cyrilzakka/clinical-trials huggingface dataset:
Amoxicillin and Metronidazole During Periodontal Treatment

The aim of this multicenter randomized clinical trial is to compare the clinical, microbiological and immunological effects of the adjunctive use of systemic metronidazole plus amoxicillin administered in different phases of the treatment of generalized chronic periodontitis.

The combination of systemic metronidazole (MTZ) and amoxicillin (AMX) to scaling and root planing (SRP) has shown to be a promising periodontal treatment. However, some essential issues associated with the use of these antibiotics remain to be established. Although these agents are often prescribed after the healing phase of the SRP procedure, there is biological plausibility to support its use in conjunction with the mechanical treatment. However, to date, no placebo controlled randomized clinical trial (RCT) has directly compared these two protocols. Therefore, the aim of this multicentric RCT is to compare the clinical, microbiological and immunological effects of adjunctive systemic MTZ+AMX administered in different phases of the treatment of generalized chronic periodontitis (GChP). 180 subjects with GChP will be randomly assigned into three groups (n=60/group) that will receive SRP-only (control group) or in combination with 400 mg MTZ+500 mg AMX beginning at the first SRP session (group test 1) or after 3 months of its completion (group test 2). All volunteers will receive clinical and microbiological evaluation at baseline, 3, 6 and 12 months, and immunological assessment (levels of 20 chemokines) at baseline and 12 months post-therapy. Nine subgingival biofilm samples will be collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical, microbiological and immunological parameters among groups and over time will be evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes will be performed using adjustments for multiple comparisons. Statistical significance will be set at 5%.

Eligibility Criteria:
Inclusion Criteria:

* ≥35 years of age;
* at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction);
* a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm;
* at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* current smoking and former smoking within the past 5 years;
* systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
* scaling and root planing an in the previous 6 months;
* antibiotic therapy in the previous 6 months;
* long-term intake of anti-inflammatory medications;
* need for antibiotic pre-medication for routine dental therapy;
* use of orthodontic appliances;
* extensive dental prosthetic rehabilitation;
* allergy to metronidazole and/or amoxicillin.
Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma

The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.

Asthma is one of the most common chronic disease worldwide, imposing a substantial social burden on children. Allergic inflammation is responsible for all clinical symptoms of asthma. The effects of allergic inflammation are: bronchial muscle constriction, excessive mucus production, and edema of mucosa, all elements of "asthmatic triad" causing bronchial obturation. Normal lung function is one of the goals of asthma management. In most of the studies the effect of monotherapy on the symptom scores, lung function parameters and bronchial hyperreactivity was assessed.

The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients
* Aged 6 to 18 with a clinical diagnosis of bronchial asthma with a duration of at least 6 months before the first visit and with current history of moderate persistent asthma
* Sensitive to house dust mites as shown by positive skin-prick tests to Dermatophagoides pteronyssinus or Dermatophagoides farinae
* To become eligible for the active treatment period, patients and their parents were required to do reproducible spirometry, whole body plethysmography and interrupter technique.
* In order to be included in the study the patients had to have a resting FEV1 of more or equal 70%.

Exclusion Criteria:

Study exclusions included:

* Active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
* Previous intubation
* Asthma hospitalisation during the 3 months before the first visit.
* Additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator.
* Excluded medications were β-blockers (eye drops included), astemizole within 3 months, or oral corticosteroids within 1 month before the first visit.
* Patients who were receiving immunotherapy were also excluded.
Glycemic Index and Polyphenol Bioavailability of Potatoes

The purpose of this study is to determine the glycemic index of four varieties of potatoes and to determine the bioavailability of polyphenols contained in these potatoes.

Ten healthy persons will have a fasting blood sample drawn and asked to randomly consume a 50g glucose drink (2 occasions), or 50g carbohydrate equivalent of cooked purple, red, yellow and white potatoes. Further blood samples will be obtained at 15,30, 45, 60, 90, 120, 180, 240 mins. Bloods from the first 2 hours will be analyzed for glucose and insulin to determine the glycemic response. Hourly blood samples will be analyzed for polyphenol to determine the bioavailability of polyphenols from the different potato variety. Urine samples will be collected before ingestion of the food items and again at 4 hours, and will be used to determine polyphenol bioavailability.

Eligibility Criteria:
Inclusion Criteria:

* healthy, non-smoker on no medication
* normal glucose tolerance
* willing to have a catheter inserted in forearm

Exclusion Criteria:

* abnormal glucose tolerance
* abnormal BMI
* on medication for a chronic disorder
The Reality of Nutritional Therapy in Brazil: Quality Assessment

Nutritional status depletion is associated with complications such as increased morbidity and mortality, worsening of patients' quality of life and increased length of hospital stay. Thus, nutritional therapy defined as the set of therapeutic procedures for maintenance or recovery of the nutritional status of the patient, becomes a procedure of extreme importance in the hospital setting. It should be carried out by an interprofessional team, in order to ensure adequate patient care. Aim: This study intends to evaluate the reality of Nutritional Therapy in Brazil, 18 and 14 years after the introduction of the resolution n ° 272 and the RDC n ° 63, respectively, regarding the practice of this important therapy and the existence of interdisciplinary teams. Method: Descriptive, observational and national study. In each Brazilian state was selected the capital, and drawn a city of average and other one of small size. Next, a public, private and university hospital in each municipality was randomly selected. Data collection will be done by means of a questionnaire, based on the Secretary of Sanitary Surveillance of the Ministry of Health resolution n ° 272 and the RDC n ° 63. The questionnaire will be applied by the researchers, and directed to the health professionals involved in the Nutritional Therapy practice in each of the selected hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Hospitals with nutritional therapy

Exclusion Criteria:

* Hospitals with no nutritional therapy
A Phase III, Randomized, Controlled and Multi-center Study of AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer

This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Age ≥ 18 years and ≤ 75 years.
3. ECOG status of 0 or 1.
4. Estimated survival ≥ 3 months.
5. Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
6. Subjects who are not candidates for radical surgical resection or local therapy and have not received systemic anti-tumor therapy in the recurrent or metastatic setting. Subjects who have received prior neoadjuvant or adjuvant therapy and whose first discovery of recurrence or metastases is ≥ 12 months after the last dose of neoadjuvant or adjuvant therapy are allowed to enroll.
7. At least one measurable disease based on RECIST v1.1.
8. Adequate organ function per protocol-defined criteria.
9. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 180 days following the last dose of study treatment.

Exclusion Criteria:

1. Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.
2. Participating in other interventional study within 4 weeks prior to the first study drug administration.
3. Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration.
4. Current presence of uncontrolled combined disease.
5. Active clinical infections.
6. History of severe bleeding tendency or coagulation dysfunction.
7. Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection.
8. Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study.
9. Current presence of significant radiographic or clinical manifestations of GI obstruction.
10. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).
11. Pregnant or lactating women.
12. Any condition considered by the investigator to be inappropriate for enrollment.
13. Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival.
Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems

The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System.

A minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation.

Outcomes will be collected until up to 2 years after surgery.

Common problems with existing clavicular plates are poor plate 'fit,' unbalance fixation, plate prominence, associated soft tissue irritation, subacromial pain, plate and/or fixation failure (due to unbalanced fixation) and high reoperation rate (for plate removal) \[1-3\]. The newly developed DePuy Synthes (DPS) variable angle locking compression plate (VA-LCP®) Clavicle 2.7 System was designed to address these problems. The system consists of lateral, shaft and medial plates and hook plates of different sizes to cover a wide variation in clavicular morphology and diverse fracture, fracture-dislocation and dislocation indications.

The objective is to describe the short and long-term clinical performance and safety of both systems, as well as the functional outcomes of this patient population.

Outcomes will be collected at baseline, 2 weeks, 6 weeks, 3 months, 6 months 1, and 2 years after surgery. In addition, the surgeons' experience and utility of the devices will be surveyed. For the short term evaluation, an interim analysis will be done as soon as 30 patients in each group have completed 6 months of follow-up (FU). The final evaluation of long-term outcomes will be done after 2 years of FU.

All treatments and follow-up visits are according to standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Unilateral clavicel injury and primary surgical treatment within 21 days from injury with a DPS VA-LCP® Clavicle Plate according to manufacturer's instruction use:

  * VA-LCP® Clavicle Plates 2.7: Fixation of clavicle bone fragments
  * VA-LCP® Clavicle Hook Plates 2.7: Fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint
  * VA-LCP Clavicle Button Hook Plates 2.7: Fixation of acromioclavicular joint dislocations
* Expected ability to attend postoperative FU visits
* Patient informed and consent obtained according to the IRB/EC defined and approved procedures

Exclusion Criteria:

* Stable clavicle fractures
* Systemic infection or infection localized to the site of the proposed implantation
* Concomitant nerve or vessel injury
* Polytrauma (Injury Severity Score ≥ 16)
* BMI ≥40
* Uncontrolled severe systemic disease or terminal illness
* Intraoperative decision to use other implant
An In-home Study of Brain Computer Interfaces

The investigators are developing a tool to help people who are severely paralyzed. This tool is called a brain-computer interface (BCI). BCIs can connect to computers or other electronic devices.

This study allows a person with ALS to communicate, control their wheelchair tilt and perform other tasks using a BCI, thus increasing their independence.

This small-scale study of the feasibility of a BCI to operate the tilt position of a power wheelchair was also designed to determine the conditions and support structures necessary for use of a BCI in the home. In this study, people with Amyotrophic Lateral Sclerosis (ALS) will have a BCI in their home. They will receive training in order to operate and maintain the BCI. The BCI will allow them to access at least one task of primary interest to them. Task may include communication, computer access, control of assistive technology, or control of wheelchair seat position. Data concerning the use of the BCI will be collected throughout the study. Custom installations will be made for each participant to connect to their wheelchair and provide communication options if needed. Each installation is expected to be a unique prototype because of the differing control requirements for the individual wheelchairs in use by the participants.

We intended to enroll six participants, but were only able to enroll one.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Presently having difficulty communicating or operating the controls for assistive technology or likely to have difficulty in the next six months.
* Able to see the BCI display
* Able to understand and remember instructions concerning participation.
* Live in an environment that can accommodate the wheelchair portable BCI host computer
* Expected to live in the same physical environment for at least 6 months.
* Has family and caregiver(s) who are supportive of participation in this research.
* Has a primary caregiver who is technically capable, willing to learn the setup and operation of the BCI system, and likely to remain with the subject for at least 6 months.
* Has been shown to be able to use a BCI (in an experimental session under another IRB, e.g. HUM 00012968).
* Has a clear understanding of the shortcomings of the present state of BCI technology

Exclusion Criteria:

* Open head lesions or a history of problems with skin breakdown on the head that may be aggravated by repeated application of electrodes.
* Inability to communicate well enough to give informed consent.
* History of photo-sensitive epilepsy
* Known significant cognitive deficits
Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE

To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)

In most current guidelines, sorafenib is considered as the second-line treatment for patients with transarterial chemoembolization(TACE) failure or refractoriness.However,the median overall survival of those treated with sorafenib monotherapy was 16.4 to 24.7 months.

Whether combining sorafenib with hepatic arterial infusion chemotherapy(HAIC) of oxaliplatin,5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective and randomized phase II trial to compare the safety and efficacy of HAIC with sorafenib in patients refractory to TACE

Eligibility Criteria:
Inclusion Criteria:

* TACE failure or refractoriness based on the Liver Cancer Study Group of Japan (LCSGJ) criteria, including appearance of vascular invasion or two or more consecutive insufficient responses of the intrahepatic lesion;
* Except for TACE, patients have received no previous anti-tumor treatment;
* The diagnosis of HCC was based on histological results;
* Patients must have at least one tumor lesion that can be accurately measured;
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment;
* No Cirrhosis or cirrhotic status of Child-Pugh class A only;
* No liver protection therapy in 2 weeks before enrolled, and meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin ≥ 32 g/L;(e) ASL and AST ≤ 5 x upper limit of normal;(f) Serum creatinine ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) \>1,500/mm3;
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy;
* Known history of HIV;
* History of organ allograft;
* Known or suspected allergy to the investigational agents or any agent given in association with this trial;
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
Innovative "Scoring System" in Breast Cancer Post Neoadiuvant Chemotherapy

Our aim is to create a Scoring System (SS) able of guaranteeing radical oncology by completely removing cancer and aesthetic outcomes in line with the needs or expectations of the patients that helps surgeons to decide the type of surgery in patients undergoing NACT.

Secondary outcome is to assess the ability of the score to avoid neoplastic relapses by evaluating:

* Loco-regional disease free-survival (LR-DFS): months between start of NACT and date of a neoplastic recurrence in residual mammary gland, in ipsilateral chest wall or in ipsilateral axilla.
* Distant disease-free survival (DDFS): months between start of NACT and date of onset of visceral or skeletal metastases.
* Overall survival (OS): months from the start of NACT to death or last follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing neoadjuvant chemotherapy
* Surgery: Breast conservative surgery; Oncoplastic surgery type II; Conservative mastactomy (nipple sparing - NSM or skin sparing - SSM)

Exclusion Criteria:

* lack of initial staging or restaging;
* previous or synchronous history of systemic malignant neoplasms.
* history of homo-or contralateral breast cancer.
* initial evidence of metastatic pathology or development of metastases during noeadjuvant chemotherapy (Stage IV)
* indication to modified radical mastectomy (MRM) without delayed reconstruction
Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients

Insomnia, a common feature of schizophrenia, has serious consequences for daytime functioning and quality of life. Although insomnia is most often treated with medication, a growing number of studies have demonstrated the efficiency of a variety of relaxation techniques, cognitive behavioral therapies and alternative medicine procedures. Acupuncture is among the oldest healing practices in the world. Part of traditional Chinese medicine, acupuncture aims to restore and maintain health through the stimulation of specific points on the body. Previous studies have demonstrated that acupuncture has a positive influence on a number of diseases and disorders, among them Depression, Chronic Pain and Sleep Disorders. Hence, the aim of the present study is to examine the effects of acupuncture as a treatment for insomnia in schizophrenic patients.The study begins with a 7-day, running-in, no-treatment period, followes by an 8-week experimental period. During the experimental period, subjects receive acupuncture treatments twice a week. During the first week of the study (no-treatment period) and the last week of the experimental period, subjects' sleep is monitored with a wrist actigraph, and subjects complete a wide spectrum of questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. schizophrenia or schizoaffective disorder - diagnosed according DSM-4.
2. capability to sign inform consent.

Exclusion Criteria:

1. unstable physical illness
2. drug or alchohol abuse or dependence