cyrilzakka/clinical-trials huggingface dataset:
The Effects of a Group-based Gaze Training Intervention for Children With Developmental Coordination Disorder

The aim of this study was to integrate a gaze training intervention (i.e., quiet eye training; QET) that has been shown to improve the throwing and catching skill of children with Developmental Coordination Disorder (DCD), within an approach (i.e., group therapy) that might alleviate the psychosocial influence of these motor skill deficits.

Children with DCD will be randomly split into either QET group or a technical training (TT). The TT group will be given movement-related instructions via video, relating to the throw and catch phases, while the QET group will also be taught to fixate a target location on the wall prior to the throw (QE1) and to track the ball prior to the catch (QE2). Each group will take part in a 4- week, group therapy intervention and measurements of QE duration obtained from a mobile eye tracking system and catching performance are to be taken before and after training, and at a 6-week delayed retention test. Parental feedback on psychosocial and motor skill outcomes will also be collected at delayed retention.

Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of Developmental Coordination Disorder or suspected to have DCD
* Scores below the 5th percentile on the MABC-2 (Movement Assessment Battery for Children-2)
* Be of normal intelligence (assessed through parent/teacher feedback)
* No neurological disorder
* Normal of corrected-to-normal vision

Exclusion Criteria:

* Score over 5th Percentile on the MABC-2
* Suffers from a neurological disorder
* Below average intelligence
* Any visual impairment
Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.

This is a nonrandomized, open-label, parallel-group, single oral dose study in subjects with chronic hepatic impairment and matched (age, sex, weight, BMI) healthy subjects. Subjects will be enrolled into 1 of 3 groups based on hepatic impairment grade: mild, moderate and normal hepatic function. An optional severe hepatic impairment group will enroll based on data from the mild and moderate hepatic impairment groups in comparison to matched healthy group. All subjects will receive a single oral dose of IPI-145 25 mg.

Eligibility Criteria:
Inclusion Criteria:

* Men or women of nonchildbearing potential between 18-70 years of age
* Body Mass Index (BMI): 18.0 - 38.0 kg/m2.
* Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
* Hepatic impairment subjects: confirmed hepatic impairment \>1 year with etiology of chronic alcoholism, chronic viral hepatitis (B or C), nonalcoholic steatohepatitis, autoimmune hepatitis, Wilson disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia
* Provided written informed consent prior to any study specific procedures

Exclusion Criteria:

* Women of childbearing potential
* Hepatic impairment subjects: fluctuating or rapidly deteriorating hepatic function, acute hepatitis, variceal bleeding within 8 weeks of screening, a history of pancreatitis within 8 weeks of screening, evidence of hepatic encephalopathy \> Grade 1, current unstable hematologic condition, and/or creatinine clearance \< 60 mL/min
* Healthy subjects: positive screening test for hepatitis B surface antigen, or hepatitis C antibody
* ECG at screening or Day -1 showing QTcF ≥ 450 msec for healthy subjects or \> 500 msec for hepatically impaired subjects
* Evidence of clinically significant medical conditions
* History of gastrointestinal disease or surgery that may affect drug absorption
* Positive or indeterminate QuantiFERON-TB Gold test at screening
* Any active infection at the time of screening or admission
Evaluation of Neuromuscular ElectroStimulation in Addition to a Physical Activity Program

The purpose of the study is to measure the muscle strength of the quadriceps 6 months from the start of the intervention, either the maximum load resistance that can be lifted in a single repetition under standardized conditions with the thigh press.

This is a prospective, longitudinal, open, comparative (two arms), randomized, monocentric study, focusing on a therapeutic strategy (muscle strengthening program with or without NeuroMuscular ElectroStimulation).

Patients will be cared for according to a nutritional and sports support program offered routinely in the investigating center, which corresponds to the recommendations for the care of patients with prostate cancer under Androgen Deprivation Therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated with pharmacological androgen deprivation therapy for prostate cancer for more than 26 weeks;
* Performance index (WHO): 0 or 1;
* Patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study;
* Patient benefiting from a social security scheme;

Exclusion Criteria:

* Weight ≥ 130 kg;
* Vegetarian food;
* Other associated neoplasia;
* Patient having undergone a bilateral orchiectomy;
* Painful bone metastases, or at risk of fracture;
* Anemia (hemoglobin \< 10 g/dL);
* Thrombocytopenia (platelets \< 50 G/L);
* Renal impairment (creatinine clearance \< 60 mL/min, or albuminuria \> 30);
* Patient planning to travel more than 4 weeks continuously in the next 52 weeks;
* Absolute contraindication to physical training (e.g. musculoskeletal, cardiovascular or neurological disorders), according to the doctor specializing in the associated medical condition;
* Contraindication to the use of the neuromuscular electrostimulation device or the impedance meter, in particular infectious disease in the acute phase, fungal infection, dermatitis, unbalanced arrhythmia, epilepsy, wearing an active implantable device (pacemaker, heart artificial, prosthesis incorporating an electromagnetic system), open wound;
* Sports activity already supervised by a third party or at an equal or higher level than the bodybuilding/muscle strengthening work recommended in the study;
* Protected adult patient (under guardianship or curatorship, or under a regime of deprivation of liberty);
* Patient participating in another research, or in a period of exclusion from another research.
Safety and Efficacy of Distal Radial Approach (SAFE-BOX)

A Prospective Registry to assess the Safety and Efficacy of Distal Radial Approach

Anaphylactic radial approach is now recognized as a basic technique in coronary artery procedures. The main advantage is increased stability due to the reduction of massive bleeding and increased patient comfort because it can move immediately after the procedure. The operator prefers access to the right radial artery because of the comfort of performing the procedure on the right side of the patient. However, the operator should frequently replace it with a left radial artery approach for various reasons, including 1) closure of the right radial artery, 2) difficulty accessing the coronary artery due to severe gambling of the radial artery, and 3) hemodialysis of the right radial artery.

As for prognosis, the left and right radial artery approaches are similar. However, the left radial artery approach is bound to experience anthropological discomfort in which the operator has to lean toward the patient. An easy solution is the approach from the anatomical left snuff box located on the back of the hand to the distal radial artery. Recently, the left snuffbox approach has been reported, and attempts are increasing in many countries. However, it is true that there is still a difference in diameter of the radial artery through the distant radial artery approach and concerns about percutaneous coronary intervention through this compared to the classical radial artery approach. Recent studies have published studies on the stability and effectiveness of distant radial artery approaches, but they are still small, and studies on specific subgroups are very scarce. Furthermore, data on the current status and performance in Korea so far is very scarce. Therefore, through this study, we would like to systematically collect and analyze data on the status and performance of the approach through the distant radial artery approach to find out the stability and effectiveness of various patient groups, treatment methods.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 20 years of age
2. Patients requiring coronary angiography or intervention
3. Patients with palpable distant radial artery

Exclusion Criteria:

1. Patients with distant radial artery too small or not palpable
2. Pregnant women
3. Patients not appropriate for the researcher to judge
Effects of Esketamine on Recovery of Consciousness After Propofol Anesthesia

Esketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor different from other gamma-aminobutyric acid (GABA) receptor agonists. Recent studies showed that subanesthetic doses of ketamine not only deepen anesthesia but also accelerate recovery from isoflurane anesthesia in mice. It is necessary to verify if it applies to human. Besides inducing behavioral unresponsiveness, an optimal and important goal of general anesthesia is to prevent connected consciousness. The results of many studies support the conclusion that anesthesia-related unconsciousness is a consistent functional disconnection of lateral frontoparietal networks.The goal of this clinical trial is to learn if subanaesthetic doses of esketamine works to accelerate the recovery of consciousness from propofol anesthesia. It will also learn about the change of brain network when administrated the esketamine during propofol anesthesia. The main questions it aims to answer are:

1. Does subanaesthetic doses of esketamine can accelerate recovery from propofol anaesthesia?
2. What will happen to brain network connection after different doses of esketamine during propofol anesthesia?


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 years to 50 years
* Patients scheduled for elective operative hysteroscopy
* Willing to sign informed consent

Exclusion Criteria:

* Contraindications of propofol and esketamine
* Contraindications for EEG;
* ASA≥III;
* BMI≥30 kg/m2 or BMI\<18 kg/m2;
* The MMSE scale score is lower than the normal value;
* Alcohol or drug abuse;
* Untreated or under-treated hypertension, hyperthyroidism, risk of increased intracranial pressure, audio-visual impairment, history of psychiatric disorders or neurological diseases, malignant tumors or other major diseases;
* Use of other neurological drugs or drugs known to interact with propofol and esketamine in the past 2 weeks;
* Pregnant and lactating women;
* The operation duration is shorter than 15 minutes or longer than 60 minutes.
A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours

This randomized, open-label, two-way crossover study will evaluate the relative bioavailabilty and safety of capecitabine rapid disintegrating tablets (RDT) versus commercial Xeloda tablets in patients with colorectal or breast cancer. Patients will be randomized to a sequence of single oral doses of capecitabine RDT or Xeloda on Days 1 and 2 of a 14-day treatment cycle with Xeloda. Follow-up will be 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients,\>/= 18 years of age
* Histological/cytological confirmation of colorectal or breast cancer
* Patient is ambulatory and has a Karnofsky performance status of \> 70%
* Body surface area between 1.5 and 2.0 m2
* Either:
* Due to receive Xeloda as monotherapy or as combination therapy as per their treating physician's treatment plan, or
* Currently receiving Xeloda monotherapy and in the investigator's opinion able to tolerate study drug dose on Day 1 and Day 2

Exclusion Criteria:

* Any contraindication to Xeloda
* Received Xeloda in the 6 days prior to Day 1
* Subjects with organ allografts (other than autologous bone marrow transplant after high dose chemotherapy)
* Renal impairment
* Pregnant or lactating females
* Participation in an investigational drug study within 28 days prior to screening
* Lack of physical integrity of the upper gastrointestinal tract, or clinically significant malabsorption syndrome
* Serious uncontrolled intercurrent infections
* History of clinically significant coronary artery disease
* Concomitant treatment with warfarin
* Known dihydropyrimidine dehydrogenase deficiency
Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty

Blood management is an important part of successful total joint replacement. Loss of blood and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has become a standard component to many blood management programs. It is used to treat or prevent excessive blood loss during surgery and in various medical conditions such as excessive bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from growing and causing problems. When this process becomes overactive it can result in excessive bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the relationship between TXA and thromboelastogram (TEG) results.


Eligibility Criteria:
Inclusion Criteria:

* Primary total hip and knee arthroplasty patients presenting to WVU Center for Joint Replacement
* 40-90 years old

Exclusion Criteria:

* Known coagulopathy
* History of venothrombotic event
* Unstable angina
* Recent Myocardial infarction (MI)
* History of bleeding events
* History of chronic anemia
* Preoperative anemia
* Current use of blood thinners including aspirin
Tobacco Cessation in Postmenopausal Women

This study investigated whether being on transdermal hormone replacement therapy (HRT) influenced smoking cessation variables in postmenopausal women undergoing short-term abstinence from cigarettes. Women were recruited into two groups according to their pre-enrollment medication status - currently on HRT (n = 17) or not on HRT (n = 13). The HRT group had their prior medication replaced with a standard 0.1 mg estradiol transdermal system and 2.5 mg of Cycrin daily. Following two weeks of medication adjustment, participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks, participants were instructed to quit smoking. They were provided with smoking cessation counseling and monitored for abstinence. Data were collected during five clinic visits on all dependent measures: Minnesota Nicotine Withdrawal Scale, Beck Depression Inventory (BDI) Scale, Profile of Mood States, Motor Speed Tasks, and Reaction Time Test.

Part II is identical to Part I, except it randomizes participants to use nicotine patch or not.


Eligibility Criteria:
Inclusion Criteria:

* 40-79 years old
* Clinical Menopause
* \> 15 cigarettes per day for at least one year
* Experienced nicotine withdrawal based on DSM IV

Exclusion Criteria:

* Currently obtaining nicotine from other sources
* Abnormal vaginal bleeding
* unstable health
* history of stroke or embolism
* history of abnormal thyroid function
* significant skin disorders
* active psychiatric disease
Optimal Duration of Stretching Exercise in Patients With Chronic Mechanical Neck Pain

controversy remains about the stretching parameters needed to achieve a particular goal or treatment outcome. In clinical practice, multiple stretching techniques are used; nevertheless, there is no evidence-based agreement on the most effective parameters. One of these parameters, that might be affecting the treatment outcome the most, is the stretching duration, thus far there is a little agreement on the optimal stretching duration.

This non agreement in exact stretching parameters is obvious between authors and researchers in the field of muscle energy techniques (MET) as well as those who have used and advocate various durations for the passive stretch that follows the contraction phase in MET.

comparison and subsequent conclusions about appropriate stretching times are mainly based on mechanical factors such as range of motion and flexibility, while ignoring the neural adversative mechanical tension that may be created during stretching exercises. According to the literature , stretching induced neural tension may adversely affect the central nervous system and nerve root function due to the absence of the perineurium, which is the primary load carrying structure. Thus, safe or unsafe limits of nerve elongation are not well established, despite several basic scientific and clinical studies.. Consequently, in the present study, the current study aimed to answer the question: Is it theoretically possible, that increased longitudinal strain and stress on the spinal cord and nerve root from continuous stretching exercises may subtly impair the neural function? Our hypothesis is that a duration threshold exists where, once reached, adverse neural function will be apparent resulting in a reduction of either or both latency and amplitudes of evoked potentials.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients had to be between 18 and 40 years of age
* have generalized neck pain for more than 3 months.
* with symptoms provoked by neck postures, movements, or palpation

Exclusion Criteria:

* Subjects' exclusion criteria included specific neck pain due to trauma, disc protrusion, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory or rheumatic disease. Furthermore, subjects were excluded if they had a history of spine surgery and any objective findings consistent with neurological conditions and vascular disorders.
Lansoprazole 30 mg DR Capsule Replicate Food Study

The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under non-fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Body Mass Index of 30 or less
* Males or non-pregnant females
* Normal clinical laboratory test results

Exclusion Criteria:

* Subjects with a significant history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
* Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
* Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
* Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least 30 days prior to the first dosing of the study.
* Subjects who have taken any investigational drug within 30 days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allow to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 180 days of dosing will not be allowed to participate.
* Female subjects with a positive or inconclusive pregnancy test result will be withdrawn from the study.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)
* HbA1c (glycosylated haemoglobin A1c) maximum 10.0% by central laboratory analysis

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication

The study is designed to compare the efficacy and safety of once daily PMR treatment with twice daily Pletaal® treatment in patients with intermittent claudication caused by peripheral arterial disease and are currently treated with cilostazol of any strength and any dosing frequency.


Eligibility Criteria:
Main Inclusion Criteria:

* Stable use of Cilostazol of any strength and any dosing frequency for at least 3 months prior to screening, for the treatment of peripheral arterial disease.
* Initial claudication distance ≥ 30 meters at the constant workload treadmill test.

Main Exclusion Criteria:

* Presence of limb-threatening chronic limb ischemia, manifested by ischemic rest pain, ulceration or gangrene.
* History of lower-extremity surgical or endovascular arterial reconstructions or sympathectomy within 3 months prior to screening.
* Presence of illness(es) (such as angina pectoris, respiratory disease, orthopaedic disease, or neurological disorders, except the study disease) limiting the exercise capacity.
* Presence of uncontrolled hypertension (based on physician's judgment) or other unstable cardiovascular disease such as congestive heart failure of any severity and myocardial infarction within 6 months prior to screening.
* History of coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months prior to screening.
* History of Buerger's disease or deep vein thrombosis within 3 months prior to screening.
* Presence of haemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding.
* Presence or history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular tachycardia with or without adequate treatment, QTc prolongation associated with cardiac disorders, or severe tachyarrhythmia within 6 months prior to screening, which is considered not suitable for this study by Investigator.
* History of type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
* Use of anticoagulant agent(s) within 6 months prior to screening.
* Use of two or more than two anti-platelet agents within 3 months prior to screening.