cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of GT201 in Combination with PD-1 Inhibitor for Advanced Head and Neck Tumors

This study is a single-arm early exploratory clinical study. designed to evaluate the safety and tolerability of GT201 in combination with a PD-1 inhibitor for the treatment of advanced head and neck tumor subjects with safety and tolerability, as well as pharmacokinetic characterization and efficacy The study consists of two phases.

The study consists of two phases, a dose-escalation phase and a dose-expansion phase.

Primary objectives

a. To assess the safety and tolerability of GT201 in combination with PD-1 inhibitor in the treatment of advanced head and neck tumors.

Secondary Objectives

1. To assess the efficacy of GT201 in combination with PD-1 inhibitors in the treatment of advanced head and neck tumors according to RECIST v1.1.
2. To monitor the pharmacokinetics of GT201 infusion in the treatment of advanced head and neck tumors: duration of back infusion of GT201 in subjects, evaluate expansion status, and correlation with the effectiveness of GT201 infusion. To characterize serum levels of T cell related cytokines such as TNF-α, IFN-γ, IL-6.

Purpose of exploratory study To analysis the changes of cell phenotypes and distribution of cell populations. To track the expansion of TIL clones by detecting T cell receptors (TCR)and other possible cytokines in peripheral blood.

Eligibility Criteria:
Inclusion Criteria:

* 1. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
* 2. Age 18 to 70 years old;
* 3. Diagnosis with recurrent or metastatic head and neck malignant tumors and received≤2 lines of systemic therapy;
* 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5. Expected survival time of ≥ 12 weeks;
* 6. Good function of vital organs;
* 7. Subjects who enter this study due to poor treatment efficacy or intolerance must have medical records describing their condition after previous treatment or imaging records of lesion evaluation before tumor sampling;
* 8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
* 2.Known mental illness, alcoholism, drug use or substance abuse;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.Those who have received other clinical trial drug treatment within 4 weeks before NMA-LD chemotherapy or plan to participate in other clinical trial drug treatment during the study;
* 5.The investigators determine that other conditions that make the patient not suitable for enrollment.
Evaluation of Procedural Analgesia for Liposonix Treatment

The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System.


Eligibility Criteria:
Inclusion Criteria:

* Subject is an adult female or male, 18 to 65 years of age.
* Subject must weigh more than 120 pounds.
* Subject must have a Body Mass Index of ≤ 30 kg/m2.
* Subject must have thickness of skin + subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm.
* Subject must be able to read, write, speak, and understand English.

Exclusion Criteria:

* Female subject who is pregnant, is suspected to be pregnant, or is lactating
* Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
* Subject has diabetes or cardiovascular disease
* Subject has had any aesthetic procedure to the region to be treated within past 6 months
* Subject has systemic skin disease or skin disease in the area to be treated
* Subject has any abnormality of the skin or soft tissues of the abdominal wall in the area to be treated
* Subject has had previous open or laparoscopic surgery in the anticipated treatment area
* Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
* Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position
* Subjects undergoing chronic steroid or immunosuppressive therapy
* Subjects who have cardiac pacemakers or any implantable electrical device
* Subjects who have metal implants of any type in the area to be treated
* History of cancer
* Subjects who have sensory loss or dysesthesia in the area to be treated
* Subjects taking chronic benzodiazepines or opiates
* Subjects with a history of severe nausea/vomiting with opioid analgesics
* Subjects with sleep apnea
* Subjects with known allergies or sensitivities to study drugs
* Subjects with liver disease
* Subjects with renal failure
Activity and Health in Nursing Homes

There is expected to be an increased need for full time nursing homes as the increase in number of older adults increases and the rate of dementia diagnosis happens simultaneous with the decrees of healthcare personnel the years to come. A lift in knowledge is needed to provide a better and more efficient healthcare to be better equipped to meet this societal challenge. Physical activity and sleep are important indicators of health, but also on effect of treatment and care for this frail population. Comprehensive mapping of personnel time spent on different tasks and older adults' physical function throughout a week gives a unique opportunity to gain new knowledge about everyday life in nursing homes. The main aim of this project is to describe associations between physical behavior, sleep and symptoms in residents in nursing homes in Trondheim Municipality and combine these with personnel time spent on different working tasks.


Eligibility Criteria:
Inclusion Criteria:

All residents in nursing homes in Trondheim Municipality.

Exclusion Criteria:

Terminal residents or residents that can not stand or walk a few steps independently.
Text Message Reminder-Recalls For Early Childhood Vaccination

Although the investigators have reached the Healthy People 2010 goal of 80% coverage among U.S. children 19-35 months of age for the primary immunization series, 20% of children still remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of vaccine preventable disease persist. Immunization reminder-recalls have been shown to be successful, but have been limited by the ability to identify and reach large target populations in a real-time, automated fashion. Reminder-recalls via text message may offer an innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a cell phone. Prior research by our team suggests that text messages reminder recalls may be an effective tool to remind parents about their children's vaccines. In this study, the investigators will demonstrate the effectiveness of tailored text message appointment and immunization reminders linked to a well-established and functional immunization registry to increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The investigators will target parents of young children from an underserved population that is primarily Latino, with low socioeconomic status.


Eligibility Criteria:
Inclusion Criteria:

* Parents of child \>9 months to 25 months
* Child with at least one visit to one of the participating clinical sites in the previous 12 months
* Parental cell phone number recorded in the registration system
The Effect of Progressive Relaxation Exercises Applied to Caregivers on Caregiving Burden and Meaning of Life

This randomised controlled experimental type study will be conducted with family members who care for the relatives of hemiplegic patients who are hospitalised in Manisa Merkezefendi and Turgutlu State Hospital Physical Therapy Services.

The population of the study will consist of the caregivers of hemiplegic patients receiving treatment in the clinic on the specified dates in Turgutlu State Hospital and Manisa Merkezefendi State Hospital Physical Therapy Service. The sample will consist of individuals who meet the inclusion criteria. Individuals in Turgutlu State Hospital will constitute the intervention group of the study and individuals in Manisa Merkezefendi State Hospital will constitute the control group of the study. The aim of this study was to determine the effect of progressive relaxation exercises applied to family members caring for hemiplegic patients on caregiving burden and meaning of life. In the intervention group, those who agree to participate in the study will be asked to fill in the Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. Relaxation exercises will be explained and demonstrated by the researcher (Funda AKTÜRK) once a day for 1 month starting from the hospitalisation to the clinic and will be played on the computer. You will be asked to perform these exercises after listening to the video (CD). Relaxation exercises are exercises based on stretching and relaxing your muscles. Before the application, in the middle of the application (15th day) and at the end of the application, all forms except the introduction form will be filled in again. In the Control Group, those who agree to participate in the study will be asked to fill in the;Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. The control group will be asked to fill in the forms at the same time as the intervention group without any intervention. If requested, progressive relaxation exercises will be applied to the control group after the end of the study

Eligibility Criteria:
Inclusion Criteria:

* Family members who have no communication problems,
* Who are 18 years of age or older,
* Whose patient will be hospitalised in the clinic for at least one month,
* Who agree to participate in the study will be recruited.

Exclusion Criteria:

* Individuals who have communication problems,
* The caregiver is not a family member,
* are 18 years of age or younger,
* The patient stays in the clinic for less than one month,
* Has previously received progressive relaxation training, and who do not agree to participate in the study will be included.
Validity and Reliability of Turkish Version of Bayer Activities of Daily Living Scale

The aim of our study is to verify the validity and reliability of the Turkish version of B-GYA.

Dementia refers to a condition in which individuals with brain damage have multiple cognitive deficits with impairment in activities of daily living (ADL). Therefore, the assessment of ADL is one of the main criteria for evaluating dementia. ADL disorders are often observed by caregivers before they are identified by psychometric testing, thus suggesting that ADL assessment can contribute to the early detection of dementia.

Evaluation of ADL has become increasingly important with the introduction of new drugs for Alzheimer's disease (AD), as well as being a helpful tool in diagnosis. Current guidelines have recognized the need for therapeutic intervention in AD to measure and document treatment effects on ADL. It has been emphasized that internationally validated and approved test tools to evaluate dementia are important for multinational clinical drug trials that evaluate the efficacy of anti-dementia drugs. Therefore, it is of great importance to find ADL scales that can be used internationally. Various ADL scales have been developed, such as Lawton's instrumental ADL (IADL), functional activities questionnaire (FAQ), ADCS-ADL, and Bayer ADL (B-ADL). Of these, W-ADL was developed based on an international pilot study to evaluate ADL deficits in patients from different cultural backgrounds.

Specifically, through a collaborative study conducted in four different countries during the development of the RDA, the researchers prepared 141 items and selected 25 of them that could be used internationally. The target group of the scale included elderly patients suffering from mild to moderate dementia or cognitive impairment. European countries: In the United Kingdom, Germany, and Spain, the validation study of the B-ADL was carried out in three stages. The aim of our research is to verify the validity and reliability of the Turkish version of B-ADL.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 60 and over
* Being literate
* Having given consent to participate in the study
* Individuals diagnosed with Alzheimer's according to the international diagnostic criteria of the American National Neurological and Communication Disorders Stroke and Alzheimer's Association (NINCDS-ADRDA) and in mild and moderate stages (\<2) according to the Clinical Dementia Rating: CDR will be included in the study.

Exclusion Criteria:

* Those who did not give consent to participate in the study
* CDR\>2
* Except for behavioral or functional symptoms associated with dementia, individuals with medical, psychiatric, neurological conditions, or physical disabilities that may significantly affect the performance of ADL will be excluded from the study.
Study of Capecitabine to Treat Recurrent High Grade Gliomas

The purpose of this study is to determine if capecitabine is effective in the treatment of high grade gliomas that have returned after completing treatment.

High grade gliomas (HGGs) represent a heterogenous group of primary brain tumors that share WHO grade III or IV classification (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma multiforme). Despite the upfront use of surgery, radiation, and chemotherapy, high grade gliomas uniformly result in recurrence and death. Palliative chemotherapy offers an improvement in time to progression, symptom control, quality of life, and potential survival; however, no established chemotherapy regimen for recurrence exists and new treatments are needed. Oral capecitabine is a rationale strategy for therapeutic palliation of recurrent high grade gliomas given its oral administration, its well-known kinetics and toxicities, its non-competitive toxicities to other high grade glioma treatments, its well established management algorithms, its established evidence of entry into the central nervous system, and its evidence of safety and efficacy in malignancies in the central nervous system.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of high grade glioma (WHO grade III or IV: anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma multiforme)
* Male or female 18 years of age or older
* Negative pregnancy test (if of childbearing potential)
* Any number of previous recurrences will be allowed
* Karnofsky Performance Status \> 60
* Hematocrit \> 30,000
* White blood cell count \> 1,500
* Platelet \> 100,000
* Absolute Neutrophil Count \> 1,000
* Bilirubin \< 1.5 x upper limits of normal
* Transaminases (ALT and AST) \< 1.5 x upper limits of normal
* Creatinine \< 1.5 x upper limits of normal
* Adequate medical health to participate in this study
* Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal)
* Ability to read and understand the informed consent document
* Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed and completing all diaries and forms

Exclusion Criteria:

* Karnofsky Performance Status \< 60
* Hematocrit \< 30,000
* White blood cell count \< 1,500
* Platelet \< 100,000
* Absolute Neutrophil Count \< 1,000
* Bilirubin \>1.5 x upper limits of normal
* Transaminases (ALT and AST) \> 1.5 x upper limits of normal
* Creatinine \> 1.5 x upper limits of normal
* Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis
Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes

We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.

Primary composite endpoints:

Cardiovascular death Non-fatal myocardial infarction and angina Non-fatal stroke Renal failure (hemodialysis/doubling of serum creatinine)

Secondary endpoints:

urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes HbA1c: more than 7% and less than 9%

Exclusion Criteria:

* insulin treatment
Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of chloroquinoxaline sulfonamide in treating patients who have stage IV colorectal cancer.

OBJECTIVES: I. Assess the antitumor activity and toxicities of chloroquinoxaline sulfonamide in patients with stage IV colorectal cancer.

OUTLINE: This is a multicenter study. Patients receive chloroquinoxaline sulfonamide IV over 1 hour weekly for 4 consecutive weeks. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 30 days.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 8 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV colorectal cancer Measurable disease defined as lesions that measure at least 20 mm in one dimension using conventional techniques or at least 10 mm with spiral CT scan not including: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Recurrent disease allowed after adjuvant chemotherapy if recurrence occurred at least 6 months after completion of therapy No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: Greater than 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal Cardiovascular: No history of symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia (e.g., supraventricular tachycardia or atrial fibrillation) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant episodes of hypoglycemia in past 6 months No known allergies to compounds of similar chemical or biologic composition to chloroquinoxaline sulfonamide No known glucose-6 phosphate deficiency or hemolytic anemia No uncontrolled concurrent illness (e.g., active infection) No concurrent psychiatric illness or social condition that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: One prior biologic therapy allowed Chemotherapy: See Disease Characteristics No more than one prior chemotherapy for metastatic disease or adjuvant treatment At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: No concurrent oral hypoglycemics or insulin Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No other concurrent investigational agents No concurrent combination antiretroviral treatment for HIV
Impact of Lecuofiltration of Packed Red Blood Cells on Different Hematological Parameters Measured by Advia 2120

Parameters of lecuofiltration of packed Red blood cells.

Impact of lecuofiltration of packed Red blood cells on different hematological parameters measured by Advia 2120

Eligibility Criteria:
Inclusion Criteria:

packed RBC ADIA2120

Exclusion Criteria:

* Whole blood
Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

Number of patients:

2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study).

Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included).

Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total.

The selection of the team that will begin with ECV (Team A) and the team that will finish with ECV (Team B) will be chosen at random before the start of the study.

A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patient scheduled for total colonoscopic exploration, during the period study
2. Patient over or equal to 18 years
3. ASA 1, ASA 2, ASA 3
4. No participation in another clinical study
5. Certificate of non opposition signed

Exclusion Criteria:

1. Patient under 18 years old
2. ASA 4, ASA 5
3. Pregnant woman
4. Patient with coagulation abnormalities preventing polypectomy: prothrombin level \<50%, Platelets \<50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
5. Inflammatory bowel disease
6. Known colonic stenosis
7. Diverticulitis less than 6 weeks old
8. Patient unable to give consent or protected by law
9. Opposition expressed for inclusion in the study