cyrilzakka/clinical-trials huggingface dataset:
Social Skills in Children With Autism Spectrum Disorders

To evaluate whether a structured social skills program, called Social Skills Development,is superior to a wait list control group on measures of interpersonal interaction. The Social Skills Development (SSD) is a 16-week, group intervention that uses activities and peer tutors to promote interpersonal skills in children 8 to 11 years of age with Autism Spectrum Disorders.Following a diagnostic and social skills assessment,children are randomly assigned to SSD or wait list for 16 weeks. Children who were randomized to the wait list are offered SSD at Week 16. Children randomized to SSD are followed for 9 months to assess the durability of gains during the first 16 weeks.

This project is designed to evaluate the acceptability and initial efficacy of a structured group treatment intervention for enhancing social behavior in 40 children with autism spectrum disorders (ASDs). An important long-term goal of this project was to develop a model for delivery of social skills training that could be tested in a larger trial and ultimately exported to schools and community settings. To accomplish these aims, we designed a randomized clinical trial to evaluate a structured social skills program for school age children with pervasive developmental disorders (PDDs)compared to a Wait List control group. Specific aims included gathering preliminary evidence on the efficacy of the intervention on various parent measures of behavior, as well as an assessment of overall social functioning by an independent rater who would be blind to treatment assignment. The Social Skills Development program uses semi-structured activities and peer tutors to promote interpersanal skills. To evaluate acceptability of the program, we planned to track attendance, attrition and parent satisfaction in the trial. Finally, to evaluate the durability of gains achieved during the Social Skills Development program, we re-assessed the subjects initially randomized to the active treatment group at 9 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* 8 to 11 years
* Full Scale IQ score \> 70
* PDD diagnosis (autism, Asperger's, PDD-Not Otherwise Specified)

Exclusion Criteria:

* concurrent, untreated psychiatric disorder(such as anxiety, depression or conduct disorder)
Self-Managed Walking Improves Function

We are conducting a clinical research trial to determine the role of self-managed walking therapy to improve walking ability in patients with diabetes mellitus and peripheral arterial disease (PAD). PAD, commonly referred to as poor circulation in the legs, is a very common disease in patients with diabetes mellitus. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. We will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function.

Peripheral arterial disease (PAD) is a prevalent illness that affects 12% of U.S adults. Diabetes mellitus is one of the strongest atherosclerotic risk factors for this disease. Among patients with diabetes mellitus, the prevalence of PAD is as high as 29%. An underutilized component of care for PAD is walking therapy. Walking has specifically been shown to improve functional status in patients with PAD and leg symptoms.

Leg symptoms in PAD include intermittent claudication and atypical leg symptoms (leg discomfort other than intermittent claudication). Patients with symptomatic PAD have impaired lower extremity functioning, which clinically manifests as slower walking speed, reduced walking distance, and lower physical activity levels. These functional deficits often hinder the ability to live independently in the community (e.g., walking to the bus stop in time for the next bus, shopping independently for groceries). Reduced physical activity is associated with an increased risk for mobility loss and a higher risk for functional decline with subsequent inability to perform activities of daily living.

Walking therapy should not be a burden and it should be something that the patient can routinely perform without the need for regular supervision, a treadmill, or to report to the hospital (i.e., self-managed walking therapy). As patients with diabetes mellitus have special needs for self-management behavior (e.g., diet, medication adherence) and, for those with PAD, a higher burden of atypical leg symptoms, the role of a self-managed walking program specific to this group of PAD patients cannot be overemphasized. Thus, this clinical trial has 2 novel aspects: 1) to evaluate the role of self-managed walking therapy for patients with symptomatic PAD and 2) to focus on patients with PAD and diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 years and older
* Diabetes mellitus
* Peripheral arterial disease
* Leg symptoms

Exclusion Criteria:

* Myocardial infarction within 3 months of enrollment
* Inability to walk for exercise secondary to chest pain, dyspnea, or poor balance
* Prior major amputation
Atorvastatin in Management of Newly Diagnosed ITP

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of atorvastatin for the treatment of adults with immune thrombocytopenia (ITP).

The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients, which have no indications of glucocorticoid therapy (platelets count \> 30\*10\^9/L )from Qilu Hospital of Shandong University in China.15 of the participants are randomly selected to receive atorvastatin in 20 mg/d combining with 10 mg/d for 6 months. Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of atorvastatin for the treatment of adults with ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. within 3 months from diagnosis,untreated patients, may be male orfemale, between the ages of 18 \~ 80 years.
3. To show a platelet count \> 30×10\^9/L and without bleeding manifestations.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts within 3 months before the screening visit.
2. Received steroids or other effective therapy for immune thrombocytopenia.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
4. Severe medical condition (lung, hepatic or renal disorder) other than ITP.
5. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
7. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
8. Patients who are deemed unsuitable for the study by the investigator.
Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture

The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture


Eligibility Criteria:
Inclusion Criteria:

Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,

Exclusion Criteria:

Serious chronic diseases, Other perennial allergies
Outcomes of Periodontal Regenerative Treatment

The aim of this recall study is to evaluate outcomes of surgical regenerative treatment of periodontal defects in a cohort of patient previously treated for gum disease at the Royal London Hospital as part of their periodontal care.

This study will be divided in two parts:

Part 1: a retrospective analysis of short-term outcomes of periodontal regenerative procedures undertaken at the Barts Royal London Dental Hospital (RLDH); Part 2: a single recall visit study in which patients identified through part 1 and willing to consent for the study will be reassessed for medium-term outcomes of the regenerative procedures previously undertaken.

For part 1 historic data will be collected from available dental records at RLDH and divided in:

* Timepoint 0: the latest available full mouth periodontal assessment before surgery and x-ray of site/s needing surgical intervention
* Timepoint 1: the latest available full mouth periodontal assessment after surgery and x-ray of same site/s at Timepoint 0

For part 2 data will be collected from patients identified through part 1 and willing to give consent for a single study recall visit:

•Timepoint 2: single study outcome recall visit (full mouth periodontal assessment and x-ray of same site/s at Timepoint 0).

Due to the nature of the study, the time elapsed between Timepoint 0 and Timepoint 2 can vary between 1 and 4 years.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for part 1 of the study:

* Patient age 18 and older
* Patients that received periodontal regenerative surgical treatment at Barts RLDH from January 2017 to January 2019 with and without the use of any biomaterials, bone graft/substitute and membrane or combinations of those.
* Available full periodontal examination records after non surgical therapy to serve as a baseline for the study and not beyond 12 months before surgery
* Available radiographic examination of the tooth treated with surgical regenerative procedure at initial examination or after non surgical therapy to serve as a baseline for the study.

Additional inclusion criteria for part 2:

-Patient able and willing to give informed consent

Exclusion Criteria:

Exclusion criteria for part 1:

* All the patients that do not match the inclusion criteria will be excluded from part 1.
* Patients that received regenerative surgical treatment for the management of gingival recession.

Exclusion criteria for part 2:

* Unable or unwilling to give consent
* Pregnant women
Continuous Blockade of the Brachial Plexus

This study will answer the question whether there is a difference in the effects and complication rates of ultrasound guided continuous interscalene block (CISB) and nerve stimulation-guided continuous cervical paravertebral block (CCPVB). The aim of this study is to evaluate the differences in efficacy and side effects - if any.

This is a prospective randomized double-blinded study that will compare two commonly used approaches for the continuous blockade of the brachial plexus: the CCPVB, which focusses on the six cervical nerve root (C6 root), and CISB, which focuses on the upper trunk of the brachial plexus. Data of sensory testing, motor strength, shoulder pain, phrenic nerve function, recurrent laryngeal nerve (RNL) function, ipsilateral Horner's syndrome, block time and medication doses used for block placement, will be collected. All observations and measurements will be made by a member of the research team who is unaware of patient allocation to any particular group.

Eligibility Criteria:
Inclusion Criteria:

* The general inclusion will be those adult patients who:

  * are between the ages of 18 and 80 years
  * have an ASA Health Classification of I, II, or III
  * are scheduled for shoulder arthroplasty or rotator cuff repair surgery
  * Patients with a BMI of =to/\< 40 Exclusion

The Exclusion criteria will include:

* Patient refusal to participate in the study or sign informed consent
* Patients with contraindications to any of the two blocks or allergy to any of the drugs used
* Patients with shoulder surgery that developed into any other surgery other than total shoulder arthroplasty or rotator cuff repair
* Patients with a BMI \>40
Safety, Tolerability and Pharmacokinetics of Inhalative Administration of BIBN 4096 BS in Healthy Male and Female Volunteers

The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalative administration of increasing doses in healthy male and female volunteers


Eligibility Criteria:
Inclusion Criteria:

* Participants should be healthy males and females
* Age range from 21 to 50 years
* (Broca-Index): within +-20% of their normal weight
* In accordance with Good Clinical Practice (GCP) and local legislation all volunteers are supposed to give their written informed consent prior to admission to the study
* As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG) and a lung function test (Raw, SGaw). Moreover laboratory parameters (including drug screening, HBs-antigen (HBs-Ag), anti HBc-antibodies, anti HCV- antibodies and Human immunodeficiency virus (HIV) test as well as pregnancy test for female subjects are to be determined

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\> 24 hours) within at least 1 month or less than ten half-lives of the respective drug before enrolment in the study (except substitution therapy regarding thyroid gland/or ovaries)
* Use of any drugs which might influence the results of the trial within 1 week prior to administration or during the trial
* Participation in another study with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug abuse
* Blood donation (\>= 100 ml) within four weeks prior to administration or during the trial
* Excessive physical activities within the last week before the study
* Any laboratory value outside the reference range of clinical relevance

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Comparative Effectiveness of the Two Splints in Trigger Finger

RME orthosis is recommended for the treatment of trigger finger. However, its efficacy has not been studied in trigger finger patients. Given the increasing popularity of this orthosis among clinicians, it is important to evaluate their effectiveness to provide evidence for its use in trigger finger. The purpose of this study was to compare the efficacy of a 6-week orthotic intervention in a randomly selected group of patients with trigger finger using MCP-blocking and RME orthoses.

Generally, three types of orthoses are used in the treatment of trigger finger. Some authors used MCP blocking orthosis, while others used DIP or PIP blocking orthosis. Comparative studies are quite limited, as only one study comparing two orthotic designs found that the MCP blocking orthosis was more effective than the DIP blocking orthosis.The MCP blocking orthosis, which restricts the MCP joint to 10-15° of flexion, is commonly used in the conservative treatment of trigger finger.An RME orthosis could be an alternative orthotic treatment option for trigger finger because it holds the MCP in an extended position. The RME orthosis is thought to prevent flexion of the affected finger, thereby limiting tendon glide. This reduces the pressure on the A1 pulley, allowing the tendon to glide more smoothly, reducing the likelihood of triggering. Despite limiting motion,the orthosis still allows the patient to perform daily activities with the orthosis. Therefore, positioning the MCP joint in extension could provide additional benefits in trigger finger. The relative motion orthosis is a new orthotic design that positions the affected finger in 10-15 degrees of extension relative to the adjacent fingers.It also has several advantages, including small size, low-profile design, easy and inexpensive fabrication, and better patient compliance. The primary objective of this study was to compare the efficacy of a 6-week orthotic intervention for pain relief in a randomly selected group of patients with TF using the MCP blocking orthosis and the RME orthosis. The secondary objective was to determine the comparative effectiveness of the orthoses on function and satisfaction with the orthosis.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with Stage 1-3 trigger finger (Froimson Classification)
* A1 pulley triggering

Exclusion Criteria:

* trigger thumb
* multiple trigger fingers on one hand
* neurological disorders
* rheumatologic diseases
* pregnancy
* patients who had received a steroid injection in the affected finger within the previous six months
* patients who had previously undergone trigger release surgery
Use of Social Media to Improve Medication Adherence in Adolescents and Young Adults With Systemic Lupus

The goal of this study was to examine the effect of an online educational program with and without a social media experience.The primary goal of this study was to determine whether medication adherence would be improved by having adolescents and young adults with systemic lupus erythematosus participate in an online educational website, with or without a social media experience. The secondary goal was to determine whether secondary outcomes such as quality of life, stress, and self-efficacy improved in this model, and whether these changes were associated with improvements in medication management.

Self-management skills, including medication management, are vital to the health of adolescents and young adults with systemic lupus erythematosus (SLE). Non-adherence with medications in patients with systemic lupus has been noted to be as poor as 40%. Success in disease control can be significantly impacted by such non-adherence. Poor medication compliance is associated with higher SLE disease activity scores and higher SLE disease activity in turn has been demonstrated to be significantly associated with a decline in quality of life. Much attention has been paid to how to improve self-management skills in adults, but less is known about how to target adolescents, an age group with a complex set of emotional and developmental needs.

The goal of this study was to examine the effect of an online educational program with and without a social media experience.The primary goal of this study was to determine whether medication adherence would be improved by having adolescents and young adults with SLE participate in an online educational website, with or without a social media experience. The secondary goal was to determine whether secondary outcomes such as quality of life, stress, and self-efficacy improved in this model, and whether these changes were associated with improvements in medication management.

Eligibility Criteria:
Inclusion Criteria:

* age between 13 and 23 at the time of recruitment
* having the diagnosis of SLE made or confirmed by a pediatric or adult rheumatologist at Penn State Children's Hospital/Hershey Medical Center
* having regular internet access.

Exclusion Criteria:

* age \<13 or \>23 years
* comorbid medical or psychiatric illness that would affect the outcome measures.
Neurodynamic Sliders Promote Flexibility in Tight Hamstring Syndrome

The goal of this study is to explore the intervention effect of home-based neurodynamic slider program on hamstring flexibility. Fifty physically active male subjects will be randomly assigned to either performing a neurodynamic sliding technique (3x20 reps) or a static stretching protocol (3x30") on a daily basis for a 6-week period. Hamstring flexibility will be assessed by means of the Straight Leg Raise at baseline, immediately after the intervention and after 4 weeks follow up.


Eligibility Criteria:
Inclusion Criteria:

* male
* aged between 18-30yrs
* recreationally/competitively active
* limited hamstring flexibility (Tight Hamstring Syndrome) (SLR≤75°)

Exclusion Criteria:

* a history of any musculotendinous hamstring injury in the previous year
* a history of neurological or orthopedic disorder affecting the lower extremities
* a history of lumbar disc herniation; or (4) a history of a cervical whiplash injury
Citicoline as Neuroprotector in Neonates Exposed to Hypoxia

Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial

Efficacy of Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial

Eligibility Criteria:
Inclusion Criteria:

* neonates with hypoxia.

Exclusion Criteria:

* hypoxic ischemic encephalopathy
Effects of Strength Exercise on Fall Risk in Elderly With Alzheimer's Disease

Interventional study to show the effects of strength exercise on fall risk in elderly with Alzheimer's disease


Eligibility Criteria:
Inclusion Criteria:

* accept to participate in the study, through informed consent
* subjects aged 60 or over with medical diagnosis of Azlheimer´s disease
* minimal physical and mental state to perform the cognitive tests and strength exercise routine

Exclusion Criteria:

* Neurodegenerative disease other than Alzheimer's disease
* Suffering from serious somatic or psychiatric illnesses
* Patients who have practiced strength exercise regularly
Quadratus Lumborum Block for Congenital Hip Dislocation Surgery

Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain.Since initial description for abdominal surgery, the quadratus lumborum block has experienced several surgeries for postoperative pain management in adults and pediatrics. One of these indication is the hip surgery and described for adult hip arthroplasty. In addition we reported two pediatric cases that single dose transmuscular quadratus lumborum block is an affective analgesia for CHD surgery. The aim of this study was to evaluate the analgesic effect of ultrasound guided transmuscular quadratus lumborum block in pediatric patients undergoing CHD surgery.


Eligibility Criteria:
Inclusion Criteria:

- American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
* Incomplete patient forms
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* American Society of Anesthesiologist's III-IV