cyrilzakka/clinical-trials huggingface dataset:
ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer

Feasibility study of a 12-week multidisciplinary telehealth rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer

A single arm feasibility study will be conducted to examine the feasibility of delivering the 12-week ReStOre programme (aerobic and resistance physiotherapy led-exercise, 1:1 dietary counselling and group education sessions) via telehealth to a cohort of upper gastrointestinal cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* be ≥ three months post oesophagectomy, total gastrectomy
* ± neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent
* adjuvant therapy must be completed
* access to home broadband

Exclusion Criteria:

* Ongoing serious post-operative morbidity
* Evidence of active or recurrent disease.

In addition those with any serious co-morbidity that would impact on exercise participation will be excluded including those with;

* Uncontrolled hypertension (resting systolic blood pressure \>180mmHg and/or diastolic \>100mmHg)
* Recent serious cardiovascular events (within 12 months) including, but not limited to cerebrovascular accident, and myocardial infarction
* Unstable cardiac, renal, lung, liver or other severe chronic disease
* Uncontrolled atrial fibrillation
* Left ventricular function \<50%.
A Test of Different Degrees of Cost Sharing on Program Uptake and Attendance

To test the uptake of four different cost sharing discounts for enrolling in the Weight Watchers weight loss program as well as outcomes (program attendance and weight loss) over 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Must be employee of Vanguard Health Systems over the age of 18
2. Must have a BMI of 21 or greater

Exclusion Criteria:

1. Must not be under the age of 18
2. Must not have a BMI lower than 21
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia

This is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of CKD-391 and CKD-331 in patients with primary hypercholesterolemia

Participants were randomly assigned in a 1:1:1:1 ratio to the following groups: combination therapy of D377 and CKD-331, D377, CKD-331, and D086. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 19 years of age
* Primary hypercholesterolemia
* Patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator

Exclusion Criteria:

* Secondary hypercholesterolemia
* Conditions / situations such as:

  1. Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels
  2. Severe renal impairment or active liver disease
* History of hypersensitivity or allergies to investigational drugs or drug of similar chemical classes.
* History of drug abuse or alcoholism within 24 weeks before screening
* Any surgical or medical condition which might significantly affect the absorption, distribution, metabolism, or excretion of investigational drugs
* Patients who have been taken with other investigational drugs within 8 weeks before screening
Music Role in PD Rehabilitation

Neurologic Music Therapy (NMT) sensorimotor techniques are increasingly used to improve spatio-temporal gait parameters and postural stability in the course of Parkinson's Disease and following stroke. Nonetheless, the neurophysiological underpinnings of NMT-mediated gait recovery is still poorly understood.

The aim of the study was to investigate the central mechanisms of connectivity related to the application of Rhythmic Auditory Stimulation (RAS) in PD gait rehabilitation. The investigators will enroll 30 patients with PD. They will be randomized into two groups: (A) gait training with Music; (B) conventional treadmill gait training. The experimental group will perform training by means of GT3 (Biodex), where the patient is able to walk (on a treadmill) following specific musical beets and rhythms. The control group will perform only gait treadmill training.

Subjects will attend 3 sessions a week for at least 4 weeks. Each session will last 45-min.

The aim of the study was to investigate the central mechanisms of connectivity related to the application of Rhythmic Auditory Stimulation (RAS) in PD gait rehabilitation. The investigators will enroll 30 patients with PD. They will be randomized into two groups: (A) gait training with Music; (B) conventional treadmill gait training. The experimental group will perform training by means of GT3 (Biodex), where the patient is able to walk (on a treadmill) following specific musical beets and rhythms. The control group will perform only gait treadmill training.

Subjects will attend 3 sessions a week for at least 4 weeks. Each session will last 45-min.

The investigators will assess the gait performance and pattern by using System BTS Smart for gait and the sensorimotor functional connectivity by using EEG, both before and after the therapy cycle. The patients will be clinically evaluated by means of Time up and go test, and ten meters. The overall motor function will be evaluated through the UPDRS III.

Power calculation by Cohen (1992) methodology will be utilized for this pilot study. Shapiro-Wilk test was applied to assess the normality of distribution. Thus, parametric and non-parametric tests will be employed for all comparisons (Wilcoxon test, ANOVA). Mann-Whitney test or ANOVA will be utilized to evaluate the level of significance in differentiation between the examined groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by PD;
* MMSE \> 21
* Hoehn and Yahr \<3

Exclusion Criteria:

* Presence of severe cognitive deficit
* Severe motor impairment (Hoehn and Yahr \>3)
* Medical illness potentially interfering with the training
The Difference Between the Extrafascial Injection and the Subfascial Injection of Quadratus Lumborum Block

Quadratus lumborum block can be used for the hip surgery and abdominal surgery postoperative analgesia. But the lower thoracic to the hip dermatome can't be blocked at the same time. The anesthetists used the same method, but had produced the different dermatome were blocked. The investigators hypothesized that this was due to local anesthetics was injected to different locations of the anterior thoracolumbar fascia. If the investigators inject local anesthetics to the anterior layer of thoracolumbar extrafascial, this produced the dermatomal coverage from lower abdominal to hip. A different situation was when the investigators injected local anesthetics to anterior thoracolumbar subfascia, the lower thoracic dermatome were blocked.

Quadratus lumborum block can be used for the hip surgery and abdominal surgery postoperative analgesia. But the lower thoracic to the hip dermatomes can't be blocked at the same time. The anesthetists used the same method, but had produced the different dermatomes were blocked. The investigators hypothesized that this was due to local anesthetics was injected to different locations of the anterior thoracolumbar fascia. If the investigators inject local anesthetics to the anterior thoracolumbar extrafascial (between the anterior layer of thoracolumbar fascia and psoas major muscle), this produced the dermatomal coverage from lower abdominal to hip. In this case, the investigators speculated the local anesthetic spread to the lumbar paravertebral space via the fascia and the fascicle of psoas major. A different situation was when the investigators injected local anesthetics to anterior thoracolumbar subfascial (between the anterior layer of thoracolumbar fascia and quadratus lumborum), the lower thoracic dermatomes were blocked. The investigators speculate that the local anesthetic injected subfascial could spread cephalad to lower thoracic paravertebral space posterior to the endothoracic fascia via lateral arcuate ligament.

The investigators confirm the hypothesis in the pilot trial. therefore, the investigators need to trial with large sample. The investigators plan to improve the clinical guidance of quadratus lumborum block technology, so that more patients benefit.

Eligibility Criteria:
Inclusion Criteria:

* Participants undergoing laparoscopic cholecystectomy. ASA: I\~II. BMI: 17\~32. The operation time is less than 2 hours. Participants volunteered for the trial.

Exclusion Criteria:

* Pregnant and lactation women. Coagulation disorders. Drug allergy. Can not communicate normally. Bacteremia. Emergency surgery. ASA: \>III.
phenotypeS in Non Ambulant Duchenne Muscular Dystrophy

The aims of the study are to prospectively collect information on several aspects of function in non-ambulant DMD patients by using a structured battery of tests including motor, respiratory and cardiac function

The aims of the study are to prospectively collect information on several aspects of function in non-ambulant DMD patients by using a structured battery of tests including motor, respiratory and cardiac function, to retrospectively review similar information on the data collected in the last decade and to establish the effect of steroids after loss of ambulation on different aspects of function.

We also aim to use this integrated approach to identify patterns of severity and progression, the most appropriate outcome measures and endpoints in each group and possible genotype/phenotype correlations.

Eligibility Criteria:
Inclusion Criteria:

* Children with genetically confirmed diagnosis of Duchenne Muscular Dystrophy will be included in the study. We will include all Duchenne Muscular Dystrophy boys who have lost the ability to walk independently.
* All patients in whom consent can be obtained will be enrolled with no exclusion criteria.

Exclusion Criteria:

* Patients lacking genetic confirmation of Duchenne Muscular Dystrophy
* Patients still able to walk for more than 10 meters.
Testing Methods of Self-persuasion Involving Cigarette Smoking

Smokers who are not actively engaged in quitting will participate in a study using self-generated text and audio text messages containing reasons to quit smoking.

Participants must have a smartphone that can accept text messages from an email address and link to a study related website to hear audio recordings, and be willing to receive a text message each weekday for two weeks between 8-9am as part of the study. After completing a phone screener, participants will complete a baseline phone survey. Within two weeks of the baseline survey, participants will come to an in-person session. At that time they will be randomized with equal probability to one of two conditions: 1) Motivational Interviewing (MI), or 2) tailored feedback on reasons for quitting. After undergoing MI or receiving tailored feedback, participants will be asked to generate message that they feel would motivate them to quit. These messages will be both text and audio. After generating and reviewing these messages, participants will then evaluate these messages before ending the laboratory session. Starting two days after their laboratory session, between 8:00am and 9:00am, staff will send participants one of the self-generated text messages with a link to also hear the message; this process will last for two weeks. Within a week of stopping sending messages, participants will be asked to complete a final phone survey to elicit smoking behaviors and provided feedback on the messaging.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* not actively engaged in trying to quit smoking
* must have smoked 100 cigarettes to date
* must smoke at least 1 cigarette per day
* must own smartphone capable of receiving messages from study email
* must agree to receive text messages between 8-9am each weekday for 2 weeks
Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness

This project will assess the utility of a brief motivational intervention to engage smokers with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a brief motivational intervention will be more effective in engaging smokers with schizophrenia to tobacco dependence treatment than an educational intervention. The educational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by teaching subjects about the negative effects of smoking and the success of tobacco dependence treatment. The motivational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by increasing subjects' motivation to change by presenting objective and personalized information regarding their smoking behaviors in a non-judgmental and supportive manner.

See Brief Summary above.

Eligibility Criteria:
Inclusion Criteria:

* Current smokers must be over the age of 18,
* Must have a diagnosis of schizophrenia or schizoaffective disorder
* Must smoke at least 10 cigarettes per day
* Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22

Exclusion Criteria:

•Those unable to give informed consent.
Nivolumab, BMS-936558 in Combination with Relatlimab, BMS-986016 in Patients with Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting

The main goal of this study is to evaluate the antitumor activity of relatlimab and nivolumab in combination in subjects with unresectable or metastatic melanoma who have not received prior treatment with immunotherapy.

This study will evaluate the antitumor activity of anti-LAG3 monoclonal antibody relatlimab and the anti-PD1 monoclonal antibody nivolumab in combination in subjects with unresectable or metastatic melanoma who have not received prior treatment with immunotherapy. The trial is designed with a lead-in phase of 2 cycles (4 week) treatment of either nivolumab, relatlimab, or the combination of nivolumab/relatlimab, followed by a combination phase of nivolumab/relatlimab treatment in all subjects. This lead-in design with accompanying tumor biopsies and peripheral blood analyses will enable mechanistic analyses of the effect of LAG3 and PD1 blockade alone and in combination to enhance understanding of mechanisms of response and resistance. Duration of response, progression free survival, and safety will be assessed as secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

• Men or women 18 years of age or older meeting AJCC 8th edition criteria for unresectable stage IIIB, stage IIIC, stage IIID, or stage IV melanoma who have not received treatment with immunotherapy in the metastatic setting

Exclusion Criteria:

* Known or suspected CNS metastases, with the following exceptions:

  * Subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment at the time of consent. Subjects must be off steroids for at least 2 weeks prior to randomization.
  * Subjects with signs or symptoms of brain metastases are not eligible unless brain metastases are ruled out by computed tomography or magnetic resonance imaging.
* Active autoimmune disease requiring treatment, with the exception of type 1 diabetes mellitus, vitiligo, resolved childhood asthma/atopy, controlled hyper/hypothyroidism, hypoadrenalism or hypopituitarism.
* Prior systemic treatment in the metastatic setting, including anti-PD1, anti-PDL1, anti-PDL2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways; or chemotherapy.
* Prior adjuvant treatment with anti-PD1, anti-PDL1, and/or anti-LAG3 antibody. Note that prior adjuvant treatment with targeted therapy (e.g. BRAF/MEK inhibition), anti-CTLA4, or treatment not otherwise specified above would be permitted.
* Ocular melanoma
Comparative Study Between Russian And Exercise in Subjects With Flexible Flatfoot

The prevalence of flexible flat foot was 13.6% in adults a cross-sectional Study (for males-12.8%; for females-14.4%).18-21-year-old Indian adults. This trial aims to compare between the effects of Russian current for tibialis posterior muscle and comprehensive exercise alone in subjects suffering from flexible flat foot on quality of life, ROM, strength of tibialis posterior and foot posture


Eligibility Criteria:
Inclusion Criteria:

* The patient's age ranges from 20 to 25 years.
* Both genders.
* patients suffering from symptomatic flat foot

Exclusion Criteria:

* Rigid flatfoot.
* Pregnancy and lactation.
* recent fracture and fixation.
* genu valgus.
* cardiac pacemaker.
* inflammatory disorders / rheumatoid arthritis.
National Study "AEC COVID-19"

Currently there is an important need to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. With a national data collection, information could be obtained to guide the management of this group of complex patients operated on during the COVID-19 pandemic, with the aim of improving their treatment in the event of a second wave. The great spread of the virus and the difficulty in controlling it over time makes it a high priority for the scientific community in order to face new outbreaks.

The national study "AEC COVID-19" is a collaborative study (in the style of those carried out at European level such as Eurosurg, Globalsurg, etc.) that aims to know the evolution, results and associated mortality of patients undergoing surgical intervention in Spain during the SARS-CoV-2 pandemic. It is an observational study, with anonymized and coded data, which aims to demonstrate the following hypotheses:

* Patients with COVID-19 have high mortality.
* Patients with both oncological and benign pathologies have high morbidity.

The situation / follow-up at 7 days and 30 days after the intervention will be included in each patient.


Eligibility Criteria:
Inclusion Criteria:

Adult patients who undergo a surgical procedure during the pandemic

Exclusion Criteria:

-
Benchmarks in Elective Laparoscopic Cholecystectomy

The aim of this observational cohort study is to define peri- and postoperative reference values for elective laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. The over-arching aim is to inspire quality improvement initiatives.

The data source is the Swedish patient registry GallRiks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ERCP). The time frame will be 2015-2023. Register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. The study will analyze data for the time of surgery and up to 30 days afterwards. Since the data is not yet available to the researchers the number of enrolled study participants can not be specified with certitude; therefore an anticipated number is given.

Eligibility Criteria:
Inclusion Criteria:

* adults ≥ 18 years of age
* laparoscopic primary cholecystectomy

Exclusion Criteria:

* patients with current acute cholecystitis, pancreatitis or cholangitis
* cholecystectomy due to malignancy
* other organ surgery performed at the same occasion
* previous upper gastrointestinal surgery
* single port access
* robotic surgery
* no data concerning surgical intervention
Are we Loading Our Patients With Sodium During Hemodialysis Treatments?

The objectives of the data search is to find out if there is correlation between pre, post serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and associated changes in pre and post systolic and diastolic blood pressure, mean arterial pressure, number of blood pressure medications and adherence to 3 times per week dialysis, mortality.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patient
Diagnostic Accuracy of a Novel Machine Learning Algorithm to Estimate Gestational Age

This is a prospective cohort study of women enrolled early in pregnancy, with randomization to determine the timing of three follow-up visits in the second and third trimester. At each of these follow-up visits, investigators will assess gestational age with the FAMLI technology and compare that estimate to the known gestational age established early in pregnancy.

The primary purpose of this research is to assess the diagnostic accuracy of the FAMLI Technology, a novel machine learning-based tool for gestational age assessment that can run on a smart phone or tablet. Study staff will enroll 400 pregnant volunteers prior to 14 completed gestational weeks and obtain accurate "ground truth" gestational age dating with standard ultrasound biometry, using the crown-rump length. These participants will then be asked to return for three follow-up visits, which will include a routine sonogram performed by a trained sonographer and the collection of a set of blind sweep cineloop videos using a low-cost, battery-operated device. The research will be conducted in Chapel Hill, North Carolina (at the University of North Carolina Hospital and/or sites associated with UNC OBGYN) and in Lusaka, Zambia (at the University Teaching Hospital or Kamwala District Health Centre). Approximately equal numbers of participants will be enrolled from each country.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* viable intrauterine pregnancy at less than 14 0/7 weeks of gestation
* ability and willingness to provide written informed consent
* intent to remain in current geographical area of residence for the duration of study
* willingness to adhere to study procedures

Exclusion criteria:

* maternal body mass index = 40 kg/m\^2
* multiple gestation (i.e., twins or higher order)
* major fetal malformation or anomaly
* any other condition (social or medical) that, in the opinion of the study staff, would make study participation unsafe or complicate data interpretation.
Diabetic Gastroparesis Study 05

This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 \[NCT03420781\] or RLM-MD-04 \[NCT03383146\] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of either Study RLM-MD-03 or Study RLM-MD-04
* Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures
* Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator.

Exclusion Criteria:

* Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020
* Participant has an unresolved adverse event (AE) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
* Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease
* Females who are pregnant, nursing, or planning a pregnancy during the study.