cyrilzakka/clinical-trials huggingface dataset:
Modified Connective Tissue Graft Wall With Wing Technique for Posterior Teeth

The investigators reported here the application of usage modified connective tissue graft wall technique for posterior teeth. The treatment outcomes suggested the efficacy of the used technique in treating recession defects accompanied by infrabony defects in molars.

Gingival recession is defined as the apical migration of the gingival margin leaving the root surface denuded. Treatment of Class III and IV defects and achievement good of results seems to be quite difficult due to the advanced loss of the soft and hard tissues supporting the affected teeth. Furthermore, partial to total loss of the interproximal papilla is one of the main challenges that contribute for achieving higher levels of esthetics especially in anterior zone. In such a case, conventional techniques of root coverage results usually in poor prognosis.

Eligibility Criteria:
Inclusion Criteria:

* recession defects in posterior teeth
* vertical infrabony defects in relation to the same recession defect

Exclusion Criteria:

* smokers
* suystemic diseases
* pregnency and lactating mothers
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory postmenopausal women.
* Age 55 years or older
* Subject has provided informed consent prior to any study specific procedures
* Received oral bisphosphonate therapy for osteoporosis at least 2 years prior to screening visit
* Screening BMD (g/cm²) values at the lumbar spine, total hip or femoral neck values of equal to or less than those listed in the protocol.
* At least 2 lumbar vertebrae and one hip must be evaluable by dual energy x-ray absorptiometry (DXA) at the screening visit

Exclusion Criteria:

* Received other osteoporosis treatment or bone active treatment
* Evidence of history of any of the following:

  * hyperthyroidism (stable on antithyroid therapy is allowed)
  * hypothyroidism (stable on thyroid replacement therapy is allowed)
  * hypo- or hyperparathyroidism
  * hypo- or hypercalcemia based on the central laboratory reference ranges
  * Recent tooth extraction (within 6 months of screening visit)
  * Paget disease of bone (subject report or chart review)
  * other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review)
* Abnormalities of the following per central laboratory reference ranges:

  * vitamin D deficiency (25\[OH\] vitamin D level \< 20 ng/mL), repletion will be allowed and subjects may be re-screened
  * hypercalcemia
  * elevated transaminases ≥ 2.0 x upper limits of normal (ULN)
* History of any solid organ or bone marrow transplant
* Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
* Known intolerance to calcium or vitamin D supplements
* Self-reported alcohol or drug abuse within 12 months prior to screening
* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
* History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Safety, Feasibility, and Tolerability of Sulforaphane in Children with Chronic Kidney Disease

This purpose of this study is to investigate potential new therapeutics in pediatric chronic kidney disease (CKD). The specific aims are to identify safe dosing and tolerability of sulforaphane (SFN) supplementation in children with moderate and advanced CKD. Secondary objectives will include preliminary exploration of changes in oxidative and inflammatory biomarkers in response to SFN supplementation in this population.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic of kidney disease
* have eGFR 20-59 mL/min/1.73m2 at the time of enrollment
* parents must be able to provide consent

Exclusion Criteria:

* weight \<30 kg
* cancer or HIV diagnosis
* history of solid organ transplantation (including kidney transplant)
* structural heart disease
* currently pregnant or plan to become pregnant
* life expectancy is less than one year
* Patients will also be excluded if they are currently taking anticoagulants, immunosuppression, or chemotherapeutics
Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer.

This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA).

To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months without disease progression after this chemotherapy.

If a patient qualifies for participation in an ongoing niraparib clinical trial or is already participating in a niraparib clinical trial, she will not be able to participate in the EAP.

Ongoing clinical trials for niraparib include:

* A Phase 3 trial in patients who have received first-line treatment for ovarian cancer (the PRIMA trial, NCT # 02655016)
* A Phase 2 trial in patients who have received multiple lines of treatment for ovarian cancer (the QUADRA trial, NCT # 02354586)
* A Phase 1/2 trial in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (the TOPACIO trial, NCT # 02657889)

Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
2. Completion of at least 2 previous courses of platinum-containing chemotherapy.
3. Had a CR or PR with duration of response \>/=6 months following penultimate chemotherapy
4. Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy \[minimum of 4 cycles\]
5. Patients previously treated with PARP inhibitors are eligible
6. Eastern Cooperative Oncology Group (ECOG, http://ecog-acrin.org/) performance status 0 or 1
7. Adequate organ function \[Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/µL; Platelets ≥ (greater than or equal to) 100,000/µL; Hemoglobin ≥ (greater than or equal to) 9 g/dL\]
8. Able to take oral medications
9. Women should not be pregnant at the beginning of the treatment and women or childbearing potential should not become pregnant while on niraparib
10. Patient should start treatment with niraparib no later than 12 weeks after completion of final dose of the platinum-containing chemotherapy

Exclusion Criteria:

1. Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy
2. Known hypersensitivity to the components of niraparib
3. Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the program treatment
4. Patient has uncontrolled hypertension
Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP

It was a study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.

The study was approved by Ethics Committee of Indonesia University. It was a single-blind randomized clinical trial at Cipto Mangunkusumo Hospital - Jakarta during August to September 2018. 72 subjects were recruited and randomly assigned into 2 groups. Patients in group B were given 0.15% mouthwash with benzydamine hydrochloride prior to procedure while patients in group C were given mouthwash with 15 ml of water. Cumulative propofol consumption per minute per kg body weight, and incidence of postoperative sore throat were measured for each group.

Eligibility Criteria:
Inclusion Criteria:

* undergoing ERCP
* ASA I-III
* BMI 18-30 kg/m2

Exclusion Criteria:

* allergic to propofol
* contraindicated to propofol
* had throat wound or laceration
* received analgesics or steroid in 24 hours priorly
* unstable during sedation
* procedure longer than 90 minutes
Effects of Exercise on the Renin-angiotensin System

Angiotensin converting enzyme-2 (ACE2) is part of the renin-angiotensin system (RAS), which is involved in maintaining blood flow and electrolyte balance. It has been shown in obese and hypertensive individuals that levels of another molecule Angiotensin converting enzyme (ACE) are much higher, leading to inflammation, fibrosis, vasoconstriction and high blood pressure. ACE2 has a protective effect from ACE, leading to anti-inflammatory, anti-fibrotic and vasodilating effects.

In animal models, it has been shown that aerobic exercise can increase levels of ACE2, while decreasing levels of ACE and offers protection to the cardiovascular system by keeping these two molecules balanced. Although the effects of exercise on the classical arm of the RAS have been studied significantly, ACE2 is a relatively new discovery and has not been studied as extensively in humans. The purpose of this research is to determine the effects of exercise training status on the RAS, specifically on ACE2 and its products.

The design of the proposed study is an intervention study, where participants are selected into either a physically active group or a sedentary group. The physically active group will be set as our control, as the physiological stress of the exercise protocol should be lower in the physically active group and limit the magnitude of the response. Both groups will be exposed to the same experimental procedure. Participants will be placed in their group based on their responses to the CSEP Get Active questionnaire. Individuals who do not accumulate less than 75 minutes of moderate to vigorous physical activity a week will be placed in the sedentary group, while those who accumulate more than 150 minutes will be placed in the active group.

Participants will be asked to avoid anti-Inflammatory medications, drugs, alcohol and smoking 48 hours prior to any of the sessions.

Participants in both groups will undergo the same testing procedure. Tests will include densitometry and a graded exercise test to measure maximum VO2 and associated parameters. Venipuncture (10 ml) will be performed before, after and 30 minutes post VO2 max test. The proposed study analysis will be conducted using a dependent groups ANOVA and Tukey's post hoc testing.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-39
* ability to exercise to exhaustion
* ability to give informed consent

Exclusion Criteria:

* chronic consumption of recreational drugs, tobacco or alcohol
* on any prescription medication or anti-inflammatory medications
* diagnosed with any chronic conditions
* current diagnosis with COVID-19
* BMI \>30
* Engage in 75-150 minutes of moderate to vigorous physical activity a week
Survivorship of the Press Fit Condylar (P.F.C.) Sigma Fixed Bearing Knee With a Cobalt Chrome Tibial Tray

The study will determine the survivorship of the fixed bearing P.F.C. Sigma knee with a cobalt chrome tibial tray at 5 years.

The primary objective of this study is to assess the survivorship of the P.F.C. fixed bearing knee system using a cobalt chrome tibial tray and moderately cross-linked polyethylene insert at 5-Years. The secondary objectives of this investigation are to evaluate additional clinical outcomes to provide further information on the performance of the P.F.C. fixed bearing knee system using a moderately cross-linked polyethylene insert and cobalt chrome tibial tray. These outcomes will include Radiographic assessment, American Knee Society Score, Oxford Knee Score and SF-12.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have given voluntary written informed consent to participate in this study
* Subjects for whom primary total knee replacement is indicated due to degenerative joint disease, including rheumatoid arthritis, osteoarthritis, avascular necrosis, and post traumatic arthritis, which is causing pain, deformity, or limitation of function uncontrolled by medical treatment.
* Subjects who, in the opinion of the Investigator, are able to understand this study, co-operate with the investigational procedures and are willing to return to the hospital for all scheduled post-operative follow ups.
* Male or Female subjects who are skeletally mature and for whom an appropriate size of device is available
* The following subjects are not considered eligible and must not be recruited to the investigation

Exclusion Criteria:

* Subjects scheduled for revision total knee arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
* Subjects aged over 80 Years
* Subjects experiencing any condition that may, in the opinion of the investigator, interfere with the total knee replacements survival or outcome (e.g. Pagets disease, Charcots disease, severe osteoporosis etc).
* Subjects who have evidence of active infections, which may spread, to other areas of the body (e.g. osteomyelitis, pyrogenic infection of the knee joint, overt infection etc)
* Subjects who are currently participating in any other clinical investigation of a device or pharmaceutical.
* Subjects having non-contained defects in the tibia or femur necessitating bone graft.
* Subjects with psychosocial disorders that would limit rehabilitation
* Subjects with a known history of poor compliance to medical treatment
* Subjects who are known drug or alcohol abusers.
* Other contraindications for the use of the P.F.C. ® S fixed bearing knee system as listed in the package insert.
* Women who are pregnant
* Subjects who are currently involved in any injury litigation claims
Insertion of PICC With Intracavitary ECG Navigation

The study subjects who are indicated for peripherally inserted central (PICC) catheter placement will undergo this procedure under the control of ECG, the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.

The study subjects who are indicated for PICC catheter placement will undergo this procedure under the control of electrocardiography (ECG), the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.

Conducting this study should allow us to see the feasibility of using real-time ECG navigation, its accuracy comparing to the chest X-ray method. ´ The second goal is to eliminate chest X-ray as an obsolete method, Also the advantages and disadvantages of both methods will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* indication for establishing long-term venous access
* 18 years of age and over

Exclusion Criteria:

* oncological patients
* non-signing the informed consent form
Non Exudative AMD Imaged With SS-OCT

The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.

This is a longitudinal observational study where the investigators will look at 450 subjects, 200 with intermediate AMD in at least one eye, or with AMD in one eye, either early or intermediate, and with late AMD (exudative) in the other eye, and 250 subjects with nGA or GA in at least one eye.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 50 and over
2. Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR Clinical diagnosis of early or early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD in the other eye OR clinical diagnosis of GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye which has never been treated with anti-VEGF agents
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from the study:

1. Below the age of 50
2. Subjects with exudative AMD in both eyes
3. Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.
4. Presence of confounding ocular diagnosis such as myopia \>6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV
5. Subjects unable to give informed consent.
6. Subjects who are unable to comply with imaging guidelines
Accuracy of Dental Implant Placement Using a Collaborative Surgery Robot

For free hand dental implant placement, a key difficulty is to accurately control the position. Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants. The goal of this randomized controlled trial is to compare the positional implant accuracy, and patient reported outcomes comparing two methods of implant placement: the use of a robotic assisted surgery and freehand surgery. Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan. Subjects will be randomized to one of the two treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a CBCT immediately after surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.

For free hand dental implant placement, a key difficulty is to accurately control the position. Improving precision of dental implant placement is considered important for safety and efficacy of tooth replacement with dental implants. In particular, more precise implant placement is expected to yield a better restoration both in terms of aesthetics and ability for self-performed oral hygiene and thus prevention of peri-implant diseases. The goal of this randomized controlled trial is to compare the positional implant accuracy, and patient reported outcomes comparing two methods of implant placement: the use of a robotic assisted surgery and freehand surgery. Patients requiring single tooth replacement with a dental implant will be digitally planned using a CBCT and an intraoral digital scan. Subjects will be randomized to one of the two treatment modalities based on the plan. The accuracy of placement will be assessed evaluating the difference between the planned and the actual position using a CBCT immediately after surgery. Subjects will be followed up for one year to assess both patient reported and professional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a single missing tooth to be replaced with a dental implant
* With sufficient bone volume and keratinized tissue at edentulous site
* Willing to comply with research appointments/schedule.

Exclusion Criteria:

* Pregnancy or intention to become pregnant at any point during the study duration
* With any systemic diseases/conditions that are contraindications to dental implant treatment
* Inability or unwillingness of individual to give written informed consent
* Inability of follow-up according to the protocol.
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are judged by the investigators to benefit from the long-term treatment and who are willing to continuously receive this drug. To continuously evaluate the safety of the Levetiracetam long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or 3000 mg/day in subjects who completed the First Period of this study.

Eligibility Criteria:
Inclusion Criteria:

* The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
* The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
* Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg

Exclusion Criteria:

* The patient has a treatable seizure etiology
* The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
* The patient has a history of status Epilepticus during the 3 months prior to Visit 1
* The patient has a past and present history of pseudo seizures
* The patient has a current diagnosis of Lennox-Gastaut syndrome
The Global PCHF-COVICAV Registry

Background: Coronavirus disease (COVID-19) is a tremendous challenge the modern world has never seen before and is overwhelming the capacities of healthcare systems worldwide. Patients with cardiovascular diseases, heart failure in particular, and cardiovascular risk factors seem to be at a very high risk if affected by COVID-19 - and vice versa there are more and more reports of cardiac manifestations with the viral disease.

Aim: The purpose of the study is to characterise the clinical course of adult inpatients with COVID-19 and concomitant cardiovascular affection in a worldwide, multicentre PCHF registry.

Methods: Retrospective and prospective data analysis. Data on demographic, clinical, selected laboratory, electrocardiography and echocardiography parameters, treatment and outcome will be collected. The principal investigator provides dedicated electronic case report form. The primary outcome is in-hospital mortality. The secondary endpoints will be ICU length of stay, hospital length of stay, the need and duration of invasive mechanical ventilation, cardiovascular hospitalisation after 3 and 6 months from index hospitalisation, all-cause and cardiovascular mortality after 3 and 6 months from index hospitalisation.


Eligibility Criteria:
Inclusion Criteria:

* Adult inpatients (≥18 years old) with laboratory-confirmed COVID-19.

Exclusion Criteria:

* Age \<18 years old.
* Outpatients.