cyrilzakka/clinical-trials huggingface dataset:
Comparison of IVR and CATI Surveys in Bangladesh

This study focuses on mechanisms to adapt the performance of interactive voice response (IVR) and computer assisted telephone interviews (CATI) surveys conducted in low-and middle-income (LMIC) setting (Bangladesh) and evaluates how the two survey modalities (IVR and CATI) affect survey metrics, including response, completion and attrition rates.

Using random digit dialing (RDD) sampling technique, participants will be randomized to one of two arms : 1) IVR or 2) CATI. Participants in the first study arm will receive an IVR survey. Participants in the second study arm will receive a CATI survey. Each questionnaire contains a set of demographic questions and one non-communicable disease (NCD) module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes). We will examine contact, response, refusal and cooperation rates and demographic representativeness by each study arm.

Eligibility Criteria:
Inclusion Criteria:

* Access to a mobile phone
* Greater or equal to 18 years of age
* In Bangladesh, conversant in Bengali language

Exclusion Criteria:

* Less than 18 years of age
Impact of COVID-19 on Pediatric Dental Practice During First, Second And Third Wave.

Assessment of impact of covid-19 on pediatric dental practice during first, second and third wave among a group of pediatric dentists.

On the 11th of March, 2020, COVID-19 (SARS-CoV-2) was declared as a pandemic by the World Health Organization. SARS-CoV-2 is an unpredictable virus that is rapidly transmitting from one country to another, and unfortunately as of today, there is no effective medication or vaccine for the disease control. This virus has gone on to cause one of the most rapidly expanding pandemics with over 9 million people being infected worldwide including the pediatric population.

Due to the unique nature of dentistry, most dental procedures generate significant amounts of droplets and aerosols, posing potential risks of infection transmission. Recent studies have demonstrated the role of the oral mucosa in COVID-19 infection, in addition to expressing the ACE2 receptor in salivary glands in the asymptomatic process in infected saliva, thus being one of the main sources of viruses.

Clinical features of COVID-19 in children include fever and cough, but a large proportion of infected children appears to be asymptomatic and may contribute significantly to transmission. Therefore, it can be assumed that, at this stage in the pandemic, all children and their parents/carers are potentially infective with the potential of cross-infection to dental stuff, parents and the public. This has, in theory, an impact on medical and dental procedures that are Aerosol Generating Procedures.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian pediatric dentists with at least Master's degree.
* Work place located in Egypt.

Exclusion Criteria:

* Participants who refuse to participate.
Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery

Incidence of anesthesia related complications in multiple gestation patients undergoing cesarean delivery has not been reported in Thailand. The aim of this study is to identify complications that occur which may derived from different anesthetic techniques used, such as hypotension, uterine atony, postpartum hemorrhage, rate of hysterectomy, blood transfusion and fetal outcome.

Nowadays, the rate of multiple gestations is increasing considerably due to the prevalence of assisted reproductive technology. As physiologic changes from multiple gestations differ from singleton pregnancy, multiple gestations are considered a high risk pregnancy. A number of complications can occur from prenatal period such as preterm labor and increase rate of maternal beta agonist usage e.g. ritodrine, terbutaline and salbutamol. These drugs cause maternal tachycardia, hypokalemia and pulmonary edema. Multiple gestations increase rate of cesarean delivery and intraoperative complications such as postpartum hemorrhage and hysterectomy can be found 3.7 times and 2.3 times respectively higher than that of singleton pregnancy.

Spinal anesthesia is the anesthetic technique of choice for parturients undergoing cesarean section, owing to its rapid onset of action, reliability, superior postoperative pain control and lower mortality rate than general anesthesia. However, the most important complication is maternal hypotension, especially in multiple gestations that may derive from more aortocaval compression comparing with singleton pregnancy. Nevertheless, some patients having contraindications for regional anesthesia e.g. thrombocytopenia, coagulopathy or pulmonary edema make anesthesiologists decide to put these patients under general anesthesia for cesarean section. General anesthesia for cesarean section in singleton pregnancy has been proved that can cause higher incidence of postpartum hemorrhage and higher rate of blood transfusion compared to regional anesthesia.

Incidence of anesthesia related complications in multiple gestation patients undergoing cesarean delivery has not been reported in Thailand. The aim of this study is to identify complications that occur which may derived from different anesthetic techniques used, such as hypotension, uterine atony, postpartum hemorrhage, rate of hysterectomy, blood transfusion and fetal outcome.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, multiple gestation underwent cesarean delivery from the past until 31 Dec 2015

Exclusion Criteria:

* Preterm delivery before 24 weeks
* Death fetus in utero
Total Extraperitoneal Approach in Orthopedic Surgery

The goal of this retrospective observational study is to evaluate the preliminary clinical and functional outcomes of total extraperitoneal approach (O-TEP) symphysial plating in patients with pubic symphysis diastasis (PSD). The study involved 15 patients (90% male, mean age 40) treated between March 2022 and May 2024.

The main questions it aims to answer are:

What are the clinical outcomes (e.g., VAS scores, Iowa Pelvic Scores, Majeed scores) following O-TEP symphysial plating? What are the surgical outcomes, including operating time, blood loss, and complications, associated with this minimally invasive technique?

Participants underwent:

Total extraperitoneal endoscopic symphysial plating, with follow-up assessments including postoperative pain scores, radiographs, and functional outcome evaluations using the Iowa Pelvic and Majeed scores.

Researchers will analyze the outcomes to see if this approach offers advantages over traditional open surgery, potentially reducing complications and improving recovery in PSD patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with pubic symphysis diastasis (PSD).
* Patients who underwent total extraperitoneal endoscopic symphysial plating (O-TEP) between March 2022 and May 2024.
* Patients with a follow-up period of at least 12 months.
* Patients who provided informed consent for the surgical procedure and the study.

Exclusion Criteria:

* Patients who required conversion to open surgery during the procedure (e.g., due to pneumoperitoneum).
* Patients with a follow-up period of less than 12 months.
* Patients with incomplete clinical or radiological data.
* Patients with contraindications to endoscopic surgery.
* Patients who did not provide informed consent for the study.
The Acute Effect of Malt Extract Versus Sucrose on the Response of Glucose and Insulin, Subjective Appetite Sensations and ad Libitum Energy Intake

Sucrose is the most used sweetener in beverage and foods in Denmark. Other sweeteners with other composition and amount of carbohydrates could be of interest in order to decrease the glucose and insulin responses after intake of a sweetened beverage/food. Malt extract has a sweet flavor but contains a different composition and amount of carbohydrates together with a small amount of protein compared to sucrose. Malt extract may therefore be a better alternative than sucrose as a sweetener due to a lower increase and more sustained blood glucose level. This could be of interest in relation to diabetes and appetite regulation but this is yet to be investigated.

Thus the objective is to investigate the effect of malt extract vs. sucrose on:

1. 3-hour change in the concentration of glucose and insulin
2. 3-hour change in subjective appetite sensations (Visual Analogue Scales, VAS scores)
3. Ad libitum energy intake

Design: 20 men will participate in the 2-way, randomized, double-blind crossover study. The test drinks is isocaloric with 75 g carbohydrates Test drinks: malt extract solution and sucrose solution (10%) Three-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch


Eligibility Criteria:
Inclusion Criteria:

* Healthy,
* BMI: 18.5-24.9 kg/m2,
* Weight stable (within +/- 3 kg) two months prior to study inclusion,
* Non-smoking,
* Nonathletic (\< 10 h hard physical activity),

Exclusion Criteria:

* BMI \> 25 kg/m2,
* Change in smoking status,
* Daily or frequent use of medication,
* Suffering from metabolic diseases,
* Suffering from psychiatric diseases,
* Suffering from any other clinical condition, which would make the subject unfit to participate in the study,
* Hemoglobin \< 7.5 mmol/l.
* alcohol and drug abuse
* blood donation, 3mo prior to the present study and during study participation
A Trial to Evaluate the Effect of Food on LEO 152020

A phase 1 trial in healthy people to evaluate the food effect on LEO 152020 in an open-label design using film-coated tablets

This trial will evaluate the pharmacokinetics and tolerability of 2 single doses of film-coated tablets in the morning after fasting or after a high-fat breakfast. The 2 doses will be separated by a washout period.

Eligibility Criteria:
Key inclusion Criteria:

* Body mass index (BMI) between 18.0-32.0 kg/m2 (both inclusive)
* In good health at screening and check-in as judged by the investigator based on medical history, physical examination, vital signs assessment, 12-lead ECG, and clinical laboratory evaluations.
* Pulse rate of 50 to 100 bpm at screening, or with minor deviations judged to be acceptable by the investigator
* Females of child bearing potential and male subjects whose partners are of child-bearing potential must also agree to use an additional effective method of contraception.

Key exclusion Criteria:

* Subjects who do not, or whose partners do not agree to use effective method(s) of contraception from the time of the first dose until 3 months (90 days) after the final dose.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
* History of any significant infectious disease within 2 weeks prior to drug administration as assessed by the investigator.
* Subjects who have received any medication within 14 days of the first dose administration, except for hormonal contraception.
* Subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical trial involving administration of an investigational drug (new chemical entity), or a marketed drug within the past 3 months prior to the first dose.
* ECG abnormalities at screening or check-in
* Heart rate of \<50 or \>100 beats per minute, unless the investigator judges the subject to be eligible for inclusion.
Optimal Timing of Postoperative Magnetic Resonance Imaging (MRI) in Patients With Extradural Spinal

This research study is evaluating suitability of a delayed magnetic resonance imaging (MRI) in management of spine tumors. Currently the standard of care is obtaining an MRI scan in the early postoperative period (within 72 hours after surgery). The purpose of this study is to see if delayed MRI (2 to 3 weeks after surgery) is similar in quality to the earlier MRI.

In this study patients will undergo 2 MRIs after the surgery instead of one MRI. Patients will have one MRI about 3 days after the surgery and one MRI about 2-3 weeks after surgery.

Primary aim:

Assess if Magnetic Resonance Imaging (MRI) at 2 to 3 weeks after surgery leads to the same clinical decisions and has the same probability of being chosen by a physician for guiding the subsequent management of the patient, compared with immediately postoperative MRI.

Secondary aims:

Investigate the differences between early and late MRI by comparing:

* Size of tumor in three dimensions;
* Extent of edema;
* Presence and extent of fluid collection;
* Spine Oncology Study Group score;
* Involvement of adjacent levels;
* Progression of tumor;
* Patient's preference/performance scale right after each image had taken: level of discomfort at around the time each MRI was performed.

Study Design:

This is a prospective diagnostic study for which no standard of care currently exists.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or primary malignant tumor involving spinal column, with or without extension into the epidural space
* Operated for debulking, decompression or separation surgery;
* A magnetic resonance imaging (MRI) scan performed within 72 hours after surgery is needed;
* Image quality acceptable for comparison with later MRI as read by a neuroradiologist;
* Karnofsky score of 60 or higher;
* Able to consent for the study.

Exclusion Criteria:

* Any patient who previously underwent spinal surgery at these levels will be excluded to eliminate late postoperative changes.
* Intradural extension of the tumor.
* Patients, whose MRI at post operative 48-72 hours are not readable due to artifacts or disease process shall not be included in the study.
* Patient not able to tolerate MRI scan due to claustrophobia or severe pain or allergic reaction to contrast.
* Patients with an estimated Glomerular Filtration Rate (eGFR) \< or = to 30 will be excluded to avoid issues related to contrast administration in such patients. This Glomerular Filtration Rate (GFR) threshold cutoff level is chosen per institutional policy, because below that level other measures would be required (hydration or no contrast administration). In order to keep the imaging information as uniform as possible in such a small study group, patients with a low GFR will not be enrolled in the study.
N-Acetylcysteine for Pediatric Trichotillomania

Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with trichotillomania can experience significant impairment due to peer teasing, avoidance of activities (such as swimming and socializing), difficulty concentrating on school work and medical complications due to pulling behaviors. Despite the fact that trichotillomania has a childhood onset, no randomized, controlled trials have been completed in childhood trichotillomania.

Research in adults with trichotillomania has demonstrated that most commonly currently prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake inhibitors) is ineffective in treating this condition. By contrast, randomized controlled trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral treatments such as Habit Reversal Therapy.

The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign side-effect profile.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 8-17 years.
* Primary DSM-IV diagnosis of trichotillomania or chronic hair pulling.
* Duration of trichotillomania greater than 6 months.

Exclusion Criteria:

* Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (IQ\<70).
* Recent change (less than 4 weeks) in medications that have potential effects on TTM severity (such as SSRIs, CMI, naltrexone, lithium, psychostimulants, anxiolytics, or antipsychotics). Medication change is defined to include either dose changes or medication discontinuation.
* Asthma requiring medication use within the last 6 months.
* Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation
* Current use (within last week) of psychostimulant medications.
* Positive pregnancy test or drug screening test
Assessment of the Increased Risk of Infection Following an Ultratrail

The increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. A number of these studies have looked at the influence of endurance events on the immune system. After prolonged exercise, a systemic inflammatory syndrome sets in, with repercussions for the functioning of the immune system. The number of lymphocytes in the blood is reduced, the function of natural killer (NK) cells is impaired and secretory immunity is impaired. During this period of immunosuppression, often referred to as the 'open window', the host may be more susceptible to micro-organisms that bypass the first line of defence.

The invetigators' hypothesis is therefore that ultratrailers are overexposed to the risk of infection due to immunodepression resulting from practising this sport. In order to support this hypothesis, the investigators would like to look at infectious complications in general and ear-nose and throat episodes (rhinitis, pharyngitis, laryngitis, etc.) in particular, which are the most common infections encountered in primary care, along with urinary tract infections.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Participating in a Grand Raid de la Réunion 2023 race (Mascareignes, Trail de Bourbon, Diagonale des Fous)
* Have a companion living under the same roof during the week preceding the race and the 21 days following the race and who agrees to answer the questionnaires
* Do not object to the research

Exclusion Criteria:

* Do not understand French
* A protected adult (guardianship or curatorship) or under court protection
The Valentines Trial

The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse cardiac events (MACE: death, myocardial infarction \[MI\], target lesion revascularization \[TLR\]) and target vessel revascularization \[TVR\]) and stent thrombosis, both early and late occurrences will be assessed.

In addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel eluting balloon treatment for in-stent restenosis.

A prioi analysis will be comparison of the safety and efficacy of patients presenting with drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, \> 18 years of age;
* Patients who present with in-stent restenosis of a previously placed stent documented by coronary angiogram for which re-PCI is planned;
* The patient has stable or unstable angina, and/or clinical evidence of ischemia (ECG, exercise test, etc.);
* The target lesion is in a native vessel;
* Up to two lesions per patient;
* Target lesion(s) stenosis is \> 50%.

Exclusion Criteria:

* The patient has had an acute myocardial infarction within the last 48 hours;
* The patient has a co-morbid illness (i.e. any illness likely to limit his/her life expectancy to \<12 months);
* Lesion(s) requiring additional stenting either bare metal or drug eluting (non, bail-out indications);
* The patient has had previous therapeutic radiation to the target vessel;
* The patient is unable the take dual antiplatelet therapy for at least 6 months;
* Patients with three or more lesions with in-stent restenosis requiring angioplasty.
Changes of Transforming Growth Factor b1 and Procollagen III in Patients With Acute Respiratory Distress Syndrome

Transforming Growth Factor-b1 (TGF-b1) is involved in the development of acute lung injury and in the fibroproliferation during acute respiratory distress syndrome (ARDS). Procollagen III Peptide (PIIINP) is a validated marker of fibroproliferation. PIIINP is associated with death in ARDS patients. The simultaneous changes of TGF-b1 and PIIINP were never studied in patients with ARDS. The relationships between TGF-b1 and the outcome of ARDS are unknown.

The aim of the study is to analyse the changes of TGF-b1 and PIIINP during ARDS and to show the relationships between TGF-b1 - PIIINP and the outcomes of ARDS.

Primary outcome: To analyse the changes of Transforming Growth Factor b1 and Procollagen III during the acute respiratory distress syndrome.

Eligibility Criteria:
Inclusion Criteria:

* ARDS with a PaO2/FIO2 \< 200 mmHg at a positive end-expiratory pressure (PEEP) ³ 5 cm H2O
* ARDS criteria from less than 24 hours
* Informed consent

Exclusion Criteria:

* Pregnancy
* Chronic interstitial or fibrosis lung diseases
* Hepatic chronic disease
* Neutropenia £1 G/l
* Corticosteroid (more than 200 mg/day of hydrocortisone or equivalent, less than 2 weeks before inclusion)
* Immunosuppressive therapy within the last 30 days
* Participation in any investigational drug or devices study within 30 days prior study entry