cyrilzakka/clinical-trials huggingface dataset:
Compared Efficacy of Patient-controlled Epidural Analgesia With or Without Automatic Boluses

Epidural analgesia is a significant feature of the everyday experience of the delivery room. Its benefits on the maternal experience and in terms of security has been widely demonstrated.

However, some women under epidural analgesia have experienced motor block, which has been found to contribute in the lengthening of the duration of labor, dystocia and instrumental delivery. Therefore, in recent years, reducing these side effects by modifying local anesthetics, concentration of local anesthetic and injected volume has been a priority, with one aim: optimize analgesia without motor blockage.

Although epidural analgesia was first provided by continuous epidural infusion, the efficacy of intermittent epidural bolus has been demonstrated. Small regularly spaced intermittent boluses lead to a more extensive and symmetrical spread of local anesthetic in the epidural space. These findings have led to a new kind of administration combining epidural intermittent boluses with patient-controlled boluses called PEIB (Patient Epidural Intermittent Bolus). On clinical grounds, PEIB is associated with reduced local anesthetic consumption and higher maternal satisfaction.

While PEIB is experimentally and clinically approved, incidence of maternal motor block and instrumental vaginal delivery don't decrease significantly with this programming. We hypothesized that automatic intermittent boluses can lead to an accumulation of local anesthetic overlapping with patient bolus. This accumulation can be the source of motor block, dystocia and instrumental delivery. Therefore, we propose to lead a monocentric prospective randomized study upon 308 patients in order to compare PEIB to epidural analgesia totally controlled by the patient. We expect a lower consumption of local anesthetic and a lower incidence of motor block, dystocia and instrumental delivery with the free automatic bolus programming.

Local anesthetic used: levobupivacaine 0,625mg/ml

Solution prepared with 200 ml of levobupivacaine 0,625mg/ml associated with analgesic adjuvants: sufentanyl 50 micrograms and clonidine 75 micrograms.

Randomization between:

- PEIB:

* automatic hourly bolus: 8ml (5mg) on 3 min
* patient controlled bolus: 8ml (5mg) on 3 min
* refractory period: 8min
* continuous infusion: 0
* maximum dose: 65mg/4h

or

- FREE programming: epidural analgesia totally controlled by the patient

* automatic hourly bolus: 0
* patient controlled bolus: 8ml (5mg) on 3 min
* refractory period: 8min
* continuous infusion: 0
* maximum dose: 65mg/4h

Supervision and care consistent with french expert conference of the SFAR (Société Française d'Anesthésie-Réanimation) on management of women under epidural analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age \>/= 18 years
* Nulliparous
* \>35 weeks of amenorrhea
* In spontaneous or triggered labor

Exclusion Criteria:

* Contraindication for epidural analgesia (pre-partum hemostasis troubles, infection)
* Multiple pregnancy
* Fetal death in utero
* Programmed or in emergency caesarian
A Cluster Randomized Trial to Evaluate Long Lasting Insecticidal Hammocks to Prevent Forest Malaria in Vietnam

In Central Vietnam, forest malaria remains difficult to control due to the complex interactions between human, vector and environmental factors. Untreated bednets had a significantly protecting effect for villagers, except for those regularly sleeping in the forest, who suffer a significantly higher number of clinical attacks. Thus, there is need to target this high-risk group with new intervention based on long-lasting insecticidal materials. Hammocks are extensively used by people working in the forest, therefore long-lasting insecticidal hammocks (LLIH) could achieve a good individual protection.

The Investigators proposed to evaluate their effectiveness in a community-based trial, comparing them to the standard vector control methods (insecticide-treated nets).

In Central Vietnam, forest malaria remains difficult to control due to the complex interactions between human, vector and environmental factors. A community-based study carried out between 1999 and 2001 showed that regular forest activity was a strong risk factor for malaria infection. Untreated bednets had a significantly protecting effect for villagers, except for those regularly sleeping in the forest, who suffered a significantly higher number of clinical attacks. Thus, there is need to target this high-risk group with new intervention based on long-lasting insecticidal materials. Hammocks are extensively used by people working in the forest, therefore long-lasting insecticidal hammocks (LLIH) could achieve a good individual protection.

The Investigators proposed to evaluate their effectiveness in a community-based trial, comparing them to the standard vector control methods (insecticide-treated nets): communities have been grouped into clusters of about 1000 înhabitants, and clusters were randomized to either the active intervention or the active control, and followed up for 24 month.

Eligibility Criteria:
Inclusion Criteria:

* All residents in the 20 concerned study clusters and willing to give informed consent to participate

Exclusion Criteria:

* People not willing to give informed consent to participate
Self-Advocacy Training for Autistic College Students at a Public University

Cases in autism spectrum disorder (ASD) have dramatically risen over the past 30 years, with the current rate of 1 in every 44 (Maenner et al., 2021) children born with the condition. Much emphasis rests on the need for various interventions, practices, and therapies during childhood to improve quality of life and success across a variety of settings. Nonetheless, as they age, all children advance through the education system and eventually leave the school system. Consequently, it should not be surprising that these children must grow up and face realities after high school. For some, this may include residential placements, living at home with family members, or working part or full time. For others, this comes in the form of postsecondary education. However, many individuals with autism might not be prepared to handle the requirements future education entails. As stated in articles by Chiang et al. (2012) and Blackorby and Wagner (1996), persons with disabilities, regardless of type, do not have successful transitions after high school compared to individuals without disabilities-even with having access to many resources in school and the community. Barriers, therefore, exist that prevent successful outcomes for students with autism attending college and obtaining a postsecondary degree. Thus, there is a need to identify strategies that can be effective in assisting autistic adults in postsecondary education to succeed, both academically and socially.

This study will utilize a concurrent multiple baseline design across participants with an embedded ABCDE design (or more specifically, an ABACADAE design). These components will be the four scenarios teaching self-advocacy skills based primarily on recognition of one's wants and needs and personal decision making. The four included scenarios will be a) requesting appropriate accommodations from disability services; b) requesting additional supports or services (daily living, social, etc.) from disability services; c) presenting accommodations to a professor; and d) meeting with disability services in the event a professor is not accommodating student needs. There will also be a pre-test/post-test comparison between scores on the self-advocacy questionnaire with data displayed in the form of a bar graph that will explore all four areas of self-advocacy: recognition of wants and needs, scheduling meetings, locating services, and personal decision making.

Eligibility Criteria:
Inclusion Criteria:

* Students to be undergraduates enrolled at a university or community college
* Students must have a confirmed diagnosis of ASD (either through an official diagnosis via documentation of the disability services or proof of self-diagnosis).

Exclusion Criteria:

* Students who are not enrolled in college, do not have a confirmed diagnosis of ASD, or who already demonstrate strong self-advocacy skills will be excluded from this study.
Nail Versus Sliding Hip Screw for Trochanteric Hip Fractures

The investigators therefore propose to undertake a further randomised controlled trial comparing the sliding hip screw (SHS) with the Targon PFT intramedullary nail. The aim is to see if the summation of the first trial of 600 participants comparing the sliding hip screw with the Targon PF nails, in conjunction with this study of 400 participants with the updated Targon PFT nail produces results that convincingly demonstrate that this particular design of implant is superior to the sliding hip screw. Because of the financial issues involved a cost benefit comparison for the two procedures is planned at the completion of the study.

Primary outcome measures will be regain of walking ability. Secondary outcome measures recorded with include mortality, length of surgery, operative blood loss, blood transfusion, post-operative complications, hospital stay, need for subsequent revision surgery and degree of residual pain.

The trial will be run as close to the ideal trial methodology for a randomised trial as specified by the CONSORT statement as possible. This will include secure randomisation, intention to treat analysis, full reporting of outcomes and follow-up by a person who is blinded to the prosthesis used. The trial will follow the code of good clinical practice as specified by the hospital trusts Research and Development Committee.

In Peterborough all hip fracture patients are admitted to the acute trauma ward and transferred to the care of MJP. Those patients that are willing to participant in one of our randomised trials are consented prior to surgery. Treatment follows standard evidence based protocols with follow-up of all patients in a hip fracture clinic. A comprehensive database is maintained for all patients containing both audit and research data. Included in this is a standardised assessment of outcome.

The sliding hip screw used if of a standard design that has been in use at Peterborough for the last fifty years. The intramedullary nails used will be the Targon PFT nail. This nail is very similar to the Targon PF nail used in the earlier trial on this topic. Bases on the results of the previous study and the experience of other users the nail has undergone minor modifications that are primarily aimed at making the nail easier to use with improved instrumentation and also a change to design of the cross screw aimed at reducing the risk of fracture fixation complications occurring.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to Peterborough District Hospital with a trochanteric hip fracture that is to be treated by internal fixation.

Exclusion Criteria:

* Patients who decline to participate
* Patients without the capacity to give informed consent
* Patients admitted when MJP is not available to supervise treatment
* Patients with pathological fractures from Paget's disease of bone secondaries from tumour
A Study to Assess New Participant's Perspectives Beyond Clinical Efficacy of Monoclonal Antibody-Based Relapsing Remitting Multiple Sclerosis (RRMS) Treatments

The primary objective of the study is to understand what the added value of natalizumab (Tysabri®) treatment is from a participant's perspective at a given time, based on a one-shot survey. The secondary objectives of the study also aim to characterize the participant's decision-making process to get the treatment; the burden of treatment, characterization of the study population, assessment of the quality of life (QoL), and fatigue dimension.


Eligibility Criteria:
Inclusion Criteria:

• Participants diagnosed with RRMS and followed by a neurologist in France.

Exclusion Criteria:

• Lack of literacy

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Screening Women for Functional Hypothalamic Amenorrhea (FHA)

What do the investigators know already? Many women suffer loss of periods (amenorrhoea). One of the most common causes of period loss is called 'functional hypothalamic amenorrhea' (FHA). FHA is difficult to diagnose and may be mistaken for other conditions causing period loss, such as polycystic ovarian syndrome (PCOS). This could cause delays in starting the correct treatment.

What is the justification for doing this study? Undiagnosed women with FHA are predisposed to complications related to low oestrogen levels, such as osteoporosis, bone fractures and infertility. The failure to accurately identify women with FHA and mislabel those women with FHA as having PCOS, may delay appropriate treatment. Treatment delay causes harm for affected women, including bone fractures and infertility.

What do the investigators propose? Improve the diagnosis of women with FHA by composing an assessment score, which could be used by women to improve the accuracy of diagnosing FHA. The investigators designed a questionnaire based on literature search, which can be used to identify women with FHA. A questionnaire-based study (on-line or in person) will be performed to identify risk of FHA, in women referred to hospital with period loss.

A questionnaire was developed to be used by women with period loss to facilitate the diagnosis of women with FHA. The development of the questionnaire was based on systematic literature review and comments from a small patient involvement group, as per National Institute for Health and Care Research (NIHR) INVOLVE guidelines.

Participants will be recruited via distributing a patient information sheet, consent form and a questionnaire to all women referred with amenorrhea to the Endocrinology or Reproductive Medicine clinics at Imperial College Healthcare NHS Trust and/or participating NHS organisations. Completion of the consent form and questionnaire is entirely dependent on each potential participant's choice.

Every woman taking part can complete the questionnaire before or after her appointment. All questionnaires will be anonymised with a unique study code, and handed back to the NHS clinician.

Eligibility Criteria:
Inclusion Criteria:

* Any woman 18-58 years of age
* Secondary amenorrhea defined by either menstrual cycle interval persistently exceeding 45 days and/or those with period loss for 3 months or more

Exclusion Criteria:

* Women who never had periods (primary amenorrhea).
Concussion Pen Screening Tool

To compare the use of the Concussion Pen to current clinical care practice. This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized. This randomization will help to control for evaluation fatigue on the part of study participants.

This will be a prospective study of a maximum of 24 subjects, with a goal enrollment of 20 subjects (10 in each cohort). All subjects will undergo clinical evaluation for concussion and will also be evaluated using the Concussion Pen. All subjects (both controls and concussion patients) will undergo all eye tracking measurements. Randomization to being evaluated using clinical care first then the Concussion Pen and vice versa will be utilized.

This will be a multi-disciplinary team with members of Physical Therapy (PT)/ Occupational Therapy (OT), Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), and Doctor of Philosophy(PhD)s who specialize in concussion assessment. This study will include a population of concussed patients as well as non-concussed patients (controls) who will be seen in CM clinics per standard of care.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for both control and study cohorts, unless stated otherwise below

* Patients cognitively 11 to 18 years of age.
* Patients undergoing evaluation for concussion in Children's Mercy (CM) clinics for concussion population.
* Patients with a history of concussion at any previous point in time (no time limits to this date).
* Patients with no history of concussion and being seen at CM PT/OT for other diagnoses for control population.
* Patients able to give verbal assent or consent (dependent on patient cognitive age), and Legally Authorized Representatives (LAR)s able to give verbal parental permission.
* English-speaking families.

Exclusion Criteria:

* Patients not within the inclusion criteria as outlined above.
* Patients with congenital vestibular dysfunction will not be included.
* Patients diagnosed with dyslexia or Attention Deficit Hyperactive Disorder (ADHD) will not be included.
* Non-English-speaking families.
* Wards of the State will not be approached for this study.
* Patients with a previous diagnosis of strabismus or convergence insufficiency will be excluded.
ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer

The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer

The molecular target for ET140202-T cells is HLA-A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). This clinical study evaluates the safety and pharmacokinetics of ET140202-T cells with TAE or Sorafenib in patients with HCC who have no available curative therapeutic options and a poor overall prognosis.

Eligibility Criteria:
Inclusion Criteria:

* AFP-expressing HCC and serum AFP \>10 x ULN
* Abandon or failure in first or second line treatment
* Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele
* Child-Pugh score of A or B, ECOG 0-2, Life expectancy \> 6 months
* Measurable disease as defined by: at least 1 liver lesion that can be accurately and serially measured.
* Negative serum pregnancy test for women with childbearing potential
* Adequate organ function as defined below:

  1. A pretreatment measured creatinine clearance (absolute value) of ≥50 ml/minute.
  2. Patients must have a serum direct bilirubin ≤3 x ULN, ALT and AST ≤5 x ULN.
  3. Ejection Fraction measured by echocardiogram or MUGA \>50% (evaluation done within 6 weeks of screening does not need to be repeated)
  4. DLCO or FEV1 \>45% predicted
  5. Absolute neutrophil count (ANC) ≥ 1500/mm3 (10\^9/L), Platelet count ≥ 50,000/mm3 (10\^9/L)
  6. INR ≤1.5 x ULN
  7. Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients with decompensated cirrhosis: Child-Pugh Score C
* Patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver.
* Patients with an organ transplantation history
* Patients with dependence on corticosteroids
* Patients with active autoimmune diseases requiring systemic immunosuppressive therapy
* Patients who are currently receiving or received within past 30 days anti-cancer therapy, local treatments for liver tumors (radiotherapy, embolism, ablation) or liver surgery
* Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)
* Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within two years. Patients with a history of successfully-treated tumors with no sign of recurrence in the last two years may be enrolled.
* Patients with other uncontrolled diseases, such as active infections Acute or chronic active hepatitis B or hepatitis C.
* Women who are pregnant or breast-feed
* HIV-infection
Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial

after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger acid suppression (high dose PPI) more effectively prevents bleeding after ESD


Eligibility Criteria:
Inclusion Criteria:

* the patients who agreed informed consent
* gastric adenoma or early gastric cancer which is eligible for conventional ESD indication

Exclusion Criteria:

* recent drug history of PPI, H2 rector antagonist, bismuth and antibiotics within 4 weeks
* recent drug history of anticoagulant or antiplatelet agent within 7 days
* s/p subtotal gastrectomy
* recurred gastric adenoma or cancer
* pregnant or breast feeding patients
RBD Longitudinal as Prognostic for PD

* Purpose - to validate a combination of biological and clinical markers in the rapid-eye-movement (REM) sleep behavior disorder (RBD) population as indicative of the pre-symptomatic stage of Parkinson's disease (PD).
* Procedures - All subjects (RBD diagnosis and controls) will have 1) a medical and neuro history and physical including videotape of movements, 2) neuropsychological testing, 3) a sleep study, 4) olfactory testing, 5) blood draw for serum testing , 6) functional MRI. All of these procedures are often performed clinically in the diagnosis of PD. Enrollment of subjects with PD is complete. Any testing performed prior to enrollment as part of the clinical evaluation may be used in place of repeating the procedure for the study. Subjects will be followed for 5 years. It is hypothesized that a 5 year follow up may capture a significant number of pre-Parkinson's subjects who will be diagnosed. Subjects may be offered a repeat enrollment after 5 years.

Enrollment of PD and PS cohorts is complete. Currently enrolling only confirmed RBD and Controls.

Eligibility Criteria:
Inclusion Criteria:

1. 35-70 year old men \& women
2. (1) Diagnosis of idiopathic RBD (see AASM criteria), 2) Normal control or control with a non-neurodegenerative disorder, age and gender-matched to (1)
3. Gives written informed consent
4. Pregnant women are not excluded, but will be identified by HCG.

Exclusion Criteria:

a A diagnosis of any non-Parkinsonian Neurodegenerative Disease.

b. Any unstable or uncontrolled medical or psychiatric condition.

c. Parasomnia or RBD not idiopathic, eg., secondary to metabolic derangement or medicine effect.

d. Renal (creatinine over 1.6) or hepatic insufficiency (LFT significantly out of range), or a history of significant uncontrolled cardiac disease.

e. Significant dementia (MMSE\<25 of 30 or MOCA\<25/30) that would interfere with study procedures or informed consent.

f. Any reason which, in the opinion of the PI, would increase the risk or decrease the value of any study procedure.

g. fMRI will not be performed for anyone for whom the screening questionnaire indicates is ineligible for MRI imaging.