cyrilzakka/clinical-trials huggingface dataset:
Lateral Sinus Floor Elevation in Implant Therapy.

The L-PRF block is a combination of bone substitute with L-PRF. The use of a L-PRF block in bone augmentation therapies could enhance and improve bone regeneration.

The primary objective of this study is to evaluate if the use of autologous leukocytes and platelet rich fibrin accelerate and promotes bone regeneration in the sinus in comparison with the standard sinus lift procedure procedure.

This is a randomized controlled clinical trial. A total of 24 patients, needing sinus lift with lateral window technique (L), will be enrolled. All patients have to fulfil all of the inclusion and none of the exclusion criteria. The trial will comprise 8 visits. Written informed consent will be obtained prior to any examination carried out for study purposes. Randomization will be performed using sealed, sequentially numbered, opaque envelopes containing treatment allocation.

Under local anaesthesia, the required L will be performed. Once the blood extraction is done the surgery can start following the normal procedure for the lateral approach of sinus floor elevation. Once the preparation of the sinus floor elevation is done the randomization envelopes will be open and the selected treatment will be applied. For the test group the sub-sinus cavity will be filled with L-PRF block and the window will be closed with L-PRF membranes. For the control group the sub-sinus cavity will be filled with only DBBM and the window will be closed with a collagen membrane. Afterwards suturing will be conducted and a CBCT will be taken for control and observation.

After 6 months the subjects return for a check-up of the healing process. A CBCT will be taken to assess the bone regeneration. Implant surgery will be discussed.

With a crestal incision the implant site will be exposed. A trephine bur of 3 mm in diameter will be use to obtain a biopsy of the test or control site. This will result in a biopsy sample of the healed site. At the exact same location of the biopsy the drilling will be performed according to implant protocol and the implant will be placed and ISQ values will be recorded. Follow-up will be till 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Need for L and oral implant placement.
* RBH \<4mm
* RBH \>4mm, but no T possible (due to anatomy)

Exclusion Criteria:

* Unlikely to be able to comply with the study procedures, as judged by the investigator
* Untreated periodontal disease
* Unfavorable plaque control
* Known or suspected current malignancy
* History of chemotherapy within 5y prior to study
* History of radiation on the head and neck region
* History of other metabolic bone diseases
* Need for systemic corticosteroids
* Current or previous use of intravenous/oral bisphosphonates
* Present alcohol and/or drug abuse
* Involvement in the planning and conduct of the study
* Psychiatric disorders which do not allow a normal treatment outcome
Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema

The purpose of this trial is to test if delgocitinib cream is effective at treating chronic hand eczema (CHE) and what side effects it may have, in children aged 12-17. There will be a range of assessments that rate the severity and extent of CHE symptoms, general health and quality of life.

Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation.

The trial will last up to 22 weeks and has a 1-4 week screening period, a 16 week treatment period and a 2 week follow up period. During the treatment period each child will use either delgocitinib cream or a cream vehicle twice a day. Which cream each child receives is chosen randomly by a computer. The cream vehicle is made of the same ingredients as the delgocitinib cream except for the active medical ingredient. There will be 8 visits with the trial doctor.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
* Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE.
* Subjects who have a documented history of inadequate response to treatment with TCS or for whom TCS are documented to be otherwise medically inadvisable.

Exclusion Criteria:

* Concurrent skin disease on the hands.
* Clinically significant infection on the hands.
* Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
* Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline.
* Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249), systemic or topical.
* Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days prior to baseline.
* Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
* Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days prior to baseline.
* Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
* Any disorder which is not stable and could:

  * Affect the safety of the subject throughout the trial.
  * Impede the subject's ability to complete the trial.
A Comparison of Long-Term Effectiveness of Two Desensitizing Products

This randomized, controlled, clinical trial aimed to compare the 6- month clinical performance of a desensitizer that contains calcium phosphate TM with a two-step self-etch adhesive SE and placebo (distilled water). At least 150 teeth wil be treated with desensitizing products and placebo randomly one third usig TM, one third using SE and one third using placebo. The efficiency of the materials will be evaluated at baseline, 1 week, 1 month, 3 months and 6 months after treatment.

The aim of this randomized, controlled, clinical trial is to compare the clinical efficacy of a desensitizer that contains calcium phosphate with a two-step self-etch adhesive and placebo through a long-term period (6 months). At least fifty patients with a sensitivity score of 6 or higher, according to the Visual Analog Scale (VAS), with at least three teeth will participate in this study. Teethmate Desensitizer (TM), Clearfil SE Bond 2 (SE) and placebo (distilled water) will be applied randomly to three teeth of each patient. Recalls will be done at baseline, 1 week, 1 month, 3 months and 6 months after treatment by applying air-blast and the sensitivity scores will be determined according to VAS. The efficiency of the materials will be determined according to the VAS scores. Data will be analyzed using Paired t test and repeated measures of ANOVA.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with 3 or more hypersensitive teeth with a VAS (Visual Analog Scale) score
2. Willingness to participate in the study

Exclusion Criteria:

1. Subjects are unwilling to participate voluntarily
2. Patients under 18 years old
3. Those that were taking analgesic medicaments
4. Pregnant and breastfeeding females
5. The presence of a systemic disease that affects the participation
6. Teeth with cervical loss of hard tissue that need restoration absolutely
7. Large/defective restoration, caries or enamel cracks in sensitive teeth
8. Teeth with vulnerability to hypersensitivity after root scaling
9. Pulpitis presence.
Clinical Study to Evaluate the Safety and Efficacy of New Probiotic Strains in Health Adults

This trial is to determine the safety of 4 new probiotic strains and to assess their efficacy in reducing the incidence and/or duration of gastrointestinal problems and infections as well as respiratory infections in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form. Healthy adults aged 18-65.

Exclusion Criteria:

* Presence of a pre-existing adverse events monitored in the study. Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major GI surgery, chronic GI illness, abnormal intestinal anatomy or significant abdominal disorder. Severe chronic illness. Known immunodeficiency. Use of immunosuppressive agents. Presence of severe immunodeficient family members. Pregnancy, 6 months postpartum period or currently breastfeeding. Women of child bearing age planning pregnancy during the course of the study. Participation in another study. Not able to understand and comply with requirements of the study.
Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Treated with OADs for more than or equal to 3 months
* HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
* Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

* Recurrent major hypoglycaemia
* Current smoking or smoking within the last 6 months
* Impaired hepatic or renal function
* Cardiac problems
* Uncontrolled hypertension
* Proliferative retinopathy or maculopathy
Improve the Treatment of Thoracic Esophageal Cancer

The purpose of this study is

1. To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on the staging and prognosis of resectable esophageal cancer, which defined by the International Association of esophageal disease(ISDE) - standard mediastinal lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to find out reasonable range of lymphadenectomy.
2. To compare the effects of Chemotherapy Group (Docetaxel + Nedaplatin) with Control Group on the prognosis of resectable thoracic esophageal cancer,and to explore the indications of adjuvant chemotherapy.

According to different location of the primary lesion，the subject can be allocated to two sub-groups:

The patient with upper or middle thoracic esophageal cancer may be assigned to two field(T)-total mediastinal lymphadenectomy group,which is control group in this study or three field lymphadenectomy-Abdominal + mediastinal + cervical lymphadenectomy group,which is study group in this study randomly.

After the operation,the patient whose primary lesion is completely(R0) resected will be assigned to adjuvant chemotherapy group or interview group randomly.

Eligibility Criteria:
Inclusion Criteria:

1. Age≤70 years old;
2. Karnofsky Performance Status（KPS）≥80;
3. Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially;
4. Clinical stage is c T 1 \~ 3 N 0 \~ 1 according to the results of endoscopic ultrasonography，chest and abdomen CT and neck ultrasonic.
5. The preoperative evaluation of organ function is tolerant of surgery and chemotherapy;
6. The subject can understand and sign the informed consent form (ICF);
7. The following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; Hemoglobin（HGB）≥9.0g/L; absolute neutrophils count（ANC）≥1.5×109/L; platelet count（PLT）≥100×109/L; total bilirubin（TBIL）≤1.5N;aspartate aminotransferase (AST)≤2.5N;alanine aminotransferase(ALT)≤2.5N;prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range;endogenous creatinine clearance rate(CRE)≤1.5N.

Exclusion Criteria:

1. Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer;
2. Advanced Esophageal Cancer;
3. Prior malignancy in 5 years recently;
4. History of previous chest radiotherapy;
5. History of cardio-cerebral vascular accident in 6 months lately;
6. The subject can not understand and sign the informed consent form(ICF).
Surgical Treatment of Pelvis in Fragility Fracture in Germany: a Prospective, National, Multicenter, Observational, Comparative Cohort Study Comparing Isolated Posterior Versus Combined Anterior-posterior Surgical Fracture Stabilization

Over a period of approximately two years, patients above the age of 65 who have suffered from an FFP equal to or higher than type IIc FFP, according to Rommens and Hofmann, will be eligible for inclusion. At least 420 patients will be included and followed up up for 12 months. Treatment and postoperative care, will be as per standard of care at the participating institution, with a free choice of isolated posterior or combined anterior-posterior surgical treatment.

Pain levels, quality of life, level of mobility and independence will be assessed at different time points. Furthermore, both clinical and radiographic outcomes, complications, morbidity and mortality associated with interventions will be evaluated. Assessment and evaluation will be performed at defined time points during FU according to standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sacral FFP (no concomitant injuries) Types: IIc, IIIc, IVb, IVc according to Rommens and Hofmann associated with fracture of the anterior pelvic ring (fractures involving the anterior lip of the acetabulum that are not regarded as acetabular fracture will be included)
* Diagnostic workup for fracture diagnosis and classification performed using CT scan as per standard of care
* Indication for surgical fracture fixation as considered by the attending surgeon
* Age ≥ 65 yrs.
* Low-energy trauma fracture, or osteoporotic fracture, or insufficiency fracture, or spontaneous fracture
* ASA-Score ≤ 3 pts.
* Ability to provide informed consent according to the IRB/EC defined and approved procedures

Exclusion Criteria:

* Patients with multiple fractures
* Instability of the pubic symphysis (ie, visibility of a widening or diastasis of the symphysis), and/or fractures of the pubic rami next to the symphysis, that indicate instability
* Pelvic fractures due to high-energy trauma
* Pathologic fractures (eg, fractures caused by malignancy or infection)
* History of pelvic fracture or pelvic ring surgery (hip joint implants do not count)
* Clinically significant or unstable medical or surgical condition that prevents surgical treatment
The Pathogenesis and Prognostic Factors of Lymphoma

The aim of this study is to describe the clinical and genetic characteristics of Chinese lymphoma patients, and to explore the relationship between those characteristics and phatogenesis.

Lymphoma is a highly common malignant tumor in Asia. This study aims to observe and describe the clinical and genetic charateristics of Chinese lymphoma patients, and to explore the relationship between those charateristics and pathogenesis and prognostic factors in the real-world population. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathological diagnosis of lymphoma (including Hodgkin lymphoma and non-Hodgkin lyphoma, eg. THRLBCL, DLBCL, MZL, CLL/SLL...) from 2007 to 2027.
* Patients with complete diagnostic, treatment and follow-up records.
* Fully comprehension and signature of the informed consent form (ICF) for participation.

Exclusion Criteria:

* Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.
* Severe mental illness.
* Patients deemed unsuitable for inclusion by the investigator.
Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis

Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin may aid sleep and also has anti-inflammatory properties, and has been suggested in managing sleep disturbance in AD patients. However, there has been no large randomized controlled trials. Hence the objective of this double-blind randomized controlled study is to determine whether supplementing melatonin is effective in improving sleep problems in children with AD.


Eligibility Criteria:
Inclusion Criteria:

* Children between 1 and 18 years of age with mild to moderate AD, affecting at least 5% of total body surface area, and with sleep problems in the previous 3 months

Exclusion Criteria:

1. Those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine
2. Those who had received therapy for insomnia within 4 weeks before the baseline visit
3. Those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments
4. Those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully
5. Those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication
6. Pregnant and lactating women and those who are presently planning to get pregnant
7. Those who had any other condition or earlier/current treatment which, in the opinion of the investigator, would render the participant ineligible for the study
Vaginal Indomethacin for Preterm Labor

Indometacin is a cyclooxygenase agent from the NSAID family that has been used to treat preterm contractions since the 70's by preventing the synthesis of prostaglandins. It has been shown to be significantly more effective than placebo and postpone labor for 7-10 days, prolong pregnancies above 37 weeks of gestation and reduce numbers of small for gestational age neonates.

Nifedipine is a calcium channel blocker agent that has been shown to reduce rates of labor within 48 hours from treatment.

Previous studies comparing rectal Indometacin to oral nifedipine were inconclusive.

Prostaglandins are synthesized in the uterus and the uterine cervix and therefore local administration of Indometacin may be more effective than other forms of administration, as been shown in a previous study.

In this study we aim to compare vaginal Indometacin administration to a commonly used tocolytic agent, nifedipine.


Eligibility Criteria:
Inclusion Criteria:

* Singe fetus
* Gestational age between 24+0/7 and 31+6/7
* At least one uterine contraction in ten minutes for at least 20 minutes upon tocography admission
* Cervical parameters: 1 cm dilation or more or 80% cervical effacement or cervical length 20mm or less

Exclusion Criteria:

* Rupture of membranes
* Vaginal bleeding
* Cervical dilation ≥5cm
* Known fetal malformations
* Fetal heart rate abnormalities
* Suspected placental abruption of adherent placental syndrome
* Known sensitivity to one of the drugs used in the study (Indometacin and nifedipine)
* Maternal hypotension and known aortic or mitral stenosis
* Presence of cervical cerclage
* Previous administration of tocolytic drugs in current pregnancy
Burosumab in Children and Adolescents With X-linked Hypophosphatemia

In this prospective longitudinal cohort study we studied the efficacy and safety of burosumab in real-clinical practice for \<13- and \>13-years old children affected with X-linked hypophosphatemia.

57 children with XLH were switched from conventional treatment to burosumab. After 12 months we assessed the efficacy and safety of treatment with burosumab on the whole cohort and separately on the cohort of \>13-years old adolescents.


Eligibility Criteria:
Inclusion Criteria:

* insufficient response or refractory to conventional therapy;
* complications of conventional therapy: hypercalciuria and/or nephrocalcinosis, and/or persistent secondary hyperparathyroidism;
* need for rapid restoration of phosphate metabolism, e.g., late diagnosis (aged \>8 years) and/or preparation for planned orthopaedic surgery.
Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving rituximab before chemotherapy may be an effective treatment for B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia.

PURPOSE: This phase II trial is studying how well rituximab works in treating young patients who are planning to receive chemotherapy for B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia.

OBJECTIVES:

* Determine the response rate in children and adolescents with B-cell non-Hodgkin's lymphoma (B-NHL) or B-cell acute lymphoblastic leukemia (B-ALL) treated with rituximab monotherapy as upfront window therapy before chemotherapy.
* Evaluate the effect of rituximab on different histological subtypes of childhood mature B-NHL or B-ALL in patients treated with this regimen.
* Investigate the rituximab response in patients treated with this regimen.
* Determine the toxicity profile of rituximab in these patients.
* Collect pharmacokinetic and pharmacodynamic data from patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1.

PROJECTED ACCRUAL: A total of 79 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically and immunohistochemically OR cytomorphologically and immunphenotypically confirmed mature B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia
* CD20 positive disease

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Adequate general condition with sufficient organ function (hepatic, renal, and cardiac)
* No known disease that would preclude protocol therapy with rituximab
* No known allergies against proteins
* No acute or previous hepatitis B infection

PRIOR CONCURRENT THERAPY:

* At least 2 weeks since prior corticosteroids
* No prior radiotherapy
* No prior or concurrent chemotherapy
* No concurrent treatment in another investigational trial