cyrilzakka/clinical-trials huggingface dataset:
STOP CSUA: phySical acTivity, mOod and sleeP in Chronic Spontaneous Urticaria and Angioedema

Chronic spontaneous urticaria and angioedema (CSUA) is a disease of the skin characterised by hives, swellings or both that last longer than 6 weeks. People with this disease commonly describe poor sleep, reduced quality of life and psychological difficulties such as depression and anxiety. This study seeks to understand relationships between physical activity, sleep and symptoms of urticaria. We are asking individuals with urticaria to wear a fitbit tracker which monitors their physical activity and sleep. Participants also download an app onto their smartphone called Athena CX which is designed by the study team in DCU. The purpose of the app is capture real-time information from participants on mood and any skin symptoms they experience. We will use this information to learn more about possible links between symptoms of urticaria and lifestyle behaviours.

Chronic spontaneous urticaria and angioedema (CSUA) is a disease of the skin characterised by hives, swellings or both that last longer than 6 weeks (1). A quarter of patients with this disease report impaired quality of life (2). Furthermore, individuals with CSUA are more likely to have depression and anxiety (3). In addition, our previous qualitative research findings have noted issues with self-compassion among this cohort (4). Fatigue and poor sleep are common (5). We seek to examine possible links between physical activity, sleep, mood and symptoms of urticaria.

For participants who give their consent, we will do this by collecting and exploring:

* Fitbit tracker data
* Information on mood via the Athena CX app
* Information on symptoms of urticaria via the Athena CX app

Electronic health applications for smartphones are increasingly used in chronic health conditions and have been piloted in chronic spontaneous urticaria for recording of symptoms, medication reminders and patient education. This study will develop a smartphone application designed specifically for this cohort of patients, entitled Athena CX focusing specifically upon symptomatology and mood.

An observational study collecting biofeedback data in this cohort will inform our understanding of this disease and future research.

Objectives

1. To delineate the psychological symptoms encountered by this cohort of patients
2. To examine whether there is a link between biofeedback data and symptoms of chronic spontaneous urticaria and angioedema (CSUA)
3. To collect linked clinical data on participants with CSUA
4. To inform an RCT examining the use of a digital behavioural intervention for patients with CSUA

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of chronic spontaneous urticaria with or without angioedema
2. Urticaria control test score \< 12 indicating poorly controlled urticaria at time of consent
3. Preference to participate in the study
4. In possession of a smartphone

Exclusion Criteria:

Unable or unwilling to provide informed consent
"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".

The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.

24 people will be included in the pilot study (12 people will be included in the intervention group - with the usage of "autotransfusion socks" during resuscitation and 12 people in the control group - without "autotransfusion socks"). Investigators will compare the hemodynamic parameters and also neurological outcome between both groups.

The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.

Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of death in Europe.

In order to improve the hemodynamic parameters during resuscitation, device for autotransfusion was developed. Devices are basically a very strong elastic stockings that also block arterial circulation. While "putting on" stockings, blood is being squeezed from the lower extremities (approximately 500 ml of blood for each lower limb). With blood being squeezed from the lower limb into the central circulation the filling of the heart is being improved; thus the device will improve the preload and also cardiac output.

A study done on an animal model showed that during resuscitation using "autotransfusion socks" increases both systolic and diastolic blood pressure during resuscitation, the perfusion of the coronary arteries improves and also the values of the partial pressure of carbon dioxide increases.

Eligibility Criteria:
Inclusion Criteria:

* OHCA (Out of Hospital Cardiac Arrest)
* age \> 18 years
* intubated
* meets criteria for resuscitation

Exclusion Criteria:

* age \< 18 years
* not intubated
* clinical signs for DVT (deep vein thrombosis), PE (pulmonary embolism)
* clinical signs of acute inflammation of limbs, broken limbs etc.
* known oncological patient
* asphyxia
* trauma patients
Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus

Barrett's esophagus can progress to esophageal cancer, but it doesn't always. Current treatment is frequent surveillance via upper endoscopy with multiple biopsies to look for changes (dysplasia). Pathologists vary dramatically in their interpretation of Barrett's Metaplasia versus dysplasia and consensus is very difficult to achieve. The investigators propose a longitudinal study of subjects with confirmed Barrett's intestinal metaplasia without dysplasia to look for predictive factors for transformation to dysplasia or cancer. Potential biomarkers can be found in serum, plasma, urine, frozen or fixed Barrett's and Normal esophageal mucosa. In addition, the investigators are testing a brushing technique from CDx, Inc. for predictive factors. Subjects must have pathologically confirmed Barrett's intestinal metaplasia without history of dysplasia to be on this longitudinal study.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 years old)
* Subjects with pathologically confirmed Barrett's esophagus, including:
* Intestinal metaplasia without dysplasia, long and short segments (\>1 cm)
* Intestinal metaplasia without dysplasia, long and short segments (\>1 cm), previously in GLNE 003
* Intestinal metaplasia without dysplasia with indefinite-for-dysplasia (or history of indefinite-for-dysplasia) provided there is no history of HGD, or EAC.
* Intestinal metaplasia without dysplasia or indefinite-for-dysplasia with a history of LGD provided the last surveillance endoscopy showed IM alone, the LGD history was at least 12 or more months ago and there is no history of HGD or EAC.
* Able to physically tolerate removal of 34 ml of blood
* Tolerate extra research related biopsies and brushings
* Willing to permit extra biopsies at future endoscopic procedures
* Ability and willingness to complete questionnaires
* Willing to sign informed consent Exclusion Criteria
* Subjects with a pathologically confirmed history of Barrett's, HGD or EAC
* Subjects with pathologically confirmed history of Barrett's LGD within the last 12 months.
* Subjects in whom esophageal biopsy would be contraindicated (eq. varices)
* Subjects with serious infections requiring IV antibiotics
* Subjects with known HIV or chronic viral hepatitis
* Subjects on active chemotherapy or radiation treatment
* Subjects who have had an esophagectomy
* Subjects with an active malignancy diagnosed or treated within 3 years except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin; Carcinoma in situ, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy; Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery
The AID Study 2: Artificial Intelligence for Colorectal Adenoma Detection 2

Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. "Back-to-back" colonoscopies have indicated significant miss rates of 27% for small adenomas (\< 5 mm) and 6% for adenomas of more than 10 mm in diameter. Studies performing both CT colonography and colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as high as 12%. The clinical importance of missed lesions should be emphasized because these lesions may ultimately progress to CRC.

Limitations in human visual perception and other human biases such as fatigue, distraction, level of alertness during examination increases such recognition errors and way of mitigating them may be the key to improve polyp detection and further reduction in mortality from CRC. In the past years, a number of CAD systems for detection of polyps from endoscopy images have been described. However, the benefits of traditional CAD technologies in colonoscopy appear to be contradictory, therefore they should be improved to be ultimately considered useful. Recent advances in artificial intelligence (AI), deep learning (DL), and computer vision have shown potential to assist polyp detection during colonoscopy.

Average experienced endoscopists (each having performed \<2000 screening colonoscopies) will perform the endoscopic procedure.


Eligibility Criteria:
Inclusion Criteria:

* All 40-80 years-old subjects undergoing a colonoscopy

Exclusion Criteria:

* subjects with personal history of CRC, or IBD.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \> 2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent.
A Prospective, Randomized Controlled Trial Comparing Traditional Methods of Neuromuscular Block Reversal to Sugammadex for Extubation in the Operating Room in ASA 4 and 4E Patients

To demonstrate that the use of Sugammadex enables physicians to perform early extubation in the operating room in ASA 4 \& 4E patients

Primary endpoint:

• Extubation in the operating room before transfer to the PACU or ICU versus keeping the patient intubated when transferred.

Secondary endpoints:

• Time to extubation - measure the difference in time from application of the surgical dressing until extubation. Atelectasis - comparison of chest x-rays (CXR): prior to surgery, on admission to PACU or ICU and 24 hours after admission to PACU or ICU (This is the routine practice at Hadassa hospital for ASA IV patients.)


Eligibility Criteria:
Inclusion Criteria:

* ASA 4 AND ASA 4E patients
* Patients scheduled to undergo any bowel, urogenital or orthopedic surgery under general anesthesia where use of neuromuscular blocking agents is indicated. -

Exclusion Criteria:

* Patients ASA 1-3 or 5
* Patients who have a medical condition which precludes extubation at the end of surgery (i.e., mesenteric event, severe hypothermia etc.).
* Presence of an advanced directive to withhold or withdraw life sustaining treatment (i.e. DNR).
* Hypersensitivity to the active substances or to any of the excipients of medications used
* Patients with severe renal impairment (including patients requiring dialysis (CrCl \< 30mL/min))
* Patients with severe hepatic impairment
* Age \< 18 years
The Corona Study of Middle Norway

CUT COVID is a cohort study establised to collect information on patients hospitalized because or with infection by SARS-CoV-2. The cohort data includes clinical data and biological samples from multiple timepoints during hospitalization, as well as data from a followup consultation 3 months after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Positive SARS CoV-2 infection

Exclusion Criteria:

-
Short Versus Long Intramedullary Nails in the Treatment of Proximal Femur Metastasis.

The goal of this interventional randomized controlled trial is to compare the clinical outcomes in treating extremities pathological fractures (fractures of limbs caused by metastatic tumors) or impending pathological fractures with short or long intramedullary nails. The main questions it aims to answer are:

1. What is the rate of developing new distant metastasis of the operated extremities?
2. Does treating extremities (impending) pathological fractures with long intramedullary nails have lower or similar reoperation rate than the short nails?
3. Are there any differences when comparing the surgical-related complication, functional outcomes and life quality assessment between treating extremities (impending) pathological fractures with long or short intramedullary nails.

Participants who meet surgical indication will be randomized into either the long or short intramedullary nail group after informed consent. The patient will receive bone fixation with the corresponding prosthesis.

Participants will be randomized into either long or short intramedullary nail groups. Participants in the long intramedullary nail group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures, while patients in the short intramedullary nail group will be fixed with a shorter intramedullary nail (defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures. Follow-up will be performed at 1, 3, 6, and 12 months after surgery to analyze the patient's function, blood sampling values, and imaging follow-up. The functional capacity will be evaluated by PROMIS questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Femur (impending) pathological fracture that is suitable for intramedullary nail fixation as determined by the physician
* Patient is willing to participate in this clinical trial and cooperate with follow-up

Exclusion Criteria:

* The patient has a more appropriate treatment alternative to single intramedullary nail fixation as determined by the multidisciplinary decision, such as,

  * The metastatic lesions involved the femur head
  * The metastatic lesions involved the pelvis
  * The metastatic lesions compromised the greater or lesser trochanter to a certain extent that arthroplasty was indicated
  * The metastatic lesions involved/occurred more distal than the intertrochanteric line
* There are justified, clinically significant rationales that either long or short intramedullary nails be a more appropriate treatment during pre-operative assessment
* The patient has imaging-confirmed distant femoral metastases before treatment
* Patient has renal cell carcinoma or sarcoma
* Patient is unable to cooperate with follow-up or to understand the trial protocol
* Patient is unable to communicate in Chinese
Clinical Study of a Fluid Accommodating Intraocular Lens (IOL) Design

The purpose of this clinical study is to evaluate the surgical, refractive, and visual outcomes with implantation of an investigational intraocular lens (IOL).

In this study, eligible subjects will receive cataract surgery with IOL implantation in both eyes. IOL implantation in the second eye is intended to occur between 7 and 15 days after IOL implantation in the first eye. Subjects will be followed for 1 year after implantation.

This study will enroll 2 cohorts. Cohort 1 subjects will be randomized to receive either the test IOL (BAL-FAIOL) or the control IOL (Monofocal). Cohort 2 subjects will receive the test IOL only (BAL-FAIOL). Cohort 2 will follow Cohort 1.

This study will be conducted in Central America.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Subjects taking medications that may affect accommodation;
* Clinically significant eye abnormalities as specified in the protocol;
* Previous eye surgery as specified in the protocol;
* Other protocol-specified exclusion criteria may apply.
Clinical Evaluation of Tunneled Coronally Advanced Flap v.s Coronally Advanced Flap With Graft for Gingival Recession

The goal of this clinical trial is to evaluate gingival recession depth reduction using tunneled coronally advanced flap compared to coronally advanced flap, both combined with connective tissue graft in patients with isolated RT2 gingival recession sites.

Gingival recession can cause clinical conditions that could be of main concern for patients. Techniques aiming for coverage of the gingival recession aim to address dentin hypersensitivity, non-carious cervical lesions (NCCLs) and enhance patient's esthetics (Cortellini \& Bissada, 2018). Mid-buccal gingival recessions have been associated with patient's esthetic discomfort (Zucchelli \& Mounssif, 2015). Most of the studies in the literature focus on the treatment of RT1 recession as they have the most favorable prognosis of full root coverage (Barootchi et al., 2020). Despite most studies focusing their attention on RT1 cases, RT2 defects are found to be the most prevalent type with 88.8% among patients according to (Romandini et al., 2020).

The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. However, these two approaches have commonly been regarded as alternatives to each other, with clinicians choosing to perform only one of them during root coverage procedures.

(Barootchi \& Tavelli, 2022) aimed in his conducted case series to designate a surgical technique to treat isolated RT2 gingival recession defects in which he was trying to achieve and combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. The study concluded that the combination of both techniques in the same surgical design can have the potential to enhance flap and graft vascularization and improve clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction.

So, this clinical trial aims to address this gap of the literature.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18 years or older.
2. Isolated recession defect classified as RT2.
3. Patients with healthy systemic condition.
4. Clinical indication and/or patient request for root coverage.
5. O'Leary index less than 20%.

Exclusion Criteria:

1. Pregnant females
2. Smokers: a contraindication for any plastic periodontal surgery.
3. Unmotivated and uncooperative patients with poor oral hygiene
4. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.
Evaluation of Impacts of Health Education for Children of Microcredit Clients in Peru

This purpose of this study is to determine whether a health education intervention for clients of a microcredit organization in Peru will improve health outcomes among clients and their children.

An increasingly popular scheme for poverty alleviation is microcredit, the awarding of small loans to individuals too poor or too remote to take advantage of traditional lending services. Studies have repeatedly shown that income is one of the factors strongly associated with physical and mental wellbeing. Yet economic growth alone doesn't necessarily lead to healthier families, especially if basic health knowledge or health services are absent in the community. Microcredit institutions have recently tried to address this issue by supplementing banking-only microcredit programs with programs that include "tie-ins" or "add-ons" such as health education or health services. A rigorous evaluation of such "banking-plus" endeavors has not yet been conducted, leaving a gap in the knowledge base regarding whether these organizations are meeting their stated goals in catering to both economic and social needs. This study attempts to address this research question using a randomized controlled trial of a health education intervention to clients of a microcredit organization in Peru.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be current clients of the collaborating microcredit organization
* Clients must be at least 18 years of age
* Children of clients must be less than 5 years of age
* Study participants must be able to speak and understand Spanish

Exclusion Criteria:

* Only one client from any particular household may participate
Asthma Control and Clinical Practice in Hungary 2009

A prospective study led amongst pulmonologists. Patients asthma control level will be evaluated based on GINA guideline criteria. HRQoL measured by Visual analogue scale. Clinical practice: non controlled patients therapy assessed.


Eligibility Criteria:
Inclusion Criteria:

* Asthma patients treated with ICS or bronchodilators

Exclusion Criteria:

* COPD
* pulmonary cancer
* pulmonary tuberculosis
Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men

The effect of resistance training with post-exercise Collagen peptides (CP) supplementation on lean body mass, maximal and explosive, isometric muscle strength as well as fat mass, resting metabolism, health parameters and compared to resistance training alone will be evaluated in a group of untrained overweight male (30-60 yrs) population in a randomized controlled trial (RCT).

Participants will perform supervised resistance training involving (Leg press, pull down, chest press, back extension and abdominal crunches) 3 times a week for 12 weeks. Participants will consume either placebo or collagen peptides (in a double blinded study design) just following resistance training on training days (And approximately the same time of day on non-training days). Prior to, and following 12 weeks of exercise, participants will be tested in body composition, maximal and explosive, isometric muscle strength, resting metabolism, health parameters. Additionally, blood samples will be taken to ensure health and training eligibility and safety.

Participants are healthy untrained overweight males (30-60 yrs)

Eligibility Criteria:
Inclusion Criteria:

* Male, between 30 and 60 years of age
* Fat mass \>25 % as measured by bioelectrical impedance analysis
* Stable weight (±5 %) and eating behaviour within the last 3 months.
* Signed informed consent

Exclusion Criteria:

* Regular physical activity \>60 min / week
* Stabile or progressive diseases/conditions (including medication) contraindicating or disabling participation in intensive exercise training and/or with potential to affect training adaptation beyond normal variation. For example:
* Contraindications against physical stress corresponding guidelines of American College of Sports Medicine (ACSM)
* Subjective symptoms during exercise (e.g., unusual physical exhaustion, dyspnoea, nausea)
* Moderate to severe mobility limitation (i.e., due to rheumatic disease)
* Diagnosis of cancer within the last 5 years
* Diabetes mellitus I and II uncontrolled arterial hypertension (systolic blood pressure \>155 for mmHg and/or diastolic blood pressure \>94 mm Hg; mild hypertension under resting condition will be allowed but such participants will be recommended to consult their general practitioner).
* Conditions contraindicating the supplementation protocol.
* Contraindications against nutritional or ergogenic supplements
* Allergy/aversion against animal protein
* Liver or kidney diseases with a non-permission to ingest certain concentrations of protein.