cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

Although several clinical trials provide evidence for efficacy benefit for Checkpoint Inhibitors plus chemotherapy for lung cancer. However, there was rare evidence for clinical evidence in Hunan province.

This prospective study aimed to assess its efficacy and adverse event for Checkpoint Inhibitors with or without chemotherapy in clincial practice. Several cohorts were devided including pathological type, treatment line, treatment regiems, combination strategies. Tissue samples were collected with permission of patients for TME evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18，Lung Cancer Confirmed by Histopathology
2. Treated with Chemotherapy with or Without Checkpoint Inhibitors.
3. ECOG 0 - 1.
4. Predicted survival ≥ 12 weeks.
5. Adequate bone marrow hematopoiesis and organ function
6. Presence of measurable lesions according to RECIST 1.1.
7. Subjects with stable brain metastases may be included in the study.

Exclusion Criteria:

Patients did not match for the Inclusion Criteria.
Retrospective Postoperative ARDS Study at Vanderbilt University

By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS.

Acute respiratory distress syndrome (ARDS) is a pulmonary disease process that affects post-surgical patients in the intensive care unit and leads to significant patient morbidity and mortality and hospital cost. Extensive research has been conducted in the diagnosis and treatment of ARDS. To date, however, very little research examining the effect of the operative course on the development of ARDS has been reported. By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS. Once identified, the variables can be confirmed by future studies and encourage change in clinical care to decrease the occurrence of ARDS in surgical patients.

Eligibility Criteria:
Inclusion Criteria:

* ARDS
* post-surgical
* ventilator

Exclusion Criteria:

* rib fracture
* pneumonia
* sepsis
Feasibility of an Extended Test Battery and Influencing Factors for Detecting Frailty

The aim of the prospective study is to assess the feasibility of a screening and baseline measurement protocol that is planned for a main study (PRÄP-GO) in a collective of 30 patients ageing 70+ scheduled for elective surgery. Comprehensive geriatric assessment scores and modified Fried frailty phenotype component evaluation are performed in all patients at baseline before elective surgery. The assessment of cognitive tests is conducted with a battery of neuropsychological tests, computer-based tests from the Cambridge Neuropsychological Test Automated Battery \[CANTAB®\] and non-computer based tests. Frailty scores from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) represent robust (0), pre-frail (1-2), and frail (3-5) health status. 10 patients without Frailty, 10 patients with Pre-Frailty and 10 patients with Frailty should be analyzed in this study and receive further comprehensive geriatric assessment testing up to seven days after surgery/discharge (before 7 postoperative days).


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 70 years
* Male and female patients
* Patient eligible for inclusion: by the patient, preoperatively
* elective surgery
* Expected anesthesia duration\> 60min

Exclusion criteria:

* Severe cardiological or pulmonary disease (NYHA IV, Gold IV)
* Intracranial interventions
* Moribund patients (palliative situation)
* Not enough language skills
* Non-consenting patients
* Participation in another prospective intervention study for study inclusion or throughout the study period.
Beginning Early and Assertive Treatment for Methamphetamine Use Disorder

The overall goal of the study is to evaluate the effectiveness of a secondary prevention strategy implemented at a systems-level to prevent stimulant related overdoses.

To date, a public health systems approach to enhance linkage and engagement in care for stimulant use disorders is lacking. This shortcoming arises in part from the lack of effective treatments for stimulant use disorders (StUD), the specific pathology of methamphetamine use, and gaps in epidemiologic knowledge related to methamphetamine use disorder. Unlike opioid use disorders, for which medications relieve dysphoric symptoms of acute withdrawal and prevent relapse, patients with StUD present to care with methamphetamine-induced psychosis and may be combative, agitated, and poorly insightful to their need for treatment. In response to community demands, our team at Denver Health recently established a pilot program, Beginning Early and Assertive Treatment for Methamphetamine Use Disorder (BEAT Meth), to protocolize the assessment and treatment of patients with methamphetamine-induced psychosis.The current research project aims to develop and conduct process and outcomes evaluations of a linkage intervention aimed at increasing continuation and engagement in treatment for stimulant use disorder.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* identified in the Denver Health healthcare system who have had a methamphetamine-related encounter at Denver Health

Exclusion Criteria:

* unable to complete the interview in English
* intoxicated or impaired and unable to consent to participate in the project and/or respond to the interview
* currently under residential involuntary psychiatric or substance treatment order (i.e., mental health hold, emergency commitment, or short-term certification)
* received any type of substance use treatment at DHHA in the last 90 days
* planning to enter substance treatment
* unable to complete the research visits in the next 90 days
Efficacy and Safety of NVP-NK4146 in Patients with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

The purpose of this clinical trial is to exploratively evaluate the efficacy and safety of NVP -NK4146 in improving mild cognitive impairment (MCI) in patients with due to Alzheimer's disease (AD) compared to placebo

36-week, single-center, randomized, double-blind, parallel-design, placebo-controlled trial

Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged 60 or older
2. Subject who meet the National Institute of Aging and Alzheimer's Associations (NIA-AA) core clinical criteria for MCI and have positive readings from amyloid PET
3. Subject who can read and understand the Informed Consent Form and legends and who voluntarily decided to participate in current clinical trial and have signed the Informed Consent Form

Exclusion Criteria:

1. Subject diagnosed with dementia according to the criteria of DSM-5 or ICD-10
2. Subject currently receiving treatment for malignant tumors (except those who have fully recovered from cancer for more than 5 years or those with basal cell carcinoma, squamous cell carcinoma, or prostate cancer may participate at the investigator's discretion)
3. Subject who are illiterate and/or without any education
4. Any other factors deemed by the investigator to be likely to ineligible for the study
The Effects of Interrupting Prolonged Sitting With Intermittent Exercise on Postprandial Lipemia

The purpose of this study is to investigate the effect of interrupting prolong sedentary behavior with interval exercise on postprandial metabolism following a high fat glucose tolerance test.

All subjects complete two trials in a randomized crossover design, with each trial occurring over 4 days with a minimum of seven days between trials. The first two days of each trial serve as a control period allowing for familiarization and the control of physical activity and calorie consumption prior to the intervention. Following each control period, subjects then perform one of the interventions on Day 3. The interventions consist of either eight-hours of prolonged sitting, or eight hours of sitting interrupted every hour by five sprints lasting 4 seconds each using the interval exercise. On day 4, all subjects will undergo a high fat glucose tolerance test to determine the body's ability to clear triglycerides from the blood as well as insulin/glucose response and substrate oxidation. Blood samples will be assayed for the previously mentioned substances and postprandial gas collection will be analyzed via indirect calorimetry.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
* respiratory problems
* musculoskeletal problems that prevent prolonged sitting or exercise
* susceptibility to fainting
* Pregnancy
A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers

To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.

Additional Study Purpose Details: Phase I safety and pharmacokinetics study.

Detailed Description:

The study was terminated on 11/12/2008. There were no safety findings in this trial that resulted in the decision to terminate the trial. The study was closed in order to change the amount of drug that subjects would take and to shorten the number of days that the drug would be taken in a new study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Elderly
* 65-85

Exclusion Criteria:

* Evidence or history of clinically significant unstable disease
Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients

Glioblastoma multiform is one of the most invasive and deadly cancers that progresses rapidly and leads to death. Surgery with radiotherapy /chemotherapy, as a treatment approach is ineffective in some cases and is associated with relapse and death. Immunotherapy is a special strategy that used as an adjunct therapy in various cancers and among the various methods of immunotherapy; it seems that cell therapy with NK cells is of special importance. A previous study conducted at the Royan Research Institute showed that NK cell proliferation and amplification resulted in the removal of glioblastoma tumor masses in the animal model. The animals had no evidence of tumor recurrence after treatment, and all tumor-related complications resolved after treatment. Therefore, in this study, the investigators intend to evaluate the safety of ex vivo activated cells in 5 patients with glioblastoma multiform whose disease has returned after treatment and who have not had any appropriate treatment.

1- patient selection 2- leukapheresis 3- CD56+ cells isolation 4- NK cells activation 5- assessment of functionality and purity 6- quality control tests 7-NK cell injection in tumor cavity.

Eligibility Criteria:
Age: 3-60 Year -

* Sex: Both
* Lansky performance scale/Karnofsky performance scale: 70-100%
* Life span expectation: \>6 months
* Hemoglobin: \> 10.0 g/dl
* Platelet count \> 100,000/mm³
* Serum total bilirubin \< 1.5 times upper limit of normal (ULN)
* ALT and AST \< 2.5 times ULN
* Serum creatinine \< 1.5 times ULN
* No diagnosis of any other invasive cancer within the past 5 years.
* No concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study

Exclusion Criteria:

* Patients whose MRI and MRS images is in favor of radio necrosis.
* Due to emergency conditions, the patient cannot tolerate the new treatment
* Lack of a suitable donor or insufficient number of NK cells.
* Development of a new neurological defect after the first injection
* Patient death during surgery
* Closing the reservoir for the next injection (if this problem is resolved, the injections will be done again).
Cognitive Training After Stroke : Effects and Mechanisms

Stroke is a major cause of severe cognitive and physical disability. Despite the high and increasing incidence, and large health, economic, social and personal consequences, studies designed to remedy cognitive impairments and improve rehabilitation care following stroke are lacking. A promising line of research have shown that weak electrical current (tDCS) can be a safe, cost-effective, and potent treatment when combined with other rehablitational approaches.

The underlying mechanism is assumed that tDCS facilitates neuronal signaling, improving plasticity and facilitating rehablitational outcome. But further research is needed to better understand the mechanisms at hand, and to better evaluate the potential clinical utility.

The scope for the current project is to investigate both cognitive and neuronal effects of tDCS in combination with cognitive training , with the ultimate goal to improve current rehabilitational healthcare. To achieve this we will use multimodal MRI, EEG, and a comprehensive battery of neuropsychological asessment, to describe and evaluate the effect of tDCS in rehabilitation purposes.

Participants are randomly assigned to either active or sham condition, using codes provided by the manufacturer and implemented by an in-house Matlab script, pseudo-randomizing participants while maintaining balance in groups of 20. tDCS stimulation is applied at six occasions for each participant, with a minimum of 48 hours between stimulations, aiming at an average of two stimulations per week. Stimulation current is1000 μA, stimulation time was 20 min for the active group with a ramp-up time of 120 s and fade-out time of 30 s. The current intensity is limited to 1 mA to limit the risk of adverse events due to the electrical stimulation. The sham stimulation consists of ramp-up followed by 40 s of active stimulation and then fade-out, following factory settings.

Cognitive training will be done by the computerized working memory training program (Cogmed Systems AB, Stockholm, Sweden) consisting of 25 online training sessions. In this study, to increase feasibility, we utilize 17 sessions over a period of three to four weeks, corresponding to approximately five weekly training sessions. On average, we aim at two training sessions combined with tDCS per week with a minimum of one day between each tDCS session. The remaining CCT sessions are performed at home.

Neuropsychological assessments and MRI assessments are conducted three times: at baseline 1, after a waiting period of 2-4 weeks (baseline 2, before intervention) and immediately post intervention. Self-reported symptoms of fatigue and depression are assessed at five time points, before, during and after completing intervention.

Eligibility Criteria:
Inclusion Criteria:

- MR/CT revealing ischemic or hemorrhagic damage (stroke).

Exclusion Criteria:

* History of illness or damage to the CNS, besides stroke.
* \<18 years of age
* Extensive cognitive decline or dementia
* Severe psychiatric disorders
* Substance or alcohol abuse
* Contraindications for MRI.
Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis

Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

The purpose of this study is to demonstrate similar efficacy and safety of GP2017 and US-licensed Humira® in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to Disease modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have been diagnosed with RA ≥ 6 months prior to screening
2. Patients must have active disease, defined as DAS28-CRP ≥ 3.2 at the time of screening
3. Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of normal
4. Patients must have had inadequate clinical response to MTX 10 - 25 mg/week

Exclusion Criteria:

1. Previous treatment with adalimumab, other anti-TNFα therapies or cell depleting agents, e.g. anti-CD20 therapy
2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during treatment
3. Nursing (lactating) or pregnant women
4. History of or ongoing inflammatory or autoimmune diseases other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
5. Systemic corticosteroids \> 7.5mg/day within 4 weeks prior to baseline
6. History or presence of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed non-invasive colon polyps, with no evidence of recurrence
7. History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months)
8. Subject known to have immune deficiency, history of positive human immunodeficiency virus (HIV) status or immunocompromised for other reasons
9. History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis)
10. History of persistent chronic infection; recurrent infection or active infections
11. History of tuberculosis, presence of active tuberculosis, latent tuberculosis as detected by imaging (e.g. chest X-ray, chest Computerized Tomography(CT) scan, Magnetic Resonance Imaging (MRI)) and/ or positive QuantiFERON-TB Gold test (QFT)
12. History or evidence of opportunistic infections, e.g. histoplasmosis, listeriosis, legionellosis
13. Positive serology Hepatitis B (either HBsAg or anti-HBc) or Hepatitis C (positive HCV-Ab or HCV-RNA) indicative of previous or current infections
Mother Milk as a Eye Drop & Premature Retinopathy

The aim of this study is to investigate the effect of using breast milk as eye drops on ROP (Retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm babies.

Study Design: Prospective randomized placebo controlled trial Setting/Participants: Premature babies who are at high risk for retinopathy of prematurity (ROP) during their stay in the neonatal intensive care unit (NICU). The study will be carried out at Baskent University and it is planned that 70 participants will be included in the study.

Study Interventions and Measures: After the randomization of the patients, 0.5 ml breast milk of the babies' own mothers will drop on the eye to the intervention group twice a day. IN the control group, %0.9 normal saline will drop as same amount. Primary outcome is any stage of ROP, secondary outcome is severe ROP (laser requiring ROP).

Eligibility Criteria:
Inclusion Criteria:

* Infants born between 22 and 32 gestational age weeks or under 1500 gr birth weight.

Exclusion Criteria:

* Infant death before first examination for ROP
* parents who want to leave from the study
* Contraindications for breast milk use (Active HIV infection, Active tuberculosis, CMV infection)
* Inborn error of metabolism like galactosemia.
* Congenital eye development disorders like agenesis, or situations that do not allow retina examination.
* other lethal congenital molformations
* congenital infections that affect the retina like TORCH infections.
A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People

The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.

The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.

The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 kg/m\^2 (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening.
* Use of tobacco and nicotine products, defined as any of the below:
* Smoking more than 5 cigarettes or the equivalent per day
* Not willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
* History(a) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant(a).
* Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).

  1. As declared by the participant or reported in the medical records
Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time

The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects.

The primary objective of this study is assess the tear film break-up time in mild to moderate dry eye subjects.

Eligibility Criteria:
Inclusion Criteria:

* Corrected VA of 0.6 LogMar or better OU

Exclusion:

* Topical ocular medication use
* Presence of Ocular conditions (blepharitis, conjunctival infections, etc)
Early Signs of Altitude Illness in Patients With COPD

This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel.

This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel. After baseline evaluation at 760 m, patients will travel by bus within 3-5 h to the Tuja Ashu high altitude clinic at 3'100 m and stay there for 2 days. During this period, participants will perform SSM. They are instructed to report to study personnel if they fulfill predefined criteria for impeding altitude-related illness.

A planned interim analysis will be performed after the first year of the study or after completion of study by 80 participants, whichever comes first to allow any necessary adaptations of the sample size or terminate the study early for futility or high accuracy of the index test.

Eligibility Criteria:
Inclusion criteria

* Male and female patients, age 18-75 yrs.
* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92%, PaCO2 \<6 kPa at 760 m.
* Born, raised and currently living at low altitude (\<800 m).
* Written informed consent.

Exclusion criteria

* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1 \<40% predicted; oxygen saturation on room air \<92% or hypercapnia at 760 m).
* Other lung disease or disorder of control of breathing
* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day)