cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Body Mass Index, Selective Motor Control and Functional Ability in Children With CP

PURPOSE:

To investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.

BACKGROUND:

Cerebral palsy is primarily a disorder of movement and posture

HYPOTHESES:

There is no correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.

RESEARCH QUESTION:

Is there a correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia?

This is an observational correlational study. SCALE will be used to assess selective motor control of lower extremity. GMFM-88 and WEE FIM will be used to assess functional ability. MAS will be used to assess degree of spasticity

Eligibility Criteria:
Inclusion Criteria:

* spastic diplegic CP, age from 6 to 9 years, able to follow verbal commands or instructions during testing procedures, 1+ and 2 according to Modified Ashworth scale (MAS), (GMFCS E\&R) selected Level II , III.

Exclusion Criteria:

* patients who had contractures or fixed deformities related to the joints of the lower limbs, injection with Botulinium toxin or any orthopaedic surgery in lower limbs within one year before study,
Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty

The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.


Eligibility Criteria:
Inclusion Criteria:

* Type II Diabetes on medication \& angioplasty within the past 6 months.

Exclusion Criteria:

* Myocardial infarction or repeat angioplasty with the past 5 months.
* Unable to perform exercise or pharmacologic stress test.
Feasibility and Preliminary Efficacy of a Web-Based Self-Help Program for College Students

The goal of this pilot study is to test the feasibility and preliminary efficacy of the repetitive negative thinking (RNT) focused web-based self-help program in college students. The main questions it aims to answer are:

* Does the program work without any help of a clinician?
* Does the program have any reducing effect on the participants' RNT, depression, anxiety, stress and cognitive fusion scores? - Does the program help participants to improve their psychological flexibility and committed actions? Participants will be administered a set of questionnaires before and after completing the 10-day long web-based self-help program, provided on a daily basis. Researchers will compare the intervention group with a waitlist control group to assess for any potential placebo effect.

After obtaining informed consent, all participants will receive a set of questionnaires for baseline measurement. Participants will be randomized into two groups using block randomization: one as the intervention group and the other as the control group (waitlist condition). This method helps ensure an equal distribution of participants with similar characteristics in both groups, minimizing potential biases and increasing the validity of the study.

Eligibility Criteria:
Inclusion Criteria:

* having internet connection and a working smart phone or computer

Exclusion Criteria:

* having thoughts of self-harm or suicide,
* diagnosed with psychotic disorder,
* substance abuse
* currently receiving psychological help
MAGNITUDE: a Phase 3 Study of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM)

To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.

This is a multinational, multicenter, double-blind, placebo-controlled study in approximately 765 participants, who will be randomized to receive a single infusion of either NTLA-2001 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of ATTR amyloidosis with cardiomyopathy
* Medical history of heart failure (HF)
* Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention
* Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 600 pg/mL and less than 10,000 pg/mL

Exclusion Criteria:

* New York Heart Association (NYHA) Class IV HF
* Polyneuropathy Disability score of IV (confined to wheelchair or bed)
* Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
* History of active malignancy within 3 years prior to screening
* RNA silencer therapy (patisiran, inotersen and/or eplontersen) within 12 months prior to dosing. Any prior vutrisiran use is not allowed
* Initiation of tafamidis or acoramidis within 56 days prior to study dosing
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
* Liver failure
* Uncontrolled blood pressure
* Unable or unwilling to take vitamin A supplementation for the duration of the study
Clonal Evolution of B Cells in High-risk CLL After Idelalisib-rituximab

The purpose of the study is to assess the evolution of B cells at a genetic and surface-marker level in high-risk CLL after idelalisib-rituximab treatment. The targeted population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will include patients with relapsed or refractory disease who require therapy with idelalisib and rituximab as per FDA label. This is an observational study for peripheral blood samples of these patients collected at pre-determined time points.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Ability to provide informed consent
* Ability to provide peripheral blood samples
* Diagnosis of CLL
* Indication(s) for CLL therapy
* At least one criterion for high-risk disease

  * Disease refractory (e.g., no response) to at least one round of chemotherapy
  * Disease that has relapsed (i.e., returned) after at least one round of chemotherapy
  * Proven presence of the 17p deletion within CLL cells
* Planned receipt of idelalisib-rituximab as per FDA guidelines and patient's oncologists

Exclusion Criteria:

* Patients who do not meet the diagnostic criteria for CLL or at least one indication for treatment.
* Patients who are receiving idelalisib with an off-label indication
* Patients who do not or cannot provide informed consent to donate peripheral blood tumor samples to our stem cell core facility
* Patients who do not provide informed consent to collect clinical, prognostic, and outcomes data during the time period that they are treated with idelalisib-rituximab
The Simultaneous Use of Supraclavicular and Distal Blocks

The aim of this study is to compare the combined ultrasound-guided supraclavicular brachial plexus block and distal median, radial, and ulnar nerve blocks, with supraclavicular block alone.

Sixty two patients undergoing upper extremity surgery will be randomized to supraclavicular only (Group S, n=31) or supraclavicular + distal (Group SD, n=31) group. Patients in group S will receive 32 mL of lidocaine 1.5% + epinephrine 5µg/mL and in group SD receive 20 mL of lidocaine 1.5% + epinephrine 5µg/mL followed by a distal median, radial, and ulnar nerve blocks using 50:50 mixture of lidocaine 2% + levobupivacaine 0.5% (4 mL/nerve). Sensory and motor block of the ulnar, median, radial and musculocutaneous nerves will be assessed every 5 minutes starting at the 10th minutes. The imaging, needling and performance times will be recorded. Also the onset and anesthesia related times, need for analgesic and first analgesic time will be noted.


Eligibility Criteria:
Inclusion Criteria:

* 18 and 80 years old patient
* American Society of Anesthesiologists (ASA) physical status I-III
* Scheduled for elective hand and forearm surgery

Exclusion Criteria:

* patient refusal
* preexisting neuropathy
* coagulopathy
* allergy to agents used
* pregnancy
* body mass index \> 35 kg/m2
* chronic obstructive pulmonary disease
* infection or previous surgery in the supraclavicular area
* systemic infection
MNK Therapy in Releasing the Superficial Fascia for Patients With AAS: an Assessor-blinded, Randomised Controlled Trial

The goal of this type of randomized controlled trial, employing a blinded evaluator methodology, to verify the clinical efficacy and safety of MNK therapy. This aims to provide a reference for clinical practitioners and AAS patients in their decision-making process.

Participants will randomly allocated into two groups using a random number table method, with forty patients in each group. The experimental group (Group 1) underwent MNK therapy to release the superficial fascia, while the control group (Group 2) received conventional acupuncture treatment.


Eligibility Criteria:
Inclusion Criteria:

* 16 to 55 years old
* Clear history of trauma within 1 to 7 days
* Presence of localized swelling, pain, bruising, and limping symptoms in the ankle joint
* Pain in the ankle joint upon resistance
* No accompanying fractures
* Diagnosis of acute ankle injury according to the "Diagnostic and Therapeutic Criteria of Traditional Chinese Medicine"
* No prior treatment before participating in this therapy
* Willingness to participate in this study and signing of the informed consent form

Exclusion Criteria:

* Individuals with clear indications for surgery
* Those suffering from gout, rheumatoid arthritis, joint tuberculosis, joint tumors, etc.
* Pregnant or breastfeeding women
* Individuals with serious primary diseases of the cardiovascular, liver, kidney, brain, and hematopoietic systems
* Those with local skin lesions or skin diseases
* Individuals with coagulation dysfunction
* Those with severe fear of needles
* Individuals unwilling to comply with the treatment regimen
Strategies Empowering Activities in Everyday Life: an Internet-based Occupational Therapy Intervention

The purpose of the study is to evaluate the feasibility, potential outcomes and the implementation process of a second updated version of an internet-based intervention in occupational therapy, focusing on self-management in activities of everyday life to promote health in people with chronic diseases.

The number of people with chronic disease is increasing as is the need of preventive efforts to facilitate their health. Chronic diseases are defined as 'long-term health conditions' that require constant attention and/or limit activities of daily living. People living with one or multiple chronic diseases experience difficulties to live an active everyday life and restrictions of engagement in various activities are common. Interventions that support their process of change and development of self-management in everyday life in relation to their changed capacity needs to be established. Research shows that the access to interventions is facilitated by the use of internet-based solutions. Hence, an internet-based occupational therapy intervention 'Strategies Empowering activities in Everyday life' (SEE) has been developed that will be evaluated in a feasibility trial.

The feasibility study is designed as a longitudinal trial with pre-test, post test evaluation without control group embedded in a mixed method approach. Data will be collected by assessment tools, qualitative interviews and group interviews. Evaluation of the feasibility of the intervention and the study design will be conducted in terms of acceptability, adherence, values, and implementation, from the perspective of patients with chronic disease and health care personnel at different organizational levels in the primary care.

The results from this feasibility study will support the continued development of SEE in future larger-scale evaluation studies. The goal is that SEE will add to existing interventions and becomes implemented in clinical practice. The results will be published in peer-reviewed scientific journals and presented at conferences.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed or at risk of developing a chronic disease/long-term condition such as long-term pain, stress-related conditions, neurological diseases and chronic fatigue syndrome
* Age: 18-75 years
* Experiencing difficulties to have an active everyday life and/or experiencing a need to develop self-management strategies in everyday life.
* Have access to a screen/computer, internet and e-ID as well as being able to use them
* Be able to participate in the program, including be ready for a process of change
* Understanding of the Swedish language in written and oral form.

Exclusion Criteria:

* Sickness or disease which causes difficulties with understanding written and verbal advice (e.g. mental or cognitive illness).
* Having an ongoing misuse
* Receiving palliative care
Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants

complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

The gold standard treatment for completely edentulous patients is a removable complete denture, which satisfies patients functional and aesthetic requirements at a low cost. However, the main problem associated with a complete denture is the instability of the complete removable denture, especially the mandibular one. Implant-assisted overdentures over two or three implants are used as a treatment option to increase stability, function, and retention of the denture at a reasonable cost. The immediate loading protocol allows the placement of temporary restoration on the day of implant placement surgery. Pierluigi Mondani pioneered intraoral welding in the early 1970s as an approach to load patients immediately with resin prosthesis and weld titanium implants to a titanium bar in their mouths. The technique of intraoral welding provides rigid splinting in cases of immediate implant loading. Occlusal loads and stability of occlusion are important to consider in the immediate loading of implants to avoid implant biomechanical failures, marginal bone loss, or even complete loss of osseointegration. Quantitative analyzers like t-scans, which are pressure-sensitive films, and virtual technology give a precise method of assessing the sequence of time and occlusal contact force magnitude by converting qualitative data into quantitative parameters. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.

Eligibility Criteria:
Inclusion Criteria:

* completely edentulous patients
* non-smokers
* good oral hygiene
* motivated patients

Exclusion Criteria:

* major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus
* the need for extensive bone grafting in planned implant site
* pregnancy
* patients under bisphosphonate treatment
* limited mouth-opening for executing the implant surgery.
Upper-body High-intensity Interval Training and Mixed Meal Responses

Cycling and running-based high-intensity interval training are well-established to improve a variety of health outcomes. However, the efficacy of upper-body high-intensity interval training, vital for individuals with lower-body impairments, has yet to be well-characterized. The purpose of this study is to compare the effect of a single bout of upper-body high-intensity interval exercise (HIIE) in comparison to traditional moderate-intensity continuous exercise (MICE) on the blood response (e.g. glucose, insulin, fats) following a meal.

This study is recruiting able-bodied adults (aged 18-65 years). Participants will need to attend the laboratory at the University of Bath for two preliminary sessions, and three main study trials.

The aim of this research is to determine the metabolic responses to a mixed-meal tolerance test following an acute bout of HIIE and an energy-matched MICE bout in able-bodied persons. The hypothesis is that HIIE and MICE will be more effective at reducing the total triglyceride responses compared to a resting control condition.

Preliminary measurements:

Preliminary testing will include measurements of weight and height. There will also be an assessment of resting metabolic rate and maximal exercise capacity. On a second visit, a HIIE familiarisation session will be performed to determine total energy expenditure of the session. All of the exercise protocols will take place on an arm crank ergometer at the University of Bath.

Main trial days:

Before all main trials, participants will be asked to refrain from performing any strenuous physical activity in the 48-h prior (i.e. day 0 and 1) and consuming alcohol/caffeine in the 24-h prior (i.e. day 1). On day 1, participants will be asked to record/replicate their diet using a weighed food-diary. Participants will be asked perform exercise (HIIE and MICE only) at 18:00 on day 1, having consumed no food (other than plain water) from 14:00. They will be given a standardised dinner to eat at 20:00, and asked to avoid the ingestion of any further food (other than plain water) for the rest of the evening.

On day 2 and upon arrival to the laboratory, a cannula will be inserted into a vein, and a baseline blood sample and expired air sample will be taken. The participant will then be asked to consume a smoothie, consisting of peanut butter, banana, coconut oil, sugar, and chocolate-flavoured whey protein powder. The meal should be consumed within 10 minutes and blood samples will be taken from the cannula at 15, 30, 45 60, and 90 minutes and then at every hour for 5 hours after consumption of the meal to monitor changes in metabolic markers. Expired gas samples will also be taken hourly and indirect calorimetry will be used to estimate relative fat and carbohydrate metabolism in response to the meal.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker
* No history of cardiovascular, metabolic, or neuromuscular disease

Exclusion Criteria:

* Individuals with a nut allergy
Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus

To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely. Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50").


Eligibility Criteria:
Inclusion Criteria:

* A clinical and histological diagnosis of CLE (DLE, SCLE, LET) who failed to respond to topical corticosteroids;
* Total RCLASI activity score of skin lesions \>6 (at least 3 points in at least 2 locations);
* At least one primary but preferably 2 methods of contraception;

Exclusion Criteria:

* Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease;
* Clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
* Active severe infection diseases, including chronic or localized;
* Patients with hepatic insufficiency (AST, ALT \> 2.5 x ULN), severe renal failure (creatinine clearance \< 60ml/min), or hypercholesterolemia characterized by:

  1. Fasting triglyceridemia \> 1.5 x upper limit of normal (ULN)
  2. Fasting total cholesterol \> 1.5 x ULN
  3. Fasting low-density lipoprotein (LDL) cholesterol \> 1.5x ULN
* Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil;
* Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin;
* Topical corticosteroids within 14 days prior to dosing;
* Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment;
* Drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John"s Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment;
* Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class and half-life);
* Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
* Concomitant medication with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolbutamide;
* Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine, nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole;

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children

The purpose of this study is to assess the cellular immune responses following 2 doses given 3 months apart of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.

The vaccine tested in this study was TDV. This study assessed cellular immune responses and safety up to 3 years post second TDV administration to healthy children aged 4 to 16 years and in dengue endemic regions.

The study enrolled 200 participants. Participants received:

• TDV 0.5 mL subcutaneous (SC) injection into the upper arm at Day 1 (Month 0) and at Day 90 (Month 3).

This multi-center trial was conducted in Panama and Philippines. 198 participants received the 2-dose schedule of TDV, and 2 participants received only the first dose of TDV (Day 1). Participants made multiple visits to the clinic and were contacted at least every week for the entire study duration post first injection.

Eligibility Criteria:
Main Inclusion Criteria:

1. Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia).
2. Are in good health at the time of entry into the study as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.

Main Exclusion Criteria:

1. Febrile illness (body temperature ≥38°C) or moderate or severe acute illness or infection at the time of enrolment.
2. History or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose an additional risk to the participant due to participation in the study.
3. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccines within 28 days after Day 1 (Month 0).
4. Previous participation in any clinical study of a dengue candidate vaccine, or previous receipt of any dengue vaccines (investigational or licensed).
Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients

The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD with symptoms over 1 year
* FEV1/FVC \< 70% and FEV1 \>= 40 and \< =70 % of predicted post-bronchodilator
* Ex-smokers for at least 12 months

Exclusion Criteria:

* Past history or current evidence of clinically significant heart disease
* Current diagnosis of asthma
* Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b