cyrilzakka/clinical-trials huggingface dataset:
Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI

The aim of the prospective observational DISTEMI-Study in people with and without Diabetes mellitus (DI) after new onset of ST-Segment Elevation Myocardial Infarction (STEMI) aged 18-80 years at inclusion into the study is to characterize in detail the clinical, metabolical, immunological and vascular phenotype, investigate the interplay between myocardial remodelling and the metabolic phenotype, monitor the progression of the disease and compare the phenotype of STEMI people with diabetes mellitus to people with prediabetes and glucose tolerant people.

In detail, the following questions will be answered:

1. Do distinct metabolic phenotypes (with respect to insulin secretion, insulin sensitivity, circulating free fatty acids and ectopic lipid storage, especially in the liver) determine myocardial infarct size and decline of contractile function of the remote myocardium?
2. Which factors modify the progression of the disease (insulin resistance, ectopic lipid storage, subclinical inflammation, abnormal energy metabolism)? People are thoroughly examined at baseline and one year after STEMI.
3. Can we identify risk profiles and their relevance for development of diabetes-associated complications as well as long-term progression of diabetes?
4. Can we improve risk assessment algorithms for targeted therapy in line with Precision Medicine?

Eligibility Criteria:
Inclusion Criteria:

* Condition after new onset of ST-segment elevation myocardial infarction (STEMI)
* Age 18-80 years
* HbA1c \<9.0%
* People with diagnosis of diabetes mellitus according to ADA and DDG criteria (i.e. HbA1c ≥6.5% and/or pathological oral glucose tolerance test)
* Healthy people with normal glucose tolerance status according to ADA and DDG criteria (i.e. HbA1c \<5.7% and normal OGTT)
* People with impaired glucose metabolism ("prediabetes") according to ADA and DDG criteria (i.e. impaired fasting glucose and/or impaired glucose tolerance and/or HbA1c 5.7-6.4%)
* Consent-able, hemodynamically stable people, without sedation (e.g. opiates) or other interfering medication (e.g. catecholamines)

Exclusion Criteria:

* Diabetes mellitus category 3 A-H (ADA criteria), gestational diabetes
* Current pregnancy
* Infectious diseases, acute infections / fever
* Immunosuppressive therapy
* Severe chronic renal, liver or heart disease (e.g. serum creatinin ≥1.6 mg/dl, peripheral artery occlusive disease stage IV)
* Malignant diseases
* Severe chronic psychiatric illness or addiction
* Participation in an intervention trial
Optimal Application Dose of Superficial Hyperthermia

Hyperthermia - a warming of the tumor at 42-43 ° C - in combination with radiation and / or chemotherapy is a proven method of treatment for malignant tumors. The amplification of the effect of radiotherapy and various chemotherapeutic agents (platinum analogues, nitrogen-Lost derivatives, cytotoxic antibiotics) is experimentally demonstrated. Randomized clinical trials have shown a better chance of survival and better local tumor control without increasing the toxicity of combined treatment especially also in children's tumors. The combination of hyperthermia and radiation therapy is more effective than radiotherapy alone. Hyperthermal temperatures increase blood circulation in tumors as a response to stimulation with heat. Tumor tissue, having a minor circulation and being acidotic, is resistant to radiotherapy, but sensitive to hyperthermia, while tumor with a high blood flow is sensitivity to radiation. This positive interaction is a compelling reason for the combination of hyperthermia and ionized radiation.

Hyperthermia, in combination with chemotherapy, increases the concentration of cytostatics in the tumor region, raising blood flow caused by warmth. In addition, hyperthermia increases toxicity of drugs in cells, being normally resistant to many drugs. Hyperthermia can synergistically be combined with chemotherapy treating "high risk" - tumors with curative intention.

In addition to the clinical use of surface hyperthermia (BSD 500 - O), with appropriate treatment of tumors up to 3 cm deep from the surface of the body with established indications and palliative indication in advanced stages of cancer, a prospective, randomized study with quality-controlled thermometry shall establish the optimal sequence of Hyperthermia in combination with irradiation. Therefore the treatment sequence of once per weeks is compared to a sequence of three times per week.


Eligibility Criteria:
Inclusion Criteria:

* Surficial tumors (\< 3-4 cm)
* ≥ 18 years
* Karnofsky Index \> 60
* No other treatment in between 30 d, applicable radiation dose min.30 Gy
* Cumulative equivalent minutes 42°C T75

Exclusion Criteria:

* Pregnancy
* Pace maker
* Metal implants
Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments

The study aims to assess clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  * Diagnosed with mRCC
  * Received IO therapy as 1L therapy
  * Received sunitinib as 2L therapy
  * Age 18 years or over at the time of mRCC diagnosis
  * Actively treated at an IMDC clinical center (to avoid incomplete data)

Exclusion Criteria:

None
Lung Deposition Via Different Inhalation Devices

The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* BMI between 18 and 30 kg/m2
* Non-smokers/non-snuffers

Exclusion Criteria:

* Pregnant and/or lactating women
* Use of oral contraceptives or hormonal implants
* Known or suspected hypersensitivity to glucocorticosteroids, inhaled lactose, or other excipients in study drugs
Outcomes of Surgery for Degenerative Lumbar Spine Diseases

The purpose of this study is to determine the effectiveness of surgery on the elderly patients with DSD.

This study based on observation and follow up of elderly patients underwent for surgery for degenrtative lumbar spine diseases and the effectiveness of the surgery on the quality of their life.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders with age above 65 years with Low Back Pain and disability.
* Pt with clinical diagnosis of degenerative lumbar spine disease.
* Pt with MRI showing Degenerative lumbar spine disease need surgical intervention.

Exclusion Criteria:

* Patients having malignancy, vertebral fractures, trauma, inflammatory illnesses, and infection.
* Patients with degenerative conditions in the cervical and /or thoracic spine.
Korea University Anam Hospital Optical Coherence Tomography Registry

All comer registry who had undergone intravascular optical coherence tomography during and/or after coronary intervention.

Optical coherence tomography registry is composed with before coronary stenting, immediate after coronary stenting and follow-up study.

Eligibility Criteria:
Inclusion Criteria:

* patients who had undergone coronary intervention and optical coherence tomography

Exclusion Criteria:

* none
Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction

The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. OMS103HP was designed to deliver targeted therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit inflammation and pain before they can begin.

The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving knee function following ACL reconstruction using a hamstring autograft. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion, and earlier return to work.


Eligibility Criteria:
Inclusion Criteria:

* 15 - 65 years of age
* In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery
* Undergoing primary unilateral ACL reconstruction using a medial hamstring (semitendinosus and gracilis) autograft
* Able to participate in the study rehabilitation protocol
* and other inclusion criteria

Exclusion Criteria:

* Allergies to any of the individual ingredients in OMS103HP
* Taking medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
* Associated knee injuries likely to interfere with evaluation of the study drug
* and other exclusion criteria
Nutritional Intervention in Migraine

Migraine is a common medical condition. Several studies suggest that obesity and/or weight gain are risk factors for aggravating migraine course, especially increase the frequency of headache episodes. The aim of the current study was to evaluate whether nutritional intervention would be able to improve clinical parameters (as assessed by MIDAS and HIT) of patients with migraine.

Women with the diagnosis of migraine according to the International Headache Society (IHS-2) criteria received individualized diet meal plan and nutritional orientation for 12 weeks according to their nutritional diagnosis. Patients were evaluated three times with an interval of 30 days between each visit. Clinical, anthropometric measurements (weight, height, waist circumference and body composition assessed by bioelectrical impedance analysis) and food evaluations were performed. Nutritional orientations were strengthened in each visit. The diet prescription did not change during intervention period. The diet quality of the patients was assessed through the Brazilian Healthy Eating Index - Revised (BHEI-R) version. Migraine severity was assessed with the Headache Impact Test (HIT) and the Migraine Disability Assessment Scale (MIDAS). Depressive symptoms were also evaluated with the Beck Depression Inventory (BDI).

Eligibility Criteria:
Inclusion Criteria:

* Women;
* Older than 18 years;
* Migraine diagnosis;
* Agree to sign the informed consent.

Exclusion Criteria:

* Patients with headaches not characterized as migraine;
* Pregnant or lactating women.
Health Promoting Lifestyle Behaviors

Assess the Health-promoting Lifestyle behaviors of Sohag University students. Identify socio-demographic determinants of the Health-promoting Lifestyle behaviors

Health is the most fundamental criterion on which man's life is dependent, and it has always been an issue throughout history. Health, according to a definition by the World Health Organization (WHO), is physical, spiritual, mental, social, emotional, and occupational tranquility, and not just the absence of illness. This definition, moreover, has been reintroduced as "people's social and economic potency and dynamicity".

Lifestyle is one of the most important determinants of health promotion that is influenced by cultural, economic, political and religious factors. Lifestyle includes day-to-day behaviors and functions of individuals in job, activities, fun, and diet.

According to WHO, 60% of related factors to individual health and quality of life are correlated to lifestyle .

Millions of people follow an unhealthy lifestyle. Hence, they encounter illness, disability and even death. Problems like metabolic diseases, joint and skeletal problems, cardio-vascular diseases, hypertension, overweight, violence and so on, can be caused by an unhealthy lifestyle. The relationship of lifestyle and health should be highly considered.

Globally, Non-communicable diseases NCDs are the leading cause of premature deaths and chronic disabilities and are responsible for almost 70% of all deaths worldwide.

Eligibility Criteria:
Inclusion Criteria:

Under graduate students in all grades of four randomly selected faculties include 2 practical faculties and 2 theoretical faculties during their academic year 2022/2023 who accept to participate in the study

Exclusion Criteria:

Students who refuse to participate in the study
Predicting Postoperative Ambulation Following Selective Dorsal Rhizotomy Based on Preoperative Gross Motor Function Score

Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills resulting from permanent, nonprogressive damage to the developing brain before, during, or after birth (Tedla \& Reddy, 2021). The worldwide prevalence of CP is 2-3 per 1000 live births (Paul et al., 2022). The most common type of CP is spastic, accounting for approximately 85% of all CP cases (Paul et al., 2022). It is divided into 3 types: hemiparetic, diparetic, and quadriparetic. Selective Dorsal Rhizotomy (SDR) is a surgical technique applied for spasticity management in children with bilateral spastic type CP (Novak et al., 2014). One of the most important points in the decision-making process for SDR surgery is the compatibility of the family's expectations with the expectations of the healthcare professional. Informing the family about the expectations is very important in the decision-making process for surgery (Waite et al., 2023). No study has been found in the literature that provides objective predictive value before surgery in terms of postoperative ambulation. The aim of this study is to examine the predictability of postoperative ambulation status in patients with Spastic Cerebral Palsy (SCP) according to the Gross Motor Function Measure-88 (GMFM-88) score before SDR.

It is an observational study. Purpose of the study: The aim of this study was to examine the predictability of postoperative ambulation status in patients with spastic Cerebral Palsy (SCP) according to the Gross Motor Function Measure-88 (GMFM-88) score before SDR.

95 children with CP were included in the study. Among SCP cases, 71(74.7%) were diparetic, 18(18.9%) were quadriparetic, and 6 (6.3%) were triplegia.

* Can the total score of a gross motor function measure before SDR predict walking after SDR?
* Can the gross motor function measure total score before SDR surgery provide an indication of the family's postoperative walking expectations?

The Gross Motor Function Measure-88 (GMFM-88) and the Gross Motor Function Classification System (GMFCS) were applied to the participants.

Eligibility Criteria:
Inclusion Criteria:

* Age between 0-17,
* Diagnosis of spastic CP,
* Participants and parents willing to participate in the study voluntarily,
* Gross Motor Function Classification System (GMFCS) level between II-IV,
* No history of orthopedic surgery before SDR surgery,
* Actively continuing the Physiotherapy and Rehabilitation (PTR) program for at least 2 months in the post-operative period.

Exclusion Criteria:

* Having different types of CP such as dyskinetic, ataxic and mixed type
* Having hemiparetic type CP
* Having a history of any surgery on the musculoskeletal system before SDR surgery
* Having received Botulinum Toxin injection within the last 6 months.
Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients

42 patients admitted in ICU with intolerance to enteral feeding (GRV more than 250 ml) are recruited. All patients enter a primary acetaminophen absorption test study as baseline. Serum levels of acetaminophen will be measured by florescence polarization method at 15,30,45,60,90,120,180,240,480 minutes after enteral administration of 975 mg acetaminophen. Then the patients will be randomized to methylnaltrexone or erythromycin group.Another acetaminophen absorption test with the same schedule will be done after the last dose of each drug.The area under the curve for acetaminophen blood level will be used to compare the effect of two studied drugs on gastric emptying time.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in intensive care unit in a university affiliated hospital
* Receiving continuous enteral feeding through a nasogastric tube
* Gastric residual volume more than 250 ml checked by aspiration technique

Exclusion Criteria:

* Receiving the study drugs or metoclopramide within 24 hours of inclusion
* Known allergy to interventional drugs or acetaminophen
* Gastrointestinal bleeding or surgery on GI system within 24 hours of inclusion
* Crohn's disease
* GI perforation or obstruction
* Short bowel syndrome
* Liver failure or 2 of the followings:

  * Transaminase enzymes more than 3 times normal
  * Prothrombin time more than 2 times normal
  * Total bilirubin more than 3 times normal
* Patients on hemodialysis or CRRT
* Hemodynamically unstable patients including:

  * Mean arterial pressure less than 65 mmHg
  * Infusion of inotropes and vasopressors
  * Uncorrected acute blood loss; hemoglobin concentration less than 6.5 mg%.
* Documented or suspected pregnancy
* Obesity; actual body weight more than 1.5 times ideal body weight
* Myasthenia Gravis.
* Opioid drug abuse
Popliteal Sciatic Nerve Block Catheter Placement for Foot Surgery

Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and motor blockade obtained with stimulating popliteal catheters versus those placed without nerve stimulation.


Eligibility Criteria:
Inclusion criteria:

* patients scheduled to undergo foot or ankle surgery at Mayo Clinic Jacksonville

Exclusion criteria:

* emergency surgery
* peripheral neuropathy in the distribution of the sciatic nerve on the operative side
* history of recent alcohol or drug abuse
* allergy to local anesthetics
* pregnancy
* coagulopathy
* subjects declined to participate
Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children

The study includes a comprehensive health examination with focus on respiratory health and the TBFV recordings using impedance pneumography (Ventica®) during sleep at night in healthy children.

Impedance pneumograpy results in healthy children to generate normal values and to stude the effect of age and gender

Eligibility Criteria:
Inclusion Criteria:

* Age 12 months-71 months, both sexes
* Healthy at the time of inclusion
* Signed informed consent

Exclusion Criteria:

* Preterm birth
* Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness
* Nasal congestion, adenotonsillar hypertrophy, signs and symptoms of sleep apnea or sleep disordered breathing
* Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
* Personal or family history of asthma
* Recurrent wheezing without respiratory infection
* Allergic rhinitis, chronic rhinosinusitis, or other chronic respiratory disorders
* Atopic dermatitis
* Diagnosed allergic sensitization
* Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion
* Any major chronic illness as judged by the investigators
* Implanted or external active medical devices such as pacemakers
The Role of the Locus Coeruleus in Age-related Distractibility

A growing body of research has highlighted the importance of frontal regions, at both the functional and structural levels, in age-related declines in attentional and cognitive processing. However, the underlying neurobiological pathophysiological changes in the brain that contribute to these declines are still largely unclear. The objective of this proposal is to investigate neural mechanisms of age-related attentional distractibility, focusing on the neural circuit initiated from the locus coeruleus (LC). In the current proposal, the investigators will test the hypothesis that the neural disconnectivity of LC with the salience network (SN) drives failures of ignoring distractors in older adults. The investigators will examine how LC-SN connectivity is associated with selective attention performance, and how improved LC-SN connectivity through a cognitive training program may lead to improved attentional performance.


Eligibility Criteria:
Inclusion:

* Healthy adult participants
* No younger than 18 and no older than 75 yrs of age
* Ability to provide written informed consent

Exclusion:

* History of surgery involving metal implants
* Possible metal fragments in the eyes
* Pacemaker
* A history of claustrophobia
* Braces
* Weighing over 250 pounds
* Pregnant or possibility of being pregnant.
* Severe medical or psychiatric conditions (e.g., blind or deaf, head trauma)
* Learning disabilities or developmental disabilities
Exploring the Use of the CO-OP With Children With EF Functions Deficits Following ABI

Purpose:

Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration. Among cognitive disorders, executive function (EF) deficits are among the most frequent and disabling, with major consequences on the development of autonomy and the course of schooling and learning. The Cognitive Orientation to daily Occupational Performance (CO-OP) could be an interesting approach for the rehabilitation of these consequences. CO-OP is a performance-based treatment approach for children and adults who experience difficulties performing the skills they want to, need to or are expected to perform. CO-OP is a specifically tailored, active client-centered approach that engages the individual at the meta-cognitive level to solve performance problems. Focused on enabling success, the CO-OP approach employs collaborative goal setting, dynamic performance analysis, cognitive strategy use, guided discovery, and enabling principles. It has been shown to be effective in a variety of populations, but has been little explored in children with ABI.

Objectives To assess whether the use of CO-OP could be of interest in children with executive functions deficits following ABI, to improve their occupational performance, their executive functioning in everyday life and their cognitive processes constituting EF.

Method

* Single case experimental study with multiple baselines across individuals and behaviors
* 14 individual sessions of CO-OP intervention.
* Two goals trained, one control goal.
* Different assessments used : Canadian Occupational Performance Measure (COPM), the Goal Attainment Scales (GAS), the Children's Cooking Task (CCT) and parent- and teacher-ratings of the Behavior Rating Inventory of Executive Functions (BRIEF) questionnaire.

Eligibility Criteria:
Inclusion criteria were:

* Age 8 to 14 years
* Diagnosis of ABI, sustained at least 6 months previously, still attending an in- or outpatient rehabilitation program following injury
* Evidence of a dysexecutive syndrome on the neuropsychological assessment
* Normal vision and hearing (with appropriate correction if necessary)
* Sufficient language skills to understand and to communicate explicitly

Exclusion criteria were:

* Non-French-speaking child or parents
* Sensory-motor or visual impairments precluding participation in the study
* Intellectual deficit (Full-Scale Intellectual Quotient (IQ)\<70), or severe impairments in comprehension, memory or attention, incompatible with understanding and choosing rehabilitation goals and participating in 45-minutes sessions
* Neurological, psychiatric, genetic or learning disability diagnosed prior to the ABI
* Severe anxiety or depression symptoms