cyrilzakka/clinical-trials huggingface dataset:
The Effect Of Ears Acupuncture On Fitness Test 12 Minutes Running in Students Of Medical Faculty UNHAN RI

The goal of this clinical trial is to study the use of ear acupuncture in 12 minutes running test on third semester of cadets of Medical Faculty, Indonesia Defense University, between intervention and sham group. The outcome measure are heart rate, blood pressure, running distance, intensity and VAS RPE also VAS leg intensity.

Ear acupuncture is a affordable, easy and non-invasive method with good evidence of effectiveness in the scope of physical training. Several previous studies has proven the effectiveness of acupuncture in physical exercise, including helping increases oxygen absorption and reduces lactic acid after exercise, lowering chronic musculoskeletal pain. In reducing pain after physical activity, ear acupuncture has been shown to reduce VAS leg intensity. This shows that ear acupuncture can helps athletes recover after intense training faster. At the Defense University of the Republic of Indonesia (UNHAN RI), Study Program students Bachelor of Medicine (cadet) has both academic demands and military training. The military education demands high stamina and physical fitness. To make sure the cadets are in a fit condition to face daily activities with a busy and numerous schedule physical activity, a physical fitness assessment is carried out at the end of each semester using the 12 run test. By doing this test, principal investigator aims to observe the effect of giving ear press needle acupuncture compare with sham on running 12 minutes in Indonesian Defense University student of medical faculty.

Eligibility Criteria:
Inclusion Criteria:

* Indonesian Defense University Military FK Student Batch 4, Third semester
* Gender male or female, age 18-20 years
* Physically healthy based on the results of medical check-ups in the last 6 months mini medical check up (blood pressure, pulse, saturation, glucose and, Hb check carried out by researchers) as well as being eligible for physical exercise, assessed by PAR-Q questionnaire, history and physical examination
* Willing to follow this research until completion and sign informed consent.
* BMI is normal
* Regularly exercise 5x a week with moderate to heavy intensity categories good physical fitness level
* Do not consume caffeine and high calorie foods high in sugar for 1 hour before the test run

Exclusion Criteria:

* Taking anti-inflammatory drugs (corticosteroids), anti pain (NSAIDS, opioids), muscle relaxants (diazepam, eperisone, etc.) or taking blood thinning drugs (anti-platelet or anti-coagulant drugs).
* Have received any type of acupuncture therapy for some time \<7 days before the study.
* History of anti-inflammatory drug treatment in the previous 2 weeks.
* There are tumors, wounds or skin infections, eczema, otitis externa and psoriasis in matchmaking area.
* There was a hypersensitivity reaction to previous acupuncture therapy (allergy metals, severe atopy, keloids, or other skin hypersensitivity).
* Participants had multiple ear piercings.
* Have had surgery on the waist, hip, knee and ankle area before last 1 year.
Predictive Factors and Subthalamic Stimulation in Parkinson's Disease

This study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study French with standardized collection of clinical data , imaging and genetic .

The investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). This is part of a process of "personalization" of the therapeutic care that is of any interest to the subthalamic stimulation. It is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . In addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a pre- therapeutic assessment and therapeutic monitoring for one year , 3 years and 5 years as part of the regular monitoring of the subthalamic stimulation
* Bilateral STN stimulation considered
* Patient able to provide their free and informed consent
* Patient with insurance coverage

Exclusion Criteria:

* Atypical Parkinson's disease do not meet the criteria of stuff .
* MP under 5 years
* Severe cognitive impairment or dementia ( Score Moca \<24 and DSM-IV criteria)
* Parkinson's Psychosis
* Reply to L- dopa \<30 %
* Against indication for surgery
* Severe brain atrophy or abnormal MRI
* The presence of another very serious condition terminal life- short-term prognosis ( malignancy ) is an indication against .
Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery

Degenerative lumbar spinal diseases have become a common health problem and the most frequent indication for spinal surgery in elderly individuals. It mainly contain lumbar spinal stenosis and spondylolisthesis, occurs in most people over 60 years of age, and patients primarily diagnosed with lumbar degenerative disease are more likely to have osteoporosis. Our study was to explore denosumab effect on bone quality and functional status in osteopenia patients with lumbar degenerative diseases after lumbar fusion surgery.

However, It was still unknown for denosumab effect on osteopenia patients after lumbar fusion. Bone mineral density(BMD), bone turnover marker, lumbar functional status Roland-Morris Disability Functioning Questionnaire (RMDQ) and quality of life EuroQol Five-Dimension (EQ-5D), and Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) score, rate of new fracture, re-operation, lumbar fusion, complications or adverse events were still unknown. Our study will explore the effect of denosumab on lumbar, total hip, femoral neck BMD and bone turnover markers, functional status EQ-5D, QUALEFFO-31 and RMDQ score of participants after lumbar fusion at 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 40 to 85 years
* who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis
* osteopenia with BMD T score between -1.0 and -2.5 via dual-energy X-ray
* low back pain or leg numbness or weakness
* MRI demonstrated signs of nerve compression

Exclusion Criteria:

* cauda equina syndrome
* progressive neurologic deficit
* history of cancer
* scoliosis greater than 15°
* back open surgery history
* have contraindications for surgery
* who had anti-osteoporosis medication within 6 weeks
Utilization of Airway Stabilizing Rod

The pediatric airway is known to be more challenging than the adult airway when performing endotracheal intubation. When a patient cannot be ventilated and/or intubated, the guidelines for airway management dictate that a laryngeal mask airway (LMA) be used as a rescue device to oxygenate and ventilate the patient. While an excellent device the LMA is seen as temporary and ultimately needs to be replaced by an endotracheal tube (ETT).

The objective is to study this device in patients with difficult airway to assess the success rate and time to intubation for placing an endotracheal tube using this device.

Eligibility Criteria:
Inclusion Criteria:

* Ages 5-18 years
* Requiring intubation
* Known difficult airway
* LMA placement possible

Exclusion Criteria:

* Known normal airway
* Procedure not requiring endotracheal intubation
* Parental refusal
* Patient dissent
Revision of the Hip Joint - Prospective Study

Between the years 1999-2011 70 patients went through a revision of the hip joint(revision after not successful Total or Partial Hip Replacement). During the revision the Acetabular implant was found to be stable and it was decided not to replace it. The polyethylene insert was replaced and was fixated using a cement. Our purpose is to evaluate the physical condition of these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients that underwent a revision of the hip replacement without removing the acetabular implant
2. Insert polyethylene with cement
ERCP Plus Laparoscopic Cholecystectomy Versus Laparoscopic Common Bile Duct Exploration and Cholecystectomy

Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.

Around 10-18% of patients undergoing cholecystectomy for gallstones have common bile duct (CBD) stones. Currently, various procedures for the treatment of cholecystocholedocholithiasis are available including open cholecystectomy plus open common bile duct exploration (OC+OCBDE), laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE), may be trans-cystic or trans-choledochal, and laparoscopic cholecystectomy plus endoscopic retrograde cholangiopancreatography (LC+ERCP), which may be performed pre, at, or after LC.

Single-session treatment of gallbladder and CBD stones is safe, efficient, shortens hospital stay, and is less expensive than staged procedures.

Although there is some evidence suggesting that LCBDE may be associated with a lower rate of retained stones compared with ERCP, previous studies comparing LCBDE with ERCP and stone extraction have collectively failed to demonstrate the superiority of one approach over the other.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with cholecystocholedocholithiasis
2. American Society of Anesthesiologists (ASA) scores of I-III
3. Age 20-70 years.

Exclusion Criteria:

1. cholangitis,
2. acute biliary pancreatitis,
3. suspected Mirizzi syndrome,
4. suspected hepatobiliary malignancy,
5. perforated gallbladder,
6. biliary peritonitis,
7. intrahepatic stones,
8. pregnancy,
9. previous cholecystectomy,
10. altered anatomy such as Billroth II reconstruction or any form of Roux-en-Y reconstruction that interfere with the endoscopic approach,
11. Contraindications to laparoscopic surgery as severe liver cirrhosis or upper abdominal surgery were excluded.
Adherence Rate of Monthly Bubble Package Among Patients Prescribed Adjuvant Endocrine Therapy in Breast Cancer Survivors

This study aims to establish the feasibility of using a monthly bubble package to improve compliance rates among women prescribed adjuvant endocrine therapy.

This study uses Bubble packaging to provide a cost effective way to improve compliance and help direct further interventions to ensure adherence in women on anti-estrogen therapy for breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Estrogen receptor positive (\> 1% estrogen expression) by immunohistochemistry
* Invasive breast cancer (stage I, II, III) or DCIS considered for adjuvant endocrine therapy

Exclusion Criteria:

* Patients with metastatic disease (stage IV)
* Patients less than 18 years of age
* Prisoners
* Patients are unable to fill prescriptions at the BCC pharmacy due to insurance limitations or personal preference
Casting Versus Percutaneus Pinning Treatment of Pediatric Overriding Distal Forearm Fractures

This is a randomized controlled trial comparing casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in under eleven years old children.

Overriding pediatric distal radius fractures have been managed with anatomical reduction performed under anesthesia with or without percutaneous pinning. This research protocol was developed due to good results reported on leaving the fractures in an overriding position.

In this randomized controlled trial, we will compare objective outcomes between casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in children.

Inclusion criteria are patients younger than 11 years old (Tanner 0) with completely overriding distal radius fractures. At the emergency department patients are randomized into two groups: finger trap traction and cast immobilization (experimental group) and anatomic reduction and percutaneous pin fixation (control group).

The current controversy is whether cast immobilization alone is an adequate stabilization or whether percutaneous pin fixation is more appropriate for displaced, complete, distal forearm (overriding) metaphyseal fractures. The objectives of this trial are to compare the outcomes between conservative treatment with finger trap method for completely displaced distal radius fractures and surgical treatment with percutaneous pinning. Our null hypothesis is that there are no radiological or clinically relevant differences in outcome measures between the two treatment groups. We consider non-inferiority proven if there is no clinically significant difference at 6 months between the two treatments groups in the primary outcome: ratio (%) of forearm rotation and wrist extension-flexion range of motion (ROM) compared to the non-affected side at 6 months (non-inferiority margin 10%).

Eligibility Criteria:
Inclusion Criteria:

* Child with open epiphysis with closed overriding metaphyseal distal radial fracture with or without an associated fracture of the ulna
* Normal communication development (languages Finnish, Swedish, English)

Exclusion Criteria:

* Bilateral forearm injuries
* Gustillo-Anderson grade II or III open fracture
* Galeazzi fracture-dislocation
* Polytrauma
* Neurovascular injury of the ipsilateral upper extremity
* History of a displaced forearm fracture
* Underlying disease affecting fracture healing
Pilot Study of an Oral Chemotherapy Teaching Tool to Improve Adherence in Patients With Multiple Myeloma

Multiple Myeloma is an incurable cancer. Therapies for it include oral chemotherapy pills. It is unknown whether patients regularly and correctly take these anti-myeloma pills. This study wants to measure the rate of adults with MM taking anti-myeloma pills correctly. The investigators also want to use a teaching tool to see if it will help patients feel more satisfied and more confident in taking their anti-myeloma pills correctly. The investigators hope to use this data from this small study to eventually do a larger study in this area.

The prevalence of patients with myeloma utilizing orally-administered myeloma therapy (OMT) is expected to continuously rise within Canada. The MASCC Oral agent Teaching Tool (MOATT) interventional tool relies on the concept of improved patient education in turn leading to improved adherence. Although the MOATT intervention is currently endorsed by Cancer Care Ontario, there is no data using the MOATT intervention in patients with myeloma or within Canada. Prior to embarking on a larger, multi-center study, a pilot study is necessary to 1) understand the feasibility, acceptability of the MOATT intervention and its preliminary efficacy 2) to determine the rates of adherence to OMT and explore factors associated with non-adherence and 3) to determine the feasibility of a larger multi-centre trial.

Eligibility Criteria:
Inclusion Criteria:

* Will include adults (age\>18) with multiple myeloma who will be initiating OMT (lenalidomide or pomalidomide in the next 6 months) for either newly diagnosed, maintenance-phase or relapsed myeloma at the JCC

Exclusion Criteria:

* Patients who reside in a facility in which their medications are administered to them (such as a nursing home)
Prospective Monitoring of BNT162b2 Second Vaccination Booster Effects in Health Care Workers (HCW)

The SARS-CoV-2 virus causes severe respiratory illness and is an ongoing global pandemic. On December 12, 2020 the FDA approved Pfizer's BioNTech vaccine BNT162b2 which is a messenger RNA type of vaccine for use. This vaccine has shown in numerous studies the ability to induce a strong immune response and provide both humeral and cellular protection against wild type, alpha and delta variants of SARS-CoV2 virus.

In Israel the national vaccine operation began in mid-December 2020 which included 2 initial doses three weeks apart. In August 2021 a first booster (3rd dose) was provided to enhance protection and due to reports of reduced immune response and clinical protection. Several studies have demonstrated that over time there is a decay in the antibody levels, and with them reduced protection.

Recently a new variant of concern has been identified (Omicron) and is causing a surge of infections worldwide. There is lack of knowledge regarding the effectiveness of the current schedule of vaccine against this new variant and whether a second booster (4th dose) will provide higher levels of clinical protection against this variant, currently the ministry of health is considering recommendations for a fourth dose for HCW.

The purpose of this study is to examine whether a fourth dose of vaccination will provide better protection against infection and clinical disease.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent.
2. Healthcare worker in one of the Clalit Health Services Medical centers and is at least 18 years of age.
3. Completed three doses of BNT162b2 according to MOH guidelines.
4. Third dose was given at least 4 months prior to enrollment.

Exclusion Criteria:

1. History of COVID-19 infection.
2. History of being treated or is currently being treated for any type of Malignancies or other co-morbid conditions that may result in protocol non-compliance.
3. Currently or in the past three months was treated with any type of Immune suppression medication (including chemotherapy, immunomodulatory drugs, biological agents that affect the immune system, any immunosuppressive drug such as corticosteroids).
4. Received in the past 4 months monoclonal antibodies of any type.
The PseAn Study - Study Protocol

The researchers aim to study the role of contrast ultrasound in detecting post-traumatic splenic, hepatic, and renal PAs compared with the gold standard of CT with intravenous contrast at different follow-up time points, and whether it can replace CT scan in the follow-up of solid organ injuries

Adult patients (18 years old and above) with proven blunt or penetrating splenic and/or liver and/or renal trauma as shown by a CT scan and classified according to the American Injury Scale American Association for Surgery (AAST) Organ Injury Scale (OIS) with OIS III and above will undergo a follow-up with both a CEUS and CT scan to detect post-traumatic parenchymal pseudoaneurysm within two to five days from injury. Follow-up over five days post-admission will be included if they were performed within the same hospitalization

Eligibility Criteria:
Inclusion Criteria:

* adult patients (18 years old and above) with proven blunt or penetrating splenic and/or liver and/or renal trauma as shown by a CT scan and classified according to the American Injury Scale American Association for Surgery (AAST) Organ Injury Scale (OIS) will be included

Exclusion Criteria:

* minor to 18 years old
Impact of Low Muscle Mass in HNC Treated With Immunotherapy

The purpose of the study is to evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)

Body composition including sarcopenia (loss of muscle mass), sarcopenic obesity, and mioesteaosis has been well reported to be an independent predictors of mortality, toxicity, and complications in cancer patients with different locations and treatments. However, there are currently no data on impact of body composition and the oncological outcomes in SCCHN patients treated with immune checkpoint inhibitors (ICI) due to recurrence or metastasic disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with recurrence or metastatic SCCHN treated with antiPDL1, antiPD1 or antiCTLA-4 drugs, alone or in combination within our institution.
* Patients who have previously signed informed consent.
* Patients with measurable tumor lesions.

Exclusion Criteria:

* Patients with non-measurable lesions.
* Patients who do not sign the informed consent.
* Patients not treated with immunotherapy.
* Patients in a double-blind trial in whom the assigned branch is not known.
Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization

In the early 2000s , professional and patient organizations are mobilizing to highlight the psychosocial impact of cancer disease , not only during but also after the acute phase.

In 2003, the government launched the Cancer Plan I reinforced in December 2011 by the Cancer Plan II whose objectives include : " Develop a personalized care taking into account the pain and psychological and social support " and " increase opportunities for patients to benefit from supportive care "and" promote the professional integration .

This study aims to show that beyond the immediate benefits of the social aesthetic cares in hospital (direct soothing, improving the quality of the skin injured by chemotherapy , feeling of escape ... ), these treatments can also affect quality of life for patients during and after hospitalization. They also may have an impact on the maintenance of social and / or professional satisfactory throughout the planned chemotherapy aplastic period .


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* Hospitalized in the Hematology care unit in UH Angers
* Initial Hodgkin lymphoma, diffuse large B-cell lymphoma and mantle cell lymphoma
* Without previous socio-aesthetic care.

Exclusion Criteria:

* Age \<18 years old.
* Patient protected by the law.
* Patient at end of life.
* Patient unable to respond to the questionnaire.
* Previous Socio aesthetic care.