cyrilzakka/clinical-trials huggingface dataset:
Patient-Provider Communication and Medication Adherence

The purpose of this study is to understand how communication between African American and white patients with high blood pressure and his/her primary care provider effects whether a patient decides to take their high blood pressure medications.

High blood pressure contributes to the racial disparities in death rates between minority patients and whites. Understanding the factors underlying racial disparities in high blood pressure-related outcomes is a major focus of Healthy People 2010. Several factors including access to care, patient preferences and lower socioeconomic status have been used to explain the differences seen in timely and effective delivery of preventive care between minority patients and whites. However, when these factors are controlled for, health disparities still exist. Recently, the Institute of Medicine identified interpersonal processes within the patient-provider relationship as a potential reason for the health disparities between minority and white patients. Specifically, providers' communication, including the ability to listen, collaborate, and be empathetic during the medical encounter has emerged as an important dimension of care that differs by race. Despite the increasing evidence that racial differences in patient-provider communication affects patient care, many of these studies have examined issues related to processes of care such as patient satisfaction with little attention to intermediate outcomes such as medication adherence. Further, studies that have used audio-taped analysis to examine racial differences in patient-provider communication are limited by one-dimensional coding systems that lack the ability to capture the mutual influence the patient and provider have on one another during the interaction. Thus, the potential pathways through which patient-provider communication contribute to high blood pressure-related disparities in minority patients compared to whites is not clearly understood. This proposed two-phase, mixed-methods research study, provides a unique opportunity to address these gaps by clarifying the effect of patient's race on patient-provider communication and medication adherence among 120 hypertensive African American and white patients receiving care in primary care practices. Specifically, findings from a qualitative analysis of patient-provider communication (Phase 1) will inform the development of a conceptual model that will be used to quantitatively evaluate the relationship between patient's race, patient-provider communication and medication adherence (Phase 2).

Eligibility Criteria:
Inclusion Criteria:

* self-identification as black/African American or white/Caucasian
* Receiving care in the Bellevue Hospital Ambulatory Care Practice from the same primary care provider for at least 3 months;
* Diagnosed with hypertension (ICD: # 401-401.9)
* Taking at least one antihypertensive medication;
* Age18 years or older
* Fluent in English

Exclusion Criteria:

* Unable to give informed consent
* Refuse to participate
Risk Factors Associated With Infection After Spine Surgery

Surgical site infection (SSI), particularly deep SSI, is one of the most serious complications after spinal surgery. evaluating the risk of SSI and, correspondingly, prescription of prophylactic measures are extremely important to prevent SSI and avoid potentially devastating consequences. A retrospective study was conducted aiming to develop a point-based prediction model of deep surgical site infection in patients receiving open posterior instrumented thoracolumbar surgery.

Data of 3,419 patients in 4 hospitals from Jan 1, 2012 to Dec 30, 2021 were retrospectively collected and were evaluated aiming to develop a point-based prediction model of deep surgical site infection in patients receiving open posterior instrumented thoracolumbar surgery. Clinical knowledge-driven, data-driven and decision tree model was used to identify predictive variables of deep SSI. Internal validation was performed by using bootstrapping methods.

Eligibility Criteria:
Inclusion Criteria:

patients who previously received open posterior instrumented thoracolumbar surgery

Exclusion Criteria:

1. were aged \< 18 years;
2. underwent surgery for the spinal infection, spine revision surgery, or cervical operation;
3. were diagnosed as superficial SSI;
4. died in hospital;
5. diagnosis of SSI was not determined;
6. had missing data more than 10% were excluded.
MK0916 in Patients With Type 2 Diabetes and Metabolic Syndrome (0916-005)

This study will test the safety and effectiveness of MK0916 in patients with Type 2 Diabetes Mellitus and Metabolic Syndrome.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes
* 18 to 65 years of age

Exclusion Criteria:

* History of Type 1 Diabetes Mellitus
* Have been treated with insulin in the past 8 weeks
* On a weight loss program and have ongoing weight loss
* Taking weight loss medication
* Have had surgery requiring general anesthesia in the past 30 days or have a planned surgery
* Have taken another investigational drug in the last 8 weeks
* Have active liver disease
* Have a history of major surgery involving gastric or intestinal bypass
A Study of Anal Cancer Development in HIV Infected People

The purpose of this study is to compare the development of abnormal cell growth or cancer in the anal region of individuals who are receiving one of two different anti-HIV treatment strategies.

Human papillomavirus (HPV) is a common viral infection among men and women. Individuals with HPV are at risk for anal dysplasia, a condition that may lead to anal cancer. It has been observed that HIV progresses more rapidly in individuals coinfected with HPV and HIV, compared to people with either disease alone. Studies that have investigated the effect of highly active antiretroviral therapy (HAART) on the progression of anal dysplasia have been contradictory and inconclusive. The role of CD4 count and HIV suppression and their contributions to the progression of anal disease needs to be determined. This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. This study will compare the times to development of high-grade anal dysplasia or anal cancer in participants who are currently enrolled in the SMART study.

Patients will participate in this substudy and the main SMART study at the same time. At the baseline visit, participants will undergo an anal swab; some female participants will have a cervical swab as well. Participants will provide a detailed sexual history including sexually transmitted infections, a history of anal-related conditions, and a history of alcohol and recreational drug use. These procedures will be repeated at each annual follow-up visit. Some participants may undergo additional anal cytology and high-resolution anoscopy with biopsy. Participants will be followed until they develop high-grade anal dysplasia or anal cancer or when the SMART study closes, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Coenrollment in the SMART study
* Normal anal cytology result. If baseline anal cytology is abnormal, high-resolution anoscopy must be performed and specimens must be obtained.
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* Current or prior history of anal or cervical cancer
* Permanent or irreversible bleeding disorder that would interfere with biopsy of the anal canal
Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site

At present, surgical resection is still the main treatment for the potential cure of rectal cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the mesorectum and separate to the pelvic floor. While transanal total mesorectal excision (TaTME) approach could be more directly separate the low mesorectum and relatively simple to complete distal rectal transection, which would bring some considerable advantages. Although active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in China. It is urgent for clinical studies to obtain the results in China. This multicenter, observational study will help to encourage research in this field and to obtain data on the safety and efficacy of this procedure in Chinese patients with rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of the rectum by biopsy
* the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
* tumor diameter less than 4cm
* baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
* tolerable to surgery
* be able to understand and willing to participate in this trial with signature

Exclusion Criteria:

* history of malignant colorectal neoplasia
* recent diagnosis with other malignancies
* patients requiring emergency surgery such as obstruction，perforation and bleeding
* tumor involving adjacent organs, anal sphincter, or levator ani muscle
* muti-focal colorectal cancer
* preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence
* history of inflammatory bowel disease or familial adenomatous polyposis
* participating in other clinical trails
* can not tolerate the surgery
* history of serious mental illness
* pregnancy or lactating women
* preoperative uncontrolled infection
* the researchers believe the patients should not enrolled in
VR Sedation in Third Molar Surgery

Anaesthesia or sedation for dental surgery is Challenging. Over-sedation, leading to upper airway obstruction, desaturation and apnoea, is very common. On the other hand, it is also very common that inadequate sedative drugs were given, leading to under-sedation with unsatisfactory experience during operation. Therefore, it is good if some other methods are provided for sedation, avoiding side effects associated with sedative drugs.

Immersive virtual reality (VR) is a form of distraction therapy and is believed to create an immersive experience that can restrict the mind from pain and anxiety and has been shown to be superior to simple distraction in reducing pain.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral impacted lower third molar that requires surgical removal
* Depth of impaction within 8mm as measured by Winter's line.
* Cantonese speaking

Exclusion Criteria:

* ASA \> III
* BMI \> 35
* Known Obstructive Sleep Apnoea
* Patients with known or potential difficult airway
* Chronic use of sedatives and opioid
* Alcohol or drug abuse
* Visual and hearing impairments
* Claustrophobia
* Cognitive impairment
* History of seizure
Expanded Access to MGAWN1 in Subjects With Suspected West Nile Neuroinvasive Disease; Suspected West Nile Virus Infection; or Substantial Accidental Exposure

This study will test an experimental drug called MGAWN1 for the treatment of West Nile infections.

The objective of this study is to provide expanded access to MGAWN1; the study is not intended for subjects who are eligible for and have access to non-expanded access protocols.

Eligibility Criteria:
Inclusion Criteria:

1. For West Nile Neuroinvasive Disease subjects: Have neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis
2. For immunocompromised subjects with suspected West Nile virus infection:

   * Receiving immunosuppressive treatment for any disease, such as autoimmune diseases, or transplant recipients; or
   * Have received organs or tissues or cells from donors likely infected with West Nile virus (as shown by serology or PCR/NAT from the donor, organs, or tissues) or
   * Have acquired immunodeficiency (other than from immunosuppressive treatment or from receiving infected transplants) or congenital immunodeficiency
3. For subjects with substantial exposure to West Nile virus: Exposure by any route, including percutaneous, inhalation, or mucosal exposure (such as might occur in a laboratory accident)
4. Develop signs and/or symptoms within 14 days before study enrollment
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects

This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A (FVIII activity: more than 5%, 1-5%, or less than 1%, respectively)
* Subjects with previous exposure to FVIII replacement therapy
* If human immunodeficiency virus (HIV) positive, documented cluster of differentiation (CD4) count more than 200/µL within 6 months of study entry

Exclusion Criteria:

* Diagnosed with any bleeding disorder in addition to hemophilia A
* Current FVIII inhibitor or history of FVIII inhibitor (defined as positive result of the reporting laboratory)
* Subject has no history of exposure to FVIII products (previously untreated patient \[PUP\])
* Subject is currently utilizing primary FVIII prophylaxis
* Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
* Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
* Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation
* Subjects with a known hypersensitivity to hamster protein
* Significant hepatic or renal impairment (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\] \>5 x upper limit of normal \[ULN\], bilirubin \>2 mg/dL or serum creatinine \>1.25 x ULN)
* Prothrombin Time \>1.5 x ULN
* Platelet count \<80,000 / µL
* Pregnant or breastfeeding women
* Unwilling or unable to follow the terms of the protocol
* Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor
Active Moms Project: Physical Activity Intervention for Low-Income Mothers

Despite the health benefits of physical activity, increasing regular physical activity levels among low-income, ethnic-minority mothers has remained a significant challenge. The current mixed-methods feasibility study explored the impact that a three-month community-based (CBI) and a home-based intervention (HBI) had on improving physical activity and fitness levels, as well as psychosocial outcomes (self-efficacy and social support) among low-income, ethnic-minority mothers. These results support the efficacy of CBIs and HBIs in improving PA and fitness levels and have important implications for improving health outcomes among low-income, ethnic-minority mothers.

Despite the health benefits of physical activity, increasing regular physical activity levels among low-income, ethnic-minority mothers has remained a significant challenge. Yet, few studies have examined the feasibility of implementing interventions to address physical activity barriers often experienced by this population. The current mixed-methods feasibility study explored the impact that a three-month community-based (CBI) and a home-based intervention (HBI) had on improving physical activity and fitness levels, as well as psychosocial outcomes (self-efficacy and social support) among low-income, ethnic-minority mothers. Thirty mothers were randomized to either a three-month community-based intervention (CBI) or a home-based intervention (HBI) and completed pre- and post-intervention assessments of physical activity (self-report, accelerometer), fitness (cardiorespiratory, muscle endurance and strength, flexibility), self-efficacy, and social support. Post-intervention focus groups were also conducted. Through formative research, this pilot work will develop and empirically test a CBI and HBI among low-income mothers for use in local community centers. The results of the proposed work have substantial public health implications and are expected to advance the investigator's understanding of how low-income mothers effectively use these intervention modalities to adopt healthy behaviors and produce change that can positively impact their health, as well as that of their children. Further, the proposed research will yield two physical activity interventions that can be readily delivered in community settings, are scalable, and are relatively low cost. Finally, these results will help identify those subgroups of mothers that may do particularly well (or poorly) with these innovative approaches to physical activity adoption and maintenance. This has important implications for the tailoring of physical activity programs to individual needs and preferences.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* a mother of a young child (\<10 years of age)
* fluent in either Spanish or English
* Sedentary (i.e., not engaging in 90 minutes or more of moderate or vigorous physical activity per week)

Exclusion Criteria:

* Not medically cleared by a doctor or by a medical history screener to engage in moderate-intensity physical activity
* Currently pregnant
Fish Oil Supplementation During Pregnancy for Prevention of Asthma, Eczema and Allergies in Childhood

The aim of this study is to prevent asthma and allergies in childhood by supplementation with fish oil (n-3 fatty acids) to the mother during pregnancy. Paticipants are mother and children participating in the ABC-(Asthma Begins in Childhood)cohort. Mothers are recruited during pregnancy and receive supplement with n-3 fatty acids or olive oil (placebo) from week 24 of gestation to 1 week after delivery. The child is followed with acute and planned visit at the research unit and diagnosis of disease is done in the research unit according to predefined algorithms.


Eligibility Criteria:
Inclusion Criteria (mother):

* Pregnant women
* Living in Sealand, Denmark
* Fluent in Danish Language
* Willing to let the newborn child participate in the study

Exclusion Criteria (mother):

* Participating in other clinical trial
Physical Activity Level and Cognitive Functions in Children With Duchenne Muscular Dystrophy

Although there are studies showing that the effect on motor performance over time in children with DMD is associated with a decrease in the level of physical activity, no publication has been found that directly examines the relationship between cognitive functions and physical activity level. Therefore, the aim of our study is to investigate the relationship between physical activity level and cognitive functions in children with DMD.

In DMD; as a result of mutations in the Xp21.2 region of the dystrophin gene, which encodes the dystrophin protein, which plays an important role in the normal contraction and relaxation of the muscle, progressive weakness starting from the proximal extremity muscles, chronic degeneration, replacement of the muscle with fat and connective tissue occurs due to the production of deficient or fully functional dystrophin. Although motor performance is one of the most prominent features in children with DMD, it has been reported that cognitive functions are also significantly affected in one third of children compared to their healthy peers. In addition, the physical activity levels of children with DMD show a significant decrease in physical activity levels after the age of 5, when motor problems are more pronounced than their healthy peers. Recently, interest in studies on physical activity level and cognitive skills in pediatric neuromuscular diseases such as DMD has increased, and studies have revealed the relationship between cognitive functions and motor performance. There are also studies showing that the effect on motor performance over time is associated with a decrease in physical activity level. However, there are no publications that directly examine the relationship between cognitive functions and physical activity level in children with DMD. Therefore, the primary aim of our study is; to investigate the relationship between physical activity level and cognitive functions in children with DMD. The secondary aims of our study are to reveal the relationship between balance and body mass index and physical activity level in children with DMD.

Eligibility Criteria:
Inclusion Criteria:

* Children who diagnosed with Duchenne Muscular Dystrophy (DMD), between the ages of 8-14, to have cognitive functions at a level to understand and apply test directives, Level 1-5 according to Brooke lower extremity functional classification will be included.

Exclusion Criteria:

* Children who have any chronic or systemic disease in addition to DMD, being above level 5 according to the Brooke lower extremity functional classification, have a cooperation problem, have had any lower/upper extremity injury and/or surgery in the last 6 months and children who did not give consent will be excluded.