cyrilzakka/clinical-trials huggingface dataset:
A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related

This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
* Subjects with HCC who have received standard systemic therapies
* HLA-A \*02
* BCLC stage B or C
* Child-pugh score ≤ 7 ol
* Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml
* Have at least one measurable leasion at baseline as per mRECIST and iRECIST
* Life expectancy of 3 months or greater
* The organ function is in good condition.

Exclusion Criteria:

* Subjects with history of another primary cancer within 5 years
* Central nervous system metastasis and clinically significant central nervous system disease
* Previous or current coexistence of hepatic encephalopathy
* Currently present with symptomatic third space fluid accumulation
* Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)
* Known history of neurological or mental disorder, including epilepsy or dementia
* Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis
* Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy
* Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection
* Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia

This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18 years and older
* Fulfilled eligibility criteria in CHTF919 D2302 (double blind study) and successfully completed the double-blind study

Exclusion Criteria:

- Early discontinuation from the double-blind study

Other protocol-defined inclusion/exclusion criteria may apply.
Oral Health Educational Program for Knowledge,Attitude,Practice of Oral Health Among Agroup of Egyptian School Girls

This study will demonstrate oral health educational program to egyptian school girls age from 12-14 years old to evaluate the change in the knowledge, attitude and practice of oral health

According to World Dental Federation 2017 oral health is defined as multi-faceted and include the ability to speak, smile, smell, taste, chew, swallow, and convey a range of emotions through facial expressions with confidence and without pain, discomfort, and disease of the craniofacial complex .Oral disease constitute a significant public health problem in developing countries due to their high prevalence, economic consequence and negative impact on the quality of the life of affected individual.

Estrogen cause change in the blood vessels and progesterone stimulate the production of inflammatory mediators which lead to increase of gingival inflammation appear as gingival enlargement, increase in gingival bleeding and crevicular fluid flow and microbial changes.

The oral health education is important tool to make the primary level of prevention. So the benefits from health education is to improve knowledge and awareness of children which results on developing favorable oral behavior and so favorable oral health status.

.As the school is consider a place for gathering large number of children so it is ideal place for conducing successful health education.

this study will Identify baseline oral hygiene knowledge, attitude and practice among 12-14 years old school children. then Record oral hygiene status by oral hygiene index simplified after that assess the effectiveness of oral health education in modifying oral health knowledge, attitude and practice

Eligibility Criteria:
Inclusion Criteria:

* girls age 12 - 14 years old

Exclusion Criteria:

* refusal to participate in the research
Trial of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Cancer

This trial is going to evaluate the efficacy and safety of IMRT / nab-TP chemotherapy for unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy regimen for local advanced and unresectable esophageal cancer patients.

Esophageal carcinoma is the sixth leading cause of cancer-related mortality from cancer with 407000 deaths and the eighth most common cancer worldwide. Concurrent chemoradiotherapy remains the mainstay of treatment for locally advanced esophageal cancer. Paclitaxel combined with radiotherapy was high efficiency and achieved encouraging results. Compared with paclitaxel, nab-paclitaxel has a low toxicity, low allergy and the tolerance is better than paclitaxel. According to the pre-clinical results, investigators designed a prospective study, which is combined nab-paclitaxel and cisplatin with concurrent chemoradiotherapy for the patients with locally advanced esophageal cancer, and evaluated the tolerability and efficacy. we design enrolled 30 patients, the end point included toxicity, progression-free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

1. inoperable locally advanced histologically confirmed esophageal cancer (T3N0M0-TxNxM1a（AJCC 2002)
2. ECOG performance status scale 0-1
3. at least 1 measurable target lesions
4. white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level \< 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and
5. normal cardiac function with no severe heart disease.

Exclusion Criteria:

1. history of esophagectomy
2. pregnancy or breast feeding
3. past history of other cancers except for cured non-melanoma skin cancer or cervical cancer;
4. concomitant treatment with other anticancer drugs.
IPTi in Mozambican Infants for Malaria Prevention

To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP \[Fansidar\] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age

The study is a randomised, double blind, placebo-controlled trial of the antimalarial drug sulphadoxine-pyrimethamine administered intermittently at 3, 4 and 9 months of age through the EPI scheme at the time of routine immunisations.

Children will be randomized into placebo and SP treatment groups by block randomization, and it is expected a similar age distribution and a similar number of children in each group.

Doses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (SP) or placebo will be given by a health assistant according to bodyweight (a quarter of a tablet for those \<5kg, a half for those 5-10 kg, and a whole tablet for children \>10 kg). The tablets will be crashed and diluted with water for their administration.

Eligibility Criteria:
Inclusion Criteria:

* Children from study area
* Signed informed consent

Exclusion Criteria:

* History of drug allergies
Pharmacogenomics of Anti-TNF (Anti-tumor Necrosis Factor) Treatment in Patients With Rheumatoid Arthritis

The main aim of this study is to identify genetic markers (at DNA and RNA level) which are involved in the response to treatment with monoclonal antibodies against TNF in patients with rheumatoid arthritis.

Rheumatoid Arthritis (RA) is a severe inflammatory disease and genetic factors are known to play an important role in its pathogenesis. Genetic factors are also involved in determining the prognosis of RA. Identifying the genetic factors that predispose to mild or aggressive RA is not easy and up to now only a few of these factors -like certain HLA-DR species- are known.

The Rheumatology department of the Radboud University Nijmegen Medical Centre (RUNMC) has collected a unique inception cohort of over 500 patients with RA, that have been followed from an early stage of disease for up to 10 years with detailed measurements of disease activity, joint damage and other characteristics of disease progression.

In this project we use this patient group to study polymorphisms in a large battery of genes for their effect on RA disease activity/progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.

Exclusion Criteria:
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia

The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.


Eligibility Criteria:
Inclusion Criteria:

* Low to highly exuding chronic wound(wound history \> 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer
* Male of female, 18 years and above
* Signed Informed Consent Form

Exclusion Criteria:

* Pregnancy or lactation
* Wound size not suitable for the wound dressing size
* Known allergy/hypersensitivity to any of the components in the dressing
Whether Using Sequential pH Would Improve Human Blastocyst Formation

Any drift in extracellular pH (pHe) from the intercellular pH (pHi) could alter the mechanism regulating transporters and exchangers through the plasma membrane. This could lead to difficulty in restoring the physiological level of pHi. The critical stages that lack robust mechanism of regulating the pHi are the denuded oocyte, early stage of fertilization or a thawed embryo. This, in turn, could lead to a significant effect of the perturbations on embryo development. Convincing evidence regarding the optimal pHe for culturing human embryo is, so far, scanty and mostly anecdotal. The embryo has been reported to have a compensatory mechanism to grow at pHe between 7.0-7.4. Others have recommended that embryo need a sequential pH to viably grow suggesting that the post-genomic activation stage needs a slightly alkaline range of pH. However, whether this holds true remains to be examined.


Eligibility Criteria:
Inclusion Criteria:

* ICSI cycles

Exclusion Criteria:

* No exclusion
Long-Term Follow Up Study for AMD3100 Patients

Objectives:

The objective of this long-term observational study is to assess progression-free survival and overall survival for a period of five years following the first dose of study treatment (placebo or plerixafor \[AMD3100\]) in protocol AMD3100-3102. Patients that received at least 1 dose of study treatment (placebo or plerixafor) in the multicenter, randomized, double-blind, placebo-controlled AMD3100-3102 study, which was designed to evaluate plerixafor plus granulocyte colony stimulating factor (G-CSF) versus placebo plus G-CSF to mobilize hematopoietic stem cells for autologous transplantation of Multiple Myeloma (MM) patients are eligible.

Informed Consent Process:

Your study doctor or staff will either meet with you in person or contact you by phone to review the study information. You will be given a copy of this consent form to review and ask questions.

If you agree to take part in this study, you should sign this consent form on the date that you agree to be in the study. If you agree to take part during a phone call with a member of the study team, you should sign and date the form right away, on the date of the phone call, and mail the form to the study doctor or staff. Please keep a copy for your own reference.

5-Year Follow-Up: You will be contacted by phone or in person at a visit, every 6 months for 5 years from the time of your first study drug/placebo dose in the 2004-0982 study. A placebo is a substance that looks like the study drug but has no active ingredients.

If you received a transplant in the 2004-0982 study, your first contact in this study will either be about 18 months from the time you began the 2004-0982 study, or at the time you sign this consent form.

If you did not receive a transplant, your first contact in this study will be at the time you sign this consent form.

At your first visit or call, you will be asked about the status of the disease, any changes in the multiple myeloma that may have occurred since the 2004-0982 study, and any additional treatments you may have received during that time.

At every visit or call after that, you will be asked about the status of the multiple myeloma, any changes in the disease, and any treatments you have received since the last visit or call. These questionnaires will take about 10 minutes each time.

Your doctor or the study staff also may contact your local doctor in order to collect information from your medical records or for information about your medical history and disease status.

Length of Study Participation:

You will be off study after your last study phone call or visit (about 5 years after your first study drug/placebo dose in the 2004-0982 study).

This is an investigational study. Up to 300 patients will participate in this multi-center study. Up to 12 will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

* 1) All patients who received the study drug (placebo or plerixafor) on protocol AMD3100-3102 (2004-0982)

Exclusion Criteria: None
Circumcision and Breastfeeding

1) To determine when the majority of male infants are being circumcised at 3 hospitals across the US (Brooke Army Medical Center, Naval Medical Center San Diego, and Dartmouth Hitchcock Medical Center. 2) To assess the breastfeeding patterns of circumcised male infants at the above-mentioned academic medical centers. Specifically, to determine if these babies are breastfeeding at the time of hospital discharge, at their newborn visit, their 2-week visit, and all subsequent well visits up until 6 months of age.

3) To determine if there is a significant relationship between the timing of newborn circumcision and breastfeeding initiation, establishment, and maintenance in the first 6 months of life. We hypothesize that the timing of circumcision will not be significantly associated with frequency of breastfeeding among mother-infant dyads during the initial months of life.


Eligibility Criteria:
Inclusion Criteria:

* All male infants born at the 3 participating sites

Exclusion Criteria:

* Gestational age \<38 weeks, twin/multiple deliveries, NICU admission, mothers who are strictly formula feeding their newborns from the time of delivery, and mothers under 18 years of age.
Using Bluetooth Home Blood Pressure Monitors With Pharmacist Interventions

Family Medicine patients with uncontrolled hypertension will be given a Bluetooth enabled home blood pressure machine to monitor their blood pressure every day for 6 weeks. The blood pressure results will be sent automatically to the patient's electronic medical record via applications on their iPhone. Study pharmacists will follow-up with the patients once per week via a telehealth appointment using the app VSee, where the blood pressure results will be reviewed. The pharmacists will also counsel the patients on lifestyle modifications in order to improve blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* must be at least 18 years old
* have a smartphone compatible with the mobile intervention (iPhone)
* have been previously diagnosed with hypertension
* have uncontrolled hypertension (SBP \> 130 mmHg and/or DBP \> 80 mmHg)
* be under the care of a primary care physician in the Family Medicine Department of the USF Morsani Center for Advanced Care
* have had at least one prescription filled at Pharmacy Plus within the last six months
* speaks English fluently

Exclusion Criteria:

* already under the care of a clinical pharmacist in the Family Medicine department
* pregnant
* have a serious existing medical condition(s) that may affect their ability to self-monitor their blood pressure (for example, stroke, dementia)
Study in Polish Acromegalic Patients Treated With Somatuline Autogel

The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg
* Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available

Exclusion Criteria:

* Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria
CGM Use in Islet Transplant Recipients

A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.

Subjects who have an Islet Transplantation may have several outcomes including time when insulin is not required followed in some cases by additional insulin for glucose control as patients get further away from transplantation. It is unclear what role automated insulin delivery systems will have in addressing glucose variability in this group of patients who may have some amount of islet function. As a precursor to understanding ways in which automated insulin delivery systems may need to be adapted, we propose to gather data on glucose variability and insulin regimens in individuals who have undergone an islet transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus
* Recipient of Islet Transplantation
* Age 18 or older
* Females, not currently know to be pregnant
* Demonstration of proper mental status and cognition for the study
* Understanding and willingness to follow the protocol and informed consent form
* Access to the internet and willingness to upload data during the study, including use of personal laptop

Exclusion Criteria:

* Pregnancy and intent to become pregnant during trial
* Use of acetaminophen (such as Tylenol)
* Current enrollment in another intervention clinical trial that affects glucose variability
GraviD-child Follow-up of the Children´s Health, Growth and Development Within the GraviD-study

GraviD is a multi-ethnic population-based pregnancy cohort. Pregnant women were invited to participate in the GraviD study when registering for antenatal care in parts of the region of Västra Götaland in Sweden in 2013-2014. All women registering for antenatal care were eligible for inclusion, as long as the pregnancy had not exceeded 16 gestational weeks. In total, 2125 pregnant women were recruited in gestational week 12 during two time-periods; fall 2013 and spring 2014. Blood sampling was performed in gestational week \<17 and again at gestational week \>31 by midwifes. After delivery, the maternity records were obtained, to collect information on child's gender, birth weight and length and other possible birth outcomes.

In the GraviD-child study, all healthy singleton children born within the GraviD study will be invited to participate in a single clinical follow up. The follow-up will be conducted when all children are between 7-8 years of age. The study centre is located at the Queen Silvia Children´s hospital in Gothenburg, Sweden. The follow up consist of several parts:

1. Measurement of body weight and height, and waist circumference.
2. A questionnaire regarding health, physical activity, sleeping habits and diet.
3. Endothelial function, a measure of how well the blood vessels dilute.
4. Ultra sound of the thickness of the vessels on the neck, wrist and foot
5. Pulse wave velocity, to measure the elasticity of the vessels on the neck and groin.
6. Body composition using bioelectrical impedance.
7. Blood pressure
8. A venous blood sample of maximum 18 ml will be drawn to analyze markers of cardiovascular health. Blood lipids (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol), lipoprotein A, apolipoproteins (Apo A1 and Apo B), liver enzymes, glucose, insulin, HbA1c, c-reactive protein, leptin, adiponectin, nutritional biomarkers (such as 25-hydroxyvitamin D) will be analyzed.

The study hypothesis is that a low maternal vitamin D status increase the risk of an unfavorable child cardiometabolic risk profile, vascular health and body composition.

Recruitment start in January 2022 and will run for about a year.

Eligibility Criteria:
Inclusion Criteria:

* Born within the GraviD study
* Healthy
* Singleton

Exclusion Criteria:

* Chromosomal abnormality
* Hyper-/Hypothyroidism