cyrilzakka/clinical-trials huggingface dataset:
Systematic Referral to Alcohol Use Dependency Treatment in Patients With Alcohol-related Liver Disease: a RCT

To evaluate the efficacy of systematically referring newly diagnosed ALD patients to AUD treatment on alcohol abstinence after 6 months. The investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing A) a referral to specialized AUD treatment (intervention) and B) standard care (control). The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.

The investigators have designed a randomized controlled superiority trial to investigate the effectiveness of systematically offering AUD treatment in newly diagnosed ALD patients to increase the proportion that are abstaining from alcohol after 6 months compared to standard care. The study will be embedded in an existing observational cohort from which already included participants will be used as controls in the RCT (n = 70). Please see Figure 1 for the flow of participants in the study. From June 24, 2024, the investigators will start to randomize eligible participants.

Randomization will take place in connection with the first visit in the observational cohort study. Study participants randomized as controls will receive standard care through their treating physicians, which consists of individualized education on the nature of ALD as well as encouragement of alcohol use cessation.

Patients in the intervention group will receive standard care in addition to an offer of referral to AUD treatment, which includes contact from the AUD treatment center to the patients and the offer of both physical and online AUD treatment.

Eligibility Criteria:
Inclusion criteria

* Age \> 18 years
* Newly diagnosed alcohol-related liver disease, defined as within six months from baseline visit.
* A liver stiffness above 8.0 kPa with 10 successful measurements and an interquartile range of less than 30% as assessed with transient elastography.
* Excessive alcohol consumption defined as \>7 units/week for women and \>14 units/week for men within the previous year.
* The patient is able to understand the purpose of the study and give informed oral and written consent to participate.
* No ongoing or recent AUD treatment defined as within 12 months. Only AUD treatment provided by a specialised AUD treatment centre counts as AUD treatment.

Exclusion criteria

* Not enough proficiency in Danish to participate in interviews and questionnaires.
* Pregnancy
Laparoscopic Skills and Cognitive Function Are Not Affected by Night Shifts in Surgeons

The aim of the study was to asses the effect of sleep deprivation during nightshift by monitoring 30 surgeons in unit of surgical gastroenterology in 4 consecutive days. The first day was pre call= day 1, second day was on call= day 2, third day was the first post call day = day 3 and fourth day was the second post call= day 4. The surgeons were monitored in order to asses how performance was on call compared to pre call and post call. The hypothesis was that they would perform worse on call than pre call, and again slightly worse post call.

The surgeons wore an actigraph consecutively on all 4 days, and would fill out a sleep diary on all 4 days as well. The surgeons were heart monitored consecutively on day 1 and 2.

The surgeons were tested in a laparoscopic simulator at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. At the same given times they would perform the d2 test of attention and prescribe medicine in the Electronic Patient Medication system in accordance with a case they were given. Furthermore they delivered a salivary sample for the determination of salivary cortisol, at the given times.

They sampled urine from 9 pm - 9 am all 4 days, in order to measure the production of melatonin in urine.

The surgeons would fill out the Karolinska sleepiness scale, VAS (Visual Analog Scale) fatigue, VAS sleep quality and VAS general well being at 8 a.m. day 1, 4 a.m. day 2, and again at 8 a.m. day 4. The Karolinska Sleepiness scale was filled out every second hour on day 2 from 4pm - 8 am on day 3.

Eligibility Criteria:
Inclusion Criteria:

* Surgeons at surgical unit of Gastroenteroloy
* Men and women between the age of 22-50 years.

Exclusion Criteria:

* Pregnancy and breastfeeding
* Endocrine disease, medically treated
* Autoimmune disease, medically treated
* Sleep disturbance, medically treated
* Intake of alcohol within 24 hours before the study and during the entire study
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of recurrent glioblastoma
* Life expectancy ≥ 12 weeks
* Received only one prior systemic chemotherapy regimen and this regimen must contain temozolomide

Exclusion Criteria:

* Patients on enzyme-inducing anti-epileptic drugs within 3 weeks prior to randomisation
* Poorly controlled hypertension
* Previous anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) therapy
Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment

This trial will study if ephedrine pretreatment before low doses of rocuronium (0.6 or 0.8 mg/kg) would provide similar intubating conditions as with the high dose of 1.2 mg/kg in patients undergoing RSII.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II

Exclusion Criteria:

* Neuromuscular disease: myopathies
* On drugs that interact with the neuromuscular junction or ephedrine
* Cardiovascular disease: hypertension or ischemic heart disease
* Increased risk of pulmonary aspiration:

  * GERD
  * Pregnancy
* Anticipated airway difficulties:

  * Mallampati grade III or IV
  * Obesity (BMI ≥30 kg/m2),
* Hypersensitivity to any of the study drugs
Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin

This is a registry of patients with non ST segment elevation Myocardial Infarction (heart attack) and/or unstable acute coronary artery syndrome treated with a standardized protocol including Bivalirudin.

Data will be collected on diagnosis, treatment and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Chest pain or symptoms believed to be an anginal equivalent and representing myocardial ischemia, lasting at least 10 minutes within the past 24 hours
* Having any one of the following:

  1. Ischemic changes on ECG: ST depression \>0.5 mm OR T wave inversion \>2 mm
  2. Positive cardiac markers
  3. New onset CHF presumed secondary to ischemia
  4. Pulmonary edema
  5. Known coronary artery disease with typical symptoms
  6. Hemodynamic instability
  7. Sustained ventricular tachycardia

Exclusion Criteria:

* For the purpose of the SSDI, patients will be excluded if we are unable to obtain their Social Security Number.
Performance Assessment of the PMD-200 in Subjects at Neurointensive Care Unit

Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive Care Unit.

The proposed study is design to further demonstrates the performance of the Nociception Level (NoL) Index in neurological impaired anesthetized patients under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia, and to correlate the NoL response to the EEG derived pain score. Validating the performance of the NoL Index may provide a tool to monitor the pain/nociception in this population.

In this study, the PI plan to demonstrate that the NoL Index is a continuous index. It is anticipated that a higher level of nociception will correspond to a higher NoL index. On the other hand, it is anticipated that higher levels of analgesic agent for the same noxious stimulus will lead to a lower NoL index.

The participants will be monitored as in a typical ICU and according to the local guidelines by various types of monitoring devices, such as: vital signs, pulse oximeter, Bispectral Index (BIS), Electroencephalography (EEG) etc.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* The subject is under general anesthesia
* The subject have a blood pressure measurement (either arterial or cuff) during the study
* A signed Informed Consent Form (ICF) has been obtain

Exclusion Criteria:

- The subject is constantly agitate or moving a lot
Using Renal Elastography Measurements for Evaluation of Glomerulonephritis Patients

All participants will clinically evaluated by history taking, full physical examination including body weight and assessment of fluid status, and blood and urine samples for lab analysis (serum creatinine, urea, sodium, potassium, corrected calcium, phosphorous, estimated glomerular filtration rate(GFR) by Cokcroft equation ((140 - age ) x body weight by Kg/creatinine by µmol )complete urine analysis including microscopic examination of urine , 24 hours urinary protein , haemoglobin level .

All participants will undergo renal shear wave elastography measurements. Values will be obtained from the upper, middle, and lower zones of each kidney. A total of six shear wave elastography measurements will be collected to get mean elastography values (MEVs) of each participant.

We will collect results of MEV plus blood and urine samples of each participant then data will undergo statistical analysis to compare between MEV of healthy persons and biopcy proven glomerulonephritis patients

Eligibility Criteria:
a-inclusion criteria :

* adult patients aged 18 years old or more
* patients diagnosed as glomerulonephritis ( biopcy proven ) and not started specific tratement in Assiut University Hospitals

  b. Exclusion criteria:
* patient with urinary tract obstruction
* patient who has GN and started corticosteroid and/or immunosuppressive drugs
* patient who has congenital anomalies in renal system
Cerebral Effects of Pulsed Radiofrequency on the Lumbar Dorsal Root Ganglion With Functional Magnetic Resonance Imaging.

Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.

Detect and prove the central effects of PRF and show the objective working mechanism.

PRF is often used technique to alleviate chronic radicular neuropathic pain, although good clinical results are observed the precise (central ) working mechanism is still unknown. This study aims to find the central working mechanism.

The investigator postulate the existence of central -cerebral effect of PRF on the DRG (dorsal root ganglion). If the investigator can detect the effect using fMRI and demonstrate the objective unequivocal proof that PRF on the DRG works than the investigator will be able to promote this technique for further use in the chronic pain states.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 y
* Radicular pain in lumbar region more than 6 weeks, neuropathic

Exclusion Criteria:

* Coagulopathy
* Implanted PM or SCS device
* Pregnancy
* Unwilling to undergo MRI
* Psychiatric disorders
A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®

It is a randomized, double-blinded, parallel, single-dose, PhaseⅠcomparative study to evaluate the pharmacokinetics and safety of QL2108 to Dupixent® in healthy Chinese adult subjects. A total of 198 healthy subjects are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml QL2108 injection or Dupixent®.

The study has a screening period of 28 days. PK blood samples will be collected from subjects to determine the serum concentration of Dupilumab, thus to evaluate the similarity of the pharmacokinetics of the two study drugs.

The investigator will perform safety evaluation for vital signs, physical examinations, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Chinese healthy subjects aged from 18 to 50 years (including the boundary value)
* Normal vital signs, physical examinations, ECG, clinical laboratory tests and imageological examination results or abnormal with no clinical significance according to the doctor's judgment;
* Body weight between 50-90kg and BMI between 19.0-26.0kg/m2 (including boundary value);

Exclusion Criteria:

* People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab
* People with a clear history of allergy and/or allergy to monoclonal antibodies of the same target /investigational drugs and their components.
* People who have special dietary requirements or are unable to follow a uniform diet.
* Dizzy blood, dizzy needle history. Blood donation \> 400 ml within 3 months or \> 200 ml within 4 weeks prior to screening, or planning to donate blood during the study.
* Having participated in drug or device clinical trials within 3 months or 5 half-lives of other investigational drugs before the study administration.
Patients With Severe Acute Exacerbation of COPD Ans Admitted in ICU Register.

The objective of this prospective observational study is to describe the epidemiological, clinical and biological characteristics of admitted patients in ICU for severe acute exacerbation of COPD, to assess the different therapeutics used, to evaluate the prognosis of patients with short, medium and long term ( 1 year) and the various factors associated with survival in ICU

This is a prospective study for which data will be collected from pseudonymised. General information on the research activity clinic of the Intensive Care Service of the CH of Versailles is provided by poster, patient booklet or debrief hospitalization, indicating to relatives and/ or patients their possible participation in retrospective or prospective studies.

This research is conducted in accordance with the reference methodology MR 004 approved by the National Commission of Informatics and Libertés (CNIL) and to which the Centre hospitalier de Versailles is committed to comply. For this purpose, an information note will be given to each patient participating in this project in order to seek its non-opposition of participation in this study.

This prospective study is based solely on the examination of files medical. The data collected are only non-sensitive medical data.

This study complies with legal and regulatory requirements. In addition, this research project was submitted to the Ethics Committee (EC) of the Société de Réanimation de Langue Française (SRLF) who gave an opinion favorable on 06/10/2022 (Registration number referenced: CE SRLF 22- 056).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 40 years old
2. COPD documented or strongly suspected

   * Chronic respiratory symptoms (dyspnoea, cough and/or sputum)
   * Exposure to a known risk factor for COPD (such as tobacco smoke)
   * If available, respiratory function tests showing non- or partially reversible obstructive syndrom (post-bronchodilator ratio FEV1/CV \< 0.7)
3. Severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea ≥ 30 cycles.min-1 or use of accessory respiratory muscles) and/or hypercapnic acidosis (with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)
4. Admission to an ICU, a step-up unit or a respiratory care unit

Exclusion Criteria:

1. Known asthma (according to the criteria of the international "Global initiative for asthma" guidelines)
2. Patient refusal to participate (information note, application for non-opposition)
Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence

Asthma affects over 10 million children in the U.S., and poses a significant health and cost burden. Metered dose inhaler (MDI) is the most common method of treatment. Studies show that up to 80% of patients demonstrate incorrect use of MDIs, which results in suboptimal medication delivery to the lungs.

Asthma control can be followed by symptoms, rescue medication usage and measures of airflow obstruction. Current options to monitor control include an asthma diary (relies on consistent use by the patient), pharmacy records of medication dispensing (dispensing does not equal usage), and peak expiratory flow (PEF) meters (significant variability in technique leading to inconsistent results).

CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI usage and to monitor asthma control. CapMedic fits on top of the MDI inhaler and provides live audio-visual-haptic cues to guide the patient for correctly using their inhaler. CapMedic includes a built-in forced expiratory flow in 1 second (FEV1, a measure of airflow) and PEF meter. It will utilize the same audio-visual-haptic hardware to implement live cues that encourage patient's effort in performing accurate at-home FEV1/PEF test. Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary.

CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI usage and to monitor asthma control. CapMedic fits on top of the MDI inhaler and provides live audio-visual-haptic cues to guide the patient for correctly using their inhaler. CapMedic includes a built-in forced expiratory flow in 1 second (FEV1, a measure of airflow) and PEF meter. It will utilize the same audio-visual-haptic hardware to implement live cues that encourage patient's effort in performing accurate at-home FEV1/PEF test. Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Asthma
* Regular user of MDI
* Asthma Control Test (ACT) scores between 15 and 25
* FEV1 between 60-80% of predicted (persistent mild-moderate)
* Disease severity in the range mild-moderate
* Access to a Smartphone and internet during the entire duration of the study.
* Cognitively able to utilize the device and express interest in participating.

Exclusion Criteria:

* Patients without asthma
* With developmental disabilities
* Do not speak English
* Do not own a Smartphone
Feeding Intervention for Infants With Crying

The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.


Eligibility Criteria:
Inclusion Criteria:

* full term infants greater than or equal to 37 wks gestation
* 3 weeks to less than or equal to 4 months of age upon enrollment
* experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment
* otherwise healthy as reported by parent/caregiver
* is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit
* taking no more than one feeding of breast milk per day
* having not initiated weaning foods or beverages other than infant formula or breast milk
* study explained and written information provided with Parent/caregiver demonstrating understanding of the given information
* informed consent signed(parent/legal representative)

Exclusion Criteria:

* Chromosomal or major congenital anomalies
* known cow's milk allergy
* receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)
* receiving an antibiotic or probiotic in the week prior to enrollment
* complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications
* infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol
* infant currently participating in another conflicting clinical study
Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)

Psychological interventions for cancer patients have been tested and found to reduce stress and improve quality of life. These interventions have been tested at academic medical centers but have not been available for use by community mental health professionals. One such intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L. Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators to train mental health professionals from across the country to deliver the BBI at their institution. Recently diagnosed cancer patients who are participating in the BBI group at these institutions may participate in a research study completing self report measures asking about psychological and behavioral outcomes (for example, mood, stress, diet and physical activity). The investigators hypothesize that individuals participating in the intervention will report improvements in outcomes, such as reduced stress and improved mood, reduced symptoms of the disease and treatment, etc., after completing the intervention and continue to report these improvements up to 6 months after the group ends. OSU will coordinate this data collection project but information about participating sites is listed in http://clinicaltrials.gov.


Eligibility Criteria:
Inclusion Criteria:

* Recent initial diagnosis of cancer without metastatic disease
* Able to speak/read English

Exclusion Criteria: Those with concurrent diagnoses of

* Organic brain syndrome
* Dementia
* Mental retardation
* non-English speaking
* Significant sensory deficit
* Severe mental illness (e.g., schizophrenia, psychotic disorder)