cyrilzakka/clinical-trials huggingface dataset:
Friends for Life Circles for Option B Plus

The main goal of the study is to support HIV-infected pregnant women initiated on PMTCT Option B+ during antenatal to adhere to lifelong ART and postpartum care visits through an enhanced group peer support intervention called "friends for life circles".

The overall goal of this implementation research is to improve retention in care and adherence to ART to 2 years postpartum among HIV infected women in urban and rural Uganda choosing PMTCT Option B+. Formative research will first be conducted to assess knowledge and attitudes regarding Option B+ and lifelong ART among PMTCT clients, community members and health workers. The formative research will inform the design of the group peer support intervention. Interventional research will then be conducted randomizing 540 women to either enhanced group peer support with income generating activities called the Friends for Life Circle (FLC) or MOH standard of care counselling with follow-up to 2 years postpartum. Primary outcomes will include retention in health care, ARV adherence and viral suppression at 6 weeks and 24 months postpartum. Secondary outcomes will include participants' health and economic outcomes.

Eligibility Criteria:
Inclusion criteria

* Age \>18 years
* Documentation of pregnancy through clinical assessment or pregnancy test
* Documentation of confirmed HIV-positive sero-status at the time of screening
* Accepting to receive option B+ for PMTCT
* Providing written informed consent to participate in the randomized trial.
* Agreeing to come the study clinic for scheduled appointments
* Agreeing to be home visited as needed to ensure follow up
* Residing within a 20 km radius around the study clinic
* Not planning to move out of the catchment area within the next 2 years

Exclusion criteria

- Social and other circumstances that may prevent the mother from coming back for follow up
Perineural Dexamethasone for Continuous Femoral Nerve Block

An alternative to improve the quality of postoperative analgesia is to use various perineural adjuvants applicable to peripheral nerve block along with local anesthetics to increase the analgesic effect. Dexamethasone is a strong and long-acting corticosteroid, which reduces postoperative nausea and vomiting and increases the duration of nerve blockade. Most of the existing clinical studies compared the analgesic effect with the placebo group after adding an adjuvant in a single shot nerve block, and there were very few cases of comparing the analgesic effect with the placebo group after adding the adjuvant in peripheral nerve block through continuous catheter infusion. Therefore, we designed this study to investigate whether the use of dexamethasone as a peripheral adjuvant for continuous femoral nerve block has a better pain and recovery profile.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
2. ASA PS 1-3

Exclusion Criteria:

1. Revision total hip arthroplasty
2. Allergy to drugs used in the study
3. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
4. Estimated glomerular filtration rate \< 30 mL/min/1.73m2
5. Opioid dependence
6. Prolongation of PT and aPTT more than twice the upper limit of normal
7. Pre-existing neurological or anatomical disorders of the lower extremities
8. Serious psychiatric disorders
Washed Microbiota Transplantation in Solid Organ Transplantation

Solid organ transplantation (SOT), an alternative therapy for end-stage diseases, offers increased longevity and better quantity of life. Posttransplant complications such as gastrointestinal symptoms, infection, and graft rejection increase risk with graft failure and death. However, the treatment of abovementioned complications remains unsatisfactory. Gut dysbiosis has been reported in patients with SOT, especially in patients with posttransplant complications. Recipients are more susceptible to gut dysbiosis as long-term use of immunosuppressants, antibiotics and corticosteroids. Restoring gut microbiome may be a promising therapy for posttransplant complications. Washed microbiota transplantation (WMT) is a newly improved methodology of fecal microbiota transplantation based on automatic facilities, washing process and a new delivery routine. In this study, investigators aimed to evaluate the efficacy and safety of WMT for postoperative complications in SOT.


Eligibility Criteria:
Inclusion Criteria:

1. solid organ transplantation recipients;
2. suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile, urinary infection) post-transplantation, graft rejection and so on;
3. is willing to undergo WMT and provide written informed consent;

Exclusion Criteria:

1. patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;
2. pregnant or lactating females;
3. unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;
4. follow up less than 1-month post-WMT;
5. other conditions judged by investigators not suitable for study participation;
Cancer Survivors Acute Exercise Response 1

The aims of this study examine the immune system, muscle metabolism, and autonomic nervous system response to an acute bout of exercise. Cancer survivors will participate in an acute bout of exercise. Blood samples will be collected before the exercise bout and at two time points after the exercise bout to assess the proposed variables.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 40-70 years

  * At least two years past detectible cancer (two years disease-free survival)
  * Have received chemotherapy and/or radiation as part of their cancer treatment
  * All cancers were of the organs/non-blood producing tissues (not blood/hematologic cancers) and while they were an adult (no history of pediatric cancer)
  * Meeting ACSM-AHA guidelines for exercise (150 minutes per week of cardiorespiratory fitness type exercises and \~two days per week of resistance training), as confirmed by a combination of a physical activity questionnaire and a cardiorespiratory fitness classification of "good" or higher (age and sex matched)
  * A BMI between 20-33 kg·m-2
  * Able to speak and read English

Exclusion Criteria:

Participants may not:

* Have any contraindications to moderate to vigorous exercise
* Have any recent illness or have been instructed not to exercise by a healthcare provider
* Participants may not have range of motion restrictions that would prevent them from participating in aerobic or resistance training with proper form (they must be ambulatory)
* Be taking medications (prescription or over the counter) known to influence immune function (including daily NSAID's and beta blockers), cholesterol-lowering medications (statins), drugs that increase bone mass (bisphosphonates), or steroids.
* Have known cardiovascular, respiratory, metabolic, or renal disease, with the exception of controlled hypertension (as defined by resting BP below 140/90) and/or controlled asthma (self-reported).
* Be pregnant
* Be unable to complete all visits (i.e. must not be planning to leave the Houston area long-term before concluding their participation in the study)
* Fall outside of a BMI range of (20 - 33)
* Consume alcohol or recreational drugs for 24h prior to visits
* Participants must not have scheduling conflicts that would prevent them from reporting to the laboratory of integrated physiology 2-3 times over the course of the study
Antibiotic Regimen for Dental Implants Cases

This study aims to:

1. To identify the most common organisms causing dental implant failure.
2. Set an appropriate antibiotic regimen according to the causative organism to limit the antimicrobial resistance by limit the use of antibiotics.

Dental implant surgery is a common treatment for replacing missing teeth and has a high success rate. Implant failure is most likely the result of multiple factors as Age, sex, smoking, maxillary implant site, quantity and quality of bone, implant surface treatments and features are some of the statistically examined parameters linked to implant failure. The most frequent and avoidable cause of dental implant failure is infection. A retrospective analysis demonstrated fewer numbers of early implant failures among those that were placed under antibiotic treatments.

Early implant failure is commonly associated with certain strains of bacteria. The most common bacteria involved are streptococci, anaerobic Gram-positive cocci, and anaerobic Gram-negative rods.Porphyromonas gingivalis and Fusobacterium nucleatum frequently colonize the implant in early and late losses and could therefore be characteristic for implant loss in general.

Thus, the antibiotic to prevent delayed healing of wound should be bactericidal and of low toxicity. Systemic antibiotic prophylaxis has been used to reduce the risk of early implant failure and local infections around dental implants.Antibiotics are one of the most cost-effective, life-saving medicines and contribute to an extended lifespan. Access to antibiotics without a prescription is a driving factor for irrational antibiotic use due to a potential lack of access to proper diagnosis and diagnostic tools. This eventually leads to the development and spread of antibiotic resistance \&it is one of the increasing public health challenges worldwide.

Eligibility Criteria:
Inclusion Criteria: Saliva samples from patients seeking dental implant procedures

-

Exclusion Criteria:

* Immunodeficiency or immunosuppressing treatment
* current antibiotic treatment
* smoking
* acute or chronic oral infection (including ongoing periodontal infection).
A Multiple Myeloma Trial in Patients With Bone Metastases

The purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Confirmed diagnosis of Multiple Myeloma
* Stable renal function defined as two serum creatinine determinations of \< 3 mg/dL
* Calculated creatinine clearance of greater than or equal to 30 mL/min
* ECOG Performance Status of 0 or 1
* Life expectancy of greater than or equal to 9 months
* If the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
* Ability to comply with trial requirements and give informed consent.

Exclusion Criteria:

* IV Bisphosphonate therapy for more than 3 years.
* Patients with a diagnosis of amyloidosis.
* Known hypersensitivity to zoledronic acid or other bisphosphonates
* Pregnant patients or lactating patients.
* Women of childbearing potential not on a medically recognized form of contraception
* Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes mellitus.
Online Cognitive Behavioral Intervention Program for Hong Kong People With Social Anxiety Disorder

This study developed an online counseling program called "EASE Online" for Hong Kong people with social anxiety disorder. The program effectiveness was evaluated by a randomized controlled trial in reducing social anxiety and improving quality of life of the participants. The 3- and 6-month maintenance effects were also tested.

Social anxiety disorder (SAD), also known as social phobia, is one of the most common mental disorders worldwide. In Hong Kong, the 12-month prevalence of SAD is 3.2% (Lee, Lee \& Kwok, 2005) with more than 230,000 sufferers. However, only 8.7% of SAD sufferers have sought medical treatment in Hong Kong (Lee et al., 2005), which means that most of the sufferers are undiagnosed and untreated. One of the most effective treatments for SAD is cognitive behavioral therapy (CBT), and internet-based CBT has shown promise in reducing general and social anxieties, as well as improving the quality of life of those with SAD (e.g. Carlbring et al., 2007; Tillfors et al., 2011). However, few studies have been conducted in this field in Hong Kong. This project aims to develop an online CBT program (including both an online platform and mobile application) for Hong Kong people with SAD, as well as evaluate its effectiveness in reducing anxiety symptoms and psychological distress, and improving quality of life at post-treatment and 3- and 6-month follow-ups. Randomized controlled trial (RCT) design was adopted for program evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents with fluency in Cantonese
* between the ages of 18 and 70
* a score of 25 or more on the Chinese version of the Social Phobia Inventory (C-SPIN) (Tsai et al., 2009)
* have not received any psychological treatment at the time of registration for participation in the project
* have access to a computer or smartphone with internet connection.

Exclusion Criteria:

* being severely depressed, with a score above 30 on the Beck Depression Inventory-II (BDI-II) (Beck, Steer \& Brown, 1996)
* having suicidal ideation in the past three months, with a score of 3 points on Item 9 of the BDI-II.
HIF-1 Alpha, VEGF and MMP-8 Levels in PICF of Smokers Versus Non Smokers

Smoking is a major risk factor for developing peri-implantitis so the current study is comparing inflammatory markers in smokers versus non smokers to know if they have a potential role in pathogenesis of peri-implantitis

Peri -implant crevicular fluid was obtained from seven smoker patients and then compared to peri-implant crevicular fluid from seven non smoker individuals.

The peri-implant crevicular fluid was obtained using periopaper strips then analyzed using ELISA kits of these markers; HIF-1 Alpha, VEGF and MMP-8

Eligibility Criteria:
Inclusion Criteria:

* Medically free patients
* Individuals with restored implants placed one year or more before study enrollment
* Both genders
* Age range 20-50 years old

Exclusion Criteria:

* Pregnant Females
* Lactating females
Randomized Study on Salt Intake and Energy Metabolism

To perform a randomized, double-blind clinical study on the effects of an increased salt intake on metabolic, cardiovascular and immunological parameters and the gut microbiota


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18 - 50 years
* Body mass index 18.5 - 29.9 kg/m2

Exclusion Criteria:

* Clinically relevant heart, lung, liver, and kidney diseases
* Current or chronic infection
* Habitual use of probiotics or dietary supplements
* Pregnancy, lactation
Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired

This clinical study aims to finalize the algorithm and assess the performance of the BOYDSense® breath glucose monitoring system prototype in patients living with type 2 diabetes.

Self-monitoring of blood glucose (SMBG) is prescribed to patients living with diabetes according to their type of diabetes, their clinical profile and their personalized needs such as therapeutic adjustments, detection of an asymptomatic hyperglycaemic drift, prevention of hypoglycaemia, or adaptation of the therapeutic strategy to the evolution of the pathology. Most of the people living with type2 diabetes mellitus (T2DM) use an invasive finger prick SMBG glucometer. A pilot study conducted by the BOYDSense mother company Alpha-MOS showed that the analysis of volatile organic compounds (VOC) in exhaled air could reliably predict blood glucose. The development of a breath glucose-monitoring device, by its non-invasive nature, should be an alternative to existing systems by making it possible to avoid capillary samples. Investigators could expect a better quality of life and a better compliance with SMBG in the majority of patients with T2DM. The objectives of our study are to improve the BOYDSense®glucose algorithm based on the VOC analysis of exhaled air; then to assess the performance of the BOYDSense® prototype with the finalized algorithm.

This study aims to gather, in patients with T2DM, successive blood and capillary reference glucose values during a meal test, and to compare them to glucose levels estimated by the BOYDSense® prototype.

All the enrolled patients will undergo a 3 hours standardized meal test with seven glucose measurement endpoints at T0, 30 min, 1hour 1H30, 2H, 2H30 and 3H post meal. Blood glucose will be measured with three different techniques: venous blood glucose measured with a COBAS 8000 automatic analyzer, SMBG measured with a commercial glucometer and blood glucose value estimated from exhaled air using the BOYDSense® prototype.

The study duration will be 4H for each enrolled patient. After the meal test being completed, the end of study procedure includes a 30 min observational period dedicated to the completion of the patients'questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed for at least 3 months.
* Acceptance of constraints related to participation in the study.
* Acceptance to participate in the constitution of a plasma library.
* Ability to sign informed consent.
* Affiliation to a social security scheme.

Exclusion Criteria:

* Ongoing prandial insulin therapy
* Treated bacterial or viral respiratory infection in the 2 weeks preceding the meal test.
* Surgical intervention under general anesthesia in the last 12 weeks.
* Asthmatic subjects with bronchospasm or under chronic inhaled therapy.
* Ongoing COVID-19 (PCR +) or contact case in the isolation period.
* Pregnancy or breast-feeding.
* Participation in another clinical study or exclusion period from another research protocol.
* Patient under guardianship, curatorship or legal protection.
Association of Ex Vivo Drug Response (EVDR) and Clinical Outcome in Ovarian Cancer

EXCYTE-1 is a multicentre, prospective observational study to investigate the relationship between ex vivo drug response (EVDR), measured in ovarian tumour-derived samples using high content imaging, and actual patient clinical response.

Patients with newly diagnosed or relapsed/refractory epithelial ovarian carcinoma, that present with malignant effusions (ascites or pleural effusions), will be enrolled in the study before starting their initial or next treatment line.

Enrolled patients will be asked to provide ascites, peripheral blood and fresh tumour tissue if available. Samples will be shipped to the sponsor laboratory and their response to standard of care drugs evaluated ex vivo.

Participants will:

* provide samples during routine clinical procedures
* agree that data about their medical history, diagnosis and health status at the following timepoints are collected: at signature of the consent form, at the time samples are provided, at start of the therapy, upon completion of the therapy, regularly after completion of the therapy


Eligibility Criteria:
Inclusion Criteria:

* Minimum age 18 years
* Signed informed consent form
* Confirmed diagnosis of ovarian cancer except low grade serous, clear cell and mucinous histology
* Where patients are treatment naïve, patients need to have disease stage FIGO (International Federation of Gynecology and Obstetrics) III or FIGO IV.
* Patient is expected to receive primary chemotherapy/maintenance after initial surgical debulking or a further line of systemic therapy in the relapsed setting according to treatment guidelines
* Feasibility of collecting malignant ascites and/or pleural effusion during either primary debulking surgery or a routine drainage procedure prior to initiation of the first or next line of systemic therapy
* ECOG (Eastern Cooperative Oncology Group) stage 0-2

Exclusion Criteria:

* Previously study participation
* Known or suspected HIV or active Hepatitis B and/or C infection or active COVID-19 infection
* Anticancer treatment or radiation therapy of the region which is to be drained or biopsied within the last 4 weeks
* Patient unfit or not willing to receive any further systemic treatment
* Patient is treated with therapeutics not tested in the assay - with the exception of anti-VEGF (Vascular endothelial growth factor) therapy
* Known pregnancy
* Sample quality criteria are not met (at least 250ml of ascites available, no signes of bacterial superinfection, no additives, at least 1% EpCAM (Epithelial Cell Adhesion Molecule) positive cells, viability at least 60%)
The MURDOCK Study Registry and Biorepository Horizon 1.5

The MURDOCK Study Community Registry and Biorepository (Horizon 1.5) aims to create a large-scale community registry and biorepository that can be used as a vehicle for future health services, epidemiologic, clinical trials and other omics-related research.

The MURDOCK Study Community Registry and Biorepository's activities include enrolling approximately 50,000 participants who live in Cabarrus County and/or Kannapolis, North Carolina. Participants must consent to (1) use of the data provided by the participant through completion of the Participant Registry Questionnaire for epidemiologic population characterization, (2) annual contact to update their MURDOCK Horizon 1.5 database record, (3) release of their medical information, including but not limited to demographic information, problem lists, medications, social and family history, and results of laboratory and other testing modalities from pre-existing paper or electronic health records or electronic health records that may become available in the future, (4) provision of a blood and urine sample, and (5) contact up to four times/year to request participation in additional research studies.

Eligibility Criteria:
Inclusion Criteria:

1. A resident of Cabarrus County and/or the city of Kannapolis (and surrounding regions) for 6 or more months of the year
2. At least 18 years of age
3. Able to understand and give written informed consent, or have a legal guardian or caregiver present to give informed consent by proxy (assent from a participant between ages 12-18 will be obtained when their parent or legal guardian consents on their behalf).
4. Willing and able to participate in all 5 components of the registry and biorepository as described above in Section III

Exclusion Criteria:

1. There are no exclusions to participation if all inclusion criteria have been met.