cyrilzakka/clinical-trials huggingface dataset:
Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes

The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy\<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel


Eligibility Criteria:
Inclusion Criteria:

* women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0)
* ECOG performance status 0-1
* start of adjuvant therapy not later than 4 weeks after surgery
* hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l
* normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT till 1.25 x normal value
* normal kidney function as defined by: creatine till 1.5 x normal value
* negative pregnancy test for patients before menopause and effective contraception
* written informed consent

Exclusion Criteria:

* prior radiation, chemotherapy, hormontherapy and immunotherapy
* patients with more than 3 afflicted lymph nodes
* afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes
* bilateral breast cancer or second carcinoma of the breast
* inflammatory breast cancer and/or distant metastases
* existing clinically relevant peripheral neuropathie
* heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least LOWN II
* patients with active infections and/or not controlled hypercalcemia
* pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva
Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)

The goal of this clinical trial is to investigate whether a smartphone app based on the Global Initiative for Asthma (GINA) guidelines can improve asthma control and quality of life, and decrease asthma-related costs in children. The main question it to answer whether this app can improve asthma control, increase the quality of life, and decrease asthma-related costs.

Participants in the intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits, while the control group received reminder calls. Researchers will compare with the control group to see if the intervention receives more asthma control improvement.


Eligibility Criteria:
Inclusion Criteria:

* aged between 3 and 18 years;
* who had access to the smartphone app;
* with asthma treatment steps 2-4, requiring regular treatment with controller medication (for at least 6 months over the past year) according to the GINA guidelines;
* who had at least two clinic or emergency department visits related to asthma in the previous year.

Exclusion Criteria:

* Children who had comorbidities, or other major medical problems, and who did not have a smartphone or whose caregivers did not have a smartphone were excluded from the study.
Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
* No prior chemotherapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status 2
* Clinically or radiologically measurable disease per RECIST criteria

Exclusion Criteria:

* Gastro-intestinal abnormalities
* Any concurrent anticancer therapy
* Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
* Other active malignancies
* Uncontrolled brain metastases
* Severe abnormalities of the cornea
* Significant cardiac disease
Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis criteria of MS fulfilling revised Mc Donald criteria (2010)
2. Uni-or bilateral optic neuropathy with worst eye VA≤ 5/10 confirmed at 6 months
3. Worsening of visual acuity during the last three years
4. Informed consent prior to any study procedure
5. Patient aged 18-75 years

Exclusion Criteria:

1. Optic neuritis relapse within the three months before inclusion
2. Normal RNFL at OCT
3. Presence of other ocular pathology (glaucoma, cataract, retinopathy, anterior uveitis, myopia\>7 dioptrics, intraocular pressure\>20 mm Hg, amblyopia, retinal or optic head abnormalities (drusen, tilted disc)
4. Bilateral visual acuity \<1/20
5. Visual impairment caused by ocular flutter or nystagmus
6. Pregnancy or childbearing potential woman without contraception
7. Any general chronic handicapping disease other than MS
8. New treatment introduced less than 3 months prior to inclusion or less than 1 month for Fampridine
Nutritional Assessment of Children With Chronic Kidney Disease

Primary outcome is assessment of nutritional status of children with CKD. Secondary outcome is assessment STAMP screening tool for detection of malnutrition of CKD children.

Pediatric Chronic Kidney Disease (CKD) has systemic implication on all aspects of normal development, including nutrition, growth, bone and mineral metabolism and neurocognitive function .

Chronic Kidney Disease (CKD) introduces a unique set of nutritional challenges for the growing and developing child .

Eligibility Criteria:
Inclusion Criteria:

* Children of both sexes.
* Diagnosed as chronic kidney disease.
* Age: 2 years up to 15 Years Children.

Exclusion Criteria:

* • Age: less than 2 years old child and more than 15 years old child.

  * Previously diagnosed to have any co- morbid or systemic disease other than CKD.
  * Irregular dialysis.
  * Renal transplant.
Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis

The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid Arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Subject provided informed consent.
* Rheumatoid arthritis present for ≥ 3 months.
* Global functional class I, II, or III.
* History of or positive for, Rheumatoid Arthritis
* Taking methotrexate consecutively for ≥ 12 weeks and on a stable dose at 10-25 mg weekly.
* Subjects currently taking NSAIDs or oral corticosteroids.
* Normal ECG values
* Immunizations up to date.

Exclusion Criteria:

* Positive Hepatitis B, Hepatitis C, Positive HIV
* Sensitivity to any of the products or components to be administered.
* Malignancy within 3 years
* Presence of recurrent or chronic infections
* Evidence of infections within the 30 days prior to randomization
* Presence of a serious infection
* Prosthetic joint infection within 3 years or native joint infection within 1 year
* History of exposure to tuberculosis without a history of prophylactic treatment
* Class IV RA.
* Felty's syndrome
* Chronic pelvic pain or hemorrhagic ovarian cyst within 3 years
* Any bleeding disorder that is clinically significant
* Low white blood cell or neutrophil count
* Elevated serum creatinine clearance
* Low hemoglobin and platelet count
* Received live vaccines within 3 months of first dose
* Alcohol and/or substance abuse within past 12 months
* Blood donation within 60 days
* Positive urine screen for drugs of abuse
* Any prior use of rituximab in the last 6 months (or other B cell depleting agents) and CD19 levels \< lower limits of normal
* Use of a weekly or bimonthly biologic within 2 weeks or monthly biologic agents within 4 weeks
* Corticosteroid injections for acute RA flare within 4 weeks
* Grapefruit juice or grapefruit containing products within 7 days of first dose.
* All herbal medicines, vitamins, and supplements within the 30 days
* The use of any experimental/investigational biologic DMARD unless off agent for 3 months; or off for 6 months for B cell depleting agents
* Known GI disease or GI procedures
* Women of reproductive potential who are unwilling to practice birth control
* Women who are pregnant/lactating/breastfeeding
* Subject with IgG levels \< lower limit of normal at screening
Home-based Transitional Telecare for Older Veterans

The project focuses on supporting home care in the post-hospitalization period (Home Health Phase), and then further optimizing the older Veterans' recovery of mobility and physical activity in the transition back to the home/community (Follow-up Phase).

Medicare-funded home care bridges gaps in the transition of patients from hospital to home; yet, it is a bridge with gaps of its own, having limited communication with both the discharging hospital physician and the receiving primary care provider and having limited knowledge of the longitudinal medical history of the patient. Once home care is completed, there is often no plan of continued support to transition the older Veteran back to optimal home/community function.

In the Home Health Phase, a VA-home care Link Team (physician, clinical pharmacist, social worker, and physical activity trainer) will provide immediate communication/coordination between the VA Ann Arbor Healthcare System (VAAAHS) and home care agencies contracted by VAAAHS. The intervention is based on a conceptual model of home care as a bridge between hospital and home, in which three interconnected domains determine short-term and long-term outcomes: medical complexity (e.g., medication management), social complexity (e.g., caregiving, environment), and functional impairment (e.g., mobility, physical activity). The VA Link Team will provide support and assessment for each domain. The team will use telemedicine technology and wearable sensors in the home to gather patient data and facilitate communication between the patient, health care providers, and the Link Team. The Follow-up Phase begins at the end of formal home care services, when the Link Team will provide patient-centered care in two ways: 1) support for the the Veteran and caregiver in the event of changes in medical condition or medications as well as social or caregiver stressors; and 2) coaching to the Veteran and the caregiver during this transition period to optimize functional mobility and physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Under VA Ann Arbor Healthcare System (VAAAHS) primary care practitioner (PCP) oversight.
* Recently discharged from inpatient hospitalization.
* Received inpatient (pre-discharge) physical therapy evaluation and have identified rehabilitation goals for care to be provided in the home.
* Identified caregiver who agrees to participate and who will be the key link if the Veteran is unable to care for himself or has memory problems.

Exclusion Criteria:

* Require highly specialized equipment or therapy (e.g. rehabilitation for spinal cord injury, prosthesis training following leg amputation).
* Have active mental health conditions (e.g. paranoia) that may interfere with program participation.
* Require strict bed rest (e.g. long-term extensive wound healing needs) or strict use of a wheelchair.
Conventional Verses Ultrasound Guided Arteria Cannulation, With and Without Local Anesthesia

The aim of the project is to compare two methods for arterial cannulation. The traditional method with ultrasound guided cannulation. The investigators goal is to improve this procedure to reduce pain and complications.

The practice of placing vascular catheters is used many times every day at almost every hospital. It is a safe procedure which generally does not imply problems. Though the procedural optimum aren't reached. The procedure still fails some times and induce complications. When the catheter is placed using the traditional method the pulse is palpated by the operator's fingers. This is only to be done near the hand wrist. In this position the catheter steadiness is fragile but because the pulse can't be sensed more proximal the operator is forced to choose this position. This it though a problem that can be solved by non invasive visualization technology. Ultrasound-guidance for central vascular access is already well-established. However, in recent years ultrasound-guidance for peripheral vascular access has gained popularity too. The evidence of multiple studies demonstrates increased success rate and reduced complication rate with ultrasound compared to blind landmark technique for vascular catheter placement.

In recent years there have been both procedural technique and technology improvements in the field of ultrasound. This has led to the improvement of procedural catheterisation techniques that now can be done by novices with higher attempt success rate than traditional method. One technique that is gaining success is the short-axis-out-of-plane technique (SAX-OOP) with dynamic-needle-tip-tracking (DNTT).Using the ultrasound machine the needle can be placed in a more proximal direction on the forearm and the investigators believe that by the help of the exposed procedure on the monitor many complications can be reduced.

Hypothesis; Firstly the investigators hypothesize that the pain induced by the conventional method inclusive preoperational lidocaine injection will be the same or more intense than using DNTT without local anesthesia. Secondly the investigators hypothesize that the use of DNTT for the placement of the arterial catheter will decrease the time spend, amount of complications (hematoma), the number of pricks, the number of utilized catheters compared to the traditional palpation method. Thirdly the investigators claim that the best anatomical place to put the catheter isn't always corresponding with the spot chosen by palpation, which increase the number of failures.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-90 years
* Fulfill the criteria of an operation
* Routine need of an arterial needle

Exclusion Criteria:

* Lack of patient consent
* Ultrasound identified plaques in the radial artery or ultrasound verified positive Allens test or traditional positive Allens test
Fecal Microbiota Transplantation for Diabetes Mellitus Type II in Obese Patients

The incidence of obesity has dramatically increased during the last three decades, leading to a significant increase of obesity-related morbidity, including type 2 diabetes mellitus (T2DM) that is characterized by resistance of target tissues to insulin action. T2DM obese patients may be treated by medications or by bariatric surgery. Both alternatives have limitations due to incomplete resolution of the diseases, high cost or potential procedural related morbidity. An increasing body of evidence points to a role of the enteric microbiota in the pathogenesis of obesity-related insulin resistance. In addition to that, the gut microbiota is directly affected by the diet composition. Studies in T2DM mice carrying human gut germs, demonstrated special interactions between the gut microbiota and the host, creating a typical microbiota composition which changes significantly following diet change from a western diet, rich with sugar, to a vegetarian diet rich with fibers. This rapid alternations in the microbiota composition has also shown in humans, after changing from western to high fiber diet. A change in diet life style may lead to an improvement in T2DM symptoms such as decrease in visceral adipose tissue.

Study design:

30 Patients will undergo 2 FMT's from a lean donor and will be randomized into 3 types of diet groups:

1. low fat high fiber diet (20% fat)
2. no change in fat intake (sham diet)
3. high fat low fiber diet (40-45% fat)

The treating physicians and the patients will be blinded for the diet arm. Before and after FMT, patients will be assessed after an overnight fast (and before taking medications) for weight, anthropometric measures, questionnaires (dietary, general health, antibiotic and probiotic exposure, oral diabetes medication quantity, and other drug exposure), blood and stool.

The investigators hypothesize that fecal microbial transplantation from a lean donor to T2DM obese patients, with the combination of low fat high fiber diet, will alter the gut microbiota composition to decrease insulin resistance through microbiota dependent metabolic and immunologic effects.

Eligibility Criteria:
Inclusion Criteria:

* 30≤BMI
* A diagnosis of T2DM (≥3 months) and one of the following:

  1. Fasting glucose level≥126mg/dL and/ or
  2. A stable dose of anti-diabetic drugs for ≥2 weeks and/or
  3. HbA1C≥6.5
* Access to a smart phone supporting the research application for tracking food consumption.

Exclusion Criteria:

* participation in other clinical trial
* incapable of signing an informed consent
* pregnancy or breast feeding
* Antibiotic treatment within the prior 3 months or predicted antibiotic treatment
* insulin medications
* drugs or alcohol addiction
* immune mediated diseases
* type 1 diabetes and latent autoimmune diabetes of adults
* systemic disease
* ischemic heart disease
* probiotics consumption
* a new or unstable treatment with anti diabetic medications

Patients will also be excluded if:

* treated by systemic antibiotic during the study
* will not be compliant with the diet
Anxiety Lowering and Deprescribing Through Emotion Regulation

The goal of this clinical trial is to test ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation), an online self-guided positive emotion intervention, in patients over the age of 65 who are candidates for benzodiazepine receptor agonist (BZRA, commonly called benzos, or z-drugs) deprescribing. The main questions it aims to answer are:

* Is ALDER relevant to and satisfactory for older adult BZRA users?
* Does ALDER help to increase positive emotions and decrease anxiety, trouble sleeping, and use of BZRA medications?

Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments, one before the intervention and one after.

ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation) is a pilot trial of an online positive emotion intervention for adults age 65 and over who are candidates for benzodiazepine receptor agonist (BZRA) deprescribing. The ALDER intervention is 5 weeks long and involves weekly self-guided positive emotion skill lessons and daily skill practice exercises, both housed on the ALDER website.

Up to n=40 patients over the age of 65 will be recruited from Northwestern Medicine Primary Care clinics. To participate, patients must have (1) a BZRA prescription from Northwestern Medicine Primary Care within the past year, (2) at least 1 NM Primary Care visit in the past year, and (3) take a BZRA at least twice a week. Participants will complete survey assessments via REDCap before and after they go through the ALDER intervention. All study activities will take place online.

Feasibility, acceptability, and adoption of the ALDER program will be assessed using enrollment and retention rates, website user data, and measures of relevance and satisfaction in the post-intervention assessment. Patient reported outcomes such as anxiety, sleep and positive affect will be measured both pre- and post-intervention and rate of BZRA usage will be extracted from participant medical records.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 and over.
* ≥1 NM Internal Medicine clinic visit within the past year.
* BZRA prescribed by NM primary care within the past year.
* Takes BZRA at least twice a week.
* Daily access to internet-connected device.
* Ability to read and speak English.

Exclusion Criteria:

* Dementia, seizure, or REM sleep disorder diagnosis.
* In hospice care.
* No daily internet access.
* Cannot speak and read English.
Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients

This study will evaluate the pharmacokinetics and pharmacodynamics of BCT194 in psoriatic patients to better understand the skin penetration of topically applied BCT194.


Eligibility Criteria:
Inclusion criteria:

* Male patients and post menopausal or surgically sterile female patients aged 18 - 75 years.
* Diagnosis of stable plaque psoriasis (with or without arthritis); diagnosed or history of psoriasis for at least 6 months prior to screening
* Psoriatic plaques accessible for microperfusion at body sites (e.g. trunk) convenient for the patients.

Exclusion criteria:

* Currently have any of the nonplaque forms of psoriasis: erythrodermic, guttate, or pustular.
* Currently have drug-induced psoriasis (new onset or exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
* Recent previous treatment with anti-TNF-α therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate, pimecrolimus, or tacrolimus.
* Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, psychiatric, or other disease which would make the patient unsuitable for the trial.
* Presence of major chronic inflammatory autoimmune diseases like rheumatoid arthritis, spondyloarthropathy, inflammatory bowel disease or systemic lupus erythematosus.
* Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes

This study looks at the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of diabetes. The study will test how insulin 965 is tolerated by the body, how it is taken up in the blood, how long it stays there and how the blood sugar is lowered. Participants will either get the new insulin 965 or the already marketed insulin glargine U100 (Lantus®) - which treatment is decided by chance. Participants will get six injections (one per day) of either insulin 965 or insulin glargine U100 under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. Participants can only be in the study if the study doctor thinks that there are no risks for their health. Women can only take part in the study if they can't have children.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening.
* Male subject or female subject of non-child bearing potential. Non-child bearing potential being surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
* Current total daily insulin treatment between 0.25 (I)U/kg/day and 1.2 (I)U/kg/day (both inclusive).
* HbA1c equal to or below 9.5%

Exclusion Criteria:

* Male of reproductive age who, or whose partner(s), is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
* Use of GLP-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.