cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Oral Nutritional Supplements (ONS) in a Meals-on-Wheels Population

Researchers will measure weight, height, hand grip strength and quality of life information of Meals on Wheels (MOW) clients who are considered to have nutrition problems. Participants will randomly be put into a group that receives either typical meals from Meals on Wheels or Ensure Plus supplements with their meals. Three months later the same data will be collected again. The objective of this study is to demonstrate the effectiveness of providing oral nutritional supplements (ONS) to MOW clients with or at risk of malnutrition on nutritional status over a 3-month period.

While it is well known that older adults are at increased nutritional risk and that nutrition intervention, such as oral nutritional supplementation (ONS) is beneficial in this population, there is limited research on the effect of oral nutritional supplements (ONS) in the Meals on Wheels population. This prospective randomized controlled trial will determine the effectiveness of oral nutritional supplements (ONS) in addition to daily meals from Meals on Wheels on weight status, hand grip strength, quality of life, and malnutrition screening scores in MOW clients with or at-risk of malnutrition over a 3-month study period.

Eligibility Criteria:
Inclusion Criteria:

* Participant is Meals on Wheels Inc. of Tarrant County client.
* Participant is 60 years of age or older.
* Participant is identified as medium or high risk of malnutrition as defined by the MST (Medium Risk MST score =2-3 or High Risk MST score =4-5).
* Participant is willing and/or able to consume oral nutritional supplements (ONS).
* Participant provides written informed consent to participate in the study.
* Participant provides authorization to use and/or disclose personal and/or health data.

Exclusion Criteria:

* Patient cannot safely consume an oral nutritional supplement (ONS).

  * Example Patient has active gastrointestinal disease (e.g., intestinal obstruction, inflammatory bowel disease, ischemic colitis, diverticulitis, irritable bowel disease, pancreatitis).
* Patient has Diabetes mellitus.
Anastomotic Leaks in Esophageal Squamous Cell Carcinoma Patients After Trimodal Therapy

To investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the prognosis of anastomotic leak.

The goal of this observational study is to investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the postoperative complications, mortality, and long-term survival of different types of anastomotic leak.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed ESCC;
* clinically staged as T3-4aN0M0 or T1-4aN+M0 by the eighth edition of the American Joint Committee on Cancer and treated with nCRT followed by McKeown esophagectomy24;
* aged 18-75 years;
* Eastern Cooperative Oncology Group performance status score ≤ 2.

Exclusion Criteria:

* cervical esophageal cancer;
* previously treated with chest radiotherapy, esophageal, or gastric surgery;
* insufficient clinical data.
Erb:Yag Laser Versus Pelvic Floor Training for the Treatment of Women With Mild to Moderate Stress Urinary Incontinence

This is a pilot study to assess the feasibility and safety to run a randomized controlled trial that compared the effectivity of erbium:yag vaginal laser versus pelvic floor training in women with mild to moderate stress urinary incontinence.

This pilot study attempts to demonstrated the feasibility and security to run a randomized controlled study that compared the effectivity of erbium:yag laser used vaginally versus pelvic floor training, coached by a physiotherapist expert in pelvic floor disorders.

Patients are going to be randomized to pelvic floor exercises (10 sessions) or erbium:yag laser (2 sessions), and assess the results at 6 and 12 moths later on.

Eligibility Criteria:
Inclusion Criteria:

* Mild to Moderated Stress Urinary Incontinence

Exclusion Criteria:

* Mixed Urinary incontinence
* Pelvic organ prolase greater than stage 2
* Previous surgery for stress urinary incontinence and/or pelvic organ prolapse
* Severe Stress urinary incontinence
Importance of Forces and Safety Features in Car Crash Multitrauma

The pupose of the study is a prospective evaluation of external and internal factors/causes of importance for the trauma and final outcome experienced by persons inside motor vehicles in serious car accidents. We hypothesise that there is an association between the use and function of safety features and the results for the patient and an association between material damage and the severity of injury.

We plan to study approximately 200 road accidents with multitraumatised patients and accidents with modern cars and severe material damage with little or moderate damage to persons inside the vehicle. A researcher will be alerted by the call centre (Norwegian 911-equivalent), move to the place of accident and take a pure observers role (unless ethically unacceptable due to lack of other health personnel). He will document the accident including use and condition of safety features, conditions inside the coupe, weather conditions, etc. Other available information on the vehicles, crashtests etc will be gathered from the manufacturer. All medical information will be gathered from the ambulance service, hospitals, pathology and forensic departments. Information from police and fire department will also be gathered.

Patient, next-of-kin, others invloved will be interviewed as appropriate in follow-up.

Four accident groups: Front-to-front or -object \> 60 km/hour, same \< 60 km/hour, car rolled over on road, car rolled over out-of-road. Factors: Age of vehicle, damage to coupe, cause of accident, on-scene time, initial evaluation by health personnel, injury severity scoring in hospital.

Eligibility Criteria:
Inclusion Criteria:

* patients with multiple trauma from severe motor vehicle accidents in Eastern Norway patients from motor vehicle accidents in Eastern Norway with severe material damage
Effect of Breathing Techniques on Migraine Attacks and Severity

Background:

Migraine is a very common neurobiological disorder caused by increased excitability of the Central Nervous System. It is among the causes of the highest morbidity worldwide. Migraine has considerable economic and social impact ; affects the quality of life of patients and disrupts work life, social activities and family life. To decrease the frequency and severity of migraine attacks may be the first goal than treating the attacks.

The study was designed as a Parallel Group, Add on, Randomized Controlled Experiment in order to observe the effects of breathing techniques on migraine-like headaches, frequency and severity.

Methods:

Participants will be divided into 2 parallel arms, intervention and control (treatment as usual). Cluster randomization will be performed to prevent intergroup contamination. Breathing techniques will be taught to the intervention group by the researcher. Both groups will continue to use pharmacotherapy for migraine. Both groups will be evaluated with migraine disability level (MIDAS) at the beginning and end of the study. The primary output of the study is to evaluate the effect of breathing techniques on the frequency and severity of attacks in migraine-like headaches. The secondary output is to evaluate the effect of breathing techniques on the MIDAS level.

Discussion:

The results of the study will provide information about the effect of breathing techniques on migraine-like headaches. The results of this study will contribute to the literature, since migraine is among the chronic diseases and pharmacotherapy options are limited.


Eligibility Criteria:
Inclusion Criteria:

* Are 18-50 Age
* Have a computer and/or smart phone
* Have an internet connection that can be used at home and at work (with a computer or smart phone)
* Are volunteer to participate in the research
* Have Frequency of attacks less than 3 months
* Fulfil diagnostic criteria of migraine like headaches

Exclusion Criteria:

* Severe anatomical defect in the airway
* Pregnancy
* Having any diagnosed psychiatric disease
* Using psychiatric medication
* Having speech and hearing problems
* Having any chronic disease which may be worsening by taking deep breath
Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site

Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function


Eligibility Criteria:
Inclusion Criteria:

1. All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
2. Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.

Exclusion Criteria:

1. Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
2. Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
3. Morbid obesity (BMI \>40).
4. Inability to maintain wrist immobilization for full planned period.
5. Severe malnutrition (prealbumin levels \<10 mg per dL within 30 days prior to surgery OR BMI \<15 (very severely underweight).
6. Other conditions felt to significantly impair wound healing per surgeon discretion.
The Effects of Dexmedetomidine on cTnI and GP-BB in Patients Undergoing OPCABG

The purpose of this study is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients undergoing off-pump coronary artery bypass Grafting.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist used as a sedative or adjuvant anesthetic drug in clinical settings.From clinical observation, dexmedetomidine has been revealed to reduce the incidence of cardiovascular adverse events in patients with heart diseases during non-cardiac surgeries.Therefore, the aim of this sudy is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients during cardiac surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing off - pump coronary artery bypass grafting
* ASA physical status III-IV
* Aged 40-70 years
* NYHA physical status II-III

Exclusion Criteria:

* Bradycardia
* Atrioventricular block
* Echocardiography suggested:LVEF \<40%, LVED\>65mm
* Allergic to the drugs
A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma (RCC) in the UK

Clinical experience with cabozantinib is limited in the UK and Ireland and there is anecdotal evidence of there being variability between clinicians in terms of where cabozantinib is used in the treatment pathway. The present study aims to collate and report the experiences of a sample of National Health Service (NHS) Trusts that enrolled patients onto the managed access programme. The study will describe the positioning of cabozantinib in the treatment pathway, associated clinical outcomes and characteristics of patients with advanced RCC receiving cabozantinib in this early clinical experience setting. The results will provide valuable information for collective learning on how to prescribe and manage cabozantinib and its optimal positioning in the patient pathway. Overall, the findings will contribute to a better understanding of how best to manage patients with advanced RCC in routine practice.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of advanced RCC
* Prescribed cabozantinib as part of the Managed Access Programme (MAP) (alive or deceased at study data collection)
* Aged ≥18 years at start of cabozantinib treatment.

Exclusion Criteria:

* Decline or lack the capacity to consent for researcher access to their medical records (if living)
* Hospital medical records are unavailable for review
Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors

This clinical trial evaluates the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates. A coaching-based navigation may perform a needs assessment and coach the participant to access relevant supportive content including physical rehabilitation, emotional and psychosocial support, and nutrition and exercise programming. This trial aims to see whether this navigation program may improve the quality of life of black breast cancer survivors.

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates.

SECONDARY OBJECTIVES:

I. To evaluate the preliminary impact of health coaching on completion of scheduled survivorship related referrals and participation in support services.

II. To determine the preliminary impact on quality of life and self-efficacy pre and post coaching.

OUTLINE:

Patients are assigned a Black patient navigator for racial concordance and receive coaching from patient navigator over 30 minutes every other week for 3 months and then monthly for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Black women \> 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment
Effects of Endurance Training on Patients With Reduced Left Ventricular Ejection Fraction (LVEF) and Cardiac Resynchronisation Therapy Especially for Cardiac Arrhythmias

A severely reduced left ventricular ejection fraction is associated with increased mortality due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that targeted training may lead to improved survival and to increased parameters of risk stratification for malignant arrhythmia. Additionally, the training may lead to an improved psychological and mental condition of the patients


Eligibility Criteria:
Inclusion Criteria:

* CRT Device

Exclusion Criteria:

* refused informed consent
Clinical Trial to Evaluate the Tolerability and the Pharmacokinetics of CKD-348

A phase I clinical trial to evaluate the tolerability and the pharmacokinetics of CKD-348.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who meet the blood pressure criteria during screening tests:

   * Systolic Blood Pressure: 90 to 139 mmHg
   * Diastolic Blood Pressure: 60 to 89 mmHg
4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 1ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial.
7. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
5. Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.

   * Alcohol: Man - 21 glasses/week Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
   * Smoking: 20 cigarettes/day
6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
8. Those who are deemed insufficient to participate in this clinical trial by investigators.
9. Woman who are pregnant or breastfeeding.
Pediatric ANCA Associated-vasculitis

The incidence in pediatrics is very low (about 0.5 per million according to a French study) and therefore the data on the pathology very poor, especially on the therapeutic level.

Without appropriate treatment, the mortality rate of the pathology is very high.

Existing treatments are almost exclusively composed of immunomodulatory and/or immunosuppressive treatments.

Complications related to pathology and iatrogeny are among the first causes of mortality from this pathology and deserve to be studied in order to be known and if possible avoided. The purpose of the study is to achieve a national comparison of clinical and therapeutic practices.


Eligibility Criteria:
Inclusion criteria:

* Minor subject (\<18 years old)
* Diagnosis of ANCA vasculitis according to the international criteria for defining the pathology, GPA or MPA form between 2011 and 2020.
* Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject (or his parents) having expressed his (their) opposition to participating in the study
* Patients with vasculitis has ANCA in the form of EGPA
* Associated pathologies that cannot be related to the diagnosis of ANCA vasculitis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.
The Effects of Intra Operative Hand Reflexology for Patients Receiving Out Patient Vein Surgery

This randomised controlled trial aims to compare the effectiveness of hand reflexology received during office based vein surgery, under local anaesthetic on patient's reports of pain and anxiety, compared to usual standard care.

The negative effects of anxiety and pain on surgical recovery are well documented. It is also accepted that distraction can be effective in pain reduction. This randomised controlled trial will explore the effect of intra operative hand reflexology on pain perception and anxiety during office-based surgery under local anaesthetic. Participants will be randomly allocated to either the experimental condition, in which they will receive a hand reflexology during treatment, or control condition in which they will receive usual standard care. Immediate and longer term outcomes will be explored.

Eight weeks after surgery, participants will return to the clinic for a follow up appointment. While they are in the waiting area they will be asked to complete a short questionnaire to assess time taken to return to pre surgical levels of functioning, pain experienced in the first four weeks after surgery, severity of venous symptoms and satisfaction with treatment.

Eligibility Criteria:
Inclusion Criteria:

* To be aged between 18 and 80
* To be able to give informed consent
* To be receiving, endovenous laser ablation or phlebectomies for the treatment of varicose veins
* To have a good understanding of written and spoken English.
* To arrive at the clinic with sufficient time before their procedure to give consent and complete the questionnaire (\>20 mins)

Exclusion Criteria:

-To be aged under 18 or over 80
International SARS-CoV-2 (COVID-19) Infection Observational Study

The general aim of this study is to estimate the rate of disease progression for adults testing positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. In some locations special facilities are being built/utilized for quarantine/public health reasons for those who are SARS-CoV-2 positive. Hospitalization is defined as a stay for at least 18 hours, irrespective of reason, at a hospital or one of these special facilities after study enrollment.

Secondary outcomes include participant-reported health status and change in severity of dyspnoea.

SARS-CoV-2 is a coronavirus that emerged in China in late 2019 causing a novel Corona-Virus Induced Disease (COVID-19). COVID-19 is spreading rapidly throughout the world. While a proportion of people with COVID-19 have sufficiently severe symptoms to require hospitalization at the time of initial symptom onset, in others the disease may remain mild, and in some cases there has been observed a worsening of symptoms a few days after initial presentation with relatively mild symptoms. There is an urgent need for understanding the progression of disease for individuals with SARS-CoV-2 infection/COVID-19 who do not require immediate hospitalization.

This is an international, observational cohort study of adults with SARS-CoV-2 infection/COVID-19 managed as outpatients (not hospitalized). This study will also be a platform for the enrollment of outpatients for randomized trials that will be conducted by the INSIGHT group.

Those with confirmed SARS-CoV-2 infection will form an observational cohort study and be followed for 28 days. Procedures and data collection have been streamlined to facilitate the enrollment of a large number of adults at INSIGHT sites around the world.

Eligibility Criteria:
Inclusion Criteria:

- Not currently hospitalized

Exclusion Criteria:

- Persons with a known positive SARS-CoV-2 test \> 28 days ago