cyrilzakka/clinical-trials huggingface dataset:
Clinical Feasibility of Computerized Labor Monitor (CLM) -Heart Application (HA)

The study is a feasibility study to check the possibility of tracking the heart rate of the fetus and to translate the outcome to the progress of the labor

Every year, millions of babies are born worldwide. Yet, despite great advances in medical technology, the method used to obtain the most critical parameter in labor management - cervix dilatation, remains a vaginal (manual) examination. This vaginal examination, intended to estimate the dilatation of the cervix and the progress of the baby's head, is inaccurate, non-continuous and involves the risk of infection to both fetus and mother. It is also uncomfortable to the mother. The consequences of infections or delayed treatment may range from simple complications to irreversible damage. Early detection of abnormal patterns of labor progress could prevent complications and shorten the labor process and hospitalization, thereby saving both aggravation and cost.

To truly manage the labor process, a labor management system is required. Such a system is expected to provide the obstetrical staff with the flow of accurate, continuous, real-time information, such as cervix dilatation.

Eligibility Criteria:
Inclusion Criteria:

1. Laboring women refered to the maternity center in active labor (3cm dilatation and contraction)
2. Gestational age 37-42 weeks. (GA)
3. Single Fetus.
4. Subjects who understand, agreed and signed the informed consent form.

Exclusion Criteria:

1. Women with abnormal placentation (Placenta previa) -
2. Abnormal fetal presentation (Breech presentation).
3. Maternal History of HIV and/or blood transmitted Hepatitis and /or active genital Herpes.
4. Need for immediate delivery (cord prolapsed or suspected placental abruption)
A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions

This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach.


Eligibility Criteria:
Inclusion Criteria:

* Adult aged 25-80
* Patient understands and has signed the study informed consent form.
* Patient is a suitable candidate for non-emergent, coronary angioplasty
* Patient has an angiographic documented Chronic Total Occlusion (i.e. \>3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow 0.
* Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization
* CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters.
* CTO lesion is suitable for antegrade approach.
* Left ventricle ejection fraction \> 25%
* Body Mass Index (BMI) \< 40

Exclusion Criteria:

* Patient unable to give informed consent.
* Patient is participating in another study with any investigational drug or device.
* Patient is known or suspected not to tolerate the contrast agent.
* Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO.
* Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
* Appearance of a fresh thrombus or intraluminal filling defects.
* Recent major cerebrovascular event (stroke or TIA within 30 days)
* Significant anemia (hemoglobin \< 8.0 mg / dl)
* Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
* Recent myocardial infarction (MI) (within the past two weeks)
* Unwillingness or inability to comply with any protocol requirements
* Pregnancy or nursing
Helium-Hyperoxia and 6MWT Distance in COPD

We assessed the effect of altering inspired gas on the 6MWT distance in COPD. We hypothesized that HeO2 would improve walking distance and reduce shortness of breath compared to both RA and O2, and potentially improve quality of life for COPD patients.

We hypothesized that inspiring helium-hyperoxia (HeO2) would significantly improve 6-minute walking test (6MWT) distance in Chronic Obstructive Pulmonary Disease (COPD) subjects.

This was a blinded, randomized crossover study. At Visit 1 we assessed pulmonary function, exercise capacity and 6MWT distance. Visits 2 and 3 consisted of four 6MWT with different inspired gases: room air by mask (RA), 100% O2 by mask (Mask O2), 100% O2 by nasal prongs (Nasal O2), and 70% He/30% O2 by mask (HeO2). Walking distance, shortness of breath, leg fatigue, O2 saturation and heart rate (HR) were assessed

Eligibility Criteria:
Inclusion Criteria:

* Exertional dyspnea
* Activity limitation
* COPD

Exclusion Criteria:

* Recent exacerbation (\< 4 wks)
* Supplemental O2
* Significant cardiovascular/musculoskeletal abnormalities
Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)

In the context of australian general practice, to determine the efficacy and safety of ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol receiving statin 40mg or more.


Eligibility Criteria:
Inclusion Criteria:

* Patients who will remain on a stable statin dose of 40mg or more, for the duration of the study
* Patients with coronary heart disease or diabetes mellitus whose cholesterol levels remain above the initial threshold for government subsidy after at least 3 months of treatment at a daily dose of 40mg or greater of a statin

Exclusion Criteria:

* Illnesses such as congestive heart failure nyha class iii or iv
* Uncontrolled hypertension
* Myocardial infarction
* Coronary bypass surgery or angioplasty with or without stent within 3 months of the enrolment visit
* Unstable angina pectoris or unstable or severe peripheral vascular disease
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, ex: type i or type ii diabetes mellitus that is poorly controlled
* Serum creatinine \>0.18mmol/l at enrolment or active renal disease with significant proteinuria
* Disorders of the haematologic, digestive (including malabsorptive disorders)
* Central nervous system including cerebrovascular disease and degenerative diseases that would limit study evaluation or participation
* Active acute or chronic hepatobiliary disease
* Patients taking the following medication: medications known to interact with statin medication including antifungal azoles, macrolide antibiotics, telithromycin; nefazodone; protease inhibitors; amiodarone; danazol and verapamil; fibrates; cyclosporin
* Tg \>4.0mmol/l while using a statin
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS patients that completed the CACZ885D2307 study


Eligibility Criteria:
Inclusion criteria:

1. Patients who completed the core CACZ885D2307 study (a patient is defined as having completed the core study if they completed the study up to and including the EOS visit with no major protocol deviations in the core).
2. Male and female patients that are ≥ 1 year of age at the time of the roll-over visit.
3. Parent or legal guardian written informed consent must be obtained before any assessment in the extension CACZ885D2307E1 study is performed.

Exclusion criteria:

1. Patients for who continued treatment in the CACZ885D2307E1 extension study is not considered appropriate by the treating physician.
2. Patients who discontinued from the core CACZ885D2307 study

Other protocol-defined inclusion/exclusion criteria may apply.
A RCT of Walking With Positive Education in Retired Elders

Three arms of experimental design were used: Pedometer walking training (PWT), positive education and pedometer walking training (PEPWT), and pedometer walking (PW). Trained walking exercise was provided by a physical education expert three times per week, 45 minutes per session. Positive education was designed and led by a licensed psychologist. Six sessions of activities targeted participants' self-strength, competence and self-efficacy in walking exercise; positive relations with others; and positive emotions about life and healthy lifestyle. Of 150 participants, 60, 60 and 30 were randomly assigned to PWT, PEPWT, and PW, respectively. Demographic information, Chinese Happiness Inventory (CHI), regular walking exercise and six-minute walking distance were assessed before and after the intervention.

Randomization (allocation ratio 2:2:1) was stratified to three arms: pedometer walking (PW), pedometer walking with training (PWT), and positive education and pedometer walking with training (PEPWT). Randomization was conducted using opaque envelops and a randomly generated number sequence by an independent research assistant who had no prior knowledge of the recruited elders. Researchers allocated participants to their treatment condition based on the randomization code in the sealed envelope (opened in order of sequence). Researchers were not blind to the patients' treatment allocation.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria included being retired from work and being at least 55 years old.

Exclusion Criteria:

* Elders who had cardiovascular disease, who were unable to walk, who had dementia or psychiatric disease, who already exercised regularly, or who were unwilling to sign the consent form were excluded from the study.
Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

The purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis.

Participants will be randomly assigned to one of two study arms. Those in one arm will receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will receive wide stimulus pulses (1 ms). The electrical stimulation will be delivered with a Vectra Genisys System.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, understand, and speak English to ensure safe participation in the project
* Difficulties with walking
* On stable doses of Ampyra, provigil, or other symptomatic-treating medications
* No systemic steroids within the last 30 days
* Not currently exercising more than 2x/wk
* Able to arrange own transportation to and from the laboratories
* Provide informed consent, including willingness to be randomly assigned to one of the two groups

Exclusion Criteria:

* Documented MS-related relapse in the last 3 months
* Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy
* Poorly controlled diabetes mellitus or hypertension
* History of seizure disorders
* Alcohol dependence or abuse (≥2 drinks/day), or present history (last 6 months) of drug abuse
* Inability to attend exercise sessions 3 days per week for 6 weeks
Low Dose Daily Erlotinib in Combination With High Dose Twice Weekly Erlotinib in Patients With EGFR-Mutant Lung Cancer

The purpose of this study is to test the safety of different ways of taking erlotinib. The investigators want to find out what effects, good and/or bad, combination daily low dose and twice weekly high dose erlotinib has on the patient and lung cancer. The investigators are also seeing whether different schedules of erlotinib are better at treating lung cancer that has spread to the central nervous system.

CNS expansion phase:

The pulse continuous regimen will be then assess in patients with EGFR mutant lung cancers and CNS involvement. An additional expansion cohort (A) will enroll 19 patients with newly diagnosed EGFR mutant lung cancer with CNS involvement at diagnosis. The patients in the expansion cohorts will undergo the same treatment plan as the patients in the dose expansion cohort. A patient in the expansion cohorts will not be replaced if he/she does not finish the first 28 day (cycle 1) treatment period.


Eligibility Criteria:
Inclusion Criteria:

* MSKCC pathologically-proven diagnosis locally advanced Stage III not amenable to definitive, curative treatment or Stage IV or recurrent non-small cell lung cancer
* Documented presence of EGFR mutation confirmed by MSKCC or a local facility.
* No prior treatment with erlotinib, gefitinib, or other EGFR tyrosine kinase inhibitors
* Age ≥ 18 years
* Measurable (RECIST 1.1) indicator lesion not previously irradiated.
* Karnofsky Performance Status ≥ 70%
* Ability to take oral medications
* A negative serum pregnancy test obtained within 4 weeks prior to the start of treatment in all women of child-bearing potential.
* All women of child bearing potential and sexually active men must agree to use adequate methods of birth control throughout the study which includes use of oral contraceptives with an additional barrier methods, double barrier methods, Depo-Provera, permanent sterilization of patient or partner or total abstinence.

Expansion A:

* brain metastases or leptomeningeal not previously treated with radiation or surgery

Exclusion Criteria:

* Inadequate recovery from any toxicity related to prior treatment (to Grade 2 or baseline).
* Inadequate hematologic function defined as ANC \< 1000 cells/mm³, Platelet count \<75,000/mm³ or Hemoglobin \<9.0g/dL.
* Inadequate hepatic function defined by AST/ALT \>3x upper limit of normal (ULN), Total bilirubin\>2x ULN, Alkaline phosphatase \>3x ULN.
* Symptomatic brain metastasis requiring radiation therapy or escalating doses of steroids.
* Patients with clinically stable brain metastases or leptomeningeal disease (previously treated or untreated) are eligible. Patients in expansion cohort A must have at least one untreated CNS lesion
* Women who are breastfeeding or pregnant.
* Any evidence of clinically active interstitial lung disease.
Hemostatic Assessment of Postpartum Hemorrhage Using Sonoclot Signature

Postpartum hemorrhage is the leading cause of maternal morbidity and mortality throughout the world. Rapid diagnosis and early management improve maternal prognosis.

Postpartum hemorrhage is defined by a blood loss exceeding 500 ml during the 24 h after delivery.

There are many causes of postpartum hemorrhage. Most cases develop from uterine atony, which accounts for 75% of cases. Even though there are risk factors for postpartum hemorrhage, it is still an unpredictable obstetric emergency.

Coagulation plays an important role in postpartum hemostasis. Primary and especially secondary coagulation disorders are risk factors for Postpartum hemorrhage.

When bleeding occurs, the decrease in fibrinogen levels is the most rapid change observed among markers of coagulation. Recent studies show that fibrinogen concentration during the initial management of Postpartum hemorrhage is the most informative biological marker for the severity of the hemorrhage.

Various methods are used to record coagulation profile. One of them is estimation by sonoclot.

Viscoelastic hemostatic assays devices (such as sonoclot) have practical advantages as point-of-care devices for monitoring major hemorrhage including a set of parameters that assesses a global coagulation profile like fibrinogen and platelet count.

Identification of coagulopathy by viscoelastic point-of-care testing can be helpful in guiding management of Postpartum hemorrhage and preventing severe maternal outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. patients in childbearing period.
2. Patients with bleeding occurring in the first 24 hours after delivery (primary postpartum hemorrhage).
3. Patients with causes of Postpartum hemorrhage like uterine atony, preeclampsia, blood diseases as inherited and prepartum acquired coagulopathies, and others e.g., acute fatty liver of pregnancy, amniotic fluid embolism, etc.

Exclusion Criteria:

1. Patients with bleeding after 24 hours from delivery (secondary postpartum hemorrhage).
2. Patients with miscarriages (bleeding before 22 weeks of gestation) or Antepartum hemorrhage.
3. Traumatic causes of postpartum hemorrhage e.g., rupture uterus, abruptio placenta, Lacerations, hematomas, Uterine inversion, and iatrogenic trauma.
Tissue Lesions in Exercise Related Ischemia

The purpose of this study is to evaluate the effect of muscle ischemia during claudication on mitochondrial function.

Comparison to patients with arterial disease but absence of lower limb claudication (Cardiac group) feasibility study.

Assess the feasibility of the study of micro-vascular function and mitochondrial on muscle sample (sartorius) in a group of arterial disease and non arteriopathy group.

Analysis of the activity of mitochondrial chain Immunochemistry of tissue markers

Eligibility Criteria:
Inclusion Criteria:

* Intervention for femoropopliteal bypass (PAD group)
* Intervention for saphenous withdrawal for coronary bypass surgery (cardiac group)

Exclusion Criteria:

* Participate in another biomedical research
* Pregnant woman
High-dose Periop Statins for Prevention of DVT

This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce inflammatory responses and deep vein thrombosis formation when given in high doses in the perioperative period.


Eligibility Criteria:
Inclusion Criteria:

* gynecologic tumor scheduled for resection

Exclusion Criteria:

* prior reaction to statins
* renal insufficiency
* liver disease
* h/o alcoholism
* prior h/o DVT or hypercoagulability
* concurrent medications that significantly affect cytochrome P450 3A4
* breast feeding or pregnancy
Prospective Evaluation of the Covered Self-expandable Metal Stents (CSEMS) for Incomplete Biliary Stone Clearance

The current standard of care for bile duct stone are endoscopic sphincterotomy and stone extraction. Placement of plastic stents is an option for incomplete biliary stone clearance. This study will use the CSEMS in patients with complex biliary stones who failed stone extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing measure that allows more successful subsequent stone clearance. However, their use in benign condition has been limited especially for biliary stone removal. The purpose of this study is to determine the feasibility, safety, easy removability, stent-stone formation rate, and migration rate of CSEMS for complex biliary stones.

same as brief summary

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Bilary stone unable to be extracted with balloon, basket, large balloon dilation of the ampulla or mechanical lithotripsy.
* Stone can be bridged by the metal stent
* Subject must be able to give informed consent.

Exclusion Criteria:

* Any contraindication to ERCP
* Patient refuses consent for the study.
Study of KHK2823 in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

This is a first in human, non-randomized, open-label, dose escalation study to investigate the safety, pharmacokinetics, immunogenicity and pharmacodynamics of repeat doses of KHK2823.

This is a Phase 1, multi-center, open-label, dose-escalation study of KHK2823 in adult patients with previously untreated AML who are not candidates for intensive remission induction therapy; relapsed/refractory AML for whom no other standard therapy is available or appropriate; or relapsed/refractory MDS who have received prior therapy with a hypomethylating agent, such as decitabine and azacitidine or who are not candidates to receive a hypomethylating agent, this would include high risk or transfusion-dependent low risk patients. Patients must have documented primary or secondary AML or MDS according to World Health Organization (WHO) criteria. Following the provision of signed informed consent, patients will be screened for entry into the study. The study consists of 2 parts. In Part 1, 3 to 6 patients per cohort will be enrolled sequentially in up to 7 dose-escalation cohorts to establish the MTD. KHK2823 will be administered once weekly. In Part 2, up to an additional 18 patients may be enrolled to further evaluate the safety, PK, PD, potential anti-leukemic activity of KHK2823.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years old with previously untreated AML who are not candidates for intensive remission induction therapy; relapsed/refractory AML for whom no other standard therapy is available or appropriate; or relapsed/refractory MDS who have received prior therapy with a hypomethylating agent or who are not candidates to receive a hypomethylating agent
* Histopathologically/cytologically documented primary or secondary AML, as defined by WHO criteria, or MDS, confirmed by pathology review at treating institution
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
* Life expectancy of at least 3 months

Exclusion Criteria:

* Histological diagnosis of acute promyelocytic leukemia (FAB Type M3)
* Clinically significant central nervous system leukemia
* Treatment of the underlying hematologic condition with systemic therapy during the treatment period, including any chemotherapy, radiation or investigational therapy, within 2 weeks prior to KHK2823 administration; or immunotherapy within 30 days prior to KHK2823 administration; with the exception of hydroxyurea (Hydrea®) for treatment of hyperleukocytosis, which must be discontinued at least 24 hours prior to the first dose of KHK2823
A Study of the Burden of Illness and Treatment Patterns in Teenagers and Adults With Hereditary Angioedema

This study is about teenagers and adults with hereditary angioedema (HAE) type I and type II. In this study, the burden of illness means the impact of HAE in terms of long-term health outcomes and the financial cost.

The main aims of this study are as follows:

* to learn how often, how severe and where on the body HAE attacks occur.
* to describe how HAE prophylaxis and on-demand medicines are prescribed and used. (Prophylaxis medicines prevent a bleed from happening and on-demand medicines treat a bleed when it occurs.)

This study is about collecting data only; participants will not receive treatment as part of this study. Existing data available in the participant's medical records will be collected. Participants will be asked to complete an electronic questionnaire either on a website or by using an app on their mobile phone; data from this questionnaire will also be collected.

Participants do not need to visit their doctor in addition to their normal visits.


Eligibility Criteria:
Inclusion Criteria:

* Participant aged \>= 12 years at the time of the last documented HAE attack in the eligibility period.
* Physician-confirmed diagnosis (or confirmation in medical records) of HAE type I or type II.
* Participant had at least one documented HAE attack during the eligibility period.
* Participant is not adequately or sub-optimally controlled according to treating physician.
* Participant (or parent/legal guardian) is willing and able to comply with the study requirements and provides informed consent or assent.

Exclusion Criteria:

* Participant enrolled in a therapeutic investigational drug or device trial during the observation period.
* Participant initiated long-term prophylaxis with Takhzyro® at any time since diagnosis.