cyrilzakka/clinical-trials huggingface dataset:
Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

This study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal occult blood test (iFOBT) and colonoscopy when positive for colorectal cancer (CRC) screening in familiar-risk population and; 2) to determine the complications associated with both strategies.

This is an observational, controlled, randomized phase III study to evaluate the effectiveness of the iFOBT for detecting advanced neoplasia (polyps \> 1cm in size, high grade dysplasia or with villous component, or CRC) in first degree relatives of patients with CRC.

Index cases will be interviewed to obtain the family tree and their first-degree relatives will be contacted to invite them to participate in the study. Index-cases, will be randomized into one of the following two groups in order that their relatives receive the same screening strategy: A) colonoscopy; or B) annual iFOBT test (OC-Sensor®, cut off ≥50 ng/ml) and colonoscopy if positive. To determine the sensitivity and specificity of the iFOBT strategy, individuals randomized to group B will be invited to undergo a complete colonoscopy following two years follow-up. In addition, epidemiological data, personal history of disease, family history of neoplasm, characteristics of lesions at colonoscopy and histological diagnosis will be recorded.

To test the hypothesis of equivalence between the iFOBT test and colonoscopy for detecting advanced colorectal neoplasm, it was considered a probability of participation, detection capability and prevalence of advanced adenomas for iFOBT of 0.750, 0.565 and 0.077, respectively, being the product of them 0.033. In the case of colonoscopy, the likelihood of participation, detection capability and prevalence of advanced adenomas in this population at risk are 0,500, 0.965 and 0.077, respectively, and their product 0.037. Accordingly, for a Type I error (alpha) of 5%, a power of 80% and a maximum deviation between the probabilities of the two tests of 0.03 the number of subjects to be included per arm is 744

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 40-75 years, first degree relatives of patients with non-syndromic CRC

Exclusion Criteria:

* Personal history of CRC, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
Palmar Arch Insufficiency as a Risk Factor for Radial Artery Occlusion After Transradial Catheterization

Transradial access (TRA) is commonly used in different medical fields due to the superficial position of the radial artery and related advantages. Despite its popularity, the incidence and importance of related complications, in particular, radial artery occlusion (RAO) remains unclear. Further, the only known independent predictors of the radial artery occlusion are the periprocedural anticoagulation as well as the catheter size. The effect of a variable arterial anatomy has so far not been evaluated.

In this context, most institutions prefer to evaluate the collateral circulation of the hand, i.e., the arterial palmar arch and forearm circulation before TRA. The most commonly employed tests are the modified Allen test (MAT) or the combination of pulse oximetry and plethysmography according to Barbeau.In addition, there are more precise, but still semi-quantitative non-invasive methods for palmar arterial collateral function testing.

Despite the wealth of these variably accurate and practical tests, invasive and direct hemodynamic measurement of the arterial forearm circulation and its components is lacking. Thus, the human physiologic circulatory reference at this site has been unknown so far. Further, the need of pre-procedural testing itself can be questioned in light of the reported, widely varying prevalence of RAO (1-38%) or critical ischemia (0-0.09%) after TRA.

The present study investigated in a first step the invasively obtained, pressure-derived hemodynamic function, i.e., the physiology of the human arterial palmar arch and forearm collateral circulation and in a second step the clinical consequences of the variable palmar arterial anatomy.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient receiving transradial coronary angiography and undergoing evaluation of the palmar arterial arch circulation as a quality control
* Written informed consent to participate in the follow-up Doppler ultrasound examination

Exclusion Criteria:

* Changed anatomical conditions of the radial artery, e.g. after coronary artery bypass surgery with radial harvest
Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy

The study hypothesis is that adalimumab induces mucosal healing in the small bowel and that mucosal healing correlates with disease activity. 30 Patients with isolated active small bowel Crohn's disease which are candidates to receive anti-TNF treatment will be included in the study. All patients will undergo patency capsule examination and capsule endoscopy afterwards. Small bowel endoscopic disease severity will be assessed by the capsule endoscopy Crohn's disease activity index (CECDAI). The patients will receive Adalimumab (Humira)injections (160mg,80mg and 40mg every 2 weeks ) for 12 weeks. on week 14 a second capsule endoscopy will be performed and CECDAI calculated again. The patients clinical condition, CDAI,IBDQ and laboratory results including CRP, CBC and fecal calprotectin will be assessed on weeks o, 7 and 14 and results will be compared with the endoscopic score.


Eligibility Criteria:
Inclusion Criteria:

1. Isolated small bowel Crohn's disease.
2. Age ≥18.
3. Active disease (CDAI≥220).

Exclusion Criteria:

1. Known fixed stricture in the small intestine.
2. Former small bowel obstruction or obstructive symptoms.
3. Patients expected to undergo small bowel surgery in the near future or had intestinal surgery in the previous 6 months.
4. Colonic disease (except ileocecal valve area).
5. Anti-TNF treatment in the last 3 months.
6. Sensitivity or lack of response to previous adalimumab treatment.
7. Current gastrointestinal infection.
8. History of malignant disease (except BCC of skin).
9. Congestive heart failure, severe renal or hepatic dysfunction.
10. Patients suffering from tuberculosis, hepatitis B or C.
11. Pregnancy or unwillingness to use contraception during study period.
12. Dysphagia or swallowing disorders
13. Gastroparesis or severe gastrointestinal motility dysfunction.
14. Patients with cardiac pacemaker or implanted cardioverter devices.
15. Unable to sign informed consent.
Effect of Oxygenated Mouthwash and Mouth Foam

The Aim of this independent, parallel, twelve-week clinical study is to assess the efficacy of a commercially available oxygenated mouth rinse and mouth foam on both plaque level and gingival status in addition to assessing the oral health related quality of life.

Participants in all groups will be examined for gingival inflammation and plaque accumulation. The difference between three trial arms lies in the product used (control, oxygenated mouth wash, oxygenated mouth foam). A comparison against no intervention was disregarded due to ethical concerns (children only examined without informing them about their oral problems). After examination at baseline participants will be assigned to one arm of intervention. All participants will be provided an oral health education and gingival scaling to remove any underlining predisposing factor for gingival inflammation as well as fluoridated toothpaste and a toothbrush. Participants within intervention arms will also be provided the product package and informed how to use it (oxygenated mouth wash, oxygenated mouth foam).

All three arms will be followed after (1week, 2 weeks, 4 weeks, 8 weeks and 12 weeks) from baseline examination.

1. Control group Won't receive an oxygenated mouthwash nor oxygenated mouth foam (20 participants) 2. Intervention Group A: 20 participants - 2 oxygenated mouthwash bottle per individual for 3 months (40 bottles in total).

3. Intervention Group B: Oxygenated mouth foam/ day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).

Eligibility Criteria:
Inclusion Criteria:

* Students and employees at College of applied Medical science over 19 years old
* Both Saudis and non-Saudis.
* Students and employees consenting to participate.

Exclusion Criteria:

* Intern students or students in their 1st year.
* Students and employees with medically compromised condition (including congenital heart disease, hematological condition, immune deficiency condition and end stage renal disease or those with organ transplant within the previous 5 year.
* Students and employees not consenting to participate.
Multicenter Infection Surveillance Study Following Colorectal Procedures

This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal surgical procedures.

This study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal procedures.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, \>18 years of age;
* Scheduled for elective colon procedure;
* Ability to complete patient survey questionnaires;
* Provision of informed consent

Exclusion Criteria:

* Patients with a prior allergic reaction to Morphine, Demerol, Dilaudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
* Procedures for hemorrhoids;
* Inability to perform follow up assessments
The Effect of Whole Body Vibration on Muscle Elasticity

This study examined the effect of whole-body vibration on pain and muscle elasticity in individuals with hyperlordosis and normal lordosis.

Flexible ruler for individuals' spinal curvatures (lumbar lordosis); back-lower back pain levels VAS; muscle elasticity Myoton Pro device; Physical functions will be evaluated with the Modified Oswestry low back pain scale.

This study examined the effect of whole-body vibration on pain and muscle elasticity in individuals with hyperlordosis and normal lordosis.

Flexible ruler for individuals' spinal curvatures (lumbar lordosis); back-lower back pain levels VAS; muscle elasticity Myoton Pro device; Physical functions will be evaluated with the Modified Oswestry low back pain scale.

The viscoelasticity properties ( tone, stiffness, elasticity) of the Musculus Trapezius and Musculus Pectoralis were assessed with MyotonPro® (Myoton AS, Estonia) during prone position on both sides.

Individuals will be divided into two groups: hyperlordosis and normal lordosis. Whole body vibration will be applied twice a week for six weeks, with a frequency of 30 Hz and an intensity of 2 mm.

A total of 28 females and males (14 individuals for each group) with hyperlordosis (\>40°) and normal lordosis participated in the study.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age,
* Having pain \>5 according to VAS measurement,
* Having normal lumbar lordosis angle between 30°-40°,
* Having hyperlordosis angle \>40°

Exclusion Criteria:

* Having Scheurmann kyphosis, ,
* Having scoliosis (Cobb angle \>10°),
* Having other congenital spine abnormalities
Childbirth Education and Birth Plan on Birth Self Efficacy in Pregnant Women

The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women.

Aim: The purpose of this study was to investigate how pregnant women's childbirth self-efficacy was affected by childbirth education and birth plans applied with the education.

Methods: The research was carried out at seven Family Health Centers in Turkey as a randomized controlled trial. The pregnant women constituting the sample were divided into 3 groups. Group 1 was given only childbirth education (Group-ED), group 2 was given childbirth education and was subjected to a birth plan (Group-ED\&P), and group 3 was the control group, each including 51 pregnant women.

Eligibility Criteria:
inclusion criteria:

* pregnant women who was in the third trimester (28-40 gestational weeks),
* who was literate or had a relative/helper who would write a birth plan to be prepared,
* who were not involved in any diagnosed risk at the present pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios and multiple pregnancy)
* who did not have any diagnosed problems with the health of fetus (such as fetal anomaly and intrauterine growth retardation).

exclusion criteria:

• who had previous cesarean section were not included in the research.
Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment

The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).

This is a Phase III, randomized, double-blind, placebo-controlled, parallel group, multi-center, efficacy and safety trial of AM-111 in the treatment of subjects suffering from severe to profound idiopathic sudden sensorineural hearing loss.

The active pharmaceutical ingredient of AM-111 is a JNK inhibitor (D-JNKI-1), a synthetic peptide consisting of 31 D-amino acids, which acts as a c-Jun N-terminal kinase (JNK) ligand.

The study consists of one treatment visit and a follow-up period until day 91.

Study participants will receive, after topical anesthesia of the tympanic membrane, AM-111 0.4 mg/mL or 0.8 mg/mL or placebo, administered into the affected ear. Following the administration, subjects will rest in a supine or reclined position for 30 minutes. Study participants will have the option for a course of oral corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72 hours prior to study treatment;
2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across those 3 contiguous air conduction audiometric pure tone frequencies that show the highest mean hearing loss compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident (defined as "pure tone average", PTA);
3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conduction thresholds at the pure tone average frequencies compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a preexisting audiogram for the affected ear not older than 2 years prior to the ISSNHL incident;
4. Age ≥ 18 years on the day of screening;

Exclusion Criteria:

1. Bilateral ISSNHL;
2. Acute hearing loss from noise trauma, barotrauma or head trauma;
3. Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below 4 kHz, when the air-bone gap is measurable;
4. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in either ear;
5. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
6. Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
7. History of otosclerosis in the affected ear;
8. Suspected perilymph fistula or membrane rupture in the affected ear;
9. Congenital hearing loss;
10. History of ISSNHL in the past 2 years;
11. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;
Efficacy of Ketoprofen Before Hysterosalpingography

hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye


Eligibility Criteria:
Inclusion Criteria:

* any patient came for Hysterosalpingography

Exclusion Criteria:

* any patient has contraindication to Hysterosalpingography
Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization

This study focuses on a two-pronged strategy to enhance the rehabilitation of stroke patients. It first investigates the application of pose estimating technologies to objectively measure posture.

This can entail capturing a patient's body position with cameras or other sensors in order to detect any imbalances or variations from normal posture brought on by the stroke. The study also looks at how well dynamic core postural chain stabilization (DCS) methods work for stroke recovery. The goal of DCS exercises is to increase stability and strength in the core, which can help with general postural control. This research aims to optimize stroke patient rehabilitation by combining a precise evaluation approach with a focused intervention strategy, which may result in improved balance, movement, and functional abilities.

Eligibility Criteria:
Inclusion Criteria:

* Stroke, either ischemic or hemorrhagic
* Standing ability and ability to perform basic movements with assistance
* Willingness to take part in the intervention and evaluations

Exclusion Criteria:

* Severe cognitive impairment hindering participation
* Unstable medical conditions affecting rehabilitation
* History of other neurological disorders affecting posture
Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.

All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
* Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
* Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
* Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
* Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* Acute disease and/or fever at the time of enrolment.
Peripheral Airway Biopsy in Sarcoidosis

Airway involvement in sarcoidosis was demonstrated in a meaningful, albeit variable, proportion of patients through biopsy of the central, endoscopically visible airways. Ideally, biopsy of peripheral airways, nowadays possible with the introduction in the market of ultrathin bronchoscopes, might be associated with an increased diagnostic yield for the detection of granulomas.

Sarcoidosis is a systemic disorder of unknown cause that primarily involves the lung and lymphatic systems and that is more reliably diagnosed if a compatible clinical picture is combined with a pathologic demonstration of non-necrotizing epithelioid-cell granulomas. Endobronchial biopsy (EBB), taken from the central airways with standard-sized videobronchoscopes, has long been used in clinical practice, although its diagnostic yield has been shown to be widely variable across different ethnicities. A recent prospective study shows that the diagnostic yield of EBB in a sarcoidosis population with large prevalence of white Europeans is 37% overall, and 22% in patients who do not have endobronchial abnormalities. The diagnostic yield of biopsies taken from peripheral airways with ultrathin bronchoscopes was never been evaluated, to our knowledge.

Eligibility Criteria:
Inclusion Criteria:

* Necessity of a pathological confirmation of the clinical and radiological (CT) diagnosis of sarcoidosis.
* Age \>18 years
* American Society of Anesthesiologists score 1-3.

Exclusion Criteria:

* Inability of unwillingness to consent
* Steroid therapy (at least 1 week) in the 2 months preceding bronchoscopy.
* Pregnancy.
* Uncontrolled coagulopathy
* Contraindication to the temporary interruption of anticoagulants or antiplatelet drugs, except aspirin.