cyrilzakka/clinical-trials huggingface dataset:
The Effect of Plaquenil on Serum Inflammatory Markers and Goiter in Euthyroid Young Women With Hashimoto's Thyroiditis

Hashimoto's thyroiditis (HT) is a common form of autoimmune thyroid disease, which affects up to 2% of general population. The annual incidence of HT worldwide is estimated to be 0.8 - 3.5 cases per 1000 persons. The thyroid gland attacked by a variety of cell- and antibody-mediated immune processes. Various auto-antibodies may be present against TPO and Tg, and ADCC is a substantial factor behind the apoptotic fall-out of HT. Activation of cytotoxic T-lymphocytes in response to cell-mediated immune response affected by helper T-cells is central to thyrocyte destruction. Recent studies showed higher pro-inflammatory cytokines in serum of patients with HT, and suggested HT is associated with regulatory T-cells dysfunction, imbalance of ratio of Th1 cell and Th2 cell, overexpression of Th17 cells.

Several studies suggested that pregnant women with HT, even at euthyroid state had higher risk of spontaneous miscarriage, more frequent post-partum depression and higher depressive, anger, and total mood disturbance risk compared to those without HT. Presence of thyroid auto-antibodies is also associated with negative pregnant outcomes including gestational hypertension, late abortion, fetal death, premature delivery and neonatal respiratory distress. Neonates from mothers with ATD have higher rate of transient hypothyroidism. Children of mothers with ATD had higher risk of positive serum thyroid auto-antibodies and development of goiter and thyroid dysfunction. However, there is no suggested treatment for subjects with HT who have normal thyroid function. Low-iodine diet and regularly follow-up were suggested.

Plaquenil (hydroxychloroquine) is an anti-malarial agent, and has been used to treat several autoimmune diseases, including lupus erythematosus and rheumatoid arthritis for more than a century. It reduced lymphocytes, production of auto-antibodies, cytokines, and immune mediators, NK cell activity, and inhibits antigens presenting to CD4 T-cells of B cells, dendritic cells and monocytes.

This study focuses on the effect of Plaquenil on thyroid auto-antibodies, inflammatory markers, cytokines, and goiter size in euthyroid women with HT.


Eligibility Criteria:
Inclusion criteria:

* Newly diagnosed (within 1 year) Hashimoto's thyroiditis by positive serum anti-TPO antibody or anti-thyroglobulin antibody
* Euthyroid state by serum free T4 and TSH level within normal limit

Exclusion criteria:

* Pregnant, planning pregnant within 1 year, or lactating women
* Renal insufficiency, abnormal liver function test
* Hematologic diseases: anemia, agranulocytosis, thrombocytopenia
* G6PD deficiency, porphyria cutaneous tarda
* Allergy to 4-aminoquinoline compounds
* Known retinopathy or visual field defect disorders
* Already receive immunosuppression therapy
Impact of Fortified Rice on Workers' Nutrition Status

The study is a single center, open label, nutrition intervention study. Healthy adult male working at a Singapore construction site are included if they fulfill inclusion and exclusion criteria. Volunteers receive fortified rice for their daily lunch and dinner each day of the week (i e 14 meals/week) over six months. Nutrition status in blood is measured at baseline and after six months of fortified rice consumption.

The study is a single center, open label, uncontrolled longitudinal nutrition intervention study. Migrant construction workers of either Bangladeshi or Indian ethnicity from a single dormitory in Singapore volunteer to participate at the study. Only eligible workers are included in the study if they fulfilled all inclusion and exclusion criteria; 20 and 51 years old, a BMI between 17.0 to 27.5 kg/m2, willing to adhere to the study procedure for at least six months, and sign informed consent, are free of current medical and/or chronic/non communicable diseases, no history of heavy smoking or alcohol consumption. The eligible subjects receive fortified rice for their daily lunch and dinner each day of the week (i e 14 meals/week) over six months. The nutrient levels per 100 g fortified rice contain 150 µg vitamin A (Vitamin A palmitate), 0.5 mg vitamin B1 (thiamin mononitrate), 7 mg vitamin B3 (niacin amide), 0.6 mg vitamin B6 (pyridoxine hydrochloride), 1 µg vitamin B12 (cyanocobalamin), 130 µg folic acid, 4 mg iron (ferric pyrosphosphate), and 6 mg zinc (zinc oxide). At baseline and after 6 months of intervention, BMI and vital signs such as blood pressure, pulse and body temperature are collected. Also, 10 ml venous blood is sampled at baseline and after 6 months of intervention and subsequently tested for hemoglobin, serum folate, and serum zinc, serum ferritin and serum vitamin B12 status. In a small subset of the migrant construction workers, an extra 5 ml blood sample is taken for homocysteine testing.

Eligibility Criteria:
Inclusion Criteria:

* 20 Years to 51 Years
* Indian or Bangladeshi ethnic origin
* BMI of 17.0 to 27.5 kg/m2
* Working at the construction site and continuing for 6 months after enrollment
* Willing and able to adhere to study procedures
* Signed the informed consent form

Exclusion Criteria:

* Conditions or diseases that the investigator considers to be not appropriate to enter the study
* Chronic illness
* History of heavy smoking (more than 10 cigarettes/day continuously for two years or more (self-reported) )
* Unable to understand informed consent (translated to Tamil and Bangladesh at basic literacy level)
Effectiveness of Flash Mediation Therapy

In order to offer a non-drug intervention for caregivers in nursing home to respond promptly to a behavioral crisis with an appropriate response to each patient, a chariot has been developed by the Institute of Ageing Well Korian (Institut du Bien Vieillir Korian) to bring together eleven mediation activities. These activities lasting about 15 minutes are based on emotion (reminiscent, games) and sensory interventions (music, massage, touch) to decentralize patient stimulus that disturbs and focus on a subject not disruptive. This emergency intervention should provide a reduction in Behavioral and Psychological Symptom of Dementia (BPSD) of nursing home patients. The main objective is to measure its immediate effect on productive symptoms (agitation, aberrant motor behavior and disinhibition). The secondary objectives are to measure its immediate impact on the well-being and psychotropic treatments, and measure its effect after two months and after four months on all BPSD with a focus on agitation, the administration of psychotropic drugs, the hospitalizations and the number of falls.


Eligibility Criteria:
Inclusion Criteria:

* People ability to object and does not oppose either by themselves or through a trusted person referred to in Article L. 1111-6 of the Code of Public Health, failing thereof, by the family, or, if a person talking to the person close and stable ties. For adults under guardianship, permission must be given by the legal representative of the person. The research will benefit from the backing of Persons Protection Committee (PPC) prior to its implementation;
* Man or woman over 60 years;
* patient living in one of the nursing homes participating in the project;
* Patient completing the diagnostic criteria for major neurocognitive disorder according to Diagnostic and Statistical Manual of Mental Disorders V criteria (DSM-V)
* The patient must have at least one of these productive symptoms (agitation, aberrant motor behavior, disinhibition) listed by the NPI-NH (score\> 2 at least one of these items)

Exclusion Criteria:

* Deafness or blindness may compromise patient assessment or participation in the intervention
Efficacy of a New Delivery System for Beta-hydroxy-beta-methylbutyrate

The proposed study will test efficacy of HMB in free acid gel to decrease muscle damage, diminish inflammatory response, and improve muscle strength recovery following an acute exercise stress. HMB in a free acid gel or in CaHMB capsule form will be administered as either a single dose before a bout of acute exercise or in multiple doses (one before and three daily doses for the 4 days following the acute exercise). We hypothesize that HMB in free acid gel will result in less muscle damage, diminished inflammatory response, and improved muscle strength recovery than either a placebo or CaHMB treatment following a bout of acute eccentric exercise. Our endpoints will include measurements of: (1) markers for muscle damage (CPK and LDH); (2) indicators of inflammation (CRP, TNF-α, IL-6, IL-1ra and IL-18); and (3) muscle strength recovery and soreness.


Eligibility Criteria:
Inclusion Criteria:

* Must live within 50 miles of Ames, Iowa
* Free of cardiac, liver, pulmonary, and kidney disease
* Free of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
* Free diabetes mellitus
* Not classified as morbidly obese (BMI must be less than 40)
* Free of cardiac, liver, pulmonary, and kidney disease
* No other serious medical illness
* Normal menstrual cycle and not pregnant or lactating
* Able to consume supplements and perform required exercise testing

Exclusion Criteria:

* Live more than 50 miles from Ames, Iowa
* Presence of cardiac, liver, pulmonary, and kidney disease
* Presence of chronic inflammatory disease including rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, and psoriasis
* Diabetes mellitus
* Classified as morbidly obese (BMI is greater than 40)
* No other serious medical illness
* Abnormal menstrual cycle, pregnant or lactating
* Not able to consume supplements and perform required exercise testing
Development of a Culturally Tailored Resilience-building Intervention for Chinese American's Advance Care Planning Discussions

Less than 15% of Chinese Americans complete advance directives. That is less than half of the 37% completion rate in the US general population. This disparity in the use of advance care planning between White Americans and Chinese Americans may extend to disparities in end-of-life care. To address such disparities in end-of-life care, we will develop and assess the acceptability of a culturally tailored resilience-building intervention to help Chinese Americans with cancer or heart disease and their family caregivers engage in advance care planning discussions.

The overall objective of this cross-sectional pilot study is to develop a culturally tailored resilience-building intervention for Chinese Americans with cancer or heart disease in Chicago. A qualitative analysis of semi-structured interviews will be conducted to identify how religious leaders addressed death-related topics with Chinese Americans with cancer or heart disease in Chicago. In addition, a usability test of a resilience-building intervention prototype will be conducted to to understand the feasibility and acceptability among 18 pairs of Chinese Americans and their family caregivers (9 pairs with cancer and 9 pairs with heart disease).

Eligibility Criteria:
Inclusion criteria for patient participants:

* Age ≥ 18 years of age
* Having a cancer diagnosis or a heart failure diagnosis documented in the electronic medical record
* Being able to read and respond to questions in English or Mandarin
* Having a family caregiver who is responsible for the care and willing to participate in the study
* Being of non-Hispanic Asian race/ethnicity

Exclusion criteria for patient participants:

* Having cognitive impairment per a Short Portable Mental Status Questionnaire with more than 3 errors
* Having received heart transplantation or a left ventricular assist device • Having completed an advance directive
* Being born in the US

Inclusion criteria for identified family caregivers:

* Age ≥ 18 years
* Being able to read and respond to questions in English or Mandarin
* Being identified by the patient as a family caregiver
Thrombocytopenia in Gestational Period

The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.

The investigators are undertaking a multicenter, open-labeled, pilot study of 50 ITP patients in pregnancy from Peking University People's Hospital and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given dexamethasone intravenously at a dose of 40mg every day for four days. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 20-50 years old.
* After 12 weeks gestation.
* Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
* Patients who have no response or relapsed after Corticosteroid or IVIG.
* Patients developed refractoriness to platelet transfusion.
* To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
* Willing and able to sign written informed consent.

Exclusion Criteria:

* Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
* Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
* Current HIV infection or hepatitis B virus or hepatitis C virus infections.
* Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.
* Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).
* Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
* Patients who are deemed unsuitable for the study by the investigator.
Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia

The purpose of this study is to evaluate the efficacy, safety and whether it can reduction of antibiotic use in the treatment of community-acquired pneumonia in children with Anerning granules combined with ceftriaxone sodium.

To evaluate the efficacy, safety and whether it can reduction of antibiotic use in the treatment of community-acquired pneumonia in children with Anerning granules combined with ceftriaxone sodium.In this study, a randomized, double blind, parallel control of placebo, multi-center clinical study will be established. According to the relevant regulations of the CFDA, 216 cases need to be registered at least.The aim population is children who suffering of community-acquired pneumonia from September 2018 to December 2019. These cases will be devided into treatment group（Anerning particle+ Intravenous ceftriaxone sodium）,control group（Anerning particle simulants+ Intravenous ceftriaxone sodium）. Each group will be treated for 10 days hospitalization and if there is adverse drug reaction during treatment, follow-up until the laboratory indicators are normal. The efficacy indicators of this study were mainly from three dimensions: Frequency of antibiotics at the clinical endpoint, Total disease efficiency, Clinical recovery time. The symptom scores changes of each group before and after treatment were observed.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for children's CAP Western medicine and consider bacterial infection;
2. Those who meet the diagnostic criteria of TCM syndrome differentiation of wind-heat and closed lung syndrome;
3. Children aged 1 to 5 years old;
4. Within 48 hours of onset of CAP;
5. The informed consent process is in compliance with the regulations, and the legal representative signs the informed consent form.

Exclusion Criteria:

1. Chest X-ray films showed obvious lung tumors and tuberculosis;
2. Those with acute infectious diseases such as measles, whooping cough, and influenza;
3. Other upper respiratory tract infections, wheezing-like bronchitis, bronchial asthma, bronchial foreign bodies and other respiratory diseases;
4. Children with severe malnutrition and immunodeficiency;
5. Combine severe primary diseases such as severe heart, liver, kidney, digestion and hematopoietic system;
6. Those who meet the CAP (severe) Western diagnostic criteria for children;
7. Clinically diagnosed or clinically considered viral pneumonia, Mycoplasma pneumoniae pneumonia;
8. allergic constitution (allergic to more than 2 types of substances), or allergic to penicillins, cephalosporin antibiotics and Anering granules and their components;
9. Researchers believe that it is not appropriate to join the group.
Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients

Epidural injection will be completed under fluoroscopy and all patients will receive 1-4 mg of Midazolam for relaxation before procedure and, if needed, 50-100 mcg of Fentanyl intravenous (IV). Radiopaque contrast (Omnipaque 300), for confirming the epidural position of the needle, steroids and local anesthetic agents will be used according to the physician performing the block and will not be controlled by the study. Patients will be randomly assigned to receive either inhaled Entonox along with the interventional block they are scheduled for or oxygen. They will be blinded about the treatment they are receiving. Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery. Those randomized to the oxygen group will receive oxygen through a similar mouthpiece for the entire duration of the procedure and recovery for 4 hours. Following completion of procedure the patient will be transferred to recovery and monitored for 3-5 hours then discharged home with instructions. Possible side effects will be monitored and recorded, pain score of patient will be recorded before discharge. All the patients will receive standard instructions regarding physical back exercises. This will be repeated for every procedure up to maximum of three blocks.

The patients will be followed during each block and over a period of 1, 3, 6 and 12 months and on each follow-up visit will complete computerized set of questionnaires as they did before the procedure. The patients charts will be then reviewed for one year after the initial procedure to determine if further epidural steroid injections or surgery for the presenting problem were required. It is anticipated that the appropriate number of patients will be enrolled within six months of study initiation.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old at time of the first procedure
* Male or female
* History of chronic low back pain for longer than 6 months due to radiculopathy, symptomatic spinal canal stenosis, disc prolapse, postlaminectomy syndrome
* magnetic resonance imaging or electromyographic evidence of nerve root damage
* Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score of \>12
* No or minimal evidence of facet joint pathology

Exclusion Criteria:

* Known contraindications for epidural injection
* Patients with ongoing workers' compensation claims
* unstable or heavy opioid use (400 mg of morphine equivalents daily),
* psychiatric disorders
* medical illness, including conditions that could interfere with the interpretation of the outcome assessments
* pregnant or lactating women
* Current or recent drug abuse (within past 6 months).
* Patient refuses regional analgesia.
* Alcohol or drug abuse
Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder

The study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease.

Metabolic abnormalities associated with cardiovascular morbidity and premature mortality are more common in patients with schizophrenia than in matched controls. Although there is some evidence that patients with schizophrenia have intrinsic abnormalities in lipid and carbohydrate metabolism, some antipsychotics (i.e., clozapine, olanzapine, quetiapine, and risperidone) are associated with increased rates of metabolic abnormalities that predispose patients to cardiovascular disease.

This is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the NIMH Schizophrenia Trials Network.

The aims of the study are to (1) determine the relative effects of switching to aripiprazole, versus continued treatment with olanzapine, quetiapine, or risperidone, on metabolic parameters associated with cardiovascular disease, and (2) to determine the effects of switching to aripiprazole versus continued treatment with olanzapine, quetiapine, or risperidone on the clinical stability of schizophrenic illness.

This study design is a multi-site, single-blind (rater) randomized controlled trial of 300 patients with schizophrenia or schizoaffective disorder comparing treatment with the following medications: olanzapine, quetiapine, risperidone, and aripiprazole. The study will enroll patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease in spite of adequate control of symptoms on their current antipsychotic medication. Patients who are taking olanzapine, quetiapine, or risperidone and who have a body-mass index (BMI) greater than or equal to 27 and non-HDL cholesterol greater than or equal to 130 mg/dl will be eligible (if non-HDL is between 130-139mg/dL, LDL cholesterol must be greater than 100mg/dL). All treatments will be open label. Raters will be blinded to treatment assignment. Patients will be followed for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with schizophrenia or schizoaffective disorder
* Currently treated with olanzapine, quetiapine or risperidone
* BMI greater than or equal to 27
* Non-HDL cholesterol greater than or equal to 130 mg/dL (if non-HDL cholesterol is between 130 - 139 mg/dL, then LDL cholesterol must be greater than 100 mg/dL).

Exclusion Criteria:

* Diabetes (FBS greater than or equal to 126) or treatment with oral hypoglycemic drug or insulin
* Non-HDL cholesterol greater than 300 mg/dL
* Serum triglycerides greater than 500 mg/dL
* Patients in the first episode of schizophrenia or schizoaffective disorder
* Known hypersensitivity to aripiprazole
* On weight loss medications