cyrilzakka/clinical-trials huggingface dataset:
Prediction Model for Multiple Pulmonary Nodules

This study compares the sensitivity, specificity and accuracy of radiologists, thoracic surgeons and a predictive model (PKUM model) to discriminate malignancy from benign nodules in patients with multiple pulmonary nodules.

It is clinically difficult to diagnose and manage patients with multiple pulmonary nodules (MPNs). We have developed a web-based mathematic model (PKUM model) by using a multi-centric database from three institutions (Peking University People's Hospital, Haidian Section of Peking University Third Hospital, People's Hospital Affiliated to Hebei Medical University) to predict the probability of a nodule to be malignant in patients with MPNs. This prospectively observational study will recruit patients with MPNs between January 2019 and March 2019, allowing radiologists, surgeons, and a predictive model (PKUM model) to discriminate malignancy from benign nodules, and compare their sensitivity, specificity, and accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly discovered, 4-30 mm multiple pulmonary nodules shown on thoracic CT scans
* Patients with at least two nodules resected for pathological evaluation

Exclusion Criteria:

* History of malignancy within 5 years
* Presence of pneumonia or pleural effusion on thoracic CT scans
* Patients with none or only one nodule resected
* Patients with initial chemo-radiation therapy
Interview TIME: Training Inspired Minds for Employment

The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs.

Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group).

Participants will have assessments that will be done over the computer or in-person at school or program site. Assessments will be about participants background, employment history, mood and feelings, autistic traits, memory, mental health issues, such as depression and anxiety, and other things. Some assessments will be audio and/or video recorded.

Please note that there will be teachers and staff consented (approximately n=32) to deliver the intervention, however, will not count for the clinical trial. Therefore, the information will not be added to the anticipated enrollment numbers in study design.

Eligibility Criteria:
Inclusion Criteria:

* Participants have a diagnosis on the autism spectrum
* Participants are enrolled in pre-employment transition services
* Participants have at least a third-grade reading level
* Are unemployed or employed and job-seeking

Exclusion Criteria:

- Not enrolled in pre-employment transition services
Use of Internet Mediated Walking Program and Pedometer in COPD

Persons with COPD are randomized to pedometer versus pedometer plus Internet mediated website to promote walking and physical activity. Primary outcome is daily step counts. Intervention lasts 3 months.


Eligibility Criteria:
Inclusion Criteria:

COPD, ability to walk, has Internet access

Exclusion Criteria:

COPD exacerbation in previous 4 weeks
Acute Kidney Injury in Coronavirus Disease-19 (COVID-19) Patients Admitted to the Intensive Care Unit (ICU)

The aim of this study is to evaluate the rate and outcomes of COVID-19 associated acute kidney injury (AKI) and use of kidney replacement therapy (KRT) in critically ill COVID-19 patients in ICUs in several large hospitals in Flanders, the northern region of Belgium. We will also explore the associations between several baseline risk factors for AKI, therapeutic strategies and COVID-19 related clinical signs and the occurrence of AKI and use of KRT.

The aim of this study is to evaluate the rate and outcomes of COVID-19 associated acute kidney injury (AKI) and use of kidney replacement therapy (KRT) in critically ill COVID-19 patients in ICUs in several large hospitals in Flanders, the northern region of Belgium. We will also explore the associations between several baseline risk factors for AKI, therapeutic strategies and COVID-19 related clinical signs and the occurrence of AKI and use of KRT.

This will be a cohort analysis of the rate of COVID-19 associated AKI and KRT during the period 1 February 2020 - 31 January 2021 in 6 large hospitals in Flanders Belgium and 3 Flemish University Hospitals. We will collect patients' baseline characteristics, specific treatment for COVID-19, other relevant therapies and severity of illness and ICU and hospital outcome data. AKI will be assessed during ICU stay up to 21 days of ICU stay, and will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition. In addition, we will assess occurrence of AKI stages, duration of AKI, duration of AKI integrated with severity stage of AKI into the area under the curve of AKI, occurrence of rapid reversal of AKI, occurrence of Acute Kidney Disease (AKD) defined according to KDIGO.

Eligibility Criteria:
Inclusion Criteria:

* Severe Acute Respiratory Syndrome CoronaVirus-2 (SARS-CoV-2) infection confirmed by Polymerase Chain Reaction (PCR) on nasopharyngeal swab or oropharyngeal swab or rectal swab or bronchoalveolar aspirate
* admission to the ICU for monitoring or organ support

Exclusion Criteria:

* asymptomatic COVID-19 patients admitted to the ICU for medical reason not related to COVID-19
Managing Cancer and Living Meaningfully

The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM). Researchers hope to better understand the potential benefits of this intervention on brain tumor patients' mood and quality of life. This may lead to improvements in doctor's understanding of how to enhance brain tumor patient's wellbeing and overall functioning.

In this study, participants will be asked to do the following things:

1. Complete \~15-minute online surveys before the program, immediately after the program (4 months), and at follow-up (6 months). . Questions will ask about mood, anxiety, death distress, quality of social relationships, and satisfaction with life.
2. Meet with an interventionist six times (biweekly) for individual sessions via Zoom, lasting 50-60 minutes each. Sessions will be audio-recorded to ensure all participants receive the same information. Participants will be asked to only use first names.
3. Complete weekly \~5 minute online surveys after each session on satisfaction with the program.
4. Complete an exit interview by telephone approximately 1 month after the 6-session intervention. This exit interview will last approximately 15-30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* have a confirmed malignant brain cancer diagnosis via histopathology
* be a minimum of 2 weeks post-surgical resection or biopsy (if applicable)
* be primarily English speaking
* be age 18-89
* obtain \>20 on the Telephone Interview for Cognitive Status (TICS)
* have current elevated depression or death anxiety symptoms
* have a reliable internet connection to participate in the Zoom therapy sessions

Exclusion Criteria:

* Major communication difficulties as determined by the research team which would prohibit psychotherapeutic interaction
* inability to meet with interventionist via an electronic device for telehealth intervention sessions
* inability to provide informed consent
Bone-biomarkers of Spinal Cord Injury Patients

Patients with spinal cord injury have a high prevalence of osteoporosis due to chronic skeletal unloading. Recently, various treatment drugs for osteoporosis have been developed. In particular, romosozumab, a sclerostin inhibitor, has been reported to have a high therapeutic effect as an inhibitor of bone resorption while promoting bone formation. However, there are a few research concerning sclerostin of spinal cord injuries patients. Therefore we want to analyze the change of sclerostin as well as factors indicating bone formation and absorption marker in spinal cord injury patient.


Eligibility Criteria:
Inclusion Criteria:

* spinal cord injury patients
* Functional ambulatory category index of 3 or less

Exclusion Criteria:

* history of using bone absorption medication within the effective period
Adherence to PTH(1-84) Treatment (FP-002-IM)

The primary objective is:

1) to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting.

The secondary objectives are:

1. to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH(1-84)
2. to describe (using available data) the long term treatment effectiveness during the 24 months following initiation of PTH(1-84) treatment in a normal clinical setting
3. to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* According to the current Summary of Product Characteristics (SmPC)
* PTH(1-84) treatment initiated within one month preceding enrolment
* The patient's written informed consent to direct access and data processing must be obtained.

Exclusion Criteria:

* According to the current SmPC
* The patient cannot participate in a clinical trial with PTH (all other trials allowed).
Blood-based Identification and Monitoring of Patients With ALK-translocated Lung Cancer

Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation of a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small cell lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor (TKI) crizotinib has produced remarkable results for ALK-positive patients, however the current diagnostic tests used in the clinic are not sufficiently detailed and require a tumor biopsy.

The aim of this study is to use a new diagnostic test to detect ALK rearrangements using next generation sequencing, which will improve the diagnosis and treatment of ALK-positive NSCLC patients. Furthermore, this test will be performed on blood samples, making it minimally invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in blood can be employed as an easy accessible and comprehensive source of information to diagnose ALK-positive disease, but also as a means of monitoring patient response during treatment. Quantitation of the the amount of ALK rearrangement will give information about which patients benefit from treatment and when treatment is no longer effective. The project will be a multicenter study where blood samples will be collected every 6 weeks from patients treated at four major hospitals in Denmark.

This study will benefit future patients with lung cancer, as it will improve both the monitoring and evaluation of their treatment. Monitoring patients during treatment will provide more knowledge of disease progression and the effect of ALK-TKI treatment, contributing to a greater selection of patients, who will respond to treatment. This will potentially allow effective treatment to continue longer than with conventional methods


Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer diagnosis
* Biopsy-verified ALK-translocation

Exclusion Criteria:

* Patients were it is not possible to retrieve a biopsy
* Patients with squamous cell carcinoma
Acupuncture for Relief of Gag Reflex

The aim of the study is to test whether stimulation of acupuncture points CV24 and P6 is better than placebo acupuncture in treatment of gagging in patients undergoing elective transesophageal echocardiography (TEE)

Patients undergoing elective transesophageal echocardiography (TEE) often report discomfort because of active gagging reflex, which sometimes preclude the performance of TEE and requires additional medication. According to existing literature, needling of acupoint CV24 effectively prevents gagging during dental procedures. We are going to use this phenomenon in patients scheduled to TEE in order to reduce discomfort during insertion of TEE probe and reduce the need for additional sedative medication. Within this investigation the patients will be randomly assigned to receive either verum acupuncture of CV24 and P6 acupoints or placebo procedure immediately before TEE examination. As outcome the incidence and intensity of gagging, total dose of additional sedative medication and hemodynamic parameters will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective ambulatory transesophageal echocardiography (TEE) without sedation
2. TEE time does not exceed 30 minutes
3. Patients without previous opioid and psychotropic medication
4. Patients aged between 30 and 65 years, able to use visual analogue scale 100 mm
5. Patients who have given written informed consent

Exclusion Criteria:

1. Current psychiatric disease
2. Local skin infection at the sites of acupuncture
3. Aged \< 30 or \> 65 years
4. TEE time more than 30 min
5. Patients who consumed opioid medication at least 6 months before surgery
6. Patients with the history of: i) psychiatric disease; ii) insulin-dependent diabetes mellitus; iii) radio- or chemotherapy; iv) peripheral polyneuropathy.
7. Patients who are unable to understand the consent form or to use visual analogue scale 100 mm
CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision

The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.


Eligibility Criteria:
Inclusion Criteria:

* Patient will be implanted with a Medtronic Conexus-enabled Cardiac Resynchronization Therapy Defibrillator (CRT-D) or Implantable Cardioverter-Defibrillator (DR-ICD) device.

Exclusion Criteria:

* Patient has permanent rapid beats in the upper chamber of the heart (Atrial Fibrillation) - (constant atrial fibrillation in which pharmacological therapy or cardioversion failed or not attempted).
* Patient plans to be on chronic warfarin therapy post-implant and is no longer receiving therapies to attempt to control the rhythm of the beats in their atrium.
* Patient has a previous ICD, CRT-D, Implantable Pulse Generator (IPG) or Cardiac Resynchronization Therapy Pacemaker (CRT-P).
Functional Exercise in Virtual Environment for Persons With Multiple Sclerosis or Parkinson's Disease

The aim of the study is to optimise the hand dexterity exercising program in virtual reality (VR) for patients with multiple sclerosis and Parkinson's disease. Little research has been published on this topic, but the preliminary results are promising. Different levels of difficulty of a VR game will be tested. The patients will be assessed using neuropsychological tests of executive functions, visuospatial abilities, mental speed, flexibility and motor speed. Functional ability, coordination and cognitive abilities will also be assessed.

Each patient meeting the inclusion criteria will be randomised to one of the four groups (i.e., 10cubes game difficulty level). The patients will perform five exergaming sessions, each session lasting for 1 hour, on five consecutive working days within the period of two weeks. The 10cubes task requires that all 10 cubes are moved within 2 minutes. Each patient will perform the task 5 times in succession with 1-2 minute breaks. The patients will be assessed using the Box \& Blocks Test, Frontal Assessment Battery (FAB), Delis-Kaplan Executive Function System (D-KEFS) and Judgment of Line Orientation (JLO) before the first session and after the last session. In addition, the patients will fill in the Intrinsic Motivation Inventory (IMI) after each session. Based on statistical sample size calculations, the study plan is to include 80 patients with Parkinson's disease and 12 patients with multiple sclerosis randomising them separately, so that the groups will be balanced in terms of size and diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* diagnose of Parkinson's disease or multiple sclerosis;
* Mini Mental State Examination score above 24;
* preserved upper limb function;
* for Parkinson's disease patients Hoehn and Yahr scale score between 2 and 3.

Exclusion Criteria:

* any communicable disease;
* severe vision impairment.
The Influence of Helicobacter Pylori Eradication on Gastric Pathology: a Long-term, Prospective Cohort Study

Helicobacter pylori (H. pylori) infection, affecting an estimated 50% of the global population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. By causing progressive damage to the stomach and may eventually result in gastric atrophy, H. pylori infection has been demonstrated to be responsible for more than 95% of gastric malignancies


Eligibility Criteria:
Inclusion Criteria:

* Patients with H. pylori infection;
* Aged 18-65 years.

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Conditions unsuitable for performance of gastroscopy, such as coagulopathy, impaired renal function;
* Pregnancy or breastfeeding;
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Sleep Disorders Pre and Post Liver Transplantation

Sleep disturbance and sexual dysfunction are common complaints of patients with cirrhosis . The term sleep disturbance describes insomnia, poor quality sleep, circadian rhythm disorders and obstructive sleep apnea and is associated with reduced health-related quality of life (HRQoL) score indices. Sleep and sexual disorders have only been formally evaluated in small studies in these patients and to date, no studies have objectively assessed these patients. In addition, no studies have been performed in these patients after liver transplantation. The investigators' hypothesis is that sleep and sexual disturbance is commonly seen in patients with advanced cirrhosis and improves after liver transplantation. However, despite this, HRQoL remain impaired because of residual sleep disturbance.This study will be unique in providing cross-sectional follow-up of patients with cirrhosis at baseline and after liver transplantation (\> 6 months).


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* Comprehend and read English
* On liver transplantation list or post-liver transplantation

Exclusion Criteria:

* Non-English speaking
* \< 18 years and \> 85 yrs
Condensed Nanofat Grafting for Treatment of Androgenetic Alopecia

Nowadays, multiple treatment modalities have been applied clinically to treat androgenic alopecia, such as Follicular unit transplantation(FUT), finasteride, platelet-rich plasma injection(PRP), etc. In this clinical trial, the investigators aim to analyze the effect of nanofat grafting on treating androgenic alopecia in male.

The investigators will treat the hair loss area of a patient by processed nanofat grafting. The participants were asked to come back 1、3、6、9、12 months after treatment for further follow-up.

Before and after the treatment, the hair and follicular will be assessed subjectively by satisfaction assessment, dermatoscope.

Eligibility Criteria:
Inclusion Criteria:

* Male patients with androgenic alopecia aging from 18 to 50.
* No scars and wounds on the alopecia area.
* No skin disease or serious cardiovascular disease.
* Preoperative examinations remain healthy.

Exclusion Criteria:

* Serious chronic heart, liver, kidney, blood system disease
* Allergic diseases, skin inflammation or wounds
* Alopecia but not androgenic alopecia
* Acute or chronic infection
* Take anticoagulant drugs
* Active vitiligo, psoriasis, systemic lupus erythematosus
The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product

This study is to quantify the effect of a natural fruit extract added to a wheat product on the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE \* Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian male.
* Body mass index (BMI) ≥ 18.0 and ≤ 25.0 kg/m2.
* Apparently healthy: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
* Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/liter (i.e. 62- 110 mg/dl) at screening.
* HbA1c ≤ 6.5 % (48 mmol/mol).

Exclusion Criteria:

* Use of antibiotics within 3 months before Day 1; use of any other medication except paracetamol within 14 days before Day 1.
Anesthesia Depth Increases Delirium Incidence

This study aimed to determine whether targeting bispectral index (BIS) readings of 55 (light anaesthesia) was associated with a lower incidence of delirium, dementia (POD), POCD and mortality but higher rates of awareness and complications than a standard of care anaesthesia blinded to depth monitoring.

Design: Randomised-controlled, double blind study, monocentric Setting: Level 2 medical center, major surgery (non cardiac) Ethics: Ethical approval for this study (Ethikkommission II der Ruprecht-Karls-Universität Heidelberg 2013-627N-MA) was provided by the Ethical Committee II University Medicine Mannheim, University of Heidelberg, Germany (Chairperson Prof W. Striebel) on Mai 12th 2008.

Patients: n=130, aged \> 70y Intervention: Light anesthesia (BIS 55 +/-5) vs. Standard of Care (BIS- blinded) Main outcome measures: Incidence of awareness, delirium, postoperative cognitive deficit (POCD), dementia (POD), memory (MAT with a computerized score for verbal working\&short term, figural working\&short term memories and well as attention level) Second aims: mortality, complications

Eligibility Criteria:
Inclusion Criteria:

* scheduled for major surgery above 60 min duration
* informed consent

Exclusion Criteria:

* emergency surgery with large blood loss and/or preoperative cardiovascular instability, scheduled regional or neuraxial anesthesia, language barriers with the unability to understand a German audio tape, unability or unwillingness to consent,hearing disabilities
A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study

The study conducted on cancer patients is designed to test safety and efficacy of limb hypothermia in cancer patients using the new Paxman Limb Cryocompression System (PLCS). Ultimately this will lead to the development of a therapy regime that will help to prevent chemotherapy-induced neuropathy in cancer patients.

The study will consist of 80 cancer patients, recruited from the National University Hospital and Curie Oncology. Based on an established optimal temperature and pressure of limb cryocompression, cancer patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and efficacy of repeated therapy. Cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. The limbs will be cooled from the digits to the elbow/knee.

Eligibility Criteria:
Inclusion Criteria:

* Age 21- 80 years.
* Signed informed consent from patient or legal representative
* Scheduled to receive weekly paclitaxel chemotherapy
* Patients may receive other chemotherapy drugs alongside taxane e.g. Platinum/Herceptin.

Exclusion Criteria:

* Open skin wound or ulcers of the limbs
* History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
* Pregnant woman
* A score of more than 5 in Total Neuropathy Score (TNS) at baseline for cancer patients