cyrilzakka/clinical-trials huggingface dataset:
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.

Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac

Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris Disability Questionnaire (RMQ)

More than 2.5 million patients present to US emergency departments (ED) annually with low back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit. Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit for acute LBP, this clinical trial proposes to determine whether there is a difference in efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Men or women age 18-64.
* Present to ED primary for management of Low Back Pain (LBP)
* Functionally impairing back pain: A baseline score of greater than 5 on the Roland-Morris Disability Questionnaire
* Musculoskeletal etiology of low back.
* Non-radicular pain.
* Pain duration \<2 weeks (336 hours).
* Non-traumatic LBP
* Participant is to be discharged home.

Exclusion Criteria:

* Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.
* Not available for follow-up
* Pregnant
* Chronic pain syndrome
* Allergic to or intolerant of investigational medications
* Contra-indications to investigational medications
Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis

The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants aged between 18-75
* Histological evidence of NASH, based on biopsy, with a Nonalcoholic fatty liver disease Activity Score (NAS) of \>= 4 with at least 1 in each component of NAS
* Histological evidence of liver fibrosis defined as NASH Clinical Research Network (CRN) System Stage 1 to 3
* Meeting any of the 3 major criteria (a, b, c):

  1. Documented evidence of type 2 diabetes mellitus
  2. High body mass index (\> 25 kg/m\^2) with at least one of the following criteria of metabolic syndrome, as defined by the National Cholesterol Education Program:

     * Central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 35 inches (female)
     * Dyslipidemia: Triglycerides ≥ 1.7 mmol/L (150 mg/dL)
     * Dyslipidemia: High-density lipoprotein (HDL)-cholesterol \< 40 mg/dL (male), \< 50 mg/dL (female)
     * Blood pressure ≥ 130/85 mmHg (or currently being treated for hypertension)
     * Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dL)
  3. Bridging fibrosis (NASH CRN Stage 3) and/or definite NASH (NAS ≥ 5)
* Agree to have one liver biopsy at Screening, one at Year 1, and one at the end of study treatment (Year 2)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × upper limit of normal (ULN)

Exclusion Criteria:

* Hepatitis B surface Antigen (HBsAg) positive
* Hepatitis C antibody (HCVAb) positive with the following 2 exceptions:

  1. Participants previously treated for viral hepatitis C with at least a 1-year period since documented sustained virologic response at Week 12 (post-treatment) may be eligible if all other eligibility criteria are met
  2. Participants with presence of hepatitis C antibody but negative hepatitis C virus ribonucleic acid RNA without treatment (i.e., spontaneous clearance) may be eligible if all other eligibility criteria are met
* Prior or planned liver transplantation
* Other known causes of chronic liver disease, including alcoholic liver disease
* History of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
* Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is ½ pint of beer \[285 mL\], 1 glass of spirits \[25 mL\] or 1 glass of wine \[125 mL\])
* Human immunodeficiency virus (HIV)-1 or HIV-2 infection
* Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding)
* Females who are pregnant or breastfeeding
* Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing and protocol requirements.
Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers

This is a single center, randomized, controlled, within subject comparison, multiple dose study to determine the sensitization potential of M518101 on normal skin under occlusive patch condition.

During the Induction Phase of the study, the study drugs and controls will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.

Following induction, subjects will have a 10 to 14-day Rest phase, after which they will enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a naïve site on the opposite side of the back.

Eligibility Criteria:
Inclusion Criteria:

* Health male or female subjects are age 18 years or older
* Signed and dated Informed Consent Form obtained prior to any study related activities
* Subjects are free of any systemic or dermatologic disorder
* For female, females of non childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test
* Subjects must be able to communicate with the investigator and understand and comply with the requirement of the study and visit schedule

Exclusion Criteria:

* Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
* Have damaged skin in or around the test sites
* Have a history of sensitivity to adhesive tape
* Have a known sensitivity to constituents present in the material being evaluated
* Have a history of, or are currently being treated for skin cancer
* Have used any study drug and/or participate in any clinical study within 60 days prior to randomization
* To engage in any type of strenuous exercise
* Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study
* Are deemed to be ineligible by the investigator
"Clinical Characteristics, Comorbidities and Outcome of Critically Sick Patients With COVID-19

COVID-19, caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), is a multisystem disease which primarily involves the respiratory tract. The first case of COVID-19 was identified in late 2019 in the province of Wuhan, China which was followed by the rapid spread of the disease globally, becoming a present-day pandemic.

Objectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.

Objectives: The aim of this study was to describe the clinical characteristics, comorbidities and outcome of the critically sick patients with COVID-19 pneumonia admitted in ICU of a tertiary care hospital in Lahore.

Material \& Methods:

Study design: Retrospective study. Study Settings: Study was conducted in Fatima Memorial Hospital, Lahore. Study Duration: Study was conducted on Covid-19 patients who were admitted from March 2021 to August 2021.

Eligibility Criteria:
Inclusion Criteria:

* Critically sick patients with COVID-19 Pneumonia
* All admitted ICU patients with a diagnosis of COVID-19 pneumonia
* Patients having positive reverse transcriptase PCR for COVID-19
* Patients with High-resolution computed tomography (HRCT) chest findings suggestive of COVID-related lung injury
* All patients above 16 years of age with both genders( males and females)

Exclusion Criteria:

* All patients with PCR negative with mild symptoms
* Patients with No signs of COVID-19 pneumonia on HRCT chest
Mental Training for CFS Following EBV Infection in Adolescents

The general aim of this study is to investigate the effect of an individually tailored mental training program in adolescents developing chronic fatigue syndrome (CFS) after an acute Epstein Barr-virus (EBV) infection. Endpoints include physical activity (primary endpoint), symptoms (fatigue, pain, insomnia), cognitive function (executive functions) and markers of disease mechanisms (autonomic, endocrine, and immune responses).

EBV-infection is a well-known trigger of CFS. A closely related research project (Chronic fatigue following acute Epstein-Barr virus infection in Adolescents; ClinicalTrials ID:NCT02335437) is a combined prospective and cross-sectional study of 200 adolescents suffering from acute EBV infection. The primary aim of that study is to identify factors that predispose to CFS 6 months after the acute infection. Thus, that project will provide a sample of thoroughly characterized CFS patients, all having the same precipitation factor (EBV-infection).

The present project is an intervention trial in the subgroup of patients that actually did develop CFS 6 months after the acute EBV infection. Patients will be randomised 1:1 to either a mental training program (10 sessions) combining elements from cognitive behavioral therapy and music therapy, or routine follow-up from the general practitioner. By its nature, treatment group allocation cannot be blinded; however, both patients and therapists will be blinded for end-point evaluation. An extensive investigational program will be carried out at three time points: Prior to the intervention, immediately after the intervention, and 1 year after the intervention. The program includes: Clinical examination; Pain threshold assessment; Cardiovascular assessment; Cognitive assessment; Sampling of biological material (blood and urine); Questionnaire; Brain fMRI; Qualitative interview; Monitoring of physical activity (accelerometer)

Eligibility Criteria:
Inclusion Criteria:

* Participant in the research project CEBA (Chronic fatigue following acute Epstein-Barr virus infection in adolescents, NCT02335437)
* Chronic fatigue at 6 months (a sum score of dichotomized responses ≥ 4 on the Chalder Fatigue questionnaire)

Exclusion Criteria:

* Other illnesses that might explain the fatigue
* Bedridden
Effectiveness of Oscillation on Postoperative Pulmonary Complications After Elective Postcardiac Surgery

Our study aims to evaluate the effectiveness of continuous high-frequency oscillation therapy in reducing PPCs in patients following elective cardiac surgery. Through a prospective, multicenter, randomized controlled trial, we seek to establish evidence that could lead to improved postoperative pulmonary care and outcomes for cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or older) undergoing elective cardiac surgery will be included. Participants must provide informed consent upon ICU admission and have at least one risk factor for PPCs, including age ≥ 75 years, American Society of Anesthesiologists (ASA) score ≥ 2, history of chronic obstructive pulmonary disease (COPD) stage ≥ 2 or asthma (moderate to severe), current heavy smoking or heavy smoking history within the past 6 months, obstructive sleep apnea, frailty index \> 0.21 or body max index (BMI) ≥ 30 kg/m².

Exclusion Criteria:

* Patients will be excluded if they have contraindications for oscillation treatment (e.g., untreated tension pneumothorax); have pneumothorax or air leak syndrome at entry; require more than 2 μg/kg/min of norepinephrine; have been diagnosed with pneumonia within 2 weeks prior to surgery; have refractory arrhythmia at entry; have a left ventricular ejection fraction \< 35%; have mean pulmonary artery pressure (mPAP) \> 35 mmHg; are postoperative from spinal surgery within the past 2 weeks; require a ventricular assist device; have renal failure requiring continuous renal replacement therapy (CRRT) at entry; are planned for re-operation within 48 hours or have undergone organ transplantation.
Effect of Dental Pulp Stem Cells and L-PRF After Impacted Third Molar Extraction

The purpose of this study is to compare the clinical and radiographic effectiveness of Leukocyte-Platelet Rich Fibrin (L-PRF) and L-PRF combined with dental pulp stem cell (DPSC) application to the extraction socket of mandibular third molars.

Patients aged between 18 and 30 years, seeking for bilateral impacted LM3 extraction surgeries and meeting eligibility criteria were included to the study. At baseline right and left impacted third molars (LM3s) were randomly assigned to one of the treatment group (L-PRF and L-PRF + DPSC). Baseline and 6th month clinical and radiographic measurements were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 30 years
* Bilateral impacted LM3 extraction surgeries requirement

Exclusion Criteria:

* Having clinical signs or symptoms of abscess or cellulitis formation
* Having a history of radiotherapy
* Having any systemic diseases interfering with wound healing and/or smokers
* Patients who had been diagnosed as periodontitis
* Patients who had LM2s with caries or restorations that have an unidentifiable cementoenamel junction
SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer

The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;
2. No previous systemic anti-tumor treatment;
3. Subjects must have at least one measurable tumor lesion per RECIST 1.1;
4. ECOG: 0-1;
5. Adequate organ and bone marrow function;

Exclusion Criteria:

1. Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;
2. Prior therapy as follow:

   1. Anti-PD-1 or anti-PD-L1;
   2. Any experimental drugs within 4 weeks of the first dose of study medication;
   3. Received major operations or serious injuries within 4 weeks of the first dose of study medication;
   4. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
4. Subjects with any active autoimmune disease or history of autoimmune disease;
5. Pregnancy or breast feeding;
Pembro+Chemo in Brain Mets

The goal of this study is to evaluate whether providing Pembrolizumab prolongs survival and preserves quality of life while minimizing side effects for patients with NSCLC with untreated asymptomatic brain metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lunch cancer (NSLC) with untreated asymptomatic brain metastases
* NSLC lacks oncogenic driver mutations
* Absence of new onset neurological symptoms
* Presence of fewer than ten intracranial lesions
* Each lesion measures three centimeters or less
* Life expectancy of greater than three months
* Adequate organ and marrow function
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Presence of oncogenic driver mutations
* Measurable lesion located within 10mm of the optic chiasm or optic nerve, or within the brainstem
* Known leptomeningeal involvement.
* Midline shift
* Serious non-healing wound, ulcer or bone fracture
* Baseline inability to participate or complete neurocognitive testing
* Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within 14 days prior to registration
* Receipt of a non-CNS minor surgical procedure (e.g. core biopsy or fine needle aspiration) within three days prior to registration
* History of allergic reactions attributed to monoclonal antibodies (mAb), compounds of similar chemical or biologic composition to Pembrolizumab
* Clinically significant cardiovascular disease
* Patients with uncontrolled intercurrent illness
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
Vascular Effect of Estradiol Valerate Versus Placebo Evaluated by Flow-mediated Dilatation of Brachial Artery

The aim of this study is to evaluate the vascular effects of estradiol valerate on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

The interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. As a result, several side effects might appear and interfere with women's quality of life and health. The use of hormone replacement therapy has contributed to the improvement in these effects. It has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (HRT) in climacteric women, on the central retinal arteries. The objective of this study is to evaluate the effects of estradiol valerate on flow-mediated dilation of the brachial artery.

Eligibility Criteria:
Inclusion Criteria:

* Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH)\>30International Units / Liter
* Healthy women
* Women that were not using drugs with potential vascular effect within the last 1 year
* Women that never used hormone replacement therapy

Exclusion Criteria:

* Smoking
* Blood Pressure \> 160/90 mm Hg.
* Breast and or endometrial cancer
* History of acute myocardial infarction
* Diabetes
* Vaginal bleeding of any origin
* Hepatic disease
* thrombophlebitis or thromboembolic disorders
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections

The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.

The trial was explained to potential subjects, the informed consent was completed and and eligibility was verified. After this, the subjects were randomized to Irrisept or SoC and an open abdominal laparotomy with primary closure due to (1) blunt or penetrating abdominal trauma or (2) acute surgical abdomen was performed. The follow-up visit was performed approximately 30 days later.

Eligibility Criteria:
Inclusion Criteria:

1. Is male or female, 18 years of age or older
2. Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR)
3. Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or
4. Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure

Exclusion Criteria:

1. Known allergy to Chlorhexidine Gluconate (CHG)
2. Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients
3. American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater (As ASA scoring is a subjective measure, if the PI finds the patient stable enough for study participation despite a score of 5, enrollment may continue.)
4. Female volunteers who are pregnant and/or breast feeding
5. Damage control laparotomy
6. Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta)
7. Currently enrolled in an ongoing, interventional, randomized clinical trial
The Relationship Between Autobiographical Memory and Motivation

People with a diagnosis of psychosis often experience low motivation and pleasure when thinking about doing future activities. This leads, quite understandably, to doing fewer activities they used to enjoy and not taking up opportunities to do new activities. One model suggests that this may be partly due to difficulties using memories of previous events to help boost motivation and anticipation before a future activity. Research shows that people with psychosis may recall previous events in less detail. These memories therefore may not be as helpful as they could be for motivation. This study will investigate this by asking people with experience of psychosis and low motivation who are seen by a care team in South London and Maudsley NHS Trust to attend two research sessions. In the first session they will be asked to recall memories of events from their lives and the researcher will assess how detailed they are and how much they refer to the past and future. Alongside this task people will also be asked to complete measures of symptoms such as low pleasure and motivation as well as a measure of depression. These will be used to find out if the detail and specificity of the memories are related to these symptoms in people with psychosis. The second half of the study will then investigate whether additional prompts to support positive memory retrieval can increase the specificity of this and subsequently improve mood, motivation and self-belief. Participants will be randomised to one of two groups. The clinical group will be guided through their memory recall using prompts and a control group will be asked to recall positive memories without prompts. If we show that supporting memory recall is beneficial then memories for past events may be an important target for future therapies.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of non-affective psychosis (as determined by medical records).
* Above 18yrs old.
* A score of at least 18 on the Clinical Assessment Interview for Negative Symptoms.
* A sufficient command of the English language to engage with the research materials

Exclusion Criteria:

* Lack of capacity to provide informed consent.
* Primary diagnosis of intellectual disability, head injury, substance misuse or known organic cause of psychosis