cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.


Eligibility Criteria:
Inclusion Criteria:

* males and females, 18 or older
* chronic phase Ph+ or BCR-ABL positive CML
* current complete hematologic response to imatinib
* lack of major molecular response
* on imatinib for at least one year
* on the same imatinib dose for at least 6 months
* adequate hepatic and renal function

Exclusion Criteria:

* History of accelerated or blast phase CML
* Serious uncontrolled medical disorder or active infection
* Significant cardiovascular disease or bleeding disorder
* Concurrent use of medications at risk of causing Torsades de Pointe
Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin.

The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for advanced stage (late stage) cutaneous T-cell lymphoma (CTCL). Almost all participants who are affected by late stage CTCL have many cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in this trial; all participants will be treated with HuMax-CD4. The response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated during this trial.


Eligibility Criteria:
Inclusion criteria

* Medical diagnosis of CTCL, and positivity for the CD4 receptor.
* Late stage CTCL.
* Have received at least one prior anti-cancer therapy with inadequate effect.
* World Health Organization (WHO) performance status 0,1 or 2

Exclusion Criteria

* Certain rare types of CTCL.
* Previous treatment with other anti-CD4 medications.
* More than two previous treatments with systemic chemotherapy.
* Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial.
* Some types of steroid treatments less than two weeks before entering the trial.
* Prolonged exposure to sunlight or UV light during the trial.
* Other cancer diseases, except certain skin cancers or cervix cancer.
* Chronic infectious disease requiring medication.
* Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases.
* Pregnant or breast-feeding women.
* Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
* If you are participating in another trial with a different new drug 4 weeks before you enter this trial.

Note: Other protocol defined Inclusion and Exclusion criteria may apply.
Effectiveness of Phenazopyridine for Pain Following Urodynamics

The purpose of the study is to determine if taking phenazopyridine (AZO) at the time of urodynamic study testing will decrease pain experienced by patients after undergoing urodynamic testing.


Eligibility Criteria:
Inclusion Criteria:

* ability to provide informed consent
* ability to complete visual analog scale
* requiring urodynamic testing
* 18 years of age or older
* must be able to read and write in English or Spanish

Exclusion Criteria:

* allergy to phenazopyridine
* a urinary tract infection in the prior 2 weeks
* women who did not undergo urodynamic testing
* patient less than 18 years old
* patients with known (noted in patient chart and verbally asked) severe renal insufficiency with GFR \<50 mL/min,
* patients with known (noted in patient chart and verbally asked) severe hepatitis
* patients with known (noted in patient chart and verbally asked) G6PD deficiency
* history of fibromyalgia
* history of interstitial cystitis
* non English or Spanish speaking
A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children

One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered approx. 1 year following the second dose

The purpose of this study is to find out more about the two doses of dengue vaccine, over a five year period, that the children received in the Dengue-003 study and to study a third dose of dengue that will be given to the children

* Do children still have dengue antibodies intended to provide protection against dengue infection one year after the two doses of vaccine given in study Dengue-003?
* Were there any major medical problems that appeared as dengue-like symptoms during the one year after vaccinations?
* Will a third dose of dengue help to further stimulate the part of the immune system intended to help protect against dengue infection?
* Is a third dose as safe as the first two doses?
* Are the local reactions to a third dose of the vaccine similar to what your child experienced after the first two doses?

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received two doses of DEN vaccine in the Dengue-003 study
* Subjects whos parents signed an informed consent form were eligible for participation in the five year follow-up study

Exclusion Criteria:

* None
Bioavailability of Two Sustained-release Theophylline Products in Healthy Males

Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg theophylline anhydrous (sustained-release product) by comparing the rate and extent of absorption of theophylline based on both single and multiple-dose profiles.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male subjects between 18 and 45 years of age
* Body weight within 10% of the ideal weight according to the Body Mass Index (BMI)
* Normal health based on medical history and findings within the range of clinical acceptability, in respect of the physical examination (including electrocardiogram and vital signs) and special investigations
* Ability to comprehend and willingness to sign both statements of informed consent (for screening and study-specific procedures)

Exclusion Criteria:

* History of serious systemic or organ disease
* A major illness during the 3 months before commencement of the study-related procedures
* Significant physical or organ abnormality
* History of hypersensitivity to theophylline or other xanthine derivatives
* Use of any medication within 2 weeks before the first administration of study medication
* Participation in another study with an experimental drug within 8 weeks before the first administration of study medication
* Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system (for example chloramphenicol, which may cause bone marrow suppression)
* Donation of blood during the 8 weeks before the first administration of study medication
* History of, or current compulsive alcohol abuse (\> 10 drinks per week), of regular exposure to other substance of abuse
* Positive testing for HIV and hepatitis B antigens within the previous 3 months
Evaluation of Oral and Dental Health of Institutionalized Orphan Children Residing in Children's Homes in Turkey

Both dental caries prevalence and periodontal status of children residing in children's homes in Sivas province of Turkey were evaluated.

This study was carried out in 16 state-protected children's homes in Sivas under the Directorate of Coordination of Children's Homes Centres of the Ministry of Family and Social Policies of Turkey. A total of institutionalized 90 orphan children between the ages of 6 and 18, who did not have any chronic diseases, were not taking medication, and were compliant and healthy, were included in the study. Since all participants of this study are under state protection, Sivas Children's Homes Center Coordination Directorate was contacted. The aim of the study and the procedures were explained in detail and official permission was obtained. The children's caregivers signed informed consent forms approved by the Ethics Committee. The examination procedures were performed by two trained dentists as recommended by the WHO. DMFT and deft, GI and PI indices were used to assess dental caries experience, gingival inflammation, and the amount of plaque on the tooth surface, respectively. Also, periodontal status and treatment need were evaluated using the CPITN index.

Eligibility Criteria:
Inclusion Criteria:

* Does not have any chronic disease.
* Not taking any medication.
* To be compatible and healthy.

Exclusion Criteria:

-
Dose Escalation/De-escalation Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases(RAD 1002)

This study will investigate the safety, tolerability, and effectiveness of changing the order of receiving radiation therapy for treating brain cancer. The investigators hope that changing the sequence of radiation therapy will lower the risk of cancer spreading throughout your spinal fluid, which covers your brain and spinal cord.

This study will attempt to determine the maximum tolerated dose of pre-operative stereotactic radiosurgery (SRS) in the treatment of brain metastases. Patients will be placed in one of two dose groups based on index tumor size, and dose will be adjusted according to presence or absence of dose limiting toxicity (DLT).

Group A: Index Tumor \> 2 cm and up to 4 cm in maximum diameter Group B: Index Tumor \> 4 cm and up to 6 cm in maximum diameter

Dose escalation or de-escalation will be conducted via a modified 3+3 method at the following levels. Group A will start at dose level II. Group B will start at dose level I.

Dose Level I: 12 Gy Dose Level II: 15 Gy

Eligibility Criteria:
Inclusion Criteria:

* All subjects must have history of histologically confirmed malignancy. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
* Newly diagnosed brain metastases (four or fewer by post-contrast MRI obtained within six weeks of study entry)
* At least one brain metastasis (index tumor) must be within 2-6 cm in maximum diameter and deemed appropriate for surgical resection by the treating neurosurgeon.
* Karnofsky performance status (KPS) of greater than or equal to 60
* Age greater than 19
* Life expectancy greater than 12 weeks
* Subjects given written informed consent

Exclusion Criteria:

* Patients with small cell lung cancer and lymphoma are ineligible.
* More than four metastases by baseline post-contrast MRI
* Prior whole brain radiation therapy
* Insufficient recovery from all active toxicities of prior therapies
* Subjects who are deemed to be poor surgical risks by the treating neurosurgeon because of medical comorbidities
* Pregnant or nursing women
* Women of childbearing potential who are not using an effective method of contraception are excluded. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to administration of SRS.
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.

Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints. It has been reported that in patients with chronic insomnia lasting longer than six months, 50% had a past or current mental disorder. This raises the possibility that treatment of insomnia may reduce the risk for psychological conditions. This double-blind, placebo-controlled, parallel, randomized clinical trial is designed to assess the efficacy and safety of esmirtazapine in patients suffering from chronic primary insomnia.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of chronic primary insomnia

Exclusion Criteria:

* Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders
* Has significant medical or psychiatric illness as causing the sleep disorder
* Diagnosed with major depressive disorder
* Substance abuse within the past year
* Night worker or work on rotating shifts
* Has had serious head injury, stroke, epilepsy
* Has a history of bipolar disorder or family (immediate family) history of suicide
* Smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory
* Drinks beverages containing more than 500 mg caffeine per day
SNIF (Sniff Nasal Inspiratory Force) Reference Values Of Mediterranean Population

SNIF test has been described as a method to explore the diaphragmatic function. But there are no defined the reference values of this test in healthy population. The investigators' hypothesis is that there is a variation on SNIF values in Mediterranean population depending on gender, age and anthropometric variables such as height and weight.

The investigators will analyze 1000 SNIF test of healthy people. The investigators will divide in 5 groups of age (20-30, 30-40, 40-50, 50-60, 60-70) and in each group the investigators will study 100 men and 100 women.

All the subjects will perform a forced spirometry, maximal inspiratory pressure (MIP) and SNIF. If spirometry and MIP are correct the investigators will consider that person has a correct diaphragmatic function and strength. Then the investigators will measure the SNIF test. With all of these SNIF values the investigators will try to achieve the reference values of this test in the different groups of age in Mediterranean population. And the investigators will compare SNIF with MIP.

Cross multicentric study. Hospitals involved: Hospital de Bellvitge, Hospital del Mar, Hospital Parc Taulí, Hospital de la Santa Creu i Sant Pau (coordinator center) and Hospital de la Vall d'Hebrón.


Eligibility Criteria:
Inclusion Criteria:

* Healthy people with spirometry and MIP values in the reference range
* Age between 20 and 70 years old
* Caucasian race

Exclusion Criteria:

* Rhinitis
* Nasal obstruction
* Frequent episodes of epistaxis
* Ongoing cold
Comparison of Envelope Coronally Advanced Flap and Modified Tunnel Technique in Soft Tissue Dehiscence Around Implants

The purpose of this study is to assess the influence of two different flap designs (envelope Coronally Advanced Flap (eCAF) and Modified Tunnel Technique (MTT)) with the addition of a connective tissue graft (CTG) in treating soft tissue dehiscences at implant sites

The primary aim is to compare the test and control groups in terms of:

1. mean mid-facial recession coverage (mRC) measured as a percentage
2. the keratinized tissue (KT) gain measured in mm
3. the keratinized tissue thickness (KTT) gain measured in mm.

The secondary aims are to compare the two groups in terms of:

1. Esthetic score, using numeric values from 0 to 10
2. patient-reported esthetics, using numeric values from 1 to 5
3. patient-reported post-operative pain, based on Visual Analog Scale (VAS) scale, measured as numbers from 0 to 10.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Periodontally and systemically healthy
* Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
* Correct implant 3-dimensional position or buccal position ≤ 1 mm
* Buccal soft tissue dehiscence ≤ 4 mm
* Only osseointegrated implants
* The patient must be able to perform good oral hygiene

Exclusion Criteria:

* Contraindications for periodontal surgery
* Patients pregnant or attempting to get pregnant
* Malpositioned implant
* Soft tissue dehiscence (STD) \> 4 mm
* Multiple adjacent implants with STD
* Existing of peri-implantitis
* Severe bone loss (≥4mm)
* Moderate-severe interproximal bone loss (implant fixture level to the alveolar bone \> 3 mm)
* Moderate-severe papilla height loss (Nordland and Tarnow implant papillae index \>1)
* Previous mucogingival surgery around the implant within the past six months or implant placement at the surgical site less than six months prior
* Smoking more than 10 cigarettes a day
Effect of Apple Cider Vinegar and Metformin Combination vs Metformin Alone in Type 2 Diabetics

'This study aims to compare the effect of Metformin alone vs Metformin plus Apple Cider Vinegar in newly diagnosed Type 2 Diabetic Patients

Diabetes Mellitus is one of the oldest diseases known to men and has been treated with multiple agents,organic and with the current pharmacological advancement,with multiple synthetic drugs as well.

Metformin has been considered first line for the treatment of Type 2 Diabetes, however presents itself with a side effect profile of GI distress, Vitamin B12 deficiency,to name a few.

Vinegar has been used as therapeutic agent for centuries for multiple ailments including diabetes. This study aims to evaluate the combined effects of drug and natural therapy and compare it with conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed Type 2 diabetic patients taking metformin 750 mg daily as the oral antidiabetic agent
* Patients with Hemoglobin A1c in the range of 6.5 to 7.5%

Exclusion Criteria:

* All newly diagnosed Diabetic Patients requiring a dosage other than 750 mg per day
* Patients on Insulin Therapy or any drugs for diabetes other than Metformin
* Pregnant and Lactating women
* Patients with food allergies to either apple or any source of vinegar
* Patients unable to communicate efficiently\\mentally challenged
* Type 2 Diabetic patients with any of the complications of long standing uncontrolled diabetes
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta

To identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of Brilinta Tablet: the occurrence of unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events (AEs), the factors that may influence safety and efficacy of the drug.

A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta

Eligibility Criteria:
Inclusion Criteria:

* Patients with Acute Coronary Syndromes
* Patients who are taking ticagrelor and ASA daily(75-150mg), or Patients who are taking ticagrelor only(In the case that the patients have contraindication with ASA. Contraindication should be recorded in accordance with local PI on CRFs)
* Patients who have signed the Data release consent form prior to enrollment in this surveillance

Exclusion Criteria:

* Patients with hypersensitivity to ingredients of this drug or with moderate or severe hepatic impairment or with medical history of intracranial hemorrhage
* Patients with pathological hemorrhage at the time of administration
* Patients being administrated strong CYP3A4 inhibitors
Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)

This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI
* Has provided informed consent and agrees to participate
* Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access

Exclusion Criteria:

* Primary PCI for STEMI
* Planned right heart catheterization
* Valvular heart disease requiring valve surgery within 30 days after the index procedure
* Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)
* Peripheral arterial disease prohibiting vascular access
* Presence of bilateral internal mammary artery coronary bypass grafts
* International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure
* Planned staged PCI within 30 days after index procedure.
* Any planned surgeries within 30 days after index procedure
* Planned dual arterial access (for example for chronic total occlusion PCI)
* Coexisting conditions that limit life expectancy to less than 30 days
* Positive pregnancy test
Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.

Patients with biopsy proven active lupus nephritis will be randomized to receive tacrolimus or mycophenolate mofetil, on top of corticosteroids, for initial treatment. Efficacy and adverse effects will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who fulfill at least 4 of the ACR criteria for SLE
2. Age \>= 18 years
3. Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
4. Serum creatinine \< 200 umol/L at the time of randomization

Exclusion Criteria:

1. Patients who refuse to be randomized for treatment
2. Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
3. Serum creatinine \>= 200 umol/L at the time of randomization
4. Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
5. Patients who are pregnant or plan for pregnancy within 12 months after randomization