cyrilzakka/clinical-trials huggingface dataset:
Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome

The investigators will conduct a randomized placebo-controlled trial of a computerized intervention targeting working memory in 30 children with comorbid Attention-Deficit/Hyperactivity Disorder (ADHD) and Tourette Syndrome (TS).

Because impairments in executive functions (EFs), such as working memory, are associated with functional impairments in youth with neurodevelopmental and neuropsychiatric disorders, strategies that target EFs are critical. Neuroplasticity-based cognitive training has been found to improve cognition in youth with ADHD and in adults with schizophrenia. In this trial, the investigators seek to extend the relevance of computerized cognitive training to youth with comorbid ADHD and Tourette Syndrome. Given the literature, the investigators hypothesize that computerized working memory training will produce gains in untrained cognitive tasks and behavioral ratings of executive functions in youth with ADHD+TS. The investigators will assess aspects of attention and executive functions in 30 affected youth and randomize them 1:1 to either neuroplasticity-based cognitive training or enjoyable age-appropriate computer games not intended to improve cognition. Cognition will be assessed again after 30 training sessions over 6 weeks and then again at a one-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. The investigators will limit inclusion to youth between the ages of 7-13 who carry current diagnoses of ADHD+TS and who have a treating physician at a Partners affiliated hospital or clinic.
2. The investigators will include youth who have undergone neuropsychological testing in the prior 3 years.

Exclusion Criteria:

1. The investigators will exclude patients with intellectual disability in order to more directly extend the prior literature to the ADHD+TS population.
2. The investigators will exclude patients with severe tics as evidenced by a score of \> 30 on the clinician administered Yale Global Tic Severity Scale (YGTSS).
3. The investigators will exclude patients with moderate to severe Obsessive Compulsive Disorder (OCD) symptoms, as evidenced by a score of \>30 on the clinician administered Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS).
4. The investigators will exclude patients treated with neuroleptics, given that these medications can be cognitively dulling and sedating and potentially lead to secondary working memory impairments.
5. The investigators will exclude families who do not have a computer with an internet connection in their homes, and in which neither a parent nor the child has an email address to receive study related communications.
6. The investigators will exclude families who anticipate or are likely to have a change in therapeutic treatments (i.e., psychotherapy or psychopharmacology) during the time frame of the trial.

NOTE: Patients treated with ADHD medications will not be excluded, but medications will be recorded for covariate analysis.
Monitoring Neonatal Resuscitation Trial

This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.

Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New Life Box uses a small variable orifice anemometer to measure gas flow in and out of a face-mask or endotracheal tube. This signal is automatically integrated to provide inspired (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from the infant is seen during a positive pressure inflation. The RFM can also calculate and measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all ventilation pressures. Using customized software heart rate, oxygen saturation and expired carbon dioxide can be integrated into the RFM.

The NewLife Box monitor presents graphical information for pressure, flow, and volume. In addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti, Vte), flow, respiratory rate and percent leak. The monitor integrates and displays physiologic data streaming from the patient (heart rate and oxygen saturation) as well as FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled, the monitor can incorporate video captured from an external camera. The video serves as a helpful aid in the interpretation of the events during the RFM waveform recordings.

The use of an RFM in the DR has the potential to improve neonatal respiratory support and reduce lung injury.

The primary objective of this study is to test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the proportion of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
* Receive positive pressure ventilation during delivery room resuscitation

Exclusion Criteria:

* Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia
* RFM not available during resuscitation
Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations

This is a phase 1 study to investigate the characteristics of PK, PD and safety in subjects with advanced malignancies with FGF/FGFR alterations.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18 or older.
2. Histologically or cytologically confirmed malignancy which was considered to be surgically unresectable advanced, relapse or metastatic .
3. Radiographically measurable disease per RECIST v 1.1
4. Documentation of FGF/FGFR alteration..
5. Documented disease progression after standard therapy ,or no standard therapy available.
6. ECOG performance status of 0\~1.
7. Life expectancy ≥12 weeks

Exclusion Criteria:

1. Prior receipt of a selective FGFR inhibitor.
2. History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
3. Currently evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
4. Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed
Tracheal Suctioning and Expiratory Pause in Bronchial Hygiene

A randomized crossover clinical trial conducted in an Intensive Care Unit of the Hospital de Clinicas de Porto Alegre (HCPA) to compare the efficacy of the two techniques on the amount of aspirated pulmonary secretion and pulmonary mechanics: aspiration of the closed system following an expiratory pause with mechanical ventilator for 5 seconds (5-Second Expiratory Pause) and aspiration of the closed system following an expiratory pause with mechanical ventilator for 10 seconds (10-Second Expiratory Pause).

After randomization, all patients will be positioned in dorsal decubitus with the head elevated at 30 degrees and will be aspirated once with a closed suction system and with a vacuum of -40cm H2O. Hemodynamic and pulmonary parameters will be collected and recorded. One of the two techniques will be applied, according to randomization, and the outcomes measured. After two hours, hemodynamic and pulmonary parameters will be re-collected, and the second technique will be applied. The outcomes will be measured again.

Eligibility Criteria:
Inclusion Criteria:

* Patients in 24 and 72 hours of mechanical ventilation.
* Patients with closed aspiration system.
* Patients hemodynamically stable (mean arterial blood pressure ≥ 60 mmHg and with dose of Noradrenaline ≤ 1μg/kg/minute).

Exclusion Criteria:

* Undrained pneumothorax and hemothorax.
* Subcutaneous emphysema.
* Patients who refuse to participate in the study.
Supervised Exercise-training in Children With Insulin Resistance or Healthy Metabolic Profile

Despite exercise training decrease blood fasting glycemia in 'average' terms, there is a wide interindividual variability after exercise training explored mainly in adults but not in children. Thus, is yet unknown what baseline health status as well as the influence of what health variable may produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes) after exercise training in school children.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed of insulin resistance by one of three plasmatic glucose control: HOMA-IR ≥3.0,
* Fasting insulin levels ≥15 µUI/dL or fasting glucose ≥100 and ≤126 mg/dL within the enrolment stage applied at school (i.e., ≤3 months),
* Physical inactivity (volume of ≤60 min/day of moderate physical activity),
* To be participating of regular practical physical education classes at school (i.e., 90 min/week),
* Living only in urban areas.

Exclusion Criteria:

* Potential medical, musculoskeletal problems or a familial history of T2DM,
* Ischemic disease,
* Arrhythmia,
* Asthma,
* Utilization of drugs that modulate the metabolic and respiratory control.
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

* Safety and tolerability
* Dupilumab systemic exposure and anti-drug antibodies

Total duration per participant of approximately 43 weeks including a screening period (14-21 days), a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).

Eligibility Criteria:
Inclusion criteria:

Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for \>=12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:

* Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting beta-2 agonist
* Forced expiratory volume (FEV1) 40 to 80% of predicted normal
* Asthma Control Questionnaire, 5-question version (ACQ-5) score \>=1.5
* Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
* Had experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma

Exclusion criteria:

* Participants \<18 years
* Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impaired pulmonary function tests
* Chest X-ray within 12 months of screening visit or at screening visit with clinically significant findings of lung disease(s) other than asthma
* Current smoker or cessation of smoking within 6 months prior to Visit 1
* Previous smoker with a smoking history \>10 pack-years

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Evaluating the Effect of Person-centred Care for Patients Admitted for Inpatient Care at an Internal Medicine Unit

Patients admitted to internal medicine care environments have complex care needs and must be treated as persons with resources and responsibilities. Person-centred care is defined as care in which the caregiver aims to get to know the patient as a person, and the care comprises a holistic approach to assess patients' needs and resources. There is strong motivation for future health care to transform into an approach that acknowledges and endorses every patient's resources, interests and needs. There is limited existing research on the benefit of implementing person-centred care in internal medicine care environments for all patients regardless of diagnosis or care pathway. Little is known about the effects of person-centred inpatient care on patients' satisfaction with care. This study includes adult patients admitted to an internal medicine inpatient unit regardless of reason for admission. The aim of the study is to evaluate effects of person-centred inpatient care on care processes, in terms of satisfaction with care and person-centred content in medical records and to evaluate effects on self-reported health and self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

* acute or elective admission with a minimum projected in-hospital stay of 24 hours
* age ≥ 18 years
* conscious and alert, with no delay in response.

Exclusion Criteria:

* cognitive impairment or a judgment by the caregivers that inclusion was not in the best interests of the patient (e.g. end of life care, impaired psychological wellbeing).
Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug. Recently, ABS has been shown to produce local hemostasis by implementing topically after major arterial vessel injury. Reducing the compression time during patent hemostasis by facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned a three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper in adjunct to short-time compression, compared to either short-time compression with conventional sterile gauzes or with a TR band after transradial diagnostic procedures.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients undergoing transradial elective diagnostic coronary procedures between November 2016 and November 2017 at the catheterization laboratory of Acibadem University Kocaeli Hospital were considered to be enrolled in the study.

Exclusion Criteria:

* The only exclusion criteria were an abnormal Barbeau's test before puncture and failure to provide written informed consent.
Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes

Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.


Eligibility Criteria:
Inclusion Criteria:·

* Current diagnosis of type 2 diabetes
* Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study
* Stable regimen (i.e., no changes in therapeutic regimen) for the past three months
* Baseline HbA1c of 7.0 to 8.9%, inclusive

Exclusion Criteria:

* Using insulin
* Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study)
* Known history of anemia or disorders associated with anemia
* Has previously used the devices being tested in the study
Effectiveness of Additional Self-care Acupressure for Women With Menstrual Pain Compared to Usual Care Alone

The aim of the study is to evaluate the effectiveness of additional self-care acupressure in women with menstrual pain compared to usual care alone.

Menstrual pain is a common problem in young women and one of the the main reasons of short term absence from school or work. There is some evidence that acupuncture and acupressure might be successful in treating of menstrual pain. Compared with acupuncture, acupressure offers the possibility for women with menstrual pain to do self-care treatment at home. However, studies have been small and self-care acupressure had been only investigated in one study from Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Women with dysmenorrhea as defined as cramping pain during every menstrual cycle
* Age: 18 to 25 years
* Up to now no prior history of a gynecological disease that could be a reason for dysmenorrhea
* Women with menstruation in the last six weeks and a duration of menstruation cycles between 3 and 6 weeks
* Women with moderate and severe pain defined as a score equal or higher than 6 on the numeric rating scale for the worst pain intensity during the last menstruation.
* Written and oral informed consent
* Women must be able to complete the baseline questionnaire in paper form, the electronic questionnaire via App and a electronic diary via App.
* Presence of a Smartphone and agreement to do data entry through the App

Exclusion Criteria:

* Acupressure, acupuncture, shiatsu- or/and tuina massage at the moment or planned in the next 8 months
* Known or planned pregnancy in the next 8 months.
Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors

Patients included in the study went through standard preoperative preparation and were informed about potential conversion to open surgery. The procedure started with LUS performed according to the department's standard guidelines (one twelve mm trocar in the midline and one 12 mm trocar in the left upper quadrant) followed by a stepwise scanning of relevant structures (e.g. liver, pancreas, retroperitoneum) with dedicated laparoscopic ultrasound equipment (BK Medical, Herlev, Denmark). If the suspected lesion(s) was detected by LUS in the relevant area (according to preoperative imaging), laparoscopic resection was attempted, and if successful the specimen was removed in an eEndo-bBag (Kebomed, Denmark) through one of the trocars. A second LUS was performed to ensure that no tumor was left behind ("loss-of-lesion(s)").

If any problem occurred during the laparoscopic procedure, the operation was converted to an open procedure. Prophylactic antibiotics were not given routinely but were administered during surgery at the surgeons' discretion.

The intra- and postoperative course and final clinical outcome including pathology reports were retrieved from the patient's electronical records. This included a postoperative follow up of at least 12 months to investigate potential incomplete resection. Postoperative complications were graded according to Dindo-Clavien (17). The pathology reports were retrieved from the Danish Pathology Registry.


Eligibility Criteria:
Inclusion Criteria:

Patients with intra- and retroperitoneal tumor(s) (IRT) detected by imaging (US/CTMR/PET or EUS) and a clinical indication for explorative laparotomy

Exclusion Criteria:

Patients with contraindications for laparoscopy, such as severe adherences were excluded
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.

Inguinal hernioplasty is a common surgery. Common surgical methods used include laparoscopic and open placement of synthetic mesh. Managing postoperative pain and preventing morbidity after open mesh hernioplasty remain considerable medical challenges.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The Xaracoll implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the surgical site to provide postoperative pain control.

This study will assess the pharmacokinetic profile of 2 doses of the XaraColl implant after open laparotomy hernioplasty and assess the relative bioavailability of the Xaracoll implant compared to a local bupivacaine infiltration.

Eligibility Criteria:
Inclusion Criteria:

1. Man or woman who is ≥ 18 years of age
2. Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free technique)
3. If female, is nonpregnant

Exclusion Criteria:

1. Scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedures
2. Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively
3. Has any clinically significant unstable cardiac, neurological, immunological, renal, hepatic or hematological disease or any other condition that, in the opinion of the investigator, could compromise the patient's welfare, ability to communicate with the study staff or otherwise contraindicate study participation
Parasitic Ulcer Treatment Trial Pilot

This is a study of optimal treatments for acanthamoeba keratitis. In the first part of the study, participants will be randomized to chlorhexidine monotherapy or chlorhexidine plus povidone iodine. After four weeks of therapy, participants will be re-randomized to early corticosteroids, later corticosteroids, or placebo.

Acanthamoeba keratitis is a rare eye infection that is difficult to treat. The mainstay of therapy is a biguanide agent such as chlorhexidine, though recent studies have found povidone iodine to be effective for killing acanthamoeba organisms in vitro. Thus, we randomize participants to topical chlorhexidine 0.04% monotherapy (i.e., routine care) versus topical chlorhexidine 0.04% plus topical poviodine iodine 2.5%. The primary outcome is clearance of acanthamoeba from the ocular surface at 4 weeks.

The role of topical corticosteroids in acanthamoeba keratitis is controversial. Topical corticosteroids can promote growth of acanthamoeba, but may also reduce inflammation and vision-threatening complications of infection. Here, we randomize participants who have completed a course of anti-amoebic therapy to one of three groups: early prednisolone sodium phosphate 1% (started at 4 weeks), late prednisolone sodium phosphate 1% (started at 6 weeks) or placebo (started at 4 weeks). The primary outcome will be visual acuity at 6 months.

Eligibility Criteria:
Trial 1 Inclusion Criteria:

* Smear or culture positive for acanthamoeba
* Age 13 years or greater

Trial 1 Exclusion Criteria:

* Interstitial or viral keratitis on history or examination
* Corneal perforation
* Therapeutic keratoplasty for acanthamoeba keratitis
* Unwillingness or inability to follow-up (e.g., living too far from hospital)

Trial 2 Inclusion Criteria

* Smear or culture positive for acanthamoeba, with 4 weeks of anti-amoebic treatment
* Age 13 years or greater
* Willing to participate in study

Trial 2 Exclusion Criteria

* Interstitial or viral keratitis on history or examination
* Fungus identified on culture and smear after 2 weeks of anti-amoebic treatment
* Corneal perforation
* Therapeutic keratoplasty for acanthamoeba keratitis
* Unwillingness or inability to follow-up (e.g., living too far from hospital)
Applications of Realtime Functional Magnetic Resonance Imaging (fMRI )

The goal of this research program is to determine the potential effectiveness of real-time fMRI training in improving mental control over pain.

A research study that looks at pain and how you experience pain. This research project aims to use virtual reality-based real-time functional Magnetic Resonance Imaging (rtfMRI) to assess brain activation during the experience of pain and while subjects attempt to mentally control their pain response.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Chronic Pain patient or healthy control
* Ability to perform the experimental task

Exclusion Criteria:

* MRI contraindication (metal implants, claustrophobia, pregnant or planning to become pregnant)
* History of psychiatric disorder (at the discretion of the investigator as to whether it interferes with the experimental task)
* History of Blistering