cyrilzakka/clinical-trials huggingface dataset:
A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors

The purpose of this observational study is to explore the efficacy of methylphenidate hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-scheduled for affective disorders (SADS)-present and life time version (K-SADS-PL).

This is a 1-year open-label (all people involved know the identity of the assigned drug), multicenter, single arm, prospective, observational study to explore under natural setting the efficacy of drug treatment in children and adolescents diagnosed with ADHD by K-SADS-PL (K-SADS-PL is a tool used for ADHD diagnosis. Patient may be diagnosed with ADHD by using K-SADS-PL to check if he or she meets the criteria according to Diagnostic and Statistical Manual of Mental Disorders \& edition (DSM-IV). After obtaining informed consent, investigator will prescribe stimulant or non-stimulant ADHD treatment medications (ie, Immediate release \[IR\]/extended release \[ER\]/osmotic release oral system (OROS) methylphenidate, atomoxetine). Efficacy and safety assessments will be performed at 4, 12, 24, 36, and 52 weeks after the first day of giving study drug. Progression of symptom improvement and adherence will be investigated and associated variables (ie, demographic, clinical, familial and treatment factors) will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Has been diagnosed with attention-deficit hyperactivity disorder (ADHD) by Kiddie-SADS-present and life time version (K-SADS-PL)
* Have not received methylphenidate or atomoxetine within 3 months prior to screening.

Exclusion Criteria:

* Has intelligence quotient (IQ) ≤70 assessed by comprehensive attention test (CAT) at screening diagnosed with congenital disorders
* Has had history of acquired brain damage (eg, cerebral palsy)
* Has had diagnosed with convulsive disabilities or other neurological disease or dysesthesia
* Has had developmental disabilities such as autistic spectrum disorder
* Has had history of schizophrenia, bipolar, or other pediatric psychotic disorder, and obsessive compulsive disorder
* Has had linguistic disability and had diagnosed with tic disorder that requires additional drug treatment.
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)

The purpose of this study is to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.


Eligibility Criteria:
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* A participant assigned female at birth is eligible to participate if not pregnant or breastfeeding, is not a participant of childbearing potential (POCBP), or is a POCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 35 days after the last dose of study intervention.
* For participants with moderate or severe hepatic impairment: Have a diagnosis of chronic (\>6 months), stable, hepatic impairment with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function).

Exclusion Criteria:

* History of cancer (malignancy).
* Had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
* Participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit.
* Participants with moderate or severe hepatic impairment who received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start.
* Healthy participants who are unable to refrain from or anticipate the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit.
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients

This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

A study to evaluate the safety and effectiveness of experimental drugs ABT-450, ABT-267 (also known as ombitasvir), ABT-333 (also known as dasabuvir), ritonavir, and ribavirin in participants with HCV. The study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18-70 years old, inclusive
* Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
* Chronic hepatitis C virus (HCV), genotype 1 infection
* Treatment-naive OR null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12)
* No evidence of liver cirrhosis

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody
* Positive screen for drugs and alcohol
* Significant sensitivity to any drug
* Use of contraindicated or prohibited medications within 1 month of dosing
* Abnormal laboratory tests
Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids

Myomectomy was preferably applied in females with reproductive requirements, which could be achieved by transumbilical laparoendoscopic single-site surgery (TU-LESS) or multi-port laparoscopic surgery (MPLS). Power morcellation used in MPLS was correlated with unidentified risk of tumor dissemination, especially in cases with accidental surgical findings of uterine sarcoma or leiomyosarcoma. Moreover, TU-LESS was reported to exceed MPLS in fast recovery. Therefore, the aim of this prospective cohort study is to compare the effectiveness of fast recovery and relative risk of tumor dissemination between TU-LESS and MPLS in myomectomy for the treatment of uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with uterine fibroids before surgery on the basis of radiological or other examinations
* will consider TU-LESS or MPLS for myomectomy

Exclusion Criteria:

* patients reluctant to long-term follow-up
Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women

Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 35 years.
* Healthy as determined by the investigator on the basis of medical history and screening evaluations.
* Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.

Exclusion Criteria:

* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
* Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
* Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.
PEMOCS: Personalized Motor-cognitive Training in Chronic Stroke

In Switzerland, approximately 20'000 persons suffer a stroke each year. Despite carefully considered rehabilitation programs, full recovery is achieved only in a small proportion of stroke survivors (www.swissheart.ch). Studies suggest that motor-cognitive trainings can improve gait, balance, and mobility in chronic stoke survivors. However, little is known about the effect of motor-cognitive trainings on cognitive functioning in chronic stroke.

The aim of this study is to evaluate the effects of a motor-cognitive training added to usual care compared to usual care alone on cognitive functions, single- and dual-task mobility, gait and health-related quality of life.

In this single-blind RCT, 38 participants will be allocated randomly to either the intervention group (usual care + motor-cognitive training by means of an exergame for 12 weeks, 2x/week for 30-40 minutes) or the control group (usual care only). Both groups will attend three assessments, at baseline, post-intervention (12 weeks after baseline), and at follow-up (24 weeks after baseline). Global cognitive functioning will be the primary endpoint and a linear mixed model will be used for analysis.

Motor-cognitive trainings, especially exergames, bear the potential for further development of innovative long-term rehabilitation solutions for chronic stroke survivors. Cognitive deficits are a common unmet need restricting daily activities mentioned by chronic stroke survivors. Exergame training following personally tailored progression to generate optimal training load may help addressing this unmet need. Therefore, this study will contribute to the on-going research objective on how to improve the long-term care of stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 years) with chronic stroke (≥ 6 months post-stroke)
* Stroke: ischemic or haemorrhagic
* Able to stand for 3 minutes and walk 10 meters, functional ambulation category ≥ 3
* Able to follow a two-stage command
* Able to give informed consent as documented by signature

Exclusion Criteria:

* Unable or not willing to give informed consent
* Other neurological diseases (e.g. Parkinson's Disease, multiple sclerosis), except cognitive deficits or dementia
* Clinical contra-indications for the study intervention
* Unable to follow the study intervention or the test for the primary endpoint (MoCA), e.g. due to a neglect, aphasia or other language problems
* Overlapping enrolment in another clinical trial
Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)

The goal of this observational cross-sectional study is to learn about vagal features in patients with syndromic and non-syndromic TAA. The main question it aims to answer is to highlight a functional condition that could help stratify patients with TAA on the risk of aortic complications.

Participant will take part by standing in supine position for 10 minutes and during active standing for 10 minutes. In this period of time, it will be possible to acquire the signals continuously and non invasively through recorded non-invasive blood pressure and piezoelectric sensor breathing belt.

Changes in blood pressure (BP) are tightly controlled by a neural surveillance system that triggers changes in response to heart rate, vascular tone, and respiration.

Therefore, studies in literature have investigated the regulatory effects of the sympathetic system on the tone of the vessels as well as on the BP, but further analysis are needed in order to describe its potential impact on the structure of the aortic wall and, in particular, its potential implications on aneurysms and risk of aortic dissections.

Considering that, in the population with TAA, the neurovegetative pattern influences the responses to different stressors (environmental, occupational and emotional) and also acts on the BP, which represents a risk factor for the TAA population, its analysis would allow to identify attitudes and behavioral predispositions and therefore response to stressors.

The non-invasive analysis of sympatho-adrenergic patterns could help to highlight a functional condition related to the "environmental stressors" which could help to stratify patients with TAA based on the level of pathological reactivity with effects on risk of aortic complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years with syndromic and nonsyndromic TAA;
* Signed informed consent;
* Patients on regular pharmacological prophylaxis (with Losartan) or naïve patients with a first diagnosis

Exclusion Criteria:

* Acute and chronic inflammatory diseases such as: liver disease, chronic renal insufficiency (creatinine \> 1.5 mg/dl) and diseases affecting the thyroid system.
Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)

The overall goal of this study is to promote awareness of Familial Hypercholesterolemia (FH). The investigators aim to enroll patients with suspected FH into the study and will randomize them to receive usual care or motivational interview. Primary study outcomes include knowledge of FH, as well as clinical and patient-reported outcomes. This study aims to promote optimal disease management and improve outcomes of FH patients.

This is a randomized 2-arm study designed to examine the impact of a personalized remote intervention that includes evidence-based risk communication and behavior change techniques with navigation. Patients who meet the inclusion criteria from both Essentia Health (Site A) and Aspirus St. Luke's Hospital (Site B) will be invited to complete the baseline survey. Participants will be randomized to one of two study arms: usual care (UC) and motivational interview (MI). Participant assignment occurs after completion of the baseline survey. Participants randomized to receive a MI will be contacted via telephone or email to schedule a date and time when they are available to receive a video or phone call from the study coordinator. During the MI, participants will be assessed on their readiness to communicate risk with family members. A letter will be sent to the participants physician for notice of the participation in the study. A follow-up survey will be sent to participants approximately 6 months after completion of the baseline survey, in both arms of the study. The study arms will be compared with regard to awareness and treatment of FH (aim 1), as well as the uptake of cascade screening in first- and second-degree relatives (aim 2).

Eligibility Criteria:
Inclusion Criteria:

* Age 2-75 years
* patients with existing clinical diagnosis or suspected FH
* known genetic mutation of FH
* patients with an initial (pretreatment) LDL level \>190 mg/dL or total cholesterol \>300 mg/dL (age \>19 years) or LDL-c \> 160mg/dL or total cholesterol \>260 mg/dL in children age 2-19 years
* patients currently taking a lipid-lowering medication and have an LDL \>124 mg/dL or total cholesterol \>195 mg/dL
* capable of providing informed consent
* Patients should reside in Minnesota, Wisconsin or North Dakota.

Exclusion Criteria:

* Lack of research authorization
* unable to provide informed consent (including non-English speaking individuals)
* known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism)
* Pregnant women and prisoners will also be excluded.
Assessment of Post-operative Pain After Different Instrumentation Techniques in Pulpectomy Treatment of Primary Molars

The goal of this clinical trial is to compare the post operative pain after using three different instrumentation techniques in pulpectomy treatment of pediatric participant. The main question it aims to answer:

If different instrumentation techniques will affect the post operative pain in pulpectomy treatment of primary molars ? Participants will evaluate the pain using Modified Wong baker pain rating scale.

Researchers will compare \[ the adaptive XP endo shaper, Fanta AF baby files, and hand K files\] to see if they will affect the post operative pain.


Eligibility Criteria:
Inclusion Criteria:

* Cooperative children free from systemic diseases.
* Teeth with sufficient coronal tooth structure.
* Teeth with necrotic pulp.
* Teeth should have 2/3 of the remaining roots.

Exclusion Criteria:

* Children taking medications up to six hours before the treatment.
* Children with multiple teeth that required pulpectomy will not be included to eliminate the possibility of pain referral.
* Excessive tooth mobility.
* Teeth with perforated pulpal floor.
* Teeth with external or internal root resorption.
Study of Oxycyte in Severe Closed Head Injury

Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that die with severe head injuries. Laboratory studies in animals and clinical trials have shown that increasing oxygen in the brain results in better brain oxygen consumption, less cell death, and better functional outcome. This study will test the hypothesis that Oxycyte is an effective way to increase brain oxygen levels in severe head injury.

Decreased brain oxygen in severe brain injuries appears to be implicated in poor functional outcome and death. Animal and clinical studies have shown that increasing brain oxygen in such patients improves functional outcome, and Oxycyte has been shown to be an effective means of delivering oxygen to tissues, including the brain. This study is an eight patient proof of concept study to test the effects of oxygen delivery with Oxycyte in patients with a severe traumatic head injury with a Glasgow Coma Scale (GCS) score of 3 to 9.

Subjects diagnosed with a severe head injury (GCS 3-9) who receive a brain oxygen monitor and microdialysis catheter, will undergo baseline monitoring for 4 hours. In the first 4 subjects the Fi02 on the ventilator will be increased to 50% for a 4 hour stabilization period and this will be followed by a single intravenous infusion of 3ml/kg of Oxycyte. The Fi02 will remain at 50% for 24 hours.

In the second 4 subjects the Fi02 on the ventilator will be increased to 100% for a 4 hour stabilization period and this will be followed by a single intravenous infusion of 3ml/kg of Oxycyte. The Fi02 will remain at 100% for 24 hours.

Subjects will be enrolled, treated, and then monitored by LICOX 02 monitor before and after infusion of PFC, and then for at least 48 hours following the discontinuation of Oxycyte.

Eligibility Criteria:
Inclusion Criteria:

* severe closed head injury patients or GCS 3-9 patients who receive brain oxygen monitoring
* ventriculostomy/ICP monitor
* at least one reactive pupil
* no known life threatening disease prior to trauma
* age 18-70 years old
* consent for microdialysis/brain 02 monitoring
* legal family representative present that can give informed consent for perfluorocarbon administration

Exclusion Criteria:

* no motor response
* both pupils fixed and dilated
* no consent available
* allergy to egg proteins
* coagulopathy
* major liver injury
* major pulmonary injury
The Effect of Mobile Application-based Information About Before and After Surgery

Aim and hypothesis: This study was conducted to evaluate the effect of mobile information given to women before and after breast cancer surgery on anxiety, distress, and quality of life. E-mobile information given to women before and after breast cancer surgery reduces the level of anxiety (I) and the level of distress (II), and positively affects their quality of life (III).

Methods: This randomized controlled study was conducted between April and August 2021 in the surgical oncology clinic-outpatient clinics of a university hospital. Patients in the intervention group (n=42) used the mobile information application for one month with routine care. Patients in the control group (n=40) received their routine care. Data were collected with data collection forms one week before and three weeks after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective surgery due to breast cancer,
* Over 18 years old,
* Read and understand Turkish,
* At least primary school graduates,
* Have internet access,
* Have a smartphone with an android operating system suitable for downloading the mobile application.

Exclusion Criteria:

* Diagnosed with active psychiatric disease,
* Using antidepressant medication,
* Vision problems that prevented them from using the mobile application,
* Scheduled for reconstructive surgery using their own tissue
Exploring the Familial Reach of Adolescent Obesity Treatment

An observational study ancillary to the randomized clinical trial (RCT) TEENS+ (R01HD095910), a family-based lifestyle intervention, for adolescents with obesity, to determine: 1) if family-wide changes to the shared home environment are implemented, 2) if ripple effects to untreated family members are observed, and 3) whether these changes are predictive of adolescents' weight management success.

Funding support from NIH via R21HD105906.

Investigators will recruit non-targeted children (8-17yrs) and caregivers living in the same household as the target TEENS+ parent/adolescent dyad. At 0, 2, 4 and 8m, the target adolescent/parent dyad (n=60), and non-targeted children and caregivers will complete anthropometric assessments, and measures of the shared home feeding and weight-related environment will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Untreated children: must be between 8-17 years of age and primarily living in the same household as the TEENS+ participants.
* Untreated caregiver: must be 18 years of age or older and primarily living in the same household as the TEENS+ participants.
* Treated caregivers: must have another individual in the household that meets the eligbility for an untreated child or untreated caregiver.

Exclusion Criteria:

* temporarily (\<1yr) living in the home
* children with a BMI\<5th%ile or caregivers with a BMI\<18.5 kg/m2
* non-English speaking
* medical condition(s) that may be associated with unintentional weight change or significant disruption to eating behaviors (e.g., hypothalamic injury, Prader-Willi, G-tube placement, or malignancy
* clinically significant eating disorder (e.g., anorexia nervosa or bulimia nervosa)
* following a medically-supervised/prescribed diet
* psychiatric, cognitive, physical or developmental conditions that would impair the individual's ability to complete assessments.
Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism

The objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with venous thromboembolism (VTE) in China.

Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and pulmonary embolism (PE), is one of the leading causes of mortality that need to be accurately diagnosed and effectively managed. Although a number of clinical decision rules in the domain of VTE have been presented in the literature, such as the well-known prediction models developed by Wells and colleagues, the prognostic models to assess VTE recurrence risk in patients who suffered from a VTE or the Pulmonary Embolism Severity Index (PESI) for short-term mortality risk in PE patients, and various other diagnostic models for both DVT and PE. They are few designed for Chinese patients. The primary objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with VTE in China.

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years old
2. First episode of PE and/or DVT (diagnosed by pulmonary angiogram, chest computed tomography pulmonary angiography(CTPA), Ventilation/Perfusion (V/Q) lung scan read as high probability by the radiologist, and/or (+) bilateral lower limb venous compression ultrasonography (CCUS))

Exclusion Criteria:

1. Patients with prior VTE
2. Cannot provide written informed consent
3. Unable to read questionnaire in Chinese or English
4. a record of pregnancy in the preceding 12 months