cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Promote Maternal and Infant Oral Health

The long term goals of this project are to develop and implement a combined prenatal and postnatal intervention to decrease early childhood caries. The program is based on risk assessment, diet intervention and counseling. To accomplish these goals a pilot study is needed to determine: 1) The ability to recruit and retain pregnant mothers in an intervention program; 2) The levels of S. mutans in pregnant mothers; 3) The ability of a diet intervention to decrease S. mutans in pregnant mothers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over;
* Pregnant
* High S. mutans levels

Exclusion Criteria:

* Younger than 18;
* Other health conditions
Pre-meal Consumption of Whey in Gestational Diabetes Mellitus From Diagnosis to Delivery

The main objective of the study is to investigate the metabolic effects of whey protein (whey protein isolate, WPI, (Lacprodan® ISO.Water. from Arla Foods Ingredients) compared with placebo when consumed by women with gestational diabetes mellitus (GDM) from diagnosis (around gestational week 28) to delivery. Any changes in substrate metabolism and energy expenditure using indirect calorimetry will also be investigated. Differences in hunger and satiety parameters as well as blood pressure and gestational weight gain will also be assessed. Furthermore, analysis on the glucose response when the women consume the intervention (whey or placebo) at home in their own environment 30 minutes before breakfast at time of diagnosis (earliest week 28) and week 36 (four days following each time point) will be made. The women will be monitored with continuous glucose monitors, activity monitors and all meals will be provided for two days following the study days in the laboratory. At delivery cord blood will be sampled for analysis on metabolic parameters and investigations on epigenetics/DNA methylations. Complications to the delivery, neonatal outcomes, anthropometrics of the child will also be assessed. Breast milk composition will also be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* GDM (OGTT level of blood glucose ≥ 9 mmol/L)
* Normal blood pressure
* Age \> 18 years

Exclusion Criteria:

* Special dietary regimes \> 1 month at time of inclusion e.g. ketogenic diet
* Daily intake of protein supplements
* Milk allergy or phenylketonuria
* Medication with effect on glucose metabolism e.g. steroids
* Do not speak or understand Danish
* Twin pregnancy
* PCOS
* PI finds the patient unfit (like mental illness, too nervous or other)
* Severe chronic illness
* Severe nausea/vomiting
* Non-breakfast eaters
* Celiac disease

The initiation of insulin treatment during the trial will not lead to exclusion from the trial.
Comparing Quality of Recovery Between ESPB and IV Lidocaine After Major Breast Cancer Surgery

The erector spinae plane block (ESPB) is gaining popularity as a regional anesthetic technique for major breast cancer surgery. Although there is controversy about its mechanism of action, emerging evidence suggests that clinical analgesia observed after ESPB in breast surgery may be due to rapid and sustained local anesthetic absorption from the injection site. Hence intravenous LA infusion (IVLI) during the perioperative period could offer an effective alternative to invasive ESPB.

Major Breast Cancer Surgery (BCS), including mastectomy or modified radical mastectomy (MRM), is a globally prevalent procedure. Unfortunately, it is associated not only with significant acute postoperative pain but also a high incidence of chronic postsurgical pain (30-50%) . To improve outcomes, regional anesthetic techniques have been explored, including thoracic paravertebral block (TPVB) and ultrasound-guided erector spinae plane block (ESPB). While TPVB is considered the gold standard, it carries potential complications such as pleural puncture and pneumothorax. In contrast, ultrasound-guided (USG) ESPB is gaining popularity due to its technical simplicity and safety. However, controversy surrounds its mechanism of action, particularly the variable cutaneous sensory loss over anterior thoracic dermatomes. An emerging theory suggests that ESPB's clinical analgesia results from rapid and sustained local anesthetic (LA) absorption from the injection site. As an alternative, intravenous LA infusion (IVLI) during the perioperative period may offer equivalent analgesia without the invasiveness of ESPB. IV lidocaine, known for its substantial analgesic properties, persists beyond its typical duration of action, likely through mechanisms beyond sodium channel blockade. Although IV lidocaine has been established as part of multimodal analgesia in various perioperative settings, data specific to major BCS remain scarce. In this prospective, multicenter, randomized, triple-blind trial, the investigators aim to compare quality of recovery (assessed using the validated Quality of Recovery 15 \[QoR15\] score) between USG ESPB and IVLI. The investigator's hypothesis is that the quality of recovery after major breast cancer surgery with IVLI will be comparable to that achieved with USG ESPB.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* 18 to 75 years of age
* Patients scheduled for primary breast cancer surgery-mastectomy, modified radical mastectomy and breast conservation surgery with sentinel lymph node biopsy +/- axillary dissection will be included in this study.

Exclusion Criteria:

* Patient refusal,
* Local skin site infection,
* Coagulopathy,
* History of allergy to local anaesthetics, and
* Patients with hepatic, renal and cardiac dysfunction
Assessing Outcomes in ED Patients With RV Failure

Millions of Americans seek emergency care for acute shortness of breath, and many undergo computerized tomographic pulmonary angiography (CTPA) testing that is negative for acute disease. Management of patients with persistent shortness of breath despite normal testing continues to pose a challenge for clinicians. Right ventricular (RV) failure is a common cause of dyspnea that brings patients to the emergency department (ED), however, it is often not considered in the differential diagnosis, remains unrecognized, or patients are not properly followed up once diagnosed. Delays in diagnosis and management of RV failure are associated with poor outcomes. The investigators propose a novel clinical pathway, which entails identifying and enrolling patients with RV failure in the ED, then referring them to a specialized cardiovascular clinic where they will receive a standardized evaluation and management plan. Our hypothesis is that management of RV failure, through this pathway, will improve patient outcomes when compared to standard care. The primary outcome will assess 1-year unscheduled healthcare visits.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \> 18 years old,
* with a non-significant CTPA scan (i.e. no acute disease), dyspnea PLUS an emergency physician performed echocardiogram with isolated RV failure OR CTPA scan with evidence of pulmonary hypertension OR comprehensive echocardiogram within 3 months of index hospital visit showing isolated RV dysfunction

Exclusion Criteria:

* Currently being evaluated and/or treated for RV failure or PH,
* those unable to have a comprehensive echocardiography performed,
* those with indeterminate RV function OR LV dysfunction on comprehensive echocardiography, and
* those patients with circumstances where they may be lost to follow-up (homeless, prisoner, severe psychiatric disorder, no reliable contact information).
Patient-specific Instruments as a Standard Procedure in Total Knee Arthroplasty

Description of logistics, learning curve and radiological results in 70 patients treated with patient specific instrumentation in total knee arthroplasty as a standard procedure

The Orthopaedic Clinic Gersthof is a teaching hospital, where the entire spectrum of joint replacements with emphasis on hips and knees is performed. Twenty surgeons perform TKAs at our institution, with approximately 400 TKAs implanted per year.

The PSI system of Smith \&Nephew® (Patient-Matched Cutting Blocks \[PMCB\]; the VISIONAIRE® technology) is applied. The preoperative image modality is based on a long leg standing X-ray as well as an MRI of the knee. The Genesis II® Endoprosthesis (Smith \& Nephew®) is used as the TKA implant.

This study is a observational monocentric prospective study.

Estimated enrollment: 70 Enrollment time: September 2011-October 2012 Primary outcome: Alignment

The postoperative X-rays (AP, lateral view, and long leg standing), taken 7-to-10 days after surgery are evaluated in terms of component position and restoration of the mechanical alignment. X-rays are routinely monitor-guided but not calibrated at our institution.

As a secondary outcome the learning curve is evaluated using the following parameters collected during surgery: the fit of the cutting blocks, changes of the implant size, bony recuts, soft tissue releases, and changes in inlay size. Gap balancing was subjectively judged by the operating surgeon. Operation time, number of blood transfusions, and early postoperative complications were recorded within the first 14 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Indication for TKA
* Genesis II endoprosthesis
* Operated using patient specific instruments (VISIONAIRE)

Exclusion Criteria:

* contraindication for MRI
* varus/ valgus deformity \>15 degrees
Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy

Postoperative pain is an important issue after thoracotomy operations. Thoracic epidural analgesia is most popular analgesic method, but sometimes it is not sufficient for pain. This study is designed to compare intercostal block with thoracic epidural analgesia in patients undergoing thoracotomy


Eligibility Criteria:
Inclusion Criteria:

lung cancer

Exclusion Criteria:

patient refusal bleeding diathesisi emergency cases

-
Evaluating a Microfinance Intervention for High Risk Women in Mongolia

The proposed study aims to test the feasibility and preliminary efficacy of a combined 4-session HIV sexual risk reduction (HIVSRR) and microfinance intervention (including 34 training session and matched savings) to reduce unprotected sex and to increase proportion of income from sex work among women engaged in high risk sexual activity in Ulaanbaatar, Mongolia. Feasibility and preliminary efficacy will be tested using a randomized clinical trial (RCT) with 134 women sex workers meeting eligibility criteria. Following eligibility screening, eligible women will complete informed consent, a baseline assessment, and be randomized to one of 2 study conditions: 1) the combination HIV sexual risk reduction plus microfinance (HIVSRR+MF); or 2) a 4-session HIVSRR alone control condition.

The study design will permit us to:

1. Examine and enhance the feasibility (i.e. recruitment, engagement, attendance, retention data collection) of a combination HIV sexual risk reduction and MF intervention with high risk women in Ulaanbaatar, Mongolia;
2. Examine the preliminary outcomes of the interventions on decreasing unprotected acts of vaginal and anal intercourse; increasing the proportion of protected vaginal and/or anal acts using barrier protection and decreasing number of sexual partners with repeated measures at baseline, immediately post-intervention, and 3 and 6 month follow-up assessments.
3. Use the results of the pilot study to inform the design of a future R01 application.


Eligibility Criteria:
Inclusion Criteria:

* She is at least 18 years of age;
* She reports having engaged in vaginal or anal sexual intercourse in the past 90 days in exchange for money, alcohol or other goods;
* She reports having engaged in unprotected vaginal or anal sexual intercourse in the past 90 days with a paying sexual partner; and
* She reports being interested in learning about and developing her own small business.

Exclusion Criteria:

* assessed to have a severe cognitive or psychiatric impairment that would interfere with the ability to provide informed consent or complete study instruments
Construction of a Cohort for Pan-Vascular Disease Among Employees of Taizhou People's Hospital

1. Participant Recruitment During the annual health check-ups for hospital staff, potential participants are recruited. Those who express interest are provided with a detailed explanation of the study's objectives, content, and procedures, and are required to sign an informed consent form.
2. Screening Phase Medical history is collected, including any previous occurrences of myocardial infarction, ischemic or hemorrhagic stroke, or history of coronary, carotid, or peripheral arterial revascularization.
3. Baseline Data Collection

1. Health Questionnaire Survey: Collect demographic information, medical history, and data on nutrition, physical activity, and smoking habits through a questionnaire.

2. Clinical Assessments: Conduct the following assessments for all enrolled participants:

* High-sensitivity cardiac troponin I and NT-proBNP testing
* Non-invasive arterial stiffness testing
* Measurement of visceral and subcutaneous fat content
* Fundus photography
* Body composition analysis

  4 Regular Follow-Up

Annual follow-up for a total of 10 years. The follow-up includes:

1. . Collection of updated demographic information and medical history, as well as repeated questionnaires on nutrition, physical activity, and smoking habits.
2. . Reassessment of the following items:

   * High-sensitivity cardiac troponin I and NT-proBNP testing
   * Non-invasive arterial stiffness testing
   * Measurement of visceral and subcutaneous fat content
   * Fundus photography
   * Body composition analysis

     5 Outcome Evaluation

1）. Primary Outcomes: Cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke events.

2）. Secondary Outcomes: All vascular events, changes in cardiovascular biomarkers, and degree of arterial stiffness.


Eligibility Criteria:
Inclusion Criteria:

1. Employed or retired individuals aged 45 years or older;
2. Willing to sign an informed consent form and voluntarily participate in health examinations and related data collection.

Exclusion Criteria:

1. History of myocardial infarction, ischemic or hemorrhagic stroke, or revascularization of coronary, carotid, or peripheral arteries;
2. Employees with severe psychological disorders who are unable to cooperate with the study;
3. Pregnant or breastfeeding women.
MIND-Matosinhos: Multiple Interventions to Prevent Cognitive Decline

The present study aims to quantify the impact of a multidomain approach to prevent cognitive decline in individuals from the general population at-high risk of dementia. It will be based on five distinct components: 1) cognitive training; 2) physical exercise; 3) nutrition education; 4) capacitation to deal with cognitive decline; 5) assessment and correction of hearing loss.

This is a community-based randomized controlled trial (RCT), which will be implemented in Matosinhos municipality (Portugal) and will be conducted over three months, possibly extensible up to 12 months.

Eligible individuals (n=300) will be randomized (1:1) into two arms: intervention and control groups. The intervention plan will be composed by five non-pharmacological strategies, namely: 1) cognitive training; 2) physical exercise; 3) nutrition education; 4) capacitation to deal with cognitive decline; 5) assessment and correction of hearing loss. This plan will be applied to both groups, but with lower intensity among the control group.

Participants' characteristics will be assessed at baseline and at three months; for those who complete one year of intervention, additional follow-ups at six and 12 months after the beginning of the intervention will be conducted. These evaluations will cover the following domains: sociodemographic, lifestyle, health and anthropometric characteristics; cognitive function; subjective memory complains; symptoms of anxiety and depression; quality of life; physical performance; levels of glycated hemoglobin and 24-hour urinary sodium, potassium, creatinine excretion as well as pH.

The results of the present study may guide future clinical practices and health policies aiming to prevent cognitive decline and reduce the overall burden of dementia.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years;
* Score equal or higher than the validated cutoff points defined as 2 standard deviations below the mean for age and education in the Montreal Cognitive Assessment (MoCA);
* ≥6 points on the Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score (CAIDE);
* ≥4 years of schooling.

Exclusion Criteria:

* Medical disability that contraindicates physical activity;
* Lack of autonomy in daily activities;
* Previous diagnosis of dementia or severe incapacity.
Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care

The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit.

The CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane, a blood circuit, a dialysate circuit and a feedback circuit.

The implementation of a CVVHDF requires the use of large amounts of biological liquid essential to enable the purification of blood during its passage through the artificial kidney.

The objective of this study is to assess time nursing work and the costs of each method.

The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit.

The CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane, a blood circuit, a dialysate circuit and a feedback circuit.

The implementation of a CVVHDF requires the use of large amounts of biological liquid essential to enable the purification of blood during its passage through the artificial kidney. The biological fluid may be supplied to the generator of CVVHDF in 2 ways:

* The conventional method, the most used: the generator operates with pockets containing dialysis fluid, these pockets to be changed regularly by nurses
* The on-line method: the generator operates with a specific water system supplying the dialysis fluid available in every room of the unit The objective of this study is to assess time nursing work and the costs of each method.

For this, 15 patients will be included in this study. Each patient performs 12 hours of each method (conventional and online), whose order will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated with or beneficiary of a social security category
* Patient with a renal failure requiring a CVVHDF for at least 2 cycles of 12 hours

Exclusion Criteria:

* N/A
Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009)

This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster

Exclusion Criteria :

* Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response
Prediction of Tongue Base Obstruction During Sleep

This study investigates the hypothesis that, in children, tongue motor functions can predict both the anatomical site and the degree of upper airway obstruction contributing to obstructive sleep-disordered breathing.

Patients will be enrolled during their visit to the ENT physician. Subsequently, their tongue motor functions will be assessed during their pre-surgical appointment. Finally, they will undergo a drug-induced sleep endoscopy prior to their surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 17 years old
* Medical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids
* Positive Pediatric Sleep Questionnaire (8 or more positive responses)
* Eligibility for surgical intervention

Exclusion Criteria:

* Neurological, cardiac, or respiratory comorbidity other than obstructive sleep-disordered breathing
* Previous surgery of the upper airway or oral cavity
* History of or current head or neck cancer
* Cranial, upper airway, or oral cavity malformation
* Contraindication to performing endoscopy
Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
* Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
* Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

Key Exclusion Criteria:

* No pigmented hair within any of the vitiligo areas on the face.
* Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
* Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
* Use of protocol-defined treatments within the indicated washout period before baseline.