cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Characteristics of Chronic Pain Developing After COVID-19

Data on pain after COVID-19 were generally collected from hospitalized patients and only include information on acute pain conditions. However, the characteristics of the chronic pain experienced after COVID-19 are unknown. For this reason, the treatment and recommendations for patients who present with chronic pain after COVID-19 are not clear. Our goal is to determine the characteristics and risk factors of chronic pain developing in COVID-19 patients and to create specific treatment recommendations for these patient groups with further studies.

Data on pain developing after COVID-19 were generally collected from hospitalized patients and only include information on acute pain conditions seen after the ilness. It is noteworthy that headache and musculoskeletal pain were seen common in first few weeks. However, the characteristics (mechanical, inflammatory, central sensitization, anxiety-related, etc.) of the chronic pain experienced are unknown. For this reason, the treatment and recommendations for patients who present with chronic pain after COVID-19 are not clear. Our goal is to determine the characteristics and risk factors of chronic pain developing in COVID-19 patients and to create specific treatment recommendations for these patient groups with further studies.

Eligibility Criteria:
Inclusion Criteria:

1. Being over the age of 18
2. SARS-CoV-2 infection demonstrated with the PCR test (testing date irrelevant)
3. Pain developed or increased after having COVID-19

Exclusion Criteria:

1. Mental retardation or mental status not eligible to answer the questionnaires
Neurocognitive Effects of Bilateral STN Versus GPi DBS in Parkinson's Disease Patients With MCI

Purpose: This is a prospective single-center, randomized, patient and evaluator-blind clinical trial to compare the neurocognitive outcomes of globus pallidus interna (GPi) versus subthalamic nucleus (STN) deep brain stimulation (DBS) in Parkinson's disease (PD) patients with mild cognitive impairment (MCI).

Deep brain stimulation (DBS) of the globus pallidus interna (GPi) or subthalamic nucleus (STN) has been accepted as the surgical treatment of choice for patients with advanced Parkinson's Disease (PD), demonstrating improvements in motor function that exceed those achieved by medical management alone. Unfortunately, a paucity of data exist comparing non-motor outcomes between DBS of the available targets. Specifically, a high prevalence of concurrent cognitive dysfunction or early dementia exists in PD patients, and it is unclear whether DBS target selection may have differential effects with regards to cognitive outcomes in PD patients with early evidence of mild cognitive impairment Previous studies indicate that stimulation of either the GPi or STN is associated with decrements in patients' verbal fluency, visuospatial memory, as well as overall cognitive decline, but those patients were randomized without consideration for baseline neurocognitive performance and it is unclear whether these effects are due to treatment or rather the natural history of these patients.

In addition to the clinical arm of this trial, another secondary goal is to evaluate several biomarkers obtained from blood and cerebrospinal in order to determine their utility if any as prognosticators of patient cognitive and motor outcomes. Specifically, we will be evaluating levels of amyloid 1-42, total tau, phosphorylated tau 181, and brain derived neurotrophic factor in the cerebrospinal fluid as well as genotyping the apolipoprotein-E gene. These proteins and genotypes are still currently under investigation as potential biomarkers for dementia as well as neuroplasticity.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of idiopathic Parkinson's disease
* deemed an appropriate candidate for DBS surgery
* Montreal Cognitive Assessment (MoCA) score \< 25
* Neuropsychological testing with the diagnosis of Mild Cognitive Impairment

Exclusion Criteria:

* no diagnosis of Parkinson's disease
* not appropriate for DBS surgery
Respiratory Rate Accuracy - Healthy Adults

The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.

1. Start data collection system(s) and allow them to run 15 minutes prior to study start of each subject.
2. Confirm that the subject meets inclusion/exclusion criteria and has signed the current IRB- approved Informed Consent Form
3. Collect Demographic and Anthropometric Data from the subject.
4. Place Pulse Oximetry Sensors
5. Place nasal cannula for capnography recordings
6. A summary of Respiratory rate protocol.

   1. Stage 1: Subject will rest quietly and breathe at a normal comfortable rate for 40 minutes. The start and stop times will be marked on the data collection system.
   2. Stage 2: Immediately after Stage 1 is complete, the subject will start the 25 minute paced breathing protocol which will ramp from 5-45 BPM. A computer program will be used to guide the subject through the stage 2 paced breathing. The start and stop times will be marked on the data collection system.

Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female
* The subject is of any racial or ethnic group
* The subject is \> 30 kg (\>66 pounds) in weight (based on measurement)
* The subject has at least one finger with a height of 0.3 - 1.0 inch (7.6 -25.4 mm) (based on measurement)
* The subject is between 18 years and 50 years of age (self-reported)
* The subject has given written informed consent to participate in the study
* The subject is both willing and able to comply with study procedures.

Exclusion Criteria:

* The subject has a BMI greater than 30 (based on weight and height)
* The subject has a history of atrial fibrillation (self-reported)
* The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as \>3 per 30 seconds (self-reported)
* The subject has an implanted pacemaker (self-reported)
* The subject has had any relevant injury at the sensor location site (self-reported)
* The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
* The subject has a known respiratory condition (self-reported)
* The subject has a known heart or cardiovascular condition (self-reported)
* The subject is currently pregnant (self-reported)
* The subject is actively trying to get pregnant (self-reported)
* The subject is unwilling or unable to provide written informed consent to participate in the study
* The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development

Our study aimed to use an AF-predict AI-ECG alert system to help physicians identify patients who need to wear a continuous cardiac rhythm monitor for new diagnoses of atrial fibrillation (AF), atrial flutter (AFL), or atrial arrhythmia with high AF risk, including premature atrial complexes (PAC) ≥ 500/24hr, burst PACs \> 20 beats, non-sustained AF/AFL.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the inpatient department or the outpatient department
* Patients need to have at least one electrocardiogram within one year

Exclusion Criteria:

* Diagnosis of atrial fibrillation/atrial flutter
* History of atrial fibrillation/atrial flutter catheter ablation
* Patients with cardiac implantable electronic devices
* Any documented electrocardiogram showed atrial fibrillation/atrial flutter and pacing rhythm
* History of received rhythm control medications for atrial arrhythmia, including Class I and Class III antiarrhythmic drugs
* Any reasons indicate for anti-coagulant agents, including vitamin K antagonist and non-vitamin K antagonist oral anticoagulant
Pharmacokinetic and Pharmacodynamic Study of a Novel Sublingual Aspirin Tablet

The objective of the study is to compare the pharmacokinetics and pharmacodynamics of a new sublingual formulation of aspirin with that of oral aspirin when administered to healthy volunteers under fasting conditions. The test product is sublingual aspirin 80 mg manufactured by Vita Green Health Products Co. Ltd, Hong Kong and the reference product is oral aspirin 80mg tablet manufactured by Synco (HK) Ltd, Hong Kong.


Eligibility Criteria:
Inclusion Criteria:

1. Male, 18 to 55 years of age
2. Body mass index between 18-27kg/m2
3. Accessible vein for blood sampling
4. High probability for compliance and completion of the study
5. No significant abnormalities in general physical examination
6. Subjects must agree to take effective contraceptive methods to prevent his partner pregnant during the time of first dose of study medication until one week of last dose administration

Exclusion Criteria:

1. History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to screening
2. Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test at the discretion of the investigator
3. Positive results for hepatitis B at screening
4. Moderate smoker (on average more than 2 cigarettes a day within 1 month prior to the start of first dosing)
5. Moderate consumption of alcohol (on average more than one drink per day within 1 month prior to start of first dosing)
6. Blood donation of more than 350 ml within 4 weeks prior to start of first drug dosing
7. Treatment of aspirin within 4 weeks before first dosing
8. Volunteer in any other clinical drug study within 2 months prior to start of first dosing
9. Hypersensitivity to aspirin or other drug in its class
Integration of Buprenorphine Into HIV Clinical Settings - Primary Care Model (PCM)

The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.

In the site led by Dr. Altice, we compare two models of providing HIV care and buprenorphine treatment. Assignments are based on participants' city of residence. In the onsite (integrated care) model, participants receive buprenorphine, substance abuse counseling and HIV care at one location: the Waterbury Hospital Infectious Disease Clinic. In the off-site model (non-integrated care) buprenorphine induction, substance abuse counseling, and HIV care will be provided at separate locations: the Community Health Care Van (CHCV), the Yale AIDS Program, and patients' own HIV providers, respectively. Data is collected from interviews with participants, reviews of medical records, and surveys and interviews with clinicians.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Clinical diagnosis of opioid dependence
* Fluent in English or Spanish
* 18 years or older

Exclusion Criteria:

* Liver function tests (transaminase only) at five times or higher than normal level;
* Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months;
* DSM-IV criteria for alcohol dependence within the past 6 months;
* Actively suicidal;
* Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);
* Methadone dose exceeding levels allowing for safe transition to buprenorphine;
* Pregnant women and women actively trying to become pregnant;
* Clinical judgment of local site principal investigator that patient is inappropriate
Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)

This study will test an intervention that aims to prevent postpartum depression by providing new mothers with information on and resources for dealing with the disorder.

Postpartum depression (PPD) is a disorder affecting many women after delivery of a child. Up to 50% of mothers may experience some depressive symptoms after giving birth, and up to 25% of them will develop major depressive disorder. Some situational factors that place mothers at risk of PPD may be changed or minimized, including social support, the mother's efficiency in handling situational stress, and distress from physical symptoms. Preparing mothers to identify potential situational triggers of depressive symptoms, enhancing their postpartum self-management skills, and providing them access to the proper social and healthcare resources may prevent them from developing major depression. This study will test the efficacy of a brief intervention that aims to prevent PPD by preparing mothers to deal with stressful triggers and depressive symptoms.

This study will last 6 months. Participants will be randomly assigned to receive either treatment as usual or the behavioral education intervention. The intervention will involve two parts. First, after giving birth and while still in the hospital, participants will complete an education session with a social worker and receive written materials about PPD. Then, 2 weeks after discharge from the hospital, participants will receive a call from the social worker, who will conduct a needs assessment that addresses participants' physical and emotional health. If a participant is experiencing distress, the social worker will refer her to appropriate resources and will reinforce self-management skills. All participants will receive a list of community and hospital resources by mail.

Study assessments will take place at 3 weeks, 3 months, and 6 months after study entry. At these points, participants will complete a 20-minute phone survey with a research assistant about their health, mood, and basic demographic information.

Eligibility Criteria:
Inclusion Criteria:

* Patient in the Maternity Unit at Mount Sinai Hospital
* Infant has a birth weight greater than or equal to 2,500 grams
* Infant has a 5-minute Apgar score greater than or equal to 7
* Self-identifies as White or minority other than Black or Hispanic; Black and Hispanic women will be referred to a parallel study with the same protocol at Mount Sinai Hospital
* Speaks English
* Has a working telephone
Symptoms and Physical Activity in COPD Patients in Europe

An observational, multinational, cross sectional study to describe 24-hs symptoms, physical activity and their relationship in stable COPD patients in Europe

The study is a multi-centre, multi country, observational prospective cross sectional study to determine the prevalence and severity of early morning, day and night-time symptoms and physical activity patterns and to evaluate their correlation between each other and with disease severity, adherence to respiratory medications, direct costs and PROs in patients with stable COPD in Europe.

Approximately 2000 patients will be enrolled in convenient sites in several (9-12) selected countries.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 40 years or older.
2. Patient has diagnosis of COPD for 1 year or more.
3. Patient has at least one spirometry with COPD criteria, fixed ratio \<0.70 post BD, in previous 12 months
4. Patient is a current smoker or an ex-smoker with a smoking history of ≥ 10 pack- years.
5. Stable patients, as stated in medical records or patient reports during visit, defined as: without exacerbation treatment at study visit neither in the previous 2 months, and without changes in maintenance COPD treatment regimen over the preceding 2 months (avoid first consult patient)
6. Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
7. After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

1. Patient has diagnosis of sleep apnea syndrome or other chronic respiratory disease different from chronic obstructive diseases. (except for non-idiopathic pulmonary fibrosis and ACOS, only if the main diagnosis is COPD)
2. An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study
3. Patient is participating in an ongoing clinical trial that might, in the investigator's opinion, influence the assessment for SPACE study
Early Immunosuppressants in Crohn's Disease

Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 yr old
* diagnosis of Crohn's disease
* intestinal lesions demonstrated during the last 6 months
* disease duration \< 6 months
* patients at high risk of disabling disease (having 2 criteria out of the 3 following: age \< 40, perinanal disease, steroid for the first flare)

Exclusion Criteria:

* prior prescription of immunosuppressants
* severe course requiring early immunosuppressants (steroid resistance, xtensive disease, disabling perianal disease)
* intestinal resection
* active infectious disease including HIV
* hepatic failure
* renal failure
* pregnancy
* high probability of poor compliance
The Drug Interaction Between Albuvirtide (ABT) and Rifampin（RIF） in Healthy Adult Subjects

This study is designed to estimate the drug interaction between RIF and ABT. This will be a single-center, open-label, parallel study in healthy adult subjects.

The purpose of this study is to describe and compare RIF and ABT pharmacokinetics following administration of 320mg ABT and 600mg RIF.12 subjects will receive 320mg ABT on Days 1、2、3、8 (Treatment 1). And 12 subjects will receive 600mg RIF daily for 16 days from Day 1 to 16, and receive 320mg ABT on Days 7、8、9 and 14 (Treatment 2).

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age between 18 and 65 years；
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including physical examination, laboratory tests, Chest X-ray, abdominal B-ultrasound and ECG; No serious liver and kidney dysfunction, normal albumin value, and other indicators are in the normal range；
* Subjects weighing ≥50 kg and their BMI within the range 18.5-27.0 kg/m\^2 (inclusive)；
* Agrees not to consume alcohol during the study；
* Both male and female subjects and their partners of childbearing potential agree to use contraception during the study；
* Females of childbearing potential must have a negative serum pregnancy test at Screening visit prior to receiving the first dose of study drug；
* ALT、AST、ALP and TBIL≤1×ULN；
* Willing and able to participate in all aspects of the study, including use of intravenous medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria:

* A positive anti-HIV-1 antibody result；
* A positive pre-study Hepatitis B surface antigen result；
* A Positive Hepatitis C antibody result；
* Syphilis infection as manifest by positive RPR；
* History of tuberculosis (TB) or lung disease；
* Currently active severe chronic diseases, metabolic diseases (such as diabetes), cardiovascular diseases, neurological and psychiatric diseases；
* Any known allergy or antibodies to the study drug or rifampicin；
* Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study；
* Active alcohol or drug abuse；
* Participation in an experimental drug trial(s) within 30 days or 5 half-lives of the Screening Visit；
* Currently active or chronic gastrointestinal dysfunction, or liver and kidney function disorders, would affect the absorption, metabolism, and/or excretion of the study drug. Subjects with a history of cholecystectomy, pepticulcer, inflammatory bowel disease or pancreatitis should be excluded；
* Use other prescription or over-the-counter medications, including vitamins, herbal medicines, or dietary supplements, 7 days prior to dosing or 5 half-life, unless the investigator believes that the drug will not interfere with the study procedure or compromise the safety of the subject；
* Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Bishop Score and Transvaginal Ultrasound for Preinduction Cervical Assessment in Multiparas

To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in multiparous women at term.


Eligibility Criteria:
Inclusion Criteria:

* multiparous patients
* singleton pregnancy
* live fetus with vertex presentation
* intact amniotic membranes
* \> 37 weeks gestation
* absence of labor
* no previous uterine surgical procedures

Exclusion Criteria:

* major congenital anomaly
The Effect of Pregabalin on the Spinal Anesthesia

Pregabalin, an anticonvulsant is widely used for treatment of neuropathic pain. Recently, it was reported that premedication of pregabalin before general anesthesia is effective to reduce postoperative pain. Up to date, there is no study about the effect of premedication of pregabalin on the spinal anesthesia. Therefore, in this study, investigators investigate the effect of premedication of pregabalin on the spinal anesthesia.

In this study, investigators investigate the effect of premedication of pregabaline 150 mg on the spinal anesthesia. Two hours before spinal anesthesia, placebo pill was administered to patients in the group C and pregabalin 150 mg was administered to patients in the group P, respectively. Time for the onset of blockade, cephalad level of analgesia and duration of analgesia were measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients of American Society of Anaesthesiologists Grades I and II

Exclusion Criteria:

* Patients with infection at the puncture site, coagulopathy, having true hypersensitivity to drugs used, diabetes and hypertension, psychiatric and neurological diseases