cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance Comparison of Two Contact Lenses

The purpose of this study is to compare the clinical performance of two contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Existing daily soft lens wearer.
* Require a distance visual correction in both eyes.
* Have a contact lens spherical distance refraction between -1.00D and -6.00D.
* Have refractive astigmatism less than or equal to 1.00D in both eyes.
* Achieve 20/30 or better corrected distance acuity.
* Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

* Requires presbyopic correction.
* Requires ocular medications.
* Grade 3 or 4 ocular abnormalities.
* Grade 3 corneal staining in more than one region.
* Has had refractive surgery.
* Any other injury or ocular surgery within 8 weeks prior to study enrollment.
* Has abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Has keratoconus or other corneal irregularity.
* Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
* Wears habitual contact lenses that are toric, multifocal or worn extended wear.
* Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
* Diabetic.
* Infectious or immunosuppressive disease.
* History of chronic eye disease (e.g glaucoma or age related macular degeneration).
* Pregnancy, lactation or planning pregnancy at time of enrollment.
* Participation in any concurrent clinical trial or in another trial in the last 30 days.
Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial

The purpose of this study study is to determine whether the Feldenkrais method is effective on pain control, functional recovery and quality of life in patients with chronic low back pain by comparing it with a Back School program.


Eligibility Criteria:
Inclusion Criteria:

* Presence of chronic nonspecific low back pain for at least three months;
* Subjects aged between 18 and 80 years.

Exclusion Criteria:

* Presence of acute low back pain;
* Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis);
* CNS and/or PNS disorders;
* Systemic inflammatory disease (eg rheumatoid arthritis);
* Systemic infectious disease;
* Neoplastic disease;
* Previous Surgery;
* Cognitive impairment;
* Pregnancy.
A Study Of PF-06263507 In Patients With Advanced Solid Tumors

To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available.
* Performance Status of 0 or 1.
* Adequate bone marrow, kidney, liver, and heart function.

Exclusion Criteria:

* Brain metastases requiring steroids.
* Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
* Active bacterial, fungal or viral infection.
A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on Levodopa

To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

To establish the efficacy of 10, 20 and 40 mg/d dose of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1 to 1 ratio to either istradefylline 10, 20 or 40 mg or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
3. On levodopa/carbidopa for at least one year, stable dose in past 4 weeks.
4. Currently take at least three doses of levodopa/carbidopa per day.
5. Predictable end of dose wearing off.
6. Able to satisfactorily complete Hauser version of a Parkinson's diary.
7. Have an average of 180 minutes of OFF time on two 24 hour diaries.
8. Be at least 30 years of age.

Exclusion Criteria:

1. Neurosurgical treatment for PD.
2. History of psychosis.
3. Diagnosis of atypical parkinsonism, secondary parkinsonism variant or Parkinson's plus syndromes.
4. Diagnosis of cancer within 5 years.
5. Mini-mental status examination score of 25 or less.
6. History of seizures or neurologic malignant_syndrome.
Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis

SPAC is a pilote monocentric prospective study about peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will included 50 patients during 2 years in the University Hospital of Nancy.

The aim of this study is to determine if the beta-lactam dosages recommended by the guidelines for management of intra-abdominal infections (published by the Société française d'anesthésie et de réanimation (Sfar) in december 2015) permitted the achievement of adequatly serum and peritoneal concentrations in the medical and surgical management of peritonitis.

The investigators will collected 3 pairs of serum and peritoneal fluid samples at 3 different times: peritoneal incision, arrival in ICU and 24 hours after admission in ICU in order to compare the concentrations and the minimal inhibitor concentration of bacteria.

The hypothesis is that of a serum and peritoneal antibiotic under dosage.


Eligibility Criteria:
Inclusion Criteria:

* Minimun age limits 18 years
* All sex
* Patients with peritonitis (community or nosocomial) regardless of pathology involved
* Patients treated in the Universty Hospital of Vandoeuvre les Nancy (abdominal surgery unit and surgical Intensive care unit JM Picard)

Exclusion Criteria:

* Beta lactam allergy
* Pregnancy
* Age less than 18 years
* No respect of recommandations for antibiotics ( molecule and dosage)
* Person under legal protection
Validation of a Novel Sham Cervical Spinal Manipulation Procedure

Primary hypotheses:

Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness will remain unchanged following the treatment procedure for both groups.

Secondary (null) hypotheses:

1. Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
2. there will be no differences between groups with respect to 2a) neck joint cavitations and 2b) forces across the cervical spine measured during the manoeuvres.

1. Develop a randomized controlled clinical trial design to optimize the testing of the effects of a sham vs real cervical manipulation.
2. Use novel modifications of both a sham a real manipulation to create "procedures" designed to optimize group equivalence in the RCT design. Then, evaluate the accuracy of 'patient post-treatment perception of treatment type' versus actual administered treatment (primary outcome #1).
3. Quantitatively evaluate group differences in local soft-tissue tenderness by algometry (primary outcome #2), as well as changes in self-reported neck pain, ranges of motion, myoelectric responses in selected neck muscles and forces imparted during the procedures.
4. Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.

Eligibility Criteria:
Inclusion Criteria:

* 21-55 years old with chronic neck pain, Males/Females
* Between 30-60 NRS 101 Scale
* ≥ 4 weeks mechanical neck pain

Exclusion Criteria:

* Cervical Spine Surgery
* Medically uncontrolled High Blood Pressure
* Past History of Stroke
* Upper Respiratory Infection within 4 weeks
* Current Symptoms of Dizziness
* Tinnitus, Blurred Vision, Vertigo, Sensory Motor Disturbance
* Current use of anticoagulant therapy
* Connective Tissue Disorder
* Primary Fibromyalgia or myofascial pain
* Metabolic/Neoplastic Bone Disease
Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36 weeks post-menstrual age (PMA). Half of participants will receive docosahexaenoic acid (DHA), an omega-3 lipid, while the other half will receive a placebo.

Every year in Canada, 1500 babies who are born early (prematurely) develop a serious lung disease called bronchopulmonary dysplasia (BPD). BPD causes major health problems in these infants, especially in their early childhood. In most situations, breast-milk is the ideal source of nutrition for growth and development of premature babies. However, diets of Canadian mothers are generally deficient in omega-3 lipids (essential fats), resulting in lower protection from these omega-3 lipids in mother's milk-fed infants. Previous research has shown that giving DHA to mothers of premature babies is safe both for the mother and for their baby, and is an efficient way of helping babies meet their dietary requirements from breast-milk. Furthermore, this previous research also suggests that this intervention may reduce the risk of BPD in premature babies receiving breast-milk.

Eligibility Criteria:
Inclusion Criteria:

1. Age more than or equal to 16 years
2. Pre-term delivery (230/7- 286/7 weeks gestation)
3. No contraindication to breastfeeding
4. Subject intends to provide own breast milk to infant
5. Randomization before or at 72 hours post delivery

Exclusion Criteria:

MOTHERS

1. Mother is taking \> 250 mg of daily DHA supplementation for last 3 months
2. Mother who is currently enrolled or has participated in another clinical trial in which she had received an investigational drug or intervention within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre)
3. Inability to comprehend and comply with study requirements
4. Participation in this study in a previous pregnancy

INFANTS

1. Significant congenital malformations in the infant (or one of the infants in case of multiple pregnancy)
2. Infant (or one of the infants in case of multiple pregnancy) who is currently enrolled in another clinical trial (unless approved by the Trial Coordinating Centre)
The PK/PD Study of SHR0532 Tablets in Healthy Subjects

In the last four decades, several classes of diuretics have been the first line option for the therapy of widespread hypertension. However, all the classes of diuretics cause alteration of potassium homeostasis. The primary objective of this study is to assess the safety and tolerability of SHR0532 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR0532 tablets in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. males or females, aged 18-45
2. subjects have no cardiovascular disease, with sitting blood pressure: 90mmHg ≤SBP\<140mmHg and 60mmHg ≤DBP\<90mmHg;
3. body mass index (BMI) between 19 to 26, and a total body weight: male ≥50.0 kg and \<90.0 kg; female ≥45.0 kg and \<90.0 kg
4. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on electrocardiogram, X-ray, Echocardiograph and B-type ultrasonic

Exclusion Criteria:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin \> 1.5 x ULN during screening/baseline;
2. Serum creatinine\>ULN)during screening/baseline;
3. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) test positive;
4. Known postural hypotension; the numeric difference of systolic blood pressure between both upper limbs \>20mmHg；
5. A clinical history of arrhythmia；subjects with Electrocardiogram QTc prolongation（male\>450ms；female\>460ms）during screening；
6. A clinical history of hyperuricemia；serum uric acid \> the upper limit of normal value (ULN) during screening;
7. A clinical history of diabetes；fasting plasma glucose or hemoglobin A1c exceeded the upper limit of normal value (ULN) during screening;
8. Subjects with previous GI discomfort -abdominal pain, diarrhea, and nausea 3 months prior to screening；
9. A clinical history of acute or chronic kidney disease;
10. Subjects with severe trauma or surgery within 3 months prior to the screening； 11.3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening;

12.Pregnant or Serum β-hCG \> 5mIU/mL at baseline or women who are breastfeeding; etc.
Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up

The investigators will contact 64 patients with atopic dermatitis (AD) who participated in a long-term tacrolimus ointment trial in Helsinki 10 years ago, and ask them to participate in this follow-up study. The investigators will do the same tests as 10 years ago, i.e. bronchial hyperreactivity, skin prick tests, serum-IgE, Mantoux-test (2 TU), and questionnaires about asthma and allergic rhinitis symptoms. The investigators also collect data about their AD medication during the last 10 years.

The investigators hypothesis is that when the skin condition improves in patients with AD the brochial hyperreactivity improves. The investigators also want to study whether different treatments play a role in the development or resolution of bronchial hyperreactivity.

We will by letters and telephone contact all patients (n=64) who fulfill the inclusion criteria for this study.

The testing in the study (bronchial hyperreactivity, skin prick testing, serum IgE) is cross-sectional, but we retrospectively collect data from the last 10 years about the skin condition and medication for atopic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patient has participated in the FG-506-06-21 study in Helsinki
* Patient was tested for bronchial hyperreactivity in the years 1998-2000
* Patient gives signed informed consent to participate in this study
Effects of Wood Smoke Particles on Influenza-induced Nasal Inflammation in Normal Volunteers

This study is focused on the pathophysiology underlying the association between exposure to particulate pollutants and risk for/response to viral infection. The investigators hypothesize that exposure to wood smoke particles (WSP) enhances influenza virus-induced granulocyte and NK cell activation, via hyaluronic acid-mediated effects on IFNg production. Oxidant stress and viral replication may also be affected. As an NIH funded ViCTER project, the purpose of the study is also to test novel assays of granulocyte activation (Doershuk lab) and lipid mediator activation (Albritton lab) which have not previously been used in this type of research.

Healthy, nonsmoking adults age 18-40 years will be recruited. This is a randomized, placebo controlled study comparing NLF granulocyte responses to LAIV administered after either WSP or clean air, in normal healthy volunteers. Subjects receive either WSP or placebo (clean air), followed by a standardized dose of LAIV and serial post-infection sampling of nasal lavage fluids, nasal biopsy and blood


Eligibility Criteria:
Inclusion Criteria:

1. Normal lung function, defined as (Knudson 1976/1984 predicted set): FVC \> 75 % predicted for gender, ethnicity, age and height; FEV1 \>75 % predicted ; FEV1/FVC ratio \>0.70 and \< 0.90.
2. Oxygen saturation of \> 94%
3. Normal blood pressure (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)
4. Symptom Score no greater than 6 (out of a possible 39) for total symptom score
5. On the day of a challenge, body temperature must be no greater than 37.8 degrees, measured orally

Exclusion Criteria:

1. A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)
2. Positive pregnancy test within 48 hours of the time of challenge
3. Use of any inhaled substance (for medical or recreational purposes). Nonsmokers must have been abstinent from smoking for the prior 12 months, having not smoked more than 1 pack over the course of the previous year and does not smoke at all 1 week prior to entrance in the study.
4. Receipt of LAIV in the current season
5. History of allergy to eggs
6. Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks
7. Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion.
8. Expected exposure of subject to immunocompromised individuals (who can be infected by LAIV) for the 3 weeks following LAIV inoculation
Efficacy and Safety of Endovascular Thrombectomy in Acute Ischemic Stroke With Posterior Circulation Large Infarct

The purpose of this study is to evaluate whether endovascular thrombectomy (EVT) combined with best medical management (BMM) leads to better functional outcomes than BMM alone in patients with acute basilar artery occlusion with posterior circulation large infarct.

This study is a multicenter, prospective, cohort study that prospectively enrolled consecutive patients with acute basilar artery occlusion and large core infarction in the posterior circulation, confirmed by imaging (CTA/MRA/DSA). Written informed consent was obtained from all participants or their legal representatives prior to enrollment. Patients were divided into the best medical management (BMM) group and the endovascular thrombectomy (EVT) group according to the treatment they received. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years old;
2. Acute ischemic stroke in the posterior circulation, the onset of stroke (or last well known) to the enrollment time within 24 hours;
3. CTA/MRA/DSA confirmed acute basilar artery occlusion;
4. Posterior circulation large infarct: NCCT or DWI showed pc-ASPECTS ≤ 5 points, or pontine midbrain index (PMI) ≥ 3 points;
5. NIHSS score ≥10 points after the onset of the stroke and before enrollment;
6. Able to live independently before the onset of the disease (mRS score ≤2 points);
7. The subject or legal representative is able to sign the informed consent form.

Exclusion Criteria:

1. Intracranial hemorrhage (except microhemorrhage) on CT/MRI ;
2. CT/MRI revealed large infarction in the cerebellar hemisphere, with significant mass effect causing compression of the fourth ventricle or brainstem;
3. CT or MRI showed bilateral complete thalamic infarction;
4. Occlusion of anterior and posterior circulation arteries confirmed by CTA/MRA/DSA;
5. The presence of intracranial tumors (except for small meningiomas and cerebral aneurysms with a diameter of \<3mm);
6. Patients with known or highly suspected chronic basilar artery occlusion.;
7. Known severe allergy to contrast agents (except for mild rash);
8. Refractory hypertension (defined as systolic blood pressure \> 185 mmHg or diastolic blood pressure \>110 mmHg) that cannot be controlled by drug therapy;
9. Known pregnant or lactating females, or positive pregnancy test before enrollment;
10. Acute cerebral infarction within 48 hours after cardiovascular and cerebrovascular intervention or major surgery (patients more than 48 hours can be enrolled).
A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2)

The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with endometriosis

Exclusion Criteria:

* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Optimization of Movement Patterns in Elite Volleyball Players

On the basis of clinical and movement analysis records players are informed on what parameters can be optimized in order to improve their performance and avoid injuries


Eligibility Criteria:
Inclusion Criteria:

Members of national volleyball team signing informed consent

Exclusion Criteria:

No specific exclusion criteria
Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder

Two groups of subjects will be included 55 subjects in electroacupuncture with 2Hz group, 55 subjects in the electroacupuncture with 100Hz group. The clinical efficacy of electroacupuncture with different frequencies (2 Hz, 100 Hz) in the treatment of MDD will be observed by evaluation indicators, such as Self-rating depression scale and Hamilton depression scale.


Eligibility Criteria:
Inclusion Criteria:

1. Patients suﬀering from MDD in accordance with the diagnostic criteria;
2. Hamilton Depression Scale score is between 21 and 35 (mild to moderate MDD);
3. 18≤age≤60 years, both gender;
4. Patients who have not used antidepressants and other psychiatric drugs (including traditional Chinese medicine), or have used them but have stopped for at least 2 weeks;
5. Patients have clear consciousness and could communicate with others normally;
6. Patients could understand the full study protocol and written informed consent is provided by themselves. Note: Subjects who meet the above six items will be included.

Exclusion Criteria:

1. Patients with bipolar disorder;
2. Patients with schizophrenia or other mental disorders;
3. Patients with severe medical diseases, tumors or diseases of the central nervous system;
4. Patients suﬀering from severe depressive episode with psychotic symptoms;
5. Suicidal patients;
6. Patients with seasonal depression;
7. Patients with organic depression;
8. Patients with alcohol or drug addicts;
9. Patients using other therapies;
10. Patients in pregnancy or lactation;
11. Patients suffering from cognitive dysfunction, aphasia or other diseases that cannot cooperate with treatment;
12. Patients with pacemakers;
13. Patients who are not suitable for electroacupuncture.