cyrilzakka/clinical-trials huggingface dataset:
Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)

The odontological radiology method Panorama is known to be able to spot calcifications in the area of the carotid arteries. The calcifications could be carotid stenoses which is affiliated with an increased risk of stroke. The study aims to investigate if panorama examinations can be used as a starting point for further investigation of the carotid arteries.

We intend to examinate 100 consecutive persons that have calcifications in the area of the carotid arteries with carotid duplex-ultrasound. The prevalence of carotid stenoses \> 50% (According to the NASCET criteria) in this group is the primary result of interest, answering the most fundamental question - should persons with calcifications in the area of the carotid arteries seen on panorama be screened with ultrasound in order to find asymptomatic carotid stenoses? Since the publication of the ACST and the ACAS studies it is clear that some of these patients might have indications for surgery.

A second part of the study aims to more fully understand what it is that the panorama examination reveals. In this part will 100 patients that are going to undergo surgery to remove their carotid stenoses will be examined with panorama. The carotid plaque that is removed during the surgery will be examined radiologically.

Primary endpoint:

* Subpopulation prevalence of carotid stenoses \> 50% in persons with calcifications in the area of the carotid arteries seen in a panoramic examination.

Secondary endpoints:

* Statistical data (sensitivity, specificity, accuracy, likelihood ratio and predictive values) for panorama to find carotid stenoses with ultrasound as gold standard.
* Qualitative description of the relationship between panoramic calcification images and the removed carotid plaques.

AMENDMENT JUNE 2011: The different arms of the study will be published seperately.

Eligibility Criteria:
Inclusion Criteria:

* Panorama to Ultrasound arm:

  * Calcifications in the area of the carotid arteries seen och panorama
* Ultrasound to Panorama arm:

  * Known carotid stenosis \> 50%
  * Must undergo carotid endoarterectomy after the panoramic examination

Exclusion Criteria:

* Panorama to Ultrasound arm:

  * Previous cerebrovascular symptoms
  * Below 18 or above 75 years of age
* Ultrasound to Panorama arm:

  * Below 18 or above 90 years of age
Stability and Crestal Bone Changes Around Implants Placed at Crestal Versus Subcrestal Level in Controlled Type Two Diabetic Patients

The objective of this study is to assess clinically the peri implant tissues, the radiological marginal bone loss and the stability around implants placed at the crestal versus the subcrestal level in type 2 controlled diabetic patients using cone beam computed tomography


Eligibility Criteria:
Inclusion criteria

* Type 2 controlled diabetic patients
* Patients with at least one missing tooth in lower jaw.
* Patients with sufficient alveolar ridge height and width (no need for bone augmentation).
* Patients with sufficient inter-occlusal distance that will allow future restoration.
* Patients with healthy periodontium.

Exclusion criteria

* Smokers.
* Para functional habits.
* Bad oral hygiene measured according to O'Leary plaque index.
* Pregnant women.
* Other local or systemic diseases that may compromise the surgical procedure, healing or osteointegration.
A RCT to Compare Post-operative Sensitivity of Restorations With Fill-Up, a Dual Curing Composite and Conventional Composite Resin

The trial compares patient-reported postoperative sensitivity of 2 existing dental filling materials. The dental filling materials will be used according to manufacturer's instructions and within the existing CE marked licence. We are interested in investigating which licensed material confers the least postoperative discomfort to our patients in normal clinical use.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is over 18
2. Patient is under 70
3. Patient is capable of informed consent
4. The tooth responds to sensitivity testing ('vitality test' with an electric pulp tester)
5. The cavity is suitable for composite restoration
6. The patient prefers composite to amalgam.
7. The restoration required involves 2 or more surfaces of the tooth

Exclusion Criteria:

1. The tooth does not respond to an electric pulp test
2. The patient is suffering dental pain at the time of consent
3. The patient is currently taking long term analgesics
4. The patient is incapable of giving informed consent
5. The patient is a child under 18
6. The patient is unable to return the VAS assessment sheets at the appropriate time
7. The tooth to be filled is periodontally involved (grade 2 or grade 3 mobile)
Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures

A prospective, multi-center, randomized controlled study was conducted to validate the safety and effectiveness of employing the medial augmentation technique (incorporating the dynamic condylar screw and medial support plate) supplemented with bone grafting for the treatment of old femoral neck fractures.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years, gender not specified;
2. Patients with femoral neck fractures who have not undergone surgery for more than 3 weeks, or patients with persistent non-union following internal fixation of femoral neck fractures;
3. Have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery;
4. Participants or their legal representatives are informed about the nature of this study and agree to participate.

Exclusion Criteria:

1. Participants who have not reached the primary endpoint of other drug, biological agent, or medical device clinical trials prior to enrollment;
2. Known history of hypersensitivity to one or more implanted materials by the patient;
3. Judged by the investigator as physically frail or unable to tolerate surgery due to other systemic diseases;
4. Active infectious foci in the hip joint or other parts of the body, as judged by the investigator;
5. Diagnosed with metabolic bone disease, radiation-induced bone disease, etc.;
6. Severe hip contracture deformity or severe muscle weakness that has been immobilized in functional position for a long time and painless;
7. Suffering from inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
8. Patients who lack the mental capacity or understanding to meet the requirements of participating in the study, or are difficult to cooperate with;
9. Other situations where the investigator deems the participant unsuitable for inclusion.
Study of the Long-Term Outcomes of Posterior Spinal Fixation With the Karma Device

The primary objective of this clinical study is to measure fusion rate in patients at 12 months following lumbar fusion in combination with posterior fixation using the Karma® device.


Eligibility Criteria:
Inclusion Criteria:

1. Skeletally mature and age ≥ 18 years of age
2. Appropriate patient as determined by the Investigator for anterior or lateral approach to lumbar interbody fusion surgery with planned posterior fixation to treat degenerative disc disease in one or two adjacent vertebral levels between L2 and S1.
3. Failed at least six months of conservative treatment. This may or may not include any of the following,

   1. Spinal injections
   2. Chiropractic care
   3. Physical therapy
   4. Activity modification and/or with anti-inflammatory medications
4. Oswestry Low Back Pain Disability Questionnaire score of at least 30%
5. Visual Analog Scale (VAS) for back/hip/lower extremity pain ranking at a minimum at least 3/10 (30%)
6. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent with a study collaborator present at the time of signing to ensure compliance.

Exclusion Criteria:

1. Patients with greater than two levels of degenerative disease or deformity for INTENDED operative levels.
2. Previous fusion or total disc replacement at the intended level/s
3. Known allergy to implant and instrument materials
4. Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
5. Degenerative spondylolisthesis of grade \>2
6. Isthmic spondylolisthesis
7. Back or leg pain of unknown etiology
8. Active systemic infection or infection at the location planned surgery
9. Active or suspected malignancy. If symptom free for 2 years, patients with prior malignancy may be included.
10. Morbid obesity defined as a body mass index \> 40
11. Patient being treated for other specific medical conditions that may affect bone density or the ability to obtain fusion (ie: steroids, etc)
12. Pregnant or have plans to become pregnant in the next year.
13. Currently a prisoner
14. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
15. Participation in a concurrent clinical study.
Physician Awareness of Patients' Preferred Level of Involvement in Decision Making

Understanding a patient's decision-making preferences can help physicians meet their expectations and may increase patient satisfaction with the decision-making process.

Many health systems are shifting policies to promote greater patient involvement in healthcare delivery. Studies have shown that general medical patients who are more active in their care are more satisfied, more committed, have a better understanding of treatment plans, and experience greater improvements in health and patient-centered outcomes when compared to more passive patients. That being said, studies have found that patients have varying preferences when it comes to decision making. Understanding a patient's decision-making preferences can help physicians meet their expectations and may increase patient satisfaction with the decision-making process.

This awareness of decision-making preferences could be beneficial in treating quality of life conditions. Patients seeking care for pelvic floor disorders make medical decisions aimed toward improving symptoms, function, and quality of life. In a recent study, researchers found that 50% of women preferred active involvement, 45% collaborative and 5% passive. However, patients were 1.56 (95% CI:1.06-2.29) times more likely to report collaborative or passive involvement after their visit (p=0.02) with 40% of patients rating their actual role as active, 48% as collaborative, and 11% as passive. In this study, 37% of women did not experience their preferred level of decision-making. Other studies have similar findings with reported 20-40% discordance between patients' preferred involvement and what was achieved.

Discordance can negatively impact patients' outcomes and experiences of care. Interventions to minimize discordance between patients' preferred and perceived involvement in decision-making may significantly improve their overall experience and satisfaction. One possible intervention is eliciting women's preferred level of involvement in decision making prior to the visit and making this information available to the physician. The current study aims to determine whether physicians' awareness of patients' preferred involvement in decision making prior to their initial urogynecologist visit affects patients' perceived involvement in decision making after their visit.

Eligibility Criteria:
Inclusion Criteria:

* Present to Loyola's Urogynecology clinic for their initial evaluation
* Agree to complete the study questionnaires
* Must be at least 18 years of age
* Must be able to read, speak and write in English

Exclusion Criteria:

* Established patients at Loyola's Urogynecology clinic
* Unable to complete the study questionnaires
* Less than 18 years of age
* Unable to read, speak and write in English
Chemotherapy in Treating Patients With Advanced Sarcoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of ifosfamide and doxorubicin in patients with advanced sarcoma.

OBJECTIVES: I. Determine the response rate, time to treatment failure, and survival in patients with advanced soft tissue or gynecological sarcoma treated with high-dose ifosfamide and doxorubicin.

OUTLINE: Patients receive ifosfamide IV continuously on days 1-5 and doxorubicin IV on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing through day 16 (or until day 20 if blood counts have not recovered by day 16). Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at treatment failure and then annually thereafter.

PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven advanced soft tissue or gynecologic sarcoma Measurable disease No brain metastases (CT scan required if metastases are clinically suspected)

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Liver function tests no greater than 2 times normal Albumin 4.0-6.0 g/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Cardiac function normal by MUGA scan or echocardiogram Other: No other prior or concurrent malignancy except radically removed nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the bladder No prior radiotherapy to indicator lesion Surgery: Not specified
Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) Trial

The investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design.

Radical lymph node dissection (LND) along the recurrent laryngeal nerve (RLN) is surgically demanding and can be associated with substantial postoperative morbidity. The question as to whether robot-assisted esophagectomy (RE) might be superior to video-assisted thoracoscopic esophagectomy (VATE) for performing LND along the RLN in patients with esophageal squamous cell carcinoma (ESCC) remains open.

The investigators will conduct a multicenter, open-label, randomized controlled trial (termed REVATE) enrolling patients with ESCC scheduled to undergo LND along the RLN. Patients will be randomly assigned to either RE or VATE. The primary outcome measure will be the rate of unsuccessful LND along the left RLN, which will be defined as 1) failure to remove lymph nodes along the left RLN or 2) occurrence of left RLN palsy following LND. Secondary outcomes will include the number of successfully removed RLN nodes, postoperative recovery, length of hospital stay, 30- and 90-day mortality, quality of life, and oncological outcomes.

Eligibility Criteria:
Inclusion criteria

1. Age between 18\~80
2. Histologically proven primary intrathoracic esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN LND.
3. Patients should have a performance status 0, 1 or 2 according to the European Clinical Oncology Group.
4. Surgical resectable(cT1\~4a, N0\~3, M0)
5. Written informed consent

Exclusion criteria are

1. Previous major thoracic surgery rendering minimal invasive approach unfeasible
2. prognosis determining malignancy other than esophageal cancer, inability to undergo curative resection and/or follow-up
3. inability to provide oral or written informed consent.
4. pre-existed vocal cord dysfunction will also be excluded.
Alcohol Use Disorders (AUDs) and Post-traumatic Stress Disorder (PTSD) Treatment for Victims of Partner Violence

The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders among women who have experienced domestic violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use after treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.

The goal of this study is to evaluate an integrated psychotherapy for PTSD and substance use disorders among female victims of intimate partner violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use post-treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.

Eligibility Criteria:
Inclusion Criteria:

* female victims of partner violence
* at least one month out of the abusive relationship
* meet DSM-IV (American Psychiatric Association, 1994) criteria for PTSD and an alcohol use disorder
* literate in English
* have not changed psychotropic medications or dosages within the past two months and agree not to during the active phase (first 12 weeks) of the intervention
* have an identified primary care physician

Exclusion Criteria:

* moderate or severe cognitive impairment as measured by a Mini-Mental State Examination score less than or equal to 18
* Histories of psychosis or mania may be excluded because the presence of these disorders is thought to impede progress in psychotherapy
A Study to Compare the Pharmacokinetics of DP-R207 in Comparison to Each Component Administered Alone

The purpose of this study is to compare the pharmacokinetics of DP-R207 (Rosuvastatin 10mg and Ezetimibe 10mg fixed dose combinations) in comparison to each component administered alone in health male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects age between 19 and 55 signed informed consent

Exclusion Criteria:

* subjects have an allergy reaction of this drug
Family-Centered Cesarean Delivery

The purpose of this study is to determine if patient birthing experiences differ between the family-centered and traditional cesarean methods. We hypothesize that the family-centered cesarean method will lead to more unique and personalized cesarean birthing experiences without increasing the risks of adverse neonatal and maternal outcomes from those documented with the traditional cesarean.

Patients will be consented and randomized to one of two delivery methods by the research coordinator, resident physician, charge nurse or nurse on the day of their planned cesarean section. Several variables of interest will be collected via the electronic medical record and within the OR. Additionally, assessment of patient satisfaction will be conducted following delivery. Questions from an 11-item questionnaire will be asked of the patient by the study coordinator, resident physician, nurse or charge nurses.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years of age
* Women with planned cesarean section
* ≥38 weeks of gestation
* Singleton fetus
* Reassuring fetal status (status of scheduled, green and some yellow

Exclusion Criteria:

* Women with an urgent or emergency clinical situation in which the medical staff caring for the patient determines that obtaining consent would interfere with the patient's clinical care
* Patients that decline to consent to participate (an opt out log including the consenters initials, time of day, and reason is kept)
* Patients with anticipated heavy intraoperative bleeding (bleeding disorders, placenta previa, suspected placenta abruption, etc.)
* Known maternal co-morbidities that could impact neonatal well-being (e.g., uncontrolled diabetes, etc.)
* Chorioamnionitis or prolonged rupture of membranes (≥18 hours in duration)
* Known fetal anomalies
* BMI ≥45 kg/m2
* Estimated fetal weight \<2000 grams
The Performance of Patient Support Program in Early Stage Breast Cancer

The purpose of this study is to compare the 1-year adherence to upfront adjuvant AI for postmenopausal, early stage breast cancer in the two observational arms; Standard Treatment and Standard Treatment plus PSP arm after one year


Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated written Informed Consent
* Have been taking upfront AI adjuvant therapy in line with current SmPC
* Be capable of completing drug intake by herself
* Be capable of understanding Chinese

Exclusion Criteria:

* Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has not been granted by SFDA
* Upfront adjuvant AI medication which has exceeded over eight weeks
* Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than AI
* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
Group Written Exposure Therapy for Posttraumatic Stress Disorder

The goal of this clinical trial is to test if Written Exposure Therapy (WET) works well in a group setting in patients with post-traumatic stress disorder (PTSD).

The main questions it aims to answer are:

* Does group WET lead to a reduction in symptoms of PTSD?
* Is group WET better at reducing the number of patients that drop out of treatment in comparison to group Cognitive Processing Therapy (CPT)?

Participants will:

* Attend 6 weekly sessions of group WET that will be delivered online by two therapists (psychologist and social worker)
* Complete questionnaires relating to their symptoms at different points throughout the treatment

Researchers will evaluate change in PTSD symptoms over time for people who participate in group WET. They will also compare the results of group WET to the results of group CPT to see if group WET shows a similar reduction in symptoms of PTSD and fewer treatment drop-outs.

The primary objective of this study is to evaluate the effectiveness of group WET (G-WET) in reducing symptoms of PTSD in an outpatient hospital setting. In order to do so, we will evaluate outcomes of G-WET from pre- to post-treatment and at one month follow-up. We will also compare outcomes of G-WET to published benchmarks of individual WET outcomes and to a representative cohort of individuals who participate in group CPT at our clinic. A secondary aim of the study is to evaluate attendance and drop-out rates for group WET. In order to achieve this, we will recruit a sample of 63 individuals between the ages of 18 and 65 to participate in a group WET 6-session protocol (1 orientation session and 5 WET sessions) from an outpatient anxiety and related disorders clinic waitlist for group CPT. Participants will complete measures assessing PTSD, related symptoms (e.g., depression, anxiety) and group cohesion at pre-treatment, post-treatment, and 1-month follow-up. Attendance and drop-out rates will also be recorded. We hypothesize that group WET will be associated with significant reductions in PTSD symptoms and related symptoms and low dropout rates (i.e., less than 10%). We also hypothesize that outcomes for group WET will be comparable to those for group CPT and published individual WET benchmarks.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and older
* Diagnosis of PTSD
* Able to provide written informed consent and can read and write in English

Exclusion Criteria:

* Diagnosis of an active severe substance use disorder (SUD)
* Diagnosis of a psychotic disorder (schizophrenia, schizoaffective disorder, etc.)
* Untreated active psychotic, manic or hypomanic symptoms
* Has attempted suicide in the 2 months prior to beginning treatment
* Has engaged in high-risk self-harm (e.g., cutting, burning, asphyxiation) in the 2 months prior to beginning treatment
* Has completed CPT in the past
* Has completed another active PTSD treatment, such as Prolonged Exposure or EMDR within the last year