cyrilzakka/clinical-trials huggingface dataset:
Emotions in the Communication and Relationship Styles of Parents With Hemophilic Children.

Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age.

The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Also in relation to its heredity.Focus on the ways in which parents of children with hemophilia manage their emotional experience.

Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age.The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Also in relation to its heredity.Focus on the ways in which parents of children with hemophilia manage their emotional experience.he diagnosis of hemophilia brings with it, in parents, fears, guilt, overprotective temptations that push us to act rather than to narrate the meaning of that need of ours, caregiving modes that risk engaging our operational side at the expense of recognizing ourselves and our feelings and emotions. We have no reason to think that that traumatic stimulus installs in us an atypical mode of resorting to our emotional intelligence. Therefore, it becomes even more significant to study parent-child communication processes on this target, to observe whether and how the adult's emotional area finds its place and expression. On the results of this work, the foundations could be laid for subsequent observational or interventional studies.

Eligibility Criteria:
Inclusion Criteria:

* Haemophilia A

Exclusion Criteria:

* No Informed Conset
Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries

Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are commonly used oral analgesics in emergency departments (ED) not only in Hong Kong but throughout the world. There are no large-scale (n\>100), prospective, randomised studies comparing paracetamol with ibuprofen in the management of acute soft tissue injury.

As paracetamol is cheaper than most NSAIDs, may be as effective in the management of acute pain and possibly with fewer adverse effects, a large-scale, randomised, controlled trial is needed to answer questions of relative analgesic efficacy, safety and cost-effectiveness. Previous comparative studies on NSAIDS have been done in this unit and have suggested equivalence between two NSAIDs and paracetamol, but numbers were small and drug doses were modest.

Objective: To compare the efficacy, safety and cost between oral ibuprofen and paracetamol in pain control for acute soft tissue injuries in an ED setting

Design: Prospective, double-blind, randomised controlled trial with three arms: oral paracetamol with placebo; oral ibuprofen with placebo; paracetamol and ibuprofen in combination

Participants: 783 subjects having sustained isolated soft tissue limb injury without significant fracture presenting to the ED of Prince of Wales Hospital

Main outcome measures: Pain relief profiles of paracetamol, ibuprofen and the combination of both; adverse effect profiles of paracetamol, ibuprofen and the combination of both; overall cost effectiveness of paracetamol, ibuprofen and the combination of both from the perspective of the healthcare provider


Eligibility Criteria:
Inclusion Criteria:

* All patients \>16 years presenting to the ED with isolated soft tissue injury without significant fracture
* between 9am to 5pm, Monday to Friday,

Exclusion Criteria:

* History of :

  * peptic ulceration or hemorrhage
  * recent anticoagulation
  * pregnancy
  * adverse reaction to paracetamol or ibuprofen
  * renal or cardiac failure
  * hepatic problems
  * rectal bleeding
  * chronic NSAID consumption
  * asthma
  * chronic obstructive pulmonary disease
  * chronic pain syndromes
  * prior treatment with analgesia for the same injury
  * physical, visual or cognitive impairment making use of the visual analogue scale unreliable
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) \< 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.


Eligibility Criteria:
Key Inclusion Criteria:

* Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit
* Moderately or severely active CD
* Minimum duration of CD of at least 6 months
* Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum
* Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present
* Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):

  * Corticosteroids
  * Immunomodulators
  * Tumor necrosis factor-alpha (TNFα) antagonists
  * Vedolizumab
  * Ustekinumab
* Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements

Key Exclusion Criteria:

* Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
* Presence of fistulae
* Evidence of short bowel syndrome
* Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
* History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
* Use of any prohibited concomitant medications as described in the study protocol
* Active tuberculosis (TB) or history of latent TB that has not been treated

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining

The aim of this study is to compare the stain effect on teeth of twice daily brushing with a 67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.


Eligibility Criteria:
Inclusion Criteria:

* Good oral health in the opinion of the investigator (excluding gingivitis)
* A minimum of 11 of the 12 permanent gradable anterior teeth at screening
* Stain levels on the buccal surfaces of the 6 maxillary and 6 mandibular anterior teeth need to be at least "mild" and present on a minimum of 4 teeth
* Modification of the Lobene Stain Index - At Visit 2, a baseline total MLSI Intensity x Area score (four sites per tooth) of greater than or equal to 8 for facial surfaces of anterior teeth.

Exclusion Criteria:

* Pregnant women or women who are intending to become pregnant over the duration of the study
* Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds).
* Current use of Chlorhexidine, Cetylpyridinium Chloride or any marketed mouthwash
* Past or current use of any drug which is known to be associated with tooth discolouration within 30 days of screening or during the study period.
* Recent history (within the last 1 year) of alcohol or other substance abuse
* Dental conditions / disease requiring immediate treatment; Crowns or veneers on more than one anterior tooth; pre-existing sensitivity to oral care products; severe periodontitis; severe recession; dental implants; active carious lesions on anterior teeth; oral lesions/manifestations; prone to aphthous stomatitis and ulceration etc.
* Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study.
* Medical condition which would require the use of prophylactic antibiotics prior to dental cleanings
* Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study treatment or procedures in the opinion of the investigator or dental assessor.
Pokemon Go and Physical Activity

The goal of this study to evaluate the association between Pokemon Go and physical activity through a survey among Pokemon Go players.

Pokemon Go is a location-based reality mobile game for iOS and Android devices developed by Niantic. Making use of GPS and the camera of compatible devices, the game allows players to capture virtual creatures, called Pokemon, who appear on cellphone screens as though in the real world. In order to search and capture the Pokemon, the players needs to go out and become more active. For this reason, the game has great potential to promote physical activity. Nevertheless, there has no study evaluating the potential impact of Pokemon Go on physical activity. The investigator proposes a retrospective online survey. Participants are instructed to enter data of their daily physical activity as reported in iPhone Health App. Number of "Steps" and % greater than 10,000 steps/day will be compared before and after installing the Pokemon Go app.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who use iPhone and have played Pokemon Go before July 31, 2016 and agree to consent to participate in the survey

Exclusion Criteria:

* Subjects who do not use iPhone
* Have not played Pokemon Go before July 31, 2016
* Unable to provide informed consent
Osteopathic Sympathetic Harmonization and Depression

Depression appears to be resistant to the available pharmacological treatments. Autonomic responses accompanied by any psychological stress are sympathetic nervous system (SNS) and neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (HPA) axis. The purpose of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous system and HPA axis in adolescents with depression.

Depression diagnosed and volunteer to participate 39 cases who between the ages of 15-21 included. All participants were recruited and randomly assigned into two groups, the osteopathy group (OG) and the placebo group (PG). Stimulation on the sympathetic truncus and prevertebral ganglia were performed in the OG group. The stimulation of the PG group was performed with a lighter touch and a shorter duration in similar areas. Each participant was filled in the demographic data form, Beck Depression Scale and State and Trait Anxiety Inventory (STAI Form - 1 and Form - 2) before the application. Emotional state visual analog scale and STAI Form - 1 was filled and blood pressure and pulse measurement were made and saliva sample was taken before application, immediately after application and 20 minutes after application.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with clinical depression by a psychiatrist according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
* Volunteering to participate in the study

Exclusion Criteria:

* Fever over 38.5
* Acute injury or infection
* Rib fracture
* Cardiac arrhythmia
* Using drugs that affect cortisol levels (oral contraceptives, hormonal drugs, antidepressants, antipsychotics etc.)
* Being pregnant, premenstrual or in the menstrual period for female participants
A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).


Eligibility Criteria:
Key Inclusion Criteria include:

* Participants with IDA and in whom IV iron treatment is indicated and defined as:

  * Participants with documented hemoglobin \<12.0 g per deciliter (dL) for females and \<14.0 g/dL for males within 60 days of dosing And
  * Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
* Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
* All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study

Key Exclusion Criteria include:

* Known hypersensitivity reaction to any component of ferumoxytol or FCM
* History of allergy to an IV iron
* History of multiple drug allergies
* Participants with dialysis-dependent chronic kidney disease
* Hemoglobin ≤7.0 g/dL
* Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)
Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery

Comparison of efficacy in management of pain in abdominal surgery between epidural versus wound infusion catheter {catheter placed within the incision site}


Eligibility Criteria:
Inclusion Criteria:

* ASA PS I-III , undergoing upper gastrointestinal surgery involving upper midline incision

Exclusion Criteria:

* Refusal to give consent.
* Contraindication to epidural analgesia (e.g.localized sepsis , Raised ICP , Myelopathy , Peripheral neuropathy ,Inherited coagulopathy)
* Addiction to opioids, or alcohol, or history of any other substance abuse.
* Allergy to local anaesthetic drugs.
* Pregnancy.
* Inability to communicate (e.g. known psychiatric disorders)
Prognostic Value of Lung Ultrasound in ST Segment Elevation Acute Myocardial Infarction (LUS-AMI)

The purpose of this study is to asses the prognostic value of lung ultrasound in patients with ST-segment elevation acute myocardial infarction.

LUS-AMI is an observational cohort prospective study that evaluates the prognostic value of lung ultrasound, specifically the number of B-lines, performed within the first 24 hours after and ST-segment elevation acute myocardial infarction, by an independent operator blinded to clinical outcomes and off-line analysis by another independent operator also blinded to clinical outcomes.

The primary outcome during hospitalization was a composite of clinically significant acute HF, cardiogenic shock, or death from any cause after LUS was performed. New-onset atrial fibrillation, acute renal injury (Acute Kidney Injury Network ≥ 1), and need for ventilatory support (invasive or non-invasive) during hospitalization were also analyzed as secondary outcomes.

The primary outcome during follow-up is one year after STEMI is a composite of any cause mortality, hospitalization secondary to cardiovascular disease (aborted sudden cardiac arrest, acute coronary syndrome, heart failure or stroke) or need for urgent coronary revascularization.

Secondary outcomes are new onset heart failure during hospitalization, acute kidney injury during hospitalization, new-onset atrial fibrillation/flutter during hospitalization, need of ventilatory support during hospitalization and new-onset clinically relevant arrhythmia (atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation) during follow-up. A short-term follow-uo (30 days after prior PCI) will be also performed to analyze a combined endpoint of death from any cause or hospitalization due to acute HF or new acute coronary syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Adults (more than 18 years) admitted with confirmed ST-segment elevation acute myocardial infarction (STEMI).

Exclusion Criteria:

* Absence of coronary artery disease and myocardial injury (false positive)
* Non interpretable lung ultrasound
* Severe lung disease (fibrosis, severe COPD, pleural disease, lobectomy or pneumonectomy)
* Acute respiratory distress syndrome
* Pneumonia or SDRA at admission or during hospitalization
* Follow-up inability
* Hemodialysis therapy previous to admission
* Life expectancy less than 6 months secondary to extracardiac pathology.
Everolimus- Versus Biolimus-Eluting Stents in All-Comers

This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer through 3 years of follow-up.

A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* all patients with at least one BES or EES for de novo stenosis

Exclusion Criteria:

* patients with at least one non-study stent
* patients with both study stent
* patients with life expectancy \< 3 years
Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

In combination with the existing literature, previous work indicates that 1) women with poor ovarian response fulfilling the "Bologna criteria" have very low pregnancy rates, irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing pregnancy rates in young patients (\<40years old) fulfilling the criteria. These findings provide a strong rationale for a definitive large RCT. The COMPORT study will provide conclusive evidence regarding the superiority or not of this novel protocol with corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders fulfilling the Bologna criteria.

Recently, the European Society of Human Reproduction and Embryology developed a new definition in order to select patients suitable for inclusion in future clinical trials as poor ovarian responders, the so-called "Bologna criteria". However, a limited number of studies has been published to date including patients with poor ovarian response according to the "Bologna criteria", whereas no randomized trial is published or ongoing for this population.

Preliminary reports in "Bologna poor responders" highlight the limited prospects for these women. Natural cycle IVF has been shown to result in disappointingly low live birth rates, regardless of patients' age and ovarian stimulation with widely accepted treatment modalities, e.g. short agonist protocol, did not appear demonstrate substantial benefits.

Nonetheless, despite the disappointing results from the vast majority of the preliminary studies in this population, a recent pilot study by our group has shown that a specific protocol may indeed be a promising option for women of younger age fulfilling the "Bologna criteria". Corifollitropin alfa followed by highly purified hMG in an antagonist protocol demonstrated an ongoing pregnancy rate of 28% in women \<40years, strongly suggesting the conduction of a future randomized trial testing this novel treatment protocol

Eligibility Criteria:
Inclusion Criteria:

* Age less than 40 years
* Fulfillment of the "Bologna criteria" for poor ovarian response.

Based on inclusion criteria two patients' categories are eligible:

1. Women \< 40 years old AND ≤3 oocytes in one of the previous cycles AND (Antral follicle count \<7 or antimullerian hormone serum values \<1.1 ng/ml)
2. Women \<40 years old and ≤3 oocytes in two the previous cycles with maximum ovarian stimulation

In addition women less than 40 years old will be considered eligible if they had undergone previous ovarian surgery or chemotherapy (risk factors for poor ovarian response) and have an AMH\<1.1ng/ml or an AFC\<7, as suggested by the Bologna criteria

Exclusion Criteria:

* Uterine abnormalities
* Recent history of any current untreated endocrine abnormality
* Unilateral or bilateral hydrosalpinx (visible on transvaginal ultrasound, unless clipped)
* Contraindications for the use of gonadotropins
* Recent history of severe disease requiring regular treatment
Optimizing Strategies to Improve STD Partner Services

This research tests the effectiveness of a social cognitive intervention (with option of patient-delivered medication) geared toward increasing patient referral of partners.

This is a four-year study involving longitudinal data collection for 800 men and women recruited from four clinics in Brooklyn, NY. Participants were eligible for enrollment at any of the study sites if diagnosed as having C trachomatis or N gonorrhoeae genital infection or if they have an STD syndrome likely to be related to either of these pathogens (i.e., males with NGU). Consenting patients were randomly assigned to receive either standard-of-care patient referral for partner notification (N = 350), a social-cognitive intervention geared toward increasing patient referral (N = 350), or the social-cognitive intervention with an option of patient-delivered medication (N = 100). Evaluation activities include an interviewer administered measure provided at baseline, one month, and six months, a screen for N gonorrhoeae and C trachomatis using urine-based ligase chain reaction screening (Abbott LCx) at baseline and six months, and medical chart abstraction at one and six months.

Eligibility Criteria:
Inclusion Criteria:

* Any individual presenting at study sites with STD-related symptoms who receives a microbiologic diagnosis with N gonorrhoeae and/or C trachomatis will be eligible for study participation if they meet the following criteria: 1) are 18 years of age or older; 2) have been sexually active in the previous two months; 3) are able to understand English or Spanish; 4) have resided within the catchment area for at least one year prior to enrollment; 5) plan to remain in the area through the course of the study period. .

Exclusion Criteria:

* Any potential participant deemed by a provider or member of the study staff to have psychological impairment, brought on by drug use or some other illness, to an extent that it would affect the ability to understand or provide informed consent.