cyrilzakka/clinical-trials huggingface dataset:
Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.

Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up.

Efficacy Evaluation:

• Primarily based on clinical inspection of the former 25 cm2 treatment area and count of the AK-lesions.

Safety Evaluation:

* Evaluation of adverse events (AEs) and serious adverse events (SAEs)
* Evaluation of newly occurred dermal adverse events (AEs) and serious adverse events (SAEs) in the previous treatment area at 6 months and 12 months of follow-up (local tolerability).
* Follow-up of unresolved adverse and serious adverse events that occurred in the previous trial SP848-AK-1101.
* Follow-up of unresolved abnormal laboratory values that occurred in the previous trial SP848-AK-1101.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Participation in the previous clinical trial SP848-AK-1101.
* Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non-Responder who withdrew from the trial prematurely.

Exclusion Criteria:

* Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunological, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, infectious, gastrointestinal abnormalities or diseases).
* Evidence of systemic cancer.
* Dermatological disease or condition in the former treatment or surrounding area that might impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.
Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India

This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy infants as established by medical history and clinical examination before entering the study.
2. Age: 6-8 weeks at the time of enrollment.
3. Parental ability and willingness to provide informed consent.
4. Parent who intends to remain in the area with the child during the study period.

Exclusion Criteria:

1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment.
2. Acute disease at the time of enrollment (temporary exclusion)
3. Concurrent participation in another clinical trial at any point throughout the entire time frame for this study
4. History of congenital abdominal disorders, intussusception, or abdominal surgery.
5. Known or suspected impairment of immunological function based on medical history and physical examination.
6. History of any neurologic disorders or seizures.
7. Any medical condition in the parents / infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.
Frequency of Xerostomia and Their Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy

The aim of this study is the evaluation of the frequency of xerostomia and their management after radiotherapy in head and neck cancer.

The quality of life of these patients is also analysed with European Organization for Research and Treatment of Cancer Quality of life Questionnaire H\&N35 (EORTC QLQ H\&N35).


Eligibility Criteria:
Inclusion Criteria:

* patient with head and neck cancer after radiotherapy treatment

Exclusion Criteria:

* patient already treated for xerostomia for other reason : Sjögren's syndrome, medication, diabetes,...
Lumbar Neuraxial Ultrasound Corrrelation With MRI

Ultrasound is used increasingly to aid placement of neuraxial blocks. Good visibility of ligamentum duramater complex and posterior longitudinal ligament (LF, PLL) has a positive predictive value of 85% for successful neuraxial block. Dural puncture could still be feasible despite the absence of a good view, as reflected by a negative predictive value of 30%.

Poor neuraxial ultrasound view could be due to limitations of ultrasound or various other anatomical reasons which might include absent LF, calciﬁcation of ligaments, spinous process contact and presence or absence of epidural or subdural fat. This will be the first study of its kind to compare neuraxial ultrasound with MRI. The aim of this study is to look for anatomical correlation between neuraxial ultrasound and MRI at various lumbar interspinous levels and to look at factors that contribute to abnormal neuraxial imaging. Assuming the predicted abnormal ultrasound images to be around 30% and predicted abnormal MRI images to be 5%, 79 images should give a power of 0.9 and alpha 0.01 to analyse the association between the two. Sample Size Calculations were performed using statistical software R version 2.15.2

After ethical committee approval, 20 consenting patients scheduled for MRI lumbar spine were included in the study. Patients with previous spinal surgeries or with gross spinal deformities were excluded. In all patients ultrasound scanning of the lumbar interspinous spaces was performed with curvilinear 2-5 MHz Sonosite probe. At each lumbar interspinous level (L1-2 to L5-S1) the best possible transverse and paramedian oblique sagittal view was obtained. The obtained ultrasound images were the graded based on the visibility of LF and PLL. The lumbar spine MRI images were analyzed by radiologists who were blinded to the ultrasound images. On MRI various parameters such as depth of epidural space, absence of LF, thickness of LF, characteristics of muscular and intervening fatty tissue, epidural/subdural fat thickness etc was noted. The correlation between neuraxial ultrasound images and various parameters observed in MRI was identified.

Eligibility Criteria:
Inclusion Criteria:

Any adult having MRI lumbar spine done

Exclusion Criteria:

Patients with previous spinal surgery Gross spinal deformities BMI more than 50
Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

The purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using modern negative pressure ventilators


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Fontan physiology with clinical evidence of Fontan failure as defined by those with one of the following in addition to Fontan circulation: New York Heart Association Class II, fluid retention, cyanosis, protein losing enteropathy, renal/hepatic dysfunction and/or subjectively qualify for hemodynamic assessment (by primary cardiologist).

Exclusion Criteria:

1. Patients which will likely require intubation for catheterization
2. Severely depressed systemic ventricular systolic function
3. Baseline airway obstruction
4. Plastic bronchitis
5. Significant OUTFLOW obstruction
Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura.

Immune thrombocytopenia Purpura (ITP) is an autoimmune condition delineated by humoral as well as cell mediated immune response against thrombocyte surface proteins GPIIb/IIIa receptors, affecting primary homeostasis leading to mucocutaneous bleeding.ITP is characterized by platelet count \<100 x 109/L. The conventional line of treatment for newly diagnosed ITP is steroids but significant disadvantages have been associated with long term use and a high risk of relapse when reducing the dose. The addition of MMF to the first line treatment of ITP resulted in substantial response and a lower risk of refractory ITP with decreased financial burden and improved outcome.

Immune Thrombocytopenia Purpura (ITP) is an acquired, immune-mediated disorder characterized by a severe decrease in peripheral thrombocyte count to less than 100 x 10⁹/L, leading to mucocutaneous bleeding. Our primary objective is to evaluate the efficacy of adding Mycophenolate Mofetil (MMF) alongside steroids in the first-line treatment of ITP, aiming for an enhanced therapeutic response, lower risk of refractory and chronic ITP, reduced financial burden, and improved overall outcomes.

The study aims to validate the efficacy and safety of MMF as a first-line treatment option for ITP while reducing the economic burden and risk of relapse associated with the condition

Eligibility Criteria:
Inclusion Requirements:

• Age: 5-60 years • Number of plates: \<30x109

Exclusion Standards:

Pregnancy; lactation; hepatitis B and C; HIV-reactive individuals; and medication allergies
Quantitative Assessment of Lumbar Facet Joint Degeneration, A Retrospective Study.

Observational study

The purpose of this observational study was to understand the quantitative assessment of the degree of degeneration of lumbar facet joints, and to improve the Weishaupt grading system by using gray-scale curve fitting and imaging parameters.

The main questions it aims to answer are: How to realize quantitative analysis of lumbar facet joint degeneration in patients with chronic low back pain with MRI?

The MRI information of patients with different grades of articular process joint degeneration has been statistically summarized in nearly 5 years


Eligibility Criteria:
Inclusion Criteria:

* (1) Age range from 20 to 80 years old; (2) Persisted chronic low back pain (CLBP) more than 12 weeks; (3) Complete preoperative X-ray and 1.5T MRI examination.

Exclusion Criteria:

* (1) Scoliosis, Cobb angle\>20°; (2) Lack of preoperative X-ray or MRI examination; (3) 3.0T MRI; (4) The interval between preoperative X-ray and MRI examinations is more than one month; (5) Previous lumbar spine internal fixation surgery; (6) Lumbar spondylolisthesis \> 5 mm, with severe dislocation of facet joints; (7) Intravertebral bone cement implantation; (8) Severe spinal joint disease (e.g. mandatory spondylitis); (9) Spinal tumors; (10) The maximum extension depth of Modic changes (MC) relative to vertebral body height was greater than 25%.
Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients

The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. The aim of the study is to show a reduction of the mortality rate of ARDS patients.

The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively investigated. It has been recently demonstrated that a systematic 48-h infusion of NMBA is associated with a significant improvement in oxygenation as compared with a control group (Gainnier et al., Crit Care Med 2004). Moreover, a trend towards a reduction in the mortality rate has been observed. The aim of the study is to show a reduction of the mortality rate of ARDS patients.

Eligibility Criteria:
Inclusion Criteria:

* ARDS with a PaO2 / FiO2 \< 150 with a PEEP \> 5 since less than 48 hrs
* informed consent

Exclusion Criteria:

* NMBA allergy
* Continuous administration of NMBA for ARDS prior inclusion
* Age \< 18 yrs
* SAPS II \> 70
* Persistent air leak
Validation of Machine Learning Based Personalized Nutrition Algorithm to Reduce Postprandial Glycemic Excursions Among North American Individuals With Newly Diagnosed Type 2 Diabetes

This is an initial validation study of the Personal Nutrition Project (PNP) algorithm in a North American population with recently diagnosed Type 2 Diabetes (T2D). This is a 2-stage, single-group feeding study in 20 individuals, including 10 participants managed with lifestyle alone, and 10 managed with lifestyle plus metformin.

The PNP algorithm, which uses a machine learning algorithm to predict postprandial glycemic, may be efficacious for generating tailored dietary advice to moderate the participant's glycemic response to food.

Eligibility Criteria:
Inclusion Criteria:

* Age \>21 years to \<70 years
* Diagnosed with T2DM within 2 years with an HbA1c\<7%
* Diabetes management by metformin or lifestyle intervention
* Fasting C-peptide ≥ 0.5 mg/mL (0.17 nmol/L) (to exclude those for whom hyperglycemic exposure is driven by β-cell failure rather than dietary behaviors, as well as those requiring escalation of the medication regime)
* Ownership a smart phone and are willing to use it to monitor multiple factors influencing glycemic response to glycemia (e.g., sleep, physical activity, diet, stress, medication, and hunger)

Exclusion Criteria:

* are unable or unwilling to provide informed consent;
* are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia);
* are pregnant, are currently trying to become pregnant, or who become pregnant during the study
* are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management)
* have had or are planning to have bariatric surgery during the study
* have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D)
* those with an active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study;
* those who use acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects CGM accuracy)39
* immunosuppressive drugs within three months prior to participation and
* Chronically active inflammatory or neoplastic disease in the three years prior to enrollment.
* Patients with known food allergy.
Quality of Life and Long-term Outcomes After Hospitalization for COVID-19

The present study aims to assess the determinants of health-related quality of life and long-term outcomes among survivors of hospitalization for Covid-19 in Brazil. The investigators will conduct a multicenter prospective cohort study nested in randomized clinical trials (coalition Covid-19 Brazil initiative) originally designed to assess the effects of specific Covid-19 treatments. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed up for a period of one year by means of structured telephone interviews. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. Secondary outcomes include all-cause mortality, rehospitalizations, return to work or study, physical functional status assessed by the Lawton \& Brody Instrumental Activities of Daily Living Scale, dyspnea assessed by the modified medical research council dyspnea scale, need of long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, and symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-revised.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Hospitalization due to proven or suspected SARS-CoV-2 infection
* Meeting eligibility criteria for Coalition Covid-19 Brazil randomized clinical trials

Exclusion Criteria:

* Death during the hospitalization
* Absence of telephone contact
* Absence of proxy for patients with communication difficulties
* Refusal or withdrawal of agreement to participate
Carbetocin Trial: Carbetocin Appropriate Rate Better Equilibrium Between Tonus (TOnus) and CIrculatioN

Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood transfusion within 24 hours after delivery (World Health Organization, Recommendations for the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009). Since PPH is more common after caesarean deliveries than after vaginal births and the rate of CS is rising over time and will probably continue to rise, the incidence of PPH is expected to increase accordingly.

A meta-analysis has shown that routine administration of an oxytocic agent after caesarean delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over oxytocin of having a longer half-life and therefore reducing the use of additional uterotonics. Based on the findings of reduced cardiovascular side-effects with a short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin minimises the cardiovascular side effects without compromising the uterine tone. Therefore, we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid compared to a bolus application in women undergoing primary or secondary caesarean delivery. This prospective, double-blind, randomised controlled non-inferiority trial will take place at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a short-infusion than after a bolus administration (primary safety endpoint).


Eligibility Criteria:
Inclusion Criteria:

* healthy women
* singleton pregnancy
* caesarean section under regional anaesthesia
* older than 18 years
* written informed consent

Exclusion Criteria:

* emergency caesarean section
* secondary caesarean section due to fetal distress
* comorbidities (cardiovascular, kidney or liver disorder, epilepsy)
* obstetric diseases (hypertension, (pre-)eclampsia)
* uterine malformation (including uterine fibroids)
* bleeding disorder
* known hypersensitivity to carbetocin or oxytocin
* fetal malformation
A Safety, Efficacy Study of CombiflexOmega Peri Versus SmofKabiven Peripheral in Patients With Parenteral Nutrition

The purpose of this study is to compare the safety and efficacy of CombiflexOmega peri in comparison to SmofKabiven peripheral in postoperative patients requiring parenteral nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 and older
* Patients are expected to require PN for more than 3 days
* Patients who voluntarily signed the consent form

Exclusion Criteria:

* Patients are expected difficult to survive more than 3 days
* Pregnant or breast-feeding women
* BMI \> 30 kg/m2
* Patients with severe blood coagulation disorders
* Patients with congenital amino acid metabolism disorders
* Patients with acute shock
* Patients with uncontrollable diabetes mellitus
* Patients with hemophage syndrome
* Patients with hypopotassemia (K \< 3.0mEq/L)
* Patients having the history of myocardial infarction
* Patients reported the following laboratory value

  * fasting TG \> 250mg/dl, TC \> 300mg/dl
  * ALT/AST ≥ 2×ULN, Bilirubin ≥ 3mg/dl (Exception : patients with periampullary carcinoma including biliary tract or pancreas)
  * Creatinine ≥1.5mg/dl
  * Ca \> 11.2mg/dl, Na ≥ 145mEq/L, Mg ≥ 2.1mEq/L, K ≥ 5.5mEq/L
* Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
* Patients having the history of drug or alcohol abuse
* General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, cardiac decompensation
* Patients are in unstable conditions
* Patients with difficult peripheral intravenous
* Patients with parenteral nutrition within 7 days prior to start of the trial
* Participation in another clinical study with an investigational drug or an investigational medical device within 28 days prior to start of study
* Patients judged to be unsuitable for this trial by investigators
Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone

35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7

AAH patients (Maddrey score \> 32 and compatible histological results) should centrally randomized into the C-NAC or C groups. Both groups received 4 weeks of prednisolone treatment, plus NAC for the combination therapy group (D1: 150, 50 and 100 mg/kg in 250, 500 and 1000 mL of 5% glucose-saline (G5%) respectively, at t=30 minutes, 4 and 16 hours; D2 to D5, 100 mg/kg in 1000 mL of G5%). Group C received 1000 mL of G5%, D1-5

Eligibility Criteria:
Inclusion Criteria:

* Patient consent
* Chronic alcohol intake in the last 3 to 6 months
* Maddrey score ≥ 32
* Liver histology compatible

Exclusion Criteria:

* Hepato renal syndrome
* Hepatocarcinoma
* Recent variceal haemorrhage
* Recent bacterial infections
* Other liver diseases associated (HCV, HBV, hemochromatosis, AIH)
* Cancers or cardiac and respiratory, HIV infection
* NAC Allergy
* No patient consent
* Acetaminophen intoxication
Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's

Those patient's that come to the sleep unit and that accept to participate in the study will undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm wrist. The outcomes that will be analyzed are:

Time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's on/light's off


Eligibility Criteria:
Inclusion Criteria:

* Patient's with OSA suspicion undergoing a PSG in the sleep unit

Exclusion Criteria:

* Neurologic disorders
* Severe comorbidities
* Other sleep disorders, such as insomnia
* No informed consent
Motivational and Cognitive Intervention for College Drinkers

In the proposed project the investigators will develop and test a novel brief intervention targeting college students who drink heavily to cope with anxiety and depression, a behavior that increases risk for the development of alcohol dependence.


Eligibility Criteria:
Inclusion Criteria:

- 1. At least 1 heavy drinking episode (4 or more drinks for women; 5 or more drinks for men).

2. Sub-clinical anxiety or depression 3. Occasional to frequent drinking related problems

Exclusion Criteria:

* 1. Clinical Axis I diagnosis 2. Current suicidal ideation, pregnancy, major medical illness, severe alcohol dependence, current hallucinations