cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer

The purpose of this study is to compare the efficacy and safety of two different chemotherapy types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Present with histologically proven or cytological diagnosis of non-squamous non-small cell lung cancer (NSCLC) Stage IIIB or IV.
* Participants must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
* Female participants must not be pregnant.
* No prior systemic chemotherapy for lung cancer.
* At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors.
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
* Adequate organ function.
* Prior radiation therapy allowed to \<25% of the bone marrow.
* Signed informed consent document on file.
* Estimated life expectancy of greater than or equal to 12 weeks.
* Participant compliance and geographic proximity that allow adequate follow up.

Exclusion Criteria:

* Peripheral neuropathy of great than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
* Inability to comply with protocol or study procedures.
* A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to complete the study.
* A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Documented brain metastases unless the participant has completed successful local therapy for central nervous system metastases and has not taken corticosteroids for at least 4 weeks before enrollment.
* Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
* Significant weight loss (that is, greater than or equal to 10%) over the previous 6 weeks before study entry.
* Concurrent administration of any other anti-tumor therapy.
* Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents, such as piroxicam).
* Inability or unwillingness to take folic acid or vitamin B12 supplementation.
* Inability to take corticosteroids.
* Pregnant or breast-feeding.
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Effect of Testosterone Therapy in Men With Alzheimer's Disease and Low Testosterone

Treatment with testosterone can improve performance on tests of spatial ability in men with low testosterone levels and Alzheimer's disease. Improved performance on these tests may mean an improved ability to get around in one's environment without getting lost or injured. This could have a positive impact on both patients and those who care for them. We will investigate what areas of the brain are involved in these improvements in spatial ability. This will be done using a PET scan, which creates a 3-dimensional image of the brain that can allow us to see how the brain functions.

Volunteers will be treated with a prescription testosterone gel applied to the shoulder or other body area each day. This treatment will continue for 6 months. Subjects will undergo a PET scan at the beginning of the study and after approximately 2 months of treatment. Subjects will undergo some cognitive testing throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease diagnosis, based on Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V)
* Total testosterone \< 300 ng/dL and/or calculated free testosterone \< 50 pg/ml
* Sufficient English to perform cognitive testing
* Stable on concomitant medications for 1 month prior to starting study

Exclusion Criteria:

* history of prostate cancer
* history of breast cancer
* gonadal endocrine disorders
* current major psychiatric illness (excluding depression)
* significant uncontrolled systemic illness
* recent myocardial infarction (within 6 months)
* renal or hepatic disease, sleep apnea
* history of alcoholism or substance abuse within the past year
* history of head injury with loss of consciousness greater than 1 hour
* testosterone or other androgen treatment within past 3 months
* history of taking other drugs that might interfere with the results of the study (ie, spironolactone, cimetidine, antiandrogens, estrogens, p450 enzyme inducers, barbiturates)
* symptomatic BPH: prostatic symptoms, prostatic masses or induration on rectal examination
* prostate specific antigen (PSA) \>4.0 mg/mL
* hemoglobin \> 17 mg/dL
* generalized skin disease that could affect the absorption of testosterone gel (ie, psoriasis).
* potentially agitated or uncooperative for procedures
Genetic, Serological Fecal and Clinical Markers in Siblings of Children With Inflammatory Bowel Disease

Although the precise etiology of inflammatory bowel disease (IBD) is still unknown, over the last decade active research allowed to gain more precise insights in the pathophysiology of IBD indicating that the chronic inflammation of the intestinal mucosa is directed against the microbiota of the gut in particularly susceptible individuals. Genetic studies and more recently genome-wide association studies (GWAS) have allowed to identify over 70 susceptibility genes which confer an increased risk of developing IBD. In the last years the attention of researchers has shifted to the identification of the early immunological changes that occur already at a preclinical stage of the disease, trying also at identifying the disease before it shows itself. Recently, the ability of a combination of serological markers in predicting the development of IBD has been demonstrated in adults. However, there are no studies evaluating a cohort of children at high risk for the disease, in whom the first immunological changes underlying the development of IBD could be studied, including a combination of genetic, serological, fecal and clinical markers.

The purpose of this study is to evaluate in a population genetically well-characterized, as siblings and twins of patients affected with IBD, early genetic, serologic, fecal and clinical markers of disease, which may be present even years before developing the disease. The identification of these markers in predisposed individuals could help to implement strategies for prevention or early treatment to modify the natural history of IBD.

This is a multicenter, prospective, study evaluating the role of serological, genetic, fecal and clinical markers in predicting the development of IBD in a high risk population. The study will be divided in two phases. In the first phase the prevalence of genetic, serologic, fecal, clinical risk factors in 100 siblings of children affected with IBD compared to 100 healthy children with no family history for IBD will be evaluated. The estimated duration of the first phase of the study is 12 months. In a second phase, a long-term follow-up (5 years) will be performed in order to evaluate the accidental cases of IBD in this population.

Eligibility Criteria:
Inclusion Criteria:

* siblings of children affected with IBD
* children without a family history of IBD

Exclusion Criteria:

* age \> 18 years
* age \< 6 years
* concomitant autoimmune disorders
Usefulness of Therapy Monitoring by Means of [(18)F]Fluoroethyltyrosine-Positron Emission Tomography (FET-PET) in Glioblastoma Multiforme Patients

The aim of this study is to establish FET-PET as an additional therapy assessment parameter in patients diagnosed with a glioblastoma multiforme receiving radiochemotherapy and adjuvant chemotherapy after previous resection or biopsy.


Eligibility Criteria:
Inclusion Criteria:

* neuroradiologically suspected Glioblastoma multiforme
* histological verification will be obtained either by microsurgery or by stereotactic biopsy. The neuropathological diagnosis will be verified by a reference neuropathologist
* patients will undergo radiochemotherapy subsequent to surgical procedure
* patients older than 18 years
* Karnofsky Performance Score \>=70
* pregnant or nursing female patients will not be included in this study
* safe contraceptive methods during the radiochemotherapy and chemotherapy

Exclusion Criteria:

* patients in whom informed consent cannot be obtained due to organic brain syndrome or insufficient language skills
* patients who cannot lie quiet for a time period of app. two hours during the FET-PEt scan
* medical history of a metastatic brain disease
* patients in whom an MRI scan cannot be performed due to claustrophobia metallic protheses or pacemakers etc.
Assessment of Health-related Quality of Life After Switching COPD Patients From a Dry Powder Inhaler to a Soft Mist Inhaler Remaining on the Same Inhalative Drug

The objective of this non-interventional, observational study is to assess whether changing Chronic Obstructive Pulmonary Disease (COPD) patients from a dry powder inhaler (HandiHaler®) to a soft mist inhaler (Respimat®), without changing the pharmacological compound, will lead to an improvement in Clinical COPD Questionnaire (CCQ) score and in the scores of the three subdomains of CCQ score: symptoms (4 items), functional state (4 items) and mental state (2 items) during a study period of approximately 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥ 40 years of age at baseline visit
* Patients with confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Patients who have been on Spiriva® HandiHaler® for ≥ 6 weeks at baseline visit
* Patients for whom a switch from Spiriva® HandiHaler® to Spiriva® Respimat® was planned prior to study inclusion. If additional inhalative COPD drugs (AICDs) are used: AICD treatment must have been stable for at least 6 weeks before study inclusion
* Signed written informed consent form to participation

Exclusion Criteria:

* Patients who have contraindications to Spiriva® Respimat® according to the current prescribing information label/ summary of product characteristics (SmPC)
* Patients who have signs of a current, acute respiratory tract infection 2 weeks prior visit 1
* Patients for whom further follow-up will not be possible at the enrolling site during the planned observational period (of approximately 8 weeks)
* Patients with confirmed diagnosis of only asthma
* Patients who had \> 1 moderate to severe exacerbation(s) within the last 6 weeks prior to study inclusion
* Patients who are pregnant or breastfeeding
* Patients participating in an ongoing interventional study
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma

The purpose of this study is to find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.

Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has been used safely in many patients, and it has killed cancer cells in some patients. One way it can kill cancer cells is by causing the patient's own white blood cells to attack the cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
* High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System,89 i.e., stage 4 with (any age) or without (≥18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
* The patients are in first CR/VGPR after conventional therapy. They have no measurable MIBG-avid soft tissue tumor assessable for response.
* Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

* Creatinine \> 3.0 mg/dL
* ALT, AST and Alkaline Phosphatase \> 5.0 times the upper limit of normal
* Bilirubin \> 3.0 mg/dL
* Patients with grade 3 or higher toxicities (using the CTCAE v3.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. Patients must have normal blood pressure for age.
* Progressive disease
* History of allergy to mouse proteins.
* Active life-threatening infection.
* Human anti-mouse antibody (HAMA) titer \>1000 Elisa units/ml.
* Inability to comply with protocol requirements
The Impact of Escape Room Experience in Nursing Students

Gamification is an applied, team-based approach in which students are actively involved. This study was conducted to evaluate the effect of escape room experience on the level of problem solving skills and professional behavior in nursing students.

This study was completed in a randomized controlled trial with 43 final year nursing students from a university. Students were randomized into intervention (n=22) and control (n=21) groups. In this study, data were collected with the Game Experience Scale, Problem Solving Inventory, and Nursing Students Professional Behavior Scale. The data obtained from the study were evaluated with SPSS 24.0. Descriptive statistics; number (n), percentage (%), mean (X), standard deviation (SD) were given. Statistical significance level was evaluated as p\<0.05. The students in the intervention group analyzed the breast cancer surgery case with the escape room experience. The students were divided into groups of 5 and tried to complete the tasks given by the researchers within 30 minutes. During the escape room practice, the researchers were present in the rooms as observers and evaluated the participants.


Eligibility Criteria:
Inclusion Criteria:

* Active students in the spring semester of the 2023-2024 academic year,
* A fourth-year nursing student,
* To take the surgical diseases nursing intern practice module,
* Preparing an individualized patient care plan for at least one surgical patient,
* Students who have previously prepared and presented at least one surgical patient-specific case with group work

Exclusion Criteria:

* Those who have lessons they did not take in 1st-3rd classes,
* Never planned care for surgical patients in previous clinical practice,
* Students who refused to participate in the study
Implementing the Spotlight AQ Platform in Adolescent/ Young Adult (16-25 Years Old) Type 1 Diabetics (T1D)

The goal of this clinical trial is to compare the Spotlight AQ survey platform to the standard of care (SOC) pre-clinic assessment in adolescents \& young adults (16-25 years old) with Type 1 Diabetes (T1D).

The main questions it aims to answer are:

* Does using the Spotlight AQ survey in clinic decrease the A1c in the people who use it?
* Do patients and healthcare providers like using the spotlight AQ survey?

Participants will use the Spotlight AQ survey before coming in to two standard of care T1D clinic visits Participants will fill out surveys describing how they feel about using the Spotlight AQ survey. Some participants may be asked to do an interview to talk about how they feel about the Spotlight AQ survey.


Eligibility Criteria:
Inclusion Criteria:

* 16-25 years old
* Patients diagnosed with T1D for at least 6 months
* On any diabetes treatment
* Using a Continuous Glucose Monitor (CGM)
* Willing/ able to use Spotlight AQ tool
* Able to give verbal assent
* Patients \& parents/caregiver speak English/ Spanish fluently
* Patients in the Children's Mercy Kansas City Hospital or Boston Children's Hospital network

Exclusion Criteria:

* \<16 years old or \>25 years old
* Mental illness that could seriously reduce their ability to participate in the study
* Lack of capacity
* In another T1D intervention study
A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.

Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV RNA \>= 5000 copies/ml by Amplicor assay.
* Signed, informed consent from parent or legal guardian for patients less than 18 years old.

Previous treatment with antiretrovirals.
Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty

The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex.

The proposed pathogenesis of functional tricuspid regurgitation (TR) in mitral valve disease seems incomplete. Because both atrioventricular valves are closely connected to each other by means of the cardiac fibrous skeleton, the geometry of the tricuspid valve is likely to be distorted after ring-annuloplasty of the mitral valve. This could lead to the development of functional TR, or to an increase in TR severity. To test this hypothesis, a prospective study will be started in patients undergoing isolated mitral valve annuloplasty.

Eligibility Criteria:
Inclusion Criteria:

* all patients 18 years of age or older undergoing minimally invasive, isolated mitral valve annuloplasty

Exclusion Criteria:

* concomitant tricuspid valve surgery
* atrial fibrillation at the moment of surgery
* poor echocardiographic windows
Quantitative Assessment of Shoulder Proprioception in Patients With Chronic Mechanical Cervical Pain

The study was aimed to compare shoulder proprioception in chronic mechanical cervical pain to a matched normal group. This study include 2 groups, 40 subjects with mechanical chronic cervical pain and 40 healthy subjects representing the control group. The primary outcome measure was the shoulder proprioception test of both upper limbs during active repositioning and quantified with angular displacement error.

The study was aimed to compare shoulder proprioception in chronic mechanical cervical pain to a matched normal group. This study include two groups, 40 subjects with mechanical chronic cervical pain and 40 healthy subjects representing the control group. The primary outcome measure was the shoulder proprioception test of both upper limbs during active repositioning and quantified with angular displacement error. Test was applied using an isokinetic dynamometer device at angle 30° for both shoulder internal and external rotation on both sides with an angular velocity 30°/sec.

Eligibility Criteria:
Inclusion Criteria:

* The age ranged from 20 to 35 years.
* Body Mass Index (BMI) between 18 and less than 30.
* Sufficient cognitive abilities that enables them to understand and follow instructions with a score more than 24 in the Mini-Mental State Examination (MMSE) scale.
* For the group with cervical pain, participants had a chronic mechanical cervical pain started from three to 12 months.
* Participants with chronic pain with a score of 3 to 65 according to the short-form of the McGill Pain Questionnaire (SF-MPQ).

Exclusion Criteria:

* Shoulder problems.
* Previous cervical or shoulder surgery.
* Shoulder or cervical trauma.
* Cervical radiculopathy.
* Sever visual and/or auditory problems.
* Cognitive impairment (a score less than 24 according to MMSE).
Results Following the Vitrification of Human Oocytes Using 2 Methodologies

The investigators are going to compare embryo developmental rates of human eggs following freezing in two different freezing methods. The investigators are going to compare the pregnancy rates following transfer to patients as well.

Null Hypothesis: The type of vitrification methodology used will not have an impact on the following:

* Survival rates
* Embryonic developmental rates
* Pregnancy and implantation rates.

Randomization of Oocytes: Oocytes will be denuded approximately 1-2 hours post retrieval and graded for maturity. Only the Metaphase II oocyte will be vitrified. Half of the oocytes within each donor will be randomized to the following treatments.

1. Frozen using an open system using a metal grid to hold the oocyte. Three to five oocytes will be frozen on the metal grid using a minute amount (\< 2-3 µls) of cryoprotectant. A top is put over the metal grid to protect the oocytes. This system has proven to be successful in limited cases in Peru. This is an open system of vitrification where the oocytes are directly plunged into liquid nitrogen. This will serve as the control.
2. Frozen in closed straws using a methodology developed by Jim Stachecki. Three to five oocytes will be frozen in ¼ cc straws. This is very similar to the method used to successfully vitrify blastocysts. This will be the experimental treatment.

Null Hypothesis: The type of vitrification methodology used will not have an impact on the following:

* Survival rates
* Embryonic developmental rates
* Pregnancy and implantation rates. Measured Outcomes The effect of vitrification technique will be measured using the appropriate statistical analysis on the following parameters.

  1. Survival rates following thawing.
  2. Effect of vitrification technique on how oocytes react to ICSI. The parameters have been previously defined at NCRS.
  3. Normal fertilization rates, abnormal fertilization rates and rates of degeneration following ICSI.
  4. Embryonic development rates. Embryos will be cultured until Day 5/6 and rate as well as quality of blastocyst will be noted.
  5. Pregnancy and implantation rates following replacement in endometrial prepared recipients.

Eligibility Criteria:
Inclusion Criteria:

* Must be healthy and pass testing as per clinic standards

Exclusion Criteria:

* Are over the age or cannot carry a pregnancy safely
Treatment of Fifth Metatarsal Zone 3 Fractures

The fifth metatarsal is one of the bones where stress fractures can occur. Current literature provides support for both operative and non-operative treatment, but is mostly based on retrospective studies. One small randomized controlled trial reported faster recovery in the surgery group, but this study is probably subject to selection bias as well as underpowered design. There is a need to strengthen the knowledge base regarding treatment of stress fractures in the fifth metatarsal. This study seeks to answer whether osteosynthesis with an intramedullar screw fixation gives faster painfree weight bearing compared to non-operative treatment with a walking boot.


Eligibility Criteria:
Inclusion Criteria:

* Zone 3 fracture

Exclusion Criteria:

* Neuropathy
* Open fractures
* High energy injuries
* Associated injury in the same or opposite extremity that may affect treatment or rehabilitation
* Pressure ulcer(s)
* Lack of consent competence
* Fracture radiologically confirmed more than six months ago
* No possibility of follow-up at one of the study centers
* Established pseudarthrosis
* Medical condition that contraindicates surgery
* Non-compliance