cyrilzakka/clinical-trials huggingface dataset:
Prediction of Drug Interactions With CYP2C9 Substrates

CYP2C9, is one of the major drug metabolism enzymes accounting for about 20% of the hepatic cytochrome P450 content and being second only to CYP3A4.

The proposed study will explore different possible drug interactions with CYP2C9 substrates by evaluating the effect of prototype inducers and inhibitors on the phenotypic trait measurement. It is expected that the identification of drugs that might interact with CYP2C9 substrates will be used to rationalize future drug interaction studies designed to evaluate the actual magnitude of effect and its clinical implications. This approach should be particularly useful when applied to those CYP2C9 drugs characterized by a narrow therapeutic index (i.e. warfarin).

This study will consist of three study periods separated from each other by a two weeks washout period. In the course of the study the subjects will receive in a double blind, crossover fashion, rifampin 300 mg. twice daily, diclofenac 50 mg twice daily. and fluconazole 200 mg. twice daily, each for one week. All drugs will be administered as identical looking tablets that will be prepared at the pharmacy of the Hadassah University Hospital and their order of administration will be randomized.On the day prior to, on day 6 of and 7 days following each drug period, the activity of CYP2C9 will be evaluated by the administration of a single phenytoin 300 mg. dose. The subjects will be requested to collect their urine for 24 hours and a single blood sample will be obtained 12 hours post phenytoin intake.


Eligibility Criteria:
Inclusion Criteria:

* Age range 20-50
* Absence of significant disease states

Exclusion Criteria:

* Known hypersensitivity to one of the drugs used in the study
* Significant disease states
* Regular use of drugs (including birth control pills)
Isotretinoin for Proliferative Vitreoretinopathy

Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an important cause of retinal re-detachment. The purpose of this study is to evaluate the effect of oral isotretinoin, which inhibits the growth of cells responsible for proliferative vitreoretinopathy (PVR), on recurrent retinal detachment.

Small retrospective studies have shown isotretinoin to be effective in reducing the rate of recurrent retinal detachment in patients with or at high risk for developing PVR. This is a prospective study to evaluate a low dose of oral isotretinoin in this regard. There are two arms to the study: 1) eyes with recurrent retinal detachment due to existing PVR, and 2) eyes with primary detachment and features associated with a high risk of PVR formation. Eligible and willing patients will receive a 12-week course of isotretinoin, and will be followed for retinal attachment rate, and PVR and/or ERM (epiretinal membrane) formation.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 year-old men or 50-70 year-old, post-menopausal women.
* Healthy enough to participate in the study.
* Willing and able to consent to participation.
* Recurrent PVR-associated RD occurring at least 2 weeks after RD repair or
* Primary RD (retinal detachment) associated with one or more high-risk features

Exclusion Criteria:

* History of hypersensitivity to isotretinoin.
* Current use of a corticosteroid (excluding topical).
* Any history of depression, anorexia, liver or pancreatic disease.
* More than one prior surgical RD repair.
* Patients with closed funnel retinal detachments.
* Patients with chronic retinal detachment, defined as longer than 12 weeks.
* Any use an oral retinoid within 6 months.
* Systemic chemotherapy within 6 months.
* Patients taking supplemental vitamin A.
* Corneal opacity sufficient to impair surgical view.
* Proliferative diabetic retinopathy.
Hybrid Artificial Pancreas in Home Setting

The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

During this study, we propose to assess an Artificial Pancreas in a group of Type 1 diabetic patients who will participate in two study periods of two-month duration with an insulin pump and a Continuous Glucose Monitoring (CGM) device. During one of these periods, called HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 et \< 70 years old
2. Having diabetes according to WHO criteria for at least 6 months, and Type 1 diabetes according to ADA criteria
3. Under basal-bolus insulin therapy using an external insulin pump for at least 3 months
4. BMI \< 35 kg/m²
5. Willing to wear a CGM device for the whole duration of the study, except during washout period, combined with the DiAs platform during the evening and night-time for 2 months
6. Trained in carbohydrate counting
7. HbA1c \> 7.5 % and \< 10%
8. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, stability on the medication for at least 1 month prior to study inclusion
9. Willing to undergo all study procedures
10. Informed consent signed

Exclusion criteria:

1. Pregnancy or breast feeding, or intention to be pregnant during the study duration
2. Use of a medication that significantly impacts glucose metabolism, e.g. steroids
3. Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
4. Patient plans to go abroad during the trial period
5. Patient is expected to be out-of-home in the evening and during night time (e.g. shift-workers, etc.) more than 25% of a study period
6. Patient does not hold any nearby party for assistance if needed
7. Patient with severe hypoglycemia including coma, mental confusion and/or convulsions requesting IV glucose injection or glucagon injection during the last year.
8. Presence of any malignant disease, unless considered as cured for more than 10 years
9. History of acute cardiovascular event during the prior year
10. History of diabetic keto-acidosis during the prior 6 months
11. Renal insufficiency with creatinin \> 150 μmol/L
12. Impairment of liver status estimated from ASAT/ALAT plasma levels \> 2x upper limits of normal values
13. Impaired cognitive or psychological abilities which may result in defective adherence to study conditions
Enhanced Recovery After Radical Cystectomy Study

Prospective non randomized study of two cohorts: usual protocol and the application of accelerated recovery protocol. F/up after discharge, 90 days and thereafter according to protocol of each center. Compliance to be assessed.

This is a prospective non randomized study of two cohorts, one defined by the usual protocol and the other one by the application of accelerated recovery protocol. It's discarded a priori a prospective randomized trial, since it does not seem feasible to avoid byass of control group when synchronizing the active intervention and control. Subjects surgery will be followed after discharge for a minimum of 90 days, and thereafter according to protocol of each center. Patients will be provided with a satisfaction survey 90 days after surgery.

The degree of compliance with the protocol will be assessed through a checklist indicating compliance with each of the steps of the protocol in both groups. All patients will sign an informed consent for the study authorizing the use of their clinical data for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients scheduled for radical cystectomy in the participating hospitals
* Signed informed consent

Exclusion Criteria:

* Refusal to sign informed consent
Physiotherapy-led Outpatient Clinic for Patients With Spondyloarthritis

The purpose of this study is to determine whether patients with spondyloarthritis are more satisfied with a physiotherapy-led outpatient clinic than usual care and whether there is a difference between patients in a physiotherapy-led outpatient clinic and those in usual care regarding disease activity, function and mobility.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis spondyloarthritis, ankylosing spondylitis, spondylarthropathy, juvenile ankylosing spondylitis, psoriatic arthritis with affection of the spine
* age between 18 and 45 (born 1969 - 1996)

Exclusion Criteria:

* also diagnosed with potentially functionally impairing neuromuscular, neurological or muscular disorders
* insufficient Norwegian language skills
* cognitive impairment
* no sign of inflammation or bone erosions in the sacroiliac joints or in the spine on imaging
Impact of Tramadol Addiction On Dental Anesthesia Success

The aim is to investigate and to find a correlation between tramadol addiction misuse among Algerian males and Dental Local Anesthesia success while performing dental care and oral surgeries.

Local anesthesia is by far the most important part of pain control in dentistry, it is the cornerstone that makes many dental procedures possible, not only for the patient but also for the dentist and dental hygienists. Since the pain and the dentist are almost synonymous for the patient, this makes dental anesthesia the most widely administered drugs in the dental clinics. Hence, the failure of local anesthesia in oral medicine presents an undesirable outcome both for the patient and for the practitioner.

The intraoperative pain being prevented by the administration of a local anesthesia must be followed by the management of the postoperative pain which can be often intense and thus requiring drugs administration. These drugs could be nonopioid or opioid analgesics which are also frequently used in general medicine as Tramadol.

Tramadol is 2-(dimethyl amino)-methyl)-1-(3'-methoxyphenyl) cyclohexanol hydrochloride. It is 4-phenyl-piperidine analogue of the opioid drug codeine. It is generally well tolerated with few and rare side effects. Moreover, comparative studies have mostly shown that Tramadol is more effective than NSAIDs for post operative pain control. However, its misuse is increasingly growing and has become obvious in Algeria.

Tramadol addiction has become very frequent, and its unjustified use is expanding. This might be attributed to the fragility of the health system and the replacement of the qualified pharmacists by non-qualified helpers or assistants.

Eligibility Criteria:
Inclusion Criteria:

* Males
* ≥18 years old \<65
* Without comorbid conditions (Hypertension, diabetes, Asthma etc..)
* Tramadol addicted (regular tramadol user)
* Only tramadol addicted, if any other drugs are regularly consumed, the patient is excluded.

Exclusion Criteria:

* Females
* ˂ 18 years old
* With comorbid conditions (HTN, diabetes, epilepsy etc..)
* ≥ 65 years old men.
* Not addicted to tramadol or addicted to other drugs with it.
Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa

This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety 0f RPE transplants to treat RP disease.

This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety 0f RPE transplants to treat RP disease.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 and under 80 years of age, both gender, in good health.
* Clinical diagnosis of retinitis pigmentosa, the results of eye electrophysiological examination accord with retinitis pigmentosa.
* The BCVA of target eye will not be better than 20/400.
* The BCVA of contralateral eye is not worse than 20/400.
* Diopter is smaller than 8.00 D, axial 28 mm or less.
* Voluntary as test subjects, signed informed consent, regular follow-up will be effected according to the specified time.

Exclusion Criteria:

* Subject with other additional retinal diseases, like diabetic or hypertensive retinopathy vascular diseases.
* Target eye ever have had a eye surgery;
* Subject with active serious diseases of the digestive system, liver kidney impairment (ALT/AST) \> 1.5 or any known liver disease, creatine \> 1.3 mg/dL) and/serious temic diseases, such as cardiovascular tem, respiratory tem, nervous tem, endocrine tem urogenital tem diseases, etc.), the history of malignancy;
* Have been ready for pregnancy during test, are lactating women;
* Ready to birth of men during the test;
* Subject with any immunodeficiency;
* Subject in the immunosuppressive therapy in the current;
* Subject with the tacrolimus or other large ring lactone class drug allergies;
* Participate in any clinical subjects in nearly six months;
* Has a history of alcohol or illicit drug abuse;
* Poor adherence to complete studies;
* Researchers believe that there may be an increased risk subjects or interfere with the clinical trials of any situation (such as when a patient is prone to mental tension, depression, mental illness, cognitive dysfunction, etc.).
Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease

Autoimmune diseases are diseases in which inappropriate immune responses that have the capability of harming host cells play an important role. Evidence suggests that the presence of certain autoimmune diseases such as rheumatoid arthritis or systematic lupus erythematosus increase the risk of cardiovascular disease (CVD). However, this evidence is inconsistent for autoimmune disorders and no systematic approach has been previously used to study the relationship between a range of common autoimmune disorders and specific forms of cardiovascular diseases such as myocardial infarction, intracerebral and subarachnoid haemorrhage, or venous thrombosis.

The investigators will use linked electronic health records to investigate whether commonly diagnosed autoimmune disorders are associated with increased risk of CVD development and whether effects differ in men and women and change with age.

The linkage of Clinical Practice Research Datalink (CPRD) to the national registry of acute coronary syndromes (the Myocardial Ischaemia National Audit Project, MINAP), Hospital Episode Statistics (HES) and Office for National Statistics (ONS) available through CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records), offers an opportunity to investigate the association between autoimmune disorders and the initial presentation of non-fatal and fatal specific cardiovascular phenotypes. The use of a systematic approach to investigate whether a range of commonly diagnosed autoimmune disorders are independent risk factors for several specific and well defined arterial and venous diseases will help to improve the investigators understanding of the role of autoimmune disorders in development of specific types of CVD in both men and women and in different age groups. It will also provide useful information to improve existing cardiovascular risk prediction methods that are used in clinical practice for patient management.

Eligibility Criteria:
Inclusion Criteria:

* One year prior to study entry
* 18 years or older
* Recorded sex
* Free of symptomatic cardiovascular disease at entry

Exclusion Criteria:

* Prior cardiovascular disease
Xinju Xiaogao Prescription Study on Overweight

Xinju Xiaogao prescription and 10% of it in the treatment of adiposity (stagnation of QI causing phlegm retention)clinical study

Charged by the three research centers in line with traditional Chinese medicine stagnation of QI causing phlegm retention 120 cases have diabetes were randomly divided into Chinese herbal compound Xinju Xiaogao prescription group and 10% of the prescription group.The treatment groups were compared 24-week step-down and regulation of body weight,waistline, blood lipids, blood sugar effect.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-60 years old
* BMI≥28kg/m2，but\<40kg/m2
* Waistline≥85cm（male）,≥80cm（female）
* Pathoglycemia must fulfill one of those four condition:
* IGT,7.8≤2hPG≤11.0mmol/,
* diabetics take medicine used to treat type 2 diabetes more than 3 month,and 5.6≤FBG≤12.2,and weight change under 4kg.
* stagnation of QI causing phlegm retention
* To sign informed consent.

Exclusion Criteria:

* After 3-6 months simply controlling their diet and more exercise treatment, body weight weight loss ≥ 5%.
* TG\>4.5mmol/L.
* Suffering from congenital heart disease, rheumatic heart disease, kidney disease, serious active liver disease, peptic ulcer disease or malabsorption syndrome.
* There is a history of pancreatitis or endocrine diseases other than diabetes, diabetes treated with insulin.
* Not suffered myocardial infarction in Past 3 months or unstable angina were confirmed.
* Had been diagnosed as "post-surgical adhesions" .
* There is a history of appetite or abuse of laxatives
* Diastolic blood pressure,uncontrolled or controlled, three times greater than 105mmHg .
* Pregnancy, prepare to pregnant or lactating women prepare.
* Allergies to Chinese medicine , allergic.
* Recurrent gallstone or a history of kidney stones.
* Mentally ill.
* Cancer patients.
* A history of gastrointestinal surgery to lose weight.
* Receiving other clinical studies nearly 3 months.
* Alcohol and / or psychoactive substances, drug abusers and addicts.
* Taking other weight-reducing aid Close within one month
Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA

The study will evaluate the detection of tumor-antigen specific immune cells in cancer patients in whom the role of the immune system is suspected.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 or over,
2. Patient presenting an invasive tumor pathology (proven or suspected). The location and / or stage of which are defined for each cohort through an amendment to the protocol,
3. Patient treated with immune-modulators or other treatments likely to modify immunological parameters,
4. Suspicion of immune mediated response or toxicities (assessed by the immunologists),
5. Peripheral venous capital usable and compatible with the realization of 2 venous accesses for lymphapheresis and absence of cardiovascular problem (heart failure, arrhythmia ...), per investigator assessement,
6. Total circulating lymphocytes\> 1000 / mm3,
7. Availability of DNA and RNA from the tumor,
8. Information to the patient and signature of informed consent or his legal representative,
9. Affiliated with a social security scheme or such a scheme.

Exclusion Criteria:

1. Inability to undergo study follow-up for geographical, social or psychological reasons,
2. Infection with HIV or hepatitis B or C viruses,
3. Patients on high dose corticosteroid treatment (\> 1 mg / kg continuously),
4. Any concomitant serious illness that may interfere with participation in the study or significantly affect the results of the study (pulmonary, heart or liver disease),
5. Contraindication to performing lymphapheresis (coagulation disorder, cardiovascular problems, venous access, hypocalcemia, psychological inability to undergo extracorporeal circulation, cachexia, etc.),
6. Pregnant patient or of childbearing age without effective contraception,
7. Persons deprived of their liberty, under guardianship or legal protection.
A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.


Eligibility Criteria:
Inclusion Criteria:

1. Persistent low back pain with at least 3 months of non-surgical therapy at one or two suspected symptomatic lumbar levels (L3/L4 to L5/S1)

   a. The recruiting physician will use their standard clinical and radiological practice to determine the one/two disc level(s) be treated, i.e., but not limited to a combination of MRI, CT and/or Technetium bone scans, functional x-rays, input from a spinal injection program (targeting facet joints and/or epidural space) and discography (a discogram performed within 12 months of the anticipated study treatment date is acceptable, as long as the subject has not had an accident or re-injury).
2. Oswestry Disability Index (ODI) for low back pain of 30 or greater
3. Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline
4. Male or Female 18 years of age or older

Exclusion Criteria:

1. Persons unable to have an MRI
2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
3. Persons with neurological or radiographic evidence of active radicular pain due to anatomical compression such as stenosis or disc herniation (persons with somatic referred pain are allowed)
4. Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level(s) or adjacent segments
5. Suspected symptomatic sacro-iliac joint
Further Studies of Attention Deficit Disorder - Residual Type (RT)

The first phase was a double-blind crossover design of methylphenidate in the treatment of adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in adult ADHD. It was hypothesized that methylphenidate would prove more effective than placebo in treating ADHD symptoms during the first phase. It was also hypothesized that methylphenidate responders from the double-blind trial would continue to benefit from treatment in the second phase. Improvement would include both ADHD symptoms and social adjustment.

All patients received a single-blind week on placebo, followed by a double-blind random assignment crossover trial of methylphenidate and placebo, with each double-blind phase lasting two weeks. Subjects who experienced moderate or marked improvement on methylphenidate would be allowed to enter a long-term, open-label trial. ADHD symptom severity was measured monthly by a structured interview, the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS), Clinical Global Impression - Improvement (CGI-I) and Global Assessment of Functioning (GAF). Social functioning was assessed by the clinician administered version of the Weissman Social Adjustment Scale (WSAS). Dosing was determined by clinical judgement, symptom improvement and AEs.

Eligibility Criteria:
Inclusion Criteria:

* Ages 21-55 years; male and female; met "Utah Criteria" for adult ADHD; 95th or higher percentile on the Parent Rating Scale and/or the Wender Utah Rating Scale;

Exclusion Criteria:

* Patients with other axis-I and axis-II diagnoses were excluded as were patients with significant medical problems.