cyrilzakka/clinical-trials huggingface dataset:
Effect of Oats on Lipid Profile

A randomized control trial to assess the effect of oats on lipid profile of mildly hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day) in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks. In total 3 assessment visits of the subjects planned for the study period.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 20 and 50 years old
* Total Cholesterol: ≥ 200 mg/dL and \< 240mg/dL
* Availability and willingness to follow study protocol
* Stable body weight for previous 3 months (not more than 5% weight change)

Exclusion Criteria:

* Subjects already on lipid lowering drugs
* LDL-c \> 190 mg/dL
* Total cholesterol \<200 mg/dL and \>240 mg/dL
* Subjects with serum creatinine levels \> 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse
* Baseline Triglycerides: \> 300 mg/dL
* Diabetes (Type 1 or Type 2) as diagnosed by a physician
* Uncontrolled hyperthyroidism (as per physician's discretion)
* Uncontrolled hypertension (as per physician's discretion)
* Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc. Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs by history
* Irritable bowel syndrome by history
* Unwillingness to give written informed consent for participation in the study.
* Pregnancy \& lactation (by history)
* Severe end organ damage
* Subjects with allergy to oats
* Heavy smokers (smoking more than 5 cigarettes per day)
Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome

The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention.

Irritable bowel syndrome (IBS) is a condition linked to disturbances in the gut-brain axis and dysbiosis. Although probiotic modulation of dysbiosis appears promising for IBS treatment, identifying the specific beneficial strains remains uncertain. Furthermore, even with an effective probiotic strain, variations in efficacy among populations are observed due to environmental heterogeneity, particularly dietary influences.

This study seeks to provide efficacy insights into Skal Pro powder 2g (containing Lactobacillus plantarum 299v 1x10\^10 colony forming unit (CFU) and GOS), shedding light on the unique mechanisms of LP299V within the Malaysian population through a randomized controlled trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* IBS diagnosed using the Rome IV criteria
* Age above 18 years old and any gender
* Any subtypes of IBS (diarrhea, constipation or mixed)

Exclusion Criteria:

* Presence of red flag symptoms (weight loss, anemia, night symptoms, abdominal mass, strong family history of cancer)
* Was prescribed antibiotic (s) within the past one month
* Medical conditions that contraindicate probiotic use including severe sepsis and pregnancy
* Presence of bowel malignancy
* Diagnosis of bowel infection within the past one month
* Previous abdominal surgeries
* Patients with overt psychiatric illnesses including schizophrenia and manic disorders
* A history of allergy to probiotic
* Was prescribed probiotic (s) within the past one month
* Was previously prescribed probiotic Skal Pro™ (LP299V™)
HIV and HCV Intervention In Drug Treatment Settings - 1

The purpose of this study is to test two strategies to reduce the risk of contracting Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) by reducing risk behaviors in patients undergoing drug detoxification.


Eligibility Criteria:
Volunteers will be IV drug users already enrolled in drug detoxification treatment.
The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.

Systemic lupus erythematosus (SLE) is an autoimmune disease and renal involvement represent one of the most common manifestations of it . On the other hand, there is evidence that vitamin D and its analogs have known immunosuppressant properties and profound effects on glomerular mesangial cell proliferation. Moreover much literature such as animal studies suggests it as a therapeutic intervention in autoimmune disease. The investigators plan to conduct a double blind randomized control clinical trial to study effects of calcitriol on progress and activity of lupus nephritis. Fifty patients with clinically quiescent SLE and biopsy-proven glomerulonephritis will be recruited. They will be treated with calcitriol for 1 year. Proteinuria, renal function, lupus disease activity, serum inflammatory markers will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Baseline Systemic Lupus Erythematosus Disease Activity Index score \<= 4
* Estimated glomerular filtration rate more than 15 ml/min/1.73m2
* Proteinuria \> 1 g/day (or proteinuria \> 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor at least 3 months
* On maintenance dose of prednisolone \< 15 mg/day with or without other immunosuppressive medications
* Serum calcium level in normal range( 8.5-10.5 mg/dl)
* History of biopsy-proven lupus nephritis clinical quiescent SLE for at least 3 month
* Willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* Pregnancy, lactating or childbearing potential without effective method of birth control
* Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
* History of malignancy, including leukemia and lymphoma within the past 2 years; Systemic infection requiring therapy at study entry
* Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
* History of drug or alcohol abuse within past 2 years
* Vitamin D deficiency(25 hydroxy vitamin D less than 20ng/ml)
* Participation in any previous trial on vitamin D analogue
* Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks
* Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D
* On other investigational drugs within last 30 days
* History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
* History of non-compliance; Known history of sensitivity or allergy to vitamin D analogs
Online Adaptive Radiotherapy for Cervical Cancer

This study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. By comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.


Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old;
2. Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;
3. 2018 FIGO Stage Ib3, II, and IIIC1
4. Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses)
5. ECOG score 0-2
6. Life expectancy greater than 6 months
7. Ability to remain lying down for more than 30 minutes
8. Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form
9. Complete blood count and basal metabolic indexes within 14 days before enrolment must meet the following requirements: NEUT ≥ 1.5\*109/L, HGB ≥ 60g/L, platelets ≥ 100×109/, blood creatinine \&lt;1.5 mg/dL. AST and ALT are within 2 times the upper limit of normal
10. Must complete baseline assessments and investigations required before treatment before enrolment
11. be eligible for regular follow-up

Exclusion Criteria:

1. Have received radiotherapy or chemotherapy in the past
2. Have undergone radical surgery for cervical cancer
3. Have a previous history of malignant tumor
4. Pregnant or lactating women
5. Presence of other serious co-morbidities such as poorly controlled cardiovascular, urinary, digestive, respiratory, hematological and central nervous system diseases.
Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008)


Eligibility Criteria:
Inclusion Criteria:

* Male
* aged 50 years or older
* a diagnostic claim for BPH
* at least one prescription claim for a 5ARI or AB in the enrollment period
* continuous eligibility for 6 months prior to and 12 months after index prescription date

Exclusion Criteria:

* diagnosis of prostate or bladder cancer during the study period
* any prostate-related surgical procedure within 1 month of the index prescription date
* prescription claim for finasteride 1 mg for male pattern baldness during the study period
Pharmacokinetics in Extracorporeal Membrane Oxygenation

The main purpose of the present study is to investigate the risk factors that affect drug pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance understanding of PK variance and improve the patients outcomes during ECMO.

Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK studies in healthy animals and critically ill animal models with or without ECMO to define the PK alterations. Clinical PK studies in critically ill patients on ECMO.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing ECMO for respiratory and or cardiac dysfunction
* Clinical indication for the antibiotics
* Clinical indication for the sedatives and analgesics

Exclusion Criteria:

* No consent
* Known allergy to study drug
* Pregnancy
* Massive fluid resuscitation (\>50% blood volume transfused) in the previous 8 hours.
* Therapeutic plasma exchange in the preceding 24 hours
Prognostic Determinants of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients

Patients with end-stage kidney disease are treated with dialysis to increase their life expectancy as well as their quality of life (QoL). Scientific researchers are currently still looking for markers to evaluate dialysis in an objective way. It has been proven before that the currently clinically used parameters (like the dialysis adequacy parameter Kt/V) are not appropriate enough to estimate dialysis dose.

The current project aims at identifying potential (predicting) biomarkers based on functional capacity, nutritional status and/or QoL.

This multisite study is an observational study during which prevalent dialysis patients are followed during maximum 3 years, and they undergo different tests.

Once a year (max 3 times), blood is sampled, stool is collected, and finger nails are taken all before a midweek session. Demographic data are registered and Davies-Stokes scores are calculated. Blood is analysed for different solutes: e.g. total and free fractions of protein-bound toxins, sedimentation, erythrocytes, hematocrit, leukocytes, thrombocytes, Ferritin, VitB12, Fasting glucose, c-reactive protein, urea, creatinine, albumin, total protein, cholesterol, triglycerides, bilirubin,...

At the same occasion, patients are questioned about different items (QoL, nutrition) by a (study) nurse or coordinator, using different questionnaires: Euroqol 5 dimension scale (EQ-5D), Patient-Reported Outcomes Measurement Information System (Promis-29), and Mini Nutritional Assessment (MNA).

A subgroup of patients were asked to perform some functional tests: Tinetti-Test, Sit to Stand (5 times), Frailty and Injuries: Cooperative Studies on Intervention Techniques (Ficsit) test, 2 or 6 minutes walking test, handgrip strength and quadriceps power measurement, back scratch test, compensatory stepping correction-backward test and skin fold measurement. All tests are non-invasive and are validated for routine measurements in the elderly.

In order to quantify sleep, patients were asked to wear a Motionwatch (Actigraphy) to register their arm movements during 2 or 3 nights as well as to fill out 2 questionnaires related to sleep: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI). To compare sleep in dialysis patients with healthy persons, age and gender matched healthy volunteers were also included in the study and were asked to sleep 2 or 3 nights with the Motionwatch and to complete the ISI and PSQI.

Patients who were transplanted got an extra blood sampling just before transplantation as well as 4 months after transplantation.

Eligibility Criteria:
Inclusion Criteria:

- end-stage kidney disease patients treated with dialysis (peritoneal dialysis or hemodialysis)

Exclusion Criteria:

* active inflammation
* malignancy
* cognitive disorder
* not understanding the dutch language
Dexamethasone Added to Levobupivacaine Improves Postoperative Analgesia

Adding dexamethasone to local anesthetic will significantly prolong duration of brachial plexus anesthesia and analgesia.

Operations of upper extremities are often performed in regional anesthesia blocks. Single-injection blocks are effective, but time limited. Adding 4mg of dexamethasone to 0.5% levobupivacaine will significantly prolong duration of brachial plexus anesthesia and analgesia for fracture operations of upper extremity. This effect will result in less opioid use postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 years or older
* ASA (American Society of Anesthesiologists) physical status I, II or III

Exclusion Criteria:

* refusal of the patients to give informed consent
* preexisting coagulation disorders
* local infection at the site of the block
* neuropathy
* drug or alcohol abusers
* known allergy to the drug used in study
* operation time exceeding six hours
The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback

The aim of this study is to compare the efficacy between Electromagnetic Stimulation therapy and Electromagnetic Stimulation therapy with Extracorporeal Biofeedback in Stress Urinary Incontinence patient.


Eligibility Criteria:
Inclusion Criteria:

1. Female patient with Stress Urinary Incontinence, over 20
2. Leakage over 2g in stress pad test
3. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

1. Mixed Urinary Incontinence which is dominant in urge urinary incontinence.
2. True incontinence
3. Overflow incontinence
4. Patient who had performed electric stimulation therapy,bladder training within 2 weeks before baseline.
5. Urinary tract infection found In urine test.
6. Patient who had pelvic organ prolapse.
7. Patient who had inserted pacemaker.
8. Pregnant woman, patient who have positive result in urine pregnancy test, patient who have plan pregnancy during study period.
9. Disorder in Neurosystem like stroke, multiple sclerosis, spinal injury, Parkinson's disease .
10. Patient who will participate in other clinical trial during this study.
11. Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
A Compassionate Access Protocol For Those Patients Who Have Completed A4001029

This is a compassionate study to provide continued access to maraviroc for only those subjects completing study A4001029 who are showing clinical benefit. Assessments of safety and tolerability of maraviroc when added to OBT will be continued.


Eligibility Criteria:
Inclusion Criteria:

* Patients having completed study A4001029 in Canada and still deriving clinical benefit.

Exclusion Criteria:

* None
LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe

Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in clinical trials demonstrated pronounced reduction of several independent risk factors for the development of atherosclerotic cardiovascular diseases.

The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a clinically relevant dose or dose range for future studies.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 75 years
* Patient with primary hypercholesterolemia with an LDL-cholesterol \> 3.0 mmol/L
* At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study

Exclusion Criteria:

* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study
Surgical Management of Giant Hepatic Hemangioma

Hepatic hemangiomas are the commonest benign mesenchymal lesions of the liver. Most of these lesions are asymptomatic. Giant hepatic hemangiomas (GHH) (\> 10 cm) are often symptomatic and require surgical intervention. This study aimed to describe the clinical findings, risk factors, diagnostic approach and management of GHH.

Hepatic hemangiomas are the most common benign tumors of the liver with the incidence of 0.4 to 20% . They are most often discovered incidentally on imaging studies. Typical hemangiomas usually do not increase in size over time and therefore are unlikely to cause symptoms. Giant hepatic hemangiomas (GHH) are defined as hemangiomas larger than 5 cm . They are usually responsible for overt clinical symptoms and complications consisting, most often, of upper abdominal pain, hemorrhage, biliary compression, or a consumptive coagulopathy that may require prompt surgical intervention or other treatments . Management of liver hemangiomas ranges from close observation to surgery depending upon the site, size and symptoms .

It is widely accepted that intervention is indicated only for symptomatic hemangiomas. Surgical resection is indicated in patients with abdominal complaints or complications, or when diagnosis remains inconclusive. The ideal surgical treatment for GHH is still controversial. Enucleation is the preferred surgical method based on the existing literature. In this study, we report our 17-year experience of clinical management of GHH.

Eligibility Criteria:
Inclusion Criteria:

* Radiological diagnosis of geant liver hamangioma.

Exclusion Criteria:

* Radiological diagnosis of liver hemangioma less than 10cm.
Casinomacropeptide and Satiety

Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle.

Assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle. Subjects will attend a 5 hour post-prandial study day. Subjects will keep food records 1 and 3 days prior to study visit, day of visit, and day after visit; food to be weighed using study provided dietary scale.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Unrestrained (score ≤ 10 on the Eating Inventory (EI) questionnaire, Stunkard and Messick 1985)
* Women
* 18 years of age
* Consume a low/moderate protein diet (12-20% protein energy).
* Meet BMI criteria of 19 to 24 kg/m2 OR 29 to 34 kg/m2, inclusive.

Exclusion Criteria:

* Women who score ≥ 10 on the Beck Depression Inventory (BDI, Beck and Beamesdorfer 1974)
* Women who score ≥ 30 on Eating Attitudes Test (EAT, Garner and Garfinkel 1979),
* Have current or past (previous 1 year) medical conditions that may interfere with any of the outcomes of this study.
* Weigh less than 110 lbs
* Are currently or have been modifying diet or exercise patterns to gain or lose weight in previous 60 days
* Have unstable body weight (fluctuations of ≥ 5 kg in 60 day period)
* Are excessive exercisers or trained athletes
* Taking any medications that would affect appetite or any other study-described endpoint will also be excluded.
* Allergies or intolerances to foods consumed in the study.
* Smoker
* Pregnant/lactation
Subthalamic Steering for Therapy Optimization in Parkinson's Disease

Twenty patients with idiopathic Parkinson's disease (PD) will be included into this single center randomized controlled double-blind clinical trial (RCT) in a cross-over design. The treatment consists of two different stimulation settings using (i) conventional omnidirectional stimulation of the subthalamic nucleus \[STN_O\] as active comparator and (ii) directional steering of STN stimulation via a segmented electrode contact \[STN_D\].

Twenty PD patients will be enrolled in this cross-over double-blind RCT to evaluate both the safety and efficacy of directional STN stimulation \[STN_D\] compared with standard omnidirectional STN stimulation \[STN_O\]. The primary outcome measure is objectively quantified muscle rigidity of the upper extremity, i.e., surface EMG recordings of the biceps and triceps muscle during standardized extension/flexion of the elbow joint (Levin et al., 2009) assessed 6 months after implantation in cross-over design. The trial is designed to detect with an 80% power a change of 0.27 mA of the therapeutic stimulation threshold with two-tailed P \< 0.05 (Wilcoxon rank sum test). Secondary outcome measures address clinical motor, non-motor, neurocognitive and neuropsychiatric symptoms, freezing of gait, and quality of life. Visits are scheduled at weeks 1 (V1), 6 (V2), 24 (V3), 27 (V4), and 30 (V5) from baseline (V0).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms

Exclusion Criteria:

* Cognitive impairment (Mini Mental State Exam \< 20)
* Suicidality, Psychosis
* Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
* Pregnancy