cyrilzakka/clinical-trials huggingface dataset:
A Community Trial for Visceral Leishmaniasis (VL)

Visceral leishmaniasis (VL) / Kala-azar (KA) is a public health problem in the many countries in the world including Bangladesh. Where more than 90,000 VL cases have been reported since 1994. The disease is fatal if not treated. Even with treatment the mortality rate is high (10%). VL is a vector-borne disease, caused by the parasite Leishmania donovani (LD) and is transmitted by female sandfly sp. Phlebotomus argentipes. Not all people exposed to the LD parasite develop disease. According to our observation only about 30% of the infected with LD parasite develop disease within one year of diagnosis. Malnutrition and intestinal helminth infection have been found to be associated with the risk of active VL. Down regulation of Th1 cellular immune response confers susceptibility to active VL. Both malnutrition and intestinal helminth infection down regulate the Th1 cellular immune response. Till now there is no established prophylaxis against active VL among the people exposed to the LD infection. Many studies including ours have been shown that periodic regular deworming reduced malnutrition significantly. Micronutrient such as zinc and iron as well vitamin A supplementation also improve malnutrition and may enhance Th1 cellular immune response. Thus we hypothesize that periodic deworming and. micronutrient and vitamin A supplementation together may reduce the risk of active VL among the people exposed to the LD infection.

The study will be carried out in the Harirampur union, Trishal, Mymensingh. This area is highly endemic for VL. Two hundred asymptomatic VL patients aged 2-60 will be enrolled to the study. Children aged less than 2 years, pregnant women, active VL case, person with chronic disease, disable individuals and those who will refuse written consent will not be enrolled to the study. After enrollment subjects will be divided into two groups through randomization. One group will receive deworming and nutritional supplement (intervention group) and other group will receive placebo (placebo group). Two groups will be followed for 12 months through active surveillance for developing of active VL. In addition morbidity data, monthly stool sampling, monthly anthropometry, urine and blood sampling at baseline, before and after treatment of active VL will be carried out Successful completion of the study and derived results from it will provide useful information that whether periodic deworming with micronutrient and vitamin A supplementation can reduce the risk of active VL among the people exposed to the LD infection.


Eligibility Criteria:
Inclusion Criteria:

* An individual with positive rK39 strip test, without past history of VL and/or symptom and sign of chronic illness.

Exclusion Criteria:

* Children aged \< 2 years,
* Adults aged \> 60 years,
* Patients of active VL,
* Pregnant women,
* People with chronic or debilitating conditions.
Peripheral Immunologic Response of Solid Organ Transplant Recipients to Depletion Versus Non-depletion Protocols

Rejection and infection are primary causes of morbidity and mortality in solid organ transplant recipients. Current clinical practice relies on immunosuppressive drug levels measured in plasma to reflect the peripheral immune response in solid organ transplant recipients. Direct measurement of the number and functions of the immune cells themselves using multi-parameter flow cytometry may enable individualized immunosuppression management for organ transplant recipients. Multi-parameter flow cytometry will be used to compare levels and functional capabilities of multiple lymphocyte subsets between cohorts of patients receiving depletion induction and those receiving a non-depletion regimen. The activation state, cytotoxic potential and the functional capabilities of these cells will be examined within patients over the first six months post transplant.


Eligibility Criteria:
Inclusion Criteria:

* liver transplant recipient

Exclusion Criteria:

* none
Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis

Psoriasis is associated with increases in markers of inflammation in the skin and blood and increasingly is thought to be a systemic inflammatory disease and risk factor for incident diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death. Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial emotional impact on an individual, which is not necessarily related to the extent of skin disease.

FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that chronic disease such as end stage renal disease with depressive symptoms have decreased cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms in patients with psoriasis.

10 Patients with psoriasis

1. Evaluate PASI score
2. Evaluate comorbidity with metabolic syndrome

   * Body mass index(BMI)
   * Checking blood pressure
   * Checking blood sugar
   * Smoking and drinking history
   * Checking blood cholesterol level
   * Risk factors of cardiovascular disease
3. PET/CT for measuring the extent and site of psoriasis with inflammation

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of plaque type psoriasis
* at least 18 years old

Exclusion Criteria:

* those who cannot understand questionnaire
* those who take antidepressant
Iressa as a First-Line Treatment in Chemonaive Patients With Inoperable Non-Small Cell Lung Cancer

The purpose of this study is to assess the overall response rate to Iressa as a first-line treatment in chemonaive patients with inoperable Non-Small Cell Lung Cancer (NSCLC)

The epidermal growth factor receptor (EGFR) is a promising target for anticancer therapy because it is expressed or highly expressed in a variety of tumors, including NSCLC.Furthermore, high levels of EGFR expression have been associated with a poor prognosis in lung cancer patients in several studies. EGFR-targeted cancer therapies are currently being developed; strategies include inhibition of the intracellular tyrosine kinase domain of the receptor by small molecules such as gefitinib (Iressa \[ZD1839\]; AstraZeneca, Wilmington, DE). Iressa is an orally active, selective EGFR tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of cancer cells.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB/IV NSCLC
* No immediate need for palliative radiotherapy and No prior chemotherapy
* age \> 20 Y/O
* ECOG PS: 0 - 2
* ANC \>2000
* PLT \>100k
* Hb \> 10
* total bilirubin \< 2.0 mg/dL
* serum creatinine \< 2 mg/dl
* SGPT and SGOT \< 2.5 ×ULN, alkaline phosphatase \< 5 ×ULN
* life expectancy \>6mos.

Exclusion Criteria:

* If the patients have brain metastases or receive radiotherapy, the disease must be stable for more than 6 weeks after the last dose of radiotherapy
* 2nd malignancies
* Unable to swallow tablets
* Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements
* Pregnant or lactating patients
* Participation in other clinical trials within 30 days of study entry
* Major systemic disease which in the investigator's opinion might confound the clinical trial
Retrospective Analysis of PET Brain Imaging in Chronic Cancer Pain

Cancer pain deteriorated in quality of life and related with numerous psychosocial problems. Over the one third of cancer patient suffered from moderate to severe cancer pain, even under adequate pain management.

The 18F-fluoro-2-deoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) images can provide quantitative results in clinical oncology. As a functional neuroimaging, the PET evidently provided anatomical activated regions, size, and spatial extent information. In this retrospective study, we use FDG-PET to investigate changes concerning the glucose metabolism in the brain with or without cancer pain.


Eligibility Criteria:
Inclusion Criteria:

* cancer patient

Exclusion Criteria:

* no brain metastasis
Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine

The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children in the age group six to eight weeks
* Born after a normal gestational period (36 - 42 weeks)
* Mother's HBsAg assured negative.
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
* Parents willing to fill the Diary Card

Exclusion Criteria:

* Administration of immunoglobulin or any blood products since birth.
* Use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of OPV \& BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.
* Previous vaccination or evidence of infection with DTP.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.
* Major congenital or hereditary immunodeficiency.
* Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination.
* Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction.
* Parent/s or guardian of subject unable to maintain diary card
* Simultaneous participation in any other clinical study
Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth

It is an observational and prospective study that will include consecutively 63 controls (fetuses with estimated fetal weight above the 10th centile) and 63 fetuses with defects in fetal growth (estimated fetal weight below the 10th percentile) during the third trimester (32-26 weeks) with gestational age at birth equal or over 37 weeks. Investigators will collect: (1) Obstetric and nutritional questionnaires, (2) maternal samples between 32-36 weeks (feces), (3) intrapartum samples (maternal blood, cord blood and placenta) and (4) postpartum samples (meconic and newborn feces at 6 weeks of life)

It is an observational and prospective study to determine the influence of the gastrointestinal microbiome on the intrauterine growth restriction (IUGR). For this purpose, investigators are planning to recruit 63 women with a diagnoses of IUGR and 63 pregnant women with a normal intrauterine growth.

Samples will be taken during third trimester (fecal and blood maternal sample), intrapartum (maternal blood, umbilical cord blood and placenta tissue sample) and post partum samples (meconic and newborn fecal samples at 6 weeks of life).

Also, obstetric and nutritional information will be registered by means of specific questionnaires.

Fecal samples will be use to study the gastrointestinal microbiome by Next Generation Sequencing techniques, whereas inflammatory biomarkers will be determine in plasma samples.

Eligibility Criteria:
Inclusion Criteria:

* Intrauterine Growth restriction (32-36 weeks)
* Vaginal delivery
* Delivery at 37 weeks

Exclusion Criteria:

* Alcohol, tabacco or other drugs consumption during pregnancy
* Antibiotic use before recruitment (3 months) or during pregnancy until delivery
* Gestational diabetes
* Fetuses anormalities
Encapsulated Calcium Absorption in Pregnancy

This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka, Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg, 1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and the other with a micronutrient supplement powder containing encapsulated calcium at the same dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium absorption will be measured using the dual stable isotope method. For each test, the formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable isotope will be given orally and a 42Ca-labeled stable isotope dose will be given intravenously. Urine will be collected for 48 hours to measure calcium absorption.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 30 years
* Current residence in Dhaka at a fixed address
* Plan to remain in Dhaka for at least 2 months from date of enrolment
* Gestational age of 27 completed weeks ± 1 week, estimated based on the recalled first day of the last menstrual period (LMP)

Exclusion Criteria:

* Complicated medical or obstetric history, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, multiple gestation, diabetes, renal disease)
* Higher risk pregnancy based on one or more of the following clinical findings at time of recruitment:

  * Severe anemia (hemoglobin \<70 g/L assessed by Hemocue)
  * Proteinuria (≥ 100 mg/dl based on urine dipstick)
  * Glycosuria (≥ 100 mg/dl based on urine dipstick)
  * Hypertension (systolic blood pressure, ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg)
* Reported use of dietary supplements that contain \>500 mg of calcium per day and/or \>400 IU (10 mcg) of vitamin D per day
* Reported use (chewing) of betel leaf, areca nut and lime (together referred to locally as paan) during pregnancy
Electrical Stimulation After Botulinum Toxin Injections to the Upper Extremity

The purpose of this study is to investigate the effectiveness of using electrical stimulation to improve upper extremity function in stroke survivors who receive botulinum toxin injections for spasticity. We hypothesize that individuals who receive the electrical stimulation could demonstrate improved benefit of the botulinum toxin injections and improved functional use of their weaker upper extremity.

This is a pragmatic investigation that will utilize a two group comparison to compare electrical stimulation to a sham stimulation in individuals who are scheduled to receive botulinum toxin injections to their upper extremity for spasticity management. The electrical stimulation will be to the antagonist muscles of the injected muscles of the upper extremity and will be administered for 4 weeks post injections.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke, within first 6 months post stroke, have not previously received botulinum toxin injections for upper extremity spasticity, hemiplegic upper extremtity, able to communicate in English.

Exclusion Criteria:

* contraindication for electrical stimulation (presence of implanted cardiac or other medical device, open wound on the wrist or hand, malignancy), fixed contracture of the elbow, wrist or hand, inability to follow simple directions, pregnancy.
Manchester Lung Health Study

The Manchester Lung Health Study (qUEST) will assess the uptake of a community-based lung cancer screening service and its impact across a deprived area of North and East Manchester, which has high rates of lung cancer. One measure will be to compare the number and stage of lung cancers detected through screening to those detected outside of screening. In addition we will investigate the potential of a blood and nose test to detect lung cancer or to help decide who would benefit from screening. We will also see if these samples can help with the interpretation of CT scans. One of the problems with lung cancer CT screening is that you detect lung nodules in which we are not sure if they are benign or cancerous. Therefore we are also looking to see if a biomarker can help us work out which are cancerous and which are benign.


Eligibility Criteria:
Main data study:

Inclusion Criteria:

- Any individual attending the Manchester Lung Health service who has a lung health check as they meet the service inclusion exclusion criteria (see below):

Manchester Lung Health service inclusion criteria:

* Age 55-80
* Ever smoker
* Registered with a GP in the North or East Manchester area

Manchester Lung Health service exclusion Criteria:

* Lung cancer diagnosis within 5 years
* Listed on a palliative care register
* Chest CT scan within 3 months

Exclusion Criteria:

- Unable to give informed consent to study participation.

Biomarker sub-study:

Inclusion Criteria:

* Any individual attending the M-LHC service who is eligible and agrees to undergo LDCT screening.
* Has consented to the main study.

Exclusion Criteria:

* Unable to give informed consent to study participation
* Decline participation in LDCT lung cancer screening
* Known blood borne virus e.g. HIV or Hepatitis B, C
Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions

The use of an ultrathin bronchoscope (UB) has recently been introduced in the diagnosis of peripheral lung lesions. The use of the UB can be supported by navigation systems such as fluoroscopy, ultrasound guidance, electromagnetic navigation, or other technologies, which have complementary potential. Further navigation techniques are still under study. The use of ultrathin instrumentation has already been shown to significantly reduce procedural times compared to traditional instrumentation.

The purpose of the study is to prospectively evaluate the institutional experience of different third-level hospital centers with the use of a UB (MP190F; Olympus Medical Systems, Tokyo, Japan) for sampling peripheral lung lesions by means of transbronchial needle aspiration (TBNA) or transbronchial biopsy (TBB), performed after fluoroscopic navigation and simultaneous radial probe-endobronchial ultrasound (RP-EBUS) assessment.

Design: multicentric, observational study.


Eligibility Criteria:
Inclusion criteria:

* Candidate for a diagnostic procedure for a new peripheral lung lesion or re-biopsy;
* Tissue sampling of the peripheral lesion performed only with UB;
* The patient's ability to understand the individual characteristics and consequences of the clinical study;
* Males and females of any ethnicity;
* Subjects who have given their informed consent to use their clinical data for research purposes.

Exclusion criteria:

* Inability to give informed consent or understand its contents;
* Unavailability of tomographic imaging;
* Failure to use RP-EBUS or fluoroscopic guidance during the procedure;
* Failure to use R.O.S.E. by the pulmonologist or pathologist during the procedure;
* Tissue sampling on the same peripheral lesion using an instrument of a different caliber in replacement or in association;
* Any other significant illness or disorder that, in the investigator's opinion, may put the patient at risk due to study participation.
Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts

The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following NAC reconstruction surgery with the BioAesthetics' dcl-hNAC graft.


Eligibility Criteria:
Inclusion Criteria:

* Patient age 18-65
* Patient desires NAC grafting ≥3 months after autologous breast reconstruction
* Patient agrees to sleep on back until grafts healed (6 weeks)
* Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until grafts healed (6 weeks)
* Patient agrees to not undergo NAC tattooing until completing study (12 months)
* Patient is able to understand and willing to sign informed consent.

Exclusion Criteria:

* History of delayed wound healing
* history of Vitamin C deficiency
* history of diabetes (Type I or Type II)
* current BMI\<18.5 or \>40 kg/m,
* patient has any other uncontrolled comorbidity.
* Patient has a history of allergic reaction to any decellularized biologic matrix product.
* Patient is currently smoking or using tobacco or nicotine products (i.e. patch, gum, or nasal spray) or has used such products in the past 12 months.
* Patient is currently receiving radiation or chemotherapy or received radiation to the breast wall.
* Patient has a history of prior NAC reconstruction
* Patient has had NAC tattooing.
* Patient is pregnant, breastfeeding or planning to become pregnant during the study period.
Healthy Age-dependent Reference Values for Microvascular Structure and Function

The greatest challenge in our ageing society are cardiovascular diseases such as stroke, heart attack, peripheral artery disease of the legs with non-healing wounds (ulcers), or diabetes. How healthy ageing affects the smallest blood vessels (microcirculation) and is not well understood. One reason for this is that no generally available medical instrument has the resolution to study the microcirculation. The recently developed optical coherence tomography angiography (OCTA), currently mainly used by eye doctors, is able to visualise the microcirculation. We have developed an automated software (OCTAVA) to determine metrics to characterise the microcirculation on the layers of density, diameter and tortuosity.

In the current study we aim at providing reference values of these metrics in hands and feet of healthy people according to age together with macrovascular function in arms and legs.


Eligibility Criteria:
Inclusion criteria:

Healthy, 20-70 years, BMI 20-30 kg/m\^2

Exclusion criteria:

Diabetes mellitus, symptoms of acute infection, cardiac arrhythmias, active malignancy, clinical signs or symptoms of cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease): angina pectoris, dyspnea, palpitation, syncope, claudication, active vasoactive medication.