cyrilzakka/clinical-trials huggingface dataset:
An Intervention Program to Improve Emotion Regulation Among Parents of Children with ASD

To examine the effectiveness of a short-term therapeutic workshop in improving reflective functioning, the belief that emotions can change, the reported use of effective emotional regulation strategies, and perceived parental self-efficacy and child behavior.

The subjects will:

Answer questionnaires and clinical interviews about the relationship with their children and their mental functioning before the workshop.

The intervention group will participate in a 4-session workshop (once a week) led by an educational psychologist specializing in autism.

Answer questionnaires and clinical interviews about emotional regulation and mental functioning among their children, and about the nature of the relationship with their children after the workshop.

Eligibility Criteria:
Inclusion Criteria:

A parent aged 18 or older of a child aged 2-18 years diagnosed with ASD

Exclusion Criteria:

* A parent under the age of 18
* A parent of a child without an ASD diagnosis
* A parent of a child with ASD diagnosis under 2 years of age, or above 18 years of age
University of Central Florida BEEAST

Since the inception of aerospace travel, NASA has been collecting biospecimens from professional astronauts for research. With the recent growth of civilian aerospace travelers, there is a need for biospecimen banking for civilian astronauts. This protocol addresses this gap by being a biobank for civilian astronauts, their family members (to be controls) and others who are also doing travel to extreme environments (pilots, submariners).

The objective of the University of Central Florida College of Medicine's Biobank for Extreme Environments, Aviation and Space Travel (BEEAST) is to acquire, store, and distribute identifiable human biospecimens and health information for medical research purposes only. The target population are astronauts, aviators, submariners, persons living in extreme environments (such as Antarctica), and their families, and people from the general population who can serve as matching controls.

Eligibility Criteria:
Inclusion Criteria:

* Primary Enrollees: adults, ages 18 and older, and persons who travel (such as space travel) or live in extreme environments (such as Antarctica).
* Secondary Enrollees: Referred adult family members (such as siblings and spouses) of primary enrollees.
* Tertiary Enrollees: Adult persons from the general public can enroll to serve as matching controls. Tertiary enrollees will be screened based on age, gender, race and ethnicity, country of residence, disease/ conditions and employment history.
* Pregnant women may choose to enroll.

Exclusion Criteria:

* adults unable to consent,
* minors (under age 18)
* prisoners
Cervical Recuperation After Vaginal Delivery

Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine the process of cervical recuperation post delivery.

Patients after vaginal delivery will be recruited after receiving a full explanation and signing an informed consent.

The goal of the study is to examine cervical length after vaginal delivery at 3 different time intervals:

1. 8 hours post delivery.
2. 24 hours post delivery.
3. 48 hours post delivery. At each interval a trans-vaginal ultrasound will be performed, evaluating cervical length. At the end of the 3rd and final ultrasound, the patient will finish her participation in the study/ Information regarding obstetric conditions such as labor induction, gestational age at the time of delivery etc. will be collected from patients' electronic files.

Eligibility Criteria:
Inclusion Criteria:

* Any patient after vaginal delivery.

Exclusion Criteria:

* Any patient after cesarean section.
Early Progressive Strength Exercise for Treatment of Acute Achilles Tendon Rupture.

The purpose of this trial is to investigate the efficacy of standard care versus standard care combined with an early progressive exercise program in improving the function of the tendon and leg muscles after non-surgical treated Achilles tendon rupture

Acute Achilles tendon rupture often results in long-term muscular deficits. Patients struggle to return to work and sports with high load on the lower leg. Early functional rehabilitation has shown good results, but research on resistance exercise is scarce and the reporting of the specifics of the exercises are poor.

Eligibility Criteria:
Inclusion Criteria:

* Acute total Achilles tendon rupture treated non-surgically
* Diagnosed within 3 days (of their injury)
* Age 18 - 65, able and willing to participate in the intervention
* Able to speak and understand Danish

Exclusion Criteria:

* Achilles tendon rupture close to insertion on calcaneus or in the musculo-tendinous junction of the triceps surae
* Previous Achilles tendon rupture or other conditions in either leg causing lower leg disability (pain, deficits in strength or range of movement)
* Treated with Fluoroquinolons or Corticosteroids within the last 6 months
* Diabetes or rheumatic diseases
* Severe medical illness: ASA score higher than or equal to 3. (ASA: American Society of Anesthesiologists physical status classification system)
Efficiency of Speech Therapy in Resistant Hypertensive Patients With Mild Obstructive Sleep Apnea Syndrome

The purpose of this study is to analyze the effect of speech therapy on quality of life, sleep quality, daytime sleepiness level and apnea-hypopnea index in patients with hypertensive patients with mild obstructive apnea syndrome.

The database will include demographic characteristics, cardiovascular risk factors and and target-organ damages. Anthropometric measurements (height, weight, and abdominal and neck circumference) will be registered. Daytime sleepiness, quality of sleep and quality of life wiill be evaluated through the respective questionnaires: Epworth sleepiness scale, Pittsburgh Sleep Quality Index (PSQI) and SF-36. In order to evaluate the airway, the Mallampati grade will be used in addition to the adapted assessment protocol from Guimarães (2009). The differences between the final score and the baseline score will be calculated and adjusted by the baseline value found in each of the questionnaires applied. Finally, the analysis excluding the patients with suboptimal adherence to speech therapy treatment (less than 85%) compared to the control group will be redone. If there are benefits of treatment with speech therapy, it will also be offered to the control group after the end of the clinical trial. Statistical analysis will be done in the statistical package SPSS version 19.0 package (SPSS Inc. Chicago, Illinois, USA). Data obtained may be of benefit to future patients and will be used only for statistical purposes. The confidentiality of the information collected will be guaranteed, thus ensuring the privacy and confidentiality of the information. In addition, the data obtained will not be used for other purposes not foreseen in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients in follow-up in the Hypertension Program (ProHart) at Hospital Universitário Clementino Fraga Filho - UFRJ at least six months;
* Patient with Resistant Hypertension and Mild Obstructive Sleep Apnea detected by polysomnography;
* All participants that give written informed consent.

Exclusion Criteria:

* Age\> 85 years;
* Cognitive deficit that prevents speech therapy;
* Severe clinical events in the last 6 months;
* Refusal of the patient to participate in the study;
* Pregnancy;
* Prior and regular use of CPAP;
* Clinical data suggestive of neurological disease with cognitive and / or motor sequelae, craniofacial malformation, severe upper airway obstruction, Neuromuscular disease, users of hypnotic drugs
Bacteriostatic Saline as a Local Anesthetic in Minor Eyelid Procedures

The investigators aim to assess whether bacteriostatic saline provides the same level of anesthesia as traditional local anesthesia while reducing pain associated with medication infusion in minor eyelid procedures

Benzoyl alcohol is an aromatic alcohol that has been used in healthcare primarily as an antibacterial preservative agent in bacteriostatic saline. It has also been shown to have anesthetic properties, and has been demonstrated to cause less pain with infusion compared to lidocaine, while maintaining adequate pain relief. The use of bacteriostatic saline alone as an anesthetic for incisional procedures in the periocular area has not yet been studied. The purpose of this study was to determine whether bacteriostatic saline provides an adequate level of anesthesia for minor in-office eyelid procedures while allowing for reducing pain associated with medication infusion compared with traditional local anesthetic agents. To assess this, the investigators will recruit 150 patients aged 18 or older undergoing minor eyelid procedures including eyelid biopsies, chalazion removal from outpatient oculoplastics clinics at UCSF. Patients will be randomized in a 1:1 fashion to undergo local anesthetic with either 1% lidocaine with 1:100,000 epinephrine or 0.9% bacteriostatic saline. Primary outcome measure will be pain level on a scale of 1-10 with regards to injection and procedure itself. These will be compared between the two groups. The investigators hypothesize that bacteriostatic saline is superior to lidocaine with epinephrine in terms of pain with injection, but will result in a similar pain level during the procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 years old
2. Undergoing clinic-based periocular procedure

Exclusion Criteria:

1. Any other topical, oral or intravenous sedating medications given alongside procedure
2. Allergy to saline, lidocaine or epinephrine
3. Unable to provide consent due to cognitive impairment
Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-

This study aims to understand the following items in post-marketing actual clinical settings to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65 years or older).

1. To confirm the use in actual clinical settings
2. To confirm the occurrence of adverse events

This study is a multicenter open-label cohort conducted in patients vaccinated with the Product; for which, case report forms will be recorded based on data presented in medical records obtained from day-to-day clinical treatment and diagnosis. "Pneumococcal vaccine health study diary" will be implemented to collect accurate safety data; to which, vaccine recipients will be asked directly to cooperate.

Eligibility Criteria:
Inclusion Criteria:

1. Geriatric patients vaccinated with this product (adult not younger than 65 years)
2. Consent of vaccine recipients \[Vaccine recipient (or his/her legally acceptable representative) must sign and date the consent form warranting that the relevant information concerning this Study was appropriately communicated to the recipient\].

Exclusion Criteria:

None
Impact of Coaching Patients on Pain Control With and Without Financial Incentivization

Opioids are commonly prescribed pain medications, but they can lead to addiction. The study team is trying to determine if providing someone with an incentive (money in the form of a Visa gift card) to use less pain medications will result in study participants actually using fewer pain tablets than allowed by their health care provider. The study team also wants to know if providing the incentive (the Visa gift card alone) works the same as the incentive (the Visa gift card) plus providing additional information about addiction and alternative pain management.

Study participants will receive the standard of care for pain management at discharge. If study participants were not hospitalized at discharge, the study team will begin that standard of pain management at the participant's first outpatient clinic visit. Study participants will be randomized to 1 of 3 groups. All groups will receive a gift card if participants return the completed medication diary to the study team.

* Group 1 will complete a medication diary. Also, group 1 will be encouraged to return any unused tablets to the study clinic.
* Group 2 will be asked to complete a medication diary. Group 2 will also have a 50/50 chance of receiving money for each unused opioid tablet returned to the study clinic.
* Group 3 will be the same as group 2 except in addition, they will be given a coaching session about the use of pain medication and a simple way that may help participants use less opioid pain medication.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from a burn injury of one or both hands/upper extremities
* Patients staying less than 2 midnights after date of injury or presenting for first visit to the clinic 4 or less days after injury
* Patients able to self-administer their oxycodone.
* Aged 18-89 years old

Exclusion Criteria:

* No burns on either hand or upper extremity
* Patients suffering chemical or electrical burns
* Patients with other traumatic injuries for which they might require opioids/pain treatment
* Patients taking opioids prior to injury
* Patients who are discharged with prescriptions other than oxycodone with a dosage of 5 milligrams by mouth every six hours as needed
Treating Drug-Resistant Childhood Schizophrenia

This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia.

Schizophrenia is a devastating illness regardless of the age at which it presents. When this disorder occurs in childhood or adolescence, the consequences in terms of functional impairment, loss of developmental opportunities, and family and societal burden are particularly dramatic.

Evidence supports the improved efficacy and/or side effect profile of atypical antipsychotic medication in adults. Thus, it is essential to examine whether the potential benefits of these agents can be extended to children, particularly children who have failed standard treatment.

Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks. Patients meet with the study team once a week to discuss progress and record side effects. Three parent meetings take place during the study. During these meetings, questions are discussed and support and education about schizophrenia are given to parents. Various scales to measure psychotic, manic, aggressive, and depressive symptoms are used to assess patients.

Eligibility Criteria:
Inclusion criteria:

* DSM-IV criteria for treatment-refractory schizophrenia or schizoaffective disorder
* Willingness to use an acceptable form of birth control, if applicable

Exclusion Criteria:

* Neurological or medical disorders that would contraindicate treatment with clozapine or olanzapine
* IQ less than 70
* DSM-IV criteria for substance (other than caffeine or nicotine) related disorder
* Failure of an adequate trial of olanzapine or clozapine
Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD

Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.

Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity (ADHD) symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have been between the ages of 4 and 11 years at the time of entry into the double blind study.
* Patients must meet diagnostic criteria for FASD.
* Patient must, at entry into doubleblind study, have met DSM-IV criteria for ADHD, any subtype. And must have an ADHDRS-IV score of \> or + 90% for age and gender on either subtest or total score for children above 5 years of age.
* Patients will continue atomoxetine/placebo until entry nto this study.
* History and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study.
* Patients must be able to swallow capsules.
* Patients must be of a sufficient mental age (3 yrs) to participate in the study.
* Patients and parents must be able to communicate effectively with the investigator and coordinator and be judged reliable to keep appointments and participate in data collection.
* Teacher must agree to cooperate with the study.

Exclusion Criteria:

* Have received an investigational medication other than atomoxetine in the previous 30 days.
* Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.
* Have used MAOIs within one month prior to visit 1.
* Patients with hypertension.
* Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder.
* Patients taking anticonvulsants for seizure control.
* Patients taking another psychotropic medication or health food supplements purported to have central nervous system activity within 5 half-lives of visit 1.
* Patients with Tourette Disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring.
* Pubertal girls.
Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi

In this study, the investigators used the covered metallic segmented airway stent modified with 3D printing to treat gastro-respiratory fistula involving carina and distal bronchi and aimed to determine the feasibility, efficacy and safety of this technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients with gastro-respiratory fistula involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy , gastroscopy and CT.
* The patients who could not tolerate surgery and did not have clinical improvement after conservative treatment.

Exclusion Criteria:

* Severe infection
* coagulation disorders
Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

The objective of this study is to test a single dose of intranasal oxytocin, compared to placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety signaling (behaviorally and/or by self report) compared to placebo. If this single dose pilot paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention or treatment for weight gain and overeating in people with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* Male or Female
* Age: 18 to 54 years
* Caucasian or Non-Caucasian
* Body Mass Index of ≥ 27 kg/m2
* One month of stable antipsychotic treatment (same medication regimen and same dose)

Exclusion Criteria:

* History of organic brain disease
* DSM-IV diagnosis of Mental Retardation
* DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine)
* DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine)
* Are pregnant or lactating
* Meet DSM-IV criteria for a past and/or current eating disorder via the SCID, or if they have a past medical history of an eating disorder, received treatment/counseling for an eating disorder and/or required hospitalization for an eating disorder. (If an otherwise undiagnosed eating disorder is detected during screening, referral to treatment will be provided.)
* Are taking weight-loss medications, whether over-the-counter (i.e. Hydroxycut, Stacker products, Metabo-Plus, CortiSlim), or prescribed, including appetite suppressants (Didrex, Tenuate, Sanorex, Mazanor, Adipex-P, Meridia, and Phentermine) and fat-absorption inhibitors (Xenical).
* Have cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. This is defined an as a score of less than 10 on the Evaluation to Sign Consent (ESC).
* Have a medical illness, dietary restrictions, or food allergies that, in the view of the investigators, would compromise participation.
* Are taking prostaglandins such as dinoprostone or misoprostol (because they interact with oxytocin).
Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder

This was a cluster randomized study of an ICU level intervention to reduce high risk of post-traumatic stress disorder (PTSD) in family members of ICU patients.

Participating ICUs had restrictive visiting policies (i.e., \<6 hours/day) before randomization.

After an observational period and a washout period, participating ICUs were randomized either to maintain their visiting policies or to liberalize their visiting policies (24 hours a day, 7 days a week.)

Family members of ICU patients are particularly exposed to anxiety, depressive, acute stress disorder, and posttraumatic stress disorder symptoms (PTSD).

It is currently unknown what type of interventions/ strategies to cope with postintensive care syndrome family would produce the best improvement. Experts suggest that symptoms in family members are potentially amenable to intervention by ICU staff. One intervention to reduce PTSD could be a liberalization of the visiting hours. However, restrictions on visiting hours in the intensive care unit (ICU) are usually adopted worldwide.

Eligibility Criteria:
Inclusion criteria :

Patient and family member \> 18 years or older,

* mechanical ventilation expected for more than 48 h and inclusion between day 3 and 5 from the beginning of mechanical ventilation,
* patient having a family member speaking and understanding French, and with the ability to visit his/her relative during the ICU stay,
* patient and his/her relative consenting to participate in the study, or obtention of family consent in case of patient incompetency

Exclusion criteria :

- Patient without family available or family not speaking or understanding French"
A Comparison Study of Bypassing Agent Therapy With and Without Tranexamic Acid in Haemophilia A Patients With Inhibitor

Activated prothrombin complex concentrate (aPCC) and recombinant activated factor VII (rFVIIa) are the only two drugs that are available to treat bleeds in haemophilia A patients with high titer inhibitors. However, management of bleeds in these patients can be challenging due to variation in response and lack of standardized methods to monitor the effect. We hypothesized that significant increase in whole blood clot stability could be achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin generation remains unaffected. In this prospective crossover study the effect of aPCC and rFVIIa with and without TXA on clot stability and thrombin generation capacity (ETP) were studied, using thromboelastography (ROTEM) and thrombin generation assay (TGA), respectively. In addition, the risk of thrombosis and disseminated intravascular coagulation (DIC) was assessed.

Patients receive the first day aPCC (75IU/kg) and aPCC in addition to TXA (20mg/kg orally) the second day. After a 14 days washout period they crosse over using rFVIIa (90 µg/kg) otherwise the same experimental setup. Blood sampling is performed at baseline, 15, 30, 60, 120, 180 and 240 minutes post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Haemophilia patients with high titer inhibitors or high-responding inhibitors, aged between 18-65 and no history of aspirin or NSAID use within the last 14 days were eligible for the study.

Exclusion Criteria:

* Patients with renal failure, liver disease, infected with immune deficiency virus (HIV), platelet count \<150x109/L, acquired haemophilia, ongoing bleeding, hypersensitivity to TXA or a history of arterial or venous thrombosis were excluded from the study.