cyrilzakka/clinical-trials huggingface dataset:
Cortisol Levels on Menopausal Symptoms - Ancillary (Addendum) Study to Protocol 16997

This is an ancillary study to Protocol 16997 to examine the stress hormone level in women with menopausal symptoms. This ancillary project will collect additional data from the 45 subjects enrolled in Protocol 16997 (no subjects have enrolled in Protocol 16997 so far). This study protocol differs from the main protocol (16997) because it will include an ACTH (Hormone) Stimulation Test which will assess the functioning of stress response in the subjects at entry and exit.

Subjects will undergo the ACTH test for this ancillary protocol in the morning when they complete 24-hour urine collection for Protocol 16997. The ACTH (Hormone) Stimulation Test will not be done in the main protocol 16997. During the ACTH test an IV will be placed in subjects arms, 25mL of blood will be drawn at -30 minutes and 6mL of blood will be drawn at -15 minutes and 0 minutes respectively. Following, 0.25mg of ACTH will be injected intravenous over 60 seconds, and a final 12mL of blood will be drawn 60 minutes later. That is, a total of 50mL of blood will be drawn to test serum blood hormone levels from the subjects during the ACTH (Hormone) Stimulation Test.

The 24 hour cortisol data collected in the main protocol 16997 will be used for this study analysis.

When subjects are consented for Protocol 16997, they will also be consented for this ancillary study. In addition to the consent visit, subjects will have two study specific visits (entry and exit) for this ancillary study. The PI will schedule the specific visits for this study to be in conjunction with those scheduled for Protocol 16997.

There is no collaborations with other sites in the ancillary study.


Eligibility Criteria:
Inclusion Criteria:

1. Women with menopausal VMS bothersome enough to warrant treatment;
2. Minimum of 7 hot flashes per day (on average);
3. Age limits: women ages 40-70 who have had at least one missed menstrual cycle or have undergone spontaneous menopause, women of any age who have medically induced menopause, women of any age who have had oophorectomy;
4. Informed written consent;
5. Ability to follow treatment protocols.

Exclusion Criteria:

Exclusion Criteria (cohort)

1. Concomitant illness with reasonable likelihood of limiting survival to less than one year;
2. Current substance abuse (alcohol or drug);
3. Pregnancy known, suspected or planned in next year.

Exclusion Criteria (TA intervention)

1. Other concomitant menopause treatment;
2. Participating in acupuncture treatment or formal psychological stress management program within the last year;
3. Participating in another treatment for VMS, unless willing to stop it 4 weeks in advance of participation;
4. HIV infection, chronic or active hepatitis or other blood-borne illness.
Somatuline Autogel Preference and Health Economy Study

The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer - self/partner administrations or healthcare provided administrations. The study will also assess if self/partner administration can be performed without loss of efficacy and with a preserved safety profile. The impact of self/partner administration on resource utilisation and costs will be studied. In addition, we will also assess the healthcare provider's experience of the two administration practices.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent from the patient and their partner (if the partner will be administering the lanreotide Autogel injections during the self administration period)
* Male or female aged 18 years of age or older
* Treated with lanreotide Autogel 90 or 120 mg every 28th day for carcinoid symptoms on a stable dose for at least 3 months prior to inclusion. The patient is presumed to be clinically stable during the coming months
* Neuroendocrine tumour confirmed by biopsy and visible on radiology

Exclusion Criteria:

* Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure
* Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study
* Has a life expectancy less than a year, as judged by the Investigator
* The patient or their partner is not considered competent in injection technique, as judged by the Investigator
Pain Catastrophizing and Routine Assessment of Patient Index Data 3(RAPID3) in Ten Categories of Rheumatology Outpatients

Fulfilling by all patients consequently seen by 6 rheumatologists in a same outpatient rheumatology clinic (in at least one month period) of a set of 6 questionnaires, including RAPID3 and pain catastrophizing scales.

Fulfilling by all patients (seen by 6 rheumatologists in a same outpatient rheumatology clinic from a university French hospital in at least one month period) of a set of 6 questionnaires including a RAPID3 score (Routine Assessment of Patient Index Data 3) and pain catastrophizing scale, as well as Pain detect and Hospital Anxiety and Depression scale questionnaires (HAD) , in ten predefined categories of disorders: rheumatoid arthritis; any spondyloarthritis; other inflammatory rheumatisms or systemic disorders; osteoarthritis of the upper part of the body; osteoarthritis of the lower part of the body; back pain and/or radiculalgia; bone disorders, including osteoporosis; tendinosis and other soft tissue conditions; peripheral neuropathy, including entrapment neuropathies; fibromyalgia and related conditions.

Eligibility Criteria:
Inclusion Criteria:

* any outpatient aged 18 or more, agreeing to fulfil the set of 6 questionnaires
* Man or woman coming to the Rheumatology Department of the Nantes University Hospital with a senior rheumatologist

Exclusion Criteria:

* Patients not fluent enough in French or suffering from neurological or psychological disorders making their responses unreliable
CLCF1 Gene Associated With Postmenopausal Osteoporosis of Kidney Yin Deficiency Syndrome

For nearly 112 million patients with osteoporosis in China, it is of great significance for preventing and treating by clearly understanding the molecular mechanism of kidney deficiency. Thus, the research group has demonstrated in the earlier research that CLCF1 is an associated gene that can regulate JAK2/STAT3 signal pathway and impact bone metabolism for kidney yin deficiency of postmenopausal osteoporosis (PMOP). To make clear understanding of the direct-acting mechanism of CLCF1 for bone metabolism, this study intends to: ①observe impacts of low expression of CLCF1 upon immunities in mice and OPG/RANKL/RANK signal system using the technology of adenovirus associated virus. ②explore impacts of over-expression and silencing of CLCF1 on B lymphocytes by culcuturing the cells together with osteoblasts. ③ analyze the impacts of treating kidney yin deficiency of PMOP by Liuwei Dihuang pill upon immunities and OPG/RANKL/RANK system, and discuss the mechanism of regulating bone metabolism by CLCF1 by OPG/RANKL/RANK system via the bridge between immune system and bone metabolism, so as to demonstrate if the hypothesis of this study that "the molecular osteoimmunological mechanism of kidney yin deficiency of postmenopausal osteoporosis (PMOP) is possibly closely related to the impacts of CLCF1 regulation of OPG/RANKL/RANK signal system on bone metabolism" is right or not.


Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they were female Han Chinese patients who had undergone natural menopause at least 2 years prior and

  * met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis"
  * met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine"
  * provided informed consent, which was approved by the Fujian Academy of Traditional Chinese Medicine Clinical Research Ethics Committee

Exclusion Criteria:

* patients who did not meet the diagnostic criteria for osteoporosis or CM standards
* patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases
* patients with abnormal liver and/or Shen function test results
* patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.
Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder

This is a randomized, double blind, placebo controlled, multi-center study to evaluate the effects of NMRA-335140 (formerly BTRX 335140) on symptoms of depression in participants with Major Depressive Disorder (MDD). The study design consists of a Screening Period (up to 28 days), and a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo). At the completion of the 6-week Treatment Period, participants who complete the study, provide informed consent, and meet the eligibility criteria may enter an extension study (NMRA-335140 501).


Eligibility Criteria:
Key inclusion criteria:

* Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening (this may be a first or recurrent episode).
* Participant's current major depressive episode must be confirmed by independent assessment.
* The symptoms of the current MDD episode have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit.
* Have a MADRS total score of 25 or higher at Screening and Baseline.
* A change in MADRS total score between Screening and Baseline of ≤20%.

Key exclusion criteria:

* Have failed 2 or more courses of antidepressant treatment at sufficient doses for at least 6 to 8 weeks for the current MDD episode.
* Currently or in the past year have been diagnosed with a personality disorder per the DSM-5-TR or in the past 3 years have been diagnosed with any of the following DSM-5-TR disorders: anorexia nervosa, bulimia nervosa, or binge eating disorder. Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, or panic disorder for whom MDD is considered the primary diagnosis are not excluded.
* Have a lifetime diagnosis of bipolar 1 or 2, schizophrenia, schizoaffective, schizophreniform, obsessive compulsive disorder, or posttraumatic stress disorder (PTSD).
* Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine).
* Are actively suicidal (e.g., any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C SSRS) (score of "YES" on suicidal ideation Item 4 or 5 within 3 months prior to Visit 1 \[screening\]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator. Participants who are currently hospitalized for MDD symptoms or suicidality are not allowed into the study. If there is a recent history (within 3 months of screening) of hospitalization due to MDD symptoms, the participant should be discussed with the Medical Monitor for eligibility.
Use of suPAR Algorithm for the ED Decision Making

Will the use of a clinical decision algorithm in the ED improve discharge or admission decisions.

Background Crowding and readmissions are common challenges in Emergency departments across Europe. The decision whether to admit or discharge the patient is challenging and is often based on clinical signs and symptoms e.g. blood pressure, pulse, respiratory rate, oxygen saturation and temperature. But some patients are unnecessarily admitted and may have been better off if sent home. Other patients may be discharged without - and one out of five patients are readmitted within a month raising the question whether the patient should have been admitted at first presentation in the ED. suPAR is a strong prognostic biomarker measured routinely in acute medical patients in some emergency department (ED) settings.suPAR is a broadly applicable biomarker of risk, and it has been developed an algorithm for simple interpretation of suPAR in clinical decisions for the study.

Objective To evaluate the use of a clinical decision algorithm in the ED with the aim of improving discharge or admission decisions.

Eligibility Criteria:
Inclusion Criteria:

* All patients above 18 years
* who are having blood taken for biochemical analysis when attending the ED

Exclusion Criteria:

* Acute medical patients that do not have blood drawn for routine biochemical testing.
* Pregnant
* Under 18 years old
* Terminally ill patients.
Immune Tolerance Induction in Haemophilia A Patients Using Wilate or Nuwiq

Uncontrolled, multi-centre, non-interventional study with a prospective and a retrospective cohort, to evaluate the efficacy of Wilate or Nuwiq in achieving complete or partial immune tolerance induction (ITI) success in severe and moderate haemophilia A patients with inhibitors


Eligibility Criteria:
Inclusion Criteria:

* Male patients of any age with moderate or severe haemophilia A.
* Patients with a first occurrence of inhibitors, inhibitors refractory to previous ITI attempt(s), or relapsed inhibitors to FVIII, with an inhibitor titre of ≥0.6 BU measured on 2 separate occasions at least 2 weeks apart.
* Informed written consent from the patient and/or the patient's parent(s) or legal guardian(s)

For patients in the prospective cohort:

* Patients who are currently on Wilate or Nuwiq ITI, have just initiated ITI, or are planned to initiate ITI treatment with Wilate or Nuwiq.

For patients in the retrospective cohort:

* Patients having received Wilate or Nuwiq ITI before entry into this study. Retrospective data will be collected for a maximum of 3 years before enrolment into the study. To be eligible, the following information is needed:
* Wilate or Nuwiq treatment details (start date, dose, treatment frequency, and dose change).
* Reliably documented bleeding frequency.
* FVIII inhibitor titres.
* FVIII half-life.
* FVIII IVR.

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

* Congenital or acquired bleeding disorders other than haemophilia A.
* A history of hypersensitivity to blood products and/or plasma-derived FVIII concentrates.
* Inability to speak/read English or French well enough to provide consent and adhere to the study.
* People who are receiving other non-factor therapies, e.g. concizumab
Surveillance HeartCare® Outcomes Registry

This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.

HeartCare is a service which includes AlloMap® and AlloSure-Heart® to provide information to help clinicians to more comprehensively monitor heart transplant recipients for allograft rejection. An approach to surveillance using HeartCare provides information from two complementary measures; AlloMap is a gene-expression profile based measure of host immune activity and risk of acute rejection. AlloSure-Heart monitors graft injury. AlloMap is the first FDA cleared test and is the only non-invasive, blood test method recommended in the International Society for Heart and Lung Transplantation (ISHLT) guidelines for surveillance of heart transplant recipients for rejection. AlloSure-Heart measures donor-derived cell-free DNA (dd-cfDNA) to help discriminate acute cellular rejection and antibody-mediated rejection from no rejection. Patients who receive HeartCare, as part of their post-transplant management, will give informed consent for information on their outcomes and other relevant clinical information, found in their medical records, to be entered into a SHORE database for purposes of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are 15 years of age or older at the time of blood draw.
2. Received a heart transplant (primary or repeat)
3. Patients who have HeartCare initiated within 3 months post-transplant

Exclusion Criteria:

1. Patients who are pregnant at the time of blood draw.
Measuring Depth of Unconsciousness at the End of Life Using Bispectral Index (BIS)

The purpose of this study is to use the BIS monitor to assess the degree of consciousness in pre-terminal palliative patients admitted to our palliative care unit and to ascertain if this tool provides a more accurate assessment of consciousness in this specific group of patients than clinical observation of consciousness and the use of sedation scales.

We hypothesize that the measured BIS results provide a more accurate assessment of the patient's level of consciousness than routine clinical observation or the use of sedation scales.


Eligibility Criteria:
Inclusion Criteria:

* Pre-terminal palliative patients with a life expectancy of 72 hours or less at the start of the observation.

Exclusion Criteria:

* lack of consent of patient or representative
Supervised Manual Physical Therapy Exercise for Ankle Disability After Motor Vehicle Accidents.

Every year more than 50 million people worldwide are injured due to RTAs which in turn makes it one of the leading causes of disability. During automobile collisions, the lower limbs are the most commonly injured region of the human body. Ankle injuries can be particularly long-lasting, resulting in excessive medical costs, inability to work, and serious psychological distress. Physiotherapists often contribute to the rehabilitation of ankle fractures, which typically starts soon after the period of immobilization. Joint mobilization led to increased ankle movement, improved gait patterns, reduced pain and the number of treatment sessions required, and hastened return to activities when compared with the usual rest, ice, compression, and elevation protocol.

Participants will be assigned into two groups:

1. Study group will receive a Supervised physical therapy exercise program in the form of Mobilization exercise, Stretching exercise, and Strengthening exercise.
2. Control group will receive a Home-based exercise program of Stretching exercises, strengthening exercises and ROM exercises.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Stable ankle fractures after motor vehicle accidents involving the distal tibia, distal fibula, or talus treated with cast immobilization, with the removed cast in the preceding seven days.
* Approval from the orthopedic specialist to weight-bear as tolerated or partial weight-bear. -- Their ages will be between the age of 18 to 50 years of age.
* Participants having no concurrent injuries or pathology, such as neurological injury or other fractures.

Exclusion Criteria:

* Patients with surgical fixation,
* Fracture malunion or nonunion,
* Syndesmosis injury, or any standard contraindication to manual physical therapy.
Immune Thrombocytopenia (ITP) Immune-Genetic Assessment

Primary ITP has wide heterogenous biology, presentation and response to therapy.

The immune-genetic assessment of ITP may help to identify differences among patients with ITP and optimize the therapeutic choice.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with primary ITP

Exclusion Criteria:

* Secondary ITP
Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Eligibility Criteria:
Inclusion Criteria:

* Speak, read and understand English or Spanish;
* Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
* One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
* Menstrual cycle lasting from 24 to 36 days;
* History of excessive menstrual bleeding;
* Negative urine pregnancy test at screening.

Exclusion Criteria:

* Six months or more (immediately prior to Screening Visit) without a menstrual period;
* Prior hysterectomy;
* Prior bilateral oophorectomy;
* Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
* Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
* Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
* Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
* Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.