cyrilzakka/clinical-trials huggingface dataset:
Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone

The goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. The main questions it aims to answer are:

* Is significant alveolar ridge resorption observed at center sites after consecutive extractions
* Is significant alveolar ridge resorption observed at the interalveolar septum after consecutive extractions, are different extraction sites associated with significantly different bone resorption
* Is a thick or thin wall phenotype associated with the amount of bone resorption
* Is soft tissue thickness change associated with the corresponding location (extraction site or interalveolar septum) and post-extraction thickness of the bone
* Is the interdental papilla height significantly affected after extractions.

Participants will undergo consecutive (two) extractions and will be evaluated after subsequent unassisted socket healing for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* Require consecutive (two) teeth replacement in the anterior maxilla
* Signed informed consent
* No significant medical conditions
* Patients with healthy periodontal conditions or previously treated to controlled and stable conditions

Exclusion Criteria:

* General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
* Pregnancy or nursing
* Any interfering medication such as steroid therapy or bisphosphonate therapy
* Uncontrolled diabetes
* Autoimmune diseases or inflammatory diseases affecting the intraoral tissues
* Radiation therapy to head or neck region
MGTA-456 in Patients With Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplantation (HSCT)

This study is designed to assess the safety and efficacy of using MGTA-456 in patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.

This phase 2 study is designed to evaluate the safety and efficacy of MGTA-456 in patients with IMD after receiving myeloablative conditioning and HSCT. MGTA-456 is an expanded CD34+ cell therapy product candidate given to induce rapid and sustained hematopoietic engraftment. In patients with selected IMDs, transplant is expected to replace defective or missing protein and preserve neurodevelopment. Since MGTA-456 offers increased numbers of HSCs over standard umbilical cord blood, it is expected to reduce the risks of prolonged neutropenia and thrombocytopenia and graft failure, and potentially transplant-related mortality (TRM). Patients with Hurler syndrome (also referred to as mucopolysaccharidosis-1H (MPS-1H)), cerebral adrenoleukodystrophy (cALD), metachromatic leukodystrophy (MLD) or globoid cell leukodystrophy (GLD) (also referred to as Krabbe disease) are eligible for this study.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 2.5 years with Hurler syndrome, age 2-17 years with cerebral adrenoleukodystrophy (cALD), age \< 16 years with metachromatic leukodystrophy (MLD) and age ≤ 10 years with globoid cell leukodystrophy (GLD) (also referred to as Krabbe)
* Cord blood grafts require genetic testing and/or demonstration of enzyme activity for patients with Hurler syndrome, MLD or GLD and are tested for very long chain fatty acids (VLCFA) to confirm there is no evidence of VLCFA consistent with ALD
* Adequate organ function
* Availability of eligible donor material

Exclusion Criteria:

* Availability of a matched-related donor who is not a carrier of the same genetic defect
* Active infection at screening
* Prior myeloablative conditioning
* History of human immunodeficiency virus (HIV) infection
The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation

The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by a panel of established circulating inflammatory biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* intermittent claudication
* resting or exercise Ankle-Brachial Index (ABI) \<0.9
* age 50 and more

Exclusion Criteria:

* critical limb ischemia
* hypersensitivity/allergies to fish or seafood
* already on omega-3 fatty acids or equivalent
* significant renal, hepatic, and inflammatory disease
* concurrent severe infections
* acute illness (MI, stroke, major surgery within 30 days)
* receiving immunosuppressive medications or steroids
An Educational Intervention to Improve Resident Comfort With Communication at the End of Life

The purpose of this study is to investigate whether the addition of teaching on communication at the end of life to the pre-existing resident curriculum will positively impact residents' knowledge and attitudes regarding communication at the end of life.

Previous research has demonstrated a lack of resident training in communication at the end of life. This can lead to anxiety on the part of residents and poor experiences with these conversations. Residents at UCSF, and affiliated sites, participate in a daily formal teaching session from 12-1 pm and an informal case conference, known as Morning Report, from 7:30-8:30 am (8-9 am at VAMC). We propose to administer a pre-intervention survey to residents to assess knowledge and attitudes regarding communication at the end of life. Over two months, residents will receive one lecture during the noon session. Clinical cases will be presented for discussion during three sessions of morning report. All sessions are voluntary and take place at all three training sites, UCSF, SFGH, and the VAMC. As residents rotate every two months between the inpatient and outpatient settings, the intervention will be repeated once to ensure that the majority of residents have the opportunity to participate. A post-intervention survey, identical to the pre-intervention survey, will be administered to assess for impact of the educational intervention. This project only involves UCSF Internal Medicine residents. No patients will be involved in this study.

Eligibility Criteria:
Inclusion Criteria:

* UCSF internal medicine resident

Exclusion Criteria:

* Not UCSF internal medicine resident
Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.

The present study is an effort to investigate the hypothesis that Platelet Rich Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation and in bone loss.

Study design

Fifty-five individuals from a suburban population were recruited. Out of them, 5 individuals refused to participate in the study. Finally, 50 participants were selected and divided into two groups, control group \[Healthy individuals\]: 25 Males/Females, aged 25 to 35 years and test group \[Chronic periodontitis patients\]: 25 Males/Females aged 30 to 45 years.

Demographic variables and periodontal parameters were measured in both the groups.The investigators explored the effect of Platelet rich fibrin (PRF)/Biphasic calcium phosphate (BCP) on differentiation and survival of osteoclasts obtained from peripheral blood of Chronic Periodontitis patients.

Eligibility Criteria:
Inclusion criteria: (Control group)

* Subjects with age group between 30 to 45 years.
* Non-smokers.
* No previous history of periodontal treatment.

Inclusion Criteria: (Test group)

* Subjects with age group between 30 to 45 years.
* Presence of atleast 20 teeth
* More than 30% of the sites with clinical attachment loss.
* Non-smokers.
* No previous history of periodontal treatment.

Exclusion Criteria: ( both the groups)

* Individuals with systemic disease
* Subjects under antibiotics or anti-inflammatory drugs within the previous 3 months.
* Pregnant and lactating women.
* Allergic to antibiotics.
Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis

The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.


Eligibility Criteria:
Inclusion Criteria:

* Completion of a qualifying zilucoplan study

Exclusion Criteria:

* With the exception of a prior zilucoplan trial, participation in another concurrent clinical trial involving an experimental therapeutic intervention (participation in observational studies and/or registry studies is permitted)
EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)

The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.

The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PR according to Guerne and Weissman modified criteria (18) and with:
* Disease evolution \> 3 months and \< 24 months.
* ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid factor positivity (ELISA, nephelometry or chemiluminescence).
* Greater than 18 years of age.

Exclusion Criteria:

* Persistent arthritis: (involvement in one or more joints \> 1 week).
* Criteria of other rheumatic diseases (RA, SLE, etc.).
* Evidence of radiographic damage (join erosions).
* Absence of ACPA or RF.
* Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine).
* Steroid treatment one month before study entry.
* Previous antitrheumatic therapy with synthetic DMARDS (methotrexate, leflunomide, sulfasalazine, cyclosporine, antimalarials.) or biological DMARDs.
* Pregnant women or who want to be pregnant during the study.
Efficacy and Cost Effectiveness of Relaxation and Response to CHF

Despite the development of significant pharmaceutical treatments, morbidity and mortality of chronic heart failure (CHF) patients remain high, patients� quality of life is poor, and their health care utilization is heavy. It is therefore important to find a cost effective non-pharmaceutical treatment to help CHF patients manage the disease. The relaxation response has been found to be effective in managing CHF-related conditions. With its favorable physiological changes, the relaxation response is likely to benefit CHF patients.

Background:

Despite the development of significant pharmaceutical treatments, morbidity and mortality of chronic heart failure (CHF) patients remain high, patients� quality of life is poor, and their health care utilization is heavy. It is therefore important to find a cost effective non-pharmaceutical treatment to help CHF patients manage the disease. The relaxation response has been found to be effective in managing CHF-related conditions. With its favorable physiological changes, the relaxation response is likely to benefit CHF patients.

Objectives:

1. To evaluate the effects of a 15-week relaxation response intervention program on improving functional capacity and health-related quality of life as compared with an ongoing 15-week educational program for cardiac disease management, and a control group of usual cardiac care; 2. To identify the costs of conducting the intervention and the cardiac care education and the costs associated with cardiac care services; and to compare cost among three study groups.

Methods:

This is a single-blind three-armed randomized trial in CHF patients who receive care at the Boston VA Medical Center. Enrolled patients are randomly assigned, with equal numbers, to one of the three study groups. Outcomes include cardiac functional capacity and self-reported health-related quality of life. We also conduct a qualitative study to interview patients by phone about their experience in the study.

Status:

This project has completed the data collection phase and is in the data analysis phase.

Eligibility Criteria:
Inclusion Criteria:

CHF diagnosis, NY stage 2 or 3

Exclusion Criteria:
Pulmonary Arteriovenous Malformations (PAVMs) in Hereditary Haemorrhagic Telangiectasia (HHT)

Computed tomography (CT) is the modality of choice to characterize pulmonary arteriovenous malformations (PAVMs) in patients with hereditary haemorrhagic telangiectasia (HHT). The objective of this study was to determine if CT findings were associated with frequency of brain abscess and ischaemic stroke.

This retrospective study included patients with HHT-related PAVMs. CT results, PAVM presentation (unique, multiple, disseminated or diffuse), the number of PAVMs and the largest feeding artery size, were correlated to prevalence of ischaemic stroke and brain abscess.


Eligibility Criteria:
Inclusion Criteria:

* Hereditary Haemorrhagic Telangiectasia (HHT) diagnosis
* Pulmonary Arteriovenous Malformations (PAVMs) related with HHT

Exclusion Criteria:

* Clinical follow-up not available in the database
Patient Educational Video for Pelvic Organ Prolapse

This is a single-blinded, randomized controlled trial investigating if a patient educational video on pelvic organ prolapse improves patient understanding of this pelvic floor disorder and satisfaction in their healthcare decision making for its management.

This is a randomized controlled trial. Participants will be randomized either to watch a pre-visit educational video on pelvic organ prolapse (POP) in addition to routine physician counseling (intervention group) or routine physician counseling alone (control group). The counseling physician will be blinded. All participants will complete a pre-visit survey that includes the Prolapse and Incontinence Knowledge - POP (PIKQ-POP) and a demographics questionnaire. The PIKQ-POP has been validated to assess for patient knowledge of POP. Those randomized to the intervention group will take a brief survey after watching the video asking if they had any technical issues with the video and confirming they watched the video. At the end of all initial clinic visits, participants will complete a post-visit survey that includes the validated Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) to assess the primary outcome of change in patient decision satisfaction. The SDS is designed to assess satisfaction with a treatment decision. The SDS was modified into the SDS-PFD to be specific for women making decisions regarding surgical treatment for pelvic floor disorders. To assess the secondary outcomes of change in decision conflict and POP knowledge, the post-visit survey will also include a validated Decision Conflict Scale (DCS) and the PIKQ-POP. The DCS was developed to evaluate the effect of health care decision aids and decision-supporting interventions on decision uncertainty. The physician will also complete a counseling survey at the end of the visit to assess their perception of patient comprehension and their ease of counseling. After undergoing their chosen management option, participants will also complete a post-management survey in follow up which will include the SDS-PFD and PIKQ-POP.

Eligibility Criteria:
Inclusion Criteria:

* Initial evaluation for symptomatic POP
* Age greater than or equal to 18 years old
* Reliable access to text or e-mail

Exclusion Criteria:

* Pregnant women
* Presence of cognitive disability
* Non-English speaking patient or requiring interpreter assistance
* Women with a history of prior pelvic organ prolapse therapy, i.e. pelvic floor physical therapy, pessary, or surgical repair
CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded"

Open enrollment study to collect data for the optimization of machine learning models for use in an app for the early detection of mental health and suicidal risk.


Eligibility Criteria:
Inclusion Criteria:

* Currently a client receiving services from a MHP at a school or outpatient setting, or at a college/university counseling center
* Age ≥ 8 years old
* Able to provide informed consent, parental permission or assent
* English as a primary language

Exclusion Criteria:

* Participants with communication disorders (linguistic or articulation)
* Any minor participants for whom parental or legal guardian consent cannot be obtained.
* Any adult participant for whom Legal Authorized Representative (LAR) consent cannot be obtained.
* History of any other serious medical or psychiatric condition that would interfere with the ability of the patient to complete the study or would make it ethically unfeasible to enroll them
* Participants with an intellectual and / or neurocognitive disability that the MHP deems a barrier to participation
* Any participant, who at the discretion of the MHP, should not be enrolled
A Feasibility Study of Group Metacognitive Therapy Versus Mindfulness Meditation Therapy

The study will examine the effectiveness of group metacognitive therapy in comparison with group meditation therapy, in patients with Generalised Anxiety Disorder. Individuals will be randomly assigned to either meditation or metacognitive therapy and undergo 8 group therapy sessions of their respective treatment condition.


Eligibility Criteria:
Inclusion Criteria:

* individual's score on the GAD-7 \& PHQ-9
* individuals who meet the DSM-IV (Diagnostic and Statistical Manual) criteria for generalized anxiety disorder

Exclusion Criteria:

* Individuals with major depressive disorder
* Individuals who report suicidality
* Individuals with a brain injury or neurological insult
* Individual who currently engage in substance abuse
* Individuals with bipolar disorder
* Individuals with psychotic symptoms
* Individuals who cannot converse or read English
Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation

This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is also frequently used in the ED in children and sometimes in adults. It has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided.

In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing procedural sedation for an urgent procedure in the Emergency Department

Exclusion Criteria:

* Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical status score \>2
Hearing Improvement After Making a Hole Surgically in Eardrum With or Without Ventilation Tube in Children With Glue Ears

The goal of this clinical trial is to compare the effectiveness of myringotomy with ventilation tube insertion to myringotomy alone in improving hearing in children with glue ear.

The main question it aims to answer is:

Does adding a ventilation tube to myringotomy lead to greater improvement in hearing compared to myringotomy alone? Researchers will compare these two surgical techniques to determine which offers better outcomes for children with otitis media with effusion.

The Participants will:

1. Have their hearing evaluated before surgery
2. Undergo either myringotomy with ventilation tube insertion or myringotomy alone
3. Have their hearing evaluated at follow-up visits at 2 weeks, 1 month, and 3 months post-operatively


Eligibility Criteria:
Inclusion Criteria:

* cases of otitis media with effusion
* more than 20 decibel (dB) conductive hearing loss on pure tone audiometry
* non-responder to medical treatment after three months of medical treatment

Exclusion Criteria:

* Children having recurrent otitis media
* Discharging ears
* History of bleeding disorder
Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture

The purpose of this study is to compare effect of sutureless thyroidectomy with vessel closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric evaluation.


Eligibility Criteria:
Exclusion Criteria:

* Pre-operative voice problems
* Pre-operative vocal cord paralysis
* Singers and teachers
* Pre-operative known advanced stage malignity
* Previously operated for thyroid diseases.
Cognitive Rehabilitation Through Personalized Virtual Reality and Paper-and-pencil Interventions in the Alcohol Use Disorder Treatment.

Cognitive dysfunction is one of the different consequences of excessive alcohol consumption, affecting many domains associated with prefrontal and temporal lobes, such as attention, verbal fluency, and memory.

This study will explore the clinical impact of two cognitive rehabilitation tools to promote cognitive improvements of AUD individuals.

Excessive consumption of alcohol affects many functions associated with the prefrontal and temporal lobes, including different executive functions, memory, and complex motor control. Among several treatments, the Transtheoretical Model, a multidisciplinary approach, is one of the most standardized. However, it lacks effective and innovative cognitive rehabilitation tools. In this study, two cognitive rehabilitation tools, already clinically validated for stroke patients, will be implemented to promote cognitive recovery of Alcohol Use Disorder (AUD) individuals under treatment in the Alcoholic Rehabilitation Center S. Ricardo Pampuri from Casa de Saúde S. João de Deus (Madeira, Portugal). Within a randomized controlled trial with 60 participants, this study intend to assess and compare the clinical effectiveness of both a paper-and-pencil tasks training and content equivalent virtual reality (VR) simulation of activities of daily living with time-matched standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients of Centro de Alcoologia Ricardo Pampuri (with Alcohol use Disorder diagnosis)
* Education (able to read and write)
* Standard neuropharmacological protocol

Exclusion Criteria:

* Abuse of other substances
* Neurological and psychiatric pathology (present or past)
* Severe depressive symptoms as assessed by the Beck Depression Inventory
* Visual problems that can affect the performance of the tasks (hemianopsy, diplopia)