cyrilzakka/clinical-trials huggingface dataset:
Local Anesthetic Nebulization for Pain Control After Laparoscopic Cholecystectomy

Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopy. Preoperative compared with postoperative administration of analgesia remains controversial. This randomized, double blind, placebo-controlled trial compared the analgesic efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients undergoing elective laparoscopic cholecystectomy.

Previous studies evaluating intraperitoneal local anesthetic administration for pain relief after laparoscopic surgery have suggested that the timing of local anesthetic administration may be critical in the success of the technique. A meta-analysis of randomized trials of intraperitoneal local anesthetic instillation in patients undergoing laparoscopic surgery found that local anesthetic instilled before surgical dissection provided superior pain relief compared to instillation at the end of surgery. Intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopic surgery. Recently, Alkhamesi et al reported that bupivacaine nebulization performed at the end of laparoscopic cholecystectomy significantly reduced postoperative pain. However, clinical benefits of preoperative administration of analgesia, compared with postoperative administration, remains controversial.

The investigators hypothesized that pain relief after preoperative and postoperative ropivacaine nebulization would be similar but better than placebo.

Eligibility Criteria:
Inclusion Criteria:

* ASA Score I-III
* Scheduled for laparoscopic cholecystectomy
* Free from pain in preoperative period
* Not using analgesic drugs before surgery
* Without cognitive impairment or mental retardation
* Written informed consent

Exclusion Criteria:

* Emergency/urgency surgery
* Postoperative admission in an intensive care unit
* Cognitive impairment or mental retardation
* Progressive degenerative diseases of the CNS
* Seizures or chronic therapy with antiepileptic drugs
* Severe hepatic or renal impairment
* Pregnancy or lactation
* Allergy to one of the specific drugs under study
* Acute infection or inflammatory chronic disease
* Alcohol or drug addiction
Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are currently on treatment with any of the following diuretics

   * Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
   * Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
   * Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose
2. Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
3. Subjects who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion Criteria:

1. Subjects with acute heart failure
2. Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
3. Subjects who are unable to sense thirst or who have difficulty with fluid intake
Effect of Intraabdominal Hypopressive Exercises on Postnatal Backache and Functional Disability

The purpose of this study was to evaluate the effectiveness of hypopressive exercise in postpartum females with abnormal hyperlordosis and back pain.

Hypopressive exercises are safe and beneficial for new moms, as they can be started soon after delivery. They help strengthen postural muscles, reduce back pain, and manage pain by reducing intra-abdominal pressure, increasing activity of postural musculature, and normalizing myofascial tension.

38 postpartum women with abnormal hyperlordosis. The women were then divided into two equal groups. Group A(n=19) received hypopressive abdominal exercise along with traditional treatment for lower back pain (LBP), while Group B(n=19) received the same treatment without hypopressive exercise. The main outcomes measured were the the Revised Short McGill Pain Questionnaire Version-2, the lumbar lordotic angle, and the patient-specific functional scale.

Eligibility Criteria:
Inclusion Criteria:

- participants must have a healthy pregnancy, a typical vaginal birth, LBP that existed 24 weeks after giving birth, and functional limitations in daily activities. The study only allowed women aged 20-35 with no more than two prior pregnancies and a BMI of less than 25 kg/m2 to participate.

Exclusion Criteria:

* women who under pharmacological or psychological treatment, had pelvic tumors, lumbar disk herniation, heart disease, hypertension, lumbar spine tumors, chronic uterine prolapse, chronic pelvic pain, lumbar spondylosis, or lumbar spondylolisthesis.
Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study.

Invasive tracheobronchial aspergillosis (ITBA) is an uncommon, but severe clinical form of Invasive Pulmonary Aspergillosis (IPA) in which the fungal infection is entirely or predominantly confined to the tracheobronchial tree. In view of the limited data concerning critically ill patients admitted to the intensive care unit (ICU) with severe influenza associated with ITBA, the investigators decided to evaluate the differences between the clinical presentations of two invasive infections: ITBA and IPA without tracheobronchial involvement (No ITBA).

Invasive pulmonary aspergillosis (IPA) is a well-known complication in severely immunocompromised hosts patients. Recent evidence has identified others populations at risk for IPA, including those with chronic obstructive pulmonary disease (COPD) and advanced cirrhosis patients in intensive care units (ICUs). Moreover, Recently influenza has been identified as a new independent risk factor for IPA and IPA was described as an early complication of influenza. IPA groups different clinical presentations: the classical angio-invasive, the broncho-invasive form and the invasive tracheobronchitis aspergillosis form (ITBA).

ITBA is an infrequent clinical form of IPA with often a fatal outcome, in which Aspergillus infection involves entirely or predominantly the tracheobronchial tree. Early diagnosis of ITBA is based on bronchoscopy examination. Severe influenza is a life-threatening condition where IPA has been repeatedly reported. Little is known on severe influenza infection complicated with IPA and still less with ITBA. Current data on ITBA in critically ill patients hospitalized for severe influenza infection has only been described in single case reports. Because ITBA has been associated with a poorer prognostic than other forms of IPA, this retrospective study aimed to analyze diagnostic and prognostic differences between ITBA and IPA without tracheobronchial lesions, in critically ill patients with influenza infection hospitalized in ICU.

Eligibility Criteria:
Inclusion Criteria:

* all ICU (Intensive care unit) patients
* patients aged from 18 years and more
* All patients hospitalized in ICU with a positive influenza RT-PCR extracted from the registry of the local virology department
* patients with a diagnosis of influenza confirmed by a positive influenza real time polymerase chain reaction (RT-PCR) from nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid, with a concomitant diagnosis of proven or probable/putative IPA and the performing of a bronchoscopy

Exclusion Criteria:

* minor or adult with guardianship
* absence of hospitalization in intensive care
* influenza infection not confirmed by PCR
Sequential Treatment of Hepatocellular Carcinoma by Transarterial Chemoembolization and Local Ablation or External Radiation

Hepatocellular carcinoma (HCC) can present itself in many forms (size, number of lesions) for the treatment of which a therapeutic panel can be elaborated and layered. If a curative treatment cannot be considered in case of an HCC classified in an intermediate stage, a Transcatheter Arterial Chemoembolization (TACE) can be proposed. In case of a partial response or the treatment of some lesions of a multifocal HCC, a combined treatment by stereotaxic radiotherapy (CK), radiofrequency ablation (RFA) or microwave ablation (MWA) may be initiated in accordance with a decision of the multidisciplinary consultation meeting.

The aim of this study was to evaluate the clinical outcome of HCC receiving MWA, RFA or CK after downstaging with TACE.


Eligibility Criteria:
Inclusion Criteria:

* a HCC treated by TACE followed by RFA, MWA and/or CK
* from 01/2010 to 12/2020
* treated by Nancy Regional University Hospital (TACE, RFA, MWA) and Institut de Cancérologie de Lorraine (CK)

Exclusion Criteria:

* Combined treatment over one year following the last TACE
* No baseline, in between or after combined treatment imaging
* Lesion appeared after TACE treatment
The Role of DLOTCA-G in the Cognitive Function Evaluation of Parkinson's Patients

The purpose of this study is to evaluate the usefulness of Dynamic Loewenstein's Occupational Therapy and Cognitive Assessment Scale for Geriatrics (DLOTCA-G) in parkinson patients.

The purpose of this study to evaluate the usefulness of Dynamic Loewenstein's Occupational Therapy and Cognitive Assessment Scale for Geriatrics (DLOTCA-G) in the early detection of cognitive impairment in parkinson patients aged 65 and over, with and without dementia.The investigators also aimed to compare the Mini Mental State Assessment Test with DLOTCA-G.

Eligibility Criteria:
Inclusıon Criteria

* Parkinson's patients aged 65 years and older with and without cognitive impairment (60 patients) and healthy control patients (30 patients)
* Hoehnn Yahr Staging between 1 and 2.5 in patients with Parkinson's diseas
* Confirmed by brain MRI from patients without vascular dementia who routinely attend the Parkinson's follow-up outpatient clinic
* At least primary school graduates
* In patients with Parkinson's dissease patients with cognitive impairment, MMSE below 20 in primary school education level; below 24 in secondary, high school and university education level
* In patients with Parkinson's disease without cognitive impairment, MMSE 20 and above in primary school education level; 24 and above in secondary, high school and university education level Exclusıon Criteria
* Preexisting cognitive impairment
* Psychiatric disorders such as psychotic disorders, mood disorders, alcohol or drug abuse
* Severe language dysfunction and/or bilateral limb motor dysfunction and inability to participate in clinical psychology tests, severe visual and/or auditory impairments
* Patients with significant cerebral atrophy or neurological vascular lesions
* The Geriatric Depression Scale was administered to all participants, and participants with a total score of 13 or more out of 30 points were excluded from the study.
Exploit the Neural Source and the Feasibility of Transcranial Direct Current Stimulation for Freezing of Gait in Parkinson's Disease and Multiple System Atrophy

In this project, the investigators will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the leg motor cortex of the FOG patients to examine whether the intervention will benefit the patients in a double blind randomized design. Six assessments with different combinations of clinical scaling, gait analysis, electrophysiological investigation and fMRI examinations before and after tDCS will be conducted. The treatment and placebo groups will be crossed over after one-month washout. The investigators will investigate whether the possible tDCS beneficial effect will be different or similar in patients with different electric sources. In addition, how long the possible beneficial effect of tDCS can be consolidated after the 5-day course of stimulation is also crucial. The investigators aim to peep the myth of FOG in PD and MSA by the multi-modality approach and hope the study will benefit the long suffering patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients meet the diagnosis of PD41 or MSA43 based on the established consensus criteria
2. Age above 30 years old and below 85 years

Exclusion Criteria:

1. Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations
2. Functional III or above congestive heart failure, or cancer with distant metastasis
3. Hoehn and Yahr stage 5 in PD or MSA
Constitution of a Prospective Cohort of Patients With Acute Suppurative Hidrosadenitis Followed in the Great West: the COVER Cohort (Verneuil Cohort)

Our primary objective with this cohort will be to define the different phenotypes of acute hidrosadenitis, the characterization of which is essential to define suitable therapeutic approaches. Indeed, our recent data allow us to note that there would be different phenotypes of acute hidrosadenitis and therefore different pathologies inducing different follow-ups and care.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with acute hidrosadenitis by a dermatologist
* Patient agreeing to be part of the study

Exclusion Criteria:

* No affiliation to a social security scheme
* Major under guardianship
* Protected persons
Quadratus Lumborum Block Versus Transversus Abdominus Plane Block for Pain Management After Donor Nephrectomy

To evaluate quadratus lumborum block effect on post operative pain scores during the first 24 hours after surgery as compared to transversus abdominis plane block after laparoscopic donor nephrectomy patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic assisted donor nephrectomy
* Patients that have elected to have a nerve block
* 18 years of age or older
* Patients of ASA status I - III

Exclusion Criteria:

* Chronic pain or narcotic usage during the preceding 30 days
* Infection at or near the intended needle insertion site
* Complex or altered abdominal wall anatomy
* Weight \<45kg
Improving Physical, Mental, and Spiritual Health in Faith-Based Settings Through Creating a Healthy Culture in Bronx, NY

The proposed study "Improving Physical, Mental, and Spiritual Health in Faith- Based Settings through Creating a Healthy Culture in Bronx, NY" aims to assess the efficacy of a holistic health intervention that seeks to integrate physical, mental, spiritual, and community engagement processes into faith-based settings, compared to usual care in Bronx, NY. Briefly, the intervention involves a seven-session faith-based small group education program conducted by trained lay educators. A health ministry at each partner religious institution will be developed and sustained

The purpose of this research study is test a holistic health intervention that combines physical, mental, spiritual, and community processes into faith-based settings in Bronx, NY. The program involves a seven-session faith-based small group education sessions to be conducted by lay educators.

Eligibility Criteria:
Intervention study participants

Inclusion Criteria:

* Age 18 and over
* Self-identify as a member of the religious institution for at least three months
* Able to read and speak in English, Vietnamese, or Khmer

Exclusion Criteria:

* Any serious health issue that may interfere with the study procedures

Key informants participants

Inclusion Criteria:

* Age 18 and over
* Must be a study implementation partner, a health ministry member, or lay educator

Exclusion Criteria:

* None

Focus group participants

Inclusion Criteria:

* Must be a participant in the intervention
* Attended at least 3 out of the 7 group education sessions as an intervention participant;

Exclusion Criteria:

* None
Effect of Dexmedetomidine on Perioperative Internal Environment and Rehabilitation of Patients Undergoing Gastrointestinal Malignant Tumor Resection

Dexmedetomidine is a highly selective alpha2-adrenergic receptor agonist with sedative, analgesic, anti-anxiety, and inhibitory sympathetic nerve excitation properties. It is commonly used in clinical anesthesia and intensive care.Radical gastrectomy for gastrointestinal malignant tumors is a common major operation in clinical practice, with long operation time, great trauma and strong stress response of patients. Dexmedetomidine is often used in general anesthesia during such operations, but its long-term use or large dose may produce certain side effects.Common side effects of dexmedetomidine include bradycardia and hypotension, etc. Previous studies have reported that dexmedetomidine can prolong QT interval and is at risk of causing tip torsion type ventricular tachycardia.Abnormal Potassium may affect myocardial repolarization and increase the risk of tip torsion ventricular tachycardia.The main purpose of this study was to observe the effects of long-term use of dexmedetomidine on perioperative internal environment such as electrolyte and rehabilitation indicators during radical general anesthesia for gastrointestinal malignancy, and the secondary purpose was to explore the optimal dose of dexmedetomidine for general anesthesia for patients undergoing radical general anesthesia for gastrointestinal malignancy.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I or II;
2. age between 50-75 years, and a body mass index (BMI) between 18.5-28 kg/m2.

Exclusion Criteria:

1. Patients whoused hormones or drugs that have a hypoglycemic nature during the preoperative state, or had bradycardia, arrhythmia, hypotension, abnormal liver or kidney function, pancreatic disease, neuroendocrine malignancy, intraoperative blood transfusion;
2. Patients who refused participation and those who needed intensive care after the surgery were also excluded from the study;
3. Patients who had severe internal environmental disorders.
Effects of Physical Training on Bone and Muscle Quality, Muscle Strength, and Motor Coordination in Children With NF1

A physical training program will improve quality of life, participation in physical activity, motor coordination, muscle strength, and bone and muscle strength in children with neurofibromatosis type 1.

Disorders of the Ras pathway have significant phenotypic overlap and include Noonan syndrome, Cardiofaciocutaneous syndrome (CFC syndrome), Legius syndrome, Costello syndrome and neurofibromatosis type 1 (NF1). NF1 is one of the most common genetic disorders presenting in childhood with an incidence of 1/3000. NF1 is associated with skeletal abnormalities such as short stature, scoliosis, and long bone fracture with non-union. We recently reported that children with NF1 have abnormalities of bone and muscle architecture as evidenced by decreased bone mineral density, decreased bone strength, and low muscle mass, all of which may predispose them to fractures and scoliosis (Stevenson et al., 2005, 2007, 2009). Our preliminary data show that children with NF1 have poor motor coordination and muscle strength, potentially secondary to abnormal neuromotor learning. We hypothesize that poor motor coordination and decreased muscle strength contribute to the osteopenia in NF1. Our objective is to identify effective and non-invasive strategies to improve motor coordination, muscle strength, and bone and muscle architecture in children with disorders of the Ras pathway, in hopes of decreasing fractures and improving physical activity levels. Plyometric physical training consists of quick, high-intensity, weight-bearing movements, and is an encouraging intervention for use in these children.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill NIH clinical diagnostic criteria

Exclusion Criteria:

* Visual impairment
* Participation in a simultaneous medical intervention trial
* Orthopedic procedure within the last 6 months.
* Pregnancy
* Home location greater than 3-4 hours drive time from Shriners Hospital
* Tibial pseudarthrosis
The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women

Purpose: During lactation, several physiological modifications occur including cellular differentiation and proliferation, as well as elevation in inflammation. The role of the Mediterranean (MED) diet rich in walnuts has been shown to favorably modify fatty acid profiles and to reduce inflammation. The study goal is to evaluate the anti-inflammatory effects of the MED diet rich in walnuts during lactation, a time of increased inflammatory response.

Procedures: A randomized, controlled dietary intervention trial among lactating women comparing the effects of a Mediterranean-style diet with walnuts to the USDA's MyPyramid Diet for Moms was commenced to determine the effects of the diet on fatty acid profiles and biomarkers of inflammation in breast milk and material serum/plasma. Secondary outcomes of interest include effects of maternal diet assignment on maternal body weight and body composition as well as infants' growth and health during the study trial period.

Population: The study population includes healthy women between the ages of 18-40 years who are within 6 months post-partum and plan to breastfeed a minimum of 3 times per day for 6 months following study entry. There have been a total of 138 participants enrolled in the study. All 138 participants are women; 34 identified themselves as Hispanic, and 104 said they were not Hispanic.


Eligibility Criteria:
Inclusion Criteria:

* plan to breastfeed 3 times daily for 6 months
* no nut allergies
* no history of cancer, renal disease, liver disease, or diabetes
* no smoking

Exclusion Criteria: