cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Nerve Stimulation for Post-operative Acute and Chronic Pain

Aim of the study to assess the efficacy of two modes of transcutaneous electrical nerve stimulation (TENS) on relief of postoperative acute pain after hip fracture surgery.

The patients underwent undergo fractured hip surgery will be distributed into three groups with respect to the mode of postoperative analgesia applied: Group I (control): PCA only; group II: PCA plus lumbar plexus \& sciatic nerve TENS (LS-TENS); group III: PCA plus surgical wound TENS (SW-TENS). TENS will be applied every 2 hours for 30-40 minutes during 48 hours postoperatively. Visual analogue score (VAS), Ramsey sedation scores, frequencies of PCA demand and counts of PCA delivery, as well as total analgesic consumption will be noted and compared between groups at various time intervals.

Visual analog scale (VAS) will be applied at 2 months postoperatively VAS and Mcgill pain questionnaire will be applied at the 6th and 24th months of the surgery to assess acute and chronic pain in the study population and the differences among groups.

Eligibility Criteria:
Inclusion Criteria: Adult patients will be scheduled for surgery due to hip fracture in Mustafa Kemal University Hospital will be included in the study.

Exclusion Criteria: Patients with a history of opioid analgesic abuse, or sensitivity to opioids, and those with clinically significant systemic (cardiovascular, pulmonary, hepatic, renal, neurologic etc.) diseases, will be excluded.
Efficacy and Safety of Pimecrolimus Cream 1% in Patients ≥ 3 Months of Age With Mild or Moderate Atopic Dermatitis

To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients \> 3 months of age with mild to moderate atopic dermatitis)

This study is not enrolling patients in the United States.


Eligibility Criteria:
The patient population must consist of male or female outpatients, age ≥3 months old with mild to moderate atopic dermatitis (IGA ≥ 1). Exclusion criteria are pregnancy, having active viral infections at the site(s) of treatment, presenting with systemic malignancy or active lymphoproliferative diseases/disorders, receiving phototherapy or immunosuppressive therapy, having used tacrolimus ointment and known allergy or hypersensitivity.
Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases

The investigators hypothesize that avoidance of the hippocampal region with WBRT (Whole-Brain Radiotherapy ) may delay or reduce the onset, frequency, and/or severity of NCF (neurocognitive function) decline, as measured with clinical neurocognitive tools.

We propose to use conformal avoidance of the hippocampal region during whole brain radiotherapy to reduce the dose to the hippocampi, thereby putatively limiting the radiation-induced inflammation of the hippocampal region and subsequent alteration of the microenvironment of the neural progenitor cells

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy.. Direct biopsy of CNS (central nervous system) lesions is not necessarily required although could constitute an allowed site of tissue confirmation as medically prudent. Patients who have been disease free for more than 5 years prior to the appearance of CNS metastases should undergo repeat biopsy of either a systemic metastasis or the CNS metastases to confirm the recurrent malignancy.
2. Patients with measurable brain metastasis outside a 5-mm margin around either hippocampus
3. Patients with measurable brain metastasis who have not been or will not be treated with SRS (stereotactic radiosurgery ) or surgical resection (Note: These treatment options are only permitted at relapse)
4. History/physical examination within 28 days prior to registration
5. Patients must fall into RTOG (Radiation Therapy Oncology Group) recursive partitioning analysis (RPA) class I or II
6. Patients must have a life expectancy of at least 4 months.
7. Age ≥ 18 years
8. Karnofsky performance status ≥ 70
9. Patients must provide study-specific informed consent prior to study entry
10. Women of childbearing potential and male participants must practice adequate contraception
11. Women of childbearing potential must have a negative, qualitative serum pregnancy test ≤2 weeks prior to study entry

Exclusion Criteria:

1. Patients with greater than 9 discrete metastases on MRI.
2. Patients with leptomeningeal metastases
3. Patients with measurable brain metastasis not resulting from small cell lung cancer and germ cell malignancy
4. Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days
5. Contraindication to MR (Magnetic resonance) imaging such as implanted metal devices or foreign bodies, severe claustrophobia AND patients unable to receive gadolinium contrast agents
6. Serum creatinine \> 1.4 mg/dl ≤ 28 days prior to study entry
7. Prior radiation therapy to the brain
8. Patients planning to undergo radiosurgery to any CNS lesion OR patients planning to have surgical resection of ALL of their CNS lesions
Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia

Fibrous dysplasia is a rare bone disease which can cause pain and fractures. It has been shown that periostin is over expressed in fibrous component in patients bones ; but periostin has never been measured out in serum of patients, although it is easy to assess. This study aims to show whether serum periostin is elevated in serum of patients with fibrous dysplasia, and if it is more elevated in patients with severe forms of the disease.


Eligibility Criteria:
Inclusion Criteria:

* patients with fibrous dysplasia of the bone
* access to social security
* informed consent

Exclusion Criteria:

* no informed consent
* pregnancy
* patients with a history of conditions known to increase periostin serum (stade IV cancer, severe asthma, pulmonary fibrosis...)
PERFECTED WP2: Implementing Optimised Hospital Care

This study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR) funded research programme.

PERFECTED's aim is to develop and pilot an evidence-based intervention to improve the hospital care of patients living with dementia who have fractured their hip. This protocol relates to Work Package 2 (WP2) of PERFECTED only.

By working collaboratively with local clinicians and stakeholders, an action research (plan-do-study-act) approach will be used to generate knowledge to understand how to best implement the intervention (PERFECTED Enhanced Recovery Pathway), which was developed from learning and research undertaken as part of Work Package 1. During the current study the PERFECTED Enhanced Recovery Pathway (ERP) will be used to optimise care on three ortho-geriatric wards for 12 months. These wards are located in Norfolk, Nottinghamshire and Yorkshire. The sole participants are NHS personnel delivering care on selected wards.

Data collection activities (observations, in-field interviews, documentary analysis and quantitative data generated from the PERFECTED ERP implementation checklist) will determine the staff training and cultural changes required to implement and maximise adherence to the PERFECTED ERP. Simultaneously, enabling the identification and exploration of areas of optimised, satisfactory and sub-optimal care. By working in partnership within and across the partner wards, action plans to address sub-optimal care will be generated, implemented and reviewed. Findings will inform the best ways to optimise care via the implementation of the PERFECTED ERP. Knowledge generated during this study will be used to develop an ERP and staff training manual. This will aid implementation of the intervention arm of a latter Cluster Randomised Control Trial (Work Package 3), ensuring the PERFECTED ERP can be utilised in the real world.

As part of PERFECTED's commitment to Public Patient Involvement (PPI), lay researchers will be trained to assist with qualitative research activities.


Eligibility Criteria:
Inclusion Criteria:

* NHS employee or student nurse
* Involved in the delivery of care to patients on partner wards in which the PERFECTED ERP is being implemented

Exclusion Criteria:

\* None
Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease

The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex over 40 years with the symptoms of a chronic obstructive airways disease
* Only patients which have not been treated with Berodual® within the last year should be included

Exclusion Criteria:

* Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berodual® metered-dose inhaler
A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.

Study population: Patients attending the Out Patient Department and admitted to Institute of Liver and Biliary Sciences.

Study design: Prospective randomized controlled trial Study period: One year- January 2017- December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be given Fecal Microbiota Transplantation through a NJ tube placed after admission to the hospital. Participants will be administered the processed fecal microbiota sample collected from a related or unrelated healthy donor for a period of 7 days.

Monitoring and assessment:

The recipient will be monitored every day after Fecal Microbiota Transplantation therapy.

The recipient will undergo physical examination, complete blood counts, at baseline and a chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day 0,4,7,14,28,90,180,270 and 365 from the start of therapy.

Microbiota analysis of the donors will be done at baseline and the recipients will be done on day 0,7,28,90 \& 180.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe alcoholic hepatitis .
* Eligible for steroid therapy.

Exclusion Criteria:

* Upper gastrointestinal bleed within the past one month.
* Active sepsis
* Serum creatinine \> 1.5 mg/dl (Hepato renal syndrome)
* Intestinal paralysis
* Hepatic or extrahepatic malignancy
* Disseminated intravascular coagulation
* Discriminant Function (DF) \>90
Bioequivalence Trial of Alprazolam 0.25 mg Tablets

The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent.

Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg (Pharmacia \& Upjohn). One tablet was the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 28 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

* Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
* Healthy, between 18 and 50 years.
* Body Mass Index between 18 and 27.5
* In good health by complete medical history and laboratory tests.
* Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.
* Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram

Exclusion Criteria:

* Alteration of vital signs
* Not complying with inclusion criteria
* History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.
* Requirement of any kind of medication during the course of the study, except study medication.
* History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer.
* Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.
* Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.
* Hospitalization for any cause in the seven months before the beginning of the study.
* Administration of investigational drugs in the 60 days before the study.
* Allergy to any medication, food, or substance.
* Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.
* Blood donation or loss =\> 450 ml in the 60 days before the beginning of the study.
* History of drug or alcohol abuse.
* Special diet requirement, for instance vegetarian diet.
* Inability to understand nature, aims, and possible consequences of the study.
* Non-cooperative attitude during the study.
* Positive anti-doping or pregnancy test.
* Breast-feeding.
* Females on hormonal treatment.
Regulatory Mechanism of Orphanin FQ in Patients With Chronic Ischemic Heart Failure

β 1 adrenergic autoantibody on cardiomyocytes β 1 adrenergic receptor increased the occurrence of malignant arrhythmia in patients with chronic heart failure, accelerated myocardial cell damage, and participated in sudden cardiac death. Our team found for the first time that endogenous orphanin enkephalin promotes arrhythmia after acute myocardial ischemia in rats, and its mechanism includes PKC pathway, regulation of action potential duration and cell membrane surface β 1 adrenoceptor internalization disorder. At the same time, N / OFQ can regulate the level of immune factors, and immune factors participate in the formation of β1-aa. This study will be verified by clinical observation and animal experiments: first, N / OFQ, IL-6 and chronic ischemic heart failure, and β 1-aa; second, relationship between IL-6 gene 572G / C polymorphism and chronic ischemic heart failure correlation of β 1-aa production; last, objective to verify whether N / OFQ is involved in the regulation of IL-6 on chronic ischemic heart failure by knocking out N/ OFQ gene in the animal model of chronic ischemic heart failure. So as to clarify the mechanism of myocardial cell and extracellular injury, and find a new target for the treatment of chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure patients with reduced ejection fraction due to ischemic heart disease.

Exclusion Criteria:

* Restrictive or hypertrophic cardiomyopathy, hypertensive cardiomyopathy, acute myocarditis, acute coronary syndrome or acute myocardial infarction in the last 2 months, valvular disease (except mitral regurgitation secondary to left ventricular dilation).
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.

Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Age ≥12 and ≤75 years old;
3. Weight ≥40kg at the time of screening
4. Patients diagnosed with HoFH
5. Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening
6. Fasting triglycerides ≤4.5 mmol/L;

Exclusion Criteria:

1. History of NYHA class III-IV heart failure or EF\<30%
2. History of uncontrolled arrhythmia within 3 months
3. History of MI,UA, PCI or CABG, stroke within 3 months.
4. History of DVT or pulmonary embolism within 3 months.
5. Planned cardiac surgery or revascularization.
6. Uncontrolled hypertension.
7. Uncontrolled diabetes mellitius (HbA1c\>8.0%）.
8. Other conditions that the researchers considered inappropriate to participate in the study.
Comparing Two Different Surgical Techniques for Breast Reconstruction

The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander under the pectoralis muscle.

The standard approach used at MSK is the subpectoral technique. This study will help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach. To decide which approach is better, the researchers will look at which technique causes fewer complications after surgery (for example, infection or the need for a second surgery). Researchers are also interested in seeing which approach causes less pain and use of pain medication after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 21-60 years
* Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage.
* Planning to undergo unilateral or bilateral mastectomy.
* Planning to undergo nipple- or skin-sparing mastectomy.
* Mastectomy weight less than 800 grams.
* Adequate mastectomy skin perfusion or patients with adequate perfusion but nonviable mastectomy skin that can be excised (≤ 4 cm) at the defect margins with otherwise adequate perfusion.

Exclusion Criteria:

* Receipt of neoadjuvant chemotherapy for locally advanced breast cancer.
* Presence of preoperative axillary lymph node metastasis.
* Presence of intraoperative sentinel node positivity.
* History of radiotherapy.
* Current smoker.
* Planning to undergo direct-to-implant reconstruction.
* BMI \>35.
* Prior sternotomy.
Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23)

The purpose of this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and of the Access anti-HAV IgM assay as an aid in the laboratory diagnosis of acute or recent HAV infection, on the DxI 9000 Access Immunoassay Analyzer.

This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays.

The objective of this study is to determine the diagnostic accuracy of Access anti-HAV and Access anti-HAV IgM assays on the DxI 9000 Access Immunoassay Analyzer, measured as clinical sensitivity and specificity.

The testing will be performed using banked, de-identified, prospective and retrospective US leftover clinical samples, and fully-anonymized retrospective known anti-HAV IgM positive patient samples procured from sample vendors.

Eligibility Criteria:
Inclusion Criteria:

Subject inclusion criteria for the signs and symptoms (S/S), at risk (A/R), HAV test ordered, and Acute HAV Infection cohorts:

* Subjects ≥ 2 years of age
* Subject or legal guardian has signed the Informed Consent Form (ICF) (a minor may need to sign an Assent Form (AF) if required by IRB)
* Subjects who are willing to donate the required amount of blood
* Subjects qualified for one (1) or more of the following four (4) Cohorts:

  * Signs and symptoms (S/S);
  * At risk (A/R);
  * Presumed S/S or A/R (HAV test ordered) and
  * Acute HAV Infection (known anti-HAV IgM positive samples) - these samples are not subject to the individual informed consent and volume criteria.

Subject inclusion criteria for the vaccination cohort

* Subjects 2 years of age or older
* Subjects able to understand and willing to sign the ICF at both pre and post vaccination time points. Subject or legal guardian has signed the Informed Consent Form (a minor may need to sign an assent form if required by IRB)
* Subjects who are willing to donate the required amount of blood: 30 mL
* Subjects with no signs or symptoms of hepatitis as determined by a medical provider, no history of known exposure to HAV
* Subjects previously unvaccinated for HAV

Exclusion Criteria:

* Subjects who previously participated in the study
* Subjects who have received experimental or investigational drugs or treatments within four weeks of phlebotomy

Note for vaccination study: Subjects were screened for anti-HAV prior to vaccination, if positive they were excluded from the study.
Factors Associated With Failure of HFNO in COVID-19 ICU Patients

To determine the factors associated with OHD failure in COVID-19 patients admitted to an Intensive Care Unit

Patients admitted into 1 participating ICU for acute hypoxemic respiratory failure due to COVID-19 between 02/01/2020 and 06/01/2022 will be assessed for OHD failure

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in ICU for COVID-19 pneumonia

Exclusion Criteria:

* under immediate ECMO
* secondary transferred from another ICU
* readmission in the ICU
* initial limitation of care
Urdu Version of the Dynamic Gait Index: Reliability and Validity Study

In this study, Investigators will observe the reliability and validity of dynamic gait index in Urdu language in Pakistani geriatric population with balance impairments.

The aim of study is to translate and culturally adapt DGI into Urdu language and secondly to investigate the reliability and validity of DGI in geriatrics Pakistani population.This study will be cross sectional survey in which convenience sampling technique will be used to enroll participants as per pre-defined criteria.

The results of study will help to know the validity and reliability of DGI in Urdu version with balance impairments in geriatric population.The reliability of the scale will be checked through internal consistency and test-retest methods. Internal consistency will be analyzed with Cronbach's alpha value.Test-retest reliability will be assessed using an intraclass correlation coefficient with 60 patients

Eligibility Criteria:
Inclusion Criteria:

* Age at least 65 years
* Ability to walk a minimum of 6m with or without a walking Aid
* One or more falls in the last year or
* Observed balance impairment evaluated subjectively by a physical therapist during the initial training session (Time Up and Go test, Morse Fall Scale)

Exclusion Criteria:

* Inability to understand or follow the instructions of the DGI
* Experience with the DGI in the last 6 months
* Acute illness or fracture in the lower extremities or knee/hip replacement within the last 3 months.