cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo

Early use of robotic gait trainers have shown many benefits, however why these benefits occur and how to maximize them is unknown. There are a few options for how a robotic gait trainer can be used, however, there is not much understanding of how these options impact rehabilitation and compensate for impairments. The investigators aim to evaluate the impacts of as single session of Trexo robotic gait training and the impact of different modes of the Trexo robotic gait trainer. The investigators will evaluate how the different settings impact things like physical activity, walking, brain activity, spasticity, and fatigue. Investigators will arrange for a familiarity and fitting session to start, so that study team members can fit the participant to the Trexo and so that participants can become familiar with the feeling of using the Trexo robotic gait trainer. After the initial fitting sessions, follow up sessions will be completed to evaluate different settings on the Trexo, for example in "endurance" mode (where the robot completes the movements for the participant) and in "strength" mode (where the robot requires some assistance from the participant). Investigators may also test different fitting settings, for example with and without the supportive seat in the Trexo. Only three visits are required (one fitting/familiarity session and two testing sessions), however participants and/or their families may choose to complete more testing sessions if they want to assess other aspects of the training. For example, if the first two testing sessions assessed physical activity, participants and their families may choose to return for further sessions to assess brain activity. The aim of the study is to determine how robot assisted gait training impacts rehabilitation and compensates for impairments, as well as to provide suggestions on how the robotic gait trainer might be improved or modified. This study is exploratory to find out more about how these robotic gait trainers, specifically the Trexo, impacts various aspects of rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Able to fit into the Trexo robotic gait trainer (\<150 lbs., \<5'7").
* Has impaired ability to walk due to a neurological or muscular disorder.

Exclusion Criteria:

* \>150 lbs.
* \>5'6" tall
* Medical contraindication to weight bearing (ie. recent orthopedic surgery)
Heart Focused Movement Effects on Cardiometabolic Risk

This study is designed as a two-group parallel randomized controlled trial (N=50) to test effects of 8-weeks of Qigong/Tai Chi (QTC) intervention compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., BMI, waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional regulation, eating behaviors, and cognitive performance).

Heart rate variability biofeedback (HRVB) will be investigated as a target to optimize Qigong/Tai Chi (QTC) practices based on the expectation that learning to, and practicing changing heart rate variability (HRV) using HRVB, in addition to QTC, will result in higher levels of HRV and coherence than just the QTC alone. This study is designed as a two-group parallel randomized controlled trial to test effects of QTC compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary). Fifty participants will be recruited and randomized to one of these groups and receive daily text prompts for 8 weeks to practice (using video links) Tai Chi Easy for 10-30 minutes (length of practice, the participants' choice). Half of the participants randomized to the HRVB enhancement will also be coached to practice HRVB to achieve coherence in their heart beat rhythms prior to practice (QTC plus HRVB group). Data collection at baseline and post intervention will assess body mass index (BMI, waist circumference/percent body fat, sleep quality, stress, eating behaviors, emotion regulation, mood (depression and anxiety), cognitive performance and changes in HRV parameters (high frequency power and coherence).

Eligibility Criteria:
Inclusion Criteria:

* 31.5 inch or above waist circumference women
* 35.5 inch or above waist circumference men
* Has a smartphone or tablet

Exclusion Criteria:

* Those who are unable to stand for 10-minute segments (e.g., wheelchair or walker bound and too weak), and/or unable to walk
* People who have been regularly practicing any form of meditative movement and or HRVB training regularly (i.e., 2 or more times per month for the past 6 months)
* Individuals with diagnosed severe heart arrhythmias, heart transplant, or those with pacemakers would be excluded because either of those interferes with accurately assessing HRV parameters.
Clinical Trial to Evaluate the Reduction of Cardiovascular Risk

Randomized parallel and double blind clinical trial in which it is intended to analyze the efficacy of a nutraceutical on cholesterol and endothelial function after the consumption of a product for eight weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes (men or women) between 40 and 75 years of age, of Caucasian race
* Women must be in the menopausal period.
* Present body mass index between 18.5 and 34.9 Kg / m2.
* The number of platelets in whole blood must be greater than 170 x109 / L
* Hematocrit greater than 40% for men or greater than 35% for women.
* Hemoglobin greater than 120 g / L for men or 110 g / L for women.
* Present fasting levels of LDL-serum cholesterol equal to or greater than 110mg / dL
* Present fasting values of total serum cholesterol equal or superior to 180mg / dL
* Volunteers able to understand the clinical study and willing to give written informed consent and to comply with the procedures and requirements of the study.

Exclusion Criteria:

* Thyroid dysfunction, infections, or with any type of chronic disease (for example, autoimmune, inflammatory).
* Subjects who have suffered an ischemic-vascular event during the last months
* Subjects undergoing medication and / or nutraceutical treatment for hypertension, diabetes or hyperlipidemia (eg Statins).
* Subjects under treatment with drugs that due to their narrow therapeutic margin require monitoring of their plasma levels (digoxin, acenocoumarol, warfarin, etc ...)
* Subjects under treatment that affect body weight or appetite.
* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Subjects who are performing or intend to perform any type of diet, hypocaloric or not, during the conduct of the study.
* Subjects who have donated a minimum of 0.5L of blood in the last month.
* Vegetarian subjects.
* Subjects, who have ingested, in the last three months, supplements of omega 3 and / or 6, (eg fish oil, evening primrose oil, krill oil, or algae oil).
* Subjects under treatment with niacin or fibrates.
* Those subjects with alcohol abuse, or with excessive alcohol consumption (\> 3 glasses of wine or beer / day) will be excluded.
* Patients undergoing major surgery in the last 3 months.
* Subjects who smoke or not, but in any case who do not modify their nicotinic habits during their participation in the study.
* Participation in another clinical trial in the three months prior to the study Lack of will or inability to comply with clinical trial procedures.
Dexmedetomidine Supplemented Intravenous Analgesia in Elderly After Orthopedic Surgery

Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. The investigators hypothesize that, for elderly patients after orthopedic surgery, dexmedetomidine supplemented intravenous analgesia can reduce the incidence of delirium and improve the long-term outcomes.

A growing number of elderly patients undergo orthopedic surgery each year. Delirium is a common complication in these patients after surgery and is associated with worse outcomes, including prolonged hospital stay, poor functional recovery, decreased cognitive function, increased health care costs, and elevated mortality rate. Previous studies showed that, for elderly patients admitted to the intensive care unit after non-cardiac surgery, low-dose dexmedetomidine infusion improved subjective sleep quality and reduced delirium early after surgery; it also increased survival up to 2 years and improved life quality in 3-year survivors. The investigators hypothesize that dexmedetomidine supplemented intravenous analgesia (in the form of patient-controlled analgesia) can also reduce delirium and improve long-term outcomes in elderly patients after orthopedic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years but \< 90 years;
* Scheduled to undergo total knee/hip replacement surgery, or spinal surgery;
* Planned to use patient-controlled intravenous analgesia (PCIA) after surgery.

Exclusion Criteria:

* Refuse to participate in this study;
* Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
* Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
* Preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/L);
* Sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
* Severe hepatic dysfunction (Child-Pugh class C);
* Severe renal dysfunction (requirement of renal replacement therapy before surgery);
* American Society of Anesthesiologists physical status \>IV, or estimated survival ≤24 h.
A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice

The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 16 gradable teeth;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

* Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
* Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Removable oral appliances;
* Fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Any diseases or condition that might interfere with the safe participation in the study; and
* Inability to undergo study procedures.
Machine Learning and 3D Image-Based Modeling for Real-Time Body Weight and Body Composition Estimation During Emergency Medical Care. Study 1

The goal of this observational study is to train and validate an AI-driven 3D camera system to estimate total body weight, ideal body weight and lean body weight in male and female adult volunteers of all ages. The main questions this study aims to answer are:

* What degree of accuracy of weight estimation can we achieve with an AI-driven 3D camera weight estimation system?
* Is this accuracy the same in adults of both sexes, all ages, and all body types (underweight, normal weight, overweight)? Participants will undergo some anthropometric measurements (height, mid-arm circumference, weight circumference, hip circumference, measured weight), a DXA scan (to measure lean body weight), and 3D imaging using a 3D camera.

There will be no interventions.

This study is a single-centre observational study to train, internally validate, and test an AI-driven 3D camera weight estimation system. Our hypothesis is that this system, when used in the management of acutely ill patients, will be able to estimate total body weight, ideal body weight, and lean body weight more accurately than other current point-of-care system. Healthy volunteers will be used to train and test the system. During a single data collection session of approximately 30 minutes, baseline anthropometric data, a DXA scan, and 3D camera images of volunteers lying on a medical stretcher will be captured. There will be no interventions, and no follow up of participants. The collected data will be used to train an AI algorithm (based on artificial neural networks) to estimate weight using a single depth image. Once the AI system is fully evolved, the accuracy of its weight estimation performance will be evaluated in an independent test dataset.

Eligibility Criteria:
Inclusion Criteria:

* Any willing volunteer.

Exclusion Criteria:

* Participants with a body weight exceeding the DXA machine capacity \>204kg (450lbs);
* Pregnant participants;
* Participants with medical conditions that could confound the study;
* Participants with any metallic surgical implants;
* Participants who have had an x-ray with contrast in the past week;
* Participants who have taken calcium supplements in the 24 hours prior to the study.
Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis

This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.

This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.

Eligibility Criteria:
Inclusion Criteria:

* Must have completed a prior ESK-001 study
* Men and Women must use highly effective methods of contraception for the entirety of the study

Exclusion Criteria:

* Pregnancy
* Received a prohibited concomitant medication
Anger Control Training for Youth With Tourette Syndrome

This is a clinical study of a cognitive-behavioral therapy known as anger control training in adolescents with Tourette Syndrome and explosive, disruptive behavior. ACT is compared to treatment as usual (TAU) in a randomized clinical trial.

This is a randomized controlled study of a cognitive-behavioral, anger control training (ACT) in adolescents with Tourette Syndrome (TS) complicated by disruptive behavior. Disruptive behaviors in TS may take numerous forms including noncompliance, anger outbursts, and physical aggression. Anger outbursts in TS have been described as rage attacks or rage storms due to their high intensity and unpredictability in response to minimal provocation. Whether these behaviors are part of TS, related to comorbid conditions, or due to the burden of chronic illness is not clear. Nevertheless, these disruptive behaviors can result in significant functional impairment and often require clinical attention. The purpose of the ACT intervention is to improve the explosive and noncompliant behavior in adolescents with TS by enhancing affect regulation and social problem-solving skills. The treatment is based on anger control training which has been empirically supported for reducing aggressive behaviors and improving social functioning in aggressive youths. The primary outcome measures include the parent-rated Oppositional Defiant Scale and the Clinicians Global Improvement Score assessed by a clinician blind to treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

1. Boys and girls, 11 to 16 years of age.
2. Diagnosis of Tourette syndrome (TS) or chronic tic disorder (CTD).
3. Significant level of disruptive behavior

Exclusion Criteria:

1. Current diagnosis of Severe Major Depression, Bipolar Disorder, Pervasive Developmental Disorder, or Psychotic Disorder.
2. Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder that may require more pressing treatment.
3. Initiation or discontinuation of a psychotropic medication treatment within six weeks of enrollment in the study
The Role of Attachment Training in Mother-infant Attachment

The study aimed to investigate the effect of attachment training given to pregnant women on mother-infant attachment.Primiparous pregnant women between 28.-38. weeks were randomized into two groups. Pregnant women in the study group were given attachment training for 15 days and the effect of the training on mother-infant attachment was investigated by using the mother-infant attachment scale at postpartum week 8 in comparison with the control group.

Pregnant women between 28th and 38th weeks of gestational age who applied to an outpatient clinic of a training and research hospital were randomized into two groups. The study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was applied as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory" developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak. Maternal Attachment Inventory, Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old with a primiparous pregnancy,
* 28 to 38 weeks of gestation,
* At least primary school graduate,
* Who can use the internet actively and can receive planned training online,
* Can speak and understand Turkish like a native speaker,
* Expectant mothers who voluntarily accepted the study.

Exclusion Criteria:

* Transferring the pregnant woman to another hospital for follow-up and treatment
* Those who cannot use active internet and will not be able to receive online education
* Not completing the post-test after the training
* Not completing the postpartum maternal attachment scale
* Expectant mothers receiving psychiatric treatment
* Those with risky pregnancies
* Any congenital anomaly in the baby
* Unwanted baby status
* Withdrawal of the candidate from the study
Evaluation of Donated Human Embryos Following in Vitro Fertilization

Couples who have created excess embryos while undergoing IVF procedures, and who do not wish to transfer those embryos or donate them to another couple may donate the extra embryos to research. The embryos are then used to develop improved laboratory techniques and conditions as well as testing the proficiency of laboratory staff.

Undergoing IVF treatment often results in the production of more embryos than can safely be transferred at one time. These extra embryos are often cryopreserved for future use. In the event that a couple decides that they do not want to proceed with using cryopreserved embryos, these embryos can be discarded, donated to another couple, or donated to research.

Embryos that are donated to research are used to identify a group of parameters that have significant predictive value for assisted reproductive technology outcomes. We hope to develop future laboratory techniques as we gain a better knowledge of gamete development, fertilization and implantation. We will test, standardize and implement better methods for freezing embryos prior to employing these techniques in a clinical setting. We hope to develop new methods to optimize the determination of genes and chromosomes in embryos. We will test the proficiency of laboratory staff on techniques and/or procedures done in the IVF laboratory. This study WILL NOT:create embryos for research, transfer embryos to an individual, develop cell lines or clones.

Eligibility Criteria:
Inclusion Criteria:

none

Exclusion Criteria:

none
Virtual Reality Based Physical Therapy for Patients With Lower Back Pain

The goal of this clinical trial is to compare chronic low back patients. The main question\[s\] it aims to answer are:

* pain and disability
* fear avoidance belief Participants will perform virtual reality exercises
* virtual reality based exercises
* Routine Physical Therapy To Compare routine physical therapy treatment in addition to virtual reality to see effects on pain, functional disability and fear avoidance belief


Eligibility Criteria:
Inclusion Criteria:

* Low back pain that persists for more than 12 weeks
* Non-radiating low back pain
* Mechanical low back pain
* Both Gender

Exclusion Criteria:

* trauma or fracture of the spine
* any cardiac disease
* any systematic disease
* history of any neurological diseases such as Parkinson's disease, stroke and epilepsy
* patient on corticosteroid or anticoagulants
* history of any Drug abuse
* any Congenital deformity
* Virtual reality games phobia
* Pregnant female
Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children

To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.


Eligibility Criteria:
Inclusion Criteria:

1. The informed consent form was voluntarily signed by the legal guardians of the subjects (children aged ≥8 years should participate in the informed consent process and sign the informed consent form).
2. Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy.
3. The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis.
4. Pediatric patients had not taken other antiallergic drugs 72 hours before screening.

Exclusion Criteria:

1. Abnormal liver function (ALT or AST \> 2 times the upper limit of normal).
2. Abnormal renal function (serum creatinine above the upper limit of normal or GFR \< 10 mL/min)
3. Electrolyte abnormalities (potassium or magnesium \< 0.8 times lower limit of normal, \> 1.2 times upper limit of normal)
4. Children who were allergic to cetirizine or had a history of serious adverse reactions.
5. Pediatric patients with unstable vital signs.