cyrilzakka/clinical-trials huggingface dataset:
Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer

This study proposes to determine the safety and tolerability of 2nd generation designer T cells in patients with gastric cancer.Designer T cells are prepared by removing white blood cells from the participant, and then modifying these cells so that they recognize tumor antigen(CEA). These modified cells are then re infused back into the participant so that they can attack and kill tumor cells.Eligibility for this study is diagnosis of carcinoma of the stomach with failure to respond to standard curative therapy. Tumors must express CEA as demonstrated by elevated serum CEA \>10ng/ml and be measurable radiologically or by physical exam.

T cells can penetrate virtually every biologic space and have the power to dispose of normal or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous remissions of cancer. However, T cells are easily tolerized to self or tumor antigens and "immune surveil¬lance" has manifestly failed in every cancer that is clinically apparent. It is the goal of this study to supply the specificities and affinities to patient T cells without regard for their "endogenous" T cell receptor repertoire, directed by antibody-defined recognition to kill malignant cells based on their expression of antigen. We will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors to yield "designer T cells" from normal patient cells. Prior studies in model systems demonstrated that recombinant IgCD28TCR could direct modified T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and cytotoxicity, the hallmarks of an effective, self-sustaining immune response. It therefore becomes of paramount interest to extend these studies to a human system of widespread clinical relevance to explore the clinical potential of this new technology. The target antigen for these studies is carcinoembryonic antigen (CEA), which is prominently expressed on tumors of the stomach, colon and rectum, breast, pancreas and other sites.

Eligibility Criteria:
Inclusion Criteria:

* CEA expressing Gastric Cancer/GE Junction (\>10ng/ml)
* Must have measurable disease radiologically or by physical exam
* Must have failed potentially curative standard therapy
* Must be 18 years of age or older
* No serious concomitant disease

Exclusion Criteria:

* Prior investigational treatment
* Requiring systemic steroids
* Serious medical conditions
* Concurrent malignancies
Efficacy and Safety of UGN-101 in Recurrent Patients

This trial is designed to evaluate the efficacy and safety of UGN-101 administered to the upper urinary tract (UUT) in patients who were treated in Trial TC-UT-03, found to be a complete response (CR) at the Primary Disease Evaluation (PDE) 1 Visit and are subsequently found to have a documented recurrence of low grade (LG) upper tract urothelial carcinoma (UTUC) at follow up (FU).

This is an open-label, single-arm, Phase 3b multicenter extension trial, designed to evaluate the efficacy and safety of UGN-101 administered to the UUT in patients who were treated in Trial TC-UT-03, found to be a CR at the PDE 1 Visit, and are subsequently found to have a documented recurrence of LG UTUC at FU.

Upon signing of informed consent, the patients will undergo their routine ureteroscopy to assess durability. A biopsy will be performed at Visit 0, if appropriate, to confirm evidence of tumor. If a high grade (HG) UTUC is confirmed by biopsy and/or cytology, the patient will be excluded from the retreatment trial. Eligible patients with confirmed LG non-invasive UTUC will be treated with 3 to 6 once-weekly instillations of UGN-101 in a retrograde fashion, per investigator's discretion.

Five weeks (± 1 week) following the last Investigational product (IP) treatment, the patient will be assessed for efficacy and safety at the PDE 2 Visit. At this visit, the patient will undergo ureteroscopy and any remaining lesions will be biopsied, and UUT urine wash will be collected for cytology.

Patients demonstrating CR at the PDE 2 Visit will undergo FU visits at 3, 6, 9, and 12 months (± 2 weeks) following the PDE 2 Visit.

The trial will be approximately 15 months, per patient: a 3- to 6-week treatment period, followed by 4 to 6 weeks post-treatment leading up to the PDE 2 Visit, and a 12-month FU post PDE 2 Visit. This trial will follow the Steering Committee, and a Data Monitoring Committee (DMC) has been assigned as established for the primary trial TC-UT-03.

Eligibility Criteria:
Main Inclusion Criteria:

1. Patients with recurrent LG UTUC who were found to be CR at the PDE 1 Visit (in Trial TC-UT-03).
2. Biopsy taken from 1 or more tumors located in the UUT shows LG urothelial carcinoma (up to 2 months before Visit 0). If there are tumors in both the kidney and the ureter, at least 1 biopsy should be taken from each location.
3. Urine wash cytology sampled from the UUT documenting the absence of HG urothelial cancer.
4. Patients must have adequate organ and bone marrow function as determined by routine laboratory tests.
5. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis

Main Exclusion Criteria:

1. Patient intends to be treated with systemic chemotherapy during the duration of the trial.
2. Patient with urinary obstruction.
3. Inability to deliver the IP to the UUT.
4. Patient has any other medical or mental condition(s) that make(s) their participation in the trial unadvisable in the opinion of the treating investigator.
5. Patient has a contraindication to mitomycin treatment, or known sensitivity to mitomycin.
Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel

PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
* No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
* Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

* Small cell or carcinoid lung cancer
* Known Central Nervous System (CNS) metastasis
* Pre-existing auto-immune or antibody mediated diseases
A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate (MTX).

The study drug will be intravenously administered.

Eligibility Criteria:
Inclusion Criteria:

* Subject has RA diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR) criteria at least 6 months prior to screening.
* Subject meets the 1991 ACR Revised Criteria for the Classification of Global Functional Status in RA Class I, II, or III at screening.
* At screening and baseline, subject has active RA as evidenced by both of the following:

  * ≥ 6 tender/painful joints (using 68-joint assessment)
  * ≥ 6 swollen joints (using 66-joint assessment)
* Subject meets the criterion for a CRP level (Latex Agglutination method) at screening.
* Subject who has continuously received Methotrexate for at least 90 days prior to screening and who is able to continue a stable dose of Methotrexate from at least 28 days prior to screening throughout the study period.

Exclusion Criteria:

* Subject has deviated from the criteria for previous and concomitant treatment before baseline.
* Subject has an ongoing infection requiring antibiotics.
* Subject is determined to be an inadequate responder to a prior biologic disease modifying antirheumatic drugs (DMARDs) or Janus kinase (JAK) inhibitors.
* Subject has participated in previous ASP5094 clinical trial.
* Subject has participated in a clinical trial or post-marketing clinical study of another ethical drug or medical device within 12 weeks (84 days).
* Subject has another inflammatory arthritis than RA, or any other articular symptom which may affect on joint assessment.
* Subject meets any of the criteria for laboratory values at screening.
* Subject has a positive T-SPOT or QuantiFERON Gold test within 90 days prior to screening or at screening.
* Subject has a history of or concurrent malignant tumor.
* Subject has autoimmune disease except for RA or any severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or mental illness.
* Subject has a history of clinically significant allergy.
* Subject has clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
* Subject has a history of Human Immunodeficiency Virus (HIV) infection.
* Subject had surgery within 30 days prior to screening or has a planned elective surgery.
* Subject has a wound that is currently healing at baseline.
Compassionate Use of Hyperbaric Oxygen Therapy

This is an observational patient registry of COVID-19 patients treated with HBOT.

The retrospective analysis will focus on the reduction in need for mechanical ventilation in COVID-19 patients. The information will be gathered prospectively. Data will be collected from the patients' medical record, including medical notes and data recorded into the study database.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with COVID-19.
* The clinical decision to use HBOT is independent of the decision to participate in registry.
* A signed and dated informed consent form for the off-label use of Hyperbaric Oxygen Therapy specific to the institution where treatment is rendered.
* Subject is willing and able to comply with instructions and scheduled visits.

Exclusion Criteria:

* The Subject has other concurrent conditions that in the opinion of the Investigator may compromise patient safety.
* The patient has an untreated pneumothorax.
Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain

A randomized study to determine safety and efficacy of single subcutaneous (SC) administration of HAL treatment in patients with CINP.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥18 years.
* Neuropathic pain has been present and is attributed to platinum and/or taxane chemotherapy.
* Patient has received a cancer chemotherapy regimen that included taxanes and/or platinum and has no active or discernible disease progression.

Exclusion Criteria:

* Current neuropathic pain with symptoms similar to CINP but attributed to causes other than platinum or taxane chemotherapy.
* Patients who have received HAL at any time prior to screening.
Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants

To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on long-term neurodevelopmental outcome in extremely low birth weight infants.

Extremely low birth weight (ELBW) infants uniformly develop anemia of prematurity and frequently require multiple red blood cell transfusions (RBCT) during neonatal intensive care. The criteria currently applied to indicate RBCT in this population are based on expert opinion rather than evidence and conclusive data of long-term effects of RBCT practices do not exist. Both, giving RBCT to improve oxygen carrying capacity and restricting RBCT to avoid RBCT associated risks and costs potentially impair long-term development. The proposed blinded randomized controlled trial was designed and will be powered to compare the effect of restrictive versus liberal red blood cell transfusion guidelines on long-term neurodevelopmental outcome in ELBW infants. ELBW infants will be randomized to receive RBCT according to liberal or restrictive RBCT guidelines, which both reflect current practice in Germany and aim for a clinically relevant difference in mean hemoglobin concentrations. The primary outcome measure is the incidence of death or major neurodevelopmental impairment determined at 24 months of age corrected for prematurity. Key secondary outcomes are the incidences of individual components of the composite primary outcome, the mental and physical developmental index scores of the Bayley Scales of Infant Development (II edition), and growth. Safety analyses will assess the incidences of all major diseases of prematurity. The results of this trial may help to improve the quality of life of these patients and reduce long-term health care costs.

Eligibility Criteria:
Inclusion Criteria:

* Infants with a birth weight of 400 - 999g

Exclusion Criteria:

* Missing written parental consent.
* Gestational age \> 29 + 6/7 weeks
* Major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period).
* Infants who died before 48 hours, infants in whom the clinical decision to withhold intensive care was made, infants who were not considered viable
* Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study
Preimplantation Genetic Screening in Women Over 35 Year

In view of insufficient evidence to routinely use Preimplantation Genetic Screening (PGS) to improve success rates after IVF, we test the hypothesis that patients with advanced maternal age (AMA) have a higher implantation rate (IR) after embryo transfer (ET) of chromosomally normal embryos following PGS compared to patients who had an ET without PGS.

In a randomized controlled trial (RCT) in patients with AMA (≥ 35 years), the clinical IR per embryo transferred will be compared after ET on day 5 or 6 between the PGS group (embryo biopsy and analysis of chromosomes 13, 16, 18, 21, 22, X and Y) and the control group without PGS.


Eligibility Criteria:
Inclusion Criteria:

* All couples with a medical indication for IVF and with a female age of at least 35 years are invited to participate in the study.

Exclusion Criteria:

* Cycles were excluded from the study if ≤ 2 fertilized oocytes were available on day 1 after oocyte retrieval (OR), or if ≤ 2 ≥ 6c stage embryos were available on day 3 after OR.
Providing Peer Mother Support Through Cell Phone and Group Meetings to Increase Exclusive Breastfeeding in Kenya

This behavioural support intervention trial will investigate the potential to increase exclusive breastfeeding rates in an urban Kenyan community through peer mother support delivered either by cell phone or through group meetings. It will follow a cohort of more than 800 women attending antenatal care at a large public hospital, and compare indicators of breastfeeding and infant and maternal health between groups receiving one or other type of peer mother support. The main part of the study will test the primary hypothesis that peer group and cell phone based support can both increase rates of EBF at 3 months by 20% relative to a control group.

The general objective was to assess whether participation from late pregnancy through to 3 months postpartum in bi-weekly cell phone based peer support (CPS) or monthly peer-led support groups (PSG) can increase adoption and duration of EBF amongst low-income women in Kenya served by a nationalized BFHI certified hospital above benchmarks achieved with current approaches and standard of care by existing facility-based support (SOC).

The study aimed to reach the following specific objectives related to message delivery on EBF:

assess the feasibility of two innovative approaches (CPS and PSG) to deliver extended postnatal peer support for EBF by women in an urban, low-income country setting; compare the effectiveness of these two innovative approaches to existing facility-based support; and compare the relative effectiveness of each type of peer support intervention.

Eligibility Criteria:
Inclusion Criteria for mothers:

1. attending antenatal care services at the target facility;
2. confirmed pregnant by a health care worker;
3. 24-32 weeks gestation at enrollment;
4. competency in KiSwahili or English (or both)
5. current resident of Nakuru municipality and expecting to reside there for the next 6 months;
6. intend to breastfeed their newborn;
7. self-report of any condition preventing the subject from breastfeeding (excluding HIV infection)
8. no history of mental illness
9. either HIV-negative on test result OR referred bto PMTCT services following verified positive HIV-test results
10. willing to participate in study described in IC forms
11. 18-45 years of age
Manual Treatment and Proprioceptive Neuromusculer Fasilitation Techniques for Patients With Adhesive Capsulitis

This study aim was to compare the effectiveness of manual treatment and proprioceptive neuromuscular fasilitation (PNF) techniques in patients with adhesive capsulitis. One group will receive classical physical therapy including hotpack,ultrason and in additon manual treatment application. Other group receive classical physical therapy including hotpack, ultrason and in addition PNF techniques. Two group will be made wand exercise at home three times a day 10 times at one session.

There is no consensus physical therapy treatment protocol in adhesive capsulitis. It is because it etiology and pathophysiology is unknown. Also it has different clinical stage. PNF techniques often used by physical therapist in adhesive capsulitis aim increasing range of motion, improving muscle strenght and decreasing pain. PNF techniques improves neuromusculer control of central nervous system via stimulating muscle spindles, golgi tendon organs and other receptors in connective tissue. However, there is limited evidence effectivenes of PNF techniques in adhesive capsulitis.

Other technique often used by physical therapist in adhesive capsulitis is manual treatment. Manual treatment decreases pain and improves function. It re-arrange glenohumeral joint arthrocinematic. It diminishes capsule fibrosis.

There is no reasearh aimed comparing the PNF and manual treatment. Our aim was to compare the effectiveness of manual treatment and PNF techiques in patients with adhesive capsulitis.

Eligibility Criteria:
Inclusion Criteria:

* adhesive capsulitis due to idiopathic or acquired reasons

Exclusion Criteria:

* Cervical disk hernia
* Neuromusculer disease
* Shoulder impingement syndrome
* Rotator cuff tear
* Corticosteroid enjeksion in shoulder
* Tumour
* Physical therapy or manual treatment is implemented same shoulder last 6 months
A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.

A new tablet form of PF-04531083 has been manufactured. Previously the compound was administered as a solution/suspension to healthy volunteers. This study will investigate the pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.


Eligibility Criteria:
Inclusion Criteria:

* Young
* Healthy volunteers

Exclusion Criteria:

* Elderly volunteers
* Patients with any existing medical conditions considered likely to impinge on study execution
Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy

The purpose of this study is to determine whether taking losartan helps people with hypertrophic nonobstructive cardiomyopathy feel better by decreasing the amount of heart muscle thickening and/or the amount of heart muscle scarring.

Hypertrophic cardiomyopathy (HCM) is characterized by idiopathic cardiac hypertrophy, heart failure, ischemia even in the absence of epicardial coronary artery disease, and arrhythmias. The pathological features of HCM include hypertrophy and disarray, interstitial fibrosis, and increased arteriolar wall thickness. Hypertrophy and fibrosis are major determinants of morbidity and mortality in hypertrophic cardiomyopathy. Some investigators have demonstrated that interstitial fibrosis and hypertrophy occur secondarily, in response to trophic and mitotic factors in the heart. Therefore, blocking trophic factors may attenuate or potentially reverse hypertrophy and fibrosis in HCM.

Angiotensin II has trophic and profibrotic effects on the heart, and blockade of angiotensin II type I receptors has been shown to attenuate myocardial hypertrophy and fibrosis in acquired cardiac disease in humans and animal models.

We hypothesize that treatment with the selective angiotensin II type receptor antagonist, losartan, will decrease both hypertrophy and fibrosis, improve diastolic function, reduce symptoms, and improve functional status in patients with HCM.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertrophic cardiomyopathy
* Left ventricular outflow tract (LVOT) gradient less than 30 mm Hg at rest
* Age 18 years or older

Exclusion Criteria:

* Contraindication to losartan
* Already taking losartan
* Contraindication to MRI
* Hemodynamic instability
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.


Eligibility Criteria:
Inclusion criteria:

* Signed Informed Consent
* Able to swallow an oral medication
* Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
* Adequate kidney and liver function
* Adequate bone marrow function
* Tumor tissue available for testing
* Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
* No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested

Exclusion criteria:

* Prior treatment regimens for advanced or metastatic breast cancer.
* Pregnant or lactating
* Conditions that would effect the absorption of an oral drug
* Active infection
* Brain metastases
* Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
* Known hypersensitivity to Taxol or excipients of Taxol
* Peripheral neuropathy of Grade 2 or greater is not permitted
* Severe Cardiovascular disease or cardiac disease requiring a device.
* Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.