cyrilzakka/clinical-trials huggingface dataset:
Clonidine Versus Granisetron for Shivering Prevension

Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption

Shivering is one of the most important periperative complications seen in clinical practice. Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition of thermoregulation resulting in hypothermia is an important cause of post anesthesia shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and serotonergic receptors also are involved of shivering.

Various drugs were studied for their potential role in prevention of peri-operative shivering such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine.

We decided to perform a well-designed study to compare clonidine and granisetron which has been recently introduced as drugs for prevention and control of shivering after spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria: Patient acceptance.,Aged between 21-40 years old, BMI: 18- 30 kg/m2, ASA: I and II., Scheduled for elective cesarean section under spinal anesthesia.

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Exclusion Criteria:

History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus

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Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation

The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive surgery is superior to cinacalcet for the treatment of persistent secondary hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly reduces the cost of treatment post transplant.

Persistent hyperparathyroidism (HPT) with hypercalcemia is prevalent after transplant (affects up to 25% of patients) and negatively affects graft and patient outcome. The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet. Several studies guarantee that cinacalcet is effective in controlling hypercalcemia derived of persistent HPT after renal transplantation. However, maintenance treatment is need because hypercalcemia increases quickly after treatment is stopped. This fact makes increase a lot the cost of transplantation in these patients.

The hypothesis of this study is that subtotal parathyroidectomy by minimally invasive surgery is superior to cinacalcet for treatment of persistent secondary HPT post renal transplant, with minimal morbidity and significantly reduces the cost of treatment after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Functioning renal transplant, GFR ≥ 30 ml / min
* Time post-transplant\> 6 months
* PTHi\>15pmol/L
* Calcium ≥2.63 mmol/L con phosphatemia ≤1.2 mmol/L
* Cervical scintigraphy
* Signed informed consent

Exclusion Criteria:

* Contraindication to surgery
Lung Ultrasound Score After ENT Cancer Surgery

After ENT cancer surgery, postoperative respiratory complications are common, especially after tracheostomy.

The objective of this study is to characterize the pulmonary status of patients after ENT cancer surgery.

We wish to collect and analyze the pulmonary abnormalities revealed by the ultrasound scans performed in the post-anesthesia care unit (PACU), at day 1 and at day 2 after ENT cancer surgery with tracheostomy.

After ENT cancer surgery, postoperative respiratory complications are common, especially after tracheostomy.

Problems with lung ventilation called "atelectasis" are largely associated with these complications. These atelectasis develop within minutes of the start of general anesthesia. Patients who develop a complication require longer postoperative oxygen treatment and more physical therapy.

The diagnosis of atelectasis can be made by standard chest radiography, which is a source of radiation and requires moving the patient. An alternative technique, lung ultrasound, is a non-irradiating examination that can be performed in the patient's bed. It is routinely performed in the postoperative surveillance room and in the intermediate care unit at the Centre Léon Bérard.

The objective of this study is to characterize the pulmonary status of patients after ENT cancer surgery.

We wish to collect and analyze the pulmonary abnormalities revealed by the ultrasound scans performed in the post-anesthesia care unit (PACU), at day 1 and at day 2 after ENT cancer surgery with tracheostomy.

Eligibility Criteria:
Inclusion Criteria:

* ENT cancer surgery with tracheostomy or tracheotomy

Exclusion Criteria:

* under 18 years old
* deprivation of liberty
* pre-existing tracheotomy or tracheostomy
* patient refusal
Asthma Education Using Child Life Services and an Asthma-based Computer Game

This is a single center pilot study designed to evaluate the effectiveness of an asthma education program in the pediatric emergency department. Asthma has reached epidemic proportions. Nine million American children are affected in the United States alone. This problem has increased 75% from 1980 to 1994, with a staggering 160% increase seen in children less than five years old.1 The American Lung Association has targeted this overwhelming problem on both national and local levels. Asthma impacts American communities who differ geographically, culturally, ethnically and by lifestyle, and as a result will present with different obstacles.

The primary objectives are: to determine whether this educational intervention (through interactions with a child life specialist and using the asthma based computer game) in the pediatric ED can influence children's \[and care givers'\] knowledge and understanding of the disease process and treatment, and to improve asthma self-management and decrease morbidity by decreasing ED use and hospitalization.

A secondary objective is to introduce the Child Life Specialist as an effective asthma educator and further strengthen the health care team.

The target population will be recruited from the pediatric emergency department. We anticipate this study to recruit over a one year period and have a one year follow up with an anticipated enrollment of 64 children and families. There will be three Child Life Specialist involved in this program.

After consent has been obtained, the child and parent will complete questionnaires (focusing on asthma knowledge, quality of life, and perception of asthma) and then a laptop will be provided to access the asthma based computer game.

During the child's ED visit the Child Life Specialist will have opportunities to open communication to address barriers or concerns, and reinforce material provided by the game. Through these interactions, the importance of communication between the child, parent and healthcare provider is highlighted.

The family will be given information to access the computer game via the internet. Follow up phone calls or e-mails will occur at 6 months, 9 months, and 12 months which will entail completing questionnaires. The questionnaires uses validated questions along with questions from the material covered through this asthma education study.


Eligibility Criteria:
Inclusion Criteria:

* Age between six to eighteen years old
* Diagnosis of asthma

Exclusion Criteria:

* Refused to participate in the study
* Unable to understand or respond to questions
* If participants are not English speaking
Metformin and Core Temperature in Obese and Lean Males

Metformin is known to increase 18F-FDG uptake in subjects using metformin in retrospective trials.

In this study the researchers aim to investigate the influence of metformin (500 mg 1/day) on temperature in the colon, glucose uptake in the colon and energy expenditure in healthy lean (BMI \< 24kg/m2) or obese subjects (BMI\>28kg/m2). The investigators will measure 18F-FDG uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure before after using metformin.

Obesity and diabetes mellitus type 2 (DM2) are health problems with a tremendous impact. Many attempts have been made to combat obesity and DM2, however, a breakthrough therapy is still lacking.

Obesity is the result of an imbalance between energy intake and energy expenditure. 18F-fluorodeoxy-d-glucose (18F-FDG) positron emission tomography computed tomography (PET-CT) pinpoint areas with high glucose turnover. Physiological 18F-FDG accumulation is frequently observed in the colon. Therefore, the colon might play an important role in increasing energy expenditure by consuming calories. However, the possibility of the colon as an energy dissipating tissue has not yet been explored. The colon could become an interesting new target of research to find a method to combat obesity.

Metformin is one of the few drugs in the treatment of DM2 that is associated with moderate weight loss. Interestingly, patients using metformin show an increased 18F-FDG-uptake in the colon. Whether this higher uptake of glucose also cause an increase in core temperature and/or an increase in energy expenditure is not known. The cause for this increase in glucose uptake in the colon by metformin use is unknown. Also, it is unknown whether this increase in glucose uptake results in an increased energy expenditure and/or an increase in core body temperature.

Objective: In this study the researchers aim to investigate the influence of metformin (500 mg 1/day) on temperature in the colon, glucose uptake in the colon and energy expenditure in healthy lean (BMI \< 24kg/m2) or obese subjects (BMI\>28kg/m2). The investigators will measure 18F-FDG uptake in the colon, temperature in the colon, insulin sensitivity and energy expenditure before after using metformin.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Caucasian origin
* Subjects should be able and willing to give informed consent
* \> 50 years old
* BMI\< 24 kg/m2 or \> 28 kg/m2

Exclusion Criteria:

* Renal failure (GFR\< 60ml/min)
* Liver insufficiency (AST or alanine aminotransferase 3 times upper value)
* Chronic use of drugs or medication
* Diabetes mellitus
* Lactate acidosis or precoma diabeticum in medical history
* Acute or chronic diseases such as: dehydration, severe infection, shock, heartfailure, pulmonary insufficiency, recent heart attack
* Alcoholism
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction

The purpose of this study is to evaluate the efficacy of APSCTC compared to two active drugs in acute pain relief.


Eligibility Criteria:
Main Inclusion Criteria:

* Males and Females aged 18 to 40 years;
* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants who require extraction of impacted mandibular third molar.

Main Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* Previous history of alcohol or drugs abuse diagnosed by DSM-V;
* Previous history of renal failure from moderate to severe;
* Women who are pregnant, lactating, or positive for β - hCG urine test.
DISSECT-N Post Market Data Collection Registry

DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.

DISSECT-N is a prospective, observational, global, multi-center, post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥18 years old
* Subject was treated in the last 7 days, or is intended to be treated, with the Valiant Navion Thoracic Stent Graft System for a dissection in the thoracic aorta
* Subject is willing to comply with standard of care clinical follow-up
* Subject or legal representative or consultee, as applicable has consented for study participation and signed the approved Informed Consent

Exclusion Criteria:

* Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this study.
* Subject is pregnant (not an exclusion if allowed per local regulatory requirements, pregnancy test to be performed where required)
* Subject has an active COVID-19 infection or relevant history of COVID-19. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 3 months prior to enrollment.
Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries

OBJECTIVES: I. Determine the relationship of closed head injury (CHI) severity, focal brain lesions, and the age at injury to the development of working memory, inhibition, and metacognitive skills in children or adolescents with CHI of varying severity.

II. Assess the development of working memory, inhibition, and metacognitive skills in relation to discourse functions, scholastic achievement, and adaptive behavior in these patients.

III. Determine the relationship between impaired inhibition, metacognitive skills, and the emergence of psychiatric disorder in these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients are assigned to one of two study groups based on when the closed head injury (CHI) occurred.

Study I (CHI that occurred at least 3 years ago): Patients undergo standardized and computer based testing of cognition, attention, planning ability, organizational ability, memory, fine motor functioning, reading and math skills, language, and behavioral and emotional functioning on day 1. Patients then undergo brain magnetic resonance imaging (MRI) on the same day. While each patient undergoes testing, the patient's parent/guardian answers interview questions regarding the patient's functional and emotional status since the injury, and the family's functional status, exposure to stressful events, and psychiatric history. Prior to the visit, a questionnaire regarding classroom behaviors, such as ability to focus in school and perform class work, is mailed to each patient's teacher.

Study II (recently diagnosed CHI): Patients undergo neurobehavioral and psychological testing as in study I once during hospitalization or soon after discharge, and then at 3, 6, 12, and 24 months. Patients undergo brain MRI at 3 months. While each patient undergoes testing, the patient's parent/guardian answers interview questions as in study I. Prior to each visit, the same questionnaire as in study I is mailed to each patient's teacher.

Both studies: A brief written summary of the patient's test results may be provided to the patient, parent/guardian, school, pediatrician, or other professional at the request of the patient and parent/guardian.

Eligibility Criteria:
* Study I: Closed head injury (CHI) that occurred at least 3 years ago
* Study II: Recently diagnosed CHI
* Both studies: Eligible if CHI resulted from acceleration, deceleration, or impact by a blunt object (e.g., motor vehicle accidents, pedestrian-vehicular injury, falls, assault except child abuse by caregiver) Preinjury emotional/behavioral problems allowed except mental retardation, autism, schizophrenia, or pervasive developmental disorder that would confound evaluation of cognitive function
Pharmacodynamics and Safety of CDFR0209

This is a randomized, open-label, two-way crossover study to investigate the pharmacodynamics(24 hour gastric pH) and the safety between repeated doses of CDFR0209 and Losec in Healthy Male Volunteers

Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trial Center of Ajou University Medical Center on the 2 day before dosing (Day -2).

On Day -1 around 8 AM, ambulatory intragastric pH recording was performed using ZepHr® pH Monitoring System (Sandhill Scientific, Inc., Highlands Ranch, CO, USA) without dosing for 24 hours.

On Day 1, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg \& sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was continued upto 24 hours after dosing.

From Day 2 \~ 6, subjects were dosed Losec 40 mg or CDFR0209 around 8 AM. On Day 7, subjects was dosed Losec 40 mg or CDFR0209 (Omeprazole 40 mg \& sodium bicarbonate 1,100 mg) around 8 AM and ambulatory intragastric pH recording was performed upto 24 hours after dosing.

After 14 days of washout period, subjects was dosed Losec 40 mg or CDFR0209 by crossover manner and ambulatory intragastric pH recording was performed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20 - 45 years
* With in 20% of ideal body weight, {Ideal body weight=\[height(cm)-100\]\*0.9}
* Agreement with written informed consent

Exclusion Criteria:

* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
* Inadequate result of laboratory test (especially, AST/ALT \> 1.25 x UNL, Total bilirubin \> 1.5 x UNL)
* Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test and Helicobacter Ab IgM
* Positive result in urea breath test
* Taking OTC(Over the counter)medicine including oriental medicine within 7 days
* Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
* Subject with known for hypersensitivity reaction to omeprazole and sodium bicarbonate
* Previous whole blood donation within 60 days or component blood donation within 30 days
* Previous participation of other trial within 90 days
* Continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day)
* An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives

The purpose of this study is to evaluate and compare the clinical retention of a resin-based fissure sealant placed with prior application of etch-and-rinse and self-etch modes of universal adhesives.

Sealants will placed on previously unsealed, caries-free permanent first molars, employing a split-mouth design. 100 patients will be included the study. The teeth will be randomized into eight groups according to the adhesive systems and modes placed under the tested resin-based sealant.

Group1: Acid-Etch + Fissure sealant (ClinPro 3M ESPE, U.S.) (Control arm) Group2: All Bond Universal (Bisco Inc., Schaumburg,IL, U.S.) - with self etch technique + Fissure sealant ; Group3: All Bond Universal - total etch technique + Fissure sealant Group4: Scotchbond (Single Bond) Universal (3M ESPE, U.S.) - self etch technique + Fissure sealant Group5: Scotchbond (Single Bond) Universal - total etch technique + Fissure sealant Group6: Clearfil Universal Bond (Kuraray, Tokyo, Japan) - self etch technique + Fissure sealant Group7: Clearfil Universal Bond- total etch technique + Fissure sealant Group8: Single Bond Plus (3M ESPE)- total etch technique + Fissure sealant

Clinical assessments will be performed according to modified USPHS criteria at 3, 6, 12, 18 and 24 months. Retention, seconder caries, marginal adaptation and marginal discoloration of the sealants will be evaluated.

The data will be analyzed statistically using Fisher's Exact test and Kaplan-Meier analysis.

Eligibility Criteria:
Inclusion Criteria:

* Teeth having clinical indication of sealing with pit and fissure sealant.
* Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures.

Exclusion Criteria:

* Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.
* Patients with systemic diseases.
Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visits. Currently efforts to treat painful episodes with use of non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since arginine is the obligate substrate for NO production, and an acute deficiency is associated with VOE, investigators hypothesized that arginine supplementation may be a safe and beneficial treatment for sickle cell pain.


Eligibility Criteria:
Inclusion Criteria:

* Established Diagnosis of Sickle Cell Disease(SS,SC,S-beta thal)
* Admitted to Hospital for pain
* Pain requiring hospitalization for parenteral narcotics, not attributable to non-sickle cell causes
* \>3 year and older

Exclusion Criteria:

* Hemoglobin less than 5gm/dL or immediate need for red cell transfusion
* Hepatic Dysfunction: increased in SGPT to \>2x normal value
* Renal Dysfunction: increased in creatinine to \>2x normal value or \>1.5
* Mental status or neurological changes
* Pregnancy
* \>10 Hospitalizations per year or history of dependance to narcotics
* Inability to take oral medications or allergy to arginine
* Inability to use a PCA device
* \< 3 years of age
Factors Influencing Cancer Patients Participation in Clinical Trials in China.

This research studies factors affecting Chinese patient participation in cancer clinical trials and their knowledge regarding clinical trials. The investigators design this study to determining how patients makes decisions about participating in a clinical trial and know about patients' attitude toward clinical trials. The investigators aim to find ways to make cancer clinical trials in China more efficient and satisfied patients participating in clinical trials in China.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of malignancy
* Aged 18 years or older
* Ability to understand and complete the questionnaire independently or with the help of a relative or staff member of the oncology department
* Patients have been consented to join an oncology treatment clinical study and have begun active treatment of an oncology clinical trial

Exclusion Criteria:

• Not meeting all eligibility criteria