cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee

This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.

Eligible subjects are randomly assigned to receive DA-5202 high dose(20mg) or DA-5202 low dose(10mg) or Na Hyaluronate once a week intra-articular injection for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients between 20 and 80 y old
* primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria and have following 3 items

  1. knee joint pain
  2. have any of the following

     1. males and females more than 50 y
     2. morning stiffness within 30 minutes
     3. crepitus
  3. presence of spur on radiological evidence
* Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically
* knee pain under weight-bearing greater than 40/100mm-VAS(Visual Analogue Scale) at randomization visit
* patients willing and able to provide signed informed consent after the nature of the study has been explained

Exclusion Criteria:

* BMI(Body Mass Index) \> 32
* complete obliteration of femoropatellar joint space on X-ray
* Kellgren-Lawrence Grade IV
* knee surgery within a year
* history of fracture, rheumatoid arthritis or other inflammatory arthritis in knee articular cavity
* intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months
* skin diseases or infection overlying the joint
* history of severe drug allergy or hypersensitivity to drugs(piroxicam, hyaluronic acid)
* history of allergy, asthma, rhinitis, angioedema, rash to aspirin or other NSAIDs (including COX-2 inhibitor)
* treatment with anticoagulants such as heparin or coumarins (warfarin etc.)
* History of GI diseases such as peptic ulcer, bleeding, perforation, ulcerative colitis, Crohn's disease within 1 year
* severe hypertension
* patients with psychiatric disorder, alcoholism, drug addiction
* presence of severe concomitant diseases or malignancy within 5 years
* have participated in another clinical trial 4 weeks prior to the study
* women of child-bearing potential who are not using \*adequate means of contraception (\*adequate means of contraception: condom, oral contraception, barrier methods using spermicide, intrauterine devices etc.)
* any condition that, in the view of the investigator, would interfere with study participation
A Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects

This is a randomized, open-label, three-sequence, three-period, three-treatment clinical trial to investigate the pharmacokinetic drug-drug interaction of Clevudin and Adefovir dipivoxil after oral administration in healthy male subjects.

To evaluate the safety, drug-tolerance, pharmacokinetics of Clevudine or Adefovir monotherapy or Adefovir and Clevudine combination in healthy male subjects

Eligibility Criteria:
Inclusion Criteria:

* Age limit is from 20 to 45 with healthy male subjects in screening
* Weight limit is from 50kg(110.23Ib) to 90kg(198.41Ib) with BMI 18.5-26 (BMI(kg/m2)= weight(kg)/{height(m)}2
* The person who fully understands and listens about this clinical trial, receives written consent to observe the notandum and decides to participate voluntarily

Exclusion Criteria:

* The person who has past history or serious disease in liver, kidney, nervous system, respiratory system, gastro-intestinal tract system, endocrine system, blood tumor, cardio-vascular system, urinary system, mental system clinically
* The person who has the past history of Gastro-intestinal operation(except simple appendectomy or herniotomy)or Gastro-intestinal system disease (Chron's disease,ulcer,acute and chronic pancreatitis, etc) that can be influenced the absorption of clinical drug
* The person who has the past history of hypersensitivity reaction about the drugs that contain the identical affiliation ingredient or ingredient of Clevudine, Adefovir dipivoxil or others drugs(aspirin, antibiotics etc)or has the significant past history of hypersensitivity reaction clinically
* The person who shows results of the 1.5 times upper limit in screening test of AST(SGOT), ALT(SGPT)
* The person who shows results of the positive HBsAg, HCV Ab,HIV Ab
* The person who has a past history of drug abuse or shows a positive result of drug abuse in urine drug analysis of screening test
* The person who takes medications of some medicine and medical supplies or oriental medicine within 2 weeks before the first administration date', or some OTC drug, vitamin supplements or health functional food within 1week (if only,it's confirmed by the investigator's judgment that they are not affected in pharmacokinetics character and safety evaluation about the clinical drugs)
* The person who participates in other clinical trials within 2 weeks before the first administration date'
* The person who donates plasma pheresis within 1 month before the first administration date, donates whole blood within 2 months before the first administration date or receives a transfusion within a month before the first administration date
* Persistent drinker(over 21 units/week, 1 unit = 10g of pure alcohol) or a drinker who can't stop drinking during hospitalization period
* Smoker who takes a drag over 10 cigarettes per day during the past three months
* The person who was judged unfit for participating in clinical trials by a investigator because of the clinical laboratory test results or other reasons
Pressure-controlled Versus Volume-controlled Ventilation During Protective One Lung Ventilation

The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.

One-lung ventilation (OLV) during thoracic surgery, in particular, video-assisted thoracic surgery is a standard practice to facilitate surgical exposure, but arterial hypoxemia has been a serious complication during one lung ventilation. Furthermore, recent studies have shown that one lung ventilation with a conventional tidal volume can involve lung injury associated with alveolar overdistension and high airway pressure. Therefore, lung protective ventilation with a low tidal volume during one lung ventilation has been suggested, and a recent study showed that protective ventilation during lung cancer surgery was associated with improved postoperative respiratory outcomes such as reduced incidence of acute lung injury and atelectasis.

During protective one lung ventilation limiting airway pressure and using low tidal volume, it is important to provide uniform alveolar expansion and maintain adequate oxygenation. A previous study suggested that the decelerating inspiratory flow delivery used in pressure controlled ventilation improved ventilation/perfusion distribution and arterial oxygenation during one lung ventilation5. Moreover, according to a recent study during laparoscopic obesity surgery, pressure-controlled ventilation improved oxygenation compared with volume controlled ventilation, which was associated with higher instantaneous flow peaks and a better alveolar recruitment6. On the other hand, other studies showed that ventilatory mode during one lung ventilation did not affect arterial oxygenation. However, these studies were performed during mechanical ventilation using conventional tidal volume, and the effect of ventilatory mode during protective one lung ventilation on oxygenation has not been clearly determined yet.The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.

Eligibility Criteria:
Inclusion Criteria:

* patients (ASA physical status I-III) undergoing elective thoracic surgery in the lateral position with at least 1 h of one lung ventilation

Exclusion Criteria:

* patients with major organ dysfunction, hemodynamic instability, or increased intracranial pressure
Muscle Ultrasound Study in Shock Patients

Intensive Care Unit (ICU) patients are known to lose muscle mass and function for many reasons, ranging from prolonged immobilization, to the effects of ICU treatments such as mechanical ventilation (MV), to the critical illness itself. Ultrasonography (US) is widely used in the ICU setting and has greatly evolved in the last decades, since it allows the non-invasive assessment of different structures, using radiation-free and user-friendly technology; its application for the assessment or the skeletal muscle is a promising tool and might help detecting muscle changes and thus several dysfunctions during early stages of ICU stay.

By using skeletal muscle ultrasound at both diaphragm and peripheral levels, the overall aim of this study is to improve knowledge in the early detection of muscle dysfunction and weakness , and their relationship with mechanical ventilation weaning and muscle strength, in critically ill patients suffering from septic shock.


Eligibility Criteria:
Inclusion Criteria:

1. adult patients (\> 18 years old) admitted to the ICU
2. with a diagnosis of septic shock
3. a SOFA score equal or superior to 8 points, at ICU admission
4. blood lactate concentration above 2 mmol/L, at ICU admission
5. expected to have more than 48h of mechanical ventilation (estimated by the attending physician)
6. expected to stay more than 5 days in the unit (estimated by the attending physician)
7. able to walk prior to ICU admission / walking aids accepted;

Exclusion Criteria:

1. pregnancy
2. lower limb amputation, fixators or open wounds
3. thoracic fixators or open wounds
4. diagnosed neuromuscular or central nervous system diseases
5. being transferred from another ICU
6. spinal cord injury
7. diaphragm pacemaker
8. palliative goals of care
9. cancers derived sarcopenia
10. cachexia
11. anorexic disorders (protein-energy malnutrition)
12. intellectual or cognitive impairments, limiting the ability to follow instructions.
Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda

This study will investigate the burden, causes, diagnostics, treatments and preventive measures related to meningitis in northern Uganda. We hypothesize that understanding the burden of meningitis, risk factors, diagnostics, treatments and the preventive measures will provide information regarding the gaps in care that can be addressed in order to improve the continuum of meningitis care. we hypothesize that our data will support the advocacy for the implementation of routine vaccination for the prevention of bacterial meningitis and improving guidelines for Cryptococcal antigen (CrAg) screening for prevention of cryptococcal meningitis, which will save lives in Uganda.

Aim 1: To prospectively collect data on 1100 patients with meningitis and meningitis symptoms who were admitted to Lira Regional Referral Hospital (LRRH) to assess burden, etiologies, pathogenesis, and outcomes of meningitis using modern diagnostic testing not previously available in Uganda.

Aim 2: To perform CrAg screening of 10,000 HIV-positive patients to determine the prevalence of cryptococcal antigenemia (infection) and conduct a case control study to compare risk factors and outcomes among CrAg-positive patients and matched CrAg-negative controls based on age, sex, TB status, ART experience, CD4 count, and viral load.


Eligibility Criteria:
Inclusion Criteria:

* 1100 patients who present with meningitis or meningitis symptoms, regardless of age or vulnerably status are eligible for meningitis testing.
* 10,000 HIV-infected patients presenting to LRRH, LRRH HIV Clinic (LIDC) or nearby outpatient clinics, regardless of age or vulnerability status, are eligible for CrAg screening.

Exclusion Criteria:

* Patients who are found not to have meningitis after initial evaluation, or are found to have other alternative diagnoses that explain their symptoms, will be excluded.
* HIV-negative patients without signs or symptoms of meningitis.
Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine

The goal of this Randomized Control Trial is to compare the effects of addition of cisatracurium to lignocaine for IVRA Vs. Plain lignocaine in All ASA physical status I \& II patients between 20 to 55 years of age, scheduled for elective hand surgery (carpal tunnel, trigger finger, tendon release, fracture reduction and tendon repair). The main question\[s\] it aims to answer are: • Does addition of Cisatracurium to plain lignocaine improve the overall quality of anesthesia? • Does use of cisatracurium lead to improved postop analgesia and decreased parenteral analgesic requirements? Participants will be Forty-four patients undergoing elective hand surgery during IVRA randomly assigned to two groups of 22 patients each. All demographic details (age, gender, body weight) will be noted, all will be briefed about visual analogue score (0 to 10) for pain. Group 1 (control group) will receive lidocaine 2% diluted with saline, group 2 (cisatracurium group) will receive cisatracurium plus lidocaine 2% diluted with saline. A standard technique would be employed for IVRA. The following parameters to be assessed: onset and offset of sensory and motor block, Intra-operative pain at 5, 10, 20, 30 minutes after tourniquet application by using visual analogue score (VAS), and postoperative pain using visual analogue score (VAS) measured at 5-minute,1, 2, 4, 8 hours postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* All ASA physical status I \& II patients between 20 to 55 years of age, scheduled for elective hand surgery

Exclusion Criteria:

* Patients with Raynaud disease, sickle cell anemia, or a history of allergy to any drug to be used.
* Also, patients who had bleeding tendency, on anticoagulant or antiplatelet therapy, significant cardiovascular, peripheral vascular, or neurological disease.
The Effect of Nimodipine on the Postoperative Cognitive Dysfunction

The calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral blood flow and inhibiting neuronal necrosis and apoptosis. Nimodipine significantly inhibited the production of tumor necrosis factor TNF-α and interleukin IL-1β, and also of nitric oxide and prostaglandin E2 from lipopolysaccharide-stimulated microglia. Abnormal cytokine networks are important in the development of nerve cell damage that leads to cognitive impairment.

All patients aged above 60 years undergoing planned neurosurgical operations in the duration up to 4 hours under general anesthesia will be included in the study. The patients will not be sedated by any type of benzodiazepine. A dose of 30 mg nimodipine or placebo will be applied 45 minutes before the surgery according to the randomization. Anesthesia will be managed according to the standardised protocol. Concentration of desflurane will be adjusted according to entropy values (target 40-50). Analgetics will be applied according to surgical pleth index (SPI) values. Sufentanil will not be applied in the last 15 minutes. Extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (TOFR) above 92%. Neither syntophylline, nor pharmacological decurarization (syntostigmine) will be applied to the patients.During the surgery, blood pressure will be maintained within ± 15% of the patient's normal blood pressure. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day.

Eligibility Criteria:
Inclusion Criteria:

* Glascow coma scale GCS 15 preoperatively
* American Society of Anesthesiologists ASA risk I - III
* planned brain surgery
* duration of procedure up to 4 hours.

Exclusion Criteria:

* blood pressure below 130/80 torr preoperatively
* previous vascular surgery
* concomitant use of antiepileptic drugs, rifampicin
* allergy to nimodipine
* known liver cirrhosis
Effects of Ozone Therapy as an Adjunct to Periodontal Treatment

This randomized, placebo controlled, split-mouth clinical study trial evaluates the effects of Ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study . Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.

Ozone therapy (OT) is very popular in medicine. Especially it use for wound healing and antibacterial properties. This randomized, placebo controlled, randomized split-mouth clinical study evaluates the effects of ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study (10 males, 10 females). Periodontal parameters, including plaque index (PI), gingival index (GI), probing depth (PD), percentage of bleeding on probing, percentage of pockets deeper than 5 mm and clinical attachment level (CAL), and percentage of ≥3 mm clinical attachment level. Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets twice a week for 2 weeks during active periodontal therapy. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 64 years of age
* Generalized chronic periodontitis(Armitage, 1999)
* Systemically healthy
* More than 20 teeth (excluding third molars)

Exclusion Criteria:

* Periodontal treatment within 6 months
* Antibiotic use within the previous 3 months
* Pregnancy and lactation
* Past or current smoking and alcohol consumption
* Contraindications for OT
* Patients with class II and III furcation defects(Staffileno, 1969)
Magnesium Supplementation in Type II Diabetes

This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium from organic magnesium citrate affects blood glucose control and insulin resistance within patients with type 2 diabetes (HbA1c\> 6%) and how the expression of certain Mg-sensitive transporting genes is affected .

The examinations are carried out in 50 subjects aged 20-80 years with existing type 2 diabetes (HbA1c\> 6%). The target parameters are determined in the blood. Blood sampling takes place at confinement, after 6 weeks and at the end of the study (week 12). In addition, blood pressure is determined and general health condition of each subject is recorded by a standardized questionnaire (SF-36).

Eligibility Criteria:
Inclusion Criteria:

* Type II Diabetics (HbA1c \> 6%)

Exclusion Criteria:

* pregnancy, lactation
* persons with severe renal impairment (glomerular filtration rate \<30 ml / min)
* use of insulin, oral antidiabetic drugs, diuretics, antacids or proton pump inhibitors within 4 weeks prior to study start and during the study
* intake of vitamin supplements, dietary supplements, mineral products or possibly enriched foods containing Magnesium within 4 weeks before study start and during the study
Safety and Efficacy of Bronchitol in Bronchiectasis

Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.


Eligibility Criteria:
Inclusion Criteria:

* Non cystic fibrosis bronchiectasis
* Have FEV1 50% - 80% predicted and ≥1.0L
* Have chronic sputum production of \>10 mL per day on the majority of days in the 3 months prior to study entry

Exclusion Criteria:

* Be using hypertonic saline or mucolytic pharmacological agents concurrently or in the 4 weeks prior to study entry
* Have airway hyperresponsiveness as defined by a positive Aridol challenge
Boost to Brittle Bones - Stem Cell Transplantation for Treatment of Brittle Bones

An exploratory, open label, multiple dose, phase I/II trial (n=15) evaluating safety and efficacy of intravenous and intraosseous infusion of allogeneic expanded fetal mesenchymal stem cells (MSC) for the treatment of severe Osteogenesis Imperfecta (OI) compared with historical and untreated prospective controls.


Eligibility Criteria:
(i)Inclusion Criteria Treatment group

1. Parent's/legal guardian's signed informed-consent form
2. Clinical diagnosis of OI type III or IV AND
3. Molecular diagnosis of OI (Glycine substitution in the collagen triple-helix encoding region of either the COL1A1 or COL1A2 gene)
4. Age between 1 to 4 years
5. BP treatment initiated before inclusion
6. Parent/legal guardian over 18 years of age

(ii)Inclusion Criteria Prospective Untreated Control Group and Historical Control Group:

1. Parent's/legal guardian's signed informed-consent form
2. Clinical and molecular diagnosis of OI (Glycine substitution in the collagen triple-helix encoding region of either the COL1A1 or COL1A2 gene)
3. Age between 4 to 8 years
4. Parent/legal guardian over 18 years of age

(iii)Exclusion Criteria Treatment group Prospective and historical control group:

1. Existence of other known disorder that might interfere with the treatment (such as severe malformations, congenital heart defect, hypoxic encephalopathy (l-lll), neurological problems, immune deficiencies, muscle diseases, syndromes) diagnosed by clinical examination
2. Any contraindication for invasive procedures such as a moderate/severe bleeding tendency or contagious infections
3. Abnormal karyotype or other confirmed genetic syndromes
4. Oncologic disease
5. Inability to comply with the trial protocol and evaluation and follow-up schedule
6. Inability to understand the information and to provide informed consent
Waiting Time in the Premedication Room on Anxiety

The primary purpose of the study is to determine the total anesthetic consumption required to reach the optimal depth of anesthesia (BIS 50) depending on the anxiety of the waiting period in the preoperative waiting room and the degree of anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Being in the age group of 18 and over
* Being literate and able to communicate
* Individuals will have surgery in ENT, Urology, Brain Surgery, Orthopedics, General Surgery, Plastic Surgery, CVS and gynecology and obstetrics departments.
* Agreeing to participate in the research voluntarily

Exclusion Criteria:

* alcohol or drug use
* history of psychiatric illness
* central nervous system disease
* use of psychotropic medication
* pregnancy
* lack of vision, hearing