cyrilzakka/clinical-trials huggingface dataset:
Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+

The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients.

Among HIV-1-infected patients, diagnosis of fibromialgy has increased over the last years . Appropriate identification of firomialgy in these patients is challenging and sometimes can be more complicated than in HIV-negative population. Concomitant infectious processes and symptoms due to HIV infection itself need to be ruled out before establishing a formal diagnosis.

The treatment of this disease frequently includes muscular relaxants , pain-killers, anti-inflammatories and antidepressives despite no drug is formally indicated for this pathology.

Duloxetine approved indications include both treatment of major depressive disorders (MDD) and diabetic neuropathic pain. Recent studies in HIV negative patients show efficacy to control pain and depressive symptoms in patients with fibromialgy The main purpose of this pilot study is to assess the efficacy of duloxetine in HIV-1-infected patients with fibromialgy.

The main purpose of this pilot study is to assess the efficacy of duloxetine in HIV-1-infected patients with fibromialgy or chronic fatigue syndrome presenting with widespread pain.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years old and more. Age +18 years old.
2. Documented HIV-1-infection.
3. Former diagnosis of fibromialgy.
4. History of good compliance with visit schedule and medication intake.
5. Patients voluntary signed the informed consent.

Exclusion Criteria:

1. Pregnant or breast-feeding females
2. Suspicion of intolerance to duloxetine.
3. History of any clinical condition that, in the Investigator's criteria, could potentially reoccur with the suggested change of therapy (sarcoma, lymphoma, etc).
4. Concomitant condition that could mimic fibromialgy (lupus, endocrine diseases, muscular diseases, multiple sclerosis)
5. or Acute illness within 15 days prior to the inclusion
6. Patients with major depressive disorder with psychotic symptoms, major depressive disorder melancholic type or bipolar disorder. Patients with other depressive disorders can be included (dysthymic disorder and depressive disorder NOS)
7. Anorexia or nervous bulimia
8. History or suspected drug or alcohol abuse.
9. Glaucoma
10. History of heart disease including cardiac arrhythmias
11. Severe obesity (body mass index \> 45).
12. Concomitant medication with IMAOS, cimetidine or quinolonas
13. Patients with hepatic or renal serious failure (Creatinin clearance \<30 ml/min)
14. Patients with Hypericum perforatum as a concomitant treatment.
A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT

The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.

This is a two stage study.

Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.

Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, 18 years of age or older
2. Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
3. Qualifying intraocular pressure (IOP) in at least one eye at Baseline

Exclusion Criteria:

1. Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
2. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
3. Females who are pregnant, nursing or planning a pregnancy
4. Presence of any abnormality or significant illness that could be expected to interfere with the study.
Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy

Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement treatment efficacy when compared to patients with chronic pain managed with oral or systemic opioid therapies. Our secondary hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement in treatment efficacy when compared to patients with chronic pain who are managed with non-opioid therapies.


Eligibility Criteria:
Inclusion Criteria:

* Males or females greater than 18 years of age with legal decision making ability.
* Subjects receiving care at the Brigham and Women's Hospital Pain Management Center.
* Subjects must have a history of chronic pain \> 6 months and must have been a patient in the BWH Pain Center \> 6 months.

Exclusion Criteria:

* Pain due to metastatic cancer or to cancer that is locally invasive
* Patients with a primary diagnosis of spasticity, receiving intrathecal baclofen
* Evidence of psychosis or hospitalization for psychiatric illness during study
* Pregnancy at any time during the study
* Altered mental status that would make subject unable to complete outcome questionnaires
* Significant chronic medical illness, such that requires frequent hospitalization or health care utilization (ie: renal failure requiring dialysis, heart failure or cardiac disease requiring surgery or intensive care admission, pulmonary disease requiring intubation or hospitalization, pancreatitis requiring hospitalization, vascular disease requiring surgery or hospitalization, etc.)
Effects of Exercise Training on Patients With Long COVID-19

Effects of Exercise training on Patients With Long COVID-19, is a single-center, randomized, controlled trial designed to evaluate the effects of 4- week aerobic exercise administered to patients with long COVID-19 symptoms. The main outcome is cardiopulmonary fitness and long COVID-19 symptom improvement. Quality of life, depression, anxiety, insomnia status and perceived stress will also be assessed before and after the exercise program.

Long COVID-19 symptoms are characterized by systemic deterioration of the entire body, leading to significant physiological and functional imbalances. Common symptoms may be related to decreased short-term or long-term exercise capacity resulting from organ tissue damage, such as myocardial and pulmonary dysfunction. Currently, even vaccines and medications cannot effectively address the long-term consequences of COVID-19. Exercise training has been proven to improve exercise capacity and quality of life during the recovery period for various chronic disease patients.

A total of 24 patients will be included in the study. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 4-week aerobic exercise training or attention control.The main objective is to assess the effects of a 4-week aerobic exercise training program on cardiopulmonary fitness and long COVID-19 symptom improvement. Secondary objectives include: to characterize baseline and intervention-related changes in quality of life, depression, anxiety, insomnia status and perceived stress status.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old;
2. Complicated with at least one of the following symptoms within 3 months after COVID-19 infection, lasts for at least 2 months, and is not caused by other diseases: Cough, fatigue, memory loss, concentration problems, palpitation easily or rapid heartbeat, chest tightness or chest pain, pain (head, limbs, lower back), slow thinking or reaction, eye discomfort or decreased vision, shortness of breath or difficulty breathing at rest, diarrhea, loss of taste or decreased taste, insomnia, hair loss, other new symptoms after COVID-19 infection
3. Tested positive for COVID-19 quantitative Reverse Transcription-Polymerase Chain Reaction (RT-PCR) or antigen kit and turned negative for at least 4 weeks before inclusion;
4. The patient understands and signs the informed consent form.

Exclusion Criteria:

1. Infected with COVID-19 within one month
2. Conditions that may be worsened by exercise, such as acute cardiac insufficiency, exercise asthma, epilepsy, etc.
3. Physical disabilities caused by bone and joint or neuromuscular diseases,
4. Complicated with other serious diseases (such as unstable angina, resting oxygen saturation \< 93%, untreated heart failure, uncontrolled arrhythmia, uncontrolled hypertension, uncontrolled type 2 diabetes),
5. Women during pregnancy and lactation;
6. Patients was assessed unsuitable for this study.
Clinic or Self-Sampling for Cervical Cancer Screening

Objective: The aim of this project was to determine the effect of clinic or self-sampling on attendance, attitudes, and anxiety in cervical cancer screening.

Introduction: Persistent infection with high-risk HPV strains is the main cause of cervical cancer.

Objective: The aim of this study was to determine the effect of clinic or self-sampling on cervical cancer screening participation, attitudes and anxiety in women.

Method: The study was conducted as a descriptive and randomized controlled study between October 2022 and December 2023 in Ödemiş ASM No. 2, Ministry of Health, Republic of Turkey. The first phase of the study was conducted with 309 women and the "Introductory Information Form" and "Attitude Scale for Early Diagnosis of Cervical Cancer" were used to evaluate participation and attitudes towards cervical cancer screening. The second phase of the study was conducted as a randomized controlled trial with 110 women in the experimental (n=55) and control (n=55) groups. The women in the experimental group were trained before the procedure and were allowed to take samples from the vaginal area on their own. The women in the control group were sampled from the cervical region by the clinician. Both groups were pretested before the procedure using the "Descriptive Information Form" and the "State Anxiety Inventory" to measure anxiety. After the sampling procedure, the post-test was administered to the experimental and control groups using the "State Anxiety Inventory".

Results: According to the screening method preferences of the women, 34% (n=105) preferred a self-test, 18.4% (n=57) preferred a test performed by a clinician in a clinic, 3.9% (n=12) preferred no method, and 43.7% (n=135) preferred both methods. In the study, it was found that the self-test option increased participation in screening. The mean total score of the women was found to be 102.896±5.660. This result shows that women have high positive attitudes towards early diagnosis of cervical cancer. In the second stage of the study, it was observed that the descriptive characteristics of the experimental and control groups showed homogeneous distribution. While there was no significant difference between the experimental and control groups in terms of anxiety level in the pretest, it was found that the control group had a significantly higher anxiety level in the posttest.

Conclusion: In this study, it was observed that women had positive attitudes towards cervical cancer screening, self-sampling increased participation in screening and decreased anxiety levels.

Eligibility Criteria:
Inclusion Criteria: Must be able to perform self-test

Exclusion Criteria: pregnancy, diagnosing the cervix
GORE Flow Reversal System and GORE Embolic Filter Extension Study

The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.

Physicians will have the opportunity to select which embolic protection device, the GORE Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting procedure.

This study is not designed to compare study endpoints between the two treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Patient, or patient's legal representative, is able and willing to provide informed consent.
* Patient must be at least 18 years of age or older.
* Patient will be selected and treated according to the GORE Flow Reversal System Instructions for Use (IFU) or the GORE Embolic Filter IFU.

Exclusion Criteria:

* Patient is contraindicated for the embolic protection device arm they are selected by the investigator to receive: Either Per the GORE Flow Reversal System IFU if the GORE Flow Reversal System is selected OR Per the GORE Embolic Filter IFU if the GORE Embolic Filter is selected

If the patient is contraindicated for both arms (devices) they may not be enrolled.
Comparison Of Measured To Predicted Resting Metabolism

The purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry.

Resting metabolic rate (RMR) describes the number of calories a person utilizes while at rest. The gold standard measurement is via inspired and expired air using a metabolic cart. However, researchers have established estimation equations and the use of body composition analysis to predict RMR when a metabolic cart is unavailable. The accuracy of the predicted equations and whole-body bioelectrical impedance (BIA) machines that produce this data is unknown. Therefore, the purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry.

Aim 1: to compare measured RMR from indirect calorimetry to values provided by the InBody 770 BIA machine and to established gender and age-appropriate prediction equations.

Aim 2: to compare RMR measured from indirect calorimetry using a metabolic cart (Gold Standard) to the Medgem handheld indirect calorimeter (FDA approved device).

Eligibility Criteria:
Inclusion Criteria:

* Men \& women, aged 18-60

Exclusion Criteria:

* Have any known or suspected metabolic diseases such as diabetes, thyroid disorder, or high cholesterol
* Have any known or suspected cardiovascular or pulmonary diseases such as hypertension
* Are currently on beta blockers, taking antihypertensives, or antidepressants
* Current smoker or quit less than a year ago
* Unwilling to provide finger stick and urine sample
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy

To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than patients who have epidural anesthesia with PCA (EPCA).


Eligibility Criteria:
Inclusion Criteria:

* Female patients ≥18 years old
* Undergoing non-emergent exploratory laparotomy with the Gynecologic Oncology service
* No clinical or laboratory evidence of end organ failure:

If available:

* Platelets \> 100 K/cumm
* Hemoglobin \> 8.0 g/dl
* Serum creatinine \<1.5 mg/dl
* Creatine clearance (CrCl) ≥30 based on the original Cockcroft-Gault formula adjusted for weight.
* INR \<1.3 reference range
* All other lab values obtained as part of general preoperative work-up must be ≤1.5x normal laboratory value.

Exclusion Criteria:

* Patients not giving consent to participate in the study
* Unable to complete self-report pain questionnaire
* Moderate to severe kidney or liver failure per lab criteria as outlined
* Inability to hold anticoagulant medications for a safe amount of time per current ASRA guidelines
* Contraindication to lumbar puncture or epidural placement, per acute pain management service such as known coagulopathy or history of clotting disorders, history of scoliosis or lumbar fusion, infection at site of entry, or current systemic infection
* Complete bowel obstruction
* Contraindication to intravenous lidocaine
* No known pregnancy and not lactating.
* Currently septic
* Patient currently taking more than 30 MME a day preoperatively (for \>30 days)
* BMI \>50kg/m2
* Intolerance/contraindication or allergy to receiving non-steroidal anti-inflammatory drugs or acetaminophen or any other medications in the pre-operative order set
Rehabilitation in Patients With Pulmonary Fibrosis

This study aims to explore the effects of exercise rehabilitation on the functional status of patients with pulmonary fibrosis, assessing both physical and psychological dimensions of health. By identifying significant improvements, we can contribute to the development of comprehensive rehabilitation strategies that enhance patient outcomes and foster a better quality of life for those affected by this challenging condition

program is essential for understanding its efficacy. Functional status refers to an individual's ability to perform daily activities and maintain independence, which is particularly important for patients with chronic illnesses like PF. Evaluating changes in functional status not only helps in determining the success of rehabilitation efforts but also provides insights into the overall impact of exercise on patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 1. \*\*Diagnosis of Pulmonary Fibrosis:\*\*
* Patients must have a confirmed diagnosis of pulmonary fibrosis, as determined by clinical evaluation and imaging studies (e.g., high-resolution computed tomography).

  2. \*\*Age Range:\*\*
* Participants should be adults aged 18 years and older to capture the adult population affected by the disease.

  3. \*\*Stable Clinical Condition:\*\*
* Patients must be in a stable clinical condition, defined as no exacerbations or significant changes in treatment for at least four weeks prior to enrollmen

Exclusion Criteria:

* 1. \*\*Other Significant Lung Diseases:\*\*
* Patients with concurrent respiratory conditions (e.g., chronic obstructive pulmonary disease, asthma, or lung cancer) that could confound the results.

  2. \*\*Acute Exacerbations:\*\*
* Individuals experiencing an acute exacerbation of pulmonary fibrosis or any significant respiratory illness within four weeks prior to enrollment.

  3. \*\*Severe Comorbidities:\*\*
* Patients with severe cardiovascular disease, uncontrolled hypertension, major neurological disorders, or musculoskeletal problems that would impede participation in exercise.

  4. \*\*Cognitive Impairment:\*\*
* Individuals with cognitive impairments that prevent them from understanding the study procedures or following the rehabilitation program.
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

This study aims to identify and assess new CMR techniques that can improve current CMR protocols.

The aim of this study is to develop a comprehensive 10-minute protocol based on function and myocardial tissue characterization without the need for contrast injection, which can be standardized for 70% of cardiac patients.

To test this 10-minute CMR protocol for its ability to significantly improve diagnostic decision-making and to reduce cost.

To test its clinical feasibility, performance and cost-effectiveness in different populations including: Non-ischemic cardiomyopathies (-)OS-CMR and Ischemic Heart Disease and CAD (+)OS-CMR

Eligibility Criteria:
Healthy Volunteers

Inclusion Criteria:

* Age: \> 18y, Informed consent No known current or pre-existing significant medical conditions that would affect the cardiovascular or respiratory system

Exclusion Criteria:

* General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.Regular nicotine consumption during the last 6 months

Patients

Inclusion Criteria:

* Age: \>18 y, Informed consent, Clinically indicated CMR exam

Exclusion Criteria:

* General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.

Regular nicotine consumption during the last 6 months
Muscle Function and Pelvic Stability While Walking in Patients With Symptomatic Lumbar Spinal Stenosis

This study is to quantify changes in muscle activity and pelvic stability during prolonged walking in patients with symptomatic lumbar spinal stenosis (sLSS) and healthy control subjects and to determine their association with the severity of the stenosis and the crosssectional area and fatty atrophy of lumbo-pelvic-hip muscles.


Eligibility Criteria:
Inclusion Criteria patients:

* Diagnosed symptomatic lumbar spinal stenosis
* Availability of lumbar MR images
* Scheduled for decompressive surgery at the University Hospital Basel

Exclusion Criteria patients:

* Prior decompressive surgery
* Body Mass Index (BMI) ≥ 35 kg/m2
* Additional pathologies that influence the mobility of the pelvis
* Use of walking aids
* Inability to provide informed consent

Exclusion Criteria healthy control subjects:

* BMI ≥ 35 kg/m2
* Pain in the lower extremity or lower back in the previous 6 months
* Prior surgery of the lumbo-pelvic-hip complex
* History of claudications
* Neurological or orthopaedic conditions that may influence gait
* Inability to provide informed consent
Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation

The objective of this trial is to compare the efficacy of electroacupuncture versus transcutaneous electric nerve stimulation for functional constipation

Both electroacupuncture(EA) therapy and transcutaneous electric nerve stimulation(TENS) are safe and effective for functional constipation, but no head to head comparing trial was conducted.

Methods：102 participants with functional constipation will be recruited and randomly allocated into the EA group and the TENS group.Participants in both groups will receive EA or TENS treatment at Tianshu(ST 25), Fujie(SP 14) and Shangju xu(ST 37) 3 times a week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Conforming to the criteria for the diagnosis of functional constipation in Rome III standard;
2. Aged of 18 to 75 years;
3. No medication for constipation has been used for at least 2 weeks before treatment. Except for emergency treatment, it has not received acupuncture treatment for constipation in the past 3 months, and has not participated in other ongoing clinical research.

Exclusion Criteria:

1. Constipation caused by irritable bowel syndrome and organically or medicated; secondary to endocrine, metabolic, neurogenic, or surgical constipation;
2. Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment.
3. Pregnant or lactation patients;
4. Subjects with abdominal aortic aneurysm, abnormal enlargement of liver and spleen and so on.
5. Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time.
6. Subjects installed with the cardiac pacemaker.