cyrilzakka/clinical-trials huggingface dataset:
Health Coach Program to Improve Chronic Disease Outcomes Following an Emergency Department Visit

The purpose of this study is to determine whether health coaching initiated in the emergency department (ED) reduces subsequent ED visits, increases primary care visits, and positively impacts health outcomes in patients with diabetes and/or hypertension.

Patients will be recruited by health coaches from the Highland Hospital Emergency Department. Eligible patients who agree to participate will be randomized to the control and experimental groups in a 2:1 ratio respectively because experimental group size is limited by health coach availability and greater loss-to-follow up is expected among the control group. Repeated measures analysis will be used to compare each outcome over the study period. In addition, subgroup analyses will be performed in order to stratify by baseline survey measures or amount of ED visits in the pre-observation period.

Eligibility Criteria:
Inclusion Criteria:

* Willing to work with a health coach
* Plans to reside in Alameda County for the next year
* Has a reliable phone number
* Speaks English or Spanish
* 18 years of age or older
* Meets at least one of the following three criteria: (1) Low medication adherence defined as a continuous medication gap of at least 1 month in the past year OR a new diagnosis of diabetes and/or hypertension; (2) No patient-identified primary care provider (PCP) or no visit to PCP in 1 year; (3) One or more visits to the ED in the last 6 months.

Exclusion Criteria:

* Life-expectancy less than 1 year
* Poorly controlled psychiatric illness
* Homeless
* Active and frequent use of illicit substances
* Currently incarcerated
* Already enrolled in a program for patients with high rates of hospitalization and/or emergency department visits
* Unable to consent due to an unstable condition or serious emotional or neurologic condition
* Admitted or anticipated to be admitted to the hospital from the ED
Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation

Chronic idiopathic constipation is most common cause of Constipation in childhood with numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin. Objectives: Comparative study between Botulinum toxin injection and Myectomy in treatment of Idiopathic Constipation

Functional constipation (chronic idiopathic constipation) is most common cause of constipation in pediatric age group. Many cases try conservative treatment but fail to respond. These cases are treated by surgical longitudinal myectomy of the anal sphincter. Now, there have been many trials of trying injection of botulinum toxin to relax the sphincter as a treatment of functional/idiopathic constipation.

In this study, the investigators will compare the results of botulinum toxin injection versus surgical myectomy to treat functional/idiopathic constipation in children.

Eligibility Criteria:
Inclusion Criteria:

* Children with Idiopathic constipation

Exclusion Criteria:

* Hirschsprung's disease or Anorectal malformations
Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

To document effectiveness, safety, and tolerability of donepezil in patients with mixed AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in patients with VaD. The effects of donepezil on executive functioning, behavior, general cognition, ADLs and global functioning will be assessed.

The trial was terminated on October 15, 2007 due to difficulties in recruiting the subjects. There were no safety or efficacy concerns regarding the study medication in the decision to terminate the trial.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies.
* Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required.

Exclusion Criteria:

* Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.
Feasibility Study of the TruSculpt Radiofrequency Device

A single-center, prospective, open-label feasibility study of the truSculpt radiofrequency device.

A single-center, prospective, open-label study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for optimal delivery of thermal energy to the skin.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, 18 to 70 years of age (inclusive)
2. Fitzpatrick Skin Type I - VI
3. Has visible fat bulges,skin laxity, or cellulite in the treatment area
4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study.
5. Subject must agree to not undergo any other procedure(s) in the treatment area during the study period.
6. Subject must be able to read, understand and sign the Informed Consent Form.
7. Subject must adhere to the follow-up schedule and study instructions.
8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
9. Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant.

Exclusion Criteria:

1. Participation in a clinical trial of another device or drug in the target area during the study period.
2. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant.
3. Has metal implant(s) within the body that is local to the treatment area, such as surgical clips, plates and screws, intrauterine device (IUD), artificial heart valves or artificial joints.
4. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
5. Diagnosed or documented immune system disorders.
6. History of any disease or condition that could impair wound healing.
7. History of diseases stimulated by heat, such as recurrent herpes zoster in the treatment area, unless treatment is conducted following a prophylactic regimen.
8. Infection, dermatitis, rash or other skin abnormality in the target area.
9. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation.
10. Pregnant or currently breastfeeding.
11. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Systemic Neoadjuvant and Adjuvant Control by Precision Medicine in Rectal Cancer

Rectal cancer represents the most complex area of multidisciplinary treatment in bowel surgery. In 2017, there were 1221 new rectal cancers in Finland. The prognosis of colorectal cancer (CRC) patients these days is almost exclusively driven by the occurrence of the metastatic form of the disease.

The treatment of rectal cancer often includes a long delay between diagnosis and the initiation of systemic chemotherapy, increasing risk for systemic metastases for those at high risk. On the other hand, the waiting time during pretreatment before surgery enables comprehensive systematic characterization of the primary tumor status before the decisions on adjuvant chemotherapy, opening a window to the use of precision in decision-making.

In this randomized controlled treatment trial, outcomes of novel precision methods to select right rectal cancer patients for treatment that they need will be compared to conventional treatment. The study aims to reduce over-treatment of those that most likely do not benefit from additional treatments. With the overall aim to reduce metastatic form of the disease, patients with high-risk features will be randomized to a treatment strategy with early systemic control by chemotherapy followed by circulating tumor DNA (ctDNA) and organoid-guided adjuvant therapy, or to conventional treatment strategy. Both state-of-the-art laboratory practice and routine diagnostic clinical pipelines are introduced to bring future diagnostic models of minimal residual disease and chemoresistance closer to current practice. The outcomes will reveal the clinical benefit of such strategy by recurrence-free survival at highest level of evidence, and produce important clinical outcome data on the application of ctDNA in everyday cancer treatment practice. The translational data on the use of ctDNA organoids to inform treatment decision and regimen selection will build knowledge of the use of such biomarkers as tools for clinical practice and clinical research. The results will be scalable worldwide in the practice of rectal cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

1. rectal adenocarcinoma,
2. World Health Organization (WHO) performance status 0-1, assessed by the MDT to be able to undergo capecitabine and oxaliplatin (CAPOX) treatment, 3) extramural vein invasion by magnetic resonance imaging (mrEMVI+) and

4) assessed by the multi-disciplinary team (MDT) to require either radiotherapy (RT) or long chemoradiotherapy (CRT) by the current standards.

Exclusion Criteria:

1. deficient mismatch repair (MMR) status,
2. non-dihydropyrimidine dehydrogenase (DPYD) genotype,
3. a contraindication to capecitabine, oxaliplatin or RT, or
4. failing in blood tests that describe the adequate circulatory, liver and kidney function for chemotherapy.
Wound Additives in Primary Total Joint Athroplasty

3 cohorts of total joint patient of 30 members each were randomized to receive PRP or Activated Collegen or no additive were studied for status of the wound at 6 weeks and recorded all complications, infections and reoperations. The three groups were than compared for statistical analysis

Background: Wound healing remains a concern in primary total joint arthroplasty given the risk of deep infections arising from hematomas, wound separations, and superficial infections. If wound additives can prevent these early complications, their universal application would be cost effective. This study examined whether two wound additives, Platelet-Rich Plasma (PRP) and CellerateRX® (activated collagen), would improve postoperative wound healing and reduce complications in primary total joint arthroplasty.

Methods: A prospective, randomized, controlled study using three cohorts with 30 patients each (Group 1: PRP, Group 2: activated collagen, Group 3: control) were examined postoperatively at two and six weeks, at which time the following data were recorded: six wound measurements, total postoperative blood loss, complications of superficial infections, and reoperations.

Eligibility Criteria:
Inclusion Criteria:

* Osteoathritis of knee and hip

Exclusion Criteria:

* Inflammatory arthritis and hypercoagulable state
Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure

To evaluate if a rest period before extubation after a successful SBT trial could reduce the extubation failure rate.

Intubation and mechanical ventilation are related with several complications. This increased the risk of mortality of intensive care patients. So, we always look for an early extubation when patients are recovered for the trigger disease. In spite of standardized manoeuvres to decided readiness for extubation these are not quite good because it has been described a failure extubation rate of 5% and a reintubation rate of 15%. Furthermore several risk factors has been associated with a major failure rate:\>65 years old, congestive cardiac insufficiency, chronic obstructive pulmonary disease, APACHE II \>12 the extubation day, BMI \>30, ineffective cough, a lot of bronchial secretions (as the need for \>2 endotracheal suctioning in the last 8h before extubation), failure of a previous SBT,alterations of high respiratory tract or intubation for more than 7 days.Patients without any of these factors risk has an extubation failure rate of 10% while if any of these are present extubation failure increase to 30%.

The most used technique as a weaning trial is named spontaneous breathing trial (SBT). Some physiological aspects suggest that breathing through an endotracheal tube could be a really effort trial. So our hypothesis is that a period of rest after SBT and before extubation could reduce the extubation failure rate.

Eligibility Criteria:
Inclusion Criteria:

* patients ventilated for more than 12h and ready to perform a SBT

Exclusion Criteria:

* patients under 18 years old,
* tracheostomy,
* excessive bronchial secretions,
* agitation,
* hypercapnia during SBT and not resuscitation orders.
The Effects of a Multimodal Approach for the Treatment of PPA

Primary Progressive Aphasia (PPA) is an untreatable neurodegenerative disorder that disrupts language functions. Available therapies are mainly symptomatic and recently attention has been gained by new techniques that allow for noninvasive brain stimulation such as transcranial direct current stimulation (tDCS). The primary objective of this study is to evaluate whether the application of Active tDCS (anode over the left dorsolateral prefrontal cortex- DLPFC with the cathode over the right supraorbital region) to the scalp during individualized language training, would improve naming abilities in the agrammatic variant of PPA (avPPA) more than use of one methodology alone. The effect of treatment on the clinical symptoms will be related to changes in brain activity (Magnetic Resonance Imaging, MRI and Functional near-infrared spectroscopy fNIRS) and in biological markers, using a multimodal approach. Finally, we will assess the long-term effects of this approach.

45 patients with avPPA, will be recruited from IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy and ASST Spedali Civili Brescia, Italy .

Inclusion criteria will be a diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011) and a FTD Clinical Dementia Rating score \>0.5 and \<2. Exclusion criteria will be the presence of any medical or psychiatric illness that could interfere in completing assessments and the presence of any medical condition that represents a contraindication to tDCS. All the patients will undergo five consecutive days a week for two weeks of treatment sessions:

15 patients will receive Active tDCS over DLPFC while performing a language training; 15 patients will receive placebo tDCS during language training; 15 patients will receive Active tDCS over DLPFC during unstructured cognitive training.

Two trained neuropsychologists will administer the neuropsychological testing in two sessions. At baseline (T0), post-treatment (T1) and 3-months (T2) follow-up assessments were conducted by the same assessor. Blood sample withdrawal at baseline (T0) and after the DLPFC-tDCS intervention (T1) will be assessed.

To elucidate the mechanisms underlying tDCS effects, structural imaging, functional connectivity (fMRI) alterations and concentration changes of hemoglobin (fNIRS) will be collected off-line. Each avPPA patient will undergo an MRI scan at the ASST Spedali Civili Brescia, Italy at T0 and T1 and a fNIRS acquisition at the IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy at T0, T1 and T2.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011)
* FTD Clinical Dementia Rating (FTD-CDR) score \>0.5 and \<2

Exclusion Criteria:

* Presence of any medical or psychiatric illness that could interfere in completing assessments
* Presence of any medical condition that represents a contraindication to tDCS.
3R Rehabilitation Management of COVID-19 Survivors

It is to explore the temporal relationships between physical fitness, cognitive, psychosocial functions, and health-related quality of life (HRQoL) in COVID-19 survivors over the first 15 months; and to determine the effects of centre-based (CBR), online-based cardiopulmonary rehabilitation (OBR), and combined centre- and online-based rehabilitation (COBR) on survivors with initially suboptimal pulmonary functions.


Eligibility Criteria:
Inclusion Criteria:

* COVID survivor at hospital discharge or 6-month post-disease onset
* Medically stable with an Abbreviated Mental Test (AMT) scores of \> 6 out of 10

Exclusion Criteria:

* Having contraindications to exercise
* Physical Activity Readiness Questionnaire (PAR-Q) reveals unsafety
* Cannot understand Cantonese
Premature Discontinuation of Contraceptive Implants

To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).

Objective:

To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).

Secondary Objectives:

To determine if participants initiating the contraceptive implant who are also provided COCR are more likely than participants receiving standard counseling to:

1. report higher levels of satisfaction with their contraceptive implant at one year following initiation
2. require less clinical follow-up and clinical resources in the year following initiation.

Eligibility Criteria:
Inclusion Criteria:

1. You are between ages of 14 to 22.9 years.
2. Started etonogestrel implant for the first time and have never used the implant before.

Exclusion Criteria:

1. There is any contraindication to estrogen containing birth control.
2. Desire of pregnancy in next 12 months.
3. Plans to move from the area in next 12 months and is not able to come to the clinic.
A Study of Tarceva for Use in Patients With Relapsed or Refractory Metastatic Non-Small Cell Lung Cancer

Tarceva, an orally available small molecule, has demonstrated potent activity in tumor models and humans. This randomized, open-label phase 2 study of Tarceva alone and of Tarceva plus VELCADE is designed primarily to determine the objective tumor response rates to these treatments in patients with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC) that is refractory to or has relapsed after front-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1)Relapsed or refractory, Stage IIIB or Stage IV NSCLC that has been histologially or cytologically confirmed. 2)One prior line of conventional cytotoxic chemotherapy. 3)Documented progressive disease(PD) during or since last prior therapy as determined by the investigator. 4)18 y/o or older. 5)Have measurable disease by RECIST. 6)Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7)Life expectancy greater than 3 mo from the date of enrollment. 8)Female patient is either post-menopausal, surgically sterilized or willing to use an acceptable method of birth control. 9)Male pateint agrees to use an acceptable method of birth control during study treatment. 10)Provide written informed consent before the conduct of any study-related procedure. 11)Willing and able to comply with the protocol requirements.

Exclusion Criteria:

1)Previous treatment w/VELCADE. 2)Pre-existing interstitial lung disease. 3)Peripheral neuropathy of Grade 2 or greater. 4)Diarrhea or vomiting greater than Grade 1 in intensity whether in the absence or presence of antidiarrheal and/or antiemetic therapy. 5)Chemotherapy, radiation therapy, treatment wtih monoclonal Antibodies, or major surgery w/in 4 wks prior to enrollment. 6)Documented greater than 10% WT loss in the 6 wks. prior to enrollment. 7)Inadequate organ function during screening as per laboratory values. 8)Myocardial infarction w/in 6 months prior to enrollment. 9)Brain metastases. 10)Any malignancy other than NSCLC occuring w/in 5 years of enrollment with the exception of basal cell carcinoma of the sin, and carcinoma in situ of the cervix. 11)Hx of allergic reaction to compounds containing boron or mannitol. 12)Known human immunodeficiency virus (HIV)+ or hepatitis B. 13)Poorly controlled hypertension, diabetes mellitus, or pyschiatric illness. 14)Pregnant or breast-feeding woman. Confirmation that patient is not pregnant must be established by a negative serum (B-hCG).15)Currently enrolled in another clinical research study or has received an investigational agent w/in 4 weeks prior to enrollment.
Assessment of the Breast Cosmesis Using Deep Neural Networks: an Exploratory Study (ABCD)

Surgery and radiotherapy in breast cancer patients can cause treatment changes and may affect the final breast appearance. In this study, we are trying to evaluate the post treatment breast photographs of the patients and subject these to Artificial Intelligence based program so as to classify into appropriate categories based upon changes from baseline. This automated solution will help in decreasing the time required to achieve this task by physicians in the clinic.

A new algorithm was introduced which is based on deep neural network (DNN) which receives an image as input and returns the coordinates of the breast key points as output. These key points are then given to a shortest-path algorithm that models images as graphs to refine breast key point localization. The algorithm learns, directly from the image, to compute features and to use those features in the analysis of the aesthetic result. This comprises of two main modules: regression and refinement of heatmaps, and regression of key points. To perform the heatmap regression, the U-Net model is used.

The goal of the first module is to generate an intermediate representation consisting on a fuzzy localization for the key points that are to be detected.

The second module receives and refines this fuzzy localization, and through complex calculations, outputting the x and y coordinates of the keypoints, and the data generated from which can be used for disease / image classification.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of primary breast cancer (invasive or in situ)
* Patient undergone breast conservation / Whole breast reconstruction
* Patient received breast RT
* Already provided written informed consent on earlier projects
* Patient provided photographs of both breasts
* Non-metastatic disease or oligometastatic
* Age \> 18 years
* Reconsent given

Exclusion Criteria:

* Mastectomy without whole breast reconstruction
* Bilateral breast cancer
* Partial breast irradiation
* Male patient
* Limited life expectancy due to co-morbidity
* Patients undergoing brachy boost
Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of lens subluxation.
* Patients need to undergo lens subluxation surgery

Exclusion Criteria:

* Active intraocular inflammation
* The intraocular pressure (IOP) was higher than 25 mmHg
* The endothelial cell count (ECC) was less than 1,200 cells/mm2
* Combined with other eye diseases
* Combined with other serious systemic diseases