cyrilzakka/clinical-trials huggingface dataset:
Influencing Factors and Interventions of Physical Exercise Behaviour of 6-Year-Old Children in Guangdong, China

The goal of this clinical trial is to examine the relationship between children's physical exercise behavior and children's Fundamental Motor Skills (FMS) before and after changing the influencing factors of 6-year-old children's physical exercise behavior in Guangdong Province, China. The main question it aims to answer is:

Is there any change of the relationship (time, group, and interaction) between 6-year-old children's physical exercise behaviour and children's Fundamental Motor Skills (FMS) before and after the physical activity intervention of the influencing factors in Guangdong Province, China?

Participants will:

Intervention group, Length: 12 weeks, 40 minutes, twice a week. The intervention will be conducted using a relevant physical fitness training program.

Control group, Length: 12 weeks. Content: Physical exercise using kindergarten standards.

Researchers will compare the data before and after the intervention to know whether the Fundamental Motor Skills (FMS) of 6-year-old children have changed.


Eligibility Criteria:
Inclusion Criteria:

* Preschool children aged 6 years old in Guangdong, China;
* Children who are of Chinese nationality;
* Male and female;
* Parents/guardians signed an informed consent form;

Exclusion Criteria:

* Have a mental illness with cognitive impairment problems;
* Children with speech or ear function impairment;
* Recent or imminent surgery (within 3 months), or medical co-morbidities;
* Parents/guardians did not sign the informed consent.
Primary Care Amoxicillin Challenge

The purpose of this project is to identify clinic patients reporting penicillin allergy who are low risk for allergic reaction, and then invite them to participate in an oral amoxicillin challenge in their primary office without need for referral to allergy/immunology. If the patient is able to tolerate oral amoxicillin, the antibiotic allergy in question will be removed from the patient's chart.

Patients with a documented allergy to amoxicillin, ampicillin, or penicillin who are deemed low-risk for true penicillin allergy based on history will be offered enrollment in the study. Patients will be scheduled for an oral amoxicillin challenge in the primary care office at a later date. During this challenge, patients will be given 10% of a weight-based dose of amoxicillin and then observed for 30 minutes for signs and symptoms of an allergic reaction. If no reaction occurs, they will be given the remaining 90% of the weight-based dose and observed for an additional 30 minutes. Emergency medications such as diphenhydramine and epinephrine will be immediately available if needed. If the patient completes oral amoxicillin challenge without a clinically significant reaction, penicillin (and/or amoxicillin/ampicillin) allergy will be removed from the patient's chart.

Eligibility Criteria:
Inclusion Criteria:

* Patients less than 18 years old who attend either of two hospital-affiliated general pediatric clinic sites who have an allergy to penicillin (or its derivatives) documented in their electronic medical record.

Exclusion Criteria:

* Patients who do not have an allergy to penicillin (or its derivatives) documented in their electronic medical record or patients with listed penicillin allergy whose parent/guardian declines to participate in the study. Patients will also be excluded if their penicillin allergy has been confirmed with either failed amoxicillin challenge or positive penicillin skin testing. Medically fragile children who cannot tolerate a direct oral challenge will be excluded but may be offered referral to allergy/immunology. If, on review of the history of the allergy, features of likely IgE mediated (onset in 1st hour of course or anaphylaxis requiring hospital care) or dangerous non-IgE mediated penicillin allergy (Stevens Johnson with penicillin, blistering rashes, penicillin related cytopenia) are obtained, these patients are also excluded from challenge but may be referred to allergy for further education and appropriate testing.
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.

This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.


Eligibility Criteria:
Inclusion Criteria:

* Post-bronchodilator FEV1/ FVC ratio of \<0.7.
* Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
* Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
* Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.

Exclusion Criteria:

* Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
* History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
The Impact of Sleep Apnea Treatment on Physiology Traits in Chinese Patients With Obstructive Sleep Apnea

The prevalence of OSA is 3.5\~4.6% in Chinese adults. OSA leads to repetitive hypoxemia, hypercapnia, and arousal from sleep and is an independent risk factor for hypertension, stroke, coronary artery disease and congestive heart failure. CPAP is the first-line treatment for OSA. But many patients do not adhere to therapy.

The upper airway(UA) anatomical abnormality is a prominent risk factor in Asian OSA patients, which might be improved by surgical strategies. However, surgery shows variable clinical effectiveness. One important reason for patients responding poorly to single treatment procedure is that multiple abnormal physiological traits contribute to OSA.

High loop gain is one of the key non-anatomical risk factors. It will be useful to individualize therapy in OSA by better understanding the reversibility of increased LG, the interaction of LG and UA anatomical change as well as the condition that trigger reduction of LG.

The project will test the hypothesis of 1) Elevated LG is induced in some patients and is reversible by treatment of OSA; 2) Change of LG is related to the improvement of sleep apnea; 3) An elevated LG is related to residual sleep apnea after upper airway surgery, which might be eliminated by adjunct CPAP therapy after surgery. The results would improve the efficiency of non-CPAP treatment and provide a potential combined treatment option for those patients with both elevated loop gain and anatomy risk factors in the Asian population.

Unstable respiratory control (high loop gain) is an important non-anatomical risk factor for obstructive sleep apnea. Studies showed high loop gain might also be acquired from long-term hypoxemia/hypercapnia due to OSA, and could be decreased by CPAP therapy in some of the individuals. Whether another treatment, i.e. upper airway surgery, could achieve a similar improvement in is not known. We hypothesize that 1) high LG could be reversible with improved hypoxemia and reduced apnea hypopnea index (AHI) by surgical treatment; 2) high loop gain at baseline may be associated with poor treatment outcomes.

PSG was performed pre- and postoperatively to assess the OSA severity in participants who underwent uvulopalatopharyngoplasty and concomitant transpalatal advancement pharyngoplasty. Loop gain were calculated using a published method by fitting a feedback control model to airflow. The loop gain values at baseline and follow-up were compared. The association between loop gain change and improvement of OSA were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70 years
* Sleep study (with apnea-hypopnea index\>5)
* Diagnosis of obstructive sleep apnea

Exclusion Criteria:

* Any known unstable cardiac (apart from treated hypertension), pulmonary, renal, neurologic (including epilepsy), thyroid, neuromuscular, or hepatic disease
* Pregnant women or nursing mothers
* Use of any medications that may affect sleep or breathing
* An uncontrolled psychiatric disorder
* Use of illicit drugs
Efficacy and Safety of a 4% Hydroquinone Cream for the Treatment of Melasma

To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo.

To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.

To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult women aged between 18-65 years old.
* Fitzpatrick phototypes I to IV.
* Presenting moderate to severe facial melasma facial, with a basal Melasma Area and Severity Index (MASI Index) between 10 and 20.
* Women of childbearing potential must use an adequate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment.
* Breastfeeding women will not be included in the study.
* Having given freely and expressly her informed consent.

Exclusion Criteria:

* Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products.
* Fitzpatrick phototype V.
* Skin pigmentation diseases different to melasma.
* Evidence of active cancer disease or diagnosis of cancer in the last year.
* Those receiving any topical or oral treatment that could interfere with melasma.
* Pregnant or breastfeeding women, or those expecting to get pregnant during the study.
* Evidence or suspicion of low compliance with the study visits and procedures.
* Participation in other clinical trial simultaneously or in the previous 3 months.
Surgery Versus Biologics for Stricturing CD--a RCT

The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.


Eligibility Criteria:
Inclusion Criteria:

1. with intestinal obstructive symptoms;
2. confirmed intestinal strictures;
3. traditional drugs failed to induce remission;
4. envidence of active bowel inflammation;
5. inappropriate for EBD;
6. acquirement of written informed consent of participant;

Exclusion Criteria:

1. unsuccessful medical treatment of intestinal obstruction;
2. complete obstruction;
3. contraindication for biologics;
4. penetrating disease;
5. short smaal bowel;
6. suspicion of bowel tumor;
7. no confirmed strictures;
8. comitant severe disese of other system;
9. obstructive symptoms under over 2 targets of biologics;
10. successful treatment with traditional drugs;
11. participate other clinical research.
Safety and Tolerability of Serum Derived Bovine Immunoglobulin in Children With Diarrhea Predominant IBS

This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate (SBI) is safe and well tolerated in pediatric patients with IBS-D.

Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant adverse events at 4 and 8 weeks and their quality of life will be better than the patients who receive placebo.

The study will consist of four phases:

Screening Phase: screen the patients for 2 weeks prior to enrollment in the study to establish objective criteria of disease presence and severity. Patients will maintain a daily symptom dairy. At the end of screening phase, we will calculate their quality of life and symptom severity scores based on the information provided by the patients and their family. Patients with an average score of 1 or greater over 14 days for abdominal pain and stool consistency will be selected for the open label trial of SBI.

Open Label Treatment Phase: patients enrolled will receive 4 weeks of SBI along with QOL questionnaires to complete. If the patient's global assessment is that they have improved, or if review of their diaries shows an improvement in symptom severity scores (decrease in symptom severity score by \> 30% from baseline), they will be eligible for the randomization phase.

Patients, who do not have any improvements during the first 4 weeks of SBI therapy, will not be randomized. If non-responders have worsening of symptoms, they will be prescribed rescue medications as per standard of care. If non-responders choose to continue to take SBI, they will be so allowed.

Randomization Phase: Patients who qualify for this phase will be randomized either to SBI or placebo. They will take their medication for 4 more weeks and complete their questionnaires, symptom as well as QOL. After this 4 week phase all patients will be offered the Open Label Extension Phase.

Open Label Extension Phase: All patients who enter this phase will be treated with SBI for another 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 8 years of age and \< 18 years of age
* Patients with a diagnosis of IBS-D as per Rome III criteria
* Patients with normal laboratory work up (CBC, ESR, CRP, amylase, lipase, celiac panel, fecal occult blood)
* Patients with normal fecal calprotectin and lactose hydrogen breath test
* Patients off motility drugs, NSAIDs for at least 2 weeks prior to enrollment in the study
* Ability to complete the study
* Patients on stable doses or other medications for at least 4 weeks prior to enrollment

Exclusion Criteria:

* Patients with h/o other GI, hepatic, renal, cardiovascular, neurologic or hematological disorder
* Patients with family history of inflammatory bowel disease
* Patients with history of abdominal surgery
* Patient with history of drug or alcohol abuse
* Patient with a history of allergy to study related products (e.g. beef)
* Use of probiotics in the previous month
* Patients who used SBI in the past
* Patients with soy allergy/sensitivity
Multicenter Study of Tetanus Patients in Fujian Province of China

Background: Tetanus is a life-threatening disease in developing countries, and accompanied by a high mortality rate. China is the world's largest developing country, and Fujian Province is a typical coastal province in China with a relatively developed economy. Therefore, the purpose of this study was to investigate the epidemiology, incidence and management of tetanus in Fujian Province and to understand the current treatment and prognosis of tetanus patients in China.

Methods: This was a retrospective multicenter observational study of patients who presented with a clinical diagnosis of tetanus at 5 general hospitals in Fujian. Data was analyzed using computer software system.


Eligibility Criteria:
Inclusion Criteria:

* This study included all patients of all age groups and both sexes who presented with a clinical diagnosis of tetanus.

Exclusion Criteria:

* None.
Prevalence of Constructed Space Maintainers in a Group of Egyptian Children

The purpose of the study is

* To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
* To assess the knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

and

- To assess the knowledge, attitude and practice of pediatric dentists towards use of space maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

The purpose of the study is

* To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.
* To assess the knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

and

- To assess the knowledge, attitude and practice of pediatric dentists towards use of space maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

PO1:

Population:

Egyptian children with constructed space maintainers and their guardians attending Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

Outcome1:

Prevalence of constructed space maintainers Knowledge, attitude and awareness of constructed space maintainers for pediatric patients' guardians.

PO2

Population2:

Pediatric dentists at Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

Outcome2:

knowledge, attitude and practice of pediatric dentists towards the use of the space maintainers.

Eligibility Criteria:
i have two population

1st population is Pediatric patients

Inclusion criteria for pediatric patients:

1. All patients with constructed space maintainers
2. Positive patient's acceptance for participation in the study.
3. Both genders are included.
4. Children Medically free from any systemic disease.

Exclusion criteria for pediatric patients:

1. Patients with orthodontic appliances.
2. Patient having one of the different following habit thumb sucking, lip biting, tongue thrusting etc.

2nd population is pediatric dentists:

Inclusion criteria for Pediatric dentists:

-All Pediatric dentists having master degree and above.

Exclusion criteria for Pediatric dentists:

-Pediatric dentists refused to participate in the study.
Efficacy of Pulsed High Intensity Laser Therapy in Psoriatic Hand Arthritis

The purpose of the study was to evaluate the therapeutic efficacy of pulsed high intensity level laser therapy in improving symptoms of psoriatic hand arthritis.

Psoriatic arthritis is a chronic, inflammatory joint disease affecting 20%-30% of patients with psoriasis. It affects peripheral joints and axial skeleton, causing pain, stiffness, swelling, and joint destruction. High-intensity laser therapy can control inflammation and improve pain relief, range of motion, and functional improvement. This study aims to examine High-intensity laser therapy efficacy in managing Psoriatic arthritis, aiming to provide a safe, effective, and noninvasive treatment method.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes of patients their age range between 30-50 years.
* Bilateral PsA following psoriasis
* All participants who are diagnosed with PsA, and experience clinical symptoms such as pain, swelling, tenderness and stiffness less than 1 year from the beginning of disease.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* Positive rheumatic factor
* Circulatory disorders
* Diabetes
* Pregnant woman
* Skin diseases like urticaria.
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy, endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic therapeutic procedures will be evaluated based on the proportion of patients with suppressed gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by an independent committee.

The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.


Eligibility Criteria:
Inclusion Criteria:

Inpatients or outpatients of either sex who require therapeutic upper gastrointestinal endoscopy and meet criteria (1), (4), (6) and one from (2), (3) or (5) in the study. Patients have to provide written informed consent for voluntary participation in the study. The criteria (2) to (4) will be confirmed by the endoscopic observation just before starting the intended treatment.

1. Patients who require therapeutic upper gastrointestinal endoscopy (polypectomy, endoscopic hemostasis, PEG, EMR and ESD)
2. Patients with a differentiated-type intramucosal gastric cancer located in the upper or middle third of the stomach (≤2 cm in size, no ulcer finding, EMR or ESD)
3. Patients with a gastric adenoma (≤2 cm in size, no ulcer finding, EMR or ESD)
4. Patients with an a single intended lesion for the treatment
5. Patients without experience of PEG tube placement in case of PEG tube placement
6. Patients who are older than 20 years at the time of consent

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study beforehand. The criteria (3) and (4) will be confirmed by the endoscopic observation just before starting the intended treatment.

1. Patients with a history of surgery to the upper gastrointestinal tract
2. Patients who require emergency endoscopy
3. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
4. Patients who require emergency endoscopic treatment except for the intended lesion
5. Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)
6. Patients with pacemaker
7. Patients with known bleeding tendency or Patients with difficulty of antithrombogenic agents withdrawal
8. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
9. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
10. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
11. Patients otherwise ineligible for participation in the study in the investigator's opinion