cyrilzakka/clinical-trials huggingface dataset:
Intestinimonas for Prevention of Type 2 Diabetes Mellitus

The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes.

Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the local microbiota in small and large intestine.

In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by Intestinimonas and similar microbiota.

The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals.

The study participants will be subjects who are overweight and are at risk of developing Type 2 diabetes.

The key objective of this randomized, placebo-controlled study is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of Intestinimonas will be compared with the low-dose tested in the initial double-blind Randomised Controlled Trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* increased BMI \> 25,
* Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose \> 140 after OGTT, or HbA1c 5.7% - 6.4%

Exclusion Criteria:

* Type 2 diabetes
Comparing Two Linkage-to-Care Models for Latinx Immigrant Patients : A Pilot Comparative Clinical Effectiveness Trial

The goal of this randomized clinical comparative effectiveness trail is to compare the effects of patient navigator models on follow-up care in Latinx and Indigenous Mexican immigrant patient populations. The main question\[s\] it aims to answer \[is/are\]:

* Participants randomized to PN-CHW compared to the PN-CS model will be more likely to follow through with follow-up care referrals
* Trust will be a driving factor as to why PN-CHW will be a more effective intervention for the patient population.

Researchers will compare patients in a patient navigator community health worker (PN-CHW) intervention to those in a patient navigator clinical staff (PN-CS) intervention to see which model of linkage to care is more effective for follow-up care in the patient population.

Participants will be asked to:

* Complete a baseline survey about healthcare access
* Receive calls and text messages from either a CHW or clinical staff
* Complete a follow up survey

The research project will be conducted at a free clinic that serves a primarily Spanish-speaking Latinx patient population in the Inland Southern California region. Patients in this study will be randomized to one of two intervention arms: Arm 1: PN model delivered by CHWs/promotoras and Arm 2: PN model delivered by clinic staff. CHWs who live in the region and work at the free clinic will deliver the PN model for Arm 1 participants. CHWs have a detailed knowledge of local health resources, as well as lived experience of the barriers patients in their community face when accessing healthcare services. Medical students who are volunteer clinic staff will deliver the PN model for Arm 2 participants. Medical students are the doctors in training who provide primary care services to patients at the CVFC under the supervision of well-established physicians. Baseline data and follow-up data at 12 weeks will be collected along with qualitative interviews with patients in both arms of the study.

Eligibility Criteria:
Inclusion Criteria:

* 1) live in the Coachella Valley, 2) 18 or older, 3) household income less than or equal to or below 200% of federal poverty guidelines, 4) do not currently have health insurance, and 5) have access to a telephone.

Exclusion Criteria:

* Do not speak English, Spanish or Purépecha (an indigenous dialect spoken among the Purépecha of Mexico).
The HeartSpare Study (Stage I)

Radiotherapy (RT) has a major curative role in women with early breast cancer, and is recommended routinely after lumpectomy and selectively after mastectomy. It has contributed to a halving of breast cancer mortality in the UK over the last 2 decades despite ever-rising cancer incidence. RT in women with left-sided tumours often exposes the underlying heart to a damaging dose. The heart is very sensitive to RT, and there were 1-2 deaths from heart disease for every 100 breast cancer patients treated during the 1960s-70s. The situation has improved in recent years, but standard RT techniques still deliver significant radiation doses to heart tissue.

Two potentially simple techniques reduce heart dose. In one, women are taught to breathe in deeply and to hold their breath for about 20 seconds while RT is given. The downward movement of the diaphragm pulls the heart away from the RT beam. In the other technique, women lie on their fronts, instead of on their backs as they normally do for breast RT. In this position, the breast falls away from the rib cage and reduces exposure of the heart. Neither technique is routinely available to women receiving breast RT in the UK for reasons that this research aims to address. The investigators need to: 1) confirm that patient position can be reproduced with millimetre precision every day using these techniques, 2) minimise costs of equipment, time and personnel required to support such techniques, 3) select the most appropriate technique for different patients and 4) train staff in centres across the UK to deliver techniques safely and effectively. By addressing all of these issues, the study aims ultimately to make heart-sparing RT available to all UK women that might benefit from treatment, thereby significantly reducing the burden of heart disease in breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Complete microscopic excision of early stage invasive ductal or lobular carcinoma (pT1-3b N0-1 M0) of the left breast following breast conservation surgery or mastectomy.
* Recommendation for whole breast (groups A and B) or chest wall (Group A only) radiotherapy (with or without tumour bed boost)
* Age ≥18
* Performance status ≤1
* Patients able to tolerate breath-hold

Exclusion Criteria:

* Requirement for nodal irradiation
* Patients with micro- or macro-scopic disease on sentinel node biopsy who have not undergone completion axillary node clearance
* Previous radiotherapy to any region above the diaphragm
Clinical Decision Support for PrEP

Scale-up of HIV preexposure prophylaxis (PrEP) is a key strategy of the federal initiative to end the HIV epidemic. However, healthcare providers lack tools to identify patients who are at increased risk for HIV infection and thus likely to benefit from PrEP. This pilot study will test the hypothesis that an electronic health record (EHR)-based clinical decision support system that incorporates an HIV risk prediction model can help providers identify patients at increased risk for HIV infection and improve PrEP prescribing in safety-net community health centers. The clinical decision support system will be implemented in the EHR at 2-3intervention clinics, while 2 control clinics will receive standard of care. The primary outcome is PrEP prescriptions. Other key metrics of PrEP-related care to be assessed include medication persistence, adherence to monitoring guidelines for PrEP, and rates of HIV/STI testing and diagnoses. The expected outcome is the foundation for a large-scale cluster randomized trial to test whether EHR-based clinical decision support tools for PrEP can improve PrEP prescribing and prevent new HIV infections in a national network of community health centers.


Eligibility Criteria:
Inclusion Criteria:

* Primary care providers at participating clinics who are licensed to prescribe PrEP

Exclusion Criteria:

* N/A
Use of Indocyanine Green in Robotic Prostate Surgeries

Imaging of the vascular nerve bundle using Indocyanine Green

Comparison of erectile function and surgical margin positivity after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery performed by imaging the vascular nerve bundle using Indocyanine Green with the results after nerve-sparing robot-assisted laparoscopic radical prostatectomy surgery without Indocyanine Green

Eligibility Criteria:
Inclusion Criteria:

* Patients with low-intermediate risk prostate cancer

Exclusion Criteria:

* Patients high risk prostate cancer
A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring

This study includes a behavioral educational intervention that focuses on healthy eating, physical activity and glucose management during pregnancy and post partum among women newly diagnosed with gestational diabetes mellitus (GDM).

This is a pilot trial in which 50 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2)Usual Care (Self-directed) educational intervention. The primary pregnancy outcome is change in A1C. The primary postpartum outcome is weight.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gestational diabetes Confirmed singleton pregnancy 24-32 weeks gestation age Planning to deliver within the study area

Exclusion Criteria:

* Pre-existing diabetes (type 1 or 2) Non-english speaking Not planning to deliver in the study area
The Effect of Case-based Teaching on Midwifery Undergraduate Students

Case-based teaching will be applied to second year midwifery undergraduate students. The intervention group (case-based teaching implementation group) and the control group each consist of 35 students.

Materials and Methods: The randomized controlled study will be conducted between March-April 2024 with 70 students (35 intervention group and 35 control group) who are studying in the second year of Kahramanmaraş Sütçü İmam University, Faculty of Health Sciences, Department of Midwifery and taking the risky pregnancy and care course for the first time. Case-based teaching will be applied to the students in the intervention group. The students will be informed about the method to be followed in the study, the voluntary information form will be read to those who want to participate in the study, and their verbal and written permissions will be obtained. "Student Information Form", "Critical Thinking Motivation Scale", "Academic Motivation Scale" and "Knowledge Assessment Form" will be applied to the students as pre-test data with face-to-face method before the classical theoretical education in the classroom. Classical in-class theoretical education will be given to all students on the most frequently encountered risky pregnancy diagnoses such as hemorrhages, hyperemesis gravidarum, oligohydramnios and urinary system diseases. In the intervention group, the cases prepared on the basis of the subject taught to the students after each subject will be applied after the theoretical teaching of each subject within the scope of the Risky Pregnancy and Care course. The application will take place on different days, in 4 sessions and in each session, case-based teaching will be done for different topics. Each application is expected to last approximately 60-100 minutes. The cases in question were created by the researchers by reviewing the literature. The students in the control group will not be given any application after the classical theoretical education in the classroom. "Student Information Form (13th and 14th questions)", "Critical Thinking Motivation Scale", "Academic Motivation Scale", "Knowledge Assessment Form" and "Visual Comparison Scale" will be applied to all students as post-test data after the case-based instruction of four subjects.

Eligibility Criteria:
Inclusion Criteria:

* Who agreed to participate in the research,
* 2nd year midwifery student taking the "Risky Pregnancy and Care" course,
* No clinical experience in hemorrhages, hyperemesis gravidarum, oligohydramnios and urinary system diseases (Health Vocational High School Graduate etc.).

Exclusion Criteria:

* Incomplete completion of data collection forms,
* Not participating in all case-based teaching phases,
* Who want to leave the study,
* Working as a midwife in any health institution,
* Who have taken this course before.
Pelvic Floor Repair Systems for Prolapse Repair

1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol.
2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
3. The study population is female subjects \> 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
4. The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure.
5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.


Eligibility Criteria:
Inclusion Criteria:

-Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair

Exclusion Criteria:

* The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse.
* Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.
* Subject has active or latent systemic infection or signs of tissue necrosis.
* Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis.
* Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered.
* Subject has had radiation therapy to the pelvic area.
* Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
* Subject has a known hypersensitivity to the graft material(s).
* Subject has uncontrolled diabetes.
* Subject is on any medication which could result in compromised immune response, such as immune modulators.
* Subject was involved in any other research trial \< 30 days of enrollment into this study.
* Subject has undergone previous pelvic surgery \< 6 months prior to enrollment in this study.
* Subject is unwilling or unable to give valid informed consent.
* Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits.
* Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).
Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit

The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress in the prevention of pressure injury (PI) in patients at medium to high risk.

This study is noncomparative, observational study.

Patients older than 18 years of age, with a high risk of PI, without PI, lying more than 20 hours a day on a XTECH®25 mattress will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department.

Patients are followed up for 35 days. The use of the XTECH®25 mattress is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with high risk of developing pressure ulcers (clinical judgment and a score \<= 12 on the Braden scale (6 (maximum risk) to 23 (no risk))
* Patient without pressure injury on the day of inclusion
* Patient up lying more than 20 hours a day on XTECH®25 mattress
* Patient with a weight \< 200 kg
* Patient (or a trusted third party) having been informed of the study and agreeing to participate

Exclusion Criteria:

* Patient at end of life (estimated life expectancy less than 6 months)
* Patient discharge from the establishment expected within two months
* Participants will be excluded from the study if they meet the following combination of criteria indicative of malnutrition according to the 2021 Haute Autorité de la Santé guidelines (Participants must meet at least one phenotypic criterion and one etiological criterion to be considered malnourished and therefore ineligible for inclusion in the study) :

A) One or more of the following phenotypic criteria:

1. Significant unintentional weight loss: A weight loss of ≥ 5% within 1 month or ≥ 10% within 6 months
2. Low Body Mass Index (BMI): BMI \< 18.5 kg/m² for individuals under 70 years old, BMI \< 21 kg/m² for individuals aged 70 years and older
3. Reduced Muscle Mass
4. Evident reduction in muscle mass AND

B) One of the following etiological criteria:

1. Inadequate nutritional intake:
2. Nutritional intake less than 50% of the energy requirements for more than one week
3. Reduced food intake for more than two weeks
4. Presence of Disease or Stress Metabolism
5. Acute or chronic illness, or any condition causing metabolic stress that increases energy requirements .
Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy

This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.

Chemotherapy Induced Peripheral Neuropathy (CIPN) is a neurological complication of chemotherapy, affecting between 50%-90% of the patients: up to 68% within the first month after chemotherapy, 60% after 3 months, and 30% after 6 months.

Neuropathic symptoms can persist in 11% to more than 80% of individuals post chemotherapy at one to three years following treatment and around 50% even after 5 years and more.

CIPN is associated with lower self-reported physical function and Quality of Life (QoL).

The clinical picture is typically sensory, with involvement of large and small sensory fibers. Motor and autonomic involvement is less frequent.

Damage to sensory nerve fibers is typically symmetrical. Sensory loss in a 'glove and stocking type' distribution leads to 'minus' symptoms (loss of function) including numbness in hands and feet, impaired perception of light touch, hypoalgesia and impaired proprioception, temperature and vibration sensation. Paradoxically, 'plus' features (gain of function) such as paresthesia (tingling like pins and needles), dysesthesia, allodynia and hyperalgesia appear simultaneously. CIPN can be functionally debilitating including impaired balance, walking slower and shorter steps and increased falls.

Active, explicit sensory rehabilitation is efficient in promoting sensation and function in individuals with neurological conditions, such as stroke and multiple sclerosis. To the best of our knowledge although CIPN is primarily a sensory deficit there is no treatment aimed at this aspect. We aim to conduct a pilot study to explore the feasibility and clinical benefit of an active, explicit sensory rehabilitation protocol for the lower limb in individuals with chronic CIPN.

This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* CIPN by self-report (present or absent) \> 3 months after last chemotherapy treatment
* age \> 18.

Exclusion Criteria:

* Pre-chemotherapy neuropathy/ sensory impairment
* recurrent falls prior to chemotherapy (more than 2 per year)
* CNS involvement
* not ambulatory before chemotherapy
* Hebrew proficiency not meeting questionnaires' needs.
Reducing Depression in Dementia Caregivers

The purpose of this study was to develop and examine the initial impact of a distance-based intervention for female family dementia caregivers. As stated in the original proposal, the primary hypothesis of the study was that family caregivers who participated in the Video Intervention would show greater reduction in psychological distress (i.e., on measures of depression and emotional distress following problematic patient behaviors) compared to those in the Basic Education condition, and that this effect would be maintained over time (3 and 6 months post-tx).

Family caregivers of individuals with dementia commonly report depressive symptoms, along with other forms of emotional distress. This study compared the effectiveness of two home-based interventions to reduce levels of depressed, anxious, and other negative moods in women living with a family member with dementia. Eligible caregivers were randomly assigned to participate in either a video/workbook/telephone coaching intervention, or to a basic education condition consisting of a workbook and supportive telephone calls. Participants were evaluated for psychosocial distress after treatment, and at 3- and 6-months following the end of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver and dementia pt live in the same home
* Resident of following states: Il,IN, IO, KS, MI, MN, MO, NB,WI

Exclusion Criteria:

* Insulin dependent diabetes
* Thyroid disease