cyrilzakka/clinical-trials huggingface dataset:
Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

This study will recruit 316 ischemic stroke patients taking aspirin.

They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month.

The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.

\[Goal\] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.

\[Trial Design\] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial

\[Participants\] Ischemic stroke patients taking aspirin

\[Methods\]

* Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
* Investigational product: Cilostazol 200mg (100mg twice per day)
* Concomitant medication: Aspirin 100 mg per day
* Medication Duration: 1 month

\[Outcome Variables\]

Primary Outcome Variable:

• the proportion of patients with aspirin reaction units (ARUs) values ≥550 on the Ultra Rapid Platelet Function Assay-ASA

Secondary outcome variables:

* the proportion of patients with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA
* ARUs values
* Bleeding time (BT)
* Fatal or major bleeding complications
* Any bleeding complications

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic cerebral infarction documented on MRI or CT
* More than 35 years of age
* Patients taking aspirin 100mg a day for 2 weeks or more before randomization

Exclusion Criteria:

* Patients taking any antiplatelets other than aspirin within 2 weeks before randomization
* Patients taking any anticoagulants within 2 weeks before randomization
* Patients taking thrombolytic therapy within 2 weeks before randomization
* Patients taking any NSAIDs within 2 weeks before randomization
* Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).
* Bleeding diathesis
* Chronic liver disease (ALT \> 100 or AST \> 100) or chronic renal disease (creatinine \> 3.0mg/dl)
* Anemia (hemoglobin \< 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
* Pregnant or lactating patients
* Patients scheduled for angioplasty or revascularization procedures within 4 weeks
* Patients scheduled for any surgery or invasive procedures within 4 weeks
* Patients having acute coronary syndrome
Chiropractic Manual Therapy and Neck Pain

Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions.

H1: Chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview.

H2: Patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index (NDI), range of motion and pressure algometry; compared to those treated by the control-control dual procedure.

H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures.

A total of 372 subjects will be recruited.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* 21 to 60 years of age
* Chronic neck pain
* Neck pain duration greater than 6 weeks
* Numeric Rating Scale greater than 30, less than 65
* Pain distribution between nuchal ridge and spine of the scapula
* Pain aggravated by local provocation maneuvers at single motion segment
* Antero-posterior glide
* Paraspinal tenderness
* Negative provocative maneuvers at adjacent segment
* Able to tolerate neck movement to 50 percent normal in all directions

Exclusion Criteria:

* Worker's compensation or other medico-legal claim
* Cervical spine surgery or fracture or dislocation
* Uncontrolled hypertension (Blood Pressure over 140 over 90)
* Stroke or Transient Ischemic Attack
* Upper respiratory infection within 4 weeks
* Severe degenerative disease of the cervical spine
* New or significantly altered pattern of headache complaint
* Connective tissue disease
* Primary fibromyalgia
* Metabolic or metaplastic bone disease
* Whiplash injury within 12 months
* High cholesterol levels not well-managed medically
* Cardiovascular surgery in the past 6 months or planned
* Use of narcotic analgesic, prescription anti-inflammatory, or muscle relaxants, anti-convulsants
* Angina pectoris
* Dizziness
* Tinnitus
* Blurred vision, vertigo, undiagnosed sensory and motor disturbances
* Radicular symptoms and signs
* Current use of anticoagulant therapy
* Upper respiratory infection
* Neck pain on provocation greater than 7 out of 10
* Provocation of radicular pain or sensory disturbance
* Hypermobility of multiple peripheral joints,
* Physical or mental impairment precluding following instructions or participating -in supine recumbent postures
Maternal Uterine Artery Doppler Study

The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.

In the setting of uteroplacental insufficiency, there is little that can be done to increase blood flow through the uterus and placenta. Historically, women with growth restricted fetuses or oligohydramnios have been placed on bed rest. Unfortunately, this treatment modality has met with only limited success. Cardiologists have long recognized the simple act of making a fist or otherwise occluding blood flow through a limb dramatically increases a person's peripheral vascular resistance. If maternal peripheral resistance can be increased, perhaps the increased differential between the maternal peripheral vascular resistance and that of the uteroplacental unit will increase flow through the uterus and placenta.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women greater than or equal to 18 years old
* Able to speak and read English
* Have a singleton pregnancy greater than or equal to 18 weeks gestation

Exclusion Criteria:

* Multiple gestation
* Less than 18 weeks gestation
* Uterine anomalies
* Fetal anomalies
* Preeclampsia
* Hypertension
* Inability to have BP cuff on left arm
Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?

This is a prospective observational study. Eligible women undergo ART treatment in our centre will be recruited for the study and each woman will only be included in the study once. Informed written consent will be obtained. Blood serum for hCG level is performed 14 days after the embryo transfer i.e. week 4. If the serum hCG level is \>10IU/L, the women are considered pregnant and blood will be saved and checked for kisspeptin level, Another blood test is repeated 1 week later i.e. week 5. A transvaginal ultrasound and blood test will be performed 1 week later i.e. week 6 to confirm the fetal viability and the number of gestational sacs and locate the pregnancy.

Blood for hCG and kisspeptin levels are checked at weeks, 4, 5 and 6. Ultrasound will be performed at gestational 8 weeks and 11 weeks. They will be referred for antenatal care when the pregnancy is confirmed on-going at 11 weeks.

The purpose is to determine whether serum kisspeptin level in women who conceive in IVF is associated with an increased risk in first trimester miscarriage and compare with serum hCG level in the prediction of the first trimester miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* Women who have a positive pregnancy test following IVF or frozen-thawed transfer

Exclusion Criteria:

* Women with renal failure are excluded due to assay interference with kisspeptin measurement
Randomized Double-Blind Trial on Safety and Efficacy of Nanordica Advanced Antibacterial Wound Dressing for Diabetic Foot Ulcer

This clinical trial evaluates the safety and efficacy of the Nanordica Advanced Antibacterial Wound Dressing (AAWD) in patients suffering from diabetic foot ulcers.

At least 170 participants will be randomly allocated to be treated either with AAWD or Aquacel Ag+ Extra wound dressing for a 4-week active phase (intervention) followed by an 8-week standard of care period.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary, written informed consent obtained prior to any study related activities.
* Males and females aged ≥18 years.
* Patients suffering DFUs for more than 4 weeks with a maximum diameter of 4 cm.
* Wound infection grades 1 (absent) or 2.
* Patients willing and able to comply with scheduled visits, laboratory sampling and study procedures.

Exclusion Criteria:

* Patients receiving systemic or topical antibiotic therapy within 7 days before the enrolment.
* Patients with any wound with known associated osteomyelitis or positive probe-to-bone test.
* Patients who have previously been randomized in this clinical trial.
* Patients who have undergone surgical procedures (e.g., radical debridement, ulcerectomy, surgical offloading, revascularization) or other advanced therapies (e.g. skin substitutes, negative pressure therapy, hyperbaric oxygen therapy) in the same leg than the index wound(s) (i.e., the ones treated and evaluated during the study) within the past four weeks, or are planned to undertake such procedures.
* Patients suffering cardiac disorders grade NYHA IV.
* Patients suffering hepatic disorders grade Child-Pugh C.
* Patients suffering advanced (stage 4) cancer.
* Patients with ankle-brachial pressure index ≤0.8 or limb peripheral arterial pressure \<60 mmHg.
* Women of childbearing potential who are pregnant, breast-feeding or not using adequate contraceptive methods.
A Retrospective Breast Reconstruction Study

To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.

This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction.

A total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.

Data will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.

Eligibility Criteria:
Inclusion Criteria:

* Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
* HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.

Exclusion Criteria:

* Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
* Female patient who underwent delayed breast reconstruction procedure.
* Female patient who underwent revision of previous breast reconstruction procedure.
An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects

The purpose of the study is to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation \[administered with Lodosyn® (carbidopa)\] and Sinemet® tablets in subjects with Parkinson's disease with Motor Fluctuations.

This is a Phase 1/Phase 2 multiple-dose, multi-center, open-label, two period sequential-treatment study in subjects with Parkinson's disease to assess the pharmacokinetics, pharmacodynamics, and safety of XP21279 sustained release formulation \[administered with Lodosyn® (carbidopa)\] and Sinemet® tablets in subjects with Parkinson's disease and to explore dose correspondence between XP21279 and Sinemet® to guide dose selection for future studies in the target population (subjects with Parkinson's disease with motor fluctuations on Sinemet®).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with a clinical diagnosis of idiopathic Parkinson's disease, confirmed by the presence of at least two cardinal signs of the disease (resting tremor, bradykinesia, rigidity).
2. Subjects must have predictable motor fluctuations of the wearing off type, defined by wearing off in at least 50% of inter-dose intervals between the first and the last daily doses as recorded on the on/off diary over 3 days (Days -4 to -2) in the Screening Period.
3. Subjects must be on stable TID or QID Sinemet® or carbidopa/levodopa regimens from morning through early evening, with a total daily dose ranging from 400 mg to 1000 mg of levodopa, for at least 1 week prior to Screening.

Exclusion Criteria:

1. History, signs, or symptoms suggesting the diagnosis of secondary or atypical Parkinsonism.
2. Subject has greater than or equal to moderately disabling dyskinesias for greater than 25% of the waking day as assessed by a score of 2 or more on item 32 and a score of 2 or more on item 33 on the UPDRS at Screening.
3. Subjects who are dosing with Sinemet® or carbidopa/levodopa during the night time.
4. Subjects who have significant neurological symptoms not accounted for by Parkinson's disease.
5. Subjects who are taking concomitantly COMT inhibitors (i.e., entacapone or tolcapone) or treated with Stalevo®, Sinemet® CR, or Madopar®/Prolopa® (levodopa/benserazide).
Quantification of Abdominal Organ Motion Using MRI

The primary aim of the study is to quantify abdominal motion in order to optimise MR imaging. The study will compare three-motion management strategies a) free-breathing, b) using an abdominal compression belt and c) using MRI-compatible visually guided breath-holds.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers

* 18 years or older,
* no MRI contra-indications
* must agree to registration as a non-patient in CWP (the local electronic healthcare records system) and have their MRIs read and reviewed for incidental findings by a clinical radiologist

Patient Volunteers

* undergoing radiotherapy to the abdominal region at the Christie NHS Foundation Trust
* Over 18 years of age

Exclusion Criteria:

* Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form
* Unable to tolerate MRI scan
* Pregnancy
* Colostomy
A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model

The purpose of this study is to evaluate the allergen-induced late asthmatic response (LAR), as measured by maximal percent fall in forced expiratory volume in 1 second, in participants with stable mild atopic asthma after treatment with JNJ 40929837 as compared to placebo.

This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double-blind (neither the physician nor participant will know which of the treatments a participant is receiving, but can access the information in case of an emergency), and crossover (method used to switch participants from one treatment arm to another in a clinical study) study. Approximately 18 participants will participate in the study. The study will consist of screening phase (30 days before the administration of study drug), treatment phase, and follow-up phase (2 weeks after the end of the last treatment period). Participants will be randomly assigned to receive JNJ 40929837, placebo, and montelukast. Each participant will receive all the 3 treatments (7 days per treatment) and each treatment will be separated by 14 days of wash-out period (no treatment). Safety evaluations will include assessments of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination, which will be evaluated throughout the study. The maximum study duration for a participant will be approximately 51 days.

Eligibility Criteria:
Inclusion Criteria: - Generally healthy - Have mild atopic asthma requiring no other treatment besides occasional short-acting beta-2-agonists - Have allergen-induced early asthmatic response of at least a 20 percent reduction in forced expiratory volume in 1 second (FEV1) and late asthmatic response of at least a 15 percent reduction in FEV1 during bronchial allergen challenge performed at screening - Females who are post menopausal, surgically sterilized, or practicing a highly effective method of birth control - Have an FEV1 at screening visit at least 75 percent of the predicted value - Have a history of asthma symptoms during exposure to indoor or outdoor allergens and a positive prick skin test done at the study site to dust mite, mixed grass pollen, or cat dander Exclusion Criteria: - Worsening of asthma or a respiratory tract infection within 6 weeks - HIV or Hepatitis B or C positive - Receipt of an investigational drug or use of an investigational medical device within the last month - Use of tobacco products of any kind currently or within 6 months - Have clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram at screening as deemed appropriate by the investigator
Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain

Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.

Subjects, once stabilized to Embeda, need only complete a minimum of 2 of the 6 week study duration to satisfy the PK endpoint. A safety follow-up visit is required at 1 week post-last dose.

Eligibility Criteria:
Inclusion Criteria:

* Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic.
* Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to \>20 mg per day of morphine, for a period of 3 consecutive days immediately prior to first day of dosing.

Exclusion Criteria:

* Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year.
* Hypersensitivity to morphine, naltrexone.
* A life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.
* Undergone surgery within 3 days prior to the first day of dosing.
Evaluation of a Cincalcet Suppression Test

The aim of the study is to compare the results of a parathyroid hormone (PTH)suppression test using a single oral tablet of cinacalcet in two groups of subjects: 1- a group of healthy adults in whom the results of the test with cinacalcet will be compared with those of the standardized PTH suppression test with intravenous calcium loading; 2- a group of patients with proven primary hyperparathyroidism in whom the results of the test with cinacalcet will be compared with those obtained during the same test, in healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Control group: healthy adult (\>18 years), having signed informed consent, taking no treatment, with effective contraception in unmenopausal women, with normal clinical examination, with normal plasma PTH, calcium, phosphorus, 25 OH vitamin D levels, with normal renal function, with normal 24 hour calciuria.
* Primary hyperparathyroidism group: adult patients (\>18 years), having signed informed consent, with effective contraception in unmenopausal women, taking no treatment known to modify calcium-phosphorus status, with normal BMI, in which the diagnosis of primary hyperparathyroidism was confirmed on plasma PTH, calcium, phosphorus, 25 OH vitamin D levels, with normal renal function, with 24 hour calciuria higher than normal.

Exclusion Criteria:

* Control group: significant medical or surgical history, creatinine clearance \<60 ml/min, liver insufficiency, arterial hypertension, psychiatric disorder able to modify the compliance to the study, tobacco intoxication, taking a treatment known to modify calcium-phosphorus status, severe known allergy, pregnant women, unmenopaused women without contraception.
* Primary hyperparathyroidism group:secondary hyperparathyroidism, creatinine clearance \<60 ml/min, liver insufficiency, psychiatric disorder able to modify the compliance to the study, tobacco intoxication, taking a treatment known to modify calcium-phosphorus status, severe known allergy, pregnant women.
Tolvaptan for Ascites in Cirrhotic Patients

Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.

This is an open label, 12 week dose escalating pilot study of tolvaptan (initiating at 15 mg a day and increasing to 30 mg a day as tolerated in addition to standard ascites treatment) of 10 cirrhotic subjects meeting all inclusion/exclusion criteria. Subjects are monitored for changes in frequency of paracentesis, quantity of ascites removed, and body weight. Additionally, subjects laboratory values were checked frequently during the first days of dosing to ensure tolerability and slow correction/increase in serum sodium.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis of liver confirmed by histology and/or combination of ultrasound or endoscopic examination with laboratory evidence
* Clinically evident ascites treated by diet and/or diuretics
* History of 1 or more therapeutic paracentesis in the previous 6 months.

Exclusion Criteria:

* History of variceal bleeding
* Current or history of Gastrointestinal bleeding within 10 days of screening
* Ascites from another cause other than liver cirrhosis (i.e. cardiac origin, peritoneal infection, or peritoneal carcinoma)
* INR (International normalized ratio) \> 3.0, neutrophils \<1500 cell/μl, platelets \< 40,000/μl
* serum bilirubin \> 3 mg/dl
* serum sodium \< 125 meQ (milliequivalent)/L
* serum potassium \<3.5 meQ/L
Metacognition Assessment in Patient With Multiple Sclerosis

This study will assessed the level of consciousness of MS patients suffering of cognitive and motor disorders. Understanding the awareness of the disease is crucial to allow better management of these patients. It has been shown, for other neurological pathologies, that a lack of awareness of deficits leads to inefficient rehabilitation and a disorder of understanding the impact of deficits in daily activities. Metacognition could be altered with age, so we will include participants between 18 and 60 years old.

Subject who have to do neurological assessement by the Multiple sclerosis Functional Composite (MSFC) will be enrolled.

The patient will estimate the time to undergo the test. This time will be compared to the time really make by the patient to realise test.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis
* Voluntary for participate to study

Exclusion Criteria:

* Neurological disease other than Multiple Sclerosis
* psychiatric disease, other than depressiveness
* illicit substance abuse
* Persons referred to in Articles L1121-5 to 8 of the French Public Health Code