cyrilzakka/clinical-trials huggingface dataset:
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

The purpose of this study is to determine if abatacept (Orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment with ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall).

This is an open label, active treatment trial to assess the efficacy and safety of abatacept in subject with PBC who have had an incomplete biochemical response to UDCA. In this trial, 20 subjects with PBC who have had an incomplete biochemical response to UDCA will be assigned to treatment with weekly subcutaneous injections of 125 mg of abatacept. The treatment phase of the study will last 24 weeks with an off-treatment follow up at Week 36.

Inclusion criteria include:

* Confirmed diagnosis of PBC
* Alkaline phosphatase \> 1.67 times the upper limit of normal after 6 months of treatment with UDCA

Eligibility Criteria:
Inclusion Criteria:

* Confirmed PBC diagnosis based upon at least 2 of 3 criteria

  1. Anti-mitochondrial antibody (AMA) titer \> 1:40
  2. Alkaline phosphatase \> 1.5 times the upper limit of normal for at least 6 months
  3. Liver biopsy findings consistent with PBC
* Incomplete response to UDCA defined by an alkaline phosphatase \> 1.67 X the upper limit of normal after 6 months of UDCA at a minimum dose of 13 mg/kg/d
* Taking a stable dose of UDCA for at least 3 months prior to Day 0
* aspartate aminotransferase (AST) and alanine aminotransferase ALT \< 5 times the upper limit of normal

Exclusion Criteria:

* Presence of concomitant liver diseases including viral hepatitis, primary sclerosing cholangitis, alcoholic liver disease, Wilson's disease, hemochromatosis, or Gilbert's syndrome.
* Prior liver transplantation
* Decompensated liver disease
* Use of immunosuppressants within 6 months of Day 0
* Use of biologic agents within 12 months of Day 0
Native-RISE (Risk Identification for Suicide and Enhanced Care)

The goal of this research is to test a systems-level suicide prevention strategy, Native-RISE (Risk Identification for Suicide and Enhanced care), that combines predictive analytics and brief contact interventions (BCIs) to reduce suicide in health systems serving Native Americans (NAs). This project aims to prove the effectiveness and scalability of Native-RISE within three Indian Health Service (IHS) health care clinics (Whiteriver, Chinle and Shiprock) already implementing suicide prevention programs and serving the White Mountain Apache Tribe (WMAT) and Navajo Nation (NN).


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-75
* Visit at least one of the three participating IHS clinics
* Identified as at risk of suicide by either an existing method or the new Native-RISE risk model algorithm

Exclusion Criteria:

* None
The Cohort Study of Early Esophageal Cancer or Precancerous Lesions Treated With Endoscopic Resection

Endoscopic Submucosal Dissection (ESD) is currently the main method of treatment of early esophageal cancer and precancerous lesions. Therefore, the investigators are looking forward to conduct a cohort study on early esophageal cancer patients undergoing endoscopic treatment collected from Zhongshan Hospital, Fudan University, comparing the WHO standard with Japanese standard of endoscopic therapy diagnosis. In addition，the investigators will collect patients' detailed informations and analyze the risk factors for metastasis and recurrence of early esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Older than 15-year-old
2. Undergoing endoscopic Submucosal Dissection (ESD) in ZhongShan Hospital

Exclusion Criteria:

Preoperative patients with recurrence and Lost to follow-up of patients within 1 year
Diagnostic Value of Sputum Cytology in Asthma-COPD Overlap

The aim of this study is to evaluate the diagnostic value of sputum cell counts in differentiation between asthma, COPD and ACO.

to examine the relationship between sputum cell counts in bronchial revers¬ibility and bronchial hyperresponsiveness

Asthma and COPD are considered as chronic airway inflammatory diseases, which are typically associated with Th2-mediated immune response in asthma and related to the characteristics of Th1-mediated immunity in COPD . Asthma-COPD overlap (ACO) is the term to describe patients who have features of both asthma and COPD, recom¬mended by the 2019 Global Initiative for Asthma (GINA) and the Global Initiative for Chronic Obstruction Lung Disease (GOLD) guidelines. Patients with asthma and COPD are commonly seen in clinical practice. In addition, compared with patients with asthma or COPD alone, patients with ACO experience frequent exacerbations and hospitalizations, have poor quality of life, a more rapid decline in lung function and high mortality, and consume a disproportionate amount of health care resources than asthma or COPD alone .

Cell count in induced sputum is a noninvasive biomarker to assess airway inflammation phenotypes. Accordingly, sputum cell counts are extensively used in the treatment of asthma and COPD. Nevertheless, the clinical application of sputum cell counts in patients with asthma-COPD overlap (ACO) remains elusive .

Eligibility Criteria:
Inclusion Criteria:

* all patients known to be Asthma, COPD, ACO

Exclusion Criteria:

* Patients will be excluded if they have confounding pulmonary comorbidities, such as pulmonary tuberculosis, interstitial lung disease, lung cancer or pulmonary infection, and had a cognitive impairment that may affect the collaboration or comprehension of the study.
Evaluation of Pain During Hysterosalpingography With The Use Of Balloon Catheter Versus Metal Cannula

The aim of this study is to compare the metal cannula routinely used in our clinical practice with intrauterine hysterosalpingography catheter as a probable alternative device in a prospective, single-blinded, randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18-47 years,
* applying for basic infertility evaluation to the Reproductive Endocrinology unit

Exclusion Criteria:

* The patients with a known hypersensitivity to iodine or radio-opaque contrast dye,
* vaginal bleeding,
* genital malignancy and
* any sign of pelvic inflammatory disease (PID) were excluded
Plasma Volume Determination by 99mTc-labeled Albumin and 125I-labeled Albumin

The purpose of the present study is to compare plasma volume determination by 99mTc-labeled albumin with 125I-labeled albumin. Fifteen subjects will be enrolled. The hypothesis is that plasma volume determined by the different methods are the same.

For many years, radioiodinated albumin has been "the golden standard" for measurement of plasma volume. There are a number of clinical situations in which a nuclide with a shorter half-life would be preferred. Furthermore, due to periodic lapses in the availability in the delivery of 125I-labeled albumin, there is a need to evaluate another nuclide as a tracer for plasma volume determination.

99mTc-labeled albumin is easily prepared by a simple and reproducible method with a high labeling efficiency and short half-life.

In this study, we want to compare plasma volume determined by 99mTc-labeled albumin with plasma volume determined by 125I-albumin (golden standard). In both procedures, plasma volume is estimated from multiple postinjection samples for accurate zero-time extrapolation in order to correct for leakage of labeled albumin from the vascular compartment.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 27 kg/m2
* Written informed consent

Exclusion Criteria:

* Hypertension (140/90 mmHg)
* Diabetes mellitus
* Any use of medication
* Pregnancy
LC-Plasma for Preventing URTIs and Reducing Symptoms

The goal of this study is to evaluate the efficacy of the LC-Plasma in preventing upper respiratory tract infections (URTIs) in healthy volunteers. Researchers will compare LC-Plasma to placebo to see if LC-Plasma prevents URTIs. Participants will take a tablet containing LC-Plasma or placebo daily for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-60 years living in Australia
* Individuals with a history of recurrent upper respiratory tract infections
* Able to provide informed consent
* Generally healthy
* Agree to not participate in another clinical trial while enrolled in this trial
* Agree to maintain their usual daily activities without significant changes. This includes not changing their current diet or stopping/starting a new exercise regimen during entire study period
* Agree not to travel internationally for over 1 month in a single trip during the intervention period (baseline to study completion).
* Females of childbearing potential must a prescribed form of birth control

Exclusion Criteria:

* Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis.
* Unstable illness e.g., changing medication/treatment.
* BMI \<18.5, \>30
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
* Individuals with chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
* Has current symptoms of an acute sickness.
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Current alcohol use (\>14 alcoholic drinks week)
* Allergic to any of the ingredients in the active or placebo formula
* Pregnant or lactating woman
* People medically prescribed medications within the last month that would affect the immune and/or the inflammatory response excluding topical steroid use.
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
* Participants with cognitive damage
* Participants with seasonal allergic rhinitis
* Regular use of antihistamines
* Individuals deemed unsuitable for participation by the Principal Investigator (PI) of this study.
Reliability of Myotonometry in the Assessment of Mechanical Properties of Thenar Muscles

This study aimed to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties.

Investigating the mechanical properties of hand muscles using simple applicable methods such as myotonometer can help to evaluate the effectiveness of programs used in hand rehabilitation, optimize the skills of performance-oriented individuals such as athletes and musicians, and create individualized treatment and training programs. In musculoskeletal-related pathologies such as carpal tunnel syndrome, studying the mechanical properties of the thenar muscles may be important to better understand hand grip strength, hand function and mobility. However, the use of myotonometer in the evaluation of the mechanical properties of the thenar muscles requires a reliability study. Accordingly, the aims of our study are: to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties.

Eligibility Criteria:
Inclusion criteria:

* being between 18 and 35 years of age
* having normal upper extremity function
* having a Montreal Cognitive Assessment Test (MoCA) score \> 26 points

Exclusion criteria:

* any neuromuscular or musculoskeletal disease
* history of upper limb injury
* upper limb surgery within the last 6 months
* body mass index (BMI) \> 30 kg/m2.
Irradiation Modulates the Pharmacokinetics of Anticancer Drugs

Radiation therapy (RT) is used as an effective local treatment modality to inhibit cell proliferation, induce cell death and suppress tumor growth. To improve the treatment outcome, in terms of both locoregional control and survival, the concurrent use of chemotherapy during radiation therapy (CCRT) is now the standard treatment for various malignancies, especially locally advanced cancers. Among the drugs used to enhance RT effect, 5-fluorouracil (5-FU) is one of the most commonly used chemotherapeutic agents of CCRT.

In the past, RT was solely used as a local treatment and its effect was estimated by local effect model. However, growing evidence shows that irradiation has direct DNA damage-dependent effects as well as sending signals to neighboring cells. Recently, we reported that abdominal irradiation could significantly modulate the systemic pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the daily treatment dose for target treatment in an experimental rat model. Additionally, the results from a clinical investigation showed that colorectal cancer patients with lower AUC of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these lines of evidence support the importance and necessity to search for the mediators responsible for the unexpected effect of local RT on systemic pharmacokinetics of chemotherapeutic agents, such as 5-FU.

In the present study, the investigators investigated whether the phenomena and mechanism of RT-PK is a fact for different anticancer drugs in human.


Eligibility Criteria:
Inclusion Criteria:

* World Health Organization (WHO) performance status of 0 or 1
* Age 18-80 years
* Locally advanced rectal cancer
* Locally advanced cervical cancer

Exclusion Criteria:

* Cancer history
* Abnormal liver and renal disease
* Immune disease
* Hematological disease
Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis

To explore effects of Autologous Blood Injection versus Platelet Rich plasma injection for treatment of chronic plantar fasciitis

After clinical diagnosis of patients with plantar fasciitis. Patients were divided into two groups. Group A (PRP injection group) and Group B (ABI group) were randomized according to web based block group randomization. Patients were evaluated prior to injection in terms of Health related quality of life scores related to foot and ankle diseases (AOFAS and FADI) and VAS. After injection at 1st, 3rd and 6th months HRQoL were compared between groups. Intra group evaluation for HRQoL were performed at f/up visits. Independent t test and repeated measure ANOVA test used for statistical analysis

Eligibility Criteria:
Inclusion Criteria:

1. Participants who were diagnosed with chronic plantar fasciitis
2. Nonresponded to o conservative treatment (stretching exercises, nonsteroidal anti-inflammatory drugs, and heel pads) for at least 6 weeks
3. Patient should be able to understand the informed consent about type of treatment and blindness and randomization
4. Visual analog scale pain higher than 5 (on a 10-point visual analog scale)

Exclusion Criteria:

1. previous history of any type of local injection treatment for heel pain
2. history of surgery for heel pain, foot and ankle disorders, fractures
3. Associated pathology involving the lower limb such as

   * tarsal tunnel syndrome
   * effusion of the ankle indicating an intra-articular disease
   * Peroneal/Achilles/tibialis tendons pathology
   * any obvious deformity of foot and ankle,
4. Patients with systemic disorder like diabetes mellitus, ankylosing spondylitis rheumatoid arthritis, hematological disease, or gout
5. Pregnancy
6. Use of antiocoagulation -
The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye

The study aims to investigate whether combined treatment of MGD massage and artificial tears will improve signs and symptoms of dry eye compared to artificial tears alone.

The meibomian glands secrete meibum which is the oily component of the tear film layer. The meibum plays a pivotal role in preventing tear evaporation and smoothening the tears film .

Meibomian gland dysfunction is a common condition that affects 39%-50% of the population. It is part of inflammatory disease of the eyelids called blepharitis. Associated syndromes are rosacea and dry eye syndrome .

Sign and symptoms are: irritation, hyperemia, burning sensation, photophobia, epiphora and blur.

Spectrometry analysis shows change it the fatty acids conformation such as increase in levels of branched-chain fatty acids and decrease in saturated fatty acids .

Subsequently the clotted meibum results in glands blockage that can be graded in 0-4 grade scale: grade 2- meibum secretion thick and oily, grade 3- meibum secretion granular-toothpaste like.

Although MGD is not often accompanied with inflammatory signs it is a common cause for evaporative dry eye.

In order to investigate the relation between meibomian gland massage outcomes and signs and symptoms of dry eye, randomized prospective study will be conducted. Patients, who arrive to Barzilai Medical Center out patients' clinic, are diagnosed with MGD 2-3 and signed informed consent form shall be included in the trial, then randomized to study group or control group.

The study group will receive meibomian glands massage and artificial drops PRN, whereas the control group will receive sham massage and artificial drops. Each visit at the clinic will include dry examinations and questionnaire.

Follow up examination are due after one week, monthly visits up to 4 months, then after half year, 8 months and one year.

Statistical methods: in order to evaluate to treatment effect T-Test analysis will be calculated, significant result is when P\<0.05.

Data will be recorded into to electronic sheets. Subjects' confidentiality will be assured by masking any identifying details and a random number will be assigned prior results analysis stage

Eligibility Criteria:
Inclusion Criteria:

* Adult Individuals (age≥18Y) with MGD levels 2-3 that are capable to make an informed decision about their participation in the trial.

Exclusion Criteria:

* pregnant women, subjects who received prior Meibomian gland massage.
Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants

A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine \[BRV-TV\] administered to healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants 6-8 weeks of age of either sex;
* Born after a gestational period of 36-42 weeks with birth weight \>2 kg;
* Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF);
* Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.

Exclusion Criteria:

* History of congenital abdominal disorders, intussusception, or abdominal surgery;
* Known or suspected impairment of immunological function;
* Known hypersensitivity to any component of the rotavirus vaccine;
* Prior receipt of any rotavirus vaccine;
* Fever, with an oral temperature ≥38.1oC (≥100.5oF); presumably measured by study staff?
* History of known rotavirus disease, chronic diarrhea, or failure to thrive;
* Baseline level of ALT or AST \>2.5 times the upper limit of normal;
* Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
* Receipt of any IM, oral, or IV corticosteroid treatment (infants on inhaled steroids may be permitted to participate in the study);
* Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids);
* Infants testing positive for HBV, HCV, or HIV infection;
* Prior receipt of a blood transfusion or blood products, including immunoglobulins;
* Any infants who can not be adequately followed for safety by telephone and/or a home visit;
* Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotavirus (RV) Vaccination

This study aims to estimate the clinical and cost impact of RV vaccinations (both Rotateq® and Rotarix®) among children aged less than 5 years using insurance claims data from commercial plans and Medicaid low-income population. The impact of incomplete and complete RV vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8 months, 8 months and onwards ) and calendar time of RV vaccination (e.g., 2006 onward).

Insurance claims data from the MarketScan Commercial Claims and Encounters Database {MarketScan Commercial (2000-2011\[Q2\])} and the MarketScan Multi-State Medicaid Database {Marketscan Medicaid (2002-2010)} will be analyzed separately; no merging of the databases will occur.

The claims data extracts are fully de-identified and compliant with the Health Insurance Portability and Accountability Act of 1996 (U.S.) (HIPAA).

For children who received at least 1 RV vaccine dose within the Advisory Committee on Immunization Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old, their observation time will be divided into three RV-vaccinated cohorts: any RV vaccination before 8 months (i.e., during the vaccination window between 6 weeks and 8 months old); complete RV vaccination (i.e., after 8 months old); and incomplete RV vaccination (i.e., after 8 months old). For children who did not receive any RV vaccine dose within the vaccination window, their observation time will be divided into four control cohorts: historical (i.e., before RV vaccines were available) unvaccinated on/before 8 months old; contemporary (i.e., after RV vaccines were available) unvaccinated on/before 8 months old; historical unvaccinated after 8 months old; and contemporary unvaccinated after 8 months old.

Eligibility Criteria:
Inclusion Criteria:

* Continuously enrolled from birth. (Note: Due to the absence of birth dates in insurance claims data, this inclusion criterion will be met if a child's year of first enrollment and year of birth are the same. If so, then the date of first enrollment will be used as proxy for date of birth.)
* Received both medical and pharmacy benefits.

Exclusion Criteria:

* Enrolled in capitation-based health plans.
* For MarketScan Commercial, residence in states with universal vaccination programs that include the RV vaccine or where RV vaccine inclusion cannot be ascertained (i.e., Alaska, Idaho, Massachusetts, Maine, North Dakota, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming).
* Lost to follow-up or had RV prior to 6 weeks of age.