cyrilzakka/clinical-trials huggingface dataset:
The Effect of The Walking Exercise Training Given According to Transtheoretical Model, and Follow-Up on Improving Exercise Behavior and Metabolic Control in Type 2 Diabetic Patients

OBJECTIVE This study aims to find out the effects of walking exercise training, which is given according to Transtheoretical Model (TTM), and follow-up on improving exercise behavior and metabolic control in type 2 diabetic patients.

RESEARCH DESIGN AND METHODS The study was conducted as a pre-test, post-test experimental model with 76 intervention (INT) groups and 76 control (CON) groups adult type 2 diabetic patients providing the criteria of the study and followed-up by the diabetes polyclinic of Adıyaman Education and Research Hospital. Patient introduction form (PIF), TTM scales and pedometer were used to collect the data. TTM based training was given to the intervention group according to the patients' change stages at hospital 10 weeks once per every 2 weeks. PIF, TTM scales were applied after the training. PIF, TTM scales were applied to the groups 9 months after the pre-test again.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with type-2 diabetes at least six months before, received basic diabetes information, received insulin and/or oral antidiabetic treatment, whose arterial blood pressure was in systolic ≤ 160 mmHg and diastolic ≤ 100 mmHg, who had HbA1c 7% and over, who were literate and had no communication problems were included in the study.

Exclusion Criteria:

* Those who had developed diabetes-related complications (advanced), were pregnant, diagnosed with cancer, had physical and mental problems that prevent walking were excluded from the study.
Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02)

Study design:

-The study will be a phase I like study to assess the extent to which prostate HistoScanning (PHS, the index test) can identify and characterize foci of prostate cancer when compared to histological samples harvested during radical prostatectomy (the reference test). The study will comprise 3 steps: first, defining the most suitable method for matching the TRUS (TransRectalUltrasonography) to histology (step 1); second, refining the algorithms (training set); third, verification of the PHS performances (test set).

Study objectives:

* Primary Objective:

  * To evaluate the extent to which PHS can discriminate between malignant lesions of the prostate versus non-malignant tissue in 3D RF TRUS data using radical prostatectomy histological step sectioning as the reference test.
* Secondary Objectives:

  * To adapt and refine PHS tissue characterisation algorithms using RF data that were previously developed using grey-level data as input.
  * To assess the accuracy of PHS in predicting the volume of prostate cancers determined by histology.
  * To assess the ability of PHS to rule in or rule out the presence of cancer \> or = 0.5 cc and of \> or = 0.2 cc as determined by histology.
  * To evaluate the ability to discriminate primary Gleason pattern 4 and 5 versus 3 or less in tumours \> or = 0.5 cc and \> or = 0.2 cc.
  * To assess the ability of PHS to correctly risk stratify patients.


Eligibility Criteria:
Inclusion Criteria:

* Age: \>or=18 year-old
* Histologically (positive biopsy) proven prostate cancer with primary and secondary Gleason patterns attributed.
* Patient planned to undergo radical prostatectomy
* Prostate cancer is deemed to be organ confined (T1-T2, Nx or No, Mx or Mo)
* No prior treatment for prostate cancer, including any type of hormonal therapy
* No major calcification is noted during the TRUS (i.e. (Diameter \>or=5 mm, spread all over the prostate or blocking to much of the ultrasound signal).
* Patient willing to give written informed consent

Exclusion Criteria:

* Patients who are either unsuitable or unwilling to enter the study or to proceed to surgical investigation.
D Vitamine and Whole Body Vibration in Functional Outcomes

Older with Chronic obstructive Pulmonary Disease (COPD) were submitted to chronic whole body vibration training during 03 months, receiving a vitamine D dose for each week or placebo vitamine. This group was compared with healthy older which were submitted to the same intervention.


Eligibility Criteria:
Inclusion Criteria:

* Older patients with COPD
* Both genders
* Sedentary according to International Physical Activity Questionnaire (IPAQ) short form
* BMI in between 22.9 and 28 kg/m2.
* Older patients with COPD should have a clinical-functional diagnosis of the disease according to GOLD (GOLD, 2018), have been ex-smokers and have not used corticosteroids or have used this drug in a stable way for at least one year (without dosage or medication modifications).
* Older volunteers should be self-referenced healthy or, if they had systemic arterial hypertension or diabetes mellitus, these comorbidities should be controlled by diet or regular medication use.

Exclusion Criteria:

* Older patients with COPD who had episodes of exacerbation in the last three months, those with pulmonary rehabilitation programs in the last year, those who used home oxygen therapy, and patients with COPD-associated comorbidities were excluded.
* Volunteers of both groups who were taking vitamin D were excluded, as well as the current smokers, although occasional, volunteers with a history of labyrinthitis or thromboembolism, who had undergone surgical procedures of any size in the last year, such as plaques, pins or cardiac pacemakers, those with unconsolidated fractures that used medications that affected bone metabolism or lean mass, or those who had difficulties adapting to the assessment or the training protocol.
Healthy Infant Development Project - Sucrose Component

Iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain threshold. The opioid system is involved in sucrose's ability to reduce pain and distress during neonatal procedures. Thus, prenatal iron deficiency might affect response to pain and sucrose analgesia. In order to compare response to pain and sucrose during heel stick in neonates with and without iron deficiency, healthy full-term Chinese infants were randomized to receive sucrose or water by syringe beforehand, in conjunction with heel stick for metabolic screening.


Eligibility Criteria:
Inclusion Criteria:

* Full term healthy neonates participating in the Healthy Infant Development RCT (NCT00613717) in the folic acid/early postnatal placebo group and pre- and early postnatal iron-supplemented infants.

Exclusion Criteria:

* birth weight \< 2500 g gestational age ≤ 37 wk major perinatal complications major congenital anomaly multiple birth
Music During Dental Children Care Under MEOPA

In France, the improvement of dental care for children in general and even more so for children with special needs is a real public health issue. Indeed, children under 6 years of age, children with a fear that is difficult to control and who have failed to receive care, or children with disabilities, have difficulties in receiving care. Because of their medical wandering before effective therapeutic care, they are up to 4 times more likely to have a very degraded oral health condition involving avulsions rather than conservative care. Moreover, these complex situations often lead to the indication of dental care under conscious sedation with an equimolar mixture of oxygen and nitrous oxide (MEOPA) or even under general anesthesia (GA); hospital sedation by administration of midazolam is exceptionally proposed. As access to GA care is largely insufficient, solutions likely to improve the success rate of care and anxiolysis provided by MEOPA associated with cognitive-behavioral management must be considered.

Among these, music has been shown to have variable neurophysiological effects (action on cardiac and respiratory rhythms and on blood pressure), depending on the style of music used. During dental care, a biological and psychological impact on emotion has been highlighted, although the few studies carried out in children in this particular context are not at a high level of proof. In children with special needs, the addition of music to MEOPA could therefore increase relaxation or distraction during dental care and improve the success rate of sedation by MEOPA. Validation of this hypothesis would limit the redirection of the young patient under GA and prevent the loss of opportunity associated with a further delay in care of several months.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 to 12 years referred for dental care under sedation in one of the four HU dental services
* Children requiring at least two sessions of the same type and duration
* Consent of the holders of parental authority, consent of the children
* Health coverage for the child (social security affiliation)
* Child and parents are French speaking and able to communicate with the medical team

Exclusion Criteria:

* Contraindications to the use of MEOPA
* Nasal breathing disorders such as a flu syndrome ("blocked nose" not allowing nasal ventilation)
* Hearing impaired children
* Patients with complications during inhalation (especially headaches)
Post-operative Pain and Child Behavior of Hall Technique Versus SDF in the Management of Carious Primary Molars: RCT

PICO question:

Papulation: children suffering from caries Intervention: Silver Diamine Fluoride Comparison: Hall technique

Outcome:

Primary Outcome: Intraoperative and postoperative pain Measurement device: Face pain scale Revised8 Measurement unit: Score 0-2-4-6-8-10

Secondary Outcome:

1. Child Anxiety Measurement device: Venham Anxiety rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5
2. Child Behavior Measurement device: Venham Behavior rating scale 9 Measurement unit: Six-point scales 0-1-2-3-4-5

Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle 1. A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride.

The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2.

Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC) 3

Eligibility Criteria:
Inclusion Criteria:

1. Age: From 4 to 6 years
2. Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease

Exclusion Criteria:

1. Tooth with signs and symptoms of pulp necrosis
2. Tooth with Root caries
3. Tooth with Spontaneous pain
tDCS Versus tsDCS for Endometriosis-related Chronic Pelvic Pain Treatment

The purpose of the study is to compare the analgesic effect of 2 mA anodal direct current stimulation on the right primary motor cortex (M1) (tDCS) with a similar stimulation on the spine (D10) (tsDCS) in healthy volunteers (HV) followed by a pilot study in patients suffering of endometriosis-related chronic pelvic pain (CPP)

- 2 groups of 5 HV will receive tDCS or tsDCS (2mA, anodal, 20min) and the thermonociceptive threshold will be measured before and after the stimulation over the abdomen (hypogastric). The HAD scale and SF-36 will also be tested.

The treatment(s) that produces the greatest increase in pain thresholds will be chosen to treat 10 patients.

- 10 patients suffering from endometriosis-related chronic pelvic pain will be treated by the most efficient treatment (tDCS or tsDCS) for 4 weeks (5 daily 20-min sessions per week), or, if no treatment modality was superior in HV, 5 patients will be treated by tDCS and 5 by tsDCS. Patients will fill in daily a dedicated diary 2 weeks before treatment, during the4-week treatment period and after this period as long as their pain level remains below 80% of their baseline pain intensity (VAS). Analgesic intake will also be monitored as well as HAD and SF-36 scores.

Eligibility Criteria:
Inclusion Criteria:

* HV: good health.
* CPP patients: surgical diagnosis of endometriosis within the last 10 years; diagnosis of chronic pelvic pain (according to ACOG); mean VAS pain score \>4 during severe episodes.

Exclusion Criteria:

* HV: chronic pain disorder; no regular medication or illicit drug use.
* CPP patients: pregnancy; other medical or psychiatric condition interfering with pelvic pain assessment.
Examination Chair for Hip Internal Rotation Range of Motion Measurement

Hip internal rotation range of motion (HIRROM) assessment is performed to assess the mobility of the hip. The assessment is typically done manually (manual testing), which induces large variability in the results between and within testers. An initial version of an examination chair (EC1) was recently developed with the aim to minimize the variability of testing results for HIRROM assessments. A new version of the examination chair (EC2) has been implemented in order to individualize the testing protocol and will be validated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Participants are pain free in the lower extremity, hip and back
* Participants signed the consent form

Exclusion Criteria:

* Participant requires pain relief medication
* History of hip surgery
* Neuromuscular disorders
* Legal incompetence
Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)

In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity. PN has its own morbidity, and in the absence of expertise, the risks of infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is an enteral nutritional technique which reestablishes the functional continuity of the anatomically present small bowel through an extracorporeal circulation of the chyme. In patients with intestinal failure with a temporary high-output double enterostomy, we hypothesize that CR, compared to PN will reduce post-operative complications after surgical reestablishment of digestive continuity, maintain the intestinal function including absorption, and reduce the complications during the transitional period pending the surgical reestablishment of digestive continuity.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* Temporary high-output double enterostomy (≥1500ml/24 hours)
* Total small bowel length ≥ 120 cm
* Downstream small bowel consisting of at least 25 cm of healthy bowel, accessible by a stoma, and suitable for chyme reinfusion
* Oral feeding resumed for at least 5 days
* Parenteral nutrition or hydration required until the surgical reestablishment of digestive continuity
* Affiliation to an health insurance (general Social Security scheme or an equivalent scheme)
* No current or planned participation in another biomedical research
* Signature of an informed consent form

Exclusion Criteria:

* Expected duration of parenteral nutrition or chyme reinfusion less than 2 weeks
* Refusal by the patient to have a mixed texture diet,
* Chemotherapy or radiotherapy before the surgical reestablishment of digestive continuity,
* Not drained intra-abdominal collection,
* Fever, uncontrolled infection, or infection treated for less than 72 hours,
* Shock of any cause,
* Creatinine clearance ≤ 60 ml/min
* Patients under guardianship.
Metabolic Phenotypes of Obesity and Diabetic Kidney Disease in Patients with Type 2 Diabetes Mellitus

1. Comparison between the 4 groups of metabolic phenotypes of obesity as regard the presence and frequency of DKD
2. Relation between DKD , obesity (BMI) and metabolic risk factors in patients with type 2 DM

Diabetes is the major cause of chronic kidney disease in industrialized countries. Individuals with diabetes and CKD are at a higher risk of developing End Stage Renal Disease and experiencing cardiovascular death. Type 2 DM complications are predicted by low estimated glomerular filtration rate and high urine albumin excretion(1).

Diabetic kidney disease is the primary cause of kidney failure globally, affecting 25% to 40% of persons with diabetes mellitus . Early diagnosis of high-risk patients is crucial due to the high-risk of progressive deterioration of kidney function leading to end-stage kidney disease, which ultimately requires kidney replacement therapy (2).

DKD risk factors include non modifiable factors like age , gender , race , genetics and modifiable factors like obesity and lifestyle. Obesity is typically associated with metabolic diseases such as hyperglycemia, dyslipidemia, and high blood pressure. Obesity's impact on renal insufficiency is debated ,and may be influenced by other metabolic abnormalities(3).

Metabolic phenotypes of obesity based on the BMI-based categories (non-obesity, obesity) and metabolic status (metabolically healthy status or metabolically unhealthy status): metabolically Healthy non-obesity (MHNO), metabolically healthy obesity (MHO), metabolically unhealthy non-obesity (MUNO) and metabolically unhealthy obesity (MUO)(3).

There is a strong correlation between obesity and the onset and course of chronic kidney disease, according to a number of population-based studies. the investigators think there are still unsolved issues about the connection between obesity and CKD(4).

so the study is concerned about detection of the relation between metabolic phenotypes of obesity and Diabetic kidney disease

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic adult patients admitted at Assiut university hospital divided into 4 groups of metabolic phenotypes according to obesity and metabolic status .

Exclusion Criteria:

1. Age less than 18
2. type 1 diabetes
3. those with a BMI \&lt;18.5 kg/m2
4. co-existing non-diabetic renal disease
5. Pregnancy and patients with malignancy
6. Urinary tract infection
Efficacy of an Exercise Program for Patients With Femoro-acetabular Impingement

The purpose of this study is to examine whether using an exercise regime on people with femoroacetabular impingement (FAI) can help reduce pain and improve function. Also, it examines whether the exercise regime will help prevent the worsening of hip cartilage deterioration.

A significant proportion of adults from ages 18 to 50 have a deformity in the neck of their femur. This can be painful and is called a femoroacetabular impingement (FAI), and could lead to ones cartilage being destroyed and possibly lead to osteoarthritis of the hip. People with this deformity in their femur have been found to move their hips differently when doing tasks such as walking, squatting or climbing stairs compared to those without this problem. The investigators are testing whether exercise that targets this difference in movement can help reduce pain, improve function and prevent cartilage damage. There will recruit 84 patients with divided into 2 groups. 42 patients will do a 8 week exercise program on strengthening muscles responsible for extending the hip and stretching muscles that are associated with flexing the hip. The intensity of the program will change with visits to the physiotherapist through the course of their exercise program. This research hopes to develop an innovative, non-surgical, low-cost, highly feasible and accessible intervention for patients with FAI.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with symptomatic FAI
* at least 3 months of groin pain
* increased pain with hip rotation
* an alpha angle greater than 60 degrees on multiplane imaging
* labral tear on MRI
* Tonnis grade of 0 or 1

Exclusion Criteria:

* diagnosed health problems other than FAI interfering with capacity to accomplish the exercise program
* previous hip surgery on the affected side
* surgery will happen within 6 months
IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML)

In this phase I extension study, the investigators seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.

In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy. In current formulations, the volume of plerixafor required to administer doses higher than 240 mcg/kg may result in significant discomfort with repeated daily injections. In this phase I extension study, we seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.

Eligibility Criteria:
Inclusion Criteria:

* Acute myeloid leukemia diagnosed according to WHO criteria with one of the following:

  * Primary refractory disease following ≥ 1 round of induction chemotherapy
  * First relapse or higher
* Age between 18 and 70 years
* ECOG performance status ≤ 2
* Adequate organ function defined as:

  * Creatinine ≤ 1.5 x institutional ULN
  * AST ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
  * ALT ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
  * Total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
  * Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
* Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study
* Able to provide signed informed consent prior to registration on study

Exclusion Criteria:

* Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
* Peripheral blood blast count ≥ 50 x 103 /mm3
* Active CNS involvement with leukemia
* Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
* Pregnant or nursing
* Concurrently receiving any other investigational agent
* Received colony stimulating factors filgrastim or sargramostim within 48 hours or pegfilgrastim within 14 days of study
* Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (excluding hydroxyurea)
* Severe concurrent illness that would limit compliance with study requirements