cyrilzakka/clinical-trials huggingface dataset:
The Effect of Inspiratory Muscle Warm-up on Decreased Diffusing Capacity for Carbon Monoxide After Maximal Exercise in Athletes

This study aims to examine the effects of inspiratory muscle warm-up (IMW) on the gas exchange capacity of the lungs (DLCO) and its potential contribution to recovery and athletic performance in elite athletes from various disciplines. The study hypothesizes that the decline in respiratory muscle capacity following high-intensity exercise, which negatively affects ventilation, diffusion, and oxygen transport, may be ameliorated through specific IMW protocol. A placebo-controlled, randomized, crossover, and double-blind design will be utilized, involving 28 elite male athletes from endurance, power, skill-based, and mixed disciplines.

Participants will complete three warm-up protocols: General Warm-up (GW), General Warm-up combined with IMW at 40% resistance intensity (GW+IMW40%), and a placebo condition (GW+IMWplacebo). Measurements will include respiratory muscle strength, DLCO (assessed at post-2, 30, 60, 90, and 120 minutes), respiratory function, and cardiorespiratory parameters during maximal exercise. This study is unique as it aims to detail the micro-level effects of IMW on pulmonary diffusion mechanisms and performance outcomes, providing novel insights into the ameliorative effects of IMW on respiratory function post-exercise. Additionally, it seeks to expand understanding of the mechanistic basis of IMW's benefits on both pulmonary diffusion capacity and athletic performance.

STUDY DESIGN This study will employ a placebo-controlled, randomized, crossover, and double-blind research design to evaluate the effects of three warm-up conditions: Control, Placebo 15%, and IMW 40%. Athletes will be randomly assigned to the conditions using a crossover approach, ensuring that all participants will experience each protocol on separate days.

The warm-up protocols will include:

General Warm-up (Control): A standard warm-up without resistance. IMW 40%: A general warm-up combined with inspiratory muscle warm-up at 40% resistance intensity.

Placebo 15%: A general warm-up combined with inspiratory muscle warm-up (placebo) at 15% resistance intensity.

Blinding will be maintained for both participants and researchers. Participants will be informed that the study aims to investigate various warm-up types, while the true purpose will remain concealed. This design will ensure reliability and minimize bias in the data to be collected.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-24 years.
* A training history of at least six years.
* Regular training frequency of at least four sessions per week.

Exclusion Criteria:

* History of smoking.
* History of physical disability or acute respiratory or cardiovascular disease within the past three months.
* Diagnosis of SARS-CoV-2 within the past three months.
* Pulmonary function measurements outside the normal clinical range (≤ 80%).
A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia

This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form;
* Male or female aged from 18 to 60 years (inclusively);
* 18 kg/m\^2≤BMI≤30 kg/m\^2, body weight≥50 kg for men and ≥45 kg for women;
* Subjects who have chronic HBV infection greater than or equal to 6 months at screening;
* 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤2000 IU/mL; ALT≤3×ULN;
* Subjects who have been on nucleoside reverse transcriptase inhibitors therapy for more than 1 year prior to screening.

Exclusion Criteria:

* Females who are pregnant or lactating at screening;
* History of alcoholic liver disease, moderate fatty liver, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
* History of cirrhosis at any time prior to or at time of screening, or having progressive liver fibrosis at screening ;
* History or evidence of hepatocellular carcinoma at any time prior to or at time of screening;
* Exclusionary laboratory results at screening: total bilirubin \>2xULN or direct bilirubin \>1.5xULN，hemoglobin \<120 g/L for males or \<110 g/L ro females，platelets count\<100,000/mm\^3 (100×10\^9/L), and absolute neutrophils count \<1,500/mm\^3 (1.5×10\^9/L).
Naltrexone Treatment for Alcoholism

This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence.
* Committed to alcohol abstinence as a treatment goal.
* Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.

Exclusion Criteria:

* Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).
* Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.
* Females who are pregnant, lactating, or not using a reliable method of contraception.
* Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.
* Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
* Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone.
* Vocabulary below the 5th grade reading level.
* Abnormal MRI scan.
* HIV infection due to the neurological sequelae.
* Significant central nervous system diseases.
* Seizure disorder or history of closed head trauma.
* Neuroendocrine disorders.
* Treatment with opiates within the last six months.
Efficacy and Safety of Sinovial®HL Single Injection in the Knee Osteoarthritis

The prevalence of knee osteoarthritis (OA) is rising worldwide, leading to disability and a reduced quality of life, particularly in elderly patients. While there are several treatment options, there is little consensus in the scientific community over which methods are most effective. Viscosupplementation with hyaluronic acid (HA) has been found to reduce pain in patients with knee OA over a period of up to 6 months, with little to no side effects. The aim of this prospective open-label, uncontrolled, observational, single-site study was to assess the efficacy and safety of a single hybrid HA injection over a period of 6 months in subpopulations of patients with low to severe symptomatic knee OA in everyday clinical practice.

Fifty patients who met the inclusion criteria participated in the study. A single intra-articular ultrasound-guided injection of hybrid HA (Sinovial®) was administered. Patients submitted Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaires at 28-, 42-, 84-, and 168-days post-treatment.


Eligibility Criteria:
The inclusion criteria

1. medical indication for viscosupplementation therapy with hybrid HA 2 patients aged between 45 and 80 years 3.diagnosis of gonarthrosis 4. gonarthrosis symptoms for at least 6 months 5. patients who failed to respond to analgesics and/or regular NSAIDs, 6. grade 2 to 3 OA in the Kellgren-Lawrence grading scale 7. pain on walking measured by the Visual Analog Scale (VAS; 0-100 mm) of at least 40 mm on the targeted knee; 8. contralateral knee pain when walking with aVAS of less than 10 mm.

The exclusion criteria were:

1. inability to understand the aim of the study
2. inability to provide acceptable consent
3. pregnancy
4. serious psychiatric disorders
5. allergy or intolerance to hybrid HA
6. secondary gonarthrosis due to systematic and inflammatory disorders.
Balance Analysis System Through Biaxial Rotation Force Platform

This study developed a system for studying an individual's postural balance in an upright position on a force platform with controlled movement of 2-axis rotation (transverse and anteroposterior), by analyzing lower limb muscle activation and data from Pressure Center of displacement.

The use of rotating force platforms has proven to be an important resource in the study of postural balance and motor control. Platforms composed of two force plates allow the analysis of the load relationship between the feet and the study of the coordination of the lower body segments in postural control. Center of pressure displacement data during perturbations generated by platform rotation allow the study of dynamic postural balance. However, devices that meet these characteristics are not common and have limitations on amplitude or speed of rotation. Thus, a force platform composed of two plates was developed, capable of collecting data for the calculation of the parameters of the center of pressure, differentiating each foot, with a computerized system to control amplitude and speed of rotation in the mid-lateral and anteroposterior axes. A new version of embedded and supervisory systems that control the device, collect and process the created data has also been developed. For platform functionality tests, volunteers were divided into three groups of 15 individuals: Group 1 (G1): women aged 18 to 40 years; Group 2 (G2): women aged 40 to 60 years; Group 3 (G3): women over 60 years old.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Ages 18 to 80 years
* Asymptomatic
* Resident of the city of mogi das cruzes.
* You will have to sign the consent form

Exclusion Criteria:

* History of dizziness or dizziness crisis not explained in the last year;
* Any musculoskeletal or neurological disorders;
* Significant pain that limits daily functions;
* Known uncorrected vestibular problems.
* Fall History
Use of Indocyanine Green in Pancreas Surgery

This study evaluates the use of indocyanine green to predict postoperative pancreatic leaks in patients undergoing transection of the pancreas.

PRIMARY OBJECTIVE:

I. To determine if altered measurement results of ICG after pancreatectomy is associated with leak rates.

OUTLINE: This is an observational study.

Patients receive indocyanine green intravenously (IV) during surgery, undergo imaging and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis
* Participant ≥ 18 years of age
* Ability to understand nature and individual consequences of clinical trial
* Written informed consent from participant or legally authorized representative
* For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention
* Participant needs to have an operative drain (any closed suction drain) after the procedure
* Participants that do not require arterial reconstruction
* Participants that require minor portal venous recounstructions including patch venoplasty

Exclusion Criteria:

* Patients with previous history of adverse reaction to contrast dye, ICG or components of the dye
* Prior pancreatectomy
* Known diagnosis of hepatic insufficiency, hepatitis, liver fibrosis or cirrhosis, or chronic pancreatitis
* Because this study focuses on hypoperfusion, patients will be excluded if in postoperative day 3-5 had any of the following: persistent SBP \<90 mmHg unresponsive to 1L crystalloid, unexpected ICU transfer, blood transfusion of \>2 units intraoperatively or 1 postoperatively, vasopressor treatment or ACLS protocol initiation
* Organ failure, anuria or NSQIP-identified complication will be reviewed by PI and attending surgeon and excluded
* Patients that require arterial reconstruction as part of their procedures
Wether VNS in Early Stage (3 Months) is Safe and More Beneficial for Post-stroke Motor Rehabilitation

Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In previous study, Vagus nerve stimulation was constricted to patients 9 months after stroke. In this randomized phase I trial, we would apply vagus nerve stimulation in an early stage (\<6 month) and observe its theraputic effect on motor function after ischaemic Stroke.We hypothesized that the early stimulation could be safe and more beneficial compared to stimulation in late stage.


Eligibility Criteria:
Inclusion Criteria:

* Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 3-36 months before surgery.

  * Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42
  * Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).

Exclusion Criteria:

* Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) . Severe cognitive impairment (Mini Mental State Examination \< 24)
vEAET for Older Veterans With Chronic Musculoskeletal Pain Pilot

An uncontrolled pilot in which Veterans age 60-95 years with chronic musculoskeletal (MSK) pain will undergo Emotional Awareness and Expression Therapy (EAET) delivered over video teleconference (VTC; together vEAET). This study aims to obtain early implementation outcomes, as well as evaluate efficacy and estimated effect sizes.

For this pilot, vEAET will be provided to outpatient Veterans age 60-95 years with chronic MSK pain in order to obtain early implementation and clinical outcomes (i.e. acceptability, feasibility, appropriateness, fidelity, and effectiveness). Each Veteran will be provided a VTC capable tablet and technological support from a research coordinator as a strategy to overcome technology based obstacles and obtain feasibility data. Veterans will receive one 90-minute individual session of vEAET plus eight 90-minute weekly group sessions of vEAET, all delivered over VTC to their homes. Assessments will be performed at baseline, posttreatment, and 2-month follow-up remotely using OutcomeMD (Los Angeles, CA), a HIPAA-compliant, VA-approved web-based platform. The entire study will be performed without any in-person visits.

Eligibility Criteria:
Inclusion Criteria:

• Eligible Veterans are age 60-95 years old and have had at least 3 months of musculoskeletal pain, including the following conditions most likely to benefit from psychotherapy based on previous research: low back, neck, leg, or pelvic pain; temporomandibular joint disorders; fibromyalgia; tension headaches; or any combination of these disorders.

Exclusion Criteria:

* Musculoskeletal conditions likely to respond surgical or pharmacologic treatment: hip or knee osteoarthritis, leg pain greater than back pain (to exclude radiculopathy), electromyography-confirmed "tunnel" syndrome (e.g., carpal tunnel syndrome), gout, neuralgias, migraine, and cluster headaches;
* Non-musculoskeletal pain conditions: autoimmune disease that typically generates pain (e.g., rheumatoid arthritis), cancer pain, sickle cell disease, burn pain, infection associated with pain, and cauda equina syndrome;
* The following conditions or circumstances: severe psychiatric disorder such as schizophrenia or bipolar I disorder not controlled with medications, active suicide or violence risk, active severe alcohol or substance use disorder, substantial cognitive impairment based on chart review, previously completed EAET, currently enrolled in another psychological treatment for chronic pain, currently in pain-related litigation or applying for pain-related compensation or compensation increase (e.g., VA service connection for chronic pain), unable to fluently read or converse in English, no internet access.
ADAMTSL4 in Idiopathic Pulmonary Hypertension and CTEPH

ADAMTSL4 (A disintegrin and metalloproteinase with thrombospondin motifs like) is a member of the ADAMTSL family. ADAMTSL4 is one of the family of 7 ADAMTS-Like proteins, themselves part of the Thrombospondin type 1 repeat (TSR) superfamily of proteins. These 7 proteins are divided into two distinct clades, of which ADAMTSL4 and ADAMTS-Like 6 form part of one clade, differing from ADAMTS-Like 1, ADAMTS-Like 3 and ADAMTS-Like 7 by lacking immunoglobulin repeat regions. ADAMTSL4 is widely expressed in brain, colon, heart, kidney, liver, lung, pancreas and spleen, yet, its precise role is unclear. in addition, ADAMTSL4 protein high expression to the medial layer of the arterial wall, and medial vascular smooth muscle cells specifically.

The objectives of the present study aimed to confirm ADAMTSL4 levels in the proteomics between healthy control population and patients with IPAH，to analyze the expression levels of ADAMTSL4 between patients with IPAH and CTEPH, and to investigate whether serum levels of ADAMTSL4 might be used as biomarkers of disease severity in these patient populations.

Eligibility Criteria:
Inclusion Criteria:

- Healthy people，patients with IPAH，patients with CTEPH

Exclusion Criteria:

- tumour，infection，Pregnancy, suckling period， Mental disorders，

Other types of PAH except CTEPH and IPAH
SARAH Exercise Program in Patients With Rheumatoid Arthritis

The aim of this study is to investigate the effectiveness of the SARAH home exercise program to be applied for 12 weeks on wrist proprioception and hand functions in adult patients with rheumatoid arthritis.

Finger/hand/wrist joints can be affected in the early period in patients with RA, and as the disease progresses, it can significantly limit the patient's functionality. Damage to articular and periarticular structures seen in inflammatory arthritis may affect the sense of proprioception by destroying mechanoreceptors located in these areas. Hand functions may worsen as a result of the worsening of the sense of proprioception, which can be defined as being aware of body parts.

SARAH (Strengthening and Stretching for Rheumatoid Arthritis of the Hand) home exercise program, which is a widely preferred approach in the case of hand involvement in patients with rheumatoid arthritis (RA), includes exercises to increase hand-wrist strength and mobility. Although the effectiveness of this program on pain, muscle strength, and range of motion has been demonstrated in large patient groups, its effect on proprioception and hand functions, which may be caused by inflammatory arthritis, has not been studied. Therefore, this study aims to investigate the effectiveness of the SARAH home exercise program on wrist proprioception and hand functions in adult patients with rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

1. RA diagnosis according to 2010 ACR/EULAR RA criteria
2. Being between the ages of 18-65
3. Being able to follow Turkish instructions
4. Volunteering to participate in the study

Exclusion Criteria:

1. Being in an acute disease exacerbation period
2. Ongoing physiotherapy/occupational/exercise treatment regarding hands within the last 6 months
3. History of steroid injection, surgery, or trauma to the upper extremity in the last 6 months
The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery

Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging


Eligibility Criteria:
Inclusion Criteria:

* age \&amp;gt; 18 years,
* confirmed diagnosis of primary CRC,
* preoperative tumor stage of cT1 to cT4, N-/+, M0 as determined by contrast-enhanced computed tomography (CT),
* no distant metastasis, -American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3-

Exclusion Criteria:

* history of previous colorectal surgery, emergent surgery, or palliative resection;
* pregnancy or breastfeeding;
* allergy or history of an adverse reaction to ICG; and
* severe mental disorder.
A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 18 to 65
* Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
* Must meet specific pain intensity criteria on the morning after surgery
* Willing to remain at the study center 2 days following surgery
* If female, must be of non-child bearing potential or practicing birth control

Exclusion Criteria:

* Is allergic to or has a serious reaction to hydrocodone, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
* Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
* Has a history of or currently has any active seizure disorder
* Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
* Has been diagnosed with cancer within the past 3 years
* Requires treatment with certain drugs for depression or psychiatric disorders
* Has specific clinically significant illnesses or laboratory abnormalities
* Received corticosteroid treatment or any investigational drug within a specific timeframe.