cyrilzakka/clinical-trials huggingface dataset:
The Role of Treatment Expectation in Exposure Training With Spider Fearful Participants

This study evaluates the role of treatment success expectation in spider fearful individuals on the actual treatment success. Half of participants will have positive treatment success expectations, while the other half will have neutral treatment outcome expectations.

The investigator plan to conduct a randomized, single blind study with two parallel groups. Both groups undergo the same standardized psychotherapeutic intervention, i.e. exposure training. All participants will receive the same exposure training in groups of maximum three participants of the same study group. The two study groups only differ regarding the induced treatment expectations towards the effects of the exposure training. While the experimental group will get an open administration of treatment and be informed in order to have a positive treatment expectation, the comparator group will receive a hidden administration of treatment and get neutral information, thus treatment expectations will be neutral. Study members conducting the exposure training with the participants will not be aware of the allocation of the study participants. Study participants will be informed about the aim of the allocated condition, but they will be blind to the aim of the study in order to induce the specific expectation. Differences in treatment outcomes are compared between both groups to investigate the association with treatment expectation.

Eligibility Criteria:
Inclusion Criteria:

* good knowledge of German language
* fulfilling criteria A-E and G for specific phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V (fulfilling criteria F is not an inclusion criteria)

  * marked fear or anxiety about spiders
  * spiders almost always provoke immediate fear or anxiety
  * spiders are actively avoided or endured with intense fear or anxiety
  * the fear or anxiety is out of proportion to the actual danger posed by spiders
  * the fear, anxiety, or avoidance is persistent, typically lasting for 6 months or more
  * the disturbance is not better explained by the symptoms of mental disorders as agoraphobia, obsessive-compulsive disorder, posttraumatic stress disorder, separation anxiety or social anxiety disorder

Exclusion Criteria:

* acute or chronic psychiatric disorder
* currently in psychological or psychiatric treatment
* knowledge of exposure training
The Impact of Oral Health Literacy on Dental Anxiety and Utilization of Oral Health Services

Oral Health Literacy is an integral part that should be taken into measures when evaluating the oral health status of any population. It has been stated that adults with low oral health literacy are more prone to miss their dental appointments and that low levels of oral health literacy, and being anxious and fearful of the dentist is a common barrier to the utilization of dental services. Unfortunately no previous studies assessed the oral health literacy level, dental anxiety and utilization of dental services among the Egyptian population. So the aim of the current study is to detect the impact of oral health literacy on level of dental anxiety and utilization of dental services among Misr International University (MIU) dental patients.

The current study is a cross sectional study that includes an interview lead questionnaire that will be carried out by second year dental students of the academic years (2018-2019, 2019- 2020). The questionnaire consists of four sections; a demographic section, a modified Arabic Rapid Estimate of Adult Literacy (ARELAD-30) Tool, Arabic Modified Dental Anxiety Scale (AMDAS), and Utilization of oral health services questionnaire. Before conducting the study, orientation sessions and thorough training of the students will be performed to ensure that the students can conduct the interview consistently and efficiently. Students will be asked to design educational materials (brochures, leaflets and posters) that aim at improving patients' knowledge and awareness regarding oral health and the utilization of oral health services. The aim of this study is to detect the impact of oral health literacy on the level of dental anxiety and utilization of dental services among dental patients.

Eligibility Criteria:
Inclusion Criteria:

* Both genders.
* Age: 18 - 60 years old.
* Dentate or partially edentulous patients with or without fixed or removable appliances.
* Healthy adults as well as adults with any chronic condition and/or under regular use of medication.

Exclusion Criteria:

* Subjects with mental or psychological problems.
* Subjects who cannot read or write.
Physical Activity and FVIII Elimination: Relevance to Personalized Therapy in Severe Hemophilia A

In persons with severe haemophilia A infused factor VIII half-life and other pharmacokinetic can vary according to determinants such as blood group, von Willebrand factor (VWF) level or age. However, FVIII pharmacokinetics (PK) has not been throughly studied in patients with severe HA as a function of daily physical activity. It si known that vigorous intensity physical activity/exercise can transiently but significantly increase circulating levels of endogenous VWF and consequently FVIII in normal subjects and in patients with moderate or mild haemophilia A. The proposed study is a Proof of Concept one as it will be aimed at investigating the relation between daily physical activity, measured by Sensewear armband device, as number of daily steps and PK variability of infused rec-FVIII concentrate. This kind of investigation has never been done and it is a great interest also for the evaluation of patient's qualitiy of life.

In persons with severe haemophilia A infused factor VIII half-life and other pharmacokinetic can vary according to determinants such as blood group, von Willebrand factor (VWF) level or age. However, FVIII pharmacokinetics (PK) has not been throughly studied in patients with severe HA as a function of daily physical activity. It si known that vigorous intensity physical activity/exercise can transiently but significantly increase circulating levels of endogenous VWF and consequently FVIII in normal subjects and in patients with moderate or mild haemophilia A. The proposed study is a Proof of Concept one as it will be aimed at investigating the relation between daily physical activity, measured by Sensewear armband device, as number of daily steps and PK variability of infused rec-FVIII concentrate. This kind of investigation has never been done and it is a great interest also for the evaluation of patient's qualitiy of life. Physical Examinations at screening and subsequent study visits a physical examination will be performed on the following body systems being described as normal or abnormal: general appearance, headand neck, eyes and ears, nose and throat, heart, abdomen, extremities and joints, lymph nodes and neurological. At screening, if an abnormal condition is detected, the condition will be described on the medical history CRF. At study visit, if a new abnormal or worsened abnormal pre-existing condition is detected, the condition will be described n the CRF.

Eligibility Criteria:
Inclusion Criteria:

* patients 12-60 yo with severe HA under FVIII concentrates prophylaxis will be selected at the Haemostasis and Thrombosis Center of the Fondazione Policlinico Gemelli IRCCS Rome (FPG)

Exclusion Criteria:

* all patients with malignant tumors or
* patietnts treated with anticoagulant / antiplatelet agents
* patients suffering from other congenital coagulation disorders (von Willebrand disease, other congenital deficiency of coagulation factors or severe thrombocytopenia (\< 30,000 Plt/uL)
Comparison of Two Devices During Colonoscopy

Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy. In this study we compare two devices: Endocuff (TM) and cap that can increase the adenoma detection rate during colonoscopy.

Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. Endocuff Vision™ has been shown to improve adenoma detection rate in several studies. Cap-assisted colonoscopy is a technique that allow improved visualization of the colonic folds by flattening the fold within the viewing field. However, studies have reported mixed results on adenoma detection in cap-assisted colonoscopy.

This is a prospective, single-centre, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy versus cap-assisted colonoscopy. Patients are randomized according to bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or cap colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Patients are followed up at 30 days for complications. This study will take place in an University Hospital in Spain. A maximum of 9 expert colonoscopists will recruit a total of 712 patients.

This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ vs cap colonoscopy in all screening, surveillance, and diagnostic patient groups. This study will guide clinicians to decide what device to use to increase adenoma detection rate in routine colonoscopy

Eligibility Criteria:
Inclusion Criteria:

* All patients who are attending for screening, surveillance or diagnostic colonoscopy.

Exclusion Criteria:

* patients with absolute contraindications to colonoscopy;
* patients with established or suspicion of large bowel obstruction or pseudo-obstruction;
* patients with known colonic strictures;
* patients with a known severe diverticular segment (that is likely to impede colonoscope passage);
* patients with active or known colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis);
* patients lacking capacity to give informed consent;
* patients on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure;
* patients who are attending for a therapeutic procedure or assessment of a known lesion, or submitted for rectoscopy or rectosigmoidoscopy;
* examination performed by a non-expert colonoscopist;
* pregnancy.
Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome

The objective of this study is to determine if citocoline is effective for balance abnormalities and to stabilize cognitive decline in patients with fragile X-associated tremor ataxia syndrome. The study will test 1000mg twice daily of citocoline for 12 months in an open label pilot study, with study visits at baseline, 3, 6, and 12 months.

The purpose of this study was to determine if citicoline was safe for the treatment of tremor and balance abnormalities and to stabilize cognitive decline in patients with fragile X-associated tremor ataxia syndrome. Ten participants with diagnosed FXTAS were administered 1000 mg of citicoline once daily for 12 months. Outcome measures and neurological examination were performed at baseline, 3 months, 6 months, and 12 months. The primary outcome was safety. Secondary outcomes included change in FXTAS Rating Scale score, a battery of neuropsychological tests, an instrumented Timed up and go test, computerized dynamic posturography, 9-hole pegboard test, and balance confidence and psychiatric symptom questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of FXTAS

  * Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG are within normal limits

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Presence of severe renal disease (BUN 50% greater than normal or creatinine clearance \<60 mL/min) or hepatic disease.
* Abnormal creatine kinase and/or platelet count in the past 6 months (as determined by lab reports obtained from primary care physicians or conducted at baseline).
* Women of childbearing potential who are pregnant at the time of screening or who will not use adequate protection during participation of the study.
* Allergy/sensitivity to the drug of its formulations.
* Concurrent participation in another clinical study.
* Active substance use or dependence.
* Serious illness (requiring systematic treatment/or hospitalization) until the subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 60 days prior to study entry.
* Inability or unwillingness of the subject or legal guardian/representative to give written informed consent.
Lipid Profile and Ultrasound Findings in Patients With Pancreaticobiliary Diseases

Gall stones happen is the most prevalent pathology affecting the biliary system due to its Physiological function of concentration of bile having a prevalence of 10%-15% and an incidence of 1.4% per year in the adult population of developed countries (Halldestam et al,. 2009). Women are more commonly affected by gall stone disease as compared to men (Attili et al,. 1995).

Multiple risk factors responsible for the Gall stone formation include modifiable factors such as lifestyle factors (reduced physical activity, rapid weight loss, fasting, and oral contraceptives (Di Ciaula et al,. 2013); dietary factors (high fat, high cholesterol, high refined carbohydrates, and low fiber ; metabolic syndrome (obesity, diabetes mellitus, dyslipidemia, and hyperinsulinemia (Cuevas et al., 2004).

Among all the above mentioned risk factors, serum lipids are considered to be the most important risk factor involved in the pathogenesis of Gall stone disease (Celika et al,. 2015). Hyperlipidemia is generally characterized by high serum levels of total cholesterol, triglycerides, low density lipoproteins (LDL-C), and low levels of high-density lipoprotein (HDL-C). Some studies have showed a significant association of hyperlipidemia with gall stones especially hypertriglyceridemia and increased LDL-C levels (Rao et al,. 2012).

Acute pancreatitis (AP) is an inflammatory condition of the pancreas that originates within the pancreatic acinar cells and causes pancreatic necrosis, systemic inflammatory response syndrome, and multiple organ failure (Crockett et al,. 2013). According to The revised Atlanta classification system from 2012 ,AP is diagnosed on the basis of two of three criteria-typically belt-like abdominal pain, an elevated serum lipase level three times above the normal threshold, and radiological imaging signs of pancreatitis (Parniczky et al,.2016).

Severe hypertriglyceridemia is a well-known cause of AP. Recent studies have suggested that elevated serum triglyceride and low high-density lipoprotein cholesterol (HDL-C) levels are associated with persistent organ failure in acute pancreatitis (Peng et al,. 2015). With the change of people's diet structure and lifestyle, the incidence and mortality of hypertriglyceridemic AP are increasing year by year and has surpassed alcohol as the second leading cause of AP (Carr et al,. 2016).

Chronic pancreatitis is a syndrome characterized by chronic progressive pancreatic inflammation, fibrosis, and scarring, resulting in damage to and loss of exocrine (acinar), endocrine (islet cells), and ductal cells(Majumder S,. 2016)


Eligibility Criteria:
Inclusion Criteria:

* Patients with age above 18 years
* Patients with confirmed diagnosis of gall stones ,acute calcular cholecystitis ,calcular obstructive jaundice ,biliary stricture ,acute and chronic pancreatitis

Exclusion Criteria:

* Patients with renal failure, hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film).
* Patients on antihyperlipidemic drugs .
CFT Self-Help for Accessing Cervical Screening After Sexual Assault

The aim of this study is to evaluate the feasibility of a new self-help intervention designed to support individuals (anyone with a cervix) to access cervical cancer screening following the experience of sexual assault, by addressing psychological barriers identified by previous research, specifically shame, low self-efficacy and the re-traumatising nature of attending to sexual health after sexual trauma.

The study aims to investigate the acceptability, feasibility and limited efficacy of a discrete, easily accessed (mobile phone, tablet or computer) self-help intervention to support people to access cervical screening independently.

The study will use a wait-list control design, with participants randomly allocated to receive access to the intervention immediately or after a six-week wait.

The intervention will be in the form of a web app and will contain a range of psychoeducational material and practice exercises following a cognitive-behavioural and compassion-focused approach to understanding and coping with trauma, building self-compassion and increasing confidence in ability to attend and complete a screening.

Eligibility Criteria:
Inclusion Criteria:

* Has a cevix
* Within age range for cervical cancer screening in UK (25-64 years)
* Experience of sexual assault (in childhood and/or adulthood; not within last 12 months)
* Currently experiencing difficulty attending cervical cancer screening
* Has access to smartphone/computer with internet
* Has a valid email address
* Able to read and understand English
* Living in UK

Exclusion Criteria:

* No cervix
* Outside of UK cervical cancer screening age range
* No experience of sexual assault or sexual assault occurred within last 12 months
* No access to smartphone or computer and internet
* Unable to read or understand English
* Not living in UK
* In acute mental health crisis
Mild and Rapidly Improving Stroke Study

The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Mild or spontaneously rapidly improving ischemic stroke confirmed by neuroimaging
* Arrival to hospital within 4.5 hours of symptom onset
* Willing to provide consent
* Available for a telephone interview at 30 and 90 days

Exclusion Criteria:

* Onset \>4.5 hours
* Unable to provide informed consent (patient or legally appointed representative
* Premorbid modified Rankin Scale \>1
* Unavailable by telephone for follow-up
Modifications in the Anaerob Threshold in Cyclists by Consuming Docosahexaenoic Acid (DHA)

In a double-blind, parallel randomized clinical trial with 38 cyclists in whom the performance improvement was determined after the consumption of docosahexaenoic acid for one month.


Eligibility Criteria:
Inclusion Criteria:

* Male between 18 and 75 years old.
* Cyclists who train three or four times a week.

Exclusion Criteria:

* Suffering some type of chronic disease.
* Consume habitually pharmacological treatments that could influence the physiological or biochemical responses to be analyzed in the present work.
* Consumption in the month prior to the start of the study, or during the performance of the same, functional food enriched with omega-3 fatty acids.
* To present during the performance of the stress tests, any of the absolute or relative contraindications dictated by the American College of Sports Medicine (ACSM, 1999) 15 would be duly informed and excluded from the present study.
Histamine and Bone Pain Association in Participants With Breast Cancer Metastatic in the Bone

This trial studies histamine and bone pain association in participants with breast cancer that has spread to the bone. Studying histamine levels in samples of blood from participants with breast cancer in the laboratory may help doctors learn more about reducing cancer bone pain and preventing further bone metastasis.

PRIMARY OBJECTIVES:

I. To correlate levels of histamine in plasma with pain scores in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy.

SECONDARY OBJECTIVES:

I. To perform exploratory studies with additional markers not mentioned, including calcitonin gene-related peptide (CGRP), stem cell factor (SCF), angiotensin II (Ang II) substance P, angiotensin 1-7 (Ang1-7), may be performed at the investigator's discretion.

II. To perform next generation ribonucleic acid (RNA) sequences using the whole blood to determine whether histamine system is involved in the development of cancer-induced bone pain (CIBP).

III. To assess the impact of pain response after radiotherapy on bone structural properties such as bone mineral density and cortical thickness, and patient quality of life, physical and psychological function.

OUTLINE:

Participants undergo collection of blood samples for histamine level analysis via enzyme-linked immunosorbent assay (ELISA).

After completion of study, participants are followed up at 1, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients with radiographic evidence of bone metastases (by plain film, computed tomography \[CT\], magnetic resonance imaging \[MRI\], positron emission tomography \[PET\] or bone scan) within 8 weeks of registration

  * Weight bearing sites: pelvis (excluding pubis), femur, sacrum and/or sacroiliac joints, tibia, up to 5 consecutive cervical, thoracic or lumbar vertebral bodies, lumbosacral spine
  * Non-weight bearing sites: up to 3 consecutive ribs, humerus, fibula, radius +/- ulna, clavicle, sternum, scapula, pubis
* Patients with and without pain related to the radiographically documented metastases are eligible for study
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

* Pregnant women will be excluded
Investigate the Renal Movement by Single Lung Ventilation in Patients Administered RIRS for Kidney Stones.

In patients undergoing RIRS for kidney stone, we aim to show the effect of single lung ventilation with a double lumen tube on operative (operation scope duration, perforation, hemorrhage, etc. complications) and postoperative parameters (stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc.) and to show changes in renal stone position during simultaneous normal ventilation and single lung ventilation.

In recent years open surgical treatment has changed to minimal invasive treatments for kidney stone treatment. Additionally, the treatment choices vary depending on the localization of the stone and its dimensions. In the European Urology Association (EUA) guidelines, it states the RIRS method can be used to treat stones up to 2 cm in the kidney. Due to RIRS the operation and scopy durations and hospital stay have clearly reduced compared to the standard treatment of percutaneous nephrolithotomy. However, the high hydrostatic pressure applied to the renal pelvis during RIRS may cause unwanted results in the postoperative period such as hydronephrosis and loss of renal parenchyma. During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation and scope durations and brings risks such as perforation during laser lithotripsy application. In this study we aimed to apply single lung ventilation during the operation (one of the indications for single lung ventilation is to increase surgical view and ease manipulation) to minimize renal movement on that side and reduce peroperative and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years
2. ASA (American Society of Anesthesiologists) 1-3
3. Patients with 2-3 cm stones in kidneys

Exclusion Criteria:

1. Patients with staghorn stones in kidneys
2. Patients with urinary system anomalies

Removal Criteria :

1. Difficult airway
2. Patients with carinal, bronchial lesions
3. Patients with bad general situation
4. Patients younger than 18 years
5. Satiated patients