cyrilzakka/clinical-trials huggingface dataset:
A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults

The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.

A randomized, double-blind, parallel group, placebo and active (prednisone) controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis (PAR).

Eligibility Criteria:
Inclusion criteria:

* Diagnosis and history of perennial allergic rhinitis.
* Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.
* Must comply with all study procedures and be literate.

Exclusion criteria:

* Use of tobacco products.
* Work a rotating shift.
* Significant concurrent medical conditions.
* Certain medications such as corticosteroids and allergy medications.
Maternal Epidural Steroids and Hyperthemia

The purpose of this study is to look to see if adding steroids to an epidural reduces the chances of having a fever in labor, and protects the baby from exposure to inflammation.

The association between epidural analgesia and increased maternal intrapartum temperature has been well documented in multiple randomized controlled trials. The exact mechanism for this elevation in temperature is unknown; however the most likely cause appears to be non-infectious inflammatory stimulation. Fetal exposure to maternal fever in utero has been linked with increased antibiotic treatment, increased neonatal sepsis evaluation, and longer length of stay for neonates. In addition there is evidence to suggest intrapartum fevers may lower the threshold for fetal hypoxic brain injury and increase the risk of cerebral palsy. The risk of neonatal encephalopathy in infants born to febrile mothers is 1% compared to 0.1% to afebrile mothers. Safe interventions are needed to prevent adverse fetal outcomes.

Eligibility Criteria:
Inclusion criteria:

* Nulliparity
* Age\>=18
* Patient requests epidural analgesia
* GA \>= 37 weeks

Exclusion criteria:

* No prenatal care
* Temperature \>99.4 at decision for epidural placement
* Cervical dilation \>4cm
* Diabetes (pre-gestational or gestational)
* Autoimmune condition
* Pre-eclampsia
* Maternal heart disease
* Current steroid use
* Active infection (bacterial or viral)
* Wet Tap (CSF on placement of epidural)
* Pre-gestational diabetes
* Known systemic infection (bacterial, viral, fungal or tubercular)
* Known allergy to steroids
* Heart failure
* Hypertensive crisis
* History of active epilepsy
Stool Microbiome, Pathogens, and Infectious Agents Among Olympic and Elite Athletes

This research is being done to investigate fecal microbiome and metabolome as well as serum analytes and single nucleotide polymorphisms in Olympic athletes in comparison with other elite athletes.

Olympic athletes, non-Olympic elite athletes, and other active adults may have genetic and metabolic profiles that are unique. These profiles may contribute to the caliber of their athletic performance, and they may provide keys to understanding select genetic and metabolic conditions.

Therefore, the specific aims of this project are as follows:

* Specific Aim 1: Characterize the fecal microbial communities in athletes participating in the summer 2016 games and in athletes not participating in the Olympic games
* Specific Aim 2: Characterize the fecal microbiome metabolome (untargeted) in athletes participating in the summer 2016 games and in athletes not participating in the Olympic games
* Specific Aim 3: Characterize selected serum analytes and single nucleotide polymorphisms (SNPs) of elite athletes participating in the Summer 2016 games and in athletes not participating in the Olympic games, via serum and saliva analyses, respectively
* Specific Aim 4: Retain specimens from Olympic athletes participating in the summer 2016 games and in athletes not participating in the Olympic games for future research
* Specific Aim 7: Examine for the presence of Zika virus RNA in study participants who exhibit symptoms

Stool, urine, and blood specimens will be collected to study the stool metabolome, as well as serum analytes and single nucleotide polymorphisms, and the nature and extent of exposure to pathogens and infectious agents. These will be compared between Olympic athletes and other non-Olympic elite athletes.

Eligibility Criteria:
Inclusion Criteria:

* Member of the Summer 2016 U.S. Olympic team and/or other elite athlete
* English speaking
* Willing to provide informed consent and biospecimens
* Willing to complete questionnaires regarding normal bowel habits and general health

Exclusion Criteria:

* None
Price Changes and Hypothetical Food Purchases in Adult Grocery Shoppers

The goal of the proposed study is to apply experimental economics in an online grocery store shopping model to examine the effects of pricing on hypothetical food purchases

Participants will be lean and overweight primary grocery shoppers aged 18 years and older. Participants will be considered lean if their body mass index (BMI = kg/m2) is less than 29.9, overweight if their BMI is greater than or equal to 30.12 To meet eligibility for the study, participants must be the guardian of a child at least 2 years or older, do the primary grocery shopping for the family, they must also report being weekly household grocery shoppers, and purchase the majority of their household's groceries once a week.

Eligibility Criteria:
Inclusion Criteria:

18 or older primary shopper in the household, at least one child over 2 years of age

Exclusion Criteria:

eating disorders, not liking study foods
Low INR to Minimize Bleeding with Mechanical Valves Trial

This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. This study will inform physicians about whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. These results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (Coumadin) treatment.

Warfarin (Coumadin) is a blood thinner used to prevent blood clot formation in patients with mechanical heart valves. Blood clots can block blood flow to the brain, heart, or other parts of the body. Mechanical heart valves increases the risk of clot so patients with a mechanical heart valve must take warfarin to reduce their risk of stroke and other blood clot-related problems.

The degree to which warfarin 'works' varies from person to person, and so dosage is determined by measuring each person's response to the drug as an 'international normalized ratio' or INR. A patient with an INR over 1.0 has blood that takes longer to clot than average, and increasing INR values represent increasing time required for blood to clot. While an INR over 1.0 decreases clotting risk, it also increases bleeding risk. It is important to carefully balance these risks.

Specific INR targets have been recommended for patients with a mechanical heart valve, but these recommendations differ between scientific groups and are based on low quality evidence. Recent studies suggest that a lower INR target range than is currently recommended can be used safely. A laboratory study showed that warfarin effectively prevents blood clot formation on mechanical heart valves as long as the INR is 1.5 or above. Two moderately-sized clinical studies showed that an INR target range of 1.5-2.5 resulted in less bleeding than the usual higher target range without increasing blood clot formation or stroke in patients with a newer valve model. Whether we could use a lower INR target range for patients with a mechanical aortic valve remains controversial.

This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. This study will inform physicians about whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. These results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (Coumadin) treatment.

Eligibility Criteria:
Inclusion criteria:

* Age is 18 or older at the time of enrolment
* Have had a bileaflet mechanical heart valve implant in the aortic position 3 or more months ago
* Written informed consent from either the patient or substitute decision maker

Exclusion criteria:

* Has a second implanted mechanical valve (any position)
* Lower boundary of planned INR range is less than 2.0
* Pregnant or expecting to become pregnant during the study follow-up
Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)

This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD).

Eligible participants will be randomly assigned (1:1) to tofogliflozin or metformin with stratification based on UACR (\<300 mg/gCr，≧300mg/gCr), an estimated glomerular filtration rate (eGFR) (\<60mL/min/1.73m2, ≧60 mL/min/1.73m2), and age (\<65 years old, ≧65 years old). The primary end point is change in urine albumin-to-creatinine ratio (UACR) from baseline after 52 weeks treatment. Changes in eGFR, HbA1c, body weight, systolic blood pressure, diastolic blood pressure, total serum proteins, serum albumin, uric acid, hematocrit, hemoglobin, red blood cell count, pulse rate, triglyceride, low-density lipoprotein, high-density lipoprotein and albuminuria class transition rate will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients
* Patients aged 20 years or older at the time of obtaining consent
* Patients with HbA1c 6.5 or more and 9.0% or less within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor / metformin)
* Patients who have been judged by their doctor to need a diabetic drug when they are first seen, or who have already taken a diabetic drug and have decided that it is necessary to add one diabetic drug.
* Patients who have been receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or longer
* Patients with eGFR of 30 or more (mL / min / 1.73m2) within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor / metformin)
* Patients with urinary albumin / creatinine ratio (UACR) of 30 or more and less than 2000 (mg / gCr) (4 weeks or more without taking SGLT2 inhibitor / metformin) within 13 weeks before obtaining consent Evaluate by inspection value)
* Patients for whom written consent was obtained based on the patient's free will after receiving sufficient explanation for participation in this study

Exclusion Criteria:

* Patients receiving treatment with SGLT2 inhibitor or metformin within 13 weeks before obtaining consent
* Dialysis patient
* Patients with a history of severe hypoglycemia
* Patients with hypersensitivity to SGLT2 inhibitor or metformin
* Pregnant women, lactating patients, and patients who wish to raise children
* Patients with BMI of 35 kg / m2 or more based on the latest measured values within 13 weeks before obtaining consent
* Patients who are contraindicated for the study drug
* Other patients who the attending physician deems inappropriate as a subject
The Effect of a Musical Toy (Xylophone) on Pain, Fear, and Parental Satisfaction During Peripheral Intravenous Cannulation in Children Aged 3 to 6 Years

This randomized controlled trial investigates the effects of using a musical toy (xylophone) as a distraction technique during peripheral intravenous cannulation on pain, fear, and parental satisfaction in hospitalized children aged 3 to 6 years. The study will be conducted in the Pediatric Health and Diseases Clinic of Trakya University in Edirne, Turkey.

A total of 64 children will be randomly assigned to either the intervention group or the control group. Children in the intervention group will be encouraged to play with a xylophone, accompanied by a nurse, before and during the cannulation procedure. The control group will receive standard care without any distraction. Pain levels will be measured using the Wong-Baker FACES Pain Rating Scale, fear will be assessed using the Children's Fear Scale, and parental satisfaction will be evaluated using the PedsQL Healthcare Satisfaction Scale.

The primary objective is to evaluate whether the use of a musical toy during IV insertion reduces pain and fear in children. The secondary objective is to determine whether parental satisfaction with the healthcare experience is improved in the intervention group. Data will be collected before, during, and after the procedure.

This study is expected to contribute to the evidence base supporting the use of non-pharmacological methods in pediatric pain management and to promote child-friendly approaches in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 3 and 6 years
* Hospitalized and scheduled for peripheral intravenous cannulation
* No hearing or mental disabilities
* No chronic disease associated with pain
* No analgesic use in the past 6 hours
* One parent present during the procedure
* Both child and parent voluntarily agree to participate
* Intravenous cannulation to be performed in a single attempt
* Parent/guardian is literate

Exclusion Criteria:

* Children with hearing impairment or mental disabilities
* Use of analgesics within the last 6 hours
* Presence of chronic pain conditions
* Parental refusal to participate
* Failed intravenous cannulation attempt
* Illiterate parent/guardian
* Any parental mental disability
* Child or parent unwilling to participate
Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors

A metaverse-based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have undergone curative surgery and adjuvant therapy. The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the program aims to enhance the patients' functional ability, opportunities, and motivation, thereby promoting healthy behavior. Outcome measures include quality of life, fear of recurrence, and adoption of a healthy lifestyle. The intervention period is 4 weeks, with evaluations conducted at baseline and week 4 of the intervention


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing adjuvant therapy after curative surgery for colorectal cancer.;
* Age 18 years old and under 65 years old, estimated survival period ≥ 6 months;
* PG-SGA (Patient-Generated Subjective Global Assessment) score less than 4.
* Be able to walk without assistance;
* Conscious and intellectually normal;
* Voluntarily participate in the research of this topic and provide the consent form for medical record review;
* Mobile phones can be used.

Exclusion Criteria:

* Patients with multiple cancers.
* Tumors not completely resected.
* Patients with severe psychological disorders, severe visual or hearing impairments, or other conditions that hinder intervention.
* Patients with severe complications such as short bowel syndrome, Crohn's disease, ulcerative colitis, diverticulitis, previous stroke, congestive heart failure or edema, liver or kidney failure, or other conditions that affect patient compliance.
* In addition to colorectal cancer or any other diseases deemed unsuitable for participation by the researchers, patients with severe heart, liver, lung, or kidney diseases.
* Patients with special dietary requirements.
Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants

The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem. The study is an observational post-market clinical follow-up study, and the study sites chose the stem variant depending on their own routine and indication.

Generally, the advantage of the Prevision implant family is that all implant variants can be implanted with basically the same instrumentation, which makes it easier to switch to another variant. All implant variants will be available at the study sites and switching between the variants in the study will be encouraged.

The aim of the study is to prove the non-inferiority of the OHS functional outcome after two years to the predecessor implant generation, and comparable revision hip stems. In addition, the patient groups treated with the different variants, and outcome of these subgroups will be descriptively compared.

Eligibility Criteria:
Inclusion Criteria:

* Revision hip arthroplasty patients treated with a Prevision hip stem
* Written patient informed consent
* Patients are able to attend at follow-up examinations

Exclusion Criteria:

* Patients \< 18 years at surgery
* Pregnancy at implantation
* Patients held in a custodial setting
* Patients in a relationship of dependence on the sponsor, the clinic or the investigator
Comparison of TLH and LAVH With Over Than 500g

Since the introduction of total laparoscopic hysterectomy in 1989, laparoscopic gynecologic surgery has undergone many advances. TLH or LAVH has the advantages of faster recovery, fewer complications and shorter hospitalization compared to total abdominal hysterectomy.

However, the hysterectomy for giant uterus has the difficulty of delivering the uterus out of the body. According to the results of TLH, LAVH and abdominal hysterectomy, TLH and LAVH show the postoperative complications were less frequent (3) and the postoperative recovery (4) and return to daily life were faster than total abdominal hysterectomy (3) even if it took longer operation time.

Therefore, laparoscopic hysterectomy has many advantages over abdominal hysterectomy and indications are increasing. However, there has not yet been a direct comparison between TLH and VALH for large uterine surgery. In this study, we compared the results including the complications, hospitalization period and so on., in undergoing operation and post-operation between TLH and LAVH for the removal of giant uterus, which is predicted to be over 500 g.


Eligibility Criteria:
Inclusion Criteria:

* Have the indication for hysterectomy for a supposed benign uterine disease
* Have a giant uterus of 500g or more
* Estimation of uterine weight more than 500g
* Uterine myoma size at 4 months or more after pregnancy due to pelvic examination
* The length of the long axis of one uterine myoma is more than 8cm or the length of the long axis for over 2 uterine myomas is more than 6cm
* Have been not pregnant at the time of presentation
* Have been appropriated medical status for laparoscopic surgery (surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion Criteria:

* Have a suspicion of malignancy or malignant tumors (cervical cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer, Endometrial cancer)
Community Acquired Sepsis Cohort

The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.

Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications of infectious diseases. In this context, the optimization of the management of septic patients from their reception in the emergency services must be a priority. However there are no predictors of progression or severity in patients admitted to emergencies despite the recommendations emphasizing the need for screening and early therapeutic management. Many scores have been proposed for intensive care unit but they remain difficult to extrapolate to other services because they are very comprehensive and require information that is difficult to obtain for emergency physicians.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years old
* Patient hospitalized during the study period for community infectious diseases at the CHU of Rennes

Exclusion Criteria:

* Written objection from the patient to the computer processing of his data
* Pregnant women
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Etodolac-lidocaine Patch in Subjects Experiencing Acute Delayed Onset Muscle Soreness

This study evaluate the efficacy and safety of Etodolac-lidocaine topical patch applied one time daily when compared with placebo in the treatment of acute Delayed Onset Muscle Soreness (DOMS) of the upper limbs.


Eligibility Criteria:
Inclusion Criteria:

* Have not engaged in significant upper extremity fitness activities for more than two times per week for ≥ 2 consecutive weeks in the past 6 months prior to screening.
* Subject has a body mass index of between 18 and 30 kg/m2, inclusive.
* Subjects who report a pain with movement score in both arms of at least 5 (based on a 0-10 NRS) secondary to DOMS approximately 24 to 30 hours after each arm was exercised.

Exclusion Criteria:

* Presence of another painful physical condition that, in the opinion of the Investigator, may confound study assessments.
* Use of pain medication (including anti-inflammatory drugs) prior to the Exercise Visit until 72 hours after randomization.
* Use of any corticosteroids (oral, injectable, topical, inhaled) from before the Exercise Visit until randomization. Corticosteroids must be washed out by at least 3 days before the Exercise Visit.
* Chronic or acute renal or hepatic disorder, inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or a significant coagulation defect.
* History of allergy (cutaneous or systemic), asthma, hypersensitivity to any of the following: etodolac, lidocaine, paracetamol (acetaminophen), acetylsalicylic acid, salicylic acid, other NSAID, other local anesthetic, known intolerance (cutaneous or systemic) to any of the ingredients in the patch.