cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung Cancer in First Line Chemotherapy

Treatment of a stage IV NSCLC is based on chemotherapy and requires before each session to check clinically, biologically and radiologically absence of infection. This biological evaluation is based on the CRP rate. Lots of infections may occur in this situation and could reduce by three the patient's life duration. However it is very important to make as early as possible a correct diagnosis of infection. CRP rate is classically higher for those patients even without any infection. In comparison with CRP, Procalcitonin (PCT) is well-known for its better sensibility and specificity for the infection diagnosis but has never been study in case of active cancer. The aim of this study is to evaluate the Procalcitonin basal rate for those patients suffering from NSCLC. It could be a simple and reliable method to use. So the investigators decided to include each new patient with NSCLC stage IV coming for his first-line chemotherapy without any infection sign, and to realize a Procalcitonin dosage before the start of the treatment. This sample will be analyzed at the chemical laboratory and the result will not be communicated to the patient physician. A new clinical evaluation will be realized either at the hospital or by phone at day 7 to search any sign of infection. In absence of infection, patient will be reevaluated at day 14, 21 and 30. In case of infection, a new Procalcitonin (and CRP) dosage will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Patient with stage IV NSCLC, hospitalized for his first seance of chemotherapy
* Medical conditions permitting chemotherapy
* Informed consent signed
* Patient covered by social insurance

Exclusion Criteria:

* Patient with small cell lung cancer
* Patients with NSCLC stage I, II or III of the Tumor Node Metastasis classification
* Patient with stage IV NSCLC, who received prior treatment (radiotherapy, chemotherapy ...)
* Patient with infection (on clinical and paraclinical criteria) not compatible with the administration of the first seance of chemotherapy.
* Pregnant or breastfeeding women Private Patient freedom or in a position to judicial protection (guardianship)
Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft

The present study aimed to evaluate the effects of enamel matrix derivatives either alone or combined with autogenous bone graft applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid transforming growth factor-β1 level and, to compare with open flap debridement. Our hypothesis is to test whether the use of autogenous bone graft and enamel matrix derivative combination in the treatment of intrabony periodontal defects enhance the clinical, radiographic and biochemical parameters in comparison to the use of open flap debridement alone.

The present study aimed to evaluate the effects of enamel matrix derivatives (EMD) either alone or combined with autogenous bone graft (ABG) applied to intrabony defects in chronic periodontitis patients on clinical/radiographic parameters and gingival crevicular fluid (GCF) transforming growth factor-β1 (TGF-β1) level and, to compare with open flap debridement (OFD). A total of 30 deep intrabony defects in 12 patients were randomly treated with EMD+ABG (Combination group), EMD alone (EMD group) or OFD (Control group). Clinical parameters including plaque index, gingival index, bleeding on probing, probing depth, relative attachment level and recession were recorded at baseline and 6 months post-surgery. Intrabony defect fill percentage was calculated on the standardized radiographs. TGF-β1 level was evaluated in GCF just before surgery and 7, 14, 30, 90, 180 days after surgery using ELISA.

Eligibility Criteria:
Inclusion Criteria:

(a) no systemic diseases as diabetes mellitus or cardiovascular diseases that contraindicated periodontal surgery and could influence the outcome of the therapy; (b) no smoking (c) no medications affecting periodontal tissues; (d) no pregnancy or lactation; (e) a good level of oral hygiene (plaque index \< 1, and full mouth bleeding on probing score \<20% after initial periodontal treatment), (f) compliance with the maintenance programme and (g) presence of at least one intra-bony defect with a probing depth ≥6 mm, radiographic depth of the defect ≥3 mm as detected on the radiographs.

Exclusion Criteria:

(a) pregnancy or lactating, (b) required an antibiotic premedication, (c) received antibiotic treatment in the previous 6 months, (d) smokers, (e) whose tooth had inadequate amount of attached keratinized gingiva (\<1mm)
Functional Rehabilitation of Older Patients With Schizophrenia

The primary purpose of this project is to evaluate the efficacy of a group therapy intervention, cognitive behavioral social skills training (CBSST), that teaches social functioning skills and cognitive-behavioral compensatory aids to older patients with schizophrenia. CBSST, therefore, targets the multidimensional deficits that lead to disability in aging veterans with severe mental illness.

This is a randomized-controlled clinical trial comparing 2 treatment conditions: Goal focused supportive care (SC); and CBSST. Subjects (N=100) will be recruited, treated for 9 months and followed longitudinally for 9 months after treatment. A multidimensional evaluation of treatment outcome, including social functioning (primary outcome), neuropsychological functioning, cognitive insight, psychotic symptoms, and health services utilization, will be conducted at baseline, end of treatment (9-month follow-up), and 9 months post-treatment. 100 patients with schizophrenia or schizoaffective disorder will participate on a voluntary basis and will be paid $50.00 per assessment visit. Subjects will not be paid or given any incentive for treatment. The following inclusion/exclusion criteria will be used: (i) Voluntary informed consent for participation (given by the patient or conservator); (ii) Age 45 or older; (iii) DSM-IV-diagnosis (APA, 1994) of schizophrenia or schizoaffective disorder at any stage of illness; (iv) No prior exposure to SST or CBT in the past 5 years; (v) Level of care required at baseline does not interfere with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric, or physical illness). We anticipate that we will be able to provide an empirically validated intervention that can be used by clinicians on multidisciplinary rehabilitation teams to reduce disability in aging patients with schizophrenia. The products from this research will be written research reports and a therapy manual and patient workbook to guide rehabilitation that can be disseminated (e.g., via the internet) to relevant clinicians.

Eligibility Criteria:
Inclusion Criteria:

* 45 years of age and older
* DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder
* Fluent in speaking, reading, and writing English
* Physically and psychiatrically stable enough to undergo various assessments in this study

Exclusion Criteria:

Has not received Cognitive Behavioral Therapy (CBT) or Social Skills Training (SST) or Dialectical Behavioral Therapy (DBT) in the past 5 years
Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)

The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (previously GS-9876) in adults with lupus membranous nephropathy (LMN).


Eligibility Criteria:
Key Inclusion Criteria:

* Kidney biopsy within the 36 months prior to screening with a histologic diagnosis of LMN (International Society of Nephrology \[ISN\] and the Renal Pathology Society \[RPS\] 2003 classification of lupus nephritis), either Class V alone, or Class V in combination with Class II.
* Urine protein excretion ≥ 1.5 grams per day
* Estimated glomerular filtration rate (eGFR) ≥ 40 mg/min/1.73m\^2 based on the modification of diet in renal disease (MDRD) formulation at screening
* No evidence of active or latent tuberculosis (TB) as assessed during screening

Key Exclusion Criteria:

* Prior treatments as follows:

  * Previous treatment with a janus kinase (JAK) inhibitor within 3 months of Day 1
  * Use of rituximab or other selective B lymphocyte depleting agents (including experimental agents) within 6 months of Day 1. Enrollment is permitted if the last dose was given \> 6 months and CD19-positive B cells are detectable at Screening.
* Use of any concomitant prohibited medications as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Optimization of PEEP for Alveolar Recruitment in ARDS

Actual setting of PEEP in ARDS is based on tables linked to FiO2, or respiratory system plateau pressure (e.g EXPRESS Study) or set regarding esophageal pressure mesurement and transpulmonary pressure calculation. Opera study should confirm if a setting approach based on esophageal pressure is helpfull for any ARDS patient in ICU without deleterious side-effect.


Eligibility Criteria:
Inclusion Criteria:

* ARDS Stades 2 and 3 with invasive ventilation (EXPRESS settings) within 3 to 12 hours

Exclusion Criteria:

* less 18 years, pregnancy, intracardiac shunt, esophageal catheter cons-indicated
Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage

This study must evaluate the benefit of a continuous audio guidance on the effectiveness of MCE directed by a volunteer.

The evaluation of the MCE for this study is based on both quantitative criteria (based on the recommendations ERC 2010)

* frequency
* depth of chest compressions.

This study compares two methods of continuous audio guide (one arm with an audio continuous guidance method by the regulator and second arm with an audio continuous guidance method by the controller relayed by an audio) to a method of incentive MCE based on a unique set made by the regulator(control arm).


Eligibility Criteria:
Inclusion Criteria:

- Healthy volunteers from the general population understanding the French language.

Exclusion Criteria:

* major physical disability;
* do not speak French
* first aid training under one year
Safety and Activity of 90Y-Labeled IDEC-159 in Subjects With Metastatic Colorectal Adenocarcinoma

This is a Phase I/II open-label, dose-escalating study in patients with metastatic colorectal cancer. The objectives of the study are to obtain information on the safety of radiolabeled IDEC-159, as well as its activity in colorectal cancer. Another objective is to determine the maximum tolerated dose (MTD). The study duration is 2 years with visits occuring daily and/or weekly for the first 3 months, and every 6 weeks until the end of the 2 year period.


Eligibility Criteria:
Inclusion Criteria:

* Sign an Institutional Review Board (IRB)-approved informed consent.
* Metastatic colorectal adenocarcinoma that has been pathologically confirmed following failed response or relapse while on or following fluoropyrimidine, irinotecan, and oxaliplatin chemotherapy. (Prior therapy with cetuximab is recommended if the tumors are epidermal growth factor receptor \[EGFR\] positive.)
* Age 18 or above.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
* Recovered to baseline toxicity from any significant toxicity associated with prior surgery, chemotherapy, biological therapy, or investigational drug.
* Adequate bone marrow reserve (absolute neutrophil count \> 1500 cells/mm3, platelet count \> 125,000 cells/mm3, hemoglobin concentration ≥ 10 g/dL).
* Radiographically measurable disease (RECIST criteria).
* Life expectancy of at least 3 months.
* Male and female subjects of reproductive potential must agree to follow accepted birth control methods, as determined by the investigator, during treatment and for 12 months after completion of treatment.

Exclusion Criteria:

* Prior radioimmunotherapy.
* Known presence of central nervous system (CNS) metastasis.
* Any lesion \> 7.5 cm.
* Total bilirubin \> 2.0 mg/dL.
* Total creatinine \> 2.0 mg/dL.
* AST and ALT \> 2.5 times upper limit of normal (ULN), if metastases to the liver \> 5 times ULN.
* Presence of a second primary malignancy requiring active treatment (except for hormonal therapy).
* Serious non-malignant disease or infection that, in the opinion of either the investigator or sponsor, would compromise protocol objectives.
* History of external beam radiation therapy to \> 25% of active bone marrow.
* History of bone marrow or stem cell transplant.
* History of granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) therapy within 2 weeks before Study Day 1.
* History of pegylated G-CSF therapy within 4 weeks before Study Day 1.
* History of major surgery, other than diagnostic surgery, within 4 weeks of Study Day 1.
* History of receiving investigational product within 4 weeks before Study Day 1 or long term toxicity from a previous investigational therapy.
* Known history of HIV or AIDS.
* Concurrent systemic corticosteroid therapy or other immunosuppressive agents, unless for the treatment of computed tomography (CT) dye allergy reactions.
* Pregnant or lactating female.
Single Port Myomectomy Versus Conventional Myomectomy

This study is about the evaluation of which benefits single port laparoscopic myomectomy has in the perspective of cosmetics and patient satisfaction.

There were several studies about feasibility and cosmetic benefit of single port laparoscopic adnexal surgery and hysterectomy compared to conventional multiport laparoscopic surgery. Meanwhile, no study mentioned benefit of single port laparoscopic surgery in myomectomy because single port myomectomy needs more labor and operator's skill than other pelvic surgery. At this point, the investigators need to verify the effectiveness and benefit of single port laparoscopic myomectomy.

Eligibility Criteria:
Inclusion Criteria:

* premenopausal women
* image confirmed myoma
* scheduled to have laparoscopic myomectomy
* number of myoma =\<4 and largest size \<10cm

Exclusion Criteria:

* scheduled to have co-operation of other surgery
* clinically significant hematologic abnormality
* DM or malnutrition
* under the medication which can affect wound healing
* previous history of other pelvic surgery
Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy Volunteers

Heart rate variability (HRV) is used to noninvasively assess the activity of the autonomic nervous system, in particular, its parts help to evaluate the cardiac sympathetic and parasympathetic activities. Increasing HRV may contribute to improving autonomic nervous system dysfunctions. In traditional medicine, acupuncture in the region of the vagus nerve distribution in the ear could increase parasympathetic activity and cause changes in HRV. Zero point located on the vagus nerve distribution is scientifically proven to enhance parasympathetic activity, however, the number of studies examining the effect of auricular acupressure at zero point on HRV is limited while this method is highly effective and convenient. In our study, we want to survey heart rate variability during auricular acupressure at Zero point on the left ear in healthy volunteers.

Participants and Methods: A randomized controlled trial is conducted by comparing the changes in HRV and elements of HRV during the auricular acupressure process at zero point on the left ear in healthy volunteers. A total of 114 participants were randomly assigned to 2 groups by computer GraphPad software and the allocation was 1:1. Participants in the experimental group received auricular acupressure at the left zero point, while the control group received placebo auricular acupressure by removing the ear seed but keeping the sticker attached in the left zero point. The primary outcome was the change in heart rate variability during auricular acupressure at zero point on the left ear. This trial will be performed as randomized, controlled, and single- blinded.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females were individuals aged between 20-29.
* Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
* Vital signs within normal range:

  * Pulse, and regularly heart rate, go together.
  * Resting heart rate: 60 - 100 beats/min.
  * Resting blood pressure: 90/60 mmHg to ≤ 140/90 mmHg.
  * Breathing rate: 16 ± 3 times/minute.
  * emperature: 36.6-37.50C.
  * SpO2 ≥ 95%.
* Body mass index (BMI): 18.5 - 23 kg/m2 .
* Had no history of cardiovascular disease, diabetes, or thyroid.
* Had no psychiatric stress problem during acupuncture day (confirmed by answering the DASS 21 questionnaire with stress points less than 15 points).
* Not currently participating in other intervention studies.
* Have no acupuncture experience yet.

Exclusion Criteria:

* Used stimulants such as beer, alcohol, coffee, and tobacco within 24 hours before conducting the study.
* Played sports 2 hours before the study.
* Had skin injuries in the area of auricular acupressure.
* Women during menstruation period, pregnancy, or breastfeeding.
* People using drugs affecting blood pressure and heart rate within 1 month.
Proof of Concept Study of Vagus Nerve Stimulation

The investigator's recent pilot study of vagus nerve stimulation (VNS) from a surgically implanted medical device to control the excess eating behaviour characteristic of Prader-Willi Syndrome (PWS) found that it was safe and acceptable. In addition, there were unanticipated marked improvements in rates of problem behaviours, such as emotional disturbances and verbal and physical outbursts. These observations indicated the need for a trial specifically focusing on the effects of VNS on problem behaviour and also that the use of VNS might be extended to include people with other neurodevelopmental disorders, such as autism spectrum conditions (ASC). The primary aims of this study are: a) to investigate whether VNS, now given by an external medical device, is associated with a significant reduction in the number and severity of maladaptive behaviours in adults with PWS; and b) to undertake a pilot study that includes others with a different neurodevelopmental syndrome who have histories of similar behaviours.

The study will be a single case cross-over design with 4 to 6 months baseline phase and a similar period of active treatment. The study cannot be blind as the stimulation is apparent but the participants will wear the device initially for four hours a day, at times convenient to them, with it switched off in the baseline phase and activated, according to standard protocols, in the treatment phase. Six adults with PWS and six with a different neurodevelopmental disorder with histories of significant problem behaviours will be included initially, with a view to extending if the analysis indicates a likely effect. Behaviours will be operationally defined and measured over time using participant and informant diaries with additional secondary outcome measures. Before and during the treatment phases autonomic nervous system and brain biomarkers will be assessed using ambulatory monitoring of heart rate variability and fMRI brain scans.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged over 18 years of age.
* Genetically and clinically determined diagnosis of PWS or meeting clinical or the presence of another neurodevelopmental syndrome such as an autistic spectrum condition.
* History of problem behaviours of, on average, at least one significant informant-reported episode each week.
* Capacity to consent.
* Able to commit to the study duration and to attend assessments in Cambridge.

Exclusion Criteria:

* Meet exclusion criteria for MRI scanning and/or unable to tolerate MRI environment.
* Serious co-morbid physical or psychiatric disorder which would disrupt ability to comply with study demands (e.g. a history of serious bipolar disorder; sleep apnoea not well-controlled with CPAP; insulin dependent diabetes).
* Current or past history of neurological disorders or trauma, including epilepsy, and head injury.
* Currently or recently (within 12 months) participating in a clinical trial of an investigational medicinal product (CTIMP) or another medical device.
* Lacking the capacity to consent.
Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin

The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.

Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers.

The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with good oral hygiene
* Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible

Exclusion Criteria:

* Medical Problems or Pregnancy
* Lack of patient's approval and compliance
* Presence of abnormal oral, medical, or mental condition
* Known allergy of resin-based materials
* Previous placements of sealants or restorations
* Bruxism or mal-occlusion
Healthy Control Population for PAIS-ME/CFS: Study to Evaluate Possible Biomarkers and Methods for Examination of PAIS-ME/CFS Diagnostics in Healthy Volunteers

Using the data from the HelP study, the underlying processes of the diseases ME/CFS and PAIS are to be researched and elucidated. The comparison of affected patients with healthy controls is intended to identify disease-specific patterns that could be related to the development or progression of the disease. The aim is to find a suitable biomarker for diagnostics and to develop therapeutic approaches.

The underlying pathomechanisms of the diseases PAIS and ME/CFS are to be investigated and elucidated in more detail. The aim is to establish a cohort of healthy controls at our MRI Chronic Fatigue Center (MCFC). Within this cohort, the measurement instruments used so far in ME/CFS diagnostics will be validated. In addition, data material from this pool should be used for the statistical evaluations of various case-control studies of our center and our cooperation partners in order to find and develop a suitable biomarker for diagnostics and therapeutic approaches for PAIS and ME/CFS.

Eligibility Criteria:
Inclusion Criteria:

* Healthy control subjects without a known medical diagnosis, except: asthma, allergies, neurodermatitis, if this does not require regular medication (self-disclosure)
* Age: 10 - 25 years
* Written declaration of consent or, in the case of minors, written declaration of consent from the participants and their legal representatives

Exclusion Criteria:

* Acute illnesses (e.g. infections) or major injuries
* Known chronic diseases (including psychological diagnoses) other than those mentioned above
* Surgery or blood transfusion in the last 3 months
* No intake of on-demand medication (e.g. painkillers) in the last 7 days before the date of the examination
* Pregnancy; Breastfeeding
* Limited legal capacity