cyrilzakka/clinical-trials huggingface dataset:
Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

This is an add-on, double blind, and randomised clinical trial with three groups: a homeopathic group, a placebo group, and a temporal control group.

The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

We test the effectiveness of an homeopathic drug versus placebo and a temporal control group (patient with no add-on treatment) following orthopedic knee surgery.

All patients have a PCA of morphine for 24 hours after surgery. After this period they can take an oral tablet of morphine on request.

Group A: Patients with study treatment (homeopathy) allocation. Double blind group with 70 patients

Group B: Patients with placebo allocation. Double blind group with 70 patients

Group C: Temporal control group with patients who take only the morphine. Open group with 25 patients

The total power: 70 +70 + 25 = 165 patients

Main Objective:

* To assess the effect of homeopathy in terms of morphine consumption delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

Secondary Objectives:

* To assess the effect of homeopathy in terms of total morphine consumption between H24 and H72 after a knee ligamentoplasty.
* To assess the effect of homeopathy on the pain perception using a analogical visual scale for 72 hours.
* To asses the placebo effect of the homeopathic treatment.

Main Assessment Criterion:

* Morphine consumption delivered by PCA between 0 and 24 hours after knee ligamentoplasty

Secondary Assessment Criteria:

* Morphine consumption between 0 and 72 hours after ligamentoplasty
* Pain assessment at H0, H4, H24 and H72 using 10 cm Analogical Visual Scale

Inclusion Criteria:

* age ranging from 18 to 60.
* patients candidates for a ligamentoplasty of the anterior cruciate ligament.

Exclusion Criteria:

* patient with corticoid and immunodepressor treatment

Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 18 to 60 years.
* Patients who are candidates for a ligamentoplasty of the anterior cruciate ligament.

Exclusion Criteria:

* Patients with corticoid and immunodepressor treatment
This Study Aims to Quantify Decisional Regret as Well as Quality of Life in Patients With Low- to High-risk Cancer and High Burden of Symptoms Undergoing Radiotherapy Using Established Questionnaires.

In this prospective registry study, patients with low-, intermediate- and high-risk tumor entities as well as patients with high symptom burden of any tumor entity in palliative constellation with indication for radiation treatment are included. This radiation treatment can be applied either as 3D-conformal RT or IGRT. The duration of treatment can range from one day to several weeks. For the primary endpoint as well as the secondary clinical and other exploratory endpoints, the 3 groups will be compared in terms of DR, QoL, toxicities and treatment plan parameters

Decisional regret and quality of life are quantified and analyzed using general linear models (e.g. linear regression models, ANOVA), taking into account covariates such as tumor stage, application of further systemic therapies, extent of the radiation area, occurrence of acute and/or late side effects. Survival time analyses and tumor control rates are evaluated using Kaplan- Meyer and Cox regression. Technical endpoints, quality of life and patient satisfaction will be described descriptively and compared between the cohorts using a mixed linear model.

Eligibility Criteria:
Inclusion Criteria:

* Indication for radiotherapy
* Patient information and declaration of consent
* Patients age ≥ 18 years

Exclusion Criteria:

* previous radiotherapy in affected site or same localisation in group 1-3
* Inability to answer the questionnaires
* Pre-existing conditions with increased risk of acute or late toxicity (LiFraumeni, Crohn's disease, ulcerative colitis)
* Simultaneous participation in other studies that could interfere with this study and/or participation before expiry of a required restriction period
* Persons who are in a dependent/employment relationship with the investigator
Immunologic Analysis of Peripheral Blood and Aspirated Thromb In AMI Patients

Researchers use FCM to analyze the immunol cell feature and its corresponding activation status, as well as the thromb aspirated through the thromb aspiration device in AMI patients


Eligibility Criteria:
Inclusion Criteria:

* uncomplicated AMI patients

Exclusion Criteria:

* any self immune disease and recent (within 1 month) or any chronic infection
The Relationship Between Second Trimester Placental Growth Factor Level and Fetal Growth Restriction

Type of the study:

A prospective observational study

Study settings:

The study will be conducted at Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department, Faculty of medicine over a period of six month from July 2017 to December 2017.

Study population:

The study population comprises 60 pregnant women at 13 to 28 week of gestation attending outpatient clinic and emergency Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department, Faculty of medicine.

Sample size justification Sample size was calculated using PASS 11.0 sample size calculation program and based on the study carried out by Benton, et al. (2016) Group sample sizes of 30 in group one (IUGR) and 30 in group two (Controls) achieve 80% power to detect a difference between the group proportions of 0.2910. The proportion in group one (the treatment group) is assumed to be 0.2940 under the null hypothesis and 0.5850 under the alternative hypothesis. The proportion in group two (the control group) is 0.2940. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500. The significance level actually achieved by this design is 0.0506. The primary outcome is birth weight below the 10 the percentile. The sample size was inflated by 15.0% to account for lost to follow up (attrition problem).

Inclusion criteria:

Singleton pregnancy between 13-28 weeks of gestation. Pregnant women aged 18 - 35 years Pregnant women with fetal abdominal circumference (AC) \< 10th percentile for gestational age (GA) on ultrasound

Exclusion criteria:

To exclude any factors that cause IUGR:

Chronic or gestational hypertension and/or preeclampsia Premature rupture of membranes A fetus with known chromosomal and/or congenital abnormalities confirmed after delivery.

Multiple gestation

Full history: including age, gravidity, parity and gestational age Clinical examination: be physically examined. Abdominal examination and measurement of symphsis-fundal height Diagnosis of IUGR will be confirmed by ultrasound and confirmed by Doppler ultrasound of Umbilical artery and cerebral artery blood flow in 3rd trimester

Eligibility Criteria:
Inclusion Criteria:

- Singleton pregnancy between 13-28 weeks of gestation. Pregnant women aged 18 - 35 years Pregnant women with fetal abdominal circumference (AC) \< 10th percentile for gestational age (GA) on ultrasound

Exclusion Criteria:

* Chronic or gestational hypertension and/or preeclampsia Premature rupture of membranes A fetus with known chromosomal and/or congenital abnormalities confirmed after delivery.

Multiple gestation
The Role of Multimodality Imaging in Left Atrial Appendage Closure

The aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial appendage closure procedures after unimodal and multimodal preprocedural imaging.

According to the investigators' primary hypothesis, simple, unimodal preprocedural imaging does not increase procedural burden of LAAC (total radiation dose, procedure time, fluoroscopy time, contrast amount). The investigators assume, that the success rate and safety of LAAC procedures is not reduced using unimodal preoperative imaging.

Regarding to postoperative imaging, the investigators aim to compare the sensitivity of different imaging techniques in detecting postoperative complications. We assume, that multimodal imaging technique increases the accuracy and sensitivity of the detection of postoperative complications (PDL, device thrombi).

Left atrial appendage closure (LAAC) is an increasingly used non-pharmacologic strategy to prevent stroke in patients with atrial fibrillation who have absolute or relative contraindications to long-term oral anticoagulant therapy, mainly due to previous major bleeding or high bleeding risk. As the majority of candidates are elderly patients with multiple morbidities, the reduction of procedural burden is of huge significance.

The aim of the present prospective, randomized, single-centre study is to examine the non-inferiority of unimodal (MDCT) vs. multimodal (MDCT+TOE) preprocedural imaging in percutaneous left atrial appendage closure. The investigators are going to assess the success rate, safety and complications of LAAC procedures, and determine the procedural burden (total radiation dose, procedure time, fluoroscopy time, contrast amount) of the interventions after preprocedural unimodal and multimodal appendage characterization and device sizing. Multimodal procedural guidance (2D/3D TOE, fluoroscopy-angiography) and multimodal postprocedural imaging (2D/3D TOE, MDCT) is going to be used to identify complications (peri-device leak, thrombus). The investigators are planning to compare the accuracy and additive value of different postoperative imaging techniques.

.

Eligibility Criteria:
Inclusion Criteria:

* Patients, who have clinical indication to LAAC and are undergoing percutaneous LAAC procedure in Gottsegen National Cardiovascular Center from 10.03.2021 to 31.12.2025
* Age above 18 years
* Informed consent
* Legal capacity

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Incapacitation
* Absence of consent
* Esophageal stenosis or diverticulum
* Active esophageal bleeding
* CT-contrast agent allergy
* Severe chronic kidney disease (GFR\<15 ml/min/1,73 m2)
* Appendage thrombus (mobile/with significant embolic risk)
* Life expectancy shorter than 12 months
* Active infection
* Significant mitral valve stenosis
* Mechanical heart valve
* Open heart surgery is indicated
Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy

The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).

The purpose of this research is to test the effect of two digital health interventions on cardiovascular health and subclinical cardiac dysfunction in postpartum individuals after pregnancies complicated by new-onset hypertensive disorder of pregnancy (HDP). All participants will undergo echocardiography and have their blood pressure/weight captured at 3 months and 12 months postpartum. If randomized to the intervention arm, the participant will be given a subscription to a mobile health application and a remote patient monitoring system, and asked to utilize these at home during the one year of the study along with usual care. If randomized to the control arm, the participant will receive care as usual.

Eligibility Criteria:
Inclusion Criteria:

* Delivery at Northwestern Memorial Hospital (Prentice Women's Hospital)
* Live birth at any gestational age
* Pregnancy complicated by new-onset HDP (pre-eclampsia, eclampsia, or gestational hypertension)

Exclusion Criteria:

* HELLP syndrome
* History of chronic diseases pre-pregnancy (hypertension, diabetes, cardiovascular disease, chronic renal disease)
* Current Omron remote patient monitoring or Noom user
* BMI\<18.5 kg/m2 at enrollment
* Inadequate gestational weight gain or gestational weight loss
Analyzing Challenging Clinical Discussions in Orthopaedics

The goal of this study is to analyze patient:provider communication surrounding the discussion of difficult clinical conversations such as knee replacement options. This study will also examine how using the teach-back communication technique can improve communication between patients and providers. Orthopedic residents, fellows, physician assistants, and attendings that agree to participate will be consented. Patients, who are likely to engage in a difficult clinical conversation, such as those who have a clinical indication for a Total Knee Replacement or a Partial Knee Replacement, will be recruited from participating providers clinical schedules. Patient:provider interactions will be recorded and then the providers will attend a 1 hour education lecture about how to use teach-back. After attending the lecture, additional patient:provider interactions will be recorded and analyzed via a qualitative approach. Additionally, providers will participate in a semi-structured interview to capture their perceptions of teach-back and what challenges and benefits they may derive from using it.


Eligibility Criteria:
Inclusion Criteria (Patient Participants):

* Age 18 years and older
* Clinical indication for multiple treatment options

Exclusion Criteria (Patient Participants):

* Non-English speaking
* Minors or non-consenting other individuals (spouses, friends, family members, children) in the patient room during the clinical visit

Inclusion Criteria (Provider Participants)

* Age 18 years and older
* A resident, fellow, physician assistant, or attending in the Duke Department of Orthopaedic Surgery

Exclusion criterion (Provider Participants):

• Non-English speaking
Adjunctive, Low-dose TPA in Primary PCI for STEMI

STRIVE will evaluate the use of adjunctive, low-dose intracoronary tissue plasminogen activator during primary percutaneous coronary intervention (PCI) for patients with ST elevation myocardial infarction (STEMI) in reducing the incidence of post-procedural myocardial blush (MBG) grade 0/1 or distal embolization.

STRIVE is a prospective, 3-arm, parallel group, blinded, randomized controlled trial evaluating the efficacy of a novel approach to prevent and treat microvascular obstruction thereby reducing major cardiovascular events using intracoronary administration of very low-dose fibrinolytic (tissue plasminogen activator, tPA) directly into the culprit coronary artery during primary PCI.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with STEMI undergoing primary PCI and,
2. ECG changes indicating large territory STEMI (defined as ≥2mm ST-segment elevation in 2 contiguous anterior precordial leads; or ≥2mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥8mm) and,
3. Randomization within 6 to 12 hours of symptom onset and,
4. Large thrombus burden with angiographic TIMI Thrombus Grade ≥3 after guidewire crossing.

Exclusion Criteria:

1. Active internal bleeding or high risk of bleeding or any prior intracranial bleeding.
2. Any other absolute or relative contraindication to fibrinolytic therapy.
3. Administration of a fibrinolytic ≤24hrs prior to randomization.
4. Cardiogenic shock on presentation.
5. Left bundle branch block (excluded because the ECG cannot be evaluated for ST segment resolution, an outcome of the study).
6. Planned upfront use of a glycoprotein IIb/IIIa inhibitor.
7. Any medical, geographic, or social factor making study participation impractical or precluding 1 month follow-up.
Impact of Theater Experience on Older Adults Living in Retirement Communities

Theater is a complex, multi-component performing art. On stage, actors not only need to memorize the script, but also be able to portray emotion and feeling through movement and move in whichever manner is deemed appropriate by the script. Acting therefore requires as much movement as it does vocalization. As training exercises in theater naturally involve boosting physical, cognitive and affective function, and social relationships, theater experience can be used to promote health and wellness. Over the last two decades, there has been an increase in the use of theater to promote health and wellness among older adults.

Thus, the overall aim of this project is to evaluate the therapeutic benefits of a 10-week theory-based theater program on physical functioning and emotional stress among older adults.

Hypothesis #1: Older adults residing in subsidized housing who participate in a theory-based theater program will demonstrate better physical functioning, and reduction in emotional stress than wait-list controls at the conclusion of a 10-week theater program.

Hypothesis #2: The positive impact of the theater program on the residents' improved physical functioning and stress level will be maintained at 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Age 62 or older living in HUD-subsidized housing
2. Residence in a subsidized apartment for at least one year.
3. Able to carry on a daily conversation with or without hearing aids
4. Intact cognition as indicated by a score of greater than 5 on the Short Portable Mental Status Questionnaire (SPMSQ)
5. Ambulatory with or without aids, as the outcome measures require participants to perform static and dynamic balance, and walking activities.

Exclusion Criteria:

1. Visual impairment that cannot be corrected with assistive devices
2. Diagnosis of progressive neurodegenerative disorders (self-report)
Time Schedules for Sending Invitations to Colonoscopy Screening

The attendance rate to population based primary screening colonoscopy within NordICC trial (The Nordic-European Initiative on Colorectal Cancer, NCT00883792) in Poland is roughly 33%. The aim of this study is to compare the effect of two different time schedules for sending invitations and reminding letters to a pre-specified colonoscopy appointment. 1,600 screening naive men and women 55 to 64 years of age are randomly assigned in a 1:1 ratio to receive invitation and reminder 6 and 3 weeks (SIX and THREE group) or 4 and 2 weeks (FOUR and TWO group) prior to pre-specified screening colonoscopy appointment date. Outcome measures are participation in screening colonoscopy within 6 months from the date of invitation, response and acceptance rate before sending a reminder. The study is powered to detect 7% difference in participation in screening colonoscopy.


Eligibility Criteria:
Inclusion criteria:

Individuals aged 55-64 years living in Warsaw area randomly drawn from Population Registry and randomized to the screening arm of the NordICC trial.

Exclusion criteria:

* Resident abroad
* Return of unopened letter of invitation and/or reminder (address unknown)
* Message from neighbour/family/post office on death of screenee (not updated in Population Registry).

Exclusion criteria for colonoscopy:

* Individuals with previous colorectal surgery (resections, enterostomies)
* Individuals in need of long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
* On-going cytotoxic treatment or radiotherapy for malignant disease
* Severe chronic (longer than trial duration) cardiac (NYHA III-IV)or lung disease
* Lifelong anticoagulant therapy with Warfarin
* A coronary event requiring hospitalization during the last 3 months
* A cerebrovascular event during the last 3 months
The Association Between Nephrolithiasis and Periodontal Status

Dental calculus is a calcified deposits firmly attached to teeth and implants surfaces. Dental calculus is strongly associated with periodontitis and considered to have indirect role in the pathogenesis of periodontal diseases. Dental calculus composed primarily of calcium phosphate mineral salts originated in the saliva covered by unmineralized bacterial layer. Composition of calculus varies from person to person and influenced by numerous variables such as: age, gender systemic disease and ethnic background.

Nephrolithiasis (kidney stones) are composed of insoluble salts of constituents of the forming urine. The most two frequent stone types are: Calcium oxalate (with a frequency of 15% -35%) and Calcium phosphate (5% -20%). The prevalence of kidney stones varies with race, sex, and geographic location. In the United States for men, kidney stone rates vary between 4%-9%, and for women, kidney stone rates range between 2%-4%.

Previous studies dealt with the connection between sialolithiasis and nephrolithiasis were inconclusive. To the authors' best knowledge no studies were done to examine the associations between nephrolithiasis and dental calculus. Thus, the aim of this study is to compare the mineral composition of both dental calculus and nephrolithiasis and determine whether nephrolithiasis composition may be linked to the periodontal status.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with nephrolithiasis
* Over 18 years old

Exclusion Criteria:

* Pregnant woman, uncontrolled diabetes (HbA1c \> 7.5%), patients who received periodontal treatment in the past 6 months, smokers
Histidine Therapy: A Project to Treat HARS Deficiency

This study evaluates the role of histidine in patients with HARS Syndrome. Children with HARS Syndrome will receive oral nutritional supplementation with histidine at a dose which will be increased in the event of acute febrile illness. Vision, hearing and plasma biomarkers will be monitored throughout the study period.

HARS syndrome is a progressive degenerative disease affecting eyesight and hearing caused by a mutation in the HARS gene which codes for an enzyme involved in protein synthesis. HARS syndrome has been exclusively found in the Old Order Amish communities in Southwestern Ontario and in Pennsylvania. Children with this disorder initially have normal vision and hearing, but with a febrile illness, can have a sudden loss of vision and hearing, as well as visual hallucinations. There is some evidence that vision loss progresses, albeit at a slower rate, even without a febrile incident. In more severe cases, fluid accumulates in the lungs (acute respiratory distress syndrome or ARDS) which can cause a drop in oxygen levels and sometimes death. There is currently no specific treatment for HARS syndrome, apart from supportive care. Anecdotal evidence of an adult with HARS syndrome who was treated with the amino acid L-histidine suggests that there was an improvement in vision, however there were no baseline objective measurements of vision prior to the use of histidine. We have designed a pilot project in which histidine will be given to children with HARS for 6 months. Investigators hypothesize that the histidine will be well tolerated and easily administered, without side effects. Investigators will monitor vision, hearing and bloodwork to determine if there is any change during the course of treatment. As well, investigators plan to administer increased doses of histidine during acute illnesses, hoping to prevent deterioration in breathing due to ARDS. The results of this initial pilot project may pave the way for a longer term study of the use of histidine.

Eligibility Criteria:
Inclusion Criteria:

1. Have molecularly confirmed HARS syndrome (Y454S homozygous).
2. Capable of giving informed consent or assent, or have an acceptable surrogate capable of giving consent on the participant's behalf.
3. Participant or surrogate decision maker is able to understand the study procedures and comply with them throughout the course of the study.
4. Able to take solid foods (ie applesauce) or swallow capsules (in younger children, capsule may be broken and contents mixed with applesauce).
5. At least 1 year of age or greater than 8 kg in weight (since histidine is supplied as a minimal dose of 500 mg/capsule.

Exclusion Criteria:

1. Unable or unwilling to give informed consent.
2. Unable to understand instructions or unable to attend clinic visits.
3. Children less than 1 year of age or less than \~8kg in weight (since histidine is supplied as 500 mg capsules).