. Deep learning (DL) artificial intelligence (AI) algorithms in medical imaging are rapidly expanding.

In this study, the investigators aim to develop and validate an easy-to-use artificial intelligence prediction model to intraoperatively identify the sentinel lymph node metastasis status. Furthermore, to explore whether this independent and parallel intraoperative lymph node assessment workflow can provide rapid and accurate skull base on lymph node fluorescent images analysis, meanwhile detecting occult lymph node (micro-) metastasis, using optical imaging and artificial intelligence.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 years female.
* The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer.
* No clinical examination of suspicious axillary lymph node-positive.
* Preoperative clinical or radiologic evidence without distant metastases (M0).
* The patient has good compliance with the planned protocol during the study and signed informed consent.

Exclusion Criteria:

* Pregnancy, breastfeeding.
* Allergy to ICG.
* Former operation or radiotherapy in the axilla or breast or thoracic wall in the same side of breast cancer.
* Psychiatric or cognitive impairment.
Safety and Efficacy of IQP- AK-102 in Reducing Body Weight

The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation.

Appetite regulation plays an important role in determining the food intake, which is a complex process influenced by biological, behavioral and environmental stimuli. Satiation (intrameal satiety) is defined as the process of feeling full and subsequently stopping food consumption during eating, it therefore reduces hunger and limits the energy consumptions during meals. On the other hand, satiety or more precisely intermeal satiety, delays the onset and possibly reduces the consumption of the next meal. High viscosity and bulking food components such as dietary fibre are expected to elicit stronger satiation/satiety than macronutrients or clear liquid.

Due to its unique physicochemical properties, dietary fibre has been recognized as a potential ingredient that helps to enhance the sensation of satiety in the upper gut by increasing gastric distension and delaying gastric emptying, which subsequently reduces the food intake, and eventually leading on to weight loss.

The investigational product is formulated from IQP-AK-102, a proprietary, patent pending combination of three soluble fibres. In-vitro studies showed synergistic properties for the fibres in IQP-AK-102. When consumed orally, IQP-AK-102 capsules dissolve in the stomach to release the fibres. Once hydrated, the fibres swell to form a thick, viscous and indigestible gel structure in the stomach. This physical structure results in increased gastric distension and delays the gastric emptying that induces satiety and fullness.

However the unique composition of IQP-AK-102 had not been evaluated in human clinical studies. The objective of this placebo controlled, double blind study was to confirm the benefit of IQP-AK-102 in weight loss through promoting satiety and managing appetite. In this study, 120 overweight and obese subjects (60 per study arm) were tested to investigate if IQP-AK-102 is effective in reducing body weight over a period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* 25≤BMI≤35
* Expressed desire for weight loss
* Accustomed to 3 main meals/day
* Generally in good health
* Consistent and stable body weight 3 months prior to study enrolment
* Consistent regular physical activity
* Commitment to avoid the use of other weight loss products during study
* Commitment to adhere to diet and lifestyle recommended for the study

Exclusion Criteria:

* Known sensitivity to the ingredients of the device
* Presence of any active gastrointestinal disease
* Malabsorption disorders
* Pancreatitis
* Stenosis in the GI tract
* Bariatric surgery
* Any other reason deemed suitable for exclusion, per investigator's judgement
Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71

The purpose of this study is to evaluate the safety and immune response of an inactivated vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).

Hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71) can be severely debilitating for some children with a risk of paralysis and death. The most susceptible age group is the 1 to 5 year olds, and the disease is spread via the oral-fecal route. Currently, there is no antiviral therapy nor there is a vaccine available to prevent HFMD. In this study, an inactivated vaccine (INV21) based on the EV71 antigen will be evaluated in terms of safety and immune response that is generated after two doses of the vaccine are given to healthy adults. Safety assessments include the frequency and severity of systemic adverse events as well as local reactions. Immune response will be assessed by measurement of EV71 neutralizing antibody levels at specified time points throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 21 to 45 years, inclusive, at time of screening
* In good health as determined by medical history and physical examination.
* Normal clinical safety laboratory examinations.
* Body mass index (BMI) in the range 19-28 kg/m2.
* Documented negative serology for HIV, Hepatitis C antibody, and Hepatitis B surface antigen.
* Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination.
* Willing and able to give written informed consent to participate.
* Willing and able to communicate with the Investigator and understand the requirements of the study.
* Low levels of EV71 neutralizing antibody.

Exclusion Criteria:

* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
* Clinically significant hematological (including bleeding disorders), renal, hepatic, pulmonary (including asthma), central nervous system (including epilepsy, seizures, convulsions, or chronic migraines), cardiovascular, or gastrointestinal disorders, according to Investigator's judgment.
* Ongoing rash or other dermatologic disease.
* Abnormal ECG as assessed by the Investigator.
* History of diabetes mellitus.
* Hypersensitivity to any vaccine.
* History of severe HFMD with CNS involvement.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
* Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study.
* History of thymic pathology, thymectomy, myasthenia or any immunodeficiency.
* History of recurring migraines or on prescription medication for treatment of recurring headaches or migraines.
* Positive urine test for drugs of abuse.
* Females who are pregnant or lactating
Prevention of Shaken Baby Syndrome

This research project seeks to implement an early intervention program that can be effective in the prevention of Shaken Baby Syndrome (SBS) and infant abuse. Our hypothesis is that the Period of PURPLE Crying intervention program can reduce shaking and abuse of infants through changes in knowledge, attitudes and behaviors about early infant crying, especially inconsolable crying. In this 3-year project, we will implement and evaluate an intervention program in selected prenatal classes, hospitals, and primary care pediatric practices.

In this randomized, controlled trial, we will enroll a total of 3000 women/families who are about to give birth or have just given birth to a healthy infant. At each of the three sites (newborn nursery, pediatrician offices and prenatal classes), we will enroll 1000 subjects. Half of all subjects will receive intervention materials (a video, pamphlet and bib/burp cloth) about infant crying. The other half, the control group, will receive comparable materials on infant safety. All subjects will be asked to complete a brief questionnaire at the time of enrollment (pre test), review the materials they receive, complete the Baby's Day Diary for 4 days when the infant is 5 weeks of age and complete a telephone questionnaire (post test) when the infant is 8 weeks of age.

The specific goals of the program are:

1. To change the understanding (i.e., knowledge and attitudes) and reduce the frustration of parents of new infants about the normality of the frustrating properties of crying;
2. To change the behavior of parents to increase caregiving contact in response to crying but to 'walk away' if frustrated;
3. To provide parents with the ability to communicate to other caregivers (relatives, baby-sitters) the knowledge and behavior to reduce frustration induced by inconsolable crying;
4. To provide effective knowledge, skills and teaching materials to health care providers in direct contact with parents concerning crying, shaking and abuse;
5. To reduce the incidence of physical abuse and shaken baby syndrome under one year;
6. To have the Period of PURPLE Crying program adopted as a nationwide early intervention project.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be new parents or parents to be who are either: 1) attending participating prenatal classes; 2) delivering a baby at the participating hospital; or 3) visiting a PSPRN (Puget Sound Pediatric Research Network) pediatrician for infant care.
* Only parents of infants born at \> 34 weeks gestation are eligible.

Exclusion Criteria:

* Parents of infants who have serious medical conditions.
* Parents who don't speak and read English.
* Parents of infants born at \< 34 weeks gestation.
RehabTouch Home Therapy for Stroke Patients

We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 85 years old
* Upper extremity weakness measured by a clinical scale
* Absence of moderate to severe pain on affected upper extremity
* Able to understand the instructions to operate RehabTouch

Exclusion Criteria:

* Concurrent severe medical problems, visual deficits, severe neglect or apraxia
* Enrollment to other therapy studies
Lumbo-pelvic Mobilization and Stabilization With Pilates Method in Low Back Pain and Movement Functionality

Lumbar pain is one of the most common injuries being the cause of morbidity in the individual generating occupational disability with strong personal, social and economic impact. As one of the methods of treatment, Pilates is a method that has good results for the management of this dysfunction. However, it is not known exactly which approach Pilates can bring better results for this population. Therefore, the purpose of this study is to compare the effects of two types of Pilates method interventions on non-specific chronic low back pain.

A blinded randomized clinical trial, will be held. 28 patients divided randomly into two groups will be assessed, the Mobilization Pilates (MP) and the Stabilization Pilates (SP). Both groups will be formed by individuals of both sexes and aged 21 to 41 years with chronic low back pain. Both groups will receive 10 sessions of Pilates Methods twice a week, with each session taking an average of 50 minutes, therefore the MP will focus on a lumbo-pelvic mobilization exercises approach and the SP will focus on lumbo-pelvic stabilization exercises approach. At the beginning and end of the 5 weeks the individuals are evaluated to verify the presence of pain and disability with VAS of pain and Oswestry Questionnaire, and also with the Functional Movement Screen. Data will be analyzed statistically.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes aged between 21 and 40 years;
* Self-reported low back pain for at least 3 months;
* Disability Oswestry Index greater than 10%.

Exclusion Criteria:

* Diagnosis of pathognomonic low back pain caused by disc herniation with root involvement, inflammatory disorders, infections, osteoporosis, rheumatoid arthritis, fracture or tumor;
* Medical contraindication to the practice of Pilates;
* Childbirth or gestation in the last 6 months;
* Be performing any type of treatment for low back pain is medicated, physiotherapeutic or alternative during the period of intervention;
* Change the level of physical or sports activity during the intervention period;
* Participants who miss two sessions in a row or four sessions alternately without retrieving them in the same week will automatically be excluded from the survey; Or do not attend pre and post-test evaluation events.
Validity and Reliability of a Low-cost Chair Dynamometer

In part 1 of the study, fourteen able-bodied individuals will undergo maximal, voluntary contraction (MVC) test of the lower limbs in two dynamometers. One being a low-cost dynamometer (S2P-CD), and the other being a gold standard dynamometer (HUMAC). Thereby the investigators will be able to assess the validity of the S2P-CD.

In part 2 of the study, eighteen persons with spinal cord injury will undergo MVC twice in the S2P-CD. Thereby the investigators will be able to assess the reliability of the measurements of the S2P-CD.

In part 1 of the study, fourteen able-bodied individuals will undergo maximal, voluntary contraction (MVC) test of the lower limbs in two dynamometers. One being a low-cost dynamometer (S2P-CD), and the other being a gold standard dynamometer (HUMAC). The tests will be carried out with 72-96 hours between them. Thereby the investigators will be able to assess the validity of the S2P-CD.

In part 2 of the study, eighteen persons with spinal cord injury will undergo MVC twice in the S2P-CD. Participants will be recruited through the Spinal Cord Injury Centre of Western Denmark (SCIWDK). The test will be carried out with 30min between them. Thereby the investigators will be able to assess the reliability of the measurements of the S2P-CD.

Eligibility Criteria:
Ablebodied individuals:

Inclusion Criteria:

* Age \>18 y

Exclusion Criteria:

* Orthopedic or other injuries that may limit maximal muscle strength

Spinal cord injured individuals:

Inclusion Criteria:

* Age \> 18 y
* Congenital or acquired spinal cord injury with some degree of preserved muscle function in the lower limbs

Exclusion Criteria:

* Orthopedic or other injuries that may limit maximal muscle strength
* Significant competing diseases
* Severe osteoperosis