cyrilzakka/clinical-trials huggingface dataset:
Genetic Predictors of Renal Dysfunction Following Heart Transplantation

Kidney disease is a common problem after heart transplantation. It may be caused by anti-rejection medications such as cyclosporine or tacrolimus. However, the reason why some people develop kidney problems after a heart transplant, but other people do not, is not fully known. This study plans to learn more about the relationship between a person's genetic make-up (DNA; deoxyribonucleic acid) and the risk of kidney problems after a heart transplant. The long-term goal of this research is to identify genetic variations that may help predict the development of kidney problems after heart transplantation.


Eligibility Criteria:
Inclusion Criteria:

* cardiac-only transplant
* 18 years of age or older at the time of cardiac transplant
* 1 year or more post-cardiac transplant
* treatment with cyclosporine or tacrolimus following transplant

Exclusion Criteria:

* combined organ transplant
* decisionally impaired
* unable to read or speak English
* unable or unwilling to provide written informed consent
Intracoronary Stenting and Antithrombotic Regimen: Lesion Platelet Adhesion as Selective Target of Endovenous Revacept

The main objective is to evaluate the efficacy and safety of treatment with 2 doses (80 and 160 mg) of Revacept versus placebo in patients with stable coronary artery disease undergoing PCI.

Revacept is a protein that is made up of an Fc fragment ("fragment crystallisable") fused to the GPVI receptor (the endogenous platelet collagen receptor). Consequently, Revacept binds to its ligand (collagen) on atherosclerotic plaques preventing circulating thrombocytes from binding to collagen exposed by the injured plaque. All this is achieved without affecting systemic hemostasis.

Thus, blocking of GPVI-dependent pathways by interfering with vascular collagen sites is commonly seen as an attractive target for an anti-platelet therapy of atherosclerotic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Men and women \>18 years of age
* Diagnosis: Clinically stable coronary artery disease
* Angiographic evidence of coronary artery disease
* Indication for PCI

Exclusion Criteria:

* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product.
* Women who are pregnant or breastfeeding or are planning pregnancy during course of trial
* Women with a positive pregnancy test on enrolment or prior to investigational product administration.
* Patients with elevated high sensitivity cardiac troponin T levels at screening
* Patients receiving antithrombotic therapy with Prasugrel or Ticagrelor within 7 days prior to randomisation
* History of hypersensitivity, contraindication or serious adverse reaction to any component of the study drug (GPVI-Fc, sucrose, mannitol), acetylsalicylic acid or clopidogrel
* History of bleeding diathesis or active bleeding within the last 30 days
* Recent intracerebral haemorrhage or trauma within the last 3 months
* Thrombocytopenia (platelet count \<30000/mm3) at screening
* Sustained hypertension (systolic BP \>179mmHg or diastolic BP \>109mmHg) at screening
* Renal failure (estimated glomerular filtration rate \< 30ml/min and/or dialysis)
* Severe systemic disease, such as known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance
* Unable to provide informed consent (e.g. severe dementia, or psychosis)
* Current severe liver dysfunction (transaminase level \>5-fold the upper normal range limit)
* Patients with an indication for anticoagulant therapy
* Participation in any other clinical interventional trial (drug/device) within less than 30 days prior to screening
* Any other contraindication to perform PCI
* Any planned additional PCI or surgery within 30 days after randomization
* Suspected poor capability to follow instructions and cooperate
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)
Theralux Extracorporeal Photochemotherapy (ECP) in Patients With Extensive Chronic Graft Versus Host Disease (GvHD)

The purpose of this study is to assess the tolerability and safety of two intensity levels of Theralux extracorporeal photochemotherapy in the treatment of subjects with steroid refractory or intolerant GvHD.

The current hypothesis is that apoptotic cells re-injected into patients induce an immunomodulation effect alleviating the GvHD symptoms. Using the Theralux procedure, the dose of photodynamic treatment may be modulated to achieve the maximal immunomodulatory effects in the treated patients.

The intervention is iterative extracorporeal photochemotherapy of autologous peripheral blood mononuclear cells (PBMC) with a rhodamine-derivative TH9402 (drug) and Theralux (device).

Graft versus host disease (GvHD) remains a major cause of morbidity and mortality related to allogeneic stem cell transplantation. While improvements in immuno-suppressive regimens have reduced the frequency and severity of acute GvHD, the incidence of chronic GvHD (cGvHD) remains unchanged ranging from 30% after sibling matched related donor transplants to over 70% after unrelated donor bone marrow or peripheral blood stem cell transplant. Factors associated with cGvHD include increased donor and recipient age, prior acute GvHD, and the use of alloimmune female donors. Conventional therapeutic approaches for cGvHD, including corticosteroids and immunosuppressive agents, have demonstrated limited efficacy in patients with extensive disease and are associated with high toxicity.

Iterative extracorporeal photopheresis has demonstrated clinical and immunomodulatory activity in subjects with acute and chronic GvHD. The currently available process of ECP has not been controlled for cell number, exposure time, or specific cell populations targeted due to the nature of the procedure. Using the Theralux procedure, defined populations of cells may be targeted, and the intensity of photoactivating agent and exposure can be modulated to achieve the maximal immunomodulatory effects in the treated subjects. This study will attempt to explore the effects of the Theralux procedure under two defined conditions. Response and toxicity will be determined at each intensity level and the dose associated with clinical response and immunomodulatory effects on DC and NK cell populations will be defined as the optimal intensity level for subsequent larger trials.

Eligibility Criteria:
Inclusion Criteria:

* Clinical features compatible with extensive chronic GvHD
* Refractory or intolerant to standard therapy

Exclusion Criteria:

* Pregnant or lactating women
* Underlying concurrent medical condition which would hinder the ability to safely administer the treatment
* Known hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Participation to another investigational trial within 30 days of study entry
Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).

This is a double-blind, double-dummy, multicenter, randomized, active-controlled, parallel group, outpatient, safety study to evaluate the long term safety of arformoterol in the treatment of subjects with COPD. Study participation will be over approximately 6 months. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Key Inclusion Criteria:

* Male and female subjects must be at least 35 years old at the time of consent
* Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD
* Subjects must have a \>=15 pack-year smoking history and a baseline breathlessness severity grade of \>=2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visits 1 and 2
* Female subjects \<=65 years of age must have a negative serum pregnancy test, females of childbearing potential must be using an acceptable method of birth control
* Subjects must be in general good health.

Key Exclusion criteria:

* Subjects with a history of asthma, with the exception of asthma diagnosed in childhood
* Subjects with a blood eosinophil count \>5% of total white blood cell count
* Subjects have had a febrile illness within 72 hours (3 days) before Screening Visit 1
* Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g., diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions)
26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP \< 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).


Eligibility Criteria:
Inclusion Criteria:

- diagnosis of essential hypertension

Exclusion Criteria:

* pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
* development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
* discontinuation from the preceding trial.
* known or suspected secondary hypertension.
* mean seated systolic blood pressure (SBP) \>= 180 mmHg and/or mean seated diastolic blood pressure (DBP) \>= 120 mmHg at any visit.
* any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
* clinically relevant hyperkalaemia.
* uncorrected volume or sodium depletion.
* primary aldosteronism.
* hereditary fructose or lactose intolerance.
* symptomatic congestive heart failure.
* patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
* any new drug or alcohol dependency since signing consent of the preceding trial.
* concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
* hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
* known allergic hypersensitivity to any component of the formulations under investigation. \[Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).\] non-compliance with study medication (defined as \<80% or \>120%) during the preceding trial.
* administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
Phase II CT-2103/Carboplatin in Ovarian Cancer

The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.

CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.

Eligibility Criteria:
Inclusion criteria:

* Histologically-confirmed stage III or IV ovarian carcinoma or primary peritoneal cancer patients who have had appropriate debulking surgery for ovarian or peritoneal carcinoma.
* Patients must be recovered from initial surgery and must enter this study no later than 12 weeks after such surgery.
* ECOG performance score of 0, 1, or 2.
* absolute neutrophil count (ANC) at least 1,500/µL.
* platelet at least 100,000/µL.
* hemoglobin at least 10 g/dL.
* creatinine no greater than 1.5 times the upper limit of normal (ULN).
* bilirubin no greater than 1.5 x ULN (if liver metastases are not present, SGOT and SGPT no greater than 2.5 x ULN, if liver metastases are present, SGOT and SGPT may be no greater than 5 x ULN.
* Alkaline phosphatase no greater than 2.5 x ULN.

Exclusion:

* Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas)
* Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from sites other than the ovary, and low malignant potential tumors including so called micropapillary serous carcinomas.
* Synchronous primary endometrial cancer or history of primary endometrial cancer.
* Evidence of any other invasive malignancies present within the 3 years before this study, with the exception of non-melanoma skin cancer and other specific malignancies as noted above.
* Any prior treatment, other than initial debulking surgery, for the cancer being treated in this study.
* Patients may have received prior adjuvant chemotherapy for localized breast cancer, if the therapy was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
* Prior radiotherapy to any portion of the abdominal cavity or pelvis.
* Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
* Administration of other investigational drugs within 26 weeks before the first treatment in this study. Toxic manifestations of previous treatments (except alopecia) must have been stable for 4 weeks.
* Presence of active hepatitis, either acute or chronic.
* Presence of active infection requiring antibiotic or antiviral therapy.
* Pregnant women or nursing mothers.
Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

Compassionate Use

Eligibility Criteria:
Inclusion Criteria:

1. Critically ill infants with either a known anatomic short gut (greater than 50% of the bowel removed) or known severe dysmotility of the gut reflecting non-functional gut similar to anatomic short gut will be offered Omegaven® when their direct bilirubin reaches 2 mg/dL. Infants who do not meet the above criteria for anatomic or dysfunctional short gut will be allowed to receive Omegaven® when their direct bilirubin reaches 4 mg/dL. The qualifying measurements of 2 mg/dL or 4 mg/dL direct bilirubin must be consecutive and obtained at least 24 hours apart.
2. Be expected to require intravenous nutrition for at least an additional 28 days
3. Patient must have documented failure of or ineligibility for the following therapies to prevent progression of PNALD:

   * Reduction of Intralipid® to 1 g/kg/day
   * Limiting trace minerals including copper and manganese
   * Initiation and use of Ursodiol
   * Cycling of parenteral nutrition
   * Advancement of enteral feedings
4. Parental informed consent must be signed.

Exclusion Criteria:

1. Have a congenitally lethal condition (e.g. Trisomy 13).
2. Have clinically severe bleeding not able to be managed with routine measures.
3. Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
4. Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.
5. Has culture positive sepsis
Community Diabetes Education Program Evaluation "Code Evaluation"

The study is intended to determine the effectiveness and efficiency of a community diabetes education program administered by a community health worker in a low-cost community clinic. We expect an improvement in overall glycemic control in the experimental group of at least 20%. We also expect to document improvement in diabetes self-management skills, quality of life and an increase in achievement of ADA standards of care4 in the experimental group.


Eligibility Criteria:
Inclusion Criteria:

* people with no health insurance

Exclusion Criteria:

* people with any type of health insurance coverage
Motherhood and Microbiome

This is a prospective cohort, enriched with women with a prior term birth, of singleton pregnancies who will be followed for the outcome of preterm birth. The main exposure of interest is the characterization of the cervico-vaginal microbiota. Women will be recruited from a population seeking routine obstetrical care at obstetrical practices at Penn. They will have three research visits during pregnancy to complete questionnaires and collect samples of cervico-vaginal fluid and cervical cells. Outcome data will be collected about the prenatal events and timing of delivery.

Patients will be recruited around the time of their routine obstetrical visits. They will be asked to participate in three visits total. Visit one/enrollment occurs between 16 and 20 weeks of gestation, visit two at 20-24 weeks, and visit three at 24-28 weeks. At each visit, vaginal swabs will be collected. The patient will also be asked to fill out a series of surveys related to stress, anxiety,and depression in pregnancy. Research coordinators will perform chart abstraction after delivery.

Eligibility Criteria:
Inclusion Criteria:

- Pregnant women receiving care in University of Pennsylvania Health System

Exclusion Criteria:

* Non-singleton pregnancy (twins, triplets, etc.)
* Known major fetal anomaly
* Known HIV positive status
* History of organ transplant
* Chronic steroid use (greater than 20 mg per day for more than 30 days at the time of first study visit)
Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage

This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.

Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).

Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions.

Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®.

Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who accept signing voluntarily the informed consent before doing any action related to the study.
* ≥18-years-old patients.
* Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.
* Single implants successfully osseointegrated placed at least 16 weeks post-extraction.
* O'Leary plaque index and or bleeding on probing ≤25%.
* Dental implants with screwed-retained prosthesis.

Exclusion Criteria:

* Systemic diseases that can interfere dental implant placement.
* Any contraindication for surgery procedures.
* Heavy smokers (\> 20cig/day).
* Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.
* Patients who have had participated with another clinical trial the last 30 days.
* Pregnant women or in lactation.
* Patients with bad oral hygiene or not motivated.
* Probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space.
* Guided bone regeneration required in the same time of the implant placement.
Helen Keller International's Enhanced-Homestead Food Production Program in Burkina Faso

Helen Keller International (HKI) has been implementing homestead food production (HFP) programs in Asia for the past 20 years and has recently begun implementing HFP programs in Africa as well. In general, these programs target women and are designed to improve maternal and child health and nutrition outcomes through three primary pathways: 1. Increasing the availability of micronutrient-rich foods through increased household production of these foods; 2. Raising income through the sale of surplus production; and 3. Increasing knowledge and adoption of optimal nutrition practices, including the consumption of micronutrient-rich foods. Evaluations of HFP programs have consistently demonstrated significant increases in household production and consumption of micronutrient-rich foods. This increased consumption, along with improvements in health and nutrition related knowledge, and increased income, could all contribute to improvements in maternal and child health and nutrition outcomes. However, to date there has been limited understanding as to how these types of programs can be optimized to maximize impacts on these outcomes.

In order to better understand the potential of these types of programs to improve maternal and child health and nutrition outcomes and how this impact may be achieved IFPRI has been collaborating with HKI to evaluate one of their E-HFP programs in Burkina Faso. The evaluation considers impact of the program through the three pathways above, and assesses anthropometric and clinical measures of nutrition, as well as looking at how the programs might be improved.


Eligibility Criteria:
Inclusion Criteria:

* Mother of child between the ages of 3 and 12 months and her child

Exclusion Criteria:

* N/A