cyrilzakka/clinical-trials huggingface dataset:
Clinical Assessment of New Treatment Regimen for Adult Fulminant Myocarditis

This is a retrospective cohort study to assess the clinical outcome of patients with fulminant myocarditis using "Life-support Based Comprehensive Treatment Regimen" and conventional therapy. In the present study, participants receive various treatment as part of routine medical care without any assignment of specific interventions to them. The process of treatment during hospitalization were recorded in medical chart and was reviewed by independent research personnel.


Eligibility Criteria:
Inclusion Criteria:

* 16 years of age or older;
* Diagnosed as fulminant myocarditis:

  * Evidence of myocarditis on biopsy or increased biomarkers of myocardial injury (TNI and CK-MB and BNP or NT-pro-BNP);
  * Acute onset of symptoms of cardiac dysfunction: dyspnea, palpation, chest pain, and/or syncope;
  * Image for cardiac injury: marked diffused reduction in left ventricle wall movement, with dramatically decreased left ventricle ejection fraction (LVEF) \< 45%;
  * Cardiogenic shock, e.g., systolic blood pressure ≤90 mmHg or mean arterial pressure \< 70mm Hg or a systolic blood pressure decrease \> 40 mm Hg, which is associated with the signs of hypofusion: cyanosis, cold extremities, oliguria, and/or changes in mental status.

Exclusion Criteria:

* Also considering acute coronary syndrome but unable to perform coronary angiography to distinguish acute coronary syndrome from fulminant myocarditis;
* Myocardial injury caused by sepsis, chemotherapeutical agents, or poisons;
* Unstable hemodynamics or shock caused by hypovolemia.
The Effect of Methylphenidate on Primary Enuresis in Children With Attention Deficit Hyperactivity Disorder

To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in children with attention deficit disorder

Children aged 5 - 10 years newly diagnosed with attention deficit hyperactivity disorder who report primary nocturnal enuresis, Investigators will obtain baseline data (from parents/caregivers) on their sleep habits and enuresis characteristics by questionnaire. After 6 weeks of methylphenidate therapy, prescribed for the attention deficit, a new questionnaire will be filled.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of attention deficit hyperactivity disorder
* History of primary nocturnal enuresis
* Normal neurological examination

Exclusion Criteria:

* Anatomical abnormality of the genitourinary system
* Concommitant treatment, pharmacological/behavioral for enuresis
* Concommitant diurnal enuresis
The Effect of Surfactant Administration on Cerebral Oxygenation

The purpose of this study is to assess changes in cerebral oxygenation during two different types (beractant and poractant) and two different routes (double lumen or single lumen endotracheal tube) of surfactant administration using near infrared spectroscopy (NIRS).


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of respiratory distress syndrome \<32 gestational weeks and/or \<1500 g birthweight

Exclusion Criteria:

major congenital anomalies complex congenital heart diseases
The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning

Background and Aim: Carbon monoxide (CO) poisoning is a significant public health issue that can cause delayed neuropsychological sequelae (DNS). DNS mechanisms involve oxidative stress, inflammation, and immune injury. Although hyperbaric oxygen therapy is widely used, its efficacy in preventing DNS remains inconclusive. Preclinical and retrospective studies suggest that Dexamethasone (anti-inflammatory and immunosuppressive) and N-acetylcysteine (antioxidant) may reduce DNS risk. This study hypothesizes that their combination can effectively prevent DNS.

Methods: This prospective pre-post intervention study will enroll CO poisoning patients into treatment (Dexamethasone + N-acetylcysteine) and control groups. The primary outcome is the incidence of DNS within six weeks post-treatment.

Objective: To determine whether combining Dexamethasone and N-acetylcysteine reduces the incidence of DNS following CO poisoning.


Eligibility Criteria:
Inclusion Criteria:

* History and clinical symptoms consistent with CO poisoning (initial blood carboxyhemoglobin (COHb) levels \>5%, or \>10% for smokers).

Exclusion Criteria:

* Concurrent use of other potentially lethal toxins. Severe trauma or burns that could be fatal. No spontaneous heartbeat or blood pressure before arrival. Poisoning time exceeding 24 hours before hospital arrival. Minors (under 18 years of age). Pregnant women. Patients or their families refuse to sign the consent form. Contraindications for the use of Dexamethasone or N-acetylcysteine (such as severe allergies) or when the physician assesses the risks outweigh the benefits.
Narrow Dental Implants in Multiple Fixed Prosthesis: A Controlled Clinical Trial

The objective of this study is to evaluate the survival of narrow dental implants (≤ 3,5 mm) in multiple fixed prostheses in comparison with standard diameter dental implants (≥ 3,75 mm) after 5 years of follow-up. The hypothesis of the study is that narrow dental implants under the evaluated conditions, have the same survival rate and clinical performance than the standard diameter implants.


Eligibility Criteria:
Inclusion Criteria:

* Patients of legal age (\>18 years) of both sexes.
* Clinical need of multiple fixed alveolar ridge rehabilitations.
* Clinical suitability to insert, at least, one narrow dental implant splinted to a standard diameter dental implant.
* Signature of the informed consent

Exclusion Criteria:

* Presence of an active infection
* Being under active treatment with, or have received in the las 30 days treatment with radiotherapy, chemotherapy, immunosuppressors, systemic corticosteroids and/or anticoagulants.
* Presence of severe haematologic disorders.
* Chronic treatment with non steroidal anti-inflammatory drugs (NSAID) or other aniinflammatory drugs.
* Previous diagnosis of chronic hepatitis or liver cirrhosis.
* Presence of Diabetes mellitus with improper metabolic control (glycosylated haemoglobine higher that 9%).
* Patients subjected to dialysis.
* Presence of malignant tumours, haemangioma or angioma in the surgical area.
* History of ischaemic cardiopathy in the las year.
* Pregnancy or plan to getting pregnant during the study.
* Metabolic bone disease
* Patientd receiving treatment with oral or intravenous biphosphonates.
* Any other condition incompatible with the participation in the study,
Characteristics of Genealogical Representations of Perpetrators of Sexual Violence.

Two French studies report that 25% of sexual abuse occurs in intrafamily sphere. To be victim of sexual abuse leads to cognitive troubles and redesign of psychological processes. Lot of studies report that offenders had been victims (30-97%). How psychological redesign is destroying genealogical representation and hinders the proper construction of family ties.

This study to study characteristics data about family, and how the patients see it, from medical records of a specific department for sexual offenders in University Hospital of Saint Etienne. Study is realized blind from criminal categories. Data are gathered with a standardized grid, to guarantee reproducibility of data collection.

The CARG-AVS study does not involve any additional examinations or consultations compared to usual practice. It consists of collecting information from patients' medical records.

Eligibility Criteria:
Inclusion Criteria:

* Patients followed up in the sexual offender's department of University Hospital of Saint Etienne.
* Patients who did the nursing assessment at time of analysis.

Exclusion Criteria:

* Patients in the preliminary follow up in the department
* Refusal to participate at this study
Epigenetics of Posttraumatic Stress Disorder and Somatoform Disorders in the Course of Psychotherapy

This reported observational clinical study aims at identifying epigenetic markers in a sample of patients undergoing high dose inpatient psychotherapy suffering from a variety of psychiatric/psychosomatic diseases such as somatoform disorders, posttraumatic stress disorder (PTSD), depression, anxiety disorders and eating disorders.

The exact epigenetic markers that will be traced are yet to define.

The investigators believe that

1. Epigenetic patterns found in the group of psychiatric patients show differences from healthy controls
2. Different diagnosis show differences in epigenetic patterns as well
3. Epigenetic patterns correlate to the severity of the psychosocial disorder as measured in interviews or psychometric ratings
4. Epigenetic patterns can change under inpatient high dose psychotherapy
5. Changes correlate to clinical psychometric variables.


Eligibility Criteria:
Inclusion Criteria:

* informed consent given by the patient
* adulthood to 65 years
* stabel physical health
* at least fluent in German language (as it is a group-therapy)

Exclusion Criteria:

* psychiatric disorder such as substance addiction, psychosis, schizophrenia.
* insufficient understanding of the terms and conditions of the study
* insufficient emotional stability to fill out the psychometric forms required for the study.
Efficacy of Temporary Positive Expiratory Pressure (TPEP) in Chronic Hypersecretion

Mechanical devices to increase the individual's bronchial hygiene are commonly used in patients with chronic retention of secretions and abnormal cough reflex. In this clinical context a new technology (namely TPEP® - Temporary Positive Expiratory Pressure) has been recently developed with the aim to improve the respiratory condition in patients suffering from chronic respiratory diseases. This trial has the aim to assess the clinical efficacy of TPEP in patients with chronic hypersecretion and airways obstruction, but with a normal competence of the cough reflex

This is a single-blind multicentre controlled randomized trial with consecutive recruitment. Randomization list by blocks will be available. Group comparison will be made between active therapies including TPEP added to conventional MABT (Intervention) or MABT alone (Control). Active therapy will last 10 consecutive daily sessions in both groups.

Primary outcome

Efficacy comparison on change in:

a.arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)

Secondary outcomes

Efficacy comparison on change in:

1. Sputum characteristics
2. Daily sputum volume
3. Perceived sensation
4. Lung functions (as assessed by spirometry and RM strength)

Eligibility Criteria:
Inclusion Criteria:

* chronic hypersecretion as defined by \> 30 mL/die sputum production (7)
* chronic airway obstruction (by definition)
* COPD, bronchiectasis, asthma, cystic disease, etc. with or without chronic respiratory failure
* adulthood
* smoking or non-smoking habit
* Peak Cough Expiratory Flow \> 150 L\*min-1 (5)
* willingness to participate

Exclusion Criteria:

* childhood
* presence of acute exacerbation
* severe concomitant cardiovascular diseases
* concomitant neoplastic diseases
* non compliance/adherence to TPEP
* concomitant use of chronic mechanical ventilation
* use of amynophyllines and/or any active drugs (e.g. N-Acetyl-Cysteine)
Parental Views Related to Colorado State Legislation About Vaccinations, Schools, and Child Care Centers

Through an online survey, participants will be shown different visual presentations of vaccination data related to schools and child care centers. Participants will rate how important this information is when thinking about their child's health and school choice. Participants will also be asked survey questions about their knowledge of Colorado state vaccination legislation, their opinions and practices related to childhood vaccinations, and their views of a Zika virus vaccine.


Eligibility Criteria:
Inclusion Criteria:

* mother of a child 12 years of age or younger
* English literacy to complete the survey

Exclusion Criteria:

* respondent has a child of appropriate age but that child will not attend a school or child care center outside of the home
Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use

This clinical trial evaluates the impact of synthetic cooling agents in combustible cigarettes on smoking perceptions and use. Menthol, a natural chemical, is a cooling agent that increases nicotine dependence among smokers. Menthol cigarettes largely contribute to the huge burden that smoking puts on public health. Approximately 43% of adult smokers smoke menthol cigarettes. Regulatory agencies have begun a ban on menthol. In response to the ban, the tobacco industry has introduced synthetic cooling agents as a flavorless replacement to provide the same cooling effects as menthol. Information gained from this trial may help researchers determine how the addition of synthetic cooling agents changes the appeal, abuse liability potential, and respiratory toxicity profile of combustible cigarettes.

PRIMARY OBJECTIVES:

I. Assess the content of synthetic cooling agents in newly introduced cooling agent non-menthol, menthol, and traditional non-menthol cigarettes.

II. Assess the subjective effects and abuse liability of cooling agent non-menthol cigarettes.

EXPLORATORY OBJECTIVE:

I. Examine acute changes to pulmonary health associated with cooling agent cigarette use.

OUTLINE: Participants are randomized to use 1 of 3 cigarette conditions at 3 different study visits.

Participants participate in ad libitum smoking sessions with either a non-menthol control, menthol, or synthetic cooling agent cigarette condition once weekly (QW) over 3 weeks on study. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the study cigarette condition at the end of each study visit. Participants also undergo nasal swab collection over 5-10 minutes and spirometry and airwave oscillometry testing over 5-10 minutes pre- and post-smoking session at each study visit.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 - 29 years
* Established cigarette user
* Willing to provide informed consent and abstain from using tobacco products 12 hours prior to the three lab sessions
* Read and speak English

Exclusion Criteria:

* Recently coronavirus disease 2019 positive (COVID-19+) or a recent COVID-19 hospitalization
* Self-reported unstable or significant psychiatric conditions
* History of cardiac event or distress within the past 3 months
* Are currently pregnant, planning to become pregnant, or breastfeeding
* Currently attempting to quit using combustible tobacco products
* Have suffered from any serious lung disease or infection in the past 30 days
Impact of Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lampung Province, Sumatra

Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping malaria transmission. The addition of primaquine (PQ) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (DHP) regimens with PQ on malaria transmission on a community wide level in Lempasing, Lampung, Sumatra.

A mass screening baseline survey enabled the description of malaria prevalence (P. falciparum and P. vivax). Malaria infected asymptomatic (from the mass screening) and symptomatic (malaria infected people attending the health center) people were enrolled in the study. Enrolled malaria infected subjects were treated with DHP and PQ according to the treatment regimen. The community was mass screened for malaria infections every 3 months and an incidence cohort screened every month for infections. The 3 aims were to look at malaria antibodies, haemoglobin levels and the incidence of malaria before and after the drug intervention.

Eligibility Criteria:
Inclusion Criteria:

* All individuals residing Lempasing village, kecamatan Hanura, Lampung province during study period

Exclusion Criteria:

* Individuals with severe or chronic disease (liver, kidney), infant and pregnant or breastfeeding woman
* Individuals that refuse to sign informed consent are excluded.
* normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA)
* willingness to sign the informed-consent form
Effects of Dietary Manipulation on Metabolism in Healthy Adults

This study will examine the potential changes in the blood levels of a recently discovered metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that in healthy adults key regulatory factors involved in lipid oxidation will respond to changes in diet, particularly fasting and diet-induced ketosis.

There is scant data regarding the metabolic events that occur in humans during ketosis which may be brought about by fasting or ingestion of diets low in carbohydrate.

We aim to employ both fasting and dietary manipulation in order to bring about a ketotic state in healthy human adults. During the study blood levels of key metabolic regulators will be monitored 1) during a 16 hour fast followed by re-feeding and 2) during dietary induction of ketosis followed by re-feeding with a standard meal.

Eligibility Criteria:
Inclusion criteria:

1. Men and women ages 18-60
2. BMI 21-28 kg/m2
3. Stable weight (variation \< 3 kg within 6 months of screening visit)
4. Ability to give informed consent
5. Ability to follow verbal and written instructions in English
6. Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)

Exclusion Criteria:

1. Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
2. Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
3. Uncontrolled hypertension (BP \> 150/90 mmHg on or off antihypertensive medication)
4. Dyslipidemia
5. Tobacco, marijuana or intravenous drug use
6. Shift workers (night shift or alternating day/night shifts)
7. Recent weight loss (\> 3 kg within 6 months of the screening visit)
8. Gastroparesis
9. Inflammatory bowel disease
10. Malignancy treated with chemotherapy within the past 3 years
11. History of pancreatitis
12. Depression or psychosis
13. Renal insufficiency (creatinine clearance \< 50 ml/min)
14. Transaminases \> 2x above the normal range
15. Known liver disease
16. Pregnancy within 6 months of the screening visit
17. Lactation
18. Failure to use medically approved contraceptive methods
19. History of an eating disorder (anorexia, bulimia or laxative abuse)
20. History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
21. New diagnosis of hypo or hyperthyroidism within 1 year of screening visit
22. History of alcohol abuse within the past 5 years
23. Seizure disorder
24. Gout
25. Kidney stones
Erector Spinae Plane Block Versus Retrolaminar Block for Analgesia in Percutaneous Nephrolithotomy

The study will investigate the effects of ultrasound-guided ESPB and RLB on intraoperative and postoperative analgesia in patients undergoing PCNL to identify a safe and effective regional block method for postoperative analgesia

All the patients will be blinded to the intervention received in this study. All patients will receive standard general anesthesia technique with endotracheal intubation and muscle paralysis. Postoperatively, all patients will receive analgesia in the form of non-steroidal anti-inflammatory drugs and paracetamol. In case the VAS scores exceeded 4 in any group, the patients will receive rescue analgesia with 25 mg IV meperidine. In both groups, the ESPB and RLB will be performed after induction of general anesthesia using portable ultrasound device.

Eligibility Criteria:
Inclusion Criteria:

- Patients scheduled for PCNL

Exclusion Criteria:

* daily consumption of analgesics
* allergy to local anesthetics
* liver dysfunction
* infection or previous surgery in the vertebral region.
* patient refusal
* pregnancy
Clinical Outcomes of Surgery After Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer

The purpose of this study was to investigate the clinical outcomes of patients with locally advanced pancreatic cancer (LA-PC) who underwent surgery after neoadjuvant chemotherapy (NACT) at Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2017 to 2020.

Pancreatic cancer (PC) has a very low survival rate. Most PC patients have non-specific symptoms that are advanced enough to be contraindications for surgical treatment; therefore, surgery is often impossible by the time PC is diagnosed. According to the NCCN guidelines, PCs with no metastases can be divided into resectable, borderline resectable , and locally advanced cases. Patients with borderline resectable PC (BR-PC) and locally advanced PC (LA-PC) currently receive multimodal therapy before surgery. The goal of these neoadjuvant treatments, including chemotherapy and radiation therapy, is to ultimately reduce local recurrence after surgery in patients with BR-PC and further improve their survival time. Additionally, several recent studies have reported results on the prognosis when surgery is performed after neoadjuvant chemotherapy (NACT) in patients with LA-PC. In the patients with LA-PC, surgery technically difficult because of major vascular invasion before NACT. Therefore, this study investigated the clinical outcomes of patients with LA-PC who underwent surgery after NACT. Additionally, the investigators evaluated factors affecting the prognosis related to survival after surgery in patients with LA-PC.

Eligibility Criteria:
Inclusion Criteria:

* The study population consists of patients who underwent pancreatectomy for pancreatic adenocarcinoma between January 2017 and December 2020

Exclusion Criteria:

* None
Ghrelin - A Possible Opportunity to Improve Appetite

The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.

Randomized study with follow up evaluations each month until preterminal state. Cancer patients will be randomised to either high dose or low dose of active treatment given as daily injection.

Eligibility Criteria:
Inclusion Criteria:

* Weight loss

Exclusion Criteria:

* Diabetes
A Study of the Alternative Administration of Ixabepilone and Vinflunine

The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.


Eligibility Criteria:
Inclusion Criteria:

* ECOG status of 0-1

Exclusion Criteria:

* Inability to tolerate venous access
* Brain mets
* Severe nerve damage
* ANC \<2,000/mm3
* Platelets \<100K
* Bilirubin \>= 1.5 times the IULN
* ALT/AST \>= 2.5 times the IULN
* Creatinine \<50 mL/min
* Prior treatment with vinflunine and/or ixabepilone
* Strong use of CYPP450 drugs