cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Camrelizumab in Real-World Study

This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.

Camrelizumab is a humanized antibody for cancer immunotherapy. The National Medical Products Administration (NMPA, China) approved camrelizumab as a first-line treatment of certain patients with NSCLC.

This is a multicenter non-interventional study, NSCLC patients who have been treated with camrelizumab will be included. The main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Histopathological diagnosed confirmed non-small cell lung cancer;
3. Have received at least one camrelizumab injection between August 1, 2019 and December 31, 2020;
4. Traceable cases.

Exclusion Criteria:

1. Patients who have received other immunotherapy at the same time;
2. Patients who were participating in other intervention studies;
3. Patients with other malignant tumors;
4. The researcher believes that the patient is not suitable to participate in this study with any other conditions .
Enhanced Recovery After Surgery In Hirschsprung Disease

The study is designed to determine if enhanced recovery after surgery (ERAS) principles could provide benefit for pediatric patients undergoing radical surgery for Hirschsprung's Disease (HD). Half of patients will receive the ERAS program, while the other half will receive the traditional program.

Optimized peri-operative care within an enhanced recovery after surgery (ERAS) protocol is designed to reduce morbidity after surgery, resulting in a shorter hospital stay. The present study evaluated this approach in the context of radical surgery for pediatric patients with Hirschsprung's Disease(HD). Patients undergoing radical surgery for HD will be enrolled in a randomized clinical trial comparing ERAS protocol vs a control group that received standard care. The primary outcome is median length of postoperative hospital stay. The second outcomes include postoperative complications rates，gastrointestinal function recovery time，mean cost per patient，readmission rates within postoperative 30 days，and the levels of stress and inflammation marker.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Hirschsprung Disease

Exclusion Criteria:

* with other disease
* receive emergency surgery
* need to do the ostomy
* full colonic Hirschsprung Disease
MASTER SL Clinical Study

The purpose of this study is:

* to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation;
* to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use;
* to determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.


Eligibility Criteria:
Inclusion Criteria:

* Male and female ≥18 years;
* Radiologically confirmed diagnosis of primary osteoarthritis (OA) of the hip and suitable for primary total hip replacement;
* Life expectancy of \>10 years;
* Voluntary written Informed Consent obtained.

Exclusion Criteria:

* Prospect for recovery to independent mobility compromised by known coexistent, medical problems;
* Requiring revision hip replacement;
* Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
* Previous organ transplant;
* Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months;
* Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score \<18 points;
* Body mass index (kg/m2) exceeds 40;
* Active or suspected infection;
* Known sensitivity to device materials;
* Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.
An Iodine Balance Experiment

A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different periods. The total iodine intake from diet, water and air as well as the total iodine excretion by urine, faces and respiration were monitored and determined, and a total of 300 samples were collected. The sweat iodine loss was also considered. Moreover, the regression curve model between the 24-h iodine intake and 24-h iodine excretion was also established.

The experiment was conducted between November and December with a total duration of 1 month. Referring to the experience from Harrison and Dworkin, however, considering the negative iodine balance reported, during the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week. The total daily iodine intake consisted of dietary iodine intake, water iodine intake and iodine from breathing, while iodine could be excreted out of human body by urine, faces, sweat and breathing. The 24-h iodine intake and 24-h iodine excretion were determined in each individual participant, and the iodine balance was calculated accordingly.

Eligibility Criteria:
Inclusion Criteria:

* The ones with normal thyroid function, urinary iodine concentration, agree with the experiment.

Exclusion Criteria:

* The ones with abnormal thyroid hormone level, urinary iodine concentration (UIC) or autoantibody-positive were excluded from the study.
Percutaneous Tenotomy of the Toe Flexor Tendon is a Simple and Efficient Method in Treating Checkrein Deformity

Checkrein deformity represents a dynamic claw toe deformity. Surgical intervention is the treatment of choice and many methods have been proposed. The purpose of this study is to evaluate the outcomes and complications of percutaneous segmental tenotomy of the toe flexor tendons.

The investigators reviewed fourteen patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010. Five patients received FHL and flexor digitorum longus (FDL) tenolysis at the musculotendinous junction; among them, two also underwent Z-plasty lengthening of the FHL tendon. Nine patients underwent percutaneous segmental toe flexor tenotomy. The Hallux Metatarsophalangeal- Interphalangeal Scale (Hallux MTP-IP scale) and Foot and Ankle Outcome Score (FAOS), English version LK1.0 self-explanatory questionnaire were used to evaluate the functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with checkrein deformity who underwent surgery in our hospital between 1993 and 2010.

Exclusion Criteria:

* Patients who had static or rigid claw toe deformity
* Patients who had claw toe deformity secondary to neuromuscular disease
Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor

BAY63-2521 Riociguat leads to the relaxation of smooth muscle cells in pulmonary arteria and may also inhibit abnormal remodeling of lung blood vessels. In patients with pulmonary arterial hypertension Riociguat showed to reduce the pulmonary blood pressure and improved the right heart function without unacceptable side effects. Here dose of Riociguat will be adjusted over 8 weeks then a Maintenance Phase of 16 weeks follows. Patients with Pulmonary Arterial Hypertension treated with stable doses of Phosphodiesterase Type-5 Inhibitors (Eg Sildenafil, Tadalafil) not appropriately responding to therapy will be included. Based on previous evidence and on the different modes of action an improvement of exercise capacity, heart function and quality of life may be expected if PDE5i treatment is transitioned to riociguat.

Where Riociguat is pending market approval or reimbursement once the treatment phase is completed drug can be made available for another 18 months (Extended Drug Supply Phase - EDSP) under study conditions. Patients may also transition at the end of the maintenance period or any time during the EDSP to any program that is intended to provide riociguat until drug approval/reimbursement, e.g. a long-term extension study, compassionate use or named patient program. Study termination is also possible at any time.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients (18 -75 years of age) with idiopathic, familial, drug/toxin induced and associated PAH due to congenital heart disease (Group I / Dana Point Classification of PH) demonstrating insufficient response to treatment with PDE-5i for at least 3 months
* Patients with and without endothelin receptor antagonist (ERA) therapy
* World Health Organization Functional Class (WHO FC) III at screening
* 6-minute walking distance (6MWD) of 165-440 m
* Cardiac index \<3.0 L/min/m\*2.

Exclusion Criteria:

* All types of PH except subtypes of Dana Point Group I specified in the inclusion criteria
* Evidence of clinically significant restrictive or obstructive parenchymal lung diseases
* Diffusing capacity of the lung for carbon monoxide (DLCO) \<30% predicted
* History or active state of serious hemoptysis / pulmonary hemorrhage including those managed by bronchial artery embolization
* Patients unable to perform a valid 6MWD test
* Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective methods of birth control, for example a combination of condoms with a safe and highly effective contraception method (prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) or a double barrier method is used throughout the study.
A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine.

Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up to approximately 34 patients may be enrolled into the study.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age ≥18 years
* Histologically documented Stage IV ductal adenocarcinoma of the pancreas
* Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
* ECOG performance status of 0 or 1
* Adequate hematologic and end-organ function
* Evaluable or measurable disease per RECIST v1.1
* For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception

Exclusion Criteria:

* Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer
* Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
* Known hypersensitivity to any component of study treatments
* Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
Interleukin-2 in Metastatic Kidney Cancer

The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used in this study will help increase tumor shrinkage.

In this phase II study, the IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a cohort of kidney cancer patients to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (\> 1440 million IU/m2/year).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a histologic diagnosis of metastatic kidney cancer. Patients may have received prior systemic therapy or may be previously untreated
2. Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
4. White blood count of \> 3500/mm3, platelet count \> 100,000/mm3, hemoglobin \> 9.0 gm/dl; bilirubin, ALT, AST \< 3 x upper limit of normal; serum creatinine \< 2.0 mg/dl.
5. Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
6. Patients with elevated temperatures \> 100.5 F must have sources of occult infection excluded.
7. Patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy.
8. Patient consent must be obtained prior to entrance onto study.
9. Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment

Exclusion Criteria:

1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
4. Lactation or pregnancy.
5. Evidence of significant cardiovascular disease including history of recent (\< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
6. Current brain metastasis.
New Biomarkers Evaluating Ovarian Cancer

The purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits.


Eligibility Criteria:
Inclusion Criteria:

* Female, age 18 years or older
* Adnexal mass present documented by imaging
* Scheduled to undergo surgery based on a finding of adnexal mass
* Able and willing to provide Informed Consent

Exclusion Criteria:

* Previous history of ovarian cancer
* Previous history of bilateral oophorectomy
* Currently known to be pregnant
* Unable to provide informed consent
A Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

The purpose of this study is to evaluate the safety of Ibrutinib in Japanese participants with treatment-naive chronic lymphocytic leukemia ( CLL) or small lymphocytic lymphoma (SLL).

This is a Phase 1, open-label and multicenter study. The study consists of a Screening Phase (28 days prior to the first administration of the study drug), Treatment Phase (time when the first dose of ibrutinib is administered until disease progression, the investigator no longer considers the treatment to be tolerable, or the participant meets any one of the discontinuation criteria) and Follow-up Phase (end of the last dose of study drug until 30 days after the last dose of study drug or the start of subsequent anti-CLL/SLL therapy, whichever comes first). Participants will be instructed to take 3 capsules of ibrutinib (at a dose of 420 mg) orally once daily starting at Cycle 1, Day 1. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets published diagnostic criteria
* For CLL participants: Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than (\>) 1.5 centimeter (cm) at the longest diameter at a site that has not been previously irradiated. Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine; For SLL participants: At least 1 measurable site of disease according to the Revised Response Criteria for Malignant Lymphoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Adequate hepatic function, defined as serum aspartate transaminase (AST) and alanine transaminase (ALT) \<2.5 × upper limit of normal (ULN), and total bilirubin less than or equal to (\<=) 1.5 × ULN (unless due to Gilbert's syndrome)
* A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) or urine pregnancy test at screening

Exclusion Criteria:

* Known involvement of the central nervous system by lymphoma or leukemia
* History or current evidence of Richter's transformation or prolymphocytic leukemia
* Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
* Any previous treatment (chemotherapy, radiotherapy, and/or monoclonal antibodies) intended specifically to treat CLL/SLL
* Received any immunotherapy, live vaccine, or investigational drug within 4 weeks prior to the first dose of the study drug
A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.

The study terminated on 08MAR2016 as it met its objectives of characterizing long term safety and tolerability. The study did not terminate due to safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Have participated in qualifying study with CP-690,550 and are 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris).

Exclusion Criteria:

* Non-plaque or drug induced forms of psoriasis;
* Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB).
* Any uncontrolled significant medical condition.
SMART@Home Feasibility Trial

The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools.

Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study.

A beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma
* Ages 11-17
* English fluency for patient and caregiver

Exclusion Criteria:

* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA

German stroke units are hesitating to use Aggrenox for secondary ischaemic stroke / transient ischaemic attack (TIA) prevention in a sub-acute treatment setting. They argue that clinical experience with sub-acute Aggrenox treatment is limited and poorly documented when compared with sub-acute acetylsalicylic acid (ASA) treatment. However, long term treatment (started after 3-6 months after stroke/TIA) with Aggrenox was safe and superior to ASA treatment in preventing recurrent strokes. There is no evidence for ASA to prevent from neurological progression after stroke during the first 3 months. Results from a cohort study suggest that starting Aggrenox within 72 hours after stroke predicts clinical improvement in the National Institute of Health Stroke Scale (NIHSS) at discharge from the hospital. Dipyridamole suppresses acute inflammatory responses to stroke.

This study is designed to investigate the tolerability and efficacy of a secondary stroke prevention treatment with Aggrenox when initiated within 24 hours of stroke onset on a stroke unit compared to later initiation after a 7 day ASA treatment and outside off a stroke unit setting.


Eligibility Criteria:
Inclusion Criteria:

-Clinical diagnosis of ischaemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Symptoms must be distinguishable from an episode of generalised ischaemia (i.e. syncope), seizure, or migraine disorder.

Main inclusion criteria:

* Patients at risk of stroke who have had transient ischaemia of the brain or completed ischaemic stroke due to thrombosis
* Symptoms of ischaemic attack began less than 24 hours prior to study medication start, are to be present for at least 30 minutes and have not significantly improved before start of treatment
* Patients are eligible for platelet inhibiting treatment
* National Institute of Health Stroke Scale (NIHSS) between 5 and 20 (at pre-screening and screening)
* Actual Modified Rankin Scale (mRS) (at baseline) is worse than retrospective mRS (before stroke)
* A contraindication for stroke lysis is given
* Patients are able to give (at least oral) informed consent and to swallow either medication

Exclusion Criteria:

* Hypersensitivity to any of the components of the product or salicylates.
* Patients with active gastric or duodenal ulcers or with bleeding disorders.
* Pregnancy during the third trimester.
* Lysis therapy.
* A platelet inhibiting therapy with Acetylsalicylic Acid (ASA) doses of more than 100 mg per day, or with clopidogrel of any dose has been planned or started.
* Time of onset of stroke symptoms is unknown (when a stroke happened during night-/sleeping time, bedtime is assumed as time of onset)