cyrilzakka/clinical-trials huggingface dataset:
Building Better Caregivers: Development and Evaluation

The program consists of a 6-week small-group workshop for caregivers of people with memory problems.

The goal of the study is to evaluate in a one year longitudinal study, program effectiveness in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving sleep, healthful behaviors and self-efficacy

The Building Better Caregivers workshop meets for 2.5 hours per week for 6 weeks in small groups of 10-16. It is peer-led (leaders already trained in the Stanford model must take a 2-day cross-training before leading a BBC workshop).

Participants will learn self-management skills such as decision making, goal setting, action planning, stress management, dealing with difficult behaviors, working with the health care system, planning for the future,building an exercise program, communication skills, healthy eating, etc.

All participants will complete follow up questionnaires and 6 and 12 months. They will have the option of completing the questionnaire by mail or telephone interview.

Once a particular workshop site is identified by a partner organization, Stanford will provide packets of consents and questionnaires to the site coordinator(non-Stanford). The site coordinator will either schedule an extra hour for the first meeting of the 6-week series, or an orientation meeting held a week or so before the workshop begins. During this time, the coordinator will announce to the prospective subjects that this study is being conducted and that they are invited to participate, and will pass out a consent, questionnaire and consent copy to each prospective participant. The consent and questionnaire are self-administered.

This study is longitudinal, so no randomization will take place.

Stanford holds no meetings, but receives the data. The site coordinators hold the orientation meetings. The workshops are scheduled by the various organizations, and they determine when and how the orientation time is scheduled. It will vary from site to site.

Eligibility Criteria:
Inclusion Criteria:

* Family or friend caregiver of someone with cognitive impairment for at least 10 hours per week
* 18 years of age or older
* Able to attend a workshop 2.5 hours per week for 6 weeks
* Speaks English

Exclusion Criteria:

* Professional caregiver
* Under 18 years of age
* Non-English speaking
Effect of Moderate Caloric Restriction on Glomerular Growth After Kidney Transplantation

One possible reason that weight gain after transplant may interfere with new kidney function is due to the enlargement of a kidney structure called the glomerulus.

The researchers believe that modest caloric intake reduction (CIR) early after kidney transplantation can reduce the enlargement (hypertrophy) of the glomerulus associated with kidney transplantation and may improve long term allograft survival, by reducing glomerular hypertrophy mediated progressive glomerulosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of kidney transplants where a post perfusion biopsy is obtained
* Body Mass Index between 25-30 kg/m2 at the time of randomization
* Non-diabetic
* Have a smart phone or active internet connection at home

Exclusion Criteria:

* Patients on dual anti platelet agents or are on oral anti coagulation medication
* Patients who have had Bariatric Surgery
Effectiveness and Safety of an Early Mobilization Protocol in a Pediatric Intensive Care Unit

This study evaluates the safety and effectiveness of an early rehabilitation program in a pediatric intensive care unit (PICU). Half of the participants will receive intensive and frequent an early mobilization program and others will receive conservative mobilization program.

The 14 early rehabilitation sessions(10=physical therapy, 4=occupational therapy) occurred per week over a 2-week period (excluding weekends) in the early rehabilitation group for 15 minutes each. The control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Children admitted to the PICU due to critical illness
* Children aged 1-18 years

Exclusion Criteria:

* Increased intracranial pressure(ICP)
* History of brain surgery
* Children with fracture
* Admitted to the participating PICU ≤ 3 days
* Children with suspected brain death
The Effect Of Addıtıonal Surgery On Muscle Strength, Proprıoceptıon And Balance In Anterıor Crucıate Lıgament Surgery

Meniscal tears and RAMP lesions are frequently seen together with ACL injuries. The aim of this study was to evaluate the effects of meniscus repair and RAMP lesion repair ACL reconstruction surgery in terms of muscle strength, proprioception, and balance. In our study, the clinical outcomes of both anterior cruciate ligament reconstruction (ACLR), medial meniscus repair (MR) and RAMP lesion repair (RR) have been compared with those of isolated ACLR.

Methods:

Fifteen patients of isolated ACLR performed, 15 patients of ACLR with MR or RR performed, and 15 healthy participants were included in our study. Besides, patients to whom ACLR and additional interventions performed divide into subgroups: 7 patients with RR and 8 patients with MR. Isokinetic muscle strength, proprioception, balance, fall risk, Lysholm Knee Scoring and Tegner Activity Level scale of patients were evaluated preoperatively and at the postoperative 6th week.

The data obtained in the research were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean, and standard deviation were used as descriptive statistical methods in the evaluation of the data. The relationship between grouped variables was tested by chi-square analysis. One-way Anova test was used to compare quantitative continuous data between more than two independent groups. Scheffe test was used as a complementary post-hoc analysis to determine the differences after the Anova test. The difference between within-group measurements was analyzed with the paired-group t-test.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18 and 40 years of age, not having had any previous knee surgery and not having any diagnosis of knee pathology, not having any musculoskeletal injury, cardiopulmonary or vestibular dysfunction that would prevent performing the tests in the study were the inclusion criteria for control group.

Exclusion Criteria:

* In addition to ACL injury, the patients with cartilage damage, knee arthrosis, misalignment in the lower extremity and additional ligament pathologies, history of previous knee surgery, any pathology in the opposite lower extremity, and additional neuromuscular diseases were excluded.
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta

The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:

1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?
2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?

Participants in the intervention group will receive:

* Fetomaternal ultrasound examination each trimester
* Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
* Supplements: multivitamin, minerals, vitamin D, fatty acid
* Intervention regarding any abnormal results of nutritional panel
* All standard maternal health services according to Indonesian Ministry of Health protocol

Participants in the control group will receive:

- All standard maternal health services according to Indonesian Ministry of Health protocol


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy in 1st trimester
* Gestational age less than 10 weeks
* Living in Jakarta greater area
* Agree to participate

Exclusion Criteria:

* Assisted reproductive technology (IVF)
* History of polycystic ovary syndrome
* History of chronic hypertension
* History of diabetes mellitus
* History of preeclampsia in the previous pregnancy
* Had chronic disease: heart disease, autoimmune disease, malignancy, chronic lung disease
* Planning to have delivery outside Jakarta greater area
* Poor obstetric history (miscarriage/ abortion more than 3 times)
Community Oncology Setting Cost Analysis and Disease Outcomes of Taxane Use in Metastatic Breast Cancer

This is a retrospective medical record abstraction study. It is a review and evaluation of up to 300 metastatic breast cancer patients treated with Abraxane or other taxanes such as paclitaxel and docetaxel to determine the overall cost of care for Abraxane compared to other taxanes in the first-line metastatic cancer setting and the cost of care for Abraxane compared to other taxanes when broken down by individual components of cost. In addition, the investigators will review the following patient outcomes: response rate, duration of therapy, toxicity, and survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients that have received Abraxane chemotherapy greater than three months from the time of chart review.
* Patients that have received taxane chemotherapy greater than three months from the time of chart review.
The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses

The purpose of this study is to explore the treatment of Low Level Light Therapy(LLLT) mitigate possible insomnia and psychological symptoms, when nurses have taken shifts.The investigators hope that the goal of this interventional research is to improve sleep quality and psychological symptoms of shift nurses in order to promote health.

Low-Level Light Therapy; LLLT is also called PhotoBioModulation; PBM, which is a new type of interventional therapy.LLLT applies low-level lasers or light-emitting diodes(LEDs) to the human body for treatment. The wavelength of irradiated light is between red light(630-700 nm) and near-infrared light(700nm-1,100nm), and leads to a positive biological effect. It is a safe, painless, non-invasive treatment method. When LLLT is applied to the brain, it can pass through the scalp, head bone and reach the brain, and then stimulating the photochemical reaction in the cells, This is called transcranial Low-Level Laser Therapy (t-LLLT) or transcranial Photobiomodulation(t-PBM). tLLLT has existed since 1967, and more than thousands of scientific studies have shown that photons can stimulate biological responses and promote the normal work of cells. t-LLLT can treat a variety of diseases, such as emotional symptoms, lower back pain, weight loss, skin anti-aging, wound healing, etc. There are no reports of side effects. The main mechanism is similar to the photosynthesis of plants. It absorbs light and produces chemical reactions, supports mitochondrial function, and significantly increases the production of ATP(the main carrier of energy in cells.)in the brain, so as to function work better and achieve self-repair. This research uses Dr. Tai's energy cap, the manufacturer is Topunion Globaltek Inc., which passed the certification of the Ministry of Health and Welfare(MOHW) for medical device in 2019. It has been modified to the second generation and is now on the market. It basically provides two kinds of red light (wavelength of 660nm) and near-infrared light(wavelength of 850nm), which is mainly used at home. The research intervention will be conducted for four weeks, pre-tests and post-tests will be conducted as indicators to evaluating sleep and psychological symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Registered nurses who consciously have insomnia and ISI\>=9.
2. People who have clear consciousness, can understand and agree to participate in this research.
3. Registered nurses who have been on shifts in the past six months.
4. Have the same type of shift within the four weeks.

Exclusion Criteria:

1. Those who have undergone head surgery.
2. Those who are pregnant.
Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture

Osteoporotic vertebral compression fractures (OVCFs) are serious health problems. Transplantation of mesenchymal stem cells (MSCs) has gained considerable attention to treat osteoporosis and OVCFs because implanted healthy MSCs could be differentiated into osteoblasts and reduce the susceptibility of fractures by facilitating new bone formation.

This study compares teriparatide (PTH 1-34) injection to combined treatment with Wharton's jelly-derived MSCs (WJ-MSCs) and teriparatide (PTH 1-34) in patients with OVCFs.

It is a randomized, open-label, phase 2 study.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women over 40 years of age
* Compression fracture of the spine confirmed by MRI or bone scan

  * When the T score of the lumbar spine is less than -1.0 in the bone density test using DXA (Dual energy X ray absorptiometry)
  * Compression fracture is between 5th thoracic and 5th lumbar vertebra
  * When a new vertebral fracture occurs in less than 3 parts of the spine
  * Compression fracture of the spine within 6 weeks after minor trauma
* Oswestry Disability Index (ODI) due to vertebral fracture is more than 30%
* Back pain due to vertebral fracture has a Visual Analogue Scale (VAS) of 4 or higher.
* In case of writing consent for stem cell transplantation therapy

Exclusion Criteria:

* Those who used osteoporosis treatment (bisphosphonate, selective estrogen receptor modulator, or parathyroid hormone) 6 months before the start of the clinical trial due to osteoporotic vertebral fracture.
* In the case of inherited, metabolic, neoplastic, or infectious bone disease other than osteoporosis
* Spinal fracture with neurological symptoms
* Those who are taking drugs that affect bone metabolism such as steroids.
* Those who have undergone spinal fixation surgery on the fracture site prior to the clinical trial
* Those who have a history of psychiatry or who are currently undergoing treatment, who have judged that it is difficult to proceed with the clinical trial under the judgment of the researcher
* Those who do not understand the purpose and method of this clinical trial as a study subject for drug or alcohol addiction
* Those who participated in other clinical trials within 30 days prior to participation in the clinical trial
* Those who may affect this clinical trial due to serious medical conditions (hypertension not controlled by drugs, diabetes not controlled by drugs, blood coagulation disease, cirrhosis, kidney failure, tumor) or immune deficiency
* Factors less than 10 g/dL of hemoglobin in general blood test
* If there is currently an acute systemic or local infection
* Others who have clinically significant findings deemed inappropriate for this clinical trial due to medical judgment by the person in charge of the clinical trial
* Those who are allergic to proteins required for cell production (fetal calf serum)
The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.

The objective of this prospective observational study is to collect clinical data on the medical device Alvision™ Interventional Cardiology Diagnostic Catheter in an unselected population in the current clinical practice

Within the scope of this observational medical device trial, brand/model of the catheter that will be used during the PCI will be decided by the physician and decision of the physician won't be interfered. PCI will be performed according to the standard clinical procedures. Data of the patients to whom Alvision™ Interventional Cardiology Diagnostic Catheter is applied will be gathered for the purpose of this study.

Eligibility Criteria:
Inclusion Criteria:

* Turkish citizen,
* ≥18 years of age,
* Has indication for a diagnostic coronarography according to Alvision™ Instruction for use,
* Has signed and dated the informed consent.

Exclusion Criteria:

* Having a known allergic reaction to any of the composition of Alvision™ Interventional Cardiology Diagnostic Catheter.
* Has synthetic vascular grafts through which the Alvision™ Interventional Cardiology Diagnostic Catheter should pass
* Participating in another medical device or pharmaceutical clinical trial
Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer

Hypothesis: To estimate the proportion of locally advanced, recurrent or metastatic nasopharyngeal cancer patients which show high somatostatin receptor density (SUVmax \>10) on Ga-68 DOTATATE imaging.

Galium-68 DOTATATE: PET imaging will be performed with a PET/CT scanner. Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection.

The standardized uptake value (SUV) will be used in the interpretation of the Ga-68 DOTATATE scans. The values gathered will be used as an estimate of the somatostatin receptor density. A patient will be considered to have an overall high somatostatin receptor density if the average SUVmax of all the representative lesions is more than 10.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced NPC or Metastatic NPC or locally recurrent NPC
* \>21 years old
* Histological confirmation of NPC

Exclusion Criteria:

* \<21 years old
* Pregnancy or breast feeding
Extracellular Signal-Related Kinase Biomarker Development in Autism

The purpose of this research study is to establish a way to help the development of targeted treatments in autism spectrum disorders. This may also help in early diagnosis of autism and may possibly predict severity. The study will compare subject's ERK (extracellular signal-related kinase) signaling to age- and gender-matched neurotypical controls and Intelligence quotient (IQ)-matched developmental disabilities.

Autism Spectrum Disorder Subject Criteria:

Inclusion Criteria:

* Diagnosis of autism spectrum disorder, based upon a clinical interview utilizing the Diagnostic and Statistical Manual-V (DSM-V)
* Age 3-25 years
* Stable dosing of psychotropic drugs for greater than or equal to 5 half-lives

Exclusion Criteria:

* Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or other substance abuse based on Diagnostic and Statistical Manual-V criteria
* Use of lithium, riluzole or other known modulators of ERK activation

Age-Matched Neurotypical Control Subjects:

* Age matched to the age of an Autistic Disorder Subject
* History of normal development

IQ-Matched Control Subjects:

* Those subjects who are included in the study based on having an IQ and age that matches the IQ and age of an Autistic Disorder Subject who has an IQ less than 70
* All IQ-Matched Control Subjects will then also have an IQ less than 70

Eligibility Criteria:
Inclusion Criteria (ASD subjects):

* Diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the DSM-V
* Age 3-25 years
* Stable dosing of psychotropic drugs for 5 half-lives or greater

Exclusion Criteria (ASD subjects):

* Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or other substance abuse based on DSM-V criteria
* Use of lithium, riluzole or other known modulators of ERK activation

IQ-Matched Control Subjects: Those subjects who are included in the study based on having an IQ and age that matches the IQ and age of an Autistic Disorder Subject who has an IQ less than 70. All IQ-Matched Control Subjects will then also have an IQ less than 70. IQ-Matched Control Subjects participate in a Screen/Baseline visit only.

Age-Matched Neurotypical Control Subjects: Those subjects who are included in the study based on having an age matched to the age of an Autistic Disorder Subject and a history of normal development. Age-Matched Neurotypical Subjects participate in a Screen/Baseline visit only.

Shipped Biomarker Control Group Subjects: For these shipping control samples, blood samples will also be drawn from adult parent/guardians of participating subjects.
Comparison of the Efficacy and Satisfaction of Blood Glucose Management Between Continuous Glucose Monitoring Versus Traditional Self-blood Glucose Measurement in Diabetic Patients After Pancreatectomy

This study aims to compare the efficacy and satisfaction of blood glucose management between continuous glucose monitoring versus traditional self blood glucose measurement in diabetic patients after pancreatectomy.

Patients will be enrolled after the 75g oral glucose tolerance test performed 7 days after pancreatectomy. Patients will be divided into two groups by randomization (continuous glucose measurement method vs. traditional self blood glucose measurement method), and 3months after surgery, HbA1c, hypoglycemic events, and satisfaction would be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 19 years of age
* Preoperative diabetes history
* Patients who underwent subtotal or total pancreatectomy
* Patients who were diagnosed with diabetes mellitus in the evaluation of endocrine function test on the 7th day after pancreaticoduodenectomy, central pancreatectomy, or distal pancreatectomy

Exclusion Criteria:

* Patients who have used continuous blood glucose measurement device more than once before.
* Elderly patients who are not accustomed to using the smartphone applications
* Serious systemic diseases that can affect diabetes (chronic kidney disease, heart failure, decompensated liver cirrhosis, etc.)
* Steroid user during the study period
* Major medical or psychiatric condition that will affect response to treatment