cyrilzakka/clinical-trials huggingface dataset:
Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and ARM B: immediate surgery with curative intent.

This is a multicenter, prospective, open-label, randomized, non-comparative, two-arm phase II trial aiming to evaluate afatinib treatment in pre-operative setting in patients with EGFR mutated NSCLC.

After signing of the informed consent, patients will be registered and screened for eligibility and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to:

* Arm A: once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection).
* Arm B: immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).

Response evaluation in the pre-operative arm will be performed through CT scans at baseline, 4 and 8 weeks.

The first 5 patients enrolled in arm A will be part of a safety run-in to check that afatinib treatment doesn't delay surgery.

Eligibility Criteria:
Inclusion Criteria:

Histological or cytological diagnosis of NSCLC;

* Patients considered operable and with resectable tumor with curative intent (anatomical resection and systematic lymph node dissection) based on evaluation by a thoracic multi-disciplinary team composed of at least a thoracic surgeon, oncologist and radiologist;
* Stage I-III (T1a-3, N0-1, M0 according to UICC version 7) NSCLC by local staging criteria potentially treatable by radical (curative) surgery. Patients with T1 tumor at baseline will be limited to 20%;
* Radiologically measurable disease according to RECIST criteria 1.1; assessed by chest and upper abdomen CT scan within 2 weeks (+1 week) prior to registration); brain CT scan or MRI according to local practice;
* No prior treatment for NSCLC is allowed;
* Adequate tissue in terms of quality and quantity for EGFR local testing.

Exclusion Criteria:

* no adequate bone marrow function within 2 weeks prior to randomization
* no adequate liver function. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal; within 2 weeks prior to randomization
* no adequate renal function within 2 weeks prior to randomization
* known positivity to human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
* known history of allergic reactions attributed to compounds of similar chemical or biological composition;
* history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years, except pT1-2 prostatic cancer Gleason score \< 6, superficial bladder cancer, non melanoma skin cancer or carcinoma in situ of the cervix;
Cognitive-motor Training Post-stroke - a Pilot Randomized Controlled Trial

Stroke is a leading and growing cause of long-term adult disability. Up to 80% of stroke patients have impaired manual dexterity reducing their independence, return to work and quality of life. Cognitive impairment is also common after stroke and growing evidence suggests a cognitive-motor interdependence with relevance for motor recovery. Previous studies show increased cognitive-motor interference (measured in dual-task) in stroke patients and that combining motor and cognitive task training (in a dual-task) may improve motor function above that achieved by single-task training. This project addresses post-stroke dexterity impairment and its relation to dual-task interference, i.e., the decrease in motor performance when performing a concurrent cognitive task. The overall goal is to provide a proof-of-concept for a dual-task interference training protocol post-stroke. We aim to establish therapeutic efficacy of dual-task vs single-task dexterity training in chronic stroke patients.Single-task training involves visuomotor finger force tracking and dual-task has an additional cognitive components including visual distraction and working memory. Training will be done 4 days/week over four weeks (total 16 sessions). Each session will include 20 mins of conventional therapy (stretching, functional exercises) followed by 40 mins motor task training (either single or dual task). This pilot randomized clinical trial will include 40 stroke patients (\> 6 months after stroke). Repeated clinical and fine-grained motor measurements will be obtained pre and post intervention and at 3 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* adults with clinical diagnosis of stroke and history of upper limb hemiparesis. Arm and hand paresis is defined as weakness according to Manual Muscle Testing (score less than 4/5 in one upper limb muscles)
* reported difficulty in opening/closing of hand or difficulty in using the hand in daily activities

Exclusion Criteria:

* inability to grasp and displace an object (minimum score of 1 on Box and Block Test, BBT)
* impaired cognition (MOCA score \<23)
* cerebellar stroke
* aphasia disturbing communication and understanding of training task
* neglect interfering with ability to see task on screen
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding

This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity.

Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.

The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.

Eligibility Criteria:
Inclusion Criteria:

* Trauma injury (blunt and/or penetrating) with evidence of active hemorrhage (torso and/or proximal lower extremity) refractory to blood component therapy and surgical haemostatic procedures at the time of randomisation
Radiographic Evaluation of a Star-shaped Incision Technique

To evaluate a star-shaped incision technique to thick-gingiva and thingingiva patients treated with implant-supported fixed prosthesis. The star-shaped incision would be an effective and simple method to reconstruct gingival papillae and avoid the gingival recession in thick-gingiva patients treated with implant-supported fixed prosthesis, and it is worthy of clinical extend.

Objective: To evaluate a star-shaped incision technique to thick-gingiva and thin-gingiva patients treated with implant-supported fixed prosthesis. Methods and Materials: 24 patients received cross-shaped incision were assigned into thick-gingiva group (16 cases) and thin-gingiva group (8 cases). Follow-up examination was carried out 3 and 12 months after final restoration. Clinical and radiographic evaluation including gingival papilla height, modified plaque index, modified sulcus bleeding index, periodontal depth, and crestal marginal bone level were utilized.

Eligibility Criteria:
Inclusion criteria

1. Good general health, no chronic systemic diseases.
2. All subjects included in this study needed to have one missing premolar or molar teeth with adjacent natural teeth.
3. All subjects included in this study had been treated with one bone-level implant insertion in the premolar or molar region. The patients had insufficient gingival papilla height (referred to contralateral natural tooth which also had insufficient gingival papilla height) and at least 2 mm of keratinized tissue width around the implant.

Exclusion criteria

1. Active periodontal infections.
2. Heavy smoking (\> 10 cigarettes per day).
Overview: Use of Respiratory Support At Home in Children

the primary outcome is to describe the perceived success of the use of the respiratory support from the parent's point of view

The use of ventilatory support, including CPAP (Continuous Positive Airway Pressure), which is a mode of ventilation with continuous positive pressure, and BiPAP (Bilevel Positive Airway Pressure), which is a mode of ventilation with two levels of pressure, has seen a significant increase in indications in recent years. The indications have become more numerous and increasingly complex. Sleep-related respiratory disorders, including obstructive sleep apnea-hypopnea syndrome, central apnea syndrome, and alveolar hypoventilation, are the primary reasons for these indications. In pediatrics, numerous conditions contribute to sleep-related respiratory disorders: ENT malformations, genetic conditions, obesity, bronchopulmonary dysplasia, neuromuscular diseases, thoracic deformities, and storage diseases.

The non-use or insufficient use of ventilatory support leads to a lack of treatment for sleep-related respiratory disorders. In the absence of treatment, the consequences are neurocognitive, cardiovascular, and metabolic, resulting in high morbidity. Non-use or insufficient use is a cause of failure of ventilatory support. Neither the use nor the failure of ventilatory support is clearly defined. It is crucial to evaluate the use of ventilatory support in order to correct factors related to non-use or insufficient use and to prevent the negative consequences resulting from unaddressed sleep-related respiratory disorders. This pilot study aims to assess the use of ventilatory support at home in pediatrics through interviews with patients and their parents. We will use a questionnaire designed for the study, consisting of 10 questions regarding sleep, symptoms, quality of life, technical issues, side effects, economic barriers, and adherence, to describe their experiences with ventilatory support.

Eligibility Criteria:
Inclusion Criteria:

* Children with respiratory support at home
* Age 0 to 18 (not yet passed) years old

Exclusion Criteria:

* Palliative care
* Invasive ventilation
* High flow oxygen therapy
Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease

Inflammatory bowel diseases are chronic and progressive entities, triggered by exposure to environmental factors in individuals with a genetic background.

One of the most common environmental factors is the type of diet which is a key influencer on pathogenesis. Nutrients alter the intestinal microbiota, thus changing the intestinal permeability. The Western-type diet encompasses sugar, fat, and protein-rich products that have some deleterious effects on the intestinal microbiome compared to the plant-based Mediterranean-type diet.

Based on this fact, diet-based therapeutic efforts have been used extensively in pediatric Crohn's disease patients and there is strong evidence that exclusive enteral nutrition (EEN) is as effective as corticosteroids to induce both clinical and endoscopic remission but this treatment strategy is underutilized in adults.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, aged between 18-75 years with a diagnosis of ileocolonic Crohn's disease (CD) confirmed using endoscopy and/or imaging technology at most 3 months prior.
* Participant or his/her legal representative have voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Adequate cardiac, renal, and hepatic function as determined by the Principal Investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that do not indicate an abnormal clinical condition that would place the participant at undue risk preclude participation in the study.
* Participant must be able to orally administer study medication/nutrient or have a designee or Healthcare Professional who can assist

Exclusion Criteria:

* Previous or current use of any medication for Crohn's disease such as biologics, immunomodulators (e.g., methotrexate, azathioprine, 6-mercaptopurine, JAK inhibitor, alpha-integrin), and corticosteroids
* Presence of complications (Fistula, abscess, fibrotic disease, imminent risk of surgery)
* Participants with a poorly controlled medical condition such as uncontrolled diabetes with a documented history of recurrent infections, unstable ischemic heart disease, moderate to severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV), recent cerebrovascular accident, and any other condition which, in the opinion of the Investigator or the sponsor, would put the participant at risk by participation in the protocol
* Participants with positive C. difficile stool assay at screening.
* Rescue therapy with steroids, depending on the severity of the disease will be initiated for patients in the EEN group who do not respond clinically and will be excluded from the study. If the number of clinically unresponsive patients was greater than 25% of the total EEN population, the study will be stopped. Criteria for clinical response are described in the "Outcome Measures" section.
First-line Gemcitabine Plus Cisplatin in Locally Advanced (IIIC Stage) Breast Cancer Patients

The goal of the study is to investigate of the prognostics and predictive role of TUBB3 expression in locally advanced breast cancer

Using combination of gemcitabine plus cisplatine as first line treatment patients with locally advanced breast cancer with high TUBB3 expression

Eligibility Criteria:
Inclusion Criteria:

IIIC stage breast cancer patients

Exclusion Criteria:

Other stages breast cancer patients
The Ovarian Reserve and Laparoscopic Ovarian Drilling

Long term assessment of ovarian reserve after more than two years of laparoscopic ovarian drilling in Polycystic Ovary Syndrome

Inclusion criteria:

Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.

Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling

Anti-mullerian hormone (as an indicator for ovarian reserve) will be measured for the two groups and data collected will be compared

Eligibility Criteria:
Inclusion Criteria:

* Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.

Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling

Exclusion Criteria:

1. Age \<19 or \> 35 years.
2. BMI \<19 or \> 35
3. patients refusing to participate in the study.
4. previous ovarian cystectomy.
The Effect Of Indıvıdual and Group Breastfeedıng Traınıng Of Candidate Mother And Father

Breast feeding is the primary step for healthy generations. Breast milk protects against diseases of childhood period starting from infancy till adulthood. Inspite of the benefits of breast milk due to various reasons a lot of women all around the world and in our country can not begin breast feeding and leave it at an early stage even if they start once. According to Turkey Population and Health Investigation (TPHI) data of 2013; while the rate of only breast feeding among; 0-1 month babies is 57.9%, among babies under 6 months this rate falls to 10.0%. In the case of maternals not carrying out the whole breast feeding conditions situations such as milk secretion decrease, troubles related to breast, babies declining breast and ending breast feeding at an early stage are seen. These problems are related to the self-effıcacy that maternal feels towards breast feeding. The researches show that in addition to the maternal, father's attitude throughout pregnancy is also effective on starting breast feeding, sustaining and maintaining it efficiently.

With this research it has been aimed to evaluate the effect of individual and group breast feeding training of future mother and father at postpartum period on breast-feeding self-effıcacy and attitude.

Research data has been gathered at Turkey Public Hospitals Institution Izmir North Public Hospitals Association of T.R Ministry of Health Tepecik Education and Reserach Hospital between the dates 01 March-30 September 2014.

As a result; it has been seen that breast feeding training is not alone enough to improve self sufficiency and attitude, and maternals have to be supported by health staff at postpartum period in hospital. It is suggested to include also fathers to the breast feeding training provided at pregnancy period.

Breastfeeding training was given to the mother and father candidates in the individual and group education group. At this stage, standard care and service in the hospital was offered to the mothers and fathers in the control group. A follow-up plan was prepared for all the mothers and fathers after the discharge from the phone.

Eligibility Criteria:
Inclusion Criteria:

* Agree to participate in the study
* Having the first pregnancy
* Communicable
* Living with his wife
* Participation in education with his wife
* Completion of 36 weeks of gestational week
* Pregnant women without risk.

Exclusion Criteria:

-
Intraoperative Floppy Iris Syndrome

An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy Iris Syndrome exists.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with floppy iris syndrome
* operable bilateral cataracts

Exclusion Criteria:

* Intraocular Pressure (IOP) \> 21mmHg
* ocular inflammatory disease
* systemic or ocular diseases affecting Endothelial Cell Count
Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia for Knee Arthroscopic Meniscectomy

Postoperative analgesia is provided by local anesthesia combined with intrathecal narcotics. In addition, for the first 24 hours, this combination has a parenteral opioid sparing effect. However, despite its benefits, this method has been associated to an increased incidence of urine retention, nausea, and vomiting, as well as pruritus. A new localized analgesic approach called as IPACK (infiltration between the knee capsule and the popliteal artery) has been employed in practice.

The goal of this study was to compare fentanyl based spinal anesthesia to IPACK Block-based spinal anesthesia during knee arthroscopy.

Patients and Methods: The study enrolled sixty patients with ASA (I-II) ranging in age from 25 to 60 years old after receiving ethical committee permission and written informed consent from patients. They were divided into two groups: group F (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) and group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml). Results: In the first 4 hours postoperatively, there were no variations in VAS scores between the two groups; however, following 4 hours and over the next 12 hours, Group I, VAS scores were lower. The amount of morphine used overall was lower in Group I, which took longer than Group F to reach initial rescue analgesia. The level of patient satisfaction 48 hours after surgery was higher in group I than in group F.

Eligibility Criteria:
Inclusion Criteria:

age from 25 to 60 years old, with ASA physical status I-III undergoing for knee arthroscopy

Exclusion Criteria:

Patient refusal, neuromuscular diseases, allergies to local anesthetics, and contraindications to spinal anesthesia such as coagulopathy and severe mitral stenosis
Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation

This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of mycophenolate mofetil in pediatric hematopoietic stem cell transplantation patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had mycophenolate treatment at least 3 days for immunosuppressant after allogenic hematopoietic stem cell transplantation
* Patients age \<18 years
* Written Study Informed consent and/or assent from the patient, parent, or guardian

Exclusion Criteria:

* Known hypersensitivity to mycophenolate mofetil or similar class of drug substance
* Patients in medically critical condition such as severe infection or unstable vital signs
* Any condition that would, in the Investigator's judgment, interfere with full participation in the study
* Patients with hypoxanthine-guanine phosphoribosyltransferase deficiency(HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome)
Impact of Environmental Factors and Metabolomics on Colorectal Cancer.

Colorectal cancer is one of the malignant tumours with high morbidity and mortality worldwide, posing a serious threat to human health. In recent years, the incidence of colorectal cancer has been on the rise with changes in lifestyle and dietary habits. Although some progress has been made in treatments such as surgery, chemotherapy and radiotherapy, however, the early diagnosis, prognosis assessment and personalised treatment of colorectal cancer still face great challenges. Therefore, it is of great academic value and practical significance to deeply explore the influencing factors of colorectal cancer occurrence, development and its prognosis, especially the research on environmental factors and metabolomics.

In this study, investigators collected clinical information, blood, urine and stool for ambient air pollution analysis, blood metabolomics analysis and stool macro-genetic sequencing by including patients from healthy control and colorectal cancer groups, respectively. Environmental factors, metabolomics and intestinal microbiota data were integrated and analysed to screen for indicators that play a key role in colorectal cancer development and construct a colorectal cancer prediction model.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy control group:

   * age ≥18 years old;
   * no history of malignant tumour;
   * willing to participate in this study and sign the informed consent form;
   * complete basic data.
2. Gastric cancer group:

   * age ≥18 years old;
   * patients diagnosed with gastric cancer by pathological biopsy before operation;
   * no chemotherapy, radiotherapy, targeted and immunotherapy before enrolment;
   * willing to participate in this study and sign the informed consent; complete clinical data.

Exclusion criteria:

* patients with primary malignant tumours other than gastric cancer;
* patients with serious cardiopulmonary insufficiency and other systemic diseases that affect the choice of treatment plan;
* patients who are not suitable for enrolment as assessed by the investigator.