cyrilzakka/clinical-trials huggingface dataset:
Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer

This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.

KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.The HER2- positive mBC subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg KN026 and docetaxol. The HER2 low expression and hormone-receptor positive mBC subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg KN026 monotherapy. The HER2 low expression and hormone-receptor negative/weak positive mBC subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg KN026 and 5 mg/kg KN046

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject \>= 18 years
* Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer
* ECOG score 0 or 1
* Life expectancy \>3 months
* According to the definition of RECIST1.1, the patient has at least one measurable lesion
* Adequate organ function prior to start treatment with KN026
* Able to understand, voluntarily participate and willing to sign the ICF

Exclusion Criteria:

* Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
* Accepted radiotherapy within 4 weeks before enrollment
* Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
* Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
* History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
* History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
* Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
Controlled Trial of Mental Health Interventions for Torture Survivors in Kurdistan

The purpose of this study is to determine the relative effectiveness of three different mental health counseling interventions in the treatment of mental health problems commonly affecting torture and trauma survivors living in Kurdistan, Iraq.

See above

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* Kurdish
* torture survivor
* currently has significant depression symptomatology.

Exclusion Criteria:

* danger to self or others
* already receiving treatment from our treatment provider
* not mentally competent to provide informed consent.
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML<60a

This protocol is part of the German AML Intergroup Trial, where the OSHO study arm is compared to the common German standard arm after randomization in a 9:1 ratio. The hypothesis involves primarily dosing and application of AraC for induction. It is expected that CR rates and as a consequence also LFS are higher in protocols using higher AraC compared to lower doses and that LFS might be superior in the study specific arm compared to the golden standard published several years ago. In the standard arm, AraC 100mg/m2/day is given as continuous infusion over 7 days. Daunorubicin is given as 60 mg/m2/day over a two hours infusion on days 3, 4 und 5. On day 22 a second induction course is applied. After reaching CR, three cycles of AraC 3 g/m2 over three hours bid are infused on day 1, 3 und 5. In contrast the OSHO arm consists of induction therapy with IDA 12 mg/m\*2 over 20-30-min-iv on day 1 - 3 and AraC 2 x 1 g/m\*2 bid over 3-h-iv on days 1+3+5+7.

A previous phase II study of the OSHO has shown high CR in patients with relapsed AML using MitoFlag. In this study we asked the question if MitoFlag is superior to IdaAraC in newly diagnosed AML patients without CR after the first induction chemotherapy. Therefore patients are randomized to receive either MitoFlag or IdaAraC and the difference in CR rates evaluated.

It is still unclear if two consolidation therapies are needed before allogeneic or autologous stem cell transplantation. This question is being addressed in the second part of the OSHO study, where patients are randomized to receive either one or two consolidation therapies.

In this study all patients with AML and an age of 18-60 years except M3 are entered


Eligibility Criteria:
Inclusion Criteria:

Adult patients \< or = 60 years acute myelogenous leukemia (AML) AML t(8;21)(q22;q22), AML1 (CBFa)/ETO, AML(inv(16)(p13q22)) und variants (CBFb/MYH11), AML 11q23, MLL-anomalies, AML with normal karyotyp myelodysplastic syndrome (MDS)RAEBT with 20-30% blasts.

de novo AML secundary AML after MDS secundary AML after chemotherapy with alkylantien sekundäre AML after chemotherapy with Epipodophyllotoxin informed consent

Exclusion Criteria:

AML M3 patients included in another clinical trial contraindications for high dose cytotoxic therapy such as renal insufficiency liver insufficiency cardiac insufficiency NYHA III + IV, acute myocardial infarction uncontroled infection like pneumonia with hypoxemia or septic schock pregnancy Karnofski-Index of 10 and less second maligancy severe, decompensated metabolism disorders
Comparative Mechanisms of Psychosocial Chronic Pain Treatments

Psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. However, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about HOW our treatments work. It may be that different treatments work via distinct pathways that are specific to a given treatment (single effect model), or it may be that different treatments work to the extent they all operate via key mechanisms that they share (additive effects model). Examination of specific and/or shared effects on outcomes of mechanisms will provide theoretical and empirical rationale for enhancing procedures and techniques most closely linked to strong outcomes and incorporating them into future interventions, while limiting the use of others that may be revealed as inert.


Eligibility Criteria:
Inclusion Criteria:

* significant daily chronic pain intensity (at least 4 on a 10-point scale; see below) and interference in performing daily activities due to pain (at least 3 on a 6-point scale; see below) for at least 6 months
* musculoskeletal pain of the low back and/or leg pain that may be related to history of degenerative disk disease, spinal stenosis, or disk herniation (radiculopathy subcategory), or muscular or ligamentous strain (chronic myofascial pain subcategory)
* age between 18 and 75 years.

Exclusion Criteria:

* meet criteria for alcohol or substance abuse problems
* meet criteria for past or present psychotic or bipolar disorders
* inability to understand English well enough to complete questionnaires or to participate in therapy
* active suicidal ideation with intent
* pain is due to malignant conditions (eg, cancer, rheumatoid arthritis), migraine or tension headache, fibromyalgia or complex regional pain syndrome.
Personalized Treatment Algorithms for Difficult-to-treat Asthma

Asthma is a common, complex and costly chronic condition. Moreover, asthma is heterogeneous in terms of treatment response. This heterogeneity contributes to the difficulty in both studying and treating asthma. This is a pilot study to improve health outcomes in youths with difficult to treat asthma with ongoing symptoms and healthcare utilization despite medium to high doses of inhaled corticosteroids. Asthma heterogeneity in both disease pathophysiology and treatment response contributes to the difficulty in both studying and managing asthma. In order to begin to develop personalized algorithms for patients, investigators need to model novel biomarkers and other factors that contribute to individual differences in asthma outcome and test other factors that contribute to individual differences in asthma outcome and test personalized treatment strategies.

With this study investigators will conduct study visits to determine and quantify known molecular, genetic, genomic, epigenetics, immunologic, and exposure biomarkers that will help elucidate molecular disease endotype within the difficult-to-treat phenotype. This information will be used along with clinical, psychosocial, and adherence data to develop a personalized treatment plan. Following the personalized treatment plan, study clinicians will prescribe the medications through a home delivery or routine pharmacy depending on the family's preference and covered by the participant's health insurance. Investigators will track disease outcome metrics including exacerbations, symptom-free days, and asthma symptom scores to determine the effectiveness of this personalized approach.

Eligibility Criteria:
Inclusion Criteria:

* History of provider-diagnosed asthma
* Meets one of the following definition for NAEPP guidelines uncontrolled moderate persistent asthma or severe persistent asthma in the past 12 months:

  * NAEPP step 3-4 with one of the following criteria in the past 12 months:

    * Two Asthma Control Test (ACT) scores \<20
    * 1 Urgent Care or Emergency Department visit or hospitalization for asthma
    * \>2 prednisone bursts
  * NAEPP step 5-6
* Current health insurance coverage at enrollment. This will be verified at V1 at the registration desk. If the family loses insurance during the study, the patient will be referred to the pulmonary social worker and financial office for assistance
* Reside at a primary home on average 5 out of 7 days a week.
* Primary home is within a 40 mile radius of Cincinnati Children's Base location or PI's discretion.

Exclusion Criteria:

* Received biologic therapy 6 months prior to enrollment
* Received systemic steroids 6 weeks prior to enrollment
* Active chronic disease apart from asthma or allergic disease
* Co-morbid lung disease
* Dependence on immunosuppressive drugs for a condition other than asthma
* Participant is pregnant
* Has a severe bleeding disorder
* Has significant developmental disability
* Share a bedroom with a currently enrolled Breath Warriors study participant
Prevalence of Dental Caries in Patients With Dental Crowding

Dental crowding causes limited access for the toothbrush, and the natural cleansing effect of the teeth by the tongue and saliva is also limited. This malposition allows for prolonged food accumulation, bacterial and plaque retention, which are important factors for the initiation and progression of dental caries.

Dental crowding causes limited access for the toothbrush, and the natural cleansing effect of the teeth by the tongue and saliva is also limited. This malposition allows for prolonged food accumulation, bacterial and plaque retention, which are important factors for the initiation and progression of dental caries .

According to the World Health Organization, the main dental problems should be subjected to periodic epidemiological surveys. Knowledge of a population's epidemiological situation is vital for planning and providing prevention and treatment services .

However, only few studies investigated the correlation between caries and crowding.Yet, their findings were inconsistent and still contradictory.

Previous systematic review concluded that there is no reliable evidence regarding the association between dental caries and crowding and further studies with adequate sample size are required. Another systematic review found an association between caries and crowding but only in the adolescent group .

As caries is a preventable disease, improving the understanding of this possible association would be beneficial for dental practitioners, public health policy makers and the general population as it will help in the application of medical model.

This Cross-sectional study can detect one of predictors of dental caries early as crowding so the dentists can prohibit future carious lesions \& help in caries prevention through orthodontic treatment \& proper oral hygiene measures.

Eligibility Criteria:
Inclusion Criteria:

* Young adults range from 12-30 years.
* Females or Males.
* Anterior dental crowding.

Exclusion Criteria:

* Patients undergoing orthodontic treatment.
* Patients who have any missing anterior teeth.
* Patients who have any physical or mental disabilities.
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)

To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

* Aged \>=40 years old
* Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
* Functional capacity class of I-III

Exclusion Criteria:

Exclusion criteria:

* Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Acute joint trauma at index joint within the past 3 months with active symptoms
* Score of \>=20 on PHQ-9 or score of \>=1 on PHQ-9 item i
* Use of mobility assisting device for \<6 weeks or use of walker
Mindfulness Mediation Intervention in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to assess the feasibility and potential impact of an eight week program of meditation on expiratory time, anxiety and dyspnea in people with COPD.

Chronic Obstructive Pulmonary Disease is a progressive multi-dimensional disease with a complex network of somatic and affective components. Anxiety is a common experience for persons with COPD both as a reaction to dyspnea (48) and as a separate co-morbid condition (10, 26). The presence of anxiety magnifies COPD symptoms and further impairs physical functioning (53). Both anxiety and COPD alter breathing patterns similarly causing irregular rapid shallow breathing at rest, which is inefficient and cannot adequately respond to increases in ventilatory demands from physical or emotional activity (121). Both COPD and anxiety are also associated with changes in neurological functioning. Whereas anxiety tends to be associated with increased amygdala activity (54), COPD is associated with a decrease in frontal cortex functioning (25, 28, 122). Persons with COPD who experience anxiety are less able to correctly process the level of physical and emotional demand for any given situation and their ability to meet that demand (46, 123). Pulmonary rehabilitation addresses both the physical and emotional symptoms of COPD, however gains in function are quickly lost over time (4). Evidence suggests that mindfulness based meditation can alter neural pathways to facilitate processing of emotions and increase quality of life for persons with COPD. The overall objective of this study is to assess the ability of persons with COPD to participate in a mindfulness meditation intervention and to examine the impact of mindfulness meditation on their anxiety levels and global sense of coherence. A modified version of Antonovsky's sense of coherence model will be used as the framework for this study. We will address the specific aims: 1) to determine the effects of mindfulness meditation on breathing patterns; 2) To determine the effects of mindfulness meditation on anxiety levels; 3) To determine self-reported adherence rates following an eight-week small group instructional course on mindfulness meditation, and 4) To determine the effects of mindfulness meditation on global sense of coherence levels in persons with COPD. The National Center for Complementary and Alternative Medicine identifies meditation as a form of CAM that focuses on the interaction among the brain, body, mind and behavior that is already practiced by 8% of persons who participate in CAM therapy. Meditation is rated a special priority research area by NCCAM.

Eligibility Criteria:
Inclusion Criteria:

* Any stage of Chronic Obstructive Pulmonary Disease
* Able to read and write English

Exclusion Criteria:

* Severe mental disability
* Inability to attend
M6-C Post Approval Study (PAS)

The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.

A prospective, concurrently controlled, multi-center pivotal study to evaluate the safety and effectiveness of the M6-C™ Artificial Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) was performed in the United States under IDE #G050254. To fulfill the concurrent control design of the study, there were clinical sites that evaluated the safety and effectiveness of the M6-C™ Artificial Cervical Disc and there were other clinical sites that evaluated ACDF. Subjects in the study were treated between May 2014 and June 2016 and remain in follow-up. The M6-C™ Artificial Cervical Disc received FDA approval to market on February 6, 2019. As a condition of approval, the FDA requested that the sponsor perform a post market approval study (PAS). The subjects enrolled and remaining in the M6-C IDE pivotal study are the prospective patient population for the PAS.

Eligibility Criteria:
Inclusion Criteria:

* Since the subjects have already been screened as part of the IDE's pivotal study, and only subjects that participated in that study make up the subject cohort for this long-term follow-up study, there are no additional inclusion criteria

Exclusion Criteria:

* Subjects who were withdrawn or withdrew consent to participate in the investigation
* Subjects who do not consent to participate in long-term follow-up or provide personal contact information to the sponsor (solely for the purposes of tracking subjects to help ensure follow-up compliance)
* Patients with terminal failures (SSI or device- or procedure-related SAE) by Month 24 and all known patient deaths in the M6-C IDE study are excluded for enrollment into the PAS
Neurally Adjusted Ventilatory Assist (NAVA) in Ventilatory Care of Premature Infants

The purpose of this study is to find out, whether it is possible to improve the ventilatory care of premature infants by using Neurally adjusted ventilatory assist (NAVA).

The study hypothesis is that by using NAVA-technology and/or by monitoring Edi-signal (the electrical signal of diaphragm), it is possible to accomplish ventilatory care to premature infants more individually.

Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications especially in premature infants with immature lungs.

In this study investigators will compare currently used ventilation methods to a new neurally adjusted ventilatory assist (NAVA). The aim is to find out, whether by using this new method it is possible to decrease the complications associated to ventilatory care and to shorten the need for mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* All children of postconceptional age from 28+0 to 36+6 weeks needing mechanical ventilation for at least 60 minutes

Exclusion Criteria:

* severe birth asphyxia, malformations, chromosomal abnormality or other condition, which will decrease the length of life
* condition which prevents the positioning of an oro-/nasogastric tube
Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)

The purpose of this study is to determine if the Childsmile programme (www.child-smile.org) with the additional maternal use of xylitol is more effective at reducing dental decay in children than a Childsmile program alone.

The children will be compared in the two groups at age two, to determine how the interventions affected the early colonization of mutans streptococci, an important risk factor of tooth decay.

At three and at five years the investigators will also examine the amount of tooth decay in these children.

Using MIDAS (Scotland's national health service dental data) records, the investigators will follow the oral health of the children until the age of 5 years.

Main hypothesis:

The maternal consumption of xylitol reduces early childhood caries

Xylitol has been shown to decrease mutans streptococci transmission between mother and child. Such maternal consumption of xylitol studies have, however not been tested in a Scottish population.

Sign 83, (www.sign.ac.uk/pdf/sign83.pdf) a Scottish government publication states that carrying out research in this area is needed.

Childsmile (www.child-smile.org) is a Scottish government programme that promotes oral health from birth, particularly amongst people living in priority areas.

Parents of newborn children who are assessed to be at risk of developing tooth decay are referred to the programme by their Health Visitor. Parents are visited at home by a Dental Health Support Worker. The dental health support worker will give more information, advice and arrange regular visits for participants to their local Dental Practice.

This research study will compare two groups; one group randomised into the childsmile preventative programme, the other group randomised into the childsmile preventative programme plus consuming 5 grams of xylitol per day.

We will be testing the mutans streptococci of the mother, at start of the study, and testing the mutans streptococci of mother and child at (child) aged two, in both groups- We will then be testing the dental decay of children in both groups

The research study will use existing NHS fife funding. NHS Fife currently employs approximately 15 dental health support workers, of which part of their role will be to support this project

Recruiting of study is planned to start in January 2010.

Eligibility Criteria:
Inclusion Criteria:

* Mother with high counts of MS (MS equal or higher than log 5)
* Child less than 3 months of age
* Has a close relationship with Fife (e.g. lives or works in Fife)
* Child seen by health visitor
* Mother who is the main carer of her children

Exclusion Criteria:

* Mother with low or no MS
* Child older than 3 months of age
* Child not seen by health visitor
* No close relationship with Fife (e.g. doesn't live or work in Fife)
* Mother who is not the main carer of her children
A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)

A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female between and including the ages of 2 and 5 years
* Patient was treated with steroids for an asthma episode in the last 3 months
* Patient was admitted to the hospital or emergency room in the last 3 months
* Patient is able to chew a tablet

Exclusion Criteria:

* Patient has been in a research study in the past 4 weeks
* Patient has visited the emergency room for an asthma episode in the past week
* Patients has a history of stomach, heart, liver, nerve, kidney or blood disease