cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect of Injectable Platelet Rich Fibrin on Stability of Dental Implant for Narrow Ridges

the main aim of the study is to evaluate the secondary implant stability when using dental implants with injectable platelet rich fibrin accompanied by non-autogenous bone graft material in narrow ridge cases versus straightforward ridges , in clinical comparative study.

the main aim of the study is to evaluate the secondary implant stability when using dental implants with injectable platelet rich fibrin accompanied by non-autogenous bone graft material in narrow ridge cases versus straightforward ridges , in clinical comparative study.

Study design:

Forty implants will be installed for this prospective clinical study, the implants will be equally divided into two groups.

Group A (control group) in which the implants will be installed in a straightforward cases.

Group B (study group) in which the implants will be installed by utilizing injectable PRF with non-autogenous bone graft material in narrow ridges.

Preparation of Injectable Platelet Rich Fibrin for the narrow ridge cases is as following:

Five ML of autologous blood to be collected from the forearm (median cubital vein \\ cephalic vein \\ basilic vein ) by needle gauge with a 5mL sterile syringe without anticoagulant. The entire blood is moved to a 5 milliliter plastic tube, directly centrifugated for 3 minutes at 700 rpm/min at room temperature. A liquid form ( Injectable PRF ) is then achieved on top of the tube just and the red corpuscles at the bottom. Subsequently, the Injectable PRF liquid form is collected from the tube by a sterile plastic syringe, Then it will be mixed with non-autogenous bone graft waiting for 4min, and applied in the area with narrow ridge( deficiency in the horizontal bone width ) .

Follow up Twenty four weeks after surgery , The uncoverage surgery is done under L.A using a tissue paunch for installing the healing abutment ( gingival former ) , Then the secondary stability of implant (Osseointegration) is to be measured using the (Anycheck ) device , and comparing the 2 groups

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age.
2. Absence of general medical contraindications for oral surgery procedures such as (Radiated jaws / uncontrolled Diabetic patient / uncontrolled hypertensive patient ).
3. Straightforward cases / narrow ridges (less than 6mm horizontal bone width) according to SAC classification ( advanced surgery ) cases.
4. Patients with reasonable oral hygiene.
5. Partially or totally edentulous alveolar ridges.

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Exclusion Criteria:

1. Uncontrolled medically compromised patients such as : (heart diseases uncontrolled blood pressure, endocrine disorders such as (diabetes , Thyroid disorders , osteoporosis ) , immuno-compromised patient and any condition influence bone healing ......etc.
2. Heavy smokers ( ≥ 20 cigarettes a day).
3. Patients with parafunctional habits.
4. Complicated cases according to SAC classification.
5. Patient with signs of acute infection and purulent exudates at the site of implant placement as revealed by clinical and radiographical examination.

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A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Patients will be randomized in a 1:1 ratio to one of the following treatment arms:

* Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m\^2 daily, 750 mg/m\^2 twice daily \[BID\])
* Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)

Patients will receive either neratinib plus capecitabine combination or lapatinib plus capecitabine combination until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years at signing of informed consent.
* Histologically confirmed MBC, current stage IV.
* Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.
* Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.

Exclusion Criteria:

* Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

Relapse contributes significantly to the chronicity of substance use disorders, one of the most costly medical/mental health problems facing our nation. The incorporation of exercise into relapse prevention efforts will address stress, a critical factor in relapse, provide other health benefits, and improve overall quality of life. Combined, these changes will reduce the risk of relapse to substance use while also lessening the burden of this psychiatric disorder upon society

About half of all individuals who receive treatment for substance use disorders (SUD) relapse within a year. Stress and an individual's biological response to it are significant predictors of relapse. Thus, interventions that decrease stress and normalize an individual's biological response to stress are desperately needed. Exercise decreases stress and improves the body's regulation of stress. The proposed project will utilize exercise as a novel relapse prevention intervention with individuals who have recently completed inpatient SUD treatment. This project will evaluate the efficacy of a motivational intervention for exercise in a randomized clinical trial of 150 SUD patients beginning Aftercare treatment at the VA St. Louis Health Care System. Participants will be randomized to one of two interventions: (1) standard care (SC), or (2) standard care plus a motivational intervention targeting exercise that lasts for six months. Participants are followed every three months for one year. Results from this study will advance exercise as a new strategy for enhancing stress regulation and prevention of relapse in SUD populations.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing residential substance use disorders treatment at VA St. Louis Healthcare System
* Age 18 or older
* English speaking;
* Substance dependence
* Recent substance use
* Does not have high blood pressure
* Documented physician clearance to undergo exercise testing \& exercise
* Plans to begin Aftercare at the clinic within the next two weeks

Exclusion Criteria:

* Severely disruptive behavior
* Serious uncontrolled psychiatric disorder
* Medical history in the past 6 months that contraindicates exercise
* Pregnancy, plans to get pregnant in the next six months.
* Currently breastfeeding
* Obese - class II
* Currently taking corticosteroids or hormonal contraceptives
* In recovery for pathological gambling
* Opiate dependence.
Comparison of Two Formulations of Biphasic Insulin Aspart 70

This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.

Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body mass index (BMI) between 19-27 kg/m\^2
* Fasting plasma glucose between 3.8-6.0 mmol/L

Exclusion Criteria:

* Participation in any other clinical trial involving other investigational products within the last three months
* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
* Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
Probiotics in Prevention of Common Cold

The objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold.


Eligibility Criteria:
Inclusion Criteria:

* males and females
* age 18-70 years
* increased risk for common cold (at least 4 episodes within 12 months)
* commitment to adhere to former diet and physical activity
* commitment not to use any products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) during the study (except for rescue medication, see 7.5)
* women of child-bearing potential have to agree to use appropriate birth control methods Written consent of the subject to participate is a prerequisite for study participation.

Exclusion Criteria:

* acute / chronic upper / lower airways disease
* chronic cough of any origin
* any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
* history of nasal reconstructive surgery
* presence of nasal ulcers or nasal polyps
* severe nasal septum deviation or other condition that could cause nasal obstruction
* congenital or acquired immunodeficiency disease (e.g. HIV infection)
* Bechterew's disease
* body temperature above 37.5°C
* suspected swine flu or influenza
* vaccination with a vaccine containing an adjuvant within 3 months prior to study start and during the study
* vaccination with a vaccine not containing an adjuvant within 6 weeks prior to study start and during the study
* stomach/gastrointestinal diseases
* serious organ or systemic diseases
* sleep disorder
* psychiatric disorders
* known sensitivity to the ingredients of the investigational product
* regular intake of products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) within the last 4 weeks prior to study start
* habitual usage of nasal drops/spray
* pregnancy or nursing
* alcohol / drug abuse
* simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days
* insufficient compliance
INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK IN PATIENTS UNDERGOING LAPARASCOPIC CHOLESYSTECTOMY OPERATION

Objective: Regional anesthesia techniques, such as peripheral nerve blocks, have a lower side effect profile and higher patient satisfaction compared to central blocks. With the introduction of Ultrasonography (USG), these techniques have become more commonly and reliably performed. The purpose of our study is to compare parameters such as intraoperative hemodynamics, postoperative analgesic requirement, and patient satisfaction between patients undergoing External Oblique Intercostal Plane Block (EOIB) with those who did not receive EOIB, which has few studies conducted on it.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18-65
* and with ASA1-2 were included.

Exclusion Criteria:• Patients younger than 18 years of age and older than 65 years of age

* Patients allergic to local anesthetics
* Patients with opioid and alcohol addiction
* Patients with perioperative signs of acute cholecystitis
* Patients with contraindications for laparoscopic surgery
* Cases with ASA III-IV were not included in the study.
A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
2. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Exclusion Criteria:

1. History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
2. Previous vaccination with any licensed or experimental pneumococcal vaccine.
3. Documented Streptococcus pneumoniae infection within the past 5 years.
4. Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.
Fraction of Oxygen on Induction of Anesthesia in Infants

Invesetigators evaluated the effect of positive end-expiratory pressure during anaesthesia induction on nonhypoxic apnoea time in infants. Invesetigators assigned infants to a 7 cmH2O positive end expiratory pressure (PEEP) with fraction of inspired oxygen 80% or 0 cmH2O PEEP with fraction of oxygen 80% group. Anaesthesia was induced with 0.02 mg kg atropine, 5 mg kg thiopental sodium and 3 to 5% sevoflurane, and neuromuscular blockade with 0.6 mg kg rocuronium. Thereafter, 80% oxygen was provided via face mask with volume-controlled ventilation of 6 ml kg tidal volume, and either 7 cmH2O or no positive end-expiratory pressure. After 3 min of ventilation, the infants' trachea was intubated but disconnected from the breathing circuit, and ventilation resumed when pulse oximetry reached 95%.


Eligibility Criteria:
Inclusion Criteria:

* We included paediatric patients aged 12 months or less about to receive general anaesthesia with endotracheal intubation.

Exclusion Criteria:

* Neonates, former preterm infants with gestational age less than 60 weeks at the day of surgery, with previous history of respiratory disease, those with anticipated difficult mask ventilation or intubation and those with upper respiratory infection within 3 weeks were excluded.
Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

The MEDIUM study (U01DA045384) is a cluster-randomized trial based in Ukraine. The main goal of the study is to test the implementation strategies for mental health treatment services in OAT clinics.

The study enrolled 12 OAT clinics from 12 geographically and epidemiologically diverse regions and randomized them 1:1:1 to three implementation arms: standard of care (SoC), ECHO facilitation, and ECHO plus pay-for-performance (P4P) incentives. Project ECHO, is an evidence-based telehealth intervention, connecting clinicians with national experts for short thematic didactic sessions and case discussions. All sites are provided with a modified Screening, Brief Intervention and Referral to Treatment (mSBIRT) intervention manual for mental disorders and regular supply of two selective serotonin reuptake inhibitors (SSRI) medications. All current and new patients at participating sites (N\~2000 at study start) are automatically eligible for SSRI prescription. The main outcomes of the study are the elements of mental health continuum of care (screening, diagnosis, treatment and retention). These outcomes are assessed in the entire patient population using de-personalized data extracted from the electronic medical record system. A sub-sample of patients (N=1,350) was recruited into a cohort and consented to assess prevalence and severity of mental disorders, various factors related to the uptake of and retention in mental health treatment (addiction severity, other substance use, co-morbidities), as well as other important covariates. These assessments are done at baseline, 6, 12, 18 and 24 months after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* All patients receiving OAT at participating sites

Exclusion Criteria:

* Not willing to participate
* Unable to sign informed consent
Ecology of Medical Care - Utilisation of Health Care in Austria

BACKGROUND: A proper understanding of the attitudes towards its own health status and concise estimates concerning the health seeking behavior of the different subgroups of a population are highly desirable. The structure of the Austrian population with regard to its age distribution and the proportion of people with immigrant backgrounds have been rapidly changing in recent years. Questions of allocating limited resources and meeting the needs of under-served populations have become increasingly important. However, data that could illuminate these issues are sparse and therefore obtaining them will be important for making sensible policy decisions.

METHODS: A telephone survey of the Austrian population for the assessment of the occurrence of any health complaint and the subsequent help seeking behavior with special emphasize on under-served minority groups - migrant population, elder people, and female gender.

AIMS: Our analysis of the data obtained should help to clarify some hitherto undocumented aspects and should provide the evidence for building a better health care infrastructure with equality of access and efficient coordination. We also hope that this information can help to allocate resources strategically according to needs and cost-efficiency in health care.


Eligibility Criteria:
Inclusion Criteria:

* 15 years and older

Exclusion Criteria:

* younger than 15 years
Assessing Outcome After H-graft Shunt Placement

The objective of this study is to evaluate the pre-operative symptoms and medical history of patients with portal hypertension who have undergone placement of H-graft portacaval shunts and correlate this with patient outcomes.

Research data will be collected by accessing the Tampa General Hospital medical record charts as well as the Harbourside medical charts, and extracting the necessary research data. The charts will be reviewed for the relevant medical information in order to assess outcomes in patients having H-graft shunts placed for the treatment of portal hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had H-graft shunts placed for the treatment of portal hypertension.

Exclusion Criteria:

* Patients under the age of 18 will not be included in this study.
The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy

The purpose of this study is to determine if cannabidiol (CBD) obtained via the state of Minnesota reduces seizures in patients with severe intractable epilepsy (Dravet Syndrome or Lennox Gastaut Syndrome), and to measure blood levels of CBD to help determine CBD concentration-response characteristics.

Patients with medically refractory epilepsy who are registering to take CBD in the State of Minnesota will be offered the opportunity to participate in this study. If consent to participation is obtained, the patient (or more likely, the patient's guardian) will be asked to begin a seizure diary for at least a 7-day period prior (ideally, longer) to receiving the CBD, and to continue tracking seizures throughout the study. Upon receipt of CBD from the Minnesota dispensary, subjects will take their CBD as directed and will return to the clinic for a repeat visit (which is part of standard care) occurring 2-8 weeks after continual use of CBD. During these clinic visits, patients undergo blood draws to monitor their other prescribed AED concentrations as part of standard of care. In addition to the standard blood draw, the research participant will be asked to provide a blood sample of 5 ml to measure CBD concentrations. As most patients are instructed to take CBD two hours prior to their standard of care AEDs, clinical experience indicates that most patients are taking CBD quite early in the morning (around 6 AM). Thus, the time of sample collection will be recorded as hours post-dose, and will likely be nearer peak serum concentrations. If a study participant has an indwelling intravenous access port, they will be asked to provide an additional sample of 5 ml at least one hour after the initial sample. During the repeat visit, subjects will be asked to continue documenting seizure activity in their seizure diary while they continue their CBD treatment. Any changes to AEDs administered concurrently with CBD will also be recorded.

Subjects who are already on a stable regimen of CBD will also be eligible to participate. At a clinic visit, they will be asked to provide a blood sample of 5 ml, the time of each sample will be recorded as hours post-dose of CBD. They will also be asked to begin a seizure diary and continue tracking seizure activity. If a patient terminates their CBD treatment, they will be asked to continue tracking seizure activity after their last CBD dose until their follow-up clinic visit, to determine change in seizure activity while on and off CBD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Dravet Syndrome or Lennox-Gastaut Syndrome
* Patients who are planning to obtain medical cannabidiol
* Patients who are already taking medical cannabidiol and are planning to stop taking it.

Exclusion Criteria:

* Patients without a diagnosis of Dravet syndrome or Lennox-Gastaut syndrome
Tick-borne Illness and Clothing Study

The high risk of acquiring tick-borne diseases by outdoor workers is well documented. Workers most at risk include, foresters, park rangers, land surveyors and other outdoor workers have frequent exposure to tick-infested habitats. Many North Carolina state employees with outdoor occupations report multiple tick bites each year, which indicates that existing tick preventive strategies may be ineffective. The principal goal of this study is to assess whether the use of long-lasting permethrin impregnated uniforms can reduce the number of tick bites sustained by North Carolina outdoor workers.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Employee of NC Division of Forest Resources, the NC Division of Parks and Recreation, NC Wildlife Resources Commission, or NC County and Local Parks and Recreation who work in Central and Eastern North Carolina
* An average of 10 or more hours of outdoor work per week during tick season
* Self-reported prior work-related tick bites

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Known allergy to insecticides