cyrilzakka/clinical-trials huggingface dataset:
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria

The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Nigerian subjects previously enrolled in the primary vaccination study NCT00678301.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
* A male or female, between and including 15-21 months of age at the time of visit 1.
* For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
* Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
* Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Administration of any pneumococcal vaccine since the end of study NCT00678301.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
* Major congenital defects or serious chronic illness.
* History of any progressive neurological disorders or seizures.
* Acute disease and/or fever at the time of enrolment.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
* Child in care.
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke

Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvement in cognitive function, particularly working memory in humans. When combined with intensive task-related training, armodafinil may accelerate motor recovery in chronic stroke patients.

The primary aim of this study is to determine whether administration of armodafinil during subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by armodafinil and, therefore, will induce an improvement in motor function and better performances on measures of motor control.


Eligibility Criteria:
Inclusion Criteria:

* First clinical stroke, either cerebral infarction or intracerebral hemorrhage
* Severe hemiparesis as measured by a Fugl-Meyer motor scale score of 0-25
* Screening Motricity Index score of 0-83
* Date of stroke onset between 7 to 21 days prior to study inclusion

Exclusion Criteria:

* Age less than 18
* Previous clinical stroke
* Pregnant and/or nursing patients
* Major psychiatric history, including psychosis and history of substance abuse
* Dementia
* Known CNS pathology such as brain tumor
* Significant language dysfunction or severe neglect that hinders comprehension, participation, and barrier to testing
* Seizures
* Left ventricular hypertrophy (LVH)
* Mitral valve prolapse (MVP)
* Severe chronic renal failure or severe hepatic failure
* History or current use of anti-epileptic medications, psychostimulants, or neuroleptics
* Current use of diazepam, phenytoin, propranolol, tricyclic antidepressants, steroidal contraceptives, cyclosporine, or theophylline
Hormones and Decision Making

An investigation of the neuropsychological processes underlying ethical decision making.

This study will investigate the influence of reward sensitivity on cheating behavior via experimental manipulation of reward sensitivity using testosterone.

Eligibility Criteria:
Inclusion Criteria:

* males between 18 and 25

Exclusion Criteria:

* recruitment will be limited to male participants between 18 and 25 years who have no current conditions that would preclude the use of testosterone. Specific exclusion criteria are:
* women of all ages
* males younger than 18 years and older than 25 years
* self-report discomfort with ingestion of testosterone for the purpose of this study
* body mass index lower than 18 or higher than 27
* prior diagnosis of major depression, posttraumatic stress disorder, phobia, anxiety disorder, or other psychiatric conditions
* first-degree relatives diagnosed with a psychiatric disorder
* presence of a medical condition that would preclude the use of testosterone
* use of medications that would preclude the use of testosterone
* consumption of more than 5 cigarettes a day
* current use of testosterone enhancing products, such as gels, creams, and injections
Hook Plate vs Tightrope in Fixation of Fracture Distal Third Clavicle

to compare the clinical \& radiological outcomes of hook plate \& tightrope fixation in fracture of lateral third clavicle.

Adult clavicle fractures account for 4% to 10% of fractures. Distal clavicle fractures occurs in 25% to 30% of all clavicle fracture.The management of fractures of the distal clavicle has been a matter of debate in literature. Neer in 1968 suggested a new classification and proposed general treatment guidelines . Type I and type III fractures are generally treated non-operatively. For type II fractures, surgical management is the treatment of choice .There are numerous operative techniques reported in the past. The methods of surgical treatment could be summarised as follows:

1. Fixation in terms of K-wires and different pins such as the Steinmann pin, and Knowles pin. This fixation could also be augmented with concomitant tension band wires
2. Coracoclavicular indirect fixation with the use of screws, suture anchors, Dacron graft or Mersilene tape
3. Open reduction and clavicular plate fixation with the use of different plate systems such as the Balser plate,locked plate,hook plate, etc.

Different surgical techniques have their own advantages and disadvantages With more than 20 techniques described so far, no single fixation is ideal and perfect. There is still no consensus regarding the best surgical method to fix these fracture ,the investigators choose two of the most common of these methods and evaluate \& compare best radiological \& clinical outcomes of both.

Eligibility Criteria:
Inclusion Criteria:

* Adults (over 16 years old) including both sexes.
* Acute fractures within 3 weeks of injury.
* Isolated \& closed fractures.

Exclusion Criteria:

* Pathological fracture of distal clavicle.
* Deteriorated general health.
* Previous history of dysfunction with the affected shoulder.
* Incomplete medical records or lost to follow up.
Evaluating the Efficacy and Safety of Empagliflozin Addition to Insulin and Oral Antidiabetic Medication (OAD) Regimen in Poorly Controlled Type 2 Diabetes and Obese Patient

The primary aim of this study is to assess the impact of incorporating Empagliflozin, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, into the existing therapeutic regimen of Insulin+Metformin+Dipeptidyl peptidase 4 (DPP-4) inhibitors in poorly controlled type 2 diabetes mellitus (T2DM) patients. The study seeks to evaluate its effect on achieving glycemic goals in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 35 years or older, diagnosed with Type 2 Diabetes Mellitus,
* Specifically, individuals with a documented HbA1c level equal to or exceeding 8.5% over the course of the last six months or more are considered eligible candidates.
* these patients should currently be undergoing treatment involving a combination of Insulin and either Metformin or Sitagliptin.

Exclusion Criteria:

* Patients with a history of recurrent urinary tract infections
* those who are currently pregnant are excluded from participation in the study.
* patients with an estimated Glomerular Filtration Rate (eGFR) exceeding 40 ml/min/1.73m²,
* Furthermore, individuals with other concurrent medical conditions, and those who are unable to provide informed consent for the study, have also been excluded.
Xtract™ Aspiration Catheter Registry Study

Intra-coronary thrombosis and thromboembolism continues to be a challenge for percutaneous coronary and other vascular interventional techniques. The Xtract™ Aspiration Catheter is a single use device designed to remove fresh, soft emboli and thrombi from the arterial system using standard catheter techniques, compatible with 6 Fr guide catheters and 0.014 guidewires. The purpose of this registry study is to validate the design and demonstrate the performance of the Xtract Aspiration Catheter as a thrombectomy catheter during percutaneous intervention of vessels in the arterial system. Subjects will be enrolled during percutaneous intervention when the Interventional Physician decides a thrombectomy catheter is needed to remove thrombus during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion
* Angiographic evidence of thrombus.
Retinal Changes in Vitamin D Deficiency

Retinal tissue parameters of pediatric patients with vitamin D deficiency will be evaluated in this prospective case-control study. The patients will be divided into 2 groups according to the vitamin D level. Retinal vessel diameters, retinal nerve fiber evaluation, choroidal thickness will be evaluated. Choroidal thinning decrease in retinal artery diameter and increase in retinal vein diameter will be detected in the vitamin D deficiency group.

The study of the relationship between vitamin D status and retinal diseases is a new concept, and there is a large gap in research focusing on the pediatric population in the literature. The importance of vitamin D in retinal maturation and its role in the development of retinal diseases at a young age is being investigated. In this sense, as far as known, it is the first study investigating retinal structure parameters in pediatric patients with vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:(Group 1):

1. age \<18 years old
2. serum vitamin D \[(25(OH) D), calcitriol\] level \<20 ngr/mL in previous two weeks
3. visual acuity \>20/20
4. manifest refraction spherical equivalent \<3D
5. normal biomicroscopic and fundus examination.

Exclusion Criteria:

1. history of any chronic ocular diseases, except for refractive error (e.g., uveitis, glaucoma, retinopathy of prematurity)
2. history of ocular surgery (e.g., cataract, strabismus, open globe injury, laser photocoagulation)
3. having an ocular abnormality (e.g., persistent fetal vasculature, optic disc hypoplasia, fovea plana)
4. history of systemic diseases that have the potential to affect ocular tissues (e.g., diabetes mellitus, Graves' disease, albinism, Down syndrome, Fabry diseases, Wilson syndrome)
5. history of any systemic diseases that can affect the serum vitamin D level (e.g., parathormone or calcium metabolism disorders)
6. already receiving vitamin D treatment.
A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA
* Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer
* Have measurable disease per RECIST 1.1
* Have an ECOG performance status of ≤1
* Must not be pregnant and/or planning to breastfeed during the trial or within 180 days of the last dose of trial intervention
* Must be able to swallow tablets
* Participants with asymptomatic or treated CNS disease may be eligible

Exclusion Criteria:

* Have known active CNS metastases and/or carcinomatous meningitis
* Have any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 1 at the time of starting trial treatment, except for alopecia, peripheral neuropathy and ongoing endocrinopathies controlled on appropriate replacement therapy
* Have significant cardiovascular disease defined as unstable angina or acute coronary syndrome, history of myocardial infarction, known left ventricular ejection fraction or heart failure, uncontrolled or symptomatic arrhythmias.
* Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) and untreated HIV infection
* Have other active malignancy unless in remission with life expectancy greater than 2 years.
* Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
* Have history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease
The Additional Effect of Different Taping Applications in Patients With Lumbar Radiculopathy

Our study aims to compare the therapeutic effects of different taping materials and techniques on pain, functionality, and tissue temperature in patients with lumbar radiculopathy.

Pain occurs due to the intervertebral disc; ligaments in the region; or degeneration, strain, and sprains in the muscles, neurogenic, inflammatory, infectious, or neoplastic problems caused by structures in and around the spine . Low back pain is a serious health problem, with a lifetime prevalence of 84% . According to the American Society of Pain's clinical practice guidelines, low back pain is classified into three categories: nonspecific low back pain, radiculopathy-induced low back pain, and low back pain associated with another specific cause. A multidisciplinary approach is recommended for the treatment of low back pain. Before pharmacological treatments, cognitive behavioral therapy, physiotherapy exercise programmes, electrical physical therapy modalities, manual therapy, and psychological therapy are frequently referenced treatment options. Taping is one of the conservative physical therapy methods that is often a preferred treatment in clinics. Rigid (athletic) taping and kinesiological taping are the most preferred taping techniques . Non-elastic taping material is used in the rigid taping application. It is used to position soft tissue and ensure that the tissues come together, are protected from contact, create compression, and prevent local swelling. Studies supporting the sensorimotor and proprioceptive sensory enhancing effects of rigid tape, which provides very good sensory input over the skin, are found in previous studies \[7-9\]. Unlike rigid tape, kinesio tape can be stretched up to 140% of its resting length due to its structure, which is the approximate stretching capacity of normal skin .

Although there are various studies related to this topic, there is still no consensus on the effectiveness of taping in patients with low back pain who have disc degeneration. The reason for this is that some studies show the positive effect of kinesio taping on the reduction of low back pain, but some cannot show the effect of taping or find any changes . The healing mechanisms of different taping treatments have not been fully clarified. Moreover, local temperature, which is one of the indicators of vascularization and tissue healing, has not been investigated widely. Our study aims to examine the effects of different taping materials and techniques on pain, functionality, and local tissue temperature in patients with lumbar radiculopathy.

Eligibility Criteria:
Inclusion Criteria:

* The criterion for inclusion in the study for volunteers was low back pain due to lumbar radiculopathy.

Exclusion Criteria:

* Exclusion criteria were skin disease, central nervous system damage, tumour in the spine, surgical operation of the spine, pregnancy, and rheumatic disease
Vitamin D Repletion in Primary Hyperparathyroidism

This study will look at the effect of 2 treatment regimens that contain vitamin D in a six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine and bones. This study should provide important information on the effect of vitamin D therapy in patients with PHPT. In addition, data from this study will guide physicians as to how best to treat their patients who have PHPT and vitamin D deficiency.

Primary hyperparathyroidism (PHPT) is a common disease in which the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. In primary hyperparathyroidism, high levels of PTH remove too much calcium from bones and deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by the excess calcium loss which weakens the structure of the bones.

Many patients with primary hyperparathyroidism also have low vitamin D (25OHD) levels which is thought to further impair bone health. Recent medical guidelines recommend treating patients with primary hyperparathyroidism who have low vitamin D levels with oral vitamin D but the optimal vitamin D dose and rate of repletion is unclear. It is, therefore, important to determine if replenishing Vitamin D will improve bone health in primary hyperparathyroidism, and if so, to assess the impact of the rate of vitamin D repletion.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed PHPT, defined by an elevated serum calcium level (we will not study normocalcemic PHPT) with elevated or inappropriately normal PTH levels.
* Vitamin D3 less than 30 ng/ml

Exclusion Criteria:

* Patients with familial hyperparathyroid syndromes
* Current or past use of the following medications: bisphosphonate within past 2 years, use of lithium or thiazide diuretics, current use of cinacalcet, use of aluminum containing medications, cimetidine, colestipol, or orlistat
* Malignancy, except cured basal or squamous cell skin carcinoma or other cured cancers that are at least five years free from recurrence
* History or current diagnosis of certain medical diseases (including sarcoidosis, active infectious granulomatous disease, HIV/AIDS, chronic kidney disease (serum creatinine \> 1.5 mg/dL), liver disease; GI diseases known to affect calcium metabolism; secondary hyperparathyroidism);
* We will also exclude patients with calcium above 11.5 mg/dL, urine calcium above 350 mg/day, and active nephrolithiasis because vitamin D repletion could potentially exacerbate hypercalcemia or hypercalciuria
* Other exclusions include protected individuals (institutionalized), prisoners, and any other prospective participant who might not be able to give voluntary informed consent.
Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.

Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective spinal cord neoplasms resection;
* Ages between 18 and 65 years old;
* American Society of Anaesthesiology (ASA) status I-III;
* Signed informed consent.

Exclusion Criteria:

* Previous adverse reaction to ketamine, s-ketamine or pregabalin;
* Patients with a diagnosed history of severe chronic pain;
* Patients with long-term analgesic treatment(gabapentin/opioids/ketamine);
* Patients with aphasia or inability to cooperate with the pain assessments;
* Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients with a diagnosed history of psychiatric disorder;
* Patients treated with gabapentin/pregabalin in the last three months;
* Drug abuse;
* Body mass index (BMI) \> 35 kg/m2 ;
* Pregnancy or lactation.
The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes

* This is a phase II, prospective, single-center, non-randomized, non-controlled study.
* Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy
* abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness \>3mm)
* ultrasound-guided FNA cytology of these nodes were performed
* the result of FNA cytology was negative (no tumour cell was found)
* patient planed to perform SLNB

Exclusion Criteria:

* pathological diagnosed ductal carcinoma in situ by excisional biospy
* abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed
* the result of FNA cytology was positive (tumour cell was found)
* T4d tumour
* patient has recieved neo-adjuvant system therapy