cyrilzakka/clinical-trials huggingface dataset:
Online Self-help for Students With Suicidal Ideation

The main goal of this study is to evaluate the effectiveness of an unguided web-based intervention for (college/university) students with suicidal ideation. This study will test the effectiveness by studying the effect on suicidal ideation and related outcomes (hopelessness and worrying) through a pre-post study design.


Eligibility Criteria:
Inclusion Criteria:

* Be student at a university or college
* Have suicidal thoughts
* ≥ 18 years old
* Have access to internet and a computer/laptop/smartphone
* Speak Dutch

Exclusion Criteria:

* /
Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®

The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* Diagnosis of haemophilia A in males or females, no age limitation.
* New patients who have not previously been exposed to Esperoct®.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Known or suspected hypersensitivity to study product or related products.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Dental Practitioners KAP Regarding Caries Preventive Measures in Cairo and Riyadah

The study aims to evaluate the knowledge, attitude, and practice of dental practitioners from Cairo and Riyadh regarding caries preventive measures.

Periodontal disease and dental caries have been regarded as the two most enormous worldwide health burdens. Currently, the distribution and severity fluctuate within a single nation or area and throughout the globe. According to epidemiological statistics, the frequency of dental caries has decreased in most industrialized nations over the past few decades. It has been suggested that it is due to the influence of multiple factors, including the use of fluoride, enhanced oral hygiene including brushing and flossing, dietary changes, and specific procedures performed in the dentist's office such as routine examinations, including diagnostic radiographs, scaling and polishing, fluoride applications, and sealants. Dental caries is a chronic, persistent dental condition that gets harder to cure as it progresses. The contemporary dental practice's preventive strategy has been acknowledged as a key factor in the recent drop in caries and a key component of the practice's service mix going forward. One of the World Health Organization's (WHO) major actions for ongoing oral health improvement is reorienting oral health services toward preventive and health promotion. A preventative approach can reduce the burden of oral health problems, as cited by WHO. Literature shows that although dentists' knowledge may be good, there are certain limitations to applying the preventive approach, lack of positive attitude, and implications in daily practice. With this background, the study aims to evaluate dental practitioners' knowledge, attitudes, and practice regarding caries preventive measures in Cairo compared to Riyadh.

Eligibility Criteria:
Inclusion Criteria:

* Licensed Egyptian and Saudi general dentists.

Exclusion Criteria:

* Undergraduate dental students
* Dental specialists
* Dentists who refused to participate
Primary Dynamization Versus Standard Interlocking Intramedullary Nail in Treatment of Tibial Shaft Fractures in Adults

fracture shfat tibia in adults treated by interlocking intramedullary nail by primary dynamic versus standard ways


Eligibility Criteria:
Inclusion Criteria:

* adult patients (18-50) fractures with mid shaft or distal shaft tibial fracture AO type A1, A2 and A3 and minimal soft tisuue damage

Exclusion Criteria:

* patients with comminuted fractures , old age more than 50 years , sclerotic bone , osteoporosis, osteopetrosis and bone deformity
Non-interventional Study Related to Fixed LAMA/LABA/ICS Triple Therapy

This is a prospective non-interventional trial to measure the health related quality of life of patients with chronic obstructive pulmonary disease (COPD) on a fixed LAMA/LABA/ICS triple therapy (Trimbow®) and characterisation of determinants of treatment adherence.

The primary goal of COPD therapy is the prevention of exacerbations and clinical deterioration. To achieve these goals, treatment adherence (i.e. taking medication as prescribed) is important. However, non-adherence (not taking medication as prescribed) is common in COPD and can be affected by lifestyle changes or use of multiple inhalers.

The effects of Trimbow® on patients' health related quality of life, adherence and clinical outcomes have not been assessed in a UK real-world setting. This non-interventional trial aims to collect data from COPD patients under routine care over a 6 month period, for whom their doctors has decided to prescribe Trimbow® as per the authorised indication. We plan to investigate any changes in quality of life, as well as changes in lung function and the need for any additional therapy over 6 months. We also plan to investigate the adherence or reasons for non-adherence to Trimbow® as used in everyday routine.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with moderate to severe COPD (with and without concomitant asthma)
2. Physician decision to start therapy with Trimbow as per its current marketing authorisation; the treatment decision should be made independently from participation in this Non-Interventional Trial
3. Patients with at least one COPD exacerbation within the previous 12 months
4. Patients willing and able to sign informed consent for use of their pseudonymised clinical data within the present Non-Interventional Trial

Exclusion Criteria:

1. Patients hospitalised due to an exacerbation of their COPD within the last 4 weeks prior to enrolment
2. Participation within an interventional clinical trial within 30 days prior to enrolment into the present Non-Interventional Trial
Laparoscopic Approach for Emergency Colon Resection

This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery.

Laparoscopic technique in elective colorectal surgery has been shown to be advantageous for patients compared to open technique. However, the feasibility and potential benefits of laparoscopic colorectal surgery in emergency setting has not been evaluated sufficiently.

The aim of this study is to compare laparoscopic and open technique in emergency colon resections. Primary outcome is the immediate recovery after operation and secondary outcome is long-term overall and cancer-specific survival.

Eligibility Criteria:
Inclusion Criteria:

* all patients in need of emergency colon resection

Exclusion Criteria:

* age \< 18 year
* trauma patients
* reoperations
* acute pancreatitis
BHV-7000 Open-Label Extension Bipolar Mania Study

The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.


Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects must have successfully completed the parent study, BHV7000-204.
2. WOCBP must have a negative urine pregnancy test at Baseline visit.
3. WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.

Key Exclusion Criteria:

1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
2. Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study.
3. Investigator deems subject at imminent risk of danger to others or themself.
Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

The purpose of this study is to investigate the efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.


Eligibility Criteria:
Inclusion Criteria

* Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements:

  * Necrotizing fasciitis
  * Compromised/failed skin grafts/flaps
  * Chronic refractory osteomyelitis
  * Soft tissue radiation necrosis
  * Diabetic wounds, lower extremity
  * Acute peripheral arterial insufficiency
  * Crush injury
  * Venous leg disease
  * Pressure ulcer
  * Other chronic, non-healing wounds
* Subjects must have signed the Informed Consent Forms.

Exclusion Criteria

* Female subjects who are pregnant or nursing.
* Anyone who is unable to give written informed consent
* Subjects with end-stage renal disease or who require peritoneal or hemodialysis.
* Subjects with current malignancies.
Executive Functioning and Mindfulness in Adults With Attention Deficit/Hyperactivity Disorder Imaging

The main purpose of this study is to evaluate changes in brain functioning using an MRI machine following mindfulness meditation training.

The broad objective of this proposal is to identify functional neuroanatomical correlates of changes in executive brain functioning prior to and following an 8-week, group-based mindfulness meditation intervention within a group of 10 adults diagnosed with Attention-deficit/hyperactivity disorder (ADHD). Another group of 10 adults diagnosed with ADHD will be placed in the waitlist condition.

Our primary hypothesis is that adults with ADHD in the treatment group will exhibit improved performance on a series of executive functioning tasks and that exposure to task stimuli will correspond to changes in neural functioning following an 8-week, group-based mindfulness intervention. Brain responses will be measured using blood-oxygenation-level-dependent (BOLD) fMRI signal in brain regions associated with emotional and executive processes prior to and following treatment.

Eligibility Criteria:
Inclusion Criteria:

* ages 18-50 years
* meet DSM-IV criteria for ADHD
* intellectual functioning ≥ 80 as assessed by an IQ screener
* generally healthy (i.e., no major medical problems)

Exclusion Criteria:

* major medical condition that would make participation unsafe (e.g., have pacemaker or other metallic implant), uncomfortable (e.g., chronic pain)
* claustrophobic, or abnormally afraid of closed-in places
* current drug use
Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.

Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).

Study centers A total of 20 subjects will be enrolled in 1 site in France.

Methodology This will be a monocentre, randomised, controlled, investigator-blind, intra-individual comparative clinical investigation.

There will be a total of 6 visits for each subject. Each subject will participate for a period of maximum 35 days.

Study population Healthy subjects, male or female, at least 18-60 years old, with phototype I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion criteria.

The clinical investigation will be conducted in 2 parts.

Part 1 - SPF determination:

To determine the SPF of Actinica® with application of two different amounts (0.8 and 2 mg/cm2).

Part 2 - Sun exposure:

To assess the performance of the different application regimens of Actinica® on protection from UVR-induced erythema throughout 1 day of sun exposure.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-60 years of age,
2. Subject with Phototype I, II or III,
3. Subject with individual typology angle (ITA) 28-70°,
4. Subject with healthy skin / not tanned on the back,

Exclusion Criteria:

1. Subject with obvious skin cancer forms within the test areas, 2. Subject with hairs on the treated area that might interfere with clinical investigation assessments, 3. Subjects who have performed sun bathing at least four months before enrolment, 10. History of sun allergy / Mallorca acne, active photo induced or photo aggravated disease, or abnormal response to the sun (e.g., photosensitive dermatoses, polymorphic light eruption, solar urticaria, systemic lupus erythematosus, or dermatomyositis).

11. The subject has received, applied or taken the forbidden treatments within the specified time frame prior to the Day 0 visit (list available on request)
Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery

Laparoscopic total colectomy (LTC) is an accepted surgical procedure for several colonic pathologies. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LTC. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LTCs.

compare the patient-selected NOSE method and conventional method in laparoscopic total colon surgery

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic total colectomy patients

Exclusion Criteria:

* no
Comparison Study of MDX-010 (CTLA-4) Alone and Combined With DTIC in the Treatment of Metastatic Melanoma

The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine \[DTIC\]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.


Eligibility Criteria:
Inclusion Criteria

* Clinical diagnosis of unresectable metastatic melanoma.
* No prior chemotherapy for melanoma, and no chemotherapy for other malignancies within 5 years and at least 4 weeks since treatment (surgery, radiation, or immunotherapy) for melanoma.

Exclusion Criteria

Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:

* Any other prior malignancy, except for the following: adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the patient has been disease-free for \>=5 years.
* Active autoimmune disease.
* Active infection requiring therapy, or chronic active HBV or HCV, or confirmed reactivity with HIV tests.
Prospective Cohort Study of the Effect of Bariatric/Metabolic Surgery on Morbid Obesity Patients With Metabolic Syndrome

The purpose of this study is to determine the change in kidney function and blood pressure after gastric bypass versus conventional medical therapy in morbid obesity. The study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.

Metabolic syndrome is strongly associated with obesity and the patients with this syndrome are at increased risk for cardiovascular disease.

Obesity constitutes a strong risk factor for the development of chronic kidney disease. Among diabetics, obesity is known to amplify the risk for kidney disease.

Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome. In addition, many observational studies have demonstrated significant reduction in proteinuria after bariatric surgery.

However, the changes in the component of cardiovascular problem among metabolic syndrome and changes in renal filtration function or progression to end stage kidney disease in morbidly obese patients after weight loss surgery have not been extensively studied. Therefore, our study mainly focus on glomerular filtration rate(GFR) with known relation to the renal function and 24 hours ambulatory blood pressure monitoring after intervention of gastric bypass or medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Morbid obesity (BMI\>30) patients with one of comorbidity (type 2 diabetes, dyslipidemia, or hypertension)
* Morbid obese patients (BMI\>35)

Exclusion Criteria:

* Prior bariatric surgery
* Malignancy (any type)
* End stage renal disease
Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis

This study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic partial irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing.

Once included, study subjects will be randomly allocated to either Miniature Pulpotomy group or Partial Pulpotomy group. MTA (Mineral Trioxide Aggregate) will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in same appointment.

Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 6 and 12 months from baseline.

Eligibility Criteria:
Inclusion Criteria:

* The patient with18 -45 years of age.
* Restorable molar teeth.
* Tooth should give positive response to pulp sensibility testing.
* Clinical diagnosis of symptomatic partial irreversible pulpitis.
* Tooth with probing pocket depth and mobility are within normal limits.
* No signs of pulpal necrosis including sinus tract or swelling.
* Non-contributory medical history

Exclusion Criteria:

* Teeth with immature roots.
* No pulp exposure after caries excavation.
* Bleeding could not be controlled in 6 minutes.
* Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic
Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants

The management options of Patent Ductus Arteriosus are still controversial and differ between centers. Recently, conservative management has been gaining interest as the evidence of benefit from medical treatment in terms of mortality and morbidity is lacking.

This study will compare oral ibuprofen (the standard treatment) with the conservative treatment, in terms of ductal closure and morbidity and mortality at discharge in preterm neonates less than 34 weeks.

A double-blinded, randomized, placebo-control non-inferiority trial was conducted in the neonatal intensive care unit (NICU) of Ain Shams University children's hospital, Cairo, Egypt.

Informed consent was taken from the parents or legal guardians before enrolment, after fully explaining to them the nature of the study. The approval of the Research Ethics Committee at Ain Shams University was also obtained.

All preterm neonates less than 34 weeks were assessed in the first 48 hours by clinical and echocardiographic examination by a cardiologist to detect PDA and exclude any congenital heart disease.

All neonates meeting the inclusion criteria will be randomized into one of two groups:

Medical treatment group and Placebo group. Targeted neonatal Echo was repeated after 5 days of the start of medical treatment by a neonatologist or a cardiologist to assess PDA closure.

After 7 days of intervention, open-label is offered to all patients with the option of another course for patients in the medical treatment group and Rescue therapy in the Placebo group.

The short-term morbidity is documented.

Withdrawal and replacement of individual subjects:

* The attending physician can decide to withdraw a subject from the study for urgent medical reasons. If they wish, parents or caregivers can leave the study at any time for any reason.
* Infants who are withdrawn from the study will be managed according to NICU Protocols.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≤ 34 weeks
* PDA Size \> 1.5 mm and predominantly left-to-right shunt
* One of the following:
* Signs of Pulmonary overflow: Left atrium/Aortic diameter ratio (LA/Ao), Left Ventricular End Diastolic Diameter (LVEDD).
* Signs of Systemic Hypo perfusion: Absent or Reversed diastolic flow in the aorta, celiac/mesenteric, or Anterior Cerebral Artery (ACA)/ Middle Cerebral Artery (MCA)

Exclusion Criteria:

* Chromosomal anomaly
* Congenital heart defect, other than PDA and/or patent foramen ovale
* Congenital or acquired gastrointestinal anomaly
* Previous episodes of Necrotizing enterocolitis (NEC) or intestinal perforation
* Active bleeding, especially intracranial or gastrointestinal hemorrhage
* Contraindications to the use of ibuprofen
Enhancing Student Learning by Simulation

As the standard of best practice, care of complicated or difficult patient needs not only knowledge but also including skills and clinical thinking in many aspects.

Simulation is now accepted as the way of teaching for adult learners. This learning method can help students to apply their knowledge, practical skills and non-technical skills. A systematic review study showed that self-directed learning (SDL) in health professions education is associated with moderate improvement in the knowledge domain. SDL also help the learners to improve self-efficacy and the learning outcomes in complicated tasks.In this study, the investigators wanted to evaluate that simulation can enhance student to do SDL in the both pre and post session period.

After approval from the instution's Ethics Committee, a prospective cohort study was conducted between November 2017 to March 2018. Twenty-five anesthesia residents were participated in this study. Students were noticed about the simulation classes which are emergencies in pediatric anesthesia and complications at one-month prior the day of practice. The list of standard references was given. On the day of study, at the institute's simulation center, students were voluntarily separated into two groups, directed- learner and observer. Post class debriefing sessions were done as routine activities. After the class, the investigator invited the students to be enrolled in this study by using the flyers. Following the consent process, three consecutive questionnaires (day 0 ,30, 90) were sent to the subjects. The data analysis will be done by using R program. The statistically significance in this study was classified at p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesia residences who are currently studying in the department of Anesthesia

Exclusion Criteria:

* Refuse to participate