cyrilzakka/clinical-trials huggingface dataset:
Effects of Thoracic Screw Manipulation in Patients With Cervical Radiculopathy

Cervical radiculopathy is a pain and/or sensorimotor deficit syndrome that is defined as being caused by compression of a cervical nerve root. The compression can occur as a result of disc herniation, Spondylosis, instability, trauma, or rarely, tumors.

Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine

Patient presentations can range from complaints of pain, numbness, and/or tingling in the upper extremity to electrical type pains or even weakness. Disc herniation accounts for 20-25% of the cases of cervical radiculopathy. Most of the time cervical radiculopathy appears unilaterally; however it is possible for bilateral symptoms to be present if severe bony spurs are present at one level, impinging/irritating the nerve root on both sides. If peripheral radiation of pain, weakness, or pins and needle are present, the location of the pain will follow back to the concerned affected nerve root Manual techniques include positional release technique, muscle energy technique, myofascial release technique, Cyriax technique, Natural Apophyseal Glides and Sustained Natural Apophyseal Glides, manual pressure release, proprioceptive neuromuscular facilitation and ischemic compression.

Thoracic spine manipulation (TSM) is defined as a high-velocity/low amplitude movement or "thrust" directed at any segment of the thoracic spine. Recent research has shown that Thoracic Joint Manipulation directed to the thoracic spine provides a therapeutic benefit to patients with neck pain and has been suggested as an appropriate strategy to minimize the risks associated with manipulation of the cervical spine

Eligibility Criteria:
Inclusion Criteria:

* Patients complaint from pain in the cervical spine and pain or paresthesia traveling from the neck into a specific region of the arm, forearm or hand
* Cervical Lateral flexion and rotation \<60 degree
* Positive scores on 3 of 4 clinical tests: Spurling's test, upper-limb neurodynamic test/median nerve bias, cervical distraction test, and cervical rotation toward the symptomatic side of less than 60°
* Hypomobility at T1- T5 thoracic vertebrae on springing test.

Exclusion Criteria:

* Participants with a history of vertebro-basilary artery insufficiency.
* Patient with history of cervical surgery or arthroplasty
* Patients with a positive history of trauma, fracture or surgery of the cervical
* spine
* Diagnosed cases of Torticollis, and scoliosis
* History of osteoporosis, Any heart disease
Prophylactic Administration of Vitamin C in Wrist Fractures

Complex Regional Pain Syndrome or posttraumatic dystrophy is a pain syndrome which develops after a trauma, surgery or for unknown reason. The incidence after wrist fractures varies in literature from 2 - 37%. The female sex is involved three times as much as the male sex. There is one study in literature which describes a prophylactic effect of vitamin C after wrist fractures. Goal of this study is to search for a dose dependent effect of vitamin C and to replicate these earlier findings.

The trial was designed as a multicentre, randomized, controlled study. Three hospitals in the Netherlands participated in this study, using the same experimental design.

Adults (18 years or above) with a wrist fracture who were seen in the emergency department of each hospital were asked to participate in this study. Patients were asked to start the trial medication on the day of the fracture. Two capsules had to be taken once daily for 50 days. Patients were allocated randomly to receive either placebo or a dosage of 200, 500 or 1500 mg of vitamin C daily.

The endpoint of the study was defined as the presence of CRPS at any moment, in the period up to one year after the fracture. All participants and physicians were unaware of the treatment allocation.

Patients were seen after 1 week, 4 or 5 weeks (or when the cast was removed), 6 or 7 weeks, 12 weeks, and 26 weeks. After one year patients were interviewed by telephone or received an inquiry letter with a postage-paid envelope for their reply. The normal fracture treatment, either conservative or operative, was not compromised by the protocol, and if necessary patients were seen more often and/or at other times than planned.

Complex regional pain syndrome was diagnosed when four of the following five symptoms were present throughout an area larger than the wrist, including the area distal to the wrist (hand and fingers), and if they occurred or increased after activity: unexplained diffuse pain, which is not in normal relation to the fracture; difference in skin color relative to the other arm; diffuse edema; difference in skin temperature relative to the other arm; limited active range of motion, unrelated to the stage of fracture treatment. If CRPS was diagnosed, the end point of the study was reached and the protocol was terminated to enable treatment for CRPS.

Eligibility Criteria:
Inclusion Criteria:

* wrist fracture
* adult (18 years and older)

Exclusion Criteria:

* no comprehension of the written information
* not able to appear for follow-up (living abroad)
Determine Return on Investment in Heart Failure Remote Monitoring Program

The study will test a hypothesis that the remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1) will have a higher return on investment compared to remote monitoring with nurse researcher follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2) and self-monitoring without intervention (Control).

The objective of this remote monitoring study is to evaluate return on investment and end-user clinical outcomes associated with the use of self-monitoring peripherals and tablet/smartphone-based Welch Allyn HealthInterlink technology without intervention (Control), HealthInterlink remote monitoring with text and email alerts sent to study subject and optional family/other caregiver (Intervention 1), and HealthInterlink remote monitoring with nurse research assistant follow-up telephone communication to study subject (on Blue alerts) or study subject's healthcare professional (on Red alerts) (Intervention 2 added to Intervention 1).

Eligibility Criteria:
Inclusion Criteria:

* Absence of significant vision, hearing, or other communication deficits
* English speaking;
* Capable and willing to give informed consent;
* Participated in the in-patient heart failure class within the last three months. Acceptable candidate for elective, non-emergent, remote monitoring as determined by ordering physician;
* Living in a private home;
* Hospital admission for Heart Failure or decompensation in the previous 12 months
* New York Heart Association (NYHA) classes II-IV, as assigned by the nurse researcher, trained by a cardiologist
* Cardiac aetiology: ischaemic, idiopathic, hypertensive, or valvular
* Left ventricular ejection fraction \<40% s an index of systolic dysfunction, combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.

or

* NYHA class II-III who had an ejection fraction \>40% and evidence of diastolic left ventricular dysfunction.
* Optional subject with a diagnosis of diabetes (indicated by HbA1c \>7).

Exclusion Criteria:

* Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
* Females who are pregnant, planning to become pregnant within 3 months, or lactating;
* Requirement for emergent placement other than private home (subject's condition would be compromised if there is a delay in placement).
* Myocardial infarction, revascularization or Implantable Cardioverter Defibrillator (ICD) implantation in the previous 6 months angina or objective myocardial ischaemia requiring future revascularization implanted ventricular or atrial pacemaker (except dual chamber ICD pacemakers with good sinus activity);
* End-stage heart failure requiring regular inotropic drug infusions;
* Chronic renal failure requiring dialysis treatment and
* Unstable angina.
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"

The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.

The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer.

This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.

The survey will enroll approximately 300 patients.

- Leuprorelin

This multi-center survey will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

- Participants with premenopausal breast cancer will be included.

Exclusion Criteria:

* Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues
* Pregnant or potentially pregnant participants and breastfeeding participants
COPE: Cannabinoids to Obviate Pain Experiment After Knee Replacement

Total knee replacement is a major and painful orthopaedic (joint and bone) surgery where the knee joint is replaced with an artificial joint. It is an effective and successful procedure to treat severe knee arthritis and reduce pain, but many patients report intense pain after the surgery.

Postoperative pain control is predominated by opioids (morphine-based drugs). While opioids are effective to manage the pain, they can have acute and chronic complications, including confusion, nausea, vomiting, constipation and high risk of addiction.

Medical cannabis is an effective and safe alternative for pain treatment. Recent studies showed that patients have reported a reduction in opioid usage when taking cannabis as a substitute for pain relief.

This study aims to investigate whether adding medical cannabis (cannabidiol - CBD) treatment will decrease the amount of opiates needed in the first 2 weeks after knee replacement compared to a group given placebo.

COPE (Cannabinoids to Obviate Pain Experiment after knee replacement) will be a single-centre, prospective, randomized, placebo-controlled, superiority trial, with two parallel groups designed to investigate the effect of cannabis as postoperative pain treatment compared to placebo on total opioid consumption after total knee replacement.

Eligible patients are: men and non-pregnant women aged ≥18 years scheduled to undergo primary total knee replacement. and with no opioid usage within the last 3 months or history of narcotic abuse.

Patients will be recruited at the department of orthopaedic surgery at St Michael's Hospital (Toronto - Canada), and informed consent will be obtained from those eligible. Central computer-generated randomization will be used to randomly assign participants to cannabis or placebo groups (1:1 ratio). Only the study pharmacist will know allocated treatments.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Men and women
* Patients with radiographic confirmation and clinical correlation for severe osteoarthritis diagnosis with an indication for total knee replacement
* Patients undergoing primary unilateral total knee replacement
* Patient is able to provide informed consent to participation in the study

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Current opioid use
* Cognitive impairment or mental illness (e.g., dementia, Alzheimer disease and psychoses), which will prevent patients from reliably providing primary outcome data
* Unable to swallow an oral tablet (medication)
* History of opiate, narcotic and alcohol abuse
* Revision total knee replacement surgery
* High risk of falls as determined by the treating physician
* Patients refusing participation
* Pre-existing/ regular cannabis use
Optical Defocus to Stimulate Eye Elongation in Hyperopia

Axial hyperopia results when the length of the eye is too short for the eye to properly focus distance objects on the retina while the focusing system is relaxed. Emmetropization is the process by which the eye actively adjusts various components of the eye to gradually improve the focus of the eye. Emmetropization frequently involves either an increase or a decrease in the growth of the eye, particularly during infancy and childhood. Numerous animal studies suggest that if an animal is exposed to retinal images located behind the retina either centrally or peripherally, the eye will grow in the direction of the focused image. If an abnormally short eye has resulted in hyperopia, exposing such an eye to retinal images partially located behind the retina might encourage axial elongation, thus reducing the hyperopia.

Hyperopia or farsightedness may cause distance vision and near vision to be blurred. Depending on the severity of the condition and the age of the patient and the status of the binocular vision system, hyperopia can also cause fatigue, asthenopia, headaches, double vision, and amblyopia. Low to moderate amounts of hyperopia rarely cause much difficulty in the young person, but will eventually cause significant near vision problems as the patient ages. Hyperopia can be caused by the eye being too short (axial hyperopia) or by the cornea being too flat or the crystalline lens being to weak (refractive hyperopia). It has been established by the PI that axial growth can be dramatically lessened in children and adolescents with myopia through the use of bifocal contact lenses prescribed in a particular way (The CONTROL Study). Studies by Earl Smith, O.D., Ph.D. have suggested that multi-zonal contact lenses that provide proper axial focus while manipulating peripheral defocus can either discourage or encourage axial growth to treat myopia or hyperopia respectively. In the present study, simultaneous vision bifocal soft contact lenses will be used to encourage axial growth in hyperopic children and adolescents with axial hyperopia in an effort to reduce hyperopia. Subjects will be randomly assigned to wear either bifocal soft contact lenses or single vision soft lenses. The bifocal contact lenses will be prescribed to provide for clear central vision at both distance and near with the near zone of the contact, thus exposing the retina to hyperopic defocus from the distance zone.

Eligibility Criteria:
Inclusion Criteria:

* Aged 5-12
* Hyperopia \> +1.25 each eye (cycloplegic refraction)
* Ability to wear soft contact lenses

Exclusion Criteria:

* Amblyopia
* Strabismus
* Astigmatism \> 1.00 diopters
* Axial Length \> 24.00 mm
Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer

Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.

The study quantifies the reduction of pain and changes in quality of life associated with vertebral augmentation. This study is conducted in patients with metastatic cancer or multiple myeloma involving the spine. This study addresses the value of vertebral augmentation in combination with radiotherapy in the setting of cancer to the spine. The patient's pain, overall quality of life, and fracture development/avoidance will be compared to patients treated only with radiotherapy in the past.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic disease to the vertebra or multiple myeloma
* Negative pregnancy test within 2 weeks prior to registration
* Life expectancy of \>= 3 months and Karnofsky performance status (KPS) score \>= 40
* Pain scale score \>=5
* Pain at involved vertebral body not adequately controlled
* Osteolysis of vertebral bodies
* Must agree to practice adequate means of birth control
* Must sign informed consent prior to study entry
* Must be able to understand the English language
* Absence of any serious cognitive or psychiatric problems potentially hampering compliance with the study and follow-up schedule.

Exclusion Criteria:

* Spinal Cord Compression
Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients

This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients. Results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.

Virtual reality (VR) imitates reality by creating an artificial 3-dimensional (3D) environment using computing technology or software. A virtual environment (VE) is created using this software with a headset, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a VE allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled VE. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. We followed in similar footsteps and designed and developed a novel, 3D simulated software platform prototype called ReCognition VR to provide VR-based cognitive exercises.

A feasibility clinical trial conducted by our group tested the ReCognitionVR cognitive interventions on older and young healthy volunteers (NCT05583903). The results of this study showed that ReCognitionVR-based cognitive exercises were feasible, acceptable, and tolerable by older healthy subjects. In stage 2 of our research study, we want to evaluate the safety, feasibility, acceptability, and tolerability of VR-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at Houston Methodist Hospital (HMH). Our premise is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed environment with beach wave sounds.

Eligibility Criteria:
Inclusion Criteria:

* ≥60 years of age
* Scheduled to undergo the following abdominal surgeries (open or laparoscopic or robotic assisted): small bowel and large bowel surgery; cholecystectomy; Whipple procedure; pancreatectomy; splenectomy.
* Richmond Agitation-Sedation Scale (RASS) Score 0

Exclusion Criteria:

* Subjects with baseline cognitive impairment
* Person with active psychiatric disorders and being treated with medications, especially schizophrenia
* Person who is deaf or blind
* Person with an underlying cognitive disorder or associated phobias (e.g., claustrophobia)
* Person participating in other clinical trials involving drugs, biologics, devices, or behavioral interventions
* Active seizure disorders
Survival Among Patients With Pancreatic Cancer Depending on Surgical Resection Rate

The primary aim of this population-based study is to investigate how a high resection rate of pancreaticoduodenectomy affects overall survival among patients aged ≥70 years with pancreatic ductal adenocarcinoma. The secondary aim is to determine if a high resection rate of pancreaticoduodenectomy increases perioperative morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed between 1 January 2010 and 31 December 2018
* Registered in the Swedish National Registry for tumours in the pancreatic and periampullary region
* Either a diagnosis of pancreatic ductal adenocarcinoma of the pancreatic head or having been resected with pancreaticoduodenectomy

Exclusion Criteria:

* None
Neuromuscular Electrical Stimulation With and Without Constraint Induced Movement Therapy in Erb's Palsy

Erb's Duchenne paralysis constitutes the single commonest form of brachial plexus injury, brachial plexus injury (BPI) is unfortunately a rather common injury in newborn children. Incidence varies between 0.15 and 3 per 1000 live births in various series and countries. The constraint-induced movement therapy (CIMT) has been used to promote functional gains in individuals with neurological dysfunctions .The constraint-induced movement therapy consists of constraining movement of the non-affected upper extremity and providing intensive training to the involved upper extremity. Neuromuscular electrical stimulation (NMES) has been used for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilisation, selective muscle retraining, and the control of oedema.The aim of this study is to compare the effects of Neuromuscular Electrical Stimulation with and without Constraint Induced Movement Therapy on Upper limb Function in Children with Erb's Palsy.

It is a Randomized Controlled Trial.The sample size calculated by using OpenEpi or GPower. Data will be collected from Jinnah Hospital,Children Hospital,Lahore medical city hospital,Farooq hospital,Rising sun institute and PSRD. The patients will be selected through non-probability convenience sampling,will be divided into two groups. The Group A will receive habituation exercises for six weeks, three times per week for thirty minutes, along with application of neuromuscular electrical stimulation for a period of 6 weeks four times a week and perform Constrained induced movement therapy techniques, each for 8 weeks.The interventions are consisted of 3weeks of casting the unaffected limb followed by 5 weeks of transference activities.. The Group B will be given neuromuscular electrical stimulation for a period of 6 weeks four times a week.Range of motion ,Flexibility exercises will be given as baseline treatment to both groups. The arm function was evaluated by the Mallet score system, while active abduction and external rotation range of motion were measured by a standard universal goniometer. Data will be analyzed by SPSS 25.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 2.5 to 8 years years
* Clinically diagnosed with erb's palsy/brachial plexus palsy
* Ability to cooperate with assessments and therapy
* Full passive ROMs in all motions at the shoulder, elbow, and wrist joints

Exclusion Criteria:

* Cognitive impairment
* Contracture in the affected upper extremity
* Injured unaffected arm
* Visual problems likely to interfere with treatment/testing
* Previous orthopedic or neurological surgery
* Previous application of CIMT
A See and Treat Paradigm for Cervical Pre-cancer

The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer.
* Age 25 and greater
* Patients of all ethnic backgrounds will be included.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Children and subjects under 25.