cyrilzakka/clinical-trials huggingface dataset:
Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD)

Bone and mineral disease is a key problem in patients with kidney disease. The available clinical parameters are non-specific, unproven for the assessment of the bone metabolism and do not reflect the complexity and diversity of the underlying bone pathology. The aim of this study is to use bone histology, novel bone markers and bone imaging results to establish a reliable decision model (diagnostic tool) that can be used to guide the individual therapy.

Bone and mineral disease is a key problem in patients with kidney disease. The available clinical parameters are non-specific, unproven for the assessment of the bone metabolism and do not reflect the complexity and diversity of the underlying bone pathology.

In this study bone histology parameters including results of tetracycline labeling will be compared to non-invasive parameters of bone metabolism (e.g. sclerostin, calciprotein particles) and bone structure obtained by imaging (e.g. bone density).

The aim of the study is to establish a reliable decision model (diagnostic tool) with these non-invasive parameters that can be used to guide the individual therapy. The decision model will be based on single calculations of the area under the curve for each parameter, including determination of the optimal cutpoint, sensitivity and specificity. These results will be integrated in a multivariate logistic regression analysis. The resulting model will enable to calculate the individual probability of the underlying bone diagnosis as a single value (without a specific dimension).

Eligibility Criteria:
Inclusion Criteria:

* Patients with kidney disease who have an indication for a bone biopsy, based on clinical, laboratory and radiologic findings

Exclusion Criteria:

* known malignant bone or bone marrow disease
The Effect of Glyceryl Trinitate and Diamox on Cerebral Haemodynamics.

After infusion / injection of Glyceryl trinitrate and Diamox it is wished to study the effect of drugs on the cerebral haemodynamics such as Cerebral blod flow and cerebral blod volume.

Experimental headache model open a unike opportunity to study the pathophysiological mechanisms behind headache in general and migrane in particular. Previous studies have used various techniques to study the cerebral haemodynamics as a basis for the headache pathophysiology. We wish to use a 3-Tesa MRI so study the cerebral haemodynamics after application of various pharmacological substances.

The most used experimental headache model is the glyceryl trinitrate model (GTN). Where infusion of the NO donor GTN induces headache and changes in the cerebral arteries. On the other hand injection of Diamox (Acetazolamide) apparently causes increase of the cerebral blod flow with out dilation of the arteries. We wish to study the precise effect of GTN and diamox on the cerebral haemodynamics such as Cerebral blod flow (CBF) and Cerebral blod volume (CBV) via a 3-Tesla MRI.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers; men and women age 18-50 years.
* weight 50-100 kg

Exclusion Criteria:

* Tension type headache more then once per month during the last year.
* Other primary headache types.
* Daily use of medication.
* Pregnant or lactating women.
* Headache on the trail day or 24 hours prior to the trial.
* Contraindications to MRI.
* Hypotension og hypertension.
* Other significant medical conditions judged by the doctor in charge.
ICBT for Persons With Stroke

Despite evidence for ICBT among those with other chronic conditions, its efficacy has yet to be evaluated among those with neurological conditions, including stroke. The aim of the current study is to pilot a tailored ICBT program developed through a patient oriented approach to improve overall wellbeing among those with stroke living in the community.

Background: Individuals with stroke can experience high levels of emotional distress leading to decreased quality of life and increased health care costs. Though mental health problems are prevalent and disabling, they often go untreated for various reasons, such as access to specialized care, rural and remote location, lack of time, or concerns about stigma related to seeking care. Internet delivered cognitive behaviour therapy (ICBT) overcomes barriers to face-to-face therapy by often reaching a much wider group of patients who experience unequal access to health care. The internet based program is based on cognitive behaviour therapy, which is an evidenced-based treatment that helps patients identify and modify thoughts and behaviours that contribute to their mental health concerns. ICBT has been shown to be effective in improving psychosocial outcomes such as depression and anxiety, along with disability and quality of life among persons with chronic health conditions.

Rationale: Despite evidence for ICBT among those with other chronic conditions, its efficacy has yet to be evaluated among those with neurological conditions, including stroke.

Objective: The aim of the current study is to pilot an ICBT program developed through a patient oriented approach to improve overall wellbeing among those with stroke

Methods: In this project, an ICBT program for those with stroke developed through a patient oriented approach will be piloted amongst a small group of participants (n=20) to examine acceptability, feasibility, and limited efficacy. At the end of the program, participants will be asked to complete a brief semi-structured interview examining barriers and facilitators to the ICBT program. Participant feedback from the interviews will be used to further improve the ICBT program to meet the needs of the population. The results from the study will be used to guide larger studies to evaluate effectiveness of the program in a community setting.

Anticipated Impact: Ultimately, the proposed project aims to improve overall wellbeing and access to health care service for those who have experienced stroke and mental health concerns.

Eligibility Criteria:
Inclusion Criteria:

* adults ≥ 18 years
* diagnosed with stroke
* resident of Canada
* access to a computer and the internet
* cognitive capacity to read and understand the content of the program.

Exclusion Criteria:

* High risk of suicide
* Serious cognitive impairment or dementia (\<21 on the Telephone Interview of Cognitive Status (TICS)
* primary problems with psychosis, alcohol or drug problems, mania
* Currently receiving active psychological treatment for anxiety or depression
* Not present in Canada during treatment; 6) Concerns about online therapy
* Physically unable to perform the tasks.
Postoperative Pain After Bupivacaine Supplementation in Mandibular Fracture Surgery

Pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. The goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures.

The main question it aims to answer are:

* Does the inferior alveolar nerve block with bupivacaine reduce the intensity of pain after mandibular fracture surgery?
* Does the inferior alveolar nerve block with bupivacaine decrease the consumption of analgesics during the first 24 postoperative hours?

Participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). Each patient will receive either a right or left inferior alveolar nerve block.

The patient:

* Will be asked to estimate the pain score by the numerical rating scale during the first 24 postoperative hours for each fracture.
* They will be given rescue analgesia in case of intense pain. The number of uses of rescue analgesia will be noted.

Researchers will compare a group of fracture that will receive the inferior alveolar nerve block with bupivacaine with a group of fracture that will not receive the inferior alveolar nerve block, to see if regional anesthesia improve postoperative pain management of mandibular fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patients with bifocal mandibular fractures ( with one fracture on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible )
* Proposed for open reduction and internal fixation of their fractures under general anesthesia;
* Having provided their informed and documented consent on a consent form.

Exclusion Criteria:

* Pathological mandibular fractures;
* History of mandibular fractures;
* Patients with bone involvement in the facial skeleton other than the two fractures of the mandibular dentate portion;
* Patients suffering from trigeminal neuralgia;
* Dental care performed in the month preceding the trauma;
* Patients who have not undergone surgical treatment with open reduction and internal fixation of their mandibular fractures;
* Patients on anticoagulants;
* Porphyrias;
* History of malignant hyperthermia;
* Known allergy to local anesthetics;
* Pregnancy or breastfeeding;
* Severe heart failure;
* Atrioventricular conduction disorders;
* Uncontrolled epilepsy;
* Hemostatic disorders;
* Non-cooperative patients.
Effectiveness of Percutaneous Foraminotomy

Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea), was performed in patients who did not show improvement lasting more than 1 month after diagnostic conventional fluoroscopically guided transforaminal epidural block with local anesthetic and steroid.

Numeric rating scale(NRS) pain score, Oswestry disability index (ODI), Roland-Morris Disability Questionnaire (RDQ), claudication distance(CD) was checked before and after the procedure.

Percutaneous Extraforaminotomy with Transforaminal Adhesiolysis may be an effective minimal invasive technique in patients not responsive to conventional epidural steroid injection.

Eligibility Criteria:
Inclusion Criteria:

* radicular pain with positive provocation factors \> 3 months
* Radicular pain at L4 or L5
* Presence of dominant side when bilateral symptom present
* Positive provocation factors: leg symptoms elicited or aggravated by walking but relieved by sitting down
* Not appropriate relief of pain routinely conservative treatment (physiotherapy, exercise, analgesic medication, epidural steroid injection) \> 3 months
* Magnetic resonance imaging(MRI) : Foraminal stenosis of Grade 1-3 (foraminal herniated intervertebral disc(HIVD) with mild to severe degree of foraminal stenosis according to AJR:194, April 2010 by Lee, et. Al)
* Subjects who signed for the consent form

Exclusion Criteria:

1. Acute back or leg pain
2. Sings of progressive neurologic deficits, including muscle atrophy and abnormal tendon reflexes
3. Patients with a history of prior spine surgery
4. Allergic response to steroid or contrast dye
5. Bleeding diathesis or over coagulopathy
6. Patients with bilateral radiculopathy or spinal stenosis at more than 3 levels
CONVIVO System to Discriminate Healthy Tissues vs Tumor Tissues During Brain Tumor Resection

The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.

Primary Objective:

The primary objective of this study is to determine the feasibility of using the CONVIVO imaging system to identify tumor type.

Secondary Objective: The secondary objectives are to determine the average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning, and to describe the ability of the CONVIVO imaging

-To describe the ability of the CONVIVO imaging system to generate readable images.

Eligibility Criteria:
Inclusion Criteria:

* The subject demonstrates the ability to understand and the willingness to sign a written informed consent document.
* The subject is suspected to be suffering from following brain tumor: low-grade glioma, high grade-glioma, metastases, or meningioma.
* The subject has been deemed eligible for surgical resection by a practicing Stanford physician.
* Macroscopic tumor visualization using IV infusion of 500mg sodium fluorescein is planned as part of the subject's standard of care treatment.
* The subject is older than 18 years.
* The subject is receiving their surgery at Stanford Hospital.

Exclusion Criteria:

\* Patients with any kind of contraindication to the use of fluorescein
Effects of Viscous Fibre Containing Foods on Satiety (Gel Form)

The purpose of this study is to assess whether low caloric, low energy density, konjac food products are effective in appetite regulation when administered as caloric replacements. It is hypothesized that replacement of typical, balanced, vegetarian meals with konjac food products will have comparable satiety scores, decreased postprandial glucose response, and will not significantly affect subsequent food intake.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking males and females
* Aged 18-70 years
* BMI between 18 - 29.9 kg/m²
* Non-dieters (1-10 score on Stunkard Eating Inventory)

Exclusion Criteria:

* Known reported history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, Celiac disease/gastrointestinal disease, or AIDS
* Weight change of +/- 3kg in the last 2 months
* Alcohol intake \>2 drinks/day
* Inability to consume KJM-G meals
* Any condition which might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
* Non-compliance with experimental procedures or safety guidelines
Assessing Parathyroid Glands Vascularisation by ICG Fluoroscopy

Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation surgery. Create an objective basis for the decision whether or not to transplant the parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and thus abstention of systematic supplementation with calcium and vitamin D in case of good perfusion.

Parathyroid intraoperative indocyanine green (ICG) angiography is a new concept. To simplify the procedure the investigators have classified images into three categories: ICG 2: good blood supply (the gland has a white color); ICG 1: traumatic gland (the gland has a grayish color) and ICG 0: the gland is not vascularized (she has a black color). The investigators have applied the same criteria for visual values.

The investigators will randomize 138 patients with good ICG test values (at least one gland that is visually ≥1 and ICG 2): 69 will be subject to the usual postoperative care in the investigators service: 24 hours monitoring with dosage of calcium and PTH in the morning on postoperative day 1 and routine supplementation with Calcimagon D3 Forte (1g Calcium and 800 IU of 25-OH-vitamin D) BD by mouth until postoperative follow-up appointment, which takes place between day 10 and 15. Depending on the results of blood tests patients will also be given Rocaltrol substitution (1, 25-OH-Vitamin D) 0.5mcg BD. The remaining patients will be monitored 24 hours in hospital looking for clinical signs and symptoms of hypocalcemia but without any blood dosage or systematic supplementation. If signs and / or symptoms of hypocalcemia develop (tingling, muscle spasms, Chvostek sign), a blood test will be performed and patients will be substituted by the usual protocol. All patients will be reviewed at 10 - 15 days of the intervention with the relevant balance sheet.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing total thyroidectomy or a totalisation thyroid procedure.
* Patients capable of understanding and able to understand the study.
* Values visually 2 and ICG 2

Exclusion Criteria:

* Parathyroid disease or prior parathyroidectomy
* Lack of informed consent
* Altered mental status of the patient.
* ICG values \<2.
Phase II Randomized Pilot Study of Body Weight Support and Treadmill Training for Chronic Thoracic Spinal Cord Injury

OBJECTIVES: I. Assess the ability of patients with and without sensorimotor loss below the thoracic spinal cord injury to execute coordinated whole-limb synergies sufficient for walking with full or partial weight support.

II. Promote weight bearing, balance, and reciprocal leg movement in these patients.

III. Elicit synchronized motor output within and between limbs in these patients.

PROTOCOL OUTLINE: This is a controlled, prospective study. Patients pairs matched for strata are randomly assigned to 1 of 2 treatment groups. Patients are stratified into pairs by age, time since onset, Frankel grade, and Motor Score Index.

One group receives body weight-supported treadmill training immediately after baseline clinical, biomechanical, and physiological measures. The second group is the control; baseline measures are identical but training is delayed for 3 months.

Patients in both groups receive training 3 days/week for 3 months. Initial treadmill velocity is 18 meters/minute; velocity is increased in increments of 6 meters/minute until the maximum speed is achieved at which each patient exhibits the best locomotor capability at full weight bearing. Patients are trained with the minimal weight support assistance necessary for effective limb progression without excessive knee flexion or hyperextension. Polypropylene ankle-foot orthosis is allowed.

Patients are re-tested after maximal treadmill velocity is achieved: following clonidine once a day for 3 days; clonidine twice a day for 3 days; cyproheptadine for 3 days; and an increased dose of cyproheptadine for 3 days. There is a 3-day washout between clonidine and cyproheptadine testing.

Patients are not advanced if they experience adverse cardiovascular effects during therapy. No concurrent therapeutic exercise for the lower extremities is allowed.

Kinematic, temporal, kinetic, spasticity, Frankel grading, Motor Index Score, metabolic, and functional outcome measures are evaluated at 3 and 6 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Traumatic or ischemic spinal cord injury Single lesion between thoracic vertebrae 1 and 12 Confirmed by computerized tomography or magnetic resonance imaging At least 12 months since onset of injury Motor recovery as follows: Ability to step not recovered OR Abnormal gait and maximum walking speed below one-half normal slow casual velocity of 60 meters/minute --Prior/Concurrent Therapy-- At least 3 months since completion of outpatient physical therapy Antispasticity agents tapered to lowest dose that limits flexor or extensor spasms interfering with sitting or comfort --Patient Characteristics-- Age: 16 to 60 Other: No clinically significant depression No drug abuse No urinary tract infection No painful musculoskeletal dysfunction, e.g., contracture or unhealed fracture No pressure sore No other medical contraindication to treadmill training, e.g.: Cardiopulmonary disease Dysautonomia
A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia, and assess wether it affectsbody-weight associated parameters. This study is accepting male and female participants age 18 years to 65 years. This study will be conducted in approximately 6 study sites in the United States. Participation could last up to 13 weeks.

This is a double-blind, randomized, multiple dose study in male and female adult subjects with schizophrenia. Subjects will undergo structural magnetic resonance abdominal imaging (MRI) scans as well as hyperinsulinemic euglycemic clamp (HEC) also known as "glucose clamp", after the check-in and towards the end of the treatment phase. Subjects will be randomized to SEP-363856 or their prior antipsychotic (PA). Subjects randomized to SEP-363856 will undergo blinded wash out of their PA, subsequent SEP-363856 blinded titration and 15 day of well tolerated SEP-363856 exposure. Subjects randomized to their prior antipsychotic (PA), will undergo pseudo PA washout, followed by pseudo-titration and 15 day of well tolerated PA exposure. Subjects will be discharged after subject is stable. All subjects will return to the clinic 7 + 2 days post discharge for follow-up assessments.

Eligibility Criteria:
Inclusion Criteria: This is not an all inclusive list

* Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
* Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version \[SCID-CT\]).
* Subject must have a Positive and negative symptoms scale (PANSS) total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
* Subject must have a Clinical Global Impressions - Severity (CGI-S) score ≤ 4 (normal to moderately ill) at Screening.
* Subject must be receiving risperidone, olanzapine, quetiapine or aripiprazole as treatment for schizophrenia at the time of Screening.

Exclusion Criteria: This is not an all inclusive list

* Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ \< 70).
* Subject has attempted suicide within 12 months prior to Screening.
* Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
* Subject is at risk of harming him/herself or others according to the Investigator's judgment.