cyrilzakka/clinical-trials huggingface dataset:
Assessment of Maximal Oxygen Uptake in Cardiac Rehabilitation

To advance the methodology for evaluating persons with heart disease and their maximal oxygen uptake, the primary aim of this study is to investigate the occurrence of a plateau in oxygen uptake. This plateau will be examined for the purpose of assessing VO2 max in persons enrolled in exercise-based cardiac rehabilitation. Furthermore, this study aims to investigate the age-related respiratory exchange ratio, and rating of perceived exertion, and describe their association with the presence of a plateau.

Heart disease and characteristics for all participants are obtained. Participants underwent a maximal exercise test on an ergometer cycle with direct measurement of oxygen uptake to assess oxygen plateau attainment. This included measurement of the maximal oxygen uptake, respiratory exchange ratio, heart rate and the ratio of perceived exertion (BORG6-20).

Oxygen uptake is measured breath-by-breath by a cardiopulmonary exercise test (CPET), and oxygen and carbon dioxide sensors were calibrated before each test along with the flow sensor, there was calibrated with a 3-litre syringe.

To examine the primary aim, the incidence of a plateau in oxygen uptake was examined by comparing the moving average of the last 15 consecutive breaths with the penultimate 15 breaths and cut-offs at \<50 ml and \<100 ml of oxygen.

Secondary criteria; Respiratory exchange ratio (RER max), Rating of perceived exertion (BORG RPE max) and heart rate (HR max) are examined to determine if the participant performs the exercise test with a maximal effort to exertion. The respiratory exchange ratio (VCO2/VO2) using age-depending RER cut-offs; 1.10 for ages 40-59 years, 1.06 for ages 60-69 years and +70 years to determine if a maximal effort is provided. There are no recommendations for RER cut-off when participants are aged above 69 years. Therefore, they must reach the RER cut-off 1.06 to be evaluated as maximal effort.

The rating of perceived exertion using the BORG RPE 6-20 scale evaluation \> 17 is considered maximal effort. The test was supervised by experienced physiotherapists, an in-house nurse supported if necessary, and a physician was available upon request. Participants and physiotherapists were blinded for VO2 max results from CPET. CPET gas exchange system was operated by an experienced researcher.

Maximal heart rate is rated as a maximal effort by cut-offs calculated as 208 - (0.7 x age in years) according to age group. Using respectively, \> 92% and \> 89% of the calculated HR max for the age group 40-59 years and the age groups 60-69 years and +70 years to consider maximal effort.

Eligibility Criteria:
Inclusion Criteria:

* participants with heart disease referred to exercise-based cardiac rehabilitation in primary healthcare settings were included

Exclusion Criteria:

* heart-related symptoms according to clinical guidelines that prevent participants from performing a maximal exercise test.
Injectable Bulking Agent Needle Guide

The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly guiding an injection needle into the appropriate tissue plane during an injectable bulking agent procedure in women using a FDA approved injectable bulking agent. The injectable bulking agent will be Durasphere EXP.


Eligibility Criteria:
Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.
A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants

The main aim of the study is to check side effect from the study treatment with TAK-771 in long term.

Participants can have taken part in the previous study TAK-771-3004 (NCT05150340). For those who can take part, the participants will receive injections of TAK-771 after the end of the previous study. The participants will be treated with TAK-771 for totally 3 years.

There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug.


Eligibility Criteria:
Inclusion Criteria:

1. Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340).
2. Written and/or electronic informed consent is obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration. If a participant is \<18 years of age, written and/or electronic informed consent should also be obtained from the participant's legally authorized representative in addition to written informed assent by a participant if appropriate.
3. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

1. Participant has developed a new serious medical condition during Study TAK-771-3004 such that the participant's safety or medical care would be impacted by participation in the study.
2. Participant is willing to participate in other clinical trials.
3. Women of childbearing potential who meet any one of the following criteria:

   1. Participant presents with a positive pregnancy test.
   2. Participant does not agree to employ adequate birth-control measures (eg, intrauterine device, condom \[for male partner\], or birth-control pills) throughout the course of the study.
Comparing the Effects of M-TAPA and TAP Block on Postoperative Analgesia in TAH

Aim is to compare the postoperative analgesic efficacy of M-TAPA block and TAP block and their effect on opioid consumption in patients undergoing open total abdominal hysterectomy (TAH) surgery.

There were three randomized groups: Group M (M-TAPA block) (n=15), Group T (TAP block) (n=15) and Group C (no block) (n=15). All patients had standard general anesthesia. Group M had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group T patients had TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients older than 35 years of age who underwent open total abdominal hysterectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing laparoscopic surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment
Idiopathic Recurrent Acute Pancreatitis (IRAP)

The purpose of this study is to collect standardized data on the diagnosis and management of idiopathic (unknown cause) recurrent acute pancreatitis. The intent is to collect data for at least five years to obtain information regarding long-term outcomes and obtain comparative effectiveness data.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Able to provide consent
3. More than one documented episode of pancreatitis (\>3 fold elevation of amylase and or lipase with abdominal pain or with body imaging consistent with pancreatitis: need two of the three)
4. Subjects with abdominal pain and enzyme elevation which is \<3 fold above normal or absence of imaging findings: these subjects who are undergoing endoscopic interventions but do not fit the "classic criteria" for pancreatitis will be included but the analysis of data of these subjects would be done separately.

Note: subjects with a diagnosis of pancreas divisum and or Sphincter of Oddi dysfunction diagnosed prior to or after entry into the study will be included in the study but their data will be analyzed separately because of the controversy regarding the association of these entities with pancreatitis.

Exclusion Criteria:

1. Unable to give informed consent.
2. Definite evidence of biliary or alcoholic pancreatitis.
3. Clear evidence of hypertriglyceridemia-induced pancreatitis (triglycerides \>1,000 mg/dl).
4. Post-ERCP pancreatitis, drug-induced pancreatitis, or any identifiable cause for pancreatitis.
5. History of pancreatic surgery.
Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)

In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.

This multicenter study is an open-labelled, randomized clinical trial for 1:1:1 ratio of lopinavir/ritonavir, hydroxychloroquine, or control arm.

Eligibility Criteria:
Inclusion Criteria:

* confirmed mild COVID-19 (NEWS scoring system 0-4)

Exclusion Criteria:

* unable to take oral medication
* pregnancy or breast feeding
* immunocompromised patients
* creatinine clearance (CCL) \< 30 mL/min
* aspartate transaminase (AST) or alanine transaminase (ALT) \> 5 times Upper limit of normal (ULN)
Study Assessing the Usability and Patient Satisfaction With Digital Urinalysis in the Context of Routine Pre-natal Care.

The study is a home-based, usability study assessing the use of the Dip Home-Based Dipstick Analyzer (HBDA) in the context of prenatal care.

300 pregnant women receive home testing kit and smartphone application (Dip HBDA) during regular prenatal visit. They are instructed to conduct a urine test (regular 10 parameter dipstick included in kit) at home using the Dip HBDA. After conducting the urine test, participants are to fill out a short questionnaire regarding ease of use, preference of testing and any problems encountered.

This study only assesses usability and questionnaire outcomes. The results of the test (indications on dipstick) are not subject to the study.

Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* Own and are familiar with use of a smartphone

Exclusion Criteria:

* They do not have use of both hands.
* Are visually impaired (cannot read user manual)
* Have dementia or mental disorder.
* Are not able to fill urine receptacle.
* Are not willing to adhere to study procedures.
* Do not own or are not familiar with the use of a smartphone.
* Have no access to a wifi / or cellular data connection at their home.
* Have impaired vision that prevents them from reading instructions.
Genomics of Kidney Transplantation

The major aim of this research study is to investigate the relationship between genetic variation in DNA (inherited code material in the cells of the body) and factors affecting transplant outcomes, like the drugs people receive or the way their immune systems work, for example. To do this, investigators will collect blood samples from participants. Genetic material will be separated from each blood sample and analyzed, looking for genetic variation.

In the past, the major problems in kidney transplantation were surgical complications, acute rejection, and infections. Right now, researchers are focusing on improving immune suppression therapy and achieving better long-term survival of kidney transplants. One of the ways to try to understand what causes loss of function after many years is to find out if there is a genetic factor involved.

There are a number of differences in specific genes that have been identified and are thought to affect transplant outcomes. Studying these gene variations (differences between people or differences between populations) is important in determining whether these variations are related to transplant outcomes and how this information can help patients achieve better long-term transplant survival.

Eligibility Criteria:
Inclusion Criteria:

* Kidney (or kidney-pancreas) transplant recipient no more than 10 days post-transplant or kidney donor no more than 30 days post-transplant or previously enrolled in Phase I of the Genomics of Kidney Transplantation Study;
* No organs other than kidney or pancreas transplanted simultaneously with the qualifying kidney transplant; and
* Participant or parent/guardian must be able to understand and provide written informed consent.

Inclusion for the Activity and mRNA Expression Cohort:

* Recipient enrolled in the Main Cohort Study;
* Informed consent for participation in the Activity and mRNA Expression Cohort;
* Age 18 years or greater as of day of transplantation;and
* Will receive tacrolimus, cyclosporine or mycophenolate as part of maintenance immunosuppression therapy.

Exclusion Criteria:

- Inability or unwillingness of the participant or parent/guardian to give a written informed consent or comply with the study protocol.

For the Activity and mRNA Expression Cohort:

- Inability or unwillingness of the participant or parent/guardian to give a written informed consent for participation in the Activity and mRNA Expression Cohort or comply with the study protocol.
Pregnancy Rate by HCG Administration Versus Urinary LH Surge Method in Patients Undergoing IUI

To compare pregnancy rate by Human Chorionic Gonadotropin (HCG) administration and urinary Luteinizing Hormone (LH) surge method for insemination in patients undergoing Intrauterine Insemination (IUI) at Montaserieh infertility center.

The present study comprised 309 infertile women candidate for IUI, randomly divided into LH surge and HCG groups (assign the number for each patient, odds number for LH and even number for HCG group). All patients were subjected to baseline ultrasound and received clomiphene citrate before undergoing serial transvaginal sonography. LH was measured using LH kit when 2-5 follicles (18-20 mm) appeared in LH surge group, and if positive, IUI was performed after 24 hours. In HCG group, the patients received HCG 1000 units and underwent IUI after 36 hours. The pregnancy rate was then compared in LH and HCG groups.


Eligibility Criteria:
Inclusion Criteria:

* infertile women candidate for IUI

Exclusion Criteria:

* women with negative urinary LH surge which required HCG administration,
* those with more than 5 follicles who had to use LH kit and not receive HCG to avoid ovarian hyperstimulation.
Treatment of Diabetic Neuropathy With Liraglutide

The purpose of this trial is to explore whether liraglutide has a long term effect on clinical symptoms and biomarkers in patients with diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Abile person of Northern European descent
* Age between 18 to 65 years
* A verified diagnosis of DM type 1 for minimum 2 years (HbA1C=7%)
* Stable DM treatment (Treatment is considered stable when the patient has been treated with basal-bolus insulin, premixed insulin or continously infused insulin with an insulin dose considered stable by investigator for at least 3 months prior to screening.)
* The participants must be able to read and understand Danish.
* Peripheral diabetic neuropathy ensured by having abnormal nerve conduction velocity
* BMI equal to or above 22
* Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
* Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.

Exclusion Criteria:

* Diabetes mellitus type II
* Estimated glomerular filtration rate (s-creatinin/eGRF) \< 60 ml/min/1.37m2
* Calcitonin \> 25
* HbA1c level \< 7%
* Patients with any clinically significant laboratory abnormalities, that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
* Patients on GLP-1 receptor agonist treatment (exenatide, liraglutide or others) or pramlintide or any DPP-4 inhibitor within 3 months prior to screening.
* Other neurological and/or psychiatric disease
* Treatment of other endocrinological disease except hypothyreosis
* Malignant neoplasms requiring chemotherapy, surgery, radiation or palliative care in the previous 5 years.
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma.
* Personal history of non-familial medullary thyroid carcinoma
* Known abuse or alcohol and/or medicine (Alcohol use in accordance with the recommendations by the Danish Health and Medicines Authority are allowed).
* Known allergy to liraglutide.
* Participation in other clinical trials less than 3 months prior to inclusion
* Female patients who are pregnant or lactating, or intend to become pregnant and male patients who intend to father a child during course of the study.
* In women, a serum pregnancy test will be conducted at baseline based on h-CG in the blood. The investigator will have to ensure that fertile female patients use a safe contraception method during the study and for at least 15 hours after termination of the study medication period.
Music Listening and Sleep in Rehabilitation of People With Acquired Brain Injury

An Injury to the brain may lead to sleep-wake disturbances which may negatively influence functional recovery, quality of life and general rehabilitation.

The purpose of this study is to investigate the effect of music listening on sleep disturbances after acquired brain injury (ABI).

During a 2 week intervention period patients with ABI will listen to music for appr. 30 minutes before going to sleep. Records of their sleep quality are compared to records of sleep quality from 2 weeks without music intervention.

H1 Hypothesis: Music listening (ML) improves sleep quality after ABI in patients.

H0 Hypothesis: Music listening (ML) has no effect on sleep quality after ABI in patients.

Participants are recruited from Vejlefjord Rehabilitation - a neurorehabilitation center in Denmark.

Patients who meet the inclusion criteria are enrolled in the study after informed consent. Participants are randomly allocated to two conditions (ML+Treatment as usual (TAU) or TAU only in a crossover design. Randomization is done by sealed envelope, and after two weeks of either ML+TAU or TAU the participants switch condition.

Participants are asked to select one of four music playlists and listen to it for appr. 30 minutes at bedtime during the intervention period. Participants will rate sleep quality and liking of the intervention.

Information about injury, demographic and socioeconomic status are derived from patient journals.

Eligibility Criteria:
Inclusion Criteria:

* in-patients with ABI being treated at Vejlefjord Rehabilitation during the entire project period
* age \> 18 years
* sleep-wake disturbances corresponding a score of 5 or more on Pittsburgh Sleep Quality Index (PSQI).
* Mentally and physically capable of administering music equipment, actigraph and self-report questionnaires.

Exclusion Criteria:

-
Comorbidities And Reducing inEquitieS

Black cancer patients tend to have worse outcomes than White cancer patients. Some of this disparity may be due to comorbidities. The purpose of this study is to improve management of co-morbidities among cancer patients in order to improve cancer outcomes and improve health equity.

Comorbidities such as diabetes and hypertension can complicate cancer treatment or can make it difficult to reach optimal health after treatment. This study will offer additional support and tools to manage cancer patient's health needs. First, the study will use a mobile health application, managed by a company called Welldoc, to monitor patient progress in real time and to provide ongoing guidance. Second, the study will connect patients with a Community Health Worker who will speak with them weekly to discuss self-care information, including medical scheduling or appointment needs, and assist with daily self-monitoring of blood pressure and/or blood glucose monitoring. Lastly, an oncology nurse will monitor reported health and triage any medical needs and whether additional medical care is needed.


Eligibility Criteria:
Inclusion Criteria:

* Black women with a diagnosis of stage 0-IV breast cancer and within a month of treatment initiation or with 6+ months of treatment left OR Black men with a history of prostate cancer who are on long-term androgen deprivation therapy;
* Blood pressure \>=120/80 OR diagnosis of diabetes
* Individuals who develop these conditions during treatment such as those scheduled to initiate steroid-containing chemotherapy or targeted PI3K inhibitor therapies
* Access to a smartphone and/or internet for the duration of the study.
* Can understand and communicate in English

Exclusion Criteria:

- Unwilling to participate in a 6-month study
Evaluation of the MP Diagnostics HTLV Blot 2.4

The purpose of this study is:

1. To assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4.
2. To conduct a sensitivity analysis of the HTLV Blot 2.4 using a known positive population.

This is a retrospective study designed to assess the validity and reproducibility of the MP Diagnostics IVD device, the HTLV Blot 2.4 (MP Blot), in various populations. The study will be conducted at three geographical distinct locations.

The validity of the MP Blot will be assessed by calculating the following:

1. Percent negative agreement with CDPHL Algorithm on 200 EIA negative specimens
2. Percent positive agreement with CDPHL Algorithm on 200 EIA repeat reactive specimens

The sensitivity of the MP Blot will be evaluated by testing 200 known positive specimens. The study will be performed using three product lots at three clinical sites.

The reproducibility of the MP Blot will be assessed by testing two replicates of a three member panel at three clinical testing sites with each of three lots of product over multiple days by three operators.

Eligibility Criteria:
Inclusion Criteria:

* EIA Negative Population

  1. Male or female
  2. Completion of a health history evaluation for routine donor screening
  3. Willing and able to provide informed consent
  4. Negative screening assay results for all ARC screening assays
* EIA Repeat Reactive Population

  1. Male or female
  2. Completion of a health history evaluation for routine donor screening
  3. Willing and able to provide informed consent
  4. Previous RR result by bioMerieux ELISA, Abbott EIA, and / or Abbott ChLIA PRISM
* Known Positive Population

  1. Male or female
  2. Willing and able to provide informed consent
  3. Previous reactive screening test using either the bioMerieux ELISA, the Abbott EIA or the Abbott ChLIA PRISM, followed by supplemental testing

Exclusion Criteria:

* EIA Negative Population

  1. Inadequate sample volume for testing
  2. Unable to provide samples that meet the sample suitability requirements for testing
  3. Positive screening result for any infectious disease tested by ARC
* EIA Repeat Reactive Population

  1. Inadequate sample volume for testing
  2. Unable to provide samples that meet the sample suitability requirements for testing
  3. Positive result for HIV, HBV, HCV, or any other infectious disease
* Known Positive Population

  1. Unwilling or unable to provide informed consent
  2. Unable to provide adequate sample volume for testing
  3. Unable to provide samples that meet the sample suitability requirements for testing
  4. Positive result for HIV