cyrilzakka/clinical-trials huggingface dataset:
Molecular & Clinical Evaluation of Low HDL Syndromes

To study the genetic cause of low HDL-C, a risk factor for premature atherosclerotic vascular disease in patients with normal total cholesterol. The focus is primarily on the identification of a single mutation, as has been demonstrated in one family.

BACKGROUND:

Low levels of high density lipoprotein cholesterol (HDL-C) have been found to be associated with an increased risk for coronary artery disease (CAD). However, the genetic basis for this association is not well understood and the clinical implications of this association have not been extensively addressed. The study, in seeking to elucidate the genetic basis for low HDL-C and examine the clinical implications of low HDL-C, focuses upon an important research topic.

DESIGN NARRATIVE:

Specific aims of the study include: 1) Collection and characterization of plasma and DNA from probands with very low HDL-C. Linkage analysis will be performed using highly polymorphic markers within or near HDL-C candidate genes. The hypothesis to be tested is that polymorphic microsatellites segregate with the low HDL-C phenotype.

2) Further genetic characterization of families evidence of linkage to specific HDL-C candidate genes identified in Specific Aim 1. The hypothesis to be tested is that structural variants in HDL-C candidates are responsible for low HDL-C.

3) Evaluate the physiologic significance of novel genomic variants identified in Specific Aim 2. The hypothesis to be tested is that structural variants will affect expression of the gene product.

4) Examine early atherosclerosis in low HDL-C syndromes. The hypothesis to be tested is that increased carotid intima-medial thickness is prevalent with isolated low HDL-C.

Eligibility Criteria:
No eligibility criteria
Follow-up Using Patient-Reported Outcome (PRO) Measures in Patients With Chronic Kidney Disease

This randomized controlled trial (RCT) will evaluate if PRO-based follow-up is at least as effective as usual outpatient follow-up in managing decline in renal function and maintaining patients' quality of life. Furthermore, we intend to characterize the target patient group that is suitable for PRO-based follow up in a group of patients suffering from renal insufficiency.

This randomized controlled trial investigates the use of Patient-reported Outcome (PRO) follow-up among patients with chronic kidney disease. Usual outpatient follow-up visits will be replaced with diagnosis-specific electronic questionnaires filled in by the patient at home. Participants in the PRO-based follow up will complete a disease specific questionnaire every 3 months. Patients with an estimated Glomerular Filtration Rate (eGFR) \< 40mL/min are randomized into three groups of follow-up

1. PRO-based follow-up (The clinicians use the PRO data to decide whether a patient needs a visit or not)
2. PRO-based telephone consultations (The clinician use the PRO-data to support the communication with the patient)
3. Usual outpatient follow-up visits (Patients are seen in the outpatient clinic)

The aim of this study is to compare the effect on the clinical outcomes, the utilisation of resources, and patient-reported outcome in three types of follow-up in a non-inferiority randomised controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Referred to the renal care services at Aarhus University Hospital or Regional Hospital Central Jutland, Viborg
* Estimated Glomerular Filtration Rate (eGFR) between 10-39 mL/min 1.73m2.
* Aged ≥18 years old
* Ability to provide fully informed written consent for participation in the study

Exclusion Criteria:

* Patients unwilling to participate in PRO-based follow-up
* Patients who, in the opinion of the consenting professional, cannot speak, read or write Danish sufficiently well to complete the PRO questionnaire unaided
* Patients with hearing disabilities
* Patients with an eGFR \> 39mL/min 1.73m2 at their first visit at the hospital
* Patients who have received (or have a scheduled date to receive) a kidney transplant
* A terminal illness that, in the opinion of the consultant assessing eligibility, is likely to lead to the death of the patient within 6 months of starting participation in the study
* Patients receiving chemotherapy, with end stage Chronic Obstructive Lung disease, or with heart failure with Ejection Fraction (EF)\< 15 %.
* A projected risk of progression to end-stage renal failure within 6 months, determined from albumin/creatinine ratio
Feasibility of Saliva and Remote Monitoring of Active Cytomegalovirus (CMV) Infection and Symptoms During Ovarian Cancer Treatment

This study evaluates the feasibility and accuracy of using saliva to remotely monitor cytomegalovirus (CMV) infection in individuals receiving treatment for ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Ability to read and write in English
* Diagnosed with ovarian cancer (ovarian, primary peritoneal, fallopian tube)
* Receiving care from providers at Mayo Clinic
* Regardless of diseases status, actively receiving treatment for ovarian cancer (frontline, maintenance, progression, recurrence)

Exclusion Criteria:

* Pregnant at the time of study participation
* Inability to provide informed written consent
* History of dementia, stroke, brain tumors or other condition which may impair cognitive functioning
Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation

In this double-blinded randomized clinical trial study, investigators assessed probiotic used to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated for pelvic cancer.

This study was prospective, unicentric, controlled with comparison to a placebo, randomised and double-blinded. Patients were stratified into three groups: prostatic cancers, gynecologic cancers without chemotherapy and gynecologic or rectal cancers with chemotherapy.

Patients were block-randomized by the research nurse and received a standard dose of Bifilact® probiotics or placebo according to the random list generated by blocks of 2, 4, or 6 patients according to random permutations. A preliminary internal pilot study was performed when the half of the expected sample size were recruited. The goal of this analysis was to test assumptions that lead to chosen sample sizes (N0) and thus, validate the feasibility of the study. Following preliminary results, the sample size re-calculated at the interim analysis is similar to that originally intended. It would be advisable to continue the recruitment as planned. No adjustment to the critical level of the test would be required in analyzes carried out at the end of study. However, another random block using higher probiotics dosage to the randomization was added with preservation of double bind. New random list were generated for each strata with a 3:1:1 ratio (higher dose, standard dose, placebo) to compensate for the starting of the latest higher dose group. All the bottles had a similar aspect, they were all identified by the commercial brand Bifilact. Also the group, either A, B or C, was circled on that bottle, depending on if that bottle belong to the placebo group, standard dose group, or high dose group. Only the nurse knew the coding system, it was also her who would assign the patient to a group, according to the randomization list. She would also hand out the bottle to the patient every week. The two registered dietician, caregivers, were totally excluded of this processes (preliminary study and randomisation) to preserve the double blind.

Eligibility Criteria:
Inclusion Criteria:

* They had a pelvic cancer: gynecologic, rectal, or prostatic,they were to receive radiotherapy treatments for a minimum of 40 Gy at the pelvic level , with or without chemotherapy and they had Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1

Exclusion Criteria:

* they had previous radiotherapy treatments in the pelvic or abdominal region, medical history of gastro-intestinal inflammation, malabsorption syndrome or inflammatory bowel disease or coeliac disease, ileostomy, daily use of anti-diarrheal medication before radiotherapy, pregnancy or breastfeeding, neutropenia or probiotics intolerance
The Effect of Fluids Consumption on Balance and Gait Function in Old Adults

Experimental design overview The proposed project is a prospective experimental RCT study design. Independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested before and after water consumption to explore whether there are differences in balance control as a result of dehydration.

Experimental design overview The proposed project is a prospective experimental study design. independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 2 hours after mineral water consumption (1 liter) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. Participants will be required to stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as little as possible.

Eligibility Criteria:
Inclusion Criteria:

* age 65 years old and older
* independent elderly adults
* do not suffer from balance problems
* mini-mental score 24 and above

Exclusion Criteria:

* old adults who suffer from neurological disease or stroke
* old adults who suffer from psychiatric state
* old adults who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)
* old adults who suffer from heart conditions
* old adults who suffer from blindness
Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients

Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin resistance with resulting hyperinsulinemia is also common among women with PCOS, along with increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative and pro-apoptotic properties, that has been shown to decrease proliferation and steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients. However, little is known about its potential beneficial effect on oocyte quality as well as other reproductive outcomes, such as implantation an pregnancy rates. The present study evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome among patients with PCOS who undergo in vitro fertilization (IVF).


Eligibility Criteria:
Inclusion Criteria:

* Women aged from 18 to 40 years old.
* PCOS diagnosis (according to Rotterdam criteria).
* Mild or moderate male factor, tubal factor or unknown infertility.

Exclusion Criteria:

* Follicle stimulation hormone (third of day of menstruation) \> 10 milli international units/L.
* Endometriosis (III o IV).
* Congenital adrenal hyperplasia.
* Cushing syndrome.
* Hyperprolactinemia.
* Thyroid disease.
* Androgenic hormone secretor tumors.
* Patients included in this trial did not take either oral contraceptives, steroids or other medications that could modify the ovarian function, insulin sensitivity or lipid metabolism 3 months before the onset of the trial.
* Severe male factor (sperm concentration \< 5 mill/ml).
* Patients undergoing oocyte vitrification to avoid hyperstimulation syndrome will be excluded.
Progressive Relaxation Exercises,Breastfeeding

OBJECTIVE: The research was conducted to examine the effects of progressive relaxation exercises on mothers' breastfeeding status, self-efficacy and maternal attachment level.

may 2022 and November 2022. The sample of the study consisted of 114 mothers who were breastfeeding in the postpartum period. In the study, 38 breastfeeding mothers were included in the PGE, GFM and control groups. Breastfeeding mothers in the PGE group were given a PGE application 3 days a week before going to bed and for 4 weeks, accompanied by a training CD prepared by the Turkish Psychological Association, under the supervision of the researcher. On the other hand, the breastfeeding mothers in the GFM group were listened to the relaxation background music included in the Progressive Relaxation Exercise CD 3 days a week before going to bed and for 4 weeks. Mothers in the control group received routine care practices applied in the clinic. The mothers in the control group did not receive any intervention and only measurement tools were applied. 'Personal Information Form', 'Breastfeeding Self-Efficacy Scale' and 'Maternal Attachment Scale', 'Visual Analog Scale', 'Breastfeeding Classification' were used to collect data. Standard Deviation, Mean, Frequency and Chi-square tests were used to evaluate the data. Analysis of variance was used for repetitive measurements for the evaluation of breastfeeding self-efficacy and maternal attachment level within the group, and one-way analysis of variance was used for the evaluation between groups.

Eligibility Criteria:
Inclusion Criteria:Mothers over the age of 18,

* At least primary school graduate, able to read and understand Turkish,
* Has a phone and internet
* Has an only and healthy baby,
* Does not have a condition that prevents him from doing PGE,
* The baby was born between 2500-4000 g,
* Those who live within the provincial borders of Uşak,
* No hearing problem,
* Mothers of babies who do not have sucking problems (cleft palate-lip, frenilium, galactosemia, prematurity),
* Mothers who do not have any health problems affecting breastfeeding (mastitis, breast abscess, nipple crack, candida albicans, flat and sunken nipples, Wilson's disease in the mother, an active disease of the mother that prevents breastfeeding, and drug use),
* Mothers without musculoskeletal disorders, The mothers who volunteered to participate in the study.

Exclusion Criteria:

* Practicing relaxation exercises before
* Mothers using chronic opioids, antidepressants and psychoactive drugs.
Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil

The purpose of this study was to follow a person's response to experimental pain after multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can tolerate the pain more, less, or the same at the end of the study.

This project investigates the phenomenon of opioid-induced hyperalgesia (OIH). Opioid analgesics, in addition to their therapeutic anti-nociceptive effects, under some conditions produce pro-nociceptive effects. This phenomenon of pain or pain sensitivity being increased by prior opioid administration is called opioid-induced hyperalgesia. It is thought to be relevant both to pain management complications and to complications of opioid dependence and its treatment. This study investigated the time-course of opioid-induced hyperalgesia development in healthy normal volunteers (N=12 completers), using a series of acute alfentanil administrations (15 mg/kg mg intramuscular (IM) per day) spaced at 3-4 day intervals, with testing for pain tolerance using the cold pressor test (CPT), and mechanical quantitative sensory testing (MQST) each administered repeatedly over time within each testing day. The goal was to determine the time course of OIH development following acute opioid administration, and to assess whether this changes over repeated acute opioid administrations.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* No active medical conditions
* BMI between 20-30
* Able and willing to perform/tolerate pain procedures
* Able to communicate in English

Exclusion Criteria:

* Lifetime substance use disorder, except for alcohol abuse/dependence in remission
* Use of opiates in last 3 months
* Ongoing marijuana use
* Acute or chronic pain
* Neurologic or psychiatric condition known to influence cold pressor testing (peripheral neuropathy, major depression, or schizophrenia)
* Current use of prescribed or over the counter pain medications
* Previous adverse reaction to opiate medications or diphenhydramine
* Use of tobacco or caffeine on study days
A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in (Day -1).
* Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.

Exclusion Criteria:

* Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator
* Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention

Other protocol-defined inclusion/exclusion criteria apply.
Optimised Fluoride Prevention by Double Rinse With Fluoride and Calcium

Aim: to determine the optimal Ca2+ concentration with 905 ppm F as NaF. Study design: Experimental study in 10 volunteers. Single blind mouth rinse with calcium lactate solution (150; 75; 0 mM Ca-lactate) is immediately followed by a standard fluoride rinse.

Procedure: Rinses are performed in the evening. The rinse combinations are given in a random order, and the subjects are unaware of the sequence. At least 3 days separates the use of each rinse. Dosage: 20 mL and 1 minute rinse with each solution.

Saliva samples: Twelve hours after rinsing, unstimulated saliva samples are collected by expectoration.

Analysis: The fluoride concentration in saliva samples are analysed Statistics and data handling: Fluoride in saliva 12 hours after rinsing are examined by one-way ANOVA, repeated measures design.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* 10 natural teeth or more
* willing to refrain from use of fluoride containing products
* signed informed consent

Exclusion Criteria:

* less than 10 natural teeth
* reduced cognitive skills
* does not speak and/or understand Swedish
* ongoing oral or systemic infections
* pregnancy
* breast feeding
EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

The discovery of cell-free circulating tumor DNA (crDNA) in blood and the maturation of technologies for ctDNA analysis have presented an attractive opportunity for minimally invasive "liquid biopsy" genomic diagnostics. The investigators plan to perform EUS-guided portal vein and hepatic vein aspiration in GI cancers patients. The aim of the current study is thus to examine the concentration of ctDNA in portal vein (EUS-guided PVA), hepatic vein (EUS-guided HVA) and peripheral blood to understand the first pass effect of the liver with gastrointestinal (GI) cancers, and the possibility of using ctDNA as a marker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for recurrence.

The discovery of cell-free circulating tumor DNA (crDNA) in blood and the maturation of technologies for ctDNA analysis have presented an attractive opportunity for minimally invasive "liquid biopsy" genomic diagnostics. The investigators plan to perform EUS-guided portal vein and hepatic vein aspiration in GI cancers patients. The aim of the current study is thus to examine the concentration of ctDNA in portal vein (EUS-guided PVA), hepatic vein (EUS-guided HVA) and peripheral blood to understand the first pass effect of the liver with gastrointestinal (GI) cancers, and the possibility of using ctDNA as a marker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for recurrence.

Eligibility Criteria:
Inclusion criteria:

1. Age \>= 18 years old
2. Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer
3. Undergoing treatment with either:

   1. Surgery
   2. Neoadjuvant chemotherapy
   3. Neoadjuvant chemoirradiation
   4. Palliative chemotherapy/ immunotherapy

      Exclusion criteria:

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   1. Synchronous cancer of other sites
   2. Cardia, high lesser curve tumors, oesophagogastric junction tumors
   3. Presence of bulky lymph nodes at lesser curve/ coeliac region precluding a clear EUS puncture site to portal vein and hepatic vein
   4. Patients with coagulopathy (international normalized ratio \>1.3, partial thromboplastin time greater than twice that of control), platelet count \<50,000x103/uL
   5. Patients unwilling to undergo follow-up assessments
   6. Patients with liver cirrhosis, portal hypertension and/ or gastric varices
   7. Patient refusal to participate

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Udall Project 2 Aim 2A&C

This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC DBS system to study the effects of globus pallidus internus and globus pallidus externus (GPi, GPe) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over 4 weeks). These experiments will elucidate the relationships between GP LFPs oscillations, lower limb function, postural control and gait performance.

This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC DBS system to study the effects of globus pallidus internus and globus pallidus externus (GPi, GPe) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over 4 weeks). These experiments will elucidate the relationships between GP LFPs oscillations, lower limb function, postural control and gait performance.

Eligibility Criteria:
Inclusion Criteria:

* Receiving DBS therapy in GP for treatment of PD
* Implanted with Medtronic Percept DBS system
* At least 3 months since initial activation of the neurostimulator

Exclusion Criteria:

* history of musculoskeletal disorders that significantly affects the ability to perform the motor tasks in the specific experiment in question
* history of dementia or cognitive impairment
* other significant neurological disorder as determined by the PI
* post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment
* lack of capacity to consent (as identified by UBACC)