cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus

Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD).

Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli pharmaceutical company developed a topical cream based on active plant extracts for treatment of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled, randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort of CKD and ESRD patients.


Eligibility Criteria:
Inclusion Criteria:

1. History of pruritus of \>8 weeks duration.
2. Severity score of pruritus ≥5 as defined by VAS
3. Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study (including Calmmax cream)
4. Negative pregnancy test result for all participating women of childbearing age;

Exclusion Criteria:

1. Known allergy to Calmmax cream
2. Any acute illness
3. Liver cirrhosis
4. Active dermatological disorder other than UP
5. Decompensated heart failure
6. Inability to give informed consent
7. Known poor adherence to medical recommendations
Patient Characteristics and Treatment Patterns From Early Crizanlizumab Use in Real-world Setting: Preliminary Analysis From Select Sickle Cell Centers

This was a retrospective cohort study using secondary data from member sites of the National Alliance of Sickle Cell Centers (NASCC) with at least five patients who initiated crizanlizumab. Patients who were prescribed crizanlizumab were included in the cohort.


Eligibility Criteria:
Inclusion criteria:

* Any patient with diagnosis of SCD based on high-performance liquid chromatography (HPLC) or hemoglobin electrophoresis at treating institution
* Treatment order for crizanlizumab; Index date was defined as the date for the first crizanlizumab treatment
* At least 12 months of available electronic medical record (EMR) data pre-index date (baseline)
* Patients must have received at least one dose of crizanlizumab
* For inclusion in pre/post analysis of effectiveness, patients must have received at least 6 doses of medication. The rates could be annualized if total post-index time was \<12 months.

Exclusion criteria:

None specified
Heart Failure After Heart Transplantation Due to Chronic Rejection

This study will investigate the prevalence of allograft vasculopathy and unexplained graft dysfunction during long-term follow-up after heart transplantation. Risk factors as well diagnostic approaches will be investigated.

During long-term follow-up heart transplant recipients are at risk of developing different complications that are likely to affect quality of life and survival. The most common cause of death during the later stages after heart transplantation is cardiac allograft vasculopathy, followed by unexplained graft dysfunction. In this study, advanced imaging techniques will be used to describe the frequency of these two complications, examine possible risk factors and study consequences on functional capacity and quality of life. Further, the investigators will investigate whether it is feasible to screen for these conditions with non-invasive imaging methods. By studying patients that have performed cardiac transplantation between 10 and 20 years ago, the investigators expect to have a significant proportion of patients with these pathological conditions. Methods that will be used include cardiac magnetic resonance imaging, coronary flow velocity reserve assessment, right heart catheterization and coronary imaging with angiography and optical coherence tomography.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplant performed more than 10 years and less than 21 years ago
* Scheduled yearly post-transplant control
* Signed informed consent

Exclusion Criteria:

* Estimated GFR \< 30 mL/min/1,73m2
* Radiographic contrast allergy
* Severe asthma or COLD with FEV1 \< 50%
* Second or third degree AV block
* Pregnancy
* In the Investigator's opinion, the patient has a clinically significant disease that could be adversely affected by study participation
Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure

The investigators test the hypothesis that different beta-blockers had a different influence on chemoreceptor response and lung diffusion capacity.

Both could influence exercise capacity in normoxic as well as hypoxic conditions.


Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure patients in stable clinical condition

Exclusion Criteria:

* No comorbidity
* NYHA class IV
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy

Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation.

It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult with an established cardiac allograft vasculopathy defined as any new luminal irregularity on coronary angiography.
* Patient must be on statins at study entry.
* Patient who is more than 12 months post-transplant.

Exclusion Criteria:

* Patient with a serum creatinine value \>2.0 mg/dL.
* Patient with a biopsy-proven acute rejection episode (\>= ISHLT 3A) within 6 months prior to study entry.
* Patient who had received any investigational drug within 4 weeks prior to study entry.
Diagnosing Drug Allergy: the T is the Key

The goal of this clinical trial is to validate a newly developed test in the diagnosis of patients with amoxicillin allergy (i.e. T-cell activation test). The main questions the study aims to assess are the reliability and applicability of this test. Participants will be asked to visit the hospital 1, 3 or 5 times during which blood is collected and when applicable, allergy skin testing is performed.

Drug allergy is a significant health issue with a serious medical and financial burden of mis- and overdiagnosis. Currently applied tests differ for immediate and nonimmediate drug allergy and have variable sensitivity and specificity. Therefore, correct diagnosis remains difficult and frequently requires potentially dangerous and time-consuming challenge tests. Drug-specific T-cells play a central role in initiation and maintenance of both immediate and nonimmediate drug allergy and can be studied in the lymphocyte transformation test (LTT). However, technical difficulties have hindered entrance of the LTT in mainstream use. The investigators' data indicates that flow-based intracellular trapping and staining of markers induced during activation (such as CD154 and cytokines) enables a rapid enumeration of rare drug-specific T-cells in the blood of patients with immediate and nonimmediate amoxicillin allergy. The ambition of this project is to validate a "one fits all" assay that meets the requirements of a safe, patient friendly, accessible, and performant test that could merits the status of a primary investigation in the diagnostic algorithms. Moreover, as the tests is cost effective, it could also become an attractive method for broader applications such as the delabelling of spurious allergies. This project will focus on allergy to amoxicillin.

Eligibility Criteria:
Inclusion Criteria:

Participants are eligible if they:

* Are ≥ 6 years
* Are capable of informed consent, or if appropriate, participants have an acceptable individual capable of giving consent on the participant's behalf (e.g. parent or guardian of a child under 18 years of age)
* Have a suspected history of amoxicillin allergy

Exclusion Criteria:

* Patients who are lacking capacity or do not have an acceptable individual capable to provide informed consent
* Pregnant women
* Breastfeeding women
Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2)

The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress.

In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the emergency for respiratory disease justifying an oxygen administration to maintain a SpO2 ≥ 92%.
* inclusion within a time less than 24 hours after the start of the oxygen at the emergency department.
* written consent of the parents of the child

Exclusion Criteria:

* Necessity of an oxygen flow exceeds 4 L / min to maintain a SpO2 higher than 92%
* Criteria of gravity justifying immediately a different technique of ventilatory support:

  * Disturbance of consciousness with a Glasgow Coma Score ≤ 12
  * Hemodynamic instability (MBP \< - 2 DS or need for vasopressors)
  * Cardiac or respiratory arrest
  * pH \< 7.35 and PaCO2 \> 55 mm Hg
  * Necessity of a urgent surgery
  * Age \< 1 month
  * Respiratory rate \> 80 b/min (1 month-2 years old), \> 40 b/min (2 - 10 years old) \> 30b/min (\> 10 years old) ou \< 10 b/min
The Use of Near Infrared Spectroscopy (NIRS) to Estimate Intracranial Pressure (ICP)

The aim of this study is to determine whether we can predict the intracranial pressure using near infra-red spectroscopy

The management of intracranial hypertension requires the presence of an intracranial pressure monitor. We are investigating whether the waveforms obtained from a near infrared spectroscopy device can predict what the intracranial pressure is non-invasively.

* Patients with intracranial hypertension who are intubated and ventilated in the ICU will be recruited
* we will record there intracranial pressure and systemic arterial pressure
* recordings from the near infrared device will be recorded and analysed off-line
* we will correlate the waveform tracings from near infrared spectroscopy and the arterial tracing

Eligibility Criteria:
Inclusion Criteria:

Patients with an intracranial pressure monitor and arterial catheter who are admitted to the ICU

Exclusion Criteria:

Less than 18 years
TMS for CRPS - Pilot Study

The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS) may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS in a small pilot study to investigate what methods may have clinical potential. This is a small pilot study to determine feasibility and signal to potentially inform future trials.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Diagnosis of CRPS (complex regional pain syndrome)
3. Average pain level reported on Numerical Rating Scale meets entry criteria
4. Ability to perform the experimental task and procedures.

Exclusion Criteria:

1. MRI contraindication (metal implants or devices, claustrophobia)
2. TMS Contraindication (eg metal implant or devices near the site of stimulation)
3. History of epilepsy
4. History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
5. Neurologic illness that would interfere with brain integrity
6. Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
7. Currently pregnant or planning to become pregnant.
8. On going legal action or disability claim.
Intravenous Lignocaine vs Placebo

To assess the mean hemodynamic responses post-intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing laryngoscopy surgery

After identifying the candidate, details will be carefully discussed with the subject. The subject (or, when necessary, the parent or legal guardian if the subject is younger than 18 years of age or under guardianship) will be read the approved protocol consent form. Patients who have given informed consent to participate in the study will be randomized into one of the two study arms one day before the procedure. The study team present will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol.

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II
* Age 20-60 years
* Mallampatti , II
* All surgeries are done under GA
* Both genders
* Those patients giving informed consent

Exclusion Criteria:

* Difficult airway assessed during pre-op anaesthesia assessment
* Unanticipated difficult airway based on the previous history of difficult intubation
* BMI \>30,
* Micrognathia and microglossia based on pre-op anaesthesia assessment,
* Diabetic patient with autonomic dysfunction liver disease, cardiovascular disease, pheochromocytoma, Cushing syndrome
* Patients who do not give informed consent
Kudzu Treatment for Alcohol Abuse

This is a study designed to test whether a single administration of kudzu extract (2 mg) will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as pretreatment 2 ½ hours before the drinking session.

In a laboratory experimental setting, subjects will be treated with placebo or 2 grams of kudzu extract 2.5 hours before an afternoon drinking session. The investigators hypothesis is that the kudzu pretreatment will reduce alcohol consumption in this free choice, self-administration paradigm.

Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding and complying with the protocol
* Good physical and mental health (normal physical exam, ECG, blood and urine chemistries)
* Body Mass Index between 18-30, inclusive
* Age 21-40 years
* Moderate to heavy alcohol drinkers (on the average 20+ drinks/week) or a self-reported pattern of incidences of binge drinking 2 or more times per week (4 or more alcoholic beverages in one sitting)
* Have a stable living situation with current postal address

Exclusion Criteria:

* Concurrent diagnosis of Axis I disorder
* Current or past alcohol dependence; may meet criteria for alcohol abuse. Other drug dependence acceptable only if greater than 3 years.
* Immediate family history pattern of alcoholism or problem drinking (parents or siblings)
* Current drug abuse (other than alcohol or marijuana abuse). Past drug abuse is acceptable.
* Subjects cannot be actively seeking treatment for any drug or alcohol dependence.
* Subjects cannot use marijuana more than once a week. Marijuana abuse/dependence are acceptable if the use criteria is met.
* Maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions.
* Tobacco use greater than 5 cigarettes per day
* History of major head trauma resulting in cognitive impairment or history of seizure disorder
* Heavy caffeine use (greater than 500 mg on a regular, daily basis)
* Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 3x the upper limit of normal
* For female volunteers, a positive pregnancy test
Evaluation Of Serum MIF Level in SLE Patients

Systemic lupus erythematosis (SLE) is a chronic autoimmune disease characterized by production of autoantibodies and the deposition of immune complexes, affecting a wide range of organs. The clinical onset of SLE derives from the interaction between genetic predisposition and environmental, immunological and hormonal factors, with a strong predilection for women of childbearing age.

SLE is usually diagnosed in young women in the third decade of life and represents the leading cause of systemic disease with secondary kidney involvement. Lupus nephritis (LN) occurs in \~50% of patients with SLE and is the most common, but not the only, cause of kidney injury in SLE. LN typically develops early in the disease course, generally within the first 6 to 36 months, and may be present at initial diagnosis.

Macrophage migration inhibitory factor (MIF) is a pleiotropic inflammatory cytokine with regulatory roles in innate and adaptive immunity and is implicated in the pathogenesis of autoimmune diseases including SLE.

MIF actively participates in multiple stages of the inflammatory response, acting on cells directly and/or potentiating the effects exerted by other stimuli. MIF overcomes the inhibitory effects of glucocorticoids on TNF alpha, IL-1 beta, IL-6, and IL-8 production.

MIF is implicated in the pathogenesis of other autoimmune diseases including rheumatoid arthritis (RA), type 1 diabetes, multiple sclerosis and Guillain Barré syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Adult SLE patients \>18 years
* fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

Exclusion Criteria:

* Patients with overlap syndrome, pregnancy, active infection, diseases other than SLE that might produce abnormal proteinuria.
* Individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, scleroderma, mixed connective tissue disease).
Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes

There are currently two sensorimotor replacement products which may be of benefit in smoking cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the purpose of this project is to investigate whether these replacements can help to alleviate tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be separated into two studies, following the same design and procedures.

Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy of a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool (e.g. stress ball) which provides no smoking-related cues.

Study 2 will investigate whether sensorimotor replacements which are more proximal to smoking (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a replacement which only delivers some of the conditioned sensorimotor cues (i.e. ECs).

The investigators hypothesise that the EC will be more effective at reducing withdrawal symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the Denic will be more effective than the EC.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or over
* Smokes at least 10 cigarettes per day
* Smokes first cigarette within 1 hour of waking

Exclusion Criteria:

* pregnant or breastfeeding
* acute psychiatric illness
* currently enrolled in other research projects
* current use of ECs or Denics
Evaluation of Functional and Biomechanical Outcome by Shear-wave Elastography in the Short to Intermediate Follow-up After Arthroscopic Rotator Cuff Repair

This exploratory project will evaluate the biomechanical and functional intermediate-term outcome (2 to 5 years) after arthroscopic rotator cuff repair (ARCR) with modern non-invasive ultrasound techniques (especially shear wave elastography (SWE)), standardized physical examinations and patient-reported outcomes. It is to evaluate the biomechanical properties of tendons and muscles of the rotator cuff, as well as the biceps muscle after ARCR and to compare elasticity and structural properties to the healthy contralateral side.

Arthroscopic repair of rotator cuff tears is commonly performed. However, recurrent tears after arthroscopic rotator cuff repair (ARCR) remain a significant clinical problem, especially in cases with large tears. Depending on literature, reported retear rates can range between 13% to 69%. Most likely, these tears reflect mechanical failure of the repair construct.

Ultrasound elastography is a recent technology and especially shear wave elastography (SWE) has experienced major developments in the past years. SWE offers an ultrasound based non-invasive quantitative tissue elasticity measurement by evaluating shear wave propagation speed which reflects the biomechanical properties of soft tissue. With this technique, the deltoid and trapezius muscle, several sections of the rotator cuff muscles and tendons as well as the proximal part of the long head of the biceps muscle can be evaluated. Results of the patient-reported outcomes and the physical examinations of the intermediate follow-up (2-5 years) will be compared with the data of the preoperative function.

It is a retrospective observational cohort study with additional prospective clinical data collection in terms of a physical examination and ultrasound examination.

There is no additional invasive procedure for this study.

Eligibility Criteria:
Inclusion Criteria:

* year of surgery between 2015 and 2020
* ARCR surgery in cases of:

  * Partial or complete supraspinatus (SSP) tear
  * Partial or complete supraspinatus (ISP) tear
  * Partial or complete subscapularis (SSC) tear
  * Combined SSP, ISP and SSC tear
* with or without biceps tenodesis during same procedure
* able to understand the content of the patient information / consent form and give consent to take part in the study

Exclusion Criteria:

* revision surgery (prior repair of the rotator cuff in the same shoulder)
* postoperative infections
* patients with a language barrier hindering questionnaire completion (either in German, French, Italian or English)
* legal incompetence
* not eligible for Ultrasound (BMI \>35, persistent frozen shoulder)
* Prior surgery or injury of the contralateral shoulder
Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

The purpose of this research is to observe the efficacy of Naltrexone and Bupropion combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.

This is a randomized, double-blind, and placebo-controlled study. Subjects with evaluation and confirmation that inclusion and exclusion criteria are met, will be treated with naltrexone sustained release 15mg once per day and bupropion sustained release 150mg once per day in the first two weeks, and naltrexone 25mg once per day and bupropion 300mg once per day during the rest of the study.The purpose of this research is to observe the efficacy of Naltrexone and Bupropion on weight loss and smoking cessation compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia by the International Classification of Diseases 10th Revision (ICD-10);
* age between 18 and 65 years old;
* on stable antipsychotic medication treatment for at least one month;
* BMI \> 28 kg/m2 according to BMI criterion for obesity in the Chinese population ， or BMI\>27 kg/m2 in the presence of dyslipidemia, or male with waist circumference over 90cm;
* smoking at least 10 cigarettes daily for one year or longer;
* desire to lose weight and quit smoking.

Exclusion Criteria:

* Binge eating or other eating disorders;
* Current use of weight loss or antidiabetic medications;
* Current substance use (except nicotine or caffeine);
* Elevated hepatic transaminase levels (\>2.5x normal range);
* Clinically significant Thyroid Stimulating Hormone（TSH） and/or thyroxine4（T4） abnormalities;
* History of seizure disorder;
* History of unstable cardiac problems or other unstable medication conditions;
* Being pregnant or nursing (for women).