cyrilzakka/clinical-trials huggingface dataset:
A Lymph Node Metastasis Predictor (LN-MASTER) in Rectal Cancer

In this study, we aim to develop and validate an easy-to-use machine learning prediction model to preoperatively identify the lymph node metastasis status for rectal cancer patients by using these clinical data from three hospitals.

In this study, participants were recruited from the Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College (development set), Changhai Hospital, Naval Medical University (external validation set 1), and the Second Affiliated Hospital of Harbin Medical University (external validation set 2), between January 1, 2016, and December 31, 2020. According to the inclusion criteria, participants who (a) were in American Joint Committee on Cancer (AJCC) stages I -III rectal cancer and (b) underwent radical surgery were recruited. In contrast, the exclusion criteria were as follows: (a) other malignancies, (b) received treatment with endoscopic submucosal dissection (ESD), (c) metastatic lesions, (d) did not undergo lymph node dissection, (e) had unavailable assessed lymph node status, and (f) received neoadjuvant therapy. The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.

Clinicopathological features included sex, age, body mass index (BMI), comorbidity, distance from the lower edge of the tumor to the anus, carcinoembryonic antigen (CEA) levels, carbohydrate antigen 19-9 (CA19-9) levels, tumor size, degree of tumor differentiation, tumor histology, vascular or lymphatic vessel invasion, AJCC T stage, clinical diagnosis of LNM, and the pathological diagnosis of LNM. Among these, sex, age, BMI, and comorbidities of each participant, such as diabetes, hypertension, hyperlipidemia, and other chronic systemic diseases, were extracted from the electronic hospital information system. Preoperative CEA and CA19-9 levels were obtained from hematological examinations at the time of rectal cancer diagnosis. The distance from the lower edge of the tumor to the anus, differentiation degree, and tumor histology were recorded based on the results of endoscopy and endoscopic biopsies. The tumor diameter and clinical diagnosis of LNM were defined using preoperative pelvic MRI or CT. The diagnosis of vascular invasion, lymphatic vessel invasion, and LNM was based on postoperative pathological diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* American Joint Committee on Cancer (AJCC) stages I -III rectal cancer
* underwent radical surgery

Exclusion Criteria:

* other malignancies
* received treatment with endoscopic submucosal dissection (ESD)
* metastatic lesions
* did not undergo lymph node dissection
* had unavailable assessed lymph node status
* received neoadjuvant therapy
Effect of Acetazolamide on Lung Water Content by Ultrasound in Patients With Respiratory Disease at Altitude

This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on lung water content by ultrasound at acute altitude exposure in patients with Chronic Obstructive Pulmonary Disease (COPD).

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on lung water content by ultrasound in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3100 m.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age 18-75 yrs.
* COPD diagnosed according to GOLD, FEV1 40-80% predicted, Oxygen Saturation (SpO2) ≥92% at 750 m.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.

Exclusion Criteria:

* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/Forced Vital Capacity \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92% at 750 m).
* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; obstructive sleep apnea; pneumothorax in the last 2 months.
* Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day)
* Known renal failure or allergy to acetazolamide and other sulfonamides
Evolution of the PR Interval in Patients Implanted With a Pacemaker Using the SafeR Mode

Observational study on long PR interval using the SafeR mode in bradycardia patients.

This observational trial aims to study the evolution of the PR interval in patients implanted with a dual chamber pacemaker with the SafeR mode. The investigators will assess the prevalence and the incidence of PR lengthening and the investigators will study the long PR interval management by physicians, depending on the data embedded in the pacemaker.

Eligibility Criteria:
Inclusion Criteria:

* Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months.
* Since implantation, the device is programmed in SafeR mode
* Patient agreed to participate, after having received the appropriate and mandatory information

Exclusion Criteria:

* Patient contraindicated for cardiac pacing, according to current available guidelines
* Permanent atrial fibrillation
* Permanent high-degree AV block
* Patient not available for routine follow-up visits
* Patient already included in another clinical study
* Inability to understand the purpose of the study / refusal to cooperate
* minor age
* Pregnancy
* Life expectancy less than 12 months
* Under guardianship
RISAS Procedure in Node Positive Breast Cancer Following NAC

Chemotherapy in clinically node positive breast cancer patients is increasingly administrated in a neoadjuvant setting. The standard treatment regimen in these cases is then: neoadjuvant chemotherapy (NAC) followed by breast surgery and an axillary lymph node dissection (ALND). NAC results in axillary pathologic complete response (pCR) in 1 out of 3 patients, indicating a complete absence of axillary metastases after completion of NAC. In such events, ALND can be regarded as overtreatment that creates unnecessary morbidity. Less invasive axillary surgery which can accurately assess axillary pCR is therefore preferred over standard ALND in all patients. In case of detection of remaining axillary lymph node metastases by this less invasive axillary surgical procedure, completion axillary treatment is standard of care.

The novel RISAS procedure is introduced as a possible less invasive axillary staging procedure. RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure. The iodine seed in the axillary lymph node metastasis will be placed prior to start of NAC.


Eligibility Criteria:
Inclusion Criteria:

* Female patient with pathologically confirmed axillary lymph node positive invasive primary breast cancer, treated with neoadjuvant chemotherapy
* Willing and able to undergo all study procedures.
* Has personally provided written informed consent.

Exclusion Criteria:

* Age \< 18
* Pregnancy or lactation
* Contra indications for undergoing iodine seed placement or sentinel lymph node biopsy, such as allergic reaction on iodine, 99m Technetium or patent blue.
* Recurrent breast cancer
* Previous axillary surgery or radiotherapy
* Patients with periclavicular lymph node metastases (cN3)
* Patients with advanced breast cancer (i.e. patients with distant metastases, treated without any furter surgical procedures)
Effect of COVID-19 Vaccine on Blood Pressure

The study aims to investigate (1) if COVID-19 vaccine impacts on blood pressure, (2) the extent of impact on blood pressure (if any), and (3) which groups of subjects are more susceptible to be affected by COVID-19 vaccine on blood

Coronavirus disease 19 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has elicited global pandemic since January 2020. Until the end of June 2021, the virus has caused 182 million confirmed COVID-19 cases and 3.95 million deaths worldwide. To stop the spread of virus, there has been rapid development of vaccine against SARS-CoV-2. Currently there has been 9 vaccines authorized for emergency use, and 8 vaccines received full approval for use in various countries. Extensive studies have been showing the efficacy of different types of vaccines against COVID-19 and its variants. Safety of COVID-19 vaccines has been a concern. Despite safety profile of different vaccines demonstrated in phase 2/3 trials, there has been evolving evidence on adverse effects of some particular COVID-19 vaccines. One of the mostly known example is vaccine-induced thrombotic thrombocytopenia (VITT). Case series report4 and observational studies on ChAdOx1 nCoV-19 vaccine showed high level of autoantibodies to platelet factor-4 (PF4) which could contribute to microvascular damage, micro-bleeding and platelet activation and therefore causes event of thrombosis. Apart from the thrombotic risk of ChAdOx1 nCoV-19 vaccine, there has been studies providing the preliminary data on effect of mRNA-based COVID-19 vaccine on blood pressure. Yet there remains lack of evidence and detailed description on effect of COVID-19 vaccines and blood pressure along the time. Given the vast population of hypertensive patients worldwide, the increasing number of people being vaccinated and the importance of blood pressure level to various human organs, it is essential to investigate the short- and long-term effect of COVID-19 vaccine on blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 years old or above
* Subjects with home blood pressure monitoring device
* Subjects with smartphone and with HealthCap application downloaded
* Subjects who understand Chinese to make an informed consent

Exclusion Criteria:

* Subjects unable to take regular home blood pressure measurement
Accessible and Inclusive Diabetes Telecoaching Self-Management Program

The purpose of this study is to develop and pilot test an accessible and inclusive Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4DM) for glycemic control in people with disabilities.

The AI4DM study will use a two-arm randomized control trial design. Eligible and consented participants will be assigned to one of two groups: 1) AI4DM intervention group with telecoaching support, and 2) attention-control group. The active intervention period will include six months of weekly and bi-weekly telecoaching calls followed by six months of follow-up and technology access, but no telecoaching calls.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus,
* Living with a permanent physical disability such as spinal cord injury (SCI), spina bifida, multiple sclerosis, stroke, etc.
* Ability to converse and read in English

Exclusion Criteria:

* Current enrollment in any diabetes-related intervention
* Severe untreated depression in the past six months
* Major cardiac event in the past twelve months
* Uncontrolled blood pressure
* Resting tachycardia
* Renal failure
* Severe peripheral neuropathy
* Unavailability of a smartphone
Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic).

The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.

This is a multi-cohort study.


Eligibility Criteria:
Inclusion Criteria

* Participants must have

  * Metastatic squamous or nonsquamous non-small cell lung cancer (NSCLC) (without known targetable EGFR, ALK, ROS1, or BRAF mutations) who either

    * a) have not yet received frontline therapy for metastatic disease and without prior exposure to anti PD-1/PD-L1 or
    * b) are relapsed/refractory with progression on anti PD-1/PD therapy.
  * Relapsed/refractory metastatic cutaneous melanoma (regardless of mutation status) with progression on a PD-1 inhibitor
  * Metastatic head and neck squamous cell carcinoma (HNSCC) who have not yet received frontline therapy for metastatic disease and without prior exposure to a PD-1/PD-L1 inhibitor.
* Cohorts 1-4 only: Melanoma participants must be currently on PD-1 checkpoint inhibitor (CPI) therapy (e.g. nivolumab or pembrolizumab) or had their last dose of PD-1 CPI containing therapy as the last previous line of therapy within 90 days prior to enrollment; PD-1 CPI therapy must be the immediate prior line of treatment.
* Cohorts 1-4 only: Participants must have progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other CPIs or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria.

  * Have received at least 2 doses of an approved PD-1 inhibitor.
  * Have demonstrated disease progression (PD) after a PD-1 inhibitor as defined by RECIST v1.1.

    * Progressive disease has been documented within 90 days from the last dose of PD-1 inhibitor.
    * Participants with melanoma will need iRECIST confirmation of progression with a second assessment at least four weeks after the initial date of progressive disease
    * NSCLC participants on PD-1 inhibitor containing therapy for less than 90 days will need iRECIST confirmation of progression at least 4 weeks after the initial date of progressive disease
* Tumor tissue sample obtained within 3 months prior to enrollment is required, and no systemic anticancer therapy given after the sample was obtained.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of equal or less than 1

Exclusion Criteria

* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Prior immunosuppressive chemotherapy, any immunotherapy other than a PD-1 inhibitor within 4 weeks of first study drug dose.
* History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy.
Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (\< 2.5cms).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 24 and 34 weeks of gestation.
* Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less

Exclusion Criteria:

* All contraindications for tocolysis (fetal distress, abruptio placenta).
* Multiple pregnancy.
* All contraindications for the use of any of the two drugs (indomethacin or nifedipine).
Simulated Screening Study for Breast Imaging

This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities:

1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)

2. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.

This is a pilot, simulated breast cancer screening study. In a population enriched with mammographic call-backs, we will study whether:

1) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)will result in a lower call-back rate than digital breast tomosynthesis(DBT)alone.

2. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.

This study will compare two new breast imaging systems to digital mammography and hand-held ultrasound that are commonly used to find and evaluate breast masses. Images will be done with digital breast tomosynthesis (DBT) and 3-D automated ultrasound(AUS) which will be done in the breast imaging clinic of the main hospital followed by the second light and ultrasound imaging that will be completed in the research lab.

Eligibility Criteria:
Inclusion Criteria:

* Women with possible masses
* All women should have had mammograms at University of Michigan Health System within 1 year before this research study.

Exclusion Criteria:

* Women who are physically unable to tolerate the length of the scan.
* Women who are less than 30 years of age or older than 80 years of age
* Women who are pregnant or lactating
* Women whose mass is in an area of the breast which makes it difficult to see in the research scans
* Womens with a single diagnosis of mammographic calcifications
* Women who have had a breast cancer with lumpectomy
* Women who are prisoners
* Women who are students or staff of investigators
* Women who cannot give consent
* Women with mammograms classified as probably benign because of follow-up of a recent benign biopsy.
* Women with breast pain who have been categorized as BIRADS(Breast Imaging Reporting and Data System) category 0(incomplete) on their most recent mammograms.
* Males, because their breast tissue is not easily imaged and numbers of potential cases are too few.
Action Observation Therapy and Mirror Therapy in Parkinson's Disease

Small muscles of the hand are affected due to involuntary movements and slowing of voluntary movements seen in Parkinson's disease. There is a loss of fine dexterity and coordination in the hand. It becomes difficult for patients to grasp and release of the objects. They become unable to perform daily activities such as buttoning up, holding keys, brushing teeth, holding forks, spoons and glasses, and writing. Therefore, a certain part of the rehabilitation program should be devoted to upper extremity rehabilitation. The aim of this study was to compare the effects of action observation therapy and mirror therapy, which have been used in the literature for many years, on upper extremity functions and quality of life in individuals with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older,
2. Diagnosed with idiopathic Parkinson's disease,
3. Parkinson's disease stage (patients with Hoehn Yahr≤3)
4. Patients who can hear and follow verbal instructions.

Exclusion Criteria:

1. Patients who cannot cooperate,
2. Patients with dementia or comorbidities affecting cognitive functions,
3. Patients with serious comorbidities (such as decompensated heart failure, decompensated kidney failure) and significant disability (such as vision loss, hearing loss) affecting functionality,
4. Patients with another disease (such as inflammatory diseases, polyneuropathy, brachial plexus lesion, loss of range of motion after trauma) affecting upper extremity functions.
5. Patients diagnosed with secondary Parkinson's disease
6. Patients with acute neurological disease
The Economics of Domestic Violence: Evidence From Bangladesh

This project aims to test the scalability and cost-effectiveness of edutainment-soap operas designed to challenge harmful social norms and promote resilience-as a strategy to improve mental health and reduce intimate partner violence (IPV) in rural Bangladesh. Investigators will run a clustered randomized control trial in which villages will be randomized to one of three versions of the same soap opera: (i) Norms: Challenges harmful norms that condone IPV, targeting the belief that violence is an acceptable way to assert control or maintain reputation, (ii) Norms + Skills: builds on the norms campaign by adding CBT-based skills for stress management and non-violent conflict resolution, (iii) Placebo: No violence content. Investigators will evaluate the impact on attitudes towards IPV and IPV incidence.

Study design features two layers of commuity-level randomization based on a 3x2 factorial design:

First Treatment Variation: Edutainment Content. Communities are randomized into one of three versions of the same soap opera:

1. Norms Campaign (176 communities): Challenges harmful norms that condone IPV, targeting the belief that violence is an acceptable way to assert control or maintain reputation.
2. Norms + Skills Campaign (176 communities): Builds on the norms campaign by adding CBT-based skills for stress management and non-violent conflict resolution.
3. Placebo Campaign (88 communities): Features unrelated content to serve as a control group, isolating the effects of norms and resiliency messaging.

This variation allows for assessing the impact of addressing harmful norms alone from the additional benefits of equipping men with practical coping skills. By comparing the Norms Campaign to the Norms + Skills Campaign, investigators test whether adding stress-coping skills yields additional reductions in IPV and related outcomes.

Second Treatment Variation: Delivery Modes. Fifty percent of communities in each treatment arm are randomized into one of two delivery modes:

1. Private Delivery: Men watch the soap opera privately at home on handheld devices.
2. Public Delivery: Men watch the soap opera publicly through community screenings.

Randomizing delivery modes enables investigators to assess whether men's responses to the intervention are driven by self-esteem concerns (private delivery) or reputation concerns (public delivery). This distinction provides critical insights into the mechanisms underlying IPV and informs the scalability of different delivery methods.

In addition to the community-level randomizations, 50 percent of men in each community are randomized into participation in a cash-for-work program. This individual-level randomization allows us to evaluate the role of economic strain in IPV outcomes, testing whether alleviating financial stress enhances the intervention's effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* married men and women over the legal age of majority in Bangladesh

Exclusion Criteria:

* No exclusion criteria were imposed.