cyrilzakka/clinical-trials huggingface dataset:
Irinotecan in Treating Patients With Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have colorectal cancer.

OBJECTIVES:

* Determine the frequency of genetic polymorphisms of UGT1 in Hispanics with colorectal cancer.
* Determine if pharmacokinetics of irinotecan and its metabolites, SN38 and SN38G, are associated with the genotype of UGT1 and clinical toxicity.
* Determine whether the genetic polymorphisms of UGT1 are associated with clinical toxicity and pharmacokinetics/pharmacodynamics of irinotecan in patients with unresectable colorectal cancer treated with irinotecan.
* Determine the response, time to progression, and survival in patients with UGT1A1 polymorphisms treated with irinotecan.

OUTLINE: Genomic DNA is isolated from blood samples from patients and analyzed for UGT1 polymorphisms. Patients are stratified according to UGT1 genotype (homozygous for wild type vs heterozygous for abnormal allele vs homozygous for abnormal allele).

Patients receive irinotecan over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven advanced or disseminated colorectal cancer

  * Progressive disease on fluorouracil based chemotherapy OR
  * Recurrence of disease within 12 months of adjuvant therapy with fluorouracil
* No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* SWOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Granulocyte count greater than 1500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT no greater than 3 times ULN (no greater than 5 times ULN if liver involved)

Renal:

* Creatinine no greater than 2.0 mg/dL
* Calcium no greater than 12.0 mg/dL

Cardiovascular:

* No myocardial infarction within past 6 months
* No congestive heart failure requiring therapy

Neurologic:

* No severe psychiatric disorders
* No history of seizures

Other:

* No active or uncontrolled infection
* HIV negative
* No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No uncontrolled diabetes mellitus (random blood sugar 200 mg/dL or greater)
* No other severe concurrent disease
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* Prior oxaliplatin allowed
* No prior irinotecan or topotecan

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
Dexmedetomidine as Adjuvant for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block for Cleft Lip Repair

To assess the efﬁcacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.

Regarding patient registry; A prior G power analysis was done. Using the results obtained from previous studies and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 20 patients per group was calculated. A drop out 10% of cases is expected, so; 22 cases per group will be required.

Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Shapiro test. Data will be presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, unpaired t test will be used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologist (ASA) physical status I or II

Exclusion Criteria:

* known allergy to any of drugs used
* coagulopathy
* any wound or infection related to puncture site
* major illness
* failure to gain consent of parents.
Visual Function, Center Point Thickness and Macular Volume After Photocoagulation

The purpose of this study is to correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume.

Photocoagulation for clinically significant macular edema is effective to reduce the incidence of moderate visual loss. Selective photocoagulation for focal macular edema statistically reduces macular thickening, measured with optical coherence tomography, as early as two weeks after treatment, without significant changes over center point thickness. Although anatomic improvement has been demonstrated with OCT, clinical improvement takes longer to be evident: the Early Treatment Diabetic Retinopathy Study describe that clinical differences in visual function are after the eight month, and all the treatment strategies for macular edema used in this study were associated with an increased rate of moderate visual loss, during the first six weeks. Differences in research can achieve statistical significance, without clinical significance. A study was conducted to identify changes of visual function three weeks after photocoagulation for focal macular edema, and to correlate them with changes of CPT and macular volume, in order to compare the behavior of anatomical changes with visual changes.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* regardless of diabetes duration and retinopathy severity level
* one or both eyes with focal clinically significant macular edema
* treated with selective or focal photocoagulation
* visual capacity under subjective refraction before and three weeks after treatment
* adequate quality 6 mm fast macular map both on the day of photocoagulation, and three weeks after it

Exclusion Criteria:

* patients with myopia over -6.00 diopters
* any retinal disease different from diabetic retinopathy at the moment of photocoagulation
* eyes with a thickened posterior vitreous
* eyes with vitreoretinal traction at the macula
* if they had required scatter photocoagulation before the three weeks evaluation
Investigation of the Effectiveness of Thoracic Mobilization Exercise in Fibromyalgia Patients

The aim of this study is to investigate the effects of mobilization exercises applied to the thoracic region on pain, anxiety, depression, disease impact questionnaire, sympathetic and parasympathetic activity in patients diagnosed with fibromyalgia.

The patients included in the study were randomly divided into two as Thoracic Mobilization Group and Control Group and will be included in the treatment programs after the initial evaluations. Patients in both groups will receive a treatment of 11 sessions in total, 5 sessions per week. Participants will be evaluated twice before and after treatment with the Fibromyalgia impact questionnaire, Beck anxiety and Beck depression questionnaires. In addition, the E-motion Faros device will be used to measure heart rate variability. Measurements of heart rate variables will be made before and after the first day of treatment, before and after the 11th session, and on the 45th day.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with fibromyalgia by a specialist physician according to the 2013 American Association of Rheumatology diagnostic criteria
* Being between the ages of 18-45

Exclusion Criteria:

* Those with neurological deficit
* During menopause and postmenstrual period
* Diagnosed with diabetes
* Those with neuropathic disease
* Those with chronic inflammation
* Have immunodeficiency
* Those with cardiac disease
* Patients who are pregnant
Cognoa ASD Diagnosis Aid Validation Study

The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.

To assess the ability of the diagnostic device to aid in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing specialist clinicians

Eligibility Criteria:
General Inclusion Criteria:

* Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
* Caregiver or HCP concern for developmental delay.
* Female or Male, \>18 to \<72 months of age

General Exclusion Criteria:

* Subjects with a prior diagnosis of ASD rendered by a healthcare professional.
* Subjects whose age on the date of enrollment is outside the target age range.
* Subjects or caregivers who have been previously enrolled in any Cognoa clinical study or survey.
ARC101 in Advanced Solid Tumors

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic solid tumor ovarian, testicular or other Claudin 6+ cancers
* Measurable or evaluable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function

Exclusion Criteria:

* Active CNS involvement
* Malignancy diagnosis other than the disease under study within 2 years prior to the first dose of study drug.
* Presence of uncontrolled ascites
* Toxicity related to prior anticancer therapy that has not returned to Grade ≤1 or baseline levels
* Clinically significant pulmonary compromise
* Active autoimmune disease within 12 months prior to first dose of study drug.
* Female participant who is pregnant, breastfeeding, or plans to become pregnant or male participant who plans to father a child either while enrolled or within 90 days after the final administration of study drug.
Functional Magnetic Resonance Imaging (fMRI) Findings in Children With Early Exposure to General Anesthesia

General anesthetic medications have been shown to cause neuronal cell death in the brains of infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI (fMRI) is a technique developed for mapping brain activation and has been utilized to examine how the brains of children with a history of early exposure to ethanol function differently from children without such a history. This study will utilize fMRI to look for specific changes in brain activation patterns in children with a history of early exposure to general anesthesia, as compared to children without such exposure.


Eligibility Criteria:
Inclusion Criteria:

1. Children ages 10-17 years with an history of exposure to general anesthesia for at least one hour in duration during the ages of 0-24 months of age.
2. The cognitive ability to complete fMRI imaging.
3. Consent of the subject's guardians and assent of the subject.
4. Right hand dominance.
5. English language speaker.

Exclusion Criteria:

1. Subjects with known possibility or knowledge of pregnancy.
2. Documentation of hemodynamic or respiratory instability documented on the anesthetic record
3. Subjects with the inability to complete MRI imaging without sedation.
4. History of prenatal ethanol exposure.
5. History of exposure to antiepileptic medication.
6. History of Attention Deficit Disorder (ADD), or Attention Deficit Hyperactivity Disorder (ADHD)
7. History of traumatic brain injury
8. History of psychiatric disease or exposure to psychoactive medications.
9. History of substance abuse.
Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity -Interval Rehabilitation.

The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval-intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.

The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Coronary heart disease
* Disease-related psychosocial morbidity
* not a disability retirements
* Insured with the German Rheinland pension (deutsche Rentenversicherung Rheinland)
* Sufficient language skills
* Age 18-58

Exclusion Criteria:

* Acute cardiac decompensation
* consuming the underlying disease
* psychotic disorder
* Acute suicidality
* pregnancy
Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers

The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after IV administration in health male volunteers

Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once intravenously. (crossover) Every time before and after taking each medication, PK parameters and safety of CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some tests(Laboratory test, V/S and Physical Examination, etc) respectively.

Eligibility Criteria:
Inclusion Criteria:

* Signed the informed consent form prior to study participation.
* A healthy male volunteer between 20 and 55 years old.
* Body weight between 55kg and 90kg, BMI between 18 and 27.
* Appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.)

Exclusion Criteria:

* Have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases
* Clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor
* Have abnormal laboratory result.

  * Hemoglobin \< 12g/dL or \> 17g/dL
  * Vitamin B12 \< 200pg/mL
  * Ferritin \< 21.8ng/mL
  * Transferrin \< 190mg/dL
  * Reticulocyte over the normal limit
  * Positive for the Triage TOX drug on urine (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)
  * Positive for HIV antibody, HBsAg, HCV antibody test
* A heavy smoker (cigarette \> 10 cigarettes per day)
* Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the first IP administration
* Have hypersensitivity reactions history for EPO, darbepoetin, excipient of IP or iron tablets
* sit SBP \< 90mmHg or sit SBP \> 140mmHg or sit DBP \< 55mmHg or sit DBP \> 90mmHg or Pulse rate \> 100 per/min
* History of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening
* Subject takes ethical drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days before the first IP administration
* Participated in the other clinical trials and administrated IP within 8 weeks prior to the first IP administration
* A heavy alcohol consumer (alcohol \> 21 units/week) or cannot stop drinking
* Bleed or donate blood (\> 400mL) within 8 weeks before the first IP administration
* Participated in this clinical trials and administrated IP
* Have a diet within 2 days before the first IP administration or cannot stop having

  * food containing grapefruit
  * food containing caffeine
* Disagree to avoid getting pregnant during clinical trial
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason
Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus

Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.

This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Ability to hold gaze sufficiently stable for study testing
* Willingness and ability to follow all instructions and comply with schedule for follow-up visits
* Have a diagnosis of keratoconus

Exclusion Criteria:

* Known allergy or sensitivity to the test articles or components
* Any disease causing abnormal topography other than keratoconus
* Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications
The Safety and Efficacy of 5% Lidocaine Patch and Flurbiprofen Patch for Relieving Acute Low Back Pain

This is a prospective, randomized, single blinded, two-arm, head to head study.

The purpose of this study is:

* To evaluate and compare the efficacy of 5% lidocaine patch and flurbiprofen patch for treatment of acute low back pain.

Determining the effect of the 5% lidocaine patch and flurbiprofen patch for improving functional disabilities and in reducing pain resulting from acute low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), Short-Form McGill Pain Questionnaire-2(SF-MPQ-2), general health status (as measured by the EQ5D), Overall treatment effect (OTE), physical exam from baseline up to 1-Months.


Eligibility Criteria:
Inclusion Criteria:

* All subjects underwent a detailed history and systemic physical examination including neurologic and musculoskeletal evaluations. To rule out any confounding etiologies, basic diagnostic laboratory tests including complete blood count and acute phase reactants (erythrocyte sedimentation rate and C-reactive protein) were performed. The patients diagnosed as having acute non-specific low back pain according to history and physical examinations were invited to participate and will be informed about the purpose and course of the study.

Main inclusion criteria

* A primary complaint of pain in the area between the 12th rib and buttock crease without leg pain
* Female or male, 20 - 80 years of age
* Low back pain of less than six weeks' duration; and at least moderate pain intensity (NRS≧4)

Exclusion Criteria:

Main exclusion criteria:

* Known or suspected serious spinal pathology and spinal implants
* Lumbar spinal surgery within the preceding six months
* Serious comorbidities preventing prescription of paracetamol
* Alternative treatment for low back pain in previous two weeks
* Chronic neurological lesion
* Chronic musculoskeletal lesion
* Active cancer
* Pregnancy
* Use of pain medication (except paracetamol) within 3 days
* Treatment site has active skin lesion or inflammation
* Known allergy to skin patch
Gastroparesis Registry 4

The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.

This observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying aims to assess the clinical, pathophysiological, and psychological similarities and differences between patients with Gp, FD.

The primary outcome will be the measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years at initial screening visit
* Symptoms of Gp and/or FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.
* Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months
* Negative upper endoscopy or upper radiographic GI series within 2 years of registration

Exclusion Criteria:

* Use of narcotic analgesics greater than three days per week
* Presence of other conditions that could explain the patient's symptoms such as:
* Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
* Active inflammatory bowel disease
* Known eosinophilic gastroenteritis or eosinophilic esophagitis
* Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute or chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
* Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
* Pancreatic disorder if present on pancreatic imaging or pancreatic function testing
* Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
* Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
* Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
* Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
* Inability to obtain informed consent