cyrilzakka/clinical-trials huggingface dataset:
Effect of Amlodipine on Anti-platelet Drug Effect in Patients With Coronary Artery Disease

Clopidogrel can reduce risk of cardiovascular disease by inhibiting platelet aggregation. It is metabolized to an active drug by a liver enzyme. Its efficacy may be measured by blood sampling for platelet activity, analyzed by VerifyNow device. Calcium Channel blocker (CCB) is also commonly used for blood pressure and anginal control in these patients. Dihydropyridine group of calcium channel blocker (e.g. amlodipine) inhibits this enzyme. There are observational studies reporting dihydropyridine CCB reducing clopidogrel effect, but the clinical implication is unclear.

This study test the hypothesis that there is no significant effect of dihydropyridines CCB on clopidogrel response compared with control. After giving consent, patients with suboptimal blood pressure or anginal control will be randomized to receive either dihydropyridine CCB or non-CCB as placebo. These patient will be follow-up in 1 month.

Clopidogrel is a pro-drug, which requires hepatic transformation by the cytochrome P450 isoform 3A4 to generate the active metabolite. It inhibits adenosine-5-diphosphate (ADP)-induced platelet aggregation by irreversibly blocking the platelet P2Y12 receptor. However, response to clopidogrel shows wide individual variability, and patients with high on-treatment residual ADP-induced platelet reactivity are at an increased risk of adverse cardiovascular events. Previous study suggest co-administration of CCBs is associated with decreased platelet inhibition by clopidogrel, but these observational studies are confounded by patient's characteristics baseline difference such as proportion of hypertension and diabetes.

The objective of this randomized controlled study is to compare amlodipine with placebo on anti-platelet effect of clopidogrel.

Eligibility Criteria:
Inclusion Criteria:

* ischemic heart disease patient, and
* given loading or maintenance dose of clopidogrel and in need of it for 1 or more month
* and in need of additional drug for optimal BP control (aim blood pressure \<130/90) or angina control.

Exclusion Criteria:

* existing use of amlodipine
* thrombocytopenia
* end stage renal failure
* allergy to clopidogrel/ amlodipine
* pregnancy/ lactation
* strong inhibitor or inducer of cytochrome P450 3A4 enzyme within 7 days before start of the study.
Clinical Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

To evaluate the efficacy of KHK7791 by comparing changes in serum phosphorus levels from baseline values between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 for 8 weeks and those receiving placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Has voluntarily provided written informed consent to participate in the study.
2. Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
3. Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
4. Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
5. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
6. Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 6.0 mg/dL at screening examination.
7. If on any vitamin D, calcimimetics regimen, bisphosphonate, calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
8. Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.

Exclusion Criteria:

1. Peritoneal dialysis was performed within 12 weeks before screening examination.
2. iPTH \>600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
3. Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
4. History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
5. Subjects who used anti RANKL preparations within 6 weeks before screening examination.
6. Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
7. Having concurrent severe heart disease or hepatic impairment.
8. Developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination.
9. Uncontrollable hypertension or diabetes.
10. Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center during the study period.
11. Any diagnosis of and treatment of malignancy within 5 years before screening examination.
Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial

The project consists of two studies where we want to throw light on the importance of physical activity/exercise to maintain physical function among cancer patients whose disease is not responsive to curative treatment. Study I is a randomised intervention study where we want to study the effect of adjusted physical exercise compared to usual care. In study II our main aim is to validate different subjective and objective methods to measure physical functioning


Eligibility Criteria:
Inclusion Criteria:

* Palliative cancer patients,
* life expectancy between 3 and 12 months,
* Karnofsky status equally or above 60,
* pain score equal or below 3 on numerical rating scale (0-10),
* cognitive function intact
Study to Evaluate Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects

A single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of multiple doses of Fluconazole, a CYP3A4 and CYP2C9 inhibitor, on the pharmacokinetics (PK) of CTP-543 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female, aged 18-60 inclusive
* Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening
* If of reproductive age, willing and able to use a medically highly effective form of birth control 4 weeks prior to first dose, during the study and for 30 days following last dose of study medication.
* Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History or presence of alcohol or drug abuse within the past 2 years
* History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds
* Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
* History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) \> 450 msec for males or QTcF \> 470 msec for females at Screening visit or prior to the first dosing
* Abnormal liver function at Screening
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
* Positive results for coronavirus infection (COVID-19) at Screening or check-in
* Positive drug or alcohol results at Screening or check-in
* Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* Vaccination with a live attenuated vaccine up to 6 weeks prior to dosing. Live vaccines include (but are not limited to) the measles, mumps, and rubella (MMR) vaccine; intranasal flu vaccine; and Zostavax for herpes zoster
A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder

The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and clinical evaluation will be recorded and potential differences that may exist due to epidemiological factors or comorbidities will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients, diagnosed with Bipolar I or II Disorder, having presented or presenting a major depressive episode (according to DSM-IV-TR) with a starting date of 6 months maximum before the inclusion.
* Current treatment with atypical antipsychotic(s) (AAP(s)) minimal 1 month and maximum 6 months prior to the first study visit
* Patient takes an AAP at an adequate therapeutic dose as indicated in the local Summary of Product Characteristics (SPC) and current medical practice

Exclusion Criteria:

* Patients diagnosed with Bipolar I or II, experiencing a hypomanic, manic or mixed episode at time of inclusion
* Pregnant or breastfeeding women, or women of childbearing potential not using a medical reliable method of contraception as stated in the SPC of the AAPs
Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)

A Double-Blind Placebo-Controlled Random Order Crossover Pilot Study of Iloperidone for Symptoms of Arousal in PTSD.

During Period A, subjects will receive 8 weeks of iloperidone or placebo (2 weeks titration period followed by 6 weeks on stable dose). Then they will be reassessed for response during Period A; study drug will be discontinued and washed out over the following 2 weeks. They will then begin Period B on the alternate blinded treatment with similar titration and assessment, initially weekly and then every other week for a total of another 8 weeks. The purpose of the study is to determine whether Iloperidone is effective in the treatment of some symptoms in patients with PTSD, particularly difficulty falling or staying asleep, trauma dreams and daytime irritability or outbursts.

Eligibility Criteria:
Inclusion Criteria:

* PTSD diagnosis

Exclusion Criteria:

* Pregnancy
* Traumatic Brain Injury greater than mild
* Primary sleep disorder
* Caffeinism
* Active substance use disorder
* Active suicidal risk
* Antipsychotic medication, antibiotics, sedatives, some antihypertensive or antiarrhythmic medication
Effectiveness of Technology-enabled Exercise Program in Firefighters With Shoulder Pain.

To assess if a technology-enabled Exercise program plus Education (TEEP + E) is more effective than Education program (EP) alone, in providing better outcomes (quality of life, at-work disability and productivity loss, firefighters' perception, adherence, overall improvement/deterioration) in firefighters with shoulder pain, at 3-, 6-and 12-month follow ups.


Eligibility Criteria:
Inclusion Criteria:

* Active duty firefighters aged 18 to 100 years, with shoulder pain.
* Do not permanently use strong pain medications.
* Able to understand spoken and written English.
* Access to computer, internet and telecommunications application software (Skype).

Exclusion Criteria:

* Firefighters who have had shoulder related surgeries in the last 6 months.
Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer

In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Histologically or cytologically documented gastric adenocarcinoma
* Performance status (ECOG scale): 0-2
* Life expectancy ≥ 3 months
* No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
* Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for adjuvant or neoadjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment.
* WIth Measurable Target lesion
* Patients should sign a written informed consent before study entry

Exclusion Criteria:

* History of hypersensitivity to fluoropyrimidines, S-1, oxaliplatin or the ingredients product
* Inadequate hematopoietic function: WBC≦5,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3
* Inadequate organ function which is defined as below:

Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN) (\>5.0 x ULN if hepatic metastasis); serum creatinine \> 2 upper limit of normal range (ULN);

* Symptomatic peripheral neuropathy ≥ NCI CTC AE grade 1;
* Receiving a concomitant treatment with other fluoropyrimidines or fluorocytosine;
* Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method;
* Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication;
* History of ventricular arrhythmia or congestive heart failure;
* Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study;
* Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical, paralytic or poor control diabetes
Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients

The purpose of the study is to determine the effect of enamel matrix protein derivative on an inflamed, periodontal-involved tooth. The hypothesis to be studied is that enamel matrix derivative protein with increase the clinical attachment level is localized sites of advanced periodontal disease.

The purpose of this study is to determine if local application of a commercially-available, FDA-approved preparation of enamel-matrix protein derivatives is effective in increasing clinical attachment levels (primary outcome), as well as alveolar bone (secondary outcome) compared to standard mechanical therapy in patients on periodontal maintenance therapy (PMT). Subjects will be divided into two groups for additional therapy in a 6-9 mm interproximal periodontal pocket at baseline: 1) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of the enamel matrix protein derivate or 2) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of saline. Samples/measurements will be obtained at the designated experimental site at baseline, 2 weeks, 6 and 12 months during PMT: 1) digital radiograph (baseline and 12 months only; bone height measurements), 2) presence of explorer-detectable supragingival plaque, 3) 30-second gingival crevicular fluid (GCF) sample (markers of inflammation, bone turnover), 4) recession from the cemento-enamel junction, 5) probing pocket depth and bleeding on probing (BOP). Following the 12-month visit, the research-specific interventions and measurements in the experimental quadrant will be removed from routine PMT.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic advanced adult periodontitis
* one quadrant with at least one 6-9 mm interproximal pocket
* overall good systemic health
* willingness to sign consent form

Exclusion Criteria:

* systemic diseases which significantly impact periodontal inflammation and bone turnover (e.g. rheumatoid arthritis)
* taking drugs which significantly impact periodontal inflammation and bone turnover
* surgical periodontal therapy within the past year
* pregnant or breast-feeding females
Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia

Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL)
* CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment

Exclusion Criteria:

- Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)
Comparison of Body and Room Temperature Saline in Urodynamics

The purpose of this study is to compare first urge, strong urge, and maximum capacity, and perception of discomfort during urodynamic testing between room temperature and body temperate saline. Twenty-four non-pregnant females referred to the urogynecology clinic for bladder testing will be enrolled into the study. Each patient will serve as her own control, undergoing the bladder testing with both room temperature and body temperature saline.

This is a prospective observational study. Patient scheduled to undergo evaluation of urinary incontinence by urodynamics in the gynecology clinic will be asked to participate. Patients will be counseled and consent forms signed. The nurse will open the envelope which randomizes the order of instillation and set up the first fluid. Normal saline in 1000ml bags are used for instillation. The bags being used for body temperature fluid will be heated using an Olympic Warmette to between 98 and 99 degrees as determined by 3M Tempadot Thermometers. Urodynamics will be performed using standard clinic protocol recording first sensation, first urge, and maximum capacity. The patient will ask to comment on the discomfort of the test using a 5 point Lickert scale for both pain and urgency (see attached questions). Patients will be allowed to void. The bladder will be filled again with the second solution with identical questions used to determine first sensation, first urge and maximum capacity. During each filling the patient will be tested for stress incontinence at 200 and 300 mls as per our protocol. Following the instillation of the second solution the patient will again be asked her perception of pain and urgency an identical scale. Maximum bladder capacities from each temperature saline tested will then be compared against maximum bladder capacity as estimated from the patients' bladder diary. The patient will then be managed as is appropriate for her test results.

Eligibility Criteria:
Inclusion Criteria:

* Females referred to gynecology clinic for urodynamics evaluation with an appropriate indication for bladder testing

Exclusion Criteria:

* Male subjects and pregnant females
Background of Different Phenotypes of Coeliac Disease

The main purpose of this study is to investigate genetic, serological, immunological and microbiata diversities between different coeliac disease phenotypes and to discover applicable prognostic markers for specific phenotypes.

The recognition of clinical heterogeneity has expanded the understanding of coeliac disease, but the factors contributing to this diversity remain unclear. Moreover, since coeliac disease is highly heterogeneous, there is a need for more individualized follow-up and support and implementation of more personalized follow-up guidelines.

In this study coeliac disease and dermatitis herpetiformis patients and healthy controls will be recruited. Genetic, clinical, immunological, micobiata and novel biomedical markers are compared between coeliac disease phenotypes and also controls and their prognostic value is assessed.

Eligibility Criteria:
Inclusion Criteria:

* Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis
* Cohort 3: friend or non-related family member of coeliac disease or dermatitis herpetiformis patient

Exclusion Criteria:

* Cohorts 1-3: Age \<18 years
* Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis not confirmed
* Cohort 3: coeliac disease or dermatitis herpetiformis diagnosis
A Study of Idazoxan in Healthy Participants

Four-part study of the safety, tolerability and pharmacokinetics of 3 forms of TR-01-XRR, 1 form of TR-01-XRS, and 1 form of TR-01-XR in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 32 kg/m2
* Medically healthy without clinically significant or relevant medical history

Exclusion Criteria:

* Evidence of recurrent disease, physical illness or medical condition that could affect action, absorption or disposition of investigational products
* Use of any prescription or over-the-counter medication that cannot be discontinued for the duration of the study
* Impaired renal function
* Cardiac abnormalities
* Positive HIV, HBsAg or HCV
* Positive test for alcohol, drugs of abuse or cotinine
Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea will be effective and safe for kidney transplant patients, allowing them to continue with MPA medication.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients \> 1 months post-transplant,
* No history of chronic diarrhea pre-transplant,
* \>3 watery/soft stools after transplant on at least 4 days in the week without anti-diarrheal for at least 2 weeks or using anti-diarrheals for at least 4 days in the week \> 2 weeks
* Subjects on at least 180mg twice a day of mycophenolate-sodium or 250 mg twice a day of cellcept

Exclusion Criteria:

* Diagnosis of any known colonic diseases (i.e. Crohn's disease, ulcerative colitis, ischemic colitis, Celiac disease), partial colonic resection, small bowel resection, history of cholecystectomy, Irritable Bowel Syndrome, fecal Incontinence, Bacterial overgrowth, infectious diarrhea (c difficle, cryptospora, giardia, isospora, Human Immunodeficiency Virus), Cytomegalovirus colitis
* Subjects with recent acute rejection treated with high dose steroids
* Subjects taking Boswellia serrata extract, over-the-counter herbs, cholestyramine, nonsteroidal salicylates (other than daily ASA)
* Subjects with active malignancy, liver cirrhosis, active peptic ulcer disease, known intolerance or resistance to budesonide, pregnancy, breast-feeding, mental retardation
* Unable to provide informed consent