cyrilzakka/clinical-trials huggingface dataset:
Effects of MDMA and Methylphenidate on Social Cognition

The purpose of this study is to assess and compare the effects of a single dose of 3,4-methylenedioxymethamphetamine (MDMA)and methylphenidate (MPH) on emotional and social cognition in healthy subjects. The investigators hypothesize that MDMA enhances affective perception for positive and impairs perception for negative emotional stimuli compared to placebo or MPH.


Eligibility Criteria:
Inclusion Criteria:

* Sufficient understanding of the German language
* Subjects understand the procedures and the risks associated with the study
* Participants must be willing to adhere to the protocol and sign the consent form
* Participants must be willing to refrain from taking illicit psychoactive substances during the study.
* Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session. Subjects must agree not to smoke tobacco for 1 h before and 4 hours after MDMA administration.
* Participants must be willing not to drive a traffic vehicle in the evening of the study day.
* Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.
* Body mass index: 18-25 kg/m2

Exclusion Criteria:

* Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (\>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
* Current or previous psychotic or affective disorder
* Psychotic or affective disorder in first-degree relatives
* Prior illicit drug use (except THC-containing products) more than 5 times or any time within the previous 2 months.
* Pregnant or nursing women.
* Participation in another clinical trial (currently or within the last 30 days)
* Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
Interstitial Lung Disease Questionnaire

1. To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how this varies between subgroups of ILD.
2. To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered breathing within ILD patient population.
3. To assess the economic impact of ILD.
4. To understand how self-aware ILD patients are regarding their treatment/management.
5. To compare the demographic details, including smoking status and occupational history, of patients with interstitial lung disease

Primary endpoint

• Health status in the target populations, as determined by the K-BILD questionnaire.

Secondary endpoints -

* Severity of dyspnoea suffered by patients
* Prevalence of anxiety and depression
* Prevalence of sleep-disordered breathing symptoms
* Degree of self-awareness displayed by patients
* The costs associated with ILD from a patient and healthcare perspective.
* Demographic details

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age greater than 18 years of age
* Any smoking status
* Diagnosis of Interstitial Lung Disease as defined below
* Full pulmonary lung function tests and routine immunological tests undertaken within 6 months of entry into study

Exclusion Criteria:

• Unable to give consent to take part
Freiburg TIPS Registry

Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial.

Clinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after TIPS implantation following a regular follow-up schedule with clinical visits at the University Medical Center Freiburg. During follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in a associated biobank.

Patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) can be included in this observational study. Further patients who have been treated between 01/01/2005 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this registry.

Patients who are allocated to TIPS implantation will be recruited the day before TIPS implantation. Detailled patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database. Further, interventional data of TIPS implantation will be included in the database.

Apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins and from the liver and portal vein that will be taken during TIPS implantation.

All patients recruited in this registry will be followed-up for at least 12 months with regular visits 3, 6 and 12 months after TIPS implantation.

Outcome parameters including development of post-TIPS hepatic encephalopathy, acute- on chronic liver failure (ACLF), infections, recurrence of clinically significant portal hypertension, need for TIPS revision and death and liver transplantation will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension

Exclusion Criteria:

* Withdrawal of written informed consent
Ultrasound (US)-Doppler for the Diagnosis of Asymptomatic Deep Vein Thrombosis (DVT) in Gynecologic Cancer Patients

The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by Doppler ultrasound in a selected group of patients suffering from gynecological malignancies.

The association between malignancy and venous thromboembolism (VTE) is well known. It has been shown that there is a high prevalence of VTE in gynecological malignancies. Early detection of VTE can identify patients who may benefit from anticoagulant therapy and prevent morbidity and mortality.

NO clear guidelines are available for anticoagulant prophylaxis in a selected group of ambulatory gynecological cancer patients. It has been shown, in other selected groups of patients that Ultrasound Doppler can be used in order to diagnose asymptomatic DVT (deep vein thrombosis).

Eligibility Criteria:
Inclusion Criteria:

* Gynecological cancer patients
* Ambulatory performance status of 0-2
* Prior to, or during, chemotherapy and/or radiation

Exclusion Criteria:

* Before or near surgery
Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record

The study team will evaluate the impact of an Infant Sleep Assessment (ISA) tool with motivational interviewing (MI) communication training on clinician-parent communication during 2-month Well Baby Visits (WBV) and parent reported and observed infant sleep practices. The study team's hypotheses are that 1) clinicians who utilize the ISA with MI training will more effectively communicate safe sleep information to their patients' parents, and 2) these parents will have safer infant sleep practices than parents whose clinicians are in a standard of care control group.

This research addresses the problem of unsafe infant sleep practices that increase the risk of Sudden Unexplained Infant Death (SUID), which includes Sudden Infant Death Syndrome and Accidental Suffocation and Strangulation in Bed. The study team will examine how a unique health information technology (HIT) tool impacts patient and provider outcomes when implemented in a pediatric primary care clinic serving a socioeconomically disadvantaged population that is primarily Black/African American. The study team's HIT tool - the Infant Sleep Assessment (ISA) - was developed through prior NIH-funded work and builds on the team's track record of innovative injury prevention research with parents and pediatric health care clinicians. During well-baby visits, the ISA assesses parents' reported sleep practices for their newborns. Using a programmed algorithm, the ISA identifies risky infant sleep practices and generates associated suggested feedback messages for the clinician that are derived from behavior change theory. This information is delivered via the electronic medical record (EMR) for the clinician's use during routine anticipatory guidance. To maximize the ISA's effectiveness, clinicians (pediatric residents) will receive a brief training in communication skills that are derived from Motivational Interviewing (MI). The study team will evaluate the impact of the ISA with MI communication training on clinician-parent communication during 2-month Well Baby Visits (WBV) and parent reported and observed infant sleep practices. The study team's hypotheses are that 1) clinicians who utilize the ISA with MI training will more effectively communicate safe sleep information to their patients' parents, and 2) these parents will have safer infant sleep practices than parents whose clinicians are in a standard of care control group.

Eligibility Criteria:
Inclusion Criteria:

* English and Spanish-speaking parents and legal guardians bringing their infants to the Harriet Lane Clinic (pediatric primary care clinic) for any of their early well baby visits (between 3-5 days up to 4 weeks of age)
* Maryland recognizes teen parents as emancipated minors, so they will be eligible to provide consent and participate.

Exclusion Criteria:

* Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.)
* Assigned resident is not enrolled in the study
Evaluation of Antihypertensive Drugs in OSA Patients

This prospective cohort study aimed to assess the phenotypic characteristics of OSA patients and their pattern of antihypertensive drugs consumption. The investigators also aimed to investigate a hypothetical association between ongoing anti-hypertensive regimen and Blood pressure control rates in these patients. Additionally, the investigators were also interested in trying to understand if the control of OSA may be influenced by the use of different classes of anti-hypertensive drugs.


Eligibility Criteria:
Inclusion Criteria:

* aged above 18 years, that attended a first visit at CHLN Hospital Sleep Unit were enrolled

Exclusion Criteria:

* severe psychiatric disease or inability to understand the information required for an informed consent.
Predictive Factors of Pelvic Magnetic Resonance in the Response of Arterial Embolization of Uterine Leiomyoma

The purpose of this study is to determine predictive factors in the pelvic magnetic resonance in the response of arterial embolization of uterine leiomyoma.

This study followed symptomatic premenopausal women with uterine leiomyoma who underwent uterine artery embolization (UAE). Treatment was accompanied by magnetic resonance imaging of both the volume of the entire uterus and the leiomyomas one month before and six months after UAE. This patients were treated at the Uterine Leiomyoma Sector of the Department of Obstetrics and Gynecology, Medicine College of the University of São Paulo. In this study, the investigators examined 179 leiomyomas in 50 patients.

Eligibility Criteria:
Inclusion Criteria:

* ultrasound diagnosis of uterine leiomyoma
* presence of symptoms (menorrhalgia and/or pelvic pain)
* indication for UAE(the desire to keep the uterus and/or contraindications for surgery).

Exclusion Criteria:

* malignant genital neoplasms
* pelvic inflammatory disease
* allergy to iodinated contrast
* coagulopathy, renal failure
* vasculitis
* pelvic irradiation
* pregnancy
* subserosal leiomyoma with a pedicle smaller than 50% of diameter of the fibroid.
Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.

Periodic leg movements during sleep is associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between periodic leg movements severity, age, gender, electromyographic power and heart rate response associated with periodic leg movements. Drug-free patients diagnosed with periodic leg movements were included. Clinical data and 24-h polysomnography recordings were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Restless legs syndrome patients
* Hospital routine for periodic leg movements diagnosis
* PLMS index \> 0

Exclusion Criteria:

* Narcolepsy-cataplexy
* Sleep irregularities and sleep deprivation symptoms
* Lack of neurological or psychiatric diseases
* Upper airway resistance syndrome
* Obstructive sleep apnea
* Treatment, cerebral lesion, medical illness
* Medication or drinks affecting sleep and wake state
Patient Comfort During Dermatologic Procedures

The goal of this study is to find the effect of holding a patient's hand on anxiety and pain during dermatologic procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Undergoing a dermatologic procedure
* Willing and able to understand and provide informed consent and communicate with the investigator

Exclusion Criteria:

* Subjects who have wound healing problems
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with self-reported mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders, cognitive disorders, depression with psychotic features, dissociative disorders
Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis

Chronic Rhinosinusitis (CRS) is a chronic condition with limited therapeutic options. Moreover, the pathophysiology is poorly understood. The aim of this study is to evaluate the efficacy of osteopathic manipulative treatment (OMT) in the course of this condition by applying several techniques supposed to be related to the autonomic nervous system. Our hypothesis is that these techniques could have beneficial effects on inflammation and head symptoms in CRS.

Methods:

A sample of 90 patients diagnosed by ENT specialist will be randomly assigned to the OMT group or the placebo group. The placebo procedure will consist in using light touch around the nose, on the throat and on the thorax. Treatment and placebo protocols are composed of two visits at day 0 and day 30.

A general practitioner will determine the eligibility for the study.

The outcomes include Peak Nasal Inspiratory Flow (PNIF) measured five times: at day 0, 30 (twice each, before and after treatment) and 180 (once). The two groups will be compared regarding short and long term evolution.

The evolution of symptoms will be assessed by the Sino-nasal Outcome Test (SNOT-22) seven times: at day 0, 30, 60, 90, 120, 150 and 180. This outcome will be analyzed using mixed effect modelling

A Qualitative study will be conducted in the two groups to understand the patients' experiences during care.

This protocol has been approved by a french ethic committee (Comité de Protection des Personnes Sud Ouest et Outre-Mer II, 2020.04.09).

Statistical analysis details:

PNIF middle term evolution:

If the two groups can be compared regarding their socio-demographics characteristics, a student's t-test will compare evolution (day 0 before treatment to day 30 before treatment) of the PNIF between groups.

If characteristics are different, a multivariate linear model will be applied.

PNIF long term evolution:

The same tests will be made. The evolution will be assessed between day 0 (before treatment) and day 180.

PNIF short term evolution:

The same tests will be made. The evolution will be assessed before and after treatment at day 0 and day 30.

SNOT-22 evolution:

Mixed effect model will assess the evolution of symptoms from day 0 to day 180

Response Shift detection:

For the SNOT-22, an Oort procedure will be performed in order to detect Response shift among individuals.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 50
* Chronic rhinosinusitis diagnosed by ear, nose, and throat (ENT) specialist or general practitioner
* informed consent given
* registered under french social security system

Exclusion Criteria:

* contraindication to spine manipulation
* receiving other treatment for CRS during this study
* being pregnant
* being under legal protection
* withdrawal of consent
Endotracheal Tube Cuff Inflation Pressure Varieties and Response to Education Among Anesthetists

Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients.

This study will investigate the endotracheal ETT cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply.

Although the increasing uses of different supraglottic devices as an alternative, the traditional endotracheal intubation is still considered the commonly used method for managing the airway of a generally anaesthetized patient. After passing the endotracheal tube through the larynx, the anaesthetist inflates the cuff or asks the anaesthesia technician to inflate it. How much air is injected into the cuff is not a major concern for almost all anaesthetists and they usually depend on palpating the external cuff tense to judge is it too much, accurate or not enough? Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. Inflation of the cuff of pressure more than 30 cm H2O can damage the tracheal mucosa by compromising capillary perfusion. When pressures are greater than 50 cm H2O, total obstruction of tracheal blood flow occurs. For long times, without any evidence-based data, it has been believed that well-trained anaesthetists are capable of determining proper ETT cuff pressures. It is presumed that anaesthetists can detect appropriate inflation pressure and overinflated ETT cuff by palpating the ETT pilot balloon. Adequacy of cuff inflation is conventionally determined by palpation of the external balloon. Previous studies suggest that this approach is unreliable. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients. However, increased awareness of over-inflation risks may have improved recent clinical practice.

The aim of the work: This study will investigate the endotracheal cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply. Material and Methods: Type of the study: Prospective controlled single-blind study. Settings: After obtaining approval by the Ethics Committee of the Suez Canal University Hospital, and written informed consent with an explanation regarding the purpose, effects, technique, and complications, all anaesthetists, working currently in the facility, are included.

Eligibility Criteria:
Inclusion Criteria:

* anaesthetists
* works at Suez canal university hospital
* resident, registrar, or senior registrar

Exclusion Criteria:

* refusal to participate
* who will not complete the 2 rounds 3 readings each
Long-Term Effects of Hydroxyurea in Children With Sickle Cell Anemia (The BABY HUG Follow-up Study)

Sickle cell anemia (SCA) is an inherited blood disorder that can cause organ damage. The BABY HUG study is evaluating the use of the medication hydroxyurea at preventing organ damage in children with SCA. The purpose of this follow-up study is to evaluate the long-term effects of hydroxyurea in children who have participated in the BABY HUG study.

SCA is an inherited blood disorder in which the body makes sickle-shaped red blood cells that contain abnormal hemoglobin. The sickled cells block blood flow in the vessels that lead to limbs and organs. This can cause pain, serious infections, and organ damage. The BABY HUG study (NCT00006400) is examining whether the medication hydroxyurea can prevent organ damage, especially in the spleen and kidneys, in children with SCA. This study is a follow-up study to the BABY HUG study and will enroll children who have participated in the BABY HUG study. The purpose of this study is to examine the long-term effects of using hydroxyurea as a treatment for SCA, including both the risks and benefits. Study researchers will also investigate the optimal age to begin treatment with hydroxyurea in children with SCA.

This study will enroll children between 2 and 7 years old who participated in the BABY HUG study. Hydroxyurea will not be provided to participants as part of this study, but participants may receive the medication from their own doctors. Parents of participants can choose for their child to participate in this study in one of two ways-by enrolling in either a passive follow-up group or an active follow-up group. For participants in the passive follow-up group, study researchers will review participants' medical records every 6 months, in addition to reviewing brain ultrasound tests and computed tomography (CT) or magnetic resonance imaging (MRI) scans, if completed. Participants will have a blood and urine collection at baseline and Year 4 (or at the end of the study, whichever comes first). Participants in the active follow-up group will take part in the same study procedures as participants in the passive follow-up group. In addition, at Year 2, participants in this group will undergo an additional blood and urine collection, a scanning procedure to obtain images of the liver and spleen, a kidney test, neuropsychological testing, and an ultrasound imaging test to evaluate liver and spleen size.

Eligibility Criteria:
Inclusion Criteria:

* All children who completed at least 18 months of follow-up visits in the initial BABY HUG study
* Children from the initial BABY HUG study who are on a chronic transfusion program or who are recipients of a bone marrow transplant

Exclusion Criteria:

* Any child who was not enrolled in the initial BABY HUG study for at least 18 months