cyrilzakka/clinical-trials huggingface dataset:
Kidney Damage in Patients With Normal eGFR

This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Provides written Informed Consent and is willing to comply with protocol requirements;
* Is at least 18 years of age;
* Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
* Has documented estimated glomerular filtration rate \[eGFR\] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.

Exclusion Criteria:

* Is a pregnant or lactating female.
* Has a history of severe congestive heart failure
* Has a history of hyperthyroidism
* Has a history of hypersensitivity to iodinated contrast agents
* Has unstable renal function
Speech Performance of Rugby Players When Using Different Types of Mouthguard

Participation in contact sports is linked to an increased risk of dental injuries. To reduce the risk and severity of sports-related dental injuries, mouthguards are often recommended to be worn during training and competition. However, athletes often complain that they cannot talk properly when using mouthguards. It is hypothesized that speech performance differs when using different types of mouthguards. A group of female national rugby players will be asked to pronounce four Malay words with plosive sounds (/p/, /b/, /d/ and /t/) repeatedly in three conditions: (i) when not using any mouthguard, (ii) when using 'boil and bite' mouthguard, and (iii) when using custom-fitted mouthguard. The sounds will be recorded for spectrographic analysis. The difference in mean voice onset time between conditions will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* adult female aged 18 years old and older
* currently representing the nation and participating actively in rugby
* native speakers of Malay (national language)

Exclusion Criteria:

* did not play rugby within the last six months
* edentulism
* used a mouthguard, orthodontic appliance or removable prosthodontics appliance within the last six months
* known history of allergy to polymers
* medical problems (ASA classification 3 and above)
Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age

Exclusion Criteria:

* History Of Known Prior Rotavirus Gastroenteritis
* Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period
Impact of Vitamin C Supplementation on Hospital Outcomes in Children Undergoing Corrective Heart Surgery for Congenital Heart Diseases

Vitamin C will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations

Inflammatory markers including CRP , TLC ,PNI , GPS NLR will be checked on admission and on discharge and compared between cases and controls Hospital length stay will also be compared between the two groups


Eligibility Criteria:
Inclusion Criteria:

* Children in the first two years who will be for corrective surgery for heart diseases congenital heart diseases
* Pediatric patients whose parents or caregivers agree to be enrolled in the study.
* Risk Adjustment for Congenital Heart Surgery -1 (RACHS-1) for Evaluation of Mortality in Children Undergoing Cardiac Surgery : the first two categories (Thiagarajan and C. Laussen 2015)

Exclusion Criteria:

* Pediatric patients with associated comorbid conditions.
Biomarkers for Clinical Hypoxia Evaluation in Cervical Cancer

Patients with locally advanced cervical cancer (LACC) are primarily treated with radiotherapy +/- chemotherapy however 5-year survival rates are \<60% with significant treatment toxicity. Hypoxia is a well-known radioresistant component of solid tumours such as cervical cancer and hypoxia modification therapies have demonstrated immense promise in treating such tumours. A major factor in determining a successful outcome with hypoxia modification is appropriate patient selection as it is hypoxic tumours that receive the most benefit from hypoxia modifying therapies. To date there is no validated hypoxia biomarker to stratify patients for therapy in cervical cancer in clinical use. This project offers a unique opportunity to examine both genetic and imaging biomarkers to optimise patient stratification when receiving curative radiotherapy for cervical cancer.


Eligibility Criteria:
Inclusion criteria:

* Patients must have a histologically confirmed diagnosis of cervical cancer
* Diagnostic/pre-treatment biopsy available
* Patients must be suitable for standard radiotherapy and brachytherapy
* Age greater than or equal to 18 years; no upper age limit
* Performance status - ECOG 0-2 (Refer to appendix 1)
* Women of childbearing age MUST have a negative pregnancy test prior to study entry and be using an adequate contraception method
* Before participant registration, written informed consent must be given according to GCP and national regulations.

Exclusion criteria:

* Participants deemed unsuitable for a biopsy (during or following radiotherapy) in the opinion of the treating oncologist.
* Patients with cardiac pacemakers, cochlear implants, intraocular foreign bodies or any other MR contraindication
* Patients with a hip replacement
* Patients with a known history of allergic reaction to gadolinium-based contrast agent
* Any contraindications to Hyoscine Butylbromide (Buscopan)
* Any patient taking ACE inhibitors. These should be stopped/substituted or they are a contraindication.
* Evidence of impaired renal function (eGFR \<15 ml/min)
* Any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the study
* Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the study
* Any other serious uncontrolled medical conditions
* Clinical evidence of metastatic disease
* Any pregnant or lactating woman
* Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
* Any patient who is currently involved in, or who has recently been involved in other research
Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition

The objective of this study was to find out whether the bioavailability of PT Dexa Medica's formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the innovator's product (Prexum® 4 mg, Servier).

The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Perindopril 4 mg tablets of PT Dexa Medica) or one tablet of the reference drug (Prexum® 4 mg, Servier).

Blood samples were drawn immediately before taking the drug (control), and at 20, 40 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 192 hours after drug administration.

Three weeks after the first drug administration (washout period), the procedure was repeated using the alternate drug.

The pharmacokinetic parameters, including AUCt, AUCinf, Cmax, t max, and t1/2, were determined based on the concentrations of the perindopril parent compound and the metabolite perindoprilat, using high-performance liquid chromatography method with tandem mass spectrometry detector (LC-MS/MS).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects
* Aged 18-55 years inclusive
* A body mass index in the range of 18-25 kg/m2
* Able to participate, communicate well with the investigators and willing to give informed consent
* Non-smokers
* Vital signs (after 10 minutes resting) are within the following ranges:

  * systolic blood pressure 100-125 mmHg
  * diastolic blood pressure 60-80 mmHg
  * pulse rate 60-90 bpm

Exclusion Criteria:

* Pregnant or lactating women
* Known hypersensitivity or contraindication to perindopril
* Intake of any prescription drug within 14 days of this study's first dosing day
* Intake of any non-prescription drug, food supplement, or herbal medicine within 7 days of this study's first dosing day
* History or presence of any liver dysfunction (ALT, alkaline phosphatase, total bilirubin ≥ 1.5 ULN)
* History of any bleeding or coagulation disorders
* Clinically significant ECG abnormalities
* Clinically significant haematology abnormalities
* Renal insufficiency (plasma creatinine concentration ≥ 1.4 mg/dL)
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug
* A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day
* A positive hepatitis B surface antigen (HBsAg), anti-HCV, and anti-HIV
* History of drug or alcohol abuse within 12 months prior to screening of this study
* Participation in a previous study within 3 months of this study's first dosing day
A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma

The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 to 65 years of age
* Percent of predicted FEV1 ≥ 50% and ≤ 80%
* At least 12% reversibility over pre-bronchodilator FEV1
* Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone powder or equivalent
* Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points

Exclusion Criteria:

* Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
* History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
* Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)
Emotional Processing Intervention for Children With TBI

Investigating an emotional processing program, that is modified for use with children, is effective for children with a traumatic brain injury (TBI).

The first stage of this project will evaluate the appropriateness of an emotional processing intervention modified for a pediatric population. The researchers will modify the intervention prior to the evaluation by the 15 typically developing children.

The second stage of the project will evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI. Emotional processing includes both facial affect recognition and social perception measures.

Eligibility Criteria:
Inclusion Criteria:

Ages of 9 and 17. Speak and read English fluently.

Healthy Volunteer or

Have sustained a TBI at least 1 year ago, that has affected his or her ability to process emotions.

Exclusion Criteria:

Previous stroke, MS, or neurological injury or disease in the past (like brain tumor or epilepsy) other than TBI.

History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).

Uncontrolled seizures or other unstable medical complications.
Comparative Bioavailability of Two Forms of Vitamin C

The purpose of this study is to compare levels of vitamin C in the blood over the 24 hour period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by laboratory results and medical history
* Females not of child bearing potential
* BMI 18-30 kg/m2
* Agrees to consume a low vitamin C diet
* Non-smoker or ex-smoker \>1 year

Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant during the trial
* Alcohol \>2 drinks per day; alcohol or drug abuse within the past year
* Cardiac conditions
* Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
* History irritable bowel syndrome, malabsorption or significant GI disease
* History of kidney stones
* Use of medications known to interact with vitamin C
* Use of supplements containing vitamin C
* Use of anticoagulants (warfarin), barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications
* History of or current diagnosis of cancer
* Uncontrolled hypertension
* History of diabetes, renal disease and/or liver disease
* Unstable psychiatric disorder
* History of or current immunocompromise
* History of hemochromatosis or hemoglobinopathies
* Participation in a clinical research trial \<30 days
* Use of acute medication w/in 72 hours of intervention
* Unstable medications \<90 days
* Abnormal liver function
* Serum creatinine \> 1.5 x upper limit of normal (ULN)
* Anemia of any etiology
* Blood donation w/in the last 2 months
* Allergy or sensitivity to test articles, foods or beverages provided during the study
* Cognitive impairment and/or unable to give informed consent
Pain Management Groups in Occupational Health Settings

This cluster randomized waiting-list controlled study will evaluate the effectiveness of pain management group activity organized by the OH on pain intensity and associated disability, and co-occurrence of mental or sleep problem in patients with chronic pain.

Pain is very prevalent among the working population causing a considerable amount of work disability days. Pain management group therapy has shown to have a significant effect on chronic pain. However, little is known of the effect of such therapy on work disability. There are especially very few studies prescribing the effectiveness of pain management groups provided by the occupational health service.

Eligibility Criteria:
Inclusion Criteria:

- chronic pain + increased risk of work disability (based on a screening survey)

Exclusion Criteria:

* a malignant disease such as cancer, or severe mental illness such as depression causing significant functional disability.
* participating in another pain group elsewhere.
* in the middle of a major life crises such as divorce.
To Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults

The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.

Randomized, double blind, multicenter, phaseⅢ study

Eligibility Criteria:
Inclusion Criteria:

* healthy Korean adults (age: over 18 years)
* who got the basic vaccination of DTP(Diphtheria, tetanus, pertussis) in the past
* Subjects willing to provide written informed consent and able to comply with the requirements for the study

Exclusion Criteria:

* subjects who have already got the additional vaccination of Td within 5 years
* subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA)

  * only applicable in step I
* subjects who have not recovered from the acute disease within 2 weeks
* subjects who have the medical history of allergic disease related to the components of investigational drug
* who got the treatment of blood product and immunoglobulin product within 3 months
* females who are pregnant
* females who are breastfeeding
* subjects who are infected from the diphtheria and tetanus
* subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination
* Subjects who are scheduled to participate in other clinical trial studies during the study
* Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
* Those who take the other medicine that affects this study or are vaccinated other vaccines
* Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment
* Subjects with a history of chronic disease obstacles to the study.
* Subjects who have episode of acute febrile (at least 37.4) after injection of vaccine during the study
* Subject who have plan of operation during the study.
* Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.
The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography

High survival rates have been reported for screen-detected Stage I lung cancer patients, but there are concerns about the potential biases of uncontrolled studies. DANTE is a prospective randomized controlled trial exploring the effects of screening with LDCT on lung-cancer-specific mortality, and on the prevalence and incidence rates of lung cancer, stage distribution and resectability rates in a selected high-risk population. The prevalence of a set of biomarkers in sputum and blood samples is also being determined.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 60-74 years
* smokers of more than 20 cigarettes/day for at least 20 years (actual smokers or ex-smokers from no more than 10 years)

Exclusion Criteria:

* severe cardiopathy
* advanced BPCO with chronic hypoxaemia (rest SatO2 \< 94%)
* chronic severe renal insufficiency
* hypertension not controlled with drugs
* type 2 diabetes or other severe systemic disease
* severe previous cerebrovascular lesions with permanent invalidity (not self-sufficient).
* severe vascular lesions with repeated ictus, trophic lesions, or limb loss, if actual smoker
* Dementia, psychosis, severe depression or maniac-depressive syndrome
* actual or precedent neoplasia, excepted skin tumor not-melanoma or scaly cells laryngeal and buccal cavity tumor, N0, recovered from more than 10 years or other tumors recovered from more than 10 years
* transplantation less than 5 years or with rejection episodes in the last 2 years
* unable subjects
Comparative Effects of Tensioning and Sliding Neural Mobilization on Nerve Root Function

the current study will try to answer the question: Is it theoretically possible, that increased longitudinal stress on nerve root from sliding or tensioning intervention may subtly affect the neural function? Our hypothesis is that tensioning and sliding, differently affect the neural function.

A prospective, parallel randomized, controlled study will be conducted at a research laboratory of our University. Participant recruitment will begin following approval from the Ethics Committee .The patients will participate in the study after signing an informed consent form prior to data collection.

Per inclusion criteria, subjects will be between 18 and 50 years of age, not currently experiencing any neck or dominant upper extremity symptoms, do not have a history significant for a chronic painful condition, and will not using pain relievers. Prior to participating in any study-related procedures, participants will read and signed an informed consent form approved by the Institutional Review Board.

Participants will be divided into three groups; One group will receive neural gliding mobilization and the other neural tensioning mobilization, both targeting the median nerve.

. the third group will receive sham neural mobilization intervention . Participants were not given information on which neural mobilization technique they were receiving; they were only told that they could receive one of two different neural mobilization techniques. Six sessions will be given every other day for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* not currently experiencing any neck or dominant upper extremity symptoms.
* do not have a history significant for a chronic painful condition.
* do not using pain relievers.

Exclusion Criteria:

* inflammatory joint disease or other systemic pathologies.
* prior history of overt injury and surgery relating to the musculoskeletal system.
* disorder related to the spine and extremities.
* musculoskeletal pain in the last three months.
Self-supporting Care Model in Home Environment for Patients With Stroke

The purpose of this study was to administer intervention based on self-supporting care model in home environment and to explore the effects of this intervention on stroke patients' activities of daily living, movement, cognition, nutritional status, and quality of life.

Subjects were randomized to intervention group and control group. The experiment was designed as randomized cross-over control trial. The primary outcome included 8 measures: Barthel Index-based Supplementary Scales, Canadian Occupational Performance Measure, Fugl-Meyer Assessment, Balance Computerized Adaptive Testing, Mini Mental State Examination-2nd edition, Mini Nutritional Assessment, Stroke Impact Scale, and Stroke Self-Efficacy Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* age \> 20 years
* Diagnosis of stroke
* The modified Rankin Scale : 2\~4
* Keep sitting for half an hour by himself/herself
* Follow instructions
* Willing to sign the subject's consent

Exclusion Criteria:

* Diagnosis of dementia
* History of orthopedic diseases or peripheral nerve injury
* readmission because of stroke
Drug Name Identification an Ignored Patient's Problem That Needs a Solution

Each of the recruited patient was given 3 different placebo drugs with 3 different mad up names to be taken for one month with different regiments.

The drug name resembled a real drug but with enough difference to prevent the patient from trying to buy it as a safety precaution. The name was printed on the box in English and Arabic letters. The coloured shape was printed to 2x2 cm dimension.

After one month the participants were intervened by a doctor blinded to the study. The doctor asked about the drug history of the patient. If the participant could remember the drug name and its correct regiment the doctor documented that. if the patent failed to remember the correct name and its regiment then the doctor asked the patient to try and remember anything about the drug.

Then the patient would be asked about the symbol on the drug and was it helpful for him in any way.

A scoring system was used to evaluate pateints memory of the drugs used 0- 3 0 is the minimal score and will be given if no recall of any drug name and 3 is the maximum score and will be given if the patient could remember the name of the tree drugs correctly.

The same scoring system was used for the symbols

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II patients

Exclusion Criteria:

* severe or life-threatening condition
* severe visual impairment
* mental or cognitive dysfunction