cyrilzakka/clinical-trials huggingface dataset:
Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration

Today it is well established that middle molecules comprise several compounds that are not effectively removed by high-flux dialyzers, and effective clearance of large middle molecules in the process of dialysis depends on the dialyzer membrane having large enough pore sizes, larger than the conventional high-flux dialyzers. Studies have found associations between levels of large middle molecule uremic toxins and immune dysfunction and inflammation, as well as adverse outcomes. This indicates that dialysis membranes having larger pores, enabling an expanded HD (HDx) with more effective removal of large middle molecules, can have a positive impact on the inflammatory state. While data is starting to appear on the long-term use of the HDx therapy, little is still known on how large middle molecules and inflammation markers are affected over time.


Eligibility Criteria:
Inclusion Criteria:

* ESRD patients age between 18 - 80 years
* Clinically stable as judged by the treating physician for 30 days prior to enrollment, as demonstrated by pertinent patient medical history, physical examination, and laboratory testing
* Hemodialysis therapy with HDF for at least 3 months immediately prior to study enrollment

Exclusion Criteria:

* No informed consent provided
* Significant psychiatric disorder, mental disability, or other condition that may interfere with the patient's ability to provide informed consent
* Pregnant, breastfeeding, or planning to become pregnant
* Unstable vascular access associated with risk of low and variable extracorporeal blood flow rate (QB)
* Chronic liver disease, known paraprotein-associated disease, known bleeding disorders (e.g., gastrointestinal bleed, colonic polyps, small bowel angiodysplasia and active peptic ulcers)
* Major bleeding episode (i.e. soft tissue bleeding, blood in stool, joint damage, retinal bleeding, extensive mucosal bleeding, exsanguination, cerebral hemorrhage) ≤ 12 weeks prior to enrollment
* Blood (red blood cell) transfusion ≤ 12 weeks prior to enrollment
* Clinical signs of acute infection ≤ 4 weeks prior to enrollment
* Active cancer, except for basal cell or squamous cell skin cancer
* Positive serology test for human immunodeficiency virus or hepatitis infection
* Scheduled for planned interventions requiring hospitalization \> 1 week
* Scheduled for living-donor transplantation within the study period
* Currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months that may interfere with this study
Post-exercise Recovery of DOMS in Recreational Athletes

The main goal of this study was to investigate the effectiveness of cryo-sauna in preventing the development of DOMS in the lower extremity. The second goal is to analyze the rate of regenerative changes in the right muscles after acute fatigue-induced exercises.

The main goal of this study was to investigate the effectiveness of cryo-sauna in preventing the development of DOMS in the lower extremity. The second goal is to analyze the rate of regenerative changes in the right muscles after acute fatigue-induced exercises.

This study design was a randomized, controlled single-blind trial with repeated measures. Moreover, the design was prepared according to the Consolidated Standards of Reporting Trials (CONSORT) for pragmatic trials. Participants were assigned into two groups: (1) experimental group (CRYO, n =16) - cryostimulation using a cryo sauna; and (2) control group (CONT, n = 15) - without any intervention. This study was conducted in the Physical Exercise Laboratory. Both groups, CRYO and CON performed a fatigue-induced protocol consisting of counter-movement jumps (CMJ) (10 set for 10 repetitions). After the fatigue exercises, only CRYO underwent cryo sauna intervention including entry immediately after, 24, 48, and 72 hours post-exercise. The order of measurements at baseline included: blood sample testing (creatine kinase, myoglobin, leukocytes) and muscle stiffness of the lower extremity. All measurements we collected at baseline, immediately post, 24, 48, 72, and 96 hours post-exercise.

Eligibility Criteria:
Inclusion Criteria:

* no previous experience with cryostimulation using a cryo-sauna,
* recreational lifestyle.

Exclusion Criteria:

* Current or prior pain or injury in the lower extremity.
* Previous history of surgery in the lower extremity.
* Cardiovascular disabilities.
Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).


Eligibility Criteria:
Inclusion Criteria:

* Women with gestation between 34 and 41 6/7 weeks.
* Premature rupture of membranes (\> 6 hours).
* Use of prophylactic antibiotic 1 hour previous to cesarean section.

Exclusion Criteria:

* Any source of infection diagnosed previous to surgery.
* Fever of unknown origin previous to surgery.
Monitoring and Evaluation of the Levothyroxin Replacement Therapy in Pregnant Women With Hypothyroidism

The aim of the study was to evaluate the clinical control program in patients with hypothyroidism during pregnancy (suggested in resent guidelines). Is it possible by monitoring the patients every 4. week during pregnancy to keep the thyroid function parameters within the recommended range?

A retrospective study of consecutive pregnant women with hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012. Patients selected through electronic medical system. Blood tests for the The hormone levels drawn from the laboratory of Clinical Biochemical Department, Herlev Hospital


Eligibility Criteria:
Inclusion Criteria:

* Consecutive pregnant women with L-T4 treated hypothyroidism followed at the outpatient clinic at the Endocrinology Unit, Herlev Hospital, Denmark during 2012
Comparison Between Conventional and CAD/CAM Complete Dentures Designed Based on Neutral Zone Concept

A within-subject cross-over study is done on eight completely edentulous patients to compare two different complete removable dentures. Group I: Heat cured Conventional complete dentures designed based on the neutral zone concept; Group II: CAD-CAM neutral zone complete dentures designed based on the neutral zone concept. Occlusal analysis is done by the T-Scan device, and evaluation of muscle activity is conducted by electromyography at insertion time, two weeks after insertion time, and one month after insertion time.

This study is designed as a randomized clinical trial applying a within-subject comparison of two different complete denture types as follows; group I: Heat cured Conventional complete dentures designed based on the neutral zone concept, group II: CAD-CAM neutral zone complete dentures designed based on the neutral zone concept. The study will be carried out on eight completely edentulous patients, each patient will receive two sets of complete dentures in a random sequence. For each denture set, at the denture insertion visit occlusal analysis and equilibration will be performed with the aid of the T-Scan device, also EMG evaluation of muscle activity will be conducted. Two weeks after, the patients will be recalled to reanalyze the occlusion after the denture settles using the T-scan computerized system. One month after the last recall visit, the EMG evaluation of muscle activity will be conducted again. The EMG and T-scan recording data will be collected and analyzed to compare the two denture types

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
2. Patients with a resorbed mandibular ridge.
3. Patients with a Class I maxillo-mandibular relationship
4. Patients with adequate inter-arch space.
5. Patients with good neuromuscular control.
6. Patients without any tempo-mandibular disorder.

Exclusion Criteria:

1. Patients with any oral diseases that may affect complete denture construction
2. Patients with bad oral hygiene.
3. Patients with neuromuscular disorders.
4. Patients with a history of parafunctional habits.
5. Hysterical patients.
6. Patients will undergo or have previously received chemotherapy or radiotherapy.
7. Drug-addicted patients.
The Effect of Dosage of Caffeine on Intraocular Pressure

The goal of the study is to determine the effect of different doses of caffeine on intraocular pressure. We hypothesized that higher dosage of caffeine would increase intraocular pressure more than lower doses.

Eligible subjects will be randomized into three groups:

1. group 1: intake of decaffeinated coffee
2. group 2: intake of coffee with lower caffeine dose
3. group 3: intake of coffee with higher caffeine dose

Intraocular pressure will be measured at 0, 30, 60 and 90 minutes after coffee intake.

decaffeinated coffee contains 0.5-2 mg of caffeine regular dose coffee contains 91.8 mg of caffeine high dose coffee contains 144 mg of caffeine

all three groups' intraocular pressure will be measured with the Goldmann applanation tonometer at 4 timepoints:

1. 0 minutes (baseline)
2. 30 minutes after intake
3. 60 minutes after intake
4. 90 minutes after intake

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* normal central corneal thickness
* normal baseline intraocular pressure

Exclusion Criteria:

* any ocular disease
* baseline intraocular pressure over 21 mmHg
* central corneal thickness less than 520 microns or more than 540 microns
Uterine Closure for Cesarean Section: a Novel Technique

In here we want to describe a new technique to uterin closure at caesarean section which has been performed about 20 years by Bülent Yılmaz. The technique (we suggest the name of the technique as Yılmaz technique) provide less resuturing need when closing the uterus in cesarean section, bringing together better wound edges, providing more effective suture in thin uteruses, stopping active bleeding areas with the same suture, thus enabling to complete the surgery at low cost by using a single suture material in almost all cases.

The aim of this study is to describe the technique and compare the blood loss of patients in caserean section between Yılmaz technique and single layer continue locked suturation .

The participants of the study were divided into two groups as uterine closure with Yilmaz technique (study group) and single layer continue locked suturation (control group). Maternal age, gestationale age, fetal weight, preoperative and postoperative hemoglobin levels are recorded. Hemoglobin decrease was calculated by subtracting the postoperative hemoglobin value from the preoperative hemoglobin values of the pregnant women.The postoperative hemoglobine decrease of the groups are compared.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent to ceseren section and

  1. singleton
  2. alive fetus

Exclusion Criteria:

The patients with

1. uterine atonia,
2. coagulaopathy,
3. plasenta previa
4. blood transfusion -
Study of ARO-AAT in Normal Adult Volunteers

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-AAT in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements
* Non-smoker for at least one year
* Normal lung function
* No abnormal finding of clinical relevance at Screening
* Normal AAT level at Screening visit

Exclusion Criteria:

* Clinically significant health concerns
* Regular use of alcohol within one month prior to Screening
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
* Recent use of illicit drugs
* Use of any drugs or dietary/herbal supplements know to interfere with liver metabolism

NOTE: additional inclusion/exclusion criteria may apply, per protocol
Adherence and Health Effects of Video Dance in Postmenopausal Women

This is a 6 month randomized clinical trial comparing video dance, brisk walking and delayed entry controls. The interventions have two phases; a 12 week initiation phase with substantial structure and supervision, followed by a 12 week transition phase, with reduced structure and supervision. Participants are 168 overweight or obese, sedentary postmenopausal women aged 50 to 65; 60 in each exercise arm and 48 in the wait list control group.

The following research questions will be assessed:

1. Is exercise adherence at 6 months better with video dance games compared to brisk walking?
2. Does video dance game exercise compared to wait list controls, induce beneficial changes in physical and mental health?
3. Does video dance game exercise compared to brisk walking better promote balance, attention and visual spatial skills, without loss of benefit to cardiovascular fitness?
4. Is video dance preferred to brisk walking for exercise among postmenopausal women? If so, who and why?


Eligibility Criteria:
Inclusion Criteria:

* Participants must be female
* age 50-65
* not currently exercising at least 20 minutes
* three times per week
* a BMI of 25 or higher

Exclusion Criteria:

* Exclusions are largely related to medical safety and include history of osteoporosis, osteoporotic fractures, active cardiovascular disease, uncontrolled hypertension, weight bearing pain that would limit exercise, seizure disorder or any medical condition or medication that would limit the safety of the study.
Neonatal Jaundice: Knowledge, Attitudes and Practices of Mothers and Medical Trainees and Providers in and Around Ogbomosho

Determine the knowledge attitude and practices of all levels of health care providers about neonatal jaundice

During the routine post-natal visit, trained research personnel will inform the mother of the infant or medical practitioner that a study in being carried out to better understand the knowledge, attitudes and practices of mothers and health care providers for neonatal jaundice. The investigators will then proceed to ask the mothers or health care professionals if they would be interested in filling out an anonymous survey that will assess their knowledge of neonatal jaundice and their practices, if any, in caring for this condition. No PHI will be included and no written consent will be obtained as the written consent would be the only link to the person participating in the survey. Verbal consent will be obtained and we will explain that their medical care and care of the children will in no way be affected by their answers to the survey. We will carefully explain that their participation in the survey is voluntary.

For medical students, they will be informed that a study is being carried out to better understand the knowledge, attitudes and practices of medical trainees for neonatal jaundice. They will then be asked if they would be interested in filling out an anonymous survey that assess their knowledge of neonatal jaundice, and their practices, if any, in caring for this condition. No PHI will be included and no written consent will be obtained, as the written consent would be the only link to the person participating in the survey. Verbal consent will be obtained and we will explain that their academic standing will not be affected by their answers to the survey. We will carefully explain that their participation in the survey is voluntary.

All surveys will contain the names and contact information of the investigators.

The survey will be administered under the direction of the researchers by the researchers and/or their trained research team.

Eligibility Criteria:
Inclusion Criteria:

* All Mothers and Health Care Workers willing to fill out survey in and around Ogbomoso, Nigeria

Exclusion Criteria:

* All Mothers and Health Care Workers not willing to fill out survey in an around Ogbomoso, Nigeria
Comparison of Scapular Stabilization and Mobilizations in Sub Acromial Pain Syndrome

The aim of this research is to compare the effect Comparison of scapular stabilization exercises and scapular mobilizations on shoulder pain, scapular kinematics, disability and functional limitations in patients with sub acromial pain syndrome Randomized controlled trials done at District Head Quarters Mirpur AJK. The sample size was 36. The subjects were divided in two groups, 18 subjects in scapular mobilization exercise group and 18 in scapular mobilization exercise therapy group. Study duration was of 12 months. Sampling technique applied was non probability convenient sampling technique. Only 25-40 years old patient with unilateral shoulder pain lasting \>6 weeks were included. Tools used in the study are NPRS, SPADI, WORC LSST and SAT.

Sub acromial pain syndrome (SAPS), an up to date terminology (shoulder impingement syndrome ) is a common healthcare problem, especially in adult where the space directly below the acromion process and above the shoulder joint, has narrowed and patients describe pain on lateral and anterior aspect of shoulder . The estimated prevalence in the general population is 7 to 26 percent and it accounts for 44 to 65% of all shoulder problems. Incidence of shoulder impingement in the US military population is 7.77 cases/1000 person-years and in UK 3 out of every 4 patient with shoulder pathologies are seeking medical treatment for SAPS. Risk factors include repetitive activity above the shoulder, decubitus sleeping position, a hook-type acromion, smoking, muscle imbalance, bone and joint abnormalities etc. Common symptoms are persistent pain without any history of trauma, difficulty reaching up behind the back, weakness in shoulder muscles, pain when the arm is raised between 70 and 120 degrees and scapular dyskinesia.

* Research surrounding sub acromial pain syndrome has experienced significant growth recently especially in the area of its management. Physiotherapy management protocol for SAPS includes, postural correction exercises, neuromuscular control exercises, Stretching's, manual therapy techniques of the shoulder, scapular stabilization and Mobility Exercises and myofacial release therapy. Scapular stabilization exercises based on open and closed kinetic chain exercises to increase muscle strength and joint position awareness.

Eligibility Criteria:
Inclusion Criteria:

* ● Unilateral shoulder pain lasting \>6 weeks

  * Patients with 3/5 positive special tests (Hawkins-Kennedy test, painful arc test, Neer test, Job test, resisted external rotation test)
  * Patients score falling above 3 on NPRS

Exclusion Criteria:

* • History of surgery, fracture, or dislocation in past 6 months

  * Traumatic onset of pain.
  * received steroid injections and physical therapy during the previous 6 months
  * BMI above 30
The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study

The purpose of this study is to examine the impact of smoking cessation on total joint arthroplasty patients with respect to perioperative complications and outcomes. The investigators will examine patients who are asked to stop smoking in any manner they choose and also refrain from nicotine replacement therapy, and those who are allowed to continue smoking during the perioperative period for their total knee or total hip replacement.


Eligibility Criteria:
Inclusion criteria:

1. Primary elective total joint arthroplasty patients undergoing surgery with a Rothman Institute arthroplasty surgeon.
2. Participant is a current smoker.
3. Diagnosis of osteoarthritis, inflammatory arthritis, and post-traumatic arthritis.

Exclusions criteria:

1. Age \< 18
2. Revision surgery
3. Prior infection in hip or knee at the surgical site
4. BMI \>40 (It is currently the standard of care in our practice to require patients to have a BMI \< 40 due to an increased risk of infection. This will not represent a change in practice.)
5. Diabetics with Hgb A1C \>8 (It is currently the standard of care in our practice to require patients to have a Hgb A1C \<8 due to an increased risk of infection. This will not represent a change in practice.)
6. Patients using chewing tobacco, cigars, or other form of oral tobacco product
7. Patients using e-cigarettes or vaporizers
Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture.

A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section.

A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure will be estimated.These will be the primary outcome measures. The secondary outcome measures will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative infection (endometritis) and wound infection..

Eligibility Criteria:
Inclusion Criteria:

• Pregnant patients with an obstetrical indication for delivery by Cesarean section

Exclusion Criteria:

• Patients with blood clotting disorders.
Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at tissue samples from patients with glioblastoma multiforme to identify biomarkers that may improve the selection of patients for epidermal growth factor receptor inhibitor therapies.

OBJECTIVES:

Primary

* Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with erlotinib hydrochloride, temozolomide, and radiotherapy on clinical trial NCCTG-N0177.

Secondary

* Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with gefitinib after radiotherapy on clinical trial NCCTG-N0074.

OUTLINE: This is a multicenter study.

Tissue samples from patients enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074 are analyzed by microarray analysis and immunohistochemistry for biological markers predicting progression-free survival and overall survival. Biological markers include epidermal growth factor expression, vIII mutant p53 gene, P-AKT, p7056k, S6, 4EBP1, STAT-3, PLC-g, Erk, ErbB2, ErbB3, ErbB4, platelet-derived growth factor receptor, IGF1R, interleukin-6, FADD, and MGMT.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility Criteria:
All patients entered onto N0177 and N0074 who have appropriate archived clinical specimens.