cyrilzakka/clinical-trials huggingface dataset:
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

PURPOSE: Randomized phase 2 trial to compare the effectiveness of chemo-radiation therapy (RT + cisplatin + 5-FU) with or without tirapazamine for the treatment of patients with stage III or IV squamous cell carcinomas of the head and neck cancer (SCCHN).

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells.

Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy.

Subjects were stratified according to pO2 values (high vs low), and randomized to 1 of 2 treatment arms, differing by the addition of tirapazamine to the therapeutic regimen. Treatment consists of two 21-day cycles of induction chemotherapy, followed by radiotherapy (RT).

Induction chemotherapy was cisplatin 100 mg/m2 per day administered over 4 hours on Study Days 1 and 22 (ie, 1st day of both induction cycles) with continuous infusion (CI) 5-FU at a dose of 1000 mg/m2 per day for 120 hours per cycle starting on Study Days 1 and 22 (ie, days 1 to 5 of both induction cycles).

Patients who achieve at least partial response proceeded to chemoradiotherapy (CRT) consisting of localized RT + cisplatin IV + 5-FU +/- tirapazamine. Location of RT was based on whether the site had a CR or PR. Radiotherapy began on day 43 (week 1), and continued for 5.5 weeks. Subjects with no response or progressive disease proceeded to salvage surgery.

A total of 63 patients were accrued for this study over approximately 5 years. 1 subject withdrew consent prior to treatment for personal reasons.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Biopsy proven squamous cell carcinoma of the following head and neck sites:

Hypopharynx Oral cavity Larynx Oropharynx Nasal cavity Unknown primary Paranasal sinus

Histologically proven poorly-differentiated carcinoma of the following head and neck sites:

Hypopharynx Oral cavity Larynx Oropharynx Nasal cavity Paranasal sinus Stage III/IV (T0-4 N1-3 M0-2) disease

PATIENT CHARACTERISTICS:

WBC at least 3,000/mm3 Bilirubin no greater than 2.0 mg/dL AST no greater than 100 U/L Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min (patients in Group N2-N3) No second malignancy within 5 years except curatively treated nonmelanomatous skin carcinoma No prior RT or chemotherapy, except prior radiotherapy to primary tumor allowed Not pregnant or nursing. Negative pregnancy test required Effective contraception required of fertile women Subjects with unknown primary cancers who had metastatic cervical lymph nodes are eligible Signed informed consent previously approved by the Institutional Review Board.
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS

VAP（Ventilator-associated pneumonia）is the most common complication of mechanical ventilation in severely ill patients. VAP is defined as pneumonia occurring 48 hours after patients receive mechanical ventilation, including pneumonia occurring within 48 hours after extubation. It is one of the important causes of hospital-acquired infection, and the incidence of VAP in children on mechanical ventilation is about 10%, or 7/1000 days of mechanical ventilation, and the overall mortality is 10-24%.Research has so far explained the relationship between bacteria isolated from human biological samples and VAP pathogens. Most studies are limited to the level of bacterial species, and there are few reports on bacterial genotyping, and there is a lack of scientific basis for the pathogenesis of VAP caused by bacteria in ventilator pipeline. The aim of the study is to investigate pathogen of the sputum in deep respiratory tract of patients with mechanical ventilation in PICU by the means of second generation sequencing (NGS).

Children receiving invasive mechanical ventilation in the intensive care unit (PICU) of the Pediatric Hospital of Fudan University will be included. Deep sputum samples were collected within 24 h and on day 5 of mechanical ventilation, respectively, and sent for NGS at the same time. Sputum etiology examination is performed with sputum culture blood free DNA test.

The basic clinical data of the children (age, sex, weight, PICU diagnosis and other basic information, as well as the time of start and end of invasive mechanical ventilation for basic diseases, Glasgow coma score (GCS score), 3rd generation pediatric mortality risk score III(Prism III score), CRP, PCT, white blood cell count and body temperature will be recorded。 Clinical data related to the use of glucocorticoids, antibiotics and other drugs as well as life support such as renal replacement therapy, extracorporeal membrane, lung oxygenation and other life support were collected. Time and method of diagnosis of VAP pathogens were collected.

By comparing sensitivity and specificity of NGS and conventional sputum specimens for detection of VAP, the clinical value of mNGS in VAP will be studied.

Eligibility Criteria:
Inclusion Criteria:

* The time of invasive mechanical ventilation was less than 24 h when admitted to PICU Total duration of invasive mechanical ventilation is over 5 days

Exclusion Criteria:

* Participants in other clinical trials in the same period No Informed Consent signed
Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System

Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use in general, gynaecological and thoracic surgical procedures.

The trial was designed using a prospective, multi-centre, single-group target value approach.

For subjects who intend to undergo general surgery, gynaecological surgery and thoracic surgery assisted by the Thoracic and Abdominal Endoscopic Surgical System.

To use the Thoracic and Abdominal Endoscopic Surgical System developed by Shenzhen Cornerstone Robotics Technology Co., Ltd. to perform surgery in the above three disciplines, and to evaluate the efficacy and safety of the experimental medical device in the surgical treatment of the above three disciplines.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years;
* Body Mass Height Index (BMI) 18\<BMI\<30kg/㎡;
* Patients identified by the investigator as suitable for general, gynaecological and thoracic surgery;
* Written informed consent.

Exclusion Criteria:

* Need for emergency surgery (e.g. gastric cancer, colorectal cancer combined with perforation, bleeding, obstruction, etc.);
* With other malignancies or a previous history of other malignancies.
* Preoperative imaging suggests that the tumour has distant metastases.
* The patient has a history of relevant surgery or previous history of other malignancy and is judged by the investigator to be unsuitable for enrolment.
* Severe bleeding tendencies or coagulopathic disorders.
* With long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders.
* Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids).
* Women who are pregnant or nursing an infant.
* With severe allergies and suspected or established alcohol, drug or substance addiction.
* Other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.
Ozonated Water in Treatment of Denture Stomatitis

The effect of Ozonated water on the treatment of oral stomatitis associated with complete denture wearer in comparison to Chlorhexidine mouthwash

Compete denture wearers having oral denture stomatitis were divided into two groups. group I used Ozonated water while group II used Chlorhexidine mouthwash. The growth of Candida albicans, the degree inflammation and pain grade were evaluated before starting the treatment then every week till one month. Also

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous male patients wearing heat cured acrylic resin removable prosthesis.
* Patients having denture associated oral stomatitis.
* Healthy patients free of any systemic diseases.

Exclusion Criteria:

* Smoker patients.
* Patients suffering from any auto immune or systemic diseases, Temporo-mandibular joint disorder ( TMJ disorders and parafunctional oral habits.
* Patients with a history of radiotherapy or chemotherapy.
* Patients having oral lesions.
Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome

The purpose of this is study is to evaluate the long-term safety of DCCR (diazoxide choline) extended-release tablets) in patients with Prader-Willi syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (subjects, as appropriate)
2. Participant must:

   1. Have participated in and completed the Study C602 Randomized Withdrawal (RW) Period;
   2. Have participated in but discontinued from the Study C602 RW Period and at least 16 weeks have elapsed since the date of their randomization into the C602 RW Period; or
   3. Have participated in Study C602 OLE period, did not consent to participate in the RW Period, and at least 16 weeks have elapsed since the date of their C602 Open-Label Extension End of Treatment Visit.

Exclusion Criteria:

1. Positive urine pregnancy test (in females of child-bearing potential)
2. Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation.
3. Participation in a clinical study of an investigational drug (including approved drugs for unapproved uses), investigational device, or therapeutic intervention subsequent to the C602 Open-Label Extension End of Treatment Visit.
Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease

The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* idiopathic Parkinson's disease.
* eligible to Azilect® treatment as per Canadian product monograph

Exclusion Criteria:

* exclusion (e.g. drug-drug interactions, contraindications, warnings and precautions) based on the Canadian product monograph.
* investigational drug within 30 days prior to study
* use of Azilect® or selegiline within 60 days prior to study
* significant medical condition
Effects of Physical Exercise on Sarcopenia After Bariatric Surgery

The study will include 60 patients awaiting bariatric surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity and sedentary behavior will be determined

Bariatric surgery is the treatment of severe obesity with associated pathologies, with proven evidence in its benefits. Treating overweight allows a better and even reversal of pathologies associated with obesity. In this context, we know that physical exercise is important in the process of weight loss, however, and especially in bariatric surgery, the characteristics of physical activity are not consensual, as well as the effect of programs and physical exercise in this population. Weight loss associated with bariatric surgery is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, which leads us to induce that after bariatric surgery, patients incur an increased risk of sarcopenia. The need for prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the framing of long-term surgical success of bariatric and metabolic surgery. This randomized clinical trial will aim to study the effects of a 16-week supervised exercise intervention program on the prevention of sarcopenia after bariatric surgery This randomized controlled trial study will include 60 patients of both sexes on the waiting list for bariatric surgery and who have subsequently performed the surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity, and sedentary behavior will be determined.

Assessments will take place in five moments, the surgery, the intervention, the post-intervention, six months after the intervention, twelve months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital
* Aged between 18 years and 60 years
* Contraindication to the practice of exercise
* Agree to participate in the study

Exclusion Criteria:

* Patients with problems in locomotion
* Surgical complications
* Psychiatric diseases and neurological disorders
Measuring Temperatures of Tissues During Endoscopy

Previous studies have indicated that tumors are warmer than the surrounding tissues. We want to ascertain that this is true for tumors in the GI tract. If so, a thermal camera in an endoscope may aid the diagnosis of tumors. The experiment entails inserting a cannula sheathed thermocouple into the work canal of an endoscope or a colonoscope. The examining physician will bring the distal end to touch the tumors he finds and their adjacent tissues, noting their respective temperatures. This experiment must be conducted before embarking on the complicated and costly project of producing a tiny thermal camera which will be able to navigate the GI tract.


Eligibility Criteria:
Inclusion Criteria:

* consenting adults

Exclusion Criteria:

* none
Hypothermia Risk With Continuous Renal Replacement Therapy

The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during continuous renal replacement therapy as compared to the Prismaflo IIS blood warmer used for the PrismaFlex system.

Blood warming devices during continuous renal replacement therapy (CRRT) have not been adequately tested.

The novel TherMax blood warmer for the newly introduced PrisMax System heats blood and replacement solutions via a dry heat plate system. In contrast, the PRISMAFLO IIS Blood Warmer for PRISMAFLEX System uses an electric heating sleeve on a standard CRRT filter set.

Data on adverse events (AE) during continuous renal replacement therapy (CRRT) has been studied and one of the most common AE was hypothermia, reported in 44% of all cases.

The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during CRRT as compared to the blood warmer used for the PrismaFlex system.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18-100 years) critically ill patients treated with CRRT.

Exclusion Criteria:

* Patients under 18 years of age. Non-RRT patients.
Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors.

The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.

This is a prospective, Phase II, single center, open-label study in a total of 200 participants with histologically proven neuroendocrine tumor or other somatostatin receptor positive tumors. Eligible participants will undergo baseline assessments at enrollment. They will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age ≥ 6 months
3. Histologically diagnosed neuroendocrine tumor or other tumor with probable somatostatin receptors subtype 2
4. Karnofsky performance status or Lansky Play Scale status of ≥ 60 (or ECOG/WHO equivalent)
5. Subject is male; or is a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (\> 1 years without menses), ≥60 years old,or of childbearing potential for whom a pregnancy test (with the results known prior to investigational product administration) is negative. A negative pregnancy test will be required for all female subjects with child bearing potential. If a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is not capable of becoming pregnant. Female must also be non-lactating.

Exclusion Criteria:

1. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not be able to fit inside the imaging machines) or otherwise cannot be safely fit into the imaging system.
2. Inability to lie still for the entire imaging time (due to cough, severe arthritis, etc.)
3. Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
4. Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
5. Peptide receptor radionuclide therapy (PRRT) within 4 weeks of Ga-68 DOTATOC PET/CT scan.
6. Treatment with Sandostatin LAR within 4 weeks, SQ Octreotide within 12 hours, or Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%).
Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing

It is common practice to carry out the therapy of periodontal diseases in two phases. In a first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are removed using a cleaning method called "scaling and root planing" (SRP). After three to six months the case is evaluated and, if necessary, further treatment is provided, usually taking a more aggressive, surgical approach. Beneficial effects of adjunctive systemic antibiotics on clinical outcomes have been shown repeatedly but specific indications for antibiotics in subgroups of diseased patients, and the optimal timing of antimicrobial therapy, continue to be issues of a long lasting controversy.This study assessed the differential outcomes of periodontal therapy supplemented with amoxicillin-metronidazole during either the non-surgical or the surgical treatment phase.

Single center, randomized placebo controlled crossover clinical trial with a one-year follow-up. Eighty participants with Aggregatibacter actinomycetemcomitans-associated chronic or aggressive periodontitis were randomized into two treatment groups. A: Antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase of periodontal therapy (T1), and placebo during the second, surgical phase (T2). B: Placebo during T1, and antibiotics during T2. Persistence of sites with a probing depth (PD) \>4 mm and bleeding on probing (BOP) was the primary outcome. Evaluations were made three months after T1, as well as 6 and 12 months after T2.

Eligibility Criteria:
Inclusion Criteria:

* Untreated moderate to advanced periodontitis (at least 4 teeth with a probing pocket depth (PD) \>4 mm, clinical attachment loss of at least 2 mm and radiographic evidence of bone loss)
* Presence of at least 12 scorable teeth (not including 3rd molars, teeth with orthodontic appliances, bridges, crowns or implants)
* Aggregatibacter actinomycetemcomitans-positive

Exclusion Criteria:

* Systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy)
* Pregnancy or lactation
* Systemic antibiotics taken within the previous two months
* Use of non-steroid anti-inflammatory drugs
* Confirmed or suspected intolerance to 5-nitroimidazole-derivatives or amoxicillin subgingival SRP or surgical periodontal therapy in the last year
AgingPLUS: Promoting Physical Activity in Adults

This study examines the efficacy of a psycho-educational intervention program, AgingPLUS, with regard to increasing middle-aged and older adults' engagement in physical activity.

AgingPLUS is a multi-component intervention program that addresses negative views of aging (NVOA), low internal control beliefs, and deficient goal planning as a risk cluster that keeps adults from engaging in health-promoting behavior. The program focuses on engagement in physical activity (PA) as the health behavior of choice. Engagement in PA is widely recognized as the best non-pharmacological, non-invasive, and cost-effective method of health promotion. Yet, only 20% of the adult population meets the recommended PA guidelines. This suggests that messages about the benefits of PA alone are not effective. Rather, it is essential to address the social-cognitive and motiva-tional mechanisms that prevent adults from adopting and maintaining a regular PA regimen. NVOA, low internal control beliefs, and deficient goal planning represent such a cluster of social-cognitive and motivational mechanisms.

Given this background, the specific aims and hypotheses of the proposed research are:

Aim 1: To conduct a randomized controlled trial examining the efficacy of the AgingPLUS program.

Aim 2: To test a conceptual model of the mechanisms underlying the intervention effects.

Aim 3: To conduct a 6-month follow-up to examine the longer-term effects of AgingPLUS.

Upon completion of this project, we expect to have successfully established evidence for the efficacy of the AgingPLUS program (Stage II of the NIH Stage Mode). The long-term goal is to develop AgingPLUS into a full-fledged evidence-based program that can be implemented in community settings (e.g., senior centers), and can serve as a fairly brief and cost-effective public health tool to promote healthy and successful aging.

Eligibility Criteria:
Inclusion Criteria:

* Adults who engage in less than 60 minutes of PA per week and who intend starting a physical exercise program.
* English speaking.
* Willingness to be randomized to one of two programs.
* Willingness to take part in the physical fitness tests and wear an accelerometer.
* Willingness to commit to follow-up testing (i.e., not moving out of the area during the study period).
* Physician clearance to take part in a submaximal exercise test and to begin an exercise program.

Exclusion Criteria:

* Signs of cognitive decline (defined as more than 4 errors on the Short Portable Mental Status Questionnaire).
* Severe vision and/or hearing loss (obtained by self-report).
* Serious problems with mobility.
* A history of neurological, mental, or substance abuse disorders.