cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348(5)

A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348(5).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years.
2. Body weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who meet the blood pressure criteria during screening tests:

   * Systolic Blood Pressure: 90 to 139 mmHg
   * Diastolic Blood Pressure: 60 to 89 mmHg
4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial.
7. Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
5. Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.

   * Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
   * Smoking: 20 cigarettes/day
6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
8. Those who are deemed insufficient to participate in this clinical trial by investigators.
9. Woman who are pregnant or breastfeeding.
Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds

The purpose of this study is to determine if there are signs of inflammation in one's blood and urine and to find out if one's body size or ethnicity has an effect on these substances.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 12 to 18 years old
* Hispanic, African American or Caucasian ethnicity
* Have a Body Mass Index (BMI) between the 5th and 85th percentile or greater than the 95th percentile
* Must currently be attending a UC Davis Pediatric clinic

Exclusion Criteria:

* Chronic liver or kidney disease, known Diabetes or other chronic illnesses (such as Sickle Cell Disease or Cystic Fibrosis)
* Subjects can NOT be acutely febrile, smoke, chronically use prescription medications or oral contraceptive pills.
Variability of Tinnitus Characterization Tools and Investigation of Audiovisual Integration in Tinnitus Perception

Characterizing the nature and severity of tinnitus in individuals presents a particular challenge. The nature of the sound (loudness and pitch) is not necessarily indicative of the effect on quality of life. Different methods are used to measure each parameter. Loudness is measured using a technique called "minimum masking," in which the subject is presented with a broadband white noise and asked to adjust the loudness level until they can no longer hear their tinnitus. Severity of tinnitus is commonly characterized using two questionnaires: the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI). These questionnaires assess the perceived severity of the tinnitus and the effect on everyday activities and quality of life. A visual analog scale (a scale from 0-10) is used as a general subjective measurement of tinnitus severity. In the first part of this study, we will measure each of these parameters over a series of sessions to establish a baseline variability for each individual.

The second part will look at the influence of context-specific visual information on auditory perception. This involves watching silent videos of a person speaking, with and without an additional tone designed to match the subject's tinnitus. The effect of this audiovisual feedback on the subject's perception of tinnitus will be assessed using a subjective rating scale and the minimum masking task.

This study is not specifically seeking to treat tinnitus, but is designed to investigate various parameters that can alter the tinnitus percept. Findings from this study will help identify parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study.

Eligibility Criteria:
Inclusion Criteria:

* Have subjective, non-pulsatile and bothersome tinnitus
* Ability to give informed consent and understand study objectives and procedures in English
* Willing and able to understand and comply with all study-related procedures
* Will not start any new tinnitus treatment during the study

Exclusion Criteria:

* Substantial hearing loss or hyperacusis that may interfere with the study
* Medical history of other ear or brain disorders
* Pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children require extra protection for their safety)
* Any handicap that prevents the subject from reliably performing the tests, such as blindness.
Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study

Both ulcerative colitis and Crohn's colitis are associated with an increased risk of developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is well established, several studies show that the risk varies widely between patients, depending on the presence of risk factors. Recently, several of these risk factors were implemented in the updated British guidelines for surveillance which are now used to determine surveillance intervals in our center. The new guideline recommends stratification of patients in a high, medium or low risk group depending on the presence of clinical and endoscopic risk factors and to adjust the surveillance interval accordingly. Although these guidelines provide a first step towards an individualized surveillance regimen, current data regarding risk factors for IBD (inflammatory bowel disease) -associated CRC are solely based on retrospective studies. Prospective data on the phenotype and genotype reliably predicting the risk of CRC is needed to further optimize surveillance in the future.

Objectives:

1. To confirm established and identify new predictive factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome.
2. To provide evidence that mucosal healing results in a significant reduction of colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA (5-aminosalicylic acid) or anti-TNF (tumor necrosis factor) maintenance therapy.
3. Study the expression of several tumor markers in biopsies, blood and faeces at baseline and determine whether expression of these markers can predict dysplasia or colorectal cancer development during follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis
* Disease duration ≥ 8 years
* Inflammation of at least 30% of colonic mucosa at some point between IBD diagnosis and inclusion
* Age 18 - 70 years
* Signed informed consent

Exclusion Criteria:

* High grade dysplasia or colorectal cancer before inclusion
* subtotal or total colectomy before inclusion
* Clotting disorder or use of anticoagulants that can not be temporarily discontinued
* Serious comorbidities which prevent performing a colonoscopy
* Limited life expectancy
* Clinical or endoscopical disease activity (at the discretion of the treating physician)
Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

The adhesive capsulitis is a disease of the shoulder characterized by pain and limitation of movement amplitude. It is defined as for etiology, having discordant theories that related it to an inflammatory condition or to an algoneurodystrophy process. There is not yet a consensus about the best option of treatment. The non-steroidal anti-inflammatories have analgesic and anti-inflammatory activity, where the mechanism of action is the inhibition of prostaglandin synthesis. The antidepressants have been increasingly used in the control of chronic pain and the major action mechanism to have the analgesic effect seems to be based on inhibition of neurotransmitters reuptake noradrenaline and/or serotonin) in nerve cell endings. Literature studies associate the practice of the nerve suprascapular blockade with anaesthetics to good results of clinical improvement of the pain, however, so far, no clinical studies comparing the efficacy of the non-steroidal antiinflammatories or tricyclic antidepressants to nervous blockage were registered in the acute treatment of adhesive capsulitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnostic of adhesive capsulitis, phase II, presenting shoulder pain,
* Limitation of anterior elevation for up to 130 degrees,
* Intact rotator cuff to magnetic resonance,
* Minimum loss of 50% of external rotation when compared to the contralateral side.
* Patients' acceptance of take part in the study after signing the FCCT.

Exclusion Criteria:

* Incapacity to fill the evaluation instrument;
* Contraindication to the use of local anaesthetics, non-steroidal anti-inflammatories or tricyclic antidepressants.
* Pregnancy and breastfeeding.
* Not follow the orientations during treatment on the weeks included in the study, such as, using other anaesthetics or procedures for the relief of pain in this period.
* Lesion of the rotator cuff, infection and others arthropathies.
* Inability to fill a protocol.
* Previous surgery on the shoulder.
Different Doses of Vitamin A Supplementation and Male and Female Morbidity and Mortality

We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for boys. The girls' response might have depended on the last vaccine received before the OPV and VAS campaign. We believe that these findings call for confirmation. In connection with a new campaign, we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we examined whether the half dose compared with the full dose currently recommended by WHO gave an equally good protection against childhood morbidity and mortality. Mortality after supplementation was lower, though not significantly so, for children who had received the half dose. However, there was a highly significant inversion of the effect for boys and girls; while the low dose was clearly better for girls, the full dose might have been slightly better for boys. The girls' responses to the high versus the low dose of vitamin A might have depended on the last vaccine received before the OPV and VAS campaign.

We believe that these findings call for confirmation. In connection with the OPV and VAS campaign in November 2004 in Guinea-Bissau, we intend to examined whether half the dose of the dose currently recommended by WHO as compared to the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

Eligibility Criteria:
Inclusion Criteria:Between 6 mo and 5 years of age and thus eligible for vitamin A and OPV campaign -

Exclusion Criteria:Overt signs of vitamin A deficiency

-
Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients

The main purpose of this study is to investigate, whether a steroid free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients and if it is possible to withdraw calcineurin inhibitors after 3 months.

Protocol synopsis Title An open, single centre, pilot study to investigate a steroid free immunosuppressive regimen for de novo renal transplant recipients followed by a two arm randomization to a calcineurin inhibitor containing and a calcineurin inhibitor free maintenance immunosuppression after three months. Study code Sterfree pilot study Project phase An open, single centre, one arm study followed by a 1:1 randomized, parallel group, comparative study after three months. Study objectives To obtain preliminary information on the efficacy and safety of a rapamycin / sodium-mycophenolate (Myfortic) / tacrolimus regimen in the absence of steroids for the prevention of acute rejection following renal transplantation. To compare a low dose tacrolimus / rapamycin / sodium-mycophenolate (Myfortic) regimen to a rapamycin / sodium-mycophenolate regimen in patients without evidence of acute rejection after three months.

Efficacy:

Primary endpoint

* Plasma creatinine (and creatinine clearance (Cockcroft)) Secondary endpoints
* Incidence of first acute rejections and total number of acute rejections
* Total number of anti-rejection treatments
* Patients successfully withdrawn from calcineurin inhibitor at three months
* Graft survival
* Patient survival

Safety:

* Graft survival
* Patient survival
* Protocol biopsies at 3 months( range: day 75 to 105) and 6 months (range day 165 to 195) sub clinical rejection
* Incidence of first acute biopsy proven rejection and total number of acute rejection episodes
* Total number of anti-rejection treatments
* Patients switched from assigned therapy due to rejection or side effects
* Patients needing steroids because of rejection
* Incidence of selected adverse events: tubulointerstitial nephrotoxicity (TOR inhibitor), leucopenia, thrombocytopenia, elevated fasting blood glucose, dyslipidemia, , electrolyte disturbances, de novo insulin dependency, gastrointestinal disorders (non infectious), neurotoxicity.
* Patients withdrawn due to adverse events

Long term patient follow up Patients will be followed up for graft and patient survival at 12, 24, and 36 months post-transplantation.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with end stage kidney disease suitable for primary renal transplantation or retransplantation
* patients receiving a graft from a living related, living unrelated or brain-death donor

Exclusion Criteria:

* patients with a low or high immunological risk constellation
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity

This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing gastric bypass surgery
* Confirmed AUROC F=0 or F\>2 liver fibrosis
* Age 30-70 years
* BMI greater than 40 kg/m2
* Negative pregnancy test (female only)
* Lab Values: Normal TSH

Exclusion Criteria:

* Autoimmune diseases
* Hepatitis B or C positive
* Heavy alcohol use
* Active smoking history
* Active cancer history
* History of asthma
* History of COPD
* Taking Plavix or Coumadin
* Blood donation within past 2 months
* Glucocorticoid Therapy
* Taking antihistamine on regular basis
VIPER: Veterans Integrated Pain Evaluation Research

The purpose of the study is to learn about the causes of different types of pain that can occur in people who have had an amputation. By gathering information through blood tests, photographs, a nerve test, and questionnaires, we hope to de-code how each individual's special characteristics affect the type and amount of pain they experience in their amputated limb.

Studies have already shown that pain following amputation might be caused by differences in a person's genes. This study may help us find out how genes affect the way you feel pain and why you may feel more or less or different kinds of pain than another person with a similar amputation. What we learn in this research study may lead to discoveries as to why some painkillers work better for some people than others.

Eligibility Criteria:
Inclusion Criteria:

* Male and female active duty military personnel age 18 years and older undergoing treatment at WRAMC and future WRNMMC with the diagnosis of post injury amputation of 1 limb, more than 3 but less than 18 months prior to enrollment. In particular, phantom limb pain patients will be included

Exclusion Criteria:

* Severe Traumatic Brain Injury (Primary major head trauma and diagnosis of traumatic brain injury resulting in documented, permanent or prolonged cognitive deficits that would preclude participation in the study (i.e. decreased intellectual capacity, marked memory deficits, or inability to communicate verbally or in writing)
* Significant cognitive deficits that would preclude participation in the study.
* Substantial hearing loss without alternative means of communication.
* Documented spinal cord injury with permanent or persistent deficits.
* Diagnosis of fibromyalgia or other chronic pain syndrome such as chronic headaches.
* Evidence of ongoing tissue damage pain, infection, bone spur, or poorly fitting prosthesis.
Clinical Trial of Emotion-Focused Skills Training for Parents

Children with externalizing and internalizing symptoms has been linked to poor emotional competence, problematic understanding and regulation of emotions. A number of recent studies demonstrates the importance of parents' active involvement in the child's recovery process and support the empirical relationship between parenting style and child symptoms. Emotional awareness and acceptance of painful emotional experience in parents leads to reduction in how these emotions are experienced in response to stressors in children. This makes the parent less vulnerable to rumination or suppression of negative emotional experience related to the child. In addition, it releases parents' emotional capacity to be mentally present and emotionally available for their child. Although neuro-affective principles from research have been incorporated in the therapeutic approaches for adults, there are currently no programs that target these mechanisms in working with children with mental health difficulties. Emotion Focused Skills Training (EFST) is an easily administrated, cost efficient treatment program specifically directed towards the parental role in promoting change in children. In this randomized controlled trial, we will compare experiential process oriented EFST with a psycho-educational version of EFST on parents of children aged 6-13 with externalizing or internalizing symptoms. Parents of 236 children will receive a two days course and 6 hours of individually delivered treatment within a 10 weeks period, either with the experiential version of EFST or the psycho-educational version. Feedback regarding outcome on externalizing and internalizing problems will be obtained from parents and teachers at 5 different periods: baseline, treatment completion and at 3, 6 and 9 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children between 6-13 with either internalizing problems, externalizing problems, or both.
* An overall final assessment of whether it is likely that the parents will be able to fully participate in the study.
* Parents who live with the child at least 50% of the time.
* Parents who agree that they need help and are motivated for the treatment.
* Parents and children who speak Norwegian
* Parents who have the time to participate in the intervention program.
* Parents who are willing to collaborate with the childs school and contact with the school teacher.

Exclusion Criteria:

* Parents: Serious or chronic mental health difficulties such as psychosis, bipolar disorder, organic disorder, ongoing substance abuse, do.
* documented sexual abuse, serious mental health problems, organic disorder and/or disability in the child.
Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure

This study was done to determine whether Simvastatin (a medication commonly used to treat patients with high cholesterol levels in the blood increases blood flow to the kidneys and improves renal function in normal volunteers and patients with impaired renal function secondary to polycystic kidney diseases.


Eligibility Criteria:
Patients with chronic renal failure:

1. Age 18 or older
2. Chronic renal failure secondary to Autosomal Dominant Polycystic Kidney Disease
3. Serum creatinine ≥ 1.4 but ≤ 2.0 mg/dl
4. Creatinine or iothalamate clearance between 35-70 ml/min per 1.73m2
5. Stable renal function for the three preceding months
6. Blood pressure needs to be adequately controlled (\< 140/90 mm Hg), with or without the use of antihypertensive agents. However, ACE inhibitors or AT1 receptor blockers must not be initiated, or have their dose increased during the study period.

Patients with normal renal function:

1. Age 18 or older
2. Normal renal function and diagnosed with Autosomal Dominant Polycystic Kidney Disease
3. Serum creatinine ≤ 1.4
4. Creatinine or iothalamate clearance ≥70 ml/min per 1.73m2
5. Renal function has to be stable for the three preceding months
6. Blood pressure needs to be adequately controlled (\< 140/90 mm Hg), with or without the use of antihypertensive agents. However, ACE inhibitors or AT1 receptor blockers must not be initiated, or have their dose increased during the study period.

Exclusion criteria include:

1. Patients using corticosteroids, cytotoxic drugs (alkylating agents, chlorambucil, cyclophosphamide), CellCept, or cyclosporin A therapy
2. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab)
3. Serum transaminase levels (AST, ALT) 2 times the upper limit of normal
4. Clinically significant medical conditions
5. Pregnant patients, patients who are breast-feeding, or women intending to conceive during the course of the study
6. Presence or suspicion of active infection, recent serious infection or chronic/recurrent viral or bacterial infection
7. Presence of concomitant renal artery stenosis.
A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-016)

The goal of the study is to learn what happens to levels of nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include, but are not limited to:

* Is in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed before randomization
* Has a body mass index (BMI) 18 to 32 kg/m\^2 (inclusive)

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer (malignancy)