cyrilzakka/clinical-trials huggingface dataset:
Effect of Three-Dimensional Lemon Video on Thirst Perception and Dehydration-Related Discomfort

This study will be conducted to investigate the effects of a three-dimensional lemon video shown to intensive care patients undergoing colorectal surgery on thirst perception and thirst-related discomfort. The study will be conducted as a randomized controlled, single-blind experimental design. The universe of this study, which will be conducted in the General Surgery Intensive Care Unit of the Necmettin Erbakan University Medical Faculty Hospital, will consist of volunteer patients who will be admitted to the intensive care unit. The sample of the study will consist of 70 patients. In the study, patients will be divided into two groups as virtual reality glasses and control groups. The virtual reality glasses group will be shown a three-dimensional lemon video. Standard care will be provided to patients in the control group. Patients will be assigned to the groups using the block randomization method. Randomization will be performed using a random number table in a computer environment (www.random.org). Research data will be collected using the Descriptive Characteristics Form, Numerical Rating Scale, and Surgical Period Thirst-Related Discomfort Scale (CDSBRÖ). Ethics committee approval and institutional permission will be obtained before collecting research data. Appropriate statistical tests will be used in the evaluation of the data.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-65,
* Those who have undergone colorectal surgery,
* Those who are oriented to time and place,
* Those who are literate,
* Those who have been admitted to the general surgery intensive care unit,
* Those who are being monitored in the postoperative period,
* Those who volunteer to participate in the study,
* Those who can communicate verbally,
* Those who are open to communication and cooperation,
* Those who do not have visual and auditory impairments,
* Those who do not use glasses or have no visual impairments,
* Those who do not have cognitive-psychological disorders,
* Those who are not diagnosed with renal failure,
* Those who do not have oral intake according to the physician's order,
* Those who are not connected to a mechanical ventilator will be included in the study.

Exclusion Criteria:

* Patients who have undergone a second surgical procedure during their hospitalization,
* Patients who have open wounds on their mouth or lips,
* Patients who have been diagnosed with migraine or vertigo,
* Patients who have nausea and vomiting will be excluded from the study.
Music During ESWL for Entire Treatment

The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).

Patients undergoing ESWL and interested in music listening are randomly divided in two groups: patients in group A listen to music during the ESWL treatment, patients in group B do not.

At the end of the treatment patients are asked to fill in a questionnaire. They are asked if they were pleased to have had the opportunity to listen to music during ESWL, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (VAS) for pain.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing ESWL and interested in music listening

Exclusion Criteria:

* Contraindication to ESWL
* No interest in music listening
* Age \< 18 and \> 80
A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric Cancer

The purpose of this observational study is to evaluate the safety and efficacy of camrelizumab and apatinib in patients with advanced gastric cancer under real-life conditions, particularly in various subgroups of gastric cancer patients, with a view to providing information about the treatment modalities and efficacy of the treatment in real-life gastric cancer patients and to explore the possible predictive biomarkers of prognosis.Patients, who had both decided to be treated with camrelizumab or apatinib prior to enrollment, were entered into one of the following three cohorts at the discretion of the investigator, based on their disease stage and prior treatment


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, both male and female;
2. patients with advanced gastric cancer diagnosed by pathology or histology and progressed or recurred after 6 months of adjuvant therapy can also be considered for enrollment;
3. Have at least one measurable lesion on imaging (RECIST 1.1 criteria), the spiral CT or MR target lesion should be ≥10 mm and lymph node ≥15 mm;
4. The investigator determines that the patient is amenable to treatment with karelizumab or apatinib;
5. Voluntary enrollment; good compliance and willingness to cooperate with follow-up.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Previous use of other immunotherapy drugs (e.g. PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA4 monoclonal antibody, etc.);
3. Prior use of other anti-angiogenic therapeutic agents (e.g., apatinib, etc.);
4. Patients who, in the judgment of the investigator, are not suitable for inclusion.
A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CD30-positive hematologic malignancy.
* Patients with HL must have failed systemic chemotherapy.
* Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
* Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.

Exclusion Criteria:

* Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
* History of allogeneic stem cell transplant.
* Patients who have had previous treatment with any anti-CD30 antibody.
Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?

This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.

Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.

Despite a trivialized use of benzodiazepine (BZD) in elderly people (EP), long-term efficacy is often questioned, and treatment has to be regularly re-examined to avoid side effects. Typical intervention techniques to aid patients in reducing their dosage involve: providing information about BZD, explaining the risks associated with a chronic exposure, and tips for a successful withdrawal. In addition, the usage of a connected device may reinforce the patient's motivation by providing details on the quality of sleep and the number of steps taken (activity).

This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.

Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.

Eligibility Criteria:
Inclusion Criteria:

* Unassisted mobility (1/1 for the locomotion item on KATZ Activities of Daily Living scale)
* Mini-Mental State Examination (MMSE) ≥ 20
* With a daily consumption of benzodiazepine for more than 3 months
* Smartphone and/or tablet with internet connection

Exclusion Criteria:

* Patient under legal protection
* Patient refuses to participate
* Patient does not speak French
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects

The purpose of this study is to assess the effect of two 4-Factor PCC formulations on Apixaban pharmacodynamics in healthy adult subjects.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects
* Body Mass Index (BMI) of 18 to 30 kg/m2
* Ages 18 to 45 years, including
* Women of childbearing potential (WOCBP) on acceptable contraception and with negative pregnancy test and not breastfeeding

Exclusion Criteria:

* History or evidence of coagulopathy
* History or evidence of thrombosis such as deep vein thrombosis or other thromboembolic disease or having a first degree relative under 50 years of age with a history of thromboembolic disease
* Any significant acute or chronic medical illness or relevant trauma
* Any major surgery within 4 weeks of dosing (prior to dosing) or planned within 2 weeks after completion of the study
* History of heavy menstrual bleeding that has produced anemia within the past 1 year
* Current symptomatic or recent gastrointestinal disease or surgery that could impact the absorption of study drug
* History of smoking within 1 month prior to dosing
* Recent history (within 6 months of dosing) of pregnancy
* Use of hormonal contraceptives
* Exposure to any investigational drug or placebo within 4 weeks of study drug administration
* Use of any agent, including but not limited to Aspirin, Nonsteroidal anti-inflammatory drugs (NSAIDs), Anticoagulants, Fish oil capsules, Gingko, etc, that are known to increase the potential for bleeding, within 2 weeks prior to dosing
* History of any severe drug allergy including allergy to Heparin or history of Heparin-induced thrombocytopenia, hypersensitivity to PCCs or Factor Xa inhibitors, or history of allergy to human blood plasma derived products; history of any adverse drug reaction to Anticoagulants or Antiplatelet agents that resulted in excessive bleeding requiring medical intervention
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.

This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients \>=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
* currently receiving Tarceva monotherapy and having failed at least one standard chemotherapy regimens;
* prior response or stable disease 12 weeks from start of Tarceva;
* documented progressive disease at enrollment;
* measurable disease according to the RECIST criteria;
* ECOG performance status 0-2;
* life expectancy \>12 weeks.

Exclusion Criteria:

* patients with active CNS lesions;
* prior treatment with agents acting via IGF-1R inhibition or EGFR targeting;
* administration with high doses of systemic corticosteroids;
* radiotherapy in the 4 weeks prior to study start;
* surgery or significant traumatic injury with in the last 2 weeks prior to study start.
HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598

RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ECOG-2598.

OBJECTIVES:

* Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ECOG-2598.
* Correlate mutations with time to progression and survival of these patients.

OUTLINE: This is a multicenter study.

Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2 gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol ECOG-2598.

PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer meeting ≥ 1 of the following criteria:

  * Recurrent disease
  * Stage IIIB with pleural or pericardial effusion
  * Stage IV disease
* Treated on protocol ECOG-2598

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The TriggerHappy Trial

This is a prospective randomized multicenterstudy focusing on PROMs after primary corticoid injection for triggerfinger with a comparison of two different injection techniques.

This study aims to compare two different methods of corticosteroid injections in patients with triggerfinger, and to study the effects of these injections by day-to-day self-assessment by the included study persons for four weeks. The patient assess: 1. Pain 2. Motion and 3. Triggering by VAS scale every day for four weeks.

Eligibility Criteria:
Inclusion Criteria:•

1. Triggering of one or more fingers and/or impaired active finger motion and/or pain during active finger motion
2. Localized tenderness volar to the MCP joint of the affected finger
3. The patient seeks treatment

Exclusion Criteria:

1. Previous treatment for triggerfinger in the finger to be treated
2. Impaired function of finger due to previous trauma/infection or other condition
3. Suspicion of other cause than triggeriinger/tendovaginitis
4. Patient not able to follow instructions
Pricing Interventions Based on Energy Content in Restaurants

The goal of this clinical trial is to examine the impact of price decreases based on energy content in a full-service restaurant on immediate dietary consumption (in terms of kilocalories (kcals), sugar, fat, and salt intake) and dietary consumption the rest of the day following the intervention; and whether the intervention effects differ based on socioeconomic position (SEP).

Participants will be asked to visit the restaurant twice. At visit 1, participants will receive a control study menu with the existing pricing structure of the restaurant. At visit 2, participants will receive the same study menu with the pricing intervention introduced.

For comparative purposes a smaller subgroup of participants will receive the control menu at both visit 1 and 2 to allow the researchers to estimate whether any pre-post changes occur in the absence of a pricing intervention (and whether change differs by SEP).


Eligibility Criteria:
Inclusion Criteria:

* UK resident, aged 18 and older, fluent in English, have an out-of-home meal at least once a month and have no dietary allergies

Exclusion Criteria:

* No further exclusion criteria as it is a real-world study
Oculomotor Testing in the Differential Diagnosis of Dementia

The aim of this study is to determine whether saccadic eye movement recording may help in the discrimination between Lewy body dementia and Alzheimer disease, in the early stages of the disease.

Study type: Interventional Study design: Intervention Model: Single group assignment Primary purpose: Diagnostic

Dementia with Lewy bodies (DLB) is the second most common cause of neurodegenerative dementia. In its early stages, the differential diagnosis of DLB and Alzheimer's disease (AD) can be challenging. The differential diagnosis is particularly important given that patients with DLB respond well to cholinesterase inhibitors but show sensitivity to neuroleptic medications which are contraindicated in DLB. DLB tends to progress more quickly than Alzheimer's disease. Diagnostic accuracy may be improved. Oculomotor recording, easy to perform could be helpful in order to identify and reliably assess fluctuating attention performance in DLB patients.

Main objective:

- to improve differential diagnosis between DLB and AD in the early stages of the disease with oculomotor measurements

Secondary objectives:

* to examine the association between the oculomotor records and neuropsychological examination assessing attention abilities and their fluctuations
* to evaluate the benefit of complementary neuropsychological tests in the distinction between DLB and AD cases
* to examine the relationship between hippocampal volume and neuropsychological examination in DLB cases
* to examine the diagnostic performance of MRI (Support Vector Machine) between DLB and AD
* to examine the interest of CSF alpha synuclein concentration to discriminate DLB from AD
* to assess at one year variations in oculomotor test scores and neuropsychological test scores Method and design Longitudinal multicenter study including 100 patients with a DLB or AD diagnosis. Clinical examination at one year.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 and over
* Patients with a diagnosis of probable DLB or AD according to the Consortium on DLB criteria (McKeith et al 2005) for Lewy bodies dementia and according to DSM IV and NINCDS- ADRDA criteria for AD or patients in whom there is diagnostic uncertainty between DLB and AD
* No major sensory deficits
* MMSE \> 20
* Having signed an informed consent form

Exclusion Criteria:

* Parkinson syndrome progressing for more than one year regarding cognitive impairment
* Use of AchEIs medication
* Taking or having taken anti Parkinson drugs
* Neuroleptic drugs over the previous three months
* Contraindication for lumbar puncture (i.e. anticoagulant agents)
* Patients with Geriatric Depression Scale (GDS) \> 10
* Taking medication that could impact dopamine transporter's measurement
* Contraindication for MRI examination
* Diseases involving the short-term survival (shorter than one year)
* Not fluent in French
* Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
* Being under guardianship
* Absence of caregiver/informant to sign informed consent form
* Non health insurance affiliation
Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the subject prior to enrolment;
* Female between, and including, 18 and 55 years of age at the time of enrolment;
* Subjects must be free of obvious health problems;
* Not pregnant and having no plan for pregnancy;

Exclusion Criteria:

* Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
* Previous vaccination against HPV;
* Having severe allergic history or other immunodeficiency;
* Chemotherapy and other immunosuppressive agents using;
A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System

To determine the safety and effectiveness of the LUMINEXX stent for the proposed indication of treatment of common and/or external iliac artery occlusive disease

The study is designed to collect safety and efficacy data on the Bard Luminexx Iliac Stent in a broad patient population having indications for iliac stenting. Effectiveness in this study will be demonstrated by the prevention of Major Adverse Clinical Events (MACE). The composite primary endpoint of this clinical trial is freedom from peri-procedural death and freedom from stented segment revascularization or restenosis (\>50%) at nine months.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legal guardian understands procedure and provides written informed consent prior to study participation.
* Patient must be able and willing to comply with all study procedures including scheduled follow-up visits and diagnostic tests.
* Lesion(s) distinctly localized in the common and/or external iliac arteries.
* Reference lumen diameter (RLD) 6 mm and 9 mm.
* Stenosis 30% and symptomatic ischemic disease (Category 1-6 Chronic Limb Ischemia or Threatened or Irreversible Acute Limb Ischemia).

Exclusion Criteria:

* Patients diagnosed with preoperative coagulation disorder or with contraindications to antiplatelet or anticoagulant therapy.
* Patients who are pregnant or planning to become pregnant during the clinical investigation.
* Patients with a life expectancy \< 3 years.
* Patients currently or scheduled to be enrolled in another investigation that conflicts with follow-up testing or may confound the study data.
* Patients with absolute contraindication to x-ray contrast media or medications normally administered during an interventional procedure.
* Patients with severe tortuosity or angulation of a vessel that may prevent access in the opinion of the investigator.
* The presence of soft, thrombotic or embolic material within or adjacent to the lesion(s) being treated with the study device, in the opinion of the investigator.