cyrilzakka/clinical-trials huggingface dataset:
Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement

Spinal surgery is associated with intense pain and associated to a history of preoperative chronic pain. Pregabalin is licensed to treat chronic neuropathic pain, particularly when high dose of opioid are required. Preoperative pain is associated with high postoperative pain scores and opioid requirement promoting persistent hyperalgesic state. The investigators will evaluate the postoperative opioid consumption and pain scores in patients scheduled for lumbar surgery and taking pregabalin since more than 15 days and compare with preoperative pregabalin-free patient that will receive pregabalin only during surgery.

Patients will be prospectively included and compared according their preoperative medication: pregabalin-treated patients (\>more than 15 days) for neuropathic pain associated to spinal surgery and pregabalin-free patients for whom pregabalin will be prescribed for 48 hours. Patients will be included without randomization as an observational study. All the patients will receive multimodal analgesia and intraoperative management will be standardized. The main outcome will be the amount of oxycodone during the first 24h after surgery. Other outcomes include pain scores, the quantification of the neuropathic pain diagnostic questionnaire (DN4), nausea and vomiting, length of stay, side-effects of pregabalin and opioid. Patients were also evaluated at three months for pain scores and DN4 score. Postoperative evaluation will be performed in a single-blind manner with investigators not include in the recruitment or the peroperative period.

Eligibility Criteria:
Inclusion Criteria:

* American Society Anesthesiologist Physical status (ASA) 1-3
* Age ≥18 years old
* Spinal surgery: discectomy, posterior or transforaminal lumbar interbody fusion limited to 2 levels, lumbar disk prosthesis
* Able to participate personality, has given free and inform consent in French
* Affiliated of beneficiary of a system of social security

Exclusion Criteria:

* Age less than 18 years or higher than 85 years old
* Refusal to participate or provide written consent
* Surgery with a combined anterior and posterior approach
* Emergency surgery, reintervention, spine fracture, metastasis
* Tricyclic antidepressant use
* Pregabalin use for other indication: other neuropathy, epilepsy, generalized anxiety disorder
* Pregnancy
* Lack of understanding of NRS and/or DN4 scores
* Hypersensibility or contraindication to levobupivacaine, paracetamol, nefopam, ketoprofen and/or oxycodone
* Participation in another clinical study
Cancer-related Thromboembolic Disease

Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.

The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk

The secondary objectives are:

* To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
* To evaluate values of other clotting activation markers in patients with cancer

Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.

Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.

The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sexes with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy
* Subjects having signed Informed Consent prior to initiation of any study procedure
* Covered by a Health System

Exclusion Criteria:

* Known bleeding or thrombophilia disorders
* Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
* Patient immobilized
* Confirmed venous thromboembolism in the last 12 months
* Active bleeding or bleedings in the last 4 weeks requiring hospitalization, transfusion, or surgical intervention
* Anticoagulant therapy at the moment of first sampling (at least one day off for Heparines and DOAc; at least 5 days off for VKA is needed)
* Antiplatelet therapy at the moment of first sampling (only if PRP TGA can be performed at site)
* Severe hepatic insufficiency
* Life expectancy of less than 3 months
* Pregnancy
Signet Ring Cell Carcinoma in Esophageal Adenocarcinoma

There has been much controversy surrounding the biologic behavior and prognosis of esophageal signet ring cell (SRCs) containing carcinomas. To clarify the biologic behavior of SRCs, the investigators compared the clinicopathologic features and prognosis of SRCs with other adenocarcinomas (ADC) of the esophagus and gastroesophageal junction (GEJ).

Adenocarcinoma (ADC) of the esophagus and gastroesophageal junction (GEJ) is an aggressive neoplasm and has a poor prognosis. Surgical based treatment has been the treatment of choice for localized esophageal adenocarcinoma.

Signet-ring cell carcinoma is a unique histologic subtype of adenocarcinoma characterized by abundant intracellular mucin accumulation and a compressed nucleus displaced toward one extremity of the cell (the so-called signet-ring cell (SRC)). According to the World Health Organisation (WHO), a true signet-ring cell carcinoma (SRCca) is defined as an adenocarcinoma in which the predominant component (more than 50% of the tumor) consists of isolated or small groups of SRC in the stroma. If the tumor contains less than 50% of those cells, it is generally considered as an adenocarcinoma (ADC).

Eligibility Criteria:
Inclusion Criteria:

- Adenocarcinoma R0 resection Primary surgery

Exclusion Criteria:

- Other histology R1 or R2 resection Neoadjuvant therapy
Impact of a Sleep Debt in Middle-Aged and Older Adults

This project has 6 aims.

1. To examine the impact of recurrent partial sleep loss in young, middle-aged and older men and women. Sleep will be restricted to 4 hours.
2. To test the hypothesis that extending bedtimes to allow for sleep recovery will reverse the metabolic, endocrine, and cardiovascular and neuro-behavioral alterations resulting from sleep restriction. Sleep will be extended to 12 hours following the 4 hour sleep restriction.
3. To test the hypothesis that there are age and gender differences in the total amount of sleep recovery obtained during the week of 12-hour bedtimes.
4. To test the hypothesis that there are age and gender differences in sleep capacity (the amount of time an individual can sleep per night when there is no sleep debt).
5. To test the hypothesis that sleep capacity is partly determined by baseline levels of slow-wave sleep and slow-wave activity.
6. To determine whether sleep capacity is related to sleep need by examining metabolic, endocrine, cardiovascular and neuro-behavioral changes with the amount of the individual sleep debt.


Eligibility Criteria:
Inclusion Criteria:

* normal weight
* healthy
* age 18-75 old

Exclusion Criteria:

* sleep disorder
* irregular life habits (shift workers, travelers)
* smokers
* on medication
* consumption of \> 2 alcohol or caffeinated beverages/day
Effect of Montelukast on Remodelling Markers in Asthmatic Children

Airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced airway remodelling features not modulated by corticosteroids, are reversible by CysLT1 receptor blockade therapy in animals. No data are available, at the present, about the potential effect of LTs receptor antagonists on airway remodelling in asthmatic children.

In the present study, the investigators aim to assess whether the addition of montelukast to ICS in mild asthmatic children to inhibit the release of MMP-9, TIMP-1, MMP-12, MMP-9/TIMP1 ratio, procollagen type I C-terminal peptide (PICP) and TGF-beta in the airway fluid collected by induced sputum in asthmatic children. 30-40 atopic children with mild persistent asthma.

Children with asthma will be recruited and evaluated with a real life open label trial: they will be randomised into two groups at first visit (T1): 1) group A: in these patients montelukast tablets 5 mg and as needed beta agonist will be administered; 2) group B: in these patients beta agonist therapy only.

All children will be evaluated after 8 weeks (T2). They will be tested for lung function, FeNO, metalloproteinase (MMP)-9, MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen type I C-terminal peptide (PICP) and TGF-beta1 levels in sputum.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria: the classification of asthma will be based on clinical history and examination and pulmonary function parameters, according to international guidelines.
* Stage and/or severity of condition: atopic children with mild intermittent asthma will be enrolled. Atopy will be evaluated by skin-prick test to common allergens in the area.
* Confirmatory physical and laboratory findings:
* Age: ranging in age 6 to 14 years.
* Evidence of susceptibility to the disease under study
* Patients have not used ICS during 3-month period prior to study entry

Exclusion Criteria:

* Patients will be excluded if they had used oral steroids in the last month.
* Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infection in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.
* Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infections in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.
Effect of Calcium Silicate Based Root Canal Medicament on Inflammatory Mediators

Calcium hydroxide is generally preferred in endodontics as an intracanal medicament because of its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited.

The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on the release of RANKL/OPG, TNF-α, PGE-2 and TGF-β1 in root canal treated teeth with periapical lesions.

Sixty patients were randomly divided into two groups using a web program according to the medication selected: Calcium silicate based root canal medicament or calcium hydroxide based root canal medicament.

After removing gutta-percha from the root canals, RANKL/OPG, TNF-α, PGE-2 and TGF- β1 samples were taken from the interstitial fluid of the apical tissues using three paper points.

At the second appointment, medicaments were removed and second sampling was performed using the same method. RANKL/OPG, TNF-α, PGE-2 and TGF- β1 levels were measured by enzyme-linked immunosorbent assay and their ratios were calculated.

Eligibility Criteria:
Inclusion Criteria:

Incisor, canine, and premolar teeth that had previously undergone root canal treatment (cases with persistent and secondary disease) and presented with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis were included. Incisor, canine, and premolar teeth with only 1 root canal were included in the study to avoid untreated extra root canals and difficulties in the preparation, obturation, and restoration of molar teeth and to make treatments more standardized.The patients had not used any antibiotics for 3 months before treatment, and patients were obviously free of systemic diseases.

Exclusion Criteria:

Patients were excluded if teeth showed the presence of a root fracture or any swelling, ankyloses, or periodontal pockets deeper than 4 mm. Teeth on which a rubber dam could not be performed were excluded. Patients with allergy to ibuprofen or ciprofloxacin were also excluded.
Ureter Identification With IRDye 800BK

Phase 1/2a study, second in-man utilising IRDye800BK in ureteric identification using fluorescence throughout abdominal surgery. Study is open label, non-randomised prospective study.


Eligibility Criteria:
Inclusion Criteria (Group A \& B participants)

* Participant is willing and able to give informed consent for participation in the trial.
* Male or Female, aged 18 years or above.
* Undergoing elective laparoscopic abdominal surgery or undergoing planned laparoscopic donor nephrectomy (donation)
* Participant has available laboratory and ECG results within 3 months of enrolment.
* Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter
* In the Investigator's opinion, is able and willing to comply with all trial requirements.
* Group A only: Participant is undergoing laparoscopic colorectal surgery
* Group B only: Participant is undergoing laparoscopic donor nephrectomy

Exclusion Criteria (Group A \& B participants)

The participant may not enter the trial if ANY of the following apply:

* Female participant who is pregnant, lactating or planning pregnancy throughout the trial.
* Significant renal impairment (eGFR of under 50mL/min/1,73m2)
* Significant liver impairment as defined as:

  * AST \> 3.0 x ULN or
  * ALT \> 3.0 x ULN or
  * Total serum bilirubin \> 1.5 x ULN
* Participants involved with another research trial involving an unlicensed medicine in the past 12 weeks.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Known allergy to D-Mannitol or citric acid
* Group B Only: Laparoscopic donor nephrectomy patients in whom the kidney recipient has refused participation or if the recipient is being transplanted in another transplant centre

Inclusion criteria for transplant recipients

* Participant must be willing and able to give informed consent for trial participation
* Male or female aged 18 years or over
* Is able and willing to comply with all trial requirements
* Receiving a kidney from a participant recruited to this study

Exclusion criteria for transplant recipients

• Female who is pregnant, lactating, or planning pregnancy throughout the trial
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of the study is to evaluate the safety and effectiveness of an investigational therapy for treating patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
* Mean IOP in each eye less than 18 mmHg at the screening visit.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant.
* History of chronic or recurrent severe inflammatory eye disease.
* Ocular trauma within the past six months in either eye.
* Other protocol-defined exclusion criteria may apply.
Clinical Application of BioCleanse Meniscus

This study will follow patients after routine surgery of a meniscal allograft transplant.

The BioCleanse meniscus is available to to all orthopedic surgeons for transplantation. The purpose of this registry is to allow close monitoring of a subgroup of patients receiving the BioCleanse Meniscus. All patients who have selected a BioCleanse Meniscus for their Meniscal Allograft transplant will be asked to join the registry. Outcomes will be measured by subjective subject questionnaires as well as X-rays and MRI.

Eligibility Criteria:
Inclusion Criteria:

* All patients, up to 10 who have selected a BioCleanse Meniscus transplant

Exclusion Criteria:

* Anyone not eligible for a meniscal transplant
Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson Disease

The investigators will investigate the effects of an 8-week resistant starch (RS) supplementation (5 g twice a day) in patients with Parkinson Disease and matched controls on:

1. symptoms of constipation (assessed by clinical scores);
2. fecal short chain fatty acid concentrations (measured by chromatography);
3. gut microbiota composition.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed to participate
* For patients: diagnosis of Parkinson Disease

Main Exclusion Criteria:

* Use of antibiotics, steroids or probiotic supplements
* Chronic or acute disorders of the gastrointestinal tract
* History of gastrointestinal surgery (other than appendectomy)
* For healthy controls: Family history of neurodegenerative disorders
Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery

This study is designed to test the hypothesis that, for older orthopedic patients who developed postoperative delirium, combining buccal acupuncture with routine care will shorten delirium duration and relieve delirium severity.

Delirium is an acute, transient central nervous system dysfunction characterized by fluctuating disturbances of attention, consciousness, and cognitive function. Delirium is common in older patients following surgery. The incidence of postoperative delirium ranges from 12.0% to 23.8% in older patients; the incidence of delirium is about 10.7-17.6% in older patients after joint replacement surgery. The occurrence of delirium is associated with worse outcomes, including increased early postoperative complications, prolonged hospital-stay, and increased in-hospital mortality, as well as long-term decline in cognitive function, quality of life, and survival duration.

Clinical use of acupuncture has a long history in China. Buccal acupuncture therapy is a microneedle technique and provides treatment for systemic diseases by acupuncturing specific acupoints in the cheek. Acupuncture is also used for delirium treatment. Studies of older patients who developed delirium in internal medicine wards found that, compared with routine care alone, combining routine care with acupuncture relieved delirious symptoms and severity more efficaciously. However, evidence in this aspect is limited. We suppose that, for older orthopedic patients who developed postoperative delirium, combining buccal acupuncture with routine care will shorten delirium duration and relieve delirium severity.

Eligibility Criteria:
Inclusion criteria:

* Aged ≥65 years, but \<90 years.
* After knee or hip replacement surgery.
* Diagnosed with delirium in the morning of enrollment.

Exclusion criteria:

* Refuse to participate in the study.
* Presence of any contraindications to acupuncture, such as puncture site infections or platelet count ≤20×10\^9/L.
* Preoperative history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
* Inability to communicate due to coma, profound dementia, or language barrier, or inability to cooperate with treatment due to agitation.
* American Society of Anesthesiologists physical status grade ≥V, or estimated survival ≤24 h.
Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.

Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking arm.However, concerns have been raised with regard to rapid infusion of large volume of blood in relatively shorter time predisposing to hyperperfusion injury including intraventricular hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk of neurological injury. It has, though, advantage of shorter timeframe allowing for effective resuscitation of preterm neonates to start as soon as possible. Thus, with countering advantages and disadvantages, the practice has not been adopted at most places. The authors planned to conduct a randomized clinical trail to compare the efficacy and safety of umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \< 32 weeks gestation confirmed by first trimester US

Exclusion Criteria:

* Any proven or suspected congenital or chromosomal abnormalities
* Placenta previa or abruption
* Cord prolapse
* Known Rh sensitization
* Fetal hydrops
* Monochorionic multiples
Longitudinal Investigation of Hippocampal Function and Morphology in Acute Lymphatic Leukemia (ALL) Patients Treated With Chemotherapy

There are two regions in the adult brain that exhibit neuronal stem and progenitor cells, generating new neurons postnatally and throughout adulthood. One is the so called subventricular zone the other is the dentate gyrus of the hippocampus. Adult neurogenesis is a physiological process representing an important functional impact for certain brain areas, especially the hippocampus. The hippocampal formation plays an important role in long-term memory and spatial navigation. Inhibition of adult neurogenesis in mice by chemotherapy or radiation is followed by significant deficits in hippocampal memory functions while hippocampus-independent memory is unaffected.

Clinical trials had shown that chemotherapy and brain radiation lead to cognitive dysfunction. However, the exact mechanisms underlying this phenomenon are still unidentified.

The aim of our study is to investigate, whether the inhibition of adult neural stem cell proliferation in the hippocampus by intrathecal chemotherapy and/or cerebral radiation is responsible for treatment induced memory deficits. We will investigate patients suffering from acute lymphatic leukaemia (ALL) that receive prophylactic intrathecal chemotherapy and brain irradiation. The study represents a longitudinal investigation including a virtual "humanized" version of the morris-water-maze to test hippocampus dependent spatial memory, as well as MR-imaging for morphological (volumetry) and biochemical (spectroscopy) data.


Eligibility Criteria:
Inclusion Criteria:

* Initial diagnosis of acute lymphatic leukaemia (ALL)
* Treatment within the German Multicenter Adult ALL (GMALL 2003) therapy study
* Age 18 to 40 years
* Eligibility for performing study procedure
* Informed consent

Exclusion Criteria:

* Neuropsychiatric disorders
* Present contraindication for MRI investigation (e.g. pacemaker)