cyrilzakka/clinical-trials huggingface dataset:
Comparison of Diagnostic Performance of Digital Breast Tomosynthesis and Ultrasound in Women With Dense Breasts

Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the that of breast ultrasound in women with dense breast.

1. Patients with dense breast will be examined for the detection of breast cancer by imaging studies.
2. The imaging including digital breast tomosynthesis (DBT), physician-performed bilateral whole breast ultrasonography will be performed according to a standard protocol.Interpretation will be conducted independently and classified according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists.
3. Definitive information about the presence of malignancy will be obtained by biopsy directed by the imaging method best depicting the lesion with 14-g or 11-g needle devices or needle localized excision. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at follow-up.
4. The diagnostic yield of digital breast tomosynthesis (DBT) compared to ultrasonography will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Women aged at 20 years
* Women who had heterogeneously dense or extremely dense parenchyma, either by prior mammography report or by review of prior mammograms
* Signed study-specific informed consent prior to registration

Exclusion Criteria:

* Had breast surgery
* Had breast core biopsy performed within the prior 6 months on the study
Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS)

The study aims to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment in IVF patients who develop severe early ovarian hyperstimulation syndrome and have all their embryos cryopreserved.

GnRH antagonist administration in the luteal phase has been proposed as a strategy for the treatment of established severe early OHSS, causing rapid regression of the syndrome on an outpatient basis. The approach has been described as tertiary OHSS prevention, thereby complementing the primary prevention (GnRH antagonist protocol) and secondary prevention (GnRH agonist trigger) that constitute the OHSS-free clinic concept. No randomized controlled trials (RCT) exist to date comparing luteal GnRH antagonist administration versus conventional treatment.

The aim of the present study is to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment with primary outcome time to severe OHSS regression, in IVF patients who develop severe early OHSS and have all their embryos cryopreserved.

Eligibility Criteria:
Inclusion Criteria:

* Women with established severe early OHSS.
* Criteria for the diagnosis of severe OHSS require:

  * the presence of moderate (or higher) ascites and at least two of the following:

    * enlarged ovaries (\>100 mm maximal diameter),
    * haematocrit (Ht) \>45%,
    * white blood cell count (WBC) \>15,000/mm3.

Exclusion Criteria:

* Women not fulfilling the above criteria
Zinc Stents for the Treatment of Gingivitis

Background This study investigates the effects of zinc-containing stents on gingival inflammation, bleeding, and plaque regrowth in gingivitis patients.

Methods A randomized, double-blind, placebo-controlled study was conducted at Çukurova University, enrolling 42 systemically healthy gingivitis patients aged 18-30. Participants were assigned to either a test group (zinc-containing stents) or a control group (placebo stents) and instructed to wear their stents for at least 12 hours daily for four weeks. Clinical measurements, including Gingival Index (GI), Plaque Index (PI), and Bleeding on Probing (BOP), were assessed at baseline, and at the 2nd, 4th, and 8th weeks. Statistical analysis was performed using IBM SPSS and RStudio.


Eligibility Criteria:
Inclusion Criteria:

* Presence of plaque-induced gingivitis \[bleeding on gentle probing at \>30% of sites examined and a gingival index (GI) of at least 1 at \>60% of sites examined\],
* Plaque index (PI) of ≥ 2 according to the modified Quigley\&Hein index,
* 18-30 years old,
* At least 20 natural teeth,
* Systemically healthy.

Exclusion Criteria:

* Pocket probing depth (PPD) of ≥4 mm,
* Interdental clinical attachment loss (CAL) detectable at ≥2 nonadjacent teeth or displaying buccal/oral CAL ≥3 mm coupled with PD ≥3 mm
* Subjects with a history of allergies to Zinc,
* The presence of hematologic disorders or any other systemic illness,
* Pregnancy and breastfeeding,
* Current orthodontic treatment,
* History of periodontal therapy,
* Use of antibiotics or anti-inflammatory medication within the preceding 6 months,
* Smoking.
Intestinal Fatty Acid Binding Protein in Very Low Birth Weight Infants With Meconium Obstruction

Urinary intestinal fatty acid binding protein (i-FABP), a marker of intestinal mucosal cell damage, has recently been proposed as a clinically useful measure in the early detection of necrotizing enterocolitis (NEC). However, there are no data on urinary i-FABP in meconium obstruction of prematurity (MOP). This study aimed to evaluate urinary i-FABP in MOP patient as a marker for early detection.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants weighing \<1,250g

Exclusion Criteria:

* major congenital anomalies
* perinatal asphyxia (cord pH \<7.0)
Nitric Oxide Control of Migrating Motor Complex: L-NMMA Effects in Relation to Receptor Blockades

The aim is to elucidate how NO works in conjunction with other neurotransmitters to regulate the migrating motility complex (MMC). Twenty-two healthy volunteers should undergo water-perfused antroduodenojejunal manometry during a control period of 4 h, followed by another 4h after a bolus injection of either saline or the NO synthase inhibitor NG-monomethyl-L-arginine (L-NMMA, 10 mg/kg intravenously) with or without atropine (1 mg) or ondansetron (8 mg). Effects on the MMC pattern are determined. Exhaled and rectal NO is monitored throughout the experiments. Effects of L-NMMA on the MMC pattern are analyzed against a background of atropine or ondansetron. Blood samples are drawn for analysis of simultaneous peptide hormone release into the bloodstream. Peptide hormone release will be correlated to the respective motility pattern elicited by LNMMA.

Dysregulation of the cyclic motility pattern controlling propulsion during fasting, the migrating motor complex (MMC), can result in small intestinal bacterial overgrowth and symptoms of intestinal obstruction. Nitric oxide (NO) acts as an inhibitory neurotransmitter by relaxation of smooth muscle cells. Little is known on how NO works in conjunction with other neurotransmitters to regulate the MMC.

Methods: Twenty-two healthy volunteers (22-38 years) should undergo antroduodenojejunal manometry recordings for 8h, 4h of which as a control period with basal motility recording and 4h after a bolus injection of either saline or the NO synthase inhibitor NG-monomethyl-L-arginine (L-NMMA, 10 mg/kg intravenously) with or without atropine (1 mg) or ondansetron (8 mg). The effects of L-NMMA on the MMC pattern are to be determined. Exhaled and rectal NO was monitored throughout the experiments as a means to secure efficient NO synthase inhibition.

Expected results: L-NMMA is expected to increase the intestinal motor activity, either as a direct effect on the small muscle cells, or through the release of some motility-stimulating gut peptide hormone (motility, ghrelin, somatostatin).

Expected conclusions: A NO donor, such as nitrite or nitrate which is converted to NO in an acidic milieu in the stomach may act as an inhibitor of motility. Thus, swallowed nitrite and nitrate from the saliva may contribute to the regulation of gastric emptying and gastrointestinal motility.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers 18-50 years of age

Exclusion Criteria:

* Age \< 18, or \> 50 years
* Any disease
* Any medication
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer

This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.

PRIMARY OBJECTIVES:

I. To assess feasibility (accrual, participation, and retention) and acceptability of a supported self-management intervention for psycho-education and stress management skills building designed for informal caregivers (intervention group n=20; waitlist control group, n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT).

II. To obtain preliminary data on caregiver intermediate (self-efficacy for \[a\] coping with cancer and \[b\] abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3).

III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.

IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.

GROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.

Eligibility Criteria:
Inclusion Criteria:

CAREGIVERS:

* Providing the majority of the informal (unpaid) care during radiation therapy for a patient meeting inclusion criteria and participating in study

CARE-RECIPIENTS:

* Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous cell carcinoma of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers)
* Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks
* Has an informal (unpaid) caregiver during radiation therapy who is participating in study

Exclusion Criteria:

* CAREGIVERS: Has a current cancer diagnosis
* CAREGIVERS: Cannot read/communicate in English
* CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is currently taking a steroid based medication will not be eligible to participate in the saliva portion of the study
* CARE-RECIPIENTS: Cannot read/communicate in English
Predicting Dropout and Outcome From Neuropsychological Functions in SUD Patients

The aim of this project is to gain a more specific understanding of how different cognitive profiles predict residential treatment drop-out, treatment retention and post-treatment outcome in a population with Substance Use Disorder.

This project collects the neuropsychological profile of residential SUD patients, in addition to treatment length, exit reason, hospital journal data and post-treatment clinical outcome data. The project aims to identify clinically relevant neurocognitive domains that predict treatment dropout and post-treatment clinical outcome. This will make it possible for future clinicians to focus their effort on neurocognitive functions most relevant for this particular patient group.

RESEARCH QUESTIONS:

1. What neurocognitive domain (and sub-domain) are the strongest predictor of treatment drop-out and retention?
2. What neurocognitive domain (and sub-domain) are the strongest predictor of post-treatment clinical outcome variables such as drug use, health and social integration.
3. Will data on treatment length, age, gender, substance abuse history or psychiatric co-morbidity predict outcome independently, or in interaction with, the neuropsychological profile?

This longitudinal prospective cohort study aims for a continuous collection of neuropsychological data baseline and post-treatment follow-up data until 2030.

Eligibility Criteria:
Inclusion Criteria:

* Substance Use Disorder (SUD) patients.
* 18 years or older.
* Qualified to consent to research participation.
* Able to speak and write in Norwegian.

Exclusion Criteria:

* Not qualified to consent to research participation.
* Insufficient understanding of Norwegian.
Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block

Regional tissue oxygenation saturation has been shown to increase in innervated regions after sympathetic block. The aim of this prospective observational study was to evaluate the changes of regional tissue oxygenation saturation by near-infrared spectroscopy after successful femoral nerve block with ropivacaine and determine whether the changes of regional tissue oxygenation saturation can be affected by the concentration of ropivacaine.

Successful peripheral nerve blocks induce sympathetic blockade, which increases local blood flow by vasodilation. The relationship between successful femoral nerve block and the variation of regional tissue oxygenation saturation was unclear.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* American Society of Anesthesiologists physical statusⅠ-Ⅱ
* Undergo elective elective knee arthroscopy with peripheral nerve block

Exclusion Criteria:

* Refusal to participate in the study
* BMI\>35
* Any contraindications to peripheral nerve block such as coagulation abnormalities, •Allergy to local anaesthetics, peripheral neuropathy
Healthy Living for You

The goal of the study is to conduct the Healthy Living with Diabetes (HLWD) program among Black individuals in a culturally appropriate manner. This study will involve 24-30 participants in total. Participants can expect to be on study for approximately 6 months.

The study objectives are to recruit and empower Black Healthy Living with Diabetes (HLWD) facilitators to deliver culturally tailored HLWD content and pilot the culturally tailored HLWD program, using the RE-AIM framework and Proctor implementation outcomes to gather preliminary implementation data. The study team will partner with stakeholders and community organizations serving Black adults, including Grace Fellowship Church and YMCA of Metropolitan Milwaukee. The central hypothesis is that the cultural tailoring of HLWD will increase the reach, adoption, implementation, and effectiveness of HLWD among Black adults.

The study aims are:

1. Co-design a culturally relevant approach to the recruitment and training of Black HLWD facilitators. The study team will partner with a stakeholder advisory board including:

   * (1) Black adults with diabetes (prior HLWD participants)
   * (2) Black community leaders
   * (3) current Black HLWD facilitators, and
   * (4) current HLWD program providers (organizational leaders in settings delivering HLWD to Black adults)

   to co-design: (a) an asset-based approach to recruiting Black facilitators and (b) an adjunct training that empowers the facilitator to use a culturally relevant approach to deliver HLWD content to Black adults.
2. Implement the culturally tailored HLWD program among Black adults. Using a mixed methods design, the investigators will assess recruitment/retention rates among Black adults (reach), feasibility of adoption among facilitators and program providers (adoption), participant adherence, fidelity of enactment and acceptability, fidelity of program delivery by facilitators (implementation), and pre-post impact on diabetes outcomes (effectiveness).

Eligibility Criteria:
Inclusion Criteria:

* self-identify as Black/African American
* have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes

Exclusion Criteria:

-
Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy

The perspective, randomized controlled trial is to investigate and evaluate the effect of Tizanidine on the function and pain of patients with rotator cuff tear after shoulder arthroscopy;


Eligibility Criteria:
Inclusion Criteria:

1 Patients who were diagnosed as supraspinatus tendon and infraspinatus tendon tear and underwent shoulder arthroscopic surgery in the Second Affiliated Hospital of Zhejiang University; 2 Age 20\~70 years old; 3 Those with a long medical history, and symptoms such as shoulder joint pain and weakness in a short period of time are obviously aggravated; 4. After 3 months of medication and physical therapy, the symptoms and functions have not improved significantly; 5 Volunteer to participate in this study, and the person and his/her family members have given informed consent to the content of this study and signed the consent form

Exclusion Criteria:

1. Patients with simple frozen shoulder;
2. Patients with shoulder joint tuberculosis, gout, tumor, rheumatoid disease or infectious disease; 3. There are other joint pain factors before operation;

4 Patients with subscapularis tendon tear, long head tendinopathy requiring surgical treatment, and severe shoulder synovitis were found during the operation; 5 Patients with upper limb nerve injury, shoulder fracture, bone defect or severe osteoporosis; 6. Patients with serious organ or hematopoietic system and other primary diseases; 7. Those who are allergic to the drugs used in this study; 8 Women who are breast-feeding, pregnant or preparing to become pregnant; 9 Patients with language and communication disorders, mental history, cognitive dysfunction, etc. who cannot cooperate with the completion of nursing intervention and research, and cannot complete the questionnaire required for this study.
Rigid Video Stylet Vs Conventional Lightwand Intubation

Lightwand is a useful alternative device for intubation but scooping movement can induce damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is rigid video stylet which has camera on distal tip of device. In many previous studies, rigid video stylet has proven advantages compared with other intubating devices.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for cervical spine surgery under general anesthesia
* aged between 20- 80 yrs

Exclusion Criteria:

* Patient who disagrees to participate this study
* Patient who has history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
* Patient who has congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation or foreign bodies in the upper airway
Comparing Various Treatments for Achieving and Maintaining Remission of Depression

This study will evaluate the effectiveness of five combinations of drug therapy and psychotherapy in maintaining remission of depression symptoms in people with recurrent major depression.

Depression is a serious illness that can interfere with a person's ability to work, study, sleep, eat, and enjoy activities that once were pleasurable. It is characterized by several symptoms, such as the following: persistent sad, anxious, or "empty" mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. If left untreated, depression symptoms can last for years, and may worsen as time goes on. Even with treatment, however, it is possible for depression to recur. Remission is a main goal in the treatment of depression and it may be accomplished through various strategies. This study will evaluate the effectiveness of five combinations of treatments, including medication therapy and psychotherapy, in maintaining remission of depression symptoms.

All participants in this study will first be treated with imipramine for 7 to 11 months. Once remission of depression symptoms has been achieved and maintained for 20 weeks, participants will be randomly assigned to one of the following five maintenance treatments for 36 months: psychotherapy plus imipramine; psychotherapy plus placebo; psychotherapy alone; medication clinic treatment plus imipramine; or medication clinic treatment plus placebo. Assessments will be made at Weeks 12 and 20 and Months 7, 11, and 36, and will include the time it takes for depression symptoms to recur, as well as scores on depression and mania severity scales.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent major depression

Exclusion Criteria:

* Unstable medical illness
* Any other simultaneous psychiatric or medical illness of greater concern than depression (index episode of depression is not primary)
Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression

The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months. Over 200 8-year-old children with at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents placement and 6, 12 and 24 months after.


Eligibility Criteria:
Inclusion Criteria:

* Subjects provided written informed consent;
* They were 7 to 9 years old;
* They have at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4;
* They were generally heallthy

Exclusion Criteria:

* They were allergic to the constituents in pit and fissure sealants
Endoscopic Ultrasound in Detailed T-staging of Upper GI Malignancies in Vitro

In our era of personalized treatment, both the prognosis and the choice of therapy for upper GI malignancies depend on the staging before any treatment. Most experts recommend EUS (Endoscopic Ultrasound) as the first line for T-staging but the diagnostic accuracy in clinical practice varies in different centers according to the published data. Neither the discrepancy between EUS and histological findings nor the variation between centers well explained. So the investigators designed this prospective study. In the present study, the investigators performed EUS on the resected specimen after surgery before fixation in formalin, evaluated the invasion of the GI wall, and marked the deepest location with sutures. And try to determine the exact accuracy of EUS staging , find the discrepancy between EUS and histologic findings.

- EUS Examination After the surgery, the specimen is filled with 0.9%NS (normal saline ) without cut open，and put into a container filled with 0.9%NS before fixation in formalin. EUS will be performed on the resected specimen.The endoscopy move from the distal to proximal side along the longitudinal axis of stomach, evaluate the invasion of gastric wall, and mark the deepest point with sutures under the EUS guided. The images were stored .

EUS images the are reviewed by two endoscopists. They are asked to stage the tumor according to the AJCC(American Joint Committee on Cancer) staging system (7th edition) , assign a level of confidence to the staging, and score the quality of the EUS image .

* Histologic Preparations and Examination Carcinoma invasion into each layer of the gastric wall is diagnosed by an experienced pathologist (L.ZW) who is unaware of the findings of the EUS imaging. The marked section will be assessed separately.
* Data analysis The diagnosis between the pathologic findings and EUS prediction will be compared. Whether the marked point was the deepest in pathologic findings is recorded. And the histological section and the EUS image of the marked point is compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with upper GI carcinoma
* Receive surgery as first treatment

Exclusion Criteria:

* previous surgery involved the upper GI tract