cyrilzakka/clinical-trials huggingface dataset:
aCute HemORrhoidal Disease evALuation International Study

The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Patient consulting for symptomatic acute phase of hemorrhoidal disease
* Confirmed diagnosis of hemorrhoidal disease

Exclusion Criteria:

* Patient consulting for emergency not related to hemorrhoidal disease;
* Patient currently taking any treatment for hemorrhoidal disease;
* Any anorectal procedure or surgery planned during the study ;
* Anorectal procedure or surgery performed or incomplete convalescence following anorectal procedure/surgery;
* Known present perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury, diseases of the anal canal;
* Pregnant or breastfeeding woman.
Outcomes and Safety of Various Conduction System Pacing Methods

The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.

In comparison with right ventricular pacing-induced electromechanical dyssynchrony, conduction system pacing is providing physiological pacing via His-Purkinje activation. Current approaches include His bundle (HBP), left bundle branch area pacing (LBBAP), and Bachmann bundle pacing. In addition, HBP and LBBAP enable correction of underlying proximal bundle branch block, consequently improving the ventricular activation time and narrowing the QRS. Furthermore, atrial activation can be improved with direct Bachmann bundle stimulation. However, the data regarding long-term performance and safety of these physiological approaches in various clinical scenarios is scarce.

With this registry, the investigators would like to obtain real-world data regarding the feasibility and safety of this physiological pacing approaches in various pacing indications and their implementation in routine clinical practice.

Implant success rate, specific implant characteristics, procedural complications, electrical parameters and clinical outcomes will be analyzed at implantation, 1-3 months after inclusion and every 6 months thereafter. Minimal follow-up will be 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Class I and II indications for permanent pacing
* Atrial fibrillation with uncontrolled ventricular rate for pace and ablate strategy
* Bundle branch block correction for HF patients
* Patients with prolonged PR interval and dromotropathy
Discovery Elbow Long-Term Survivorship

The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.

Eligibility: Patient(s) must be enrolled in the Discovery Multi-Center Prospective Study. The patient must consent to participation in the Discovery Long-term Survivorship Study.

In order to continue to follow the multi-center subjects long-term Biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. The annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. The Patient ASES questionnaire and survivorship data questions will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Participant in the Discovery Elbow Multi-center Study
2. Consent to participate in the Discovery Elbow Long-Term Survivorship Study

Exclusion Criteria:

1. Patient is not a Discovery Elbow Multi-center Participant
2. Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study
Mechanisms Of Change in Adolescent Pain Self-management

The MOCAS Study aims to describe the mechanisms through which sleep deficiency affects youth responses to an online pain self-management intervention over a 6-month period. The study is a single arm trial with repeated measurements using surveys, daily diaries, and actigraphic monitoring.

The study objective is to characterize how sleep deficiency influences youth's ability to engage with, implement, and benefit from pain self-management intervention. The investigators will recruit a cohort of 80 youth, ages 12 to 17 years, with chronic musculoskeletal, head, or abdominal pain into a single arm trial conducted at one site. Assessments will occur at baseline, immediately after intervention, and repeated at 3 months post-intervention. Mediators will be assessed at mid-treatment (4 weeks). All youth will receive an 8-week internet-delivered pain self-management intervention (WebMAP). Following the recommended Common Data Elements for self-management three self-management processes are measured including patient activation, pain self-efficacy, and self-management skills, and patient-reported outcomes of health (global health, fatigue) and pain (pain symptoms, pain-related disability). Positive and negative affect and executive function are assessed as potential mediators. Sleep deficiency is comprehensively assessed with subjective measures, daily sleep logs, and ambulatory actigraphy monitoring to measure disrupted sleep, amount of sleep, sleep quality, and insomnia symptoms.

Eligibility Criteria:
Inclusion Criteria:

* 12-17 years old
* Has chronic pain (for at least 3 months)
* Has internet access/email address

Exclusion Criteria:

* Diagnosis of a serious, comorbid health condition (e.g. cancer, arthritis, cystic fibrosis, lupus, etc.)
* Parent/adolescent doesn't speak English
* Active psychosis/suicidal ideation
* Currently taking stimulating medications
* Diagnosed sleep disorder (sleep apnea or narcolepsy)
* Severe cognitive impairment/unable to read at 5th grade level or complete surveys independently
Obex, a Nutritional Supplement, in Overweight and Obese Spanish Women

The aim of the study is to evaluate the effects of a dietary supplement (Obex®) on anthropometric and physiological variables in Spanish women between 35 and 60 years who are overweight or obese.

The nutritional supplement consists of natural plant extracts such as Caralluma fimbriata, Phaseolus vulgaris, Acai Berry and other antiobesity agents: ornithine, carnitine fumarate, essential fatty acids and certain amino acids, vitamins and minerals.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 35 and 60 years.
* Body Mass Index (BMI) greater than 27 kg/m² and lower than 35 kg/m²
* Ability to provide informed consent

Exclusion Criteria:

* Presence of any endocrine, hepatic, renal or cardiovascular disease.
* History of bariatric surgery
* Pregnancy or lactation
* Concomitant disease with reduced life expectancy
* Severe psychiatric conditions
* Drug dependence
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).

Iron deficiency anaemia (IDA) is a common problem associated with many chronic diseases such as chronic kidney disease (CKD). IDA can have a substantial medical and quality of life (QoL) burden on the subjects. Therapy of these subjects includes treating the underlying cause of IDA and restoring haemoglobin (Hb) concentration and iron stores.

This study evaluated the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).

The study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline; a cumulative dose of 1000 mg was recommended). The study subjects were monitored for up to 8 weeks from baseline.

Eligibility Criteria:
Inclusion Criteria includes:

1. Men and women, ≥ 18 years
2. Hb ≤ 11 g/dL
3. Chronic renal impairment, as defined by either (i) eGFR \< 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) Estimated Glomerular Filtration Rate (eGFR) \< 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model
4. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %
5. Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation
6. Willingness to participate and signing the informed consent form

Exclusion Criteria includes:

1. Anaemia predominantly caused by factors other than IDA
2. Hemochromatosis or other iron storage disorders
3. Previous serious hypersensitivity reactions to any IV iron compounds
4. Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
5. Undergoing dialysis for treatment of CKD
6. Planned surgical procedure within the trial period
7. Decompensated liver cirrhosis or active hepatitis
8. Alcohol or drug abuse within the past 6 month.
9. Pregnant or nursing women.
The Effect of Anesthesia on Systemic Inflammatory Immune Index in Major Abdominal Cancer Surgeries

The effects of different anesthesia methods on the immune system are variable. In this study, we investigated the effect of inhalation anesthesia and total intravenous anesthesia on the SII value in major abdominal cancer surgeries.

The study was planned prospectively, observationally, on a total of 90 patients who underwent major abdominal cancer surgery. 84 patients were evaluated. The patients were seperated in two groups as inhalation anesthesia and total intravenous anesthesia (TIVA). The demographic data of the patients, type of cancer, type of surgery performed, ASA classification, preoperative chemotherapy intake, preoperative hemogram, postoperative 2nd and 24th hour hemogram, intraoperative and postoperative blood transfusion, and duration of surgery were recorded. Platelet, neutrophil, lymphocyte and SII values were saved.

Eligibility Criteria:
Inclusion Criteria:

* major abdominal cancer surgeries

Exclusion Criteria:

* blood transfusion in last 72 hours
* patients with infection
* hematologic malignancy
* patient controlled analgesia
Electro-acupuncture for Central Obesity

In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.

This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 \[24\]; not receiving any other weight control measures or any medical and/or drug history in last 3months.

Exclusion Criteria:

Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.
Efficacy and Safety of Escócia Association in the Treatment of Acute Pain

The purpose of this study is to evaluate the efficacy and safety of Escócia association in adults with acute pain.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants, aged 18 years and older, with renal colic admitted in the emergency service, or those who underwent an extracorporeal lithotripsy procedure to eliminate kidney stones.

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception;
* Participants weighing less than 50 kg;
* Participants with suspected other causes of acute abdominal pain;
* Participants with a known history of peptic ulcer, gastrointestinal bleeding, perforation or inflammatory bowel disease;
* Participants with hypovolemia or dehydration;
* Renal failure, defined by the estimated glomerular filtration rate \[eGFR\] \<60 mL / min / 1.73 m2;
* Participants with a known medical history of cerebrovascular bleeding, hemorrhagic diathesis (hemophilia), blood clotting disorders; postoperative of coronary artery bypass graft surgery, or using anticoagulants, including low heparin dose (2500-5000 units every 12 hours);
* Participants in the postoperative period with a high risk of bleeding or incomplete homeostasis;
* Participants with cardiovascular disease, chronic heart failure or with increased risk of cardiovascular events are at the discretion of the investigator, in order to include the participant;
* Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;
* Participants using pentoxifylline, probenecid or lithium salts;
* Participants with megacolon and / or paralytic or obstructive ileus;
* Participants with glaucoma and myasthenia gravis;
* Participants on treatment with MAO inhibitors, or participants who have been treated with these drugs within 14 days;
* Participants on epilepsy not adequately controlled treatment.
Efficacy of NAT-FM Treatment for Fibromyalgia

The main objective of this study is to analyse the efficacy of the NAT-FM multicomponent treatment program as coadjuvant of treatment-as-usual (TAU) compared to TAU alone.

In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of NAT-FM treatment in the short- and long-term, the research team will seek to identify relevant moderators and mediators of clinical change.

* This is a two-arm RCT focused on the safety and potential efficacy of the multicomponent program NAT-FM as coadjuvant of treatment-as-usual (TAU) vs. TAU alone.
* NAT-FM combines Classical Structural Assessment (CSA) and Ecological Momentary Assessment (EMA) to obtain more reliable information about the dynamics of the variables to be evaluated, to record the affective and cognitive impact of each activity, and to explore its potential delivery in real-world clinical practice.
* The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as self-efficacy and pain catastrophizing.

Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 75 years-old.
* 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
* Able to understand Spanish and accept to participate in the study.

Exclusion Criteria:

* Participating in concurrent or past RCTs (previous year).
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
Effects of Increasing Mean Arterial Pressure on Renal Function in Patients with Shock and with Elevated Central Venous Pressure

The purpose of this study is to assess the effect of a higher mean arterial pressure on renal function for patients with shock and elevated central venous pressure.

Current recommandation for mean arterial pressure (MAP) target is 65 mmHg for septic shock, but optimal target to prevent acute renal failure (ARF) remains unknown.

High central venous pressure (CVP) can lead to acute renal failure through venous congestion , and is associated with acute renal failure in intensive care unit.

A decrease of renal perfusion pressure, defined by MAP - CVP, has been shown to be associated with risk of acute renal failure.

The main objective of this trial is to evaluate if an optimisation of renal perfusion pressure, by a higher MAP when CVP is high (≥ 12 cmH2O), can improve renal function.

In this interventional monocenter trial, each patient will be evaluated during 2 consecutive periods of 6 hours, with a temporary MAP target

* Target at 65-70mmHg during 6 hours
* Target at 80-85mmHg during 6 hours

Patients will be randomized into two groups to define the order of targets. There will be a stratification on previous arterial hypertension. Renal function will be measured at the end of each period.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old )
* Arterial hypotension requiring the etablishment of catecholamines
* Norepinephrine dose ⩾ 0.1µg/kg/min at the inclusion
* High central venous pressure ≥ 12mmHg
* Cardiac output monitoring (PICCO or Swan Ganz)

Exclusion Criteria:

* Anuria
* Patient with an emergency indication of renal replacement therapy (severe hyperkalemia, severe metabolical acidosis with pH \<7.15, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration \> 40 mmol/l)
* Pregnant, lactating or parturient woman
* Patient deprived of liberty by judicial or administrative decision
* Patient with psychiatric compulsory care
* Patient subject to legal protection measures
* Patients with do-no-reanimate order or withdrawal of life sustaining support
Progressive Mobility Program and Technology to Improve the Level of Physical Activity and Functionality of ICU Patients

The purpose of this study is to verify if a protocol of early and progressive mobility which includes the use of technology is able to increase the level of physical activity and improve functionality and respiratory and muscular function of Intensive Care Unit patients compared with conventional Physical Therapy.

The evolution of treatment in the Intensive Care Unit (ICU) has increased the survival and morbidity post hospital. Functional disability in these patients has its main factor in the weakness and loss of muscle mass, which is the major complications reported by these patients. The most negative result in long-term post ICU is the impact on quality of life and functional decline due to muscle disorders and fitness. This is achieved by the period of inactivity and prolonged rest, leading to losses and changes in various body systems. Given these facts, interventions for greater mobility in bed and out of it are very important. Early mobility programs has proved beneficial, however, as in other types of rehabilitation, the exercises should be prescribed with its specific characteristics, including the intensity. However, little has been described in the researches abut the activity level in the ICU, and using a quantitative measure. The use of technology seems to facilitate the offering of this type of therapy, supplying the limitations. Therefore, there are little evidences about these topics and randomized controlled studies to investigate these factors.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the Emergency Intensive Care Unit of Clinical Hospital, Medical School, University os Sao Paulo
* inspired oxygen fraction ≤ 60%
* positive end expiratory pressure ≤ 10 points
* peripheral oxygen saturation ≥ 90%
* respiratory rate ≤ 35
* without cardiac arrhythmia or acute ischaemia
* heart rate \> 50 bpm and \< 140 bpm
* without high or raising dose of vasoactive drugs
* mean body pressure \> 60 mmHg and \< 120 mmHg
* without active bleeding
* without prescribed bedrest

Exclusion Criteria:

* transference from other hospital
* diagnosis of neurological disorders
* intensive care unit stay \< 4 days
* contraindication to mobilization
Effects of the Short-Chain Fatty Acids-Targeted Dietary Interventions on the Selected Autonomic Functions in Humans

Recent data feature short-chain fatty acids (SCFAs), products of gut microbial fermentation, as modulators of the blood pressure of the host. Such modulation may evoke (or arise from) changes in the autonomic reflexive mechanisms, but the link remains unexplored. Therefore, the study aims to explore potential relationship between the dietary intervention-induced changes in the SCFA plasma/fecal content and alterations in the sensitivity of the cardio-respiratory autonomic reflexes.

In this cross-over, placebo-controlled study, a group of healthy volunteers will undergo three distinct stages of a four-week dietary intervention, separated by at least two weeks of washout periods. During each stage, participants will receive one of the following interventions:

* raw potato starch (a source of resistant type 2 starch, which is a substrate for the endogenous production of SCFAs)
* sodium butyrate (a direct, exogenous source of this SCFA)
* an amylase-accessible waxy maze starch (a placebo). Plasma and fecal SCFA concentrations will be measured, along with the comprehensive evaluation of the cardio-respiratory parameters and the sensitivity of the autonomic reflexive mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* age 18-40 years

Exclusion Criteria:

* chronic disease of the nervous, cardiovascular or respiratory system
* disease of the digestive system, including history of the intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance and other malabsorption disorders
* blood pressure-lowering treatment within the past year
* tobacco smoking within the past year
* antibiotic/probiotic treatment and laxative/prokinetic usage in three months preceding the anticipated enrollment