cyrilzakka/clinical-trials huggingface dataset:
Uterine Microbiome in Recurrent Pregnancy Loss

The female genital tract microbiome may reflect female reproductive health and may be related to pregnancy outcomes. Disturbances in this microbiome may be associated with adverse reproductive outcomes. The investigators hypothesize that the endometrial and vaginal microbiome composition in women with a history of recurrent pregnancy loss are different, compared with those in normal fertile women.

The investigators want to describe the endometrial microbiome composition in normal fertile women and women with a history of recurrent pregnancy loss by analyzing mid-luteal phase vaginal swab and endometrial biopsy samples using 16S rRNA sequencing.

Eligibility Criteria:
1. Recurrent pregnancy loss patients

   Inclusion Criteria:
   * 18-38 years old
   * Having a regular menstrual cycle, from 25 to 35 days
   * Having ≥ 2 recurrent pregnancy loss and
   * Couples with normal karyotype results
   * Having no condition causing pregnancy loss such as antiphospholipid syndrome, abnormal thyroid function.
   * Agree to participate in the study

   Exclusion Criteria:
   * Irregular menstrual cycle
   * Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid)
   * Using intrauterine device within the last 3 months
   * Using antibiotic/vaginal pessary/contraceptive pills within 2 weeks
   * Having sexual intercourse within 48 hours
2. Healthy control patients

Inclusion Criteria:

* 18-38 years old
* Having a regular menstrual cycle, from 25 to 35 days
* No history of pregnancy loss
* Having 1 or more live birth, with the youngest child ≥ 6 months old
* Agree to participate in the study

Exclusion Criteria:

* Irregular menstrual cycle
* Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid)
* Using intrauterine device within the last 3 months
* Using antibiotic/vaginal pessary/contraceptive pills within 2 weeks
* Having sexual intercourse within 48 hours
Development of the MDASI-Spine Tumor Module

The goal of this research study is to learn the severity of certain symptoms in patients with tumors of the spine or spinal cord. Researchers also want to learn if the M. D. Anderson Symptom Inventory-Spine is a good way to rate these symptoms.

Primary Objective:

1. To evaluate the psychometric properties of the MDASI-Spine in patients with tumors involving the spine or spinal cord.

Secondary Objective:

1. To describe the severity of commonly occurring symptoms experienced by persons with spine tumors.

If you agree to take part in this study, you will complete the M. D. Anderson Symptom Inventory-Spine Tumor Module survey. This survey will ask you to rate the severity of certain symptoms you may have had in the last 24 hours on a scale of 0 (not present) to 10 (the most severe you can imagine). You will also be asked to rate how your symptoms get in the way of your daily activities using the same 0 to 10 scale. This survey should take about 10-15 minutes to complete.

Information regarding your clinical history (tumor type, location, treatment, and other medications) and demographic information (age, gender, ethnicity, religion, educational level, and marital status) will also be collected. This information will be used to evaluation whether there is an association between symptom severity and these factors.

Once you have completed the survey, your participation on this study will be over.

This is an investigational study. Up to 128 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of a tumor involving the spinal cord (intramedullary or extramedullary)
2. Age \> or = to 18 years of age
3. Ability to speak and read English. Non-English speaking subjects will be included in future studies, once the final instrument has been developed.

Exclusion Criteria:

1. Patients \< 18 years of age
2. Evidence of gross cognitive dysfunction limiting memory or ability to complete a self-report questionnaire as determined by evaluation of physician or mid-level provider.
Measuring Cholesterol in the Fasting and Postmeal State in Patients With Type 2 Diabetes

Many patients with type 2 diabetes have difficulty attaining cholesterol goals, partly due to the recommendations for fasting measurements that may not be practical in the typical clinical setting. Focus toward therapy is shifting toward non-fasting assessments but little is known about the usefulness of this approach in diabetes, where postmeal cholesterol levels are more abnormal. This is an observational study examining fasting and postmeal lipids (cholesterol) in patients with type 2 diabetes using standard means and NMR.

Current treatment guidelines for dyslipidemia focus on fasting lipid panels, specifically LDL cholesterol (LDL) but compliance has been shown to be poor. Therefore, focus has shifted to non-fasting measurements. However, there has been limited data in patients with type 2 diabetes and further study is needed to illuminate the lipid changes that occur in the non-fasting state. This observational study examines fasting and postprandial lipids in patients with type 2 diabetes using standard chemical analysis and NMR. For comparison, lipid panels will be obtained at baseline and 3 hours following a standard meal in 30 patients with type 2 diabetes. These measurements will then be analyzed based on current ATP III guidelines. We will investigate the degree to which the postprandial assessments agree with the fasting assessments and the agreement between LDL and the two alternative measures --- non-HDL and NMR-LDL.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-75
* male or female
* Type 2 diabetes
* Hemoglobin A1C less than 9 at last measurement (within 3 months)

Exclusion Criteria:

* Pregnancy
* Non-English speaking.
* Inability to fast for 12 hours
* Hypoglycemia requiring assistance in the previous 6 months
* Unwilling to consume the standardized meal
The Effects of Aging and Estrogen on the Pituitary

The purpose of this study is to study the effects of aging and estrogen on the brain. Specifically, this study will examine how the hypothalamus signals the pituitary gland to secrete reproductive hormones and how that changes with aging.

Although it is clear that loss of ovarian function plays a major role in the menopause in women, there is evidence from animal studies that primary age-related hypothalamic and pituitary changes may also contribute to reproductive aging. Complete cessation of ovarian function results in the loss of negative feedback of ovarian steroids and inhibin on the hypothalamic and pituitary components of the reproductive axis. An increase in serum levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) occurs in postmenopausal women with removal of negative ovarian feedback. However, levels of LH and FSH after menopause decline steadily as a function of age in most though not all studies.

The current study is designed to determine: 1) whether negative feedback on LH and FSH occurs at the pituitary; and 2) whether there is an effect of aging on estrogen negative feedback at the pituitary. Younger and older postmenopausal women underwent a baseline study and a second identical study after a month of low dose estrogen replacement. The study protocol consisted of the following: 1) administration of a GnRH antagonist (Nal-Glu at 150 mg/kg that blocks endogenous GnRH so that the dose and interval of pituitary exposure to GnRH are precisely controlled; 2) beginning 8 hours following GnRH antagonist administration (at a time when LH had reached its nadir following GnRH receptor blockade), administration of 4 graded doses of GnRH (25, 75, 250 and 750 ng/kg every 2 hours with 2 hours of blood draws following each dose). Blood was sampled every 30 min for 4 hours before antagonist administration, every 30 min for the following 7 hours and then every 10 min until the completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* 45-55 or 70-80 years old
* History of natural menopause defined by the absence of menses for at least 12 months (or history of surgical menopause defined as bilateral oophorectomy) and a FSH level \>26 IU/L
* On no hormonal medication or herbal supplements and/or over the counter menopause therapy for a minimum of 2 months prior to study
* Normal thyroid stimulating hormone, prolactin, factor V Leiden, and complete blood count - Normal blood urea nitrogen and creatinine (\< 2 times the upper limit of normal)
* basal metabolic index ≤ 30
* Non-smokers or smoke less than 10 cigarettes/day

Exclusion Criteria:

* Absolute contraindications to the use of physiologic replacement doses of estrogen, including a negative screening mammogram within the past 24 months
* History of coronary artery disease
* On medications thought to act centrally on the GnRH pulse generator
* Past history of hypersensitivity or allergy to narcotics, vancomycin, muscle relaxants, aspirin, and/or anaphylactic reaction(s) to other drugs
* Prior history of breast cancer and/or blood clots
Personalised Risk-based Breast Cancer Prevention and Screening

This is a cohort study, applied research and T3 translational genomics to estimate the impact of genetic risk for breast cancer detection in the screening program. The study group base consists of 28 389 female participants, currently in the age-group 22-79, in the Biobank of Estonian Genome Centre. The study is aimed to demonstrate the usability of personalised approach for adjusting and stratifying screening recommendations, based on predicted genetic risk estimates for breast cancer in the situation, where the genome data could be available from all women who have given informed consent for that. The project includes both the detection of moderate and high hereditary breast cancer risk carriers as well as high risk polygenic risk-score (consisting several single nucleotide polymorphisms) carriers among healthy individuals for application of personalised prevention and screening strategies.


Eligibility Criteria:
Inclusion Criteria:

Cohort 1:

* Available NGS (WGS or WES) data for detection of breast cancer moderate to high genetic risk variants in BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
* Available genetic (WGS, genotyping) data for PRS calculation, participants in age 40-74 will be further selected;

Cohort 2:

* Available genotyping data;
* No available NGS data for BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
* Participants in the age group 40-74 with available genetic data for PRS calculation;

Cohort StMG:

• Female participants in Estonian Biobank in the age group 50-69 participating at least once in the current Estonian population-based screening program during 2016-2020.

Exclusion Criteria:

Cohort 1: breast cancer in the medical history; Cohort 2: breast cancer in the medical history. Cohort StMG: none.
Dietary and Dialysate Sodium Reduction on Body Fluid Volume and Inflammatory State in Hemodialysis Patients

Objective: To evaluate the influence of dietary sodium reduction on body fluid volume and inflammatory state in hemodialysis (HD) patients.

Design: Prospective controlled randomized study. Setting: Dialysis Unit of Botucatu Medical School Hospital, Sao Paulo State University, Brazil.

Patients: Adult patients on HD for at least 30 days and C-reactive protein (CRP) ≥ 0.7 mg/dl were randomly allocated into two groups: Group A: 21 patients treated with a 2g sodium restriction in their habitual diet, and Group B: 18 controls. Inflammatory, biochemical, hematological and nutritional markers, as well as dialysis dosage were assessed at baseline and after 8 and 16 weeks.

The prognosis of chronic kidney diseases (CKD) patients is strongly compromised by cardiovascular (CV) complications. Inflammation is established as a major risk factor for CV complications in these patients, occurring in approximately one third of them. Recently, growing evidences have suggested the body water volume expansion is a cause of inflammation in CKD. In a previous study Rodrigues Telini showed that dietary sodium restriction reduced the inflammatory markers levels in hemodialysis (HD) patients. Similar results were observed in patients treated by reduction of HD dialysate sodium concentration. However in both studies no significant reduction in body volume markers was observed. These results could be due to small number of patients or low sensibility of volume markers; on the other hand they could suggest a direct role of sodium as an inflammatory inducer independently of volume. With a larger number of patients and using a more sensitive volume marker as the B-type natriuretic peptide (BNP), this study intends to confirm the hypothesis that sodium mobilization can reduce the body water volume and attenuate the inflammatory in HD patients. A hundred thirty-five patients will be enrolled and divided in three groups with 35 patients: A, treated by reduction of 2 grams in daily sodium intake; B, exposed to reduction of sodium dialysate from 138 to 135 mEq/L and C, control group. The patients will be followed up by 16 weeks and inflammatory markers (CRP, interleukin-6, and tumor necrosis factor) as well as volume markers (Watson formula, electrical bioimpedance measurements and BNP concentration) will be determine each 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* included patients aged ≥ 18 years who had been on hemodialysis for at least 90 days, and were diagnosed with inflammation. Inflammation was defined as C Reactive Protein ≥ 0.7 mg/dL

Exclusion Criteria:

* acute inflammatory processes confirmed by clinical criteria and/or complementary tests
* acute inflammatory diseases
* tuberculosis
* use of antibiotics within the past two months
* chronic inflammatory diseases
* neoplasias
* chronic obstructive pulmonary disease
* use of central venous catheter and positive HIV serology
"Re-instrumentation vs Flap Surgery"

There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.

The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18aa
* Patients with periodontal disease
* Less than 20 cigarettes/day
* No systemic antibiotic therapy in the last 3 months
* At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
* Full-mouth plaque score and full-mouth bleeding score \<15% at baseline (re-evaluation) measured at six sites per tooth
* No previous periodontal surgery at the experimental tooth

Exclusion Criteria:

* Connective tissue diseases
* Diabetes
* Pregnancy or lactating
* Furcation involvement
* Crowned tooth
* Severe tooth mobility (class III)
* Radiographical horizontal bone resorption exceeding the 50% of the root
Evaluate Educational Interventions for Increasing Fertility Knowledge and Awareness

Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness.

Fertility knowledge and awareness is considered insufficient in women of reproductive age from developed countries. The objective of this study is to evaluate if educational interventions in oocyte donors increase on their level of fertility knowledge and awareness through a RCT. The investigators will evaluate the effect of the interventions through a questionnaire filled in at first visit (pre-test) and at the end of the treatment (post-test); the investigators will compare the increase in the total score between groups.

Eligibility Criteria:
Inclusion Criteria:

* Women candidate to oocyte donation

Exclusion Criteria:

* Previous donations cycles at the center
Actigraphic Analysis of Treatment Response

The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

Actigraphic measurements will be recorded every 30 seconds and will be recorded for an 11 day baseline period, followed by a 10 day period of the initial pharmacological interventions. The non-invasive nature of watch-like actigraphy devices is particularly attractive for use in pediatric populations. Meaningful treatment response measurements are obtained when actigraphic data is combined with psychometric and observational repeated measurements. Subsequent to the initial data collection the parent consented and the child assented to extend the study and continue measurements.

The case study included baseline and repeated psychological, observational and actigraphic measurements that were initiated prior to treatment with risperidone and repeated throughout the treatment process with the final data collected in July 2010.

The Personality Inventory for Children (PIC) is an objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment associated change.

A primary observer (mother) was trained to report symptom percentages present since previous observations utilizing the operationally defined and observer defined items of the systematic observation scale throughout the treatment process.

Actigraphic measurements provide a basis by which to measure sleep and sleep onset latency as well as periods of mobility and immobility. When programmed to record activity every thirty seconds, thousands of measurements are quickly captured.

Actigraphic measurements were made utilizing a watch-like actigraphic device with an 11 day baseline actigraphic measurement period and continued measurements that included the initiation of a Once-Daily, Bedtime (q.h.s.) pharmacological intervention for 6 days, followed by a planned adjustment to Twice a Day (b.i.d.) dosing that was measured for an additional 4 days. Repeated actigraphic studies were subsequently conducted after 22 months of risperidone treatment and were collected along with the repeated observational and psychometric data.

This case study explores activity and sleep characteristics related to behavioral characteristics and treatment response and the utility of single subject repeated actigraphic, psychometric and observational measurements and monitoring of treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Kabuki Syndrome
* Medication Naive
* Single subject preparing to receive pharmacological intervention

Exclusion Criteria:

* Inability to wear actigraphy device
Peri-operative Hypothermia in Children

This study aims to determine the incidence of hypothermia in the local paediatric population in the peri-operative period, identify the risk factors involved, and thereafter develop and implement clinical practice guidelines to reduce IPH such that temperature monitoring and heat conservation measures can be implemented in a cost-effective way. The secondary objectives are to determine the adverse outcomes of hypothermia and warming measures

Background Hypothermia, defined as core body temperature less than 36 degrees Celsius, occurs frequently during the course of surgery in patients across all ages, especially in the young. It causes significant medical consequences including cardiac events, bleeding, surgical site infection, increased shivering and patient discomfort, as well as longer hospital stays. Although guidelines exist for health care providers in terms of temperature management during surgery, these guidelines are not always followed as the warming measures can be costly, for example, single-use temperature probes and disposable blankets, with potential risks of the equipment overheating causing burns and contamination during surgery

Methodology The investigators aim to include up to 6,000 children presenting for either scheduled or emergency surgeries. Core temperature before, during and after surgery using routine temperature monitoring devices such as tympanic, axillary, oral, rectal and SPOTON (a non-invasive method using a sticker placed on the forehead) will be measured. Other outcomes collected will include cardiac arrhythmias, blood loss, hyperthermia, burn injuries, shivering, discomfort, length of PACU and length of hospitalization, wound infection rates, . Patients will receive the usual heat-loss prevention and warming measures.

Interim analysis of the first 2000 patients using the SPOTON method of continuous core temperature monitoring will be done to determine incidence and duration of peri-operative hypothermia. This monitoring modality will be compared for agreement with the conventional tympanic and forehead infra-red thermoscan methods. Patient and perioperative risk factors predisposing to hypothermia will be identified to guide in the formulation of clinical practice guidelines tailored to the local population. Guidelines will be implemented, and post-implementation incidence of IPH will be determined A pre- versus post-implementation cost analysis will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* All paediatric patients ages 16 and younger undergoing elective or emergency surgeries in paediatric major and day surgical operating theaters in KK women's and Children's Hospital.

Exclusion Criteria:

* Patients undergoing operative procedures under local anaesthesia
* Patients with impaired temperature control e.g., severe head injury, febrile illness
* Patients who are admitted to intensive care unit (ICU) post-operatively.