cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics Study of CJ-40001 and NESP® After Single Dose Administration in Health Male Volunteers

The purpose of this study is to compare the pharmacokinetics and safety after a single subcutaneous or intravenous administration of CJ-40001 and NESP® in healthy male volunteers.

The purpose of this study is to compare the pharmacokinetics and safety after a single subcutaneous or intravenous administration of CJ-40001 and NESP in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Male aged 19 to 55 years at the screening
* Subject with BMI between 19 kg/m2 and 28 kg/m2 (inclusive)
* Subject who is able to participate in the whole study process
* Subject who provided written informed consent voluntarily after being fully informed of the study objectives, procedures and the investigational product

Exclusion Criteria:

* Subject who has a medical history of gastrointestinal, cardiovascular, respiratory, hepatobiliary, hematologic/oncologic, neuropsychologic, endocrinological, immunologic or renal disease that may be aggravated by the investigational product
* Subject with a systolic blood pressure of equal to or greater than 140 or less than 90 mmHg or with a diastolic blood pressure of equal to or greater than 90 or less than 60 mmHg
* Subject who has allergic disease that needs to be treated
* Subject with a history of drug allergies to any ingredient of the investigational product or marketed drug
* Subject with a blood hemoglobin value less than 13 g/dL or more than 17 g/dL
* Subject with a blood reticulocyte value more than the upper reference limit
* Subject with a blood vitamin B12 or ferritin or transferrin value less than the lower reference limit
* Subject with any non-negative results in blood serology (HBV, HCV, HIV, RPR) tests and in an examination of syphilis
* Subject who smokes more than 10 cigarettes per day
* Subject who consumes alcohol more than 140 g per week
* Subject with a history of drug abuse
* Subject who was administered with any investigational product, erythropoietin or iron supplement within 60 days prior to the screening
* Subject who donated whole blood within 60 days or blood components within 30 days prior to the screening
* Subject who took any herbal medicine within 30 days or any prescription drug within 14 days or over-the-counter drug considered to affect study within 10 days prior to the screening
* Subject who does not agree to use medically acceptable methods of contraception or who has plan to provide sperm during the study period
* Subject whom the investigator determined to have clinically significant findings in ECG
* Subject whose liver function is decreased with an AST, ALT or bilirubin value more than 1.5 times the upper reference limit
* Subject whose renal function is decreased with a GFR value calculated using MDRD equation less than the lower reference limit
* Subject whom the investigator determined to have clinically significant findings in clinical laboratory test
* Subject who is inappropriate as a subject of this study by the investigator's decision
Climacteric Therapy With Applied Relaxation Using InterNet

The aim is to evaluate effects of internet-based applied relaxation (a simplified version of cognitive behavioral therapy) for women with menopausal symptoms mainly vasomotoric symptom (VMS), i.e. hot flashes and sweating. Sixty postmenopausal women with VMS will be recruited and 30 randomized to applied relaxation (AR) via internet and 30 to a control group which is a non-treated waitlist group.

At baseline, after 10 weeks of therapy and six, 12 and 24 months after end of therapy women will be asked to fill in diaries about hot flashes and answer questionnaires on Quality of Life (Women's Health Questionnaire; WHQ, anxiety and depression measured with Hospital Anxiety and Depression Scale; HADS and one measuring sleep, Insomnia Severity Index; ISI as well as one about knowledge of the climacteric and hormone therapy).

The waiting list group will be offered internet based AR after 10 weeks with the same follow-up as the treatment group.

See above

Eligibility Criteria:
Inclusion Criteria:

* A minimum of 7 moderate or severe hot flashes per 24 h or 50 hot flashes per week in average at least during one week before randomization (mild = hot flash without sweating as recognized by the woman but not disturbing the woman, moderate = hot flash and sweating as recognized by the woman but that does not lead to disruption of ongoing activity, severe = hot flash with sweating that leads to disruption of ongoing activity)
* Natural menopause (at least 12 months without any menstrual bleedings at all)
* At least 45 years of age during present year
* Access to computer with Internet
* Ability to read and speak Swedish
* Freely informed concent for participation

Exclusion Criteria:

* Induced menopause (e.g. hysterectomy, oophorectomy, chemotherapy, radiation therapy over abdominal- and/or pelvic region)
* Early or premature menopause (before 45 years of age)
* Breastcancer disease with ongoing therapy with antiestrogen or aromatase inhibitors
* Ongoing usage or use during the last month of hormone therapy or other treatment aimed for hot flashes (e.g. natural remedies affecting hot flashes, acupuncture, dietary supplements aimed to treat hot flashes
* Treatment with psychopharmacological drugs (e.g SSRI or SNRI) or frequent use of benzodiazepines, drugs for insomnia(\> 1 times/week)
* Untreated or unstable endocrinological- or metabolic disease( e.g thyroid disease)
* Undiagnosed vaginal bleeding after menopause
Adnexal Masses : Correlation Between MRI (Magnetic Resonance Imagery) and Anatomopathology

The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics of adnexal masses with their anatomopathological characteristics.

Several studies have identified the characteristics of adnexal masses obtained by different imaging techniques (echography, scanner and magnetic resonance) and corresponding to benign, borderline or malign masses (Kurtz et al 1999, Grabowska-Derlatka et al, 2013, Tanaka et al 2011, Asch et al 2008).

Recently, studies have even established ecographic and magnetic resonance imaging scores combining these characteristics (Thomassin-Naggara 2013, Timmerman 2005), some of these characteristics being considered as more suspect than others.

However, these studies have considered adnexal masses in their globality only and to our knowledge, none have correlated their imagery characteristics with their precise anatomopathology characteristics.

The goal of this study is thus to correlate the pelvic magnetic resonance imagery characteristics of the adnexal masses with their anatomopathology characteristics, in order to add complementary information for the future management of masses that are defined as borderline according to imagery.

Eligibility Criteria:
Inclusion Criteria:

- Every woman aged 18 years and more, with a planned pelvic magnetic resonance imagery and a planned adnexectomy within the institution.

Exclusion Criteria:

- Insufficient technical quality of the pelvic magnetic resonance imagery images or of the anatomopathological analysis.
Functional Recovery in Critically Ill Children

Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is associated with increased mortality and length of stay, and negatively impacts long-term functional outcomes and quality of life in affected patients and their caregivers. While delayed mobilization adversely affects clinical outcomes, early rehabilitation in the critically ill adult population is safe, feasible, cost effective, results in more ventilator free-days and better functional outcomes at hospital discharge. In contrast, there is a paucity of this research in pediatrics. Our research suggests that immobilization is common in critically ill children, and rehabilitation is delayed particularly in the sickest children who are arguably at highest risk of morbidity. It is unclear however, whether delayed rehabilitation leads to adverse outcomes in critically ill children, as has been demonstrated in adults. Our objectives of this study are to evaluate if immobilization and delayed rehabilitation negatively impacts short-term clinical outcomes and the time to functional recovery in critically ill children. The investigators hypothesize that the following factors may influence functional recovery and morbidity in critically ill children:

* Pre-morbid condition
* Age
* Time-to-initiation of acute rehabilitation
* Critical illness disease severity

Overall Study objectives:

1. To describe the functional recovery following prolonged immobility and delayed rehabilitation in critically ill children.
2. To explore the predictors of impaired functional recovery following immobilization in critically ill children.

Prior to conducting a definitive multi-centre study to answer our research questions and achieve our study objectives above, we will conduct a pilot study in order to demonstrate feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Age over 12 months to 17 years
* PCCU stay of ≥ 48 hours
* Patient is limited to bed-rest and has not been mobilized during the first 48 hours of PCCU admission
* Equal to or greater than one organ dysfunction on PCCU admission (as measured by PELOD)
* Informed consent of patient/substitute decision maker.

Exclusion Criteria:

* Age: \< 12 months or ≥18 years
* Patients admitted to step-down/intermediate care
* Patients transferred from Neonatal intensive care unit and never discharge home.

iv) Patients who are already mobilizing well, or are at baseline functional status at time of screening v) Admission diagnosis of a neuromuscular disorder: e.g. Acute Guillain-Barré Syndrome, Botulism, Myasthenia Gravis), or acute spinal cord injury/transverse myelitis vi) Not expected to survive PCCU/hospital stay vii) Previously enrolled into study less than 6 months ago and/or still undergoing study procedures at time of screening
Genetic Polymorphisms & The Risk for Sepsis After Trauma

The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.

The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death

Eligibility Criteria:
Inclusion Criteria:

Admitted to the Intensive Care Unit (ICU) at Harborview Medical Center after suffering a traumatic injury

* ability to obtain a 5 ml blood sample
* Expected to be in the ICU for more than 24 hours

Exclusion Criteria:

* We will exclude subjects with chronic medical conditions for the reasons stated above as well as vulnerable populations (children, pregnant females, and prisoners)
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury

The goal of this interventional study is to evaluate the safety and preliminary effectiveness of the ARC-IM Therapy to improve hemodynamic management in people with sub-acute or chronic spinal cord injury.

Participants will be implanted with the ARC-IM Thoracic System which aim to deliver, at the low thoracic level, targeted epidural electrical stimulation that will support natural hemodynamic control.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Must provide and sign the Informed Consent prior to any study-related procedures
* Traumatic Spinal Cord Injury
* Spinal cord injury lesion level between C3 and T6 (inclusive)
* AIS- A, B, C or D
* SCI ≥ 1month
* Confirmed orthostatic hypotension
* Stable medical, physical and psychological condition as considered by the investigators
* Able to understand and interact with the study team in Dutch or English
* Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments
* In case participants need continuous support from a personal caregiver in daily life, then the presence of their caregiver during the visits to the study site is needed, including independent transport (not dependent on a cab)

Exclusion Criteria:

* Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
* Diseases and conditions that would require regular MRI
* The inability to perform an MRI due to metal, magnetic or electrical device in the body (e.g. oral implant with magnet, mtal splinter, neurostimulator, artificial heart valve, clips, stents...) as assessed by the MRI form of Sint Maartenskliniek
* The inability to withhold antiplatelet/anticoagulation agents perioperatively
* History of myocardial infarction or cerebrovascular event within the past 6 months
* Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
* Clinically significant mental illness in the judgement of the investigators
* Botulinum toxin non-vesical and vesical injections in the previous 3 months before the enrolment
* Presence of significant pressure ulcers
* Recurrent urinary tract infection refractory to antibiotics
* Presence of indwelling baclofen (e.g. intrathecal baclofen pump) or insulin pump
* Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding
* Lack of safe contraception for women of childbearing capacity
* Intention to become pregnant during the course of the study,
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Enrolment of the investigator, his/her family members, employees, and other dependent persons
Oral Low-molecular Weight Hyaluronic Acid in the Treatment of Atrophic Vaginitis

To evaluate the effectiveness of low molecular weight hyaluronic acid oral tablets for the treatment of atrophic vaginitis.


Eligibility Criteria:
Inclusion Criteria:

* at least 12 months postmenopausal
* mucosal atrophy and the main bothersome related symptoms, such as itching, burning, and dyspareunia.
Pain Assessment and Transcranial Magnetic Stimulation Tolerability in Patients With a Functional Neurological Disorder

Functional neurological disorders (FND) are motor, sensory or cognitive symptoms without an identified lesion. This is a very common reason for consultation in neurology. Transcranial magnetic stimulation (TMS) may be performed in these patients both for diagnostic purposes (in the context of motor evoked potentials) and for therapeutic purposes. The main objective of the study is to evaluate tolerability of TMS in patients with FND, in particular the pain caused by stimulation and the possible modification of painful or non-painful symptoms generated by this TMS. The secondary objectives are to assess chronic pain symptoms of these patients quantitatively and qualitatively, to assess expectations of these patients with regard to the performed examinations and to assess their expectations regarding magnetic stimulation performed for therapeutic purposes.

The investigators have therefore developped a questionnaire that will be submitted to all consecutive patients who meet the inclusion criteria and who have given their consent to participate. This questionnaire will be performed in three phases: 1) a few minutes before the realization of evoked potentials and TMS 2) 10 minutes after evoked potentials and TMS 3) two weeks after evoked potentials and TMS (by telephone).

The data collected will be:

- Phase 1 (a few minutes before the explorations): Quantitative assessment of pain Brief Pain inventory Characteristics of pain Analgesic treatments already received and respective efficacy Expectation for diagnostic tests (confirmation/exclusion of diagnosis, ...) Expectation for TMS performed for therapeutic purposes (partial/complete recovery, motor/pain symptoms, ...)

- Phase 2 (10 minutes after diagnostic explorations and therapeutic TMS): Quantification of pain generated by TMS Quantification of discomfort generated by TMS Change in pain symptoms after TMS Change in motor, sensory or cognitive symptoms after TMS Other side effects of TMS

- Phase 3 (two weeks after TMS, by telephone): Quantitative assessment of pain Brief Pain inventory Quantification of pain generated by TMS Quantification of discomfort generated by TMS Change in pain symptoms after TMS Change in motor, sensory or cognitive symptoms after TMS Other side effects of TMS

Eligibility Criteria:
Inclusion Criteria:

* Patient referred to Avicenne hospital to explore a suspected functional neurological disorder
* Patient able to complete the questionnaire

Exclusion Criteria:

- Lack of consent
Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients

Immobilization and bed rest of patients in intensive care units (ICU) increases their risk for muscle dysfunction and prolonged mechanical ventilation, leading to physical deconditioning and loss of functionality. Active mobilization is a therapeutic strategy that typically involves exercises in which the patient uses his or her own strength and muscular control, is a feasible, safe, and low-cost intervention to improve muscle dysfunction and disability in patients at the ICU. Despite scientific advances, the current description and prescriptions of exercises at the ICU remain incomplete with respect to the control and the description of the variables of training load (volume and intensity), programming, and progression.

This prospective double-blind (patient and evaluator). This study will be conducted in accordance with Consolidated Standards of Reporting Trials recommendations. The trial will be performed at the University Hospital Professor Edgard Santos in Salvador, Bahia, Brazil. This study was approved by the institutional hospital ethics committee (approval reference number 2.371.933). Before enrollment, written informed consent will be obtained from participants or their legal guardians.

Eligibility Criteria:
Inclusion Criteria:

* Being able to roll in the bed and bridge.
* Barthel score of at least 70 weeks before admission to the ICU
* Ability to interact with the researcher

Exclusion Criteria:

* Mortality rate in excess of 50% according to Acute Physiology and Chronic Health Disease Classification System II (APACHEII)
* Present intracranial pressure increase
* Cardiorespiratory arrest,
* Has unstable fractures that hamper progression in levels of mobilization,
* Severe lower limb injury or amputation
* Neuromuscular disease
* Underwent radiotherapy and / or chemotherapy in the last 6 months.
ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia

Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia

As a newly marketed sedative hypnotic agent, fospropofol disodium is currently the only water-soluble precursor drug of propofol in China. It has the characteristics of long duration of action, low incidence of injection pain, respiratory and circulatory system related adverse events, and no lipid metabolism related adverse reactions, providing anesthesiologists with another sedative option during surgery. However, there are currently few clinical observation studies on this drug, and there have been no reports on its effective dosage in different age groups. Therefore, this study aims to observe the 90% effective dose (ED90) in anesthesia induction and maintenance in adults of different ages, providing effective clinical evidence for its application in clinical anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80 years old, elective surgery under general anesthesia.
* ASA I-II;
* Surgical duration\>30 minutes;
* Sign an informed consent form.

Exclusion Criteria:

* American Society of Anesthesiologists(ASA)≥ III;
* Body mass index (BMI)\<18 kg/m2 or\>30 kg/m2;
* Individuals with a history or potential history of drug abuse or alcohol dependence;
* Preoperative use of sedative or analgesic drugs;
* Individuals with severe liver and kidney dysfunction;
* Individuals who are allergic or potentially allergic to propofol and lipids;
* The types of surgeries that directly affect hemodynamics, such as large vessel surgery and other surgical procedures;
* Patients with abnormal coagulation function, endocrine disorders, or other factors affecting hemodynamic status;
* Participants in other clinical studies within the past 3 months;
* researchers deemed it inappropriate for participants to participate in this study.
Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest

This is an open label study in which eligible IPF subjects who are using supplemental oxygen at rest will receive GBT440 orally daily.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of IPF.
* Receiving supplemental oxygen for use at rest.
* Weight ≥ 40 kg.
* Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 30 days after the last dose of study drug.

Exclusion Criteria:

* FEV1/FVC \< 70%
* History of other interstitial lung diseases.
* Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening.
* Corticosteroid (\> 10 mg per day of prednisone or an equivalent) administered for 7 days or longer, within 30 days of screening.
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device).
* Female who is breast-feeding or pregnant
* Current smoker or history of smoking within 3 months from screening