cyrilzakka/clinical-trials huggingface dataset:
Genital Hygiene Education and Pregnancy

Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infections on genital hygiene behavior and self-care ability. The hypotheses of this study were determined as follows:

H1a: Genital hygiene education affects genital hygiene behavior in pregnant women.

H1b: Genital hygiene education affects self-care ability in pregnant women.

Genital hygiene behaviors are of great importance in preventing urinary tract infections, especially during pregnancy. The study was conducted to determine the effect of genital hygiene education given to pregnant women diagnosed with urinary tract infection on genital hygiene behavior and self-care ability. The study was conducted in the gynecology and obstetrics clinics of a hospital in eastern Turkey between September 2021 and February 2022. Personal Information Form, Genital Hygiene Behaviors Scale and Self-Care Ability Scale were used to collect data. In the power analysis, the sample size was calculated as 80 pregnant women in each group (80 experimental, 80 control). Pregnant women in the experimental group received genital hygiene education in 4 sessions, while no intervention was applied to the control group. Descriptive statistical analyses and t-test in dependent-independent groups were used in the analysis of the data.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who were literate, - Who had completed their pharmacological treatment (antibiotic treatment) for UTI according to medical records were included in the sample

Exclusion Criteria:

* - Those who had previously received training to increase genital hygiene behavior,
* Those who had a risky pregnancy,
* Those who were diagnosed with any health problems related to the pregnant woman and the fetus were not included in the study
Feasibility Study: Sleuth Monitoring System

The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.


Eligibility Criteria:
Inclusion Criteria:

* Age \> = 18 years at time of enrollment
* Either of the following:

  1. MI \> 30 days prior to enrolment and LVEF \< = 35% by echocardiography (or nuclear imaging as necessary)
  2. Syncope of unknown etiology

Exclusion Criteria:

* Life expectancy \< 12 months following enrollment
* Active infection
Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children

This study is designed to evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving cognition, hemoglobin, iron status and total body iron among school children in urban Bangalore.

Background: Iron (Fe) deficiency is a major cause of anemia in children. Fortification of wheat flour with NaFeEDTA, a highly bioavailable iron fortificant that protects Fe from the phytic acid present in wheat flour, could be a practical approach to addressing this problem.

Aims: To evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving mental performance and reducing iron deficiency and improving body iron stores in urban, school going Indian children.

Methods: A randomized, double-blind, 7 month, school-based feeding trial was carried out in Bangalore, India. Iron-depleted (serum ferritin, SF \<20 µg/L), and/or iron deficient (serum transferrin receptor, TfR \>7.6 mg/L), 6 -13 year old children (N=194) were randomly assigned to either receive a whole wheat flour based lunch meal fortified with 6 mg Fe as NaFeEDTA or an identical unfortified control meal. The meals were administered under supervision and left overs were weighed. Hemoglobin (Hb) and iron status were measured at baseline, 3.5 months, and 7 months. At baseline and at 7 months, the study children were also subjected to a battery of cognitive tests to assess attention/concentration, motor development, visuospatial and verbal abilities. Sensory evaluation using triangle tests were carried out using meals prepared from the fortified and unfortified whole wheat flour.

Eligibility Criteria:
Inclusion Criteria:

* Children with depleted iron stores (serum ferritin \< 20 µg/L or iron deficiency serum transferrin receptor \>7.6 mg/L)

Exclusion Criteria:

* Hb \< 8g/dl, any metabolic illness, use of medication, on iron supplementation
An Analysis Into the Cause and Preventional Method of Thromboembolic Disease in Gynecological Surgery

The aim of this cross-sectional study is to describe the specific situations of thromboembolic disease in gynecological surgery and identify the risk factors of it.

The electronic medical data of 54 patients who undergo operations to treat gynecological diseases but develop thromboembolic disease will be analyzed retrospectively in this study. The location, symptom and other situations of embolism will be described and multiple linear analyse will be employed to identify the risk factors of it.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in the study with informed consent;
2. Females aged 20-80 who are confirmed with some gynecological diseases and are treated with surgery but embolism happens unfortunately.

Exclusion Criteria:

1. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
2. Patients with blood diseases prone to thrombosis and those with a history of thrombus were excluded;
3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
4. Other diseases or heavy injuries that will interfere with the results;
5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Concurrent Chemo-radiotherapy With Intensity-Modulated Radiation Therapy (IMRT) for Limited Disease Small Cell Lung Cancer (LD-SCLC)

The investigators' group was the first to perform a phase II trial in patients with limited disease (stage I-III) small-cell lung carcinoma (SCLC) in which only the fluorodeoxyglucose-positron emission tomography (FDG-PET) positive lymph nodes were irradiated. In this trial, only 3% of isolated nodal failures were observed. However, all patients in that study were treated with 3D conformal radiotherapy (3DCRT). At present, IMRT techniques have become more standard in lung cancer. Because of the lower radiation dose to the lymph nodes outside of the planning target volume (PTV) with IMRT, higher incidences of isolated nodal failures may occur. In this trial, the investigators will investigate the patterns of local relapse after IMRT with concurrent chemotherapy in patients with stage I-III SCLC.

Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on FDG-PET scan to a dose of 45Gy in 30 fractions in 3 weeks (1.5Gy BID). Radiotherapy will be delivered concurrently with cisplatin (or in case of a creatinin clearance of \<60ml/min, carboplatin) and etoposide chemotherapy. When after 4 cycles of chemotherapy and concurrent chest radiotherapy, no disease progression is observed and the WHO performance status is 0-2, PCI (prophylactic cranial irradiation) will bee offered to a dose of 25 Gy in 10 daily fractions.

The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic.

Eligibility Criteria:
Inclusion Criteria:

* Histological of cytological proven SCLC
* UICC stage I-III, which are amendable for radical local treatment
* Performance status 0-2
* IMRT technique

Exclusion Criteria:

* Not SCLC or mixed SCLC and other histologies (e.g. non-small cell carcinoma)
* Stage IV
* Performance status 3 or more
* No IMRT technique
Minimally Invasive Treatments of the Thyroid

This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC)

Image-guided thermal ablations have been successfully applied in the treatment of several type of tumors, and have been recently proposed as a potential alternative to surgery also in patients with thyroid diseases, and named "Minimally Invasive Treatments of the Thyroid (MITT)". These minimally invasive treatments, compared to surgical treatment have similar efficacy, fewer complications, better quality of life, and better cosmetic outcomes. These procedures allow precise delivery of the heat locally to the lesion, sparing the surrounding thyroid tissue, and thus minimizing the invasiveness of the treatment and the impact on thyroid function.

This study aim to establish a prospective registry of the cases of patients treated with MITT for a Papillary Thyroid MicroCarcinoma (PTMC), in order to validate the safety of the procedure and to set the basis for collecting long term results in a large cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18years
* Patients with diagnosis of papillary thyroid microcarcinoma, citologically proven, suitable for MITT.
* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
* Patients must be accessible for follow-up

Exclusion Criteria:

* Tumors \> 1 cm, other citological type, refusal of MITT, unsuitable for MITT, unmanageable coagulative disorders
* Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
Exercise Training in Patients With Left Ventricular Assist Device

The objective of the study is to test whether 12 weeks of structured supervised exercise training on top of usual care improves functional capacity in patients with end-stage heart failure with continuous flow left ventricular assist device (LVAD).


Eligibility Criteria:
Inclusion Criteria:

* chronic end-stage systolic heart failure
* stable on left ventricular assist device, meaning

  1. no major change in therapeutic regime within past 4 weeks: no new additional disease modifying drug (ACE inhibitor, ARB, sacubitril, beta-blocker), no change in disease modifying drug dosage more than 50% (excluded: diuretics), no initiation of a cardiac rehabilitation for a minimum of 4 weeks
  2. post implantation ≥ 3 months
  3. expected further period on the device for a minimum of 3 months after recruitment into the study
* ability to complete the study in compliance with the protocol.
* general ability of the patient to declare willingness to participate in the trial.
* written informed consent

Exclusion Criteria:

* acute illness that does not allow exercise, including unstable heart failure, acute myocarditis, acute pericarditis, stroke
* untreated life-threatening cardiac arrhythmias
* uncontrolled hypertension
* intracardiac thrombus
* inability to perform cardiopulmonary exercise testing at least 1 minute at 20W
* uncontrolled diabetes
* uncontrolled kidney disease
* recent embolism
* concurrent, continuous, or intermittent dobutamine therapy
* complex ventricular arrhythmia at rest or appearing with exertion
* supine resting heart rate \> 100 beats per minute
* severe pulmonary instability
* hemodynamically relevant valvular disorders
* significant change in cardiovascular medication within the previous 4 weeks (see inclusion criteria)
* severe anemia (hemoglobin \<8 g/dl), however patients with moderate anemia (hemoglobin \<11 g/dl) may be recruited if clinically stable (investigator assessment)
* clinically relevant musculoskeletal disease
Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy

The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy.

The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy. Forty children with dyskinetic CP will be assigned randomly into two groups (A \& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions weekly/3 successive months. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to wearing Thera Togs soft orthotic undergarment. Patients evaluation will be carried out before and after the intervention programs to assess gait and balance performance using Noraxons myo pressure plate and Biodex balance system.

Eligibility Criteria:
Inclusion Criteria:

* The levels of gross motor function will be selected between levels I and II according to Gross Motor Function Classification System (GMFCS); have the ability to walk 10 m independently without an orthosis; should be cognitively competent and able to understand and follow instructions; height will be more than 100 cm to fit with the Biodex balance equipment.

Exclusion Criteria:

* If participants use an assistive mobility device; GMFCS levels III, IV, and V; fixed contractures of lower limb musculature; hip dislocation; significant spinal deformities.
Increasing Colorectal and Breast Cancer Screening in Women

This study compares the efficacy (adherence and stage) of four interventions to promote colorectal (CRC) and breast cancer (BC) screenings among women ages 50 to 75. They are:

1. usual care;
2. a TIWeb (tailored intervention Website)
3. a CSC (cancer screening call) and
4. TIWeb + a CSC. This study also compares the cost-effectiveness of the 4 interventions to promote CRC and BC screening among women ages 50 to 75.

This study addresses innovative approaches to increase adherence to screening tests for colorectal and breast cancer - two cancers that have the greatest impact on female cancer mortality in the United States.The cancer burden in women could be significantly reduced by increasing participation in recommended screening for colorectal cancer (CRC) and breast cancer (BC) in all eligible women. This research tests intervention to simultaneously increase both CRC and BC screening using behavior change strategies, and also estimates the efficacy and cost-effectiveness of the interventions. Two groups of women, Group A (adherent to BC screening guidelines, but NOT to CRC screening guidelines) and Group B (non-adherent to BC \& CRC guidelines) are randomized to 1. Usual Care, 2. TIWeb, 3. CSC and 4. TIWeb +CSC.

Eligibility Criteria:
Inclusion Criteria:

* a patient of any of the participating physicians
* not having had a fecal occult blood test (fobt) in the last 12 months
* not having had a fecal immunochemical test (fit) in the past 15 months
* not having had sigmoidoscopy more than 5 years ago
* not having had a colonoscopy more than 10 years ago
* have high-speed internet access

Exclusion Criteria

* a personal history of colorectal cancer
* a personal history of breast cancer
* a personal history of colorectal polyps
* a personal history of inflammatory bowel disease
* having any medical conditions that would prohibit a mammogram or CRC screening
* have already had CRC screening
Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Oral and Oropharyngeal SCC

There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Oral and oropharynx (exclusion vallecula) squamous cell carcinoma
* T1 or T2
* unique, untreated tumor
* N0 or nodes \<3cm
* complete pathological resection
* no perineural spread, vascular emboli \<5
* pN0 or \<=2N+R-
* signed inform consent

Exclusion Criteria:

* Vallecula carcinoma
Verbal Encouragement in Swimming

Verbal encouragement (VE) is used to enhance the performance in several sports, even though no studies have been conducted in swimmers and no effects have been reported in elite athletes by some Authors. Besides influencing motor performance, VE is also known to enhance the physical load, thus increasing the probability of developing fatigue. The aim of this research was to study VE in swimmers by evaluating both chronometric performance and muscle fatigue (using sEMG).


Eligibility Criteria:
Inclusion Criteria:

* at least 1 year of experience in training aimed at regional and international competitions
* a score ≥ 200 points on the personal best in the 200m freestyle, in accordance with the international point score (IPS) (http://www. swimnews.com/ipspoints)
* being healthy

Exclusion Criteria:

* having a disease
Cohort Study of Risk Reducing Salpingectomy

Women undergoing surgical sterilization will be interested in risk reducing salpingectomy, and surgeons performing the procedure will be able to successfully complete the salpingectomy.


Eligibility Criteria:
Inclusion Criteria:

* Women \> 35 years requesting sterilization as interval procedure OR at time of cesarean delivery
* At least one living child
* English or Spanish speaking
* Sterilization planned as interval (laparoscopic) procedure via Family Planning Clinic services or at time of delivery
* Delivery by cesarean section (planned or following labor)

Exclusion Criteria:

* Age \< 30
* Medical complications that increase risk for surgical bleeding (e.g. Idiopathic thrombocytopenic purpura (ITP); von Willebrand disease (vWD); need for prophylactic or therapeutic anticoagulation)
Comparison of the Accuracy of Telehealth Examination Versus Clinical Examination in the Detection of Rotator Cuff Tears

The purpose of this study is to compare how accurately a pseudo-telehealth shoulder examination diagnoses rotator cuff tears compared to a regular clinical examination. MRI is used as the gold standard.


Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or older, presenting with shoulder pain, and seen in the Duke Sports Medicine clinic by Dr. Wittstein or Dr. Lassiter

Exclusion Criteria:

* Patient cannot have had prior shoulder arthroplasty, instability or history of fracture/dislocation. Pregnant women will be excluded from the study because there will be an MRI. Anyone unable or unwilling to have an MRI will be excluded from the study.
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer

The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis.
* lack of routine effective treatment,failure of routine treatment or relapse
* age of 18-70,ECOG 0-2 and estimated survival is above 3 months
* had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin C.

Exclusion Criteria:

* Serious internal diseases
* uncontrolled primary and metastatic brain tumor
* sizes of tumor does not meet the requirement of injection
Effect of Whole-body Vibration on TcPO2

In order to determine the effect of whole body vibration on TcPO2 levels in patients with type 2 diabetes, 40 subjects will undertake whole body vibration exercise three times a week for 12 weeks. TcPO2 will be measured before and after the intervention. A second control group with type 2 diabetes will also have TcPO2 levels measured before and after the 12 weeks of the study.

Objective: To determine the effect of whole body vibration exercise on levels of TcPO2 measured in the feet of patients with type 2 diabetes, in order to create recommendations for prevention of diabetic foot.

Material and Methods: controlled open clinical trial consisting in 2 arms, as follows: 1) control group under care for type 2 diabetes, and 2) intervention group, who, in addition to the standard care, will undergo an exercise program of whole body vibration three times a week, with progressive intensity, for a period of 12 weeks. Partial pressure of transcutaneous oxygen (TcPO2) will be measured in the feet of the participants at baseline and after 12 weeks, with 40 patients per group.

Statistical analysis: demographic information of the subjects will be described as arithmetic means, standard deviation, percentages, frequencies. Comparison between groups will be done with Student t for independent data or Mann-Whitney U when convenient. Baseline and final measurements will be compared. inter and intra group comparisons will be made by repeated measurements. For qualitative values, chi square will be used. Multivariate analysis will be performed to control for confounding variables. The level of significance will be a value of 0.05.

Eligibility Criteria:
Inclusion Criteria:• Patients with diagnosis of type 2 diabetes less than or equal to six years, under care and having concluded the 4th or 5th medical visit.

* Non-smokers.
* Residents of Mexico City
* Both sexes.
* 40 to 69 years old.
* Agreeing to participate through signature of informed consent.
* HbA1c between 6.0 and 9.0 %.
* Blood pressure less than or equal to130/80.
* Total cholesterol ≤ 240 mg/dL, triglycerides ≤300 mg/dL.
* Stable weight over the last 6 months ( \<10% variation).

Exclusion Criteria:• Patients with severe motor handicap and amputations of pelvic members.

* With exposed lesions in subcutaneous tissue (ulcers) in the sole of the foot, diabetic foot (Wagner 3 or more) or intermittent claudication.
* With important alterations in balance.
* With a recent surgery.
* Gravidity.
* Deep venous thrombosis.
* With pacemaker.
* Recent myocardial ischemia.
* Orthopedic implants.
* Recently-placed mammary prosthesis.
* Exoskeletal prosthesis.
* Discopathies.
* Neoplasia in the last 5 years.
* History of 2 episodes of severe hypoglycemia in the last year.
* Chronic kidney disease with creatinine clearance estimated at \<60 ml/min.
* Severe non-proliferative retinopathy, uncontrolled macular edema.
* Hepatic failure (Child-Pugh "C") and/or heart failure (functional Class - NYHA-: III-IV).
* Patients with hemoglobinopathies, severe anemia (≤7.5 g/dL), known hemolytic disease.