cyrilzakka/clinical-trials huggingface dataset:
Morphine Versus Ketorolac in Renal Colic

The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in renal colic.

The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in renal colic.

The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : chlorhydrate drotaverine 40 mg, xilocaine 100 mg, both diluted in 100 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of renal colic
* grade 5 pain on a 1-10 visual pain scale

Exclusion Criteria:

* contraindications of ketorolac or opioids
* pregnancy
* allergies to ketorolac or opioids
* refusal of participation
Assessment of Dried Blood Spot Thyroglobulin and Urinary Iodine Concentration in Pregnant Women

To avoid iodine deficiency and its consequences in pregnant women and their offspring, women should reach a sufficient iodine intake long before conception. To monitor iodine status, median urinary iodine concentration (UIC) is widely used in pregnant women (PW). Thyroglobulin (Tg) us another marker used to assess iodine status . In this study, urine samples as well as dried blood spots will be collected to measure UIC and Tg (as well as other hormones to define thyroid function) in PW. The results shall be used to reassess the threshold which defines iodine status in PW according to UIC.


Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy
2. No major medical illness, no thyroid disease, and taking no chronic medication
3. No use of iodine containing dietary supplements
4. No use of iodine-containing X-ray /CT contrast agent or iodine containing medication within the last year
5. Aged between 18 and 44 at enrollment
6. Singleton pregnancy
7. Non-smoking
8. Residence at study site since 12 months or longer
Pupillometry for Pain Assessment in Critically Ill Patients

This study was part of a quality improvement project at the Department of Anesthesiology and Intensive Care Medicine, Charité - Universitaetsmedizin Berlin.

Being in pain is reported to be one of the most important stressors in critically ill patients and worsens outcome. The evaluation of pain using validated scores in patients who are able to self-report significantly improves the quality of analgesic therapy and health related outcomes in intensive care patients.

However, behavioral pain score that are used in sedated or delirious patients, often underestimate the severity of pain.

The primary aim of this study is to investigate if measurement of the pupillary light reflex Amplitude correlates with the results of pain assessment using validated pain scores in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients
* aged 18 years or older
* patients with an expected intensive care unit length of stay of of at least 48 hours.

Exclusion Criteria:

* not German speaking
* traumatic brain injury
* stroke
* increased intracranial pressure
* ocular disease or surgery.
Development and Application of a Dynamic Three-dimensional Quantitative Facial Measurement Device

The aim of this project is to successfully develop and industrialise the "Facial Movement 3D Dynamic Quantitative Measurement Device", which is a commercial device that can provide dynamic indicators of facial movement, and can practically solve the evaluation problems of facial paralysis for doctors and patients, and has important clinical value and social benefits.

Based on the current optimal high-precision face key point technology, the effective high-precision automatic face recognition model conforming to the Asian face is established through specialised training with targeted marker data, time series training optimisation based on optical flow, and local image tracking technology. The 3D reconstruction technique is then used to reconstruct the 3D spatial coordinates of the face keypoints, so as to realise the multi-camera 3D tracking of the face keypoints. The displacement of the key points is used to respond to the facial muscle activity characteristics of facial paralysis patients.

Eligibility Criteria:
Inclusion Criteria:

1. Older than 14 years
2. No history of facial surgery, facial trauma, or scars obscuring the facial features.
3. Able to perform relevant actions according to instructions
4. Willingness to participate in the study

Exclusion Criteria:

1. Unwillingness to participate in the study
2. Unable to co-operate with relevant command actions
3. Obvious trauma, scars, etc. obscuring the facial features
4. Less than 14 years of age
Randomized, Controlled Study Evaluating CERE-110 in Subjects With Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate the potential benefits of CERE-110 in the treatment of Alzheimer's disease. CERE-110 is an experimental drug that is designed to help nerve cells in the brain function better. CERE-110 uses a virus to transfer a gene that makes Nerve Growth Factor (NGF), a protein that may make nerve cells in the brain healthier and protect them from dying. The virus used in CERE-110 does not cause disease in people. CERE-110 has been carefully studied in laboratory animals and is in the early stages of being tested in people.

Fifty patients with mild to moderate Alzheimer's disease will participate in this study. Half of the study subjects will have CERE-110 injected into the brain during a surgical procedure, while the other half will undergo a "placebo" surgery where no medication will be injected. All study participants will be followed for at least two years after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate Alzheimer's disease
* Approved medications for Alzheimer's disease may be taken if the dose has been stable for 3 months
* A study partner who can attend all study visits
* Good general health
* Medically able to undergo neurosurgery

Exclusion Criteria:

* Significant neurological disease other than Alzheimer's disease
* Significant depression or other psychiatric disorder
* Unstable medical conditions
Demographic Characteristics of Children Suffering From Mental Retardation or Cerebral Palsy in the Israeli Arab Community

To evaluate the demographic characteristics of patients suffering from mental retardation or cerebral palsy in the Israeli Arab community. Specific questionnaires will be developed and will be distributed amongst this population in order to identify these characteristics.


Eligibility Criteria:
Inclusion Criteria:

* cerebral palsy
* mental retardation
* Israeli Arab
* Israeli Jewish

Exclusion Criteria:

* all others
Impact of Influenza Vaccination in Pregnancy Video Education

We evaluated the impact of viewing an educational video about influenza vaccination in pregnancy just prior to a routine prenatal visit on vaccination health beliefs and vaccination rate. We hypothesized that the video would positively impact both vaccination health beliefs and vaccination rate compared to a control video.

We studied the impact of influenza in pregnancy video education that was developed by the CDC and currently available to the public on the internet. We looked to see if viewing the video just prior to a routine scheduled prenatal visit could positively influence health beliefs regarding vaccination and improve the rate of vaccination that day. Patients were randomized to view the intervention video or a control video of similar length about hand washing. Pre visit and post visit questionnaires were given about vaccination health beliefs. We also asked if the shot had been recommended by the physician. One month after the visit, we used a structured phone interview to gather additional information regarding why participants who had not been vaccinated made that choice.

Eligibility Criteria:
Inclusion Criteria:

* pregnant
* English as primary language
* scheduled for a routine prenatal visit
* no documented influenza vaccination 2013-2014

Exclusion Criteria:

* Cleveland Clinic Employee
* high risk pregnancy
* allergy to eggs
* allergy to influenza vaccination
Effect of Resistance Exercises on Liver Enzymes Post Burn.

Resistance training will be performed for 8 weeks with thrice-weekly sessions on non-consecutive days. The program will consist of seven exercises: triceps press, biceps curl, lat pull-down, calf raise, leg press, leg extension and sit-ups using dumbbells and sandbags. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching followed by a resistance exercise that will be done as a circuit, ending with a 5-minute cooldown. The 1 repetition maximum (1RM) is measured at baseline and following the intervention. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first and second weeks, progressing to two circuits, using 60% of their 1RM and repeating 10 times for the third and fourth weeks. In the fifth and sixth weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last two weeks, patients will do three circuits using 70% of their 1RM and repeat 10 times. A 90-second rest will be allowed between sets of exercises (Hallsworth et al., 2011).

Sixty patients who have partial thickness burn with burned body surface area (BBSA) about 30% to 50% will participate in this study after their release from intensive care unit. Their ages will be ranged from 20 to 45 years. The participants will be selected from Orabi hospital and randomly distributed into two equal groups.

1. Group A (Study group): This group includes 30 burned patients who will receive resistance exercises 8 weeks (3times/week) by using dumbbells and sand bags in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment.

1. Group B (Control group): This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* The subject selection will be according to the following criteria:
* Age range between 20-45 years.
* Male and female patients will participate in the study.
* All patients have burn with BBSA about 30% to 50%.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* The potential participants will be excluded if they meet one of the following criteria:
* Cardiac diseases.
* Burn of sole of foot.
* Exposed hand or foot tendons.
* Lower limb amputation.
* History of liver diseases.
* Body mass index (BMI=kg/cm2)\<30%.
Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil Anesthesia

The aim of this prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.

Monitoring Antinociception during general anesthesia is still a big challenge in the field and has not become clinical routine yet. Recently, for the Surgical Pleth Index SPI a benefit for the patient in terms of reduction of remifentanil use, less unwanted effects and shorter recovery from anesthesia was reported. However, there are new variables like the ANI that are developed to measure antinociception during anesthesia.

In the present study the investigators want to evaluate, whether ANI detects a painful tetanic stimulus during general anesthesia using propofol or sevoflurane and different concentrations of remifentanil.

Eligibility Criteria:
Inclusion Criteria:

* age between 18- 65 years,
* ASA physical status I or II,
* elective surgery in general anesthesia planned,
* written informed consent

Exclusion Criteria:

* pregnancy,
* history of cardiac arrhythmia,
* presents of any neuromuscular or neurologic disease,
* use of CNS-active medication or abuse of alcohol/illicit drugs -
Effect of Quadratus Lumborum Block in C/S

to compare postoperative analgesic effects of USG guided QLB-2 and QLB-3 blocks after C/S. We hypothesized that QLB-3 may be more effective for pain relieving than QLB-2 after C/S.


Eligibility Criteria:
Inclusion Criteria:

* pregnancy with a gestation of 37-41 weeks parturients who were scheduled for elective cesarean delivery under general anesthesia
* obtained patients informed consent

Exclusion Criteria:

* inability to comprehend
* bleeding diathesis
* allergy to the study agents
* localized infection
* block failure
Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers

Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 50-80 years old
* Active smoker (≥ 15 PA) or former smoker (≥ 15 PA)

Exclusion Criteria:

* Recent history of chest CT scan (within 12 months)
* Person unable to climb 2 floors
* Weight \> 140kg
* Personal history of cancer \< 5 years (currently being monitored by thoracic imaging)
Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?

Brachial plexus blocks have some advantages, but also have some disadvantages as well. As with all nerve blocks, having to wait sometime for an effective block, sometimes failure to achieve an adequate block and possible requirement for isolated nerve block, having to wait a long time for resolution of the block, and immobilization of the extremity for some time can be seen as handicaps for brachial plexus block as well. In the present study, Study was aimed to compare the effects of bupivacaine warmed to body temperature and kept at room temperature on the onset time of ultrasound guided infraclavicular brachial plexus block.

The study design was approved by the locale ethics committee. This double-blinded, randomized, controlled clinical trial recruited 60 patients aged between 18 and 65 years with the American society of anesthesiologists (ASA) physical status classification systems I/II and III who were candidated for surgical operations on any of the forearm, wrist and hand regions. All the participants were asked to sign an informed consent form after having been provided with details of the aim and proceedings of the study.

Patients were excluded from the study if they had a neurological and neuromuscular disorders, psychiatric problems, cardiopulmonary diseases, coagulopathy, infections or allergy to local anesthetic agents.

The patients were equally and randomly distributed into a 24C° 20 ml 0,5% bupivacaine group (Group 1), and 37C° 20 ml 0,5% bupivacaine group (Group 2) via closed envelope technique. All the participants were premedicated with 0.05 mg/kg of intravenous midazolam and monitored routinely before attempting nerve block.

Bupivacaine stored for at least 2 hours in a bain-marie (Memmert Waterbath WNB7, Germany) at 38˚C (regular temperature calibration was made) for Group 2.

The block process was accomplished by an anesthesiologist, who was blind to the temperature of bupivacaine and local anesthetic agent was administered by different anesthesiologist.

At the end of the ICBP block, an anesthetist blinded to the technique evaluated sensory and motor block in every minutes between 5th and 30th minutes as follows. The innervated areas (each dermatome) was evaluated using a pinprick test. The motor block was evaluated by bromage modified scale in every minutes between 10th and 30th minutes. Anxious patients were administered additional midazolam. Subjects refusing awake surgery were administered a propofol infusion with supplemental oxygen as necessary.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18 and 65 years
2. American society of anesthesiologists (ASA) physical status classification systems I/II and III
3. Candidate for surgical operations on any of the forearm, wrist and hand regions.

Exclusion Criteria:

1. Neurological and neuromuscular disorders,
2. Psychiatric problems
3. Cardiopulmonary diseases
4. Coagulopathy
5. Infections
6. Sllergy to local anesthetic agents.
TAP Block vs LAWI for Analgesia Post-cesarean Section: RCT

Adequate pain control after cesarean delivery is a significant concern both for parturients and obstetric anesthesiologists. Transversus Abdominis Plane (TAP) block and local Wound infiltration with anesthetics are alternatives for reducing the severity of pain, total analgesic consumption, and opioid side effects. Both the TAP block and wound infiltration are superior to placebo; however, it is unknown which provides better analgesia after cesarean delivery because of a scarcity of randomized clinical trials. So, we hypothesized that the TAP block would decrease postoperative pain and postoperative cumulative opioid consumption at 24 hours


Eligibility Criteria:
Inclusion Criteria:

1. Women who underwent cesarean section under spinal anesthesia.
2. Aged ≥19 years and less than 40 years.
3. Gestational age ≥ 37 Weeks.

Exclusion Criteria:

1. Body mass index (BMI) ≥40 kg/m2.
2. History of recent opioid exposure
3. Hypersensitivity to any of the drugs used in the study.
4. Significant cardiovascular, renal, or hepatic disease
Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor

The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using thermodilution. The Vitalstream device is a continuous noninvasive physiological monitor (Caretaker Medical LLC, Charlottesville, Virginia, further referred to as "CTM") provides heart rate, continuous noninvasive blood pressure (BP), respiratory rate, stroke volume and cardiac output.

The device is currently undergoing IEC 60601 Medical Safety Standards testing and has already passed all FDA-required emission and discharge testing. The Vitalstream tracks central aortic BP via pulse analysis, specifically Pulse Decomposition Analysis ("PDA"), of the peripheral pulse at a distal site, typically finger. The device uses a low pressure \[30-40 mmHg\], pump-inflated, finger cuff that pneumatically couples arterial pulsations via a pressure line to a custom-designed piezo-electric pressure sensor for detection and analysis. Physiological data are communicated wirelessly to a tablet-based user interface via Bluetooth. The Vitalstream monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject.

Eligibility Criteria:
Inclusion Criteria:

* Adult post-cardiac surgery needing cardiopulmonary bypass and use of the pulmonary artery catheter (PAC) as standard of care, (s/p coronary artery bypass graft (CABG), valve, heart transplant, major aortic \& other vascular surgery, and a combination of CABG and valve procedures)
* patients (age \> 18) admitted to the Intensive Care Unit (ICU) with a pulmonary artery catheter (continuous or intermittent thermodilution cardiac output) and an arterial catheter for Blood Pressure (BP) monitoring (standard of care)

Exclusion Criteria:

* Patients without an appropriately positioned or functioning (PAC) pulmonary artery catheter admitted to the cardiac surgery ICU after surgery. Patients on left ventricular assist device (LVAD) support
COVID-19 e Telepsychotherapy: Which Variables Affect Therapeutic Experience?

COVID-19 pandemic forced a widespread adoption of telemedicine, including telepsychotherapy.

Telepsychotherapy has been proven to be effective before COVID-19 breakout (Poletti et al., 2020); however, both patients and therapists were skeptical about this modality.

The aim of this study is to probe the experience of telepsychotherapy in both patients and therapists, during the COVID-19 lockdown. Thus, when the adoption of online colloquia was mandatory and not an option.

Crucially, studying the experience of telepsychotherapy during the COVID-19 pandemic allows i) investigating also the experience of those patients and therapists that were not favorable to this kind of intervention and ii) comparing the experience of therapy in the online and face-to-face modality, in the same patients and therapists. Furthermore, we collect several psychological variables that possibly influence the experience and efficacy of telepsychotherapy (e.g., personality traits, attachment state of mind, previous traumatic experiences) to define the psychological profile behind a favorable or negative experience of telemedicine in both patients and therapists. As crucial novelty, this information is collected in both patients and their therapists, allowing the direct comparisons between the experience of the therapeutic relationship (e.g., empathy, alliance) from two different point of views.

The results of the present study may help in the definition of possible subgroups of patients who may be sufficiently responsive to telepsychotherapy and those who may benefit - exclusively - of face-to-face interventions.


Eligibility Criteria:
Inclusion Criteria:

* Licensed and currently practicing psychotherapists
* Individuals currently undergoing a psychotherapy

Exclusion Criteria:

* not applicable
Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors

evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects 50 years of age or older and less than 85 years of age (\>50 and \<85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes:

   * to. Primary or secondary osteoarthritis
   * b. Collagen disorders and/or avascular necrosis of femoral condyle
   * c. Moderate valgus, varus or flexion deformities (HKA between ± 10°, flexion contracture \<10°) -
2. Patients consent and able to complete scheduled study procedures and follow-up assessments.
3. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.

Exclusion Criteria:

* Simultaneous participation in other studies
* Patients not capable of understanding and wanting and therefore unable to sign the informed consent
* Patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.