cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Electrolyte Imbalance in Chronic Kidney Disease:A Study at Tertiary Care Hospital in South Punjab,Pakistan

an observational cross-sectional study is done to calculate the electrolyte imbalance at different stages of chronic kidney disease at tertiary care hospital.

an observational cross-sectional study is done to calculate the electrolyte imbalance at different stages of chronic kidney disease at tertiary care hospitals of south Punjab, Pakistan .The outcomes of chronic kidney disease and end stage of renal failure will be calculated according to standard protocol. Under the supervision of pathologists, pharmacologists, pharmacists, nephrologists, urologists and biostatistician. The standard protocol was authorized by ethical committee of each center. patient consent form was

Eligibility Criteria:
Inclusion Criteria:

* CKD patients ranging
* age from 20-80
* dialysis and pre-dialysis patients
* who provide written consent form

Exclusion Criteria:

* congenital one kidney patients
* organ or kidney donors and transplantation
* pregnant women
* renal injury during trauma
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged ≥ 18 but ≤ 75 years
* Histologically confirmed to be HER2-positive invasive breast cancer
* Treatment-naive patients with stage II-III
* Eastern Cooperative Oncology Group (ECOG) score 0-1
* Good level of organ function

Exclusion Criteria:

* Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
* Received any other anti-tumor therapy at the same time
* Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
* Stage IV breast cancer
* With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
* Inability to swallow, chronic diarrhea, intestinal obstruction, and a variety of factors affecting drug administration and absorption
* Participated in other drug clinical trials within 4 weeks before enrollment
* History of allergies to the drug components of this protocol
* Clinically significant pulmonary diseases
* Clinically significant cardiovascular diseases
* History of immunodeficiency
* Active hepatitis and liver cirrhosis
Drug Eluting Stents In The Critically Ischemic Lower Leg

The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. It will be investigated whether there is a difference in 12 month angiographic patency of the stented area using the 2 different stent systems.


Eligibility Criteria:
Inclusion Criteria:

* Stenotic (\> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
* A maximum of two focal target lesions in one or more infrapopliteal vessels
* Length of lesion is maximally 40 mm, allowing maximally 2 stents to be implanted
* Reference vessel diameter should be 2-3.5 mm
* Symptomatic critical limb ischemia (Rutherford 4, 5)
* The patient must be \> 18 years of age
* Life-expectancy of more than 12 months
* The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
* The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
* The patient must provide written patient informed consent that is approved by the ethics committee

Exclusion Criteria:

* Patient refusing treatment
* The reference segment diameter is not suitable for available stent design.
* Unsuccessfully treated (\>30% residual stenosis) proximal inflow limiting arterial stenosis
* Untreatable lesion located at the distal outflow arteries
* More than two infrapopliteal lesions in the same limb
* Previously implanted stent(s) or PTA at the same lesion site
* Lesion location requiring kissing stent procedure
* Lesion lies within or adjacent to an aneurysm
* Inflow-limiting arterial lesions left untreated
* The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
* The patient takes Phenprocoumon (Marcumar).
* The patient has a history of prior life-threatening contrast media reaction.
* The patient is currently enrolled in another investigational device or drug trial.
* The patient is currently breast-feeding, pregnant or intends to become pregnant.
* The patient is mentally ill or retarded.
* Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
* Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
* Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampin) within 90 days following the procedure.
* Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
* Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
Comparison of Two Cognitive-Motor Rehabilitation Approaches Via Exergames: a Study of Cognitive, Motor and Behavioral Functions in Huntington's Disease Patients

Huntington's disease (HD) is a rare, hereditary neurodegenerative disorder. It generally manifests itself between the ages of 40 and 50, and results in motor impairment (choreic movements, balance disorders, gait disorders, etc.), cognitive impairment (executive functions, attention, etc.) and behavioral impairment (apathy, depression, irritability, etc.). To date, there is no curative treatment for HD, and drug therapies have little effect on symptomatology, particularly motor symptoms. Physical activity and cognitive stimulation appear to be promising tools in the fight against the progression of various symptoms in certain progressive neurological conditions, including HD. In addition, the use of exergame as an interface is becoming increasingly widespread and offers encouraging prospects in the management of certain neurodegenerative diseases (Parkinson's disease, multiple sclerosis, spinocerebellar ataxia type 3).

The aim of our project is to carry out a preliminary evaluation of the clinical benefit of a management program combining physical activity and cognitive stimulation, compared with a sequential management program.


Eligibility Criteria:
Inclusion Criteria:

* Adults at inclusion
* Huntington's disease diagnosed and confirmed by genetic analysis
* Patient with stage 1-2 HD with a motor UHDRS score ≥ 5 and a CFT between 6 \< CFT ≤ 13
* Patient with written informed consent or third-party consent
* Affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Poor understanding of the French language
* Participation in interventional research modifying management
* History likely to interfere with cognition (established stroke, sequelae of traumatic brain injury, active epilepsy, learning disorders, alcohol dependence syndrome, drug use, psychiatric disorders), severe cognitive deficit (MMSE \<16), clinically significant pathological condition which, in the investigator's opinion, could interfere with the subject's safety or the evaluation of study results
* Pregnant or breast-feeding women
* Persons deprived of their liberty by administrative or judicial decision
* Persons under compulsory psychiatric care
Medical and Surgical Treatment for Idiopathic Granulomatous Mastitis

This study evaluates the clinical response rate of topical steroids in the treatment of idiopathic granulomatous mastitis in female adults. Half of the participants will receive topical steroid and the other half will receive local wide surgical excision.

Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast disease of unknown etiology.It may present with many findings that clinically and radiologically mimic breast cancer.

Although IGM as a disease has been known for nearly four decades, the optimal treatment approach has not been established. Surgical intervention in the form of wide surgical excision was the mainstay of treatment before 1980, and is still performed depending on local expertise and preference.

Currently,surgical treatment and systemic steroid treatment are frequently employed. With the consideration of side effects of longterm systemic (oral) steroid usage, topical steroid without systemic use were assessed and showed satisfactory curative effect. But the data concerning the use of topical steroid therapy are still very limited.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Granulomatous Mastitis

Exclusion Criteria:

* Breast Carcinoma
MCG for Risk Stratifications of Patients With Chest Pain

This prospective cohort study is aimed at identification and risk stratification of patients who have symptoms of acute chest pain suspected with acute coronary syndrome （ACS） using Magnetocardiography （MCG）.


Eligibility Criteria:
Inclusion Criteria:

* Those with suspected ACS who presented with symptoms of acute chest pain.
* Signed informed consent.

Exclusion Criteria:

* Those with known structural heart disease such as cardiomyopathy and valvular disease;
* Those with atrial fibrillation, supraventricular tachycardia, atrioventricular block and other arrhythmias that have not returned to normal;
* Those who have chest pain with known pulmonary embolism or aortic coarctation;
* Those who are thought to be incapable of completing the MCG examination by an attending physician (or physician with higher qualifications) due to unstable clinical conditions, metal implants, etc;
* Those who are unable to perform magnetocardiography examinations due to claustrophobia, etc., or those who fail to receive magnetocardiography examination;
* Those with malignant tumors;
* Pregnant or lactating women.
* Those with acute or critical illnesses of other systems, such as acute or severe respiratory illnesses, marked abnormalities in liver function or kidney function.
Investigating Superion™ In Spinal Stenosis

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study endpoint is the rate of overall subject success at 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 45 years of age
* Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart)
* Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal)
* Must be able to sit for 50 minutes without pain and to walk 50 feet or more

Exclusion Criteria:

* Axial back pain only
* Fixed motor deficit
* Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device
* Unremitting pain in any spinal position
* Significant peripheral neuropathy or acute denervation secondary to radiculopathy
* Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
* Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation
* Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
* Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)
* Spondylolysis (pars fracture)
* Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2
* Insulin-dependent diabetes mellitus
* Prior surgery of the lumbar spine
* Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)
* Infection in the disc or spine, past or present
* Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
* Tumor in the spine or a malignant tumor except for basal cell carcinoma
* Involved in pending litigation of the spine or worker's compensation related to the back
Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs

The drugs GSK189075 and GW869682 result in increased caloric losses. This study is investigating how if taken over 8 weeks that affects weight loss, food intake and the composition of the body. The body composition (fat,water, lean mass) is determined using a new investigational MR technology.


Eligibility Criteria:
Inclusion criteria:

* BMI of 30 - 40kg/m
* Females may be included if they are surgically sterile or post-menopausal

Exclusion criteria:

* Change in body weight \>4% in the last 3 months
* History of eating disorders
* had bariatric surgical intervention for obesity
* have type I or II diabetes
* Thyroid disorder not under control
* Renal or hepatobiliary disease
* Excessive alcohol consumption
* Use of drugs of abuse
* donated of blood in the last 3 months
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model

The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Tension headache
* All other primary forms of headache
* Cardiovascular, Central Nervous system (CNS) and autoimmune diseases
* Gastrointestinal disease
* Previous or clinical signs of mental illness or substance abuse.
* Participation in a clinical study of a medicinal product without regulatory approval or marketing authorisation within 1 month prior to this trial
* Pregnancy/nursing
* Daily intake of medication (except oral contraceptives)
Emdogain Adjunctive to Autotransplantation

The goal of this randomized clinical trial is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level. The main question it aims to answer. What is the benefit, in terms of clinical attachment level and probing depths, of using enamel matrix derivatives adjunctive to tooth autotransplantation? Participants will be subjected to a digitally guided surgery of tooth autotransplantation. The protocol of the test group will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus.


Eligibility Criteria:
Inclusion Criteria: Adult patients attending the University Complutense of Madrid for dental treatment were eligible to participate in the study if they met the following criteria:

* adults (≥18 years old) capable of providing informed consent, teeth deemed-unrestorable in need of replacement
* presence of a viable, healthy, periodontally stable, and nonfunctional tooth (e.g., third molar) suitable for autotransplantation
* periodontally healthy individuals or those with stable periodontal conditions after periodontal therapy.

Exclusion Criteria:

* clinical attachment loss of the donor teeth (CAL less 6 mm)
* compromised general health or patients with systemic diseases that could influence the therapy outcome (uncontrolled diabetes mellitus, bone disorders, etc.)
* pregnant or nursing women
* chronic use of corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immune-modulator drugs
* patients requiring medications that affect bone metabolism (bisphosphonates
* chronic oral mucosa diseases
* evident signs of severe bruxism or clenching habits
* smokers of more than 10 cigarettes per day
* non-compliant patients with 25% plaque index at the time of re-evaluation after non-surgical periodontal therapy and oral hygiene instructions
* patients unable to attend study-related procedures and follow-up visits
Comparison of Femtosecond Laser Assisted Cataract Surgery to Conventional Phacoemulsification Cataract Surgery

In this project, the investigators aim to compare the safety, efficacy, and predictability outcomes of conventional CEIOL surgery to Femtosecond-laser-assisted CEIOL (FLACS) in an effort to improve cataract surgery outcomes. The investigators hypothesis is that FLACS may lead to preservation of endothelial cells compared to conventional CE IOL.

This study will only include patients who are eligible to undergo cataract surgery. All patients will receive treatment that is FDA approved for cataract surgery. Because all study participants will have been scheduled for elective cataract extraction regardless of their participation in this study, there will be little or no additional surgical risk associated with participation. A total of 720 patients are expected to be enrolled in the study during a period of 2 years. The investigators will recruit patients with bilateral operable cataracts. One eye will undergo cataract surgery using conventional cataract extraction technique including phacoemulsification whereas the second eye will undergo FLACS. No significant increased risk to the patient is expected in either arm of the study compared to routine cataract surgery. The patients will be examined as per previous post-operative cataract surgery guidelines on POD1, POW1, POM1, POM3, POM6, POY1 and POY2. The only treatment difference will take place at the time of the cataract surgery. Post-operatively, endothelial cell count will be obtained by the no-touch technology of specular microscopy at baseline as well as three months after surgery. If the study ends prematurely, the investigators do not anticipate any significant change in the care of the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years of age
2. Ability to understand and sign an informed consent
3. Visually significant cataract eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye
4. Ability and commitment to follow up for 18 months after surgery
5. No other ocular pathology and no previous/concurrent surgery

Exclusion Criteria:

1. Any other ocular pathology that may affect best-corrected visual acuity
2. Previous or concurrent ocular surgery
3. Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
4. Patients with keratoconus or keratectasia
5. Patients who are blind on one eye
Health Literacy Activation RCT Among the COPD Patients and Designated Support Dyad

This study investigates whether increasing health literacy among COPD patients and their designated health coach during a hospital admission caused by symptoms exacerbation will lead to better health outcomes including increased health quality, and lower healthcare utilization.

Until recently, contemporary methods to chronic disease management have failed to consistently tailor approaches among patients with low health literacy. They have produced mixed results in terms of successful interventions to address the needs of these populations. Low health literacy is especially common in medically underserved communities, including in North Philadelphia. This is reflected in the predominantly low-income and racial/ethnic minority population of the patients at this medical center. Management of chronic conditions such as COPD is complex. Patients with low health literacy find it especially challenging to self-navigate disease management. However, there is a lack of information on approaches to improve health outcomes among COPD patients with low health literacy.

The long-term goal is to develop and evaluate a model of interventions to improve healthcare outcomes for socially disadvantaged populations. The objective is to pilot a randomized controlled trial that evaluates the effects of an intervention that provides enhanced education and material support, on adherence to care, among patients admitted for COPD-related issues and their home support dyad.

The central hypothesis is that: compared to the standard educational intervention delivered by a registered nurse, the addition of an enhanced intervention (enhanced education, problem-solving skills and facilitative support) and the inclusion of a patient-designated support pair will result in greater adherence care and improves quality of life, especially among patients with low health literacy.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be 55 years old and above
* A history of hospital admissions for COPD related issues
* Able to designate a support person that can help them manage their condition
* Discharged home

Exclusion Criteria:

* Dyads unable to participate in the education session
* Patients discharged to a skilled nursing facility or rehabilitation facility.
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)

To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 19 to 45 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2

Exclusion Criteria:

* Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy to Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds
* History of allergy or intolerance to metformin or other similar acting agents
* Prior exposure to saxagliptin
* Prior exposure to metformin within 3 months of study drug administration.
* Estimated creatinine clearance (Clcr) of \< 80ml/min using the Cockcroft Gault formula