cyrilzakka/clinical-trials huggingface dataset:
Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis.

This study aims to evaluate the effectiveness of preoperative administration of Diclofenac Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative pain are selected. Full medical and dental history will be obtained from all patients treated during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is to be confirmed. The primary outcome is success of buccal infiltration using articaine.The secondary outcomes are pain on injection. Patients will be recruited from the outpatient clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active pain (moderate-to-severe) in mandibular molars.
* Patients with prolonged response to cold testing and electric pulp tester.
* Patient with the ability to understand and use pain scales.
* Patient with vital coronal pulp tissue on access.
* Patient who accept to enroll to the study.

Exclusion Criteria:

* Patients' allergies or any other contraindication to diclofenac potassium or articaine.
* Pregnant and lactating females.
* Patients having pain medication in the last 6 hours.
* Patient has more than one symptomatic mandibular tooth in the same quadrant.
* Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
* Patients with active peptic ulcer and gastrointestinal disorders.
* Patients with history of bleeding problems or anticoagulant use within the last month.
Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery

The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on the surgical approach. The posterolateral approach is compared to the axillary approach especially in term of development of a chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thoracic surgery intervention by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,

Exclusion Criteria:

* planned surgery by thoracoscopy or extended surgery,
* mental disability,
* vulnerable person within the meaning of French law,
* inability to communicate by phone,
* poor understanding of French.
Establishment of Radiomics Database by Clinical Application of Multiparametric MRI Based on Incoherent Undersampling

This study aims to establish radiomics database for pancreas cancer from multiparametric MRI including DCE-MRI obtained by using incoherent undersampling and radial acquisition for clinical staging as well as quantitative analysis.


Eligibility Criteria:
Inclusion Criteria:

* surgical candidate for pancreatico-duodenectomy
* characteristic finding of pancreatic adenocarcinoma on prior CT or MRI
* OR histologically diagnosed with pancreatic adenocarcinoma
* signed for informed consent

Exclusion Criteria:

* under 18 years
* not eligible for pancreatico-duodenectomy
* unresectable patients (locally advanced on prior CT/MRI or metastatic disease)
* tumors with suspicion of other histologic types (neuroendocrine, IPMN, etc)
* any contra-indication of contrast-enhanced MRI
* recurred pancreatic cancer
Rhomboid Intercostal Plane Block vs Local Anesthetic Infilteration for Postoperative Analgesia After Thoracoscopic Surgery

The purpose of the study is to evaluatethe effects of rhomboid intercostal block( RIB ) on postoperative pain after thoracoscopic surgery compared with local anesthetic infiltration ( LA )


Eligibility Criteria:
Inclusion Criteria:

* ASA status I \&II

Exclusion Criteria:

* Allergic constitution
* Severe cardiovascular or hepatorenal insufficiency
* Coagulation system disease
* Injection site infection
* Morbid obesity (BMI\>40 kg/m2).
Care4U: Self Management Intervention for Older Adult Caregivers

Older adults caring for others often neglect their own health. This research is being done to see if helping caregivers focus on their own needs can improve their health and ability to care for others

The specific aims are to evaluate the Care4U intervention in order to refine the intervention for a larger clinical trial, which includes 1) subject acceptability of the intervention, 2) evaluation of intervention delivery, fidelity, and data collection, and 3) evaluation of the components of the intervention (patient activation, knowledge, self-efficacy, and CV self-management strategies).

Recruitment was conducted in 2 acute care hospitals from April 2013 through Dec 2013. Six caregivers were enrolled during this time, with one dropping out after baseline.

The participants completing the study (n=5) provided data related to the aim. Four participants were able to use Adobe Connect via the provided laptops with written instructions and phone coaching. Delivery of the intervention via Adobe connect was enjoyed by the participants, with minimal connectivity problems. Participants were interested in websites and videos related to their health, but did not relate exploring these links on the laptop desktop without suggestion from the PI.

Eligibility Criteria:
Inclusion Criteria:

* Describes self as an informal Caregiver of patient who has undergone cardiac surgery (revascularization, valve, or combination)and performs ≥1 activity of daily living or instrumental activity of daily living for the patient
* ≥ 65 years
* Self-reports ≥1 modifiable cardiovascular risk (hypertension, hyperlipidemia, physical inactivity, obesity)
* Lives in the same residence with patient
* Oriented to person, place, and time (asking the subject to state their name, where he/she is (for example what building, town and state) and what time it is (time, day, date)
* Able to hear, and speak and read English

Exclusion Criteria:

* Permanent residence in skilled or assisted care facility
* Participation in 3 times per week exercise during the past 6 months. -
The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite

House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the eyes, and running nose. The investigators test a possibility to immunize subjects sensitized against house dust mite with extracts from their own gut bacteria "auto-vaccination".

see above

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age 18-35 years
* known allergy on house-dust mite
* GINA 0-1

Exclusion Criteria:

* anamnestic incompatibility to parts of autovaccine
* asthma \> GINA I°
* chronic disease conditions or infections
* pregnancy
* inhalative or systemic steroid use
* any immunosuppressive therapy
* intake of any other probiotic medication (e.g. E.coli nissle 1917)
* participation in any other study at the same time
* substance abuse
* Incapability of understanding the study's purpose and performance
* smoker
Monoclonal Antibodies Elimination in Breast Cancer Patient

This Study evaluates covariables being able to potentially influence the elimination of the monoclonal antibodies (trastuzumab, bevacizumab and denosumab).

Monoclonal antibodies are very widely used in cancer treatment . Certain patients benefit from these antibodies for several years and it is conceivable to wonder about the evolution of the pharmacokinetics of these antibodies.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosed cancer
* patient treated by bevacizumab or trastuzumab
* Life expectancy of at least 3 months
* For the women: menopausal women for at least 24 months, sterilized surgically, or, for the women old enough to procreate, use a method of effective contraception (oral contraceptives, contraceptive injections, intra-uterine devices, method of the double barrier, the contraceptive patches). This contraception will have to be pursued during 6 months after the end of the treatment by bevacizumab or by trastuzumab.

Exclusion Criteria:

* For Patients treated by trastuzumab: Dyspnoea of severe rest in touch with complications due to the disease or requiring an oxygen therapy.
* Hypocalcemia severe untreated
TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.

Study TMC114-C214 is a randomized (patients are assigned to different treatment groups based on chance), controlled, open-label trial to compare the efficacy (effectiveness), safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in treatment-experienced HIV-1 infected patients. This research study will look at the safety of TMC114 and effectiveness in reducing the amount of HIV(viral load) in the blood. People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors (PIs) or both. The duration of the study will be approximately 106 weeks, which includes a 4 to 6 week screening period, 96-week treatment period, and 4-week follow-up period. TMC114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of Ritonavir. Kaletra (LPV/RTV) is either a tablet or capsule taken twice a day. The oral capsule contains 133.3 mg LPV, 33.3 mg RTV and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir. Dosing for all medication will occur for 96 weeks and you will be randomly assigned to either TMC114 or Kaletra.

Eligibility Criteria:
Inclusion Criteria:

* Patient has documented HIV-1 infection
* Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks
* Plasma HIV-1 RNA \>1000 copies/mL
* General medical condition does not interfere with the assessments and the completion of the trial

Exclusion Criteria:

* Patients for whom an investigational Antiretroviral is part of the current regimen, with the following exceptions if applicable (depending on local regulatory approval)
* tenofovir, emtricitabine, atazanavir, fosamprenavir
* Previous or current use of lopinavir, enfuvirtide (T-20), tipranavir and TMC114
* Life expectancy of less than 6 months
* Pregnant or breast-feeding
* Females of childbearing potential not willing to use effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 14 days after the end of the treatment period
* Patients with significantly decreased liver function or decompensation, irrespective of liver enzyme levels
* Participation in other investigational trials without prior approval of the sponsor
Hyperthermia and the Amelioration of Autism Symptoms

The febrile hypothesis of Autism Spectrum Disorder (ASD) stems from the observation that clinical symptoms improve during fever. This fever induced amelioration of symptoms could be due to one of three possible causes, (1) the direct effect of temperature; (2) a resulting change in the immune inflammatory system function associated with the infection or fever; and/or (3) and increase in the functionality of a previously dysfunctional Locus Coeruleus-Noradrenerigic (LC-NA) system. Little has been done to explore the potential direct effect an increased body temperature may have on autism symptomology. Parental reports have demonstrated that during febrile episodes children with ASD have improved social cognition and language skills, and decreased disruptive behaviors. In order to further explore the direct temperature effect, further investigation is needed, which the investigators propose below. The investigators propose to complete a one year double blind crossover study with 15 children with ASD between the ages of 5 and 17 years old. Five children with ASD will complete a control protocol prior to beginning the full protocol with 10 additional ASD children. This will allow for any needed amendment of protocol parameters prior to completion of the full protocol.


Eligibility Criteria:
ASD Controls Inclusion Criteria

* Aged 5 to 17
* Meets ASD criteria on the DSM-IV TR that is supported by the ADOS or the ADI-R

ASD Control Exclusion Criteria

* Children who are currently ill will not begin treatment until they are well.
* Females who are pregnant.
* Children who have abnormally high blood pressure prior to starting study treatment.
* Children with a BMI greater than 30.0 or below 18.5
* Children with history of seizures or cardiovascular problems

ASD Case Inclusion Criteria

* Meets ASD criteria on the DSM-IV TR that is supported by the ADOS or the ADI-R
* Aged 5 to 17
* Have a past history of improvement during febrile episodes

ASD Case Exclusion Criteria

* Children who are currently ill will not begin treatment until they are well.
* Females who are pregnant.
* Children who have abnormally high blood pressure prior to starting study treatment.
* Children with a BMI greater than 30.0 or below 18.5
* Children with history of seizures or cardiovascular problems
IVF Failure and Pregnancy Loss on Couples' Psychological Stress

The goal of this observational study is to learn about The purpose of this study was to compare the psychological differences between couples after IVF transplant failure and IVF pregnancy loss, including the differences in anxiety, depression, stress and post-traumatic stress between women and their spouses. The main question it aims to answer is:

What are the psychological effects of IVF implantation failure and IVF pregnancy loss on women and the psychological differences between couples? Participants already taking IVF as part of their regular medical care will answer online survey questions about their joint pain for 1 years.

The goal of this observational study is to learn about The purpose of this study was to compare the psychological differences between couples after IVF transplant failure and IVF pregnancy loss, including the differences in anxiety, depression, and stress between women and their spouses. Some couples will experience symptoms of post-traumatic stress reaction (PTS), and there are also large differences. The differences between couples discussed in this study also pay attention to male spouses. Guidance and education for male spouses can reduce cognitive differences between couples and generate understanding and empathy, which is conducive to promoting the stability of family relations and intimate relationships.

1. Does the number of IVF implant failures have a differential effect on anxiety, depression and fertility stress in women and their partners?
2. Does pregnancy loss after IVF transplantation have a differential effect on anxiety, depression, fertility stress and post-traumatic stress responses in women and their partners?

Eligibility Criteria:
Inclusion Criteria:

1. Couples who have undergone IVF at our center and have completed at least 1 embryo transfer.
2. Female age 20-45 years, male age 22-45 years.

Exclusion Criteria:

1. Couples with contraindications to pregnancy.
2. Couples who undergo donor IVF.
3. Infertility women caused by organic lesions.
4. Couples with previous mental disorders.
Online Training for Healthcare Professionals: a Possible Strategy for Prevention of Burnout

This study aims to evaluate the effects of online training on self-esteem and occupational stress of healthcare professionals, in order to evaluate the potential of this intervention as a preventive measure to Burnout syndrome. The study will be developed in three phases,the first being the period of one week before the intervention(t0), when instruments will be first applied.The second phase corresponds to intervention period, when the instruments will be reapplied after the second (t1), third (t2) and fourth (t3) training intervention. The third phase corresponds to the follow up (t4-t8), when all instruments used in the second phase will be reapplied in 2 months (t4), 4 months (t5), 6 months (t6), 8 months (t7) and 12 months (t8) after the end of the intervention.

The sample will consist of 100 health professionals randomized into two groups (50 in each group): intervention group (I), formed by those who will participate in the online training and control group (C), formed by those who will receive the intervention after research is finished.

The hypotheses are: the online training will have greater effect on the increase of self-esteem, and will be identified in health professionals: low levels of global self-esteem, high levels of occupational stress and average levels of burnout.


Eligibility Criteria:
Inclusion Criteria:

* Health professionals who work at University of Sao Paulo General Hospital
* Agree and sign the Inform Consent Form.

Exclusion Criteria:

* Those who, one week before training, presents anxiety and depressive symptoms (GAD ≥ 14 e/ou PHQ ≥ 14)
* in psychotherapy during data collection;
* diagnosed with Burnout syndrome.
Early Physiotherapy in Covid Patients

Based on the hypothesis that early physiotherapy in patients hospitalized for COVID-19 improves their functional capacity, perceived quality of life and decreases anxiety. Our main objective is to analyze the differences between groups with respect to functional deterioration, need for oxygen therapy and anxiety when implementing an early physiotherapy program.

We propose a randomized clinical trial with two arms and single-center, to be developed in hospitalization units and intermediate respiratory care units (IRCU), with patients diagnosed with COVID. The sample will consist of an experimental group of 66 admitted patients with COVID-19 to whom an early physiotherapy program will be implemented from 48-72 hours after admission. The control group will be made up of another 66 admitted patients with COVID-19 who will receive the treatment according to the usual procedure of the hospital center.

Sociodemographic and clinical variables will be collected, including: modified MMRC dyspnea scale, amount of oxygen therapy, MRC-SS, sit to stand test, hand grip, Tinetti, HADS anxiety and depression questionnaire, SF-12 quality of life questionnaire, clinical frailty scale (CFS) and FRAIL scale. Patients in both groups will be re-evaluated two months after hospital discharge with the above variables in addition to the PCFS post-COVID patient functional status scale.

A basic descriptive analysis and logistic regression will be performed to determine the effect of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the hospitalization unit or intermediate respiratory care unit, diagnosed with COVID-19 pneumonia, of legal age and who consent to participate in the study. Pregnant patients or patients with dementia, terminal illnesses or those in which there are communication problems (language problems, comprehension ...) will not be included.

Exclusion Criteria:

* Patients who are transferred to another acute hospital due to impossibility of completing the follow-up period, exitus during hospital admission and those who revoke consent.
Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

The aim of this study is to assess effect of psychiatric profile on visual sensitivity and overall health status in patients who underwent surgery for vestibular schwannoma and were prehabituated by chemical vestibular ablation.


Eligibility Criteria:
Inclusion Criteria:

* T3, T4 vestibular schwannoma
* recorded growth of a tumour
* hearing loss greater than 50% in PTA

Exclusion Criteria:

* T1 vestibular schwannomas
* no growth progression
* normal hearing
Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm

Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 20 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps \<5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen.

In this feasibility trial, the investigators try to find out if CSP with a new designed polypectomy snare is efficient and safe in terms of complete resection (R0), pathological evaluation and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* indication for colonoscopy
* signed informed consent
* at least one polyp of the size 10-15mm
* American Society of Anesthesiologists-classification (ASA) I-III

Exclusion Criteria:

* American Society of Anesthesiologists-classification (ASA) IV-VI
* Inflammatory bowel disease (IBD)
* known/suspected invasive colorectal cancer
* contraindications for polypectomy
* emergency indication for colonoscopy
Association Between a Biological Pattern of Dysregulation of the HPA Axis and Mental Disorders in Children Exposed to Early Life Stress

The purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the HPA axis and mental disorders in children exposed to early life stress.

The purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the HPA axis and mental disorders in children exposed to early life stress.

Cortisol secretion lead to define two groups : pathologic versus normal cortisol secretion.

Mental disorders is evaluate with Mini-Kids II (a mental health questionary) and lead to define two groups : mental disorders versus no mental disorders

Eligibility Criteria:
Inclusion Criteria:

* Aged 8 to over 10 years
* To be entrust to ASE of Finistère in stable environment (the same place of residence since 6 months or more)
* French speaking
* Oral consent by children
* Informed and signed consent by tenured of parent authority

Exclusion Criteria:

* Don't want to participate
* To have chronic neurologic or endocrinal pathology or don't have access to verbal language.