cyrilzakka/clinical-trials huggingface dataset:
Pain Coping Strategies in Children With CP

The aim of the study is to describe pain coping strategies and their evolution in children and adolescent with cerebral palsy.

Towards the end of the 20th century, Lazarus and Folkmann developed the concept that the individual provides "cognitive and behavioral efforts to control, reduce or tolerate the internal or external demands that threaten or exceed his or her resources". These cognitive and behavioral efforts are grouped under the term "coping", which describes a process rather than personality traits or abilities. Coping is not about controlling stress but about diminishing, avoiding, tolerating or accepting it.

The pain, "unpleasant sensory and emotional experience related to a bodily injury", aims to warn the individual that the integrity of his body is threatened, and is thus a real "stressor". It will lead to the choice of coping strategies, which depends in part on the characteristics of the individual (his beliefs, stress endurance, anxiety propensity) and environmental variables (characteristics of the painful situation, social support and emotional connections, information about the threatening situation). Many studies have shown that the strategies used to cope with chronic pain in adults and children play a major role in the adjustment of patients to their pathology, in terms of emotional distress, disability, and quality of life. The different types of strategies have been widely studied in the literature in so-called "typical" children. Active strategies classically found in pediatrics are distraction, cognitive self-instruction, and problem solving. These active strategies are said to be positive because they have been proven to help children manage pain more effectively than passive strategies such as catastrophism, helplessness, or seeking social support, which are dysfunctional because they are not focused on the problem and increase the negative consequences associated with pain.

This study is about children with cerebral palsy (CP) because the great variability and complexity of the manifestations of the pathology and the therapeutic treatment make it that there is a big risk for the child to experience pain, with a prevalence of pain ranging from 60% to 73%, depending on the evaluation methods. Research has done a great deal in recent years to improve the assessment and management of inborn or induced pain in children with disabilities, with many validated recommendations, even though this still appears to be a neglected comorbidity in PC. However, coping strategies of PC children with pain have never been studied. The purpose of this work is to describe these strategies in PC children and adolescents, as well as their evolution.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnostic of cerebral palsy
* GMFCS I, II, III, IV
* Oral language skills with syntactic abilities

Exclusion Criteria:

* Acute pain episode
* severe cognitive impairment
Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencingvitreoretinopathy

Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients; to prove the percentage of PVR-IC decides the risk of serious PVR occurring after surgery; to investigate the safety and efficacy of early local steroids drug intervention in patients with severe postoperative PVR.


Eligibility Criteria:
Inclusion Criteria:

* (1) Age: 18-60 years old, regardless of gender; (2) Clinical diagnosis of with rhegmatogenic retinal detachment (RRD); (3) Surgery for Retinal Detachment is required; (4) Myopia \< = 800 degrees; (4) PVR classification: no restrictions; (5) Patients undergoing the first or second operation. (6) Patients volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

* (1) Exudative detachment of retina; (2) Those who are allergic to the drugs used in the study; (3) Combined with other eye diseases: other fundus diseases, glaucoma, corneal opacity diseases, genetic diseases); (4) history of internal eye surgery \>=3 times; (5) Postoperative follow-up could not be scheduled; (6) Patients with systemic diseases (such as asthma, heart failure, myocardial infarction, liver failure, kidney failure and other major diseases).
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.


Eligibility Criteria:
Inclusion Criteria:

* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
* Topical medication use at the region to be treated;
* Cutaneous disease or active gynecological disease which may interfere in study results;
* Personal history of allergic disease at the area to be treated;
* Allergic or atopic history;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale

The purpose of this study is to test a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life. The goal is to develop a clinical survey that can improve the care of pediatric narcolepsy.

WHO IS ELIGIBLE?

* Children and adolescents with narcolepsy between the ages of 9-17 years
* Diagnosis must be verified by a signed letter from physician in order to participate
* Participants must be able to understand the purpose of the study

PARTICIPATION DETAILS

* Upon enrollment participants will receive an email containing a link to complete HIPAA compliant online surveys about narcolepsy symptoms, quality of life, and daily function. Surveys should take no more than 30 minutes.
* One week later, some participants will receive another email with a link to complete a 10-minute follow up survey

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents ages 9-17
* Have a diagnosis of narcolepsy type 1, narcolepsy type 2, or mild to moderate obstructive sleep apnea (OSA)

Exclusion Criteria:

* A history of visual or hearing impairment
* A co-morbid neurodevelopmental disorder such as autism or schizophrenia
* No access to computer/tablet/smart phone to complete questionnaires
Smoking Cessation in Groups and With Tobacco Pastils

The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.

The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product should be used for 7 weeks. Seven group meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.

Eligibility Criteria:
Inclusion Criteria:

* smoking \> 13 cigarettes/day
* healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia)
* motivated for cessation
* motivated to use tobacco pastils
* motivated for group support

Exclusion Criteria:

* severe diseases
* psychiatric diseases
* using antipsychotic drugs
* used NRT/bupropion in the last 3 months
* consuming \> 6 drinks/day
* pregnant/lactating
* stopped smoking more than 2 days during last 3 months
Video Education About Nasogastric Tube Feeding

Summary Aim: This research was conducted to determine the effectiveness of education given to students using video in feeding with the nasogastric tube for pediatric patients.

Method: It was a randomized controlled experimental study. The sample of the study consisted of 61 nursing students. The students included in the study were divided into two equal groups: the experimental and control groups. Video-supported education material of the experimental group and theoretical education was applied to the control group. Before and after the education, a post-knowledge test was made and evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Being a student of the Department of Nursing
* Taking the child health and diseases nursing course and being successful
* Volunteering to participate in the research

Exclusion Criteria:

* Participate and quit the study
* Being a 1st and 2nd year nursing student
* Failure of the child health and diseases nursing course
Maintenance Treatment for Ovarian Carcinoma in Remission by an Antiangiogenic Treatment Strategy

Preclinical studies showed that metronomic chemotherapy can induce tumor regression secondary to apoptosis of the tumor blood vessels. This effect was increased by combining metronomic chemotherapy with anti-angiogenic drugs. Metronomic chemotherapy has already proved clinical effects too, especially on patients with breast or prostate carcinoma. This study is aimed to test the efficacy of an experimental metronomic chemotherapy regimen in a cohort of patients with ovarian cancer. Patients will receive the proposed regimen as maintenance treatment following response induction by the conventional maximal tolerated dose (MTD) regimen of Carboplatin and Paclitaxel. Our regimen will include Cytophosphan combined with two agents which are expected to act as indirect angiogenic inhibitors: (a) celecoxib, as a selective COX-2 inhibitor and (b) low-dose Methotrexate, as successfully practiced for suppressing the inflammatory manifestations of rheumatoid arthritis. All components of our regimen will be administered orally and continuously for one year based on the hypothesis that its anti-angiogenic properties will be able to suppress the recovery of residual disease, thus extending the time to progression (TTP), and possibly the overall survival as well.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic proof of papillary-serous ovarian cancer or 1ary peritoneal carcinomatosis.
2. Histological grade III.
3. Original disease in stage III.
4. ECOG performance status: 0-2.
5. Age: 20-80 years.
6. Previous chemotherapy with paclitaxel and carboplatin (only).
7. Previous cyto-reductive surgery.
8. Clinical Complete Response (both physically and by imaging).
9. CA 125 should be either normalized (in at least 50 patients) or while still in decreasing values at monthly measurements.
10. CBC at normal values or with any toxicity at a grade limited to I by NCIC-CTC.
11. Liver and renal functions \< 1.5 upper normal limits (UNL) by SMA.
12. The patient's signature on the informed consent.

Exclusion Criteria:

1. Mucinous type ovarian carcinoma.
2. Histological Grade I-II.
3. Current continuous treatment by steroids or by NSAIDs, or by anti-coagulants for "non protocol" reasons.
4. Previous history of active peptic ulcer.
5. Current participation in any other treatment study.
Impact of Eating Beans on Metabolism

The purpose of this research is to test how eating a meal containing beans impacts how participants' bodies use food for energy.

The objective of this project is to test whether consuming a whole food that naturally contains resistant starch (RS), such as pulses, increases fat oxidation. The primary hypothesis is that consuming a RS-rich meal in which the RS is derived from a whole food (i.e., pinto beans, pinto bean flour) will increase postprandial fat oxidation to a greater extent than consuming a meal low in RS but containing the same amount of energy and macronutrient content.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>18.5 or \<30 kg/m2
* Ability to understand and sign the consent form
* Ability of transportation (i.e., participants must be able to provide their own transportation to the Grand Forks Human Nutrition Research Center)
* Non-smoking or use of other tobacco products, including e-cigarettes
* Not taking steroid-based medications; not planning to or currently attempting to gain or lose weight
* All females of childbearing age must be on birth control for a minimum of 3 months prior to start of study

Exclusion Criteria:

* Inability or unwillingness to consume any food item in the test meals
* More than a 10% change in body weight within the past 2 months
* Participation in a weight loss diet/exercise program
* Current or planned pregnancy
* Lactation
* Uncontrolled hypertension (systolic \>160 mmHg or diastolic \>100 mmHg)
* Diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
* Fasting glucose \> 100 mg/dL or non-fasting (1-2 hours after eating) \>140 mg/dL
* Using medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids, antidepressants)
* Non-English speaking
Sleep Spindles and Memory in Rolandic Epilepsy

The investigators are recruiting children with Rolandic epilepsy and children without epilepsy (aged 4 years old and above) for a non-invasive brain imaging study using Magnetic Resonance Imaging (MRI), Magnetoencephalography/Electroencephalography (MEG/EEG), and experimental tasks. The investigators hope to determine the brain circuits and brain rhythms affected in these children and ultimately identify new treatment options for childhood epilepsy patients.

This is a prospective study of epilepsy biomarkers in a total of 100 subjects of ages 4-18. Participants will spend about 5 hours at the Massachusetts General Hospital (MGH) Athinoula A. Martinos Center for Biomedical Imaging. They will undergo training on a memory task concurrent with EEG/MEG recordings. During the EEG, subjects will wear headphones that will deliver a quiet pink noise stimulus intermittently during a nap. The auditory stimulus will be calibrated in volume to not cause arousals. After napping, subjects will undergo cognitive testing and memory task testing.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 4-18 years
2. Diagnosed with childhood epilepsy with centrotemporal spikes (CECTS) or Rolandic epilepsy by child neurologist
3. Has EEG with sleep activated centrotemporal spikes
4. Has had at least 1 focal motor or generalized seizure

Exclusion Criteria:

1. Has abnormal brain MRI
2. Has other unrelated neurological disease
3. Unable to have an MRI/MEG

   1. Claustrophobic
   2. History of frequent vomiting
   3. Permanent metal in body, braces
   4. Over MRI weight limit: 350lbs
Type of Gonadotropin and Embryo Kinetics of Development

The study is proposed to determine the effect of three types of gonadotropins that are currently used in protocols of controlled ovarian stimulation in women undergoing in vitro fertilization techniques on the kinetics of embryonic development.


Eligibility Criteria:
Inclusion Criteria:

* Women \<38 years old
* Weight \<60 kg
* Own oocytes
* Patients have to provide signed informed consent

Exclusion Criteria:

* Oocyte donors
* Vitrified oocytes
* Severe male factor (\<1 million spz/ml)
* Weight \>60 kg
Lactoferrin in Treatment of Fe Deficient Anemia In Cirrhosis

Iron deficiency and altered homeostasis due to inflammation and decreased iron utilization are main factors involved in anemia in liver disease. Lactoferrin is a first line defence protein for protection against microbial infections and subsequent development of systemic disease as seen with systemic inflammatory response syndrome (SIRS) and sepsis. Lactoferrin with iron has been shown to be efficacious with anemia in chronic disease, in pregnancy and in cancer patients with fewer side effects than oral iron alone. High exposure to iron is associated with increased inflammation which is associated with worse cardiovascular outcomes. Lactoferrin can help reduce the total iron dose and hepatic inflammation.

Lactoferrin is a highly conserved, monomeric 80 kDa single polypeptide chain contained in most mammalian exocrine secretions, such as milk, saliva and tears, bronchial, and intestinal secretions. LTF is also found in the secondary granules of neutrophils a glycoprotein present in milk, has been demonstrated to possess a multitude of biological functions. Lactoferrin in Inflammation and Sepsis The antimicrobial activity of LTF is well documented and consists of two mechanisms: one is iron dependent and deals with high affinity of LTF to iron (bacteriostatic), and the other one is due to LTF affinity to lipopolysaccharide (LPS) to function as a direct bactericidal agent for Gram-negative organisms. Small changes, such as single nucleotide polymorphisms, can affect outcomes against pathogenic agents . LTF interacts with cell surface receptors involved in "danger signal" recognition \[e.g., toll-like receptor (TLR)4, CD14, and CD22\]. At the molecular level, LTF seems to reduce LPS-induced monocyte activation and subsequent production of pro-inflammatory mediators. Lactoferrin in Anemia in Liver Disease The hepatic expression of the hepcidin gene is regulated by signals which reflect body iron status and erythropoietic activity. The regulation of hepcidin by iron status includes a signal from the circulating transferrin via hepatocellular transferrin receptor (TfR2). Like transferrin, lactoferrin will deliver iron to hepatocytes but unlike transferrin, lactoferrin cannot deliver iron to erythroid cells. Lactoferrin does not interact with TfR1 or TfR2.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years
2. Either gender
3. Patients with chronic liver disease with iron deficiency anemia with transferrin saturation\<20% and Hemoglobin in Non-pregnant women (15 years of age and above) \<12g/dl and in men \<13g/dl -

Exclusion Criteria:

1. Those who do not consent to participate in the study
2. Inability to obtain informed consent from patient or relatives
3. Severe preexisting cardiopulmonary disease
4. Renal dysfunction (S. Creatinine ≥ 2mg/dL)
5. Pregnancy/Lactation
6. Post liver transplant patients
7. HIV infection
8. Patients who are on psychoactive drugs, like sedatives or antidepressants
9. Patients who are too sick to carry out the protocol
Knee Arthroscopy Cohort Southern Denmark (KACS)

PURPOSE: To investigate the natural time course of patient-reported outcomes after meniscus surgery and identify factors associated with good and bad outcome after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Assigned for arthroscopy on suspicion of a medial and/or lateral meniscus tear.
* Age \>18 years at time of recruitment
* Having an email address
* Able to read and understand Danish

Exclusion Criteria:

* Patients who will or have previously undergone surgical reconstruction of the anterior or posterior cruciate ligament (ACL or PCL) in either knee
* Fracture to the lower extremities (i.e. hip, leg or foot) in either leg within the last 6 months prior to recruitment
* Not mentally able to reply to the questionnaire
Helicobacter Pylori Infection Occurrence in Russia

This study is planned to reveal the occurrence rate of H.pylori infection in ambulatory settings' patients in Russia and to compare the occurrence rates in different years in treatment-naïve and previously treated subjects.


Eligibility Criteria:
Inclusion Criteria:

* willingness to participate (based on the signed informed consent form);
* age older than 12 y.o. (for subjects younger than 18 y.o. written informed consent of a legal representative was obligatory);
* availability of demographic data and medical history, including previous treatment for H.pylori infection

For subjects of "treatment-naïve" group:

* no previous treatment for H.pylori infection in the anamnesis;
* at least 6 weeks after previous use of any antimicrobial agents for any reason;
* at least 2 weeks' time frame free of use of proton pump inhibitors, other anti-secretory agents and bismuth preparations.

For "Previously treated" group of subjects:

* infection caused by H.pylori established earlier and
* not less than 6 weeks after the end of eradication therapy with at least 2 antibiotics and a proton pump inhibitor for at least 7 days, based on a patient's report

Exclusion Criteria:

* history of surgery on chest, stomach, gut (excluding appendectomy or laparoscopic cholecystectomy performed more than 6 month before the enrolment);
* advanced stage of chronic obstructive pulmonary disease,
* allergies to citruses,
* pregnant and breastfeeding women.
Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years with informed consent
* SLE defined by meeting 4 or more ACR classification criteria
* Biopsy-proven active proliferative lupus glomerulonephritis ISN classification Class III or IV
* Active renal disease

Exclusion Criteria:

* Pregnant, lactating or further fertility requirements
* Serum creatinine \> 3 mg/dL
* Serum ALT or AST \> 3 times upper limit of normal
* Severe, progressive renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
* Previous treated with cyclophosphamide or T2.
* Not discontinuing MMF, azathioprine, leflunomide, methotrexate, calcineurin inhibitor before 1 month of randomization.
* Active or chronic infection, including HIV, HCV, HBV, tuberculosis
* Patient with malignancy