cyrilzakka/clinical-trials huggingface dataset:
Multiple Doses of BI 207127 NA, BI 201335 NA Followed by the Combination of BI 207127 NA and BI 201335 NA in Healthy Male Volunteers

Study to investigate the pharmacokinetic drug-drug interaction potential of BI 207127 NA and BI 201335 NA on each other at steady-state and to quantify the effect of BI 207127 NA, and BI 207127 NA combined with BI 201335 NA, on the activity of CYP 2C9 and CYP 3A4 using the probe substrates tolbutamide (CYP 2C9) and midazolam (CYP 3A4).


Eligibility Criteria:
Inclusion Criteria:

* Healthy males (caucasian)
* Age ranging ≥ 21 and ≤ 50 years
* Body mass index (BMI) ≥ 19 and ≤ 29.9 kg/m2
* Willing to complete all study-related activities
* Volunteers give their written informed consent prior to admission to the study

Exclusion criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of photosensitivity or recurrent rash
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or clinically relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the trial or during the trial
* vulnerable subjects (that is persons kept in detention)
* exclusion of contraindications or hypersensitivity to midazolam and / or tolbutamide
* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\> 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the reference range if indicative of underlying disease or poor health
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to treatment medication and/or related drugs of these classes
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF, or QTcB interval \>450 ms)
* Homozygous carriers of the UGT1A1 (uridine diphosphate glucuronosyltransferase 1A1) enzyme polymorphism \*28 and \*60
Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%

Phase II systemic bioavailability crossover study to measure the exposure of Col-118 topical 0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2%

A double-blind, randomized, 2-way crossover, safety, pharmacokinetic/-dynamic (PK/PD) study of 0.18% COL-118 facial gel and 0.2% brimonidine ophthalmic solution administered in male and female patients with moderate to severe erythematous rosacea.

Twenty male and female subjects with moderate to severe erythematous rosacea will be randomized into 2 groups of 10 subjects.

Each group will be randomized to receive 2 treatments (Treatments A and B, in Sequence 1: A/B or Sequence 2: B/A), as follows:

Treatment A: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after four hours;

Treatment B: One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically.

There will be at least a 1-day washout between dose administrations (Period 1 and Period 2).

Blood samples for PK analysis of brimonidine levels will be collected at the following time points during Period 1 and Period 2: 0 Hour (prior to dose) and at 1, 2, 3, 4 (prior to 2nd dose), 5, 6, 7, and 8 hours post-dose.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age
* Clinical diagnosis of rosacea
* A score of ≥ 3 on the CEAS
* A score of ≥ 3 on the PSA
* IOP ≥ 10 mm Hg
* Non-pregnant and non-lactating females

Exclusion Criteria:

* History of hypersensitivity or allergies to any ingredient of the study drugs, unless approved by the Investigator
* Use of brimonidine prescription medications within 14 days prior to Check-in
* Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in, unless deemed acceptable by the Investigator
* Use of systemic or topical steroids applied to the face 14 days prior to Check in
* The use of any Rx or OTC products for the treatment of acne or rosacea within 14 days prior to check in
* The use of isotretinoin within 180 days prior to check in
Platelet Leukocyte Aggregates in Acute Cardiac Syndrome vs Healthy Volunteers

This project aims to refine previous studies including the investigators work recently published in August 2012 Journal Thrombosis and Thrombolysis. That study showed a relationship between the level of platelet leukocyte aggregates in patients with acute coronary syndrome. The investigators intend to compare the characteristics of platelets, monocytes and neutrophil data of volume, scatter and conductivity obtained from routine blood count level with flow cytometry results defining platelet leukocyte aggregates. The investigators hypothesize that there will be a direct correlation between elevated platelet-leukocyte aggregates and biophysical data from the blood count.

The goal is to investigate whether there is a simple and inexpensive method to test the level of platelet leukocyte aggregates through the blood count test. The parameters which are obtained routinely for white blood cell counts include: capacity - electrical conductivity (conductivity) - dispersion (scatter), and volume. Though these values are not reported routinely, they can be accessed for each blood count.

The premise is that through blood counts (no need for specialized flow cytometry) and through the parameters mentioned a conclusion can be reached about platelet leukocyte aggregates. This will then aid in prognosis about the risk of an acute event for every patient with ischemic heart disease who comes to the emergency room.

Eligibility Criteria:
Inclusion Criteria:Signed consent form, over 18 years of age, diagnosis of STEMI or non-STEMI as per following:

* Acute ST Elevation Myocardial Infarction (STEMI) was diagnosed in patients with high level of troponin I (\>0.4 ng/ml), ST segment elevation in at least two contiguous leads of the ECG (or new LBBB) and/or ischemic chest pain.
* Acute Non ST Elevation Myocardial Infarction (Non STEMI) was diagnosed if level of troponin I was \> 0.4 ng/ml, patient had ischemic chest pain or ST-T depression and/or T-wave inversion on ECG.

Exclusion Criteria:Inability to sign consent form, under 18, participation in other research projects within previous 6 months.

-
Arm Swing During Walking in Early Multiple Sclerosis

Multiple sclerosis (MS) is the most common central nervous system inflammatory demyelinating disease which causes motor and sensory deficits, cerebellar symptoms, and balance problems. Due to these symptoms, gait abnormalities are common in MS, even in patients with low degrees of impairment. The upper limb has an important role on postural control and gait stability. Affected arm swing movement and asymmetry during gait are common in neurological disorders such as Parkinson's disease (PD) even in early stages of the disease and arm swing treatment has been acknowledged to enhance gait and normalize arm swing in individuals with PD.

The presence of arm swing changes during walking in MS patients, similar to PD, especially in the early period, may be an indicator of balance problems, this was, however, not investigated as such. Therefore, the aim of the current study is to assess the arm swing during gait in people with MS shortly after their diagnosis in early MS.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed with MS in the last 30 days,
* Patients who were recovered from their symptoms and were clinically stable

Exclusion Criteria:

* Patients who had an acute medical illness in the past 6 months, any other neurological and psychiatric diseases
* Patients who had any orthopedic, rheumatologic, or vestibular conditions that affect walking
* Patients who had exacerbations between the first and second evaluations
Pregnancy Outcomes With a GnRH Antagonist Protocol Versus GnRH-Agonist Protocol in ICSI Cycles

Cycles with GnRH agonist and GnRH antagonist were compared and main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates, were analized.

160 women were equally divided between a GnRH antagonist protocol (Group 1) versus a GnRH agonist protocol (Group 2) in ICSI cycles. The trial was conducted between September 2005 and December 2006. The mean age in both groups was 32 (range 22-40). The main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates.

Eligibility Criteria:
Inclusion Criteria:

* Infertility couples, absence of endometriosis (confirmed by a previous surgical procedure to investigate infertility), polycystic ovarian syndrome, FSH levels \< 12 IU/l, basal levels of estradiol \< 20 in the group submitted to the agonist protocol and beginning of stimulation on day 2 in group submitted to antagonist protocol, in the absence of ovarian cysts on the endovaginal ultrasound

Exclusion Criteria:

* use of exogenous LH during stimulation
Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis

Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis.

Mesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is injected submucosally around and over the tissue after removal of a granuloma tissue during surgical intervention.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of chronic laryngeal or tracheal stenosis;
* absence of cartilage damage.

Exclusion Criteria:

* refuse of patient to participate in the trial;
* acute infectious diseases;
* chronic mental disorders with severe manifestations;
* pregnancy/lactation;
* intercurrent severe chronic diseases;
* HIV, Hepatites B/C;
* active tuberculosis;
* alcohol use disorder/drug addiction;
* cachexia of any origin;
* malignant neoplasms.
A Combined Exercise Programme Involving Strengthening, Flexibility and Aerobic Exercise for Lower Back Pain: a Randomised-controlled Study

This study will recruit from the community otherwise healthy participants with low back pain to take part in an 8 week intervention. There are 3 arms - a control arm of usual exercise; a running intervention group; and a swim/cycle intervention group. The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running or swim/cycle), a schedule of gradually intensifying strengthening exercises and flexibility exercises. There are baseline, 8 week and 1 year questionnaires including validated PROMS to determine pain and function.

This study will recruit from the community otherwise healthy participants with low back pain to take part in an 8 week intervention. There are 3 arms - a control arm of usual exercise; a running intervention group; and a swim/cycle intervention group. The intervention groups undertake 8 weeks of a combined exercise programme including aerobic elements (running or swim/cycle), a schedule of gradually intensifying strengthening exercises and flexibility exercises. There are baseline, 8 week and 1 year questionnaires including validated PROMS to determine pain and function.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45 years
* Participant is willing and able to give informed consent for participation in the study
* Suffering from chronic NSLBP (more than 3 months, localised below the costal margin and above the gluteal folds)
* Suffers from pain or functional limitations as a result of their LBP (minimum VAS (back) score of 3/10 or ODI score of at least 5/50 or RMD score of at least 5/24 (note, unlike ODI, RMD does not describe specific cuts offs for different levels of disability)
* Able to exercise

Exclusion Criteria:

* Radiating pain to leg / sciatica / acute radiculopathy
* Specific diagnosis/condition for LBP (e.g. herniated disk, degenerative disk disease, spondylolysis, spinal stenosis, spinal tumour, facet joint damage)
* History of osteoporosis , arthritis, scoliosis, or kyphosis.
* Current spinal infection, cancer or a current fracture (any bone).
* History of spinal/back surgery
* Unable to participate in physical activity and exercise
* Pregnant or breast feeding
* History of substance abuse
* History of psychiatric illness (eg. depression, dementia, schizophrenia) for which currently taking medication
* History or current neurological condition (e.g. epilepsy)
* Not in possession or have access to adapted equipment (phone, computer, functioning WIFI)
* Unable to understand and communicate in English
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period

This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to Insulin glargine U300 in insulin pre-treated patients with uncontrolled T2DM.

Maximum study duration per participant will be approximately 37 weeks per patient: up to 1 week screening period, 24 weeks insulin glargine U300 treatment period and 12 weeks observational extension period.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age≥18 years) who diagnosed with type 2 diabetes
* Patients who should initiate Insulin glargine U300 treatment following local label and guideline at investigator's discretion, including:

  * insulin naive patients (no current or previous insulin used during the last year prior to screening except for a maximum 10 days in relation to acute illness or surgery, etc.) uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit on stable dose treatment with ≤ 2 OADs (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) within 8 weeks prior to screening, at least one of which must be on maximum tolerated dose, or
  * patients uncontrolled (HbA1c between 7.5% and 11.0%) at screening visit with other basal insulin, or
  * patients controlled with other basal insulin but experienced frequent hypoglycemia or with increased hypoglycemia risk at investigator's discretion
* Patients who treated with basal insulin must have a stable dose of antidiabetic drugs (dose change no more than ±20% vs. the dose on screening visit for basal insulin) within 8 weeks prior to screening

Exclusion Criteria:

* Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or at baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study
* Use of any product containing short or rapid acting insulin in the last 3 months prior to screening (unless used for ≤10 days in relation to hospitalization or an acute illness)
* Use of oral anti-diabetic drugs other than those allowed and listed in the inclusion criteria, Glucagon-like peptide-1 (GLP-1) receptor agonists, or any investigational agent (drug, biologic, device) within 3 months prior to screening visit
* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening
* Known hypersensitivity / intolerance to insulin glargine or any of its excipients
* Pregnant or lactating women
* Women of childbearing potential with no effective contraceptive method
* Participation in another clinical trial

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with tendonitis or bursitis of the shoulder, elbow or knee. Eligible patients will have tendonitis or bursitis or the shoulder, elbow or knee and will be randomized (1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 21 days. Patients will return to the clinic for assessments on Day 3, Day 7, Day 14 and Day 21; a follow-up assessment will be conducted by telephone on Day 35. At each visit through Day 21, patients will rate their average pain intensity during daily activities and while at rest using the 11-point scale (range 0 to 10), and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. The use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as prn rescue medication.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or older
* Diagnosis of tendonitis or bursitis of the shoulder, elbow or knee
* Meet pain entry criteria
* Willing to discontinue use of any pain medication not provided by study

Exclusion Criteria:

* Have tendonitis or bursitis secondary to a systemic inflammatory disease, calcification or requiring surgery
* Have received corticosteroids in the 30 days preceding screening
* Have a history or physical examination finding that is incompatible with safe participation in the study
* Have a history or physical examination finding that is incompatible with study product use
* Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
* Are taking medications that may significantly affect renal function
Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

The primary objective of the study is to assess the efficacy of DHA in patients with SLE.

This is a Phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the Safety, Pharmacokinetics and Efficacy of four oral treatment regimens of DHA versus placebo while taking standard of care (SOC) treatment with corticosteroids in adult subjects with Systemic Lupus Erythematosus (SLE).

Eligibility Criteria:
Key Inclusion Criteria:

1. Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology;
2. Positive antinuclear antibodies (ANA);
3. Activity Index (SLEDAI) score must be 6-11 points, inclusive;
4. Stable dose of prednisone (\<30mg/d) for at least one month ;
5. Active mild to moderate SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG);
6. Males or females between 18 and 65 years old;
7. Weight of 45 kg or greater.

Key Exclusion Criteria:

1. Active Severe Lupus as defined by BILAG Index Level A or two or more of Level B in any body system/organ;
2. Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections;
3. Presence of active central nervous system (CNS) disease requiring treatment;
4. Subjects with active, severe SLE disease activity which involves the renal system;
5. Substance abuse or dependence;
6. History of malignant cancer within the last 5 years;
7. Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion;
8. Subjects received any live vaccination within the 30 days prior to Visit 2;
9. Subjects received intravenous immunoglobulin (IVIg) or,plasmapheresis,or High dose prednisone or equivalent (\> 100 mg/day) within 90 days prior to Visit 2;
10. Subjects who have had therapy with cyclophosphamide within 180 days prior to Visit 2 .