cyrilzakka/clinical-trials huggingface dataset:
Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects

Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a synchronized manner.

The PSG data will be scored manually by a trained polysomnographic scorer, according to standard criteria for this clinical routine.

The data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep stages, snoring (optional) and body position (optional), in addition to parameters specific to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT) and will be compared to the PSG's manual scoring which serves as a "Gold Standard".

Subjects with cardiac disorders, referred to the sleep lab will be offered to participate in the study. Subjects will be asked to sign an informed consent form and will be screened for inclusion exclusion criteria.

Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate pre-study electronic case report forms.

The subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP 200/WP200U wrist device, which includes the PAT and pulse oximeter probes will be worn on the wrist.

The investigator will not have access to the WP200/WP200U data while scoring the PSG data. During the study recording, the WP200/WP200U data will be recorded inside the device, without being displayed on the PSG monitor. Furthermore, the WP200/WP200U analysis is done automatically without knowledge of the PSG scoring results.

Eligibility Criteria:
Inclusion Criteria:

* Age between17-90
* Subject is able to read understand and sign the informed consent form.
* Subject with diagnosed cardiac disorders and/or other comorbidity
* Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab

Exclusion Criteria:

* Permanent pacemaker: atrial pacing or VVI without sinus rhythm
* Finger deformity that precludes adequate sensor appliance.
* Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)
A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women, 18-50 years, inclusive.
* Cyclic abnormal uterine bleeding (heavy or prolonged).
* Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.
* Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
* Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia.

Exclusion Criteria:

* History of uterine surgery that would interfere with the study endpoints.
* Known coagulation disorder including bleeding disorder or clotting disorder.
* History of, or current uterine, cervix, ovarian, or breast cancer.
* Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal range.
Physician Perceptions About Parenteral Hydration in Latin America and Spain

The purpose of this study is to assess palliative care physicians' attitudes, beliefs and practice patterns related to parenteral hydration at the end of life in Latin America and Spain.

Objectives:

1. To assess palliative care physicians' attitudes, beliefs and practice patterns related to parenteral hydration at the end of life in Latin America and Spain.
2. To assess cross-national differences in practice patterns related to parenteral hydration at the end of life. (Latin America vs. Spain).
3. To determine the percentage of physicians who practice parenteral hydration at the end-of-life in the hospital setting and the home setting.
4. To examine the association between providers' parenteral hydration practice patterns and:

   * 1. provider demographic characteristics;
   * 2. specific characteristics of their practice settings; and
   * 3. training and experience in end of life care;
5. To determine which factors most predict the practice of parenteral hydration at the end of life among palliative care physicians.

This study is a collaboration between MD Anderson's Departments of Palliative care and Rehabilitation Medicine, Health Disparities Research, the Latin American Association for Palliative Care (ALCP) and the Spanish Society for Palliative Care (SECPAL). The proposed study involves a 10-15 minute online survey of palliative care physicians from Latin America and Spain to assess their attitudes, beliefs and practice patterns related to parenteral hydration at the end of life.

Eligibility Criteria:
Inclusion Criteria:

1. Palliative care physicians practicing in Latin America and Spain and affiliated with either the ALCP or SECPAL.
2. Physicians must report dedicating at least 30% of their practice to palliative care.
3. Physician must be 18 years of age or older.

Exclusion Criteria:

1) None
Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

This proof of concept study will evaluate the ability of a new, ultrasound based technology called Bullseye Constructive Shearwave Interference (CSI) (trade name, Bullseye Elasticity Quantification) to measure lymphedema of the upper arm among breast cancer survivors.

The study's hypothesis is that the CSI device can detect the presence of clinically significant lymphedema when compared with the standard arm tape measurement.


Eligibility Criteria:
Inclusion Criteria:

* Any subject with a history of unilateral breast cancer who has completed definitive treatment for breast cancer (i.e. previously undergone surgical resection, with or without adjuvant radiotherapy and/or chemotherapy). Subjects must have completed all recommended adjuvant radiotherapy. Subjects who continue on systemic therapy may be included at the discretion of the treating physician.
* Subjects with a history of unilateral axillary sentinel biopsy, lymphadenectomy or dissection are eligible for inclusion.
* Subjects taking hormonal therapy are eligible for inclusion
* Subject has any stage lymphedema

Exclusion Criteria:

* Active rash or skin tears/injury in bilateral upper extremities
* Subjects with history of contralateral breast cancer treatment
Dermacyd Silver Frutal (Lactic Acid) - Compatibility.

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.


Eligibility Criteria:
Inclusion criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Diseases which can cause immunosuppresion, such as diabetes, HIV
* Personal history of atopy
* History of sensitivity or irritation for topic products
* Cutaneous active disease (local and/or general) which can modify the study results
* Use of new drugs and/or cosmetics during the study
* Cutaneous reaction
* Previous participation in studies using the same product in test
* Volunteer which has immunodeficiency congenital or acquired
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block

Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. Thus, TAP block is widely implemented in perioperative management of colorectal cancer patients.

Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries.

Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. With the increasing use of ultrasound guidance during peripheral nerve blocks, trunk blocks such as the transversus abdominis plane (TAP) block are widely used for analgesia after abdominal surgery.

The advantages of TAP block include being less invasive than epidural analgesia, lower incidence of hypotension, and shorter hospital stay. Due to these advantages, TAP block has become a widely preferred method.

Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries. The study will be conducted in a tertiary oncology hospital in Turkey and 84 colorectal cancer patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer diagnosis
* undergoing colorectal cancer surgery

Exclusion Criteria:

* allergic reaction to local anesthetics
* bleeding anomalies
* infection in TAP block area
The Detection and Factors of Brown Adipose Tissue in Different Locations of Adults

Retrospective studies have combined positron-emission tomography and computed tomography (PET-CT) to identify adipose tissue with a high rate of uptake of 18F-fluorodeoxyglucose(18F-FDG) as active brown adipose tissue(BAT). In addition, biopsy specimens and immunohistochemical staining with a UCP1-specific antiserum were used to indicate that normal adults were able to have BAT. However,these studies only chose few subjects and limited to the neck tissue. Therefore, the investigators intend to test BAT in different parts of adults and analyse the clinical factors.

The investigators will promote the cross-sectional study from 2010 to 2013 in Shanghai. Data on demographic statistics, medical history,physical examination and fasting blood sample will be collected for all patients. Adipose tissue of adults will be collected from different regions, such as cervical, perirenal, along the large blood vessels and trachea, because they are included in the range of surgical therapy and are the major locations of BAT. Adipose tissue samples will be used to immunohistochemical stain, to detect the expression of BAT related genes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who underwent surgical therapy and the operation scope includes BAT sample sites.

Exclusion Criteria:

* Pregnant women
* With implantable medical electronic instrument
* Younger than 18 years
Coping After Pediatric Scoliosis Surgery

This is a prospective, randomized controlled trial evaluating the efficacy of expanded patient education and coping skills on pain management following multilevel pediatric spinal surgery. The intervention will include a smartphone- based platform and a comprehensive library of peri-operative educational and coping skills videos as a means for better addressing the psychosocial elements of a child's individual pain experience. The study evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate functional recovery up to 6 weeks after surgery.


Eligibility Criteria:
Inclusion criteria:

- All children ages 11 to 18 years old treated with primary multilevel spinal surgery of any approach

Exclusion Criteria:

* Non-English speaking
* Non-idiopathic scoliosis, such as neuromuscular, congenital or syndromic.
* Other comorbidity, including developmental delay.
* Any surgical complication that results in significant divergence from our institution's standard scoliosis pathway.
* Unplanned admission within 6 weeks of index operation.
* Active treatment psychotherapy and/or cognitive behavioral therapy for any reason
A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.


Eligibility Criteria:
Inclusion Criteria:

For the dose escalation phase:

1. Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer \[AJCC\]). For the dose expansion phase: (i) Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer \[AJCC\]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mCRC) for which no further effective standard therapy exists.
2. Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
3. Evidence of measurable disease

Exclusion Criteria:

1. Previous therapy with a MEK inhibitor.
2. Symptomatic or untreated leptomeningeal disease.
3. Symptomatic or untreated brain metastasis.Patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging.
4. Known acute or chronic pancreatitis.
5. Clinically significant cardiac disease
6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818
7. Previous or concurrent malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
8. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL).
9. History of thromboembolic or cerebrovascular events within the last 6 months

Other protocol-defined inclusion/exclusion criteria may apply
RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.

In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.

Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects.

In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.

The regimen of consolidation therapy is recommended as multidrug combination chemotherapy (including high-dose Methotrexate or Cytarabine combined with Asparaginase) or alternating with Blinatumomab (28 ug/d×28d). If Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) is not performed, consolidation therapy needs at least 4 courses before 2 years maintenance therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 15-65
* Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
* Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days
* ECOG score 0-3
* Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine ·aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
* Renal function: endogenous creatinine clearance ≧30ml/min
* Patients must be able to understand and willing to participate in the study and must sign the informed consent form.

Exclusion Criteria:

* Ph+ (BCR-ABL1 positive) ALL
* T cells ALL
* Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
* Acute mixed-cell leukemia
* Central nervous system leukemia
* HIV infection
* HBV-DNA or HCV-RNA positive
* Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
* Pregnant or breastfeeding patients
* The study patient was refused enrollment
Paracetamol and Neuropathic Pain

The aim of this study is to evaluate the analgesic effect of paracetamol in patients suffering from pain with a peripheral neuropathic component in the presence of their usual treatment.

This is an interventional, randomized, placebo-controlled, double-blind, crossover study about the use of paracetamol in therapeutic doses in peripheral neuropathic pain patients. The analgesic effect of paracetamol will be assessed by the painful intensity measured by numerical pain rating scale over one week after taking paracetamol/placebo.

The secondary objectives will be:

* To determine the number of patients in whom paracetamol is effective in reducing pain by at least 30% and 50%,
* To evaluate the effect of paracetamol on pain, on the number and intensity of paroxysms,
* To evaluate paracetamol consumption,
* To evaluate the effect of paracetamol on neuropathic pain patient,
* To evaluate the effect of paracetamol on mechanical allodynia,
* To monitor routine biological parameters (liver function),
* Compare Glutathione (GSH) concentrations before and after taking paracetamol,
* To perform a blood test for paracetamol and its metabolites before and after each study period,
* To perform urine dosage of paracetamol and its metabolites before and after each study period,
* To study pharmacogenetics parameters,
* To evaluate patient feeling and satisfaction after taking paracetamol,
* To evaluate the effect of paracetamol on cognition, anxiety, depression and sleep by different questionnaires,
* To collect adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 65 years,
* Patient suffering from chronic pain (for more than 3 months) with the characteristics of peripheral neuropathy and having pain assessed by a numerical scale ≥ 3 for one week, with at least 10 assessments completed,
* Patient agrees with not to take paracetamol, other than the treatment provided as part of the protocol, from inclusion to completion of the study,
* Acceptance to give a written consent.

Exclusion Criteria:

* Patient taking paracetamol daily,
* Patient with a contraindication to paracetamol administration (liver or renal failure, ...),
* Patient with a biological evaluation evaluated by the investigator as not compatible with the trial,
* Patient with a medical and/or surgical history evaluated by the investigator to be not compatible with the trial,
* Patient with drug treatments evaluated by the investigator to be not compatible with the trial,
* Pregnant or nursing woman,
* Patient with a cooperation and an understanding that does not allow for a strict compliance under the conditions set out in the protocol,
* Patient participating in another clinical trial, or being in an exclusion period, or having received a total amount of compensation exceeding 4500 euros over the 12 months preceding the start of the trial,
* Patient benefiting from a legal protection measure (curatorship, guardianship, protection of justice...),
* Patient not affiliated to the French Social Security system,
* Paracetamol intake during wash-out period.
Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA

The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.

The ductus arteriosus remains patent in about 40% to 80% of very low birth weight infants. Early treatment by intravenous ibuprofen L-lysine (IV ibuprofen) has been suggested in preliminary studies to close the ductus and shorten hospital stay. This study aims to determine the effect of early treatment with IV ibuprofen given to the very low birth weight infant with a non-symptomatic patent ductus arteriosus (PDA) at less than 72 hours of life to accelerate and maintain ductal closure, thereby reducing the need for rescue therapy.

Eligibility Criteria:
Inclusion Criteria:

* Premature newborn infant of either gender with a birth weight of 500 to 1000 grams, appropriate for gestational age;
* Non-symptomatic PDA with evidence of ductal shunting documented by an echocardiogram (ECHO);
* Less than 72 hours of age at the time of randomization;
* If infant is one of a multiple birth, he/she is one of the two (2) oldest infants who meet the eligibility criteria;
* Consent form signed by parent.

Exclusion Criteria:

* Either major congenital malformations and/or chromosomal anomalies;
* Proven, severe congenital bacterial infection;
* Maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure \< 72 hours prior to delivery;
* Treatment with pharmacological replacement steroid therapy at anytime since birth;
* Unremitting shock requiring very high doses of vasopressors (i.e. inability to maintain mean arterial blood pressure appropriate for gestational age ± 2 SD using volume and maximal vasopressor therapy as defined by the individual institution);
* Renal failure or oliguria defined as urine flow rate \< 0.5 mL/kg/hr in the 8 hours prior to randomization (Anuria is acceptable if infant is in first 24 hours of life);
* Platelet count \< 75,000/mm 3;
* Clinical bleeding tendency (i.e. oozing from puncture sites);
* Expected survival less than 48 hours in the opinion of the attending neonatologist;
* Participation in other clinical intervention trials. Exceptions may be made if approved by Medical Director or designee, RPD Pharmaceutical Department;
* Symptomatic PDA as documented by 3 of the following 5 criteria
* Bounding pulse
* Hyperdynamic precordium
* Pulmonary edema
* Increased cardiac silhouette
* Systolic murmur Or, in view of the neonatologist is deemed to have a hemodynamically significant ductus.
* Exposure to NSAIDs at any time since birth.