cyrilzakka/clinical-trials huggingface dataset:
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH \< 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Symptom onset less than 24 hrs prior to diagnostic CT scan
* Spontaneous ICH less than or equal to 30 cc or primary IVH
* IVH obstructing 3rd and/or 4th ventricles
* ICH clot stability at 6 hours or more post IVC placement
* IVH clot stability at 6 hours or more post IVC placement
* Catheter tract bleeding stability 6 hours or more post IVC placement
* EVD placed per standard medical care
* SBP less than 200 mmHg sustained for 6 hours prior to drug administration
* Able to randomize within 72 hours of diagnostic CT scan
* Historical Rankin of 0 or 1

Exclusion Criteria:

* Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor
* Presence of a choroid plexus vascular malformation or Moyamoya
* Clotting disorders
* Platelet count less than 100,000, INR greater than 1.4
* Pregnancy
* Infratentorial hemorrhage
* SAH at clinical presentation
* ICH/IVH enlargement that cannot be stabilized in the treatment time window
* Ongoing internal bleeding
* Superficial or surface bleeding
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial.
* No subject or legal representative to give written informed consent
Dosage and PD Study of Eftrenonacog-alfa

The purpose of this study is to evaluate the performance of different methods for measuring factor IX activity levels in haemophilia B patients treated with eftrenonacog-alfa and assess its pharmacodynamics (PD) in a real-life setting.

A recent European survey showed that increasing number of hemophilia B patients was switched from standard to extended half-life drugs. While some clinicians currently prefer to treat empirically rather than based on laboratory results, adoption of replacement therapy based on extended half-life products such as eftrenonacog-alfa may increase the interest in individualized pharmacokinetic assessments allowing the development of an initial dosing regimen. Thus inaccurate FIX activity measurements might be critical, especially when FIX trough level is used to tailor patient dosing regimens. It is therefore important that FIX activity levels are accurately determined allowing adequate recovery without increasing the cost of medical management of hemophilia B patients due to unnecessary dose corrections.

With the expansion of the prescription of eftrenonacog-alfa, the problem of accurately measuring its recovery has risen within hemostasis laboratories. Chronometric one-stage assays (OSA) are currently the most widely performed tests for FIX activity measurement. They are based on activated partial thromboplastin time (aPTT) reagent and factor-deficient plasma. Various aPTT reagents are commercialized. They could lead to a substantial variability in FIX results. Chromogenic two-stage assays (CSA) are less frequently used in clinical laboratories. They present fewer reagent choice compared to OSA. Several studies have evaluated OSA and CSA performances in samples spiked with eftrenonacog-alfa and have evidenced that some commonly used aPTT reagents would not be suitable for accurately monitoring this product. Whether these results are commutable to post-infusion samples collected from real-life patients remains unclear.

Unlike the measurement of a unique coagulation factor activity, thrombin generation assay (TGA) is a dynamic global test that explores the coagulation cascade as well as the anticoagulant pathways. TGA could be therefore a valuable tool to monitor replacement therapy in hemophilia B patients.

Hence the investigators sought in a real-life setting to compare 2 CSA and 1 OSA reagents to a product specific OSA in severe hemophilia B patients supplemented with eftrenonacog-alfa. The investigators also aimed to evaluate the pharmacodynamics (PD) of eftrenonacog-alfa using TGA.

Eligibility Criteria:
Inclusion Criteria:

* severe haemophilia B patients
* treated with eftrenonacog-alfa

Exclusion Criteria:

* any other haemostatic or replacement therapy
Immediate Effects of Manipulation Versus Stretching on Upper Trapezius Pressure Pain Thresholds

The purpose of this study is to determine the immediate effects of cervicothoracic manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and cervical ROM.


Eligibility Criteria:
Inclusion Criteria:

1. Absence of current neck pain
2. Aged 18 - 70 years
3. Able to lie on stomach or back without difficulty

Exclusion Criteria:

1. 'Red flag' items indicated in Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc.
2. History of neck whiplash injury
3. Diagnosis from physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms
4. Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes
5. Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)
6. Prior surgery to neck or upper back
7. A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency)
8. Diagnosis from physician of fibromyalgia syndrome
9. Currently pregnant, or could be pregnant
Effects of CDP-Choline on Gating and Cognitive Deficits in First Episode Schizophrenia

People with schizophrenia tend to have problems with attention and concentration. Studies found that these patients are unable to block or gate out non-relevant and distracting information (e.g., noises). This may lead to brain overload. Cognitive abilities like concentration, memory, and learning may worsen. This ability to filter sensory information has been linked to a gene that affects the way nicotine acts in the brain. Patients with schizophrenia have a high rate of cigarette smoking. 60% to 90% smoke compared with 25% of the general population. It has been suggested that these patients may use nicotine to improve their ability to block out distracting information. Brain wave activity (EEG) in response to sounds has been proved useful in understanding this gating problem. The present study uses EEG measures and performance tasks to find out what a new nicotine-like treatment, which will be added to ongoing treatment medications, does to gating and cognition. It is hoped that this new treatment will improve the way in which patients process information, as this may help them in day-to-day activities.

* A sample of 40 patients will be recruited from the Champlain First Episode Psychosis Program, a service of The Ottawa Hospital, which is run in conjunction with the Schizophrenia Program of the Royal Ottawa Mental Health Center.
* In this randomized, double-blind, placebo-controlled, cross-over design study, participants will attend the laboratory for four test sessions and will receive either a single dose of CDP-choline (500 mg, 1000 mg or 2000 mg) or placebo at each test session
* EEG recordings (with a focus on the P50 ERP) and cognitive testing measures will be collected in each test session to determine any possible gating or cognitive effects of CDP-choline. A saliva sample will also be collected to determine any genetic differences in the effects of CDP-choline
* The investigators carefully engineered study aims to assess the optimal dosing of a nicotinic cholinergic agonist, CDP-choline to increase P50 suppression and cognitive efficacy in an early schizophrenia population with abnormal P50 suppression.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 - 60 years old
* Meet DSM-IV/DSM-IV-TR criteria for First Episode Schizophrenia
* Clinical stability of the past 2 months \[assessed with the PANSS\]
* Treatment with a single antipsychotic medication (concomitant psychiatric medications allowing on an "if needed basis".
* Smoker or non-smoker

Exclusion Criteria:

* Any comorbid Axis I disorder including a current or recent history of alcohol/substance abuse
* A clinically significant medical illness or organic brain disorder known to cause psychosis or cognitive impairment
* Recent head trauma (\<6mos)
* Major learning disability
* Body mass index \>38kg/m¬2
* Use of illicit drugs
* Abnormal hearing
A Clinical Research Studying Interventions for Nighttime Fears in Preschool Children

Nighttime fears (NTF) and sleep disruptions in preschool children continue to be major problems in clinical services. The aim of this study is to test the efficacy of two interventions designed for preschool children suffering from NTF: (a) a CBT adaptation combining parent involved play, which will include multiple standard cognitive-behavioral techniques, namely psycho-education, problem solving via play, gradual exposure and reinforcement management; and (b) Triadic Expressive Play Therapy, based on Virginia Axline's (1947) eight basic principles of play therapy. Parents will take an active part both in and in between treatment sessions in both intervention groups. In addition to the review of the outcomes of these interventions, the proposed study aims to identify variables that moderate and mediate treatment effects.

In an attempt to meet these aims, the investigators will recruit 90 children suffering severe NTF and their parents who seek treatment. At baseline the investigators will assess children's NTF and general fears, sleep patterns and disruptions, behavior problems and potential moderators (i.e. playfulness, oppositionality, desire for control and parental anxiety). Assessment will be based on both objective and subjective measures, including interviews with the child and parents, questionnaires and actigraphy. The investigators will then randomly assign these children to one of two conditions: CBT with parent involved play or Triadic expressive play therapy. Possible mediators (i.e. the therapeutic alliance, patient compliance, motivation etc.) will be evaluated after each of the active intervention sessions. The effects of the interventions will be assessed by comparing four time points: baseline, first week of intervention, 1 month and 6 months subsequent to administration.

The main hypotheses of the proposed study are: (a) A positive correlation will be found between the severity of NTF and the severity of sleep disruption at baseline, and a reduction in NTF will be associated with an improvement in sleep; (b) Both interventions will significantly reduce nighttime fears, but greater impact will be evident in the CBT group; (c) Higher levels of playfulness and lower levels of oppositionality and desire for control, as well as parental anxiety will predict desirable outcomes. (d) Stronger therapeutic alliances, in addition to higher levels of motivation and compliance will be associated with greater intervention effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* NTF exist for a minimum of 2 months, with significant adverse impact on the child and the family, requiring parental involvement for at least two nights per week to comfort the child.

Exclusion Criteria:

* major health or neurological-developmental problems
* concurrent psychiatric treatment
* concurrent psychotherapy or any other intervention aimed at reducing the child's nighttime fears.
A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants

The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants.


Eligibility Criteria:
Inclusion Criteria:

* Be female of childbearing potential (women with tubal ligation are not accepted)
* Have a body weight equal to or over 45 kilogram (kg) and a body mass index (BMI) 23 within the range of 18 to 30 kilogram / square meter (kg/m\^2) inclusive
* Have a systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, and diastolic blood pressure no higher than 90 mmHg
* Agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last dose of study drug
* Have a negative serum pregnancy test at screening and a negative predose urine pregnancy test on Day1 and Day 21 of Cycle 1 and Cycle 2

Exclusion Criteria:

* Participant has a past history of heart arrhythmias (extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
* Participant is currently pregnant or planning to become pregnant or lactating (from screening through at least 8 weeks after receiving the last dose of study drug)
* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for HBsAg or hepatitis C virus antibody at screening.
* Participant has a history of or present allergy to the oral contraceptive (OC) or JNJ-42847922, or drugs of these classes, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
* Participant has a history of alcohol/drug abuse or dependence within 12 months of the study: history of regular alcohol consumption averaging greater than (\>) 14 drinks/week for women within 6 months of screening
The Effect of the Self-Care Support Program on Women with Endometriosis

This study, was aimed to evaluate the effect of self-care support program (self-care training in endometriosis + motivational interview) applied to women with endometriosis on quality of life, self-care behaviors, depression, anxiety and stress levels.

This study is a randomized controlled experimental study conducted to evaluate the effect of self-care support program applied to women with endometriosis on quality of life, self-care behaviors, depression, anxiety and stress levels.The research was carried out with the participation of two groups. Endometriosis Self-care Support program-ESSP (intervention group) will be applied to one of the groups, while the other group (control group) will receive standard treatment within the scope of the hospital protocol. Then, women's quality of life, self-care behaviors, depression, anxiety and stress levels will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive age (between 18-49 years old),
* Diagnosed with endometriosis (symptomatic patients),
* Having no medical or gynecological problems other than endometriosis,
* Literate,
* Mobile phone user,
* Non-pregnant,
* No communication barrier
* Not diagnosed with a psychiatric illness,
* Who volunteered to participate in the research,
* Women who can speak and understand Turkish will be included.

Exclusion Criteria:

* Who could not attend any session of ESSP (only in the intervention group),
* Filling the data collection forms incompletely,
* Pregnant at the time of the study and
* Women who have been hospitalized and/or had surgical operations for gynecological and medical reasons will be excluded.
Relationship Between Prenatal Maternal Distress and the Quality of General Movements at 3 Months

Depression and anxiety symptoms are common during pregnancy which may disturb the intrauterine environment by affecting the mother's physiological responses to stress, and ultimately impair fetal and postnatal development. There is increasing evidence about the effects of maternal distress on young brain tissue leading to some structural changes. The neurological footprints of these structural changes on the young brain may be caught early in life by a video assessment of General Movements (GMs) quality.

Depression and anxiety symptoms are common during pregnancy and are estimated to affect 7% - 20% of pregnant women, constituting significant risks for mothers and babies. Depression and anxiety may disturb the intrauterine environment by affecting the mother's physiological responses to stress, and ultimately impair fetal and postnatal development. Increasing evidence shows that prenatal exposure to maternal depression and anxiety is associated with several lifelong adverse outcomes in children, including physical health problems, emotional and behavioral difficulties, and low verbal IQ.

Such maladaptive outcomes are thought to have a neurobiological basis and there is increasing evidence about the effects of maternal distress on young brain tissue leading to some structural changes. However, what is more important is that the neurological footprints of these structural changes on the young brain can be caught early in life. The neurological status of infants can be determined early in life by video assessment of General Movements (GMs) quality. In this study at the age of 3 months, a video assessment of the quality of GMs will be performed to evaluate neurologic conditions.

Eligibility Criteria:
Mothers Inclusion Criteria:

* Mothers aged 18 to 40 years,
* Singleton pregnancy
* No smoking during prengnancy
* No illicit drug or alcohol use during pregnancy,
* No major health conditions requiring invasive treatments (e.g., dialysis, blood transfusions, chemotherapy),
* No diagnosis of psychotic illnesses (eg, schizophrenia,bipolar or borderline personality disorder), and
* No major autoimmune diseases
* No pregnancy-related complications: (including prenatal infection, pregnancy-included hypertension, gestational diabetes, oligohydramnios, polyhydramnios, preterm labor, vaginal bleeding, placenta previa, or anemia).

Infant inclusionary criteria:

* infants were born at 36-42 wk of gestation
* uncomplicated singleton birth,
* no pre-existing neurologic conditions or major head trauma, neonatal intensive care unit stay limited to observation only (ie, no interventions), and
* infant discharged from the hospital with the mother.

Mothers Exclusion Criteria:

* post partum depression and/or anxiety
* delivery complication

Infant exclusion criteri:

* infant birth before 36 weeks gestation
* infant weight lower 2500gr at birth
* Apgar score 0f \<7 at 5 minutes
* Major neonatal complications
* Identified neurologic, genetic or congenital syndrome
he Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery

Randomized, open, single-center, controlled prospective studies were designed to obtain reliable level I evidence in evidence-based medicine.Based on the premise of at least a 6-fold reduction in pancreatic fistula, as observed by Kawai et al after early drainage.Considering the overall incidence of pancreatic fistula after standard pancreatectomy at our center (approximately 20%), we would expect this complication to occur in approximately 3.4% of cases in Group A.α was set as 0.05 and β was set as 0.2 (efficacy was 80%), indicating that the total number of study subjects was at least 114 patients (at least 57 patients in the experimental group and 57 patients in the control group).


Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-2;
* The amylase value in the drainage tube of patients receiving pancreaticoduodenectomy or distal pancreatectomy was lower than 5000 IU/L on the first day after surgery;
* postoperative drainage tube placement;
* Patients with no obvious contraindication to surgery;
* Expected postoperative survival ≥3 months;

Exclusion Criteria:

* Pancreaticoduodenectomy and pancreaticogastric anastomosis were performed;
* Suspicion or abdominal bleeding within 5 days after surgery;
* suspected biliary and intestinal fistula within 5 days after operation;
* On the fifth day after the operation, abdominal CT reexamination showed local effusion with a depth greater than 3cm.
CT DOSE Collaboratory

This is a pragmatic stepped-wedge cluster randomized controlled trial to explore variation in doses used for diagnostic CT by pooling radiation dose data across diverse healthcare delivery systems.

To compare different strategies for lowering and optimizing dose and identify the barriers and facilitators to implementing successful dose optimization strategies and standardizing practice.

The investigators are using a stepped-wedge cluster randomized controlled trial, collecting radiation dose information on CT from across all collaborating health care facilities, and leading several different interventions to optimize dose across facilities. In addition to collecting the CT radiation dose data, and using these results to provide feedback to the collaborating health care facilities, they will be conducting surveys of several individuals at each site, including key informants, such as lead radiologists, technologists, and medical physicist, and radiology administrators.

They will compare and identify facilitators and barriers (assessed through surveys of participating facilities) associated with successful and failed implementation of dose optimization.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic CT scans of the head, chest, and/or abdomen/pelvis performed within the study period

Exclusion Criteria:

* non-diagnostic scans that are not of the head, chest, and/or abdomen/pelvis