cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Efficacy of Dextromethorphan/Quinidine in Treating Irritability in Huntington's Disease

The purpose of this study is to assess efficacy and safety of dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg) in patients with irritability due to Huntington's disease.


Eligibility Criteria:
Inclusion Criteria:

* Verified HD mutation carriers;
* Irritable as diagnosed by the Irritability Scale with a score \> 14;
* Stable concomitant medication (no change of medication during last 30 days prior to inclusion);
* Written informed consent by prospective study participant before conduct of any trial-related procedure. Participant must be able to make an informed decision of whether or not to participate in the study.

Exclusion Criteria:

* Hypersensitivity to dextromethorphan (e.g., rash, hives), quinine, mefloquine, quinidine, or dextromethorphan/quinidine with a history of thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome induced by these drugs;
* Pregnant or nursing women;
* Active suicidality based on the answer "yes" in questions 4 and 5 of the Columbia-Suicide Severity Rating Scale (baseline version);
* Woman of childbearing potential, not using highly effective methods of contraception such as oral, topical or injected contraception, IUD, contraceptive vaginal ring, or double barrier method such as diaphragm and condom with spermicide) or not surgically sterile (via hysterectomy, ovarectomy or bilateral tubal ligation) or not at least one year post-menopausal;
* Male not using an acceptable barrier method for contraception;
* Presence of any medically not controllable disease (e.g. uncontrolled arterial hypertension or diabetes mellitus);
* Clinically significant renal (calculated creatinine clearance \< 30 ml/min) or hepatic dysfunction;
* Patients with pre-existing hepatic disease;
* Individuals with a history or complete heart block, QTc prolongation or tornadoes de pointes, or at high risk of complete AV block;
* Family history of congenital QT prolongation;
* History of unexplained syncope within the past year;
* Use of drugs containing quinidine, quinine, or mefloquine;
* Individuals currently taking strong CYP3A4 inhibitors or tetrabenazine;
* Use of certain antidepressants--amitriptyline, clomipramine, desipramine, fluoxetine, paroxetine, sertraline, venlafaxine;
* Use of certain heart rhythm medications--amiodarone, flecainide, procainamide, propafenone;
* Use of certain medicines to treat psychiatric disorders--chlorpromazine, haloperidol, perphenazine, pimozide, quetiapine, risperidone, thioridazine.
* Use of tamoxifen;
* Presence or history of seizures or diagnosed epilepsy;
* Severe cognitive disorders defined as a score \< 18 on the MOCA;
* Clinically relevant abnormal findings in the ECG, the vitals, in the physical examination or laboratory values at screening that could interfere with the objectives of the study or the safety of the subject as judged by the investigator;
* Participation in another investigative drug trial within 2 months;
* Subjects who are unlikely to be compliant and attend scheduled clinic visits as required as determined by the Investigator.
Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction

Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role STEMI patients with heavy thrombus burden (TB).

The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.

Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role in STEMI patients with heavy thrombus burden (TB).

The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients with heavy thrombus burden as assessed by TIMI score of 0-1 or thrombus burden classification 4-5

Exclusion Criteria:

* STEMI patients with low thrombus burden (TIMI 2-3 or TB 0-3)
* History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs.
* Symptomatic hypotension and/or an SBP \< 100 mmHg at the time of randomization.
Effectiveness of Warm Acupuncture in Patients with Postherpetic Neuralgia

Postherpetic neuralgia (PHN) is the most common clinical complication of herpes zoster. PHN can persist for months to years, and in some cases, the pain may last for more than five years. Patients suffering from severe, prolonged pain endure significant distress, which seriously affects their quality of life and daily activities. Moreover, PHN can lead to insomnia, anxiety, depression, or even suicide. Currently, the treatment of PHN primarily focuses on pain management. First-line treatment options include gabapentin, pregabalin, tricyclic antidepressants, and 5% lidocaine patches.

Acupuncture is a widely used non-pharmacological therapy. A large number of clinical trials have demonstrated its effectiveness in treating various neuropathic pain conditions, including PHN. Acupuncture not only reduces pain perception but also alleviates anxiety and improves the quality of life for PHN patients. Among different acupuncture techniques, Warm Acupuncture (WA) is considered the most effective for treating peripheral neuropathic pain. Clinical case reports have also shown its pain-relieving effects in PHN patients.

However, there has been no study in Vietnam on the effectiveness of WA in pain reduction for patients with PHN. Therefore, this study is conducted to evaluate whether WA is effective in reducing pain and ensuring safety for treating PHN patients with Qi Stagnation and Blood Stasis syndrome. The findings will serve as a basis for the broader application of WA in the treatment of PHN.

Patients with Postherpetic neuralgia in the trunk area, belonging to the Blood Stasis syndrome. They will be treated with a combination of Warm Acupuncture and Gabapentin.

The intervention period is four weeks. Warm Acupuncture will be performed five times a week and Gabapentin is administered daily for 4 weeks.

Data on the Visual Analog Scale (VAS), and side effects of Warm Acupuncture and Gabapentin will be recorded before the study and weekly for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a history of herpes zoster in the trunk area.
* Individuals diagnosed with Postherpetic neuralgia (PHN) by a dermatologist, based on PHN diagnostic criteria, with pain persisting for 3 months or more after the skin lesions have healed.
* Individuals with a pain intensity score of ≥ 3, assessed using the Visual Analog Scale (VAS).
* Individuals diagnosed with Qi Stagnation and Blood Stasis syndrome by a Traditional Medicine doctor.
* Individuals aged 18 years or older.
* Individuals who volunteer to participate in the study and sign a consent form.

Exclusion Criteria:

* Active herpes zoster lesions, confirmed by the dermatologist treating the patient.
* Pregnant or breastfeeding women.
* Patients with severe cognitive impairment who cannot understand the study protocol.
* Patients with a history of allergy to Gabapentin.
* Currently participating in another interventional study.
Identification of Factors Associated With Physical Activity Levels in Adult Muscle Diseases

To evaluate physical activity levels and factors associated with physical activity levels in adult patients with muscle diseases.

The same protocol will be applied all of the patients and healthy subjects. Individuals will be informed in detail about the study and demographic and physical properties will recorded after receiving approval. Evaluation programme that consisting of pain, fatigue, falls, activity limitations, quality of life, muscle strength assessment and functional assessment will be applied. After the evaluation, individuals will be given detailed information on the use of SenseWear activity monitors. Individuals will wear SenseWear activity monitors on right triceps muscle for 5 days. The data stored on the device will be recorded in computer using the software. Individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity). Physical activity levels will be assessed by subjective aspects of physical activity questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of muscle diseases
* Adult patients with muscle diseases who are able to walk independently

Exclusion Criteria:

* Clinical diagnosis of systemic problems
* Any orthopedic problems that will affect the performance of the physical activity
* Clinical diagnosis of neurological disease other than muscle disease
* Clinical diagnosis of cognitive impairment
* Individuals who underwent surgery in the last 6 month
Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers

The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of patients with acute bacterial gastroenteritis (traveler's diarrhea.

This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe other gastrointestinal-related symptoms, or tenesmus of \<72 hours duration.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute bacterial gastroenteritis
* Traveler from an industrialized country
* Capable of giving Informed Consent

Exclusion Criteria:

* Fever (\>100.3 degrees)
* Pregnant or Breast Feeding or Not using adequate birth control
* Known or Suspected (co-)Infection with non-bacterial pathogen
* Symptoms of acute gastroenteritis of \>72 hours duration
* Bloody Diarrhea
* Concomitant antibacterial with activity against enteric bacterial pathogens
* History of IBD
* Unable/Unwilling to comply with study protocol
* Greater than two doses of an antidiarrheal medication within 24 hours
* \> 2 doses of anti-diarrheal medication within 24 hours
* Antimicrobial treatment within 30 days
Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections

The purpose of this study is to determine the efficacy of retrieving tissue samples via an x-ray guided needle that is inserted into the infected tissue in the shoulder. The procedure using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is done at the time of surgery. By doing the synovial biopsy prior to a revision surgery, the investigators hope to avoid more invasive intervention if it is not needed. Some patients may appear to have an infection but once the biopsy is taken and the results are read, there may not be an infection and therefore no need for a revision surgery.

The primary research objective is to assess the diagnostic accuracy of percutaneous synovial biopsy for detection of implant-related intra-articular shoulder infections (IISI).

The secondary objectives are to document the frequency of pain associated with shoulder synovial biopsy and to determine the correlation and agreement of several indices of infection as a means of providing preliminary evidence toward a clinical decision rule to rule in or rule out the diagnosis of implant-related intra-articular shoulder infection.

The third objective is to determine the rates of (re)infection, functional outcomes, and quality of life, over a two year follow up period following revision surgery.

The fourth objective is to determine whether an association exists between the biopsy location within the joint and relative yield and positive culture rates.

The fifth objective is to identify, develop, and validate tissue-specific biomarkers for the detection of IISI.

It is our hypothesis that synovial biopsy is valid tool for use in the diagnosis of shoulder arthroplasty and fracture implant related infections.

Eligibility Criteria:
Inclusion Criteria:

1. Previous shoulder surgery including hemiarthroplasty, total shoulder arthroplasty or reverse total shoulder arthroplasty, or internal fixation for shoulder fractures
2. Suspicion of infection, including acute fever and complaints of pain and/or stiffness post operatively
3. Revision shoulder surgery for patients described in (1)
4. Provide consent

Exclusion Criteria:

1. signs or symptoms of bacteremia or sepsis requiring urgent treatment, which would preclude the possibility of synovial biopsy
2. Unable to speak or read English/French
3. Psychiatric illness that precludes informed consent
The Effect of Kangaroo Care Education on Mother-Infant Bonding, Maternal and Neonatal Comfort

Kangaroo care encompasses early and continuous skin-to-skin contact, frequent and regular breastfeeding, early discharge from the hospital, and other supportive care practices necessary for the infant . Through kangaroo care, the transition of newborns from intrauterine to extrauterine life is facilitated, and a strong and secure bond between the mother and the newborn is established. Kangaroo care, which does not require any additional equipment or special preparation, is a safe method that can be easily and frequently implemented due to its numerous benefits. Since maternal and neonatal health affects not only the family but also public health, maternal and neonatal comfort is considered to be of great importance. Kangaroo care is believed to contribute positively to the enhancement of this comfort and the strengthening of the mother-infant bond. Despite the well-documented benefits of kangaroo care in the literature, its implementation in our country has not reached the desired level. This study is planned to determine the effect of kangaroo care education provided to pregnant women in the third trimester on mother-infant bonding and maternal and neonatal comfort.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for Pregnant Women:

* Aged 18 years or older,
* Primiparous (first pregnancy),
* Between 35-38 weeks of gestation,
* Able to speak Turkish and/or without communication barriers,
* At least a primary school graduate,
* A healthy pregnancy,
* Good health status during and after delivery,
* No contraindications for providing kangaroo care,
* No physical and/or mental health issues,
* No infectious diseases transmitted through contact,
* Willing to participate in the study,
* Use of WhatsApp application,
* Pregnant women expecting a single baby will be included in the study.

Inclusion Criteria for the Infant:

* Full-term,
* No need for oxygen support,
* No congenital anomalies,
* No infectious diseases,
* Stable general condition.

Exclusion Criteria:

* Exclusion Criteria for Pregnant Women:
* Multiparity,
* Foreign nationals, migrants, or those with communication difficulties,
* High-risk pregnancies,
* Physical and/or mental health issues,
* Presence of an infectious disease transmitted through contact,
* Refusal to participate in the study,
* Non-users of phone and/or WhatsApp application,
* Pregnant women expecting multiple babies will be excluded from the study.

Exclusion Criteria during Data Collection:

* Women who no longer wish to continue in the study after volunteering,
* Women who cannot be reached via WhatsApp and/or phone,
* Women whose infants experience death (exitus),
* Women whose infants have conditions preventing the application of kangaroo care will be excluded from the study.
Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

The purpose of this study is to compare how well three different doses of ketamine, given as a spray into the nose, help to sedate children and help them tolerate repairs of cuts on their faces.

Procedural sedation is frequently used to facilitate distressing and painful procedures in the pediatric emergency department. However, administering an intramuscular medication or placing an intravenous line to give intravenous medications can be as distressing as the procedure itself. Oral medications generally take longer to work and are subject to first-pass metabolism. Another alternative is to give the medication by the intranasal route, which only requires a spray into the nose. Ketamine is a good sedative drug with favorable qualities, and is often used intramuscularly or intravenously. It has been used intranasally as a pre-induction by anesthetics, sedation for CT scans, and brief dental procedures, but its use has not yet been demonstrated in the setting of the pediatric emergency department for procedural sedation. We will be comparing three different doses of ketamine, applied intranasally using a mucosal atomization device, and determining if there are any differences in efficacy of sedation, time to onset of sedation, duration of sedation, caregiver and physician satisfaction, and number of adverse events. We will also use this opportunity to determine ketamine bioavailability when given intranasally using the mucosal atomization device.

Eligibility Criteria:
Inclusion Criteria:

* Children between 1 to 7 years old
* Simple facial laceration, defined as: linear; requiring two or more sutures; no greater than 5.0 centimeters; does not cross the lid margin of the eye; does not require a plastics/face surgery consult; occured within the last 24 hours.
* Physician feels that intravenous sedation is required to perform the laceration repair

Exclusion Criteria:

* Closed head injury, any alteration in level of consciousness, clinical suspicion of intracranial injury or increased intracranial pressure
* Any conditions that qualify patient as American Society of Anesthesiologists' (ASA) III or IV
* Known diagnoses of hyperthyroidism or porphyria
* Glaucoma or penetrating eye injury
* Hypertension
* Any contraindication, including drug allergy, to study medications
* Severe trauma with other injuries requiring operative intervention
* Abnormal neurological exam in a previously normal child
A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes

The study is a prospective unblinded randomized trial to evaluate the feasibility of conducting a sleep extension intervention trial and the sleep extension intervention among the young adults. The study also wants to assess whether a sleep-extension intervention has an impact on the insulin resistance levels of young adults. The intervention consists of an education session and to extend the sleep time at least one hour but can be up to 2 hours per night for 4 weeks.

Insulin Resistance has been shown to put a person at risk for developing Type II diabetes. There is a correlation between sleep deprivation and insulin resistance.The study wants to assess the feasibility by enrolling 20 subjects in a year. The study also wants to assess the feasibility of the sleep extension intervention among young adults by examining the number of subjects that are randomized to intervention arm will complete the study.

Another intent of the study is to examine how sleep behaviors affect risks for developing type 2 diabetes and to determine their willingness to participate in a 4-week home-based program (intervention) focused on personal sleep behaviors.

Subjects enrolled in the study and are randomized to intervention group and control group. The intervention group will receive one education session consisting of strategies for sleep hygiene which is the routine for going to sleep and instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks. At the end of 4 weeks subjects will have a blood draw and will complete the questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Age must be 18-25 years old
* Self-report short sleep
* BMI ≥ 30 (the World Health Organization's classification of being obese)
* Insulin Resistance determined by serum analysis
* Be willing to extend time in bed by one hour total per night
* Read and speak English.

Exclusion Criteria:

* Night shift worker;
* Sleep disorder diagnosis;
* Medical diagnosis of diabetes or pre-diabetes;
* Currently pregnant or lactating or with history of gestational diabetes;
* Actively participating in a weight loss program;
* Hospitalization in past 3 months for any medical or psychiatric condition;
* Having a major chronic illness (e.g. cancer, Lupus)
Tranexamic Acid for Unilateral Total Knee Arthroplasty

Total knee arthroplasty is often associated with excessive postoperative bleeding due to increased fibrinolysis. Hence, the objective of the proposed of this multicentre study is to determine the peri-operative bleeding comparing the application of topical and intravenous tranexamic acid with the habitual surgical haemostasis.

Objectives:

1. Principal: To assess if the topical and intravenous tranexamic acid reduce less or at least than 20% the blood losses with respect to the habitual haemostasia in patients, after unilateral total knee arthroplasty.
2. Secondary: To assess the treatment safety. To perform a cost- analyses.

Methods: Randomized, multicentre, open and parallel clinical trial with three comparative groups: Topical tranexamic acid, Intravenous tranexamic acid and habitual haemostasia. In all patients, a single drainage of 8mm will be inserted in the joint, and it will remain closed during one hour after the closure of the skin.

Nº of participant centres: 2. Random allocation will be centralised in "Hospital de la Santa Creu i Sant Pau".

Main outcome: Total blood loss (mL) in the post-operative period collected by the habitual drain system ).

Secondary outcomes: Total blood loss (mL)and hidden blood calculated by Nadler's formula. Proportion of patients with blood transfusion, complications of surgery wound, haemoglobin pre and post-operative, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.Direct cost analysis.

Substudy: Pharmacokinetic study. The first 24 patients included in "Hospital de la Santa Creu i Sant Pau" for tranexamic acid (12 topical- 12 intravenous) to determine:

1. Plasmatic concentrations of tranexamic acid
2. In topical and intravenous tranexamic acid administration determine the absorption rate and drug bioavailability by these routes: maximum plasma concentration, time to reach Cmax, AUC, and half-life.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral Total knee arthroplasty
* The patient consent to participate

Exclusion Criteria:

* Antecedent of thromboembolic disease
* Patient with cardiac alterations of the rhythm
* Patients with valvular cardiac prosthesis
* Patients with pro-thrombotic alterations of coagulation
* Treatment with anticonceptive drugs