cyrilzakka/clinical-trials huggingface dataset:
A Study for the Treatment of Diabetic Peripheral Neuropathic Pain

The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pain due to bilateral peripheral neuropathy induced by type 1 or 2 diabetes mellitus. The pain must have been present for at least 6 months and be evaluable in feet, legs, or hands.
* Participants with hemoglobin A1c (HbA1c) less than or equal to 9.0 percent at Visit 1.
* Participants in whom HbA1c had been measured 42-70 days before Visit 1 and subsequent HbA1c levels have been within +/- 1.0 percent of the level at Visit 1.
* Participants with a mean of the 24-hour average pain severity scores (round off to a whole number) of 4 or higher, as calculated from the patient diary for 7 days immediately before Visit 2

Exclusion Criteria:

* Participants who have undergone renal transplant or who are currently on renal dialysis.
* Participants who have a history requiring pharmacotherapy within the past year or current history of psychiatric disease, such as mania, bipolar disorder, depression, anxiety disorder, or eating disorder.
* Participants with hypertension with poor control of blood pressure (systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) or diastolic blood pressure greater than or equal to 110 mmHg
* Participants with alanine transaminase (ALT) or aspartate transaminase (AST) greater than or equal to 100 Units per Liter (U/L) at Visit 1.
* Participants unable to discontinue prohibited concomitant drugs or concomitant therapies after Visit 1.
Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate

Study in participants with RA who have an inadequate response to methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Active RA for least 6 months
* Current RA defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) at screening and baseline (swollen and tender/painful joint count must not include distal interphalangeal joints) and at least 1 of the following at screening: Erythrocyte sedimentation rate ≥ 28 mm or C-reactive protein \> 15 mg/L
* At least 1 of the following at screening: Rheumatoid factor positive or Anti-cyclic citrullinated peptide antibody positive
* Currently taking methotrexate for ≥ 12 weeks and on a stable dose of methotrexate at 15 to 25 mg weekly for ≥ 4 weeks at day -1.

Exclusion Criteria:

* Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
* Class IV RA
* Felty's syndrome
* Presence of serious infection
* Significant concurrent medical conditions
* Pregnant or breast feeding
* Significant Laboratory abnormalities
* Any disease-modifying anti-rheumatic drug (DMARD) other than methotrexate within 28 days
* Leflunomide or live vaccines within 3 months
* Previous use of any experimental or commercially available biologic DMARD
A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy

The aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 at date of inclusion
* Previous surgical reconstruction of the midfoot with Midfoot Fusion Bolt(s) for one of the following indications:

Neuroarthropathy Deformity of the foot with neurological impairment - Signed informed consent according to local regulation

Exclusion Criteria:

- Prisoner at date of inclusion
Aged 3-6 on Children's Sleeping Habits

One of the most important points in sleep health is the sleep habits of children. Natural disasters cause sleep problems in children, increase or decrease in sleep duration, change in sleep habits and adversely affect sleep quality. According to Erikson's theory of psychosocial development, children aged 3-6 are entrepreneurs. It is the period when children begin to learn and apply the rules, and independence efforts are developed in the child. Negative sleep behaviors and sleep problems are common during this period, but children can develop positive sleep habits if properly and consistently guided by their parents. Rituals such as fairy tales, lullabies, night lamps, toys can help children relax and calm down and gain sleep habits.

The research design is a randomized controlled experimental type study designed to evaluate the effect of sleeping companion toys given to earthquake survivors aged 3-6 years on children's sleep habits.The Children's Sleep Habits Scale will be used to determine the sleep habits of children in the earthquake area by pre-interviewing the parents of children aged 3-6. Children aged 3-6 with sleep problems will be divided into control and experimental groups according to their scale scores. The part up to this section constitutes the preliminary test of our research.

Children aged 3-6 years in the control group and their parents will not receive any intervention.

Families of the children in the experimental group will be given a sleep companion gift to give to their children. Children's sleep habits scale will be applied as a post-test to determine children's sleep problems 15 days after they receive a gift from their sleep friend. Then, sleep habits scale mean scores will be calculated and a comparison will be made between pretest and posttest mean scores.

Eligibility Criteria:
Inclusion Criteria:

* Ages ranging from 3 to 6
* Earthquake living
* Parents being literate
* Parents and children who accepted the study and gave voluntary consent

Exclusion Criteria:

* Being a 3-6 year old child who has previously had a sleep disorder finding
* Being visually, hearing or speech impaired
* Children aged 3-6 with mental disorders
Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma

This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic Pancreatic Ductal Adenocarcinoma with histological or cytological proof
* Age ≥18 years
* At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area
* Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days)
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
* Life expectancy ≥12 weeks
* Negative serology (HIV, hepatitis B and C)
* Adequate organs function
* Proven Post-menopausal status or negative urinary or serum pregnancy test
* Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment
* Patients affiliated to the social security system
* Patient must have signed a written informed consent form

Exclusion Criteria:

* Any other primary tumor or secondary malignancy except basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
* Known cerebral metastasis
* Uncontrolled severe infections
* Patients with Kaposi's sarcoma
* Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
* Previous treatment with taxane and/or gemcitabine (for pancreas cancer only)
* Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient
* Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment
* Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial
* Participation in another clinical trial within 14 days prior to randomization
* Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced
Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy

Abstract

Background:

Local external cooling of the postoperative field is a treatment paradigm aiming for enhanced recovery after joint surgery. It is supposed to reduce pain and improve mobilization, enabling same day surgery.

Hypothesis:

Systematic postoperative cooling and compression after knee arthroscopy will reduce pain and also be reflected by changes in local levels of metabolic and inflammatory variables in the synovial membrane.

Study design:

Prospective randomised study; Level of evidence 1.

Methods:

Forty-four otherwise healthy patients were included in the study and randomised to systematic cooling and compression or NO cooling and compression after knee arthroscopy. Microdialysis of the synovial membrane was performed postoperatively with measurements of PGE2, glucose, lactate, glycerol, glutamate and blood flow (ethanol exchange ratio). Local temperature was monitored as well as postoperative pain (VAS and NRS).

Results:

The application of a cooling and compression device after knee arthroscopy resulted in significantly lower temperature in the operated knee (skin, joint capsule and intraarticularly).

The cooling and compression diminished energy requirements in synovial tissue and a 3 temperature sensitive influence on inflammation (PGE2) were shown. No effect on postoperative pain was detected.

Conclusion:

Local cryotherapy and compression after knee arthroscopy significantly lowered local knee temperature postoperatively. A correlation with synovial PGE 2 and temperature was shown.

Since PGE2 is a pain and inflammatory marker this implicates a positive anti-inflammatory effect induced by postoperative local cooling and compression. Hypothermia is proposed to have a protective effect in ischemic tissue. This is probably due to a decreased metabolic rate and therefore decreased energy requirements as shown by stable levels of lactate despite lower blood flow indicated by increasing ethanol ratio.


Eligibility Criteria:
Inclusion Criteria:

* indication for knee arthroscopy due to suspected meniscus injury

Exclusion Criteria:

* osteoarthritis or known systemic inflammatory disease, eg RA
Strength and Dexterity of Less Affected Hand of Hemiparetic Cerebral Palsy Children

The contralateral hand deficits are often masked by the complex clinical presentation of the more affected hand in children with spastic hemiparesis. Thus, intervention targeting the contralateral hand is not often a component of the child's rehabilitation plan of care. The presence of bilateral hand deficits, even if subtle in the contralateral hand, may limit the transfer of unimanual gains following rehabilitation to bimanual activities of daily living tasks. However, conservation of upper-limb function of the less-affected side is highly important for individuals with hemiparesis, because this side is often employed as a compensatory 'tool' in performing activities of daily living . Therefore, the current study will be conducted to determine and compare the motor abilities of the less affected hand of children with hemiparesis.

An impairment of the less affected hand of hemiparetic cerebral palsy children can be detrimental to the development of bimanual skills. It would be beneficial to identify and quantify the severity of any impairment of the less affected hand of hemiparetic cerebral palsy children. Hemiparetic cerebral palsy may present with substantial deficits in hand function, because bimanual activities involve the ability to use the affected and contralateral hands together for grasp and stabilization. Several authors have evaluated bimanual involvement in cerebral palsy but these studies have not compared the contralateral hand with norms. The less affected hand is widely regarded as "normal" or "unaffected" and is consequently rarely evaluated.

Several authors have reported incidental findings of subtle deficits in the less affected extremity, noted that hemiparetic children "also presented motor impairments in their non-paretic hand, especially in dexterity.

The purpose of this study is to assess the grip ,pinch strength and dexterity of less affected hand of hemiparetic cerebral palsy children and compare with dominant hand of normal peers

Eligibility Criteria:
Inclusion Criteria:

* Children will be recruited according to the following criteria:
* Age range between 6 and 10 years.
* Both sexes
* The degree of spasticity rang from grade 1 to 1+ according to Modified Ashworth scale (Appendix II).
* They can follow the order during the testing.

Exclusion Criteria:Children will be excluded from the study if they had any of the following criteria;

* Significant visual or auditory defect that may affect their performance.
* Previous orthopedic surgery for upper extremity.
* Injection with Botulinium toxin in the last 6 months.
* Structural deformities in any joint or bone of the upper limbs.
* Practicing any form of sports.
A Comparison of Two Techniques for Choosing the Best Place to Put a Pacing Lead for Cardiac Resynchronisation Therapy

Cardiac resynchronisation therapy (CRT) using biventricular pacing (BiVP) is established as an effective treatment for heart failure. Unfortunately up to 45% of patients do not respond, with no improvement in symptoms or cardiac size. Reducing the proportion of non-responders has become the key research focus in CRT.

Targeting the position of the left ventricular (LV) pacing lead within the coronary vein network has previously been shown to increase the proportion of responders to CRT. Several techniques have been tried for targeting lead position, of which the best investigated are the use of speckle-tracking echocardiography to target the lead position to the site of latest mechanical activation of the left ventricle, and the use of invasive monitoring to select the pacing site at which the greatest acute haemodynamic response (AHR) to BiVP occurs. Both techniques are limited by groups of patients in whom the techniques are not possible or provide limited useful information.

The relationship between these two measures is unknown - there are no previous studies that have investigated correlation between the site of latest mechanical activation determined by echo and the site of maximal AHR. It is likely that a hybrid technique using both of these investigations might allow optimal lead positioning in more patients, or that if the information is shown to be equivalent, more streamlined techniques can be designed.

This study will also be able to contribute towards several important secondary questions. In particular the investigators will study the possibility of using non-invasive cardiac output monitoring (NICOM) to assess haemodynamic response rather than an intravascular pressure monitor wire. The investigators also wish to assess whether the site of latest mechanical activation is changed by right ventricular pacing.


Eligibility Criteria:
Inclusion Criteria:

* With ejection fraction \<35%
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Indication for cardiac resynchronisation therapy

Exclusion Criteria:

* Left Ventricular Ejection Fraction \>35%
* Severe peripheral vascular disease (that would make arterial access more risky)
* Haemodynamic instability (such that a longer procedure is inadvisable)
Descriptive Study of a French Sample of "at Risk" and Pathological Gamblers Followed in a French Structure Specialised in Addictive Disorders.

International surveys about pathological gambling estimate that there are about 1 to 3 per cent of gamblers who develop a pathological behavior about gamble.In France, pathological gambling is not a priority of public health, in contrast with other addictive disorders, like alcoholism or nicotine addiction. The aim of our study is to describe accurately for the first time in France, a sample of "at risk" and pathological French gamblers. We want to collect socio-demographical and clinical data from this subjects (story of the addictive behaviour, co morbidities, and more specifically, detailed study of pathological gamblers' personality), in order to compare our data with those of international literature.Secondarily, we want to test the feasibility of this kind of detailed evaluations for another study planned for 2007-2008 and which purpose will be to compare pathological gamblers' personality characteristics according to the kind of game that they mainly practice.The participation at the study will be proposed to every patient consulting in the "service d'addictologie du CHU de Nantes". The study consists in a single evaluation (about 8 hours) with standardized tools used all other the world.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 70
* Consulting or ex-consulting since 2000 in the "service d'addictologie du CHU de Nantes"
* Who meet sufficient criteria of pathological or "at risk" gambling in the DSM-IV section about pathological gambling
* Who accept to participate
* Who give their consent
* Who don't have any exclusion criteria

Exclusion Criteria:

* Gambling behaviour directly and chronologically explain by an acute maniac fit
* Superior function trouble
* Who don't agree to participate
* Difficulties in reading or writing in French
Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response

Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.


Eligibility Criteria:
Inclusion Criteria:

* age (years) at least 18 years
* no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity as determined by the principal investigator)
* baseline FEV1 ≥ 65% of predicted normal at Visit 1
* evidence of atopy to an allergen suitable for inhalation challenge following skin prick testing such as house dust mite, grass, cat or horse
* fall in FEV1 of ≥ 20% at a dose of methacholine ≤ 600mcg (methacholine PD20) at Visit 1
* positive response to allergen inhalation challenge (fall in FEV1 of ≥ 15% after inhalation of allergen at a dilution 1:32 or more dillute.
* absence of respiratory infection for at least 4 weeks prior to Visit 1
* absence of significant worsening of asthma that requires health care intervention or prolonged change in medication due to allergen exposure (or other trigger) for at least 4 weeks prior to Visit 1
* women of child-bearing potential shall not be pregnant or lactating
* non-smoker (cigarettes, vaping); ex-smoker with \<10 pack year history allowed; cannabis use will be evaluated on a case-by-case basis
* if on as needed budesonide/formoterol therapy, no reported use within 3 weeks prior to allergen challenge

Exclusion Criteria:

* Smoker \>10 pack year history
A Retrospective Analysis of Patients With Full Thickness Wounds in Limbs With Critical Ischemia

Once the patients are identified that have a full thickness wound on a limb clearly identified as having critical limb ischemia, these patients will be evaluated. The data that will be extracted from each chart will include patient's age, patient's gender, number of office visits, presence of diabetes, presence of osteomyelitis, type and amount of antibiotic administered, number of hyperbaric oxygen treatments, and if the wound healed.

Clinicians have even learned to group patients into different etiologic categories based on underlying disease such as diabetes mellitus, decubitus ulcer, surgical site infection, venous insufficiency, arterial insufficiency and others. It seems that wounds have been grouped into these categories because of their common barriers, which should allow us more precise algorithms and may provide better outcomes. That is diabetics tend to have the barriers of poor perfusion, endothelial cell dysfunction, white blood cell dysfunction, hyperglycemia, neuropathy and repetitive trauma. Venous insufficiency patients tend to have perivascular cuffing and peri wound edema. However patients with venous leg ulcers commonly have peripheral arterial disease and diabetes (3). The point is regardless of the etiology of the wound every patient must be evaluated for all barriers on every visit. Arbitrarily dividing chronic wounds in the etiologic categories has not significantly improved wound healing outcomes.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the study are patients that demonstrate the following:

  * A limb with a TCpO2 less than 20 with a full thickness wound.
  * Initial visit from August 1, 2002 to December 31, 2005.

Exclusion Criteria:

* The exclusion criteria for the study are patients that demonstrate the following:

  * Partial thickness wound or no wound in limb with critical ischemia.
  * A medical record that does not clearly demonstrate critical limb ischemia or does not clearly demonstrates a full thickness wound.