cyrilzakka/clinical-trials huggingface dataset:
Comparing Ankle Fusion to Ankle Replacement

End-stage ankle arthritis (ESAA) is a debilitating condition associated with severe pain, dysfunction, and reduced quality of life. Many patients with ESAA have difficulty walking for even 100 feet or up a single flight of stairs. Patients seeking surgery for ESAA have two primary treatment options: ankle arthrodesis (i.e., ankle fusion) and ankle arthroplasty (i.e., ankle replacement). Few studies have directly compared the effectiveness of these two procedures, and no randomized controlled trials (RCTs) have been performed.

The investigators will compare the following in subjects undergoing ankle arthrodesis and ankle arthroplasty before surgery, and post-surgery at 3 and 6 months, and on an annual basis up to ten years.

1. Overall physical function and ankle specific function
2. Ankle pain intensity and interference with activities
3. Activity levels
4. Overall general health
5. Post-surgical complication rates

The investigators will also identify prognostic factors that are predictive of higher physical function, ankle specific function, reduced pain, improved general health, and overall patient satisfaction.

From study inception until March 2014, the investigators conducted a multi-site randomized controlled trial (RCT) comparing the effectiveness of ankle arthrodesis and ankle arthroplasty over a 2-year follow-up period. The study used a modified Comprehensive Cohort Design. Subjects unwilling to randomize to surgery could still participate in the study by entering into the preference cohort and select surgery in consultation with their surgeon.

By March 2014, no subjects had entered into the randomized cohort. The Data and Safety Monitoring Board (DSMB) recommended stopping recruitment in the randomized arm of the study since no subjects were willing to randomize to surgery. All patients were enrolled in the preference cohort and selected arthrodesis or arthroplasty. Despite the change in study design, the objectives remain unchanged.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ankle arthritis
2. Failed conservative care and deemed a surgical candidate
3. Adult patients between 21 and 89 years of age
4. Ambulatory but whose primary impediment to pain-free ambulation is ankle arthritis

Exclusion Criteria:

1. Recent surgical, neurological, metabolic, or lower limb musculoskeletal problem that might impair the ambulation measures in the study such as severe knee or hip osteoarthritis
2. Complicated procedures requiring multiple corrections
3. Inflammatory arthritis with multi-focal disease (i.e. arthritis that affects multiple parts of the body)
4. Inadequate cognitive or language function to consent to participate
5. Unable or unwilling to participate in clinic follow-ups and/or remote follow-ups for 24 months after surgery
6. Unwilling or unable to comply with postoperative management program
7. Lack of a telephone number or stable mailing address
Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit

The investigators developed a digital intervention that aims to help adolescent and young adult cancer survivors (AYAs) manage symptoms of depression. This tool includes daily mood tracking, a psychoeducational module about cancer and depression, four components that are based on evidence-based interventions for depression. The goal of this study is to evaluate the acceptability of procedures for a future trial in which the investigators will test which component or combination of components meaningfully contribute to improvements in depressive symptoms among AYAs. Additionally, the investigators will evaluate study feasibility as well as intervention acceptability, satisfaction, usability, and engagement.


Eligibility Criteria:
Inclusion Criteria:

* Age at enrollment (adolescents 15-17, emerging adults 18-25, young adults 26-39)
* Age at diagnosis (adolescents 12-17, emerging adults 15-25, young adults 15-39)
* Time since completion of treatment: 1 month to 5 years
* Language: Fluent in English (spoken and written)
* Technology: Own smart phone with data plan

Exclusion Criteria:

* Mental Health: Current diagnosis of severe or persistent mental illness
* Suicidality: Severe suicidal ideation (including plan and intent)
SINEMA Model of Care to Improve the Health of Stroke Patients in Rural China

Despite the significant burden of stroke in rural China, secondary prevention of stroke is scarce. The aim of the study is to develop a system-integrated technology-enabled intervention (SINEMA) model for the secondary prevention of stroke in rural China and evaluate the effectiveness of the model compared with usual care. The hypothesis is that trained village doctors, equipped with digital health technology, can provide essential evidence-based care to stroke survivors in rural China.

The SINEMA trial is a cluster-randomized controlled trial to evaluate the effectiveness of implementation of a system-integrated and technology-enabled model of care to improve the secondary prevention of stroke in Nanhe County, a rural area of Hebei province, China. Fifty villages from five townships are stratified randomized in a 1:1 ratio to either the intervention arm (implementing SINEMA model) or the control arm (usual care).

After a baseline survey, intervention will be implemented in 25 intervention villages, lasting for 12 months. Follow-up survey will be conducted in the same way in all villages at 12-month after the initial of the study. Process evaluation will be conducted every three month, and economic evaluation will also be conducted.

Eligibility Criteria:
Inclusion Criteria: those who

* are aged more than 18 years old;
* have a history of stroke (including ischemic and hemorrhagic stroke) diagnosed at county hospital or higher-level facilities, and currently in a clinically stable condition and not receiving acute stroke treatment;
* will live in this village for at least nine months during the next 12 months;
* have a basic communication ability (i.e. can understand simple instructions);
* give participant informed consent and are willing to participate in the study.

Exclusion Criteria: those who

* are unable to get out of bed without maximum assistance;
* have serious life-threatening disease such as cancers;
* who have an expected life span of less than 6 months.
Efficacy of Using 3D Motion Tracking Toothbrush in Dental Plaque Control

The objective of this study was to compare the efficacy of computer-assisted TBI (toothbrushing instruction) using a smart toothbrush and smart mirror (STM system) in plaque control to that of conventional TBI.

The STM system comprises a smart mirror, which is integrated into a computer monitor, and a 3D motion-capture device inside of a modified toothbrush holder. The computer program displays a toothbrushing animation in the mirror. Toothbrush motions detected by sensors embedded inside the holder are captured and sent to the server for analysis.

The investigators evaluated the efficacy of TBI with a STM system by analyzing the reductions of the modified Quigley-Hein plaque index in

1. st study - 60 volunteers (adults) - The data for which have been published (reference)
2. nd study - 42 volunteers (schoolchildren) - manuscript prepared
3. rd study - 60 volunteers (adults and children)

These participants were separated randomly into two groups: conventional TBI (control group) and STM system TBI (experimental group).

The changes in the plaque indexes were recorded immediately, 1 week, 1 month, and 10 months (1st study only) after TBI.

Eligibility Criteria:
Inclusion Criteria:

* Participants with poor oral conditions need more toothbrush instruction
* Participants were required to have their gingivitis and baseline plaque scores \>1.5 (the Turesky Modification of the Quigley-Hein index)

Exclusion Criteria:

* if they had gross dental caries or orthodontic appliances, or were medically compromised.
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)

The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness (CIMT) as a surrogate marker of cardiovascular risk.

The aim of this study was to measure the effect of moderate (5mg) and intensive (40mg) lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness as a surrogate marker of cardiovascular risk and to obtain whether CIMT correlated with the plaque components in coronary arteries evaluated with Intravascular Ultrasound Virtual Histology (IVUS-VH).

Eligibility Criteria:
Inclusion Criteria:

1. STEMI,
2. no prior treatment with statins and
3. a non significant lesion in one of the two non-culprit coronary arteries. -

Exclusion Criteria:

1. age below 18 or above 81 years,
2. unconscious patients,
3. serum creatinine \> 176μmol/L,
4. total-cholesterol \> 7.0 mmol/l,
5. hypothyroidism ((TSH \> 1.5 x ULN (upper limit of normal)),
6. current liver disease (ALAT \> 2 x ULN),
7. unexplained creatine kinase \> 3 x ULN,
8. alcohol or drug abuse within the last five years,
9. prior myopathy or serious hypersensitivity reaction caused by statins,
10. women with childbearing potential who were not using chemical or mechanical contraception,
11. pregnant or breastfeeding women,
12. history of malignancy unless a disease-free period of more than five years was present,
13. patients with abnormal lung function test (LFT),
14. participation in another investigational drug study less than four weeks before enrolment in the present study,
15. treatment with cyclosporine or fibrates. -
Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings

A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with chimeric antigen receptor modified T cell (CAR-T) therapy among patients with DLBCL.


Eligibility Criteria:
Inclusion Criteria:

CAR-T cohort:

* Patients had at least one International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code for DLBCL.
* Patients received CAR-T therapy following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment that the patient received.
* Patients were at least 18 years of age as of the index date.
* Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2020 Part D data is not available in the current data cut; eligibility requirement in the Part D data was not required.
* Patients were further classified into CAR-T IP and CAR-T OP cohorts depending on where the administration occurred.

Allo-HSCT cohort:

* Patients had at least one ICD-10 diagnosis code for DLBCL.
* Patients received allo-HSCT following DLBCL diagnosis. The date of allo-HSCT procedure was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment the patient received.
* Patients were at least 18 years of age as of the index date.
* Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2020 Part D data is not available in the current data cut; eligibility requirement in the Part D data was not required.

Exclusion criteria:

• Patients had a medical claim associated with a clinical trial (ICD-9 CM code V70.7; ICD-10 CM code Z00.6) during one month before and after the index date.
Effect of Acupressure on Postoperative Pain With Gynecologıcal Surgery

In this study, the effect of acupressure on postoperative pain level in women with abdominal gynecologıcal surgery will be studied and it will be conducted as a randomized controlled intervention study to examine the relationships with each other.The sample group will consist of 102 women, 51 in the intervention group and 51 in the control group.Within the scope of the study, the data will be collected using the 'Personal Information Form and Short-Form McGill Pain Questionnaire (SF-MPQ)' created by the researcher. Data will be analyzed using SPSS-26 package.

In this study, the effect of acupressure on postoperative pain level in women with abdominal gynecologıcal surgery will be studied and it will be conducted as a randomized controlled intervention study to examine the relationships with each other.The sample group will consist of 102 women, 51 in the intervention group and 51 in the control group.Within the scope of the study, the data will be collected using the 'Personal Information Form and Short-Form McGill Pain Questionnaire(SF-MPQ)' created by the researcher. Data will be obtained by the researcher by faceto-face interviews with women. In addition, women in the intervention group will receive acupressure once on postoperative days 0 and 1. Acupressure points related to gynecological surgery (large intestine (LI4), stomach (ST36) and spleen (SP6)) will be applied for a total of 12 minutes with 2 minutes of pressure on each point. Women in the control group will continue their routine care. Data will be evaluated with SPSS-26 package.

Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older,
* Being literate,
* To be able to understand and speak Turkish,
* No deformity or lesion in the areas where acupressure will be applied,
* Undergoing abdominal gynecologic surgery with general anesthesia,
* Any narcotic or epidural for pain control after surgery lack of analgesia
* Participation in the routine pain protocol of the clinic

Exclusion Criteria:

* The presence of any systemic disease that causes chronic pain,
* Receiving spinal or epidural anesthesia,
* Patients who are administered narcotic or any analgesic drug other than the routine pain protocol applied in the clinic after surgery
TMTP1-ICG Mapping in Colposcopy-directed Biopsy

Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Suspicious of cervical disease required a colposcopy-directed biopsy.
* Subjects must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:

* Breast-feeding or pregnant.
* Ongoing participation in another clinical trial with an investigational drug with 3 months.
* Own allergy towards ICG and/or alcohol.
* Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases.
* Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency.
Active Surveillance on Papillary Thyroid Microcarcinoma

The study is a multi-center prospective cohort study of active surveillance in papillary thyroid cancer with low risk. The purpose of the study is to observe natural course of low risk papillary thyroid cancer in Korean population, and comparison of prognosis between active surveillance group and conventional surgery group. Patient will be well informed about their choice of active surveillance or surgery.


Eligibility Criteria:
Inclusion Criteria:

* who agreed to the agreement form
* who is older than 18 years old
* who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category V or VI
* whose thyroid cancer is smaller than 1 cm length

Exclusion Criteria:

* who cannot routinely follow-up according to the study schedule
* who was diagnosed by fine needle aspiration or needle biopsy of Bethesda category I, II, III, or IV.
* who have hyperthyroidism which needs treatment
Tracking Physical Activity Throughout Chemotherapy for Breast Cancer

Physical activity during chemotherapy has been shown to increase patient health and wellbeing as well as improve outcomes in breast cancer patients. The primary aim of this project is to determine the feasibility of incorporating wearable sensors into clinical care by having breast cancer patients, undergoing chemotherapy, wear a commercially available monitor (Fitbit) that tracks physical activity, sleep, and heart rate monitor.

Although there are many benefits of engaging in physical activity during cancer treatments, activity levels typically decline throughout treatment. Existing research has primarily relied on self-reported activity levels and only captured periodic snap shots or retrospective reports of activity levels, which are subject to recall bias. Exactly how activity levels change throughout chemotherapy is not known. This study will provide minute-by-minute level objective physical activity data across the entirety of the patient's chemotherapy treatments. This in depth data will provide a new perspective on the patterns of activity levels and help to identify if there are critical times in which to intervene to prevent declines in physical activity.

The investigators will assess the feasibility of the pre-treatment recruitment by documenting recruitment rates and participant acceptance of wearing the accelerometer.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Diagnosed with breast cancer
* Scheduled to receive chemotherapy, but has not yet started chemotherapy
* Receiving chemotherapy at a University of California, San Diego clinic
* Willingness to wear the Fitbit throughout the course of chemotherapy
* Access to a computer or Bluetooth enabled phone to sync Fitbit data
* Able to read and communicate in English

Exclusion Criteria:

• Serious physical limitation that greatly limits mobility
Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19

A case-control trial was conducted to test the early postpartum period clinical outcomes of newborns born to pregnant women with and without COVID-19.


Eligibility Criteria:
Inclusion Criteria:

Pregnant women on labor or preterm labor. Pregnant women who underwent programmed or emergence cesarean

Exclusion Criteria:

Those who were transferred to another hospital without or within a short period of delivery
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven Small-cell lung cancer (SCLC)
* Stage of extensive disease defined by the presence of distant metastases
* At least 1 unidimensionally measureable lesion
* WHO performance status 0 to 1
* No previous SCLC-related chemotherapy
* No previous SCLC-related surgery
* No previous radiotherapy (excepting for brain metastasis)
* Adequate function of major organs and systems

  * Nervous system

    * No Grade 2 or greater peripheral neuropathy
  * Cardiovascular:

    * No symptomatic congestive heart failure
    * No unstable angina pectoris
    * No arrythmia needing continuous treatment
    * No other uncontrolled concurrent illness

Exclusion Criteria:

* Superior vena cava syndrome or obstruction of any vital structure
* Untreated malignant hypercalcemia
* Pleural effusion as the only manifestation of disease
* Extensive disease amenable to radiation therapy
* Symptomatic brain metastases requiring whole brain irradiation
* Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix
Analysis of the Nervous System in Patients With Fabry's Disease

Fabry's disease a genetic disorder (X-linked recessive) due to the absence of the enzyme ceramidetrihexosidase. The disease is characterized by abnormal collections of glycolipids in cells (histiocytes) within blood vessel walls, tumors on the thighs, buttocks, and genitalia, decreased sweating, tingling sensations in the extremities, and cataracts. Patients with Fabry 's disease die from complications of the kidney, heart, or brain.

The purpose of this study is to measure levels of a protein marker (PGP 9.5) in the skin, blood, and fluid surrounding the brain and spinal cord (CSF) in patients with Fabry's disease. In addition the study will attempt to determine if levels of the protein are directly related to the severity of disease in the nervous system.

PGP 9.5 protein levels will be measured in normal volunteers and patients with other diseases of the nervous system then compared to the levels recorded in patients with Fabry's disease.

This research study is designed to improve the understanding of Fabry's disease. Patients participating in it will not directly benefit from it. However, knowledge gained as a result of this study may contribute to the development of effective therapies for Fabry's disease.

OBJECTIVE: The purpose of this protocol is to study the natural history of Fabry disease in the different organ systems, understand its pathogenesis, and develop adequate clinical outcome measures for therapy trials. Development of sensitive outcome measures is a prerequisite of enzyme or gene replacement trials in patients with Fabry's disease. STUDY POPULATION: Patients with Fabry disease of all ages. The patients are not foregoing available treatment to participate in this protocol. Experimental treatment is not part of this study. STUDY DESIGN: Patients will typically be seen once a year at NIH. Patients will have comprehensive testing in order to evaluate the state of their health as affected by the Fabry disease. OUTCOME MEASURES: All potential clinically relevant areas will be evaluated comprehensively with a particular emphasis on the vasculopathy and the peripheral neuropathy of Fabry disease.

Eligibility Criteria:
* INCLUSION CRITERIA:

All patients with Fabry's disease will be considered as potential candidates for this study.

EXCLUSION CRITERIA:

All candidates must be serologically nonreactive for human immunodeficiency (AIDS) virus. HIV positive patients will be excluded because of the effects of the latter illness on the nervous system.

Patients with Fabry's disease will be excluded from participation if they have additional illnesses such as cancer, diabetes or vasculitis that could potentially involve the nervous system.

The general health and well being of each candidate must be sufficient to allow for a modest amount of blood drawing, collection of appropriate laboratory specimens and performance of necessary roentgenograpic and magnetic resonance (MR) imaging studies. In addition, each candidate must be able to return to the National Institutes of Health (NIH) annually for monitoring of clinical and laboratory parameters.
Phase 0/1 Study of 212Pb-NG001 in mCRPC

The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.

This is a single site, open label, non-randomized, non-controlled intervention study with an initial microdosing run-in part (phase 0), followed by a conventional dose-escalation phase 1 part.

Eligibility Criteria:
Key Inclusion Criteria:

* ECOG performance status of 0 to 2
* Life expectancy \>6 months
* Histological, pathological, and/or cytological confirmation of prostate cancer
* Metastatic castration resistant prostate cancer
* Failure of conventional treatment or such treatment not available/accepted by patient
* PSMA avid mCRPC lesions confirmed by PSMA PET/CT
* Adequate hematopoietic, kidney and liver function

Key Exclusion Criteria:

* Concurrent or other cancer diagnosis last two years, except for carcinoma in situ
* Concomitant diseases not compatible for radioactive therapy
* Previous PSMA-targeted radioligand therapy
* Concurrent serious (as determined by the Principal Investigator) medical conditions

Note: Other protocol defined Inclusion/Exclusion criteria apply.