cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer

IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic, refractory or recurrent disease of advanced adenocarcinoma of the stomach or the lower esophagus proven by histology
* CLDN18.2 expression of the biopsy material from the cancer confirmed by immunohistochemistry
* At least 1 measurable site of disease according to RECIST criteria

Exclusion Criteria:

* Less than 3 weeks since prior chemo-or radiation therapy
* Other concurrent anticancer therapies
* Concurrent anticoagulation with vitamin K antagonists
* Therapeutic doses of Heparin (prophylactic doses accepted)
* Uncontrolled or severe illness
Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC).

The objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.

We want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia.

Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after the birth.

Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.

Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate.

The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event.

The study will last 3 years. The number of patient to include is 280.


Eligibility Criteria:
Inclusion Criteria:

* pregnant patients aged more than 18 years and more than 12 weeks of gestation for FD group, 20 weeks of gestation for PE or IUGR group , presenting either:
* PE (arterial pressure more than 140 mm Hg and 90 mm Hg) and at least a proteinuria evaluated on stick (one point) or 300 mg/24h.
* IUGR with biometries below 5° percentile according to the graphs of fetal echography college after 20 weeks of gestation.
* FD after 12 weeks of gestation or with a cranio-caudal length of more than 45 mm.
* Normal pregnancy adjusted for gestational age and parity : Patient should have no cardio-vascular past with a normal complication at the inclusion time and from which pregnancy remains uneventful until the term. The onset of premature delivery, hypertension or fetal growth restriction will exclude patients from the control group.
* social security cover
* written informed consent

Exclusion Criteria:

* Foetal malformation
* APLS known
* Set back of patient consent
Expanding Exercise Programming for Veterans Through Telehealth

The goal of this study is to evaluate the acceptability and feasibility of a group telehealth exercise program for Veterans with lower extremity osteoarthritis (OA). Methods: This is a randomized pilot trial where Veterans (n=50) receive a group telehealth exercise program (3 months), followed by an exercise maintenance phase (6 months) that includes either text messaging alone or text messaging plus group telehealth exercise booster sessions. The primary outcomes for this study are feasibility and acceptability of the intervention. Feasibility will be assessed through number and source of referrals, recruitment, and retention. Acceptability will be assessed through surveys and interviews for participants and providers addressing reasons for participation, satisfaction, perceived appropriateness, and overall experience containing Likert scales and both yes/no and open-ended questions. Exploratory outcomes, assessed at multiple time points during the course of the study, will measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and changes in performance measure and physical activity assessed remotely through individual telehealth sessions. Data will be collected at baseline, 3-, 6-, and 9-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of symptomatic knee or hip OA
* Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year
* physically inactive (add definition)

Exclusion Criteria:

* No telephone access
* hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months
* recent hospitalization for cardiovascular/cerebrovascular event
* serious mental health condition or behavioral issues precluding participating in group exercise
* terminal illness
* motor neuron diseases
* severely impaired hearing, vision, or speech
* non-English speaking
* current participation in another OA or exercise intervention or lifestyle change study
* other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study
* no primary care physician visit in past 12 months
* pregnant women
* insufficient internet connectivity to participate in group telehealth
Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma

This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DLBCL.
* Received at least one combination chemotherapy regimen with rituximab, such as R-CHOP, R-ESHAP or equivalent.
* Progression or relapse since most recent therapy.
* At least one measurable lesion that is both greater than or equal to 2 cm by conventional CT or greater than or equal to 1.5 cm by spiral CT.

Exclusion Criteria:

* Previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or central nervous system lymphoma.
* Primary refractory disease.
* Received an allogenic stem cell transplant.
Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)

The aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma at high risk of relapse and to compare them with the survival times and relapse rates in previous studies (historical control).

Observational study to evaluate the tolerability and efficacy (vs historical controls) of a high-dose therapy scheme with interferon-α-2b (IntronA®):

Adjuvant treatment with interferon-α-2 has been demonstrated in a number of studies to have an antiproliferative effect on malignant melanoma. In these cases a response rate of up to 20% could be achieved with a dose of 10 million IU or more 3x/week or daily. Kirkwood et al. showed in a study carried out in ECOG (the Eastern Cooperative Oncology Group, study no. 1684) that there was a clear and significant survival advantage versus the observation group with the following dose:

20 mio IU/m² interferon-α-2b (IntronA®) 5x/week iv over the course of one month followed by 11 months with 10 mio IU/m² 3x/week sc.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants
* Age 18-70 years
* Malignant melanoma stage II or III (\>/= 1.5 mm tumor thickness, no distant metastases or Malignant melanoma with lymph node metastases or Lymph node metastases with unknown primary tumor
* An excision border of at least 2 cm around the primary tumor
* Therapy must start within 12 weeks after surgery of the tumor/of the lymph node metastases
* ECOG status 0-1 (= Karnofsky Index \>/= 80)
* Laboratory parameters

  * Hematocrit \>= 33%
  * Leukocytes \>= 3000/μl
  * Thrombocytes \>= 100000/μl
  * Alanine aminotransferase(ALT) \<= 2x normal values
  * Bilirubin \<= 2x normal values

Exclusion Criteria:

* Known allergy to one of the medications or any of its component parts
* Refusal on the part of participants capable of childbearing to use a reliable contraceptive
* Lactating mothers
* Presence of distant metastases
* Another primary tumor of different histological origin than corresponding to the indication (except when the relapse-free interval is \> 5 years, or the tumor is a cervical carcinoma in situ, a basal cell carcinoma or cutaneous squamous cell carcinoma)
* Participants on corticosteroid treatment or treatment with an immunomodulating substance
* Preexisting psychiatric illness, particularly serious depression
* Prior adjuvant radio-, chemo-, or immuno-therapy
* Treatment with an investigational drug within the prior 30 days
* Participant history that includes cardiac arrhythmia, cardiac insufficiency requiring treatment, or anthracycline administration
* Myocardial infarction within the prior year
* An unstable medical condition (apart from the indication) that in the judgment of the investigating physician excludes the participants from the study
* Psoriasis (a relative exclusion criterion, since interferon can aggravate psoriasis; decision to be based on risk/benefit analysis)
Impact of Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used web-based instructions at St. Paul's Hospital.

Colorectal cancer (CRC) is a relatively common and life threatening condition that affect one in thirteen individuals in their lifetime. Colonoscopy is the most used procedure to allow gastroenterologist to identify colorectal malignancies or precancerous lesions at an earlier stage, which affords a greater chance for cure. However, low bowel cleanliness hinders polyp detection rates and therefore colonoscopy effectiveness. In the past, the majority of the studies have focused on pharmacological factors to optimize bowel preparation quality. Recently, the non-pharmacological factors have been found to have significant increases in bowel preparation quality. The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used web-based instructions at St. Paul's Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a colonoscopy as outpatients

Exclusion Criteria:

* Unable to speak English
* Unwilling to participate in reading online materials
The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients

Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo, fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast media, local anesthetics or analgesics. In addition, there is increased osteoporosis in mastocytosis patients due to the activity of mast cell mediators on osteoblasts and osteoclasts. Symptoms of mastocytosis respond poorly to treatment with antihistamines or other antiallergic drugs. There is currently no specific treatment for this disease with the exception of rare cases. There are, however, some case reports suggesting that omalizumab might decrease symptoms including hypotensive events.

The aim of the study is to investigate whether patients suffering from mastocytosis benefit from a 6 month course of omalizumab with regard to symptoms and quality of life and whether the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the efficacy of omalizumab in patients with mastocytosis.

* Trial with medicinal product

The study will take place as double-blind placebo controlled study. After a first a run-period of 2 months for all participants randomization (1:1) in two group will take place:

Group A: With omalizumab treatment for 6 months; dosage and administration schedule according to body weight and total IgE level (1/2 of the patients). Group B: Placebo (1/2 of the patients). After 4 months of treatment in both groups patients are encouraged to stop all drugs given to reduce mast cell related effects, mainly antihistaminics . In case that disturbing symptoms are reoccurring patients are allowed to restart these drugs. The evaluation will take place after 5 months of treatment.

Finally, a follow up visit 1 and 4 months after the study will take place.

Eligibility Criteria:
Inclusion criteria:

* Histological proven mastocytosis (cutaneous or systemic);
* Diagnosis made by one marrow unction and/or skin biopsy or other histological work up;
* Age: 18-70 years

Exclusion criteria

* Age \<18 years;
* Known hypersensitivity to omalizumab or any of its components;
* History of cancer in previous 5 years;
* Patients with serious infections;
* Patients with active tuberculosis or undergoing anti-TB therapy;
* Patients currently treated with systemic immunosuppressive agents;
* Female patients who are pregnant or breast feeding;Contraception must be performed by a save reliable and accept method such as oral or implanted contraceptives, intravaginal or male preservatives or permanent methods such as tubal ligation.
* Patients with known positivity for human immunodeficiency virus (HIV). HIV screening will be performed by an HIV 1/2 Antibody-detection test.

Note: Specific immunotherapy for insect sting allergy is no exclusion criteria.
Does Social Media Impact Adolescent Mental Health?

The mental health of adolescents in the United States has seen a steep decline since 2011, roughly coinciding with the increasing popularity of social media and smartphones. But does social media have a causal impact on the mental health of adolescents or are concerns about the effect of social media on kids a form of public hysteria? In this study, the investigators will conduct the first field experiment in 11-14-year-olds to examine whether, how, and for whom social media harms mental health.


Eligibility Criteria:
Inclusion Criteria:

1. is an adolescent who is between the ages of 10 and 14;
2. is an adolescent whose parents have decided to buy them their first smartphone;
3. is an adolescent both of whose parents/guardians consent for them to be in the study;
4. is an adolescent who assents to be in the study; 5) is an adolescent who speaks and reads English sufficiently to complete surveys and provide informed consent.

Exclusion Criteria:

1. is an adolescent who has severe developmental problems (e.g., autism, severe language delay);
2. is an adolescent who is currently or has ever been diagnosed with severe or moderately severe mental illness;
3. is an adolescent who is currently or has ever experienced suicidal ideation.
Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome

The purpose of this study was to determine the effects of Aliskiren on insulin resistance (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic syndrome. The efficacy of Aliskiren was compared to Amlodipine.


Eligibility Criteria:
Inclusion criteria:

* Male or female adults aged 18 to 55 years, inclusive.
* Sitting diastolic blood pressure ≥80 mm Hg and/or sitting systolic blood pressure ≥ 130 at screening.
* Metabolic Syndrome as defined by the Adult Treatment Panel (ATP) III criteria.
* Hypertension (defined above) and impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) plus one or more out of the remaining 3 criteria to satisfy entry into the study. IGT and IFG will be classified according to American Diabetes Association (ADA) guidelines:

  * IFG: Fasting plasma glucose of 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l)
  * IGT: Two-hour plasma glucose of 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l)
* Abnormal Positron Emission Tomography (PET) results at baseline. (Myocardial Blood Flow (MBF) of less than or equal to 35%.)
* Abnormal euglycemic clamp results at baseline. (Glucose infusion rate (GINF) of less than or equal to 4.2 mg/kg/min.)
* Body mass index (BMI) of less than 40.

Exclusion criteria:

* Smokers (use of tobacco products in the recent past)
* Cardiovascular abnormalities including myocardial infarction, angina pectoris, hypertensive encephalopathy, stroke, transient ischemic attack, valvular heart disease, ventricular arrhythmia, A-V block, atrial fibrillation or cardiac revascularization/angioplasty in the past 12 months.
* Symptoms or clinical evidence of congestive heart failure or known left ventricular ejection fraction \< 40%.
* Supine Blood pressure ≥ 160 mmHg systolic or ≥110 mmHg diastolic.
* Clinically significant echocardiogram (ECG) abnormalities, including history of a prolonged QT-interval syndrome.
* Significant autonomic dysfunction.
* Severe bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* Clinically significant drug allergy, atopic allergy (asthma, urticaria, eczematous dermatitis).
* Pregnant or breastfeeding females. Pre-menopausal females who are not practicing a non-hormonal method of birth control.
* African Americans will not be eligible for this study.

Other protocol-defined inclusion/exclusion criteria may apply.
Effectiveness of Phototherapy With and Without Probiotics

Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The standard treatment for neonatal jaundice is phototherapy but probiotics along with it can reduce the duration of phototherapy and hospitalization stay, secondarily can reduce the risk of nosocomial infection.

Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The comparative analytical study was conducted after the ethical approval for one year (Jan 2022-Jan 2023) in the neonatal unit of The University of Lahore Teaching Hospital, Lahore, Pakistan. 76 preterm neonates fulfilling the selection criteria were included in the study and divided into two groups.

Standard phototherapy was applied in both groups and group A probiotic (Saccharomyces boulardii) 125mg, twice daily, orally (in 5cc of milk whichever the baby was taking) was given till discharge from the hospital. The primary outcome measurements were the duration of phototherapy and the length of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* All the Neonates with indirect hyperbilirubinemia,
* Born at ;37 weeks of gestation
* Both male and female neonates were included in the study

Exclusion Criteria:

* Neonates with sepsis,
* bilirubin level in exchange transfusion range
* direct hyperbilirubinemia
* Neonates with respiratory distress syndrome, severe birth asphyxia, intubated and critically sick
Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver

Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (Food and Drug Administration \[FDA\] approved) agents fails in most cases. Recently conducted clinical studies indicate that patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a safe, effective and ethical manner.

Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (FDA approved) agents fails in most cases. Recently conducted clinical studies indicate that patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a safe, effective and ethical manner.

Eligibility Criteria:
Inclusion Criteria:

* Veno-occlusive disease of the liver
A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Persistence of antibody response at 5 years after one dose of MenACWY or Menomune

Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
* Female subjects were to be negative for pregnancy

Exclusion Criteria:

* History of meningococcal disease
* Receipt of any meningococcal vaccine outside of parent study (V59P6)
* Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
* receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
* any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study
An Outcomes Study to Determine the Reasons Patients on Biologic Therapy Discontinue Treatment and Fail to Follow-up With Their Providers

Patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider.

Retrospective chart review and patient interviews to evaluate the reason patients discontinue biologic therapy and/or fail to follow up with provider. This research intends to improve the continuity of care by determining why patients stop therapy and what can be done to improve their experience with the provider, pharmaceutical companies and specialty pharmacies.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults ≥ 18 years of age.
* Was receiving first or second biologic therapy
* Has not had a follow up with treating physician in ≥ 9 months

Exclusion Criteria:

* Actively receiving biologic therapy

  * Was not receiving first or second biologic therapy