cyrilzakka/clinical-trials huggingface dataset:
Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

A clinical trial to investigate the influence of CYP2C19 polymorphism on pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Are able to provide written informed consent.
2. The subject is a healthy Korean aged 20 to 45 years, inclusive.
3. The subject weighs at least 55 (for female, 55) to 90 kg and has a body mass index (BMI) range of 18 to 25 kg/m2

Exclusion Criteria:

1. Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
2. Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
3. Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
4. Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)
5. Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product
6. Subject who have history of allergy on omeprazole
7. Subject who can not continue proper contraception method during study period.
8. Subject with a positive urine HCG test result on screening. (in case of woman subject)
9. Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period
10. Subjects who consume more than 10 cigarette per day or who are unable to abstain from smoking during the PK/PD testing period
11. Subjects who are unable to abstain from grapefruit or caffeine containing food 3 day prior the first administration of the investigational product
12. Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.
Hanyang University Medical Center Arthritis Network

Rheumatoid arthritis is a relatively common autoimmune disease that affects about 1% of the population. Its impact on health-related quality of life of the affected patients and the national medical cost are enormous. However, a systemic prospective cohort study of rheumatoid arthritis has not yet been established in Korea, so data on characteristics and prognosis of Korean rheumatoid arthritis and their response to therapy and adverse events are limited. Therefore establishment of large prospective cohort of Korean rheumatoid arthritis is imperative.

With inauguration of a steadfast prospective cohort of Korean rheumatoid arthritis patients in The Hospital for Rheumatic Diseases at Hanyang University, where patients gather from all over Korea forming the largest and most diverse patient pool in Korea, we will be able to define the characteristics and prognosis of Korean rheumatoid arthritis patients and gather information on treatment response and adverse events. This will eventually lead to improvement of health-related quality of life in Korean rheumatoid arthritis patients and provide opportunity for reliable comparison study with research institutes from other countries. The data gathered through the cohort will provide valuable foundational information for the genetic studies, pharmacological economic analyses, and standard treatment guidelines of Korean rheumatoid arthritis patients.

This study is a longitudinal prospective cohort of Korean rheumatoid arthritis patients comprising of all Korean adult rheumatoid arthritis patients satisfying the 1987 revised American College of Rheumatology (ACR) criteria and voluntarily agreeing to participate in the study with following objectives;

Primary Objectives:

1. Gather information on treatment response and adverse events of various pharmacological therapies for treatment of Korean rheumatoid arthritis patients
2. Identify the incidence and mortality rates of concurrent diseases including the cardiovascular \& gastrointestinal diseases and assess the contributing factors involved

Secondary Objectives:

Enrich understanding of disease characteristics, treatment response and adverse events in Korean rheumatoid arthritis to promote health and increase the health-related quality of life in Korean rheumatoid arthritis patients

Eligibility Criteria:
Inclusion Criteria:

* Korean adult rheumatoid arthritis patients satisfying the 1987 revised American College of Rheumatology (ACR) criteria
The Von Willebrand Disease (VWD) International Prophylaxis Study

The von Willebrand Disease Prophylaxis Network (VWD PN) is an international study group formed with the goal of investigating the role of prophylaxis in clinically severe VWD that is non-responsive to other treatment(s).

The most common indications for vWD prophylaxis included joint bleeding, epistaxis, gastrointestinal (GI) bleeding, and menorrhagia. Thus, an effort to establish optimal treatment regimens for these indications, through a period of prospective evaluation, is the primary focus of this research. Other goals include a retrospective study of the effect of prophylaxis on bleeding frequency, and a retrospective natural history study of GI bleeding in VWD.

Eligibility Criteria:
Inclusion Criteria:

Type 1: eligible for participation if

* ≤20% RCo and/or ≤20% FVIII; and
* DDAVP non-responsive, defined as occurrence of bleeding episodes not responding satisfactorily to desmopressin, or deemed non-responsive a priori by the investigator; and
* Bleeding indication criteria are met

Type 2: eligible for participation if

* DDAVP non-responsive, defined as occurrence of bleeding episodes not responding satisfactorily to desmopressin, or deemed non-responsive a priori by the investigator; or Type 2B;
* Bleeding indication criteria are met

Type 3: eligible for participation if

* Bleeding indication criteria are met

Bleeding Indication Criteria:

* Joint Bleeding: documentation of at least two apparently spontaneous bleeding episodes in the same joint in the six months prior to enrollment; or three or more apparently spontaneous bleeding episodes in different joints in the six months prior to enrollment.
* GI Bleeding: history of two or more severe GI bleeding episodes associated with either a drop in hemoglobin of ≥ 2 g/dl or requiring red blood cell transfusion or treatment with VWD concentrate.
* Failure to identify other causes of bleeding.
* Menorrhagia: a diagnosis of menorrhagia; prospectively completed Pictorial Blood Assessment Chart score \>185 or required treatment with a VWD product for menstrual bleeding on one or more occasions in the year prior to enrollment.
* Normal cervical cytology (PAP) within the six months prior to enrollment for females ≥ 18 years of age.
* Epistaxis 1. Three or more bleeding episodes in a six-month period that required treatment with VWD concentrates or red cell transfusions.
Morphology of the VMO in Patients With PFPS and Healthy Young Adults--A Sonographic Study

Background：Patellofemoral pain syndrome（PFPS） is a common knee disorder characterized by anterior or retropatellar pain associated with activities that load the patellofemoral joint. Previous studies reveal that the vastus medialis obliquus（VMO） is an important dynamic medial stabilizer of the patellar. Insufficiency of the VMO leads to lateral shift of the patella and the increases the patellofemoral contact force. An in vitro study conducted by Hubbard JK. et al. claimed that there were no significant relationship between several morphologic characteristics of the VMO and the extent of patellofemoral joint deterioration. We consider that the condition might be different in vivo, so we chose ultrasonogrphy as the measurement tool to examine the morphology of the VMO in PFPS patients and healthy controls. Purpose：To determine if there are significant differences in several morphologic parameters of the VMO between patients with PFPS and healthy controls under 50. Method：31 PFPS patients and 31 matched healthy adults under 50 were recruited for the study. The HDI 5000 ultrasonography machine was used to evaluate morphologic parameters of the VMO, including the percent of patella attachment, fiber angle, the volume attached to the patella, and the change of shape of the VMO.


Eligibility Criteria:
Inclusion Criteria:

1. under 50 years old.
2. Have a diagnosis of PFPS.

Exclusion Criteria:

1. Diagnosis other than PFPS，such as meniscal lesion, ligamentous instability ,patellar tendon pathology, traction apophysitis, radiation pain, referred pain, ect.
2. Knee operation within three month.
3. X-ray findings (1)joint space narrowing (2)osteophyte formation
IRESSA Combined With Radiotherapy & Gemcitabine as First-Line Treatment in Locally Advanced Pancreatic Cancer

The primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour intravenous (iv) infusion that can be administered in combination with ZD1839 250 mg once daily and a standard course (45 Grays \[Gy\]) of radiotherapy in patients with locally advanced, unresectable pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed pancreatic cancer (aspiration biopsy by fine needle \[PAAF\] by USE or biopsy guide by ECO-CT). It is mandatory the diagnostic by USE and will recommend the aspiration biopsy with this technique
* Tumoural volume by TAC \< 500 cc
* Aged 18 to 75 years inclusive
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) £ 1
* Life-expectancy of more than 12 weeks
* Women of child-bearing potential must be willing to practice reliable methods of birth control to prevent pregnancy

Exclusion Criteria:

* Previous radiotherapy or chemotherapy for malignant disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
* Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L), platelets less than 100 x 109/L or haemoglobin less than 9 mg/dL; Prothrombin time (PT) less than 50%; Serum bilirubin greater than 2.5 times the upper limit of reference range (ULRR; Creatinine clearance less than 45 mL/min; ALT or AST greater than 2.5 times the ULRR
* Active dermatoses (e.g. psoriasis, eczema)
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or drugs with known corneal toxicity
* Known, severe hypersensitivity to ZD1839 or any of the excipients of this product
Proprioception, Muscle Strength and Kinesiophobia After Anterior Cruciate Ligament Reconstruction

Fear of re-injury after anterior cruciate ligament reconstruction surgery (ACLR) affects individuals' return to sports and physical activity negatively. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.

Factors such as graft type, patient age, activity level and athletic experience, as well as psychological factors such as psychological readiness for return to sports, fear of re-injury, and motivation during the rehabilitation process, affect returning to sports after ACLR. Fear is a psychological reaction that occurs after injury and is clearly seen during the period when athletes continue to actively participate in sports. Individuals' confidence in their knees and pain after surgery affect their fear of movement.

While kinesiophobia provides benefits in protecting injured body parts in the acute phase of pain, it can lead to inactivity, emotional stress and risk of re-injury in the long term. Kinesiophobia changes the biomechanics of movements and pain perception. Insufficient muscle strength and instability in the knee negatively affect confidence in the knee. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-35
* History of ACL reconstruction surgery at least 6 months ago

Exclusion Criteria:

* History of previous lower extremity surgery
* History of lower extremity injury within the last 6 months
* Having a vestibular or neurologic pathology that would affect balance
Instrument-assisted Soft Tissue Mobilization Versus Integrated on Mechanical Neck Pain

the aim of this study is to investigate the efficacy of instrumented assisted soft tissue mobilization versus integrated neuromuscular inhibition technique on mechanical non-specific neck pain

Mechanical neck pain is a prevalent condition in various populations. Neck pain occurrence is affected by several factors, involving environmental, psychological, and social aspects. Neck pain represents the fourth major disorder responsible for a person's year lived with disability and ranked eleventh as disability-adjusted life years of a person. The neck pain incidence ranges from 10.4 to 23.3% in 1-year time, while the range of prevalence was 0.4 to 86.8%. It has a high prevalence among computer users, office workers, and females, especially females aged 35 to 49 years old. Myofascial trigger point (MTrP) might play an important role in the formation of mechanical neck pain and is known as a hyperirritable spot in skeletal muscle that is accompanied with a hypersensitive palpable nodule in a taut band. IASTM and integrated play an important role in the treatment of mechanical neck pain.this trial has three groups; one will receive IASTM+ conventional, the second will receive integrated + conventional and the third will receive conventional treatment for four week

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed as non-specific neck pain with upper trapezius active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
2. body mass index from 18 to 25 kg/m2
3. their ages from 18-35

Exclusion Criteria:

1. if they had trigger point injections within the past 6 months
2. history of neck or upper back surgery, trauma or fracture
3. history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
4. cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases
Parathyroid Hormone for the Treatment of Humerus Fractures

Hypothesis:

The investigators want to study whether parathyroid hormone improves healing of humerus after a fracture. The investigators will assess healing of the humerus with Constant score.


Eligibility Criteria:
Inclusion Criteria:

* proximal humeral fracture eligible for conservative treatment.
* able to understand the protocol
* signs an informed consent

Exclusion Criteria:

* liver disease
* kidney disease
* severe osteoporosis
* malignant disease
* bone metabolic disease
* oral treatment with bisphosphonates during the last 3 months.
* treatment with Denosumab during the last 6 months.
* intravenous treatment with bisphosphonates during the last 12 months.
Stopping Biological Therapy in PCD Study

The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.

This clinical trial in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.

The primary endpoint is clinical relapse at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 1. At least 18 years old 2. Have a confirmed diagnosis of perianal Crohn's disease according to established clinical, endoscopic, radiological and histologic criteria 3. On biological therapy (anti-tumour necrosis factor, anti-integrin, anti-IL12/23) for at least 6 months 4. Confirmation of radiologically healed perianal Crohn's fistulas on MRI pelvis within the past 12 months by experienced radiologists 5. In steroid-free clinical remission for at least 6 months with fecal calprotectin \<250 μg/g 6. Stable doses of immunosuppressants for at least 3 months if immunosuppressants are used 7. Written informed consent

Exclusion Criteria:

* 1. History of severe acute or delayed infusion reaction to biological therapy 2. Fistulising Crohn's disease to organs other than perianal Crohn's fistula (fistulation to skin, intestines, bladder etc.) 3. Prior history of diverting ileostomy, colostomy, proctocolectomy or proctectomy 4. Known pregnancy 5. Terminal illness
A Study of [14C]GB491 in Male Healthy Subjects

This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered.

In addition, this study will also evaluate the safety of a single dose of \[14C\]GB491 when given to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male volunteer between 18 and 50 years of age inclusive
* A total body weight \>=50kg, and a BMI of 19.0-26.0 kg/m2
* A signed informed consent document

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Subjects with HBsAg-positive, or HCV-Ab-positive, or TPPA-positive, or HIV infection
* Subjects with a history of habitual constipation/diarrhea, irritable bowel syndrome, or inflammatory bowel disease
Whole Body Vibration Exercise Training for Institutionalized Elderly

It is hypothesized that whole body vibration exercise group will have significantly more improvement in physical functioning and reduction in fall incidence among institutionalized elderly, compared with conventional exercise group and control group.


Eligibility Criteria:
Inclusion Criteria:

* Functional Ambulation Category 1 to 4
* able to understand simple verbal commands
* able to tolerate intermittent physical activity for at least 45 minutes
* able to perform knee flexion \>45 degree
* able to stand with or without support for 1 minute or more

Exclusion Criteria:

* peripheral vascular disease
* any symptoms associated with vestibular disorder
* any contraindications to exercise (e.g. unstable angina)
* any serious illnesses that preclude participation (e.g. cancer)
Epidemiology and Clinical Features of Uveitis in a Tertiary Referral

The aim of the study is to report the pattern of uveitis in patients attending a tertiary referral center at the University hospital in Montpellier. The patients seen at the specialized consultation for uveitis between 2002 and first semester 2018 were included.

Data about demography, clinical features and final diagnoses were collected and updated during the differenet visits. The medical records were restrospectively rewieved and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patients seen at the specialized consultation for uveitis between 2002 and first semester 2018

Exclusion Criteria:

* Patients under 18
Efficacy and Safety of Industrially Prepared 3 Chamber Bag Parenteral Nutrition for Premature Infant

This study was designed to evaluate whether industrially prepared standardizing total parenteral nutrition is at least non-inferior to compounded TPN and provides nutritional intakes according to the new guidelines and provides the expected weight gain in preterm babies with a birth weight between 1250 and 2000g admitted in our NICU between 2015 \& 2018

Parenteral nutrition (PN) is mandatory in the nursing of very low birth weight ((V)LBW)) babies during the first weeks of life. Numerous discussions exist about the indication of individually tailored or standardized PN formula. (V)LBW babies are known as fragile unstable babies with special requirements. Many neonatal intensive care units (NICU) prefer a tailored prescription for that kind of patients. Making a daily individual tailored prescription is often complex for numerous reasons: it is time consuming, it may be source of faults and incompatibility, it needs a senior neonatologist to review the prescription and has to arrive during daytime hours at the pharmacy. Tailored PN is often administrated with a delay, as one can only prescribe having reviewed the results of blood sampling. This delay can range from 6 to 12 hours. Numeta G13°/0E is a standardized, industrial, ready to use PN specifically designed to meet the nutritional requirements of preterm newborn infants for whom enteral nutrition is not possible or insufficient. New Espghan guidelines were published in 2018 recommending nutritional intake targets of 2.5g-3.5 amino acids per kg/day and 90-120 kcal/kg/day. Our NICU wants to evaluate their compliance to these new guidelines. Before November 2016, it was common practice in CHU Tivoli to feed the preterm baby with a compounded binary TPN solution and lipids were administered separately in Y-line. In November 2016, we switched to an all-in-one TPN with standardized composition (Numeta G13%E, Baxter) Numeta G13°/0E is stored at room temperature and is ready to be infused in a few minutes. Numeta G13%E is presented in the form of a three-chamber bag (3CB) or a two chamber bag (2CB). The activation of the lipid bag is optional, resulting in a solution containing glucose, electrolytes, amino acids and (optionally) lipids. Additions of water, electrolytes in the bag or on the side help to customize the bag to the specific needs of newborns that need intensive care.

Eligibility Criteria:
Inclusion Criteria:

* premature patients in the NICUs with a birth weight between 1250 and 2000g

Exclusion Criteria:

* death or parenteral duration less than 10 days