cyrilzakka/clinical-trials huggingface dataset:
Magnesium Sulfate for Fetal Neuroprotection

Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017) in any of the groups will receive the allocated treatment at least 20 minute before the procedure (emergency CS).

measures to reduce the effect of hypoxia will be applied to all participate through:

* The position of the mother will be changed to left lateral position (allow increased blood supply).
* I.V. fluid bolus (to avoid maternal dehydration).
* Oxytocin or cervical ripening agent will be discontinued.
* Fetal heart rate monitoring with cardiotocography will be attempted.
* If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing for emergency operative delivery.
* After birth, Apgar score will be used to identify distress newborns that need resuscitation.

The study comprised 200 pregnant women. They were divided into two groups each are 100:

* Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive MgSO4.
* Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive placebo

Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017) in any of the groups will receive the allocated treatment at least 20 minute before the procedure (emergency CS).

measures to reduce the effect of hypoxia will be applied to all participate through:

* The position of the mother will be changed to left lateral position (allow increased blood supply).
* I.V. fluid bolus (to avoid maternal dehydration).
* Oxytocin or cervical ripening agent will be discontinued.
* Fetal heart rate monitoring with cardiotocography will be attempted.
* If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing for emergency operative delivery.
* After birth, Apgar score will be used to identify distress newborns that need resuscitation.

The study comprised 200 pregnant women. They were divided into two groups each are 100:

* Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive MgSO4.
* Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive placebo

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at least 37 week of gestation.
* Not more than 35 years old.
* Fetal distress (perinatal asphyxia) diagnosed by CTG changes (Non reassuring or pathological changes according to NICE guidelines 2017).
* Clinical chorioamnionitis.
* Prolonged rupture of membranes

Exclusion Criteria:

* Medical disorders such as chronic hypertension, preeclampsia, eclampsia, DM, pulmonary hypertension, hepatic coma with risk of renal failure, and any renal, cardiac or pulmonary disease.
* RH -ve.
* Consanguinity.
* Preterm labor.
* Fetal malpresentation.
* Contraindications to the use of Magnesium Sulphate.
* Any indication for magnesium Sulphate therapy (seizure prophylaxis or tocolysis).
* Myasthenia gravis.
* Congenital fetal anomalies.
* Fetal growth restriction (birth weight \< 10th Percentile for gestational age).
* Advanced cervical dilation (8cm).
Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

Double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators aim to include a total of 120 patients, randomized to two equal groups. Participants in the intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for spinal anaesthesia. Participants in the placebo group are administered 12.5mg bupivacaine and saline to match the volume of intervention goup. Primary end points are opioid consumption and possible adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* elective primary total knee arthroplasty
* ASA I-III
* written consent

Exclusion Criteria:

* rearthroplasty
* ASA IV-V
* inadequate spoken finnish for reliable pain assessment
* Dementia or otherwise impaired cognition
* contraindication for any medication or substance used in survey protocol
* weight \<50kg or BMI ≥35 kg/m2
* preoperative SpO2 less than 93%
* clinical suspicion that subject can not use PCA adequately
* history of substance abuse or current excessive use of alcohol
* preoperative use of either pregabalin, gabapentin or strong opiates
Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay

To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the "BRONJ Assay") in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV) administration of Bisphosphonates (BP).

The Micromedic BRONJ Assay is intended for the qualitative analysis of genetic changes which may be indicative of increased risk to develop BRONJ osteonecrosis of the jaw (ONJ) following IV administration of drugs of the Bisphosphonate family.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria Study Group (all of the following):

1. Subject is ≥18 years old
2. Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium; Or; Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium and was also treated by oral BP such as sodium alendronate, and in the opinion of the PI, IV treatment was significant enough to be considered as the cause for BRONJ
3. Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS (American Association of Oral and Maxillofacial Surgeons)
4. Subject has signed the informed consent or consent can be waived

Inclusion Criteria Control Group (all of the following):

1. Subject is ≥18 years old
2. Subject is or was a Multiple Myeloma and/or other cancer patient who is, or has been IV treated with the BP zoledronic acid and/or pamidronate disodium for at least two (2) years (continuously or cumulatively)
3. Subject has not developed any signs or symptoms of BRONJ
4. Subject has signed the informed consent or consent can be waived

Exclusion Criteria:

1. Subject has been treated with irradiation to the jaws or head and neck at levels exceeding 35 Gy
2. Pregnant or lactating women
3. Subject has been treated with either bevacizumab or sunitimib
4. Subject has been treated with Allogeneic hematopoietic stem cell transplantation (HSCT)
Probiotics in Systemic Lupus Erythematosus

Dysbiosis, or disruption of the gut microbiota, leads to the onset of autoimmunity. Increasing data suggest that the gut microbiota is changed in various murine lupus models as well as in human systemic lupus erythematosus SLE patients. Ingestion of lactobacilli, which have immunoregulatory properties, may be a viable strategy for controlling disease development and progression in patients with lupus, such as increasing the remission period and decreasing flare frequency.

1. Patients will be recruited and evaluated for eligibility.
2. Patients who met the eligibility criteria will be randomly assigned to either control or interventional group.
3. Patients in the control group will receive their standard therapy for 12 weeks and patients in the interventional group will receive their standard therapy plus one sachet daily of lacteol forte sachets for 12 weeks.
4. Collection of demographic data, full medication history, and full medical history will be performed at baseline and every 4 weeks.
5. Assessment of disease activity using SLEDAI-2K score, quality of life using the validated Arabic LupusPROv1.8 questionnaire, and Pain assessment using the validated Arabic version of the Short-Form McGill Pain Questionnaire will be performed at baseline and at the end of the study.
6. Safety and tolerability monitoring will be performed weekly using a side effect and/or adverse effect monitoring sheet.
7. Blood and urine samples for laboratory investigations will be withdrawn at baseline and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years, male or female.
2. Patients are willing to sign a written informed consent.
3. Patients fulfilling American college of rheumatology classification criteria for SLE.
4. Patients diagnosed with active systemic lupus erythematosus defined as SLEDAI-2K score more than 4.

Exclusion Criteria:

1. Patients ˂ 18 years or ˃65 years of age.
2. Patients with a history of drug allergies to probiotics administration.
3. Pregnant or breastfeeding females.
4. Current probiotics use.
5. Patients scheduled for surgical intervention during the study period or up to 2 weeks after the end of the study.
6. patients suffering from active severe neuropsychiatric manifestations of SLE.
7. Patients with other auto-immune diseases.
8. Patients suffering from any type of cancer.
9. patients participating in other clinical trials.
Association Between Sleep Quality and Self-Care in Heart Failure Patients

The research will be conducted as a prospective and relational study to longitudinally investigate the effect of sleep quality on self-care in patients with heart failure (HF) and to evaluate the relationship between self-care, sleep quality, and cognitive functions. The sample size was calculated using the multiple linear regression model with the G\*Power Version 3.1 program. Based on a medium effect size of 0.15, an alpha of 0.05, a power of 0.95, and 18 predictors, the sample size was determined to be 188. Considering a potential dropout rate of 10%, it was decided to complete the study with a minimum of 207 participants.

Data will be collected from patients who apply to the Dokuz Eylül University Cardiology Outpatient Clinic and meet the inclusion criteria. After signing the informed consent form, participants will be followed up at baseline, the 1st month, the 3rd month, and the 6th month by telephone. The Statistical Package for Social Sciences (SPSS) 24.0 will be used to analyze the numerical data of the research. Descriptive statistics, including number, percentage, mean, and standard deviation, as well as inferential statistics such as the χ2 test, t-test for independent groups, and multiple linear regression, will be employed in the data analysis.


Eligibility Criteria:
The study will include patients who:

* Are diagnosed with heart failure according to international guidelines,
* Are aged 18 years or older,
* Can communicate via phone, and
* Are willing to participate in the study.

Exclusion Criteria:

The study will exclude patients who:

* Have been hospitalized within one month prior to inclusion,
* Have experienced major psychological trauma or stress in the last three months,
* Have serious comorbidities or malignant cancers,
* Have advanced hearing impairment,
* Are using prescription drugs for insomnia or psychiatric conditions,
* Work night shifts, or
* Reside in nursing homes.
Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section

Postoperative pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS) under spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 45
* American Society of Anesthesiologists (ASA) physical score I or II

Exclusion Criteria:

* Patients who received general anesthesia
* hypersensitivity to the agents to be used
* body mass index (BMI) greater than 35 kg/m2
* coagulopathy
* local infections
* opioid addiction
* pregnancy-related hypertension or diabetes mellitus
Effects of Mindfulness Based Stress Reduction Intervention in Patients With Non-alcoholic Fatty Liver Disease

The purpose of this research study is to find out about the usefulness of mindfulness for weight loss and improvement of physical and mental health in people who have non-alcoholic fatty liver disease (NAFLD).

Adding mindfulness to lifestyle changes for weight loss may improve fatty liver disease in particular and overall health and well-being in general by helping sustain weight loss and maintain a healthy lifestyle. This study will allow researchers to learn more about it.

Non-alcoholic fatty liver disease is a condition where there is accumulation of excess fat in the liver of people who drink little or no alcohol. It is part of the metabolic syndrome characterized by diabetes, or pre-diabetes (insulin resistance), being overweight or obese, elevated blood lipids, as well as high blood pressure, all are risk factors for the disease.

In this study, participants will receive usual care, and in addition, they may be asked to participate in a mindfulness-based stress reduction program for 8 weeks. Usual care involves the routine clinic follow up visits and routine lab tests and imaging studies.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of NAFLD and ALT \>35 U/dl.
2. At least 2 features of Metabolic syndrome (defined by Adult Treatment Panel III (2005 revision)).
3. Age 18-80 years.
4. BMI ≥25 Kg/m2.
5. Capable of providing written or signed informed consent.

Exclusion Criteria:

1. Any known cause of liver disease other than NAFLD as confirmed by patient's history, laboratory data, and/or histological findings.
2. Decompensated liver cirrhosis based on laboratory data and clinical manifestations (varices, ascites, or encephalopathy).
3. Any previous experimental interventional treatment of NAFLD or NASH within the past 3 months.
4. Pre-existing diseases/conditions that could interfere with the results or the completion of this trial based on the investigator's judgment.
5. Unstable metabolic syndrome and other serious chronic medical conditions.
6. Unstable type 2 diabetes (any of the following):

   * Requiring medication adjustment within the last 3 months.
   * Patients requiring GLP-1 agonists treatment.
   * No more than 10% modification in insulin dose if on insulin.
   * If on SGLT-2 inhibitors, need to be on stable dose with more than 5% weight loss in the last 3 months.
7. Unable to adhere to out-patient clinic management program.
8. Do not speak English on a daily-user level.
9. Pregnant or planning to become pregnant within the following 6 months.
10. Active substance use disorder.
11. Does not accept follow-ups over 1 year from time of inclusion (T0).
12. Inmates.
Fascial Therapy in Elbow Hemophilic Arthropathy

Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Secondary disorders to this joint degeneration include: biomechanical alterations, loss of range of movement and periarticular muscle atrophy.

Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of the elbow.

Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients will be recruited in 6 centers, from different regions of Spain.

Intervention: Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:

Measuring instruments and study variables: goniometric evaluation (range of movement); visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.

Expected results: First, it is intended to demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in the perception of elbow pain and joint mobility is expected. An improved functionality of the upper limb is also foreseen and with it, an enhanced perception of quality of life of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* Patients adults (over 18 years)
* Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment with the Hemophilia Joint Health Score)
* Patients pn prophylactic treatment with FVIII / FIX concentrates.

Exclusion Criteria:

* Patients without ambulation ability
* Patients with inhibitors
* Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests
* Patients who have not signed the informed consent document.
Early Foley Catheter Removal After Diverticular Colovesical Fistula Repair

Patients undergoing surgical repair of colovesical fistula will have have "early" (post-operative day 3) cystogram and removal of bladder catheter. Outcomes from the "early" group will be compared to historical "late" group data to determine if early bladder catheter removal is safe.

There is defined time for foley/bladder catheter removal after colovesical fistula repair in the current surgical literature. This study will be a prospective cohort study evaluating outcomes after early foley catheter removal (on post-operative day 3), specifically bladder leak, 30-day readmissions and adverse events. This cohort will be compared to a retrospective "late" group, who had foley catheter removal later in their hospital course.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and over
* Undergoing surgical repair of diverticular colovesical fistula

Exclusion Criteria:

* Patients with active and untreated genitourinary cancers
* Subjects with known or suspected Inflammatory Bowel Disease as the cause of colovesical fistula.
* Individuals who are not expected to regain normal bladder function after surgery as defined by either pre-existing bladder dysfunction with chronic indwelling urinary catheter, supra-pubic catheter, or surgical urinary diversion
* Individuals who require re-operation prior to Foley removal
* Adults unable to consent
* Pregnant women
* Prisoners
* Individuals who are not yet adults (infants, children, teenagers less than 18 years old)
Preventing Contrast-induced Nephropathy: Evaluating Hydration Strategies and L-carnitine Administration

The general objective of this open, pilot study is to characterize biological parameters related to acute kidney injury among patients undergoing a programmed coronarography with injection of contrast material. The study focuses on two main factors that may influence acute kidney injury: (1) sodium chloride hydration strategy versus sodium bicarbonate hydration strategy and (2) presence of oral L-carnitine treatment versus absence of oral L-carnitine treatment. We will also test for a potential interaction between these two factors.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is scheduled for a coronarography
* The patient can come back to the hospital on days 2 and 7 after the coronarography for follow up
* The patient has moderate to severe renal insufficiency (glomerular filtration rate \< 60 ml / min / 1.73 m\^2)
* The patient has not had any oral antidiabetic treatments, or diuretic treatments, within 48 hours preceding the coronarography
* Lack of treatment with ACE inhibitors or ARA2 24 hours prior to coronary

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by another study
* The patient is under judicial protection
* The patient is under any kind of guardianship
* The patient refuses to sign the consent form
* It is impossible to correctly inform the patient
* The patient is unable to participate in follow-up visits at days 2 and 7 after the coronarography
* The patient is pregnant or breastfeeding
* The patient is taking L-carnitine
* The patient has a contra indication for a treatment used in this study
* Acute heart failure
* Infarction, acute phase
* Hemodialysis patient
* Myeloma
* Epileptic patient treated with Depakine (valproic acid) (carnitine can lower epilepsy-related thresholds by speeding up the metabolism of Depakine)
Effects of Diet Versus Diet Plus Aerobic and Resistant Exercise Program in Overweight Women

Adult women aged 18-50 years and overweight (preobese) with a BMI of 25-30 kg/m2 will be included in the study. Participants will participate in an eight-week diet and diet plus aerobic and resistance exercise program. Patients will be referred from the Nutrition and Diet Polyclinic of Bezmialem Vakıf University to this study, which will be conducted to investigate the effects of exercise program on postural control, musculoskeletal system disorders, functional capacity, and sleep.

Subjects who accepted to participate in the study will be randomized and divided into two groups as study and control groups. A computer-based randomization program (random.org) will be used to determine the cases to be assigned to the study and control groups. 2 numbers consisting of 12 numbers will be determined by random selection from the numbers between 1 and 24. The first of these number sequences will be considered as the study group and the second as the control group. Each patient included in the study will be asked to draw one of the sealed envelopes in which the numbers 1 to 24 are written. The case will be assigned to the study or control group according to the number sequence in which the drawn number is included. While the women in the study group are expected to perform regular walking with a diet for eight weeks and a 3-day aerobic and resistance exercise program per week, the subjects in the control group will be followed up with diet and regular walking. Initially, participants will be educated on healthy eating habits through one-on-one dietitian consultation. A personalized calorie-restricting nutrition program will be given. According to this program, the daily energy intake of the individual will be reduced to provide 0.5-1.0 kg of body weight loss per week.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25-29.9kg/m2
* Being between the ages of 18-50
* Agreeing to participate voluntarily in the study

Exclusion Criteria:

* Pregnancy
* Presence of systemic disease that will prevent participation in an aerobic exercise program
* Presence of conditions such as pain or surgery that will prevent participation in an aerobic exercise program
* Participating in a regular exercise program within the last 1 year