cyrilzakka/clinical-trials huggingface dataset:
HAND FUNCTIONS OF CHILDREN WITH A SPECIFIC LEARNING DISORDER

Children with Specific Learning Difficulties (SLD) may have problems with fine and gross motor skills compared to their healthy peers. These children may have poor manual dexterity. Taken together, it is not clear how motor and sensory competence of the hand are affected together. In this study, it was aimed to evaluate the sensory and motor ability of the hand and to compare the examined parameters between the SLD group and the healthy control group.

Specific learning disability (SLD) is a common neurodevelopmental disorder that begins at school age and sometimes goes undetected until adulthood. Its incidence in school-aged children is about 5-15%. Children with SLD have difficulty in fulfilling academic qualifications. In addition, there are various problems with fine motor skills, motor-coordination, balance and gross motor skills.

Upper extremity speed and dexterity affect fine motor performance (as they involve manipulative tasks that require a certain amount of time and higher motor skills). In the literature, it is reported that manual dexterity is a stronger predictor than balance on the functional mobility of children with SLD, and it is emphasized that strategies to improve dexterity performance should be focused in interventions for fine motor skills for these children. In addition, it is demonstrated that taking the necessary precautions and planning by evaluating the gross and fine motor skills in detail in SLD is important for the independence and achievements of children in their daily living activities.

Weak hand skills are expected in children with SLD. Problems based on hand performance can be addressed in a more comprehensive way by comparing these children with children with typical development in terms of motor performance and functional mobility. Similarly, although it is recommended to evaluate senses such as touch and stereognosia when evaluating fine motor performance in these children, no comprehensive study including sensory and motor evaluations has been found in the literature.

In this study, in children with SLD; It is aimed to examine the limitations of hand motor and sensory functions in daily activities in terms of general motor competencies and hand skills of the child and to compare them with the healthy control group.

Eligibility Criteria:
Inclusion Criteria:

* To have a diagnosis of special learning disability (regarding DSM-V criteria)
* To be in the age range of 8-14

Exclusion Criteria:

* Any acute or chronic orthopedic or neurological disease that may affect walking performance,
* Any surgery within the last 6 months,
* Severe sensory (hearing, vision, etc.) impairment that prevents him/her from taking commands
* Cognitive and mental severe impairment
A Smartphone Application for Screening of Developmental Disorders in Children

The detection of developmental disorders in the child is often late because the parents do not have the information necessary to consult at the first clinical signs. For example, the diagnosis of autism spectrum disorders is made at the age of 5, so earlier diagnoses are possible earlier or even in the 1st year with appropriate questionnaires.

An application (Malo) has been developed to allow through regular questionnaires from 1 month to 3 years old to assess the child's development by his parents in the form of a digital health record assessing several areas at regular intervals (monthly the 1st year then every 3 to 12 months): sensory, psychomotor development, sleep, height and weight, cognitive and addictions (especially to screens). The questions will be adapted to the age of the child. An alert suggesting to consult the general practitioner or the pediatrician will be generated according to an algorithm validated by a committee of experts.

Based on a study model on health data already carried out as part of the triage application for patients suspected of COVID 19 coronavirus disease.fr with 14 million users in 6 months having improved the relevance of calls to the 15 (8 times fewer unnecessary calls) and general practitioners.

This study will assess parental interest in this application.


Eligibility Criteria:
Inclusion Criteria:

* Parent of a child or more under 3 years of age (1 month to 3 years)

Exclusion Criteria:

* Parent of a child who has already been diagnosed with a developmental disorder, known physical or mental disability
Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics)

The HIP study is designed to follow the clinical experience of young hypertensive children receiving candesartan cilexetil (Atacand) who are between the ages of 1 and less than 11 years old. The study is open label with no concurrent control group. To be eligible for HIP, children must have completed Study 328 without discontinuation due to a study drug-related AE and in the investigator's opinion, have an on-going clinical indication for an orally administered suspension of candesartan cilexetil to control blood pressure. Children will return to clinic every 3 months (more frequently at the investigator's discretion) for safety and efficacy evaluations. Safety will be monitored by serum chemistries, urinalyses, echocardiograms and by physical examinations at specified clinic visits. Blood pressure and heart rate will be measured at each clinic visit. Study drug is administered orally once a day. Investigators determine the efficacious dose ( 0.05 mg/kg; 0.2 mg/kg; 0.4 mg/kg) on a vist-by-vist basis depending on the child's BP response. It is anticipated that study dose will align closely with the effective anti-hypertensive dose determined in Study 328. If the child's hypertension is not well-controlled, dose adjustments up to a maximum of 0.4mg/kg/day and/or the addition of other antihypertensive medications are permitted, with the exception of other angiotensin receptor blockers. The HIP study offers eligible children up to two additional years of treatment with the liquid formulation of Atacand.


Eligibility Criteria:
Inclusion Criteria:

* Must have participated in Protocol 328 (without discontinuation due to a study drug related AE).
* Must sign an informed consent prior to initiating any stus dy procedures.
* Have, in the opinion of the investigator, an on-going clinical indication for oral liquid formulation of candesartan cilexetil to control hypertension
* Weight ≥ 10 kg and ≤ 40 kg.

Exclusion Criteria:

* Any situation, clinical condition (such as clinically significant declining renal function) or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study.
* Estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m2 for non-transplant patients and \<40 ml/min/1.73m2 for transplant patients based on the Schwartz Formula (Schwartz et al 1987) as determined at enrollment into Study 328.
* Impaired liver function defined as either acute liver disease or chronic liver disease with persistently elevated liver enzyme values judged clinically significant by the investigator.
* Currently using any medications that, in the opinion of the investigator could negatively affect the subject when given together with candesartan cilexetil.
A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

The study evaluates the addition of itraconazole to glucocorticoids in management of acute stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will receive glucocorticoids while the other half will receive itraconazole and glucocorticoids

The management of allergic bronchopulmonary aspergillosis (ABPA) includes two important aspects namely institution of immunosuppressive therapy in the form of glucocorticoids to control the immunologic activity, and close monitoring for detection of relapses. Another possible target is to use antifungal agents to attenuate the fungal burden secondary to the fungal colonization in the airways. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory.

Itraconazole, an oral triazole with relatively low toxicity, is active against Aspergillus spp. in vitro and in vivo. The activity of itraconazole against Aspergillus spp. is more than that of ketoconazole. The administration of itraconazole can eliminate Aspergillus in the airways and can theoretically reduce the allergic responses in ABPA. We hypothesize that itraconazole when given in the acute stages of ABPA will decrease the chances of relapse and progression to glucocorticoid-dependent ABPA.

Eligibility Criteria:
Inclusion Criteria:

Treatment naive patients of allergic bronchopulmonary aspergillosis (ABPA) defined by the presence of all the following:

* asthma
* immediate cutaneous hyperreactivity on Aspergillus skin test or A.fumigatus specific IgE levels \>0.35 kUA/L
* elevated total IgE levels \>1000 IU/mL and, two of the following features:
* presence of precipitating antibodies against A.fumigatus in serum
* fixed or transient radiographic pulmonary opacities
* total eosinophil count \>1000/µL
* bronchiectasis on HRCT chest

Exclusion Criteria:

* Intake of systemic glucocorticoids for more than three weeks in the preceding six months
* Exposure to azoles in the last six months
* Immunosuppressive states such as uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure and others
* Patient on immunosuppressive drugs
* Pregnancy
* Enrollment in another trial of ABPA
* Failure to provide informed consent
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease.

PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.

OBJECTIVES:

Primary

* Determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide.

Secondary

* Determine the tolerability of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily for 6 months in the absence of disease progression.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of systemic mastocytosis

  * Aggressive or borderline (smoldering) disease (in first line or more)
  * Relapsed or progressive disease
* Measurable or evaluable disease
* Presence of c-Kit D816V mutation in the skin, spine, or infiltrated organs
* No nonsymptomatic mastocytosis

PATIENT CHARACTERISTICS:

* Life expectancy \> 3 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 1 month prior to, during, and until first menstrual cycle after completion of study treatment
* Bilirubin \< 2 times normal (unrelated to disease)
* Liver enzymes \< 2 times normal (unrelated to disease)
* Creatinine ≤ 300 mmol/L
* No central or peripheral neuropathy leading to psychiatric concerns
* No HIV positivity
* No active infection or other serious underlying illness that would preclude treatment
* No history of thromboembolism or deep vein thrombosis
* No geographical, social, or psychological reasons preventing medical monitoring

PRIOR CONCURRENT THERAPY:

* More than 4 weeks since prior antitumor therapy (e.g., chemotherapy, radiotherapy)
* No other concurrent treatment specific for this disease
* No concurrent participation in another experimental drug trial
Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery

Surgical Site Infections (SSI) represents a significant complication in plastic surgery. Infections can result in a prolonged recovery and impair long-term cosmetic appearance. One potential method to reduce infection is by applying a thin layer of dermal glue over the sutures at the site of incision immediately after the surgery. Conventional closures, such as sutures or staples, leave the site vulnerable until epithelialization occurs in 24 to 48 hours. In contrast, dermal glue provides an instant, waterproof barrier and it has been shown to have intrinsic bacteriostatic properties. The glue is supplied as a liquid enclosed in a vial and when applied, polymerizes rapidly in an exothermic reaction in the presence of moisture to form a solid adhesive. 2-Octylcyanoacrylate (2-OCA)-based glue is formulated to be more flexible than previous preparations. The application of dermal glue is rapid, simple and requires no specific follow-up as it naturally sloughs off overtime. The purpose of this study is to determine if 2-OCA-based glue can reduce the rate of surgical site infection following surgery. Patients undergoing breast surgery will be recruited and randomized to either a group receiving a layer of glue over sutures following surgery or no treatment. Patients will be followed up at 30 days and at 8 months for signs of infection, additional complications and the visual appearance of the scars. The cost of treating and infection will be calculated to determine if using dermal glue to prevent infection is economically feasible. This research has the potential to find a method to reduce surgical site infection, which can be applied to other surgeries.


Eligibility Criteria:
Inclusion Criteria:

* patient has provided signed consent
* undergoing surgery on the breast

Exclusion Criteria:

* Infection within 30 days
* Previous hypersensitivity to cyanoacrylates or formaldehyde
The COMparison of CALcium Bioavailability Between AlgaeCal® and a Proprietary Supplement

In a crossover, single blind, randomized trial the calcium bioavailability of two calcium supplements will be compared.That is AlgaeCal®(Algaecal Inc, Vancouver, Canada)(1 dose is 3 capsules of 180 mg calcium), derived from ocean algae and the proprietary calcium supplement Caltrate 600® (Wyeth Consumer Healthcare, Inc).

After a screening visits 20 healthy male subjects aged 20-50 years will spend a day at the research center to examine calcium bioavailability data. They will be randomized to consume either first the AlgaeCal® supplement or the Caltrate 600® supplement. After a one week wash-out period subjects will be supplemented with the other supplement. During the examination day blood and urine samples will be collected before and until eight hours after the supplementation for analyses of calcium, creatinine, phosphorus, albumin and 25 Hydroxy vitamin D. Subjects are instructed to avoid taking calcium and/or vitamin D supplements 1 week before and during the entire study period. In addition, they are not allowed to take medication that may affect calcium metabolism.

The hypothesis of the study is that calcium bioavailability of the AlgaeCal® supplement will be higher than that of the Caltrate 600® supplement.

This was a single centre, single-dose, randomized, two way cross-over study in healthy male subjects.

The study consisted of the following visits:

1. A screening visit to select eligible subjects according to the inclusion/exclusion criteria detailed in the study protocol.
2. Visit 1 in which subjects who satisfied the selection criteria were assigned to one of the two intervention sequences (Algaecal®/ LCCS or LCCS/Algaecal®) according to the randomization list;
3. Visit 2, after at least one week of wash-out in respect to visit 1. Subjects arrived at the centre early in the morning The first blood sample was drawn before the ingestion of the calcium supplement and every hour after for the following 8 hours. Urine sample were collected before the ingestion of the calcium supplement and every 2 hours after for the following 8 hours. During each study visit the subjects were present in the site centre from the morning to the evening. Calcium supplement was given under fasted condition and during the eight hours after the product ingestion, according to the protocol, only water ad libitum was allowed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy free-living men aged 20 to 50 years-old
* Consent to the study and compliance with study product

Exclusion Criteria:

* Calcium supplements or calcitriol taken one week or less before the first kinetic visit
* Heart disease
* Circulation problems
* Parathyroid gland disorder
* Kidney disease
* Past or present kidney stones
* Gastrointestinal disturbances that could potentially affect the absorption of calcium supplements
Assessing the Effects Of Treadmill On LPA, Sitting Time, and Cardiovascular Risk

The purpose of this study is to:

1. Evaluate the relative efficacy of a treadmill desk intervention on light physical activity and sitting behaviors at work over four weeks;
2. Evaluate the relative efficacy of a treadmill desk intervention on the cardiovascular risk profiles (blood pressure, body weight, body fat percentage) over a four-week period.

American workers spend 70-80% of their time at work sitting at a desk, working on a computer, talking on a telephone, and sitting in meetings. Traditional approaches to increase MVPA in the workplace may not be sustainable as they require deliberate and dedicated time away from work, and may be perceived as harmful to productivity. Sedentary behavior interventions, in contrast, do not interfere with daily tasks and productivity and require small but cumulative changes in posture and LPA throughout the workday.

Sedentary behavior interventions in the worksite, including those conducted by our team, have shown promising effects. Studies that have used multi-level approaches targeting individual, social, and environmental factors have been most effective. The most robust environmental support has been the use of sit-stand workstations, providing distinct opportunities for workers to reduce sitting while maintaining productivity. However, treadmill desks may provide an even greater opportunity to both reduce sitting and increase LPA during the workday. Thus, a pilot study is required to test the efficacy of this approach to reduce sitting and increase LPA in the workplace.

Eligibility Criteria:
Inclusion Criteria:

* Not currently pregnant or planning to become pregnant during the 11 week study period.
* Able to read and write in English.
* No current use of a sit/stand or treadmill desk.
* Work that is done in a predominately stationary position.
* Working at UMN West Bank Office Building at least 30 hours per week.
* Not currently meeting physical activity guidelines.
* No balance issues (i.e. healthy vestibular system)
* No contraindications to standing or walking
* Weight stable for the past 12 months.
* Taking no more than 3 prescription drugs, with stable dosage, over the past 12 months
* Answer of no to all Physical Activity Readiness-Questionnaire (PAR-Q) questions

Exclusion Criteria:

* Currently pregnant or actively trying to become pregnant during the 14 week study period.
* Unable to read and write in English.
* Working less than 30 hours per week.
* Currently meeting physical activity guidelines.
* Non-sedentary job.
* Current use of treadmill desk
* Any reported balance problems
* Anyone with contraindications to standing or walking
* Weight fluctuations of more than +/- 10% of their body weight in the past year
* Individuals taking more than 4 prescription drugs and/or unstable dosage of medications over the past 12 months if taking 3 or less.
* Answer of yes to any PAR-Q questions
Cryoablation for Advanced Bone and Soft Tissue Tumors

This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. All eligible patients were enrolled. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. Clinical data of eligible patients were scheduled to be retrospectively collected from December 2016 to February 28, 2022. All patients eligible for inclusion. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

Eligibility Criteria:
Inclusion Criteria:

No age restriction, male or female.

The pathological diagnosis was a subtype of bone and soft tissue sarcoma.

The clinical stage was determined to be metastatic or locally unresectable bone and soft tissue sarcoma.

At least one cryoablation of tumor lesions was performed in our hospital.

Target lesions can be evaluated according to the efficacy evaluation criteria for solid tumors (RECIST; Version 1.1) Measure diameter changes.

Follow-up data were complete.

Exclusion Criteria:

Not applicable.
A Scalp Lotion Toimprove Sensitive Scalp Syndrome

Overall, 100 Caucasian subjects participated in this 6-weeks lasting study, AC5+ was applied daily. All subjects had clinically confirmed mild to moderate alopecia and self-declared sensitive scalp. Instrumental assessments included Trans Epidermal Water Loss (TEWL), inflammation markers, clinical assessments included the severity of erythema, inflammation and greasiness. Subjective/Self assessments comprised the intensity of the scalp itch/pruritus and the evaluation of their head hair status (volume, abundance, strength). Same assessments were provided by the investigators.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* mild alopecia:
* female: Ludwig type 1
* male: Hamilton III to IV type

Exclusion Criteria:

* Moderate or severe alopecia
* Dandruff
Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection.


Eligibility Criteria:
Inclusion Criteria:

* The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features.

  1. corneal epithelial defect with stromal infiltration
  2. reaction in anterior chamber
  3. positive for bacteria or fungus
* The patients have to receive subconjunctival antibiotic injection twice at least.
* The patients must be informed consent.

Exclusion Criteria:

* The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs.
* The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection.
* Unable to cooperate with the treatment.
* Pregnant women
Safety Study of Stopping Thromboprophylaxis Based on Ultrasound Results After Total Knee Replacement

The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.


Eligibility Criteria:
Inclusion Criteria:

* First total knee joint replacement
* Signed informed consent

Non-inclusion Criteria:

* History of venous thromboembolism/major bleeding/Heparin induced thrombopenia
* Active cancer
* Long-term anticoagulation