cyrilzakka/clinical-trials huggingface dataset:
Calcium-vitamin D & Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women

The improvement of maternal and child health remains a key issue in global health. Production and improved accessibility of healthy and nutrient-rich milk-based products could potentially tackle health and nutrition inequalities in low-income countries.

This study will assess the acceptability of a multi-component intervention, including provision of calcium/vitamin-D fortified milk and periodontal therapy (PT), for improving maternal periodontal health and metabolic and inflammatory profiles. The IMPROVE trial is a feasibility randomised controlled trial (RCT) with parallel qualitative process evaluation. The target population is low-income, pregnant, Brazilian women, with periodontitis, who have not seen a dentist in the last 6 months. A series of focus group discussions and interviews with the target population will be conducted to identify key barriers and enablers to adoption and implementation of the intervention in prenatal clinics in Rio de Janeiro/Brazil. Participants will be allocated to 4 groups: 1) early PT (during pregnancy) plus fortified milk; 2) early PT plus plain milk; 3) delayed PT (after delivery) plus fortified milk; 4) delayed PT plus plain milk.

The final results will contribute to the understanding of the significance of calcium and vitamin D for short and long-term health and the occurrence of diseases, as well as to inform the current global debate on vitamin-D supplementation and fortification policy.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 year;
* Up to 16 weeks' gestation;
* Having ≥ 20 teeth;
* Diagnosis of periodontitis (≥ 1 tooth with at least one of periodontal sites with ≥ 4 mm of clinical attachment loss and bleeding on probing on the same site);
* Not received regular dental treatment in the last 6 months (except from those who only visited the dentist for an emergency appointment e.g. tooth extraction);
* Cognitively and physically able to complete an interview and oral examination; and
* Willing to participate (including provision of blood samples)

Exclusion Criteria:

* Diagnosis of HIV/AIDS, psychosis, diabetes before pregnancy, thyroid disease, or disorders causing vitamin D hypersensitivity (e.g. sarcoidosis and other lymphomatous disorders);
* Diagnosis of lactose intolerance or milk allergy;
* History of renal stones or family history of renal stone and hyperparathyroidism;
* presence of extensive dental cavity and decay;
* Use of antibiotics or any immune-suppressants or medication known to affect vitamin D/calcium metabolism; and
* Consumption of ≥4 servings/day of dairy products or taking vitamin D supplements at \> 400 IU/day.
Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

Polycystic ovary syndrome is the most common endocrine and metabolic disorder in gynecology. Traditional Chinese medicine has a good clinical effect in the treatment of PCOS. We intend to conduct this trial in strict accordance with the requirements of evidence-based medicine, through a multi-center, randomized, controlled study, using a double-blind, randomized, placebo-controlled study design method to clarify that Zishen Qingre Lishi Huayu Recipe restores spontaneous ovulation in PCOS patients. The overall efficacy of improving the characteristics of Kaohsiung and glucose and lipid metabolism is optimal, and high-level evidence-based evidence is obtained to form a diagnosis and treatment plan for promotion.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as PCOS patients, the diagnostic criteria is: modify the Rotterdam criteria. All subjects must have: no ovulation, combined with polycystic ovarian or / and hyperandrogenism.
2. Age: 20 to 40 years old, no maternity requirements.
3. Willing to be treated according to the treatment plan specified in this study.

Exclusion Criteria:

1. Hyperprolactinemia: In the past year, patients with normal levels can be included.
2. Menopausal FSH levels：FSH \> 15 mIU/mL. In the past year, patients with normal levels can be included.
3. Patients with thyroid disease: TSH \< 0.2 mIU/mL or \>5.5 mIU/mL. In the past year, patients with normal levels can be included.
4. Patients with poorly controlled type 2 diabetes:HbA1c\>7.0%, or patients receiving antidiabetic drugs.
5. Patients currently diagnosed with severe anemia (HGB \<10 g/dL).
6. Patients with a history of alcohol abuse: Alcohol is defined as drinking 14 times a week or more or binge drinking.
7. Currently suspected Cushing's syndrome patients.
8. Patients suspected of having adrenal or ovarian tumors secreting androgen.
9. In patients with hypertension who are currently untreated or have poor blood pressure control, the interval between two blood pressure measurements is ≥ 60 min, systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg.
10. Patients currently diagnosed with metabolic syndrome
11. Take hormonal drugs, Chinese medicine prescriptions and proprietary Chinese medicines in the last 3 months.
12. There is a history of pregnancy in the last 6 weeks.
13. Abortion or production history in the last 6 weeks.
14. A history of breastfeeding in the last 6 months.
15. Patients with a history of deep vein thrombosis, pulmonary embolism or cerebrovascular disease.
16. Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, and mental patients
17. Patients who are expected to discontinue treatment during the trial or who are unable to adhere to treatment for 3 months should be excluded.
18. Reluctant to sign the informed consent form for this study.
Pentoxifylline Treatment of Acute Pancreatitis

The purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and Drug Administration (FDA) for treatment of circulation problems, but its use in this study is investigational, which means that the FDA has not approved it for the treatment of pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.

Subjects will be put in one of two groups by chance (as in the flip of a coin). This is done so that neither you nor the investigator will know which group you are in.

You will be put into either the treatment group or the control group.

* The treatment group will receive a drug called pentoxifylline
* The control group will receive a placebo (matching pill that has no medication in it) You will take the pills by mouth starting from the time of admission. You will receive a total of 9 doses over the first three days of your hospitalization (72 hours).

When subject have standard patient care blood draws, additional blood will be taken to do the research tests. The additional blood tests will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. The additional tests will require about 2 teaspoons (10 ml) of blood per day; the maximum amount of extra blood taken would be less than 3 tablespoons (40.0 ml). Information from your medical record will be gathered while you are hospitalized and after your discharge. The study will continue to gather clinical follow up information up to four months.

Eligibility Criteria:
Inclusion Criteria:

1. Predicted Severe Acute Pancreatitis
2. Enrollment within 72 hours of diagnosis
3. Ability to give informed consent
4. Age \>17 years

Exclusion Criteria:

1. Moderate or severe congestive heart failure
2. History of seizure disorder or demyelinating disease
3. Nursing mothers
4. Pregnancy
5. History of prior tuberculosis or risk factors for tuberculosis
6. Evidence of immunosuppression (malignancy, chronic renal failure, chemotherapy within 60 days, ongoing steroid treatment\*, and HIV)- (\*the exception of prednisone use will be allowed to participate).
7. Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)
8. Evidence of active or pending hemorrhage.
9. Paralytic ileus with vomiting
Thiazolidinediones (TZD) Bone Loss and the Effects on Bone Marrow Differentiation and Osteoblast Formation

Thiazolidinediones (TZDs) are a commonly used antidiabetic drugs currently used by over a million patients in the United States. Recent studies have shown that treatment with TZD may increase the risk of bone fractures. The cause of bone loss is not known. We believe that TZD may cause increased accumulation of fat in the bone marrow, which may cause decrease bone formation and weak bones. .

This study aims to determine if TZDs increase the amount of fat and decrease the number of bone producing cells in the bone marrow.

A total of 5 subjects who require surgery for mandible (jaw) fracture and bone graft will be recruited. Some patients who will undergo mandible surgery will require a bone graft. In this procedure, a small piece of bone from the hip is placed in the mandible. In this study, a small amount of bone marrow fluid (5 mL or 1 teaspoon) will be obtained after the bone graft is completed. Obtaining the bone marrow will not result in additional pain or health problems. The effect of TZD on bone marrow and bone forming cells will be studied. The cells obtained during surgery will be grown at Dr Beck's laboratory at Emory University School of Medicine.

A working hypothesis suggests that the increased fracture risk in patients taking TZDs is the result of TZDs altering the differentiation capacity of bone marrow stromal cells pushing them towards the adipocyte lineage at the cost of osteoblast formation thereby decreasing bone formation.

Study AIM:To determine whether TZD exposure in vitro alters bone formation and the differentiation capacity of bone marrow stromal cells by promoting adipocyte lineage differentiation and lowering osteoblast formation.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females between the ages of 18 and 80 years undergoing ileac crest bone graft to repair traumatic mandible fracture.
2. Patients admitted for elective or emergency surgery or trauma.

Exclusion Criteria:

1. Subjects with history of decompensated diabetes (blood glucose \> 200 mg/dl)
2. Critically ill patients with multi-organ failure, relevant hepatic disease or impaired renal function (serum creatinine ≥ 2.0 mg/dl)
3. HIV
4. Hemolytic anemia and/or hematocrit \< 28%
5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
6. Pregnancy
Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response

To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and therapy response from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.

Multiple Sclerosis (MS) is an autoimmune disease that damages the central nervous system (CNS) and disrupts communication to and from the brain by attacking the myelin sheath surrounding neurons. It impairs control of bodily functions and leads to clinical disability as the disease progresses. The worldwide population is estimated at 2.5 million. MS typically develops in young adults; primarily women in their early 30s. The etiology of MS is not fully understood, but it is noted that the prevalence of MS differs with geography and ethnicity.

Biomarker signature panels are important tools for monitoring treatment response and screening for individuals who are unlikely to benefit from certain therapies. To establish a baseline and further characterize gene expression in MS, blood samples from individuals with MS will be collected. A rapid blood test to predict a treatment response would be an innovative diagnostic product that could aid in identifying individuals that may benefit from the targeted therapy. In the long term, such a test could bring significant clinical benefits by enabling individualized treatment to better control the disease, unburdening healthcare costs, and dramatically improving the management of MS.

In order to analyze gene expression data from individuals diagnosed with MS, the study will collect blood samples and information from up to 1500 subjects for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 or older
* Have a permanent address in the United States for the duration of the study
* Have an email address and access to the internet for the duration of the study
* Able to provide informed consent
* Self-reported diagnosis of MS

Exclusion Criteria:

* None
Chronic Obstructive Pulmonary Disease and Health Coaching

The aim of this study is to determine the effect of the health coaching approach applied to patients with Chronic Obstructive Pulmonary Disease on the perceived social support of the patients.

Research Hypotheses:

H0: Health coaching approach has no effect on perceived social support in patients with COPD.

H1: Health coaching approach has an effect on perceived social support in patients with COPD.

The current study is in the design of a single-blind randomized controlled trial. Patients were randomized into intervention group (n:34) and control group (n=34). Coaching interview will be held once a week for 6-8 weeks with the patients in the coaching group. Coaching sessions will be based on the social support the patient receives from family and friends.

Both the coaching group and the control group will be given information about COPD. This information will be given face to face first. Later, the booklet of the training given will be delivered to the patients via message.

The data was collected using the socio-demographic information form,COPD Assessment Test (CAT), and Multidimensional Scale of Perceived Social Support (MSPSS).

Data Analysis will be done with SPSS package program

Eligibility Criteria:
Inclusion Criteria:

* over 40 years old,
* diagnosed with COPD for at least 6 months,
* without stage III and IV heart failure,
* without any cancer diagnosis,
* no communication problems (such as those who do not have problems in expressing - themselves, no hearing problems),
* not diagnosed with cognitive and mental dysfunction (such as Alzheimer's, dementia, bipolar disorder, major depression)
* Patients who agree to participate in the study will be formed.

Exclusion Criteria:

* with any cancer
* with stage IV heart failure
* patients requiring clinical follow-up due to acute COPD exacerbation
Myocardial Infarction Size Reduction With Atorvastatin

The purpose of this study is to determine if oral atorvastatin administered just before percutaneous coronary angioplasty for acute myocardial infarction improves early and late heart function as compared to placebo.

Left ventricular remodelling after a myocardial infarction refers to changes in shape and function of the infarcted and uninfarcted myocardium. Remodelling begins minutes after acute myocardial infarction and may continue for months or years, leading to dilation of the left ventricle (LV) and an increased LV volume. As studies show, LV volume strongly correlates with long-term mortality. Reperfusion after a period of ischaemia (through medication or PTCA) leads to so-called 'reperfusion injury'. This results in myocardial dysfunction and damage, which can lead to LV remodelling.

In a study where atorvastatin was administered at the onset of reperfusion infarct size was reduced. Atorvastatin led to protection of the reperfused myocardium, independently of its effects on cholesterol.

The objective is to measure the effect of atorvastatin, administered orally before reperfusion therapy by PTCA, on infarct size and microvascular reperfusion.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients (aged \> 18 years) who are to undergo a primary PCI for a first acute ST elevation myocardial infarction will be asked to participate in this study.

Exclusion Criteria:

* Previous myocardial infarction
* Previous coronary artery bypass grafting (CABG)
* Cardiac rhythm is other than normal sinus rhythm.
* Electrical instability.
* The patient is in Killip class 3 or 4 of heart failure.
* Need for intra aortic balloon counterpulsation therapy
* The patient is unable to hold his/her breath for up to 20 seconds due to age or concomitant illness.
* Implanted electronic devices are present: pacemakers, internal defibrillators, ECG-registration devices, neurostimulators, implanted drug infusion devices, cochlear implants etc.
* Previous vascular surgery: aneurysm clip, carotid artery vascular clamp, aortic clips, or venous umbrella
* Prosthesis (orbital/penile, etc.)
* Spinal/intra-ventricular shunts.
* Swan-Ganz catheter; transdermal delivery systems.
* Metal fragments: eye, head, ear, skin.
* Implants held by magnets.
* Known allergy to MR contrast media
* Prior use of statins
* No PCI performed
* No recanalisation achieved
Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Psoriasis Vulgaris - CHINA201002016-2

The purpose of this study is to determine whether Triptergium wilfordii, and Acitretin are effective and safe in the treatment of patient of moderate to severe psoriasis vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes, between the age 18 and 75 years.
* Have a diagnosis of psoriasis vulgaris,PASI score of 7 or greater.
* Capable of giving informed consent and the consent must be obtained prior to any study related procedures.

Exclusion Criteria:

* Currently have erythrodermic,guttate or pustular psoriasis.
* Have any active dermatoses which may affect disease assessment of psoriasis.
* Have used any investigational drug,any biologic or any systemic immunosuppressants within the previous 1 month..
* Have used topical medications/treatments that could affect psoriasis or PASI evaluation (eg, corticosteroids, tar, phototherapy et al.) within 2 weeks.
* Have any acute or chronic or recurrent infectious disease,which was difficult to control.
* Have the history of HBV or HCV infection,or HIV antibody test positive.
* AST, ALT or blood fat levels must be within 1.5 times the ULN range for the laboratory conducting the test.
* Are pregnant, nursing, or planning pregnancy in the coming two years(both men and women) while enrolled in the study.
* Have any severe systemic disease or have a history of malignancy.
* Have shown a previous hypersensitivity to Triptergium wilfordii or Acitretin.
* Have any other condition not suitable to join in trial,which are judged by investigator.
Study to Determine How BCX4161 is Metabolized and Eliminated by the Body

The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males
2. Age 30 to 65 years of age (inclusive)
3. Body mass index of 18.0 to 32.0 kg/m2
4. Must be willing and able to communicate and participate in the whole study
5. Must provide written informed consent
6. A history of regular bowel movements
7. Must agree to use an adequate method of contraception

Key Exclusion Criteria:

1. Participation in a clinical research study within the previous 3 months
2. Current or history of any drug or alcohol abuse in the past 2 years or positive drugs of abuse screen
3. Current smokers
4. Radiation exposure, including that from the present study, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
5. Clinically significant medical history, current medical or psychiatric condition, ECG finding, or laboratory/urinalysis abnormality
6. Activated partial thromboplastin time or PT outside of normal laboratory limits
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence

The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.

This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to assess safety, efficacy, and treatment retention during maintenance treatment.

Eligible patients had completed 1 of 2 primary efficacy and safety studies of the higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006 \[NCT01908842\] or OX219-007 \[NCT01848054\]). The total duration of study treatment was 24 weeks.

Eligibility Criteria:
Inclusion criteria

* Signed informed consent form.
* Completion of 1 of 2 primary efficacy safety studies of BNX sublingual tablets (OX219-006 or OX219-007).
* Female patients of child bearing potential who used a reliable method of contraception (hormonal, condom with spermicide, intrauterine device) during the previous OX219-006 or OX219-007 study and continue to use it for the OX219-008 study. Females who are not of child-bearing potential who are either surgically sterile (by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation), or postmenopausal, as defined by being at least 50 years of age and having had an absence of menses for at least 2 years, were also eligible.

Exclusion criteria

* Females who are pregnant (positive pregnancy test result) or lactating, or planning to become pregnant during the study.
* Participants who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
* Participants who are participating in any other clinical study in which medication(s) are being delivered or who had used an investigational drug or device within the last 30 days.
* Participants with any known allergy or sensitivity or intolerance to buprenorphine, naloxone, or any related drug, or history of any drug hypersensitivity or intolerance that, in the opinion of the investigator, would compromise the safety of the subject or the study.
* Participant with a contra-indicated serious medical condition.
* Participants who are at suicidal risk as determined by any of the following: a history of suicidal ideation ≤ 3 months prior to baseline with a score of 4 (intent to act) or 5 (specified plan and intent) on the Columbia Suicide Severity Risk Scale (C-SSRS).