cyrilzakka/clinical-trials huggingface dataset:
Screening Anxiety and Depression Among Patients with Chronic Musculoskeletal Pain Within Physiotherapy Practices

This study will investigate whether physiotherapists can accurately identify symptoms of anxiety and of depression in patients with chronic musculoskeletal pain (primary aim). The prevalence of co-morbid anxiety and depression in patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia within physiotherapy practices will be established (secondary aim).

The International Classification of Diseases describes chronic musculoskeletal pain as pain that arises as part of a disease process directly affecting bones, joints, muscle or related soft tissue lasting longer than 3 months. The global burden of chronic musculoskeletal pain is substantial, with a recent systematic review indicating a 26% prevalence in the general adult population and 39% in those older than 65 year. Chronic musculoskeletal pain also contributes to almost 20% of the global years-lived with disability, and it is one of the major causes of work loss and early retirement. Population-based research has shown that chronic pain conditions are risk factors for developing depression and anxiety. Co-morbid depression and anxiety are strongly associated with more severe pain, greater disability, and poorer health related quality of life. Both are also important reasons for poor treatment adherence within physiotherapy practices. When managing patients with chronic musculoskeletal pain, physiotherapists need to be able to identify patients who have an increased likelihood of depression and anxiety and to facilitate appropriate management by either facilitating patients in coping with anxiety and depression via for example physical activity or relaxation techniques and/or referring them to a medical practitioner for definitive diagnosis and intervention. Although there is some recognition of screening for depression in physiotherapy practices, the role physiotherapists can have in detecting anxiety and depression is largely ignored. The primary aim of this project will be to investigate whether physiotherapists can accurately identify symptoms of anxiety and of depression in patients with chronic musculoskeletal pain. The focus will in particular be on patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia. The accuracy of screening via a numeric rating scale will be compared with the accuracy of screening via 2 brief items. A secondary aim is to describe the prevalence of co-morbid anxiety and depression in patients with chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia within physiotherapy practices.

Eligibility Criteria:
Inclusion criteria:

Physiotherapists:

- Physiotherapists of AXXON, the Belgian Professional Physiotherapy Organization.

Patients

- Self-reported chronic neck and / or shoulder pain, chronic low back pain, rheumatoid arthritis, osteoarthritis or fibromyalgia.

Exclusion criteria:

* Not meeting inclusion criteria.
* No additional exclusion criteria.
Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period.

For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.

This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for smoking. The secondary aims are to determine the effects of the products on biomarkers of exposure and toxicity. Other secondary aim includes examining the effects of the two products on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and Oregon Research Institute (ORI).

Eligibility Criteria:
Inclusion Criteria:

* smoking at least 10 cigarettes daily for the past year,
* in good physical health (no unstable medical condition;
* no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria:

Subjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.
Melatonin Effects on Cardiovascular Disease Mechanisms in the Menopause Transition: A Randomized Clinical Trial

The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.


Eligibility Criteria:
Inclusion Criteria

* Age 40-55 years old
* Female individuals with intact uterus and at least one ovary
* Currently in the menopause transition

  o Defined as self-reported bleeding patterns encompassing the early and late perimenopause phases, in accordance with the Stages of Reproductive Aging Workshop (STRAW) Criteria:6 a difference of ≥7 days in the length of consecutive menstrual cycles which recurs within 10 cycles from the first occurrence (early menopause), or 2 to 12 months of amenorrhea (late perimenopause)
* Hypertension

  o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg
* On stable medical regimen (≥ 2 months) if taking other medications

Exclusion Criteria

* Prescription sleeping medications or melatonin supplementation
* Pregnant or lactating
* Night shift work
* Current or recent (within the past 2 months) use of hormonal contraceptives
* Current or recent (within the past 2 months) use of hormone replacement therapy
* On prescription aspirin
* Severe lactose intolerance
* History of substance use disorder
* History of suicidal ideation
* History of clinically diagnosed anemia or low hemoglobin levels (\<11.6 g/dL) within the past 12 months
* Active cancer
* Severe daytime sleepiness (score \>15 at the Epworth Sleepiness Scale)
* Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators
* Inability to provide written consent and/or to speak and read English
* Any other medical, geographic, or social factor making study participation impractical
Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction

The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .

Three hundred consenting patients undergoing routine esophagogastroduodenoscopy (EGD) procedures will be recruited for examination at the gastroesophageal junction with our developed OCT imaging system. The patients will undergo a clinical EGD procedure including endoscopic biopsy. The first step in the procedure follows the standard care with the performance of the surveillance endoscopy. The study experimental procedure will then begin. This study requires the use of a balloon . The balloon placement method is in accordance with current standard clinical practice and involves the insertion of a guide wire through the auxiliary channel of the endoscope. The endoscope is then removed, leaving the guide wire in place, and the OCT balloon is inserted the required distance (determined during the endoscopy) over the guide wire to the GE junction. The OCT balloon will then be inflated and will remain in this fixed position throughout the entire procedure. Once the OCT imaging probe is in place, OCT image data will be continuously collected over the length of the balloon(approximately 5 cm).

It is expected that the total examination time including insertion and inflation of the OCT balloon, OCT imaging and removal of the OCT balloon will add no more than 10 minutes to the total length of the EGD.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18,
* capable of giving informed consent,
* are undergoing elective EGD, and
* if female are willing to take a pregnancy test

Exclusion Criteria:

* patients on oral anticoagulation medications,
* with a history of hemostasis disorders and
* patients that are pregnant
Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch

The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.

Kidney transplantation is widely recognized as the optimal therapy for the management of end-stage renal disease. Presently, the deceased donor kidney waiting list has expanded disproportionately with the number of transplant procedures that are performed in the United States. To further compound this problem, as many as 1/3 of the patients on this list are highly sensitized against a broad range of potential donors.

In order to address this problem, we developed an antibody depletion protocol that permits transplantation in patients who have a positive crossmatch with their live donor. The protocol consists of standard immunosuppressant therapy, plasmapheresis, and intravenous immunoglobulin infusion. We have successfully performed transplantation in over 100 such patients with low complication rates.

Because these patients have been exposed to their donor's human leukocyte antigen (HLA) they are at high risk for both acute cellular and acute antibody-mediated rejection. This intent of this prospective, randomized, open-label trial is to determine whether induction therapy (i.e. therapy given at the time of transplantation for prophylaxis) with Thymoglobulin is associated with a lower 6-month incidence of acute cellular and antibody-mediated rejection than with our standard therapy, daclizumab.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years or older)
* End-stage renal disease
* Identified to have positive lymphocytotoxic crossmatch or flow cytometric crossmatch with live donor

Exclusion Criteria:

* Deceased donor recipients
* Pregnancy
* Active infection
* History of cancer within the past two years (with the exception of non-melanomatous skin cancer)
* History of heparin induced thrombocytopenia
* Medical contraindications to transplant procedure
Role of Urinary Sphingosine 1-Phosphate as a Biomarker for Detrusor Hyperactivity in Multiple Sclerosis

This study aims to establish a link between urinary Sphingosine 1-Phosphate (S1P) levels and detrusor activity in multiple sclerosis (MS) patients. MS often involves urological symptoms, primarily overactive bladder. The gold standard for evaluation and treatment monitoring is invasive urodynamic testing. Preliminary research at Toulouse University Hospital suggests urinary S1P levels may be a potential biomarker for detrusor activity in MS. This study aims to confirm this potential biomarker's utility.


Eligibility Criteria:
Inclusion Criteria:

* French residents enrolled in the social security system
* Patients diagnosed with multiple sclerosis (according to McDonald 2017 criteria), whether receiving treatment or not
* Patients scheduled for urodynamic assessment as part of their management

Exclusion criteria:

* Pregnant or lactating females
* Patients under legal guardianship
* Untreated urinary tract infection at the time of inclusion
* Known anatomical subvesical obstruction Known pelvic floor disorder Urothelial carcinoma Interstitial cystitis Augmentation cystoplasty
Perioperative Analgesia Using Ultrasound (US) Guided Transversus Abdominis Plane (TAP) Block

Perioperative analgesia using US guided TAP block

Perioperative analgesia using US guided TAP block

Eligibility Criteria:
Inclusion Criteria:

* adult undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* history of cardiorespiratory disease
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status

Cross-sectional analytic study of pulmonary mechanics comparing lean and obese children with asthma followed by a randomized, SHAM-controlled 3-arm intervention trial of inspiratory training on small airway dysfunction and inspiratory muscle function.

The central objective of the MICA (Mechanistic Study of Inspiratory Training in Childhood Asthma) study is to assess key respiratory mechanisms in 6-17 year olds with symptomatic asthma (with and without obesity) in response to IT. Our central hypothesis is that obesity promotes dyspnea and worse asthma control via inspiratory muscle fatigue/dysfunction (IMD) and small airway dysfunction (SAD), and that IT will improve inspiratory muscle function and small airway measures.

The sample size calculations and main analyses for the IT trial are designed as a traditional parallel arm intervention trial (any dose IT vs. SHAM control) with visits 1-2 serving as the baseline evaluation and the main IT endpoints being collected at the 8-week visit.

In depth phenotyping involving measures of respiratory mechanics and muscle functioning and a RCT involving inspiratory training will address these objectives.

Eligibility Criteria:
Inclusion Criteria:

* 6-17 years of age
* Documented clinician-diagnosed asthma
* Currently requiring 2 or more controller prescriptions to treat disease (i.e. moderate to severe persistent disease)
* Either obese (≥95th percentile BMI and less than 170% of the 95th CDC percentile) or have a normal BMI (BMI 5th to 84th CDC percentile)

Exclusion Criteria:

* ACT (asthma control test) score \<17
* Ever intubated for asthma
* FEV1 \< 50% of predicted at enrollment
* Currently pregnant
* Legal guardian unable to consent in English or Spanish
* Any major chronic illness that, in the opinion of the PI, would interfere with participation
* Younger than 6 years of age
Comparative Effects of Circuit Training and Trunk Stabilization Technique in Basketball Players

In the sports world, physical training is the most important factor because physical training increases the efficiency and the effectiveness of the sports. The players performance depends on various factors, but the main factor of players performance is physical training. Training contributes tremendously towards the achievement of such aims of this area in sports. The circuit training is a non-stop, high intensity, basketball specific workout. It increases overall speed and quickness, explosive power, upper and lower body strength, vertical jump and, most of all, the athlete's conditioning.

This study will be a randomized control trial and will be conducted in National stadium and Ravians Basketball club Lahore. The study will be completed within the time duration of six months. Non-probability convenience sampling technique will be used to collect the data. The sample size of total 24 athletes will be taken in this study. The participants will be divided into two groups i-e, one group will receive circuit training and other group will receive trunk stabilization exercises.

Circuit training consisted of 6 exercises, divided in 2 blocks (1st block contains ½ squats, bench press and pushups and 2nd block contains burpees, squat thrust and lunges) of 3 minutes. The stabilization exercise group will repeat 6 exercises (Balance Ball with Pocket Knife, Reverse Crunch, Russian Return, Shuttle, Leg Lift, and Back extension) for 6 weeks. Lane agility drill, Sprint test, Vertical jump test, Star excursion test will used to evaluate outcomes

Eligibility Criteria:
Inclusion Criteria:

* Males
* Age between 16-30 years
* No pain complaint
* Recreational activity
* Participate voluntarily
* Players have spent at least one year in sports

Exclusion Criteria:

* Higher BMI
* joint, meniscus, or ligament damage
* lower extremity surgical history
* persistent knee instability
* cardiac/musculoskeletal/vestibular/neurological issues
Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in patients with atopic dermatitis. Patients will receive GR1802 injection or Placebo every 2 Weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with AD according to Williams criteria with a history of at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥4 at Baseline.
2. Inadequate response or intolerance to topical glucocorticoid therapy for AD within 6 months prior to screening.

Exclusion Criteria:

1. Not enough washing-out period for previous therapy.
2. Concurrent disease/status which may potentially affect the efficacy/safety judgement.
3. Abnormal laboratory test results at screening that, in the judgment of the investigator, may affect the subject's ability to complete the trial.
4. Women who are pregnant or breastfeeding, or planning to become pregnant, breastfeeding during the study.
5. Other
HPV Self-Sampling in Somali Women

This study plans to assess the effect of implementing HPV self-sampling in primary care on uptake of cervical cancer screening in 30-65 year old Somali women who are due for cervical cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* Identify as a Somali woman
* between ages of 30-65
* eligible for cervical cancer screening

Exclusion Criteria:

* Ineligible for cervical cancer screening, including having a history of cervical cancer or a hysterectomy without intact cervix
Timing of Complete Revascularization for Multivessel Coronary Artery Disease in STEMI

The study will compare clinical outcomes between complete revascularization during hospitalization for ST elevation myocardial infarction (STEMI) and intervention after 30 days and intervention based on outpatient non-invasive ischemia testing in patients with multivessel coronary artery disease (MVD) presenting with first ever ST elevation myocardial infarction.

This study is prospective, randomized, multicentre, open label study in patients with ST elevation myocardial infarction (STEMI) with multivessel coronary artery disease (MVD) defined as \>70% stenosis in a non-culprit vessel, initially treated with culprit only primary PCI. The patients will be enrolled in four high volume PCI centers after successful culprit only primary PCI and then randomly assigned to one of three treatment arms:1. complete revascularization of all non-culprit significant lesions in a single session during initial hospitalization; 2. same revascularization in a single session after 30 days; 3.revascularization or it's deferral based on ischemia testing using Dobutamin stress echocardiography. The study will explore differences in occurrence of major adverse cardio-cerebral events (cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization) and complications of interventions during 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and electrocardiographic signs of first ever ST elevation myocardial infarction (chest pain lasting less than 12 hours with persistent ST elevation of ≥ 1mm in two contiguous leads on ECG recording)
* Multivessel coronary artery disease (MVD) on initial coronary angiogram, defined as visually assessed stenosis of more than 70% of any of the non-culprit vessels
* Treated with primary PCI of infarct related artery (IRA) only.

Exclusion Criteria:

* Hemodynamically unstable patients defined as presence of cardiogenic shock, intraaortic balloon pump (IABP) implantation and mechanical ventilation prior, during and after primary PCI;
* Presence of significant valvular disease;
* Decision that patient needs to be treated with coronary artery bypass graft (CABG) and/or valvular replacement or reconstruction surgery after initial culprit only PCI;
* Myocardial infarction is caused by stent thrombosis:
* Chronic total occlusion of any of the coronary arteries on initial angiogram;
* Previously treated by CABG surgery;
* Estimated life expectancy less than one year.
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation


Eligibility Criteria:
Inclusion Criteria:

* Men or women greater than or equal to 18 years old.
* ECOG ≤ 1
* Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

Exclusion Criteria:

* Active brain metastases
* Myocardial infarction within 6 months of study day 1
* Gastrointestinal (GI) tract disease causing the inability to take oral medication
Lung Recruitment and Postoperative CPAP

General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation.

General anesthesia lowers FRC thereby promoting airway closure and absorption atelectasis. Alveolar recruitment manoeuvers recruit collapsed alveoli, increase gas exchange, and improve arterial oxygenation. However, the effect of recruitment manoeuvre is short lasting and does not extend to the post operative period. Postoperative CPAP keeps the lung open and can improve oxygenation in the early postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing laparoscopic surgery for abdominal cryptorchidism.

Exclusion Criteria:

* Cardio-respiratory illness.
* Unsatisfactory preoperative peripheral arterial oxygen saturation.
* Unsatisfactory preoperative hemoglobin level.
* Neurological or psychiatric disease.
* Children with a BMI \>95th percentile for age.