cyrilzakka/clinical-trials huggingface dataset:
Predicting the Metabolic Biomarkers Associated With Injury in Athletes

For elite athletes, sports injuries significantly impede the further enhancement of their competitive performance. Consequently, the significance of preventing, detecting, and addressing potential injury issues has become increasingly critical. Currently, the comprehensive evaluation of athletes' physical function and condition primarily depends on a range of physiological, biochemical, and immunological indicators. However, these methods have progressively exposed their limitations. As an advanced bioinformatics technology, omics research demonstrates unique advantages. By leveraging multi-omics research and analysis, it is possible to more accurately observe the physiological and biochemical changes that athletes undergo during training and competition, as well as their regulatory mechanisms. This approach can provide practical data, identify biomarkers that can warn of potential injuries, and offer precise guidance for training monitoring and injury prevention. It also provides a foundation for developing diverse, precise, and personalized sports programs and rehabilitation plans.

Investigators will collect fasting venous blood. White blood cell count, red blood cell count, erythrocyte specific volume, hemoglobin, C-reactive protein, procalcitonin, erythrocyte sediment rate, lactic acid,creatine kinase, liver function indicators, blood urea, blood creatinine, blood uric acid, blood testosterone, blood cortisol, immunoglobulin (IgG, IgA, IgM) and ferritin levels were measured. The levels of IL-2, IL-6, IL-1β and TNF-α were determined by ELISA. Blood samples were purified and analyzed by proteomics, metabolomics and lipidomics methods. Urine and stool samples were collected and analyzed by multi-omics method.

Eligibility Criteria:
Inclusion Criteria:

1. Age： Athletes 12-30 years old
2. Acute injury during exercise: such as muscle, sprain, contusion, torn ligament, dislocation, fracture.

Exclusion Criteria:

1. Athletes with serious cardio-cerebrovascular disease and abnormal liver and kidney function
2. Recent use of drugs or supplements that affect metabolism.
3. Pregnancy, lactation or special conditions that may affect metabolism.
A Registry of AL Amyloidosis (ReAL)

The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.

Thanks to this registry, it will be possible to collect data at diagnosis and during follow up, in order to be able to describe the natural history of AL amyloidosis in a real-world setting and to define and validate prognostic models, response and relapse criteria applicable at any point of the disease.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of systemic AL amyloidosis;
2. treatment-naïve (pre-treatment data collected at participating center available for retrospective part);
3. age ≥18 years;
4. ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);
5. planned (or ongoing) follow-up at participating center.

Exclusion Criteria:

1. non-AL amyloidosis;
2. previous treatment for AL amyloidosis.
Amino Acid Profile in the Fetus and the Neonate

Up-to-date, the preterm newborn nutrition is based on human breast milk or it's imitations. However, the growth rate is known to be reduced compared to the fetal growth rate. In order to attempt a better growth rate of the preterm newborn infants it is important to evaluate the metabolic components of the fetal blood and try to find components that might influence its growth.

Little is known of the metabolic components of the fetal blood, including amino acid profile. The aim of the study is to evaluate amino acid profile in the fetus blood in different gestational ages and compare it to post natal period.


Eligibility Criteria:
Inclusion Criteria:

* All new-born infants 5 of each gestational age

Exclusion Criteria:

* none
Effects of Cultura Yoghurt in Irritable Bowel Syndrome (IBS) Patients on Intestinal and Immunological Changes

To determine the effect of cultura probiotic yoghurt on number of responders to treatment during 8 weeks of treatment in comparison to placebo. To determine the effect of cultura yoghurt on change in total score of (IBS) irritable bowel syndrome severity index during 8 weeks of treatment in comparison to placebo in IBS out patients.

Recent research has shown taht probiotic may give positive effect on symptoms among patients with (IBS) Irritable Bowel Syndrome. The mechanism behind the positive effect are not known but a positive effect on different cytokines are a possible mechanism. Also effect on the large intestine bacterial mass could be of importance.

Eligibility Criteria:
Inclusion Criteria:

Signed consent to participate age 18-70 years IBS according to Rome II criteria

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Exclusion Criteria:

1. Participation in a clinical study one month prior to screening visit and throughout the study.
2. Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
3. Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator.
4. Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
5. Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator.
6. Severe psychiatric disease as judged by the investigator.
7. Previous history of drug or alcohol abuse six months prior to screening.
8. Intolerance or allergy against milk products or gluten.
9. Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study.
10. Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
11. Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study.
12. Pregnant or lactating or wish to become pregnant during the period of the study.
13. Lack of suitability for participation in the study for any reason as judged by the investigator.
Power-Assisted Therapeutic Electrical Stimulation to Upper Extremities

Power-assisted therapeutic electrical stimulation (TES) or conventional TES to upper extremities in acute stroke patients were performed in a randomized controlled trial. The changes in finger and hand function will be evaluated. The hypothesis is that a power-assisted TES is more effective than a conventional TES.


Eligibility Criteria:
Inclusion Criteria:

* acute or subacute phase of stroke

Exclusion Criteria:

* chronic phase of stroke
Effectiveness of WB-EMS Versus HIT-Resistance Training (RT)

The main aim of the study is to determine the effects of Whole-Body Electromyostimulation (WB-EMS) on body composition and muscle strength compared with the "golden standard" High Intensity Resistance Exercise Training (HIT) in healthy sedentary middle aged males.


Eligibility Criteria:
Inclusion Criteria:

* male, 25 to 55 years old
* sedentary / untrained
* Body Mass Index 20 - 30 kg/m2

Exclusion Criteria:

* absent ≥ 2 weeks during the interventional period
* medication or diseases with relevant impact on muscle metabolism
* conditions that prevent WB-EMS (e.g. epilepsy, cardiac pacemaker)
* severe neurological diseases
Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery

Phantom pain is associated with cortical reorganization after amputation. This phenomenon should not play a role in transsexual women, since the cortical representation of the male sex organs is presumably altered. The study investigates the incidence of phantom pain in this patient population.

For this study the following question should be investigated:

Is the incidence of phantom pain and local chronic postsurgical pain lower in sex reassignment surgery from male to female compared to inguinal tumor orchidectomy?

Phantom pain is a common and much studied phenomenon after amputation.The loss of visceral organs is also associated with phantom pain. Under entirely different conditions than the removal of a tumorous testicle, sex reassignment surgery from male to female sex occurs in transsexual women. In this operation, parts of the penis and both testicles are removed and a plastic surgical transformation is made into a female genital.The surgical trauma is greater compared to an orchidectomy.

The sex reassignment surgery is expressly desired, the amputated tissues are rejected or perceived as not belonging to the patient's own body and thus do not appear as a loss. The group of patients with tumor orchidectomy acts as a control group.

In addition to the incidence of phantom pain and chronic local postoperative pain in comparison between the two groups, the secondary objectives of the study were defined as the occurrence of phantom pain, the type of pain and the intensity of pain.

Two patient groups were compared, the group after sex reassignment surgery (GAC) and the group after inguinal orchidectomy for testicular tumor (ORC).

A total of 265 transgender women were written to, 46 of whom had undergone surgery in Tübingen and 219 in Munich. The operations took place between 2002 and 2014.

For the group of patients after orchidectomy, 158 men who had undergone surgery in Tuebingen between 2010 and 2014 were contacted by letter.

The pseudonymization was done with a combination of letters and numbers, which were created with a key generator program.

The patients received a questionnaire divided into several categories, these categories were questions on demography, pre- and postoperative pain as well as phantom pain, pain processing, quality of life, sex life and urological questions.

Eligibility Criteria:
Inclusion Criteria:

* Surgery at least 6 month before data collection
* german speaking

Exclusion Criteria:

-
SHARE - Symbicort and Health Economics in a Real Life Evaluation

The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent,
* asthma,
* previously treated with glucocorticosteroids and B2-agonist

Exclusion Criteria:

* History of smoking, pregnancy, any significant disease or disorder which may put the patient at risk because of study participation
Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery

The goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally.

Specifically, it aims to answer the questions:

* In fetuses who are facing upwards (occiput posterior, OP) or sideways (occiput transverse, OT) during labor, does changing the patient's position during active labor to a side-lying posture with a peanut ball increase the chances of them having a successful, spontaneous vaginal delivery?
* Does changing the patient's position in active labor affect the position of the baby at the time of delivery?
* Do intentional position changes in labor impact patient-perceived autonomy during their labor and delivery experience?

Participants will:

* Receive an ultrasound during labor to determine the position of their baby
* Be asked to adopt a specific position in labor (side-lying with peanut ball) if they are randomized to the study group
* Receive additional ultrasounds during labor to assess their baby's position
* Fill out a questionnaire about their labor experience following the delivery of their baby

In this randomized trial, the investigators aim to evaluate the effects of early ultrasound diagnosis and active management of fetal malposition during the first stage of labor. Specifically, the investigators will compare the modified Sims (side-lying) position ipsilateral to fetal spine with the addition of a peanut ball versus free maternal position choice in occiput posterior (OP) or occiput transverse (OT) fetuses diagnosed by ultrasound during active labor, defined as greater than 6cm cervical dilation. The primary outcome will be operative delivery rates, defined as either cesarean delivery or instrumental vaginal delivery with vacuum or forceps. The investigators will also assess rates of spontaneous rotation to occiput anterior (OA) position at complete dilation and at delivery, as well as the impact of the position changes on the patient's labor experience and their perceived autonomy.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age \>18
* Term gestation (\>37 weeks)
* Singleton pregnancy
* Spontaneous or induced active labor (cervical dilation 6-9cm)
* Epidural anesthesia
* Cephalic fetal presentation, OP/OT position diagnosed by bedside ultrasound
* Continuous external fetal monitoring
* Ability to consent

Exclusion Criteria:

* Multiple gestations
* Unanesthetized labor
* Known fetal anomalies
* Known intrauterine fetal demise
* Inability to consent
MBSR for Pain Catastrophizing in SCD

Significance: The purpose of this exploratory study is to test the feasibility, accessibility, and effects of a mindfulness-based stress reduction program (MBSR) on reducing pain catastrophizing in persons with sickle cell disease (SCD) and chronic pain. One of the most difficult symptoms for SCD patients to manage is chronic pain. Approximately one-third of SCD patients experience chronic pain, which is associated with pain catastrophizing. Pain catastrophizing is a negative mental state toward pain stimuli and pain experience, and is associated with increased pain severity, pain interference, and lower social functioning, physical functioning, and mental health. There have been no psychobehavioral intervention studies that have attempted to alter the experience of pain catastrophizing in persons with SCD. MBSR is a complementary group-based therapy that emphasizes nonjudgmental awareness of thoughts, feelings, and bodily sensations. With no pharmacological or non-pharmacological treatment for catastrophizing in persons with SCD, MBSR offers a potential solution to this highly significant problem for both SCD patients and providers. This project will be the first randomized controlled trial (RCT) of MBSR to reduce pain catastrophizing, and improve quality of life for SCD patients with chronic pain.

Methods: This study will enroll 60 adult patients with SCD and chronic pain from the Duke Adult Sickle Cell Clinic. Patients will be randomized to a MBSR or wait-listed control group. The MBSR group will complete a 6- week, group-based telephonic MBSR program that is administered by a certified MBSR clinician once a week for 90 minutes. MBSR feasibility, acceptability, and effects on pain catastrophizing will be assessed by questionnaires at baseline, week 1, 3, and 6 in both groups. At the end of week 6, 10 randomly selected MBSR participants will complete semi-scripted telephone interviews to help assess intervention acceptability, and the wait-listed control condition will be offered the same MBSR intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent,
2. Are \>age 21,
3. Self-identify (to the PI at baseline assessment) that they are experiencing chronic, non-cancer pain that has persisted on most days for more than 6 months, and adversely affects their function or well-being,
4. are able to speak and read English,
5. Have access to a telephone (or cell phone) in the home for the intervention and individual assessment interviews (data from the SCD clinic indicate 82% of patients have a cell phone),
6. Have access to a CD or mp3 player for homework assignments and daily practice,
7. Are available during the scheduled telephone intervention, and
8. Complete and return the baseline assessment

Exclusion Criteria:

* Patients will be excluded if they report previously studying MBSR, currently receiving mindfulness-based or cognitive behavioral therapies, or being regular practitioners of mindfulness, including yoga.
MEDTRUM A7+ TouchCare Insulin Patch Pump (MedInPS)

Demonstration study of the interest of the MEDTRUM A7+ TouchCare insulin patch pump versus INSULET Omnipod® patch pump

Compare the daily use of two single usage patch pumps and demonstrate the interest of use of the A7+TouchCare® (Medtrum) patch pump for type 1 \& 2 diabetes management.

Main objective is an estimation of Patients A1C (Glycated Haemoglobin) based on the average blood glucose (obtained from a Flash glucose monitoring) and to compare it in both groups.

Secondary objectives:

* comparison of mean A1C (laboratory values) between the two groups at Baseline and study end. Comparison to be established in a non-inferiority
* Observe Skin \& overall Tolerance, Technical incidents with the device (failure, disconnection, catheter obstruction...)
* Collection of Glucose metrics (minimum, maximum, average/median, standard deviation, out of range value, percentage of time in range, glucose variability)

Eligibility Criteria:
Inclusion Criteria:

* Patient with type 1 or 2 diabetes, 18 years of age and over
* Patients already equipped with Omnipod® ® (INSULET) insulin patch pump and Abbott FreeStyleLibre sensor®.
* A1C ranking from : \>= 6,5% to \<= 9.5%
* Any type of rapid insulin except FIASP (which can be substituted if necessary) with 60 IU max per day (unauthorized use of insulin supplements by pen injector)
* Patient able to receive and understand study information, give written informed consent, and easily participate to the trial
* Patient affiliated to the French social security system

Exclusion Criteria:

* - Patient already participating in another study
* Patient under the protection of justice or under guardianship or curatorship
* Type 2 diabetic patient requiring a daily insulin dose \> 60 IU
* Patients not suitable for suing insulin pump such as: severe psychiatric disorders, rapidly progressing ischemic or proliferative retinopathy before laser treatment, and exposure to high magnetic ﬁelds
* Patients allergic to nickel and adhesive
* Pregnant women, breastfeeding women
* Or any other criteria as appreciated by the study investigator.
Content Validation of Quality of Life and Symptom Questionnaires for Pheochromocytoma and Paraganglioma

The purpose of this qualitative study is to evaluate the clarity and comprehensiveness of two disease-specific questionnaires, and to evaluate how effective these questionnaires are at assessing the quality of life and symptoms of patients with pheochromocytoma or paraganglioma.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent and be willing to comply with protocol requirements
* Participant is aged ≥ 18
* Have a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma with active symptoms or within 60 days of curative therapy

Exclusion Criteria:

Patient is currently asymptomatic from pheochromocytoma/paraganglioma diagnosis or duration \> 60 days from curative therapy

* Participant has a clinically significant disorder, including alcohol or drug abuse, which may interfere with study participation or which may affect the outcome of the study as judged by the investigator.
* Participant has a mental disability or significant mental illness, legal incapacity or limited legal capacity or any other lack of fitness, in the investigator's opinion, to preclude the subject's participation in or ability to complete the study.
* Participant is currently too unwell to take part in the study.
Effect of Low Tidal Volume Ventilation in Improving Oxygenation and Thus Reducing Acute Lung Injury in the Cardiac Surgical Patient

We propose that as low tidal volume ventilation has proven to be beneficial in patients with established ARDS it may have a role in preventing the onset of acute lung injury in the cardiac surgical population. Institution of low tidal volume ventilation in the operating room may reduce the release of the cytokines and interleukins that have been known to contribute to the development of acute lung injury. In this study, we propose that the institution of low tidal volume ventilation in the operating room will reduce the incidence of acute lung injury. Measurement of PaO2 to FiO2 ratio twenty four and forty eight hours post operatively will help determine if there is a difference in oxygenation between the two groups. Chest X-ray findings, time to extubation and length of ICU stay will also determine if there is a role for low tidal volume ventilation in the operating room. We will also attempt to establish a causative mechanism by measuring plasma levels of cytokines known to be associated with the development of ARDS.

Methods- A single center randomized controlled trial was undertaken in 149 patients comparing ventilation with 6 ml/kg TV to ventilation with 10 ml/kg TV in patients undergoing elective cardiac surgery. Study ventilator settings were applied immediately after induction of anesthesia and continued throughout surgery and the subsequent Intensive Care Unit stay. The primary endpoint of the study was time to extubation. Secondary endpoints included the proportion of patients extubated at 6 hours, indices of lung mechanics and gas exchange as well as patient clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients coming in for cardiac surgical procedures will be recruited into the study.
* Both men and women will be recruited into the study.
* All patients over the age of 18 will be recruited into the study.
* Discussion between the surgeon and the primary investigator will happen prior to approaching the patient to obtain informed consent.

Exclusion Criteria:

* Patients with preexisting respiratory failure and active infection will be excluded from the study.
* Patients undergoing one lung ventilation during surgery will be excluded from the study.
* Patients undergoing emergency cardiac surgery will be excluded from the study.
FitMi Plus Home Therapy for Stroke Patients

The investigators will investigate the efficacy of a newly developed functional exercise device (FitMi Plus) for people in the chronic stage after a stroke compared to the FitMi Basic (i.e. without functional exercises). FitMi Plus combines objects commonly used during activities of daily living with sensors that can track and record the patient's direction and degree of movement as they perform specific functional tasks described on a computer.


Eligibility Criteria:
Inclusion Criteria:

* Experienced 1 or more strokes \>6 months prior to enrollment
* Upper Extremity Fugl-Meyer Score \>=15 and \<=55 out of 66
* Absence of moderate to severe upper extremity pain (\<= 4 out of 10 on the visual-analog pain scale)
* Ability to understand the instructions to operate FitMi products

Exclusion Criteria:

* Lack of concurrent severe medical problems
* Lack of visual deficits
* Lack of severe neglect or apraxia
* No concurrent enrollment in another therapy study