cyrilzakka/clinical-trials huggingface dataset:
Pharmacogenomics of Paclitaxel in Ovarian Cancer

This study will try to determine whether or not certain genes are responsible for the huge variation in toxicity and effect observed between patients treated with paclitaxel (chemotherapeutic drug). Specifically we will study this in patients with ovarian cancer who receive paclitaxel/carboplatin chemotherapy after primary surgery.

Paclitaxel is an antineoplastic drug used in the treatment of ovarian cancer. The effect and toxicity is unpredictable in the individual patient. Paclitaxel is removed (eliminated) from the organism by oxidation. CYP2C8 is the enzyme mainly responsible. P-glycoprotein (Pgp) is an efflux transport protein natural to the human organism. Pgp is responsible for excretion of drugs via the bile and the kidneys and is thought to play a role in chemotherapy resistance. Paclitaxel is substrate for Pgp. Single nucleotide polymorphisms are possible causes for variation in both CYP2C8 and Pgp expression/function. We will study a possible role of these genetic variations as predictors of paclitaxel toxicity and effect and the possible implications for individual dosing in the future.

We want to determine the metabolic capacity of approximately 100 ovarian cancer patients and comparing this with genotypes, acute toxicity(eg. bone marrow suppression and neuropathy) and response to treatment(ie. CA125 response, progression free survival and overall survival). The metabolic capacity is estimated using a "sparse sampling" approach applying advanced computerized pharmacokinetic/dynamic modelling as opposed to traditional "frequent sampling" pharmacokinetic studies which burden the individual patient more.

Patients are recruited in collaboration with Oncological departments throughout Scandinavia.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnose and histology of invasive epithelial ovarian/tuba or peritoneal cancer
* FIGO stage IIb-IV any grade or FIGO Ia-IIa only grade 3 or clear cell carcinoma (any stage and grade)
* Natural candidate for paclitaxel 175mg/m2 + Carboplatin (AUC=5-6)
* Baseline CA125≥70 AND/OR evaluable disease after RECIST (incl ultrasound)
* 18 years or older
* Caucasian (ie.parents and grandparents are Caucasian)
* Performance status 2 or lower (after WHO/ECOG)

Exclusion Criteria:

* Prior malignant disease apart from cervical carcinoma in situ and basal cell carcinoma of the skin
* Prior chemo / radiotherapy
* Ongoing or imminent other chemotherapies
* Pregnant or lactating
* Fertile woman of childbearing potential not willing to use adequate contraception
* Neurological symptoms (any kind) worse than CTCAE grade 1
* Active infection or other serious disease that could impair on treatment and/or follow-up
Study With Oral Isovue in Abdominopelvic CT

This is a retrospective clinical study with prospectively designed blinded evaluation of CT images in adult and pediatric patients who underwent CT examinations of the abdomen and pelvis and were orally administered a solution of Isovue-300 to opacify the GI tract to distinguish it from adjacent abdominal and pelvic structures. The study will collect already existing data, such as demographic data, adverse events and CT images, for all chronologically enrolled patients who meet the inclusion/exclusion criteria prospectively defined in this protocol


Eligibility Criteria:
Patients will be included in the study if:

* Demographic and safety data are available for analysis
* Complete set of CT images performed after oral administration of Isovue-300 are available for assessment
* Isovue-300 was orally administered during an interval time of 60-20 minutes before the CT scanning.

Patients will be excluded from the study if:

* Oral contrast agent received within 1 week prior to the CT scan
* Undergone any abdominopelvic surgery procedure that resulted in alteration of the bowel transit time prior to the CT exam
* CT exam with oral administration of Isovue was performed because of a known or suspected condition of bowel obstruction
* Patient did not actively drink the contrast solution.
Curative D2 vs D1 Lymphadenectomy in Operable Gastric Carcinoma

Gastric carcinoma is the second most common cause of cancer-related deaths and its main treatment modality if potentially curable is surgery but the optimal surgical resection is controversial. The aim of the current study was to assess the outcomes of curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding postoperative morbidity and mortality, disease recurrence and survival rates.

80 consecutive patients with potentially operable gastric carcinoma were randomized via concealed envelopes into 2 groups (each included 40 patients), group I managed by radical gastrectomy with D1 lymphadenectomy while group II managed by radical gastrectomy with D2 lymphadenectomy . Both groups were compared regarding postoperative mortality, morbidities, tumor recurrence and 2 years survival rates.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed gastric carcinoma
* Potentially operable gastric carcinoma without evidence of distant metastasis

Exclusion Criteria:

* Complicated gastric cancer (obstructed or perforated)
* Locally irresectable tumor
* Previous or coexisting cancer
* Prior gastric surgery or neoadjuvant chemotherapy
* Contraindication for major surgery
A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab \[RoActemra/Actemra\] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* moderate to severe rheumatoid arthritis (DAS28 \>3.2) of 6 months duration
* inadequate clinical response to non-biologic DMARDs or anti-TNF
* bodyweight \</=150 kg

Exclusion Criteria:

* rheumatic autoimmune disease or inflammatory joint disease other than RA
* major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening
The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents

This study is a single site, double-blind, randomized, placebo-controlled parallel group design. this study is designed to directly examine the efficacy of a single daily dose of atomoxetine taken in the morning in alleviating sleep initiation insomnia in children with ADHD. Primary outcome measures are sleep parameters, specifically mean sleep onset latency (time of onset to persistent sleep), as measured by actigraphy/sleep diary, and parent and child-reported evening settling difficulties, as measured on the evening subscale items of the parent and child versions of the DPREMB-R. Secondary outcome measures include: additional actigraphic sleep parameters (night wakings, sleep duration, and sleep efficiency), daytime sleepiness (Pediatric Daytime Sleepiness Scale, sleepiness visual analogue scale (VAS), and morning behaviors on the DPREMB-R); ADHD symptom improvement (ADHD-RS, parent version; provider-completed CGI); a neurocognitive measure of attention and impulsivity (CPT); executive functions (Brown ADD Scale for Children) and functional outcomes/quality of life (CHQ).


Eligibility Criteria:
Inclusion Criteria:

Subjects are children aged 6 through 17 years with DSM-IV criteria-defined ADHD and sleep initiation insomnia.

Exclusion Criteria:

the sleep onset delay must not be exclusively related to direct or rebound effects of psychostimulant treatment. All subjects will be screened for primary sleep disorders with survey questionnaires (Children's Sleep Habits Questionnaire, CSHQ (12) and Restless Sleep Questionnaire) (Visit 1); subjects scoring above a pre-defined threshold for OSA and/or RLS/PLMD symptoms will be excluded from the study. Other exclusion criteria include IQ \< 80 (WISC-III screen at baseline), history of significant chronic medical illness (diabetes, severe asthma), co-morbid depression or other significant psychiatric co-morbidities (ODD, LD not excluded; determined by screening with the Diagnostic Interview Schedule for Children (DISC)), history of chronic use of sedating (eg, antihistamines) or alertness-enhancing (eg, caffeine) medications, history of conditions for which use of atomoxetine is contraindicated (eg, narrow angle glaucoma), use of other prescription medication for ADHD and/or use of prescription/OTC medication for sleep (eg, alpha agonists, hypnotics, melatonin, antihistamines) following the screening visit, and history of failure to respond to an adequate (defined as appropriate dose and adequate duration of therapy) previous trial of atomoxetine
TSPO-PET/MRI in Surveillance of Neuroinflammation in the Central Nervous System

Central Nervous System (CNS) inflammation is an immune response activated in the brain and spinal cord by microglial cells and astrocytes, commonly occurring under conditions such as central nervous system ischemia, autoimmunity, infection, toxins, and trauma.

Microglial cells, as the innate immune cells of the central nervous system, are responsible for driving the inflammatory response and play a crucial role in sensing environmental changes, responding to harmful stimuli, and engulfing dead neurons. They also present antigens to T lymphocytes, mediating interactions between the peripheral immune system and the central nervous system. Factors released by neuronal cells can either promote or inhibit inflammation, and monitoring the level of inflammation driven by microglial cells is essential for the diagnosis and treatment of central nervous system diseases.

MRI is the primary imaging method for central nervous system inflammation, but it can be challenging to diagnose. PET/MR, a technology that integrates PET and MR imaging, provides high-quality diagnostic images and is valuable for the early detection, diagnosis, and assessment of central nervous system diseases. The radioactive ligand 18F-DPA-714 PET, targeting the translocation protein (TSPO), can visualize activated microglial cells, which may have a gain effect in detecting active central nervous system inflammation.

This study aims to explore the application of 18F-DPA-714 PET/MR in the early diagnosis, treatment evaluation, and prognosis of central nervous system inflammation.


Eligibility Criteria:
Inclusion Criteria:

-Clinical diagnosis of ischemic stroke, autoimmune ecephalitis, Neuromyelitis optica spectrum disorders, or multiple sclerosis, etc.al

Exclusion Criteria:

* Claustrophobia
* Metal Implants
* Pregancy
* Breast-feeding
* Renal insufficiency (GFR \< 60 mL/min/1.73m2)
* Allergy or other contraindication to gadolinium-based MR contrast agent
The Need for Rehabilitation and the Connection With Attachment Styles Among Patients With Gynaecological Cancer

The purpose of this study is to provide new knowledge about:

* Integration of rehabilitation in a highly specialized gynaecological department.
* Development and testing of an individually adapted rehabilitation process.
* Needs for rehabilitation among women with gynaecological cancer.
* Connection between adult attachment style for women with gynaecological cancer and their quality of life, rehabilitation needs and symptoms of depression /PTSD.


Eligibility Criteria:
Inclusion Criteria:

* suspicion of gynaecological cancer
* surgery for gynaecological cancer

Exclusion Criteria:

* do not speak Danish
Effectiveness of a Typhoid Conjugate Vaccine in DRC

This is a prospective cohort evaluation of vaccine effectiveness of a single dose of Typbar-TCV® against symptomatic blood culture-confirmed typhoid fever when administered through a mass vaccination campaign to children 9 months to \<16 years of age in Kisantu, DRC.

This study is conducted in Kisantu, DRC and is comprised of a mass vaccination campaign of children aged 9 months to \<16 years with a single dose of Typbar-TCV® and a concomitant surveillance study to assess the incidence of culture-confirmed typhoid fever in the population during a period of three years following vaccination. Safety events will be monitored for 30 minutes following vaccination for all participants. In a subset of age-eligible participants living in the study area, the investigators will assess local and systemic solicited adverse events/adverse reactions and unsolicited adverse events occurring within the first 7 days post-vaccination and unsolicited and serious adverse events within 28 days post-vaccination. A population census will be conducted at baseline to enumerate and characterize the population under study and demographic information will be collected to allow for minimization of potential sources of bias during analysis. An interim censuses and a census at study closure will be carried out to update population information.

The investigators hypothesize that the Typbar-TCV® vaccine is effective in large scale vaccination campaigns, thereby lowering the incidence of blood-culture confirmed typhoid fever in children. Lessons and experiences on vaccination feasibility and uptake will be important for informing TCV introduction across the African continent.

Eligibility Criteria:
Inclusion Criteria:

* Parent/guardian willing and able to provide informed consent; assent will be sought for participants between 12 and \<16 years of age
* Resident of the defined study area, Kisantu Health Zone at the time of vaccination
* Age between 9 months and \<16 years (i.e., ≤15 years and 364 days) on the day of vaccination

Exclusion Criteria:

* The participant has a known allergy to any of the vaccine components,
* Any medical reason perceived to increase risk to health posed by vaccination as judged by a medical professional
* Self-reported pregnancy in females greater or equal to 11 years of age who have reported menarche
A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 2 diabetes mellitus
* On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control
* Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control

Exclusion Criteria:

* History of type 1 diabetes mellitus or a history of ketoacidosis
* Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent
* On a weight loss program and is not in the maintenance phase or has

started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation

* Medical history of active liver disease (other than non-alcoholic

hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease

* Human immunodeficiency virus
* New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke or transient ischemic neurological disorder within the past 3 months
* History of malignancy ≤5 years prior to study participation except for adequately treated basal cell or squamous cell skin cancer, or in situ

cervical cancer

* Clinically important hematological disorder (such as aplastic anemia,

myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

* Pregnant or breast-feeding, or is expecting to conceive or donate eggs

during the trial, including 21 days following the last dose of study drug
The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes

The purpose of the trial is to verify the effectiveness and safety of glimepiride compared with sitagliptin as an add-on therapy to metformin in severe insulin deficiency diabetes.

This clinical trial is a multi-centre, prospective, intervention, randomized-controlled clinical trial, and uses a superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.

Eligibility Criteria:
Inclusion Criteria:

* According to the World Health Organization (the WHO) 1999 criteria for the diagnosis of type 2 diabetes; the subtype was allocated to severe insulin deficiency diabetes (SIDD) at diagnosis using data-driven diabetes clusters APP.
* Men and women aged ≥ 18 years and ≤ 75 years;
* Diagnosed as severe insulin deficiency diabetes by the cluster classifier of Peking University People's Hospital at the initial stage of the disease course;
* Metformin monotherapy with dosage ≥1500 mg/day for at least 8 weeks;
* Diabetes duration less than 5 years;
* The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c \<10.5%
* estimated estimated glomerular filtration rate (eGFR)\>=60 ml/min1.73m2, alanine aminotransferase(ALT)\<120U/L ;
* If other drugs are used during the course of the disease, these drugs should be withdrawn for more than 8 weeks;
* Without acute diabetic complications at present.

Exclusion Criteria:

* Type 1 diabetes or other special types of diabetes mellitus; glutamic acid decarboxylase antibody (GADA) positive, the subtype was allocated to other subtypes at diagnosis using data-driven diabetes clusters APP.
* Pregnancy or have a pregnancy plan within a year;
* Lactation or have a lactation plan within a year;
* Renal insufficiency, eGFR\<60; transaminase elevated, ALT\>= 120U/L; unstable coronary heart disease.
* Recurrent spontaneous diabetic ketosis or uncorrected acute diabetic complications;
* Participated in other clinical trials within 8 weeks before randomization; Unable to complete the study follow-up for 6 months; Have situations such as operation and need to change to insulin therapy in 6 months.
* Use concomitant medication such as glucocorticoids which can affect blood sugar.
* The investigator judged that it is not suitable to participate in this clinical trial.
Open Label Placebo to Reduce Prescription Opioid Use

The goal of the proposed study is to examine the efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. People with acute pain will receive their standard dose of opioid medication for pain management. In addition, some people will be asked to take placebo pills, honestly described as placebos, as well. Patients will answer a few short questions over the phone once per day for seven days about pain and opioid use. The investigators hypothesize that participants in the open label placebo group will take fewer opioids and have less pain than those in the treatment as usual group.

America is in the midst of an opioid epidemic. One of the reasons opioid addiction and overdose deaths have recently increased is that doctors are frequently prescribing opioid medication as a treatment for pain. If researchers can develop ways of increasing the pain-relief patients experience from a set amount of opioids, then doctors might ultimately be able to prescribe fewer opioid medications, which could help curb the opioid crisis.

Although "placebos," a medication whose benefit derives solely from positive psychological factors rather than pharmacological factors, are often disparaged in medicine, research suggests that placebos can actually help reduce pain. In fact, there is reason to think that placebos are effective even when a patient knows they are taking a placebo.

The goal of the proposed study is to examine the efficacy of using an honest placebo to relieve pain for patients with an acute pain condition. People with acute pain in the Emergency Department, or patients undergoing hand/wrist surgery, will receive their standard dose of opioid medication for pain management. In addition, some people will be asked to take placebo pills, honestly described as placebos, as well. Patients will answer a few short questions over the phone once per day for seven days regarding their pain, opioid use, and placebo use (only those assigned to take placebo pills).

Eligibility Criteria:
Inclusion

* 18 years or older
* English Speaking
* Has a working smart-phone
* Able to provide informed consent
* Present for upper or lower extremity fracture (ED sample only) or for hand or wrist surgery (hand surgery sample only)
* Are expected to be prescribed opioids at discharge
* Are expected to be discharged from the Emergency Department (ED sample only)
* Intends to take 1 or more doses of opioid medication as prescribed

Exclusion

* Chronic opioid use
* Unlikely to follow-up (discretion of investigator and treating provider)
* Having been diagnosed with a psychotic disorder
* Having a current medical marijuana prescription
* Currently receiving worker's compensation or intending to apply for worker's compensation
* History of opioid use disorder
* Allergy to opioid medication
Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients

The purpose of this study is to investigate whether cloxacillin lock is effective in prevention of double lumen infection.

Double lumen infection is one of the causes of morbidity and mortality in hemodialysis patients. Many strategies used to prevent it and one of them is antibiotic lock. Thus we select chronic hemodialysis patients and divided them into 2 groups. One group received cloxacillin and heparin as catheter lock and the second group received only heparin lock.

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis for 3 months
* at least 2 time dialysis/week

Exclusion Criteria:

* active infection
* acute renal failure