cyrilzakka/clinical-trials huggingface dataset:
Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.

This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets (400 mg/d,200mg bid) in patients with advanced, inoperable gastric cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival time.

Eligibility Criteria:
Inclusion Criteria:

* All patients provided written, informed consent.
* Have histological or cytological documentation of gastric adenocarcinoma;
* Have received currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects.
* Standard therapies include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab for patients who had Her-2 positive tumours;
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Life expectancy of at least 3 months;
* Have adequate bone-marrow, liver, and renal function at the start of the trial.
* Prothrombin time international normalized ratio≤1.5；

Exclusion Criteria:

* Patients with brain metastases.
* Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
* Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin \>1.5 times upper limit of reference range, aspartate or alanine aminotransferase\>2.5 times the upper limit of normal if no demonstrable liver disease).
Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition

The aim of the present study is to evaluate both Hall technique and atraumatic restorative technique in comparison to the conventional restorative technique in the management of carious lesions in primary molars.

This study is a three arm randomized controlled clinical trial. Eligible children will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. One hundred and fifty five teeth will be randomly allocated into 3 groups fifty two each. Group I will be assigned to Hall technique Group II will be assigned to atraumatic restorative treatment using Glass ionomer cement, and Group III will be assigned to a conventional restoration and will serve as a control.

Eligibility Criteria:
Inclusion Criteria:

* Children free of any systemic disease or special health care needs.
* Cooperative children ( positive/ definitely positive) according to Frankl's behavior rating scale.
* Children who are willing to participate in the study
* Tooth inclusion criteria:

  * Primary molar teeth with occlusal or occlusoproximal carious lesions into dentin (International Caries Detection and Assessment System) (ICDAS) codes: 3-5
  * Absence of clinical signs or symptoms of irreversible pulpitis
  * Absence of fistula or abscess near the selected tooth clinically and radiographically
  * Absence of spontaneous pain
  * Absence of pulp exposure
  * Absence of pathological mobility by placing the points of a pair of tweezers in an occlusal fossa, and gently rocking the tooth bucco-lingually.

Exclusion Criteria:

* Clinical signs and symptoms of irreversible pulpilitis.
* Tooth mobility
* Spontaneous pain
The Efficacy of Doxazosin for Cocaine Users

Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse among cocaine dependent participants.

The NE system, especially the alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. The results of this study will provide medical safety data on the duration of the induction schedule that will be optimal for attaining our target dose of 8 mg doxazosin daily and will guide future pharmacotherapy trials using Doxazosin or related alpha 1 receptor antagonists for cocaine addiction.

This 17-week double-blind, placebo controlled clinical trial includes a 13 week medication trial (weeks 1-13) and up to 4 week washout period(weeks 14-17). Qualifying subjects will be randomized to receive Doxazosin 8 mg/day, or placebo during the study participation.

Medication induction will occur at a rate of 2mg/week until 8mg/day target dose is achieved as follows:

1. Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
2. Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants will be stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)

Both groups will be tapered off doxazosin or placebo over study weeks 14-17.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV diagnosis criteria for cocaine dependence, as determined by self-reported use of cocaine at least once weekly for at least 1 month prior to study entry; a positive urine test for cocaine; and a score greater than 3 on the Severity of Dependence Scale
* If female, willing to use contraception throughout the study

Exclusion Criteria:

* Meets DSM-IV diagnosis criteria for dependence on any drugs other than cocaine, or tobacco
* Current major psychiatric illness, including schizophrenia, bipolar disorder, or other psychotic disorder
* Current suicidal or homicidal ideation
* Current use of a prescribed psychotropic medication that cannot be discontinued
* History of or current major medical illness, including major heart, kidney, endocrine, or liver disorder; abnormal liver function (SGOT or SGPT levels three times greater than normal); or high blood pressure or low blood pressure
* High risk factor for heart disease, seizure disorders, or any illness for which disulfiram or methadone treatment would be inadvisable
* Currently taking metronidazole or clotrimazole
* Pregnant or breastfeeding
Performance Evaluation of Different Daily Disposable Multifocal Contact Lenses

The objective of the study was to compare the lens performance of two daily disposable multifocal contact lenses.

This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type was worn for approximately 3-4 weeks: the lens prescription of each lens type was optimized after a 3-8 days wearing experience, then participants began a 2 week (14-21 day) wear period.

Eligibility Criteria:
Inclusion Criteria:

1. Were at least 42 years of age and had full legal capacity to volunteer;
2. Had read and signed an information consent letter;
3. Self-reported having had a full eye examination in the previous two years;
4. Anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week
5. Were willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wore multifocal soft contact lenses, for the past 3 months minimum

   * Maximum of 7 participants per site were habitual wearers of daily disposable lenses
   * Maximum of 3 habitual wearers per site of 1-Day Acuvue Moist Multifocal
   * Maximum of 1 habitual wearer per site of ACUVUE OASYS MAX 1-Day MULTIFOCAL
   * Maximum of 3 habitual wearers per site of MyDay Multifocal
   * Maximum of 7 participants per site were habitual wearers of frequent replacement lenses
   * Maximum of 1 habitual wearer per site of ACUVUE OASYS for PRESBYOPIA
7. Had refractive astigmatism no higher than -0.75DC in each eye;
8. Were presbyopic and required a reading addition of at least +0.75D and no more than +2.50D;
9. Could be fit and achieved binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS, near addition as per study design)

Exclusion Criteria:

A person was excluded from the study if they:

1. Were participating in any concurrent clinical or research study;
2. Had any known active ocular disease and/or infection that contraindicated contact lens wear;
3. Had a systemic condition that in the opinion of the investigator may have affected a study outcome variable;
4. Were using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable;
5. Had known sensitivity to the diagnostic sodium fluorescein to be used in the study;
6. Self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Had undergone refractive error surgery or interocular surgery.
Prone Patient Positioning in Reducing Tumor Motion and Improving Breathing Reproduction in Patients With Lung Cancer Undergoing Radiation Therapy

This clinical trial studies prone patient positioning in reducing tumor motion and improving breathing reproduction in patients with lung cancer undergoing radiation therapy. Prone patient positioning during radiation therapy may help kill tumor cells without harming normal tissue.

PRIMARY OBJECTIVES:

I. Quantify the three-dimensional tumor and normal tissue (thoracic and abdominal) motion, deformation and volume changes with the respiratory cycle during imaging in prone vs. supine positioning.

II. Quantify the three-dimensional tumor and normal tissue (thoracic and abdominal) motion, deformation and volume changes with the respiratory cycle and alterations thereof during a radiotherapy series.

OUTLINE:

Patients undergo one conventional computed tomography (CT) scan and one 4 dimensional CT (4D CT) scan in both supine and prone positioning before undergoing radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Measurable disease on the planning computed tomography (CT) scan
* Patients with lung cancer visible on fluoroscopic imaging or planning CT who are scheduled to receive external beam radiation treatment will be eligible for this study

Exclusion Criteria:

* Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
* Pregnant females
Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery

A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized High-fiber/low-fat meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Must have histologically or cytologically confirmed colorectal adenocarcinoma.
* Planned for primary tumor resection at the University of Chicago Medicine ≥21 from date of obtained informed consent. Patients with metastatic disease but undergoing primary site resection are eligible for the study.
* Age ≥18 years.
* Patients \<18 years of age, children are excluded from this study, because they have unique nutritional requirements that might not be met by with the standardized diet. The food in the diet is designed for adults and would not be feasible for children, especially those attending school. In addition, colon cancer is extremely rare in children.
* May have received neoadjuvant therapy (chemotherapy, radiation).
* Patients with Hepatic arterial infusion (HAI) pumps are considered eligible.
* Ability to understand and willing to sign an informed consent, participate in the dietary intervention, collect stools, donate blood, and complete a pre-nutritional evaluation and compliance/patient satisfaction survey.

Exclusion Criteria:

* Previous ostomy (ileostomy or colostomy) or definitive plan for an ostomy (ileostomy or colostomy) during the procedure.
* Antibiotic exposure within 60 days before diet initiation. Antibiotic exposure is defined as a 'course of treatment to treat an infection'. Prophylactic antibiotics prior to a procedure is okay.
* Prebiotic/Probiotic exposure within 60 days before diet initiation.
* Concomitant separate malignancy.
* Allergy to perioperative medications (oral neomycin/metronidazole for bowel preparation, intraoperative prophylactic intravenous cefazolin and metronidazole).
* Patients who are pregnant are not eligible for the study. Pregnant women are excluded from this study because the preoperative diet is not specifically formulated to meet the specific nutritional requirements during the prenatal period.
* History of inflammatory bowel disease
* Severe food allergies precluding the ability to tolerate the standardized dietary intervention.
* Patients with uncontrolled intercurrent illness
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

RATIONALE: An orientation and patient education program and telephone counseling may help improve the quality of life in patients with peritoneal surface malignancies.

PURPOSE: This clinical trial studies quality of life and survivorship care in patients undergoing surgery and chemotherapy for peritoneal surface malignancies.

PRIMARY OBJECTIVES:

I. Assess feasibility of instituting an orientation program, brief follow up care and phone calls in this patient population.

SECONDARY OBJECTIVES:

I. Reduce pre-treatment distress and anxiety. II. Improve pre-treatment self-efficacy. III. Provide educational material delivered by the SRB. IV. Improve overall post-operative QOL ratings at 3 months, relative to discharge.

OUTLINE:

Patients and their caregiver(s) receive a hyperthermic intraperitoneal chemotherapy (HIPEC) orientation with a Survivorship Navigator (SN) over 90 minutes following their initial surgical consult. Patients then receive telephone calls over 20-30 minutes from the SN once weekly for 3 weeks prior to HIPEC. . After HIPEC, patients meet with the SN for 20-30 minutes to discuss adjustments and adaptation to the surgery and hospitalization 3-4 days post-HIPEC, biweekly for two weeks, and weekly thereafter until hospital discharge. After hospital discharge, patients receive telephone calls from the SN twice monthly for 1 month.

Eligibility Criteria:
Inclusion

* Patients who undergo CS and HIPEC for peritoneal surface malignancy
Bone and Vascular Health in Postmenopausal Women With Type 1 Diabetes

The study is designed to evaluate the differences in bone mineral density (BMD) and Carotid Intima Media Thickness (CIMT) between postmenopausal women with type 1 diabetes (T1D) compared to postmenopausal women without diabetes.

Type 1 diabetes (T1D) is an autoimmune disease requiring lifelong insulin treatment. Having T1D increases the risk of death, especially in women with T1D.

Heart disease and fractures due to osteoporosis (brittle bones) are the leading causes of death in women with T1D.

Since both diseases share certain common risk factors such as age, menopause, smoking, physical inactivity, and diabetes, this study is designed to find link between bone density and cardiovascular risk.

This study has only one visit. All participants will undergone bone density testing using a dual energy x-ray absorptiometry (DEXA) machine and measurement of carotid intima media thickness (a marker of carotid atherosclerosis) using carotid ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* T1D as defined under CACTI study OR Controls as defined as no current diabetes (HbA1c \< 6.5% and fasting blood glucose \< 126 mg/dl, no diabetes diagnosis and no use of anti-diabetic medication),
* Diabetes duration of 10 years or greater, and
* Postmenopausal women. Menopause is defined as no menstrual periods for at least 12 consecutive months OR FSH greater than 40 IU/L on at least two occasions.

Exclusion Criteria:

* Chronic diseases, which can affect the BMD measurement such as:

  * Uncontrolled coeliac or thyroid disease,
  * Addison's disease,
  * Malabsorption syndrome,
  * Rheumatologic disorder,
  * Parathyroid disorders,
  * Cancer other than skin cancer, and
  * Chronic kidney disease with eGFR less than 30.
* Medications that can affect BMD results such as:

  * Oral or injectable steroid intake for more than 3 months,
  * Immunosuppressant and osteoanabolic or antiresorptive medications for osteoporosis treatment, and
  * Previous fractures or deformities making it difficult to perform DXA at hip and spine.
Renal Denervation in Heart Failure With Preserved Ejection Fraction

The purpose of this study is to determine whether renal sympathetic denervation (RSD)(a treatment that lowers the activity of the sympathetic nervous system) is useful in the management of patients with heart failure with preserved ejection fraction (HF-PEF).

Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in heart failure with preserved left ventricular ejection fraction. The current study aims to evaluate efficacy of renal sympathetic denervation for the modulation of the SNS in patients with HF-PEF.

Eligibility Criteria:
Inclusion Criteria:

* EF\>40%
* NHYA 2-3
* Evidence of HF-PEF (mixture of dilated left atrium, left ventricular hypertrophy, raised E/E', elevated LVEDP/PCWP, raised BNP)

Exclusion Criteria:

* Previously documented EF\<40%
* Hypertrophic, restrictive, dilated cardiomyopathy
* Significant valvular heart disease
* Unfavourable renal artery anatomy for renal denervation
* eGFR\<45
* Contraindication to MRI
* Myocardial infarction, unstable angina or cerebrovascular accident in last 3 months
Analysis of the Diagnostic Performance of LacryDiag, a New Analyzer of the Ocular Surface in the Dry Eye

LacryDiag is a new Conformity European (CE) marked diagnostic imaging device devoted to the analysis of the ocular surface. It is an "all in one" device that provides 4 data: non-invasive break-up time (Non-Invasive Break-Up-Time (NIBUT) without fluorescein eye drop); height of the Tear Meniscus (TM); an infrared image of the meibomian glands; a picture of the lacrimal film by interferometry. it's performance will be compare between in diagnosing dry eye syndrome with the standard clinical evaluation, in 80 patients suffering from dry eye diseases and followed at the consultation of the Ophthalmology department of the University Hospital of Saint-Etienne.

The primary purpose of this study is to compare the value of Break-Up-Time (BUT) between Non-Invasive Break-Up-Time (NIBUT) measured by LacryDiag and Standard Break-Up-Time (SBUT) measured by usual practice.

Eligibility Criteria:
Inclusion Criteria:

* Affiliates or beneficiaries of social security scheme
* With Dry eye of any cause, diagnosed with conventional means
* Signed informed consent

Exclusion Criteria:

* Major blepharospasm
* Serious illness preventing participation according to investigator
* Allergy to fluorescein
* Pregnant or / and breastfeeding women
* Under guardianship, curatorship or safeguard of justice
* Unable to express their consent
* Person in emergency situation
Remifentanil Versus Sufentanil for Intubation Condition Without Myorelaxant

The main objective is the comparison of intubation conditions after anesthetic induction bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients undergoing surgery for tooth extraction.

Intubation without myorelaxant with propofol and sufentanil is classic but less efficient than induction with curare on achieving perfect intubation conditions. The use of a protocol without curare is sometimes justified for short gestures or when you want to avoid allergia. Remifentanil often provides excellent intubation conditions without myorelaxant. However, remifentanil was never compared to sufentanil in terms of intubating conditions without muscle relaxant.


Eligibility Criteria:
Inclusion Criteria:

* patients 18 to 60 years
* American Society of Anesthesiology (ASA) 1 or 2
* scheduled for surgical tooth extraction under general anesthesia with intubation
* signed consent form

Exclusion Criteria:

* criterion of difficult ventilation or intubation
* chronic alcoholism or opiate use
* beta-blockers or calcium channel blockers treatment
* allergy to paracetamol or ketoprofen
* patient under protection of justice
Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism

Dystonia is a disabling symptom affecting both patients with idiopathic Parkinson's disease (PD) and atypical parkinsonism (AP).

Botulinum toxinum (BoNT), by blocking muscle contraction, is a possible treatment for focal dystonia.

The benefit of BoNT treatment has been proven in some focal dystonia associated with PD or AP.

The investigators aim to give an overview of the efficacy of BoNT in a variety of focal dystonia in a large cohort of parkinsonian patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Parkinson's disease or Atypical Parkinsonism
* Age \> 18 years
* Reported dystonia
* At least 1 injection with Botulinum toxin realized

Exclusion Criteria:

* Refusal to participate in the study
Visual Function After Bilateral Implantation of AcrySof® Toric

The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataracts
* 40\~80 years of age
* 4 Days - 1 Week interval between a single patient's surgery
* dilated pupil size (in dim light) ≥ 4.0 mm
* Anticipated correction with an IOL of +10 Diopters \~ +25 Diopters
* 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

Exclusion Criteria:

* Preoperative ocular pathology
* Previous intraocular or corneal surgery
* An increased risk for complications which could require vitreoretinal surgery
* Corneal irregularities
* Corneal opacities
* Current contact lens usage(within 6 months prior to first surgery)
Fibrinogen Concentrate in Isolated Traumatic Brain Injury

Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma fibrinogen concentrations decrease earlier and more frequently than other coagulation factors,predicting massive bleeding and death.

The purpose of this study is to try early injection of fibrinogen concentrate in severe isolated traumatic brain injury and investigation the effect of it on post bleeding and complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe isolated traumatic brain injury.

Exclusion Criteria:

* Severe abdomen or extremities trauma.
* Severe bleeding from abdomen or extremities.
* Congenital coagulopathy (Hemophilia, protein S and C deficiency, Factor 5 Leiden deficiency and ...).
* Warfarin, Heparin, Enoxaparin, Dabigatran and other anticoagulation drugs consumption.