cyrilzakka/clinical-trials huggingface dataset:
Prospective Study With FLOT in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Patients with locally advanced or metastatic gastric carcinoma or carcinoma of the esophagogastric junction without prior palliative therapy will be treated with 8 cycles of the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrollment a unique and detailed clinical evaluation of the dissemination of the disease will be done which includes a differentiated regard of the metastatic status. patients will be classified as having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic disease. In arms A and B surgical intervention is planned if operability is reached. The hypothesis is that by classifying patients more individually by the state of their disease, patients in arm B will have a significantly prolonged overall survival compared to patients in arm C.

250 patients with locally advanced or metastatic gastric carcinoma or carcinoma of the esophagogastric junction without prior palliative therapy will be treated with 8 cycles of the FLOT scheme (up to 12 cycles if the response is favourable). Prior to enrolment a unique and detailed clinical evaluation of the dissemination of the disease will be done which includes a differentiated regard of the M-category in the TNM classification. A prospective stratification will classify the patients as having either (A) locally advanced, (B) limited metastatic, or (C) extensive metastatic disease. In addition, the pharmacogenetic risk profile of the patients will be evaluated by a combined analysis of two genetic polymorphisms of the metabolism of the applied substances (XPD312, GSTT1). For the assessment of the disease, reference regions are examined by CT or MRI scans and if applicable endoscopy prior to the start of the study, every 2 months during and after the end of therapy until progression of the disease occurs. Evaluation of quality of life (by standard forms like EORTC-Q30 and others) is continued after progression. Clinical examinations (blood count, assessment of toxicity, anamnesis) is performed every two weeks for evaluation of toxicity and application of chemotherapy. After informed consent is given, peripheral blood of the patient will be analysed for the pharmacogenetic risk profile. Representative tumor material will be analysed by immunohistochemistry and quantitative PCR for the expression of several molecular factors.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or locally advanced gastric cancer or adenocarcinoma of the esophagogastric junction
* No prior chemotherapy in metastatic state
* Adequate blood and biochemistry parameters

Exclusion Criteria:

* Hypersensitivity for 5-FU, Leucovorin, Oxaliplatin or Docetaxel
* KHK, cardiomyopathy or cardiac insufficiency
* Malignancy \<5 years ago
* Brain metastases
* Severe internal disease or inadequate blood and biochemistry parameters
* Pregnancy and lactation
Audit of International Intraoperative Hemotherapy and Blood Loss Documentation

The investigator hypotheses anesthetic records do not contain detailed information on hemotherapy and blood loss estimation. Therefore anesthetic records will be collected from different institutions and analyzed for items concerning hemotherapy contained.

The anaesthetic record is the primary way anesthetists document and communicate information regarding hemotherapy. Records vary in content and design. Several organizations published recommendations, but perioperative hemotherapy is not sufficiently detailed for the purpose.

Anesthetic records will be analyzed for 20 defined hemotherapy and monitoring items by two independent investigators. Disagreements will be resolved by a the principle investigator.

Eligibility Criteria:
Inclusion Criteria:

* Anesthetic records

Exclusion Criteria:

* Incomplete records
Efficacy of Visual Screening in Ontario

Amblyopia (lazy eye), is the leading treatable cause of vision loss in childhood. Uncorrected refractive errors (ie farsightedness) can lead to difficulties in school. Unfortunately, many children do not receive vision screening until they have already developed irreversible vision problems. We will conduct a cluster randomized clinical trial in which schools, not individual children, are randomly allocated to receive a kindergarten visual screening program or to receive no intervention by the research team (i.e., "care as usual"). We will compare the prevalence of visual problems (and proportion of children with reading problems) when the children are in Grade 2, after allowing for at least one year of treatment.

The proposed study is a single-masked cluster randomized clinical trial, with randomization and analyses occurring at the level of "schools" (i.e., we are not randomly assigning individuals to groups). To assess the efficacy of a visual screening program, we will compare visual outcomes in 25 schools randomly chosen to receive the program and 25 schools allocated to "care as usual" one year after screening. The screening tools are HOTV crowded acuity, Preschool Randot Stereoacuity Test, and Plusoptix Autorefractor. The outcome measures will assess later differences between schools receiving the visual screening program and control schools for prevalence of (1) visual and (2) reading problems. A lower prevalence of either or both problems in schools where the visual screening program was offered would provide evidence for the efficacy of vision screening. Primary outcome measure is the prevalence of amblyopia, reduced stereo vision, and untreated clinically significant refractive errors in "screened" versus "care as usual" schools. Secondary outcome measure is the proportion of children performing 1 standard deviation below average on reading scores in "screened" versus "care as usual" schools.

Eligibility Criteria:
Inclusion Criteria:

* Screening: children enrolled in senior kindergarten (age 5-6 years)
* Follow-up: children enrolled in Grade 2 (age 7-8 years)

Exclusion Criteria:

• None
PPMI Tau PET Imaging

The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging) will evaluate if \[18F\] PI-2620 facilitates better understanding of Tau deposition in the brain in Parkinson's disease (PD).

The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging) is a companion study to the Parkinson's Progression Markers Initiative Clinical protocol (PPMI-002; NCT04477785). After consenting to the PPMI Clinical protocol, participants interested in completing an additional scan under this study will be asked to complete consent, additional activities, and one \[18F\]PI-2620 PET imaging scan as part of this study. Enrollment in the PPMI Tau PET Imaging companion study will facilitate comparison of tau deposition to clinical, imaging, blood and CSF tau already acquired in these PPMI participants under the PPMI Clinical protocol. The primary goal of this imaging study is to test whether positron emission tomography (PET) with \[18F\] PI-2620 can visualize in vivo brain tau deposition in participants with PD. The secondary goal is to evaluate tau deposition in PD LRRK2 mutation carriers given recent data that tau pathology may be present in those individuals.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in PPMI Clinical protocol
* Able to provide informed consent
* Male or Female (Females must meet additional criteria specified below, as applicable)

  * Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of \[18F\]PI-2620.
  * Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
  * Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
  * Females of childbearing potential must not be pregnant, breastfeeding or lactating.
  * Females of childbearing potential have a negative urine pregnancy test prior to \[18F\]PI-2620 injection on day of PET scan.

Exclusion Criteria:

* Exposure to an effective radiation dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines during the past year.
* Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.
Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury

The purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 60 years
* Traumatic spinal cord injury
* ASIA Impairment Scale A-D
* The injury must be within two weeks
* Patients submitted written informed consent

Exclusion Criteria:

* Traumatic spinal cord injury with brain injury or peripheral nerve injury
* Patients with severe multiple injuries and unstable vital signs
* Non-traumatic spinal cord injury caused by spinal tumors, hematoma, myelitis, etc.
* Patients with central spinal cord injury
* Patients with a completely transected spinal cord
* Patients with fever or acute infection
* Ongoing infectious disease, such as tuberculosis, HIV, hepatitis, syphilis, etc.
* Patients with anemia, coagulopathy, and other known blood system diseases
* Patients with malignant tumour
* Patients with neurodegenerative diseases, or any neuropathies
* Patients with ankylosing spondylitis
* Patients with a previous history of spinal surgery
* Patients who are pregnant or possibly pregnant
* Patients with psychiatric, addictive or any other mental disorders that can not give a truly informed consent
* Patients who are participating in other clinical trials
Sequential HIV Therapy in Treatment Resistant HIV-1 Infected Patients

This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.

Mathematical modeling has suggested that cyclic use of antiretroviral therapy can be an effective strategy in lowering viral load in HIV-1 infected patients when regular triple drug combinations have lost efficacy due to the emergence of HIV resistance mutations.

This is an open label, crossover pilot study to explore the safety and efficacy of a rapid cycling regimen of antiretroviral combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral therapy.

The objectives are to study the feasibility, safety and efficacy of sequential combination therapy in HIV-1 infected patients with virus harboring genotypic resistance to at least three classes of antiretroviral agents and who currently have no adequate treatment options available.

This is an open-label, crossover, pilot study. Patients that fail their current regimen, and who currently have no adequate treatment options left, will be randomized to start either an alternating triple combination, or to start a continuous quadruple regimen of drugs. After 6 weeks, patients will crossover from either strategy to the other strategy for another 6 weeks. Each period is preceded by an interruption of all antiretroviral therapy for 4 weeks. In the study period when regimens are alternated, two combinations of three drugs with the least possible cross-resistance will alternate every week.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected patients
* At least 18 years of age
* Males or non-pregnant, non-lactating females
* Documented virological treatment failure on at least 3 classes of antiretroviral drugs
* No adequate antiretroviral therapy possible with currently available antiretroviral agents
* Virological treatment failure is defined as plasma HIV-1 RNA levels \> 5000 while taking at least three different antiretroviral drugs
Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

Operative shoulder arthroscopy under regional block anesthesia often presents with hemodynamic challenges for the anesthesiologist, knowing that a low systolic blood pressure is required to minimize the bleeding. Regional anesthesia is successfully performed to many patients in whom tracheal intubation or the placement of a laryngeal tube is undesired. Propofol has traditionally been used to provide sedation in patients undergoing shoulder arthroscopy under regional anesthesia. In contrast to Propofol, Dexmedetomidine is a highly selective α-2 adrenoceptor agonist that has been shown to provide sedation, analgesia and anxiolytic effects with minimal respiratory depression. Due to the effect of both drugs on blood pressure, the investigators set out to compare intraoperative hemodynamics of both drugs, along with the surgeon's satisfaction and the degree of comfort provided to patients undergoing interscalene brachial plexus block for shoulder arthroscopy. The investigators also assessed whether the type of anesthetic agent used for sedation accounted for other differences in intra and post-operative outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists score (ASA) I or II.
* Elective Shoulder arthroscopy.

Exclusion Criteria:

* Allergies to any of the used medications.
* ASA score of III or above.
* Cardiac abnormalities.
* Contraindications to regional blocks.
* Patient refusal.
Breast and Cervical Cancer Educational Intervention for Latinas in Western New York

This pilot clinical trial studies a breast and cervical cancer educational intervention for Latinas in Western New York. An outreach program may help minority cancer patients overcome problems that keep them from receiving cancer screening.

PRIMARY OBJECTIVES:

I. Investigate the extent of linguistic and cultural tailoring necessary to adapt Esperanza y Vida outreach programs for Hispanics in Western New York.

II. Evaluate the effectiveness of the Esperanza y Vida program intervention to increase breast and cervical cancer knowledge and screening behaviors in Hispanic participants compared to a control health education program on diabetes.

III. Determine the factors associated with and/or predictive of screening of Hispanics in Western New York (WNY) as compared to New York City (NYC) and Arkansas to describe how the intervention impacts barriers and motivations for screening in diverse Hispanic populations.

OUTLINE:

Key informant interviews with local "gatekeepers" of Hispanic culture groups in WNY and focus groups with Hispanic cancer survivors with screened and unscreened participants are conducted during the first phase of research. Participants are then randomized to 1 of 2 arms.

ARM I: Participants engage in the Esperanza y Vida educational information session for breast and cervical cancer.

ARM II: Participants engage in an educational information session for diabetes.

After completion of study treatment, participants are followed up at 2 and 8 months.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are generally healthy, ambulatory, and able to participate in social events in their communities
* No women, men, or children of any ethnic or social background are ever excluded from the educational programs, although recruitment will focus on Hispanic/Latinos
* Children may be present with parents, but will not be included in any research activities, unless they are emancipated minors (under 18 and married)
* Men are included in all of the research activities, but will not be included in the follow-up telephone surveys to assess breast and cervical screening as they do not obtain screening Pap smears, clinical breast exams, or mammograms; men may be asked about their intent to assist women in obtaining screening
Drug Use Evaluation of Clindamycin in Critical Care Units in Alexandria Main University Hospital

Irrational use of antibiotics is a one of the main health system problems,it leads to antibiotic resistance,increasing antibiotics side effects and the total cost. This study is a medication use evaluation study aims to evaluate intravenous clindamycin prescribing practice in critical care units in Alexandria Main University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years old or more .
* Patients on clindamycin as an empirical treatment.
* Patients started clindamycin as an emperical treatment in other departments but the physician approved to continue it in critical care.

Exclusion Criteria:

* Children (less than 18 years old)
* Patients started clindamycin as a defenitive treatment (based on microbiological culture results).
Digital vs Analog Impression in Cases of All-on-4 - Prosthesis

Fifty six patients were randomly enrolled in the study. Participants were randomly stratified into two control groups and two test groups, from which conventional pick up and digital impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial) received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted) received two anterior axial implants and two distal tilted implants.

All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis were evaluated at 6m,12m, and 24 months follow up period.


Eligibility Criteria:
Inclusion Criteria:

* completely edentulous patients with age range from 50-65 years.
* physically and psychologically eligible participants for implants placement.
* adequate bone to receive 4 interforaminal implants.

Exclusion Criteria:

participants were excluded if

* medical conditions that precludes implants placement
* smokers
* patients suffering from any parafunctional habits
MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?

The investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal MRI alone is sufficient or whether it is necessary to perform a total skeletal MRI.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* Patient has been diagnosed with multiple myeloma (\> 10% medullary plasma cells + monoclonal protein) or symptomatic myeloma (myeloma + CRAB symptoms (hypercalcemia, renal failure, anemia, bone lesions), or indolent myeloma (myeloma with symptomatic criteria).

Exclusion Criteria:

* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breast feeding
* The patient has an absolute contra-indication for MRI (pace-maker, claustrophobic patient, metal heart valve)
Morning Light Treatment at Home to Reduce PTSD Symptoms

There is evidence that some of the circadian photoreceptors, the intrinsically photosensitive retinal ganglion cells (ipRGCs), project directly to the amygdala, an area of the brain implicated in PTSD. Thus, a self-administered morning light treatment at home (shifts clock earlier and stimulates ipRGCs) may be a potentially efficacious adjunctive strategy for reducing PTSD symptoms. This study will test a 4 week daily 1 hour morning light treatment (active vs placebo) in individuals with PTSD. Outcome measures include measures of PTSD and depression.


Eligibility Criteria:
Inclusion Criteria:

* Probable PTSD based on the PCL-5 score
* Fluent in English
* Willingness and ability to comply with the protocol

Exclusion Criteria:

* Current or recent (past 6 months) alcohol or substance abuse problems
* Past or present psychotic or bipolar disorders
* Significant suicidal ideation or suicidal behaviors in past 6 months
* Unable or unwilling to give written informed consent.
* Severe hearing and memory problems.
* Cognitive impairment or mental retardation that interferes with subject being able to understand study requirements, consent form, etc.
* Special events (e.g. weddings, exams, surgery) planned during 5 weeks of study
* Unable to travel for study visits
* Pending legal cases/litigation
* Has a serious or unstable medical illness (including but not limited to cardiovascular disease, uncontrolled diabetes, advanced liver disease, kidney failure, seizures, cancer which is likely to result in hospitalization in next year).
* Reports significant chronic migraine. For migraines, subjects will only be excluded if they report that bright light can trigger migraines.
* Vision problems, retinal disease, or history of eye surgery.
* Taking photosensitizing medications
* Have previously had light treatment.
* Uncontrolled narcolepsy, sleep apnea or restless leg syndrome
* Likely to have undiagnosed, significant sleep apnea
* Likely to have undiagnosed, significant restless leg syndrome
* Prescribed hypnotics, over the counter sleep aids and antidepressants permitted providing all medications stable for 30 days before and during the study). All current medications must be non-photosensitizing.
* If in psychotherapy must have been for at least 30 days.
* People taking melatonin will be asked to abstain for a month before and during the study
* Has traveled outside the central time zone
* Have worked a night-shift the past month.
* Has winter depression
* Is pregnant, trying to get pregnant or breastfeeding.
* Household has a child \<2 years old or a child that does not sleep through the night
* Is unavailable for a 5 week period
* Fail urine drug test at screening visit (after prescribed medication accounted for)