cyrilzakka/clinical-trials huggingface dataset:
Impact of a Alveolar Ridge Preservation Technique on the Need of Performing Guided Bone Regeneration for Dental Implant Placement

The aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.

The main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. Bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age

  * at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession;
  * adequate oral hygiene, i.e. plaque index score ≤10%;
  * mesial-distal width of inter-dental space ≥7 mm;

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) score ≥III
* presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing
* a history of radiotherapy to the head and neck region
* presence of conditions requiring chronic use of antibiotics
* medical conditions requiring prolonged use of steroids
* history of leucocyte dysfunction
* history of bleeding disorders
* history of renal failure
* patients with metabolic bone disorders
* patients with uncontrolled endocrine disorders
* disability affecting oral hygiene
* alcohol or drug abuse
* HIV infection
* smoking \>10 cigarettes a day or cigar equivalents
* conditions or circumstances that would prevent completion of study participation
* mucosal diseases
* presence of osseous lesions
* severe bruxing or clenching habits
* persistent intraoral infections
* compromised alveolus (dehiscence, etc)
A Long-Term Study on Safety of JNS001 in Adults With Attention-Deficit Hyperactivity Disorder

The main purpose of this study is to evaluate long-term safety and tolerability of JNS001 at 18 to 72 mg per day in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

This is a multicenter, open-label (all people involved know the identity of the intervention), dose-titration (to adjust the dose of a drug until optimal result is reached), long-term safety study in adult patients with a diagnosis of ADHD. The study consists of the Long-term phase (4-week titration period and 44-week maintenance period) and the 1-week Post-study phase. The 4 week-titration period is to find the individualized dose for each patient regardless of the treatments in the preceding study (JNS001-JPN-A01). Patients will be titrated from a starting dose of 18 mg/day for 7 days, and continue with a weekly (+/- 2 days) increment of 9 or 18 mg until an individualized dose is achieved. The titration period will be followed by a 44-week maintenance period which has combined 48-week (1-year) treatment duration with the titration period. During the maintenance period, the dose will be adjusted between 18 to 72 mg depending on the patients' symptoms. In the post-study phase, safety information will be collected after the last dose of the study treatment or premature discontinuation. The study drug will be administered with water once daily in the morning at doses of 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, or 72 mg per day. The study treatment period is 48 weeks (titration period of 4 weeks and maintenance period of 44 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Patients (and their legally-acceptable representative if patients are 18 or 19 years old) must have signed an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
* Patients who completed the preceding study (JNS001-JPN-A01), are considered to be appropriate to continue JNS001 treatment into this extension study by investigator or subinvestigator
* Women of childbearing potential must have a negative urine pregnancy test at the final assessment in the preceding study. If sexually active, continue to use an effective method of birth control throughout the study
* Men must agree to use a double-barrier method of birth control and not donate sperm during the study and for 90 days after receiving the last dose of study drug.

Exclusion Criteria:

* Patients who have reported AEs which would prevent transfer to this study from the preceding study (JNS001-JPN-A01)
* Patients who had been judged ineligible as patients for this study by investigator or subinvestigator
TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz

The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study.

Primary Objective:

To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.


Eligibility Criteria:
* Patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily.
A Study Of ¹²⁹XE MRI To Assess Disease Progression In Patients With COPD Treated With Or Without Azithromycin And Standard-of-Care Medications

This study will test whether daily use of azithromycin will reduce the rate of exacerbations and improve lung ventilation and perfusion assessed by XE-MRI. The sensitivity of XE-MRI to detect COPD progression will be compared with standard clinical assessment measures including standard lung function tests, 6 minute walk test, and patient reported quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Current or former smokers with years ≥ 10 pack years
* mMRC dyspnea score \> 1
* Post-bronchodilator FEV-1/forced vital capacity (FVC) \<0.70 at Visit 1 or Visit 2
* Cohort A: GOLD Stage 2-4 COPD with a history of ≥ 2 moderate/severe exacerbations within a 12-month period in the 24 months prior to screening
* Cohort B: GOLD Stage 1 COPD with a history of ≥1 moderate/severe exacerbations within a 12-month period in the 24 months prior to screening
* Receiving SOC background drug therapy as per GOLD or British Thoracic Society (BTS) guidance for COPD for 12 weeks prior to screening Visit 1
* On an eligible bronchodilator medication (LABA ± LAMA) ± ICS therapy for ≥12 weeks prior to Visit 1
* Chest X-ray or CT scan within 6 months prior to Visit 1, or during the screening period (prior to Visit 2), that confirms the absence of clinically significant lung disease besides COPD
* Use of contraceptive measures

Exclusion Criteria:

* Diagnosis of significant respiratory disease other than COPD
* Comorbid conditions that may interfere with the evaluation of an investigational medical product
* Known sensitivity or allergy to azithromycin
* A COPD exacerbation and or pneumonia within 4 weeks prior to Visit 1
* Use of systemic corticosteroids within 4 weeks (oral or intravenous) or within 12 weeks (intramuscular IM) prior to screening Visit 1
* MRI is contraindicated
* Any known arrhythmia, bradycardia or severe cardiac insufficiency
* Participant can not hold breath for 15 seconds
* Participant does not fit in the ¹²⁹XE vest coil used for MRI
* Pregnant, lactating, or intending to become pregnant during the study or within 4 weeks after the last dose of the investigational medical product
* History or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
* For participants in Cohort A: Known significant hearing impairment as indicated by a score of ≥ 26 on the Hearing Handicap Inventory in the Elderly-Screening Questionnaire or as determined by the investigator
* History of Clostridium difficile (C. difficile) diarrhea Clinically significant ECG changes, which in the opinion of investigator warrants further investigation or with a QTc interval \> 450 ms
Prevalence of Bacterial Contamination on Smart Cell Phone vs. Non-smart Phone

Using smartphone is increasing in hospital with various purpose and it has more extended surface than non-smart phone. Therefore investigators can consider the bacterial contamination rate of smartphone will be higher than that of non-smartphone.

Hospital-acquired infections(HAI) are causing grave concern in almost all the hospitals of the world and causing increased morbidity and mortalities.

The transmission of HAI occurs through hospital staff and inanimate hospital environment, equipment, and devices that the hospital staff use.Recently, cellphones (CP) were blamed to cause nosocomial infections.

The mobile phones are used routinely all day long but not cleaned properly, as health care workers' may do not wash their hands as often as they should. The aim of the present study was to evaluate the prevalence of bacterial contamination of mobile phones in ICU health care providers. and especially compare the contamination rate between smartphone and non-smartphone.

Using smartphone is increasing in hospital with various purpose and it has more extended surface than non-smart phone. therefore we can consider the bacterial contamination rate of smartphone will be higher than that of non-smartphone.

Eligibility Criteria:
Inclusion Criteria:

* healthcare providers of MICU who have cellular phones

Exclusion Criteria:

* healthcare providers of MICU who have not cellular phones
Cardiac Rehabilitation and Additional Physical Training in Elderly Patients After Acute Coronary Syndrome

The aim of this study is to evaluate functional and physical capacity, health-related quality of life and associations with frailty in older patients after ischemic heart disease and interventional treatment with an individualized physical training program in the second phase of cardiac rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Patients after acute coronary syndrome and percutaneous coronary intervention or coronary bypass surgery;
* Age 65 years and older;
* 6-minute walk distance (6-MWD) ≥150 meters;
* Left ventricular ejection fraction ≥ 40%;
* Patient's agreement to participate in the study.

Exclusion Criteria:

* combined coronary artery bypass grafting and valve surgery;
* Cardiac devices;
* Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
* Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive or linguistic deficits.
Evaluation of a Digital Pre-therapy Patient Education Program (StartHjelp) in Outpatient Mental Health Care

Community mental health centers (CMHCs) face significant challenges in meeting the needs of individuals with mental health issues. For example, due to high demand, there are long waiting lists and low engagement rates. Innovative interventions are urgently needed to address these challenges to improve patient engagement, coping skills, and overall health outcomes. Educational and self-management interventions have shown promise in enhancing patient activation and treatment satisfaction in other contexts. They may therefore be potential solutions to reduce the identified challenges in the mental health service. To bridge these knowledge and practice gaps, this study aims to evaluate a digital pre-therapy patient education program tailored specifically for adults with mental disorders. This intervention aims to enhance treatment satisfaction, patient activation, knowledge, patient engagement, and overall mental health outcomes.

Community mental health centers (CMHCs) play a pivotal role in the provision of comprehensive care and support for individuals with mental health challenges. However, these centers often face formidable obstacles, including surging patient demands, lengthy waiting lists, high dropout rates, and barriers to engagement, stigma, and negative attitudes. Given these challenges, there exists an urgent imperative to develop innovative interventions that can enhance treatment satisfaction, patient activation, knowledge, and patient engagement, and ultimately yield improved mental health outcomes. One promising approach for addressing these challenges lies in the realm of patient engagement and enablement strategies, particularly through the implementation of digital educational interventions.

The investigators hypothesize that utilizing innovative technology to deliver an early digital self-management educational program improves treatment satisfaction, patient activation, knowledge, patient engagement, and overall mental health outcomes without substantially increasing service costs. The impact of utilizing innovative technology to deliver an early digital pre-therapy patient education program through the HelsaMi web patient portal is promising. By leveraging technology, it is possible to reach a wider audience and provide accessible and convenient information, with the same standard to all patients. This approach has the potential to improve patient outcomes, increase treatment adherence, and reduce the burden on healthcare resources. By demonstrating the benefits of digital interventions, our research will pave the way for more efficient and cost-effective mental healthcare services, benefiting both patients and healthcare systems.

Eligibility Criteria:
Inclusion Criteria:

* Put on the waiting list for mental health outpatient treatment in the active study period.
* Willing to participate in the study
* Over 18 years
* Understand written and spoken Norwegian

Exclusion Criteria:

* In need of acute help
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)

This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).

Participants enrolled can expect to be on the study for a total duration of approximately 2 years, during which there will be a screening period followed by a single administration of CB-010 and then 24 months of safety follow-up and monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SLE according to 2019 EULAR/ACR classification criteria for at least 6 months
* Cohort 1 LN:

  1. Class III or IV lupus nephritis
  2. Urine protein-to-creatinine ratio (UPCR) ≥ 0.8 mg/mg
  3. Refractory to glucocorticoids and at least 2 immunosuppressive therapies
* Cohort 2 ERL (Patients with class I and II LN may be included in the ERL cohort if their SLEDAI-2K is ≥ 8):

  1. SLEDAI-2K ≥ 8
  2. Refractory to glucocorticoids, and at least 2 immunosuppressive therapies
* Adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria
* Females must be either of nonchildbearing potential, defined as postmenopausal or surgically sterile or agree to use a highly effective double barrier method of contraception or vasectomized partner

Exclusion Criteria:

* Has active severe central nervous system (CNS) lupus in the previous 3 months from planned LD start date
* Has received any other investigational treatment for any indication within the 4 weeks or 5 half-lives
* Prior treatment with cellular therapy (genetically modified cells), gene therapy directed at any target, allogenic or autologous stem cell transplant or organ transplant
* History of infection with human immunodeficiency virus or evidence of hepatitis B or C virus infection
* History of hypersensitivity to Cyclophosphamide, Fludarabine, or any of the components of CB-010
* Received a live vaccine ≤ 6 weeks prior to start of LD
* Patients for whom magnetic resonance imaging (MRI) studies are contraindicated or who cannot tolerate them
Retrospective Study of the Safety and Efficacy of Patients With RVO in Subjects Who Completed Parent Study CLS1003-201

The purpose of this non interventional retrospective study is to continue to collect data from patients following their completion of Protocol CLS 1003-201: "Safety and Efficacy of Suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Macular Edema Following Retinal Vein Occlusion" (ie, the parent study).

This is a non-interventional, retrospective study of up to 6 months for subjects that completed the parent study CLS1003-201. This study is designed to collect data from patients following their parent study exit visit, through either the time of the next treatment for RVO or at least 6 months following the parent study exit visit, whichever occurs first.

During this non-interventional retrospective study, the following data will be collected in an online questionnaire (or where required, on paper) provided by Clearside:

* Next RVO therapy administered (if applicable), including reason for treatment
* Continued documentation of current or changes in medical or ocular conditions following parent study
* Concomitant drug or therapy changes
* Visual acuity, including details on the method used in the assessment
* Central retinal thickness, including details on the equipment used in its determination
* Intraocular pressure, including details on the equipment used in its determination

Subjects will be selected based on parent study primary investigator's access to their medical records access, following exit from CLS1003-201. Data will also be collected on the total number of patients included in this non interventional study as well as reasons patients were excluded. Data will be summarized from the randomization treatment assignment in the parent study.

Eligibility Criteria:
Inclusion Criteria:

* Completed enrollment and did not receive additional aflibercept therapy in the Parent study, CLS1003-201

Exclusion Criteria:

* N/A
A Study of Omega-3 as an Augmentor of Antidepressant Treatment for Major Depression

The purpose of this study is to determine whether augmentation of antidepressant medication with Omega-3 polyunsaturated fatty acids increases the speed and degree of improvement for patients with major depression

The study will be a 4 week, parallel-group double blind randomised control trial of the efficacy pf Omega-3 as an augmentor of antidepressant treatment for depression. People aged between 18 and 65 with a first or new episode of depression warranting treatment with antidepressant medication will be recruited. In addition to their antidepressant medication, participants will be randomly allocated to receive either Omega-3 (fish oil) or placebo (paraffin oil)for 4 weeks. Participants will commence treatment with the antidepressant and Omega-3/placebo simultaneously. Participants will be followed up at 1,3 and 4 weeks and will be asked to rate their mood daily for the 4 week study period. Blood samples will be taken pre and post treatment to measure change in Omega-3 levels.

Eligibility Criteria:
Inclusion Criteria:

* Participants must present with a first or new episode of DSM IV non-psychotic major depression warranting treatment with antidepressant mediation.
* Must be able to give informed consent.

Exclusion Criteria:

* History of psychosis or mania/hypomania or personality disorder.
* Non-English speaking or otherwise unable to provide historical information.
* Having taken Omega-3 dietary supplements in the last 3 months.
* History of allergy to Omega-3 supplements, finfish or shellfish.
* Pregnancy, breast feeding or plans to become pregnant during course of study.
* Post-natal depression
* Current drug or alcohol abuse or dependence or history of abuse or dependence over the last 12 months.
* Unstable thyroid function
* Hepatic or renal impairment or other medical conditions that may interfere with the absorption and metabolism of Omega-3 polyunsaturated fatty acids
* Coagulopathy or anticoagulant treatment due to theoretical bleeding risk.
* Patients who, in the investigator's judgment pose a current serious suicidal or other safety risk, or patients who will not likely be able to comply with the study protocol.
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level

There is a high prevalence of poor sleep quality among university students studying in different areas such as medicine, nursing, art, science, social work etc. and in different countries. However, the studies done especially for physiotherapy students, and in Turkey, as well, are not many. Therefore, we aimed to search the sleep quality among physiotherapy students, and observe the association between the health related quality of life and physical activity level of the physiotherapy students.

The physiotherapy students were included. Their quality of sleep will be assessed by Pittsburgh Sleep Quality Index. The physical activity will be searched by International Physical Activity Questionnaire, and SF-36 will be used to assess quality of life. Data is going to analyzed statistically

Therefore, recent studies are focusing on the sleep quality of university students in different countries, and reporting that medical students pharmacy students, nursing students are experiencing poor quality of sleep. However, to our knowledge, studies done on sleep quality of students and especially the physiotherapy students are not available in Turkey, yet.

Hence, since the university students are one of the high risk groups for developing poor sleep quality, we aimed to evaluate if the sleep quality of the physiotherapy students in both gender are associated with their quality of life and physical activity level.

Eligibility Criteria:
Inclusion Criteria:

* Being physiotherapy and rehabilitation students
* Being the age between 18-26 years old
* Being voluntary to participate to the study

Exclusion Criteria:

* Not having any systemic disease
* Any expressed psychological condition