cyrilzakka/clinical-trials huggingface dataset:
Observatory on Impact of Life Styles on Health Outcomes

The present is an observational study conducted on the general population in villages of Southern Italy every year during the world hypertension day. So far, A total of 412 persons (193 males and 219 female, 14-85 years) were recruited during the XI and XII World Hypertension Day (2015 and 2016). The study was approved by the relevant institutional Ethical Committee of Salerno University.

In occasion of the World Hypertension Day in may , boots are organized in the major squares of the southern italy villages, and volunteers of the Medical School of Salerno collect through means of questionnaires, anamnestic data and dietary habits, and measure blood pressure after 5 minutes in the sitting position, 3 times with an interval of 2 minutes using validated, ESH approved electronic oscillometer (A100, Microlife, Italy), according to the ESC/ESH guidelines. Other questions regard previous cardiovascular conditions or events (coronary heart disease) and cardiovascular accidents (TIA and stroke). Eventual drug treatment and Vitamin D supplementation is also annotated. A venous blood sample is drawn from the antecubital vein and blood is stored for biochemical analysis at the University Hospital Centralized Service. Data are digitally stored for analysis.

Anamnestic and biochemical data regarding age, sex-specific cholesterol, HDL cholesterol, systolic BP and cigarette smoking pre-existing conditions and way of life are used for the calculation of cardiovascular risk according to the Framingham Cardiovascular Risk Score. Familiarity for cardiovascular disease is defined as cardiovascular events in parents and siblings less than 50 years old.

The validated questionnaire alternate Mediterranean Diet Score (aMed), is administered to assess adherence to the Mediterranean Diet . Laboratory assessment of blood samples. A venous blood sample was collected in two tubes of 5.0 ml and centrifuged in the day. The time of the last meal was recorded during the data collection. Blood glucose, insulin, blood urea nitrogen (BUN), creatinine, calcium, phosphorus, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, 25(OH)D, PTH, Vitamin B-12 and folic acid are assessed. Glomerular filtration rate (GFRs) is estimated using the equation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) .

Eligibility Criteria:
Inclusion Criteria:

- General population

Exclusion Criteria:

* Subjects who do not sign informed consent and do not give authorization will be excluded from the study
* Subjects fed through parenteral feeding
Study of AK156 in Primary Osteoporosis Patients

The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary osteoporosis
* Patients who have vertebral fractures at the time of screening

Exclusion Criteria:

* Patients diagnosed with secondary osteoporosis
* Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study
Using Cultural Ceremonies to Reduce Intimate Partner Violence and HIV Transmission

Violence against women (VAW), the most extreme manifestation of the unequal power balance between women and men, is a major global public health concern. One of the most common forms of VAW is that perpetrated by a husband or other intimate partner. In Ethiopia, 70.9% of women reported having experienced physical and/or sexual intimate partner violence (IPV) in their lifetime, demonstrating the pervasiveness of the problem. A growing body of evidence has also linked IPV and HIV risk.

This study is a cluster randomized controlled trial assessing the impact of a community-based intervention focused on Intimate Partner Violence and HIV delivered in the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion and conflict resolution. Villages will be randomly assigned to one of 4 study arms (3 intervention and one control arm): 1) Women only participate in the intervention, 2) Men only participate, 3) Both men and women (couples) participate, 4) Women and men receive the control intervention comprising a short informational session on violence reduction.


Eligibility Criteria:
Inclusion Criteria:

* currently married or cohabitating with partner
* residing in selected village for at least 6 months

Exclusion Criteria:

* eligible women who do not consent
Clinical Trial of Tahitian Noni Juice Safety

For 28 days, healthy volunteers will consume one of four daily quantities of Tahitian Noni juice: 0 mL (placebo), 30 mL, 300 mL, or 750 mL. Hematology, biochemistry, urinalysis, vital signs, and adverse events measurements will be made at 0 (baseline), 2, and 4 weeks, as well as during a two-week follow up (week 6). Electrocardiogram (ECG) measurements will also be made for each volunteer during the pre-study screen and at week 6.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were male or female, aged between 18 and 65 years inclusive.
* Subjects had a BMI of between 19 and 30 kg/m2 inclusive.
* Prior to study commencement, subjects signed and dated a witnessed informed consent form.
* Subjects had a satisfactory documented medical history during the 21 days prior to study commencement.
* Normal blood biochemistry, haematology, urinalysis and ECG were confirmed during the 21 days prior to study commencement.
* Subjects had negative virology profile (hepatitis B surface-antigen and hepatitis C virus antibody) confirmed during the 21 days prior to study commencement.
* Females of child-bearing potential had a documented negative urine pregnancy test and were not lactating or trying to become pregnant during the course of the study. They were using an adequate method of contraception. A female of non-childbearing potential was defined as one who had been post-menopausal for at least 12 months, had been surgically sterilised, or had a hysterectomy at least 3 months prior to study start.

Exclusion Criteria:

* Subjects with any evidence or history of clinically significant hepatic or renal disorder, cardiovascular, respiratory, metabolic, immunological, neurological, psychiatric or gastrointestinal disease.
* Subjects with a history of asthma or allergic skin rash or other relevant allergic reaction.
* Subjects with known hypersensitivity or intolerance to drugs in general.
* Subjects with a history of alcohol abuse (more than 28 units per week for males and more than 21 units for females).
* Subjects who tested positive for hepatitis B surface-antigen and hepatitis C virus antibody.
* Subjects who had been on a course of prescribed drug treatment within 28 days of the study start that had not been approved by the Principal Investigator.
* Subjects who had taken any over the counter (OTC) drugs, vitamins, herbal remedies or used topically applied preparations within one week of study start unless the Principal Investigator had given approval.
* Subjects who smoked more than five cigarettes daily.
* Subjects who participated in a clinical trial or donated more than 500 ml of blood in the three months prior to study commencement.
* Female subjects who were pregnant, lactating or trying to become pregnant during the course of the study.
The Purpose of This Study is to Investigate Safety and Tolerability of Tropifexor.

The purpose of this study is to determine whether dosing tropifexor is safe and tolerable.

This was a randomized, subject and investigator blinded, multicenter, parallel-arm study to assess the safety and tolerability of tropifexor dosed in the evening as compared to dosing in the morning in subjects with non-alcoholic steatohepatitis (NASH). Subjects whose eligibility was confirmed were randomized with stratification by domicile status at Day 1 of the treatment period into tropifexor (200 μg) AM dose group (hereafter referred to as AM dose group) or tropifexor (200 μg) PM dose group (hereafter referred to as PM dose group) in a 1:1 ratio. Subjects in the AM dose group took tropifexor in the morning and placebo in the evening while subjects in the PM dose group took placebo in the morning and tropifexor in the evening for 4 weeks in a blinded manner.

Eligibility Criteria:
Inclusion Criteria:

-Presence of Liver Disease

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
* Subjects taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 3 months before randomization:

Type 1 diabetes and Uncontrolled Type 2 diabetes defined as Glycated hemoglobin (HbAlc) ≥ 9.5% at screening

-Calculated estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m2 (using the Modification of diet in renal disease (MDRD) formula) Subjects with contraindications to Magnetic resonance imaging (MRI) imaging.
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.


Eligibility Criteria:
* Signed informed consent
* Ability and willingness to comply with the requirements of the study protocol
* Age ≥ 18 years
* Documented history of histologically confirmed CD20-positive follicular NHL (Phases I and II); for Phase I, other CD20-positive indolent lymphomas (marginal zone lymphoma and small lymphocytic lymphoma) are also included. Patients with a history of a CD20-positive NHL of mixed (indolent/aggressive) histology may also be included in Phase I if the most recent relapse biopsy shows only indolent NHL
* Indolent lymphoma (Phase I) or follicular lymphoma (Phase II) that either has relapsed after a documented history of response (CR, CRu, or PR) of ≥6 months to a rituximab-containing regimen or was refractory to a previous rituximab-containing regimen
* Bi-dimensionally measurable disease, with at least one lesion \>1.5 cm in its largest dimension
* Absolute B-cell count ≥LLN at screening (Phase I only)
* ECOG performance status of 0, 1, or 2
* For patients of reproductive potential (males and females), use of a reliable means of contraception during the study and for 1 year following the last dose of study treatment
* For females of childbearing potential, a negative serum pregnancy test within 14 days prior to enrollment

Exclusion Criteria:

* Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab or radioimmunotherapy)
* Prior use of any non-CD20-targeted monoclonal antibody therapy within 6 months of enrollment
* Current or recent lymphoma treatment
* History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
* Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
* Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
* Untreated or persistent/recurrent malignancy (other than lymphoma)
* Known active bacterial, viral, fungal, mycobacterial, or other infection
* A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
* History of recurrent significant infection or bacterial infections
* Positive hepatitis B or C serology
* Positive human immunodeficiency virus (HIV) serology
* Pregnancy or lactation
* Central nervous system lymphoma
* Recent major surgery within 4 weeks of screening, other than diagnostic surgery
A Study of TRS01 in Participants With Post-surgical Ocular Inflammation

The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are:

* 18 years of age or older.
* Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
* Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery.
* Have vision ≥ 20/200 in the non-study eye.
* Able to self-administer eye drops (tested during screening by self-administration of "artificial tears"), or have a care provider that can administer the drops.
* Have no known sensitivity /allergy to the TRS01 or formulation excipients.
* Using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol
* Randomization inclusion criteria as specified per protocol.

Exclusion Criteria:

* Scheduled to undergo cataract surgery in the non-study eye for the duration of the study.
* Receiving specific medication/interventions as specified per protocol
Zushima Plaster for Treating Knee Osteoarthritis

The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima plaster for patients in knee osteoarthrosis post-marketing.


Eligibility Criteria:
Inclusion Criteria:

* Ages 40-75;
* Unilateral or bilateral knee OA, confirmed radiographically;
* Patients taking oral NSAIDs prior to the breakthrough period will be permitted;
* VAS pain score is or above 20mm.

Exclusion Criteria:

* Knee is swollen and hot;
* Allergic to any ingredient in Girald Daphne Bark Plaster (Girald Daphne Bark, Lithargite, Linseed oil, Red lead) ;
* Congestive Heart Failure and Edema;
* Advanced renal disease;
* Knee joint skin is burst or skin disease or allergies.
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetics of a single dose of a pregabalin controlled release (CR) tablet administered fasted in the evening relative to a single dose of the CR tablet administered immediately following a 600 to 750 calorie evening meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR) capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.

Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR capsule

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
5-fluorouracil for Treatment of Stable Vitiligo

Vitiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal.

Vtiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal. 5FU is a well-known chemotherapeutic agent that has been used for colorectal cancer treatment. The drug prevents DNA synthesis by inhibiting the thymidylate synthetase. The hyperpigmenta-tion of the skin is the most side effect observed with 5-FU therapy which directed its use in treat-ment of vitiligo. Besides, many studies reported that 5-FU could induce regimentation in vitiligo by direct stimulation of melanocytes and increasing melanosomes numbers in the keratinocytes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable vitlligo

Exclusion Criteria:

* patients under the age of 10 years.
* Individuals with a history of the Koebner phenomenon, a tendency for keloid or hypertrophic scarring
* Pregnancy.
* Recent isotretinoin therapy within the last 6 months.
Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients

The aim of this study is to evaluate whether anti-HLA donor-specific antibodies monitoring can be used as an effective tool for stratification of immunological risk in Polish kidney transplant recipients.

Monitoring of immune response is one of the most important goals in the management of the patients after kidney transplantation. Researchers and clinicians are trying to extend the survival of the renal graft. Currently, it is believed that the main cause of late transplant loss is antibody-mediated rejection (ABMR). Anti-HLA donor-specific antibodies (DSA) are a proven risk factor for the development of humoral rejection and transplant loss. Antibodies in sensitized recipients occur before transplantation (preformed) or may develop de novo (in 13% -30% of patients).

DSA damage the graft in various mechanisms (complement activation, direct influence on endothelial cells, antibody-dependent cytotoxicity) leading to different clinical-morphological phenotypes. The pathogenicity of DSA is determined by number of their additional characteristics, such as: class, specificity, strength, C1q complement binding, IgG subclass . Monitoring the presence of DSA in the kidney recipient serum with the determination of their characteristics may improve the stratification of the risk of immunological loss of the renal allograft.

There is no effective treatment for ABMR, hence DSA monitoring allows for early intervention such as biopsy or modification of immunosuppressive therapy at an early stage of rejection.

Eligibility Criteria:
Inclusion Criteria:

* Deceased-donor kidney transplant recipient
* Older than 18 years
* Written consent by the patient

Exclusion Criteria:

* Younger than 18 years
* Lack of written consent by the patient
Effect of Endoscopic Papillary Large Balloon Dilation on Recurrent Rate of Patients With Recurrentstones in Bile Duct

The recurrent rate of CBDS in patients with recurrent CBDS is high. It was reported that up to 60% of patients had stone recurrence within two years after stone retrieval by ERCP. Although EPLBD is useful for for extraction of large CBDS with less operation time and mechanical lithotripsy.It is not known whether EPLBD could prevent the recurrence in patients with recurrent CBDS.Although Harada et al found that EPLBD might reduce the short-term recurrence of CBD stones in patients with previous ES. It is a retrospective study with a small sample size (n=94).

Here a prospective, randomized controlled study including two tertiary centers was designed. The aim of this study was to investigate whether EPLBD could reduce the recurrence rate in patients with recurrent CBDS.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80
2. Patients with recurrent CBDS after ERCP

Exclusion Criteria:

1. Benign or malignant CBD stricture
2. Recurrent stone within 3 months after ERCP
3. Previous endoscopic papillary large balloon dilation (EPLBD)
4. Prior surgery of Bismuth II and Roux-en-Y
5. Septic shock
6. Coagulopathy (INR\>1.3), platelet\<50000 or using anti-coagulation drugs
7. With expected life span less than 24 months
8. Pregnant women
9. Refusal or unable to give written informed consent
Exercise Plus Epoetin Alfa in Treating Cancer Patients Who Have Anemia-Related Fatigue

RATIONALE: Exercise may decrease anemia-related fatigue, improve strength, and build up lost muscle tissue. Epoetin alfa may help improve cancer-related anemia, energy levels, and quality of life. Exercise plus epoetin alfa may be effective treatment for anemia-related fatigue.

PURPOSE: Phase II trial to study the effectiveness of exercise plus epoetin alfa in treating cancer patients who have anemia-related fatigue.

OBJECTIVES: I. Determine the effect of progressive resistance training and epoetin alfa on lean body mass, fatigue, exercise tolerance, functional capacity, and total body weight in cancer patients with anemia related fatigue.

OUTLINE: Patients undergo progressive resistance training (PRT) consisting of 3 sets of 8 repetitions of concentric (lifting) and eccentric (lowering) exercises over 4-6 seconds each using bench press, arm pull, knee extension, knee flexion, and double leg press followed by 1-2 minutes of rest between sets. Patients undergo warm up and cool down periods over 10 minutes prior to and following PRT. Patients perform PRT 3 times a week for 12 weeks. Patients also receive epoetin alfa subcutaneously once weekly over 4-12 weeks in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of nonmyeloid malignancy with cancer related fatigue Anemia (hemoglobin less than 10 g/dL) No clinical or radiographic evidence of lytic bone metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Greater than 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No dementia or evidence of mental incompetence No physical handicap precluding aerobic or resistance exercise No clinical abnormality that would render exercise a risk HIV negative No contraindications to epoetin alfa Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 8 weeks since prior epoetin alfa Chemotherapy: Concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: Not specified Other: Concurrent anticancer therapy allowed At least 1 month since prior strength training of greater than 3 hours a week
Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects

OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function after induced hypocalcemia.

II. Determine the relationship of parathyroid hormone secretion to microdeletions in the same region of chromosome 22q11 as found in patients with DiGeorge anomaly.

PROTOCOL OUTLINE:

Patients are given sodium citrate over a 2 hour infusion on day 1. Blood is drawn at times -30, -15, 0, and every 10 minutes thereafter during the infusion. On day 2, patients are given calcium gluconate over a 2 hour infusion. Blood is drawn at times -30, -15, 0, and every 10 minutes thereafter during the infusion.

Eligibility Criteria:
* Diagnostically shown repaired or palliated conotruncal cardiac defects, including tetralogy of Fallot with pulmonary stenosis or pulmonary atresia, truncus arteriosus, or interrupted aortic arch type B