cyrilzakka/clinical-trials huggingface dataset:
A Phase III Study Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer

This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.

In order to evaluate the impact of omentectomy for advanced gastric cancer on patient survival, we designed this trial. Patients who received curative gastrectomy were divided into two groups based on whether they underwent omentectomy. The purpose of this study is to prove the non-inferiority of omentum preservation compared with omentectomy in patients with T3-T4a gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);
2. Physical condition and organ function allows to tolerable abdominal surgery;
3. Willing and able to comply with the program during the study period;
4. Written informed consent provided;
5. ≥ 18 and ≤ 70 years of age; preoperative gastric cancer patients with pathologically confirmed;
6. With more than a 6-month life expectancy;
7. No other serious concomitant diseases; Sufficient organ functions;
8. No previous history of chemotherapy or radiotherapy;
9. All patients accept 8 cycles XELOX chemotherapy regimen;
10. Clinical stage: T3-4aN0-+M0; 11 . Macroscopic types :Borrmann I-III;

12. Not greater curvature tumor; with distal or total gastrectomy； 13. No previous surgery for any abdominal disease, except an appendectomy for appendicitis, a laparoscopic cholecystectomy for gallbladder stones; No previous history of peritonitis, pancreatitis; 14. Karnofsky performance status (KPS)\>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1.

Exclusion Criteria:

Pregnancy or breast feeding; 2. Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency; 3. Organ transplantation patients need immunosuppressive therapy; 4. Severe recurrent infections were not controlled or with other serious concomitant diseases; 5. Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; 6. Psychiatric disease which require treatment; 7. Have the history of organ transplantation; 8. Within 6 months before study starts and in the process of this study, patients participate in other clinical researches. 9. Advanced gastric cancer with omentum invasion 10. Patients can't treated with XELOX after surgery; 11 . Macroscopic types : Borrmann IV; 12. Tumor invasion of adjacent organ (T4b) or with distant metastasis#M1 #; 13. Tumor invasion the greater curvature invasion.
Plasma Rich in Growth Factors (PRGF-Endoret) in the Regeneration of Post-Extraction Sockets

Immediately following tooth removal, a healing process begins that affects the eventual alveolar bone volume and architecture of the alveolar ridge. Satisfactory and timely healing are essential to obtain ideal functional reconstruction. Traumatic removal of a tooth, or a poor healing response, may lead to excessive bone loss delaying tooth replacement, requiring expensive and time-consuming reconstructive surgeries, or even the inability to be corrected. The Plasma Rich in Growth Factors (PRGF-Endoret) has shown its therapeutic potential effect to minimize the consequences of this aggression, promoting the regeneration of both hard and soft involved tissues.


Eligibility Criteria:
Inclusion Criteria:

* subjects of both genders and ≥ 18 years old
* Indication of a simple one molar extraction in the mandible.
* Possibility of observation during the follow-up period.

Exclusion Criteria:

* Unerupted third molars or with horizontal inclination.
* Severe swelling prior to surgery in the areas designated for extraction.
* Suffering an alteration or a serious hematologic disease.
* Be currently undergoing or have received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and/or anticoagulants 30 days prior to inclusion
* In regular treatment with NSAIDs or other anti-inflammatory drugs.
* History of chronic hepatitis or cirrhosis.
* Diabetes mellitus with poor metabolic control (glycosylated hemoglobin \>9%)
* Patients undergoing dialysis.
* Presence of malignant tumors, hemangiomas or angiomas in the extraction area.
* History of ischemic heart disease in the last year.
* Pregnancy or planned pregnancy during the study follow-up period.
* Metabolic Bone Disease.
* Patients taking bisphosphonates both orally and intravenously.
* In general, any inability to participate in the study.
The Combination Therapy of Fractional Laser and PRP Compared With Nanofat Grafting and PRP Synergy in Treating Striae Gravidarum.

Nowadays, multiple treatment modalities have been applied clinically to treat striae gravidarum, such as laser therapy, microdermabrasion, platelet-rich plasma injection(PRP), etc. To some extent, these treatments can improve striae gravidarum. In this clinical trial, the investigators are going to treat striae gravidarum by using two different kinds of combination therapies. One is fractional laser and PRP injection synergy, and the other one is treated by nanofat grafting with PRP injection.

The investigators will pick out two areas of most severe striae gravidarum on a participant's abdomen. One of the areas will be treated by fractional laser once every three months for 2 times combined with PRP injection once a month for 6 times. Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times. The participants were asked to come back 1、3、6、9 months after treatment for further follow-up.

Before and after the treatment, the striae gravidarum will be assessed subjectively by satisfaction assessment, dermatoscope and ultrasound, and objectively by immunohistochemical analysis.

Eligibility Criteria:
Inclusion Criteria:

* The striae gravidarum was appeared within 3 years
* Age ≤ 35 years old
* Not in lactation
* Not pregnancy within one year

Exclusion Criteria:

* Skin allergy
* Skin inflammation or wound
* Platelet dysfunction syndrome
* Take anticoagulant drugs
* Acute or chronic infection
* Chronic liver disease
* Photodermatosis
* Active vitiligo, psoriasis, systemic lupus erythematosus
* Other clinical trial
Visual Assessment for Pressure-time Curve

Airway pressure-time (P-t) curve and stress index (SI) assessment have been proposed to guide the mechanical ventilation settings and minimize ventilator-induced lung injury.

The stress index (SI), which has been proposed to guide the mechanical ventilation settings and minimize ventilator-induced lung injury. It reflects the change of respiratory compliance during inspiration. Value of SI equals to 1 that indicates a constant compliance, whereas values lower and higher than 1 indicate increase and decrease of compliance over inspiratory time, suggesting tidal recruitment and tidal hyperinflation, respectively. Based on the different values of SI showing different shapes, SI of straight curve equals to 1, SI of concave curve lower than 1 and convex curve higher than 1, the investigators speculated that the SI value could be reliably and accurately estimated by visual inspection of the P-t curve.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older; intubated and mechanical ventilated by volume-control ventilation with constant flow;

Exclusion Criteria:

* evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube; evidence of the stiff chest wall, such as existing the pleural effusion, intra abdominal hypertension, chest injuries and abdominal injuries.
Oxygenation Instability and Maturation of Control of Breathing in Premature Infants

Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. These infants are also exposed to hyperoxemia.

The objective of this study is to determine the extent to which exposure to frequent episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their evolving lung disease is associated with altered maturation and function of their respiratory control system.

This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Most extreme premature infants present with respiratory failure due to altered lung function compounded by breathing instability due to an immature respiratory control function.

Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. As a result, these infants receive oxygen supplementation but this is often excessive and these infants are also exposed to hyperoxemia. The extent to which these episodes of hypoxemia or the exposure to hyperoxemia impact on the maturation and function of the control of breathing system in extreme premature infants during the evolving stages of their respiratory disease is unknown. This is a prospective study that will systematically evaluate such association in extreme premature infants.

The main objective of this study is to determine the extent to which exposure to frequent episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their evolving lung disease is associated with altered maturation and function of their respiratory control system.

This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).

Eligibility Criteria:
Inclusion Criteria:

* Premature infants born at 23 0/7- 28 6/7 weeks gestational age
* Postnatal age up to equivalent to 36 weeks postmenstrual age
* Requiring supplemental oxygen and/or receiving mechanical ventilation, CPAP, nasal ventilation or nasal cannula

Exclusion Criteria:

* Severe congenital anomalies that may affect life expectancy or pulmonary or neurosensory development
* Severe CNS pathology that may alter respiratory control function
Tumor Registry of Advanced Renal Cell Carcinoma

The purpose of this registry is to record information of therapy reality of metastatic or locally advanced Renal Cell Carcinoma by office-based medical oncologists in Germany.

The RCC Registry is a prospective, longitudinal, nation wide cohort study that collects data on the treatment reality of patients with mRCC. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Patients are followed until death or for a maximum of 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic or locally advanced Renal Cell Carcinoma requiring therapy
* Start of first palliative therapy within 1 year before enrollment of patient to registry; since enrollment of 1000 Patients: start of first palliative therapy within 4 weeks before enrollment

Exclusion Criteria:

-
Evaluation of Antithrombotic STrategies in STEMI Patients in China

EAST-STEMI is the first perspective, multicenter, large-scale registry focusing on the evaluation of real-world medical quality (especially PCI quality) and antithrombotic strategies in STEMI patients undergoing emergent PCI in a regional representative sample in China with 2 years follow-up. Clinical decision support tools (including ischemic score, bleeding score, etc) will be developed and validated based on the database. Novel biomarkers to predict the prognosis and to support risk stratification will be explored by using the blood samples.


Eligibility Criteria:
Inclusion Criteria:

1. Age\>=18yrs
2. STEMI patients undergoing emergent PCI
3. Signed informed consent

Exclusion Criteria:

1. Difficult to follow up or obtain accurate information (e.g., long-term overseas stay, speech or mental disorders)
2. Other severe diseases (e.g., liver failure, renal failure and advanced stage of cancer)
The Neuroendocrine Effects of Pioglitazone in Patients with Cancer and Cachexia

The goal of this clinical trial is evaluate the effect of pioglitazone compared with placebo on skeletal muscle insulin sensitivity in subjects with cancer and cachexia.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Documented histologic or cytologic diagnosis of non-small-cell lung cancer or gastrointestinal cancer that is locally advanced and inoperable or metastatic (e.g., spread to distant organs)
* Cachexia defined by Fearon criteria
* Insulin resistance syndrome, defined with the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
* Ability to provide written informed consent, willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures
* Provide written approval by a qualified healthcare professional
* Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria:

* Prior diagnosis of type 2 diabetes
* Prior or current thiazolidinedione (TZD) therapy
* Known hypersensitivity to TZD
* New York Heart Association (NYHA) class I-IV heart failure
* History of or actively treated bladder cancer
* Current use of CYP2C inhibitor (e.g., gemfibrozil) or CYP2C inducer (e.g., rifampin)
* Inadequate hepatic function
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 16 weeks
* Contraindications to magnetic resonance imaging (e.g., implanted cardiac device, cochlear implant)
* Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol
Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer
* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
* Has had an ocular examination in the last two years
* Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
* Has clear corneas and no active ocular disease
* Can be successfully fit with the lenses to be used in the study
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* Is pregnant or lactating
* Has undergone corneal refractive surgery
* Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
* Other protocol-defined inclusion/exclusion criteria may apply
Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis

The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of radiographically confirmed joint damage progression over a one-year period as a primary endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be discontinued, and the subjects will be monitored for one more year (the follow-up period) to investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory purposes.

This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the following criteria:

  1. Subjects who developed RA within one year after onset of RA.
  2. Subjects who have never received MTX before (MTX naive)
  3. Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）
  4. Subjects must satisfy at least two of the three criteria (Anti-CCP antibody positive, Rheumatoid factor positive, Presence of X-ray erosion） for poor prognostic factors. The anti-CCP antibody positive is essential for every patient.

Exclusion Criteria:

* Patients who have a diagnosis of any other type of inflammatory arthritis.
* Patients who have a secondary, non-inflammatory type of arthritis.
* Patients who have used with MTX, reflunomide, or any other biologics prior to the start of study drug administration.
* Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
* Patients who currently have, or who have a history of, tuberculosis.
* Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
* Patients who currently have, or have a history of, malignant tumor
* Female patients who are breastfeeding or pregnant, who are of childbearing potential
Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population

The goal of this randomized controlled trial is to investigate the effect of injection of autologous amniotic fluid in the healing of the scar of cesarean section among high-risk population. Investigator's aim is to know : quality of wound healing, rate of infection and time needed for complete healing. Participants will be divided into two groups. All participants will undergo cesarean section. We will inject autologous amniotic fluid in the edges of the wound during skin closure in half of the participants. Wound healing will be assessed at 1st, 2nd and 6th week postoperatively.

After surgery, participants will be observed along 6 weeks (at 1, 2 and 6 weeks intervals) and scars will be assessed regarding color, thickness, pliability and presence of exudate.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 30 years old.
* Anemic patients
* Maternal chronic disease e.g., Diabetes and Hypertension
* BMI of \> 25 Kg/m2.
* Underwent previous CS.

Exclusion Criteria:

* Rupture of membrane.
* No previous section.
* Anhydraminos.
* Congenital malformation of the fetus.
The Effect of Phenolic Compounds in Osteoarthritis; a Nutritional Intervention

The main objective of the study is to elucidate the beneficial effect of a dietary supplement with phenolic compounds in patients with OA versus ascorbic acid.

The analysis of the data is expected to clarify the role of the new supplement as one with a positive effect on OA-related biomarkers, on functional abilities and on the quality of life of patients with OA.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic knee OA (patients with at least moderate symptoms)
* patients should be able to walk without a medical or other support device (such as a walking stick, crutches, or a kneecap).

Exclusion Criteria:

* Patients undergoing physical therapy or TENS, have rheumatoid arthritis, fibromyalgia, spinal disorders or any other disorders that according to the physician is a bias, stiffness\> 30 minutes, have scheduled knee surgery or any other programmed surgery during the trial, show WOMAC pain scale \<4 for pain overall, those with a diagnosis of kidney or liver disease, coagulation disorders, any form of cancer, HIV infection, type I diabetes, those with unregulated type II diabetes, those using illicit substances or having a history of substance or alcohol abuse over the past 2 years (or those who consume more than 2 typical alcoholic beverages / day in the present), those using corticosteroids within 2 months prior to randomization and during the trial, those who change their diet or supplementation 1 month or during the recruitment/trial, those using ascorbic acid supplement or any phytochemical-rich supplement, women on estrogen replacement therapy, during pregnancy or lactation and those judged by the researcher as unable to perceive and comply with the obligations laid down in the Protocol and for which consent and voluntary participation is sought.
Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases

Due to the limited efficacy of its treatment modalities, there is a stringent need to improve the prevention and early diagnosis of peri-implantitis. In fact, to date clinical and radiographic tools are not able to discern which patients are going to develop peri-implantitis and, among the ones already with peri-implantitis, which ones are currently loosing bone and which ones are going to progress.

This project aims to analyze for the first time the whole large scale proteome and metabolome of peri-implant crevicular fluid (PICF) with an integrated approach from implants with peri-implant diseases.

Twenty-five patients with at least one implant with peri-implant mucositis and one implant with peri-implantitis will be selected. For each of the selected participants, the PICF from an implant with peri-implant mucositis and from an implant with peri-implantitis will be sampled two different times before treatment. One year after the corresponding treatment is provided, the PICF of the treated implants with peri-implantitis will be sampled again.

Both proteomic and metabolomic profiling of the samples will be carried out. The most important strength of this project will be the ability to evaluate together the whole proteome and the whole metabolome and to integrate them in the same framework.


Eligibility Criteria:
Inclusion Criteria:

* At least one implant with peri-implant mucositis and one with peri-implantitis

Exclusion Criteria:

* Previously treated implants to be included
The Effects of Health Education in Cardiovascular Diseases Prevention and Treatment

The purpose of this study is to evaluate the effects of health education given by nurse on out-patient compliance in cardiovascular diseases prevention and treatment.


Eligibility Criteria:
Inclusion Criteria:

* first diagnosis cardiovascular disease

Exclusion Criteria:

* Severe liver and kidney disease or cancer
* Limb movement disorder
* Cognitive impairment
* History of malignant arrhythmia or severe heart failure patients have a high risk of sudden death
* Diabetes
* Cerebrovascular disease
* History of atherosclerotic disease hospital