cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration

This goal of this single-blind, simple randomized, positive-controlled prospective study is to evaluate the effects of additive-manufactured personalized titanium mesh and traditional titanium mesh in guided bone regeneration for large alveolar bone defects. The study will assess the short-term and long-term efficacy, safety, and incidence of complications of the additive-manufactured personalized titanium mesh, along with an analysis of risk factors. Participants will be followed up for two years after surgery with free-of-charge clinical and radiographic examinations.


Eligibility Criteria:
Inclusion Criteria:

1. Patients missing single or multiple teeth with moderate to severe bone defects in the edentulous area requiring complex guided bone regeneration. （Moderate bone defects: bone loss with residual alveolar ridge width between 1 mm and 3 mm; severe bone defects: bone loss with residual alveolar ridge width ≤ 1 mm.）
2. The edge of the edentulous area within 1 mm is alveolar bone, with no adjacent tooth roots or nerve canals, ensuring complete retention of the personalized titanium mesh edge. The apical edge of the edentulous area within 2 mm is alveolar bone, with no nerve canals, ensuring that retention screws for the personalized titanium mesh can be designed in this area.
3. The patient and/or his/her guardian agrees to participate in this trial and signs the informed consent form.

Exclusion Criteria:

1. Patients with edentulism.
2. Patients with mild bone defects (residual alveolar ridge width greater than 3 mm).
3. Presence of acute or chronic infection in the surgical area.
4. Presence of acute or chronic infection in the teeth adjacent to the edentulous area.
5. Participation in similar trials or other interventional clinical trials within 30 days prior to signing the informed consent form.
6. History of metal allergies, severe allergy history, or severe immune deficiency.
7. Uncontrolled metabolic diseases, such as Type 1 diabetes or Type 2 diabetes (HbA1c ≥ 7% or fasting blood glucose ≥ 7 mmol/L despite medication control), severe liver or kidney dysfunction (ALT, AST \> 2 times the upper limit of normal, serum creatinine above the upper limit of normal).
8. Long-term use of steroid medications.
9. History of drug abuse or alcoholism.
10. Pregnant or breastfeeding women.
11. Poor compliance.
12. Other conditions deemed unsuitable for participation by the investigator.
A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes

BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro.

The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg.

This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate dosing visits.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for at least (or equal to ) 12 months,
* Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
* Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)

Exclusion Criteria:

* Type 2 diabetes mellitus,
* The receipt of any investigational product within 3 month prior to first dosing,
* Clinically significant abnormalities, as judged by the investigator,
* Any systemic treatment with drugs known to interfere with glucose metabolism,
* History of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening
* Blood or plasma donation in the past month or more than 500mL within 3 months prior to screening
Nurse Counseling for Physical Activity in Primary Care Patients

Many elderly primary care patients are at high risk for health complications and functional impairment due to low levels of physical activity. Previous trials of counseling of elderly patients in primary care clinics have not demonstrated lasting physical activity change and have not evaluated fitness changes associated with any increased activity.

Background:

Many elderly primary care patients are at high risk for health complications and functional impairment due to low levels of physical activity. Previous trials of counseling of elderly patients in primary care clinics have not demonstrated lasting physical activity change and have not evaluated fitness changes associated with any increased activity.

Objectives:

The primary objective was to determine if nurse telephone counseling could assist 60 to 80 year old VA primary care patients to establish and maintain a regular walking program.

Methods:

In this randomized clinical trial, 60-80 year old patients were referred to a walking program by primary care providers. All participants received individualized counseling by the nurse and, over the next year, one of three follow-up interventions: 1) 20 calls initiated by the nurse; 2) ten calls initiated by the nurse and ten initiated by an automated telephone message delivery system; or 3) no follow-up calls. All kept walking diaries and mailed these in to a data collector blinded to intervention group. Follow-up research visits were scheduled at six and 12 months. Self-reported walking, the primary outcome measure, was assessed from the walking diaries and validated by reports of significant others and accelerometer data. Improvement in fitness was assessed at 12 months with a standardized six minute walking test. Tinetti mobility scores, body mass index, and body girths were also assessed. Several quality of life measures were also administered.

Status:

Complete.

Eligibility Criteria:
Inclusion Criteria:

60-80 year old patients referred to a walking program by a primary care provider.

Exclusion Criteria:
Identifying Key Attributes and Learning From a Local Falls Prevention Ambassador Programme

Managing falls for care home residents can be challenging for care home staff who work in complex settings and with residents with complex needs. Our previous research has identified that care homes would like more ongoing support and learning to improve their confidence in managing falls. One such programme is being set up in Lincolnshire.

The Lincolnshire Care Association are setting up a falls ambassador programme designed to provide ongoing support and learning for care homes on falls management. Exploring what this programme involves, what topics are covered and identified by care homes and whether they feel more confident in managing falls will help other areas in setting up similar programmes.

This research will explore the key attributes of the Lincolnshire Falls ambassador programme and explore whether it supports care home staff to feel more confident in managing falls by asking staff about their confidence before and after, observing the topics that are covered in the group meetings and by interviewing members of the programme after it has been established.

To explore the key attributes of the Lincolnshire Falls ambassador programme and explore whether it supports care home staff to feel more confident in managing fall.

The following objectives will be achieved:

Describe the key activities of the programme. Identify the key themes of the discussions and shared learning. Explore whether care staff feel more confident in falls management. Identify barriers and facilitators to delivering the programme.

Survey: Pre and post survey of care home staff confidence. The survey will be distributed electronically using MS Forms by the programme leader at the start of the programme and after the programme. The survey will take up to 15 minutes to complete.

Interviews: Interviews with care home staff that have attended the programme to explore their learning and confidence. These will be undertaken face-to-face at a location convenient to the participant or over the telephone. With consent the interviews will be audio recorded and transcribed. If the participant prefers written field notes will be taken. The written transcripts and field notes will be classed as source data and retained. Any audit recording will be deleted to avoid retaining any personal identifiable information.

Observations: Observation of group meetings as part of the programme to identify the key areas of learning. The researcher will attend the meeting which will be either face-to-face or online. Field notes will be taken by the researcher and retained as source data.

Eligibility Criteria:
Inclusion Criteria:

* Any care home staff member attending the local falls ambassador programme

Exclusion Criteria:

* None
Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil

Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing urethral pain during urodynamic test.

Patients will be randomized into two groups: 1) Lidocaine Gel 2) Paraffin Oil. They will fill out 1 visual analogue scale (0-10) for urethral pain during the test.

Eligibility Criteria:
Inclusion Criteria:

* All men who will be referred for urodynamic test

Exclusion Criteria:

* Active infection
* Permanent Catheter
Evaluation of AlcoholEdu for College

The study examined whether an online course for college freshmen (AlcoholEdu) had an effect on alcohol misuse and related problems, using a randomized controlled design with 30 universities.


Eligibility Criteria:
Inclusion Criteria:

* Colleges without an online alcohol prevention course
* Able to implement AlcoholEdu course for all incoming freshmen
* Able to provide random student samples for data collection
* Able to obtain IRB approval for study

Exclusion Criteria:

* Already implementing alcohol prevention course for incoming freshmen
* Not able to implement online alcohol prevention course
* Not able to provide random student samples for data collection
* Not able to obtain IRB approval for study
The Acute Effects of Coffee on Glucose Metabolism

The purpose of this study was to determine the acute effects of decaffeinated coffee, caffeinated coffee and caffeine on glucose metabolism in humans


Eligibility Criteria:
Inclusion Criteria:

* healthy young males
* nonsmokers
* moderate alcohol users

Exclusion Criteria:

* not on any medications that could alter glucose metabolism
* no history of blood disorders
Comparative Evaluation of the Effect of Different Adjunctive Air Polishing Powders in Nonsurgical Periodontal Therapy in Patients with Stage II and III Periodontitis

The aim of this clinical trial is to evaluate and compare the effect of a newly designed air-polishing device (APD) using Erythritol, Glycine, and Trehalose air-polishing powders in nonsurgical periodontal therapy with control (conventional scaling and root planning) following the concept of guided biofilm therapy (GBT) as an adjunctive to subgingival instrumentation (SI) in nonsurgical periodontal therapy for Stage II and III periodontitis patients both clinically and microbiologically.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals of both sexes with an age between 30 and 65 years, having at least 16 natural teeth in function,
2. Stage II and III (moderate to severe) periodontitis, having at least 16 teeth with the need for SI
3. Interproximal plaque index (API) ≤ 35%; patients with Good oral hygiene.
4. No history of systemic disease that may influence periodontal disease

Exclusion Criteria:

1. Pregnancy or breastfeeding,
2. Smokers with more than seven cigarettes per day
3. Patients that had a treatment with antibiotics within six months before the study
4. Need for periodontal surgery or adjunctive antibiotic treatment to the SI
5. Patients who had any periodontal treatment during the last year before the study.
6. Patients with known systemic or autoimmune disease.
Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services

The purpose of this study is to determine the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population.

Study Goal:

To determine the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population.

The Intervention:

A. Brief, concise messages conveyed to women during group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period.

B.IEC materials such as posters and brochures that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women.

C.Use of a screening tool (Appendix A) to assess pregnancy risk for postpartum women coupled with a brief counseling message depending upon risk classification which includes referral to FP services for those currently or soon-to-be at-risk of pregnancy.

D.Convenient offer of FP services to women attending vaccination services for their infants either concurrently with vaccination services, or at the same facility and on the same day, but at a different time from vaccination services.

Study Design:

Experimental, two-group (intervention/control) pretest (pre-intervention) /posttest (post-intervention) design 12 month intervention period. A mid-course collection of process data will also be conducted at 6 months to assess the degree to which the intervention is being implemented as intended and to provide an opportunity for corrective action if needed.

Participants: Women attending vaccination services for their infants, and vaccination and FP providers

Eligibility Criteria:
Inclusion Criteria:

Clients:

* adult women, aged 21 years and older, or married women ages 18 to 20 who have achieved legal majority status by emancipation due to marriage,
* bring their infants between the ages 6-12 months to immunization services at study sites

Providers:

* all health care providers who currently provide immunization services to infants and/or family planning services within the selected facilities.
LUTATHERA Injection General Use Result Survey

This study is a multicenter observational study with a central registration system and all-case surveillance system without a control group.

From the date of the first dose of this drug until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).

For patients who discontinue treatment with this drug during the observation period, necessary variables will be examined until 40 weeks after the last dose of this drug during the observation period and recorded in the case report forms (CRF).

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with this drug for the following indications during a certain post-marketing period

  * Indication: Somatostatin receptor-positive neuroendocrine tumor Patients who started to receive this drug before the contract for this study will also be included in the study population and it will be allowed to register them after the contract so that all patients who receive this drug will be included in this study. Patients treated with this drug for off-label indication will also be included in this study to register all patients received this drug.

Exclusion Criteria:

* Not applicable
ECG Leadwires: Disposable Versus Cleaned, Reusable

Null hypothesis: (1) there is no difference in rates of ICU-acquired infection based on using disposable or cleaned, reusable ECG leadwires and (2) In cardiac surgical telemetry floors, there is no difference in false or nuisance sightings or crisis calls based on using disposable or cleaned, reusable ECG leadwires.

Primary purposes: Using a randomized controlled trial methodology and randomizing similar (matched) intensive care units (ICU) to either disposable or cleaned, reusable ECG-LW: 1. Is there a difference in the rate of blood stream infection (BSI) and ventilator-associated pneumonia (VAP) in ICU environments (medical ICU, surgical ICU, cardiothoracic ICU, and neuroscience ICU) and surgical site infection (SSI); specifically, sternal wound infections in cardiothoracic ICU that utilize disposable vs. cleaned, reusable ECG-LW? 2. Is there a difference in ICU length of stay based on ECG-LW used: disposable vs. cleaned, reusable? 3. After controlling for patient age, comorbidity index and after removing patients who's date of BSI or VAP infections were within 48 hours of admission to the ICU, is there a difference in the rate of (A) blood stream infection (BSI), (B) ventilator-associated pneumonia (VAP) and (C) SSI in ICU environments (when applicable) that utilize disposable vs. cleaned, reusable ECG-LW? Secondary purposes: Using a randomized controlled trial methodology and randomizing similar telemetry units to either disposable or cleaned, reusable ECG-LW: 1. Is there a difference in the number of false/nuisance sightings/crisis calls (i.e., lead off, no telemetry, lead failure or other false alarms) identified by the Central Monitoring Unit (CMU)? 2. Is there a difference in true sightings/crisis calls identified by the CMU based on unit assignment of disposable or cleaned, reusable ECG-LW? 2b. If yes to #2, is there a difference in types of true sightings/calls identified by the CMUbased on assignment of disposable or cleaned, reusable ECG-LW?

Eligibility Criteria:
Inclusion Criteria:

* Primary HO: patients treated in an ICU setting; Secondary HO: Patients treated in cardiac telemetry setting

Exclusion Criteria:

* None
Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe

In the context of environmental pollution of the French West Indies by chlordecone and questions about health consequences, monitoring at the peripubertal age of children born alive in the TIMOUN cohort is justified in several respects: - existence of an already established mother-child cohort whose live-born children will reach peripubertal ages during the period 2020-2022; - opportunity to verify hypotheses put forward on the basis of toxicological data acquired in laboratory animals and the hormonal characteristics of chlordecone (endocrine disruptor); - strong societal demand for such research to be carried out because of concerns about the sensitivity of children and adolescents to the effects of environmental xenobiotics, in particular on sexual development and the age of puberty; - recommendation of the Scientific Council Chlordecone Inserm - InVS; specific action of the National Plan Chlordecone IV.

The French West Indies are permanently polluted by chlordecone. It is an organochlorine insecticide used from 1973 to 1993 in Guadeloupe and Martinique to control banana root borers. Its physico-chemical properties give it great stability and are at the origin of its persistence in the environment. Soil, flora and wildlife pollution from chlordecone in the Caribbean was first documented shortly after its introduction in 1973. However, it was not until 1999 that this pollution was extended to waters intended for human consumption and to various local, vegetable and animal, land and aquatic foodstuffs. The population is also affected, as confirmed by impregnation studies, with exposure nowadays occurring mainly through the consumption of contaminated food. The contamination of the French West Indies populations by this insecticide raises many questions about its possible health consequences. In order to assess the effects of chlordecone exposure on child development in Guadeloupian children, a longitudinal and prospective study, the Timoun mother-child cohort, was initiated. Between 2004 and 2007, women in the second trimester of pregnancy who planned to give birth in the public hospitals of Grande-Terre and Basse-Terre (accounting for 70% of all deliveries in Guadeloupe) were invited to participate in the study. Children born to these included women have been enrolled to several follow-ups during the last years (3, 7, 18 months and 7 years of age).

Eligibility Criteria:
Inclusion Criteria:

* Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007) and whose parents agreed to be contacted later.
* Residing in Guadeloupe at the peripubertal age
* Affiliation to a social security scheme
* Agreement to participate in the study and informed consent signed by the minor
* Study participation agreement and informed consent signed by the parents

Exclusion Criteria:

* Refusal to participate in the research
Palliative Care Needs Assessment of the Population Living in Mayotte (French Island of Comoros)

This qualitative study aims to explore the assessment of palliative care needs of the population living in Mayotte, French territory of the Comoros.

The aim is to offer a palliative care service tailored to the needs of the population in this area.


Eligibility Criteria:
Inclusion Criteria:

* patients study: to be at the palliative stage of his illness, informed consent
* family study: being a family or caregiver of a patient in palliative care, informed consent
* care workers study: being a care worker of a patient in palliative care, informed consent

Exclusion Criteria:

* 0
IHT for Mild Cognitive Impairment

This phase I clinical trial will examine the safety and efficacy of intermittent hypoxia training (IHT) for up to 12 weeks to treat subjects with mild cognitive impairment (MCI).


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women ages 55 to 79 years old who have been diagnosed with MCI.
* Must be willing to be assigned to either group: treatment or sham-treatment control.
* Able to pay multiple visits to the lab for the proposed assessments.
* Able to breathe moderately hypoxic air via an air-cushioned, disposable facemask.
* To have controlled stabilized chronic conditions of at least 6 months duration, such as hypertension, coronary artery disease, diabetes or metabolic disease, chronic bronchitis, degenerative osteoporosis or arthritis and/or other aging-related chronic conditions.
* Must be depression-free at the time of enrollment.
* Must have arterial oxygen saturation at or above 95% and cerebral tissue oxygenation at or above 50% at rest.
* Woman subject must be post-menopausal.

Exclusion Criteria:

* Unwilling to sign a written consent to participate in this double-blinded placebo-controlled phase I trial.
* Diagnosed with AD-dementia or have impaired independent daily functioning; with MMSE \<20 and/or CDR ≥1.
* Unable to visit the lab independently.
* Claustrophobic to facemask and hyper-reactive to hypoxia exposure.
* Expecting any major surgery or transplant.
* Have un-controlled chronic conditions including systolic-diastolic pressures over 150/90 mmHg with medications, diabetes, chronic renal failure (based on the medical history questionnaire), obstructive sleep apnea (based on the medical history), recurrent chest pain, seizures or epilepsies, moderate to severe carotid stenosis or calcification, brain aneurysm, uncontrolled allergic rhinitis, pulmonary fibrosis, emphysema, cancer, infectious disease, atrial fibrillation, regular pre-mature ventricular contractions, myocardial ischemia or infarct, 2nd or 3rd degree atrio-ventricular blockade.
* Have severe head injury or traumatic brain injury, stroke (hemorrhagic and/or ischemic).
* Have currently diagnosed depression.
* Currently have COVID-19.
* Have any metallic implants or who are claustrophobic.
* Currently participating in any interventional study and/or have been previously exposed to hypoxia, such as residing more than two months at altitudes above 5000 ft. within the past 3 years or previously participated in a hypoxia training study.