cyrilzakka/clinical-trials huggingface dataset:
Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients

Purpose:

To explore and compare antihyperalgesic effects of butorphanol, flurbiprofen axetil, and a combination of both received before anesthesia induction.

To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.

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There are a dramatically increasing number of evidences that administration of the potent, ultra-short-acting opioid remifentanil seems to cause opioid-induced hyperalgesia (OIH) more frequently and predictably compared with the others, likely due to its rapid onset and offset. Therefore, prophylaxis of remifentanil induced hyperalgesia is indispensable to postoperative comfort and satisfaction.

There is no denying the fact that OIH is related to central glutaminergic system and N-methyl-d-aspartate (NMDA) receptor-activation induced central sensitization. Prostaglandins can promote glutamate release from both astrocytes and spinal cord dorsal horns with subsequent activation of the NMDA receptors, and flurbiprofen axetil, as non-steroidal anti-inflammatory drugs (NSAIDs), not only functionally antagonizes the NMDA receptor activation via inhibition of prostaglandins, but also is a targeted drug which gathers at the site of inflammation, thus greatly enhances the analgesic effect. While butorphanol has both spinal analgesic and sedative functions because of predominantly central κ-receptor agonist activation, other advantages of butorphanol include few side effects, very low addiction potential, and low toxicity on account of a partial agonist-antagonist activity to μ-receptor. Moreover, antihyperalgesic activity of κ opioids at the site of inflammation has been reported in various acute pain models. The following study is carried out to evaluate whether butorphanol combined with flurbiprofen axetil can be safely and effectively applied to preventing postoperative hyperalgesia induced by remifentanil in patients undergoing lower abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo lower abdominal surgery under a short general anesthesia of less than 2 hours
2. Subject's American Society of Anesthesiologists physical status is I-II.
3. The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion Criteria:

1. Subject has a diagnosis of renal or liver failure.
2. Subject has a diagnosis of Insulin dependent diabetes.
3. Subject is allergy and contraindication to butorphanol or NSAIDs.
4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
6. Subject is pregnant or breast-feeding.
7. Subject is obese (body mass index \>30kg/m\^2).
High-dose Cytarabine and Survival in AML

In adults with acute myeloid leukemia, especially those \< 60 years of age, high-dose cytarabine consolidation therapy has been shown to influence survival, but the appropriate dose has not been defined.

Background In adults with acute myeloid leukemia, especially those \< 60 years of age, high-dose cytarabine consolidation therapy has been shown to influence survival. However, the appropriate dose has not been defined. We evaluated survival after cytarabine consolidation therapy at three different doses.

Design and Methods We conducted a single-center, retrospective study involving 499 acute myeloid leukemia patients, aged 18-92 years, all evaluated between 1978 and 2007. Of those 499 patients, 400 received curative treatment and 203 received cytarabine consolidation. The latter were divided into three groups: low-dose (receiving \< 1.5 g/m2 of i.v. cytarabine, every 12 h, on 3 alternate days, for up to 4 cycles); medium-high-dose (\< 45.45 g-the median dose-by the end of the cycles); and very-high-dose (≥ 45.45 g by the end of the cycles).

Results Among the 400 patients receiving curative treatment, five-year survival was 22.8% (91 patients). Cytarabine consolidation dose was an independent determinant of survival (significant differences were found among the groups), whereas age, karyotype, induction protocol, French-American-British classification and etiology were not. In comparison with the very-high-dose group, the risk of death was 3.871 times (95% CI, 1.043 to 14.370 times) higher in the high-dose group (p=0.043) and 9.775 times (95% CI, 2.493 to 38.320 times) higher in the low-dose group (p=0.001), assuming, in both cases, that age, karyotype, French-American-British classification and etiology of acute myeloid leukemia were constant.

Conclusions Consolidation therapy with high-dose cytarabine appears to improve survival in patients with acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of acute myeloid leukemia
* age 18 years or above
* must have been treated with potentially curative therapy

Exclusion Criteria:

* children or age less than 18 years
* palliative therapy
Muscle Transplantation in Strabismus Surgery

All the patients underwent standard muscle transplantation, where the resected extra stump of lateral or medial rectus muscle was transplanted to the medial or lateral rectus muscle using 6-0 prolene which wasrecessed by a standard recession technique


Eligibility Criteria:
Inclusion Criteria:

* Patients with esotropia or exotropia of more than 60 prism dioptre

Exclusion Criteria:

* Muscular paralysis.
* High myopia. .Dissociated vertical divergence. .Accommodative esotropias.
* Large vertical deviations associated Alphabetic syndromes
* previous surgeries in either eye
Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy

Our project aims to develop a new therapeutic approach in epilepsy-associated attention disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids, containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children with epilepsy. Secondary objectives include:

* To evaluate the impact of a supplementation of PS-Omega 3 on quality of life.
* To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid profiles.
* To assess the tolerance of a supplementation of PS-Omega 3.
* To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures.
* To describe the impact of a supplementation of PS-Omega 3, at 24 weeks,

  1. on attention disorders in children with epilepsy,
  2. on quality of life,
  3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects aged 6- 16 years, suffering from epilepsy (any type) and attention deficit hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V criteria in 12 clinical sites in France.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 15 years and 11 months.
* Children of either sex (male/female) suffering from epilepsy regardless of syndrome classification.
* Subjects on a stable dose of antiepileptic drugs (AED) for at least one month prior to inclusion and subjects for whom no change is considered a priori for the three months following the inclusion.
* Diagnosis of ADHD inattention or mixed type according to the DSM V criteria.
* Subjects must agree to study participation and their parents/legal guardian must provide written inform consent prior to participation in the study.

Exclusion Criteria:

* Subjects less than 6 years or older than 16 years old
* AED not stable for at least one month and/or a change in AED is expected in the three months following inclusion.
* Diagnosis of ADHD hyperactivity type exclusive according to DSM V criteria.
* Mental retardation defined by a score \< 70 on the verbal comprehension and perceptual reasoning Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV), performed within 18 months prior to inclusion or at V1.
* Diagnosis of a psychiatric comorbidity other than ADHD according to the DSM V criteria, including: pervasive developmental disorders including autism disorders; bipolar disordersand psychotic disorders.
* Children suffering from diabetes, any type.
* Use of psychoactive drugs in ADHD within the previous month: Methylphenidate, Amphetamine, Atomoxetine, Modafinil and Antidepressants whatever the class.
* Use of dietary supplementation, other than vitamins, within the last 3 months.
* Use of ketogenic diet within the last 3 months.
* Allergy to fish or other sea products.
* Soy allergy.
* Absence of coverage by social security.
Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment Infusion Phlebitis

Patients receiving nutritional emulsion for at least 3 days will be treated with Hirudoid cream or placebo cream to prevent and treat phlebitis caused by the infusion. The treatment is continued after the end of infusion for at least 7 days.

Number of patients developing superficial phlebitis and duration of phlebitis will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are admitted to the hospital requiring to receive infusion of a complete nutritional emulsion for 3 days (Kabiven® Peripheral, 1400 kcal, 1920 ml, 750 mosmol/L, pH 5.6),
* Aged 18-65 years.
* Patients who are able to understand the requirements of the study and agree to sign an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the study.

Exclusion Criteria:

* Patients known to be allergic to Hirudoid or any ingredients of Hirudoid
* Patients with impaired skin integrity caused by lesion or soft tissue trauma
* Patients having skin lesions with ulcerations or any other severe dermatologic disease
* Patients has been received a complete nutritional emulsion infusion within 7 days of inclusion
* Patients with severe uncontrolled medical conditions, which makes it undesirable or unsafe for the patients to participate in the study, such as: Acute or chronic uncontrolled severe infections,Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, serious uncontrolled cardiac arrhythmia or any other clinically serious cardiac disease, Uncontrolled diabetes as defined by fasting serum glucose \> 1.5 x ULN; optimal glycaemic control should be achieved before starting trial therapy, Uncontrolled bleeding
* Patients known to have coagulation disorders such as Haemophilia, Thrombocytopenia, Thrombosis, Other severe hematologic conditions like leukaemia, especially with abnormal coagulation
* Patients who have symptoms of microangiopathy (small vessel disease) or neuropathy related to diabetes and other diseases
* Patients with hyperthyroidism and hypothyroidism
* Patients who are pregnant or breast feeding
* Patients who are on anticoagulant therapy (last 2 weeks)
* Patients with severe psychiatric conditions
* Patients who are unable to bear legal responsibility or unable to understand the study
* Patients who are unreliable or unable to comply with the protocol, like alcohol or drug abusers
* Patients who had been participated in another clinical trial in the past 12 weeks
* Patient is relatives of, or staff directly reporting to, the investigator
* Patient is employee of the sponsor
Continuous Postoperative Use of Low-Dose Combined Oral Contraceptivesfor for Endometriosis-Related Chronic Pelvic Pain

Because ovarian sex steroids fluctuations during the menstrual cycle are implicated in the pathogenesis of the endometriosis-related chronic pelvic pain (CPP), the oral contraceptives (OCs) are used with non-contraceptive indication for this disorder.

To date, OCs are widely used as medical treatment in patients with endometriosis, in addition, they are recently experimented as post-surgical therapy. Traditional cyclic regimen, with 21 days of active pills with 7 days of placebo or suspension, is usually adopted. Furthermore, recent studies suggested that long-term continuous OCs use can be effective in the postoperative period both as second- and third- line treatments after cyclic regimen failure. In these studies a combined treatment with ethinilestradiol (0.02 mg) plus desogestrel (0.15 mg) were used and compared with baseline or ciproterone acetate.

A recent study showed a deeper ovarian and endometrial suppression with continuous OCs in comparison with cyclic OCs, providing a physiological rationale for continuous OCs use for noncontraceptive indications. Furthermore, to date, no study compared post-operative continuous versus cyclic OCs in patients with endometriosis-related CPP.

Premenopausal women with endometriosis-related CPP scheduled for laparoscopic surgery to our Academic Department of Gynecology will be consecutively enrolled. Subjects with hystologically confirmed endometriosis at laparoscopy (stage I-IV of the American Society Reproductive Medicine), a subjective severity of pelvic pain by using a visual analogue scale (VAS 1-100) of at least 70, and without immediate desire of pregnancy will be enrolled.

Briefly, all patients will undergo conservative laparoscopic surgery for endometriosis. Thereafter, a low-dose monophasic OC containing 2.0 mg clormadinone acetate plus 0.03 mg ethinil-estradiol (Belara®, Grunenthal, Milan, Italy) will be administered. Patients from the experimental group will be treated with a continuous regimen, while patients from the control group will receive the OC with a cyclic regimen consisting of 21 days of active pills with 7 days of placebo. The drug and the placebo will be similar and will be labelled according to the subject number. For the overall study-period, operators and patients will be blind to the treatment allocation.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal state
* Endometriosis-related chronic pelvic pain
* Hystologically confirmed endometriosis at laparoscopy
* Subjective severity of pelvic pain by using a visual analogue scale of at least 70
* No immediate desire of pregnancy

Exclusion Criteria:

* Age ≤18 or ≥ 40
* Previous use of drugs for treating CPP (wash-out period of 3 months), with exclusion of non-steroidal anti-inflammatory drugs
* Contraindication to estro-progestin compounds
* Major medical diseases
* Psychiatric disorders
* Pelvic inflammatory disease
* Adnexal patologies
* Unability to complete the daily diary
* History of alcohol or other drugs abuse
BioFiber Scaffold Post-Market Observational Study

The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.

Rhe BioFiberTM Scaffold post-market surveillance study is a prospective, single arm, multi-center observational study with sites in the US and France.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older

  * Patients with full thickness rotator cuff tears (confirmed at time of surgery) that are eligible for rotator cuff repair.
  * Patients willing and able to comply with the requirements of the study protocol and provide informed consent.

Exclusion Criteria:

* Patients with active or latent infection
* Patients with decreased vascularity
* Patients with pathological soft tissue conditions
* Patients with a known allergy or sensitivity to tetracycline hydrochloride or kanamycin sulfate
* Patients with a known allergy or sensitivity to bovine collagen (BioFiber-CM only)
* Participating in a concurrent study that has not been approved for concurrent enrollment by the Clinical Study Manager
Multimodality Neuromonitoring in XLIF

This is a prospective, non-randomized multi-center study to evaluate intraoperative neuromonitoring results in subjects who undergo eXtreme Lateral Interbody Fusion (XLIF) surgery at any number of levels inclusive of L4-5.

Subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will undergo neuromonitoring during the XLIF operation, as per standard care. They will then be re-evaluated immediately after surgery and at the first standard postoperative follow-up visit (6 weeks) to assess for presence of new neural deficit. If a new neural deficit is identified, the patient will be followed per the Investigator's standard follow-up schedule until symptoms have resolved (or are deemed permanent).

A total of 300 subjects will be enrolled in this study from multiple centers. The subjects will have degenerative conditions of the lumbar spine with planned treatment including XLIF surgery. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria below in order to be considered for enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless surgical treatment is clinically indicated earlier
* Indicated for extreme lateral interbody fusion at any number of levels inclusive of L4-5
* At least 18 years of age at the date of written informed consent
* Able to undergo surgery based on physical exam, medical history and surgeon judgment
* Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
* Signed and dated informed consent form

Exclusion Criteria:

* Patient has a mental or physical condition that would limit the ability to comply with study requirements
* Patient is a prisoner
* Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
* Patient has an underlying neurological disease or neurological deficit that is not associated with the condition for which he/she is seeking surgical intervention (e.g., diabetic peripheral neuropathy)
* Patient is participating in another clinical study that would confound study data
A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)

The purpose of this study is to test the effectiveness of group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine.

The purpose of this study is to test the effectiveness of a group psychotherapy designed specifically for male veterans and active-duty personnel with Post-traumatic Stress Disorder (PTSD), Major Depressive Disorder (MDD) and with disturbances in their sleep or daily routine. We will compare two group therapies, one of which has been examined in previous studies for veterans with PTSD. Both group therapies have been shown to reduce symptoms of anxiety and depression in some veterans. However, neither group therapy has been proven to be more effective than treatment as usual for PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Veteran or active duty military personnel
* Current posttraumatic stress disorder (PTSD), at least moderate severity
* Criterion A exposure to trauma occurring after the age of 18
* Major depressive disorder (MDD), at least moderate severity
* Disturbances in sleep (primary insomnia, insomnia related to PTSD, or nightmare disorder) or daily routine

Exclusion Criteria:

* Current or past bipolar disorder
* Current psychotic disorder
* Substance abuse/dependence in last 30 days
* Uncontrolled serious medical condition or neurological disorder
* Currently working an overnight shift
* Primary untreated sleep apnea, restless legs syndrome
Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment

A multi-center, open-label, extended treatment, clinical trial examining the safety of administering multiple does of panitumumab by intravenous (i.v.) infusion to patients who have previously received panitumumab and benefited from treatment


Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and sign an IRB approved Informed Consent Form
* Male or female 18 years of age or older
* Female patients who are post menopausal (no menstrual period for a minimum of six months), surgically sterilized, or are using an oral or implanted contraceptive, double barrier birth control, or an intrauterine device (IUD) and have a negative serum pregnancy test upon entry into this study; or male patients willing to use contraception upon enrollment and during the course of the study
* Previously received and tolerated panitumumab treatment on studies 20020374 Part 2 or 20030138/20040116
* Is considered "stable" or "responding" based on the RECIST (20020374 Part 2) or WHO (20040116) criteria, at the final treatment visit of the previous panitumumab clinical trial and the screening visit for this study
* No more than 2 months (60 days) have elapsed since the final treatment visit of the previous panitumumab clinical trial
* Karnofsky score \> or = 70%

Exclusion Criteria:

* Brain metastases (20040116 patients are allowed only if controlled and asymptomatic)
* Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed). Exception: Patients in the Motzer Intermediate Risk Group from 20020374 Cohort 2 with uncontrolled high corrected calcium (\>10 mg/dl) may be enrolled
* Use of any anti-tumor therapy or investigational drug, other than panitumumab, between the last visit of the previous panitumumab study and the initial visit in this 20020375 study
* Prior treatment with another anti-EGFr agent, other than panitumumab
* Myocardial infarction within 1 year prior to entering the study
* Has other cancer that has been active and required treatment within the past 5 years (basal cell carcinoma or cervical carcinoma in situ are allowed)
* Pregnant or breast feeding female; female of childbearing potential (defined as: post menarche and is biologically capable of becoming pregnant) unwilling to use birth control (as defined in the inclusion criteria) during and for 6 months following treatment
* Male patient unwilling to use birth control (as defined in the inclusion criteria) during and for 1 month following treatment
* Known to be HIV positive
* History of any chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the Investigator may increase the risks associated with study drug administration
* Allergy to the ingredients of the study medication or to Staphylococcus Protein A
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis