cyrilzakka/clinical-trials huggingface dataset:
Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery

Guided Bone Regeneration (GBR) is a well-established surgical technique that employs barrier membranes to ensure the stability of bone augmentation material while preventing the infiltration of soft tissue, thereby facilitating new bone formation.

The primary objective of this randomized controlled trial is to assess the performance and safety of the Lyoplant® collagen membrane as a barrier membrane in GBR for patients undergoing dental implant surgery. Additionally, the study aims to compare the Lyoplant® membrane with the Bio-Gide® collagen membrane, with the goal of demonstrating the non-inferiority of the Lyoplant® membrane in terms of radiographically measured bone gain compared to the comparator.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing to give a voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the Informed Consent Form (ICF).
* Patients with the capacity to consent for themselves.
* Patients in need of an implant with a simultaneous GBR procedure.
* Presence of buccal bony dehiscence with a vertical defect height (VDH) ≥ 1 mm and ≤ 6 mm after implant placing.
* The tooth at the implant site must have been extracted or lost at least 8 weeks before the date of bone augmentation (volumetrically healed site).

Exclusion Criteria:

* Patients \< 18 years.
* Currently pregnant or breastfeeding women.
* Major systemic diseases (e.g. recent myocardial infarction, cerebrovascular accident or valvular prosthesis surgery, a poorly stabilized diabetes mellitus, severe hypertension, severe peripheral artery occlusive disease, malignancies, autoimmune diseases, or kidney diseases, untreated or uncontrolled periodontal disease, uncontrolled drug or alcohol abuse, uncontrolled psychiatric disorders).
* Acute infectious diseases.
* Immunocompromised patients.
* Serious disturbances of bone metabolism and/or serious bone diseases of endocrine etiology.
* Medical conditions requiring prolonged use (\> 6 months) of steroids and/or ongoing treatment with gluco- and mineralocorticoids and with agents affecting calcium metabolism (e.g. calcitonin), and/or anticoagulative therapy.
* Previous or current use of antiresorptive drugs (ARDs) (e.g. bisphosphonates, selective estrogen receptor modulators (SERMs), denosumab, hormone replacement therapy and calcitonin).
* Previous oral / maxillofacial radiotherapy.
* Heavy smoker (\>10 cigarettes/day). In the case of vapors with nicotine, the use of \>300 puff vapors (equivalent to 10 cigarettes/day) are not allowed.
* Health conditions, which do not permit the surgical treatment.
* Use of the Investigational Device / Comparator in infected areas.
* Known foreign body sensitivity to implant materials.
* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies) if it could impact the result of the study.
Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate in Patients With Advanced Malignancies

This is an investigator-initiated, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Erythrocyte-αPD-1 conjugates in patients with advanced malignancies

This is an investigator-initiated, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Erythrocyte-αPD-1 conjugates in patients with unresectable or metastatic advanced malignancies who have failed previous systemic therapy.

The study was divided into two phases: dose escalation and dose expansion

Eligibility Criteria:
Inclusion Criteria:

1. The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
2. Regardless of gender, aged 18 to 75 years old (including threshold);
3. Patients with advanced malignant tumors who have been confirmed by histopathology;
4. Patients with histopathologically confirmed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment;
5. ECOG≤1；
6. Expected life ≥ 3 months；
7. Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; Pregnancy testing results for women of childbearing age within ≤ 7 days before the first trial drug administration must be negative. Women of childbearing age include premenopausal women and women within 2 years after menopause.

Exclusion Criteria:

1. People with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases,
2. Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
4. There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.
6. Subjects with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment;
7. Having hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment
MK0767 Added to Insulin Therapy in Patients With Type 2 Diabetes (0767-030)

This study will look to see if MK0767 works better than placebo in controlling blood sugar in patients with Type 2 Diabetes who are taking insulin but do not have adequate control of their blood sugar.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes with inadequate glycemic control
* Patient is on stable insulin therapy alone or with one oral antidiabetic agent
* Male or non-pregnant female 21 years or older
* Total daily dose of insulin must be less than or equal to 30 but not greater than or equal to 200 units/day

Exclusion Criteria:

* Have a history of type 1 diabetes mellitus
* History of ketoacidosis who are being treated with insulin
* Are taking 2 or more antidiabetic agents in combination with insulin
Novartis Pandemic Influenza A (H1N1) Vaccine(s) Observational Comparative Safety Study

The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.


Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant OR was pregnant following the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest and have already experienced a pregnancy outcome
* Consents to participate in the study

Exclusion Criteria:

* Is not currently pregnant OR was not pregnant at the time of or after the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest
* Does not consent to participate in the study
* Has received a non-Novartis pandemic influenza vaccinee
Behavioral Contract Adherence Intervention

There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve RTRs' IST adherence rates (contracts are written, signed agreements between the RTR and healthcare provider in which the RTR agrees to be adherent to IST according to mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs' health-related quality of life (HQoL) and healthcare utilizations and costs. The primary hypothesis was that at one year post trial enrollment, RTRs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater HQoL and lower healthcare utilizations and costs. Once it is better understood how to implement effective IST adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based intervention on IST adherence; (2) determine the relationship between IST adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were collected over a 12-month period for each RTR study participant and analyzed. This project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult RTRs by providing data regarding an adherence intervention and the impact of IST adherence and the behavioral contract intervention on RTRs' health and economic outcomes and HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs' graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to dialysis, morbidity, mortality, and healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

* renal transplant recipient
* at least 21 years of age
* receive an immunosuppressant regimen that contains oral cyclosporine or tacrolimus
* be at least one year post-transplant
* obtain immunosuppressant therapy from Avella Specialty Pharmacy for at least one year prior to study enrollment and during the study period

Exclusion Criteria:

* pregnant
* prisoner
* institutionalized
* unable to give informed consent
Titanium-prepared Platelet-rich Fibrin in Periodontal Regeneration

In this study, the possible effect of blood group distribution on the content of blood biomaterial was investigated. 64 volunteers were included in the study. Various parameters were evaluated. As a result, it was concluded that blood group distribution does not affect blood biomaterial content.

The aim of this split-mouth, randomized, and controlled study was to compare open flap debridement (OFD) alone against OFD with autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF) combined in treating intrabony defects (IBD). Subjects were 20 systemically healthy patients with chronic periodontitis according to 2017 World Workshop. Bilateral operation sites in patients (40 sites) were randomly selected for OFD alone or OFD+ T-PRF combined. Clinical parameters (probing depth (PD), relative attachment level (RAL), and gingival marginal level(GML)), radiographic parameters (intrabone defects (IBDs) and periodontal bone support (PBS)), and growth factors levels (GFL) in gingival crevicular fluid (GCF) (platelet-derived growth factors (PDGF-BB), fibroblast growth factors (FGF-2), relative ratio of receptor activator nuclear factor kappa-B (RANKL)/osteoprotegerin (OPG)) were analyzed. The Wilcoxon signed-rank test, the Student's t-test, the two way ANOVA, and the Tukey post hoc test were used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

1)Patients with bilaterally similar periodontal intrabone defects (IBDs)

Exclusion Criteria:

1. Who did not show the necessary oral hygiene during the non-surgical periodontal treatment process,
2. history of periodontal therapy in the preceding 1 year,
3. presence of devital tooth, Grade II, or higher mobility of the tooth, and less than 3 bone walls or a defect in the furcation at the site of the bone defect,
4. history of any systemic diseases that can alter the course of the periodontal disease,
5. smokers,
6. use of antibiotics,
7. pregnant/lactating women.
Comparison of Medical Therapies in Marfan Syndrome.

The investigators are looking at the different impacts of atenolol, verapamil and perindopril on large artery and lv function in marfan syndrome. It is a double-blind, randomised cross-over trial.

The investigators recruited 21 patients with confirmed diagnosis of Marfan syndrome from two centres. The investigators performed radial artery applanation tonometry and pulse wave analysis to derive central aortic pressure and haemodynamic indexes pre-and post administering Atenolol 75mg, Perindopril 4mg and Verapamil 240mgs each for four weeks with a two week wash-out between medications. All patients underwent detailed functional and anatomical echocardiographic assessments at each visit.

Inclusion criteria were ages 16-60 years with no treatment or β-blocker or other monotherapy only for Marfan syndrome. Patients with previous aortic dissection or aortic surgery, severe valvular regurgitation, aortic diameter at the sinotubular junction ≥ 5.0cm, contraindications to specific drug treatment, e.g. asthma and β-blocker, or those who were pregnant or at risk of pregnancy were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Ages 16-60 years old with no treatment or β-blocker or other monotherapy only for Marfan syndrome

Exclusion Criteria:

* Previous aortic dissection or aortic surgery
* Severe valvular regurgitation
* Aortic diameter at the sinotubular junction ≥ 5.0cm
* Contraindications to specific drug treatment, e.g. asthma and β-blocker
* Those who were pregnant or at risk of pregnancy
Recombinant Human Fibroblast Growth Factor-2 (rhFGF-2) In Gingival Recession Defects

This study was a single-arm trial to obtain preliminary data on the efficacy of collagen membranes impregnated with recombinant human fibroblast growth factor (rhFGF-2) in the treatment of Miller's class I and class II gingival recessions.

Soft tissues can be regenerated to cover root exposure and a thin biotype can be converted into a thick biotype by using recombinant human growth factor technology. A recent review stated that growth factors could enhance soft tissue regeneration which includes restoration of mucogingival architecture and regeneration of periodontal hard and soft tissues including bone, cementum and periodontal ligament fibers. Fibroblast growth factor-2 (FGF-2), a heparin-binding cytokine with strong angiogenic activity stimulates the proliferation of undifferentiated mesenchymal cells. These functions can be applied in mucogingival surgery as FGF-2 promotes bone and cementum formation and exhibits an increased potential to promote periodontal regeneration in recession defects.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy subjects between 20-55 years presenting with Miller's class I or class II gingival recession\[

Exclusion Criteria:

* 1. Recessions associated with root demineralization/caries, deep cervical abrasion or pulpal pathology, 2. Patients with history of systemic conditions affecting periodontium and, 3. Smokers.
A Clinical Study of Association Between Postoperative Dyslipidemia and Organ Rejection in Transplant Patients

Abnormal lipid metabolism is a common complication after organ transplantation, with pathological changes in lipid parameters occurring in approximately 60-80% of cardiac transplant recipients receiving triple immunotherapy with cyclosporine, imid azathioprine, and methylprednisolone. With the significant increase in long-term survival and increasing age of transplant patients, atherosclerotic cardiovascular diseases, such as those caused by dyslipidemia, have become a major cause of transplant organ failure and recipient death. However, the causes of dyslipidemia after organ transplantation, as well as the effects and mechanisms of dyslipidemia on transplant rejection, are unknown.

Previous studies have found that 1. increased lipid levels occur in recipients after heart transplantation; 2. during rejection, hepatic PCSK9 expression is increased in recipients; 3. a high-fat environment increases the immunoreactivity of human peripheral blood lymphocytes. It is suggested that PCSK9-lipid disorder-immune cell interactions may be associated with the development of transplant rejection.

In this project, we propose to (1) establish a long-term follow-up system for postoperative cardiac transplantation patients in our department to track the characteristics of lipid changes in transplantation patients, to clarify the link between dyslipidemia and rejection, and to provide a strong evidence-based medical basis for the management of lipids during the perioperative period and in the postoperative period; (2) expand the dimensions of lipid-related assays under the support of the above system, and to incorporate transcriptomic, proteomic, and metabolomic research methods to elucidate transplantation rejection in a multidimensional manner. (ii) Expanding the dimensions of lipid-related assays to include transcriptomic, proteomic, and metabolomic studies to elucidate the relationship between PCSK9 and dyslipidemia in transplant patients; (iii) Adopting single-cell sequencing technology to deeply reveal the potential mechanism by which changes in lipids affect T-cell-mediated rejection of cardiac transplants. The mechanism of T-cell-mediated cardiac transplantation rejection is revealed by single-cell sequencing.


Eligibility Criteria:
Inclusion Criteria:

* After heart transplantation
* Age ≥ 18
* Disease duration: symptomatic heart failure ≥ 6 months prior to screening date
* The patient's informed consent

Exclusion Criteria:

* Refusal of the patient to provide consent
* Suspected poor capability to follow instructions and cooperate
* Another life-threatening disease with poor prognosis (survival less than 2 years)
* Participation in any other clinical study within less than 30 days prior to screening date
Dose Escalation and Expansion Study of CM313 in Subjects With Relapsed or Refractory Multiple Myeloma and Lymphoma

This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CM313.

The dose escalation part will determine the MTD of CM313 in subjects with relapsed and/or refractory multiple myeloma (RRMM) or lymphoma based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design).

The dose expansion part includes two cohorts. Cohort 1 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Dexamethasone in subjects with RRMM. Cohort 2 will evaluate the safety and preliminary anti-tumor activity of CM313 in combination with Rd regimen (Lenalidomide/Dexamethasone) in subjects with RRMM or newly diagnosed MM (NDMM).


Eligibility Criteria:
Key Inclusion Criteria:

* Dose escalation: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies and subjects with recurrent and refractory lymphoma.
* Dose expansion_cohort 1: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies.
* Dose expansion_cohort 2: subjects with RRMM who have progressed on, or could not tolerate, all available established therapies, or subjects with NDMM.
* For MM: Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
* For MM: Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL) or urine M-protein level \>=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) \>= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
* Eastern Cooperative Oncology Group (ECOG) performance status score \<＝2.
* Women of childbearing potential and male subjects must agree to remain abstinent or use contraceptive methods as defined by the protocol.
* Side effects of any prior therapy or procedures for any medical condition has recovered to NCI-CTCAE v.5.0 Grade ≤ 1.

Key Exclusion Criteria:

* Previous treatment with any anti-CD38 therapy.
* Subjects with concurrent plasma cell leukemia.
* Received a cumulative dose of corticosteroids equivalent to greater than or equal to ( \>=) 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication).
* Vaccinated with live, attenuated vaccine within 4 weeks prior to the first dose.
* Received an allogenic stem cell transplant or an autologous stem cell transplant within 3 months before first dose of study drug.
* Central nervous system (CNS) involvement.
* The forced expiratory volume in one second (FEV1)\<60%.
Minimally Invasive Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF) As a Surgical Treatment of Atlantoaxial Dislocation

The conventional treatment for atlantoaxial dislocation is atlantoaxial fixation and fusion using the Goel-Harms technique, which involves a midline incision, dissection of the occipital muscle group, and is associated with disadvantages such as damage to the posterior ligament and muscle, high incidence of postoperative occipital cervical pain, and significant blood loss due to intraoperative bleeding and postoperative drainage. Since 2013, various studies have reported minimally invasive posterior atlantoaxial lateral mass joint fusion techniques through muscle spaces, but previous studies were all case reports, without sufficient reliability and controlled studies. The Department of Orthopedics at Peking University Third Hospital has been using the minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion (Mis-PALF) technique for the treatment of atlantoaxial dislocation since 2015, with preliminary good clinical results. In order to further compare the advantages and disadvantages of the two surgical methods from a larger sample, a randomized controlled study is planned. The patients will be randomly divided into two groups, with the experimental group receiving the Mis-PALF surgery and the control group receiving open atlantoaxial fusion and fixation. There will be a 1-2 year follow-up to compare the safety and effectiveness of the two surgical methods for the treatment of atlantoaxial dislocation.


Eligibility Criteria:
Inclusion Criteria:

1. Age range from 0 to 80 years old, regardless of gender
2. Diagnosed with atlantoaxial dislocation, suitable for posterior surgical treatment
3. Index of assessment integrity
4. Agree to participate in the study and sign the informed consent

Exclusion Criteria:

1. Atlantoaxial dislocation without surgical treatment
2. Atlantoaxial dislocation treated by other operation, such as TARP