cyrilzakka/clinical-trials huggingface dataset:
Treatment Patterns and Treatment Outcomes for Acromegaly

This is a human, prospective and retrospective, single-center study of patients who have undergone treatment for acromegaly in New York City since 1981. The project will characterize, among other factors, the treatment methods received by patients, who administered the treatments and the success of this therapy in terms of biochemical control.

The first phase of this study will be to contact all subjects in the cohort by a mailing introducing them to the study. This will be followed by a phone call and administration of a questionnaire by phone or by mail. The questionnaire will collect current information on acromegaly treatment, morbidities other relevant history. Subjects will provide verbal consent to participate in this questionnaire part of the study and review of their medical records by the Principal Investigator (PI) and study staff.

In the second phase of the study, subjects will be invited to come for a visit that will be conducted by the PI and study staff at the Pituitary Center of Columbia University Irving Medical Center. At this visit written informed consent will be obtained. The investigators will review the subjects' medical history that is obtained from the subject and review any records and laboratory test results provided by the subject and conduct clinical and laboratory assessments. Although all subjects participating in Phase 1 will be invited to participate, it is estimated that 120 of the subjects invited will come for the one visit over the 2-year time frame of this study.

In the third phase of the study a chart review for collection will be conducted and all data will be compiled. All subjects agreeing to participate, both in person and by mail, a chart review of all relevant patient data including demographic, clinical, biochemical, surgical and follow up information. Data from questionnaires and record reviews will be compiled for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females.
* Ages 18 and over.
* Presenting to the PI or one of the sub-investigators for evaluation of acromegaly.
* Must be an Acromegaly subject that have undergone Pituitary surgery with Dr. Bruce or Dr. Post or Present it to principal investigator Dr. Pamela Freda at the Neuroendocrine Unit at Columbia University Medical Center for evaluation of Acromegaly.

Exclusion Criteria:

* Subjects who are unwilling to comply with the procedures outlined in the study.
* Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures.
* Not being treated for acromegaly either by Dr. Bruce, Dr. Post or Dr. Freda.
* Are unwilling to provide informed consent to participate in the study.
Estimating Lymphocyte Counts from DNA Methylation

The goal of this observational study is to assess lymphocyte levels in colorectal cancer patients using DNA methylation levels in tissues or blood. The main questions it aims to answer are:

Can DNA methylation features calculate lymphocyte levels? Can the calculated lymphocyte levels assess the efficacy and prognosis of immunotherapy?


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with colorectal cancer by colonoscopy pathology and deemed eligible for immunotherapy after assessment.
2. Neoadjuvant immunotherapy regimen includes PD-1 or anti-PD-L1.
3. R0 resection is performed after neoadjuvant immunotherapy.
4. Complete immunotherapy efficacy assessment data and follow-up data are available.
5. The tissue bank stores the required whole blood and tissue samples for the experiment.

Exclusion Criteria:

1. Concurrent other malignancies.
2. Neoadjuvant immunotherapy not conducted according to the standard protocol.
3. Severe adverse chemotherapy reactions that lead to the discontinuation of immunotherapy midway.
4. Lack of complete neoadjuvant chemotherapy efficacy assessment data or follow-up data.
5. The tissue bank does not store the required whole blood or tissue samples for the experiment.
6. Patients with concurrent other immune system diseases.
Impact of Right Atrial Occlusion on TEVAR Outcomes

Though the application of thoracic endovascular aortic repair (TEVAR) for treatment of aortic pathology is expanding, there remains a gap in the literature examining how intraoperative "reduction or elimination of aortic impulse" (REAI) techniques, in particular the use of right atrial occlusion, may impact patient important clinical outcomes. This study aims to provide prospective data from a large cohort of TEVAR patients to explore clinical outcomes following TEVAR procedures and, specifically, whether right atrial occlusion has significant impact on clinical outcomes, as compared to other REAI techniques. The results from this study may inform future perioperative TEVAR practices and improve TEVAR patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* thoracic endovascular aortic repair
* right atrial balloon occlusion for reduction or elimination of aortic impulse
* endograft deployment in landing zones 0-3

Exclusion Criteria:

* age 18 years or younger
* non-thoracic endovascular aortic repair
* reduction or elimination of aortic impulse using technique other than right atrial balloon occlusion
* endograft deployment in landing zones 4 and beyond
Lifei Xiaoji Wan in Treatment of Advanced NSCLC

This study is to evaluate the clinical efficacy of Lifei Xiaoji Wan for advanced non-small cell lung cancer (NSCLC), establish the treatment scheme, and obtain high-quality clinical evidence.

Non-small cell lung cancer (NSCLC) is a disease with high morbidity and mortality, poor prognosis, and a lack of safe and effective treatment. Lifei Xiaoji Wan has significant advantages in the treatment of advanced NSCLC, but the a lack of high-level clinical evaluation evidence and accurate mechanism of action research. According to the previous animal experiments of the team, it was proved that Lifei Xiaoji Wan can significantly inhibit the tumor growth ability of lung cancer mice, and inhibit the proliferation, clonal formation, and migration ability of lung cancer cells. This topic intends to adopt the method of multicenter randomized controlled study to observe the Lifei Xiaoji Wan for advanced NSCLC patients' overall survival (OS), progression-free survival (PFS), Functional Assessment of Cancer Therapy-Lung (FACT-L), TCM symptoms and syndrome and safety, help to clarify the role of Lifei Xiaoji Wan in TCM prevention and treatment of lung cancer, can provide high-level evidence for TCM prevention and treatment of lung cancer research and clinical.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of NSCLC.
2. The tumor stage (TNM) stage is from III to IV.
3. 18-80 years old.
4. The expected survival period is\> 3 months.

Exclusion Criteria:

1. Early-stage patients with prior surgery and no recurrence.
2. Patients with serious dysfunction of the heart, liver, heart, kidney, and other important organs.
3. Mental illness and other patients were unable to complete the study.
BE Study of Naftifine HCL

The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study.

The study duration for each patient was 6 weeks: Following were the visit details.

V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females aged more than or equal to 18 years
2. Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae)
3. The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)

Exclusion Criteria:

1. Pregnant or lactating or planning to become pregnant during the study period
2. Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
3. Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
4. Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
5. Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
6. Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
7. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
8. Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
9. History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
10. Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation
Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial.

The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.


Eligibility Criteria:
Inclusion criteria:

* Patients with aortic valve disease where there is indication for implantation of a biological stented aortic valve with or without coronary bypass surgery.
* Age 60 years Sinus rhythm

Exclusion Criteria:

* Patients planned for double valve surgery
* Patients with active endocarditis
* Patients with atrial fibrillation/flutter
* Patients in anticoagulation treatment of other reason.
* Patients with previous cerebrovascular accidents or insults.
* Patients with TCI
* Patients with hypercoagulable conditions, disseminated intervascular coagulation, haemophilia or any other blood coagulapathy or related condition, whereby the blood coagulation process is not readily controllable
* Patients with pacemaker
* Any other disease than valve disease that will considerably increase the operative risk and increase the probability that the patient dies within one year after the operation, for example because of terminal cancer
* Patients that is HIV-positive or have active AIDS
* Patients that are known drug abuser
* Patients in chronic haemodialysis or other types of dialysis
Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer

The aims of the trial are (1) to determine the tolerability rate in the setting of a multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and complete pathologic response rate in patients with locally advanced rectal cancer who are treated with an integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated and pathologically proven adenocarcinoma of the rectum.
* MRI staged T3 or T4, any N.
* Lower border of tumour must be within 12 cm of anal verge.
* Age greater than or equal to 18 years.
* ECOG Performance Status 0-1 (Appendix 2)
* Absolute neutrophil count greater than or equal to 1.5 x 109/L, haemoglobin greater than or equal to 90 g/L, and platelets greater than or equal to 100 x 109/L.
* Adequate renal function: GFR greater than or equal to 55 mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques).
* Bilirubin and ALT less than or equal to 1.5 x upper limit of normal.
* No symptomatic peripheral neuropathy greater than or equal to grade 2.
* Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive.
* Has provided written informed consent for participation in this trial

Exclusion Criteria:

* Presence of metastatic disease.
* Prior pelvic radiotherapy
* Febrile intercurrent illness or infection.
* Previous history of unstable angina
* Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment
* Acute coronary syndrome even if controlled with medication
* Myocardial infarction within the last 12 months
* Concurrent treatment with other anti-cancer therapy.
* Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
* Locally recurrent rectal cancer.
Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis

Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy with thumb splinting vs. splinting only.

Patients with radiologically and clinically confirmed Eaton-Glickel II osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo SVF injection and splinting vs. splinting only.

Baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months after enrollment. The primary end-point is 6 months and the primary outcome is pain visual analogue scale and patient-rated wrist evaluation (PRWE).


Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years
* Eaton-Glickel II thumb CMC osteoarthrosis
* Symptom duration \> 3 months
* Pain visual analogue score \> 30 mm
* \< 3 months of treatment with thumb splinting
* American Society of Anaesthesiologists physical status (ASA) I-III
* Fluent in written and spoken Finnish

Exclusion Criteria:

* Age \<40 or \>70 years
* Eaton-Glickel I, III-IV
* Symptom duration \< 3 months
* Pain VAS \< 30 mm
* Post-traumatic osteoarthrosis of thumb CMC I
* Rheumatoid arthritis or other inflammatory joint disease
* The use of per oral corticosteroids or other immunomodulatory drugs
* Less than 6 months after another operation of the same upper limb
* Other condition of the same upper limb requiring surgery
* Malnutrition
* Neurological condition affecting upper limb function
* Heavy smoking (\> 20 cigarettes per day)
* Alcohol or drug abuse
* Previous history or active cancer
* Previous history of allergic reaction to local anaesthetic
Belatacept for Renal Transplant Recipients With Delayed Graft Function

Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.

Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).

Eligibility Criteria:
Inclusion Criteria:

1. Signed Written Informed Consent
2. Deceased donor renal transplant recipient
3. Men and women, aged 18-60 years of age

Exclusion Criteria:

1. Seronegative or unknown EBV serostatus
2. Patients unwilling or incapable of providing informed consent.
3. Patients with active tuberculosis or positive TB test without evidence of infection treatment.
4. Patients with demonstrated acute rejection on first biopsy evaluation for delayed graft function; Second transplant or multiple organ transplant; patients more than 12 days post renal transplant prior to enrollment
5. Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for study enrollment by the primary physician
6. Inadequate vein access to receive monthly IV infusions
7. Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or Belatacept preventing therapy.
8. Pregnant women or women of child bearing age not willing to commit to dual contraception prophylaxis
9. Use of alemtuzumab (Campath 1-H©), basilixumab (Simulect©) and daclizumab (Zenapax©) are not permitted in this protocol; Use of other immunosuppressive agents must be limited to those specified in this protocol.
10. Prisoners or subjects who are involuntarily incarcerated.
11. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
12. Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or class II
Telehealth Activity Intervention After Lumbar Spine Surgery

The overall objective of this randomized controlled study is to examine the preliminary efficacy of a physical activity intervention that includes wearable technology and remote physical therapist support in patients undergoing lumbar spine surgery. Patients will be randomized to receive 8 sessions of a telehealth physical activity intervention (n=30) or usual postoperative care (n=30). The Investigator's central hypothesis is that a postoperative telehealth physical activity intervention will lead to greater improvements in objective physical activity (primary outcome) and patient-reported physical function, disability, and pain (secondary outcomes) compared to usual care in patients undergoing lumbar spine surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18 years or older
2. Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
3. English speaking

Exclusion Criteria:

1. Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy
2. Patients having surgery for spinal deformity as the primary indication
3. Patients having revision surgery
4. Patients having surgery for pseudarthrosis, trauma, infection, or tumor
5. Presence of back and/or lower extremity pain \< 3 months
6. History of neurological disorder, resulting in moderate to severe movement dysfunction
7. Unable to provide stable address and access to internet and smartphone or tablet/iPad/computer/laptop indicating the inability to participate in the intervention
Reducing Fasting Time for Breast Milk to 3 Hours

The aim of this study is to ascertain Gastric residual volume (GRV) of gastric contents in 35 infants who are breast fed 3 hours prior to general anaesthesia. The secondary aim of this study is to ascertain how well ultrasound (USS) derived measurement of GRV, using the gastric antrum cross sectional area (ACSA), correlates to direct measurement via aspiration.

Current UK guidance recommends a fasting time of 4 hours for breast milk prior to general anaesthesia. Gastric emptying (GE) of breast milk and formula preparations has been extensively studied in neonatal intensive care settings for preterm and low birth weight infants, in order to establish optimum feeding regimens for growth. Methodologies utilised in such studies can make applying findings to current routine anaesthetic practice difficult: Such as inclusion of very low birth weight infants, use of fortified breast milk, administering feeds via nasogastric tube and pre-medication of children prior to GA with atropine.

There is a paucity of evidence in breast fed, un-premedicated term babies/infants subjected to a 3 hour fast prior to GA.

Pulmonary aspiration is known to be a rare event associated with lower morbidity and mortality in children than adults . In animal studies, instillation of acidified milk solutions into the lungs of anaesthetised rabbits is associated with increasing severity of lung injury as volume of solution increases above 0.8 ml/kg regardless of pH.

Anaesthetising a child or adult with a full stomach is more hazardous and requires alteration of the anaesthetic technique to minimise risk of aspiration. Gastric ultrasound (USS) is a useful tool for assessing stomach volume prior to induction of anaesthesia. Various formulae have been devised to convert measured gastric antral area to volume in children. USS is validated in older children and adults in measurement of gastric ACSA and derived volume of gastric contents.

We will perform a prospective, interventional study of 35 term infants aged 37 weeks to 18 months, undergoing elective surgery

Eligibility Criteria:
Inclusion Criteria:

* Babies born at or after 37 weeks post menstrual age
* Babies born prior to 37 weeks who are now more than 37 weeks corrected post menstrual age (PMA)
* Elective surgery
* Breast fed including expressed breast milk, in isolation or combination with solids or formula.

Exclusion Criteria:

* Babies who are less than 37 weeks PMA,
* Ex premature babies who are now greater than 37 weeks PMA but who have significant lung, heart, kidney or liver disease.
* Known delayed gastric emptying
CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study

The main purpose of this study is to measure the amyloid burden, defined as extracellular volume (ECV) assessed by Magnetic Resonance Imaging (MRI) over time in a subset of up to 150 participants enrolled in ION-682884-CS2 (NCT04136171).

This pilot study will determine the efficacy of ION-682284 in reducing the amyloid deposit on the heart tissue compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

To participate in the ION-682884-CS2MRI sub-study, participants must meet all inclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).

Exclusion Criteria

1. Contraindication or sensitivity to MRI contrast agents
2. Orthopnea of sufficient severity to preclude supine scanning at screening.
3. Weight or body girth exceeds the limits of the cardiac MRI machine specifications.
4. Contraindication to cardiac MRI scanning, as assessed by local MRI safety questionnaire/checklist.