cyrilzakka/clinical-trials huggingface dataset:
Fever and Febrile Support for Parents and Carers of Children 2016

To assess the suitability and user-friendliness of an information leaflet for parents on management of fever and febrile illness in children. The purpose of the leaflet is to provide evidence-based information for parents regarding fever and febrile illness in children.

The aim of this study is to assess the suitability and user-friendliness of an information leaflet for parents on management of fever and febrile illness in children. The purpose of the leaflet is to provide evidence-based information for parents regarding fever and febrile illness in children. The potential benefit of the leaflet is empowerment parents to take responsibility for monitoring their child's illness, thereby enabling parents to take effective and informed action when required.

The investigators hypothesise that provision of a user friendly information leaflet for parents increases knowledge and provides decision support to guide parents fever management.

This study will investigate the ability of an information leaflet to increase parental knowledge regarding the management of fever and febrile illness in children. Three leaflets were designed. Stakeholders were consulted to select the most appropriate leaflet prior to the beginning of the trial. One leaflet will be used in the trial.

A prospective, multi-centre, randomized, two-parallel arm, controlled trial with blinded outcome ascertainment will be conducted. Three information leaflets were designed based on a previous survey with parents in Ireland. One leaflet was selected for use as the intervention following consultation with stakeholders.

The Primary Objective of the project is to quantify if reading and understanding a leaflet on fever and febrile illness management increases parental knowledge on the subject.

Eligibility Criteria:
Inclusion Criteria:

* Parents with at least one child aged five years of age or younger at the time of recruitment.
* Parents of healthy children.

Exclusion Criteria:

* Parents who did not have at least one child aged five years of age or younger at the time of recruitment.
Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury

This study was initially designed to test the efficacy of Venlafaxine HCl in reducing incidence of the onset of major depression after a new spinal cord injury (SCI). After several protocol modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with SCI.

The successes of psychological and pharmacological modes of intervention in treating depression, both alone and combined, are well documented in the literature. While a great deal of research has identified specific clinical indications for many antidepressants currently available in the general population, little is known about the clinical indications of these agents in SCI. This study is proposed to test the benefits of Venlafaxine HCI (Effexor XR) for reducing mild to moderate symptoms of depression among people with SCI. The intervention will last 12 weeks and there will be 13 assessments and data collection points. Data will be collected at 26 weeks also. Eight face to face contacts are anticipated.

Because of the change in protocol to reducing mild to moderate symptoms and substantially lower enrollment than anticipated (1/6th of what we anticipated), we deleted a number of study outcomes listed in the 2011 posting of this study. Most of these were not part of the original posting in 2008, and those that were deleted were no longer relevant to new protocol's focus on reducing mild to moderate depression. The two outcomes reported here were most relevant to the revised protocol.

Eligibility Criteria:
Inclusion Criteria:

* Having sustained an SCI at least six months prior to enrollment.
* Neurological impairment ASIA Grades A-D.
* Mild to moderate depressive symptoms.
* English speaker
* Age 18 years or older
* Able to communicate with study personnel

Exclusion Criteria:

* No neurological impairment due to SCI.
* Presence of cognitive deficits precluding and giving informed consent and completion of survey based assessment tools.
* Psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, other psychiatric diagnosis including bipolar disorder).
* Medical contraindications (terminal illness or unstable medical condition as determined by medical history and/or examination).
* Pregnant or unwilling to use birth control if female and sexually active.
* Presence of glaucoma.
* Prior use of study drug without success or being treated with another antidepressant medication and being unwilling to taper off to take the stud drug.
* Willing to travel to Ann Arbor Michigan.
* Expecting to take or currently taking another experimental study within 30 days
* Major surgery scheduled within 12 weeks
A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma

To observe the safety, tolerability and clinical effects of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma.

This is a prospective, open-label, one-arm, single center clinical trial, aimed to evaluate the safety, tolerability, and efficacy of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma. A total of 30 patients are planned to be enrolled into the study. Patients with diagnosis of Relapsed or Refractory NK/T-cell Lymphoma will be treated with Chidamide plus Etoposide capsules. The primary end points are objective responder rate (ORR) and a time to response(TTR) and response duration (DOR) and progression free survival(PFS) and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1.age:10-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months 2 patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH); 3.Refractory or relapse after at least 2 regimen 4.Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence; 5.No chemotherapy contraindications: hemoglobin ≥ 100g / L, absolute neutrophil count ≥ 1.5 × 109 / L, platelets ≥ 80 × 109 / L, ALT, AST ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal Upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / L; 6.At least one measurable lesion 7.There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal; 8.Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication; 9.There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied.

10.Can understand the situation of this study and sign the informed consent voluntarily

Exclusion Criteria:

1. rejecting providing blood preparation;
2. allergic to drug in this study or with hemophagocytic syndrome;
3. rejecting adopting reliable contraceptive method in pregnancy or lactation period;
4. uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）；
5. with severe infection;
6. with primary or secondary central nervous system tumor invasion;
7. with Chemotherap or radiotherapy contraindication;
8. ever suffered with malignant tumor;
9. Human immunodeficiency virus (HIV)-positive patients
10. Drug abuse or long-term alcohol abuse that affects the evaluation of test results;
11. Have peripheral nervous system disorder or mental disorder;
12. Those who have no legal capacity or whose research is affected by medical or ethical reasons;
Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing

The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.

All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.

Eligibility Criteria:
Inclusion Criteria:

* infant in 3-12 months of age with first episode of wheezing or bronchiolitis
* written informed consent by parents

Exclusion Criteria:

* Previous wheezing episode or confirmed asthma or bronchiolitis
* recent bronchodilator use
* immune deficient
* immunosuppressive drug use
* croup or pneumonia diagnosis
* loss of follow up
S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery

RATIONALE: Some tumors need growth factors produced by the body to keep growing. Suramin may interfere with the growth factor and stop the tumor from growing.

PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with stage III or stage IV adrenocortical cancer.

OBJECTIVES: I. Assess the response of patients with adrenocortical carcinoma treated with suramin. II. Evaluate the qualitative and quantitative toxic effects of this therapy.

OUTLINE: Patients are described according to stage, performance status, prior radiotherapy, prior surgery, and prior mitotane therapy. Patients receive suramin IV for 5 days in the first week, then twice a week for 2 weeks, and then weekly for a total of 12 weeks. Hydrocortisone is taken PO twice daily. Following a 12 week rest, patients receive a second course; those with stable or responding disease continue treatment for a maximum of four courses.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued at a rate of 6-7 per year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed adrenocortical carcinoma in Stage III or IV and incurable by surgery Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: WBC at least 4,000/mm3 Absolute granulocyte count at least 2,000/mm3 Platelet count at least 150,000/mm3 Prothrombin time and partial thromboplastin time no greater than upper limit of normal (ULN) Hepatic: SGOT and alkaline phosphatase no greater than 2 times ULN Renal: Creatinine clearance at least 50 mL/min Serum creatinine no greater than ULN Other: No second malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma of the skin,in situ carcinoma of the cervix, or other cancer for which patient has been disease free for 5 years Not pregnant or nursing Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy At least 4 weeks since prior biologic therapy (one regimen only) Chemotherapy: No concurrent chemotherapy At least 4 weeks since prior mitotane No other prior chemotherapy allowed Endocrine therapy: At least 6 weeks since prior hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiation therapy (to less than 25% of bone marrow) No concurrent radiation therapy Surgery: Prior surgery allowed in relapsed patients with no other prior treatment
Effects of Epidural Anesthesia and Analgesia on the Prognosis in Patients Undergoing Pancreatic Cancer Surgery

The purpose of this randomized controlled trial is to investigate the effects of epidural anesthesia and analgesia on the overall survival，disease-free survival and recovery in patients undergoing pancreatic cancer surgery. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing elective pancreaticoduodenectomy for pancreatic cancer .
2. ASA statusⅠ-Ⅲ.
3. 18 years to 80 years （adults）.
4. Able to understand, communicate and sign an informed consent form.

Exclusion Criteria:

1. Laparoscopic surgery.
2. Preoperative chemotherapy or radiotherapy.
3. Pregnancy.
4. Allergic to any drugs used during the study.
5. Long-term receiving β-blockers.
6. Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery.
7. Abnormal coagulation functions (platelet count prior to surgery \<100000/ μL , APTT value is more than the normal value, INR \> 1.3 or clopidogrel that cannot be discontinued 7 days prior to surgery).
8. Complicated with severe heart disease (NYHA classification \>3), severe renal insufficiency (serum creatinine \>1.8mg/dL or receiving renal replacement therapy), severe hepatic disease (Child-Pugh classification

   = C), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/L ), or acute infectious diseases (WBC\>10000/μL) before surgery.
9. BMI \> 35.
10. All contraindications to epidural anesthesia and analgesia.
11. Chronic opiate medication/drug abuse.
12. Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.
13. Refuse to sign an informed consent form.
The Clinical Results of Derotational Osteotomy Based on 3D Osteotomy Template for Treatment of Recurrent Patellar Dislocation Combined With Patellofemoral Maltracking

For severe recurrent patellar dislocation with poor patellar maltracking, derotation osteotomy is an effective clinical treatment. However, derotation osteotomy requires very high requirements for the surgeon. It is necessary to determine the osteotomy surface, control the axis and complete internal fixation in three dimensions. The deviation of the osteotomy surface may cause deformities such as postoperative knee valgus, knee hyperextension, or restricted extension. The hypothesis of this study is to design a 3D osteotomy template for derotation osteotomy with the aid of computer-assisted simulated surgery. Compared with traditional osteotomy, it can effectively improve the treatment effect of recurrent patellar dislocation due to poor patellar maltracking. The incidence of postoperative knee valgus shortens the operation time and reduces the number of intraoperative fluoroscopy. This study intends to adopt a randomized controlled study, and the selection criteria are adolescent patients with recurrent patellar dislocation, aged \>14 years, with a positive J sign. The experimental group used mimics 20.0 software to reconstruct the three-dimensional model of the patient based on the full-length images of the lower limbs in the weight-bearing position and the CT of the hip, knee and ankle before the operation. The osteotomy template was designed and 3D printing technology was used to make the osteotomy template for intraoperative osteotomy. The control group used traditional de-rotation techniques. The knee joint range of motion, patella stability, residual rate of J-sign, knee valgus angle, femoral anteversion angle, gait analysis, etc. were compared between the two groups after surgery, and the differences between the two surgical techniques were evaluated


Eligibility Criteria:
Inclusion Criteria:

* patients with recurrent patellar dislocation
* \>14 years old
* positive preoperative J-sign
* agree to participate the study

Exclusion Criteria:

* Combined with other ligament injuries of knee joint
* Skin and soft tissue conditions do not permit surgery
Efficacy and Cost-effectiveness of Different Caries Preventive Protocols

To compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness.

Caries risk assessment and preventive measures have been performed over years with different perspectives without attention to budgeting and economic value and the preventive protocols remain uncertain for adults.

caries prevention, for example using fluoride varnish, has been found only limitedly cost-effective in clinic settings, which is why alternative strategies involving home-based interventions are sought .Electronic health (E-health) interventions for patient motivation and enhancing of patient adherence, for example via reminders about the reinforcement of hygiene measures and dietary counseling as well as recall visits were found to be of value This randomized controlled clinical study aims to compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness

Eligibility Criteria:
Inclusion Criteria:

* High caries risk patients.
* 18-25years.
* Males or females.
* Participants approving to enrol in this study.
* Participants not enrolled in any other study.

Exclusion Criteria:

low or moderate caries risk

* Participants with systematic conditions.
* Patients younger than 18 years.
* Evidence of parafunctional habits.
* with developmental dental anomalies.
* undergoing or will start orthodontic treatment.
* with removable prosthesis
Pilot Investigation of a Multinutrient Supplement on Skin Aging and Aging Metabolites in Healthy Women

We are seeking healthy female volunteers to determine if multinutrient supplementation affects visible signs of skin aging as well as blood measurements of aging. We are seeking smokers and non-smokers.

Skin antioxidant levels as well as blood metabolites may change as the human body ages1,2. Although the chronological aging process is unstoppable, the physical signs of aging, particularly characteristics of the skin, may be delayed through a variety of medical interventions such as topical medications or resurfacing lasers. It is not currently known whether skin carotenoid antioxidant levels correlate with skin aging characteristics, although studies with other antioxidants suggest this may be true 3. In addition, while selected blood metabolites correlate with changes in age2, we do not know if this correlates with skin changes. Our current study focuses on whether differences in skin carotenoid levels and blood metabolite levels correlate with skin aging characteristics in age-matched subjects. Furthermore, we will explore whether three months consumption with a commercial multi-nutrient formulation (LifePak Nano) affects metabolic markers of aging, skin aging characteristics including skin elasticity and transepidermal water loss. We will also examine whether smokers respond differently from nonsmokers in the above parameters after supplementation.

Eligibility Criteria:
Inclusion Criteria:- Fitzpatrick Skin type I or II

* Nonpregnant Females, age 18-30 or 50-70
* Body Mass Index Normal or Overweight
* If age 18-30, must be non-smoker
* Willing to fast for 8 hours prior to a blood draw; Exclusion Criteria:- History of cosmetic surgery
* Use of anti-aging medications within 3 months of enrollment
* Use of over-the-counter anti-aging creams (not sunscreens) more than once per week within one month of enrollment
* Use of dietary supplements including vitamins within one month of enrollment
* Use of tanning beds or excessive UV exposure (greater than 2 hours per day) within one month of enrollment
* Use of sunless tanners within one month of enrollment
* Uncontrolled or ongoing serious medical condition
* Participation in another clinical study involving use of an investigational drug or product
* Medical condition which, at the discretion of the investigator, will have a significant impact on ability to judge participant's skin characteristics, including age.
A Simplified Questionnaire to Detect OSA in COPD Patients

To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a simplified questionnaire was developed for identifying those COPD patients with severe OSA.

To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a simplified questionnaire was developed for identifying those COPD patients with severe OSA.

With patient's BMI, neck and waist circumference, snores, witnessed apnea...

Time frame suspect to enroll 5 patients in 1 month and complete 4 patients at least we need 24 months to complete 120 patients

Eligibility Criteria:
Inclusion Criteria:

* stable COPD patients

Exclusion Criteria:

* cancer exacerbation in recent 2 months pregnancy central type sleep apnea claustrophobia chronic respiratory failure
Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)

1. In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing
2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER

1. Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER
2. Cross over study design:

   * Group 1: Once daily dose for 2 month then into BID in divided dose for 2 months
   * Group 2: BID in divided dose for 2 months then into QD dose for 2 months
3. Dose adjustment may be done in the first 4 weeks.
4. Compare the benefit, side effects, and patient preference between the QD vs BID dosing

Eligibility Criteria:
Inclusion Criteria:

1. Age: 30-80
2. Parkinson disease
3. On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER
4. On stable antiparkinsonian medication for at least 4 weeks
5. Who signed consent to the study

Exclusion Criteria:

1. Who are on less than 2 mg of Requip or 0.375 mg of Mirapex
2. Who have dementia, psychosis, major depression and other serious neurological or medical problems
3. Who are allergic to the similar medications
4. Who has history of heavy metal poisoning
5. Who were on othe clinical trials of other medications within the last 4 weeks
6. Who are pregnant or lactating
7. Who are considered not eligible by the investigator
Nutrient Fortified Oat Drink

This study will follow a randomized, double-blind, placebo-controlled, parallel-group design to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve nutrient status and iron deficiency in young children compared to an unfortified control beverage.


Eligibility Criteria:
Inclusion Criteria:

* 5-7 years old
* Children with parental consent
* Not suffering from diarrhea, respiratory infections and fever at time of interview and for the past two weeks
* No history of blood disorder or malaria
* Had not participated in any feeding program for the past 4 months
* Children with Hb \> 70 g/L to \<120 g/L (WHO/UNICEF/UNU, 1998)
* CRP \<10 mg/L

Exclusion Criteria:

* All children aged \< 5 years old and \> 7 years old
* Without parental consent
* Undergoing treatment for any chronic ailment, diagnosed as suffering from any sort of illness e.g. fever, diarrhea, stomach ache, cough and colds at the time of examination or during the past two weeks.
* Reported current or history of blood abnormalities/hemoglobinopathies
* Children with all normal Hb levels or very low Hb \< 70 g/L
* CRP \>10mg/L
Cohort Study in Fujian Province

In this study, Chinese residents aged 35 to 75 years old were recruited from Fujian Province. Physical examination, questionnaire survey and biological sample collection were performed at baseline, and at least 4 years of follow-up were conducted. Information on newly discovered cardiovascular metabolic illnesses and comorbidities was collected during follow-up, and repeated surveys similar to baseline were conducted. To explore the relationship between environment, diet and lifestyle and the risk of cardiovascular metabolic diseases and concomitant disorders.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35-75, having lived in Fuzhou, Putian, Quanzhou, Nanping, Xiamen, Zhangzhou, Longyan, Sanming, or Ningde in Fujian Province for more than 6 months.

Exclusion Criteria:

* Anyone diagnosed with coronary heart disease, stroke, or cancer.
* Anyone with a severe disability who is unable to participate in the study.