cyrilzakka/clinical-trials huggingface dataset:
Angiotensin II Antagonist in Severe Sepsis

The investigators propose a clinical study of irbersartan for the early treatment of severe sepsis patients with elevated predicted risk of death between. This study will evaluate whether early administration of the the angiotensin receptor blocker irbersartan provides significant reduction of 28 days mortality and multi organ failure incidence to patients with severe sepsis.

Background: Angiotensin II (ANG II) is a potent vasoconstrictor and diminishes vasodilator responses in arteries. In addition to direct effects on vascular tone, ANG II affects multiple aspects of microvascular function through promotion of leukostasis, induction of capillary permeability and depletion of glutathione. Binding of ANG II to its receptors (in particular AT1) mediates intracellular free radical generation that contributes to tissue damage by promoting mitochondrial dysfunction.

Angiotensin receptor blockers (ARBs) interrupt renin-angiotensin system (RAS) overactivity by blocking a specific receptor that mediates the pathogenic activity of angiotensin II. Objectives: The clinical question objective of this study is if the antiinflammatory effect of ARBs is relevant in sepsis management and in particular if ARBs are able to improve survival and reduce the incidence of Multi Organ Failure in septic patients.

Methods:

STUDY DESIGN: Experimental; prospective, randomized, multicenter, phase III trial.

STUDY POPULATION: Three hundred adults within 12 hrs of recognition of severe sepsis, with Acute Physiology and Chronic Health Evaluation (APACHE) II-predicted risk of mortality between 20% and 80% are eligible.

Settings: 5 Italian Intensive Care Units. Oral irbesartan (total dose of 75 mg) or placebo administered every 24 hrs for 15 days. Analysis of data performed by a blind operator. Expected results: about 25% reduction in 28-day mortality rate and incidence of multi organ failure in the study population.

Eligibility Criteria:
Inclusion Criteria: adults within 12 hrs of recognition of severe sepsis, with Acute Physiology and Chronic Health Evaluation (APACHE) II-predicted risk of mortality between 20% and 80% are eligible.

Exclusion Criteria:Patients already treated with ACE inhibitors or ARBs will be excluded. Patients admitted in shock conditions (systolic blood pressure lower than 90 mmHg) will be excluded. Patients with severe renal failure (serum creatinine of 2.0 mg/dL or dialysis) will be excluded.
Systematic Review And Meta-Analysis Of Psoriasis Treatments.

This project involved a systematic literature review of published trials of treatments for moderate-to-severe plaque psoriasis. Data was extracted from the publications on various psoriasis endpoints including the Physician Global Assessment (PGA), Dermatology Life Quality Index (DLQI), and Short-Form 36 (SF-36). A traditional meta-analysis and a mixed treatment comparison was conducted on the extracted data.

This project involved a systematic literature review of published trials of treatments for moderate-to-severe plaque psoriasis. Data was extracted from the publications on various psoriasis endpoints including the Physician Global Assessment (PGA), Dermatology Life Quality Index (DLQI), and Short-Form 36 (SF-36). A traditional meta-analysis and a mixed treatment comparison was conducted on the extracted data. We included all published randomized controlled trials of treatments for moderate-to-severe psoriasis that met the study inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Randomized controlled clinical trials of treatments for moderate-to-severe plaque psoriasis.
* Trials had to evaluate at least one of the following: Physician's Global Assessment (PGA), Dermatology Life Quality Index (DLQI) and/or the Short-Form 36 (SF-36).

Exclusion Criteria:

Observational studies

* Trials that did not report the Physician's Global Assessment (PGA),
* Dermatology Life Quality Index (DLQI) or the Short-Form 36 (SF-36).
Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients

With mechanical thrombectomy now representing standard of care for treatment of acute ischemic stroke secondary to large vessel occlusion, identifying adjunctive techniques that result in improved outcomes for patients with LVO has become an issue of increasing importance. A number of retrospective studies have demonstrated that flow arrest during the clot retrieval process results in less clot fragmentation, lower rates of distal emboli, higher revascularization rates and improved rates of good neurological outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* A clinical diagnosis of acute stroke, with a deficit on the NIHSS of 2 points or more.
* Intracranial arterial occlusion of the distal intracranial carotid artery or middle (M1/M2) or anterior (A1/A2) cerebral artery, demonstrated with CTA, MRA, or DSA.
* Treatment can be initiated (groin puncture) within 6 hours of symptom onset.
* Planning to mechanical thrombectomy with a stenting retriever.
* Signed informed consent prior to entering study.

Exclusion Criteria:

* Moderate stenosis, severe stenosis, or occlusion of the ipsilateral extracranial carotid artery.
* Previously deployed stents in the ipsilateral carotid artery.
* Dissections of the ipsilateral carotid artery.
* Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0.
* Baseline platelet count \< 50.000/µL.
* Baseline blood glucose of \< 50mg/dL or \>400mg/dl.
* Severe, sustained hypertension (SBP \> 220 mm Hg or DBP \> 110 mm Hg).
* Renal insufficiency with creatinine ≥ 3 mg/dl.
* Patients in sedation and intubated patients could not be included if baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation.
* Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
* Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
* Subject participating in a study involving an investigational drug or device that would impact this study.
Transdermal Lidocaine for Pain Control During Hysterosalpingography

the study aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Hysterosalpingography

hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Eligibility Criteria:
Inclusion Criteria:

* any patient came for Hysterosalpingography

Exclusion Criteria:

* any patient has contraindication to Hysterosalpingography
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand.

The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).


Eligibility Criteria:
Inclusion Criteria:

1. Patient has signed an Informed Consent Form(ICF).
2. Patient Must not be pregnant or breastfeeding and agree to use birth control
3. Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant laboratory or physical examination findings;
4. Patient meets protocol-defined criteria for Irritable Bowel Syndrome with Constipation(IBS-C), including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria
5. Patient meets protocol-defined eDiary completion Compliance and agrees to refrain from making any new, major life-style changes that may affect IBS-C symptoms

Exclusion Criteria:

1. Recent history of mushy or watery stools
2. Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study
3. Patient currently has both unexplained and clinically significant alarm symptoms or systemic signs of infection or colitis.
4. Surgery to the gastrointestinal tract
5. Usage of prohibited medications
The Effect of Whole-body Vibration Training

The whole-body vibration programme employed in this study partly improved the biomarkers and health beliefs of the prefrail community-dwelling older adults.

The experimental group participated in a 12-week whole-body vibration training that conducted 3 times per week, with 5-min continuous vibration at 12-Hz frequency and 3-mm amplitude each time

Eligibility Criteria:
Inclusion Criteria:

* Age of 65 years or older and living in a community
* Full consciousness and able to communicate verbally
* No severe cognitive disorder

Exclusion Criteria:

* Impaired mobility after recent surgery
* Major illness such as cancer
* Severe hearing impairment and inability to fully understand and follow instructions
Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in Japanese

The primary objective of this study is to investigate the safety and tolerability of single and multiple oral doses of AZD7295 in healthy male Japanese subjects. This will be done by comparing the effect of AZD7295 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD7295 in the body.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent
* Healthy male Japanese volunteers aged 20-55 years
* BMI between 18 and 27 kg/m2
* Have negative screens for HIV, hepatitis B and C viruses and syphilis

Exclusion Criteria:

* Use of prescribed medication within 2 weeks prior to the dose of study medication
* Participation in another study that included drug treatment within 16 weeks before the start of the present study.
* History or presence of gastrointestinal, hepatic or renal disease or a condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
* History of severe food or drug allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged relevant by the investigator.
Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers

The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the pharmacokinetics of warfarin in healthy adults volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study specific evaluation is performed.
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m², inclusive.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has clinically significant out-of-range PT, INR, activated partial thromboplastin time, fibrinogen, protein C, or protein S.
* Subject has abnormal prolongation of skin bleeding time at Screening.
Exploring Unmet Needs and Attitudes to Skin Self-examination in Melanoma Survivors

This is a prospective, multi-centred cohort study whereby the EUNASS Study questionnaire will be administered electronically to identify needs of melanoma survivors, the extent to which these needs are being met, and identify areas which have the greatest need for development. It will also evaluate behaviour in relation to sun protection and skin self-examination (SSE). It will be a self-completed questionnaire.

Qualitative work using semi-structured interviews will explore the needs of melanoma survivors in greater depth, will present examples of potential interventions to improve SSE and explore factors that determine the likelihood of engaging in an intervention which can address unmet needs, such as improving SSE. Taken together, the data will provide the evidence base to inform the development of an intervention to improve SSE, which can subsequently be tested in secondary care services.


Eligibility Criteria:
Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the study.

* Male or Female, aged 18 years or above.
* Histological diagnosis of primary cutaneous invasive melanoma (any Breslow thickness) at 3 - 12 months from diagnosis (as most primary treatment will be complete by 3 mths)
* American Joint Cancer Committee Version 8 \[2018\] (AJCC V8) Stage I - III melanoma at time of recruitment
* Able to complete an electronic questionnaire

Exclusion Criteria:

* Other current active internal malignancy (i.e. does not include non-melanoma skin cancers)
* Inability to independently complete electronic questionnaire
* AJCC V8 Stage IV melanoma at time of recruitment
* Clinical stage of disease unknown / unconfirmed
A Lifestyle Intervention for Type 2 Diabetes Patients in Kuwait and Its Impact on Glycaemic Control

This was an unblinded, randomised controlled study, the purpose of which was to investigate the impact of a structured health education intervention on the glycaemic control of Type 2 diabetes patients within a Kuwaiti cultural context.

The control group continued to receive routine clinical advice, in addition to the individual session. The intervention group was enrolled in a structured group-based educational program for the duration of the study (12 months). Physical, physiological and biochemical outcome measures were assessed at baseline and then at a 12-month follow up. The total duration of the study, including the recruitment, the screening, the pilot study, the educational sessions and the follow-up, was 14 months altogether, from December 2014 to February 2016. The study consisted of the following three phases.

* Phase 1: included the initial recruiting of diabetes patients at an Al-Rehab polyclinic and the baseline assessment of their medical, dietary and physical activity history, in addition to the biochemical assessment.
* Phase 2 (pilot study): Five patients were chosen from the recruited patients for a pilot study to be monitored for one whole month (30 days) in order to evaluate the lifestyle intervention's safety, its compliance to the educational sessions, and anticipated barriers and results. Recruitment continued during the pilot study.
* Phase 3 (main study): This phase was based on recommending lifestyle intervention to the intervention group of diabetes patients. The educational sessions were scheduled every two weeks and a total of four sessions was provided. Both intervention and control groups were received individual sessions at the beginning and at the end of the study.

Later, there was a follow up of the intervention and the control groups at the end of the study, to measure the intervention's effectiveness and evaluate the results.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, treated with diabetes medications but not on insulin only, and who had other chronic diseases associated with diabetes, such as hypertension and hyperlipidaemia

Exclusion Criteria:

* History of major disabilities such as cardiovascular disease (CVD), an inability to walk, cancer, and Chronic Obstructive Pulmonary Diseases (COPD).
Efficacy of Erector Spinae Plane Block Versus Infraclavicular Subomohyoid Block in Shoulder Surgery

The study aimed to compare Erector Spinae Plane (ESP) block versus infraclavicular subomohyoid (ISO) block in the provision of efficacy of either technique in postoperative analgesia in shoulder surgery, aiming to testing the safety of each block in terms of incidence of complications. Patients will be randomly divided into two groups, Group E will receive Erector spinae block and group I will receive infraclavicular subomohyioid block. The local anesthetic solution that will be used in both blocks will be a total volume of 30 mls 0.25%bupivacaine plus 3mg preservative free Dexamethasone. The time between recovery from anesthesia and first pain experienced, as verified by NRS ≥ 3 and first need of a rescue analgesic, will be defined as the duration of analgesia. The total dose of intravenous morphine (the rescue analgesic) used over 24 h postoperatively will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, above 18 years old.
* ASA physical status I
* Scheduled for shoulder surgery

Exclusion Criteria:

* Morbid obese.
* Previous surgery in the same shoulder.
* History of psychiatric disorder.
* Pulmonary disease.
* Contraindication to regional nerve block (e.g. skin infection at the puncture site, coagulopathy).
* Allergy to any of medications that will be used
Risk Taking Behaviour in MSM and the Denial of Sexually Transmitted Diseases and HIV

Four focus groups , each of 10-15 males, ages 20-50 years old, MSM will be conducted by a medical sociologist. Two groups will be HIV negative participants and two groups of HIV positive MSM. Every group will meet for two hours. The focus group will be recorded and the collected data will be processed further for evaluation and extraction of the relevant information.

The volunteers will sign an inform consent prior to entrance to the study.

The questions that will be discussed during the focus groups: The first sexual contact with a male, what is risk, risk taking behavior, control over your daily life, self esteem and evaluation, risk denial.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-50
* MSM, willing to participate
* Agree to sign an inform consent

Exclusion Criteria:

* No exclusion criteria
Sustained Natural Apophysial Glide Versus Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Neck Pain

this study will be conducted to investigate the effect of sustained natural apophysial glide and Instrument assisted soft tissue mobilization on pain intensity, cervical range of motion and neck functional disability level in patients with chronic mechanical neck pain

Neck pain is a common musculoskeletal disorder in the era of technology. The International Association for the Study of Pain (IASP) has defined neck pain as:"Pain perceived as arising from anywhere with in the region bounded superiorly by superior nuchal line, inferior by an unoriginally transverse line through the tip of first thoracic spinous process, and laterally by saggital plane tangential to the lateral border of neck. Mulligan pioneered specific manual approach called mobilization with movement (MWM).The advance of this approach was aimed for application on the spinal joints. He claimed that his technique could improve the spinal range of motion (ROM) and decrease pain through the correction of a positional fault occurring between the surfaces of the involved facet joints. The most commonly used Mulligan technique is called "sustained natural apophyseal glides" or SNAGs, this technique has introduced in 1999 by Mulligan and is performed by applying an accessory glide along the axis of the facet joint of the affected level while the patient is doing an active movement from weight-bearing position. The pressure applied by the therapist in a cephalad direction over the spinous process (centrally) or the transverse process (unilaterally) or to the articular pillar of the affected vertebra.The IASTM therapy is designed to promote the restart of connective tissues by resorbing extra fibroses, encouraging collagen secondary to fibroblast recruited healing. In turn this leads to scar tissues, adhesions, and fascial limitations being released and broken down. M2t blade is a multifunctional instrument invented by Adam Bro ger that is reasonable in price and has many planes that can be used in treatment. Its efficiency in improving patients symptoms was proven through many studies. sixty patients with mechanical neck pain will be assigned randomly into three equal group; group A will receive mulligan plus traditional, group B will receive IASTM plus traditional and group C will receive traditional only

Eligibility Criteria:
Inclusion Criteria:

* Sixety patients of chronic mechanical neck pain diagnosed and reffered from physicians will be participants in the study .
* Patients of both genders will be included.
* The age of the participants will beranged from 20 and 55 years
* The BMI ranged between 18.9 and 25 kg/m2
* All patients who suffered from neck pain more than 3 months.

Exclusion Criteria:

* Malignancy
* cervical and cranial surgery
* Recent fractures
* spinal tumors
* severe disc herniation
* uncontrolled hypertension
* Heart Disease ( arrhythmia, pacemaker).
* Pregnant and breast feeding women.