cyrilzakka/clinical-trials huggingface dataset:
Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome

The purpose of this randomized double-blind clinical trial is to determine the effectiveness of manual therapy for patients with subacromial impingement syndrome of the shoulder. We hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and spine will be more effective in reducing pain and shoulder disability at short-term (6 wk) and long-term (3, 6, 12 months) as compared to therapeutic exercise only.

Subacromial impingement syndrome (SAIS) is a frequent cause of shoulder pain. Clinical trials investigating the effectiveness of manual therapy have demonstrated improvements in outcomes when manual therapy has been added to a program of therapeutic exercise. However, the these clinical trials (3) have significant limitations and generalizability. Two of the three 3 trials had a small number of subjects (14 \& 22 subjects) and all 3 trials had only short term follow up (\<12 weeks) and used non-validated self report outcome measures. These limitations reduce the confidence with which clinicians can apply these results to the patients they treat with SAIS. Clear evidence is needed to justify the cost and clinician time required to perform manual therapy in the delivery of patient care. Therefore, the purpose of this randomized clinical trial is to examine the short-term and long-term effectiveness of manual therapy in addition to therapeutic exercise as compared to therapeutic exercise only in patients diagnosed with SAIS.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms associated with athletic activity (35% of patients)
* Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria:

  1. Reproduction of symptoms with impingement test: either Hawkins- Kennedy or Neer Test
  2. Pain during active shoulder elevation at or above 60 degrees
  3. Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation
* Shoulder disability: 25/100 (0 = no disability)
* Able to understand written and spoken

Exclusion Criteria:

* Severe pain; pain is \> 7/10 on NPRS (0 = no pain)
* Shoulder surgery on affected shoulder
* Traumatic shoulder dislocation within the past 3 months
* Previous rehabilitation for this episode of shoulder pain
* Reproduction of shoulder pain with active or passive cervical motion
* Systemic inflammatory joint disease
* Global loss of passive shoulder ROM, indicative of adhesive capsulitis
* Full-thickness rotator cuff tear, as evidenced by any one of the following:

  1. Markedly reduced shoulder external rotation strength
  2. Drop arm test
  3. External rotation lag sign
  4. Lift off test
  5. Positive findings on MRI or ultrasonography
Vivo Prediabetes Study: Online, Live, and Interactive Strength Training for Older Adults With Prediabetes

This research trial studies the effect of an online, live and interactive strength training program on physical function and strength in older adults with prediabetes.

It is well established that in-person resistance training is an effective form of exercise to increase physical function and quality of life amongst adults. However, older adults report not participating in resistance training due to lack of age appropriate programs, fear of a gym setting, poor access to a gym, joint and other kinds of pain, and lack of social support. These barriers have been compounded as a result of COVID-19 pandemic, wherein older adults are encouraged to socially isolate, leading to even less physical activity. Vivo is a virtual small group exercise program designed for adults 55 and addresses these major barriers to strength training by coaching through an interactive online training session incorporating social support and social engagement.

The investigators plan is to test a highly attractive technology platform specifically designed to meet the needs of older adults to demonstrate that resistance training exercise can be scaled and effective with diverse older adults and remove the barrier of having to go to a gym setting to see benefits. The investigators will test feasibility in a real world sample of adults ≥60 with prediabetes, a very prevalent, serious and often silent health condition that affects 1 in 3 adults in the US and is associated with high rates of sarcopenia, or loss of muscle mass.

In the next study, Phase II NCT06458530, investigators will examine the effects of Vivo on physical function and glycemic level in sedentary older with prediabetes

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years;

  * Diagnosis of Pre-diabetes within prior 12 months: fasting glucose between 100 to 126 OR HbA1c between 5.7 and 6.4%
  * Ambulatory and community-dwelling
  * Sedentary: less than 150 minutes of moderate physical activity OR less than 75 minutes of vigorous physical activity per week
  * Have not engaged in resistance training for at least 6 months prior to enrollment
  * Low functioning (defined as able to do at least 1 chair stand without using hand in 30 second but unable to meet the moderate function criteria for age and gender)
  * Access to WiFi (or internet connection) in defined exercise space
  * Willing to maintain weight and current diet throughout the study

Exclusion Criteria:

* Inability to complete physical function assessment or inability to do a chair stand without using hands.
* Use of antidiabetic medications
* Use of testosterone supplement or replacement
* Clinical disorder precluding/interfering with participation or assessments

  * Unstable angina, arrhythmia, uncontrolled hypertension
  * End Stage Renal Disease on Hemodialysis
  * Lower extremity amputation or paralysis
  * Neurological conditions causing functional or pronounced cognitive impairments
  * Active malignancy except for non-melanomatous skin cancers
* Unable to provide consent
* Weight instability
Resection for Multiple Hepatocellular Carcinomas (HCC)

Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains controversial. The aim of this study was to investigate the outcome of a consecutive cohort of patients resected for multiple HCC, without macrovascular invasion, in order to identify clinically reliable parameters to select patients for surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients with multiple HCC without macrovascular invasion on liver cirrhosis

Exclusion Criteria:

* macrovascular invasion;
* normal liver;
* distant or lymphnodes metastasis
Leprosy Active Searching Trial in Brazil

The goal of this clinical trial is to assess whether a multifactorial active case-finding strategy improves the detection of leprosy cases in Brazil compared to usual screening practices. The main questions it aims to answer are:

- Does the intervention increase the number of new leprosy cases detected compared to standard care?

Participants will:

* Receive community awareness about leprosy.
* Be screened using the Leprosy Suspicion Questionnaire at priority areas identified by georeference tools.
* Undergo clinical evaluation by a trained medical team
* If leprosy is diagnosed, affected patients will collect complementary laboratory exams

Healthcare professionals from primary care units will receive training in leprosy, while researchers will monitor changes in leprosy incidence over a 12-month period using data from Brazil's national notification system. The study will provide insights into underdiagnosis and the clinical profiles of diagnosed patients.


Eligibility Criteria:
Inclusion Criteria:

(I) Municipalities

* Municipality recognized by the Brazilian Institute of Geography and Statistics as part of the Brazilian Federation.
* Municipality with operational epidemiological classification by the Ministry of Health (BMoH) as: 'municipalities with cases in the period from 2015 to 2019'.
* Municipality with authorization/consent from the government to participate in the study.

(II) Primary Health Units (Unidade Básica de Saúde or UBS) • UBS with territorial coverage (linked population) within the participating municipality.

(III) Participants

• Patients with positive Leprosy Suspicion Questionnaire (LSQ): children under five years old with Free and Informed Consent Form (ICF) signed by parents/guardians, 5-17 years old with ICF signed by parents/guardians and Free and Informed Assent Form (IAF) signed by the minor, and patients over 18 years old with ICF signed for: rapid test collection, comorbidity questionnaire and clinical evaluation; and if leprosy diagnosis is confirmed, collection of complementary exams.

Exclusion Criteria:

(I) Municipalities

* Municipality with extreme population size (municipalities with a number of inhabitants lower than the 10th percentile and higher than the 90th percentile).
* Municipality with operational epidemiological classification by the BMoH as: 'municipalities without cases in the period 2015 to 2019'.
* Municipalities with active or recent participation (less than one year) in other active-finding strategies, in addition to the usual ones: ministerial, Non-Governmental Organizations (NGOs), academic, among others.

(II) Primary Health Units

* UBS with limited multidisciplinary team (absence of physicians, nurse and/or community health agents).
* UBS with difficult access (no access by land, i.e. riverside populations).
* UBS with territorial coverage exclusively of indigenous populations.

(III) Participants

* LSQ negative.
* Patients with a previous diagnosis or history of treated leprosy.
* Patients residing/registered outside the selected municipality.
Study of the Effect of Botulinum Toxin Injection in Rectus Femoris and Triceps on the Length and the Strength During Locomotion in Chronic Hemiparetic Patients

The aim of this randomized controlled study is to quantify the modification during locomotion of chronic hemiparetic patients of the strength and the length of Rectus Femoris and Triceps Surae induced by botulinum toxin injection type A.

The main hypotheses of this study based on previous studies are that botulinum toxin injection increases on one hand the length of the muscle injected during gait and on the other hand decreased the strength of the muscles injected.

The investigators also hypothesized that botulinum toxin injection improved the strength of the antagonist muscles and normalized the pattern of strength of the muscles injected during gait.

The aim of this study is to compare versus placebo the effects of BTX-A injection on :

* the maximal length of the muscles injected during gait
* the maximal lengthening velocity of the muscles injected during gait
* the maximal strength of muscles injected during gait
* the inter-limb coordination assessed by continuous relative phase
* the kinematic parameters such as peak knee flexion during swing phase of the gait cycle and peak ankle dorsiflexion during stance phase.

To that end each patient included in the study will be assessed before injection, one month after the BTX-A injection and 3 months after BTX-A injections.

All patients will underwent a clinical examination, a 3D gait analysis and a isokinetic dynamometer analysis.

The comparison of the results in the group treated by BTX-A will permit to show that one month after BTX-A injection peak length during gait of muscles injected, maximal lengthening velocity peak knee flexion during swing phase and peak ankle dorsiflexion increase significantly.

It will also permit to show that the maximal strength of muscles injected decreases whereas the strength of antagonist increases It will also permit to demonstrate that multisite BTX-A injection improve coordination of paretic and non paretic lower limb the inter-group comparison will permit to demonstrate that these modification are mainly due to multisite BTX-A injections.

Eligibility Criteria:
Inclusion Criteria:

* men or women aged \> 18 ans
* unilateral stroke more than 6 months
* ability to walk 10 meters without assistive device
* decrease of peak knee flexion in swing phase of the gait cycle due to a spasticity of Rectus femoris muscle
* plantarflexion in swing phase of the gait cycle due to a spasticity of the triceps surae
* informed consent approved
* oral contraception

Exclusion Criteria:

* Aphasia
* anteriority of lower limb surgery less than 6 months
* underlying disease
* pre-existing neuro-muscular disorders
* pregnancy
* absence of oral contraception
* last botulinum toxin injection \< 3months
* hypersensitivity reactions
* co-administration of aminoglycosides
Virtual Reality Animation and Ice Massage on The Hoku Point

The goal of this study was to compare the effects of ice massage and virtual reality animation on labor pain, duration, and satisfaction with delivery.

The main questions aims to answer are:

H1 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor pain.

H2 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' labor duration.

H3 There are differences between Ice massage group and/or virtual reality animation groups and the control group in women's' satisfaction.

This randomized controlled trial (n = 94) includes three arms. Two intervention groups (ice massage (IMG); virtual reality animation (VRA)) and one control group, (CG). Personal information form, and Visual Analog Scale (VAS) and Birth Satisfaction Scale will used to collect data. Frequency and percentage calculations, Mann Whitney U, Kruskal Wallis test, chi-square test, Tukey's honestly significant difference test, and will used for data analysis.


Eligibility Criteria:
Inclusion Criteria:

* Term primiparous and singleton pregnancies,
* Longitudinal and vertex position of the fetus,
* Body Mass Index (BMI) below 30,
* cervical dilatation of 0-3 cm,
* who agreed to participate in the study

Exclusion Criteria:

* applying pharmacological intervention during labor,
* having a risky pregnancy,
* want to withdraw from the study,
* having ice allergy,
* being visually impaired.
Predictive Factors of Conversion in Laparoscopic Colorectal Cancer Resection

Background Laparoscopic resection is the treatment of choice for colorectal cancer. Rates of conversion to open surgery range between 7% and 30% and controversy exists as to the effect of this on oncologic outcomes. The objective of this study was to analyze what factors are predictive of conversion and what effect they have on oncologic outcomes.

Material \& Methods From a prospective database of patients undergoing laparoscopic surgery between 2000 and 2018 a uni- and multivariate analyses were made of demographic, pathological and surgical variables together with complementary treatments comparing purely laparoscopic resection with conversions to open surgery. Overall and disease-free survival were compared using the Kaplan-Meier method.

Laparoscopic resection of colorectal cancer is the surgical option of choice provided that established oncologic principles are guaranteed \[1-4\].

Apart from the well-known advantages of minimally invasive surgery (shorter hospital stays, lower pain levels, faster return of bowel functions and rapid return to normal daily activities) reductions in operative morbidity and mortality have been reported together with oncologic outcomes which are similar to those of open surgery \[5-7\].

However, reported conversion rates to open surgery are highly variable (7% - 30%) as is the impact of conversion on oncologic outcomes \[8-10\]). The objectives of this study were to identify the risk factors associated with conversion and to assess their impact on operative morbidity and mortality and long-term oncologic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All laparoscopic colorectal neoplasia, laparoscopic resected

Exclusion Criteria:

* Palliative and emergency procedures
XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)

The primary objective of this study is to collect accelerometer data from subjects monitored in an EMU with concurrent video EEG.

XLTCS (LNE-800) is an international multicenter prospective data collection study to gather accelerometer data. The population under the study comprises patients monitored in an Epilepsy Monitoring Unit (EMU) with concurrent video EEG and who are expected to have at least one seizure with tonic-clonic convulsive movement.

A maximum of one hundred and fifty (150) patients will be enrolled and will wear an accelerometer, and up to 6 sites may participate in this study. The total enrollment period will take approximately 2 years.

Once the accelerometer was adhered to the subject, subjects will be followed for a minimum of 2 days and a maximum of 10 days.

Subject participation will run concurrently with the EMU admission. Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.

Eligibility Criteria:
Inclusion Criteria:

1. Four (4) years of age or older.
2. Admitted to an Epilepsy Monitoring Unit for video EEG monitoring.
3. Based on medical history, expected to have at least one seizure with tonic-clonic convulsive movement during the EMU stay as determined by the investigator.
4. Capable of understanding and willing to comply with instructions and study procedures.
5. Subject or guardian must be willing and able to complete informed consent/assent.

Exclusion Criteria:

1. Based on medical history, expected to have only non-epileptic events during the EMU stay as determined by the investigator.
2. Based on medical history, known to have only absence seizures.
3. Medical or psychiatric condition that in the investigator's judgment would prevent the subject's successful completion of the study.
4. Participants with known hypersensitivity or skin sensitivity conditions that will preclude attachment of the accelerometer.
5. Participants who are also taking part in another clinical trial that could confound the results of the study; these patients can be included into the study only if LivaNova has provided written approval.
Effects of Metformin on Airway Ion Channel Dysfunction in Cystic Fibrosis-related Diabetes

The purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with CF-related diabetes (CFRD)

Up to 30 patients with CFRD on highly effective CFTR modulator therapy who meet criteria and agree to participation in the study will be placed on metformin 500mg twice daily (low) and 1000mg twice daily (normal) in a randomized order (simple randomization). There will be a dose-escalation with each dosing regimen starting with 500mg twice daily for a week, followed by 500mg in the AM and 1000mg in the PM for another week and finally followed by 1000mg twice daily until the end of normal dose cycle (in those in the normal dose portion of the crossover trial). A matching placebo pill will be utilized so participants do not know which dosing regimen, low or normal, they are on during each 14-week period. Participants will continue each dosing regimen of metformin for 14 weeks with a washout period of 2 weeks between dose changes. To minimize risk of B12 deficiency, a known side effect of long-term metformin use, we will also provide a supplement of 1000 µg oral cyanocobalamin daily for the duration of the trial.

Eligibility Criteria:
Inclusion criteria:

1. Age \>18 years with a prior diagnosis of CF.
2. Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor for 30 days prior to day 0
3. 3. Diagnosis of CFRD with evidence of continued glucose intolerance at least 6 months after starting elexacaftor/tezacaftor/ivacaftor will be based upon one of the following:

   1. Insulin use
   2. Hemoglobin A1C \>6.5%
   3. Fasting glucose \>126 mg/dl
   4. Non-fasting glucose \>200 mg/dl (random or as part of a 2-hr OGTT)

Exclusion criteria:

1. Prior lung or liver transplant
2. Use of supplemental oxygen
3. BMI \<18
4. CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
5. Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
6. Cardiac, renal (creatinine clearance \<45 mL/minute), neurologic, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in the study
7. Alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase \>1.5X the upper limit of normal; bilirubin \>3 mg/dL
8. Taking medications that interact with metformin.
9. Vitamin B12 deficiency
10. Pregnancy or lactation
11. Inability or unwillingness to comply with an approved contraceptive method during the study period (females of childbearing age)
12. Use of medications known to be strong CYP inducers or moderate to strong CYP inhibitors
13. In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the subject inappropriate for enrollment
14. Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome
Functional Magnetic Resonance Imaging of Opioid Withdrawal in Healthy Human Volunteers

Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. However, we do not know how withdrawal affects the brain. We know that a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. Through imaging of the brain by fMRI, we hope to see how opioid withdrawal, with and without the administration of ondansetron, affects brain activity.

During the study, each participant attended three separate lab-based acute opioid withdrawal sessions. The first session was undertaken in a mock MRI scanner and was designed to determine if participants could tolerate withdrawal in the scanning environment. Participants who were able to successfully and safely tolerate opioid withdrawal while in the scanner were approved to continue with the following study sessions. Participants were then pretreated intravenously (IV) with either 0.9% normal saline placebo or 8mg ondansetron. Later, participants in all sessions received IV naloxone (10mg/70kg) to precipitate opioid withdrawal. Participants were assigned to ondansetron or placebo pretreatment conditions in a randomized, double-blinded, and counter-balanced order. Objective Opioid Withdrawal Scale (OOWS) and Subjective Opioid Withdrawal Scale (SOWS) were assessed throughout the study to quantify withdrawal. Study timeline progressed as follows: T=-165, 8mg ondansetron or placebo infusion, T=-135, Morphine infusion (10mg/70kg), T=-41 preparation for MRI, T=-21, start MRI, T=-13, baseline OOWS/SOWS, T=-9, start of fMRI, T=0 Naloxone induced withdrawal, T=5, OOWS, T=15, OOWS, T=20, Retrospective OOWS.

Eligibility Criteria:
Inclusion Criteria

* Patients will be healthy male volunteers, ages 18-35.

Exclusion Criteria

* Females were excluded due to menstrual cycle modulation of opioid response.
* We will exclude individuals with Raynaud's disease or a history of coronary artery disease.