cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004

To evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004

A phase 1 clinical trial to compare and evaluate the safety and pharmacokinetic characteristics after multiple administration of JC-013 and JLP-2004 in healthy adult volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged 19 years or older at the time of screening
2. At the time of screening, those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
3. Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography)
4. Those who be considered suitable for clinical subjects according to the results of laboratory tests (hematology tests, blood chemistry tests, urine tests, serum tests, blood coagulation tests, urine drugs tests), physical examinations and 12-lead electrocardiography at the time of screening
5. Those who voluntarily decide to participate and agree in writing to comply with the subject compliance requirements during the clinical trial period after receiving a detailed explanation of this clinical trial and fully understanding it

Exclusion Criteria:

1. Those who have current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history.

   ① Renal impairment

   ② Liver disorder
2. For women, pregnant women (Urine-HCG positive) or breastfeeding mother
3. Those who have clinically significant hypersensitivity reactions such as asthma, hives, allergies, etc. to the main ingredient (Pelubiprofen), additives, or other drugs (aspirin or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)) and have a history of hypersensitivity reaction
4. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
5. Those with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs
Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION

The aim of the present randomized trial is to assess the efficacy of wound drains in terms of reducing the rates of surgical site infection in obese patients with gynecological cancer.

Many prophylactic methods have been suggested for the treatment of surgical wound infections, including the prolonged administration of antibiotics as well as the use of subcutaneous tissue drainage, the use of which has been shown to be particularly effective in overweight patients. While its importance seems to be moderate in obese patients as well as those that suffer from malignant disease, to date, it remains unknown if wound drains may help reduce the rates of surgical site infection in obese patients that suffer from cancer. In the field of gynecological oncology data are limited to anachronistic studies whose methodological value is limited; hence, guidelines are primarily based in data of high risk of bias as to date, the value of subcutaneous tissue drainage in obese women undergoing surgery for gynecological cancer has not been documented in a large randomized study.

Considering the significant impact of surgical site infection on the interval to adjuvant therapy (as patients with infectious diseases cannot receive chemotherapy or radiotherapy), it becomes evident that every effort has to be made in order to help reduce the rates of SSI to help maintain acceptable intervals that will ensure appropriate care of patients.

Eligibility Criteria:
Inclusion Criteria:

This prospective randomized study will include obese (BMI\> 35) patients who will undergo primary surgery for ovarian or endometrial cancer

Exclusion Criteria:

Immunodeficient patients (systemic disease including HIV infection, systemic lupus erythematosus etc) Patients with hematologic diseases
Incretin Hormones in Type 1 Diabetes Mellitus;Effect of Metformin Treatment

Investigators aim is to conduct an RCT to study the effect of adjunct metformin treatment to insulin monotherapy in patients with type 1 diabetes, targeting the intestinal incretin secretion. The patients will be randomly allocated to metformin or placebo treatment for 4 months

Compared to the large armamentarium of antidiabetic agents for Type 2 Diabetes Mellitus (T2DM), the insulinocentric therapeutic approach in Type 1 Diabetes Mellitus (T1DM) has distracted the scientific perspective from the rise of novel therapies. Insulin monotherapy has long overshadowed the overall hormonal dysregulation that demarcates T1DM . In specific, the significance of the gut-derived incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic peptide), which are implicated with glucose metabolism via the gut-pancreatic axis, has been merely addressed.

Investigators' goal in the current protocol is to delineate the glucoregulatory role of incretin hormones in T1DM and the therapeutic advantages of adjunct metformin treatment over insulin monotherapy. In the absence of such knowledge, the development of effective strategies to improve metabolic homeostasis and ameliorate complications in T1DM patients will remain problematic. The central hypothesis of the study is that metformin, as an incretin-secretagogue, will enhance postprandial incretin secretion in T1DM patients, which will be reflected in reduced glucagon secretion and improvement in glycemic volatility. Mechanistic insight will be provided through changes in specific amino acids and metabolites patterns, chronic inflammation and the microbiome composition.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* T1DM (Diagnosis of diabetes before the age of 35 years and insulin use within 1 year of diagnosis)
* Treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)

Exclusion Criteria:

* Any cardiovascular disease within the last 3 months
* NYHA stage 3 or 4 heart failure
* Uncontrolled angina
* Liver failure \[AST\>135 IU/L or ALT\>129IU/L (3 x the upper normal limit)\] • Kidney failure or GFR\<60 ml/min/1.73m2
* Gastrointestinal disease or gastroparesis
* Prior diagnosis of cancer within 2 years
* Other medication that affect glucose metabolism within the last 3 months (metformin, SGLT2, GLP-1 analogues, amylin analogues, systemic glucocorticosteroids)
* Untreated or uncontrolled thyroid disease
* Pregnancy or breastfeeding
* Alcohol consumption \> 2-drinks per day or other substance abuse
Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing

The purpose of this study is to determine the prevalence and treatment rates of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing in the Magee-Womens Hospital outpatient clinic using a non-invasive urine STD test.

This study has three primary objectives: 1) to determine the prevalence of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing - a population likely at increased risk of acquiring STDs; 2) to determine the rate of successful treatment in women diagnosed with STDs in this venue.

Eligibility Criteria:
Inclusion Criteria:

* Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing.
* Ability to provide written informed consent.

Exclusion Criteria:

* Diagnosis and/or treatment for an STD within 4 weeks of enrollment in the study.
Lung Function and Airway Inflammation in Portland Cement Workers

The aim of the study is to examine inflammation in the airways and in peripheral blood, in workers in a cement plant i Norway.

OBJECTIVE: Former studies have presented conflicting data on the association between exposure to Portland cement dust and respiratory effects. Our goal is to examine inflammation in the airways and in peripheral blood in subjects exposed to cement-dust.

METHODS: All non smoking, dust exposed, workers from one department in the largest cement plant in Norway, are invited to participate. The workers will perform spirometry and induced sputum (IS) after a period of regular work with cement dust exposure, and again after a minimum of 5 days without exposure. Information on respiratory symptoms, allergy and former respiratory disease will be given on a self-reported questionnaire. IS was performed and processed as described by Pin et al. Differential cell counts will be carried out. Inflammatory markers in induced sputum and in peripheral blood will be measured. We want to use a crossover design were the cases are used as their own controls, but we will also include external controls.

Eligibility Criteria:
Inclusion Criteria:

* Cement dust exposure
* Non-smoker or ex-smoker \>3 years

Exclusion Criteria:

* Infectious disease during the last 3 weeks
* Chronic airway disease
Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease

Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.

Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.

The crowd: patients with primary glomerular nephritis, diabetic nephropathy patients.

Study design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with primary glomerulonephritis or diabetic nephropathy;
2. Aged from 18 to 70 years，male or female
3. GFR≥45ml/min/1.73㎡
4. 0.5g≤24 hours proteinuria≤3.0g
5. glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
6. Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
7. Obtain the agreement of patients or their guardians, and signed informed consent file

Exclusion Criteria:

1. Secondary nephropathy
2. People allergic to Shenyankangfu tables
3. Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
4. Pregnant or lactating women
5. Be participating in another clinical study at the same period
Ozone Therapy in Patients With Diabetic Neuropathy

Diabetic neuropathies are the most prevalent chronic complications of diabetes mellitus. The early recognition and appropriate management of neuropathy in the patient with diabetes is important for patient's quality of life and life expectancy. Ozone is well known to have anti-inflammatory and analgesic effects through the inhibition of pro-inflammatory mediators; as well as. stimulation of anti-inflammatory mediators' release

Introduction:

Diabetic neuropathies are the most prevalent chronic complications of diabetes mellitus. The early recognition and appropriate management of neuropathy in the patient with diabetes is important for patient's quality of life and life expectancy. The clinical symptoms of DPN range from pain and burning sensations (at rest or at night) to hypoesthesia, paresthesia, and/or numbness . Diabetic neuropathy can be axonal or demyelinating and can affect large or small neurons. Schwann cells, which are the most abundant glial cells, act as nerve axon insulators and modulators of neurobiology through their role in metabolic support and injury protection. In diabetic patients, church cells' function is disturbed, leading to loss of glial-axon communication and nerve homeostasis, which leads to fiber loss, neurodegeneration, and pain. Nerve conduction studies can detect these changes; however, there has been no effective therapy for the treatment of DPN until now.

Ozone is well known to have anti-inflammatory and analgesic effects through the inhibition of pro-inflammatory mediators; as well as. stimulation of anti-inflammatory mediators' release . Previous studies showed that Ozone promotes peripheral vascular integrity via induction of Vascular Endothelial Growth Factor (VEGF), Transforming Growth Factor Beta (TGF-β1) an Platelet-Derived Growth Factor (PDGF), according with the studies of Professor Bocci that demonstrated significantly increase and release of PDGF, TGF- β1 and VEGF in presence of Ozone .

Eligibility Criteria:
Inclusion Criteria:

* Sixty adult diabetic patients (type II DM)
* clinically symptomatized painful neuropathy for six or more months.

Exclusion Criteria:

* Patients with other causes of neuropathy (e.g., vitamin B12 deficiency), hereditary neuropathies and entrapment neuropathies, overt neuropathy with foot ulcers and/or amputation, peripheral vascular diseases, vertebral pathologies (e.g., previous surgery, foraminal stenosis, spinal canal stenosis, and/or vertebral disc herniation)
* Patients with other medical conditions such as connective tissue diseases, thyroid disorders, significant renal or hepatic dysfunction, platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability and septicemia
* local infection at the site of the procedure
* Consistent use of nonsteroidal anti-inflammatory drugs within the last two weeks
* Systemic corticosteroid administration or local injection at the suspected treatment site within the last month
* Recent fever or illness, hemoglobin level \<10 g/dL, platelet count \<105 _ 109/L, and/or tobacco use.
The Effect of Online Based Mentoring Program on the Blood Glucose and Satisfaction Score in Type 1 Diabetes Patients

Purpose:

To evaluate the effects of online based mentoring program on the blood glucose and satisfaction score in type 1 diabetes patients. Peer group mentoring will be as effective as guidance by the doctors.

Methods:

80 type 1 patients will be randomly divided into two groups (e.g. mentoring program group and control group). All patients will receive routine check up and blood test for ordinary type 1 patients. In addition, program group patients should register their SMBG, exercise, food intake and insulin dose on the website designed for this study and receive advices of mentors from peer group. Every patient will submit questionnaire on the first day of the study and the last day(after 12 weeks) of the study.

Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c (HbA1c) ≥8.0% were randomized to mentored (glucometer transmission with feedback from mentors) or control (glucometer transmission without feedback) groups and were examined for 12 weeks. Five mentors were interviewed and selected, of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18, more than 6 month after the diagnosis of type 1 diabetes
* HbA1c \> 8% despite of multiple insulin injection or insulin pump
* who are capable of using the internet

Exclusion Criteria:

* pregnant women
* who cannot use the internet
* those who does not want to participate in the study
Evaluation of Low Level Laser Therapy in Primary Tooth Pulpotomy Treatment

In our study, it was aimed to compare the long-term effectiveness of diode laser and low level laser therapy and primary tooth amputation treatments using calcium hydroxide (LLLT+CH) in primary second molars with deep dentinal caries. Ninety patients ( 42 Gırl, 48 Boy) aged 6-9 years with deep dentin caries in the mandibular second molar were included in the study. The patients were randomly selected according to the treatment to be applied and divided into two groups as the diode laser group (N=45) and the LLLT+CH group (N=45). The patients were called for control appointments at the 1st, 3rd, 6th and 12th months after the treatment, and both clinical and radiographic follow-ups were performed. Chi-square and Fisher's Exact tests were used to compare categorical variables according to groups in statistical analysis, and p\<0.05 was considered significant. When the study results at the end of 12 months were evaluated, the diode laser group had a clinical success rate of 95.6%, and a success rate of 93.3% radiologically; The LLLT+CH group had a success rate of 97.7% clinically and 90.9% radiologically. There was no statistically significant difference between the success rates of the groups (p\>0.05). According to the clinical and radiographic results of our study, it was determined that diode laser and LLLT+CH amputations showed similar success rates in primary second molars with deep dentin caries. It has been seen that both methods can be used safely in primary tooth amputations. It is thought that clinical and histological studies and studies examining the effectiveness of dental laser applications in primary tooth amputation treatment are needed.


Eligibility Criteria:
Inclusion Criteria:

Clinical Criteria

* No systemic disease
* Not allergic to the materials used
* Children with scores of 1 and 2 according to the Frankel behavioral scale
* Those who have erupted permanent first molars
* The one in occlusion with the opposing tooth
* Not having bad oral habits
* No structural anomaly in the teeth
* No spontaneous or nocturnal pain
* No sensitivity to palpation or percussion
* Abscess and fistula formation free
* No pathological mobility
* During treatment, pulp bleeding is controlled within 5 minutes.
* With a crown that can be made of stainless steel crown (PÇK)

Radiographic Criteria

* Having a deep dentin caries lesion very close to the pulp
* No resorption in the bifurcation and periapical area
* Periodontal space is healthy and there is no periapical region pathology
* Absence of internal and external root resorption in roots
* No calcified masses in the pulp
* Teeth that did not exceed one-third of the physiological root resorption were included in the study.

Exclusion Criteria

-Children with a score of 1 and 4 on the Frankel Scale were excluded.
First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL

Aims: A nationwide study to prospectively validate

1. The complete histological and molecular remission rate for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL
2. The durability of complete histological remission after antibiotics
3. The usefulness of pattern of NF-kB, BCL10, BAFF, and CagA by IHC staining in prospectively predicting the Hp-dependence of gastric pure (de novo) DLBCL
4. The frequency of t(11;18)(q21;q21) translocation in gastric pure (de novo) DLBCL in Taiwan.
5. The association between the CYP2C18/CYP2C19 genetic polymorphisms and eradication of Hp infection after antibiotics.

The study will validate the use of antibiotics as first-line therapy for stage IE (and perhaps IIE-1) Hp-positive gastric pure (de novo) DLBCL. The status of NF-kB, BCL10, BAFF, and CagA IHC nuclear staining will help to tailoring the treatment for early-stage gastric pure (de novo) DLBCL. And 50-60% of stage IE / IIE-1 pure (de novo) DLBCL patients can be cured by 2-weeks of antibiotics rather than the 6-months of relatively toxic front-line systemic chemotherapy. The investigators shall also elucidate the distribution of CYP2C18/19 in patients with pure (de novo) DLBCL and their association with the efficacy of sequential antibiotics for eradication of Hp infection.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have histologically confirmed H. pylori-positive primary gastric pure (de novo) gastric DLBCL.
2. Patient must have no prior chemotherapy or radiotherapy for his/her gastric pure (de novo) gastric DLBCL.
3. Patients must have evaluable disease by endoscopy and/or by computed tomography.
4. Patients must have documented H. pylori infection before treatment, if any of the following test show positive result: histology, rapid urease test (CLO-test), C13 urease breath test, and serology.
5. Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
6. Patients who are either newly diagnosed or already starting anti-H. pylori therapy but not have follow-up endoscopy and biopsy are eligible.
7. Patient must have signed the informed consent, and agree to provide achieved pathologic material for immunohistochemical / fluorescence in situ hybridization study and RT-PCR for t(11;18)(q21;q21) determination.

Exclusion Criteria:

1. Patients with extensive gastrointestinal tract involvement.
2. Patients with previous history of extranodal lymphoma.
3. Patients with stage IIE-2 or beyond disease: infiltration of regional lymph node.
4. Patients with cardiopulmonary status that do not allow repeat endoscopy.
5. Patients with prior chemotherapy or radiotherapy for their primary gastric lymphoma.
6. Patients who had previous anti-H. pylori therapy and without pretreatment pathology achieve material for histological review and immunohistochemical study.
The Effectiveness of Neurodynamic Mobilization in Carpal Tunnel Syndrome

This randomized, clinical, single-blinded, controlled study will initially planned to include 86 patients diagnosed with carpal tunnel syndrome who applied to Kütahya Health Sciences University, Evliya Çelebi Training and Research Hospital, Physical Medicine and Rehabilitation outpatient clinic and Kutahya City Hospital.Patients aged 20-55 years who were diagnosed with mild and moderate carpal tunnel syndrome by electromyography (EMG) in the last 6 months were included in the study. The patients were randomized into two groups using the computer-assisted randomization method. Median nerve mobilization and ultrasound therapy will be given to the study group, and only ultrasound therapy will be given to the control group. All the patients were evaluated with the Visual Analog Scale (VAS), Hand and Pinching Grip Test, Boston Carpal Tunnel Questionnaire (BCTQ) and Median Nerve and Abductor Pollicis Brevis Muscle ultrasonography before the intervention and at the third week of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mild-to-moderate CTS on the dominant hand, based on the electrodiagnostic examination.
* Aged 20-55 years.
* Consent to receive the described treatment.
* Lasting symptoms at least 3 months

Exclusion Criteria:

* A systemic inflammatory disease.
* Any disease that can cause polyneuropathy, for example, diabetes mellitus.
* A cognitive disorder.
* Receiving psychotherapy.
* A pacemaker.
* Any disease that can affect the central nervous system.
* Carpal tunnel syndrome surgery history