cyrilzakka/clinical-trials huggingface dataset:
Intravitreal Conbercept for Idiopathic Choroidal Neovascularization

The purpose of this study is to evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy as primary treatment for ICNV.


Eligibility Criteria:
Inclusion Criteria:

* Patient who give voluntary signed informed consent
* Patient affiliated with the Tianjin Medical University Eye Hospital or similar
* Patient with ICNV with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanin green) and/or SD-OCT in the studied eye
* Patient willing, committed and able to return for all clinic visits and complete all study-related procedures

Exclusion Criteria:

* Pregnant women
* Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
* Patient who is protected adults according to the terms of the law (French public health laws)
* Involvement in another clinical trial (studied eye and/or the other eye)
* Patient with non-ICNV, especially:

  * AMD
  * High myopia defined as refraction ≥ - 6 diopters
* Other curative treatment of ICNV in the studied eye during the last 3 months before the first intravitreal injection: anti-VEGF therapy, juxta- or extra-foveal macular laser, photodynamic therapy, surgery, external radiotherapy, transpupillary thermotherapy ...
* Medical history of retrofoveal focal macular laser photocoagulation in the studied eye
* Subretinal haemorrhage reaching the fovea centre, with a size \> 50% of the lesion area
* Fibrosis or retrofoveal retinal atrophy in the studied eye
* Retinal pigment epithelial tear reaching the macula in the studied eye
* Medical history of intravitreal medical device in the studied eye
* Medical history of auto-immune or idiopathic uveitis
* Proved diabetic retinopathy
* Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
* Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
* Arterial hypertension that is not controlled by an appropriate treatment
* Previous or actual treatment with systemic administration of anti-VEGF therapy
* Known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanin green, anaesthetic eye drops
* Active or suspected ocular or peri-ocular infection
* Serious active intra-ocular inflammation in the studied eye
* Medical history of intra-ocular surgery within 28 days before the first injection in the studied eye
* Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
* Follow up not possible during 12 months
Overcoming Barriers to HIV/AIDS Care and ART Initiation

The study will evaluate interventions to improve engagement in HIV care following HIV diagnosis through a voluntary counseling and testing program. The specific aims are to (1) determine if a VCT-based intervention of CD4 count testing, alone or in combination with peer counseling, improves linkage to HIV/AIDS care; (2) assess the impact of the intervention on ART initiation. The study will recruit 450 HIV-positive individuals from VCTs and randomize a third to standard counseling and referral, a third to receive CD4 testing at the VCT with results return by phone after 1 weeks, and a third to receive the same CD4 testing combined with peer counseling. These combined investigations will create a comprehensive understanding of obstacles to appropriate HIV/AIDS care and result in new interventions to achieve measurable outcomes in applied settings.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years or older and
* Testing HIV-positive for the first time at a voluntary counseling and testing (VCT) center.
* Willing to receive counseling to encourage linkage to care at a comprehensive care center (CCC).
* Willing to have a CD4 count test conducted at the enrollment visit.
* Willing to have a telephone follow-up where they may receive additional counseling and/or have their CD4 count results returned to them.
* Willing to be contacted over 1 year to determine if they linked to care.

Exclusion Criteria:

* Previous positive HIV test.
* Currently taking antiretroviral medications.
* Currently pregnant (females only).
* Currently participating in another research study or trial.
* Not planning to remain in Nairobi for the next 12 months (not including short trips out of Nairobi).
Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result

The concept of the investigators risk-adapted multicenter treatment trial for younger adults, AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after first induction therapy and/or high risk karyotype \[abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p), complex\]; intermediate-risk: complete remission after induction therapy and intermediate risk karyotype \[normal, abn(11q23), abn(16q22), other rare aberrations\]; low-risk: complete remission after induction therapy and low risk karyotype \[t(8;21)\]. Patients exhibiting a t(15;17) were treated in a separated trial (APL HD95). Treatment consists of a first induction therapy with ICE followed by a second cycle ICE in case of response to first induction therapy. Patients with refractory disease after first induction therapy are assigned to a salvage therapy with A-HAM (all-trans retinoic acid, high-dose cytarabine and mitoxantrone) and the search for potential hematopoietic stem cell donors is extended from the family to unrelated persons. All patients achieving a CR after induction therapy with ICE are assigned to a first consolidation therapy with HAM. For intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended during the hematological recovery after the first consolidation. Second consolidation therapy was stratified according to the risk definition. For high risk patients a allogeneic transplantation is assigned from a related or unrelated donor preferentially after a dose-intensified conditioning therapy. All patients with intermediate risk and an HLA-matched family donor are assigned to allogeneic transplantation. Intermediate-risk patients without a family donor and normal karyotype at diagnosis are randomized between an autologous stem cell transplantation and a second course of HAM. The other intermediate-risk patients are assigned to autologous transplantation. For low-risk patients a second course of HAM is assigned.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML, de Novo or secondary after Myelodysplasy, or with therapy-induced AML after healed primary malignom; or refractory anemia with excess of blasts in transformation (RAEB-t); the diagnosis must be confirmed morphological, cytochemical and with immunological phenotyping
* Cytogenetical tests must be performed for each patient
* Age: 16 - 60 years
* All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.

Exclusion Criteria:

* Organic insufficiency: Insufficiency of the kidneys (Crea \> 1.5 x upper normal serum level), or insufficiency of the liver (bilirubin, SGOT or AP \> 2 x upper normal serum level) uncaused by the AML; severe obstruction or restrictive ventilation disorder, heart failure with a ejection fraction \< 0.5
* Secondary malignom
* Other severe diseases
* Pregnancy
* Participation in an concurrent clinical study
Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer

The purpose of this study is to test the effectiveness, safety and side effects of two chemotherapy drugs (gemcitabine and cisplatin) when combined with surgery after chemotherapy for patients with upper urinary tract cancer. The hypothesis is that undergoing chemotherapy prior to surgery will have a beneficial effect on prognosis and may improve overall survival as in patients with bladder cancer, and will allow better tolerance of chemotherapy than if it were given after surgery.

This study will look at improving overall survival of those undergoing nephroureterectomy for upper tract TCC (transitional cell carcinoma, comparing the pathological response of tumors treated with Neoadjuvant Chemotherapy (gemcitabine and cisplatin) before surgery. There have been reported studies of neoadjuvant chemotherapy in the treatment of upper tract TCC, there have been no studies to date that include the chemotherapy agents gemcitabine and cisplatin that are currently indicated in treating TCC of the bladder in the neoadjuvant and adjuvant setting. These agents have been proven to have a better overall safety profile and tolerability allowing more patients to complete their regimens. Secondarily, study will compare disease free overall survival among patients treated with neoadjuvant chemotherapy and surgery versus surgery alone. This study may elucidate the potential benefit of these agents when treating TCC of the upper tracts and may provide a survival advantage in this specific patient population as compared to a historical cohort.

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0-2
* Estimated GFR\>60
* High grade TCC on initial biopsy
* Clinical stage T1-T3, Nx, Mx based on the AJCC Classification system
* TCC confined to the ureter or renal pelvis
* Grade II neuropathy or less

Exclusion Criteria:

* Any other malignancy over the previous five years with a risk of relapse that exceeds 30%
* History of previous cystectomy
* Evidence of metastatic disease
* History of pelvic irradiation or prior chemotherapy
Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis

Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis

People with cystic fibrosis (CF) are prone to chest infections (pulmonary exacerbations) and suffer premature death due to respiratory failure. Patients that experience more frequent pulmonary exacerbations have worse prognosis and early antibiotic treatment of pulmonary exacerbations is therefore one of the major goals of CF care. Antibiotic treatment is often currently delayed, since we rely on patients contacting the CF team when they develop worsening symptoms. We hypothesise that if we could allow patients to detect and receive treatment for early pulmonary exacerbations by measuring urinary biomarkers, this would minimise lung damage and result in improved clinical outcomes.

In phase 1, 40 patients will be asked to collect daily urine samples, in addition to recording daily spirometry and a daily symptom score for 4 months. Phase 1 aims to identify the urinary biomarkers that are associated with CF pulmonary exacerbations. In phase 2, the same 40 patients will be asked to collect and test a daily urine sample using a novel testing device in addition to recording daily spirometry and a daily symptom score for 4 months. Phase 2 aims to validate the use of the urine testing device as a method of diagnosing early pulmonary exacerbations.

In summary, this study aims to develop and validate a novel noninvasive point of care (near-patient) diagnostic testing system, to allow people with CF to diagnose early pulmonary exacerbations by measuring urinary biomarkers. If successful, we hope that this will provide patients with an easy to use device, which will empower patients and their caregivers to treat exacerbations at an earlier stage, with potential health and economic benefits.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed CF diagnosis
* Aged \>18 years of age
* Patients able and willing to give informed consent
* Requirement for at least one course of intravenous antibiotics for a pulmonary exacerbation within the previous 3 months.

Exclusion Criteria:

* Patients not able or not willing to give informed consent
* Patients who are currently participating in another clinical trial (excluding observational studies)
* Pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract operation) in the previous 4 weeks, or any other factor that prevents safe measurement of spirometry.
Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection

The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients ≥ 18 years of age.
2. Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.
3. Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.
4. The patient has given written informed consent to participate in the study.

Exclusion Criteria:

1. Solid organ transplant recipient is CMV seropositive at the time of transplant.
2. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
3. Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
4. Patients with thrombocytopenia (\<25,000/mm3 ), with an absolute neutrophil count of \< 1,000/mm3); and/or leucopoenia (\< 2,000/mm3), or anemia (hemoglobin \< 6 g/dL) prior to study inclusion.
5. Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
6. Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.
7. Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
8. Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
9. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
10. Inability to cooperate or communicate with the investigator.
A 2 Week, Crossover Trial of Dietary Nitrate in Obstructive Sleep Apnoea Syndrome (OSAS).

Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.

Acute consumption of dietary nitrate (as beetroot juice) has been shown to decrease systemic blood pressure in multiple populations as well as increase organ perfusion in areas of interest such as the pancreas and brain. Obstructive sleep apnoea syndrome (OSAS) is associated with high blood pressure, dysglycaemia and impaired vigilance. The effect of dietary nitrate in OSAS has not been reported.

The investigators hypothesize that chronic nitrate consumption might decrease blood pressure and dysglycaemia and improve vigilance compared to a placebo beetroot juice.

This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint ambulatory blood pressure will be assessed in conjunction with demographics, questionnaires, vigilance and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable,
* Untreated OSAS out-patients

Exclusion Criteria:

* Using continuous positive airways pressure therapy
* Pulmonary hypertension
* Active CVD
* Active musculo-skeletal conditions
* Taking vasodilators
* Diabetes mellitus
Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection

The purpose of this study was to compare the effects of limaprost(Opalmon® ) on walking ability, low back pain and leg pain after transforaminal epidural steroid injection (TFESI) was administered compared to the placebo group.

This study is a prospective, randomized, comparative clinical study that is assigned to a placebo group or a trial group before transforaminal epidural steroid injection (TFESI) is performed.

The subjects of the study will receive an explanation of the study and decide to participate voluntarily in patients who have decided to undergo TFESI for neurogenic claudication and low back pain or leg pain due to lumbar spinal canal stenosis (LSS).

All study subjects are presented with TFESI at the level appropriate for their symptoms in the operating room and then returned to the recovery room. All participants will be monitored for non-invasive blood pressure, electrocardiography, heart rate, and peripheral oxyven saturation during and after the procedure.

Patients assigned to the placebo group will take placebo three times a day and one tablet once from the first day after receiving TFESI. Patients assigned to the trial group will take limaprost (Opalmon®) three times a day, one tablet once from the first day after receiving TFESI. In both groups, the drug was administered for 12 weeks.

In both groups, during the first 4 weeks, no drug changes or additional procedures were observed, and only Acetaminophen was allowed as a rescue drug.

After TFESI, visits at 4 weeks, 8 weeks and 12 weeks to collect each measurement variable.

Eligibility Criteria:
Inclusion Criteria:

Patients aged 18 to 85 years

Patients with a new or known diagnosis of lumbar spinal stenosis on Magnetic Resonance Imaging (MRI)

Patients scheduled to undergo TFESI due to low back pain or leg pain

Exclusion Criteria:

Refusal of a patient

Coagulopathy

Systemic infection or local infection at the needle injection site

Patients with lumbar instability

Neoplasms in the needle path

Allergy to amide-type local anesthetics

Decreased cognition to the extent that NRS is incomprehensible

Patients with peripheral vascular disease (including peripheral arterial disease)

Patients taking anticoagulant or antiplatelet drugs

Patients with severe cardiovascular disease or liver or kidney disease

Patinets with cerebral infarction

Patinets with a history of gastrointestinal bleeding

Patinets who have had lumbar spine surgery or are expected to receive it within 12 months

Patients who show positive in the straight leg elevation test

Patients who are allergic or sensitive to limaprost (Opalmon®) and placebo or their ingredients
The Effects of Fatigue on Exercise-Induced Hypoalgesia During a Dynamic Resistance Exercise

The primary purpose of this study is to compare immediate changes in pain sensitivity (pressure pain threshold) during quiet rest, low fatigue exercise, and high fatigue exercise.

Participants will attend three sessions. Participants will fill out questionnaires, undergo pain sensitivity testing, and be randomly assigned to complete a high and low fatigue exercise on either the second or third session. During the exercise, participants will complete three sets of a single leg knee extension exercise with weight equivalent to 50% of their 1 repetition maximum until they report either a high or low fatigue level. Immediately before and after each set, the research team will examine immediate changes in sensitivity to pressure (pressure pain threshold).

Eligibility Criteria:
Inclusion Criteria:

* Pain-free
* 18-60 years old
* Participant can appropriately perform the knee extension exercise (assessed during screening)

Exclusion Criteria:

* Non-English speaking
* Regular use of prescription pain medications
* Current or history of chronic pain condition
* Currently taking blood-thinning medication
* Systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions
* Any contraindication to the application of ice, such as: uncontrolled hypertension (blood pressure over 140/90 mmHg), cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise
* Known presence of cardiovascular, pulmonary, or metabolic disease
* Current use of tobacco products
* Not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+)
* Surgery, injury, or fracture to the lower back or lower extremity within the past 6 months
Low-dose Radiotherapy in iNHL

The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of low-dose radiotherapy (3 Gy\*4f) in indolent lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Pathology proved iNHL
* ECOG PS ≤3
* Signed Informed consent

Exclusion Criteria:

* History of radiotherapy at the same site
* Primary malignant lymphoma of the gastrointestinal tract
* CTV (Clinical Target Volume)\>500ml
* Others that researchers consider inappropriate
Lancet Blood Volume Comparison Study

The primary objective of the study examines the success rate of various OneTouch Delica lancet sizes across depth settings of the OneTouch Delica lancing device. The sample size is based on 30 subjects per lancet size for a given depth setting. Each subject is lanced 4 times with two lancet sizes at a single depth setting. There will be 120 paired lancing events for each lancet size within the group.

Null hypothesis (H0): there is a 90% success rate of attaining a minimum blood volume of 1.0μL for the 28g lancet across all depth settings.

Alternate hypothesis (H1): the success rate of attaining a minimum blood volume of 1.0μL for the 28g lancet across all depth settings is less than 90%.


Eligibility Criteria:
Inclusion Criteria:

* Must have been diagnosed with type 1 or type 2 diabetes for at least 1 year
* Must be doing Blood Glucose Monitoring, at least twice daily for at least 6 months
* Subjects must be between 18 and 85 years of age.
* Subjects must be able to perform all tasks required in this protocol.
* Subjects must be willing to complete all study procedures.
* Subjects must be able to speak, read and understand English and understand the Informed Consent document.

Exclusion Criteria:

* Subjects with neuropathy or any other nerve damage in the hand or fingers
* Subjects who are taking prescription anti-coagulants or more than one full aspirin per day during the past week or have clotting problems that may prolong bleeding (persons taking Plavix or a daily low dose aspirin will not be excluded but this will be recorded).
* Subjects taking prescription medications for neuropathy.
* Subjects with hemophilia or any other bleeding disorder.
* Subjects with infection with a blood borne pathogen (e.g., HIV, hepatitis).
* Subjects having a condition such as a cognitive disorder, which in the opinion of the Investigator would put the person at risk or seriously compromise the integrity of the study (PI will sign case report form if subject is excluded).
* Subjects working for Facet, LifeScan Inc., or a competitive company.
* Subjects with missing digits.
* Subjects who are pregnant or nursing.
* Subjects on chemotherapy.
* Subjects with poor circulation to the hands as judged by a refill time of more than 5 seconds