cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Physical Activity for the Management of Stereotyped Behavior and Anxiety in Children with Autism Spectrum Disorder

The primary purpose of the study is to investigate whether physical activity can significantly manage stereotyped behavior and anxiety in children diagnosed with Autism Spectrum Disorder (ASD). The study aims to contribute to the existing literature by providing robust evidence on the efficacy of Physical Activity intervention for ASD, which could inform clinical practices and improve treatment outcomes.

The current quantitative study will be carried out in two phases. A cross-sectional survey will assess the autism category (mild, moderate and severe), stereotyped behavior and anxiety in autistic children during the first phase. A randomized controlled trial (RCT) will be done during the second phase where children with Autism Spectrum Disorder who are identified with moderate category of autism, stereotyped behavior and anxiety will be categorized into two groups i.e. waitlist control group and intervention group through the process of randomization. Then physical activity intervention would be applied to participants in the intervention group. The control group is the waitlist control group so initially no intervention will be given to participants in the control group but the intervention will be given to the control group participants once the study is completed. The physical activity intervention would be implemented on participants using individual and in-person modes. The pre-and post-assessment will be done at Times 1 and 2 within and between control and interventional groups. After doing post assessment the difference between pre and post-assessment will be compared to explore the efficacy of physical activity intervention in children with Autism Spectrum Disorder.

Eligibility Criteria:
Inclusion Criteria:

Autistic children who are students of special education school. Only autistic children age 8 to 12 are part of the study. The participants who completed the informed consent will be part of the study. Participants who were showing symptoms of mild to moderate level of autistic symptoms as assessed by childhood autism rating scale. Participants should not have any physical or other mental health condition that would Prevent them from engaging in physical activity sessions safely were part of this study.

Exclusion Criteria:

Adults students are not part of the study. Autistic children who are not part of special education school. The participants who are severe autism category not part of the study. The participants who are under serious clinical condition will not be part of study.
Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery

Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.

46 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo spine surgery, were randomized and divided into two groups. (23 patients in each of the control and superficial ESP groups). Superficial ESP block was performed for SESP group and standard (opioid-based) analgesia performed in the control group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative numeric rating scale values were the primary outcome measure. 24-hour total morphine consumption was secondary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18-65
* Patients who will undergo spine surgery (at least two level)
* ASA I-II-III patients

Exclusion Criteria:

* Clinically known local anesthetic allergy
* Morbid obesity (body mass index\>40 kg m2)
* Clinically diagnosis of opioid, alcohol and substance dependence
* Clinically diagnosis of psychiatric disease
* Coagulopathy
* Patients with ASA IV-V
* Single level surgery
Spinal Curvature, Mobility, and Low Back Pain Relationship in Women With and Without Urinary Incontinence

The aim of this study was to investigate the relationship among sagittal spinal curvatures, mobility, and low back pain in women with and without urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 65 years,
* diagnosed with stress and mixed urinary incontinence
* healthy women

Exclusion Criteria:

* Women with prior history of injury or surgery related to spine,
* spinal deformity,
* systemic pathology,
* any rheumatologic disease,
* neurologic condition,
* symptomatic pelvic organ prolapse,
* malignancy,
* pregnancy
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans

Resveratrol is a natural polyphenol (a compound containing a phenol functional group) that can be found in many plants. The purpose of this research is to study the effects of resveratrol on the action of insulin (a hormone produced in the body by the pancreas that regulates the amount of sugar in the blood), fat accumulation, and inflammation in the body.

Participants will meet with the study team to discuss dietary recommendations. Each participant will be instructed to follow a standardized diet plan and to avoid vigorous exercise before beginning the study. Participants will be given a 28 day supply of resveratrol capsules (Two 500 mg capsules taken twice a day). A comprehensive study of whole-body insulin action called a pancreatic clamp will be done and small samples of fat and muscle will be taken before and after the administration of resveratrol.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 26-35
* Non-smoker
* Normal screening labs (CMC, chemistry, LFTs PT/PTT)
* No CAD
* Good IV access

Exclusion Criteria:

* High cholesterol
* \<4 week history of participation in another drug trial
* Severe hypertension
* Heart disease
* Liver disease of liver abnormalities
* Cerebrovascular disease, i.e. stroke
* CVD
* Seizures
* Bleeding disorders
* Muscle disease
* Cancer
* HIV
* Hepatitis (all types)
* Mentally disabled persons
* Pregnant women
* Allergies to Novocaine, Lidocaine, Benzocaine
* Subjects on the following medications:

  * Anticoagulant and antiplatelet drugs
  * Anti-epileptic drugs
  * Mexiletene
  * Quinidine
  * Cyclosporine
  * Tacrolimus
  * HIV protease inhibitors
REal-time Data Monitoring for Shared Adaptive, Multi-domain and Personalised Prediction and Decision Making for Long-term Pulmonary Care Ecosystems (RE-SAMPLE)

The main objective of this RE-SAMPLE cohort study is to identify from a real-world data (RWD) set that will be collected, a subset of data that can be potentially used as important predictors and parameters for disease progression of COPD and complex chronic conditions, and multi-morbid exacerbations. The secondary objective is to evaluate the feasibility of RWD collection from a patient's perspective.

Study design: This is a prospective observational cohort study to collect RWD in patients with COPD and complex chronic conditions, with a maximum of 38 months of follow-up. Measurements are performed and RWD are collected by using the Healthentia mobile phone application at baseline (e.g. patient characteristics), daily (e.g. symptom diary), during follow-up visits and at deterioration, and from hospital data (e.g. healthcare visits). The choice of parameters and measurement tools that will be collected during the cohort will be updated every three months during the first year of the cohort (via protocol amendments). These updates are based on citizen-design sessions and on new literature insights. Prognostic models will be developed including predictors derived from the RWD collection.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD according to the GOLD criteria \[5\] (FEV1 \< 80% of the predicted value and FEV1/FVC \< 0.70);
* Patients can be included both at stable state and during exacerbation/hospitalization;
* At least one comorbidity:

diabetes mellitus (glucocorticoid-induced, or stable type 1 or 2), chronic heart failure (clinical diagnosis according to the ESC guidelines), ischaemic heart disease (history of myocardial infarction, angina pectoris), active symptoms of anxiety and/or depression (≥11 Hospital Anxiety and Depression Scale , and/or anxiety or depression symptoms being treated at the time of inclusion);

* Under treatment at one of the pilot sites (MST, TUK, GEM);
* \>40 years of age;
* Smoker or ex-smoker;
* Able to understand, read and write the language spoken in the country of the pilot site.
* Accessibility to internet;
* Written informed consent from the subject prior to participation.

Furthermore, 25% of the patients should also have ≥ 2 exacerbations, defined as respiratory problems that required a course of oral corticosteroids / antibiotics in the two years preceding study entry; and/or ≥ 1 hospitalisation for respiratory problems in the two years preceding study entry; and/or modified MRC (mMRC) score of 3 or 4 (COPD patients with these scores have a higher chance of exacerbating).

Exclusion Criteria:

* Serious other diseases with a low survival rate;
* Presence of any other active lung disease (e.g., sarcoidosis);
* Severe psychiatric illness, diagnosed by anamnesis;
* Maintenance therapy with antibiotics
* Patients with cognitive impairment (Mini Mental State Examination (MMSE) \< 24)
Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome

The aim of the study is to investigate the physical activity level, aerobic capacity and dietary habits among a cohort of females with premenstrual syndrome

premenstrual syndrome can be defined as a recurrent disorder that occurs every month in the luteal phase of the menstrual cycle, and subside with the onset of menstruation. It is characterized by a complex set of symptoms, which include physical, psychological and behavioral changes with varying severity. This can interfere with the lives of females. Physical exercise improves PMS through rising endorphin levels, reducing adrenal cortisol symptoms, leading to lesser anxiety, depression and greater pain tolerance, as previous studies showed that it was effective in decreasing pain as well as mental and physical symptoms of PMS. Recently, lifestyle changes have gained more importance than pharmacotherapy. Lifestyle changes include many methods including diet regulation and exercise. 30 minutes of aerobic exercise is recommended for at least 3 days per week to contribute to the regulation of both body composition, mood and to improve physical symptoms. Evidence suggests that it can be helpful in reducing symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 1-suffering from PMS (as determined by PMS scale) 2-Their ages range from 20 to 35 years 3-Having regular menstrual cycle

Exclusion Criteria:

* 1-Smoking 2-Following any special diet 3-Taking any medication 4-History of chronic disease 5-Having any psychiatric or gynecological problems
Safety and Efficacy of the Minimally Invasive Bentall Procedure Via a Small Right Intercostal Incision in Patients With Aortic Root Lesions

This study intends to include patients who had aortic root lesions and were treated with Bentall surgery from January 2019 to July 2023 in the First Affiliated Hospital of Xi'an Jiaotong University. The patients will be divided into the minimally invasive group and control group according to the surgical methods: the former underwent minimally invasive Bentall surgery through a small right intercostal incision; the latter underwent traditional Bentall surgery through a median sternal incision. By comparing the clinical data of patients in two groups, we will investigate the effect and safety of minimally invasive Bentall surgery.


Eligibility Criteria:
Inclusion Criteria:

- Patients who were diagnosed with aortic root lesions and treated with the Bentall procedure at the First Affiliated Hospital of Xi'an Jiaotong University from January 2019 to July 2023 will be included in this study.

Exclusion Criteria:

* Previous sternotomy or aortic root surgery;
* Combined coronary artery disease requiring simultaneous coronary revascularization;
* Combined aortic arch lesions requiring simultaneous aortic arch surgery;
* Preoperative comorbidities with severe single or multiple organ failure;
* Incomplete clinical information;
Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

The purpose of this study is to assess healing after tooth extraction with simultaneous socket augmentation (bone grafting during the same appointment as the extraction) when the surgeon uses a surgical microscope, compared to when the surgeon uses dental loupes (magnifiers that are mounted on the surgeon's glasses). These devices magnify and shine light on the area where the surgeon operates.

After a tooth is extracted, a hole is left in the bone called a socket. During the first year of healing after a tooth extraction, there may be up to 60% loss of bone volume at the site. Loss of bone at the edentulous ridge (toothless area) may make it more difficult to place dental implants later. Dental socket grafting is performed to reduce bone resorption after tooth extraction. Grafting involves filling the socket with bone graft (donated human cadaver derived) and covering it with a protective collagen membrane. This graft prevents resorption of the ridge and is slowly replaced with the patient's own bone. The investigators will be trying to determine if bone healing is better if the surgeon uses more powerful magnification.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Single maxillary or mandibular hopeless tooth (a maxillary or mandibular anterior tooth or premolar) planned for extraction due to periapical pathology with a minimum ≥2 mm of the size of the periapical radiolucency shown on a peri-apical film.
3. The patient is planned for implant restoration for the hopeless tooth
4. The study site allows for implant placement with or without additional bone augmentation procedures after the healing
5. Adequate edentulous space for the final restoration on the implant

Exclusion Criteria:

1. Current smokers or quit smoking less than 6 months
2. Major or uncontrolled medical conditions, e.g. poorly controlled diabetes mellitus (HbA1c \>8.0%, uncontrolled systemic disease or condition known to alter bone metabolism, e.g. osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, etc.
3. Pregnancy, breast-feeding, could be pregnant or planning to become pregnant in the next 4 months (self-reported)
4. Taking medications known to modify bone metabolism (i.e. bisphosphonates, corticosteroids, hormone replacement therapy)
A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer

Based on preclinical data, ZD1839 is considered a novel and promising therapeutic approach with potential application in the treatment of human breast cancer. Therefore it could be very important and clinically relevant to know if ZD1839 is capable of eliminating occult tumour cells circulating in the blood of breast cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Histologically or cytologically confirmed breast cancer
* Metastatic breast cancer (stage IIIB and IV)
* Patients should have received at least one course of standard systemic chemotherapy for their metastatic disease. There should be at least one month between end of chemotherapy treatment and trial entry.
* ER+ve patients should have received adjuvant hormonal treatment
* Detection of CK-19 mRNA positive cells in the blood by real time PCR despite the previous administration of chemotherapy and if appropriate hormonal therapy
* Aged 18 years and over
* Paraffin-embedded tissue available for tumour histology (EGFR testing, ER, PgR, Her-2-neu testing)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
* Patients willing to undergo regular detection of circulating occult tumour cells in the blood by immunocytochemistry and/or RT-PCR
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Any concurrent systemic treatment for breast cancer (including chemotherapy, radiotherapy, hormonotherapy, monoclonal antibodies)
* Known severe hypersensitivity to ZD1839 or any of the excipients of this product
* Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy (except alopecia)
* Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR)
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
* Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 3 times the ULRR.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
* Pregnancy or breast feeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
* Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
Prevention of CF Exacerbation in Childhood: PREVEC Study

Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. The aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.


Eligibility Criteria:
Inclusion Criteria:

* CF disease is defined as the combination of:

  1. characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoea);
  2. and/or abnormal sweat test (Chloride \> 60mM);
  3. and/or two CF mutations.

Exclusion Criteria:

1. cardiac abnormalities;
2. mental retardation;
3. no technical satisfactory performance of measurements;
4. on the waiting list for lung transplantation;
5. non-compliance with the home-assessments;
6. patients with Burkholderia Cepacia;
7. participation in another intervention trial.
Rescue Emetic Therapy for Children Having Elective Surgery

To compare ondansetron, metoclopramide, diphenhydramine, and placebo in order to determine which anti-emetic is most efficacious as a "rescue therapy" for pediatric patients ages 3-18 who have post-operative vomiting after a standardized prophylactic regimen of ondansetron and dexamethasone. We hypothesize that anti-emetics with a different mechanism of action than the prophylactic regimen will be the most effective "rescue therapy" in children having surgery in an ambulatory surgery center.

1. Problem: Despite commonly-used anti-emetics for prophylaxis, some children still go on to develop post-operative vomiting (POV).

   Goal: To determine which anti-emetic--ondansetron, metoclopramide, diphenhydramine, or placebo--is most efficacious for pediatric patients in this situation.
2. Hypothesis: Anti-emetic medications that have a different mechanism of action than the prophylactic regimen will be the most efficacious "rescue therapy."
3. Hypothesis: Metoclopramide at the dose of 0.5 mg/kg (max dose 20 mg) will be more effective than ondansetron, diphenhydramine, or placebo as "rescue therapy."


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients 3-17 years old
2. Patients scheduled for tonsillectomy and/or adenoidectomy (with and without myringotomy) , or dental restoration,
3. Patients receiving a general anesthetic (inhaled agent without nitrous oxide) with POV prophylaxis with two agents (ondansetron and dexamethasone)
4. Post operative vomiting in PACU or second stage recovery requiring antiemetic rescue.

Exclusion Criteria:

1. Vomiting in the past 24 hours or antiemetics in previous 24 hours
2. Allergy or sensitivity to ondansetron, dexamethasone, metoclopramide, or diphenhydramine
3. Patients with diabetes
4. Patients with seizures
5. Patients receiving a benzodiazepine premedication
An Observational Study of Patients With Malignant Lymphomas Treated With MabThera® SC in Everyday Clinical Practice

This observational study aims to assess the therapeutic responsiveness of MabThera SC in patients with malignant lymphomas under everyday clinical practice conditions. Patients with previously untreated CD-20 positive follicular non-Hodgkin's lymphoma (NHL) or previously untreated CD-20 positive diffuse large B-cell lymphoma (DLBCL) who are planned for therapy with MabThera SC according to the assessment of the physician will be prospectively enrolled for observation. No study specific measures are required; treatment and documentation will be performed according to usual clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Women and men aged \>=18 years
* Previously untreated CD-20 positive follicular NHL
* Previously untreated CD-20 positive DLBCL
* Planned therapy with MabThera SC according to the assessment of the physician (before the start and independent from this study)
* Suitability for the therapy with MabThera SC

Exclusion Criteria:

All contraindications, interactions and incompatibilities for therapy with MabThera SC
Online Resilience Intervention in Older Adults

Resilience in older adults is important for Healthy aging. The purpose of this study was to examine the effectiveness of an on-line program of resilience interventions among older adults.

Healthy aging not only free from illness but also need to maintain healthy physical and mental function, be active in social life and contribute to society. Aging bring comprehensive impacts toward family, society and country, especially in individual. Resilience intervention can improve the intrinsic health and well-being for older adults. Good physical activity benefits to healthy aging. The purpose of this study was to examine the effectiveness of an on-line program of resilience interventions among older adults.

Eligibility Criteria:
Inclusion Criteria:

* able to read Chinese, and aged 65 years or older.

Exclusion Criteria:

* with a psychiatric diagnosis and who had a neoplasm
Indwelling Stent Discoloration Project

The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents.

The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents observed in some patients, particularly those from Japan. We will also test and compare them to stents from Canadian patients. Furthermore, we will determine whether the discolouration promotes bacterial adhesion and/or encrustation of the stent.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 19 years of age (Vancouver, British Columbia, Canada - for Japan different age limit as applicable)
* Patient has indwelling ureteral stent

Exclusion Criteria:

* Pregnancy
* Positive Urine Culture
* Active cancer
* Recurrent urinary infections
* Gross hematuria
* Inability to provide informed consent
* Physician/Surgeon refuses to enter patient into study