cyrilzakka/clinical-trials huggingface dataset:
Locating Nociceptive Stimuli on Digital Body Chart

Digital body charts are used to assess the pain experience in people with pain. People are asked to report their pain by shading a human body template on a digital tablet. The aim of this study is to investigate whether people with chronic low back pain, compared to healthy volunteers, consistently locate on a digital body chart all nociceptive stimuli induced in the lumbar region.

Healthy volunteers and people presenting chronic low back pain, will be recruited. A standardized grid will be drawn over the participants' lumbar region. Circular electrodes, connected to a constant current stimulator, will be applied at points on the grid. All participants will be blinded to the electrode locations. Painful electrocutaneous stimuli will be randomly delivered for each electrode. Participants will be instructed to draw with a stylus pen on a digital body chart displayed on a tablet where they will perceive each painful stimulation.

The body chart will be centred on a canvas 768x1024 pixels (pxl), and pain location will be defined by X and Y coordinates. The consistency in reporting the location of each painful stimulation will be described through coordinates.

In addition, only people presenting chronic low back pain will be asked to provide information about their lifestyle, level of disability, actual pain and general pain, assessment of kinesiophobia and health status.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain (duration more than three months)

Exclusion Criteria:

* denial of informed consent;
* presence of pacemaker;
* pregnancy or possible pregnancy status;
* lumbar surgery (spinal fusion);
* documented degenerative pathology of the central nervous system;
* documented concomitant pathology altering sensitivity (e.g. diabetes, fibromyalgia);
* reduced motor control of the dominant hand (reported by every subject as conditioning the writing and therefore the ability to compile the body chart);
* presence of skin moles and/or scars on the back that may interfere with the conduction of the electrical stimulus.
Clinical Evaluation of the CADenceTM System in Detection of Coronary Artery Diseases

The purpose of the study is to evaluate the effectiveness of the CADence system, a non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in the coronary tree.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Willing and able to give informed consent
* Indicated for angiography evaluation.

Exclusion Criteria:

* Pregnant or nursing
* Presence of pacemaker/defibrillator
* Presence of artificial valve
* Presence of severe valve disease
* Presence of congenital heart defect
* Left Ventricular Assist Device (LVAD)
* Presence of a bypass graft
* Presence of scars on the site thorax areas
* Coarctation of the aorta
* Participation in trial within 30 days prior to collecting CADenceTM data
* Asthma with wheezing
* Inability to lie flat in the supine position
* Acute STEMI
* Heart Transplant
* Recent Cocaine Use
MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. This diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. The lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.

PRIMARY OBJECTIVES:

I. Identification of one of more lesions suspicious for prostate cancer using a novel MRI protocol, not identified by transrectal ultrasound (TRUS) alone and to determine if the lesions identified by MRI demonstrate clinically significant prostate cancer based on pathologic findings (ie. Gleason \>= 7 or percentage of core involved with cancer \> 50%).

SECONDARY OBJECTIVES:

I. Average time for MRI scan per patient. II. Correlation of lesions on MRI to radical prostatectomy specimens. III. To determine whether MRI 3 dimensional (3D) T2 half-Fourier acquired single turbo spin-echo (HASTE) or sampling perfection with application optimized contrast using different flip angle evolutions (SPACE) protocols provide improved rates of prostate cancer detection.

IV. Yield of additional clinically significant prostate cancer diagnoses based on MRI targeted lesions on biopsy.

V. Rate of benign pathology identified by MRI (i.e. false positives). VI. To compare costs associated with the use of MRI over TRUS biopsy alone.

OUTLINE:

Participants undergo pelvic MRI. Within 1-2 weeks, patients undergo scheduled prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Abnormal prostate-specific antigen (PSA) blood test

  * \> 2.5 ng/mL for men \< 50 years (yrs) of age
  * \> 3.5 ng/mL for men \< 60 yrs of age
  * \> 4.5 ng/mL for men \< 70 yrs of age
* Abnormal digital rectal exam (i.e. palpable nodule, induration or firm area to the prostate)
* Scheduled for a TRUS biopsy based on clinical suspicion for prostate cancer

Exclusion Criteria:

* Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer
* Contraindications to TRUS/prostate biopsy (BX)

  * Currently on blood thinning agents (Plavix, Coumadin etc.) or bleeding disorder
  * Active urinary tract infection
  * Acute painful perianal disorder (i.e. rectal abscess)
* Contraindications to MRI

  * Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips
  * The presence of an implanted pacemaker or implanted defibrillator device
  * Patients with contraindications for MRI due to embedded foreign metallic objects: bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient
  * Implanted medical device not described above that is not MRI-compatible
  * Known history of claustrophobia
* Individuals with a short life expectancy (\< 10 years)
Organized Self-management Support for Chronic Depression

This study aims to adapt and pilot test two core elements of an organized care program (systematic telephone outreach and monitoring to improve quality and continuity of pharmacotherapy, and structured psychoeducational group programs focused on patient activation and self-management) in a population-based sample of patients with chronic or recurrent depression.

This study aims to adapt and pilot test two core elements of an organized care program (systematic telephone outreach and monitoring to improve quality and continuity of pharmacotherapy, and structured psychoeducational group programs focused on patient activation and self-management) in a population-based sample of patients with chronic or recurrent depression. Two forms of group self-management training will be evaluated: a Peer-Led Chronic Disease Self-Management Group (after that developed by Lorig and colleagues) and a Therapist-Led Cognitive-Behavioral Therapy Group. Approximately 100 patients with chronic or recurrent depression were randomly assigned to one of four conditions: 1) usual care; 2) phone care management; 3) phone care management plus peer-led self-management group; or 4) phone care management plus therapist-led CBT group. Blinded assessments will examine clinical outcomes (SCL depression score, depression diagnosis by SCID), functional outcomes, and process variables (self-efficacy for managing depression, use of coping strategies) over 12 months. If patients choose not to participate in treatment, reasons for dropout were assessed. The data collected will provide:1) an evaluation of the feasibility and acceptability (including recruitment, intervention uptake and continued participation) of the intervention programs; 2) preliminary evaluation of effectiveness, i.e., the effects of each intervention on patient outcomes and process of care; and 3) information to inform the design and implementation of a full-scale effectiveness trial (refinement of intervention programs and measurement strategy, necessary sample size).

Eligibility Criteria:
Inclusion Criteria:

* history of at least one major depression in the last two years
* history of recurent major depression or dysthymia
* significant residual symptoms after 6 months of treatment

Exclusion Criteria:

* history of mania or hypomania
* cognitive impairment
* near-terminal medical illness
* intent to disenroll from health plan

emergent clinical needs

-
Eisenmenger Syndrome in the Nordic Countries

This is a historical cohort study with retrospective collection of data comprising all Nordic patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is to determine prognostic factors for mortality and morbidity.

The following variables are obtained from national registries for each individual fulfilling the inclusion criteria:

* Personal data: Gender, day of birth, vital status (dead/alive), date of death, cause of death, all cause hospitalization days
* Specific cardiac malformation diagnosis
* Heart-lung transplantation.
* Social data: Highest educational level, marital status, employment status (Denmark only)

Primary endpoints

* Incidence and prevalence of Eisenmenger Syndrome
* All-cause mortality
* All-cause morbidity (hospitalization for any cause)
* Heart-lung transplantation
* Advanced treatment
* Mortality with AT
* Highest educational level
* Personal income
* Marital status
* Job status

Eligibility Criteria:
Inclusion Criteria:

* Eisenmenger syndrome

Exclusion Criteria:

-
Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA

The aim of this study is to investigate the clinical outcome of the two different, but widely used, surgical approaches (Posterior approach and Lateral approach) of primary total hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main study and two sub-studies. The main study investigates the patient-reported outcome measures (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the level of physical function and pain within the first 3 month after surgery, and ii) investigate the potential difference the two approaches have on gait-patterns and maximal isometric hip-muscle-strength, within the first year after surgery. Both approaches are described with potential drawbacks. Posterior approach has a higher risk of dislocation of the prostheses and revision due to dislocation compared with Lateral approach. Contrary, Lateral approach is described with the potential drawbacks of pain, lower physical function, gait abnormalities and muscle weakness, leading to less satisfied patients. However, according to a Cochrane analysis from 2004 concludes, more investigation is needed to determine the extent of differences.


Eligibility Criteria:
Inclusion Criteria:

* Age: 45-70 years, both included.
* Patients schedule for primary cementless total hip arthroplasty.
* Endstage hip osteoarthritis(OA) or minor dysplasia of the hip(CE-angle \> 20 degrees).

Exclusion Criteria:

1. more major joint (hip or knee) than the current hip affected with OA, with expected joint replacement surgery within a year.
2. Prior joint replacement surgery on any major joint (hip, knee) in lower limb.
3. BMI above 35.
4. Any physical disability that prevents patients from walking 20 meters without aid.
5. The patients is not suitable for standard cementless prosthetic components.
6. Any neurological disease (ex. cerebral thrombosis, Parkinson) compromising the walking ability.
7. Any severe medical condition compromising walking ability (ex. chronic heart failure, chronic obstructive pulmonary disease).
8. Severe dementia.
9. Inability to read and understand Danish writing and oral instructions.
10. Do not want to participate
Feasibility Study on a Nordic Lifestyle Intervention Trial Among Men With Prostate Cancer

PURPOSE:

To evaluate the feasibility of a future Nordic intervention trial, including vigorous activity and a high intake of whole grain rye, among prostate cancer patients on active surveillance.

Additionally, to investigate effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among prostate cancer patients on active surveillance.

In the present feasibility study it will be established whether it is possible to enroll participants for this particular kind of intervention among this particular patient group, and if compliance with the intervention is possible to gain by the tools planned: individual counselling with a dietician and a physiologist, interviews on diet, exercise tests and diaries on diet, exercise and steps taken.

Furthermore, the investigators will investigate if we are able to detect effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among the participants (24 men) within the short intervention period (6 months) for this particular feasibility study.

Biomarkers of effect and compliance are measured in blood, urine and prostate tissue samples. Metabolomics and the following biomarkers are measured in blood and urine samples: Alkyl resorcinols, enterolactone, tnf receptor 2, e-selectin. ICAM1, IL1-alpha, IL6, triglycerides, HDL/LDL, s-insulin, HbA1c, C-peptide, CRP, IGF1, GLP1, cholesterol, cathepsin and glucose.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven prostate cancer within 2 years prior to enrolment
* PSA ≤ 10 ng/ml, Gleason-score ≤ 6, clinical localized prostate cancer ≤ cT2a or PSA ≤ 10 ng/ml, Gleason-score ≤ 7, clinical localized prostate cancer ≤ cT2a.
* Maximum 1/5 tumor positive biopsy rate
* On active surveillance (elected to forgo treatment)
* Level of testosterone normal in sera

Exclusion Criteria:

* Prior history of cancer, except for non-melanoma skin cancer, unless considered cured without signs of treatment failure for at least five years
* Less than 10 years of life expectancy
* Conditions or behaviors likely to affect the capability of participating fully in the intervention
* Moderate to severe co-morbidity (kidney, liver, heart or respiratory problems) or the general physical constitution
* Gluten intolerance
* Inflammatory bowel disease (e.g. Crohn, colitis)
* Physical handicaps
Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy

Gait abnormalities, which occur in Cerebral Palsy (CP), are characterized usually by a toe-to-floor or a plantar-to-floor initial contact (equinus gait), followed by an early braking of the tibia's forward progression (during ankle dorsiflexion). This causes consequently a trunk deceleration. Moreover, children with CP have difficulties to stabilize the trunk and the head in the space, and that could have impact on gait. If equinus gait is often attributed to the triceps surae spasticity, recent works suggest rather that this early braking of the dorsiflexion could be a motor adaptation to axial postural control difficulties. This thesis project aims firstly to attest that locomotor disorders are related to these difficulties in the stabilization of the axial body segments in children with CP and, secondly, to show that improving the trunk and head postural control with a specific rehabilitation protocol could reduce the early braking of the dorsiflexion and, consequently, the gait abnormalities observed in CP.


Eligibility Criteria:
Inclusion Criteria:

* Gross Motor Function Classification System I or II
* no or minimal contracture of the triceps surae
* presence of soleus spasticity

Exclusion Criteria:

* botulinum toxin injections or surgery in the lower limb respectively in the 6 and 12 months preceding the study
* any modification of the physical or orthopaedic therapy within the last two months
* minimal hip flexion above 20° in a clinical examination
* pain in the lower legs when standing or walking
Strategic Intervention on Preserving Motor Function During Awake Craniotomy

This study aims to compare the motor functions after traditional or a new surgical plan during awake glioma resection surgery.

This study concentrates on patients with type III motor area glioma. In the awake surgery, The investigators compare the new surgical plan, which the investigators use a monopolar stimulator to determine and retain the tumor margin within 5mm from the posterior limb of the inner capsule. For the traditional surgical plan, the investigators use bipolar stimulator according to the current standard surgery plan. After the positive points are identified by stimulator, the positive points are retained in order to preserve the motor function while all the non-positive points of the tumor are resected. This study is designed to determine whether the new surgical plan is more suitable for type III motor area glioma patients.

Eligibility Criteria:
Inclusion Criteria:

* 1)Age ≥ 18 years \<65 years; 2)Histopathological diagnosis with low grade glioma (LGG) according to the 2021 World Health Organization (WHO) criteria; 3)Patients with primary type III (the tumor is less than 5 mm away from the posterior limb of the inner capsule) supratentorial glioma in the motor area confirmed by radiologist; 4)No history of biopsy, radiotherapy, or chemotherapy.

Exclusion Criteria:

* 1) Patients who received radiotherapy, chemotherapy or anti-tumor biotherapy within 1 month before the test; 2) Patients who received immunotherapy within 3 months before the test; 3) Patients who participated in other clinical trials within 3 months before the test ; 4) Patients with a history of severe allergies or allergies; 5) Pregnancy, breastfeeding or those who are fertile but have not taken contraceptive measures; 6) Have other serious medical diseases or severe uncontrollable infections; 7) Drugs and drugs Abuse, long-term alcoholism and AIDS patients; 8) Those who have uncontrollable seizures, or lose self-control due to mental illness.
Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee

The primary objective of this study, comparing ART 44 to ART 50, will be the evaluation of digestive tolerability (and in particular of diarrhoea).


Eligibility Criteria:
Inclusion Criteria:

* Female or Male, aged 40 to 80 years, outpatient;
* Presenting with internal femorotibial osteoarthritis:

  * Symptomatic for more than 6 months;
  * Meeting ACR clinical and radiological criteria;
  * Overall mean VAS score of knee pain in last 24 hours \> 40 mm (with no NSAIDs for over 72 hours and no analgesics for over 24 hours);
  * Pain present for at least one day out of 2 in the month preceding enrolment;
  * Radiological stage II to III (Kellgren and Lawrence) (image less than 12 months old).

Exclusion Criteria:

* Associated predominant symptomatic femoropatellar osteoarthritis;
* Chondromatosis or villonodular synovitis of the knee;
* Paget's Disease.
A Nutritional Management Algorithm in Older Patients With Locally Advanced Esophageal Cancer

Patients with esophageal and gastroesophageal junction (GEJ) cancer often have weight loss, swallowing problems, and poor appetite. This may affect their ability to tolerate cancer treatment.

The purpose of this study is to see if the researchers can apply a set of nutrition guidelines designed specifically for patients with cancer who are older than 65 years of age. The questions will allow them to assess the nutritional status and make appropriate referrals. If the patients are having swallowing problems or losing weight, the researchers want to address the nutritional problems early in the course of their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ age of 65; no maximum age limit.
* Patients who will receive induction chemotherapy followed by combined chemoradiotherapy at MSKCC for localized stage I-III esophageal or gastroesophageal junction cancer.
* Patients can receive chemoradiotherapy preoperatively prior to surgical resection or as definitive/primary chemoradiotherapy.
* Patients can be KPS ≥60, as long as primary provider feels that patient is candidate for combined modality chemoradiotherapy
* Be able to provide informed consent

Exclusion Criteria:

* Enrolled on a phase I trial
* Patients with a feeding tube previously placed.
* Not English-speaking
Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis

The purpose of this study is to determine whether atorvastatin, aggressive lifestyle intervention, and their interaction are effective in delaying the progress of pre-clinical atherosclerosis.

Primary prevention of atherosclerotic disease remains a big challenge. Currently, it is not clear how to treat those subjects with evidence of pre-clinical atherosclerosis but without obvious conventional risk factors. This randomized, placebo controlled, double blind study is to evaluate the effect of Atorvastatin 10 mg daily, therapeutic lifestyle change, and their combination, on the progression of CIMT in those with higher baseline CIMT value but are not belong to 'high risk' category, according to the conventional risk factors.

Eligibility Criteria:
Inclusion Criteria:

* CIMT is not less than 0.9 mm
* without Clinical diagnosis of atherosclerotic disease
* without Diabetes
Improved Rehabilitation After Spinal Surgery in Adolescents

Impact of the OFA technique on postoperative recovery from adolescent spine surgery and the incidence of chronic postoperative pain.

RACAROFA is an observational, prospective study based on the hypothesis that the OFA technique effectively improves the long-term postoperative rehabilitation of adolescents and reduces the incidence of CPSP. A prospective French multicentre study on this topic is currently not feasible, as other multicentre studies (pain monitoring by the ANI, blood saving strategy) would interfere with potential recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Patent with idiopathic or secondary surgical scoliosis
* Management by the paediatric anaesthesia team at the Mother and Child - Hospital of the University Hospital of Nantes
* Non-opposition to inclusion in the study collected orally from the patient and parents
* Satisfying oral and written comprehension of the French language, without interpreter
* Ability to participate in a telephone interview

Exclusion Criteria:

* Patient that does not understand French correctly
* Patient unable to express himself/herself correctly in French
* Patient with a non-scoliotic surgical spinal pathology
* Refusal to participate in the study
* Absence of a record of non-opposition to participation in the study from the patient and his or her parents
* Cerebral palsy or any other condition that does not allow participation in a telephone interview without particular difficulty.