cyrilzakka/clinical-trials huggingface dataset:
QLB vs. Wound Infiltration in Cesarean Section

Effective postoperative analgesia after cesarean section (CS) is important because it enables early ambulation and facilitates breast-feeding. A 2009 Cochrane review concluded that wound infiltration with local analgesic after CS reduced opioid consumption. In addition, two regional anesthetic techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum block (QLB), have been shown in multiple studies to reduce post-operative opioid consumption after CS. A recent randomized controlled trial showed that QLB is more effective in reducing morphine consumption post-CS compared to TAP. No randomized controlled trial to date, however, compared the analgesic effect of QLB with infiltration of the wound after CS. The objective of the study is to compare the analgesic effect of QLB type 2 with wound infiltration after CS.

Effective postoperative analgesia after cesarean section (CS) is important because it enables early ambulation and facilitates breast-feeding. Post-CS analgesia is usually multimodal. At our hospital, patients are routinely given a combination of parenteral paracetamol, metamizole and tramadol at fixed intervals with additional intravenous piritramide on demand. The well-known side effects of piritramide (nausea, vomiting, and sedation) may interfere with interaction between mother and child, breast-feeding and post-partum experience in a dose-dependent manner. Alternative strategies to reduce rescue opioid analgesic consumption post-CS section are, therefore, required.

A 2009 Cochrane review concluded that wound infiltration with local analgesic after CS reduced opioid consumption. In addition, two regional anesthetic techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum block (QLB), have been shown in multiple studies to reduce post-operative opioid consumption after CS. A recent randomized controlled trial showed that QLB is more effective in reducing morphine consumption post-CS compared to TAP.

Telnes et al. compared TAP block with wound infiltration with local anesthetic following CS. They found no reduction in cumulative morphine consumption and more pronounced sedation associated with TAP block. No randomized controlled trial to date, however, compared the analgesic effect of QLB with infiltration of the wound after CS.

The objective of the study is to compare the analgesic effect of QLB type 2 with wound infiltration after CS.

Eligibility Criteria:
Inclusion Criteria:

* Parturients scheduled for an elective caesarean delivery under spinal anaesthesia with an American Society of Anesthesiologists physical status I or II, singleton pregnancy, and gestational age ≥ 37 completed weeks.

Exclusion Criteria:

* Congenital or acquired coagulopathy.
* Allergy to local anaesthetics.
* History of drug abuse.
a Risk Assessment and Management Program Using Telecare Consultation Among Patients With Diabetes Mellitus

Telecare consultation, which is defined as a two-way synchronized visual (voice and image) communication between patients and healthcare professionals using telecommunication applications such as Zoom, has become a major trend in recent years. The current COVID-19 pandemic provides an impetus to drive change and increase the uptake of telecare consultation in healthcare. To the best of investigators' knowledge, there is no translational research available that simultaneously implements and evaluates the telecare model of care delivered in a primary care setting. The present study will be the first in Hong Kong to fill this service and knowledge gap in the care of DM patients.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 or above, having a confirmed diagnosis of diabetes, having regular follow-ups in the clinic

Exclusion Criteria:

* having dementia, having unaccompanied hearing or vision loss, not having an Internet connection at home
Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.

Technique development: In first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without GNAQ mutation.

Validation: The tumor DNA detection rate will be estimated from metastatic uveal patient's blood. The investigators will study 40 patients to obtain at least 15 patients bearing a GNAQ mutation in the primitive tumor or in metastasis. With those 15 patients, the investigators will determinate the most sensitive technique and the best cost/efficiency ratio.

Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years.
* Patient with a metastatic choroidal melanoma.
* Patient with tumor or metastasis available for GNAQ (Guanine nucleotide blinding protein) status characterization.
* Patient able to stand a blood collection.
* Signed written informed consent approved by competent authority and ethic committee.

Exclusion Criteria:

* Patient without social protection/insurance.
* Current pregnancy and lactation.
* All social, medical, psychological, situations making the study impossible.
* Person deprived of liberty.
A Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults Using Real-World Evidence

This study will collect effectiveness and safety data on JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults based on real world data.

There will be 30 participants selected who undergo 3D imaging before and after JUVÉDERM VOLUX® treatment for digital analysis assessments. Up to 90 participants enrolled either prospectively prior to JUVÉDERM VOLUX® treatment or retrospectively after JUVÉDERM VOLUX® treatment.

Eligibility Criteria:
Inclusion Criteria:

-Participant has chin retrusion seeking chin enhancement who have received or plan to receive VOLUX chin treatment in Hainan Boao Super Hospital.

Exclusion Criteria:

* History of hypersensitivity to lidocaine,HA, or Streptococcal protein
* History of tendency to develop hypertrophic scarring
* Untreated epilepsy or porphyria
* Current cutaneous inflammatory or infectious processes (eg, acne, herpes) in the treatment area
* Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
* Permanent filler, semi-permanent filler, or fat injected in the treatment area
* Temporary filler, other than VOLUX, injected in the treatment area within 12 months before enrollment
* Females who self-report current pregnancy or breastfeeding
Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood

This research will help us to understand whether transcranial direct current stimulation (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in people with Parkinson's disease and related disorders. Some of the disorders that will be studied to understand if tDCS can be useful include Parkinson's Disease, Multi-System Atrophy (MSA) and progressive supranuclear palsy (PSP).


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease or a related disorder (e.g. Multiple Systems Atrophy) as diagnosed by a neurologist specializing in Movement Disorders
* Age \>= 18 years

Exclusion Criteria:

* Skull defect at or near site of tDCS delivery.
* History of a significant stroke or traumatic brain injury.
* History of other brain conditions that could impact interpretation of results (such as MS, brain tumor, encephalitis).
* Presence of implanted electrical or metallic devices in the head or body (examples include cardiac pacemakers or defibrillators, Baclofen pumps, deep brain stimulators, ventricular shunts with metallic parts, vagus nerve stimulators)
* Presence of ferrous metal in the head (except titanium; for instance shrapnel)
* History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common antidepressants)
* Pregnancy
Effect of Branched-chain Amino Acid Supplementation on Muscle Damage

Seventy-eight recreational athletes who never resistance trained will be randomly assigned into three groups of twenty-six. Branched-chain amino acid will be supplemented for 18days at 0, 200 or 400 mg/body weight(kg)/day in jelly. Participants will be asked to perform elbow flexions on the 12th day of supplementation. Maximum voluntary contractions will be measured before, during and after the supplementation period to compare the effects of different doses of branched-chain amino acid has on muscle damage markers.

Previous studies have not been able to show consistent effects due to various reasons. The major limitations are the lack of enough data on the amount and duration of branched-chain amino acid supplementation, and the level of muscle damage for branched-chain amino acid to be effective. Based on a recent meta-analysis, it has been suggested that to be effective, branched-chain amino acid should be supplemented more than 200mg/kg/day before a low-to-moderate intensity exercise bout. Therefore, this study is designed based on the above suggestions and to compare the effect of different doses of branched-chain amino acid on muscle damage markers in healthy recreational active individuals.

Three treatment groups (n=26) will be randomly assigned to be supplemented with either 200mg BCAA/kg/day (BCAA200), 400mg BCAA/kg/day (BCAA400) or placebo (fiber supplement; PL). Supplements will be provided in jelly in a single blind fashion to be ingested 1hour after each of the three main daily meals for 18days. Anthropometric measurements (body weight, lean mass, height), body temperature, ultrasound (US), strength assessment (maximal voluntary contraction, MVC), resting metabolic rate (RMR), rate of perceived exertion (RPE), delayed onset of muscle soreness (DOMS) and blood samples (duplicates; myoglobin; BCAA) will be collected before, during and after the supplementation period at different time points (see appendix for the above tables). Repeated-bout effect (RBE) on both arms will be measured 7 days after the damage inducing session.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females at the age of 18-40
* Endurance trained athletes
* Weekly exercise duration is less than 150minutes but more than 30 minutes

Exclusion Criteria:

* Individuals who cannot endure three days for not eating meat
* Diabetic
* Have been performing resistance trainings
* Have been taking protein supplement
* Have been consuming a high level of protein in the regular diet
* Have been taking omega-three and vitamin E supplements
* Have been taking anabolic Steroids
* Have been taking regular medications
* Have cardiovascular Disease
* Have a history of joint \& Muscle Injuries
* Females with irregular Menstrual Cycle
Postoperative Pain in Single-visit and Multiple-visit Retreatment Cases

The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after retreatment using different techniques. Patients whom need retreatment were included. The presence of postoperative pain was assessed after retreatment cases at 1, 6, 12, 24 and 48 hrs.

The aim of this clinical study was to evaluate the intensity and duration of postoperative pain after single-visit and multiple-visit root canal retreatment procedures. Patients who have asymptomatic failed endodontically treated teeth were included in this study and routine channel treatment procedure will be applied to these teeth. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Eighty asymptomatic teeth were randomly participated into four treatment groups in terms of intracanal medicament applied. The presence of postoperative pain was assessed after 1, 6, 12, 24 and 48 hrs. Postoperative pain was recorded by each patient by using visual analogue pain scale. Before the retreatments, the nature of the study, complications and associated risks were totally explained and written informed consent was obtained from all study participants. The patients were offered local anesthetic before the treatment start. The routine root canal retreatment procedure was applied. Different intracanal medicaments used between sessions in accordance to the manufacturers' instructions. At the end of retreatment, each patient was given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth was examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.

Eligibility Criteria:
Inclusion Criteria:

Patients who were not included the study who;

* were pregnant or breast feeding during the duration of the study,
* have systemic disease,
* have any pain and/or any facial swelling, abscess,
* were immunocompromised,
* were under 18 yrs. and over 65 yrs. age,
* were taking antibiotics or corticosteroids within previous three months,
* have multiple teeth that required retreatment at the same time period; for eliminating pain referral,
* have root canals that could not be well-treated with orthograde retreatment.

Exclusion Criteria:

The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
Study to Evaluate the Effect of Injection Lypolysis (Lipodissolve) Treatments to Reduce Body Fat

The combination of phosphatidylcholine (PPC) and deoxycholate (DC) injected into subcutaneous fat is often popularly referred to as "Lipodissolve" therapy. Despite its attractiveness as an easy and noninvasive cosmetic treatment, the safety, effectiveness, and how the injections might work remain unclear. This study will investigate the hypothesis that injections of PPC/DC will reduce the amount body fat in the treated area. If so, the mechanisms responsible for the fat loss will be explored to find out whether fat cells die from toxic effects or are broken apart by the PPC/DC. Patients will receive at least 2 (no more than 4) treatments with PPC/DC injections every 2 months. Several methods of measuring fat loss will be used in the study, including photography and measurement of patients, tissue biopsy, blood tests, and MRI. The study will also record side effects of the treatments as well as patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Body Mass Index (BMI) no greater than 30
* Excess fat in the lower abdomen area

Exclusion Criteria:

* Cigarette smoker
* Diabetes
* Pregnant or breast feeding
* Use anticoagulants (blood thinner), aspirin or other non-steroidal anti-inflammatory drugs that cannot be discontinued
Requests for Medical Termination of Pregnancy for Psychological or Social Maternal Reasons

When the request for termination of pregnancy is made at a term of less than sixteen weeks of amenorrhea, the patients have complete decision-making autonomy. This is called voluntary termination of pregnancy. On the other hand, when they are made after this term, their requests must be subject to a multidisciplinary assessment. This is called medical termination of pregnancy for maternal indication. Schematically, there are two categories of indications: "organic" (progressive cancer, severe heart disease, etc.) and "psycho-social". In the latter case, and although the recommendations of the CNGOF recommend a formalization of these requests in the centers where the patients are received, strong disparities are observed in practice. In addition, there are few epidemiological and clinical data concerning these medical terminations of pregnancy with a psychological or social maternal indication in the literature.

The objective of this work is to describe the demographic characteristics of patients who have made a request for termination of pregnancy after the legal deadline for psychological or social maternal reasons, and to specify the care pathways of these patients.

Retrospective cohort (from 01/01/2016 to 02/28/2022) single-centre involving data from patients followed at the Maison des Femmes, and eligible for the study.

The demographic and care pathway variables will be the subject of a descriptive statistical analysis.

Expected results: improvement of knowledge relating to patients who consulted for termination of pregnancy after sixteen weeks of amenorrhea and their care pathway.

Outlook:

* Improving the knowledge of health professionals and therefore of care pathways, with a view to a more homogeneous use of legal systems.
* Improvement and simplification of care pathways.

Eligibility Criteria:
Inclusion Criteria:

* Minor or adult patients who have been seen at the Maison des Femmes in the context of a request for termination of pregnancy for psychological and/or social maternal reasons, including patients subject to a legal protection measure (guardianship , curators) during the consultation
* Consultation between 01/01/2016 and 02/28/2022

Exclusion Criteria:

* Refusal of inclusion in a study explained in the medical file (patient or guardian)
* Objection to the use of data or refusal to participate (patient or guardian)
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector

The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped\&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector

The devices under investigation, NAVIGO 4LV models Pilot, 2D , and ARC are the new quadripolar coronary venous leads with polyurethane lead body, intended to be used with defibrillators with ventricular resynchronization therapy.

The new lead design with the presence of 4 electrodes that allows several combinations in programming pacing vectors, is intended to benefit both the patients by improving response to therapy, overcoming high pacing threshold and avoiding phrenic nerve stimulation, and the investigators by reducing the number of re-interventions needed.

This clinical investigation is a pre-market release study intended to analyze safety and electrical performance of NAVIGO 4LV leads pre-shaped (S-shaped \& U-shaped) and Straight leads models. The primary endpoint data will be used to support the achievement of the CE mark of NAVIGO 4LV leads.

The primary endpoints will be evaluated at 1 month post-implantation; secondary endpoints will be evaluated up to 2 years post-implantation. The duration of patient inclusion will be approximately 10 months for pre-shaped NAVIGO family (S-shaped \&U-shaped) and approximately 21 months for straight ones.

The post implant follows-up visits will take place at Hospital discharge, weeks 10, 6 months and every 6 months until 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Any patient presenting a CRT-D indication as detailed in the ESC guidelines
* Primary implant of a PLATINIUM 4LV CRTD or upgrade from an existing ICD connected to a RV lead with a DF4 connector (DF4LLHH) to a PLATINIUM 4LV CRT-D
* Signed and dated informed consent

Exclusion Criteria:

* Patients for whom a maximum single dose of 300 µg dexamethasone sodium phosphate (DSP) eluted from the NAVIGO 4LV lead maybe contraindicated
* Venous anomalies precluding transvenous implant (contraindication of a Pacemaker or ICD implant)
* Active myocarditis, pocket and/or lead infection
* Stroke/myocardiaI infarction one month prior to implant
* Already included in another clinical study that could confound the results of this study.
* Inability to meet Follow-up visits at the implanting centre as defined in the investigational plan.
* Patient less than 18 years old or under guardianship
* Known pregnancy, women in lactation period or in childbearing age without an adequate contraceptive method (failure rate \< 1%)
* Drug addiction or abuse
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day.

The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to control secondary hyperparathyroidism without simultaneous administration of other vitamin D compounds.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 yrs
* On hemodialysis for at least 3 months (thrice weekly)
* iPTH \>300pg/ml or histological evidence of secondary hyperparathyroidism
* Calcium \> 8.1 mg/dl

Exclusion Criteria:

* Unstable clinical condition
A Digital Intervention for HIV Prevention in Black Adolescent Girls

The purpose of this study is to develop and evaluate an innovative behavioral HIV prevention videogame intervention to bolster motivation and provide skill-building opportunities to improve Black adolescent girls' ability to negotiate around risk including advocating for partner HIV/sexually transmitted infection (STI) testing, increasing their knowledge and awareness of HIV/STIs, and for reducing sexual risk-taking behaviors.

This study will develop and evaluate a multiplayer videogame aimed at Black adolescent girls with the intent of teaching the ability to negotiate around risk including advocating for partner HIV/STI testing, increasing their knowledge and awareness of HIV/STIs, and for reducing sexual risk-taking behaviors.

The intervention will be developed and delivered as a social, multiplayer videogame, a compelling context for Black adolescent girls who constantly interact and seek counsel from their peers. To this end, the Specific Aims, focusing on Black adolescent girls aged 14-18 years, are to:

1. (Phase 1) Translate the culturally and socially-tailored card game One Night Stan to a multiplayer videogame called InvestiDate using game design and content experts and focus group input from 30 Black adolescent girls.
2. (Phase 2) Conduct a pilot randomized controlled trial comparing the multiplayer videogame InvestiDate (the new adaptation of the One Night Stan intervention) vs. an attention/control non-health-related multiplayer videogame with 80 participants collecting assessment data at baseline, one, and four months to:

   1. Determine the intervention's acceptability and feasibility by collecting quantitative and qualitative data on Black adolescent girls' satisfaction and gameplay experience of the intervention.
   2. Determine the preliminary impact of the intervention on knowledge (information), intentions/attitudes (motivation), social norms, and behavioral skills as related to: i) HIV/STI testing and partner testing and ii) condom use, and iii) sexual risk behavior reduction, such as alcohol and drug use.

Eligibility Criteria:
Inclusion Criteria:

Both phases (includes focus groups- Phase 1)

* Black (race)
* Heterosexual
* Currently enrolled in high school

Pilot Test (Phase 2)

* Ability to participate in web-based videogame
* Willing to sit for at least 60 minutes (to play the game)
* No HIV testing in the last 12 months
* Ability to provide assent or parental/guardian consent

Exclusion Criteria:

* Failure to meet inclusion criteria