cyrilzakka/clinical-trials huggingface dataset:
Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer

The purpose of this study is to describe the real-world effectiveness and patterns of use of adjuvant nivolumab in adult participants with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) in China.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 years or older at the index date
* All patients must have Stage II or Stage III carcinoma of the esophagus or gastroesophageal junction and have histologically or cytologically confirmed predominant adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer at the time of initial diagnosis.
* Participants initiated nivolumab in adjuvant Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) treatment within the index window.

Exclusion Criteria:

* Participation in a clinical trial of an investigational drug concurrently during the adjuvant nivolumab treatment.
* From the date of diagnosis of EC or GJEC to data end period, patients were diagnosed with a primary diagnosis of a cancer other than EC or GJEC that requires systemic or other treatment
Effect of Mindful Eating on Weight Management in Breast Cancer Survivors

This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors.

Being overweight is associated with increased risk for chronic disease and premature death in breast cancer survivors. This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors. The one-group pre-posttest study design included eight weekly group-based mindful eating sessions on strategies to intentionally and attentively consume food. Anthropometrics, blood pressure, mindfulness, nutritional intake, and physical activity were collected at baseline and 12-weeks follow-up. Data on feasibility and acceptability were collected at study completion.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female
* Breast cancer survivor (in remission)
* Completed cancer treatment at the time of study enrollment
* Body Mass Index (BMI) equal or greater than 25 kg/m²

Exclusion Criteria:

* None.
Angulated Screw-retained Crowns Following Immediate Implant Placement

There are two choices of restorations and implant abutments connection now: cemented and screw-retained.The excess cement, which would be difficult to completely remove, might lead to series of biological complications. The angulated screw channel (ASC) abutments, which recently introduced by Nobel Biocare , largely address the problem with visible screw access that may compromise esthetics. However, all of the present studies were clinical reports, thus the clinical efficacy of ASC abutments still needs the verification of evidence-based medicine with larger sample. Therefore, we designed a randomized controlled clinical trial study, aiming to verify the clinical efficacy of the ASC abutments by comparing screw-retained (with ASC abutments) single implant crowns with cemented ones in esthetic region.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old and in good health;
2. Single tooth implant (type 1) in the esthetic region;
3. Patients with natural teeth adjacent to single implant crowns;
4. Patients with periodontal treatment before implant surgery;
5. The implants are from Nobel Biocare system with tapered link and the permanent restoration is a single crown and all-ceramic;
6. Soft tissue in the implanting-and-adjacent areas is healthy and free of infection

Exclusion Criteria:

1. Multiple implants in the esthetic region, or the restoration is a bridge
2. Patients with bone augmentation procedures;
3. Heavy smokers (\>10 cigarettes/day);
4. Medically compromised patients (American Society of Anesthesiologists (ASA) classification III-IV);
5. Implants in an incorrect three-dimensional position (definition according to ITI VOL1);
6. Uncontrolled diabetes mellitus;
7. Unwilling to participate in the present study.
Video Education to Improve Rural Cancer Care Delivery

The purpose of this study is to understand if a video-based education program delivered on a tablet device will improve care coordination experiences for patients with cancer living in rural areas.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a newly diagnosed Stage I, II, or III disease at the time of enrollment.
* Patients to be treated with adjuvant chemotherapy or recent initiation of (within 1 month of starting) adjuvant chemotherapy.
* Patients with a history of previous malignancy treated with chemotherapy within the last 3 years are not eligible, as their perceptions of care coordination may be impacted by their previous treatment.
* Patients must be ≥ 18 years of age.
* Patients must be able to read, write, and speak English. Study materials and telephone calls are only available in English.
* Patients must be residents of Hawaii, Kauai, or Maui counties
* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients

Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used.

The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.

Central venous catheter (CVC)-related thrombosis and infections are frequently occurring complications and may cause significant morbidity in patients with hematological malignancies. Interventions to decrease fibrin deposition have the potential to reduce CVC-related thrombosis and infections.

At present heparin is most often used as locking solution for central venous catheters in hematological patients despite a lack of evidence regarding the efficacy and safety. Trisodium citrate (TSC) had been shown to be an effective antimicrobial catheter locking in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with hematological malignancies who were going to receive a CVC for intensive chemotherapy including patients for stem cell transplantation
* written informed consent
* 18 years or older

Exclusion Criteria:

* the presence of a central venous catheter at admission
* history of central venous catheter related thrombosis or infection
* indication for anticoagulant treatment or prophylaxis
* patients with totally implanted catheters
* catheters impregnated with antimicrobial agents
Endocan Blood Level in Pulmonary Circulation

Endocan is a proteoglycan produced by the vascular endothelium. Animal studies suggested that the synthesis mainly happen in the pulmonary circulation, but this hypothesis has never been confirmed in humans.

The investigators will measure endocan levels in both pulmonary and systemic venous blood in patients undergoing on pump cardiac surgery.

The main objective is to quantify the difference of endocan blood level between the pulmonary and the systemic circulation.

Eligibility Criteria:
Inclusion Criteria:

* Planned on pump coronary artery bypass surgery
* Non opposition

Exclusion Criteria:

* Age \< 18 years old
* Emergent surgery
* Valvular replacement surgery
* Combined cardiac surgery
* Patients with inflammatory, infectious or evolutive neoplastic pulmonary disease
* Patients with valvular problems, in particular aortic insufficiency
* Patients who refuse to participate
* Legal inability or disability
* Patients who will probably not cooperate for the study
* Pregnancy and/or breast feeding
* Patients not in the Social security system
* Patients in the exclusion period of another study
Anesthetic Efficacy of Articaine and Lidocaine in Lower Molars With Irreversible Pulpits

The aim of this study was to verify the effectiveness of an anesthetic called articaine for dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine. Two types of local anesthesia (oral injection) in accordance with the solution used were performed. For patients anesthetized with articaine, an injection of anesthesia close to the tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the bottom of the mouth was made. Differences between both techniques are mainly regarding the area of numbness. In the injection with articaine only a small part of the lip and the tooth was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth and half of the tongue on the same side was numbed. The treatment was electronic randomized and there was equal chance to one or another treatment. The investigators are studying this new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to an emergency treatment, if it really decreases the feeling of numbness and discomfort during the service. Patients receiving articaine were submitted to cone beam exam at no cost.

Aim: This randomized clinical trial compared the anesthetic efficacy of buccal infiltration (BI) with 4% articaine (AR) and inferior alveolar nerve block (IANB) with 2% lidocaine (LI), both with 1:100,000 epinephrine, in symptomatic mandibular molars with irreversible pulpitis. Likewise, we compared the efficacy of the primary infiltration (BI or IANB) with one supplemental injection (intraligamentary infiltration with articaine for AR and BI with articaine for LI). The influences of buccal cortical bone thickness and root distances to buccal cortical bone on articaine performance (AR) were also evaluated using cone-beam tomography. methodology: Volunteers presenting symptomatic mandibular molars with irreversible pulpitis were randomly divided into two groups (30 for AR and 20 for LI). Success was recorded when complete pain-free treatment was achieved after primary injection or when one supplemental injection was needed for emergency endodontic procedures.

Eligibility Criteria:
Inclusion Criteria:

* long-lasting moderate to severe pain during cold test
* absence of periapical radiolucency except for a widened periodontal ligament (evaluated in periapical radiographs)
* vital coronal pulp on access opening

Exclusion Criteria:

* Previous history of allergy to local anesthetics
* Subjects with systemic diseases
* Pregnancy and lactation
* Subjects taking any kind of medication that could change or influence the outcome of this research
* Subjects without painful symptoms
* Negative thermal testing, periapical lesion, incomplete root formation, presence of fistula or abscess, cracks or fractures
Intramedullary Nailing of Tibia Fractures

Currently, the treatment of choice for tibial fracture is intramedullary nailing. This procedure has been shown to have low rates of infection, high rates of bone healing, and a faster return to weight bearing and activity in comparison to conservative treatment. In concurrent fractures of the posterior or medial malleolus and the tibia, it is now common to identify, reduce, and fix the malleolar fracture prior to intramedullary nailing of the tibia. In this retrospective study, our aim is to establish that reducing malleolar fractures prior to tibial nailing is a safe treatment in which the reduction of the malleolus is maintained intraoperatively, postoperatively, and remains reduced until the fracture has healed.


Eligibility Criteria:
Inclusion Criteria:

* All patients, 18+ years of age, that have been treated at the University of Utah over the past five years for tibial fracture combined with medial or posterior malleolar fracture.

Exclusion Criteria:

* None
Intracorporeal Versus Extracorporeal Morcellation: Clinical Efficacy and Safety Outcomes

The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopy for uterine myomas with international guidelines surgical indications
* Presence of at least one uterine myoma larger than 4 cm
* Aged between 18 and 40 years

Exclusion Criteria:

* Presence of uterine neoformations suspicious for malignancy
* Medical major disorders associated
* Acute or chronic psychiatric disorders
* Ascertained Premenstrual syndrome
* Use of drugs that can affect cognitive ability or state of consciousness and alertness during the last six months prior to enrollment
* Presence of calcified fibroids ultrasound examination
* Presence of adnexal lesions
* Detection of a pattern of endometrial hyperplasia with atypia determined in the course endometrial biopsy performed for abnormal uterine bleeding
* Abnormal PAP test
* Positive Pregnancy Test
* Previous use of laparoscopic surgery increased
Dual Site-Dual Channel Non-invasive Brain Stimulation for Motor Function in Healthy Subjects

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in healthy subjects. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex, ii) anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 2) M1 stimulation: anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex; 3) PMC stimulation: anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 4) sham stimulation


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects with age over 19 years old

Exclusion Criteria:

* history of disorders involving central nervous system
* patients with severe medial or psychiatric disease
Genetic Biomarkers Associated With Child Language Development in Taiwan (II)

A study of the relation between genetic biomarkers and child language development in Taiwan.

The interaction between gene and environment (G×E) can be a very complicated process that influences child development. As a pilot study of child development biomarkers, this study investigates genes related to child language development and language disorder.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria of Healthy Child:

* Central nervous system disease
* Neuromuscular Disorders
* Congenital Abnormality
* Genetic Disease
* Dysesthesia
* Hearing Impairment

Inclusion Criteria of Child with language disorder:

* Patients with Language Disorder
* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria of Child with language disorder:

* Hearing Impairment
* Inclusion Criteria of Adult:
* His or her child participated in this study, and gene abnormality was found.
M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.


Eligibility Criteria:
Inclusion Criteria

* Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC.
* Availability of tumor (primary or metastatic) archival material or fresh biopsies is mandatory
* Participants with BTC must have failed or be intolerant to 1L systemic platinum-based chemotherapy administered for locally advanced or metastatic disease. Only one prior treatment line is allowed
* Disease must be measurable with at least 1 unidimensionally measurable lesion by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
* Life expectancy \>= 12 weeks as judged by the Investigator
* Adequate hematological function defined by white blood cell (WBC) count \>= 3 \* 10\^9/Litre with absolute neutrophil count (ANC) \>= 1.5 \* 109/Litre, lymphocyte count \>= 0.5 \* 10\^9/Litre, platelet count \>=75 \* 10\^9/Litre, and hemoglobin (Hgb) \>= 9 grams/decilitre
* Adequate hepatic function defined by a total bilirubin level =\< 1.5 \* upper limit of normal (ULN), an aspartate aminotransferase (AST) level =\< 2.5 \* ULN, and an alanine aminotransferase (ALT) level =\<2.5 \* ULN. For participants with liver involvement in their tumor, AST =\< 5.0 \* ULN and ALT =\< 5.0 \* ULN is acceptable
* Adequate coagulation function defined as prothrombin time (PT) or international normalized ratio (INR) =\< 1.5 \* ULN unless the participant is receiving anticoagulant therapy
* Albumin \>= 3.0 grams/decilitre
* Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
* Adequate renal function defined by either creatinine =\< 1.5 \* ULN or an estimated creatinine clearance (CCr) \> 40 milliliter (mL) per minute (min) according to the Cockcroft-Gault formula or by measure of CCr from 24-hour urine collection
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Ampullary cancer was excluded
* Significant acute or chronic infections
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
* Interstitial lung disease or its history
* Participants who were not eligible for or have not been treated with 1L systemic chemotherapy
* Anticancer treatment within 21 days before the start of study intervention
* Concurrent treatment with nonpermitted drugs
* Prior participation in a M7824 clinical trial
* Prior therapy with other immunotherapy or checkpoint inhibitors, such as anti-PD 1, anti PD L1, anti- cytotoxic T-cell lymphocyte-4 (CTLA-4) antibodies.
* Pregnancy or breast feeding
* Systemic anticancer treatment after failing 1L platinum-based chemotherapy
* Other protocol defined exclusion criteria could apply
Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety

OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication behavior in anxious patients with varying histories of using other drugs.

II. Establish outpatient methods for the study of self-medication and drug reinforcement in patients vulnerable to prescription drug abuse or dependence.

III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of vulnerability in these patients.

IV. Identify personality, attitudinal, or other variables that might predict different patterns of self-medication.

V. Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.

PROTOCOL OUTLINE: This protocol involves different experiments examining self-medication with anxiolytic medications in selected patients, and cognitive-behavioral therapy for anxiety. Capsules are color coded and taken under double-blind conditions. Compliance is monitored with the Medication Event Monitoring System, which automatically registers the date and time each bottle is opened.

The physician directs therapy administration, using some combination of the following: blind choice test, antianxiety agent(s), placebo, and cognitive-behavioral therapy.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Primary diagnosis of generalized anxiety or panic disorder Determined by Structured Clinical Interview for DSM IV
* Hamilton Anxiety Scale (HAM-A) score at least 14 AND Profile of Mood States (POMS) tension/anxiety scale score at least 20
* Concurrent diagnoses allowed: Mild to moderate agoraphobia Simple or social phobias Secondary unipolar affective disorders
* No current substance abuse, dependence, or substance abuse treatment Drug-free urine sample required
* No history of other primary Axis I diagnosis other than tobacco dependence

--Prior/Concurrent Therapy--

* No prior formalized non-drug therapy for anxiety disorder
* No concurrent prescription psychoactive medication
* No history of benzodiazepine dependence

--Patient Characteristics--

* Age: 18 to 50
* Other: Medically healthy Negative pregnancy test required No occupational requirement to work in hazardous situations
A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.


Eligibility Criteria:
Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing informed consent. - Subjects fulfilling at least one of the below criteria (For this inclusion criterion the aim is to include minimum 80% of individuals with a previous episode of hypoglycaemia (criterion e). The remaining subjects will have to fulfil at least one of criteria a-d.): - a) Experienced at least one severe hypoglycaemic episode within the last year (according to the ADA definition, April 2013 (An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.). - b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m\^2 per CKD-EPI by central laboratory analysis. - c) Hypoglycaemic symptom unawareness (History of impaired autonomic responses (tremulousness, sweating, palpitations, and hunger) during hypoglycaemia). - d) Treated with insulin for more than 5 years. - e) Episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (equal to or below 70 mg/dL \[equal to or below 3.9 mmol/L\])) within the last 12 weeks prior to Visit 1 (screening). - Subjects diagnosed (clinically) with type 2 diabetes mellitus. - Treated with basal only insulin (once daily or twice-daily insulin (insulin detemir; insulin glargine 100 U/mL, biosimilar of insulin glargine 100 U/mL or insulin Neutral Protamine Hagedorn)) equal to or above 90 days prior to the day of screening with or without any of the following anti-diabetic drugs with stable doses for equal to or above 90 days prior to screening: - a) Metformin - b) Dipeptidyl peptidase -4 inhibitor - c) Sodium-glucose co-transporter 2 inhibitor - d) Alpha-glucosidase-inhibitors (acarbose) - e) Thiazolidinediones - f) Marketed oral combination products only including the products listed in criteria 5a-5e - HbA1c equal to or below 9.5% (80 mmol/mol) at screening by central laboratory analysis. - BMI equal to or below 45 kg/m\^2. Exclusion Criteria: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening