cyrilzakka/clinical-trials huggingface dataset:
Effect of Augmented Reality Intervention on the Range of Motion, Muscle Strength, Function of Upper Extremity and Balance in Children With Spastic Hemiplegic Cerebral Palsy: A Randomized Clinical Trial

Cerebral Palsy (CP) is a disorder of the development of movement and posture, causing activity limitations attributed to nonprogressive disturbances of the fetal or infant brain that may also affect sensation, perception, cognition, communication, and behavior. Motor control during reaching, grasping, and walking are disturbed by spasticity, dyskinesia, hyperreflexia, excessive coactivation of antagonist muscles, retained developmental reactions, and secondary musculoskeletal malformations, together with paresis and defective programing. Weakness and hypoextensibility of the muscles are due not only to inadequate recruitment of motor units, but also to changes in mechanical stresses and hormonal factors. As it affects the children, therefore it should be emphasized. Effect of Augmented Reality (AR) based therapeutic games on the range of motion, muscle strength,function of upper limb and balance of spastic hemiplegic cerebral palsy children would be assessed through goniometer, manual muscle testing (MMT), disability of Arms, Shoulders, and Hand (DASH) questionnaire, and Pediatric Berg Balance Scale, respectively.

A total of 30 children with spastic hemiplegic cerebral palsy would be recruited and randomly divided into three groups, 10 in each group. The demo-graphical data would be collected through a general demographic questionnaire. Outcome measures would include Goniometer to determine the Range of Motion (ROM), Manual Muscle Testing (MMT) to determine the upper limb muscle power/strength, disability of Arms, Shoulders, and Hand (DASH) questionnaire to assess the function of upper extremity, and Pediatric Balance Scale to determine the body balance.

Eligibility Criteria:
Inclusion Criteria:

Children with diagnosed spastic hemiplegic cerebral palsy, aged between 6 to 12 years, having sufficient cognitive capacity to understand the basic instructions and to cooperate with the instructor during the assessment and intervention, ambulant- classified as level 1 or 2 on Gross Motor Functional Classification System, able to move the affected body parts easily, and sufficient for functional activity- score of 1 or 2 on Modified Ashworth Scale, good general health, without any other known neurological or orthopedic diagnoses, as confirmed by health professionals and their parents.

Exclusion criteria:

Children who have received motor therapy treatment (e.g. Botulinum Toxin/Constraint-Induced Movement Therapy) in the past six months or plan to receive such treatment during the study,those with severe attention deficits, or those who have a history of seizures which can be triggered by television light (confirmed by the child's therapist or pediatric neurologist), or those children who have visual and/or hearing impairments, or children with musculoskeletal contractures or deformities will be excluded from the study.
To Investigate the Relationship Between the Viscoelastic Properties of the Zona Pellucida of Human Oocyte and the Blastocyst Utilization Rate

In in vitro fertilization (IVF) treatment, oocyte quality is one of the key factors influencing the success rate of fertilization. The zona pellucida (ZP) is a spherical structure that surrounds the human oocyte and, together with cumulus cells, forms the cumulus-oocyte complex (COC). These two components engage in bidirectional communication and metabolic regulation to support oocyte growth and maturation. Additionally, the physical rigidity of the zona pellucida plays an important role in the fertilization process.

OPAL X1 is a non-invasive and highly safe device specifically designed to measure the viscoelastic properties of the zona pellucida. This system consists of an ultra-precise pressure control mechanism and analytical software to assess oocyte quality before fertilization. OPAL X1 applies pressure through a micropipette while simultaneously recording the movement of the zona pellucida within the micropipette. An algorithm then analyzes the recorded motion images and classifies the oocytes into different quality grades (Grade A, B, C).

This study aims to investigate the correlation between oocyte classification results obtained from the OPAL X1 grading system and oocyte quality. By integrating spindle-view and time-lapse technology, the study seeks to identify the optimal parameters for oocyte quality assessment. Furthermore, these findings will be applied to predict the success rate of intracytoplasmic sperm injection (ICSI), the likelihood of blastocyst formation, and pregnancy outcomes after embryo transfer. Ultimately, this study aims to provide more efficient and timely embryo development information before IVF, assisting clinicians in formulating and optimizing IVF treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

1. Women who have started the in vitro fertilization (IVF) treatment and related examinations.
2. Female participants aged ≤38 years with an anti-Müllerian hormone (AMH) concentration greater than 1.1 ng/mL and a collected oocyte count of more than 10.
3. Participants who consent to undergoing IVF with intracytoplasmic sperm injection (ICSI) and time-lapse embryo culture.

Exclusion Criteria:

1. Women diagnosed with untreated uterine abnormalities as assessed by a physician.
2. Participants with a body mass index (BMI) outside the range of 18.5-30 kg/m\^2.
3. Patients undergoing IVF using sperm retrieved through surgical extraction.
4. Patients undergoing IVF using donated oocytes or donated sperm.
A Study of S6G5T3 in the Treatment of Acne Vulgaris

To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

In this Phase 3, multi-center, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 9 years of age with facial acne vulgaris will be eligible for enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study.
2. Male and female 9 years of age and older.
3. Have 2 or fewer cysts or nodules.

Exclusion Criteria:

1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter \[mm\] in diameter).
2. Acne conglobata, acne fulminans and secondary acne (for example, chloracne, drug-induced acne).
3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma).
4. Underlying disease that requires the use of interfering topical or systemic therapy.
5. Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.
AST Clinical Investigation

Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.


Eligibility Criteria:
Inclusion Criteria:

* people ( disbetes people)with at least 8 hours of limosis

Exclusion Criteria:

* After meal(when doing the test)
* take Hypoglycemic Drugs(when doing the test)
* with insulin(when doing the test)
* after strenuous exercise(when doing the test)
* Pregnant women
* neonates
* patients in a hyperglycemic-hyperosmolur state, with or without ketosis.
* patients who are dehydrated, hypertensive, hypotensive or in shock.
The Effects of a Springtime Home Cleanse on Skin, Gut, Metabolic and Mental Health

This pilot study will evaluate the effects of a Springtime Home Cleanse on skin, gut, metabolic, and mental health. The study will also assess changes in overall quality of life. The results will be used to design a larger cleanse-based study in the future.

Short-term dietary cleanses and other popular detoxification methods are thought to eliminate accumulated toxins from the body and subsequently, promote health and well-being. Although previous studies have reported improvements in weight loss, blood pressure and insulin resistance with these practices, there is not enough scientific evidence to corroborate these claims. Therefore, the objective of this pilot study is to determine the effects of a short-term dietary cleanse on various parameters of skin, gut, metabolic and mental health and evaluate the aforementioned health claims.

Eligibility Criteria:
Inclusion Criteria:

* Males and females (ages 18-69)
* Individuals must be able to read and comprehend study procedures and consent forms.
* Individuals who have baseline metabolic, gut or stress dysfunction
* Individuals must be able to minimize activity during the home cleanse for full participation and compliance.
* Individuals must be willing to reduce caffeine, sugar, alcohol, dairy and carbohydrate rich foods throughout the study.
* Individuals must be willing to have flash photo facial images taken with imaging systems.

Exclusion Criteria:

* Individuals with a known allergy to lime or lime juice, ginger or ginger pickle, turbinado sugar, rock salt, curcumin, coriander, fennel, cardamom, cinnamon, trikatu, yellow mung dal, kitchari spice, triphala, dashamula and guduchi powder, castor oil and chyavanprash.
* Individuals who are lactose intolerant, or with a known allergy to ghee.
* Individuals who are in the process of being vaccinated.
* Individual who have a history of gastrointestinal inflammatory diseases or a history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis) or other similar systemic diseases in the opinion of the investigator.
* Individuals who are recovering from a serious illness (requiring hospitalization), infection (requiring hospitalization), or surgery within one month of starting the study or unwilling to wait one month after their illness, infection, or surgery prior to starting the study.
* Individuals who are recovering from a non-serious illness or infection who are recovered and unwilling to wait 2 weeks from their illness or infection.
* Individuals who are in a concurrent intervention based clinical research study at this site or any other facility in the past two weeks.
* Has a condition or is on a medication the investigator and/or designee believes could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results.
* Individuals who have had exposure to systemic antibiotics within the month prior or unwilling to wash out for a month.
* Women who are pregnant or breastfeeding.
* Individuals who are cognitively impaired.
* Prisoners
Recommendations for the Treatment of Children With Burkitt's Lymphoma

This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.

This is the 4th Burkitt's Lymphoma (LMB) study by the GFAOP group. This study hopes to include at least 14 Sub Saharian countries some of whom have never participated in a LMB study. The evaluation of improvement in early diagnosis should be possible in this study. The study hopes to be able to evaluate children earlier, with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for children with a stage IV disease.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.

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Exclusion Criteria:

Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.
HA35 Acute Alcohol Study

Eligible subjects will be asked to take a placebo/treatment capsule for a total of 3 days and then participate in a study visit on the fourth day. This study visit will include a medical exam, clinical labs, questionnaires, body composition measurements, and urine and stool collections. Additionally, participants will consume a sugar cocktail to measure their gut permeability, participate in an acute ethanol challenge, and undergo two muscle biopsies. The study will take approximately 3-4 hours and a designated driver will need to drive the participant home. On the fifth day, you will be asked to return to drop of the 24-hour urine collection.

Interested subjects will be assessed for eligibility and a written informed consent will be obtained. The screening visit will consist of a medical exam, clinical labs (if not available in medical record), and questionnaires. Those who pass the screening will be eligible for a baseline visit (may be combined with screening if appropriate labs are already done). The baseline visit will include collection of blood, urine, and stool samples, body composition measurements, and randomization into either HA35 or placebo groups. Patients will be instructed to take the HA35 or placebo daily in the morning before breakfast 3 days prior to the day 4 visit. Patients will be informed that they will need to have a driver that is known to them for the day 4 visit. In the morning of the day 4 visit, confirmation of a driver will occur prior to starting study procedures. During the day 4 visit, patients will have an acute ethanol challenge where they will need to consume 2mL/kg of vodka in 100mL of juice in under 60 minutes. Muscle biopsies will be collected before and after the challenge and blood will be collected throughout the day. In addition, patients will be given lactulose/mannitol/sucralose/sucrose cocktail to measure gut permeability. The costs of any of these tests/procedures will not be billed to the patient and will be covered by the department. The participant will not be responsible for any costs.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men
* Ability to understand and willingness to provide written consent

Exclusion Criteria:

* Any known chronic illness including but not limited to cancer (except non-melanoma skin cancer)
* Poorly controlled diabetes (Hemoglobin A1c \>9.5 g/dl)
* Untreated hyper/hypothyroidism
* Uncontrolled hypertension or hypercholesterolemia
* End-stage renal disease
* Liver disease of any etiology
* Coronary artery disease or stroke
* Active intravenous drug use
* History of gastric bypass
* Medications known to alter muscle protein synthesis (systemic corticosteroids, tamoxifen, high dose estrogen, testosterone, or anabolic steroids)
* Pregnancy
* Past alcohol use disorder
* Abnormal clotting factors
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy

The purpose of this study was to determine the efficacy and safety of BCX9930 monotherapy for the treatment of PNH compared to continued C5 inhibitor therapy in adult PNH participants with residual anemia despite treatment with a C5 inhibitor.

This was a randomized, active comparator-controlled, open-label, parallel-group, 2-part study. Parts 1 and 2 were conducted in the same participants.

Part 1 of the study was designed to evaluate the efficacy, safety, and tolerability of oral BCX9930 monotherapy for 24 weeks versus continuing C5 inhibitor therapy in participants with PNH with inadequate response to their current C5 inhibitor therapy. Participants were randomized to either discontinue C5 inhibitor therapy and start BCX9930 monotherapy or to continue C5 inhibitor therapy for the 24-week randomized treatment period. The primary efficacy and safety analyses were based on Part 1.

Part 2 of the study was designed to evaluate the long-term safety, tolerability, and effectiveness of BCX9930 monotherapy when administered through Week 52. All participants in Part 2 received BCX9930. Participants who were randomized to BCX9930 monotherapy in Part 1 continued to receive BCX9930 in Part 2. Participants who were randomized to C5 inhibitor therapy in Part 1 discontinued that therapy at the Week 24 visit and received BCX9930 in Part 2.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 years old
* Body weight ≥ 40 kg
* Documented diagnosis of PNH
* Currently being treated with a stable C5 inhibitor regimen
* Documentation of current vaccinations against Neisseria meningitidis and Streptococcus pneumoniae or willing to start vaccination series
* At screening: PNH clone size of ≥ 10% and hemoglobin ≤ 10.5 g/dL

Exclusion Criteria:

* Known history of or existing diagnosis of hereditary complement deficiency
* History of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation
* Myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition
* History of malignancy within 5 years prior to the screening visit
* Active bacterial, viral, or fungal infection or any other serious infection within 14 days prior to screening
* Treatment with anti-thymocyte globulin within 180 days prior to screening
* Initiation of treatment with an erythrocyte or platelet growth factor, or danazol within 28 days prior to screening
* Receiving iron supplementation with an unstable dose in the 28 days prior to screening
Schulze Muscular Dystrophy Ability Clinical Study

The primary objective of the Schulze study is to evaluate the function of the upper limbs of subjects diagnosed with neuromuscular disorders, with and without use of the Abilitech Assist device in the clinic and home environments. Functional outcomes will include documenting active range of motion and the ability to perform activities of daily living (ADLs) using the standardized Canadian Occupational Performance Measure (COPM) and the Role Evaluation of Activities of Life (REAL) assessments. Secondary objectives are to assess the safety record and report on adverse events (AEs) and parameters related to device usage, including device usage time and the time required to don/doff the device. Secondary objectives also include characterization of user upper limb performance based on etiology.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects between 10 and 99 years of age, with onset of neuromuscular conditions that cause quadriparesis
2. MMT score of 1-3 in the elbow, wrist and hand; and a MMT score of 2-3 in the shoulder of at least one of the subject's arms
3. Ability of subject to raise their forearm off of their lap or laptray
4. Willingness to comply and participate with the study protocol and attend the study sessions
5. Ability to communicate verbally and respond to questions and commands
6. Ability to provide informed consent
7. Selected for participation based on investigator discretion

Exclusion Criteria:

1. Use of invasive ventilator
2. Open wounds or chronic pressure sores on upper extremities, neck, back or torso
3. Significantly unstable upper extremity joints
4. Unhealed bone fractures in the upper extremities
5. Active rotator cuff tear, grade 2 or 3
6. Surgical fixations limiting full passive range of motion
7. Uncontrolled upper-limb spasticity that significantly limits normal range of motion
8. Uncontrollable pain in the neck, shoulders or upper limbs
9. Ability to fully raise both hands simultaneously above their head with ease as defined by the investigator
10. Lack passive shoulder abduction of 120 degrees
11. Lack 90 degrees of passive elbow extension
12. Unable to follow instructions
13. Exhibit significant behavioral problems
14. Inability to provide consent
Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea

This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.

This is an open-lable, single-arm, evaluator-blind and prospective study aimed to evaluate the feasibility of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OSA, based on AHI 10\~60 (as assessed per baseline PSG).
* Subject understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form.
* BMI ≦ 28.

Exclusion Criteria:

* Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
* Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the device. (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Sleep Therapy System.
* History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
* History of allergic reaction to silicone.
* Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
* Currently working nights, rotating night shifts, planned travel across four or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices.
* Current use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study.
* Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including New York Heart Association (NYHA) class III or IV heart failure, CAD with angina or myocardial infarction (MI)/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the study.
* Female subjects who are pregnant or intend to become pregnant during the study period.