cyrilzakka/clinical-trials huggingface dataset:
ARC1905 (Anti-C5 Aptamer) Given With Lucentis 0.5 mg In People With Neovascular Age-Related Macular Degeneration

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis® 0.5 mg/eye, or with one induction dose of Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

* Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram.

Exclusion Criteria:

* Previous or concomitant therapy with intravitreous corticosteroids.
* Any of the following underlying diseases including:
* Diabetic retinopathy
* History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment.
* History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
* Clinically significant impaired renal (serum creatinine \>2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. Patients with results outside these ranges may be enrolled in consultation with Ophthotech.
* Stroke (within 12 months of trial entry).
* Any major surgical procedure within one month of trial entry.
* Previous therapeutic radiation in the region of the study eye.
* Any treatment with an investigational agent in the past 60 days for any condition.
* Women who are pregnant or nursing.
* Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the ARC1905 formulation.
Preemptive and Precise Intervention for CKD-SHPT

Through multi-center randomized controlled trial studies on preemptive surgical intervention in patients with chronic kidney disease (CKD) - secondary hyperparathyroidism (SHPT), to precisely evaluate the safety and effectiveness during perioperative period, and the long-term outcomes by 1-year follow-up. The follow-ups include the evaluation of the overall quality of life, calcium and phosphorus metabolism, hyperparathyroidism level, vitamin D metabolism, bone mineral density, soft tissue and vascular calcification.


Eligibility Criteria:
Inclusion Criteria:

* 1) Chronic Kidney Disease Stage 3-5d patients aged ≥18 years;
* 2) The diagnosis is consistent with CKD-metabolic bone disease and SHPT after evaluation by a kidney specialist;
* 3) Sustained blood immunoreactive parathyroid hormone level of \> 300ng/ml, and had received drug treatment;
* 4) Persistent hypercalcemia and/or hyperphosphatemia that is not responding to medication;
* 5) Imaging suggested evidence of at least one parathyroid nodular hyperplasia;
* 6) Signed the informed consent.

Exclusion Criteria:

* 1) Age \<18 years old;
* 2) Patients with dialysis duration \< 3 months, or with other unstable dialysis state;
* 3) Kidney transplant patients;
* 4) Who is considered inappropriate to participate in this study after evaluation by the supervising physician.
The Mass Balance Study of [14C]JT001

This study is a single center, single dose, non-randomized, open design clinical study.By quantitative analysis of the biological samples of subjects after oral administration of \[14C\]JT001, the data of human radioactive excretion rate and the main excretion pathway will be obtained. The main metabolites ,metabolic pathways and elimination pathways of JT001 will be identified.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult males
2. Age: 18-45 years old
3. Body weight: Body mass index (BMI) is between 19.0 and 26.0 kg/m2 (including boundary values), and the body weight of the subject is not less than 50.0 kg;
4. Voluntarily sign informed consent;
5. Subjects were able to complete the trail according to protocol.

Exclusion Criteria:

1. Physical examination, vital signs, routine laboratory examination, imaging examination abnormal and clinically significant
2. The electrocardiogram was abnormal and was considered clinically significant by the investigators, or has a history of organic heart disease
3. Has hepatitis B (HBV) or hepatitis C (HCV) or HIV antibody and syphilis antibody positive;
4. Any drug that inhibits or induces the drug transporters P-gp and BCRP has been used within 30 days prior to the screening period
5. Any conditions that may affect drug absorption.
6. Previous antineoplastic therapy meets washout requirements.
7. Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease
8. Habitual constipation or diarrhea.
9. Significant radioactive exposure within 1 year.
Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu

The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.


Eligibility Criteria:
Inclusion Criteria:

* age above 15 years old
* admitted to intensive care unit
* proven or strong suspicion of H1N1 Influenza infection
* diffuse pneumonia (for less than 96 hours)
* need for non invasive or invasive mechanical ventilation

Exclusion Criteria:

* pregnancy
* an age of 15 or less
* rapidly fatal underlying disease with a life expectancy of one month or less
* more than 3 organ dysfunction upon admission
* previous treatment with corticosteroids (ie prednisone 30 mg per day or more, or equivalent, for at least one month)
* formal indication for corticosteroids (eg Addison disease, status asthmaticus)
* already on corticosteroids for 2 days or more in the management of the current episode
* acute lung injury not related to viral pneumonia
* presence of H1N1 related acute myocarditis or encephalitis
* receiving antiviral treatment for more than 5 days
The Study of Metastatic Pancreatic Adenocarcinoma

Phase I part, Primary objective: the maximum tolerated dose of S-1 in the SLOG regimen Secondary objectives: the dose-limiting toxicity of the regimen Phase II part, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate (ORR) + stable disease ≧ 16 weeks), Time to tumor progression, Progression-free survival, Overall survival ,Safety profile, Biomarker study

Phase I: 2\~24 patients Phase II: Considering a design with p0 = 0.25 and p1 = 0.40 for which error is 0.10 and errors is 0.20, these constraints can be met with a two-stage Simon's design of 25 patients in the first stage and 27 patients in the second stage.

Eligibility Criteria:
Inclusion criteria:

1. Patients must have cyto-/histologically confirmed, recurrent or metastatic adenocarcinoma of the pancreas (mPAC).
2. Patients must have no history of prior chemotherapy.
3. Patients with prior radiotherapy.
4. Patients' baseline ECOG performance status must be 2.
5. Patients' life expectancy must be 12 weeks or greater.
6. Patients' age must be 20 and 75.
7. Patients must have adequate bone marrow function.
8. Patients must have adequate liver and renal function.
9. All patients must be sign and give written informed consent.

Exclusion criteria:

1. Patients who have major abdominal surgery, radiotherapy.
2. Patients with central nervous system metastasis.
3. Patients with active infection.
4. Pregnant or breast-nursing women.
5. Patients with active cardiopulmonary disease.
6. Patients who have peripheral neuropathy \> Grade I.
7. Patients who have serious concomitant systemic disorders.
8. Patients who have other prior or concurrent malignancy.
9. Patients who are under biologic treatment for their malignancy.
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection

The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Presenting for a screening, surveillance, diagnostic, or therapeutic colonoscopy
3. Found to have:

   * a sessile serrated lesion or hyperplastic polyp ≥ 10 mm during procedure (Serrated Cohort) or
   * a 10-19 mm conventional adenoma during procedure (Adenoma Cohort)
4. Ability to provide informed consent

Exclusion Criteria:

1. Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
2. Polyps confirmed to be anything other than:

   * sessile serrated lesion or hyperplastic polyp on histologic diagnosis (Serrated Cohort) or
   * conventional adenoma on histologic diagnosis (Adenoma Cohort)
3. Patients with Ulcerative Colitis or Crohn's disease
4. Polyps with features suggestive of submucosal invasion
5. Polyps that are not able to be removed endoscopically due to location (e.g. extending into appendiceal orifice or diverticulum)
6. Patients with a known or suspected diagnosis of any of the following polyposis syndromes with known genetic mutations:

   * Familial Adenomatous Polyposis Syndrome
   * MUTYH associated Polyposis Syndrome
   * Juvenile Polyposis Syndrome
   * Cowden's Syndrome
   * Peutz-Jeghers Syndrome
7. Subjects whose colonoscopy procedure is not able to be completed due to bowel prep precluding polyp identification.
Early Intervention for Erectile Dysfunction After Laparoscopic Resection for Rectal Cancer

Although the high prevalence of erectile dysfunction (ED) was detected among male patients after the treatment for colorectal cancer, published reports depicting the erectile dysfunction experience of patients with colorectal cancer ot underpin service development are insufficient. Furthermore,unlike patients with prostate cancer, men with colorectal cancer are not routinely offered information and treatment for erectile dysfunction.However, investigations on patients after surgery for prostate cancer could provide some potentially useful insights. The ability of sildenafil and vacuum erection device (VED) to aid in the return of erections after nerve-sparing radical prostatectomy has been established, which may benefit rectal cancer patients after surgery with ED.

Laparoscopic surgery, although technically demanding and associated with a long learning curve, has the advantage of clear visualization for the smallest structures,including the autonomic nerves. Laparoscopic resection for rectal cancer could thus facilitate preservation of the pelvic autonomic nerves.

This study aimed to identify whether early intervention is effective at reducing the rate of ED at 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. 18 \< Age \< 70
2. Sexually active men without the consistent use of erectile aids pre-operatively
3. Rectal cancer confirmed by histology
4. Undergoing a bilateral nerve sparing laparoscopic rectal resection
5. IIEF-5 domain score \> =20 before surgery
6. Presence of a female sexual partner
7. Willingness to participate in clinical research as evidenced by their signature on the informed consent form

Exclusion Criteria:

1. Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months
2. Has taken or has been prescribed nitrate medication in any form in the last 6 months
3. Contraindication to sildenafil (e.g. nitrates, hypersensitivity)
4. Contraindication to vacuum erection device (e.g. coagulation abnormality, stick cell disease)
5. Men with a history of known penile deformity or Peyronie's disease
6. Pre or postoperative androgen therapy
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years old
* History of HIV-1 infection
* On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening
* Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks

Exclusion Criteria:

* CD4 counts \< 100 cells/mm3
* Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or greater during the prior 2 months
* Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin
* Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess
Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op.


Eligibility Criteria:
Inclusion Criteria:

1. MRI confirmed diagnosis of a full thickness supraspinatus tendon tear necessitating surgical intervention (rotator cuff repair)
2. Subject is male or female age 18 or older
3. Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study

Exclusion Criteria:

Subjects who meet ANY of the following criteria will be excluded from the study:

1. Shoulder pain primarily attributed to any of the following:

   1. Ligament rupture due to use of fluoroquinolones
   2. Capsular tear
   3. Fracture of the humeral head
   4. Inflammation of the joint or surrounding tissue (i.e. osteoarthritis, bursitis)
   5. Neuropathic, radiating pain from conditions resulting in damage or inflammation of the nerve
   6. Previous history of autoimmune connective tissue disorders (i.e. rheumatoid arthritis, systemic lupus erythematosus)
2. Known history of poor compliance with medical treatments
3. Subject has bilateral supraspinatus tendon tear
4. Subject has signs and symptoms of an active infection of the shoulder joint
5. Retraction of the supraspinatus tendon exceeding 1.5 cm in length
6. Subject has additional injuries requiring further surgical intervention to the ipsilateral arm
7. Subject has had previous surgery in the target arm within the past 6 months prior to treatment or plans to have surgery other than Rotator Cuff Repair in the target arm within 180 days of treatment
8. Subjects currently receiving radiation therapy or chemotherapy
9. Subjects has used an investigational drug, device or biologic within 12 weeks prior to treatment
10. Subjects who are pregnant at enrollment or are planning to become pregnant within 180 days of treatment
11. Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
12. Allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
13. Workers' compensation patients
Clinical Pre-screening Protocol for Ovarian Cancer

The pre-screening study is established to pre-screen tumor samples from ovarian cancer patients to identify if they, at a later stage of their disease, will benefit from treatment with any investigational cancer drugs available to Oncology Venture, when these drugs are approved for future clinical studies by local authorities.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological confirmed epithelia ovarian cancer
* Relapse after 2 or more chemotherapies for ovarian cancer
* FFPE tumor tissue available

Exclusion Criteria:

* Other primary malignancy within the last 5 years prior to enrolment
Neurologic Complications in Peripheral Regional Anesthesia - An Evaluation Based on a Standardized Protocol

To evaluate the incidence of neurologic complications as a consequence of peripheral regional anesthesia, all patients receiving peripheral nerve blocks will be evaluated according to a standardized protocol screening pain, motoric and sensory function recovering to defined periods, and according to a study protocol defining the items.

Neurologic complications as an adverse effect occur in all types of regional anesthesia. Reviewing the literature, the incidence spreads from 0.02 up to 3 percent. The incidence remains unclear because of different types of definitions, too. In this study, we evaluate all patients receiving peripheral regional anesthesia 24 hours after block performance according to a standardized study protocol. In case of any conspicuousness concerning motoric or sensory function or pain, the patient will be evaluated again after 48 hours. Further on, in case of neurologic dysfunction, periods of investigation will be after 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months and 1 year. This study includes the definition for nerve damage concerning motoric and sensory neural function and pain.

The patients will be recruited among all patients from our hospital receiving continuous peripheral regional anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* All patients receiving peripheral regional anesthesia

Exclusion Criteria:

* Missing agreement
MRI-based Neuroimaging Predictors of Clinical Improvements Following Therapy in Children With Cerebral Palsy

The aim of this study is to explore the relationship between brain MRI-metrics and hand function observed in children with cerebral palsy (CP),compared between baseline and the third month, and thus determine the early MRI-based neuroimaging predictor of clinical improvement following therapy in children with CP.

Cerebral palsy (CP) is the commonest cause of neurological disability in children. The upper limbs are often affected, with significant hand involvement from an early age.There are various methods of treatment for CP children with hand function disability. However, there is a lack of effective methods to predict the prognosis.

This prospective cohort study will include children with occupational therapy (OT) or OT plus acupuncture and massage methods. Children with CP will be evaluated in terms of upper limb motor function using the manual ability classification system (MACS), fine motor function measure (FMFM). The Brain injuries of Children will be evaluated by MRI.

The aim of this study is to explore the relationship between brain MRI-metrics and hand function, compared between baseline and the third month, and thus determine the early MRI-based neuroimaging predictors of clinical improvements following therapy in children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Age: 3-18 years
* Spastic cerebral palsy
* The complete clinical and MRI data

Exclusion Criteria:

* previous acupuncture and massage methods
* botulinum toxin upper limb injections
* braces artifact, excessive motion, afraid to enter the MRI
* parents were not interested in the MRI sessions
Study to Evaluate the Efficacy and Safety of SLV306 in Subjects With Hypertension

This study is to compare the efficacy and safety of increasing doses of SLV306 with amlodipine.


Eligibility Criteria:
Inclusion Criteria:

* sitting office diastolic blood pressure between 90 and 109 mmHg
* office systolic blood pressure between 140 and 179 mmHg
* mean day-time diastolic 24-h ABPM blood pressure \>= 85 mmHg inclusive at baseline

Exclusion Criteria:

* known secondary hypertension
* decompensated congestive heart failure
PICSI Impact on Euploidy in Assisted Reproduction

Hyaluronic acid (HA) is a major component of the cumulus complex surrounding oocytes. Intracytoplasmic sperm injection (ICSI) involves injection of a selected sperm into the oocyte. Embryologists select sperm with normal morphology and progressive motility. Physiologic intracytoplasmic sperm injection (PICSI) involves sperm selection for ICSI based on hyaluronan binding. Mature sperm which bind to HA have greater genomic integrity and reduced levels of DNA fragmentation. Earlier observational studies demonstrated improved outcomes in assisted reproductive technologies (ART) including improved clinical pregnancy rates, decreased miscarriage rates and higher live birth rates. A large multicentre randomized trial, the HABSelect trial, which included over 2,500 couples, found that PICSI did not improve term (\>37 weeks gestation) live birth rates compared to standard ICSI. However, mechanistic analysis of the data from the HABSelect trial showed a significant reduction in miscarriage rates, most notable in couples where the woman was aged over 37 years where a significant reduction in miscarriage rate was seen (40% with ICSI vs 15% with PICSI). A 2021 retrospective sibling oocyte study, including 45 cycles, compared fertilisation and embryo development and found higher fertilisation rate in PICSI cycles. No difference was observed in clinical pregnancy rates; miscarriage rates and live birth rates were not reported. We aim to prospectively study PICSI vs standard ICSI in sibling oocytes to investigate if PICSI improves embryological and ART outcomes, particularly fertilisation rate, embryo euploid status and miscarriage rate, where the female patient is aged over 35 years.


Eligibility Criteria:
Inclusion Criteria:

* Couples undergoing a planned ICSI-PGT-A cycle using their own fresh gametes
* Female age \> 35 years and/or Male age \> 40 years
* Minimum of two mature eggs at time of egg maturity assessment

Exclusion Criteria:

* Couples undergoing a planned IVF cycle (even if converted to ICSI)
* Patients using donor gametes for an ICSI cycle
* Patients using frozen gametes for an ICSI cycle
Genetic Epidemiology--Development of Cardiovascular Risk

To determine how genetic and environmental factors influence the co-occurrence of obesity and hypertension during development and to identify cardiovascular risk factors in adolescence that will predict cardiovascular disease in adults.

BACKGROUND:

Obesity and hypertension are two of the major risk factors for cardiovascular disease (CVD) and those with obesity have a greater risk of hypertension. In children and adolescents, high body mass index correlates with elevated blood pressure. Genetic factors make a significant contribution to the variation of obesity and hypertension.

DESIGN NARRATIVE:

Anthropometric, cardiovascular, physiologic and physical fitness data were used to investigate a series of critical issues about the etiology, heterogeneity, comorbidity and developmental trajectories of CVD risk factors, including obesity, hypertension and cardiovascular health. Using the two datasets, the main questions of the study were addressed. How do genes and environment act and interact to create covariation between obesity and hypertension, and were the genetic and environmental factors the same at all ages (from childhood to late adolescence and adulthood) in both sexes? Areas of research included the following: causes of individual differences in anthropometric and cardiovascular characteristics, their covariation and developmental change or continuity in adolescence, parent-offspring transmission, prediction of cardiovascular risk, and sex, race and population differences in genetic and environmental contributions on cardiovascular risk factors.

Eligibility Criteria:
No eligibility criteria