cyrilzakka/clinical-trials huggingface dataset:
Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy

Type 1 diabetes (T1D) is an autoimmune disease that usually occurs in children and reduces their pancreatic islet beta cells and thereby limits insulin production. Millions of individuals worldwide have T1D, and the number of children with diagnosed or undiagnosed T1D is increasing annually. Insulin supplementation is not a cure. It does not halt the persistent autoimmune response, nor can it reliably prevent devastating complications such as neuronal and cardiovascular diseases, blindness, and kidney failure. A true cure has proven elusive despite intensive research pressure over the past 25 years. Notably, Dr.Zhao and his team have successfully developed a groundbreaking technology Stem Cell Educator therapy (Zhao Y, et al.BMC Medicine 2011, 2012). To date, clinical trials in adult patients have demonstrated the safety and efficacy of Stem Cell Educator therapy for the treatment of T1D and other autoimmune-associated diseases. Here, the investigators will evaluate the safety and efficacy of Stem Cell Educator therapy in children with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 1. T1D patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association.

  2. Children from 3 through 18 years old and body weight \> 15 kg.

  3. Presence of at least one autoantibody to the pancreatic islet β cells (IA-2, GAD, ICA, ZnT8, or IAA).

  4. Written informed consent from the child and child's parents or legal representative.

Exclusion Criteria:

* 1. Any clinically significant diseases in liver, kidney, and heart.

  2. Additional exclusion criteria include no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency

  3. Significantly abnormal hematology results at screening.

  4. Presence of any infection diseases or inflammation conditions, including active skin infections, flu, fever, upper or lower respiratory track infections.
Plant Sterol-Enriched Palm Oil to Improve Lipid Profile and Inflammation in Hyperlipidemic Individuals

This is a placebo-controlled double-blinded trial aimed to evaluate the effect of palm oil enriched with plant sterols on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. Subjects were assigned to intervention oil which contained plant sterol and control oil which was the same as the intervention oil but did not contain plant sterol for 8 weeks. Data collected included nutritional status, energy and macronutrients consumption, blood lipid profile and inflammatory marker (hsCRP).

Cardiovascular diseases, including coronary heart disease (CHD), are currently positioned amongst the leading causes of mortality globally. Risk factors of CHD include, among others, hypercholesterolemia and elevations in systemic inflammation. Functional foods enriched with compounds showing cholesterol-lowering effects are considered as one among various dietary and lifestyle intervention strategies to tackle this problem. A CHD-preventive effect of dietary plant sterols has been broadly discussed, not only due to their ability to reduce blood cholesterol level, but also to their proven anti-inflammatory potential. Palm oil is one amongst the most widely consumed edible oils in the world. Up to date, despite its widespread use, especially in Asian countries, no study has been conducted using palm oil as a vehicle for plant sterols. The aim of the placebo-controlled double-blinded trial presented here was therefore to evaluate the effect of palm oil enriched with plant sterols, used as a cooking oil, on lipid profile and systemic inflammation marker in 100 adult hyperlipidemic residents of Bogor, Indonesia. The study had 2 arms; intervention group in which subjects were given oil which contained plant sterol and control group which in which subjects were given the same oil as the intervention group but did not contain plant sterol for 8 weeks. The oil was consumed as cooking oil. Data on energy, macro nutrients, and cooking oil consumption were collected through interviews at baseline, week 2, 4, 6, and endline. Body weight and height measurement for nutritional status assessment and blood sample collection for biomarker analysis was conducted at baseline and endline.

Eligibility Criteria:
Inclusion Criteria:

* aged 25-60y
* total cholesterol concentration ≥200 mg/dL
* not requiring lipid-lowering drug therapy during the trial

Exclusion Criteria:

* secondary hyperlipidemia
* fasting triglyceride concentration \>3.5 mmol/L
* body mass index \>35 kg/m2
* use of any lipid-lowering drug
* suffering from gastrointestinal diseases or severe concomitant diseases
Physical Activity and Sexuality After Reduction Mammaplasty

This prospective controlled trial was designed to determine whether breast reduction may influence physical activity and sexuality of breast hypertrophy women.

Breast hypertrophy is a frequent condition among women; reduction mammaplasty is one of the most performed procedures in plastic surgery.Previous studies have demonstrated that breast hypertrophy is associated to back pain, and patients often complain about physical limitations due to this condition, as well as sexual impairment. Thus, this trial was designed to test the hypothesis that reduction mammaplasty may improve physical and sexual performance of breast hypertrophy patients,and patients'satisfaction with the results of the operation. Three validated tools were used: the International Physical Activity Questionnaire (IPAQ), the Female Sexual Quotient and the Breast Evaluation Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* breast hypertrophy
* candidate to reduction mammaplasty
* body mass index under 30Kg/m2
* women with sexual activity

Exclusion Criteria:

* pregnancy, delivery or breast feeding during the last 12 months
* body mass index over 30Kg/m2
* breast cancer history
* previous breast surgery
* smoking
Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis

The purpose of this study to assess the longitudinal changes in left and right ventricular global strain after chemotherapeutic strategies in cardiac light chain amyloidosis.

Light chain amyloidosis is a disease characterized by localized or systemic accumulation of amyloid fibrils in tissues caused by abnormal folding of light chain immunoglobulins and affecting organ functions. In the treatment, chemotherapeutic agents are used that prevent the clonal proliferation of plasma cells in the bone marrow. Although the hematological response is standardized in evaluating the treatment response, there is no adequately effective method for assessing cardiac response. Despite the use of various scores, imaging-based systems continue to be developed to increase the sensitivity of these methods.

After being informed about the study, it is planned to recruit and follow-up AL-Amyloidosis patients with cardiac involvement who are currently receiving/planned chemotherapy followed by hematology or who are planned for bone marrow transplantation within 1 year after obtaining written consent from the patients.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Patients who give the informed consent
* Patients with cardiac primary light chain amyloidosis or due to multiple myeloma who are newly diagnosed, currently receiving chemotherapeutic treatment, or are scheduled for bone marrow transplantation

Exclusion Criteria:

* A history of myocardial infarction, coronary artery disease, PCI and revascularization
* \< 18 years old
* A history of severe aortic and mitral valve disease
* Patients who do not give the informed consent
* A history of severe hypertension (SBP\>180 mmHg or DBP ≥110 mmHg or the need to use three or more antihypertensive agents)
* Stable coronary artery patients with ischemia data in stress tests (exertion test, myocardial perfusion scintigraphy)
* Presence of non-amyloidosis, systemic, inflammatory or autoimmune disease
* Patients whose cardiac imaging is not interpretable
A Pilot rTMS Trial for Neuropsychiatric Symptoms of Long-COVID

This is a pilot randomized trial of rTMS for symptoms of fatigue and brain fog, and other neuropsychiatric symptoms of Long-COVID (Post-COVID, post-acute sequelae of COVID-19 infection, PASC). Twenty participants diagnosed with Long-COVID and recruited from the UCLA Long-COVID clinic will be randomized to receive active rTMS versus sham stimulation for 15 treatments followed by another 15 open-label rTMS treatments. Investigators will compare the safety and tolerability of rTMS vs Sham and examine within-group changes in symptoms of fatigue, sleep, pain, mood, and subjective and objective cognitive impairment. This project will provide information and pilot data for future larger clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. 18+ years of age
2. Prior hx of PCR confirmed COVID-19 infection. Determined by the PI or participant's physician.
3. Subsequent development of post-acute neuropsychiatric symptoms with fatigue and brain fog as primary outcomes
4. USE of Psychotropic medications
5. Stable on psychotropic medications for 4+ months
6. Confirmed diagnosis of Long COVID
7. Subjects are willing and able to adhere to the treatment schedule and required study visits

Exclusion Criteria:

1. Mentally or legally incapacitated or unable to give informed consent
2. MOCA \< or = 24
3. Infection of poor skin condition over the scalp where the rTMS device will be positioned
4. Pregnancy: Female participants will be tested for pregnancy at baseline and agree to use a medically acceptable form of birth control throughout the study, for women younger than 60.
5. Lifetime history of diagnosed bipolar disorder; psychosis, such as schizophrenia, schizophreniform, or schizoaffective disorder; intellectual disability (intellectual developmental disorder); organic brain damage; or suicide attempts in the past 24 months.
6. Severe MDD with suicidality of Psychosis- excluded
7. As-needed use of benzodiazepines and beta-blockers will be permitted but discouraged during assessment days.
8. Current abuse or dependence on alcohol or any illicit drug of abuse (disorder in last 6 months). Any recent use of cocaine or opiates will also be exclusionary.
9. Participants with asthma or with a history of serious, uncontrolled medical illness or instability (including significant cardio-pulmonary disease, organic brain including significant cardio-pulmonary syndrome, pre-existing dementia, seizure disorder, cerebrovascular disease, and diabetes)
10. Taking medications known to lower seizure thresholds (Clozaril/ Wellbutrin)
11. Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or primary or secondary tumors in the central nervous system.
12. Presence of an implanted metallic and magnetic-sensitive medical device present in the body scan, including but not limited to a cochlear implant, infusion pump, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, aneurysm clip, metal prosthesis, or metal aneurysm clips or coils, staples, or stents.
Empowering Adolescents to Lead Change Using Health Data

This study is a cluster randomized trial carried out in schools of secondary cities of four low- and middle income countries. Baseline surveys in 30 randomly selected schools will assess the health behaviours of 13-17 year old students as well as school policies and practices. The intervention arm (15 schools) will use the baseline information to develop a package of actions in collaboration with students, teachers, and local authorities that will subsequently be implemented an monitored over two years. Follow-up surveys to evaluate the effectiveness of the implemented actions will be conducted after two years in all 30 previously selected schools.

The objective of this study is to generate health information through school surveys and use this information directly and locally, involving adolescents, to change policies and plan programmes to improve health.

The study is carried out in secondary cities of four low- and middle income countries, including Sekondi-Takoradi, Ghana; Jaipur, India; Spanish Town, Jamaica; and Fez, Morocco.

In each of the four cities, 30 schools are randomly selected. Baseline surveys will be conducted to assess (1) 13-17 year old student's health behaviours using the Global School-based Student Health Survey (GSHS); and (2) health policies and practices in the selected schools using the Global School Health Policies and Practices Study (G-SHPPS). Additionally, the physical activity module of the GSHS questionnaire will be validated against objective measurement devices in one randomly selected class of 15 randomly selected schools.

Schools will be randomly allocated to the intervention (15 schools) or control arm (15 schools) of the study. The intervention group will participate in interactive workshops using the Global Accelerated Action for the Health of Adolescents (Global AA-HA!) approach and the framework of Making every school a health-promoting school to:

1. Identify adolescent health needs through exploring the collected data;
2. Assess policies and practices already in place;
3. Identify gaps and needs for action to improve health. Students, teachers and local authorities will propose and prioritize policy and programme solutions from menus of effective interventions for school-, community- or city-level implementation, supported by the Ministries of Health and Education and WHO.

Repeat GSHS and G-SHPPS surveys will be conducted two years later in all schools to assess effectiveness of the interventions.

Eligibility Criteria:
Inclusion Criteria:

* School going
* Aged 13-17 years

Exclusion Criteria:

* Not going to school
* Outside the age range 13-17 years
Assessment of Mechanisms of Improved Wound Healing

The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.

This study involves research and the investigators hope to learn the following: how or what effect one or more anabolic ("tissue building") agents have on muscle metabolism, wound healing, and immune function after severe burn. The agents include the following: growth hormone, insulin-like growth factor-1 in combination with its binding proteins, insulin, Beta-adrenergic blockers, Alpha Adrenergic Agonist, anabolic steroids such as testosterone, Oxandrolone and nandrolone, ketoconazole and its derivatives, dehydroepiandrosterone, fenofibrate, diet or the application of skin substitute.

Eligibility Criteria:
Inclusion Criteria:

* Patient is between 0 and 90 years of age
* Patient 18 years and older consents to participate in study protocol. If patient is not able to consent, consent will be obtained from closest family member or legal guardian. Parental permission will be obtained for patients less than 18 years of age. Assent will be obtained from children 7-17 years of age if child is physically/mentally able to do so.
* greater than 30% TBSA burn requiring at least 1 operation with donor sites for skin grafting

Exclusion Criteria:

* Known history of AIDS, AIDS-related complex, Human Immunodeficiency Virus
* History of cancer within 5 years
* Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases
* Chronic glucocorticoid or non-steroidal anti-inflammatory drug therapy
Influence of Nevirapine on HCV Viral Load

Nevirapine-based antiretroviral therapy is associated with lower plasma HCV viral load in HIV/HCV-coinfected individuals.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection.
* Older than 18 years.
* Chronic hepatitis C.
* Undetectable HIV viral load during one year before starting study.
* To have not received HCV therapy during one year before starting study.
* To have not started efavirenz or protease inhibitors o nucleoside analogs during 6 months before starting study.
* Non contraindications for drugs included in this study.
* To change an antiretroviral regimen including efavirenz or protease inhibitors by nevirapine due to side effects, interactions or pregnancy (NVP group)
* To continue with a antiretroviral regimen including efavirenz or protease inhibitors (non-NVP group)

Both groups will be matched according to these variables:

* Liver stiffness.
* HCV genotype.
* Hospital.
* Time from starting antiretroviral therapy.
* Previous third drug (EFV or PI) to introduction of NVP.

Exclusion Criteria:

* HCV therapy during follow-up
PARTNER Recruitment and Brief Intervention Pilot Study

Purpose of the study:

This is a pilot randomized controlled trial to identify methods of involving underage youth in interventions to reduce alcohol use through the primary health care system. The trial will compare the effectiveness of using an onsite behavioral health specialist for screening, intervention and referral with basic written information and staff recommendations typically provided in primary care offices.

There will be approximately 3-5 sites who will participate in this study. These sites may include two private practices in Roxboro and Creedmoor, North Carolina, the Duke Hospital and two practices in the Five County region of NC who are implementing Integrated, Collaborative, Accessible, Respectful, and Evidence-based (ICARE). In each clinic one day of the week (or 2 half days) will be chosen randomly from the days the clinic identifies as appropriate. During this time a behavioral health specialist (BHS) will be on site to recruit potential participants. All patients will be asked to speak to the specialist. On two other randomly selected days printed material will be given to all parents of underage patients and the underage patients. This material will describe the study and give the specialist's contact information. If the patients are 18 to 21 years old the material will be given directly to the patient.

The BHS will ask all interested participants to sign the informed consent/minor consent and one parent/legal guardian will be asked to counter sign the informed consent if subject is not 18 years of age yet. All participants signing informed consent will be given the CRAFFT and the PARTNER basic information questions in an interview with the specialist.

The primary outcome measure will be the number of participants recruited per day by the on site BHS versus appointment recruitment method. In addition, the total number of clinic visits for patients' ages 14 to 21 years old on each day of the week will be totaled by age, gender and ethnicity to determine the penetration rates for the recruitment procedures. And lastly, medical records at the treatment referral sites will be checked to identify the number of participants referred.

The study will recruit subjects at each site for approximately last six months.

Eligibility Criteria:
Inclusion Criteria:

Ages 12 through 20.

Exclusion Criteria:

None
Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.

The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.

The secondary aims are to:

Validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).

Evaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.

Evaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.

Evaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and \<18 years: ellume.lab Flu A+B Test only; and
* Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and
* Rhonorrhea or blocked nose; and
* Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and
* Participant (or parent/legal guardian) able to read and write in English.

Exclusion Criteria:

* Participants aged \<1 year.
* Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days.
* Participants who have been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
* Participants who have had a nose bleed within the past 30 days.
* Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months.
* Participants currently enrolled in another clinical trial or have used any investigational device within 30 days preceding informed consent.
* Participants 18 years of age or older unable to understand English and consent to participation.
* Parent/legal guardian of Paticipants \<18 years of age unable to understand English and consent to participation of child.
* Participants who have had prior exposure to iTreat Flu A+B Test.
* participants who have been previously enrolled in the iE-FLU-AUS-1701 study.
Incidence and Prognostic Significance of HER-2 Status Discordance Between Primary Breast Cancer and Paired Recurrent/Metastatic Lesions

About a half of HER2-negative breast cancer show HER2-low expression that can be targeted by new antibody-drug conjugates. The main aim of this study is to describe the evolution of HER2 expression from primary BC to relapse by including HER2-low category in both primary and recurrent BC samples. Patients with matched primary and relapse BC samples were included. 1299 patients were included.


Eligibility Criteria:
Inclusion Criteria:

Patients with available HER2 status of primary breast cancer and relapse/metastases

Exclusion Criteria:

Patients with other malignancy
Effects of Whole Body Vibration in Subacute Stroke Patients

The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone turnover, physical fitness and neuromotor performance in patients with subacute stroke.

Brief periods of Whole body vibration (WBV) have been shown to improve bone density in post-menopausal women and children with cerebral palsy. In addition to the apparent benefits on bone health, WBV has been shown to increase muscle strength, postural control, muscular blood flow and oxygen uptake in various populations. Therefore, WBV can potentially be used as a tool to improve muscle strength, balance, and cardiovascular performance, especially for those with relatively low level of functioning. Stroke patients are therefore possible beneficiaries of WBV, as they often demonstrate muscle weakness, balance deficits, and poor cardiovascular function, in addition to bone loss. Only one pilot study has examined the effects of WBV in stroke patients. Van Nes et al.showed that postural stability in chronic stroke patients is improved after a few minutes of WBV at 30Hz and 3mm amplitude. The overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone turnover, physical fitness and neuromotor performance in patients with subacute stroke.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stroke
* medically stable
* able to understand simple verbal commands
* of chinese origin

Exclusion Criteria:

* previous stroke in addition to the current admission
* other neurological conditions, in addition to stroke
* significant musculoskeletal or vascular conditions in the lower extremity
* metal implants in the lower extremity
* previous fracture in the lower extremity
* are taking or were taking bone resorption inhibitors