cyrilzakka/clinical-trials huggingface dataset:
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital

The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.

ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or over
2. Patient able to cooperate with study procedures and able to perform tests reliably
3. Patient willing to sign informed consent
4. Patient able and willing to complete postoperative follow-up requirements
5. Glaucoma：one/both eyes are affected by glaucoma
6. Pterygium： patient with pterygium

Exclusion Criteria:

* Known allergic reactions to collagen
Auditive and Renal Long Term Outcomes - Risk After Aminoglycoside Therapy in Neonates (AURORA)

Gentamicin, in combination with a beta-lactam antibiotic, is commonly used for treatment of neonatal sepsis. Neonates have a high volume of distribution. It is a paradox that most neonatal dosing schedules still recommend lower gentamicin doses (4-5 mg/kg) than in older children (≥ 7 mg/kg). In the neonatal unit in Tromsø a simplified gentamicin high-dose (6 mg/kg) regimen has been in use since 2004.

The investigators have previously shown that this regimen was associated with low number of elevated trough levels, low numbers of prescription errors and no evidence for ototoxicity in the immediate neonatal period. However, the long-term safety of gentamicin therapy in neonates is not well studied when it comes to ototoxicity and possible nephrotoxicity.

The objective of the current study is therefore to perform a detailed hearing evaluation, including an extended high-frequency (EHF; 9-16 kHz) audiometry, in a follow-up study of children (participants) aged 6-15 years who were exposed to a high-dose gentamicin regimen in the neonatal period. Moreover, we will investigate blood pressure and urine biomarkers to assess renal tubular function. The aim is to include 250 children exposed to gentamicin in the neonatal period and a control group of 25 healthy children.

EHF audiometry is a more sensitive method for detecting ototoxic damage and provides evidence of ototoxicity before any hearing loss is detected by conventional systems. This is the background for choice of method.

The primary outcome is the difference in average hearing threshold in the EHF range between the control group and the exposed group.

Secondary outcomes are i) difference in average hearing threshold in the EHF range between the children with gentamicin trough levels \> 1.0 mg/L versus those who had lower trough levels, ii) markers of renal tubular function (kidney injury molecule 1) and iii) blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Exposed to gentamicin therapy in the neonatal period and treated at neonatal unit at the University Hospital of North Norway

Exclusion Criteria:

* Not able to cooperate during an audiometry
Progesterone and Doppler in Recurrent Abortion

Recurrent pregnancy loss is classically defined as the occurrence of three or more consecutive pregnancy loss. The American Society of Reproductive Medicine has recently redefined recurrent pregnancy loss as two or more pregnancy losses. A pregnancy loss is defined as a clinically-recognized pregnancy means that the pregnancy has been visualized on an ultrasound or that pregnancy tissue was identified after a pregnancy loss.

Spontaneous pregnancy loss is a surprisingly common occurrence. Whereas approximately 15% of all clinically recognized pregnancies result in spontaneous loss, there are many more pregnancies that fail prior to being clinically recognized. Only 30% of all conceptions result in a live birth.

Although no reliable published data have estimated the probability of finding an etiology for recurrent pregnancy loss in a population with 2 versus 3 or more miscarriages, the best available data suggest that the risk of miscarriage in subsequent pregnancies is 30% after 2 losses, compared with 33% after 3 losses among patients without a history of a live birth. This strongly suggests a role for evaluation after just 2 losses in patients with no prior live births. An earlier evaluation may be further indicated if fetal cardiac activity was identified prior to a loss .

Eligibility Criteria:
Inclusion Criteria:

1. pregnant 7-12 weeks documented by pregnancy test \&/or ultrasaound.
2. History of at least 2 prior spontaneous abortion before 12 weeks of gestation.
3. Age: 18-35 years
4. Willing and able to give informed consent.
5. Rh +ve patient
6. BMI: 18-32
7. Viable pregnancy through the detection of fetal pulsations by ultrasound
8. Singleton pregnancy
9. Apparently stable pregnancy (no history of vaginal bleeding in this current pregnancy or signs of sac separation in ultrasound)

Exclusion Criteria:

1. Patients diagnosed to have Anti-phospholipid syndrome or another recognised thrombophilic or autoimmune conditions.
2. Pregnant \> 12 weeks.
3. Contraindication to progesterone use.
4. Diabetic patients, have glucose intolerance.
5. Multiple pregnancies.
6. Thyroid disorder
A Healthy Volunteer Study To Assess Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation

The purpose of this study in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
* Women must be of non childbearing potential
* Body Mass Index (BMI) of 25 to 35 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms, optic nerve disease or retinal disease.
* History of habitual smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0
HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy

The main purpose of the study is to describe changes in plasma HPV DNA levels in patients with locally advanced cervical cancer during radical radiochemotherapy (CRT) and to correlate changes with response to treatment. Monitoring of the response to treatment will also be assessed in FDG PET CT imaging.

Ninety-five per cent of cervical cancer cases are caused by persistent infections with carcinogenic HPVs. Locally advanced stage IB2 to IVA cervical cancers are treated with definitive chemoradiation therapy (CRT). Despite known clinical prognostic factors of poor treatment outcome such as advanced stage and positive nodal status, we still don't know predictors of relapse.

HPV status will be assessed in the neoplastic tissue and DNA from the blood serum of patients with cervical cancer will be isolated and analyzed by real-time PCR. Plasma HPV DNA would identify patients with residual disease after CRT due to persistent detectable HPV. This would earlier detect high risk patients who would benefit from adjuvant therapy.

While metabolic response in post - therapy FDG PET CT is predictive of survival, there is usually 3 months waiting period time needed to perform this imaging. This pilot study will provide preliminary estimates of the correlation between plasma HPV DNA level, PET finding and clinical outcome in polish cervical cancer patients.

Eligibility Criteria:
Inclusion Criteria:

Age Limits: more than 18Y Histologically confirmed squamous cell carcinoma, FIGO stage IB-IVA planned for radical radiochemotherapy Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2

Exclusion Criteria:

Patients who have received any anticancer treatment for their cervical cancer. Eastern Cooperative Oncology Group (ECOG) performance status \> 2 Other cervical cancer tumor histologies (e.g. small cell, serous) Contraindications to 18FDG PET-CT Contraindication to radiochemotherapy Known pregnancy or lactating
Effects of Early Oral Feeding After Resection of Gastric Cancer

The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.

Most patients who undergo gastric resection for gastric cancer have maintained going on a fast of over three days after operation. Surgeons have believed that early oral feeding might worsen patients' condition by prolonged postoperative ileus. Therefore, patients received nothing by oral route until resolution of the ileus. However, the current trend toward minimal operative injury and early discharge from hospital. In addition, development of operative technique and instrument make the operation time to be short and the patients to be fast recovery, and thus it is possible to feed early in less than two days after operation. The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.

We collect fifty-eight patients for this study and divide into two groups using randomization method. In the early feeding group, patients will receive the liquid diet two day after operation followed by soft diet postoperative three day. Meanwhile, the patients who categorized into control group will start the liquid diet postoperative four day followed by soft diet postoperative six day. We evaluate the morbidity or mortality rate and laboratory findings. Of course, it is supposed to be same in amount of fluid and calories between two groups.

Eligibility Criteria:
Inclusion Criteria:

Patients who underwent gastrectomy for adenocarcinoma of stomach with following criteria:

1. Performed curative resection
2. Have The American Society of Anaesthesiologists (ASA) score of less than 3

Exclusion Criteria:

1. Patients who have simultaneously other cancer.
2. Patients who underwent gastric resection at past time.
3. Patients who have cancer with bleeding or perforation or obstruction.
4. Patients who have any injury to the pancreas capsule on operation.
5. Patients who get pregnancy.
6. Patients who are treating diabetics with Insulin.
Registry of Patients That Have Undergone ICA or PCI

In Invasive Coronary Angiography there are multiple invasively obtained measurements to determine the funcitonal significance of Cornary Artery Disease. In this Registry, patients who have undergone Invasive Coronary Angiography or Percutaneous Coronary Intervention are included to investigate diagnostic and prognostic implications of the invasive measurements.


Eligibility Criteria:
Inclusion Criteria:

* 18 years
* Has undergone or will undergo a clinically indicated invasive coronary angiography.
* Has undergone or will undergo a clinically indicated percutaneous coronary intervention.

Exclusion Criteria:

* Not willing / unable to provide informed consent.
Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity

The purpose of this study is to define clinical and demographic features within the population suffering from cervical deformity to assist health professionals to make important treatment decisions.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years of age or greater
* Cervical deformity (kyphosis C2-7 greater than 10 degrees or scoliosis with coronal cobb greater than 10 degrees)
* Plans for surgical correction of cervical deformity

Exclusion Criteria:

* Active tumor or infection
* Acute trauma
* Unwillingness to provide consent or complete study forms
* Prisoner
* Pregnant or planning to get pregnant during study period
Genetic Susceptibility to Kidney Cancer

This study will further the understanding of the genetic events leading to the development of RCC.

This study will further the understanding of the genetic events leading to the development of RCC; explore the genetic basis for genetic instability and how it affects cancer risk; and eventually provide a means of identifying a subgroup of individuals who are most likely to develop RCC. Such individuals may then be targeted for intervention programs such as chemoprevention or dietary modification.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of any ethnicity or sex, who have a been diagnosed with possible Renal Cell Carcinoma within the past year.

Exclusion Criteria:

* Must not have received chemotherapy, biological therapy or radiation therapy in the 6 months preceding enrollment will
* Must not have had RCC, or metastatic RCC,
* Must not have had a renal transplantation
Effect of Positive Expiratory Pressure on the Management of Chest Trauma

Chest trauma (CT) are a common problem in our environment caused mainly by traffic accidents and causal and domestic accidents among the elderly population. CTs, in some situations, can lead to sequelae such as fibrothorax secondary to hemothorax and / or empyema and residual chronic pain. Clinical regulations and guidelines recommend a guideline for chest physiotherapy (CP) for all patients with rib fractures, but there is little scientific evidence. It would be interesting to establish CP treatment protocols and describe the most appropriate techniques according to the type and stages of thoracic trauma consolidation.

Objective: To evaluate the effect of Positive Expiratory Pressure (PEP) breathing added to conventional CP in terms of aid secretion clearance, pain control, pleuropulmonary radiological abnormalities, restoration of lung function, and admission days in the immediate phase of the CT.

After acceptance to participate in the study, patients will be computerized randomized into 2 groups:

* PEP group: positive expiratory pressure breathing.
* CONTROL group: conventional CP treatment without positive pressure brething. The period between day 0 and 20 days post-trauma is considered an immediate phase of CT.

Once admitted, an initial evaluation by the doctor will be performed, and pleuro-pulmonary complications, the presence of respiratory failure, and pain control will be evaluated. The chest physiotherapist will perform a clinical and secretion assessment using the Seva test and a dynamic costal examination. The medical treatment of pain control will begin, and the treatment of CP will begin, where it will be randomized in 2 groups: 1- PEP group: positive expiratory pressure breathing with the help of a PEP bottle device. 2-CONTROL group: conventional CP treatment without positive pressure breathing will be daily FR sessions, on weekdays. Upon admission, hospital discharge and post-discharge, radiological checks (simple radiography) will be performed and forced vital capacity will be measured with forced spirometry.

Eligibility Criteria:
Inclusion Criteria:

* Chest trauma with three or more rib fractures with or without hemopneumothorax
* Failure to meet any exclusion criteria

Exclusion Criteria:

* Non-cooperative patients for not understanding chest physiotherapy techniques.
* Presence of respiratory failure on admission: PaO2 \<60mmHg i / or PaCO2\> 50mmHg.
* Medical indication for mechanical ventilation or non-invasive ventilatory support.
* Presence of undrained pneumothorax.
* Complications that limit early mobility.
Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim

RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with ipilimumab with or without sargramostim may help doctors learn more about the effects of ipilimumab and sargramostim on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.

OBJECTIVES:

* To compare the pathology of primary melanomas, melanoma metastases, and post-treatment melanoma metastases in relation to clinical outcomes for patients receiving ipilimumab plus sargramostim (GM-CSF) and patients receiving ipilimumab alone.
* To determine the effects of the addition of systemic GM-CSF to ipilimumab on effector immune function in patients with metastatic melanoma.
* To determine the effects of the addition of systemic GM-CSF to ipilimumab on regulatory immune function in patients with metastatic melanoma.
* To determine the effects of the addition of systemic GM-CSF to ipilimumab on anti-tumor humoral immunity in patients with metastatic melanoma.

OUTLINE: Serum, peripheral blood mononuclear cells, and tumor tissue (from primary tumor and post-treatment biopsies) samples are analyzed for biomarkers predictive of clinical outcomes, immune function, and anti-tumor humoral immunity by IHC, RT-PCR, flow cytometry, ELISPOT assays, and ELISA.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of measurable unresectable stage III or stage IV melanoma
* Treated with ipilimumab with or without sargramostim on clinical trial ECOG-E1608
* Primary tumor tissue and optional post-treatment biopsies of tumors from easily accessible tissues

PATIENT CHARACTERISTICS:

* ECOG performance status 0 or 1

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Diagnostic for the Early Detection of Bladder Cancer

To improve upon the non-invasive detection of bladder cancer by further validating a multiplex ELISA assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.

Environmental exposures, specifically tobacco smoke, increases the risk of many cancers, including bladder cancer. To date, there are no diagnostics capable of detecting bladder cancer early, that is prior to clinical presentation. Because of this severe limitation, nearly 30% of patients initially present with stage 2 and higher bladder cancer. Stage 2 bladder cancer has a 5-year survival of 50%, while stage 3/4 have a 5-year survival of \<20%. Ideally, bladder cancer would be preventable. Unfortunate, this has not come to fruition. If these stage 2-4 bladder cancer cases could be detected at Stage 1 (5-yr survival \>94%), then its possible to see an improvement in bladder cancer survival rates (21-23).

in this study, a urine-based diagnostic that possesses the potential to accurately identify patients who harbor bladder cancer prior to clinical manifestation will be tested.

Eligibility Criteria:
Inclusion Criteria:

Participants must be:

1. Age 50 years or older
2. \>20 pack year history of tobacco exposure
3. Free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
4. Scheduled to be evaluated in the Pulmonary Rehab Clinic or Lung Cancer Screening Clinic
5. Willing and able to give written informed consent
6. Willing to provide voided urine sample
7. Be able and willing to complete semi-annual research clinic visits for 4 years

Exclusion Criteria:

Participants must not have:

1. History of hematuria (microscopic or gross) within 2 years of signing consent.
2. Previous history of bladder cancer
3. A known active urinary tract infection or urinary retention
4. An active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat.
5. An ureteral stents, nephrostomy tubes or bowel interposition
6. A recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)
Defibrotide in the Human Endotoxemia Model --- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide

Defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of veno-occlusive disease. Although it has been in clinical use for almost 30 years, the exact mechanism of action has never been fully elucidated. Thus, the effects of defibrotide will be investigated in the human endotoxemia model in order to gather further information on its actions.

Defibrotide (DF) is a highly complex polydisperse mixture of single-stranded phosphodiester oligodeoxyribonucleotides derived from the controlled depolymerization of porcine intestinal mucosal DNA. The entire mode of action remains unknown. Its actions may be summarized to pro-fibrinolytic, anti-inflammatory and anti-coagulatory actions. To better define the mechanisms of Defibrotide the effects of the substance will be investigated in the well-established endotoxemia model. Sixteen healthy volunteers will be randomized to receive LPS±defibrotide/placebo and four subjects will be randomized to receive Placebo± defibrotide/placebo in a single center, randomized, double blind, placebo controlled, two-way crossover trial. Immediately after a 2h infusion of 6,25mg/kg bodyweight defibrotide or placebo a LPS bolus of 2ng/kg bodyweight will be infused. Analyses will be performed by blood sampling at pre-defined time-points.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* \<90kg body weight
* Normal findings in medical history and physical examination unless the investigator considers the abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers abnormalities to be clinically irrelevant
* Ability to understand the purpose and nature of the study, as well as the associated risks

Exclusion Criteria:

* Intake of any drugs that may interfere with the trial's endpoints or drugs (i.e. platelet inhibitors, anticoagulants, etc.)
* Positive results of HIV or hepatitis virology
* Acute illness with systemic inflammatory reactions
* Known allergies, hypersensitivities or intolerances to any of the used substances
* Acute or recent bleeding episodes, increased risk of bleeding at the discretion of the investigator
* Participation in an LPS trial within 6 weeks of the first study day
* Pregnancy or breastfeeding