cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

* Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
* Subjects on stable doses of metformin \>/= 1500 mg daily (SAD cohorts) or \>/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
* HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
* Fasting C-peptide \>1.12 ng/mL (SAD cohorts) or \>/= 0.8 mg/mL (MAD cohorts) at screening

Exclusion Criteria:

* History of Type 1 diabetes mellitus
* Evidence of diabetic complications with significant end-organ damage
* History of chronic pancreatitis or at high risk for pancreatitis
* Poorly controlled hypertension
* History of cardiovascular or cerebrovascular event or procedure
To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke

Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.

It is demonstrated that post-stroke hyperglycaemia is associated with poor outcome. Yet, the efficiency of aggressive insulin serum glucose control is not established. Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin. The purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin. The study will include carotid territory stroke at the acute stage (\< 6 hours of onset) confirmed by MRI, and randomized in intravenous versus subcutaneous insulin. The percentage of patients in the target range (mean capillary glycaemia within 24 hours \< 7 mmol/l) is the primary outcome. The secondary outcomes include comparison of Modified Rankin Scale at 3 months, rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Carotid territory stroke
* MRI performed in the first five hours of stroke onset
* Baseline National Institutes of Health Stroke Scale (NIHSS) \> 4 or \< 26
* Time between MRI and treatment under one hour

Exclusion Criteria:

* Pre-existing Modified Rankin Scale of three or higher
* Advanced or terminal illness with risk of death in the next 6 months, addiction
Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia

The purpose of this study is to determine the efficacy of different lens treatments (normal spectacle lens, ortho-K, \& Myovision) on myopia control in Chinese adolescent patients.

Different lens treatments include normal spectacle lens, orthokeratology, and Myovision (a specially designed spectacle lens commercially available with peripheral defocus controlled as relative myopia).

This study is to evaluate the efficacy of these three methods in controlling myopia progression. Until now, there is no sufficient clinical evidences to compare different lens treatments.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent myopia patients
* Myopic refraction between -1.00D and -4.50D
* Astigmatism equal or less than -1.50D
* Normal break up time of tear film (BUT \> 10s)

Exclusion Criteria:

* Existence of any ocular diseases except ametropia
* Hyperopia
* Severe dry eye
BO and DO in Women With Cystocele Before and After Cystocele Repair

The changes of lower urinary tract function after cystocele repair are important for perioperative consultation and management. Thus, the aim of this retrospective study was to evaluate the prevalence of bladder oversensitivity and detrusor overactivity in women with ≥ stage II cystocele and the changes of storage function after cystocele repair.

Bladder oversensitivity and detrusor overactivity are two important diagnosis of urodynamic study regarding storage function of bladder. Between November 2010 and October 2020, all women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair were reviewed. Those women who had complete data of preoperative and postoperative 3-month follow-up urodynamic data were excluded from this study. Bladder oversensitivity was diagnosed if the volume of strong desire was less than 300mL. Detrusor overactivity was defined as the occurrence of involuntary detrusor contractions during filling cytometry.

STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression tests were used for statistical analysis as appropriate. A p \< 0.05 was considered as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Women with ≥ stage II cystocele
* Received cystocele repair
* Complete urodynamic study before and after surgery

Exclusion Criteria:

* Recurrent cystocele after repairment
* Incomplete data
* Chronic infection
Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Strength, Functionality and Post Operative Complications

The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications.

The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by two minimal invasive/incision surgeries (MIS) versus the traditionally lateral approach.

The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after MIS than after traditional lateral surgery. Patients in the MIS group will also be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.

With total hip replacement surgery, the orthopaedic surgeon's aim is not only pain relief for the patient, but also restoration of hip joint biomechanics resulting in a minimal functional deficit and maximal longevity of the implant. It is not exceptional that these patients still experience mild to moderate long-term impairments postoperatively. These impairments include pain, muscle weakness of the hip abductors, contracture of the hip, gait disorders, as well as weakness of hip extensors and flexors. These problems may in turn lead to complications such as joint instability and loosening of the implant. When the lateral surgical approach is used, major concerns after total hip replacement surgery are muscle abductor weakness/atrophy, tendon defects of the gluteus minimus muscle, and unsuccessful reattachment or denervation of the anterior gluteal flap.

Minimal incision/invasive surgery (MIS) is defined as a surgical approach performed through a short skin and muscle incision to avoid injury to muscles and tendons. Following minimally invasive approach reduced muscle trauma has been found. Moreover clinical outcome improved, as the gluteus medius muscle can be spared more successfully. However, it is debated whether or not the overall results of MIS are superior, or even as good as the traditional hip replacement surgery in terms of component placing and time to revision of the prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for THA
* Diagnosis of primary osteoarthritis as the main cause for elective THA
* American Society of Anesthesiologists (ASA) score I, II, and stable III

Exclusion Criteria:

* Musculoskeletal diseases
* Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.
Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors

This is an open-label, multicenter, Phase Ib dose-escalation study designed to assess the safety, tolerability and pharmacokinetics of oral dosing of cobimetinib and pictilisib administered in combination in patients with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
* Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
* Life expectancy greater than or equal to (\>=) 12 weeks
* Adequate hematologic and end organ function
* Agreement to use an effective form of contraception for the duration of the study

Exclusion Criteria:

* History of prior significant toxicity from another mitogen-activated protein kinase (MEK) pathway inhibitor requiring discontinuation of treatment
* History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) pathway inhibitor requiring discontinuation of treatment
* Allergy or hypersensitivity to components of the cobimetinib or pictilisib formulations
* Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1
* Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1
* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
* Prior anti-cancer therapy within 28 days before the first dose of study drug treatment in Cycle 1
* History of diabetes requiring daily medication, or history of Grade \>= 3 fasting hyperglycemia
* Current severe, uncontrolled systemic disease
* History of clinically significant cardiac or pulmonary dysfunction
* History of malabsorption or other condition that would interfere with enteral absorption
* Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
* Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics
* Active autoimmune disease
* Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
* Pregnancy, lactation, or breastfeeding
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
* No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays
A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury

The purpose of this study is to investigate whether V158866 is safe and effective for the treatment of neuropathic pain due to spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 - 65 years
* documented spinal cord injury at or below T5
* moderate pain at or below the level of the spinal cord injury for at least 3 months
* compliant with daily diary
* stable pain scores on the NRS
* mean pain intensity of at least 4 and not more than 9 on the NRS (or if the mean NRS score is \>9, the mean Gracely score must be ≤19)

Exclusion Criteria:

* women of child-bearing potential
* men who intend to father a child
* a history of multiple drug allergies, hypersensitivity to any cannabinoid
* an increased risk of seizure
* evidence of depression and/or a score of \>19 on the BDI-II
* suicidal ideation or suicidal behavior in the past 10 years
* a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
* a positive urine test for cannabis at screening
* taking excluded medications that cannot be stopped
* a positive pregnancy test
Relatives Visit Prior to Hospital Admission & Intensive Care Unit

The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of family in an intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Family of a patient for hospital admission for surgery

Exclusion Criteria:

* Cognitive impairment
The Effect of Aromatherapy on the Insulin Injection Pain

Needle phobia occurs in more than half of diabetic patients due to the pain caused by frequent insulin injection. Therefore, this study evaluated the effect of topically administered lavender aromatherapy on the pain of insulin injection in diabetic patients.

Diabetes Mellitus (DM) is a serious chronic disease that negatively affects the quality of life. To control the course of the disease and to reduce its complications, insulin treatment is planned for the whole life of Type 1 diabetic patients, and frequently for approximately 40% of Type 2 diabetic patients. Frequent or incorrect administration of insulin injections may lead to the development of complications such as regional pain, ecchymosis, or hematoma on the injection site. It is emphasized that the pain caused by repeated insulin injections negatively affects the psychological well-being of the individuals as well as their physical comfort. Pain control is one of the main tasks of nurses. By alleviating pain, the patient's acceptance of treatment increases, and thus the quality of life improves. In the literature, lavender is reported to have the ability to heal burns and insect bites as well as analgesic, wound healing, antibacterial, antifungal, sedative, and antidepressant effects. The main components of lavender, such as lavender and linalyl acetate and linalool, are also recommended as topical analgesics in animal models. Whatever the cause, acute pain is a serious problem for individuals with chronic illnesses. Therefore, this study evaluated the effect of topically administered lavender aromatherapy on the pain of insulin injection in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years of age or older,
* having Type-1 DM or Type-2 DM disease,
* being conscious and communicating, not having mental and cognitive impairment,
* not having eczema and fragrance allergy to lavender,
* not having an alcohol or narcotic addiction,
* not having a head injury or convulsion history,
* not having a diabetes-related neuropathy, and
* if the patient took sedatives or analgesics, at least 6 hours would pass,

Exclusion Criteria:

* having a history of addiction or diagnosed psychological disorders,
* having an unstable hemodynamic status,
* having skin disease symptoms such as wounds and eczema at the insulin injection site and,
* having an allergy to lavender.
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation

The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.

Detailed information is provided elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and able to give consent
* Patients with an indication for TF-TAVI as judged by the local multi-disciplinary heart team
* Feasibility of transfemoral access route using commercially available transcatheter heart valves and delivery systems
* Written informed consent

Exclusion Criteria:

* Vascular access site anatomy not suitable for percutaneous vascular closure device
* Vascular access site complications prior to the TAVI procedure
* Known allergy or hypersensitivity to any component of the VCD
* Active bleeding or bleeding diathesis
* Absence of computed tomographic data of the access site before the procedure
* Systemic infection or local infection at or near the access site
* Limited long-term prognosis due to other comorbid conditions
* Patient cannot adhere to or complete the trial protocol for any reason
* Pregnancy
* Participation in any other interventional trial
* Patients with mechanical heart valves in mitral position
* Patients with elevated international normalized ratio (INR) due to oral anticoagulation therapy requiring reversal of vitamin K antagonists prior to TAVI using prothrombin complex concentrate
Effect of Zoledronic Acid in Primary Knee Osteoarthritis

We try to find out the effect of zoledronic acid over pain of primary knee osteoarthritis and also functional status in a period of 6 months.

This will be a double blind placebo controlled randomized clinical trial at department of rheumatology, Bangabandhu Seikh Mujib Medical University (BSMMU) from January 2023 to December 2023. Total 92 primary knee OA patients will be enrolled by following the inclusion criteria of ages 50 years and above with primary knee OA informed written consent. Then randomization will be done into group A and group B following a randomization table, each consist of 46 patients. Consecutive sampling technique will be followed. Primary knee OA will be diagnosed on the basis of ACR clinical and radiological criteria. Relevant laboratory investigations will be done. Baseline pain status will be measured by Bangla version of Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), visual analog scale (VAS) and numerical rating scale (NRS) and quality of life will be measure by European quality of life scale (EQ-5D-5L). Then one group will receive single infusion of 5mg zoledronic acid and another group will receive the placebo. Each patient will be allowed take NSAIDs on requirement basis with documentation and follow non pharmacological treatment of OA. At the end of 6 months, again pain and functional status will be measured by WOMAC scale

Eligibility Criteria:
Inclusion Criteria:

1. \>= 50 years
2. Knee OA by ACR criteria
3. Patient who will be willing to participate in the study

Exclusion Criteria:

* 1. Known inflammatory arthritis 2. BMI \>= 40 kg/m2 3. Prior diagnosis of cancer 4. Prior use of bisphosphonates 5. Use of intra articular corticosteroid or hyaluronic acid preparations within 3months 6. Metabolic causes of OA (crystal associated arthritis, acromegaly, wilson's disease, haemachromatosis, Hyperparathyroidism, DM) 7. Mechanical causes of OA (epiphyseal dysplasia, congenital dislocations, limb-length inequality, hypermobility syndromes, avascular necrosis)
Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis

Pediculosis capitis is a parasitic infestation that can cause scalp pruritus and quality of life disturbances. There are two objective measurement for pruritus, visual analog scale (VAS) and 5-D itch scale, which can assess the severity of the scalp pruritus and the latter can also asses the quality of life affected by pruritus. Even though VAS can not be used to evaluate the impact of pruritus on quality of life, it is very easy to use while 5-D itch scale is complex and not child-friendly.

The aim of this study is to determine the relationship between two different pruritus scales and to establish validity of pruritus VAS scale in evaluating quality of life in children with pediculosis capitis. We compare two pruritus scale on students with pediculosis of two boarding school in Bogor, West Java, Indonesia.

This study used cross sectional design study.

Subjects with eligible criteria were included and informed consent from the parents or legal guardian were obtained.

The diagnosis of pediculosis capitis was made based on the findings of eggs, larva, or an adult parasite on the scalp or in the hair of the students. All subjects were asked for both VAS and 5-D itch scale.The VAS is categorized into five groups based on the point, as follows: 0 for no pruritus, \<3 for mild pruritus, ≥ 3 - \<7 for moderate pruritus, ≥ 7 - \<9 for severe pruritus, and ≥ 9 for very severe pruritus. The 5-D itch scale consists of five parameters: duration, degree, direction, disability (sleep, leisure/social activities, housework/errands, work/school), and distribution of the pruritus with points ranging from one to five.

Data were recorded for statistical analysis, a chi-square test was used to determine the relationship between two categorical variables. The correlation coefficient between the VAS and 5-D itch scale was calculated using Spearman's rank correlation

Eligibility Criteria:
Inclusion Criteria:

* Students studying in Junior high school at Boarding School in Bogor with medium length hair who were clinically diagnosed with pediculosis capitis
* Willingness to participate as a research subject (to be interviewed and undergo physical examination), and after being explained the details of the study, granted the headmaster permission to sign consent in their name (informed assent)

Exclusion Criteria:

* Chemical treatment of PC within 10 days before the trial
* History of permethrin hypersensitivity
* Unwillingness to participate as a research subject
* Mild-to-severe secondary infection
* Long or short hair