cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Twin Study - Cohort Study of Blood Pressure

To analyze the genetic and environmental contributions of juvenile hemodynamic determinants of blood pressure, including cardiac output and systemic vascular pressure, to adult cardiovascular risk.

BACKGROUND:

Identifying individuals at a young age who are at risk for future development of hypertension in adult life is a public health issue of great importance. The imperfect nature of blood pressure tracking throughout childhood and adolescence, and the fact that the genes which determine blood pressure in childhood may not be the same ones which operate in adulthood make it clear that improved predicting models are needed. The twin-parent study design allowed testing more subtle genetic and environmental hypotheses than was possible with nuclear families or twins alone. The longitudinal component permitted an analysis of developmental changes in the genetic expression of the hemodynamic determinants of blood pressure. The inclusion of unlike sex twins permitted an analysis of the consistency of genetic and environmental effects across the sexes.

DESIGN NARRATIVE:

The longitudinal comparison of the cardiovascular responses of adolescent twins and their parents was initialed in 1983. Three cohorts of twin families were enrolled, each cohort beginning 18 months apart. Both monozygotic and dizygotic twins were included. Variables measured included demographics, family history, personality, blood pressure, anthropometry, stage of puberty, dynamic exercise, isometric exercise, psychological stress, echocardiography, genotyping, and lipid profiles. Each cohort revisited every 18 months.

A fourth cohort of 330 preadolescent twin pairs stratified by sex and zygosity was recruited from an established population-based twin registry. The hemodynamic determinants of blood pressure were assessed by non-invasive measurements of cardiac function including echocardiography and response to isometric and dynamic exercise. Zygosity was determined by questionnaire and confirmed by dermatoglyphic analysis and blood group tests. Anthropometric and hemodynamic measurements in the parents were compared to those in the children. The study included up to five sets of longitudinal measurements, thereby permitting an evaluation of whether the same or different genes operated at different ages encompassing pre-puberty, puberty, and post-puberty.

Eligibility Criteria:
No eligibility criteria
Anticoagulation Profile in Pregnant Women Treated with Three Times a Day of Low Molecular Weight Heparin (LMWH)

Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous or multiparous women with single intrauterine pregnancies who require therapeutic low molecular weight heparin during their pregnancy.
* Participants must be age 18 or older.

Exclusion Criteria:

* Women with multiples.
* Women less than age 18
* History of Heparin Induced Thrombocytopenia (HIT)
* Allergy to enoxaparin
Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures

The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.

In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. This study was performed to evaluate the long -term effectiveness and safety of a new fully covered SEMS for benign biliary strictures.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has benign biliary stricture
3. Subject must be able to give informed consent

Exclusion Criteria:

1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
2. The subject is unable to give informed consent
Effects of Dietary Fiber on Gastrointestinal Function

The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.

The study is a blinded, cross-over design with subjects completing three, two-week treatment periods, separated by two, two-week washouts. Volunteers will consume a dietary fiber for two of the treatment periods at two dose levels. The fiber will be added to foods and dispensed to subjects to be consumed twice a day during each treatment period. During the control period, subjects will receive the same study foods, but with no added fiber. Major outcomes will include fecal weight, and responses to questionnaires that assess fecal characteristics, bowel habits and gastrointestinal tolerability.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women
* age 18 - 54 years
* BMI \< 30 kg/m2

Exclusion Criteria:

* presence of GI or other serious diseases known to affect GI function
* recent use of antibiotics
* very high fiber intake
* use of medications known to affect GI function
* presence of allergies to study foods
Relationship and Sexual Satisfaction of Stoma Patients

Anonymous questionnaire regarding relationship and sexual satisfaction as well as quality of life of stoma patients.

With an anonymous questionnaire relationship, sexual and life satisfaction of stoma patients are investigated. The questionnaire will be made public by support groups and stoma nurses. Analysis of data and publication of sexual and relationship satisfaction of stoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Ileostomy or Colostomy

Exclusion Criteria:

* Disease affecting sexual functioning
* Disease affecting daily life
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumors
* Advanced colorectal cancer or other adenocarcinomas
* Tumor progression after standard chemotherapy, or where none yet approved
* At least one unidimensionally measurable lesion
* Karnofsky performance \>= 70%
* Life expectancy of at least 3 months
* Age \>= 18 years
* Signed, written Institutional Review Board (IRB)-approved informed consent
* Acceptable liver function:

  * Bilirubin \<= 1.5 x upper limit of normal (ULN)
  * AST (SGOT) and ALT (SGPT) \<= 2.5 x ULN, OR
  * AST (SGOT) and ALT (SGPT) \<= 5 x ULN if liver metastasis
* Acceptable renal function:

  * Serum creatinine within normal limits, OR
  * Calculated creatinine clearance of \>= 60 mL/min/1.73 m2 for certain patients
* Acceptable hematologic status:

  * Absolute neutrophil count (ANC) \>= 1500 cells/mm3
  * Platelet count \>= 100,000 (plt/mm3)
  * Hemoglobin \>= 9 g/dL
* Urinalysis: No clinically significant abnormalities
* Acceptable coagulation status:

  * Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits, OR
  * For patients on anticoagulation therapy, status within therapeutic range
* For men and women of child-producing potential, use of effective contraception
* Tumors accessible for needle biopsy

Exclusion Criteria:

* Significant cardiovascular disease.
* A marked baseline prolongation of QT/QTc interval
* Long QT syndrome
* Required use of medication on dosing days that may cause torsade de pointes.
* Infections requiring intravenous (IV) systemic therapy
* Pregnant or nursing women
* Treatment with chemotherapy or investigational therapy \< 4 weeks (28 days) prior to study entry (6 weeks for nitrosoureas, mitomycin C, or Avastin).
* Treatment with radiation therapy or surgery either within 2 weeks prior to study entry, or not yet recovered if 2-4 weeks prior to study entry.
* Unwillingness or inability to comply with protocol procedures.
* Known active uncontrolled infection with HIV, hepatitis B, or hepatitis C
* Serious nonmalignant disease (e.g. hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
* Concurrent use of other investigational agent(s)
* Serious concurrent medical illness
RSA-measured in Vivo Migration and Micromotion in the DePuy Tri-Lock, Corail and Deltamotion Hip Replacement Components

Hip replacements are being performed on an increasingly active population, who are likely to wear their implants out prematurely. New hip replacements have been devised to minimise the risk of failure. DePuy RSA RCT is a randomised controlled trial designed to compare the performance of two established types of hip replacements using Corail and Tri-Lock stems along with Deltamotion acetabular component. The primary objective of the trial is to compare the long term stability of these two devices.To do this, the study will use an advanced 3D Xray technique to detect migration of the components at 3 years. The study will also measure micromotion of Corail, Tri-Lock and Deltamotion components, patient reported outcome measures and change in bone density.This study is being conducted at a single site, at the Nuffield Orthopaedic Centre, Oxford.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 65 years and men aged between 18 and 70 years.

  * Participant is willing and able to give informed consent for participation in the study.
  * Diagnosed with hip osteoarthritis.
  * Able (in the Investigators opinion) and willing to comply with all study requirements.
  * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

* Any patients with an inflammatory arthropathy, osteoporosis or deformities of the proximal femur.

  * Patients who have significant co-morbidities that would make follow-up difficult or uncomfortable.
  * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
OCT and OCT-A Afer Diabetic Vitrectomy in PDR

Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR )


Eligibility Criteria:
Inclusion Criteria:

* Cases with complicated PDR as persistant vitreous hemorrhage or tractional retinal detachment involving or threatening the macula underwent PPV with or without ILM peeling

Exclusion Criteria:

* eyes with media opacity after PPV not allowing imaging of the macula
Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients

Limited data exist describing the use and role of vibrators in a urogynecology population and no randomized controlled trials investigating the use of vibrators as a therapeutic tool to enhance sexual and pelvic floor function in urogynecology patients has been conducted. This study aims to evaluate the efficacy of vibrator use in improving sexual and pelvic floor function in urogynecology patients who report sexual dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* • Women aged 18 and over presenting to the urogynecology clinic.

  * Women diagnosed with one of the following urogynecologic conditions

    o Pelvic organ prolapse, urgency incontinence, overactive bladder, stress urinary incontinence, fecal incontinence, recovering from a urogynecologic surgery over 6 weeks following surgery and clear for intercourse. Patients post op who continue to have pelvic floor dysfunction can be candidates for the study if they continue to have one of the pelvic floor dysfunctions listed.
  * Patient will be screened with the FSFI and will be eligible if they score less than 26.55
  * Patient's must be willing to use a vibrator.
  * Able to provide informed consent.
  * Not currently using a vibrator or has not used a vibrator in the past 3 months.
  * Able to read and write in English

Exclusion Criteria:

* • Patients with cognitive impairment.

  * Patients with refusal or discomfort with vibrator use.
  * Currently using a vibrator or has used a vibrator in the past 3 months.
  * Patients unable to provide informed consent.
  * Patients not clear for intercourse following their surgery
  * Patients with surgery within 2 months of recruitment.
Effect of Femoral and Sciatic Nerve Blocks, Combined with General Anesthesia, in Postoperative Pain Levels and Phantom Limb Pain Development in Patients Undergoing Lower Limb Amputation

The goal of this observational study is to determine the effect of femoral and sciatic nerve blocks, combined with general anesthesia, in postoperative pain levels and phantom limb pain development in patients undergoing lower limb amputation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lower limb amputation 10cm cephalad or 10cm caudal of the knee, due to Peripheral Arterial Disease

Exclusion Criteria:

* Any form of dementia
* Prior chronic neuropathic pain as assessed with DN4 questionnaire
* Surgery under neuraxial anaesthesia
* Inability to complete a Numeric Rating Scale to assess pain
* Contraindication to ropivacaine
SSNHL in Head & Neck Cancer Patients

A sound dosimeter will be used to measure noise level to which a population of head and neck patients on the otolaryngology ward are exposed to. The device is the EXTECH 407764 type II sound level meter (IEC 651 RS232). The device will be configured to OSHA and ISO standards, and calibration confirmed in a sound booth with a sound level calibrator. The dosimeter captures A-weighted sound levels between 30 and 130 dB. Specifically, participants included in the study will be head and neck cancer patients on the otolaryngology floor at VG site. Measurements will be taken three times a day at random intervals. Each measurement will be taken in a similar manner. The dosimeter will be placed on the head side of the bed at the level of patient's ear one inch away from the ear and kept there for ten seconds to get a representative level. The overall measurements will be averaged (Leq) for statistical analysis. Investigators will randomly select 50% of the patients and give them protective ear plugs to be used while the participants are inpatients, and the other 50% will not provide them with ear plugs (like what is being done now). Investigators will obtain a baseline hearing test prior to admission and 7 days after admission and then a repeat hearing test at 3 weeks after discharge. The goal is to establish if there is a temporary or a permanent threshold shift.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnoses of head and neck disease requiring surgery.
* Must be expected to be admitted to ENT floor.
* Must be able to conduct a hearing test.

Exclusion Criteria:

* a diagnoses of SNHL.
* participants with low mental capacity.
Surgical TReatment of Women With Deep ENDometriosis

TrEnd trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. The main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* age \>/= 18 years;
* presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum.

Exclusion Criteria:

* age \<18 years:
* presence of coexisting inflammatory bowel disease;
* patients who have received previous pelvic radiotherapy.
Clinical Outcomes, Viscoelastic Properties and Central Pain Mechanisms After Eccentric Training in Neck/Shoulder Pain

Objectives: The aims are to 1) evaluate the clinical impact of eccentric training in female computer users with chronic NSP, 2) compare pressure hyperalgesia, temporal summation of pain (TSP), and conditioned pain modulation (CPM) in female office workers with and without NSP, and 3) assess changes in central pain responses after training.

Methods: In part A, twenty office workers with NSP will be compared with 20 healthy controls. In part B, the NSP group will undergo a 5-week eccentric training program. Participants will report their pain intensity, and complete the Neck Disability Index, and the Disabilities of the Arm, Shoulder and Hand questionnaire. Pressure pain thresholds (PPTs) will be assessed over the neck and forearm. Cuff algometry will identify pain detection (PDT) and tolerance thresholds (PTT). TSP will be evaluated by visual analogue scale pain scores during 10 repetitive cuff stimulations. CPM will be calculated as the difference in PDT with and without a conditioning painful stimulus. Outcomes will be measured at baseline and post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* Neck / shoulder pain has to last more than 12 weeks', with an average score higher than 2 on a 11-point Numeric Pain Rating Scale within the last 24 hours and during the week before data collection.
* All subjects will have to work for a minimum of four hours per day using a computer, should speak and understand English, and could not be involved in regular strength training of the neck/upper extremities

Exclusion Criteria:

* previous whiplash; a history of neurological or mental illnesses; consumption of pain killers within the last 24 hours; drug addiction, defined as the use of cannabis, opioids or other drugs; fibromyalgia; previous cervical spine or upper limb surgery; carpal tunnel syndrome; concomitant injury or pain from the lumbar spine; and heart diseases or hypertension.
Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement

This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral aortic valve replacements (TAVR) at Yale New Haven Hospital (YNHH).

This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive TAVR at YNHH.

Hypothesis 1: TAVR surgery done under monitored anesthesia care are performed using some combination of the following anesthetics: dexmedetomidine, propofol, fentanyl, and midazolam.

Hypothesis 2: Age-adjusted dosing of these agents will be insufficient to account for extreme age after controlling for preoperative comorbid status.

Hypothesis 3: The rate of conversion to general anesthesia will be unrelated to the type of conscious sedation used.

Hypothesis 4: ICU length of stay, delirium, hospital length of stay, and length of hospital stay will be shorter for patients who were sedated using dexmedetomidine vs those without.

Research Plan: The research will be done via chart review and analysis of data already contained in the Multicenter Perioperative Outcomes Group databases at Yale. The possible risks are primarily the risk to privacy that is inherent in any retrospective chart review. The benefit may be to suggest areas of future study to improve sedation practices for TAVR at Yale and elsewhere. Information recorded will include demographic and preoperative medical assessment from prior to the TAVR, the anesthetic record, and the post-operative course of recovery for patients undergoing TAVR. These data will include age, gender, comorbidities, laboratory values, vital signs, and the results of imaging studies as well as other records potentially related to the above hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent TAVR at YNHH under planned conscious sedation with monitored anesthetic care

Exclusion Criteria:

* Patients who received monitored anesthesia care without the receipt of any study intervention drug (propofol, fentanyl, midazolam, or dexmedetomidine).
Foley Catheterization Following Sacrocolpopexy

The objective of this study is to prospectively evaluate the effects of early versus delayed removal of transuretheral catheters following sacrocolpopexy. The investigators specific aim is to determine the optimal time of removal of an indwelling transurethral catheter postoperatively in an effort to reduce the risk of postoperative urinary retention and urinary tract infection associated with catheter use. The investigators hypotheses are as follows:

Hypothesis 1: Longer duration of postoperative catheter use will result in decreased postoperative urinary retention.

Hypothesis 2: Shorter duration of postoperative catheter use will result in lower incidence of urinary tract infection.

Patients scheduled to undergo sacrocolpopexy for pelvic organ prolapse at the University of Oklahoma Health Sciences Center will be recruited for this study. Written informed consent will be obtained from all participants prior to the scheduled surgery and before the randomization process. This study will contain two arms, each with two groups. The first arm will have participants receiving sacrocolpopexy for pelvic organ prolapse; the second arm will consist of participants receiving sacrocolpopexy plus a concomitant procedure for stress urinary incontinence. Each participant will be assigned to the arm that matches their scheduled procedure; they will then be randomized into one of the two study groups within that arm. Randomization will be performed by placing note cards in sealed envelopes with "Group A" or "Group B" listed on the card. One envelope will be placed with each participant's preoperative packet and opened on the day of surgery after the operation is complete.On the date of the procedure, a urinalysis will be performed prior to the routine administration of prophylactic antibiotics. At the beginning of the procedure, a transurethral catheter will be placed as is routine for this procedure. At the conclusion of the procedure, the sealed envelope containing the participant's group designation will be opened and she will be assigned to one of two groups. Group A participants will have their catheter removed on postoperative day 1 and Group B will have their catheter removed on postoperative day 2.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 21
* Scheduled to undergo sacrocolpopexy at the University of Oklahoma Health Sciences Center

Exclusion Criteria:

* Age \< 21
* Elevated postvoid residual measurement on preoperative exam
* History of urinary retention
* Medical or surgical indication for prolonged catheterization
* History of neurologic problems