cyrilzakka/clinical-trials huggingface dataset:
Acupuncture Therapy Combined With Breathing Training for Patients With Stroke Complicated

The goal of this prospective randomized controlled study is to explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. The intervention group and control group were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. To evaluate the clinical efficacy of both groups.

To explore the clinical efficacy of acupuncture therapy combined with breathing training in patients with stroke complicated with pulmonary infection. Using a prospective randomized controlled study, 72 patients with pulmonary infection after stroke admitted to our hospital from May 2020 to May 2021 were randomly divided into the intervention group and control group, with 36 patients in each group. Both groups were treated with conventional drug therapy, rehabilitation therapy and breathing training for 2 consecutive weeks. On this basis, the intervention group additionally received acupuncture therapy. The traditional Chinese medicine (TCM) syndrome score and clinical pulmonary infection score (CPIS) before and after treatment, time of fever relieving, time for the disappearance of cough, expectoration and moist rales in the lung, white blood cell count (WBC), serum C-reactive protein (CRP) level, calcitonin (PCT) level and pulmonary indexes were compared between the 2 groups, respectively, to evaluate clinical efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria of Western medicine for stroke complicated with pneumonia
* conforming to the TCM syndrome of vital qi deficiency and phlegm-heat obstructing the lung
* confirmed as the initial onset of stroke through CT or magnetic resonance imaging (MRI)
* clear consciousness, no cognitive impairment, and ability to cooperate with pulmonary function assessment and rehabilitation training
* willingness to participate in this study and sign the informed consent

Exclusion Criteria:

* Patients with systemic multi-organ failure such as the heart, brain, kidney, etc
* patients with a coronary metal stent or pacemaker implantation
* patients with malignant tumors
* patients with severe cognitive impairment, depression or mental disorders
* patients with pulmonary infections before stroke or caused by other causes
* patients in the acute phase of infection
Feasibility Evaluation of Magnetic Resonance Imaging and Positron Emission Tomography for Bladder Cancer Diagnosis and Staging

The purpose of this study is to to find out if the MRI and PET scans can truly stage patients with bladder cancer. Both scans use newer ways to find out if your disease has grown beyond the bladder. The radioactive tracer used for the PET scan is called C-11 Acetate. We want to see if PET scan will be able to take a picture of the inside of your body that is better than other scans such as the CT scan and MRI. Therefore, the findings of the PET scan will be compared with other imaging studies as well as the surgical findings.


Eligibility Criteria:
Inclusion Criteria:

* Thirty (30) patients will be enrolled in this pilot study.
* All patients will have a clinical or histologic diagnosis of bladder cancer with active disease identified within the bladder at the time of consent and imaging.
* Patients with primary resectable lesions, and localized or regionally extensive disease will be eligible with residual disease in the bladder at the time of imaging.
* All patients will have consented to treatment at MSKCC

Exclusion Criteria:

* Prior pelvic radiation for bladder cancer
* Non-transitional cell histologies
* Patients deemed not appropriate surgical candidates
* Patients that are pregnant or lactating
* Patients that cannot tolerate being in the PET or MRI scanner for the duration of the study. Patients deemed unable to receive a contrast enhance CT will remain eligible.
* Vulnerable patients (minors, mentally retarded, prisoners, etc.)
Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients

Melatonin may represent an effective complementary treatment to standard anticancer treatments in order to reduce asthenia, depression, sleep disturbances, cognitive impairment and performance status as part of quality of life. Moreover, melatonin has been evaluated in several clinical trials in cancer patients with no side effects. It could be particularly of interest in elderly cancer patients as they exhibit a significant deficiency of melatonin production .

The investigators propose to perform a prospective and randomized study to study the effect of a melatonin supplementation on the quality of life of elderly advanced/metastatic cancer patients (age ≥ 70) treated for a locally advanced or metastatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age \> = 70 years.
* Performance status \< = 2 (WHO criteria)
* Life expectancy \> 3months
* A patient with solid tumor locally advanced or metastatic
* Indication of systemic anticancer treatment : oral or IV chemotherapy, endocrine therapy, target therapy or immunotherapy
* MMS-orientation ≥ 7 (geriatric Mini Mental State face-to-face questionnaire)
* Able to swallow and retain oral treatment
* Patient who signed the participation consent before entering the trial
* Patient able to read, write and understand French.
* Affiliation to the french social security scheme (or beneficiary of such a scheme) under the terms of the law of 9 August 2004.

Exclusion Criteria:

* Haematological cancers
* Renal failure or hepatic failure
* Auto-immune disease
* Diagnosed neurodegenerative diseases
* Unability to fill out questionnaires
* melatonin treatment ongoing or completed for less than 3 months
* Treatment with an investigational drug, participation to another therapeutic clinical trial within \<30 days
* Hypersensitivity to melatonin or any of the excipients
* Current Treatment with fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, estrogen
* A history of known or suspected excessive alcohol use.
* Patient refusing to participate and / or unable to give informed consent
* Patient unable to complete the questionnaires even with the help of a relative or a nurse
* Patient does not have the capacity to comply with the study requirements
* Patient deprived of liberty by a court or administrative.
Oxidized Omega-3 Supplements With Different Oxidation

The oxidation level of unsaturated fatty acid supplements commercialized in capsules could be a serious problem for manufacturers and a risk to consumers; health by ingesting substances whose effects are not desired. Therefore, the main objective of this paper is to analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose the investigators have designed a single-blind, parallel-groups, randomized controlled trial. Finally, 52 women between 25 and 75 years old were randomly distributed into three groups: (1) took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, (2) took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet and (3) no capsules, only received the diet. There was a 30 days follow-up . All groups followed a low cholesterol diet. Circulating glucose, total cholesterol, triglycerides and glutamic pyruvic transaminase were determined at the beginning and end of a 30 day period.

The assignment of women to distinct groups was carried out following the classification criteria established by (NCEP, 2002), and performed by the research team. Women were randomly assigned to one of three parallel groups, in a near 1:1:1 ratio. Group 1 (n=20) took two capsules per day of less oxidized oil (containing 300 mg EPA-DHA per capsule) and diet. Group 2 (n=18) consumed two capsules per day of oxidized oil (containing 300 mg EPA-DHA per capsule) and diet. Finally, group 3 (n=19) performed the diet but did not take any capsule. Therefore, the design was a single-blind (participants did not know what type of capsule they were receiving), parallel-group, randomized controlled trial conducted at the Miguel Hernández University of Elche (Spain).

Statistical analysis was carried out using STATGRAPHICS Centurion XV software (StatPoint Technologies, Inc. Warrington, VA); likewise, significance was defined at p\<0.05. Data are reported as mean standard error of the mean (SEM). Intragroup statistical comparisons were performed using the following hypothesis tests, both parametric and non-parametric: t-test, sign test and signed rank test for paired samples. Intergroup statistical comparisons were performed using the one-way analysis of variance (ANOVA) and the Kruskal-Wallis hypothesis tests. Also, Fisher least significant difference (LSD)Multiple Range Test and Tukey HSD were used in order to determine which means were significantly different from the others.

Methods for additional analyses Generalized multiple regression was used to statistically analyse the relationships between the variations in the lipid profile and the consumption of w-3 dietary supplements.

Eligibility Criteria:
Inclusion Criteria:

* presence of dyslipemia with no indication of drug treatment
* blood cholesterol levels ranging 250-300 mg/dL
* triglycerides (TG) 160-175 mg/dL

Exclusion Criteria:

* pregnancy
* lactation
* participation in another supplementary feeding programme
Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries

The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter "VB device") for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries).


Eligibility Criteria:
Patients with traumatic or iatrogenic vessel injuries in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries ) with a reference vessel diameter ranging from 4.0 to 12.0mm.
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis

This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women with demonstrated Coronary Disease
* AtheroAbzyme positive during screening process
* Elevated Total Cholesterol
* Willingness to take study nutritional supplement once a day for 3 months

Exclusion Criteria:

* Women who are pregnant, nursing or intend pregnancy during the period of treatment
* Known milk, soy or whey allergy
Voice Analysis as a Predictor for Difficult Intubations

To investigate if signal processing can detect subtle changes in speech production clinically relevant to oropharynx anatomy that may provide an objective measure in the assessment of the presumed difficulty of intubation.

The purpose of this study is to investigate whether changes in phonation (sounds coming from vocal cords that occur when a person speaks) can be used as a reliable measure to predict airways that may be difficult to manage in the operating room.

One of the reasons the Preoperative Surgical Assessment (PSE) is performed is to assess subjects for signs of a difficult airway. At this time, none of the assessments have proven to be both highly sensitive and specific. Multiple studies have shown that specific characteristics of a subject's speech can suggest that they may have an issue with the anatomy of the oropharynx (the area consisting of the back of the throat to the vocal cords). Prior research has shown that studying velar vowel sounds, those vowels that require the use of the back of the tongue to pronounce, can be used to predict a disorder called obstructive sleep apnea (a disease associated with difficulty breathing).

The Investigators are trying to determine whether the development of a simple voice study conducted during the PSE visit could alert the Anesthesiologist caring for the subject in the operating room to use the extra precautions provided for people who have a documented history of a difficult airway. It is hoped that the voice analysis test being developed in this study will have the ability to objectively predict a difficult airway for future patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to provide informed consent
* A known documented history of having a difficult airway
* An age-matched control subject with normal airways.

Exclusion Criteria:

* Unable to consent for themselves
* Non-English speaking subjects
* Pregnant Subjects
* Previous Vocal Cord Surgery
* Previous Head and neck surgery that would alter anatomy of hypopharynx

We will not include:

* Prisoners
* Pregnant women
* Individuals who are not yet adults (infants, children, teenagers)
* Adults unable to consent
* Adults who cannot speak English We will not be enrolling subjects who cannot speak English. The subjects must be able to understand the research team member who is testing them as well as the research paradigm.
Dalfampridine and Gait in Spinocerebellar Ataxias

Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions for patients with spinocerebellar ataxia.

Twenty spinocerebellar ataxia patients will be randomized to receive either Dalfampridine or placebo over a total period of 10 weeks. After entering the study, patients will return every 2 weeks for evaluation. After four weeks, intervention will be stopped and patient will enter a 2-week wash out period where they do not take any drug. Then, patients will be given the opposite treatment (Dalfampridine or placebo) and this "crossover" study will be performed for another 4 weeks. Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions.

Eligibility Criteria:
Inclusion Criteria:

* Individuals at age 18 years or older.
* Individuals who can provide the informed consent
* Genetic confirmed definite spinocerebellar ataxias (SCA)
* Able to complete two trials of the timed 25-foot walk at screening

Exclusion Criteria:

* Patients who has severe ataxia and unable to ambulate.
* Any orthopedic condition that would affect motor performance.
* Patients with secondary ataxia from general medical disorders
* Individuals who have major psychiatric disorders that prevents compliance
* History of epilepsy
* Patients with active drug or alcohol use or dependence that would interfere with adherence to study requirements
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

Elderly patients are vulnerable to postoperative complications. Preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. This study aims to investigate the feasibility and efficacy of perioperative oral decontamination and immunonutrition supplement on reducing postoperative complications in elderly surgical patients.

This study is a prospective, single center, two-by-two factorial randomized controlled trial to evaluate the feasibility and efficacy of perioperative oral chlorhexidine decontamination and immunonutrition supplementation on postoperative complications in elderly surgical patients. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited and randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care with/without immunonutrition supplementation).

Eligibility Criteria:
Inclusion Criteria:

1. age≥65 years;
2. undergoing non-cardiac surgery (expected duration \>2 hours);
3. scheduled for general anesthesia and endotracheal intubation;
4. ASA classification I-IV;
5. with intermediate to high risk of respiratory complications assessed by ARISCAT score (Assess Respiratory Risk in Surgical Patients in Catalonia);
6. inform consent obtained

Exclusion Criteria:

1. emergency surgery;
2. preoperative pneumonia;
3. allergic to chlorhexidine;
4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
5. expected intervention of immunonutrition\<3 days.
Mindfulness-based Intervention in COPD Dyads

This study evaluates the effectiveness of a Mindfulness-Based Stress Reduction intervention (MBSRI) on the reduction of stress, anxiety, and depression in people with COPD and their family caregivers. The experimental group will receive the MBSRI and the control group an informational intervention on stress management.

People affected by Chronic Obstructive Pulmonary Disease (COPD) and their family caregivers (named dyads) often suffer from psychological distress, because of the physical problems and social isolation imposed by the disease. Such psychological distress can influence the ability of patients and caregivers to manage the disease. Mindfulness-based interventions have showed benefits in improving the psychological status in various clinical situations. A 8-week mindfulness based-stress reduction intervention will be offered to a group of COPD patient-caregiver dyads and its effectiveness will be assessed comparing the effects on a control group to whom an informational intervention on stress reduction will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Persons able to read and understand Italian.
* people affected by COPD stage C (GOLD 3 o 4, and/or 2 or more exacerbations per year or 1 or more hospitalizations for exacerbations and score of COPD assessment test-CAT \< 10 or mMRC 0-1).
* People affected by COPD stage D (GOLD 3 o 4, and/or 2 or more exacerbations per year or 1 or more hospitalizations for exacerbations and score of COPD assessment test-CAT ≥ 10 or mMRC ≥ 2).

Exclusion Criteria:

* Persons or dyads not able to guarantee the presence on the MBSR intervention sessions for the four months requested.
* Persons with diagnosis of anxiety or depression.
* Persons that have practiced before or actually practice yoga or mindfulness.
* Persons with cognitive impairment.
* Persons under continuous oxygen therapy.
* Persons with diagnosis of cancer or other terminal diseases or any psychiatric problem.
The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery

Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.

The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for primary total hip replacement,
* Between 55 and 85 years of age,
* ASA 1-3 and BMI between 18 and 35.

Exclusion Criteria:

Patients who are:

* Unable to cooperate
* Does not speak Danish
* Has allergy for drugs used in the trial
* Drug or alcohol abuse
* Epilepsy
* Medically treated diabetes
* Known kidney disease
* Daily use of analgetics
* Apart from NSAID
* Paracetamol or COX2 inhibitors
* Are treated with a antidepressive.
Effect of rTMS of the Cerebellum on Parkinson's Disease

The goal of this clinical trial is to learn about the efficacy of low-frequency rTMS of the cerebellum in Parkinson's disease.

The main question it aims to answer is: how to improve Parkinson's disease by rTMS.

Participants will be treated with active low-frequency rTMS/sham rTMS over the cerebellum and receive: 1) resting state functional magnetic resonance imaging (fMRI), 2) blood sampling, and 3) Unified Parkinson Disease Rating Scale (UPDRS) before and after the treatment course.

Researchers will compare the data collected from fMRI scan, blood sample analysis, and UPDRS rating between the active rTMS group and sham controls before and after the treatment to see if there are meliorating effects of rTMS on Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Parkinson's disease according to the clinical diagnostic criteria for Parkinson's disease (2015 edition) by the Movement Disorder Society (MDS)
2. Citizens of the People's Republic of China of either sex, aged between 40 and 80 years.
3. Able to give informed consent and follow the research plan.
4. Hoehn-Yahr (H-Y) stage ≤ 3
5. Patients received a Parkinson's stable medication before treatment (assessed via self report), which continued during treatment.

Exclusion Criteria:

1. History or diagnosis of severe psychiatric disorders, such as depression, anxiety disorders, schizophrenia spectrum disorders, and bipolar disorders.
2. Subjects with a clinically defined neurological disorder (assessed via self report) including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, history of stroke, transient ischemic attack within two years, cerebral aneurysm, dementia, multiple sclerosis.
3. Significant cognitive disorders (Mini-Mental State Exam (MMSE)\<24 points) or unable to complete the questionnaire independently.
4. Intracranial implants, such as cochlear implants, aneurysms clips, shunts, stimulators, electrodes, cardiac pacemakers and vagus nerve stimulation devices.
5. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold (assess via self report).
6. Showed significant discomfort after receiving the rTMS treatment.
7. Participated in other clinical trials.
8. Inability to read or understand Chinese.
Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.


Eligibility Criteria:
Inclusion Criteria:

* subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (PDAC)
* subject must have adequate renal function
* ECOG performance status of 0-2
* women of child-bearing age and men must agree to use contraception prior to and during the study

Exclusion Criteria:

* subjects receiving any other investigational agents
* significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
* pregnant or breastfeeding women