cyrilzakka/clinical-trials huggingface dataset:
Postoperative Patient Comfort and Quality of Micturition in Suprapubic Tube vs. Transurethral Catheterization After RARP

The purpose of the study is to determine, whether the postoperative quality of micturition and continence can be improved depending on the urinary drainage catheter and retention after robot assisted radical prostatectomy. Another finding could be the study of the pain assessment of the patient, as well as the pain medication at the various derivatives. Further check whether infections and the presence of bacteriuria can be reduced or avoided by the form of urinary drainage.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 Years
* Voluntarily agreement to participate in this study
* filled in and signed Informed Consent
* release of medical records for regulatory or research purposes
* clinically organ-confined prostate cancer
* recommended and planned robot-assisted radical prostatectomy

Exclusion Criteria:

* Participation in other interventional trials that could interfere with the present study
* International Prostate Symptom Score (IPPS) \> 18
* History of radiation or chemotherapy
* History of transurethral prostate resection
* unable to provide informed consent
* unwillingness to storage and forwarding of pseudonymous data
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta

This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI).

Pharmacodynamic effect will be determined by serological biomarkers and radiologic assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.

This study was previously posted by Mereo BioPharma and was transferred to Ultragenyx in February 2021.

Eligibility Criteria:
Inclusion Criteria:

* Osteogenesis imperfecta
* Two or more previous fractures
* Bone mineral density Z-score of ≤ -1.0 and \> -4.0

Exclusion Criteria:

* Open epiphyses
* Fracture within last 2 weeks
* Treatment with bisphosphonates/teriparatide (last 6 months)
* Surgery within last year

Other protocol-defined inclusion/exclusion criteria may apply
Induction With Foley OR Misoprostol (INFORM) Study

Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with pre-eclampsia. The only cure, however, comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and transcervical Foley catheterization - are already used by some in low resource settings, but their relative risks and benefits are not known. These interventions could optimize the care pathway for women needing induction of labour. This is especially important in low resource settings where improvement is most needed and the potential to reduce the maternal and neonatal mortality and morbidity is the greatest. The ideal induction agent would result in a relatively short induction to delivery interval without risk to fetus and with low rates of emergency caesarean section. The induction to delivery interval is especially important in pre-eclampsia and eclampsia where the condition may deteriorate rapidly until delivery. Inductions with prostaglandins, including misoprostol, are sometimes associated with uterine hyperstimulation and consequent fetal hypoxia, whilst the effectiveness and safety of Foley catheter as an induction agent has been persistently questioned. This study will identify the risk, benefits and trade-offs in efficacy, safety, acceptability and cost of these two low cost induction methods.

This is a pragmatic, open-label, randomised control trial of two methods for labour induction among women with pre-eclampsia. Women requiring delivery for preeclampsia in two hospitals in Nagpur, India will be randomised to one of two treatment groups: transcervical Foley catheter or oral misoprostol tablets.

Eligibility Criteria:
Inclusion Criteria:

* Ongoing pregnancies with a live fetus in whom the decision has been made to induce vaginal delivery because of preeclampsia or uncontrolled hypertension. Women will be included irrespective of whether an intrapartum caesarean section on fetal grounds or would be considered or not.
* Women age ≥18 years
* Signed informed consent form

Exclusion Criteria:

* • Women with previous caesarean sections

  * Those unable to give informed consent
  * Multiple pregnancy
  * History of allergy to misoprostol
  * Ruptured membranes
  * Chorioamnionitis (by clinical diagnosis)
A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B

The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-B.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years and older.
2. 5 ≦ Child-Pugh score ≦ 12
3. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(4) copies/mL within 30 days of baseline.
4. Patient is documented to be HBsAg positive for \> 6 months.
5. Patient is HBeAg positive or negative.
6. Patient has ALT or AST levels which are in the range of \> 1 x ULN and \< 15 X ULN
7. Patient with liver cirrhosis diagnosed by imaging study within 1 year or clinical evidence of portal hypertension
8. Life expectancy of at least 12 months
9. Female patient with a negative urine(Beta-HCG) pregnancy test taken within 14 days of starting therapy.
10. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
3. Patients previously treated with clevudine, entecavir, lamivudine, adefovir, telbivudine or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient with clinical evidence of hepatocellular carcinoma
6. Patient has alpha-fetoprotein \> 400ng/mL.
7. Patient has Hemoglobin \<8g/dL (Male), 7.5g/dL (Female) or WBC \<1,500mm3 or Neutrophils \<500/mm3 or Platelet count \<30,000/mm3.
8. Patient is pregnant or breast-feeding.
9. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
10. Patient has a clinically relevant history of abuse of alcohol or drugs.
11. Patient with previous liver transplantation
12. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
13. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Using Ecological Momentary Assessment to Develop an Adaptive Psychological Intervention for Young Adults With Chronic Pain

The goal of this observational study is to determine real-time contextual vulnerabilities associated with pain in young adults to inform ideal treatment targets for a just-in-time adaptive intervention (JITAI). The main question it aims to answer is:

-What contextual factors and vulnerabilities will predict momentary, next-day, and weekly pain severity? 50 young adults, ages 18-25 with a diagnosis of childhood-onset primary chronic pain, will complete 1) baseline questionnaires on REDCap to collect data on sociodemographics, medical history and treatment, psychological health (i.e., current mood symptoms and previous psychiatric conditions/treatment), and pain (e.g., duration, location) and 2) a 28-day EMA via mobile app to collect survey data on dynamic factors.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-25
* diagnosis of childhood-onset chronic pain who were seen for an initial evaluation at Seattle Children's Hospital outpatient specialty clinics.

Exclusion Criteria:

* not fluent in English
* does not have regular access to the internet and access to a smartphone device (to complete EMA questions)
* presence of chronic disease or serious medical illness (e.g., arthritis, cancer, diabetes)
* serious cognitive impairment or developmental disorder (e.g., autism, intellectual disability)
Dermal Micrografts in Regenerative Surgery

Objective assessment of the effectiveness of a micro-fragmented dermal extract obtained with Rigenera™ technology (patented by Human Brain Wave) in promoting the wound healing process in an in-vivo homogeneous experimental human acute surgical wound model.

The aim of the study is the objective assessment of the effectiveness of a micro-fragmented dermal extract obtained with Rigenera™ technology (patented by Human Brain Wave) in promoting the wound healing process in an in-vivo homogeneous experimental human acute surgical wound model. The study includes 20 patients with 24 acute post-surgical soft tissue loss and a planned sequential two-stage repair with dermal substitute and autologous split-thickness skin graft. Each acute post-surgical soft tissue loss is randomized to be treated either with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with Rigenera™ technology (group A - Rigenera™ protocol) or with Integra® dermal substitute only (group B - Control). The re-epithelialization rate in the wounds is assessed in both groups at 4 weeks through digital photography with the software "Image J". The dermal cell suspension enrichment with the Rigenera™ technology is considered effective if the re-epithelialized area is higher than the 25% of the total wound surface as this threshold is considered far beyond the expected spontaneous re-epithelialization rate.

Eligibility Criteria:
Inclusion Criteria:

* Post-surgical defect in any site of the body with a size range 4-400 cm2.

Exclusion Criteria:

* Wound infection, chemotherapy in the last 6 months, use of corticosteroids or immunosuppressive treatment, metabolic, endocrine, autoimmune and collagen diseases.
Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?

This within -subject study will be conducted to evaluate the proper number of unsplinted implants ;( three, four and five implants) for the edentulous maxilla opposed by mandibular two-implant overdentures.


Eligibility Criteria:
Inclusion Criteria:

* o Healthy and free from any systemic diseases that may interfere with the osseointegration of implants.

  * Patients have completely edentulous maxilla for at least 6 months after last extraction with opposing mandibular two-implant Overdentures.
  * The patients have angle class I maxillomandibular skeletal relation and sufficient interarch space not less than (10-12 mm) as detected by tentative jaw relation.
  * Maxillary and mandibular alveolar ridges covered with healthy, firm, relatively even thickness and even compressible mucosa as detected by palpation with the blunt end of the mirror and free from any signs of inflammation or flabbiness as detected by clinical examination.
  * Good quality and quantity of maxillary residual alveolar ridge, as detected by CBCT, available for implant width (3.7mm, 5mm for anterior and posterior implants respectively) and length (12mm, 10mm for anterior and posterior implants respectively) this was ascertained by CBCT.

Exclusion Criteria:

* o Any history of metabolic or systemic diseases that may affect integration of implant or connective tissue health surrounding implant.

  * History of irradiation in head-and-neck area.
  * Heavy smokers (more than 10 cigarettes per day)
  * Parafunctional habits such as bruxism.
  * Psychiatric disorders or unrealistic expectations.
  * Positive pregnancy test up to 5 days before surgery.
  * Severe thrombocytopenia and bleeding disorders.
  * Pathologic condition of soft tissue (bacterial and viral stomatitis, hyperplasia, cyst, fibrous lesions)
  * Patients with local contraindications for implant placement due to localized bone defects and poor bone quality (D5).
  * Patients with TMJ disorders or poor neuromuscular coordination.
Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)

The primary study objective is to demonstrate the clinical effectiveness of SERETIDE therapy compared to the current care in management of moderate to severe persistent asthma patients in Korea.


Eligibility Criteria:
Inclusion criteria:

* Male or female subjects aged 18 years and over who are willing to give a written consent to participate in the study.
* Subjects with a documented clinical history of reversible airways obstruction (history taking is acceptable) for at least 12 months and, in the opinion of the investigator, is able to comply with therapy and to complete the Daily Record Cards (DRCs) correctly.
* Subjects able to demonstrate the ability to effectively (physically and/or mentally) use a DISKUS (a dummy DISKUS provided for test).
* A female is eligible to enter and participate in this study
* Subjects with access to telephone (mobile or landline at home)

Exclusion criteria:

* Previous use of ICS /LABA combination inhaler (SYMBICORT (Astrazeneca) or SERETIDE) 12 weeks prior to Visit 1.
* Subjects with known or suspected hypersensitivity to inhaled steroids or Beta2-agonists.
* Subjects who have had other changes in their regular asthma medication within 2 weeks of Visit 1.
* Subjects who have had a lower respiratory tract infection within 4 weeks of Visit 1.
* Subjects who have a smoking history of 10 pack years (e.g. 10 cigarettes/day for 20 years or 20 cigarettes/day for 10 years or 40 cigarettes/day for 5 years) or more at the time of Visit 1 (Current smoker can be included even if his/her smoking history is less than 10 pack years at the time of Visit 1).
* Subjects who suffer from serious, uncontrolled diseases (including serious psychological disorders) likely to interfere with the study.
* Subjects who are on immunotherapy
* Subjects who have taken any investigational drugs within 4 weeks of Visit 1.
* Subjects who have, in the opinion of the investigator, evidence of alcohol or drug abuse.
* Females who are pregnant, lactating or are of child bearing potential and are likely to become pregnant. Females of childbearing age may be included if, in the opinion of the investigator, they are exerting adequate contraceptive precautions.
* Subjects who have previously been enrolled into this study
* Patients on regular oral or parenteral steroid therapy in the last 4 weeks or more than 3 courses of steroid in the last 6 months
* Subjects who have FEV1 or PEFR of less than 50% predictive value.
An Observational Study of Long-term Outcomes of HIV-1 Infection in Persons Who Become HIV-1 Infected After Enrollment in HIV-1 Vaccine Trials

An observational study of long-term outcomes of HIV-1 infection in persons who become infected after enrollment in HIV-1 vaccine trials

A descriptive and observational study of long-term outcomes of HIV-1 infection in persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials

Eligibility Criteria:
Inclusion Criteria:

* Participants must meet the following criteria in order to be eligible for inclusion in the study:

  1. Confirmation of HIV-1 infection after enrollment in an HVTN vaccine trial in which HIV-1 infection constituted an endpoint, according to the diagnostic algorithm specified in the parent protocol.
  2. Ability and willingness to provide written informed consent to participate in the study.
  3. Ability and willingness to adhere to the on-study follow-up schedule.
  4. Ability and willingness to provide adequate information for locator purposes.
  5. Participants who are currently on ART or who previously received antiretrovirals as part of post-exposure prophylaxis, pre-exposure prophylaxis, or previous treatment regimen will be eligible for inclusion in this protocol. Their previous treatment history will be collected. If a participant has been on ART for more than 2 years, please consult with the protocol team leadership prior to enrollment.
  6. For participants initiating ART, agreement of participant and PHCP to initiate potent and durable ART regimens in accordance with local and international guidelines. Examples of potent and durable regimens are provided in Appendix H. Participants who initiate ART not consistent with regimens outlined in Appendix H may enroll with permission of the protocol chair or designee(s).

     Exclusion Criteria:
* Persons who meet the following criteria will be excluded from the study:

  1. Any medical, psychiatric, alcohol/drug dependency or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a participant's ability to give informed consent.
  2. Participants who meet these additional criteria will be excluded from the study:
* Participants undergoing acute therapy for serious medical illnesses (in the opinion of the site investigator) within 14 days prior to initiation of ART.
* Participants with chronic, acute, or recurrent infections that are serious (in the opinion of the site investigator).
* Participants who must continue with chronic (maintenance) therapy (e.g., tuberculosis \[TB\], pneumocystis pneumonia \[PCP\]), must have completed at least 14 days of therapy and be clinically stable prior to initiation of ART.
* Oral and vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses, as defined by the site investigator, present no restriction to eligibility.
* Participants undergoing radiation therapy, systemic chemotherapy, or receiving an immunomodulator within 45 days prior to initiation of ART. (A tapering course of corticosteroids as acute therapy for PCP or other conditions is an exception.)
Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial

The primary aim of the current study is to conduct a cluster-randomized control trial to evaluate the effectiveness of a novel digital intervention in reducing anxiety and digital eye strain compared to usual care among Chinese children during the period of home confinement.

In response to the coronavirus disease 2019 (COVID-19), many countries have taken the decision of school closure after the confirmation of coronavirus cases in the general population. In China, the burden of COVID-19 is among the highest in the world, with more than 80,000 cases confirmed by 11th March 2020. An estimate of 220 million children and adolescents are confined at home for weeks with inadequate level of physical activity and more susceptible to anxiety. There is also a concern of digital eye strain for many children who spend hours daily in front of a computer screen for recreation or learning purposes.

Recess represents an essential scheduled period in a school day for psychological and physical relaxation. During the unusual period of home confinement, many schools have already issued physical activity requirement and policy recommending recess and physical activity breaks. However, recess could be easily skipped by students during online learning at home.

Mobile health intervention offers a potential opportunity for capitalizing on digital technology as a feasible modality to encourage recess activities, especially in regions where social distancing is implemented as an emergency measure. The primary aim of the current study is to conduct a cluster-randomized control trial to evaluate the effectiveness of a novel digital intervention during recess in reducing anxiety and digital eye strain compared to usual care among Chinese children during the period of home confinement.

Eligibility Criteria:
Inclusion Criteria:

* Grade 7 (12-13 years old) students in Duanzhou District, Zhaoqing city
* Students under home confinement and enrolled in online learning courses, during the COVID-19 outbreak

Exclusion Criteria:

* Autism Spectrum Disorders and Pervasive Developmental Delay or Disorder
* Mental Retardation
* Psychotic Disorders and Schizophrenia
* Mania or Hypomania disorders
* Suicidal behavior and/or acute plan that require higher level of care
* Participation in psychotherapy
Cuff Inflation-supplemented Videoscope-guided Nasal Intubation

Epistaxis or post-pharyngeal bleeding is the most common complication after nasotracheal intubation (NTI). Prior thermal softening of the endotracheal tube (ET) has been recommended as one of the methods to prevent nasal trauma from nasotracheal intubation. However, thermal softening of tubes tends to adversely affect the nasotracheal navigation of the ET.

During NTI under conventional direct laryngoscopy, the tip of the Macintosh laryngoscope is advanced into the vallecula, indirectly elevating the epiglottis by applying pressure on the hyoepiglottic ligament. Although this maneuver allows optimal visualization of the glottis, it lifts the larynx away from the tip of the advancing nasotracheal tube (NTT), which generally lies along the posterior pharyngeal wall. Most clinicians use Magill forceps to direct the tip of the NTT anteriorly to enter the glottis. Magill forceps may cause damage to the cuff of an ET or may injure oropharyngeal mucosa.

The use of a video laryngoscope and a cuff inflation technique has been proposed as a method for reducing the malalignment of tubes. Indirect laryngoscopy using a Video laryngoscopy can reduce malalignment by minimizing lifting the glottis during laryngoscopy. The cuff inflation technique (wherein the cuff of ET tube is inflated with 15 mL of air) has been used while performing "blind" NTI to guide such malaligned polyvinyl chloride (PVC) ET tubes into the laryngeal inlet. Recently, one study reported that the cuff inflation technique consistently improved the oropharyngeal insertion of the different ET tubes of varying stiffness during direct laryngoscope-guided NTI.

There has never been study about effect of cuff inflation technique on navigability when performing NTI under video laryngoscopy guidance with ET tubes of varying stiffness.Investigators assessed and compared the incidence of nasal injury and nasotracheal navigability with two technique during cuff inflation-supplemented NTI guided by video- laryngoscopy


Eligibility Criteria:
Inclusion Criteria:

* ASA status I-III, older than 18 yr, who under went elective surgery and requiring ET intubation as part of anesthetic management were enrolled in the study.

Exclusion Criteria:

* Patients with bleeding diathesis, history of recurrent nasal obstruction or any nasal/pharyngeal surgery, and those with anticipated difficult tracheal intubation were excluded.