cyrilzakka/clinical-trials huggingface dataset:
Multiple Joint, Structural Barbell Resistance Exercise Improves Information Processing Speed

This study investigated the effect of acute multiple joint, structural barbell resistance exercise on information processing speed and conflict-related neural activity in older adults via a crossover, sham control, randomized control trial.


Eligibility Criteria:
Inclusion Criteria:

1. male adults aged 50-65 years old
2. exercise ≥ 150 minutes/week
3. normal or corrected-to-normal vision
4. right-handed

Exclusion Criteria:

1. dementia (MMSE ≥ 24)
2. any medical condition listed on PARQ
3. depression (BDI-II score ≤ 13)
4. any diagnostic cardiovascular, neurological and other chronic diseases
The Effects of Stress on the Clinical Performance of Residents in Simulated Trauma Scenarios

Medical practice \& training are inherently stressful situations. However, the effects of stress on educational \& clinical performance are not well defined. The purpose of the current study is to examine the effects of stress on performance of residents in simulated trauma scenarios. The hypothesis is: 1) acutely stressful scenarios will be appraised as threat by residents and result in elevations of heart rate and salivary cortisol; 2) increased subjective \& physiological stress will result in impairments in performance; and 3) greater stress responses will result in greater clinical impairments.


Eligibility Criteria:
Inclusion Criteria:

* University of Toronto General Surgery \& Emergency medicine residents

Exclusion Criteria:

* No ATLS training
* Residents from other programs
Proximal Femur Reconstruction Following Resection of Primary Bone Tumors: Analysis of the Clinical and Radiographic Results

From the archives of the Rizzoli institute all the patients (approximately 150 patients) undergoing oncological reconstruction of proximal femur from 01/01/1991 to 31/12/2023.

A review will be made from the medical records, radiological imaging, and histological data of these patients


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients surgically treated with an oncological reconstruction of the proximal femur at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2023
* Age: 18-90 years old (at the time of primary surgery)
* Diagnosis of bone sarcoma
* Patients with available clinical and imaging data

Exclusion Criteria:

* At least one inclusion criterion not met
SToP: Venous Thromboembolism Screening in the Trauma Population

This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma surgery service at Intermountain Medical Center who are deemed to be at high risk for venous thromboembolism. Once identified and enrolled, subjects will be randomized to receive bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and major and clinically relevant bleeding episode rates, both during the index hospitalization and at 90 days post-discharge.


Eligibility Criteria:
Inclusion Criteria:

1. Inpatient status on Intermountain Medical Center (IMC) trauma surgery service, admitted within 24 hours of injury.
2. Age ≥18 at the time of injury
3. Meets the definition of high-risk for VTE according to current IMC trauma service guidelines

Exclusion Criteria:

1. Patient age \<18 years at the time of admission to the hospital
2. Pregnancy
3. Prisoners
4. Patients with a life expectancy of less than 30 days
5. Patients with a known hypercoagulable state including:

   * Factor V Leiden
   * Protein C and S deficiencies
   * Dysfibrogenemia of any sort
   * Active cancer
   * Antiphospholipid antibody syndrome
   * History of DVT or PE within past 6 months
   * Myeloproliferative disorders
6. Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital.
7. Patient elects to opt-out of the study
Pressure Ulcers in Knee Replacement Surgery

From the point of view of nursing to know exactly the different risk factors for the onset of pressure ulcers is very important as it allows to accurately orient preventive care interventions.

All the variable that could influence the development of pressure ulcer in patients undergoing knee replacement surgery are identified and collected: age, sex, body max index, risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers (typology of the devices used, such as air mattresses with alternating or static pressure, heel drains, frequency of mobilization carried out by both the patient care), management of eventual incontinence (use of diapers, urinary catheter), type of anesthesia, type of analgesia, length of stay, the ASA physical status classification system (ASA score), comorbidity, cancer, use of devices for controlling the position of the operated limb (foam valve), the number of physical therapy sessions actually carried out.


Eligibility Criteria:
Inclusion Criteria:

* Primary knee joint replacement
* Secondary knee joint replacement

Exclusion Criteria:

* Cancer patients
* Adult or Senior with pressure ulcer at the heel
Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients

In this study we try to review the possible effects when using modern hydroxyethylstarch solutions 6 % versus albumin 5% during living donor renal transplantation.


Eligibility Criteria:
Inclusion Criteria:

* end stage renal disease, for living donor renal transplantation

Exclusion Criteria:

* severe cardiac or hepatic dysfunction, re-transplantation, coagulopathy
CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic

The hypothesis of this work is that the COVID 19 pandemic and the associated lockdowns are likely to modify the adherence to positive airway pressure (PAP) treatments among patients with sleep apnea. Identifying these patients and identifying adherence "trajectories" over time would help mobilize human and telemedicine resources on the patients most in need.

The primary objective of this study is to compare PAP adherence during lockdowns in 2020 with the corresponding weeks during 2019.

Eligibility Criteria:
Inclusion Criteria:

* patient treated/monitored by the Adene group
* treated for sleep apnea syndrome (i.e., an initial apnoea hypopnea index (iAHI) ≥ 30/h or iAHI ≥ 15/h (and more than 10/h respiratory-effort-related arousal or cardio-metabolic/respiratory comorbidities) associated with symptoms from among sleepiness, tiredness, snoring, headaches, hypertension, reduced vigilance, libido disorders, nocturia, choking or suffocation during sleep, daytime tiredness)
* Positive airway pressure (PAP)-treated for at least 4 months before January 1, 2019
* continuous PAP during 2019
* continuous PAP during 2020
* acceptance of PAP telemonitoring with consent given for data collection and data anonymization

Exclusion Criteria:

* less than 360 daily PAP tele-monitored data per year for 2019
* less than 360 daily PAP tele-monitored data per year for 2020
Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children

Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and blood pressure in children.To differentiate between contractility and the effect of the circulating volume, some of the subjects will receive additional fluid.This will be evaluated using two transthoracic echocardiac exams within the first 30 min of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II children
* 1-6 years
* urological surgery

Exclusion Criteria:

* Cardiac disease
* Diabetes
A New Class IIb MD in Proctological Disorders

The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes aged between 18 and 75 years.
2. Patients reporting symptoms of haemorrhoids (grade 1-3\*), anal fissures and proctitides or already diagnosed with haemorrhoids (grade 1-3), anal fissures and proctitides; diagnosis confirmed by proctological examination at Screening Visit.

   \*Grade 1 - Haemorrhoid protrudes into the anal canal but does not prolapse outside the anus.

   Grade 2 - Haemorrhoid protrudes through the anus during straining or evacuation but returns spontaneously.

   Grade 3 - Haemorrhoid protrudes through the anus during straining or evacuation but needs to be manually returned to position.

   Grade 4 - Haemorrhoid remains prolapsed outside of the anus.
3. Patients agreeing not to use any other systemic or topic medicinal / product to treat haemorrhoids, anal fissures and proctitides during the study and not to modify their personal hygiene products.
4. Female patients of childbearing potential following a reliable contraceptive method (according to Investigator's opinion).
5. Willingness to participate in the study and to sign an informed consent form.

Exclusion Criteria:

1. Patients presenting infective anal or rectal pathologies (in particular bacterial infections associated with proctitides or proctitides caused by viral infections).
2. Patients presenting complicated haemorrhoids.
3. Patients with Crohn's disease or malignancy.
4. Patients presenting undiagnosed abnormal rectal bleeding.
5. Patients with known or suspected rectal hypersensitivity.
6. Patients presenting coagulation disorders or on anticoagulant drug therapy (except clopidogrel or acetylsalicylic acid).
7. Patients in treatment with topic or systemic medications / products to treat haemorrhoids, fissures and proctitides, currently or in the 2 weeks prior to Screening Visit.
8. Patients using laxatives or stool softener currently or in the 2 weeks prior to Screening Visit.
9. Patients pregnant or breastfeeding.
10. Patients reporting past or present narcotic addiction or alcoholism.
11. Patients that participated in any other clinical trial during the last month or participating in any clinical trial while participating in this trial.
12. Patients reporting allergy or intolerance to any component of test product, placebo or rescue product.
13. Patients who in the opinion of the principal Investigator are at risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
14. Patients presenting contraindications to Proktis-M (rescue product), according to concerning leaflet.
The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration

The purpose if this study is to assess the response to nerve root infiltration therapy in patients with cervical or lumbar disc herniations.

This prospective, observational study examines the response to routine infiltration therapy in patients suffering from disc herniations of the spine. Using health-related quality of life questionnaires (SF-12 and Neck Pain and Disability Scale and Oswestry Disability Index) and the visual analogue scale the patients will be categorized into ultra-early-, early-, mid-term-, late-responders and non-responders. A two year follow-up of up to 250 patients is planned. With the anonymized participation of this study no patient will experience a change in his treatment plan. Valuable therapeutic management considerations might be drawn from the published results of this study for future patients.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic (pain) one-level cervical (C3-C8) or lumbar (L1-S1) radiculopathy with radiological evidence of discal nerve root compression
* Minimum VAS of 20/100
* Age between 18 - 70 years

Exclusion Criteria:

* Multilevel disc herniations with multiple symptomatic nerve root compressions
* Higher motor deficits (Paresis M 0-3 of a peripheral muscle)
* Age \< 18 or \> 70 years
* Pregnancy
* Allergic reaction against steroids or local anaesthetic
* Bleeding disorder (Tc \< 100.000/ul, Quick \<50%, INR \> 1.5, abnormal PTT)
* Known bleeding diathesis
* Continued anticoagulants (Warfarin = Marcoumar must be bridged with low- or high-molecular heparin; commonly, intake of Aspirin or Clopidogrel is no contraindication for infiltration therapy but is routinely paused when possible)
* Pseudoradicular pain (e.g. in facet arthrosis, iliosacral arthrosis...) - as evaluated to the best of the knowledge of the admitting physician and radiologist performing the infiltration
* Osseous spinal or foraminal stenosis
* Myelopathy
* Severe scoliosis
* Active neoplasm
* History of spinal infection / spondylodiscitis
* History of spinal surgery or previous infiltration therapy on the currently painful segment
* Rheumatic disease
Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis

This study will compare the efficacy of cognitive therapy and exposure therapy for treating hypochondriasis.

Hypochondriasis is defined as a preoccupation with the fear of having a serious disease based on the person's misinterpretation of bodily symptoms (APA). For a long time hypochondriasis was seen as difficult to treat. Meanwhile effective psychological treatment for hypochondriasis exists. Psychotherapies using cognitive therapy (CT), cognitive behavioral therapy (CBT), exposure therapy (ET) or behavioral stress management approaches are effective in reducing symptoms of hypochondriasis. However, few studies compare different types of psychotherapy. In addition, in these studies numbers of participants were small, no differences between different treatments were found, and one third of the participants showed no satisfactory change. This study will compare the efficacy of CT and ET in a larger sample of 84 participants.

Participants in this randomized controlled trial (RCT) will first undergo baseline assessment. Then they will be randomly assigned to either CT, ET or a waiting list (WL), all conditions are for the duration of 12 weeks. CT includes psychoeducation, attention training, cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention. ET includes change of safety behavior, exposition (in sensu and in vivo), and relapse prevention. Both treatment trials contain the identical number of sessions. Treatment response will be assessed at week 12 and additionally one and three years after treatment. Participants of the WL will be assigned to CT or ET after the waiting period.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for hypochondriasis
* German fluency and literacy
* Informed consent

Exclusion Criteria:

* Major medical illness expected to worsen significantly
* Currently in psychotherapy
* Suicidal tendency
* Clinical diagnosis of alcohol or drug addiction, schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV
Black Cohosh Extract for the Management of Moderate to Severe Menopausal Symptoms in Thai Women

Cimicifuga racemosa (black cohosh) rhizome and root extract have been used to treat menopausal symptoms. To date, there are still scarce information about its efficacy in Thai women with menopausal symptoms. The purpose of this study will assess the efficacy of black cohosh extract in management of menopausal symptoms in Thai women.


Eligibility Criteria:
Inclusion Criteria:

* Thai women, aged ≥ 40 years
* Peri- or postmenopause
* Moderate to severe menopausal symptoms from Kupperman menopausal index score at least 20

Exclusion Criteria:

* Using any drugs or hormonal treatment within 1 month before enrollment
* BMI ≥ 30 kg/m2
* Allergic to drugs or any ingredient
* Liver disease or AST ≥ 37 U/L or ALT ≥ 40 U/L or total bilirubin ≥ 1 mg/dL or direct bilirubin ≥ 0.3 mg/dL
* Psychiatric disease
* Alcohol consumption or any elicit drug use
* Vegetarian (may consume more phytoestrogen)
Arabic Version of the EARS Questionnaire

A study to translate and cross-culturally adapt the Exercise Adherence Rating Scale (EARS) into the Arabic language, and assess its psychometric properties.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain patients: aged 18 years or older, experienced non-specific CLBP of 3 months or longer, pain localized to the lumbar region.
* Knee OA patients: eligible participants must meet the knee OA diagnostic criteria according to the American College of Rheumatology (ACR).

Exclusion Criteria:

* degenerative systemic diseases
* neurological symptoms
* lumbar stenosis
* spondylolisthesis
* history of spinal or knee surgeries
* pregnancy
* rheumatoid arthritis
* serious pathological conditions (inflammatory arthritis and malignancy)
* individuals who cannot read and understand documents written in the Arabic language.
Medical and Surgical Treatment of MRONJ (Medication-related Osteonecrosis of the Jaw Bones)

MRONJ is an acronym used to describe medication-related osteonecrosis of the jaw bones. It has been reported by the AAOMS that bisphosphonates or denosumab can cause this condition. The management of medication-related osteonecrosis of the jaw (MRONJ) is challenging, and there is ongoing debate over whether medical or surgical treatment is the gold standard. The aim of this retrospective study is to investigate the efficacies of medical and surgical treatments of MRONJ and comparatively evaluate their outcomes.

This study analyzed 116 MRONJ lesions in 102 patients, divided into medical and surgical treatment groups. Sixty patients in medical treatment group were treated with antibiotherapy following oral hygiene instructions, which included daily chlorhexidine mouthwash recommendation in addition to routine oral hygiene measures.The systemic antibiotherapy spanned 3 weeks. Once the intraoral infection was contained and brought under control, the borders of the necrotic bone were expected to become more prominent and spontaneous sequestration was expected to follow. Forty-two patients were treated surgically. During follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded. Outcomes after 12 months were categorized into four healing response groups. (H1) Complete healing: Complete healing with a total coverage of previously exposed bone by the oral mucosa, (H2) Partial healing: Healthy progress for clinical outcomes and downstaging of the lesion according to the AAOMS criteria, (H3) Stable disease: No clinical alterations without any change for the clinical stage of the lesion, (H4) Progressive disease: Deteriorated clinical outcomes following lesion upstaging.

Associations between variables and outcomes were assessed using Chi-Square and Fisher's exact tests.

Eligibility Criteria:
Inclusion Criteria:

* Use of antiresorptive and/or antiangiogenic drugs and consequent development of MRONJ.
* Absence of head and neck radiotherapy.
* Presence of necrotic bone in the maxillofacial region for at least 8 weeks.

Exclusion Criteria:

* Having undergone head and neck radiotherapy.
* Presence of active radiotherapy and/or chemotherapy.
* Missing information in treatment and follow-up records
Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy

The aim of this study is to compare the possible efficacy of baclofen and gabapentin on postoperative pain in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* - Age between 18-60 years old.
* Both male and female patients will be included.
* Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
* Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
* Patients fit for anesthesia and surgery.

Exclusion Criteria:

* Patients with BMI \>55 kg/m2.
* Patients with previous procedures for the treatment of obesity.
* Pregnant females and lactating women.
* Patients with psychological or psychiatric disease
* Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
* Patients who experienced vomiting within 24 hours before surgery.
* Patients with history of alcohol or drug abuse.
* Patients with hypersensitivity or contraindications to any of the drugs used in this study.
Implantable System for Remodulin Post-Approval Study

The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.

The ISR PAS is an observational, prospective, non-randomized, multi-center study. It will enroll a minimum of 50 newly implanted patients at up to 10 US sites, observing and reporting catheter-related complications and pump failures through 5 years post implant.

Eligibility Criteria:
Inclusion Criteria:

* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
* Subject is intended to receive an eligible ISR product.
* Subject is at least 22 years of age.

Exclusion Criteria:

* Subject is pregnant.
* Subject who is expected to be inaccessible for follow-up.
* Subject with exclusion criteria required by local law.
* Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness).
The Effect of Adjunct Vitamin a on Community-Acquired Pneumonia in Southern Iranian Children: a Randomized Clinical Trial

This randomized clinical trial included 105 children with CAP who were admitted to Bandar Abbas Children's Hospital. Participants were randomly assigned to two groups: a control group receiving standard antibiotic therapy and an intervention group receiving standard antibiotics plus vitamin A (25,000 IU for 2 days). Key data collected included age, sex, duration of hospitalization, treatment duration, and daily Respiratory Index of Severity in Children (RISC) scores.

Children to present with CAP symptoms

Eligibility Criteria:
Inclusion Criteria:

* children to present with CAP symptoms, including fever, cough, pulmonary rales, respiratory distress (age-adjusted tachypnea: \>50 breaths per minute for infants under 1 year, \>40 for ages 1-5 years, and \>30 for those over 5 years), and radiographic findings indicative of pneumonia.

Exclusion Criteria:

* underlying immunodeficiency, chronic respiratory conditions, concurrent use of immunosuppressive medications, prior high-dose vitamin A intake, and hospitalizations shorter than 24 hours
HFNC vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation

For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

For AECOPD patients, most of patients don't need respiratory support, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages: discomfort, low humidity and unstable fraction of inspired oxygen(FiO2) in inspiratory gas. Therefore, we design a RCT to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

Eligibility Criteria:
Inclusion Criteria:

* AECOPD; pH≥7.35, PaCO2\>45 mmHg

Exclusion Criteria:

* Need to be intubated immediately; refuse to engage in the study; severe organ dysfunction