cyrilzakka/clinical-trials huggingface dataset:
Role of Ultrasound Guided Transversus Abdominis Plane Block in Pain Control After Hepatectomy

Inadequately managed acute pain following abdominal surgery originates from somatic pain signals in the abdominal wall and is linked to various unfavorable postoperative outcomes. These consequences encompass patient distress, respiratory complications, delirium, myocardial ischemia, extended hospital stays, an elevated risk of chronic pain, heightened analgesic consumption, delayed bowel function, and an increased need for rescue analgesics.

This study aims to assess the postoperative analgesic efficacy of ultrasound-guided Transversus Abdominis Plane (TAP) block using oblique subcostal and posterior approaches in hepatectomy.

Pain control is vital to achieve enhanced recovery after abdominal surgeries . TAP block had been demonstrated to improve pain related outcomes after abdominal surgeries.

Postoperative pain management for patients undergoing hepatic resection is a challenge due to the risk of perioperative liver dysfunction.TAP block is a promising regional analgesic technique. This study aimed to evaluate the effect of US-guided subcostal approach versus combination of both subcostal and posterior approaches of TAP block

The patients will be randomly divided into two groups :

group A will recieve oblique subcostal TAP block and group B will recieve both subcostal and posterior TAP block .

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II patients. aged 18 to 50 years. 70 to 80 kg.

Exclusion Criteria:

* patients under 18 years of age.

  * History of Allergic reactions to study drugs.
  * Opioid or analgesic abuse, and chronic treatment with opioids, or non-steroidal anti-inflammatory drugs.
  * History of bleeding tendency or coagulopathy .
Rapid Sequence Induction Czech Republic: Survey

Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to Czech society of anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4 clinical scenarios in which RSI should be used. In the questionnaire the participants have to choose RSI or no and they have to describe all the next steps on anesthesia induction process in each single clinical scenario.

Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to Czech society of anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4 clinical scenarios in which RSI should be used. In the questionnaire the participants have to choose RSI or no and they have to describe all the next steps on anesthesia induction process in each single clinical scenario.

* 1st. scenario - adult patient with acute abdomen in the OR to be anesthetized
* 2nd. scenario - 4 years old child with acute abdomen in the OR scheduled for an acute surgery
* 3rd. scenario - pregnant women scheduled for an elective caesarean section in the OR
* 4th. scenario - geriatric patient with hiatal hernia scheduled for an elective laparoscopic cholecystectomy.

In each scenario the several steps of the RSI sequence has to be answered:

Is RSI indicated? Y N

Peripheral vein line before induction? Y N

Nasogastric tube before/after induction or without?

Patients position: neutral, head-up, head-down?

Preoxygenation - 3/5minutes, breaths, (CPAP)/Positive end-expiratory pressure (PEEP)?

Sellick manoeuver? Y N

Drugs for induction (order with the number in the row) - propofol, etomidate, ketamine, thiopental, midazolam, suxamethonium, rocuronium, cisatracurium, atracurium, vecuronium

Manual hand-bag ventilation after induction: with limited pressure/contraindicated

Airway: tracheal tube with the cuff/without cuff/laryngeal mask

Comments

Eligibility Criteria:
Inclusion Criteria:

* all members of ČSARIM and www.akutne.cz

Exclusion Criteria:

* not members of ČSARIM and www.akutne.cz
Evaluation of Postoperative Pain After Single Visit Retreatment of Symptomatic and Asymptomatic Teeth

Introduction: The aim of this study comparing the post operative pain after the retreatment of asymptomatic and symptomatic teeth that during single visit treatment with rotary and reciprocal nickel titanium files.

Methods: One hundred and forty one patients scheduled for non-surgical endodontic retreatment were included for evaluation. Eighty five patients who needed endodontic retreatment were assingned to 2 groups according to semptomatic or asemptomatic teeth and 4 subgroups with rotary and resiprocal files. Endodontic filling material was removed with One Flare and MicroMega REMOVER files in the retreatment kit. Patients then recorded their postoperative pain on a VAS scale at 24h, 48h, 72h, 7 days and 14 days post-treatment. Results were analyzed using the Shapiro-Wilk, Mann-Whitney U, Kruskal-Wallis, Dunn-Bonferroni and Pearson Chi-square tests.

Retreatment is the procedure performed to regain healthy periapical tissues that the teeth have undergone root canal treatment are re-infected due to apical or coronal leakage, or after an inadequate root canal treatment. When primary root canal treatment fails, the first treatment option is non-surgical retreatment to eliminate the infection. In general, the reported success rate of retreatment ranges from 62% to 91%.

This randomized clinical study's primary goal is to evaluate the postoperative pain following a single visit of root canal retreatment for asymptomatic and symptomatic mandibular premolars using reciprocal and rotary file systems. Therefore, this study aims to compare the effect of one curve mini (rotary file system) and one reci (resiprocal file system) nickel-titanium file systems on postoperative pain after non surgical endodontic retreatment within symptomatic and asymptomatic teeth.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Apical Periodontitis
* Asymptomatic Apical Periodontitis
* Adult patients between 18-67 years aged

Exclusion Criteria:

* Patient under 18 years old
* Complicating systemic disease
* Allergies to local anesthetic agents
* Acute apical abscesses
* Periodontal pockets deeper than 5 mm or more mobilty than level 1
* Bruxist and teeth-grinding patient
* Pregnant women
* Presence of external root resorption
* Root fracture
* Root perforation
* Calcified root canals
The Effect of 3D Autostereoscopic Video-game Play on the Visual Fatigue in Children

This study aims to examine the specific effect that 3D game play has on the control of the eyes horizontal movements. It will examine the youngest group of consumers this technology is marketed to, 7 to 11-year-olds and no children under 7 years of age will be recruited to this study as per Nintendo's hardware guidelines, which recommends that children under 7 years of age not play in 3D mode. It will examine the effect of playing in 3D for 30 minutes on horizontal fusional amplitudes compared with a control group playing in 2D for 30 minutes.

This study will be a prospective blind randomised control trial. The participants will be randomised into one study group, with participants playing a game in 3D; and a control group, with participants playing the same game in 2D. The study is blind due to the use of an independent assessor, reducing testing bias by ensuring that the tester does not know the randomisation results. The known dependant variables are the total horizontal fusional amplitudes at 1/3m and 6m and the independent variable is the use of 2D or 3D game play.

Eligibility Criteria:
Inclusion Criteria:

* Male and female 7 to 11-year-olds with no prior history of binocular vision / ocular motility dysfunction.

Exclusion Criteria:

* Corrected visual acuity of less than 0.000 tested with SLT at 3m.

  * Interocular visual acuity difference of 0.100 (tested with SLT) or greater, which could indicate the presence of Amblyopia.
  * The presence of any manifest deviation (Tropia).
  * Presence of any ocular motility dysfunction, which affects primary position.
  * Reduced binocular convergence of 10 centimetres or less.
  * Stereoacuity of less than 170" (this may indicate the presence of a microtropia or other undiagnosed pathology).
  * Any prior or existing medical history of epilepsy or seizures.
  * Any prior or existing medical history of repetitive strain injury.
Effect of Repeated Transcranial Magnetic Stimulation on Aggressive Impulsive Behavior in Patients With Borderline Personality Disorder in a Social Exclusion Paradigm.

Patients with a main diagnosis of borderline personality disorder will be recruited and will be randomized for the application of low frequency repeated transcranial magnetic stimulation (rTMS) protol or sham rTMS protocol. A pre-treatment and post-treatment measurement of the severity of BPD symptoms, impulsivity, and aggressive behavior will be carried out in all participants using self-administered questionnaires. All participants will be asked to participate in a passing ball game (Cyberball) with the intention of investigating aspects related to social inclusion / exclusion and measurements will be made regarding planning using the maze test. Participation in the Cyberball and the assessment of the planning will be carried out before and after the application of the treatment protocol.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient consultant in the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz.
* Main diagnosis of borderline personality disorder according to DSM-IV-TR.
* In the case of having some type of pharmacological treatment using SSRIs, antipsychotics and / or anticonvulsants, this should be maintained without modifications for at least 2 weeks prior to the start of the study and during the follow-up period.
* Comorbidity with some other personality disorder according to the SCID-II, with the exception of antisocial personality disorder.
* Acceptance of participation in the study by signing the informed consent.

Exclusion Criteria:

* Subjects who did not agree to participate.
* Diagnosis of current antisocial personality disorder, bipolar disorder, psychotic disorders, severe major depressive episode, substance use disorder (except nicotine), and post-traumatic stress disorder.
* Presence of any comorbid neurological disorder.
* Diagnosis of intellectual disability.
* Subjects in whom the use of rTMS is contraindicated: history of seizures, pregnancy, presence of pacemaker, heart disease, and presence of a metallic object.
* Electroencephalographic evidence of some type of abnormality in the excitability of the central nervous system (dysrhythmias, paroxysmal activity, graphical elements suggestive of epileptic activity, etc.).
Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage

In the aetiology of postpartum uterine atony, hypoxia is considered an important factor although some suggest that peripheral oxygen saturation is not influenced by oxygen inhalation in women during the first and second stages of labor. Enhancing oxygen delivery to myometrium through additional inhaled oxygen may improve uterine contractions. Therefore, it is reasonable to consider that oxygen inhalation may promote myometrial contraction and prevent postpartum haemorrhage (PPH) due to uterine atony. The tendency for the uterus to relax in women encountering respiratory problems immediately after cesarean section under general anaesthesia further strengthened this theory.

The aim of this study was to evaluate the effectiveness of oxygen inhalation immediately after vaginal delivery on blood loss. The investigators hypothesized that inhaled oxygen helps to maintain uterine retraction during immediate postpartum period and hence reduces vaginal blood loss.


Eligibility Criteria:
Inclusion Criteria:

* gestational age between 37 and 42 weeks;
* singleton pregnancy;
* live fetus;
* cephalic presentation;
* neonatal birth weight of 2500-4500 g;
* parity between one and five;
* maternal age \< 35 years old;
* vaginal birth

Exclusion Criteria:

* blood pressure ≥ 140/90mmHg;
* placenta previa;
* placental abruption;
* a history of any bleeding during pregnancy;
* a history of curettage;
* cesarean section or any uterine scar;
* a history of postpartum hemorrhage;
* polyhydramnios;
* signs or symptoms of maternal infection;
* known uterine anomalies;
* history of any drug use during labor;
* abnormal placentation;
* coagulation defects;
* instrumental deliveries;
* hemoglobin concentration \< 8 g/dL;
* history of anticoagulant drugs;
* beta-mimetic medications during pregnancy;
* prolongation of the first stage of labor \> 15 hours
Trial of NanoPac Intratumoral Injection in Lung Cancer

This study evaluates the use of NanoPac injected directly into tumors in the lung of people with lung cancer.

NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle paclitaxel will be injected directly into tumors in the lungs of people with small cell or non-small cell lung cancer. All subjects in this study will receive NanoPac and will be evaluated to see if NanoPac is safe and has an effect on the tumor within the lung.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Age ≥18 years and able to tolerate the EBUS-TBNI procedure;
* Histologically/cytologically confirmed lung cancer. Eligible subjects may include, for example: primary or recurrent non-resectable disease, locally advanced stages II and III with nodal disease, stage IV advanced disease;
* At least one lesion documented via imaging (within 4 weeks of Screening) which can be accessed using EBUS-TBNI;
* Subject is not a candidate for surgery;
* Has received or plans to receive SOC chemotherapy; adequate hematologic recovery must be confirmed according to the institution's SOC;
* Performance Status (ECOG) 0-2 at study entry;
* Life expectancy of at least 6 months;
* Adequate marrow, liver, and renal function at study entry;

  * ANC ≥ 1.5 x 109/L;
  * Hemoglobin ≥ 9.0 grams/dL;
  * Platelets ≥ 75 x 109/L;
  * Total bilirubin ≤ 1.5x institutional ULN;
  * AST/ ALT ≤ 2.5x institutional ULN;
  * Creatinine ≤ 1.5x institutional ULN;
* Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.\*

Exclusion Criteria:

* Significant cardiac disease (Class III or IV per New York Heart Association guidelines);
* Active bacterial, viral, or fungal infections (including active AIDS, hepatitis B or hepatitis C);
* Symptomatic central nervous system (CNS) metastasis which are neurologically unstable, or CNS disease requiring increase in steroid dose (treated metastatic disease and stable steroid use are not excluded)
* Known hypersensitivity to study agent;
* Pregnant or breastfeeding women.
A Study on the Effect of 2 Pen Devices on HbA1c

The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* receiving at least 3 prandial injections per day with short-acting or analogue insulin

Exclusion Criteria:

* Insulin pump therapy
* receiving pre-mixed insulin preparations
Choroidal Blood Flow Response to Hand-grip Test in Progressive Glaucoma

The present study is designed to compare the response of choroidal blood flow to the hand-grip test in glaucoma patients with and without visual field progression.

Glaucoma is a worldwide leading cause of blindness. The key features of glaucoma are damage to the optic nerve head and progressive visual field defect, which is not necessarily only related to an increase in intraocular pressure. It has been suggested that ocular blood flow alterations in glaucoma are related to systemic vascular dysregulations.The hand-grip test has been suggested as a potential tool to unravel vascular dysregulation in the ocular circulation. Although applied routinely in clinical practice, a proper study testing the effectiveness of this test is lacking. The present study is designed to compare the response of choroidal blood flow to the hand-grip test in glaucoma patients with and without visual field progression.

Eligibility Criteria:
Inclusion Criteria: Patients fulfilling two out of three of the following criteria in one or both eyes: a) typical glaucomatous disc, b) visual field damage (a cluster of three points (except rim points) in at least one hemifield reduced by 5 dB or greater and including at least one point reduced by 10 dB or greater; a cluster of two points reduced by 10 dB or greater; or three adjacent points on the nasal horizontal meridian that differed by 5 dB or greater from their mirror points on the opposite side of the meridian), c) intraocular pressure above 21 mm Hg at least at one occasion. Furthermore, patients need to have a series of at least 5 visual field examinations, after exclusion of the first test, for assessment of progression.

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Exclusion Criteria:

* Ametropia \> 3dpt
* Inadequate transparency of ocular media as defined by physical examination
* Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
* Any abnormality which in the physician's view would prevent reliable applanation tonometry or LDF of at least one eye
* History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis
* History of ocular trauma or intraocular surgery within the past 6 months
* History of infection or inflammation within the past 3 months
* History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment
* Patients with a significant history and/or active alcohol or drug abuse (significant is defined as that which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study).
Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™

Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France.

This is a prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period in France. The study is requested by French Health Authorities in 2010 for reimbursement renewal, to maintain reimbursement for pulmonary valvular replacement by bioprothesis in approved indication in France. The study was closed in 2013.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring pulmonary valvular replacement for correction of right ventricular ejection path malfunction (stenosis and/or pulmonary regurgitation).

Exclusion Criteria:

* Patient or legal representative refusal to data collection or processing
* Patient unable to guarantee follow-up data collection, in particular for patients living abroad
Safety and Acceptability Study of a Placebo Antibody-Based Nonhormonal Contraceptive Intravaginal Ring

In order to deliver nonhormonal vaginal contraceptive using anti-sperm antibodies, a new vaginal ring design using a capsule-IVR will be utilized. Evaluating the safety and acceptability of this device early in the product development cycle is important, not only because device/formulation characteristics become increasingly difficult to alter as product is advanced into clinical trials, but also because user adherence can directly impact clinical trial outcomes.

There is a gap in commercially available reliable, effective contraception methods that do not contain hormones. Mucommune is developing a novel non-hormonal contraceptive in the form of a capsule-intravaginal ring (IVR) that releases highly potent contraceptive antibodies (MM008) that rapidly bind and trap sperm. These antibodies have been developed over the past 5 years and the target on sperm cells was initially obtained from a patient with infertility due to anti-sperm antibodies.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent
2. Age of 18 - 45 years at enrollment
3. Female participants, born female
4. Willing and able to

   * communicate in English
   * complete all required study procedures
5. Subjects willing to abstain from vaginal intercourse and use of vaginal products for the first week of the study and until cleared by the study physician.

Exclusion Criteria:

Participant reports any of the following:

1. Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage, piercing) within 21 days prior to Enrollment Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap smear as well as IUD removal are not exclusionary
2. Current use of an IVR (e.g., Nuvaring)
3. Prior hysterectomy
4. Females who are pregnant based on positive pregnancy test by urine HCG
5. Cervicovaginal inflammation or epithelial disruption on colposcopy at the screening examination.
6. Current active gynecological abnormalities or sexually transmitted infection and/or vaginal pathogens (e.g. gonorrhea, chlamydia, mycoplasma genitalium, trichomonas, candida species, bacterial vaginosis) at the screening examination.

   Note: Subjects may be treated and re-screened for participation.
7. Has any other condition or is participating in another research study that, in the opinion of the Principal Investigator or designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.