cyrilzakka/clinical-trials huggingface dataset:
Mind Body Syndrome Therapy for Chronic Pain

The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care (control arm) and an active control arm. The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient 18 ≥ years old
* Chronic back pain
* Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment
* Willingness to consider mind-body intervention
* At least score of 2 or more on Roland Disability Questionnaire
* At least score of 3 or more back pain bothersomeness

Exclusion Criteria:

* Patients \< 18 years of age
* Patients \> 67 years of age
* Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome (note that pain related to disc disease is not an exclusion unless there are neurological impairments)
* Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia, and bipolar disorder
Adaptations to Breast Cancer and Exercise Using Telehealth (ABRACE: Telehealth)

The aim of the present study is to determine the effects of 12 weeks of multicomponent training associated with a health education program carried out remotely, compared to a health education-only program, on psychological and physical outcomes of women in primary treatment for breast cancer. For that, 36 women will be randomized to a multicomponent training group carried out remotely associated with health education or health education group. The psychological and physical outcomes will be measured pre (week 0) and post-intervention (week 13) in both groups, always by the same investigator blinded in relation to the groups. The multicomponent training group will carry out an exercise program twice a week, and health education will also be carried out on one of the two days. In this group, the conversation on the topic of the week will take place during stretching. The sessions (on pre-established and non-consecutive days) will be held by video call (approximately 60 min) in small groups (maximum three participants) and will be given by students of the Physical Education course, previously trained to perform the intervention. The order of the multicomponent training will be joint mobilization, aerobic stimulus, balance exercise, strength exercises and stretching of the main muscles used during the training session. For the participants of the health education group, also, once a week, a material with several topics related to the management of breast cancer diagnosis and physical activity will be sent by message. In addition, two days after this material is sent, a conversation will be held with the participants of this group, at a google meet of approximately 30 minutes, about the theme sent by message. The themes will be depression, pain, fatigue, body image, symptoms in the arm and breast, vasomotor symptoms, neuropathy, arthralgia, sexual dysfunction, quality of life, physical activity and eating habits. To analyze the outcomes collected, it will be used Generalized Estimating Equations (GEE) and the Bonferroni post-hoc test.


Eligibility Criteria:
Inclusion Criteria:

* Women from the city of Porto Alegre and Pelotas in southern Brazil
* Women diagnosed with breast cancer in stages I-III
* Women undergoing primary treatment (adjuvant or neoadjuvant chemotherapy or only radiotherapy) of breast cancer
* Women can not be practicing periodized and systematic physical exercise programs

Exclusion Criteria:

* Women can not have reached more than 50% of the completion of chemotherapy or only radiotherapy treatment
* Women can not have the following comorbidities:

  * autonomic neuropathy or severe peripheral neuropathy, proliferative diabetic retinopathy, non-proliferative diabetic retinopathy, uncompensated heart failure, unstable angina, peripheral amputations, uncontrolled arterial hypertension, chronic renal failure, severe psychiatric disorders and musculoskeletal impairment that limits physical exercise.
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female 6 months to 17 years 11 months of age, inclusive;
* Female subjects of childbearing potential must use adequate contraception
* Diagnosed with CDAD

Exclusion Criteria:

* Concurrent use of oral vancomycin or metronidazole or any other effective treatments for CDAD
* Fulminant colitis
* History of inflammatory bowel disease
* Pregnant or breast-feeding
* Need for concurrent use of some P-glycoprotein inhibitors during therapy
Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.

The main objective of our study is to investigate the metabolic effects of a i) ordinary whey protein (WHE) and ii) a specific whey protein fraction (speWHE) when the interventions are ingested by patients with type 2 diabetes 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate the glucose response when the patients ingest the interventions at home in their own environment 30 minutes before breakfast and dinner (2days) and also monitor glucose levels without interventions (2 days).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Type 2 diabetes (T2D) diagnosis
* No medical treatment or metformin/sulfonylureas(SU) alone in the treatment of T2D
* No daily use of protein drinks
* Hba1c between 40 mmol/mol and 69 mmol/mol
* 20 kg/m2 \< BMI \< 35 kg/m2
* Screening blood test: 1200 pmol/l \> C-peptid \> 370 pmol/l

Exclusion Criteria:

* Other diabetes medication than metformin/SU (e.g. insulin, GLP-1 analog, DPP-4 inhibitor, SGLT2-inhibitor)
* Affected screening blood test assessed by the primary investigator(PI)/sponsor
* Does not understand or speak danish
* Milk allergy
* PI finds the patient not fit (e.g. mental illness, too nervous or other)
Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery

This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.

This study will be a clinical prospective study. It is observational for all aims except with regard to the Meditation Intervention, which will be limited to 100 pectus and 100 spine participants (randomized to 50/50 in each arm). We will recruit 600 qualifying participants over the study period to acquire the necessary data to derive a predictive model matching phenotype to genotype. This study will not interfere with the standard anesthetic or perioperative care except for blood sampling from an indwelling line, and the use of additional integrative health procedures (focused-attention meditation guidance, as well as routine massage and breathing techniques) for the randomized meditation group. Research staff will administer psychosocial and somatosensory assessments, as well as record relevant data from participant's medical records. Integrative health will assist in teaching focused-attention meditation to the randomized meditation participants in the preoperative phase. Actigraphy devices will be provided to all participants, and MUSETM to those in the randomized meditation group. The pain team, in accordance with the Pectus Pain Management Protocol, will direct perioperative pain management.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8 years of age through adulthood
* Diagnosis of pectus excavatum or adolescent idiopathic scoliosis
* Scheduled for endoscopic pectus excavatum repair or spine fusion

Exclusion Criteria:

* History of or active renal or liver disease
* Major surgery requiring opioids in the last 5 years
* Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
* Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included
* History of seizures currently treated on medication (participants off medication and seizure free for greater than one year may be included)
* Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine
* Needing postoperative ventilation or intraoperative cardiac bypass standby
* BMI \>35
* Pregnant or breastfeeding females
* Non-English speaking
* Definite developmental delay
Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness

The purpose of the study is to determine whether occupational therapy and physiotherapy delivered in a primary care setting to adults with chronic illness is effective in improving health.

Primary health care is changing so that people receive the care that they need at the front line. Rehabilitation has been identified as one service that should be offered in primary care, to address the needs of adults who have or are at risk of poor health from chronic conditions such as arthritis, heart disease and depression.

Two full time therapists (one physiotherapist and one occupational therapist) will offer rehabilitation to a sample of 170 adults with chronic illness over an 18 month period (170 people will also be enrolled in a control group) at the Stonechurch Family Health Centre. Key outcomes include health, hospital admissions and emergency room visits.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 chronic condition
* 3 visits to family physician in the past year

Exclusion Criteria:

* None
A Study to Evaluate ITCA 650 Compared to Sitagliptin for the Treatment of Type 2 Diabetes

Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c between 7.5%-10%
* on metformin monotherapy
* BMI between 25 \& 45 kg/m2

Exclusion Criteria:

* taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
* history of pancreatitis
Determining the Effects of an Evidence-Based Practice Education Intervention Program Applied to Nursing Students

It was planned to evaluate the effectiveness of the evidence-based practice education intervention program in 3rd year students of the Faculty of Nursing on their knowledge, attitude, behavior and future use of evidence-based practice, and their awareness and attitudes towards research and developments.

The study was parallel group (experimental-control), randomized controlled experimental design with pretest-posttest design.

It was carried out in 3rd year students of nursing department of Selçuk University Faculty of Nursing in Konya province.

Study data were collected from 108 students between February 2023 and June 2023. Nursing students in the intervention (n = 54) and control groups (n = 54) were determined by randomization method.

A total of 12 hours of Evidence-Based Education intervention was applied to students in the intervention group, spread over 7 sessions. The educational intervention was created in line with the literature. No application was given to the students in the control group. Data were collected using the Students' Knowledge, Attitudes and Behavior Towards Evidence-Based Nursing Scale and the Nursing Students' Awareness and Attitudes Towards Research and Developments in Nursing Scale.

Paired Sample T test and Wilcoxon test will be used in pre-test and post-test comparisons. Mann Whitney U, Kruskal Wallis, One Way Anova test will be applied to determine the difference between groups. Statistical significance level was accepted as p˂0.05.

Eligibility Criteria:
Inclusion Criteria:

* Be registered in the third year of nursing
* Having taken a research course

Exclusion Criteria:

* The student suspends his/her registration or transfers to another university
* Not volunteering to participate in the study
Study Evaluating Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors

The primary purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of CMD-193 administered intravenously (IV) to subjects with advanced malignant tumors. The secondary purpose is to obtain preliminary information on the pharmacokinetics and antitumor activity of IV CMD-193.


Eligibility Criteria:
Inclusion Criteria:

* Malignant solid tumor progressed, or no standard treatment available
* Tumor expression of Lewis Y antigen

Exclusion Criteria:

* Cancer therapy within 28 days before enrollment
* Pregnant or breastfeeding women
* Unstable or serious concurrent medical conditions
Multimedia Information for Patients With Renal Biopsy

This study takes place in the Divisions of Nephrology. Patients undergoing renal biopsy were randomized to control group or multimedia information intervention group. The control group received routine care, and the multimedia information intervention group received a multimedia information. After the pre-test, the two groups performed the 1 to 3 post-tests on pre-operation, post-operative day 1 and post-operative day 9. This study used questionnaires that including General Self-Efficacy Scale, Pain Visual Analogy Scale, Visual Analogue Scale for Anxiety, and Positive and Negative Affective Scale.

This study takes place in the Divisions of Nephrology at Chang Gung Memorial Hospitals. Patients undergoing renal biopsy were randomized to control group or multimedia information intervention group. The control group received routine care, and the multimedia information intervention group received a multimedia information. Multimedia information intervention is based on self-efficacy theory. The multimedia videos contain the information associated with renal biopsy, which including the purpose, indications, preparations for the examination, process, patient experience sharing, complications, precautions, home care and stress adjustment strategies. In addition, the investigator also provide face-to-face consultations on answers and clarifications for the content of the videos and telephone consultations to understand the self-care situation of patients on the third day after discharge. After the pre-test, the two groups performed the 1 to 3 post-tests on pre-operation, post-operative day 1 and post-operative day 9. This study used questionnaires that including General Self-Efficacy Scale, Pain Visual Analogy Scale, Visual Analogue Scale for Anxiety, and Positive and Negative Affective Scale. Generalized Estimating Equations (GEEs) will be used to o analyze data.

Eligibility Criteria:
Inclusion Criteria:

1. patients are at least 20 years old
2. patients need to undergo a renal biopsy
3. patients can communicate in Chinese or Taiwanese
4. patients agree to participate in the research and sign the consent form
5. patients have family members accompanying

Exclusion Criteria:

1. patients have undergone renal biopsy before
2. patients have history of mental disorder
3. patients use anticoagulants
Effects of Flaxseed Supplementation in Metabolic Syndrome

To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and anthropocentric measurements in subjects with metabolic syndrome, in a randomized, open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received 30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome will be measured at the baseline and at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report

Exclusion Criteria:

* history of allergy or high consumption of nuts, flaxseed, or sesame seeds
* clinically diagnosed renal, liver, heart, pituitary, thyroid, or psychiatric disorders impairing the patient's ability to provide written informed consent
* history of cardiovascular diseases, cancers, alimentary tract disorders affecting absorption
* pregnancy, lactation, and lack of effective birth control in women of child-bearing potential
Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block

Transforaminal epidural block (TFEB) with local anesthetics and steroid is effective to treat spinal radicular pain. However, inadvertent intravascular injection can lead to severe neurologic complications. Digital subtraction angiography (DSA) during epidural block might increase the detection rate of intravascular penetration, compared to real-time fluoroscopy (RTF). But, DSA has disadvantages, such as additional radiation exposure to physicians and participants and the high cost of the new and upgraded fluoroscopic equipment. In this study, it was designed to compare DSA and RTF for detection of intravascular penetration in the same participant who underwent cervical TFEB.

The investigators prospectively examined the participants who received cervical TFEB. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected at the rate of 0.5 ml/sec under RTF. Thirty seconds later, 2 ml of nonionic contrast media was injected at the rate of 0.5 ml/sec under DSA.


Eligibility Criteria:
Inclusion Criteria:

* participants with radiating pain from spinal stenosis and herniated nucleus pulposus.

Exclusion Criteria:

* pregnancy, allergic to contrast media, participants refusal, and participants with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.

PRIMARY OBJECTIVES:

I. To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging.

OUTLINE:

Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
* Patients with renal function (estimated glomerular filtration rate \[eGFR\] \>= 30)
* Any disease type

Exclusion Criteria:

* Pregnant women
* Patients with impaired renal function (eGFR \< 30)
* Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
* Patients with contraindications to the use of intravenous contrast such as allergic type reactions
Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)

This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.


Eligibility Criteria:
Inclusion Criteria:

* Participants, who completed the last treatment visit of the previous double-blind brexpiprazole BPD trial and who, in the opinion of the investigator, could potentially benefit from administration of brexpiprazole for the treatment of BPD.
* Male or female outpatients, ages 18 to 65 years, inclusive, at the time of informed consent of the previous double-blind brexpiprazole BPD trial.

Exclusion Criteria:

* Sexually active males or females of childbearing potential (FOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. Male participants must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of investigational medicinal product (IMP).
* Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
* Participants who participated in a clinical trial within 90 days prior to screening/baseline (with the exception of a previous brexpiprazole double-blind BPD trial) or who participated in more than 2 clinical trials within a year prior to screening/baseline.
* Participants who develop a medically significant abnormality.