cyrilzakka/clinical-trials huggingface dataset:
Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)

The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been well studied. However, there were no randomized controlled study on comparing the long-term outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy can be replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage cervical cancer.

This study comprises two parts: PHENIX-I: To compare the outcomes of managements with and without pelvic lymphadenectomy for patients with negative sentinel lymph node; PHENIX-II: To compare the outcomes of managements with and without pelvic lymphadenectomy for patients with positive sentinel lymph node. Patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (lymphovascular space involvement), IA2, IB1, and IB2 cervical cancer are eligible for our study. The tumor diameter should be less than 3cm. Sentinel lymph node biopsy will be performed at the beginning of operations. After pathological examination of frozen section, patients will be assigned to PHENIX-I or PHENIX-II study according to their status of sentinel nodes. In both parts of this trail, patients have equal chance to be randomly assigned to experimental arms (radical hysterectomy only) and reference arms (radical hysterectomy and pelvic lymphadenectomy).Adjuvant treatments will be planned according to postoperative pathological factors. The primary objective is disease-free survival at 3 years for PHENIX-I and 2 years for PHENIX-II. The secondary end points are overall survival, long-term outcome of sentinel lymph node biopsy and the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed cervical carcinoma
* Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
* Original clinical stage must be FIGO (2018) stage IA1 (lymphovascular space involvement), IA2, IB1, IB2 and IIA1
* No suspected node should be found on imaging examination (RESIST 1.1)
* Age between 18-65
* Patients must give signed informed consent
* P.S status: 0-1
* Estimated survival time \> 3 months
* Tumor diameter ≤ 3 cm

Exclusion Criteria:

* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Investigator consider the patients can't finish the whole study
* With normal liver function test (ALT、AST\>2.5×ULN)
* With normal renal function test (Creatinine\>1.5×ULN)
* WBC\<4,000/mm3 or PLT\<100,000/mm
* The whole cervix has been occupied by tumor and there is no normal surface left for tracer injection
* History of severe heart disease or deep venous thrombosis; 4) Presence or history of other malignant disease
* Gestation or perinatal period
* Intention to fertility preservation.
Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis

The aim of the study is to evaluate the effect of preoperative administration of acetaminophen- codeine -caffeine combination on the success of the inferior alveolar nerve block versus bacetaminophen alone or placebo in patients with symptomatic irreversible pulpitis.

After ensuring eligibility, patients will be given premedication 1hr before treatment,which will be done in single visit.

After 1 hour, Pretreatment pain "pain after administration of analgesic or placebo" will be recorded using 0-10 numerical rating scale (NRS) .

Local anesthesia will, then, be done through inferior alveolar nerve block using 1.8 ml Mepivacaine.

The teeth will be isolated using rubber dam and access cavity will be prepared using #2 high-speed round bur.

The patients will be asked to rate their pain on the NRS. The degree of pain during access preparation and/or instrumentation will be recorded.

Success will be defined as no pain or mild pain during endodontic access preparation and/or instrumentation. Any pain more than no pain or mild pain will considered a failure.

The patients will be instructed to return after 2 days to complete the treatment procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aging between 18-50 years old.
2. Patients with mandibular molar with symptomatic irreversible pulpitis.
3. Systemically- healthy patients.
4. Patients who agree to attend for recall appointments and provide a written consent.

Exclusion Criteria:

1. Pregnant or lactating female patients.
2. Patients had allergies to any of test medications.
3. Patients had taken analgesics medication within the last 6 hours.
4. Moderate or severe marginal periodontitis i.e. pocket probe\>3mm.
5. Non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease
Efficacy and Safety of One-Stage Hybrid Coronary Revascularization

Coronary revascularization could be accomplished either by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). PCI with drug-eluting stent (DES) implantation is featured by minimal invasive, low complication and rapid rehabilitation. CABG is characterized by improved long-term, event-free survival attributable to the use of left internal mammary artery (LIMA) graft. Hybrid coronary revascularization (HCR) consists of LIMA bypass to left anterior coronary descending artery (LAD) by minimal invasive direct coronary artery bypass (MIDCAB) and PCI of other stenosed coronary arteries with DES implantation. One-step HCR entails LIMA-LAD anastomosis performed through MIDCAB, immediately followed by PCI for non-LAD lesions, sometimes for diagonal branch, in the hybrid operating room. Limited data are available in comparing one-step HCR to PCI alone for the treatment of multivessel coronary artery disease(MVD). The current EAST-HCR study will investigate the efficacy and safety of one-step HCR for patients with MVD, as comparing to PCI alone.


Eligibility Criteria:
Inclusion Criteria:

1. 18 Years and older
2. signed the informed consent
3. indicated for revascularization, with possible bypass segment in LAD and amendable lesions by PCI in other vessels
4. anatomy requiring as following: (1) Multivessel CAD involving the LAD (proximal or mid) and/or LM (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment in LCX or RCA, including: (2) LAD disease, and a major diagonal lesion, either bifurcation or independent in location, with both requiring revascularization (determined by QFR or FFR) (3) LM distal bifurcation lesion (Medina 1,1,1), intended for 2-stent approach if randomized to PCI
5. Heart team discussion after angiogram, with conclusion of suitable candidate for either PCI or HCR
6. Able to tolerate and no plans to interrupt dual anti-platelet therapy for 3\~12 months
7. Willing to comply with 2-year clinical follow-up

Exclusion Criteria:

1. Previous cardiac or thoracic surgery
2. Previous PCI of the LM and/or LAD within 12 months
3. Totally occluded left main vessel
4. Cardiogenic shock or LVEF \<30%
5. Previous STEMI within 30-day prior to randomization
6. Concomitant vascular or other cardiac disease with plan of surgical treatment
7. Indication for chronic oral anticoagulation therapy
8. Previous stroke history within 6-month prior to randomization
9. Survival expectation less than 3 years due to non-cardiac illness
10. Allergy or hypersensitivity to any of the study drugs or devices used in the trial
11. Enrolled in additional clinical study
12. Informed consent not available or noncompliance with follow-up
13. Pregnant
Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia

The purpose of this study was to develop an integrative intervention for schizophrenia taking into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of our cognitive remediation group training: Problem Solving and Cognitive Flexibility training (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We hypothesized that training executive function and metacognition would allow us to achieve improvements in neurocognition, functioning and psychiatric symptoms of patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* More than 2 years illness duration
* Literate
* Mini Mental Status Examination score over 24
* Global Assessment of Functioning scores between 40 and 70

Exclusion Criteria:

* Current acute illness exacerbation
* Mental Retardation
* Neurological disorder which impairs cognition
* Currently participating in social skills training or cognitive remediation
* Change of antipsychotic medication one month before the trial or during the 40 study weeks
* Diagnosis of alcohol or drug dependence within 6 months of trial commencement.
Children's Compliance With Toothbrushing Using Manual U-shaped Toothbrush Versus Regular Toothbrush

To assess the child's compliance towards manual U-shaped toothbrush versus regular manual toothbrush.

Research has shown that an undesirably high proportion of communities find thorough toothbrushing with a standard manual toothbrush challenging to achieve a plaque-free state, as evidenced by high worldwide gingivitis and periodontitis. This is consistent with investigations that reveal insufficient frequency of brushing, poor brushing technique, and inadequate brushing session duration when compared with standard-of-care professional recommendations.

The U-shaped brush is an intervention chosen for the present study because it can attract children's attention and make brushing fun and routine. With bristles angled at 45° and available in various sizes according to age, the U-shaped brush is useful for removing plaque. It can be used starting at age three or older. It is dependable for children because its two-sided design can clean the upper and lower arches in one motion. Since design affects plaque removal to varying degrees, various authors have examined the effects of different toothbrush designs on plaque removal.

Eligibility Criteria:
Inclusion Criteria:

1. children aged 5 to 10 years, in good general health, and medically free.
2. Cooperative patients who will comply with follow-ups.
3. Parents who accept to sign informed consent.

Exclusion Criteria:

1. Children with fixed or removable orthodontic appliances.
2. Children with a physical disability, and medical disability.
3. Children who will be unable to attend follow-up visits.
4. Parents refuse to give written formed consent.
Open Label Study of Long Term Evaluation Against LDL-C Trial

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)

Exclusion Criteria:

* Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the parent study
* Have an unstable medical condition, in the judgment of the investigator
* Known sensitivity to any of the products to be administered during dosing
* Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
Application of DCE-MRI Based on 4D FreeBreathing in Predicting the Efficacy of Immune and Targeted Therapy in Lung Cancer

This study aims to address the challenge of predicting the efficacy of targeted and immunotherapy in lung cancer patients. By utilizing two DCE-MRI images-one before treatment and one after one treatment cycle-along with the patients' clinical and pathological information, we aim to achieve accurate prediction of the therapeutic efficacy of targeted and immunotherapy in lung cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Tumor size greater than 2 cm
2. Age between 18 and 75 years

Exclusion Criteria:

1. Presence of MRI contraindications (e.g., metal implants, pacemaker implantation, etc.)
2. Allergy to gadolinium contrast agents
3. Lesions difficult to delineate on images due to conditions such as atelectasis or diffuse lesions
Testing an Online Insomnia Intervention

The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. The rationale for this mixed methods proposal is that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will represent a novel and easily accessible intervention for reducing alcohol intake among high-risk heavy drinkers.


Eligibility Criteria:
Inclusion Criteria:

* engage in weekly alcohol binge episodes
* moderate to severe insomnia

Exclusion Criteria:

* history of severe alcohol or other substance use disorder
* obstructive sleep apnea
* schizophrenia
* bipolar disorder
* psychotic spectrum disorder
* lack of internet access
* lack of English fluency
* pregnant or nursing
Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide

This study aimed to assess the clinical and radiographic success for photo-activated oral disinfection (PAD) and calcium hydroxide in indirect pulp treatment (IPT) of young permanent molars.

Indirect pulp treatment is a procedure in which pulp exposure is prevented by preserving the carious dentin bordering the pulp and sealing the pulp with a biocompatible material. . Calcium hydroxide is the gold standard for pulp capping, it permits reparative dentin bridge formation, maintains pulp vitality, protects the pulp against harmful stimuli and has antimicrobial effect. However, several disadvantages were reported with its use over time including poor seal, lack of chemical and mechanical adhesion, poor strength, long-term solubility, enhanced degradation after acid etching and tunnel defects in the dentin bridge . The operative tradition is to remove softened dentin to eliminate infected tissue; however, it is impossible to eradicate all the micro-organisms because few will persist although all soft dentin was excavated.

Evidence suggest that for arresting caries lesions, it is not crucial to completely remove the infected dentin and that selective caries removal and composite restoration can yield better clinical results . For more conservative and effective treatment, disinfection instead of complete caries removal has been encouraged. . PAD is an advanced technology utilizing two non-toxic components, a photo-activating liquid and a LED light source that selectively target and abolish cariogenic bacteria and periodontal pathogens . The usage of PAD in caries management can eradicate residual bacteria in soft dentin, reassures rapid healing and improve the prognosis of treatment .

Eligibility Criteria:
Inclusion Criteria:

* Restorable lower first permanent molars with deep carious lesions
* Absence of clinical signs and symptoms of irreversible pulpitis, fistula, swelling in periodontal tissues or abnormal tooth mobility
* Absence of adverse radiographic findings
* Compliant patient/parent and (e) Absence of any systemic disease.

Exclusion Criteria:

• Previously restored teeth .
Cognitive Remediation of Schizophrenia in a Community Mental Health Setting

The purpose of this study is to investigate the usefulness of neuroscience-guided cognitive training combined with community-based supported employment for people with schizophrenia. The investigators will examine the effectiveness of moving our study of neuroplasticity-based restorative targeted cognitive training out of the laboratory and into the community setting; and the investigators will also investigate its utility in enhancing functional outcome in chronically mentally ill adults who are participating in supported employment.

Neurocognitive functioning will be assessed at baseline (study entry), after cognitive training (6 months), and at 12 month follow-up, using the MATRICS Consensus Cognitive Battery (MCCB). The investigators will assess the following six constructs identified by MATRICS as separable, fundamental dimensions of cognitive impairment in schizophrenia, with a likely sensitivity to intervention \[26\]: 1) Speed of Processing, 2) Attention/Vigilance, 3) Working Memory, 4) Verbal Learning and Memory, 5) Visual Learning and Memory, and 6) Reasoning and Problem Solving (executive functioning). The investigators will also administer the delayed memory trials of HVLT and BVMT, Trails B, and D-KEFS Color-Word Interference Test \[27\], and will make one modification to the MCCB in utilizing BACS Tower of London \[28\] in place of NAB Mazes.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder(DSM-IV criteria)
* between the ages of 18-65
* English as primary language (learned before age 12)
* no major medical or neurological disorder that precludes participation in the study

Exclusion Criteria:

* We will not exclude subjects with substance abuse or dependence as we wish to investigate the real-world effectiveness of this cognitive remediation approach when combined with SE. As per the clinical policy at Community Services, however, patients will not be permitted to attend the SE program or to participate in the study if they are acutely intoxicated. Subjects who miss 5 consecutive days of participation due to intoxication will be dropped and a replacement subject will be recruited.
Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial

An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion.

A convenience sample of 16 patients admitted to the Department of Thoracic surgery University Hospital Centre Zagreb and scheduled for esophageal carcinoma surgery were enrolled prospectively in the study between June 2011 and August 2012.

Patients were randomly allocated into two groups, one of which received ≤ 8ml/kg/h of intraoperative fluid ("restrictive group") and another that received \> 8 ml/kg/h of fluid ("liberal group").

Patients were excluded if they were younger than 18 years; if they had severe lung disease, chronic renal insufficiency, or a physical status classification \> III on the American Society of Anesthesiologists (ASA) scale; or if it was impossible to perform epidural catheter placement or thoraco-phreno-laparotomy.

All patients underwent esophagectomy carried out according to the Lewis-Tanner approach.

Data on arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the ratio PaO2/FiO2 were collected 10 min after anesthesia was induced and again 6 h after surgery. Data on the metabolic markers creatinine and lactate were collected 10 min after anesthesia induction and 6 h after surgery.

ANOVA tests were performed to determine significant differences in mean values between study groups. Independent-sample t-tests were used to test differences in mean values between the restrictive and liberal groups for each of the two sets of measurements separately (10 minutes after anesthesia induction and 6 hr after surgery). P \< 0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* esophageal carcinoma
* Lewis Tanner procedure (median laparotomy and right thoracotomy)

Exclusion Criteria:

* younger than 18 years
* severe lung disease
* chronic renal insufficiency
* a physical status classification \> III on the American Society of Anesthesiologists (ASA) scale
* impossible to perform epidural catheter placement
* thoraco-phreno-laparotomy
Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety

The goal of this study is to evaluate the tolerability of the new formulation of Dorzolamide+Timolol preservative free developed in OSD Aptar Pharma multidose system in comparison with Dorzolamide +Timolol BAK preserved ophthalmic formulation.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* Patients with POAG and OH
* PIO \< 20 mmHg
* Under treatment with Dorzolamide + Timolol BAK preserved at least 6 month after
* OSDI \> 13 \& one of these ocular signs (BUT \<6sec or Schirmer test \< 5 mm/5min or corneal staining positive)
* Corneal thickness between 520-580 um.

Exclusion Criteria:

* Patient with severe respiratory diseases (asthma, COPD and other bronchospactic diseases).
* Patient with cardiovascular diseases (Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock).
* Severe renal impairment (CrCl \<30 mL/min)
* Progressive diseases of the retina other than glaucoma
* Inflammation and/or infecctions active
* Ocular surface syndrome other than Ocular Surface disease
* Eyelid disorder
* Systemic adminsitration of Betablockers or carbonic anhydrase inhibitors
* Patient that requires another antigluacomatous eye drop other than fixed combination of Dorzolamide/Timolol
* Patients who use regularly lubricant eye drops
* Patient who use regularly contact lenses
* Patient with autoinmune diseases
* Patients who underwent kerato-refractive laser procedures, cornea or corneal surface surgery, including, but not limited to, LASIK and PRK, within 6 months prior to the baseline visit.
* Patients who have undergone a laser procedure or intraocular surgery or extraocular in either eye within 6 months prior to the baseline visit.
* Patients with severe central visual field loss in either eye based onclinical judgment of the investigator. For the Humphrey and Octopus perimeters, the severe loss The visual field is defined as a sensitivity less than or equal to 10 dB in at least two(2) of the four (4) visual field test points closest to the fixation point
* Patients with known hypersensitivity to any of the components of bothdrugs under study.
* Pregnant or lactating women.
* Women of childbearing age who are not using a contraceptive method.