cyrilzakka/clinical-trials huggingface dataset:
95% Effective Dose(ED95) of Remimazolam During Dexmedetomidine Pretreatment

General anesthesia with double-lumen endobronchial tubes intubation is the main anesthesia method in thoracic surgery.However, double-lumen endobronchial tubes intubation can produce greater stimulation and cause more cardiovascular reactions, and the ideal anesthetic drugs can effectively reduce adverse reactions.Remimazolam is a new type of benzodiazepine drug that can be safely used for the induction and maintenance of general anesthesia, and it is an ideal and short-acting anesthetic alternative.As the new drug has had a short clinical entry time.There are few clinical data in all aspects, so it is necessary to clarify its rational use in the induction of anesthesia.Dexmedetomidine is a highly selective α 2 adrenergic receptor agonist, and it is currently the most popular adjunct to clinical anesthesia.However, the clinical data of anesthesia induction by dexmedetomidine combined with Remimazolam are rarely reported.

In the case of prior use of dexmedetomidine, to explore 50% effective dose (ED50) and ED95 of Remimazolam for the induction of anesthesia to inhibit the cardiovascular response of double-lumen bronchial intubation, in order to provide more data for the rational use of remimazolam and a reference for clinical rational drug use.

This study is a clinical trial of adaptive design dose exploration evaluating the effect of dexmedetomidine pretreatment on the effective dose of remimazolam tosilate inhibiting cardiovascular response to intubation of double-lumen endobronchial tubes.Following the design principle, conduct dynamic exploration by sequential method, using the near ED95 drug dose for subjects according to the pretest.To determine whether the next subject increases or decreases the pre-set fixed drug dose according to the previous subject. The trial was stopped when seven exchange points occurred, at which point the total sample size was obtained.

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Eligibility Criteria:
Inclusion Criteria:

* Optional Video-Assisted Thoracoscopic Surgery (VATS)
* More than 18 years old
* American Association of Anesthesiologists (ASA) grade I\~III

Exclusion Criteria:

* Systolic pressure ≥160 mmHg or diastolic pressure ≥110 mmHg or heart rate ≥ 110 beats / min in the operating room when quietly
* Long-term use of analgesia or sedation drugs before surgery
* Pregnancy, lactation, pregnancy possibility and planned pregnancy
* Allergy history of the test drug
* Mental illness or an inability to communicate normally.
Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study

It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation seems be useful in symptoms amelioration in several neurological disease. Few studies have been performed in Parkinson's disease. A total of 126 patients suffering from PD will be recruited in 6 italian neurological centers. The study will be a cross-over multicenter study with the randomization of the sequence. The patients will be randomly assigned to 2 groups receiving for 8 weeks either the Equistasi medical device, or an equivalent placebo. Gait analysis will be recorded in each patient at the beginning and at the end of the treatment assigned. After 4 weeks of wash-out, the treatment will be crossed and a new gait analysis recording will be performed. Finally a last recording will be taken at the end of the last 8 weeks. Secondary outcome will be the MDS-UPDRS (Movement Disorder Society - Unified Parkinson Disease Rating Scale), PDQ-39 (Parkinson Disease 39 Questionnaire ), ABC (Activity Specific Balance Confidence Scale).


Eligibility Criteria:
Inclusion Criteria:

* Patient with rigid-acinetic bilateral PD form
* At least 4 years of disease history
* H\&Y between 2-3
* Stable drug therapy response without any change performed in the 3 months before the study.
* Presence of freezing (FOG) and of postural instability not responding to parkinsonian therapy.
* MMSE\>24/30 (Mini-Mental State Examination)

Exclusion Criteria:

* Systemic illness
* Presence of cardiac pacemaker
* Presence of deep brain stimulation
* Presence of severe dysautonomia with marked hypotension
* Obsessive-Compulsive disorder (OCD)
* Major depression
* Dementia
* History or active neoplasia
* Pregnancy
Testing an Online Intervention to Improve Parents' Communication With Gay and Bisexual Sons About Sex and HIV

Young men who have sex with men (MSM) are at high risk for HIV infection in the United States, representing 80% of all infections among youth ages 14-24, and 92% of infections among boys ages 14-19. Despite these risks, the field has not even one HIV prevention intervention shown to be effective in decreasing sexual risks or increasing HIV testing among adolescent MSM (AMSM). Historically, reaching AMSM for HIV prevention has been challenging, given their relative geographic isolation and lack of access to traditional gay congregating spaces (e.g., bars and many gay-related social networking websites). However, the investigators have developed a novel online platform for delivering interventions to parents of LGB youth that currently sees thousands of visitors each year. HIV prevention advocates have identified parents of AMSM as an untapped resource for reducing HIV risk in this population. Parent-child communication about sex has well-demonstrated associations with adolescent risk behaviors, and interventions with parents of heterosexual youth have been shown to be effective in increasing parent-adolescent communication, and thereby, reducing adolescent health risks. Thus, the aim of the proposed study is to pilot test the efficacy of an online intervention to increase and improve parent communication with AMSM about sexuality and HIV, with the ultimate goal of decreasing adolescent sexual risk and increasing HIV testing. This will be achieved by randomizing parents who come to seek resources on the investigators' existing website to receive either (a) a film designed to support parents of LGB youth, or (b) that film + the online communication intervention materials, and then gathering longitudinal, online data from parents in both study arms and their AMSM sons over a 2-4 month period. It is hypothesized that parents in the intervention group will increase their communication with their sons about HIV and condoms.


Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian of a child with all of the following characteristics:

  1. cisgender male
  2. age 14-22
  3. self-identify as gay or bisexual
  4. lives in the same house with parent at least 2 days per week.

     Exclusion Criteria:
* Child with known HIV infection
Spinal Stabilization Exercises in Individuals With Transtibial Amputatıon

Lower extremity amputation causes rapid changes in musculoskeletal system. With the effect of these changes, the energy requirement for prosthetic ambulance is much higher than normal ambulance. Although methods such as the reduction of the segmental load of the prosthesis and the preference of the different prosthetic components for energy expenditure have been emphasized, the effect of exercise types has not been investigated in our knowledge. Therefore, the aim of the current study is to investigate the effect of spinal (Core) stabilization exercises on energy expenditure in combination with the classical physiotherapy program in patients with unilateral transtibial amputation. Individuals with transtibial amputation included in the study will be randomly divided into two groups. In group 1, basic exercises related to amputation will be applied for 8 weeks and in group 2 basic exercises with spinal stabilization exercises will be applied to the individuals. At the beginning and at the end of the exercise intervention, energy expenditure and exercise capacity will be evaluated by a portable exercise test device during '6 Minutes Step Test'; fatigue assessment will be done before and after 6 Minutes Step Test with 'Modified Borg Scale'; the strength of deep spinal muscles will be evaluated with 'Stabilizer'; dynamic balance and functional mobility will be evaluated by 'Timed Up \& Go' Test; and the effect of the prosthesis on mobility will be evaluated by the sub-scale 'Mobility' of 'Prosthetic Evaluation Questionnaire'.


Eligibility Criteria:
Inclusion Criteria:

* Having unilateral transtibial amputation of at least 6 months in which the stump volume becomes stable,
* Being prosthetic users (For homogenization of the groups in terms of external support used, individuals with transitibial amputation included in the study should use total contact socket and carbon foot prosthesis systems - Pin System, Passive Vacuum System or Active Vacuum System),
* Having at least "four" quadriceps and hamstring muscle strength in the amputated limb according to Lovett's manual muscle test method.

Exclusion Criteria:

* Having any disadvantage about prosthetic device usage in terms of stump length, shape and edema,
* Having movement limitation,
* Having phantom pain in the stump,
* Having any discomfort or health problem (cardiopulmonary, neurological or orthopedic problems) that may affect gait other than amputation,
* Having multiple extremity loss.
Self-help and Education on the Internet for Functional Motor Disorders

A randomised trial to the effect of a newly developed education and self help intervention for patients with a functional motor disorder on general health, quality of life, illness perception, symptom severity and other secondary outcome measures.

Patients will be referred to the study from all neurology centers in the Netherlands that are found willing to participate. After informed consent is acquired, patients will be randomised into one of these two groups: usual care only or the education and self help intervention added to usual care. At baseline, after 3 months and after 6 months patients will fill out questionnaires at home online or on paper.

Patients will not be blinded for the intervention. The researcher is blinded during analysis of the data. During the study contact between the researcher and the participants will be restricted to research related topics. All contact between participants and the researcher will be documented.

To increase generalisability and applicability in clinical practice after the trial the investigators have chosen to add the intervention to usual care and to keep exclusion criteria to a minimum.

Our education and self help internet intervention is an especially designed website with an educational approach. The content of the intervention is written by a team of international experts and consists of education about the mechanism of functional motor disorders and it's treatment and of self help advice and exercises. During the trial the website will only be accessible with a log-in. The education and self help internet intervention is self-explanatory and unguided.

The medical ethical committee of the University Medical Center Groningen has taken our research under review and has decided this study does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO-Wet Mensgebonden Onderzoek).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of functional motor symptom from a neurologist
* The motor symptom(s) cause(s) distress or impairment in social, occupational or other important areas of functioning.
* Able to read Dutch
* Access to a computer with internet connection on a regular basis

Exclusion Criteria:

* Incapacitated (Not able to provide informed consent)
* Accidental finding of a motor symptom in a patient with other (functional) complaints.
* Known existing visitor of the (previously available, but currently offline) translated version of a website by Dr. Jon Stone
Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis

Few studies have evaluated an extensive list of possible risk factors for NAFLD for their association with presence and severity of histologic features. We wish to conduct a retrospective study on these possible factors (including demographics, comorbid diseases, and medications) for their association, if any, with severity of histopathologic findings. This study hypothesize that certain risk factors, specifically those contributing to or consisting of metabolic syndrome, will have higher NASH Fibrosis stages.

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in Western countries, and is projected to become one of the foremost indications for liver transplantation (2). Both NAFLD and its most severe histopathologic subtype, non-alcoholic steatohepatitis (NASH) can progress to cirrhosis and its complications including hepatic malignancy, and are thus an important target for study. It is well-known that several risk factors are associated with the development of NAFLD, including obesity, type 2 diabetes mellitus, and metabolic syndrome (1), however their association with the presence and severity of histologic features of NAFLD/NASH has not been extensively examined. This study can help determine prognostic indicators for NALFD/NASH which can be useful in its prevention and treatment.

This is a retrospective chart review and de-identified data analysis. Data will be extracted from the patient database from the Methodist Liver Institute from April 2013 - June 2020. Patients with confirmed NAFLD/NASH via liver biopsy will be selected and NAFLD Activity Score and Fibrosis stage will be assessed. Data will then be collected on demographics, comorbid diseases, and medications from EPIC EMR system used by Methodist Health System.

Eligibility Criteria:
Inclusion Criteria:

* Patients identified to have biopsy-proven NASH within April 2013 - June 2020
* Minimum age 18, no upper limit of age
* Patients with complete records

Exclusion Criteria:

* Age \<18 years
* Incomplete records
* Diseases other than NASH
DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry

Three methods are actually used in newborn screening for sickle cell disease (SCD) in France: isoelectric focusing, high performance liquid chromatography and capillary electrophoresis. New technologies are currently under development such as Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS) using the SpOtOn Diagnostics Reagent Kit available in United Kingdom only.

Zentech company (Liège, Belgium) is developing a package for SCD newborn screening using MS/MS technology. The main objective of the present study will be to compare this new technique with the technique actually used in the hospital center of Lille (sub-contractor for SCD newborn screening of Lyon) and the haemoglobin analysis to test its accuracy (sensitivity and specificity).


Eligibility Criteria:
Inclusion Criteria:

* Infants with SCD newborn screening conducted in the hospital center of Lyon

Exclusion Criteria:

* Insufficient quantity of sampling
* Parents' opposition to their newborn's participation in the study
Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care (IDSein)

The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.


Eligibility Criteria:
Inclusion Criteria:

* Woman with histologically confirmed invasive breast cancer for whom surgery is scheduled
* Age\> 18 years old
* Performance status ECOG \<2
* Patient speaking and understanding French and able to complete questionnaires
* Patient affiliated or beneficiary of a social security scheme
* Patient having read the information note and not objecting to the use of the data collected

Exclusion Criteria:

* male
* Patient treated with neoadjuvant chemotherapy
* Patient participating in a therapeutic trial
* Patient with metastatic breast cancer
* Patient with bilateral breast cancer
* History of cancer of less than 5 years
* Active infection or other serious underlying condition that may prevent the patient from receiving treatment
* History or progressive psychiatric illness
* Person deprived of liberty or under guardianship
* Inability to undergo medical monitoring for geographical, social or psychological reasons Indication of emergency amputation
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Patient hospitalized without consent
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
* UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.
* Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:

  1. prednisone ≤ 20 mg/day or equivalent or
  2. beclomethasone ≤ 5 mg/day or
  3. budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day

Exclusion Criteria:

* Prior approved biologic therapy used for the treatment of UC.
* Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
* Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.
* Azathioprine, or 6-mercaptopurine within 1 day of Day 1.

NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
Oral Nutritional Supplement Preferences in Patients With Cancer

Patients diagnosed with cancer have a particularly high risk of developing malnutrition due to the disease itself and due to symptoms of cancer treatments that can affect food intake such as reduced appetite, nausea, fatigue, and alterations in taste and smell. Nutritional treatment is essential in the prevention and treatment of malnutrition. Oral nutritional supplements (ONS) are often recommended to cancer patients who need to increase their nutritional intake and are unable to meet their nutritional requirements by consumption of normal food alone. However, patient compliance with ONS depends on sensory acceptability of such products. Therefore, the objective of this study is to investigate preferences of sensory characteristics of ONS among cancer patients. Additionally, possible associations between taste and smell alterations and dietary intake, malnutrition risk, and quality of life will be investigated. The results from this study will optimize recommendations of ONS in the clinical setting and encourage new efforts among manufacturers in developing acceptable sensory characteristics of ONS to cancer patients. Findings from this study will contribute to improving nutritional treatment for cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients diagnosed with lung cancer
* Patients receiving cancer treatment of different types
* Age 18 years or more
* Provided signed informed consent
* Understand written and oral Norwegian

Exclusion Criteria:

* Severe mental or cognitive disorders
* Contraindication to consume ONS (dysphagia, inability to swallow oral nutritional supplements)
* Allergic or intolerant to any of the ingredients in the ONS
* Terminally ill patients (\<3 months to live)
* A clinically significant disease or condition that could, in the investigator's opinion make the patient unfit for the study
Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis

The values of laboratory examinations which are useful for the diagnoses of appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). However up to date there is no laboratory marker for the pre-operative diagnosis of appendiceal perforation in acute appendicitis. Recently hyperbilirubinaemia has been associated with appendiceal perforation. Aim of this retrospective study is therefore to investigate if hyperbilirubinaemia has a diagnostic value for the pre-operative diagnosis of appendiceal perforation in patients with appendicitis.

We identified 538 patients with histologically proved acute appendicitis who underwent laparoscopic or conventional appendicectomy between January, 2004 and December, 2007 in a surgical department of an academic teaching hospital. A retrospective multiple chart review of the medical records including laboratory values (bilirubin, CRP, white blood count) and histological results was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Appendicitis and a preoperative laboratory workup with Leukocytes, C-reactive Protein, Bilirubin and liver transaminases GOT and GPT

Exclusion Criteria:

* Alcoholism
* A history of viral hepatitis
* Gilbert's disease
* Dubin Johnson syndrome
* BRIC (benign recurrent intra-hepatic cholestasis) and other documented biliary
* Hemolytic or liver diseases associated with hyperbilirubinaemia.