cyrilzakka/clinical-trials huggingface dataset:
Naltrexone in Borderline Personality Disorder

The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.


Eligibility Criteria:
Inclusion Criteria:

* In- and Outpatients:Borderline personality disorder according to the Diagnostic and Statistical Manual for Mental Disorders, 4.Edition (DSM IV)
* DES-(Dissociative Experience Scale)-score: \> or equal 18 according to amendment4 (former value according to amendment 2 was \> or equal 25).
* Urinary test of opiates negative
* No psychopharmacological treatment for two weeks prior to study (fluoxetine four weeks)
* No Lithium for two months

Exclusion Criteria:

* Lifetime diagnosis of psychotic disorder
* Current major depressive disorder (MDD)
* Lifetime diagnosis opioid dependence or current opioid abuse (10 to 7 days prior to study)
* Comedication with opioid analgetics
* Known naltrexone intolerance
* Liver disease
* Pregnancy and lactation period
* Other severe medical or neurological diseases
* Simultaneous participation in another study
Effect of Various Sealers on Healing of Teeth With Apical Periodontitis

This study will compare the effect of three different sealers on healing of teeth with apical periodontitis after primary root canal treatment.

Various sealers with different chemical composition and properties are available but it is yet not clear if one sealer is superior to other in terms of healing of apical periodontitis.

Three different groups of sealers will be used- a zinc oxide based sealer, an epoxy resin based sealer and a bioactive silicone based sealer. Mature mandibular permanent molar with the diagnosis of apical periodontitis (as confirmed clinically \& by periapical radiograph) will be chosen for the study. Primary non surgical root canal treatment will be performed. The sealer will be randomly selected just before obturation of root canals. The patient will be allotted to one of the three groups.

* Group I: Zinc oxide eugenol sealer group. The material will be mixed according to manufacturer instructions and applied to canals using a lentulospiral and the obturation will be performed.
* Group II: Epoxy resin based sealer group. The material will be mixed according to the manufacturer's instructions and obturation will be done.
* Group III: Bioactive silicone based sealer: The material will be used according to the manufacturer's instruction and obturation will be performed

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria of the study will include:

* Patient willing to participate in the study.
* Age \>18 years.
* No history of antibiotic use within the past month or requiring antibiotic premedication
* No history of prior analgesic use during past 24 hrs.
* Mature permanent mandibular molar having apical periodontitis requiring primary root canal treatment.
* There must be a radiographic evidence of periapical radiolucency (minimum size 2mmx2mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber

Exclusion Criteria:

* Re-treatment
* Unwillingness of patients
* The presence of a difficult canal anatomy (root canals with an extreme curvature ≥30 deg), internal or external resorption and immature teeth.
* Accident or complication during treatment (calcified canals ,inability to achieve apical patency in any canals) Immuno-compromised, diabetic, pregnant and hypertensive patients.
* Teeth that are peridontally compromised
Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies

Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.

Design:

* Prospective Randomized Controlled trial
* Population analysis based on Intention To Treat
* Patient and data analyzer blinded (double-blind trial)

Outcomes observed:

* Primary: pain
* Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption

Nbr of patients included: 260

Port used: Triport, Olympus

Eligibility Criteria:
Inclusion Criteria:

* Cholecystolithiasis
* Age 18 to 75 y.o.
* BMI \< 35

Exclusion Criteria:

* Immunodeficiency
* Choledocholithiasis
* Previous upperGI open surgery
Preoperative Chewing Gum and Postoperative Nausea and Vomiting

General anesthesia for surgery can often lead to postoperative nausea and vomiting (PONV). Additionally, decreased or paralyzed bowel movements are among the most common complications following abdominal surgery, causing pain, abdominal distension, nausea, and vomiting, which can delay patient recovery and extend hospital stays. Therefore, meticulous perioperative management is crucial.

In recent years, efforts have been made to reduce the burden of surgery, decrease postoperative complications, and promote rapid rehabilitation for a quicker return to daily life. These efforts also aim to reduce healthcare costs by shortening hospital stays and optimizing resources. Various interventions, such as early feeding, early removal of nasogastric tubes, and physical therapy, have been trialed in clinical settings to prevent prolonged bowel inactivity and paralysis. However, due to limited clinical efficacy, these methods are not routinely used.

Recently, many researchers have reported the benefits of chewing gum in enhancing bowel motility and reducing PONV. However, there is limited research on the impact of chewing gum on PONV in robotic surgeries, which are considered less invasive compared to open or laparoscopic surgeries. Furthermore, there is particularly scarce research on the effects of preoperative gum chewing.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged 19 to under 70 years
2. Scheduled elective robotic surgery
3. American Society of Anesthesiologists (ASA) Physical Status Classification I or II

Exclusion Criteria:

1. Cases where robotic surgery was planned but suddenly converted to another type of surgery
2. Patients with a history of dental damage, dentures, loose or capped teeth, or other unstable dental conditions
3. Patients with a history of temporomandibular joint (TMJ) damage or surgery
4. Head and neck surgeries
5. Emergency surgeries
6. Refusal to participate in the study
Pathophysiology Based Therapy of Early Onset Epileptic Encephalopathies

Genetic epileptic encephalopathies (EEs) are a group of very rare and severe, pharmaco-resistant epilepsy forms characterized by an early onset, e.g. first years of life, and an often severe developmental delay. Genetic defects were found in different ion channels such as potassium or sodium channels explaining well the pathological neuronal hyperexcitability leading to seizures. Further mutations were also found in proteins relevant for cell structure, DNA/RNA processing or the synaptic vesicular metabolism. Specific and individualized therapies have not been established neither in the clinical routine nor in controlled studies. The goal of this monocentric non-blinded non-placebo controlled phase IIb study is the evaluation of the effectivity of anticonvulsive drugs specifically working on the ion channels defective in some subtypes of EEs in order to establish a standard and individualized therapy for these rare diseases based on the specific genetic defect.

During the study, the sodium channel blockers phenytoin and lacosamide and the potassium channel blocker kinidinsulfate will be given under standardized conditions to patients with an early onset and pharmaco-resistant genetic epilepsy with and without mutations in the potassium channels KCNT1 and KCNQ2 and the sodium channel gene SCN2A. The primary endpoint will be a significant seizure reduction under trial medication compared to baseline. Secondary endpoints will be the improvement of electroencephalographic characteristics of the respective EEs.

Eligibility Criteria:
Inclusion Criteria:

* highly active epilepsy (≥ 1 seizure per day)
* epilepsy with onset 0-3 months of age
* pharmaco-resistant epilepsy (2 or more standard anticonvulsive medications tried before)
* recently max. two stable anticonvulsive drugs for minimum 4 days before study start
* patients under continuous monitoring control
* patients younger than 1 year of age

Exclusion Criteria:

* high grade cardial rhythm disorders
* severe liver, renal and electrolyte blood parameter changes
* metabolic or lesional origin of epilepsy (metabolic screening results and cranial MRI available)
* parallel participation in other studies (must be finished two month before study start)
* missing informed consent
Comparison of Ropivacaine-Poloxamer 407 Hydrogel and TAP Block for Postoperative Pain Management in Laparoscopic/Robotic Gastrectomy

This study aims to determine whether Ropivacaine-Poloxamer 407 hydrogel provides non-inferior pain control compared to TAP block for patients undergoing minimally invasive gastrectomy. The results will guide postoperative pain management practices and enhance recovery protocols for gastric cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery.
2. Patients who have undergone a complete surgical resection (R0 resection).
3. Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
4. Patients aged 20 years or older.
5. Patients who have undergone laparoscopic or robotic gastrectomy

Exclusion Criteria:

1. Patients under 19 years of age.
2. Presence of ascites or peritoneal metastasis.
3. Patients who have undergone preoperative chemotherapy or radiotherapy.
4. Diagnosis of malignancies other than gastric cancer.
5. Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing.
6. History of allergy or adverse reactions to Ropivacaine or other local anesthetics.
7. Pregnant women.
8. Patients with preoperative chronic pain conditions, including CRPS.
9. Patients with long-term preoperative use of opioid analgesics.
10. Patients with psychiatric disorders deemed likely to interfere with study participation.
11. Patients with severe liver disease, renal disease, or arrhythmia.
Priming Through Timing. Using Opposing Strategies to Enhance Motor Learning for Individuals With Parkinson's Disease

The purpose of this study is to determine how using auditory cues of a metronome at various frequencies impacts the gait mechanics and balance in people with Parkinson's disease when walking over ground and on a treadmill. We will enroll 10 participants with a diagnosis of Parkinson's disease (Stages 2 or 3). All participants will complete 18 training sessions over 6 weeks and participate in pre- and post-testing of gait and balance.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a diagnosis of Parkinson's Disease (made by movement disorders specialist) will be included in this study. Additional inclusion criteria include: self-reported ability to walk \~6 minutes overground as well as walk on a treadmill for a total of 10 minutes with rest breaks as needed, and be classified as Stage 2, or 3 on the Hoehn and Yahr Scale (Goetz et. al, 2004).

Exclusion Criteria:

* Exclusion criteria include Hoehn and Yahr Stages 1, 4, or 5, uncontrolled cardiorespiratory/metabolic disease (e.g., cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema), or other neurological or orthopedic disorders that may affect walking. The investigators will also exclude participants with severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures.
A Study to Investigate the Impact of a Multiple Micronutrient (MMN) Beverage Powder on Vaccine Response in School Children

This will be a double blind, two-arm, parallel-group, stratified for gender, randomised, controlled study in participants aged 7-10 years (yrs). The aim of the study is to test the hypothesis that MMN fortified beverage may help improve immunity outcomes as assessed through vaccine response in 7-10 yrs old school participants.


Eligibility Criteria:
Inclusion Criteria:

* Understanding and willingness to participate in the study as demonstrated by participants' parents and/or Legally acceptable representatives (LARs) voluntary written informed consent, participants' written assent
* Participants aged between 7-10 yrs, inclusive
* Good general and mental health
* Participants with Z-scores of BMI for age of ≥-3 to ≤+1

Exclusion Criteria:

* Children in Care (CiC)
* Known or suspected intolerance or hypersensitivity to the study material or any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
* Participant who has already been administered cholera vaccine in any form prior to this study and any known contra-indication to oral cholera vaccine
* Participant who consumed any antibiotics during the week prior to the first dose of study vaccination until the end of the study
* Severe anemia (Hb \< 8 g/dL), recent history (2 months) of serious infections, injuries and/or surgeries
* Participant consuming nutritional supplement and/or health food drinks on regular basis (≥ 3 times a week) in last 3 months
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder
* Participants likely to move out of geographical range of the study within study duration
* Child of an employee of the sponsor or the study site or members of their immediate family, sibling of participant already enrolled in the study
* Previous participation in this study, in another clinical study or receipt of an investigational drug within 30 days of screening visit; participation in any nutritional study or didactic nutritional education in last 6 months of the screening visit
Systolic Time Intervals a Prognostic Tool of Heart Failure in Emergency Departement (STI/AHF)

The performance of STIs and clinical scores alone and their combination to predict short term prognosis of acute decompensated heart failure.

Acute heart failure is a leading cause of hospitalization and death.Prediction of these adverse events is still challenging.

STI is an old technique based on the recording of two parameters: electrocardiogram and phonocardiogram, and from them measuring the different systolic intervals:

pre-ejection period (PEP),electro-mechanic activation time (EMAT), Left ventricular ejection time (LVET) and systolic time ratio (RTS) were measured.

The aim of these study is to demonstrate whether systolic time intervals (STIs) can improve clinical scores EFFECT (Enhanced Feedback for Effective Cardiac Treatment) and GWTG-HF (Get With the Guidelines-Heart Failure) for predicting 30 day mortality and readmission in patients with acute decompensated heart failure (ADHF) in the ED.

Eligibility Criteria:
Inclusion Criteria:

* non traumatic dyspnea
* age more than 18 years old.

Exclusion Criteria:

* ECG diagnostic for acute myocardial infarction
* ischemic chest pain within the prior 24 hours
* history of a heart transplant
* pericardial effusion
* chest wall deformity suspected of causing dyspnea
* coma
* shock,Mechanical Ventilation, vasopressor drugs
* arrhythmia serious and sustained,
* pace maker
* severe mitral valve disease,
* severe pulmonary arterial hypertension
* renal failure with creatinine \>350micromol/l
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study

The purpose of this post-authorisation medical device study is to obtain real life data on the use of Tumor Treating Fields (TTFields) in patients with pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Histologically confirmed pleural mesothelioma without any option of curative resection
* Planned treatment with NovoTTF-200T System according to IFU and medical guidelines
* Life expectancy more than 3 months at day of enrollment
* Signed informed consent for use and processing of data

Exclusion Criteria:

• Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment
Study of ONO-2506 in Patients With Acute Ischemic Stroke

The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to placebo in patients with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have a clinical diagnosis of acute ischemic stroke
2. Subjects within 72 hours after onset of the stroke
3. Other inclusion criteria may apply.

Exclusion Criteria:

1. Subjects who are scheduled to have surgical operations likely to affect the prognosis (including intravascular surgery and circulatory reconstruction)
2. Subjects who are pregnant or lactating, or who have child-bearing potential, or who wish to become pregnant.
3. Other exclusion criteria may apply.
Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones

Urolithiasis is a common disease in urology. With the continuous progress of science and technology, the treatment of kidney lithiasis has undergone revolutionary changes, and the previously commonly used open surgical lithotomy method has been gradually eliminated, and replaced with less traumatic treatment methods. Percutaneous nephroscopy can theoretically treat the vast majority of kidney stones, especially in the treatment of kidney stones \> 2 cm, it is widely used. With the development of ureteroscopy technology, the adaptation of ureteroscopy for the treatment of kidney stones has been expanding, and people have gradually paid attention to it with less damage and higher safety. This study aims to evaluate whether the efficacy and safety of soft ureteral lithotomy in the treatment of 2-4cm kidney stones is equal to that of percutaneous nephrolithotomy through prospective randomized controlled clinical trials, so as to provide more choices for physicians and patients, and provide theoretical basis for the standardization of clinical practice and the rationality of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. The patient agrees to participate in the experiment and signs the informed consent, including compliance with the requirements of the experiment
2. American Society of Anesthesiologists (ASA) score of 1-2, tolerate surgery
3. Age 18-70 years old
4. Diagnosed with renal stones via CT scan, with the largest diameter of the stone being 2-4 cm.

Exclusion Criteria:

1. Excessive obesity, BMI \> 28
2. Severe urinary tract infection not corrected
3. Previous history of kidney transplantation or urinary tract diversion surgery
4. Uncorrected bleeding or patients with coagulation dysfunction
5. Urinary system congenital malformations, such as polycystic kidney, horseshoe kidney, pelvic ectopic kidney, etc
6. Combined with serious heart and lung dysfunction and failure of important organs and cannot tolerate anesthesia or surgery
Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP

The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.

This is a randomized controlled trial involving single administration of 8 mg Dexamethasone per IV preoperatively among women undergoing vaginal reconstructive surgery for pelvic organ prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy

Exclusion Criteria:

* Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
* Regional anesthesia for surgical procedure
* Chronic pain requiring opioid treatment daily
* History of allergy to the study medication
* Severe renal and liver disease
* Pregnancy
* Non English speaking
* Psychiatric disorder that will preclude completion of questionnaires
* Minor surgery that does not involve overnight admission
* Surgery that does not involve hysterectomy or vaginal intraperitoneal apical suspension
* Hypersensitivity reaction to steroids
* Evidence of systemic fungal infection
* Evidence of any systemic infection
* Uncontrolled diabetes
A Study of the EMPOWER Program for Latinx Caregivers of ICU Patients

The researchers are doing this study to find out whether EMPOWER (Enhancing \& Mobilizing the Potential for Wellness \& Emotional Resilience) may reduce emotional distress in Latinx caregivers of patients in the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Informal caregivers of patients, who were admitted in an ICU or step-down unit during their current admission/stay or within 2 weeks of discharge from their last admission/stay.
* Informal caregivers listed as a designated health care proxy or decision-making patient surrogate by ICU medical staff.
* Age 18 years or older as per self-report.
* Residing in New York or New Jersey as per self-report or able to complete modules while complying with current telehealth regulations.
* Spanish-speaking as per the Spanish language assessment items below and willing to receive the intervention in Spanish.

  * What is the participant's preferred language?
  * (Specify Lang)___________________________
  * How well does the participant speak Spanish?
  * Very well (PARTICIPANT IS ELIGIBLE)
  * Well (PARTICIPANT is ELIGIBLE)
  * Not well (PARTICIPANT is NOT ELIGIBLE)
  * Not at all (PARTICIPANT is NOT ELIGIBLE)

Exclusion Criteria:

* Informal caregivers who score low, moderate or high on the Columbia Suicide Severity Rating Scale.