cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants

The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m2.
* Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations.

Exclusion Criteria:

* Participants must not have clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.
* Participants must not have prior exposure to BMS-986446 (PRX005).
* Other protocol-defined Inclusion/Exclusion criteria apply.
Effectiveness of Deep Cervical Flexor Muscle Exercises in Patients With Tension-Type Headache

The aim of this study is to evaluate the effects of deep cervical flexor muscle exercises on pain, spinal posture, and sensory sensitivity in patients with tension-type headaches. Designed as a single-blind randomized controlled trial, the study will assess participants' pain levels using the Visual Analog Scale (VAS), sensory sensitivity through the Sensory Sensitivity Scale, and spinal posture via a digital inclinometer for objective measurements. This research seeks to determine the effectiveness of these exercises in managing pain, improving spinal posture, and contributing to the enhancement of sensory sensitivity.

The objective of this study is to comprehensively evaluate the impact of deep cervical flexor muscle exercises on three key outcomes in patients suffering from tension-type headaches: pain intensity, spinal posture, and sensory sensitivity. Tension-type headaches, often associated with poor posture and muscular dysfunction, can significantly affect daily functioning and quality of life. This study seeks to explore whether targeted exercises for the deep cervical flexor muscles can alleviate these symptoms.

Designed as a single-blind randomized controlled trial, this research will involve carefully selected participants who will be randomly assigned to either an intervention group or a control group. The intervention group will undergo a structured exercise regimen focusing on deep cervical flexor muscles, while the control group will not receive this specific intervention.

To measure the effectiveness of the intervention, three primary assessment tools will be employed: pain levels will be evaluated using the Visual Analog Scale (VAS), which provides a subjective yet widely accepted measure of pain intensity; sensory sensitivity will be assessed using the Sensory Sensitivity Scale, offering insight into changes in sensory perceptions related to the headache condition; and spinal posture will be objectively measured using a digital inclinometer, which quantifies postural alignment and deviations.

This research aims to contribute to the understanding of non-pharmacological interventions for tension-type headaches, providing evidence on whether deep cervical flexor exercises can reduce pain, improve spinal posture, and positively influence sensory sensitivity, potentially offering a holistic approach to managing these chronic headaches.

Eligibility Criteria:
Inclusion Criteria:

* being diagnosed with tension-type headache

Exclusion Criteria:

* whiplash injury,
* significant neck trauma (caused by trauma to the neck, fracture, distortion, or violent attack that have caused the current NP),
* nerve root compression of the cervical spine,
* persistent headache attributed to traumatic injury to the head
* cluster headache,
* trigeminal neuralgia,
* pregnancy,
* breastfeeding,
* severe physical and/or mental illness
A Single Session Pain Psychology Class for Spine Surgery Patients

This project tests the feasibility a single session pain psychology class (TREK for Surgical Success) for patients undergoing spine surgery and compares outcomes in those who engage in the class to a historical group of similar patients undergoing usual care perioperatively. As of January 2020, the class option has been updated to include an online video module platform, to be used for patients unable to attend in person.

The proposed study intends to utilize a psychobehavioral protocol from Darnall and colleagues to deliver a single session behavioral medicine for pain intervention for the spine surgery patient entitled "TREK (Transform, Restore, Empower, Knowledge) for Surgical Success" (TREK for SS). The intervention is based off of the above noted evidence based 2 hour pain psychology class that has been used in the chronic pain population and is also currently being tested in other surgical populations. Use of this established and evidenced based treatment for the proposed project enhances the treatment fidelity. The proposed project addresses questions in the literature such as the benefits of this class in an in-person or online format and its adaptability and effectiveness in the spine surgery population.

The primary objective of the proposed project is to determine the feasibility of a single session digital behavioral medicine for pain intervention (TREK for SS) offered the perioperative period of lumbar spine surgery as measured by patient satisfaction and intervention acceptability ratings and retention rates. In this study the perioperative period is defined as a 8 week window straddling the surgery date. A secondary objective of the study is to gather preliminary data to support the efficacy of TREK for SS as measured by relevant post surgical outcomes compared to a group of historical controls who received usual care. Should this pilot study demonstrate effectiveness in lumbar spine surgery patients, there is the potential to study larger groups of patients and to integrate the class into the standard of care as a cost-effective intervention for the spine surgery population. Additionally, findings from this pilot study could substantiate the need for training in the class protocol across disciplines so that barriers to receiving pain psychology intervention can be minimized.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 and older
* Undergoing lumbar laminectomy with or without fusion

Exclusion Criteria:

* None
Place of the Video-laryngoscope in Learning Intubation by Simulation

The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners.

The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. They used a low-fidelity manikin designed for learning airway management. The first part of our session consisted in a theoretical training. The second part was the practical training with procedural simulation.

Simulation is nowadays a widespread teaching method, particularly in airway management. The direct laryngoscope is the most commonly used device for learning intubation. As for the videolaryngoscope, it is mostly used on an advanced level, for teaching difficult laryngoscopy to professionals. Its impact on teaching intubation to beginners remains unclear.

The aim of the study was to determine the impact of the videolaryngoscope on reducing the time needed to intubate on a low-fidelity manikin for beginners.

The investigators conducted a randomised crossover study, which took place in the simulation department of the medical school of Tunis. They used a low-fidelity manikin designed for learning airway management. They included 35 trainees.

The first part of our session consisted in a theoretical training, during which one single instructor exposed the anatomical basis and the material needed: a direct laryngoscope (Macintosh) with a number 3 curved blade, a videolaryngoscope (Med-Captain) with a number 3 curved blade and a number 7 tracheal tube with a stylet.

The second part was the practical training with procedural simulation. The investigators randomized the trainees in two groups.

Each trainee proceeded to three intubations with each device, in the specified order.

The investigators used the SPSS software for data analysis. The investigators considered a p-value \< 0.05 as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* fifth year's medical students.
* consentment of the participants

Exclusion Criteria:

* participants who had previously performed a tracheal intubation.
Chest Mobility, Strength, Physical Activity and Quality of Life in Parkinson's Patients With Post-COVID-19

To comparative pain intensity, chest mobility, cough strength, muscle strength, physical activity levels and quality of life in Parkinson's patients with post-COVID-19 and without post-COVID-19 was aimed in current study. Knowledge in the literature regarding this topic is still obscure.

Acute worsening and long-term sequelae of motor and non-motor symptoms have also been described in Parkinson's patients during and after SARS-CoV-2 infection, which is also known as prolonged COVID. The effects of COVID-19 on pain, chest mobility, cough strength, muscle strength, physical activity levels and quality of life in Parkinson's patients are still unclear today. For this reason, in this study, it was aimed to comparatively investigate pain, chest mobility, cough strength, muscle strength, physical activity levels and quality of life in Parkinson's patients with COVID-19 and without COVID-19 and to show the relationships between these outcome measures.

Eligibility Criteria:
Inclusion Criteria for Parkinson's patients with post-COVID-19;

* Being diagnosed with COVID-19 at least 12 weeks ago and recovered,
* Being over 18 years old,
* Volunteering to participate in the research,
* Being diagnosed with Parkinson's disease
* Comorbid conditions (such as hypertension, diabetes) are under control
* Being able to perceive assessments (Standardized Mini Mental Test score of 24 and above)
* Having the ability to ambulate and walk independently
* Being in stage 1 - 4 according to the Modified Hoehn-Yahr Scale

Inclusion criteria for Parkinson's patients without post-COVID-19;

* Not being diagnosed or suspected of COVID-19
* Being over 18 years old,
* Volunteering to participate in the research,
* Being diagnosed with Parkinson's disease
* Having comorbid conditions (such as hypertension, diabetes) which are under control
* Being able to perceive assessments (Standardized Mini Mental Test score of 24 and above)
* Having the ability to ambulate and walk independently
* Being in stage 1 - 4 according to the Modified Hoehn-Yahr Scale

Exclusion criteria for Parkinson's patients with and without post-COVID-19;

* Sudden drug or dose change during the study period
* A history of any acute/chronic orthopedic, cardiovascular, pulmonary, psychiatric or neuromuscular disease that may prevent measurements from being made.
* Having had myocardial infarction and pulmonary embolism in the last 30 days,
* Having a history of additional neurological (stroke, head trauma, peripheral nerve diseases, brain and spinal cord tumors, etc.) diseases other than Parkinson's disease
* Having severe vision loss or vestibular dysfunction
* Patients with blood pressure values above 140/90 and below 90/50 in blood pressure measurements made before the study, with arrhythmia on ECG, with a history of shortness of breath and/or palpitation
Analgesic Effect of Peripheral Cutaneous Nerve Block of Knee Joint After Total Knee Arthroplasty

Local anesthesia was performed on patients with total knee arthroplasty (TKA) through two different injection sites of local anesthetics and two local anesthetic drug . The pain score of patients after TKA was collected, then the analgesic effect of patients after TKA through two different injection sites and two different local anesthetic drug were analyzed and evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients between the ages of 40-75, who meet the indications for total knee arthroplasty(TKA) surgery, plan to undergo unilateral TKA surgery, can tolerate surgical trauma, and have no surgical contraindications;
* 2. Patients who have good medical obedience and can cooperate to complete the evaluation of various indicators after the operation and continue to receive follow-up;
* 3. There is no contraindications to combined spinal-epidural anesthesia;
* 4. Agree to accept this trial and sign an informed consent form.

Exclusion Criteria:

* 1. Allergic to test drugs;
* 2. Abnormal liver, kidney or heart function;
* 3. People who have chronic pain symptoms in other parts of the body other than the knee joint;
* 4. Patients with a history of multiple operations on the knee joint, or patients with abnormal anatomical structures;
* 5. Patients who cannot perform early functional exercise after unconventional knee replacement or other systemic diseases;
* 6. Cannot communicate with researchers normally.
Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs is usually considered as a major risk factor for bacterial tracheal colonization and subsequent development of ventilator-associated pneumonia. The rate of leakage around the cuff is related to the pressure differential across the cuff, namely the difference between the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff. Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff towards fluid leakage. However, this preventive effect of PEEP is compromised during prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a high-volume low-pressure tracheal tube cuff when performed with a high level of suction pressure (- 400 mbar) and a large size of suction catheter size (16 French).

This clinical study aims to confirm these experimental data in patients under mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* intubated with a Hi-Lo Evac tube since less than 48 hours
* under continuous sedation
* written consent signed

Exclusion Criteria:

* hemodynamic instability
* allergy of blue dye
Level of Middle Cranial Fossa Dura in Patients With Cholesteatoma

Cholesteatoma is a destructive lesion that progressively expands in the middle ear, mastoid or petrous bone and leads to destruction of the nearby structures. Erosion, which is caused by bone resorption of the ossicular chain and otic capsule, may cause hearing loss, vestibular dysfunction, facial paralysis and intracranial manifestations

Cholesteatoma has three Classical forms: (1) Congenital, primary or genuine cholesteatoma: occurs behind an intact tympanic membrane. Primary acquired cholesteatoma: looks like a limited diverticulum of the pars flaccida with little or no history of otorrhea. Secondary acquired cholesteatoma: develops with posterosuperior perforations in eardrum and expansion of the disease process into the antrum, mastoid, attic and middle ear. Granulation tissue, polyps and foul- smelling otorrhea are common findings in this type

Eligibility Criteria:
Inclusion Criteria:

* All adults above the age of 18 presented to the Assiut university Clinic with

cholesteatoma will be included in the study.

Exclusion Criteria:

1. Patients with previous mastoid surgery
2. Patients with Craniofacial anomalies or cleft lip and palate
3. Pediatric populations ≤ 18 years old
4. Patients with congenital ear anomalies
Chronic Pelvic Pain in Women - Conservative Group Treatment Compared to Standard Conservative Treatment.

The purpose of this study is to evaluate the effect of a multidisciplinary group based treatment compared to standard physiotherapy for women with chronic pelvic pain (CPP). The hypothesis is that multidisciplinary group based treatment is more effective than standard physiotherapy for women with CPP. The participants will be randomized to one of two treatment arms, and the treatment effect will be evaluated 12 months after start of intervention.

Background: Chronic pelvic pain (CPP) is a common source of pain and reduced quality of life among women throughout the world. CPP is a complex condition, and the understanding of both etiology and effective treatment is limited. The newest/latest clinical guidelines recommend a holistic and multidisciplinary treatment approach to this condition.

In accordance with the guidelines a multidisciplinary group based treatment for women with CPP has been started at the University Hospital of North Norway. The treatment is offered to patients who are considered to benefit from conservative treatment approach.

Method: To investigate the effect of a group based treatment compared to standard conservative treatment by physiotherapists in primary or secondary health care, a randomized controlled trial will be conducted.

Patients who are found eligible and consent to participate in the trial, will be randomized to one of the two treatment options. Data will be registered at baseline, 3, 6 and 12 months after start of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pelvic pain lasting minimum 6 months
* Motivated for group intervention

Exclusion Criteria:

* Pelvic pathology that needs medical treatment other than conservative
* Pregnancy, or labour last 12 months.
* Abdominal or pelvic surgery the last 6 months
* Botox injections in pelvic areas last 4 months.
* Drug addiction or using large dozes of analgesics
* Serious psychiatric diagnosis. Consent capability is necessary.
* Not speaking/writing Norwegian language
* Previously treated by physiotherapist involved in the group intervention in this project
Opioid Analgesia for MAB

Our primary objective will be to determine if a strong opioid, oxycodone, given at a dose recommended for severe pain in addition to ibuprofen decreases maximum pain scores compared to ibuprofen and placebo in women undergoing medical abortion (MAB). Results of this study will help future providers understand whether prescribing opioids are an important adjunct for pain control in women undergoing MAB.

This study will include 152 women undergoing MAB. Women will be randomized to oxycodone 10mg oral versus placebo and stratified by gestational age (\<7wks, 7-10wks). The primary outcome will be maximum reported pain score measured at 6-8 hours and 24 hours after misoprostol administration.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Seeking elective medical abortion
* In good health
* Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
* Able and willing to receive text messages via phone
* Literate in English
* Able and willing to give informed consent and agree to the study terms
* Have assistance at home; no motor vehicle use while taking study medications

Exclusion Criteria:

* Lack of access to cell phone and texting capabilities
* Early pregnancy failure
* Contraindications to the study medications: Oxycodone, Ibuprofen
* Contraindications to medical abortion with Mifepristone or Misoprostol
* History of methadone or heroin use
* Used alcohol in the past 24 hours
* Used marijuana \>4 times per week
* Any opioid in the past 30 days
* Using additional pain medications
The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception

In this study we will assess the incidence and severity of intraoperative and postoperative pain and determine the effect of preoperative anxiety on intraoperative and postoperative pain incidence. Secondary outcome is to assess provider perception of pain.

This is a prospective, observational study. Following obtaining written formal consent parturients will be requested to fill out the following questionnaires

1. Three questions to predict acute pain:

   * Verbal numeric score Anxiety 0-10
   * Anticipated postoperative pain level
   * Anticipated analgesic requirements
2. Speilberger STATE-TRATE inventory index
3. Pain Catastrophizing Scale In the post anesthesia care unit (PACU) parturients will be approached and requested to fill out a questionnaire regarding intraoperative pain, medication consumption, anxiety and nausea. Furthermore parturients will also be approached at 12 hours and 48 hours postpartum and questioned regarding anxiety levels and medication consumption and requested to fill out the OBSQOR 11 questionnaire at 12 hours postpartum.

Additionally, both the attending anesthesiologist and obstetrician will be questioned regarding the parturient's level of intraoperative pain, postoperative pain levels anxiety medication consumption, uteronic management, surgical technique and management.

Eligibility Criteria:
Inclusion Criteria:

\*Women undergoing an elective cesarean section under spinal anesthesia with the ability to comply with the study requirements will be eligible for participation

Exclusion Criteria:

* All women unable to receive spinal anesthesia or with inadequate spinal anesthesia prior to the beginning of surgery (Less than T4 Sensory Level to pinprick assessed from blunt tip needle in caudal to cranial direction )
* All women receiving antianxiety medication
* Language barrier
A Study of IBI306 in Participants With Hypercholesterolemia

This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.


Eligibility Criteria:
Inclusion criteria

1. Males and females ≥ 18 to ≤ 75 years of age
2. Diagnosis of hypercholesterolemia
3. LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
4. Very high or high cardiovascular risk
5. TG≤500 mg/dL(5.64 mmol/L)

Exclusion criteria

1. Uncontrolled hypertension
2. Uncontrolled hyperthyroidism or hypothyroidism
3. Severe renal dysfunction
4. Known sensitivity to any of the products to be administered during dosing