cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing

Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. Magnesium sulfate combined with polyethylene glycol is less used in the world. This multicenter, randomized, controlled trial is aimed at to evaluate the efficacy and safety of magnesium sulfate combined with low-volume polyethylene glycol for preoperative bowel preparation for colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old, male or female
* To undergo screening, surveillance and diagnostic colonoscopy
* Signed written informed consent

Exclusion Criteria:

* Subjects with therapeutic colonoscopy for colorectal polyps
* Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding
* Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon
* Subjects with renal or liver dysfunction, congestive heart failure or rhabdomyolysis
* Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration
* Subjects with constipation (\<3 times a week, difficult defecation, dry stool, less amount)
* Subjects with serious cardiac and cerebrovascular diseases,suffering from metabolic disease or endocrine disease
* Subjects who had previously undergone colorectal resection
* Women with positive pregnancy tests or pregnancy plans, and women in lactation or allergic to the investigational drugs and their ingredients
* Subjects who are participating in other clinical trials or receiving special drugs
* Subjects with any other conditions that the investigator considered inappropriate for inclusion
Association of Triglyceride-glucose Index With Cardiac Hemodynamics

1) To estimate the prevelance of IR in obese patients based on TYG index . 2) To screen early cardiovascular abnormalities in obese asymptomatic patients using conventional echocardiography and electrocardiogram . 3) To detect association of cardiovascular hemodynamics with TyG index . Assess cardiovascular risk in obese patients .

Obesity has been a health problem of growing significance all over the world; its prevalence is increasing in both developed and developing countries . According to WHO data, 39% of the global population above 18 years of age are overweight and of these, 13% are obese. Obesity is a chronic (long-term) medical disease. Both overweight (BMI \>25 kg/m2) and obesity defined as a ( Body Mass Index, or BMI, of \>30 kg/m2) are associated with an increased risk of cardiovascular diseases. This is a consequence on the one hand of obesity itself and on the other hand of associated medical conditions (hypertension, diabetes, insulin resistance ,stroke ,sleep apnea, osteoarthritis, gallstones, high cholesterol, gout, and certain types of cancer ) . Obesity produces a variety of hemodynamic alterations that may cause changes in cardiac morphology which predispose to left and right ventricular dysfunction. Various neurohormonal and metabolic alterations commonly associated with obesity may contribute to these abnormalities of cardiac structure and function. Cardiovascular diseases, including heart failure (HF), atrial fibrillation (AF), and coronary artery disease (CAD), are often associated with obesity. The duration of obesity has a direct impact on the incidence of cardiovascular disease.The triglyceride-glucose (TyG) index is the logarithmized product of fasting triglycerides and fasting glucose and has been proposed as the alternative indicator of IR ( with sensitivity 96.5 % and specificity 85% ) due to its relevance to lipotoxicity and glucotoxicity compared to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), which is expensive due to insulin measurement .TyG index has demonstrated a close relationship with cardiometabolic outcomes, namely diabetes, arterial stiffness, hypertension, cardiovascular disease (CVD), stroke and obesity-related cancers in previous studies.

Eligibility Criteria:
Inclusion Criteria:

* The study will include obese patients over two years duration ( Jan 2023 to Jan 2024 )( age above 18 years old ; written consent will be obtained )

Exclusion Criteria:

* History of heart failure or patient known to have congenital heart disease, primary or secondary myocardial disease .

Medications associated with weight gain . Patients with previous cardiac diseases (arrhythmias - valve disease). patients who have recently used glucocorticoids or antipsychotics. Patients on statins .
Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis

the aim of the study is to evaluate the effectiveness of partial-body cryotherapy (PBC) on the symptoms of patients with multiple sclerosis during a rehabilitation stay.

Multiple sclerosis (MS) is a chronic heterogeneous disease with an unpredictable clinical course. Symptoms can include paralysis, ataxia, spasticity, incontinence and fatigue syndrome.

Fatigue is considered to be the most prevalent and disabling of the symptoms at all stages of the illness and its occurs in 70-80% of patients. This characteristic of the disease directly impacts the quality of life of patients, affecting their social and physical well being.

Physical rehabilitation is often prescribed in the management of MS, and is recognized to improve modifiable impairments in MS.

However, the benefit of physical activities may be limited by heat stress also named Uhthoff syndrome frequently observed in patients with MS.

Cryotherapy is commonly used as a method to relieve pain and inflammation without marked side effect in respect to contraindication. However well designed studies on PBC in patients with MS are still too sparse.

The investigators propose to evaluate the effectiveness of PBC on the symptoms of MS patients during a rehabilitation stay in out- or inpatients.

Eligibility Criteria:
Inclusion Criteria:

* men and woen over 18 years old and under 65 years old
* with multiple sclerosis
* 0-6 points in the expanded disability states scale (EDSS)
* with MS in remission (at least 6 months since the last relapse)
* able to understand and respect the protocol and its requirement
* who signed the consent prior to any other procedure protocol

Exclusion Criteria:

* major patients under guardianship/curators/legal protection
* pregnant patients
* patients with contraindication for cryotherapy
* patients unable to complete the entire program
* patients with substantial change in pharmacological treatment the month before the start of the study
A Pilot Study Examining a Reinforcement Approach to Improve Diabetes Management

Glucose control is necessary to avoid the immediate and long-term adverse effects associated with type 1 diabetes, and frequent self-monitoring of blood glucose is the first important step to achieving glucose control. Data suggest that large proportions of adolescents and young adults fail to adhere to standard guidelines of self-monitored of blood glucose testing and have hemoglobin A1c levels \>7.5%. A finite period of poor metabolic control can lead to increased risk of medical complications over an individual's lifespan, necessitating novel interventions to improve self-monitored blood glucose testing and metabolic control in emerging adults with type 1 diabetes. The investigators treatment approach, which provides direct tangible reinforcement for objective evidence of behavior change, is efficacious in decreasing substance use, reducing weight, and improving medication adherence.

The purpose of this project is to develop and pilot test an intervention based on behavioral economic principles for improving self-monitored blood glucose testing in young persons with type 1 diabetes. In this pilot study, patients will text in, via cell phones, each time they test, and a return text will inform them of reinforcer vouchers earned. The investigators will collect data on self-monitored blood glucose testing frequency and A1c levels preceding treatment initiation and throughout a 6 month treatment period. If promising, a randomized trial will lead to larger scale evaluations of reinforcement interventions alone, or in combination with multimodal treatment approaches, and it may be applied to other clinical issues such as adherence to continuous glucose monitoring. Importantly, this intervention can be administered remotely and in an automated fashion, allowing for widespread adoption if efficacious.


Eligibility Criteria:
Inclusion Criteria:

* age 15-21 years old
* diagnosis of type 1 diabetes (T1D) \>12 months via ADA guidelines (Silverstein et al., 2005)
* average A1c \>7.5% and \<11% during the year before study entry, and most recent A1c \>7.5% but \<11%
* SMBG user with clinical recommendations to test \>4 times/day
* past month SMBG \<4 times/ day on average
* English speaking and able to read at \>5th grade level

Exclusion Criteria:

* have a major psychiatric or neurocognitive disorder that would inhibit participation
* have a major visual impairment
* meet DSM-IV criteria for pathological gambling
* have a significant other medical condition that impacts diabetes management
* plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched
* are pregnant or trying to become pregnant
* are participating in another clinical trial
Antithrombin III Concentrate After Liver Transplantation

This study was designed to demonstrate more effective administration method of AT-III in immediate post-liver transplantation period.

Antithrombin III(AT-III) concentrates have been used to prevent critical thrombosis in the immediate post-liver transplantation period without clear evidence regarding the optimal dose or administration scheme.

The investigators retrospectively analyzed the clinical data from the patients who received liver transplantation and developed pharmacokinetic model of AT-III in the previous research. According to this study, optimal AT-III activity level will be well-maintained with smaller dose with continuous infusion than with intermittent infusion which is widely accepted way of administration currently.

A prospective study was planned to show the more effective manner of AT-III concentrate administration after liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled operation
* Living donor liver transplantation
* Adult patients (\>=18 years old)

Exclusion Criteria:

* Patients under 18 years old
* Emergency operation
* Deceased donor liver transplantation
Abdominal Symptom Phenotype Study in Children

Children and adults commonly suffer from recurrent abdominal (stomach) pain. One type is called irritable bowel syndrome (IBS). IBS in adults and children is one of the most common and costly health care problems in the US. Some children have pain frequently (recurrent pain) while others rarely have pain. The investigators are conducting this study to help us answer questions about the causes and treatments, and management of IBS in children.

The purpose of this study is to find out if there is more than one type of IBS in children. If there is, this will be important in deciding the best treatments. The investigators also want to learn how children with IBS differ from those who do not have recurrent abdominal (stomach) pain.

Functional gastrointestinal (GI) disorders (FGIDs), in particular irritable bowel syndrome (IBS) in adults and children, are among the most common and costly health care problems in the US. IBS disproportionately affects adult women (10-15% in western nations) and adolescent girls. Yet, health care providers remain challenged to provide effective clinical management. The etiology of IBS is not well defined and likely multi-factorial.

A Need to Define Subgroups of IBS:

This study emerges from the claim that identification of patient subgroups will advance our understanding of IBS and ultimately help develop treatment approaches. Most studies have lumped together patients with IBS into 2 groups (constipation-, diarrhea-predominant) and tested whether they differ from healthy controls. We propose that a paradigm shift is in order. We should recognize that IBS likely has multiple causes and therefore, multiple expressions. We speculate that by understanding better defined patient subgroups and linking them to newer biomarkers or tests, ultimately will further the understanding of the origins and create effective treatments.

Eligibility Criteria:
Inclusion Criteria:

IBS:

* Age 7-12 years
* Females
* Meet criteria for irritable bowel syndrome without evidence of organic disease
* Developmentally normal
* English speaking (as the psychological measures are either not available or validated in Spanish)
* No other chronic, significant (e.g., diabetes, migraines) medical conditions
* No menses

Controls:

* Age 7-12 years
* Females
* No abdominal pain
* No GI or chronic medical conditions (e.g., diabetes)
* Developmentally normal
* English speaking (as the psychological measures are not available or validated in Spanish)
* No menses

Exclusion Criteria:

* Non-english speaking
* Developmentally or cognitively impaired
* Males
* Menses
* No mother in the household for administration of the psychological measures
* Use of any anti-depressants
* History of migraines or chronic pain disorders
* On narcotics for at least 1 week prior to enrollment
* On any NSAIDs or pain reliever for at least 24 hours prior to enrollment
* Sought psychotherapy in past 6 months for abdominal pain
Liver Embolization Approaches for Tumor Management

The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 yoa
* patients with patients with primary or secondary liver disease not amenable for surgery or ablation
* patients with primary or secondary liver tumors candidates for major surgery prior to induction of hypertrophy
* able and willing to sign informed consent

Exclusion Criteria:

* pregnant women
* patients with uncorrectable coagulopathy
* diffuse extrahepatic disease
* for lobar TACE and TARE - presence of bilodigestive shunt
* for TARE - \>20% hepatopulmonary shunt
A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease

The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age.
* Provided written informed consent.
* Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at Visit 1.
* Be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months.
* Have any planned ocular and/or lid surgeries over the study period.
* Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit .
* Have an uncontrolled systemic disease.
* Be a woman who is pregnant, nursing or planning a pregnancy.
* Be a woman of childbearing potential who is not using an acceptable means of birth control
* Have a known allergy and/or sensitivity to the test article or its components.
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema

One of the most common conservative treatments of lymphoedema is Complex Decongestive Physiotherapy (CDP). The bandage is one of the most important components of the treatment process. The multilayer short-stretch bandage is used to maintain volume reduction and prevent lymph backflow caused by compression. However, some patients refuse or postpone treatment or show a lower compliance with compression bandaging.Kinesio® Tex tape (KT) is a new technique for managing lymphoedema in the field of physical and alternative therapy, and it may affect decongestion of lymphatic fluid accumulated under the skin. Some studies which showed that KT was an effective for patients with BCRL, it was applied on both the affected arm and anastomosis. One of these studies also reported that a significant reduction in limb volume in patients who were applied of the tape only to the affected arm. This significant effect could also be seen by applying KT only to the anastomosis. In literature, however, there is no evidence to support this theory. So the aim of this study is to determine the effectiveness of KT which was applied to anastomotic regions along with CDP in the management of BCRL.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had unilateral BCRL and women aged over 18 who were 'significant', 'marked', or 'severe' lymphoedema.

Exclusion Criteria:

* Patients with paralysis on part of the affected arm,
* Patients who had undergone CDP more than once within six months,
* Patients who had an active infection,
* Patients who had a skin disease.
Automatic Administration of Oxygen During Respiratory Distress

Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen in the emergency department in a patient population admitted for acute respiratory failure.

Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the emergency for respiratory disease (or cardiac - acute pulmonary edema)justifying an oxygen administration to over 3 L / min to maintain a SpO2 ≥ 92%.
* Inclusion within a time less than two hours after the start of the oxygen at the emergency.
* Patient consent,or a close.

Exclusion Criteria:

* Necessity of an oxygen flow exceeds 15 L / min to maintain a SpO2 higher than 92%.
* Criteria of gravity justifying immediately a different technique of ventilatory support:
* Disturbance of consciousness with a Glasgow Coma Score ≤ 12
* Serious ventricular rhythm disorders
* Hemodynamic instability (SBP \<80mmHg or recourse to vasopressors)
* Cardiac or respiratory arrest
* pH \< 7.35 and PaCO2 \> 55 mm Hg
* Necessity of a urgent surgery, or coronary revascularization
* Age \<18 years
* Pregnant women, lactating
* Patient not relevant
* Unavailability of the prototype FreeO2
Tourniquet Use in Hallux Valgus Surgery

Prospective, single-center, randomized interventional clinical trial of tourniquet use in hallux valgus surgery. Patients will be their own controls.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 who has been informed and has signed the consent form
* Patient to be operated on for bilateral hallux valgus with no difference in the procedure performed between the 2 feet, the deformity must not differ by more than 10° (angle M1P1) between the 2 sides.
* Surgery planned on the same day for both feet

Exclusion Criteria:

* Arthritic hallux valgus requiring arthrodesis
* Inflammatory pathology (rheumatoid arthritis, etc.)
Mechanisms of Weight Loss in Patients Diagnosed With Achalasia

Currently there are no existing data to determine why some achalasia patients lose weight while others do not. The purpose of this study is to gather data from patients diagnosed with achalasia to determine if differences may be identified between those who lose weight and those who do not that would help us better understand the mechanism of weight loss in this population.

Patients either diagnosed with or being evaluated for achalasia and scheduled for standard clinic visits with the principal investigator as part of their routine care will be considered for participation in this study. Blood work, vital signs, and 24-hour dietary recall will be collected over a period of one year. These data will lay the foundation for future scientific endeavors to : a) assess requirements for dietary and/or nutritional supplements; b) formulate an achalasia diet; c) develop clinical practice standards; and d) design an intervention study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is able to provide written informed consent to participate in the study before completing any study-related procedures
2. Subject is male or female aged 18-75 years, inclusive at time of consent.
3. Subject has a documented diagnosis of achalasia based on high resolution manometry and endoscopy report.
4. Subject has been or will be scheduled to undergo either EGD with pneumatic dilation or surgical myotomy as routine care for treatment of achalasia.
5. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.

Exclusion Criteria:

1. Subject has any condition or abnormality, current or past that, in the opinion of the principal investigator, would compromise the safety of the subject or interfere with or complicate the assessment of signs or symptoms of achalasia. Such conditions may include psychiatric problems; neurologic deficits or disease; developmental delay; lung transplant; or previous gastroesophageal surgery.
2. Subject has had previous pneumatic dilation of treatment of achalasia.
3. Subject has had botulinum toxin (botox) injection for treatment of achalasia.
4. Subject has a history or high risk of noncompliance with treatment or regular clinic visits.