cyrilzakka/clinical-trials huggingface dataset:
Glycemic Control, Type II Diabetes, Parathyroidectomy

The purpose of this study is to assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus.

Primary hyperparathyroidism (PHPT) is known to affect the kidney and skeletal system, however, recent data have suggested that patients can also exhibit an increased cardiovascular risk and metabolic abnormalities Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia, with an estimated prevalence of 0.8% in the general population. Type 2 diabetes mellitus (DM) is the most prevalent chronic disease with an estimated prevalence of 10%. Based on the estimated prevalence of this two conditions, we would expect a comorbid prevalence of both diseases in the same individual of approximately 0.08%. However, the prevalence of DM in patients with PHPT is much higher ranging from anywhere 7.8% to 22%, suggesting that this is not mere coincidence.

While the exact mechanism is not clear, in vivo study demonstrated that parathyroid hormone (PTH) reduces the insulin-stimulated uptake as well as decrease glucose transporter and the insulin receptor. Hypercalcemia can also be associated with impaired insulin sensitivity and insufficient suppression of gluconeogenesis. In some patient series, some improvement in glycemic profiles have been shown in patients after parathyroidectomy (PTX).

In addition, both DM and PHPT are known risk factors for the development of bone abnormality patients with DM have increased risk of hip fractures while cortical bone (i.e. the forearm) are more commonly affected in patients with PHPT. There are currently very few studies evaluating the interaction of both conditions in terms of patient skeletal profiles and bone health.

Participants with PHPT and DM will be recruited and followed over the course of a year. There are two groups: the group of patients that decided to pursue a parathyroidectomy, and a group of patients that will be managed non-surgically. Clinical data will be collected along with blood tests.

Eligibility Criteria:
Inclusion Criteria:

1. Study group: Consecutive patients older than 18 years old with concomitant PHPT and DM who will undergo PTX. The indications and need for surgery will be independent from the research team.
2. Control group: Consecutive patients older than 18 years old with concomitant PHPT and DM who will not undergo PTX. The indications to forgo surgery will be independent from the research team.

Exclusion Criteria:

1. Patients with recurrent or persistent PHPT will not be included.
2. Patients who are included but have evidence of recurrent or persistent PHPT based on six-month laboratory workup will be excluded from the final analysis (\<5% expected)9.
3. Patients with type 1 diabetes mellitus
4. Patients with secondary and/or tertiary hyperparathyroidism
Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People

This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute therapy appointments during pregnancy, and four 30-minute therapy appointments at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll (early second trimester-mid third trimester). Compensation is provided.

Medication for opioid use disorder (MOUD) can effectively prevent overdose and death for pregnant and postpartum people with opioid use disorder (OUD). Yet, only half of birthing people continue to use MOUD postpartum, increasing risk for overdose two-fold. This study will evaluate acceptability of a technology-enhanced behavioral intervention that aims to improve retention in and adherence to MOUD during the peripartum period. The intervention contains a brief behavioral intervention targeting malleable risk factors for treatment dropout, opioid cravings, and return to illicit opioid use: anxiety sensitivity and sleep deficiency. An adjunctive mobile application will supplement therapy sessions and contains a medication adherence feature involving daily (or multiple/day) notification reminder to take medication at a scheduled time and dose consistent with the participant's prescription.

Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant and less than 33 weeks gestational age,
* History of OUD within past 3 years,
* Confirmed prescription for sublingual buprenorphine products (i.e., Suboxone, Subutex, Zubsolv) for the purpose of treating OUD,
* Living in the United States,
* Between 18-45 years of age.

Exclusion Criteria:

* Carrying multiples (i.e., twins, triplets, etc.);
* High-risk pregnancies including the following conditions: hyperemesis defined as hospitalization for intractable nausea and vomiting, hypertensive disorders of pregnancy (e.g., gestational hypertension, preeclampsia), placenta previa, or vaginal bleeding in current pregnancy after the first trimester;
* Current psychotic symptoms and/or active suicidal intent;
* Experiencing cognitive or emotional impairment that precludes providing informed consent;
* Incarcerated/pending incarceration or institutionalized during the study period.
Identifying Prognostic Variables for Persistent UL Dysfunctions After Breast Cancer Treatment -Reliability and Validity

Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment.

The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment.

This study aims to find reliable and valid assessment methods for the prognostic factors and upper limb function itself in a small group of BCS and healthy volunteers.


Eligibility Criteria:
Inclusion Criteria for breast cancer patients

* Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer.
* Patients who receive adjuvant radiotherapy .
* Patients with a cognitive and language functioning enabling coherent Dutch communication between the examiner and the participant
* Patients who can comply with the protocol at baseline assessment and willing to provide written informed consent

Inclusion criteria healthy volunteers

* Healthy women and men(quickDASH\<15) age- and gender-matched with a breast cancer patient from the main study
* Volunteers who can comply with the protocol at baseline assessment and willing to provide written informed consent

Exclusion Criteria breast cancer patients

* BCS with widespread distance metastases, previous breast surgery, or planned bilateral surgery
* And/or with a diagnosis of a neurological or rheumatological condition, diabetes,
* And/or BCS who are not available the entire duration of the study

Exclusion Criteria healthy volunteers

* History of breast cancer
* Patients with a diagnosis of neurological or rheumatological condition, diabetes
New Retinoid Agent Combined With Arsenic Trioxide for Untreated Acute Promyelocytic Leukemia

The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.

The primary objectives of this study are in newly diagnosed APL patients:

* To evaluate the efficacy (complete and molecular response rates) and toxicity of NRX 195183 in induction therapy
* To evaluate the efficacy (molecular response rates) and toxicity of NRX 195183 in combination with arsenic trioxide (As2O3) in consolidation therapy.
* To evaluate the efficacy (event free-survival, disease-free survival) and toxicity of NRX 195183 as maintenance therapy for patients with APL who achieve a molecular complete response.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis Patients must have a clinical diagnosis of acute promyelocytic leukemia (APL) morphology or FAB M3 variant confirmed by RT-PCR assay for PML-RARα or chromosome analysis/FISH showing t(15:17) translocation. A patient may be entered prior to confirmatory studies, but a patient who is subsequently found to be PML-RARα negative will be removed from protocol treatment.
* Prior Treatment The patient must not have received any systemic definitive treatment for APL, including cytotoxic chemotherapy, retinoids or arsenic trioxide. Prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient.
* Age: Patients must be of age eighteen (18) or above.
* Other Criteria

  * Patients must have the following laboratory values:

    * Bilirubin equal or less than 1.5 times the upper limit of normal.
    * Creatinine equal or less than 1.5 times the upper limit of normal
* Pregnancy / Nursing Status

  * Patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. Treatment under this protocol would expose an unborn child to significant risks. treatment. Women and men of reproductive potential should agree to use an effective means of birth control. There is an extremely high risk of fetal malformation if pregnancy occurs while on treatment in any amount with retinoid drugs even for short periods.

Exclusion Criteria:

* Non-APL, AML patients should be excluded from the study.
* Other serious illnesses which would limit survival to 1 year.
* Psychiatric conditions which would prevent compliance with treatment or informed consent.
* Uncontrolled or severe cardiovascular disease. This would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
* AIDS or HIV positive patients, although HIV test is not required for accrual.
A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants

The purpose of this study is to evaluate the safety, tolerability, and PK of single and multiple ascending doses of VX-840 in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Female participants must be of non-childbearing potential
* Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2)
* A total body weight greater than (\>) 50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
Physicians Work Distribution in a Danish Emergency Department

physicians in the Emergency Department spend their time on interviewing and examining patients, file documentation, communication with colleagues about the patients.

Introduction of IT technology aims to reduce the administrative workload. However it is the impression that more and more time are used behind the PC rather than at the side of the patient.

The aim of this study is to describe how the time is distributed between different task for an ED physician, and to analyse whether there are differences in time distribution if the physician is working in the outpatient area versus admission area of the ED.


Eligibility Criteria:
Inclusion Criteria:

ED physicians employed in the ED department

Exclusion Criteria:

-
Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma

The purpose of this study is to evaluate the efficacy and safety of Oncolytic Adenovirus(H101) combined with PD-1 inhibitor in patients with advanced malignant pleural mesothelioma who have previously been resistant to advanced PD-1 inhibitors.

By monitoring the clinical symptoms of patients with advanced immune resistant pleural mesothelioma treated with adenovirus injection combined with programmed death receptor (PD-1) inhibitors, we analyze and explore the effectiveness and safety of using oncolytic virus drugs. Exploring the influencing factors of using oncolytic adenovirus injection combined with PD-1 inhibitors to reverse immune resistance in MPM patients. Evaluate the safety of the drug, and finally evaluate the quality of life of patients using oncolytic adenovirus injection(H101) combined with PD-1 inhibitors.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old (including boundary values), regardless of gender.
2. Confirmed as late stage MPM patients who have failed immunotherapy.
3. The patient or their legal representative can understand and sign the informed consent form.
4. At least one lesion that can safely undergo intratumoral injection or intrapleural injection of oncolytic adenovirus as the target lesion, with a diameter of spiral CT ≥ 1cm or ordinary CT ≥ 2cm, and can be measured through imaging methods.
5. ECOG score 0-2.

Exclusion Criteria:

1. Physicians participating in the study believe that patients may not be able to provide continuous follow-up information.
2. Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases).
3. Contraindications to relevant drugs (such as oncolytic adenoviruses, PD-1 inhibitors, etc.)
Everolimus Related Pneumonitis in MBC

To study the drug-related pneumonitis during mTOR inhibitor therapy in patients with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal woman (or premenopausal women treated with LHRHa) diagnosed with HR+，HER2- metastatic breast cancer
2. Treated with everolimus for at least one month in metastatic setting
3. With baseline and at least one follow-up chest CT during everolimus therapy.
4. Complete medical history

Exclusion Criteria:

1. Incomplete medical history
2. Radiographic imaging unavailable
An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.


Eligibility Criteria:
Inclusion Criteria:

* The patient has completed the previous CLDT600A2407 study and is able to immediately enter this extension study with no study drug discontinuation
* Patient is willing and able to comply with the study drug regimen and all other study requirements
* The patient is willing and able to provide written informed consent to participate in the extension study.

Exclusion Criteria:

* Patient is pregnant or breastfeeding.
* Patient is co-infected with HCV, HDV, or HIV.
* History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply.
The Effects of PFMT and MPE in Elderly Women With SUI.

The aim of the study was to compare the effects of PFMT and MPE on SUI frequency and explosure from symptoms, PFM activation response and strength of lumbar stabilizing muscle in elderly women with SUI.

Stress Urinary Incontinence (SUI) is associated with situations which bladder pressure exceeds the pressure at which the urethra has the capacity to remain closed, such as physical exertion, coughing, and sneezing. SUI is more predominant in women worldwide, with a prevalence ranging from 10% in young women to 45% in the elderly. Physiotherapy interventions in SUI include patient education including recommendations for bladder and/or bowel training, fluid management, and diet modification; modalities for decrease pain; pelvic floor muscle training (PFMT) with or without biofeedback and/or electrical stimulation to improve strength and coordination of the pelvic floor muscle (PFM) and stabilization exercises to improve strength of abdominal and/or lumbar stabilizer muscles.

PFMT includes repetitive contraction of the PFM, which increases perineal support and improves the muscle tone of the PFM. Modified pilates exercises (MPE) is a mind-body approach that includes slow, controlled movements that focus on posture and breathing.

The aim of the study was to compare the effects of PFMT and MPE on SUI frequency and explosure from symptoms, PFM activation response and strength of lumbar stabilizing muscle in elderly women with SUI. In this study, thirty-four elderly women who were diagnosed with SUI were randomized into Group 1: PFMT (n=17) or Group 2: MPE (n=17). Both groups performed their exercises twice a week for 12 weeks and accompanied by a physiotherapist. Incontinence Severity Index (ISI), Urogenital Distress Inventory-Short Form (UDI-6) and Incontinence Impact Questionnaire-Short Form (IIQ-7) were used to assess SUI frequency and explosure from symptoms, electromyography (EMG) device was used to assess PFM activation response and a stabilizer was used to assess strength of lumbar stabilizing muscle. The assessments were performed at baseline and after 12 week treatment. The effect size was calculated for the assessments used in the study.

Eligibility Criteria:
Inclusion Criteria:

1. being volunteer to participate in a study;
2. being a woman over the age of 65;
3. having the diagnosis of SUI;
4. participants who scored at least 24 on the Mini Mental State Exam (MMSE).

Exclusion Criteria:

1. having a neurological disease;
2. having PFM which cannot contract;
3. having a urinary tract infection;
4. having the stage two or higher pelvic organ prolapse; and
5. participants who received a SUI treatment in the recent year.
Understanding Evaluation of Patient Information Sheets by User Testing Method

The purpose of this randomized, open label, crossover, single site study is to compare the PISs of two Multiple Sclerosis clinical trials to elucidate potential aspects of the given written information that could impact on the smooth running of the studies.

The participation to a clinical trial is based on two forms of information: the spoken information, usually given by a clinician during the enrolment meeting, and the written information, reported on the Participant Information Sheet (PIS). Numerous studies performed to improve and enhance informed consent, have used different methods to evaluate the quality of the given information such as: interview, checklist, questionnaire, readability formulae. Even if these tools can be useful, they show evident limits in detecting the real efficacy of the proposed consent form in terms of the patient's comprehension.

User Testing (UT) is a method originally developed in the 1990 in Australia, to assess how a text about medicinal products performs with its intended users and not just its content.

Generally, the UT is based on an iterative 4-step process in a cohort of participants (the target group):

* individual reading of the text;
* individual questionnaire for a quantitative and qualitative evaluation;
* a brief semi-structured interview to each participant;
* a text revision to address any problems identified from participant feedback; Then the revised document is tested again with a second cohort and this iterative process continues until all issues with the document are resolved. However, a methodological issue not yet explored is whether the UT could be used to compare two different PISs, in order to elucidate aspects that could be involved in improving or worsening the understanding of a PIS.

UT has been recently used to evaluate the PIS belonging to phase I and phase III clinical trials (CT) in Myeloid Leukemia, immunomodulatory therapy and for poor responders in vitro fertilization. To date, in no case the UT method has been tested in patients affected by chronic disease like Multiple Sclerosis (MS).

We want to apply the UT approach to highlight the critical issues and communication difficulties present in PISs used in MS clinical trials.

Eligibility Criteria:
Inclusion Criteria: PwMS (60%) and Caregivers (40%):

for PwMS:

* 18 years or older;
* MS diagnosis according to McDonald criteria;
* Informed consent to the present study for caregivers:
* 18 years or older;
* in being a person who takes care of a PwMS;
* Informed consent to the present study

Exclusion Criteria:

- not having taken part in one of the following trials evaluated in the present study: A) Observational Study of the Prevalence of CCSVI in Multiple Sclerosis and in Other Neurodegenerative Diseases (PIS-A); B) BRAin VEnous DRainage Exploited Against Multiple Sclerosis (PIS-B).
Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116

This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female postmenopausal subjects
* Age: 45 to 65 years (inclusive)
* Body mass index (BMI) : ≥18 and ≤30 kg/m²
* Non-smoker for 3 months (former smokers who quit smoking \>3 months before the first study drug administration may be included)

Exclusion Criteria:

* Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion,and effect of the study drugs will not be normal
* Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (occasional use of paracetamol or ibuprofen is permissible)
* Any severe disease within the last 4 weeks prior to the first study drug administration
* History of orthostatic hypotension, fainting spells, blackouts
* Any malignant tumor and history thereof
* Any other medical condition which, at the discretion of the investigator, would make study participation unadvisable
* Any clinically relevant finding at the physical- and gynecological examinations
* Allergy, hypersensitivity, or non-allergic drug reactions to any excipient of the IMP or reference/interaction product
* Regular alcohol consumption equivalent to \>20 g alcohol per day
* Urine screen positive for any drug or cotinine