cyrilzakka/clinical-trials huggingface dataset:
Study Assessing the Safety and Therapeutic Effect of Buprenorphine in MDD Patients

The primary objective of this study is to assess the therapeutic effect of Buprenorphine in MDD population.

The secondary objectives of this study are to assess the therapeutic effect, the feasibility and safety of buprenorphine in a MDD population.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients and inpatients
* Men and women 18-68 years of age.
* Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.
* Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.
* The patient did not respond to at least one antidepressant medication given for an accepted dose and duration.
* If currently taking Benzodiazepines, the patient must be clinically appropriate to discontinue treatment with those agents, and able to tolerate no benzodiazepines during the study period.
* Capable and willing to provide informed consent
* Able to adhere to the treatment schedule.

Exclusion Criteria:

* Depression secondary to a general medical condition.
* History of substance abuse or dependence within the past 6 month (except nicotine and caffeine).
* All antidepressant medications, must have been in stable dosage for at least 6 weeks prior to entry into the study, with no anticipation of change over the duration of the study.
* Use of any medication(s) listed on the Excluded medication list within the time that mansion for each medication on the list.
* Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features • Bipolar disorder • Eating disorder
* Presence (within 12 months of baseline) of a personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
* Use of a Monoamine Oxidase Inhibitor (MAOI) within 2 weeks of the screening visit
* Use of a CYP3A4 Inhibitors and CYP3A4 Inducers within 2 weeks of screening visit.
* Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 6 month
* Known or suspected pregnancy
* Women who are breast-feeding
* Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
* Patients with severe respiratory insufficiency or asthma - anticipation require examination of pulmonologist.
* Patients with severe hepatic or renal insufficiency.
* Patients with history of head injury, increased intracranial pressure, hypotension, prostatic hypertrophy or urethral stenosis- anticipation require examination of neurologist.
Endovascular Limb Salvage in Trinidad and Tobago

The purpose of this study was to investigate limb salvage rates in patients with critical limb ischemia after endovascular revascularization.

A retrospective analytical study assessing limb salvage attempts and outcomes in 157 consecutive patients with CLI and tissue loss. It was for the period of May 2018 and May 2021 at Eric Williams Medical Sciences Complex.

The objectives of this study include Primary: To determine the success rate of target lesion revascularisation using endovascular limb salvage techniques in Critical limb ischemia patients with minor and major tissue loss.

Secondary objectives included:

1. to compare and contrast limb salvage rate to international standards
2. to assess the maintenance of amputation-free survival and bipedal ambulation
3. to evaluate the angiosome concept and its effect on wound healing
4. to evaluate primary patency rate
5. to assess the overall morbidity and mortality of endovascular treatment for critical limb ischemia
6. to observe the outcomes of various wound healing techniques and its efficacy

Eligibility Criteria:
Inclusion Criteria:

CLI patient with tissue loss who underwent infra inguinal endovascular limb salvage

Exclusion Criteria:

CLI patients with tissue loss who had surgical bypass CLI patients with no tissue loss
A Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228A in healthy subjects.

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-228A compared with coadministration AD-2281 and AD-2282 in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit
* The Age equal to or greater than 19 in healthy volunteers at the time of screening visit

Exclusion Criteria:

* Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
* Other exclusions applied
A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients

The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.

This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.

Eligibility Criteria:
Key Inclusion Criteria:

* A clinical diagnosis of moderate to severe COPD according to the following criteria:

  * Current or ex-smokers with at least 10 pack-year smoking history
  * Post-bronchodilator FEV1 \>/= 35% and \</= 80% of predicted normal value
  * Post-bronchodilator FEV1/FVC (forced vital capacity) ratio \<0.70
  * Post-bronchodilator improvement in FEV1 \>/= 100 mL

Key Exclusion Criteria:

* Current evidence or recent history of clinically significant or unstable disease (other than COPD)
* Current diagnosis of asthma
* Presence of history of clinically significant allergy requiring treatment
* COPD exacerbation within 6 weeks
* Use of daily oxygen therapy \> 10 hours
* Thoracotomy with pulmonary resection
* Use of systemic steroids within 3 months
* Lower respiratory tract infection within 30 days
* Upper respiratory tract infection within 30 days requiring treatment with antibiotics
* History of tuberculosis, bronchiectasis, or other non-specific pulmonary disease
* Prolonged corrected QT (QTc) interval \>450 msec males and \>470 msec females, or history of long QT syndrome
Objective Quality of Life Detection Validation

The purpose of this research study is to:

* Collect data to use in the development of a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) such as deep brain stimulation (DBS) and drug pumps.
* Determine the level to which specific activities reflect with quality of life in individuals with PD.
* Obtain feedback from individuals with Parkinson's disease and clinicians on the usability of the system.

The investigators aim to develop a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) and identify when AT recipients are in need of a therapy adjustment. This system will integrate ambulatory PD monitoring with context aware activity detection as the daily activities a patient performs are often the best predictors of quality of life (QoL). In this study the Kinesia 360 system will collect motion data to measure tremor, bradykinesia (slow movement), and dyskinesia (involuntary movements) from individuals with PD to track their symptoms throughout the day. A smartphone will collect information on subject location and activity using the GPS, accelerometers, and microphone within the phone to find correlations between activity and patient wellness. This data will be used to improve detection over time and predict whether patients are candidates for advanced therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent
2. Diagnosed with PD
3. Hoehn and Yahr scale I-III
4. Able to travel to Great Lakes NeuroTechnologies
5. Ambulatory and capable of using the Kinesia 360 system
6. Able to understand and follow instructions regarding using the device

Exclusion Criteria:

Any subject that does not meet the subject selection criteria will be excluded from this study. Children will be excluded from this study due to the fact that they are unlikely to have PD. Subjects that are not capable of functioning independently or are so symptomatic as to compromise their safety will also be excluded.
Polyphenol Metabotypes in People with Diabetes Type 2

This cross-sectional study seeks to characterize the overall polyphenol metabotype in patients with T2DM in comparison to age-matched individuals without diabetes. Additionally, the study aims to identify factors that influence the polyphenol metabotype (transit time and gut microbial capacity to degrade polyphenols in particular).


Eligibility Criteria:
Inclusion Criteria:

* all participants
* between 40-85 years
* age-matched individuals without diabetes
* BMI between 18.5-30
* no metabolic syndrome
* persons with T2DM
* at leats 2 years of clinical diagnoses of T2DM
* stable medication use for at least 1 month

Exclusion Criteria:

* pregnancy of breastfeeding
* in last month
* acute use of anti/pre/probiotics
* start of new drug or dietary supplements
* major changes in diet
* major lifestyle changes
* diseases
* Gastrointestinal diseases (inflammatory bowel disease)
* Bariatric surgery
* Other forms of diabetes (cystic fibrosis/MODY/T1DM)
* Heart problems (NYHA 3/4) or previous cardiovascular events
* Liver problems: non-alcohol steatohepatitis (NASH) and cirrhosis
* Lung problems (COPD - GOLD 3/4), cystic fibrosis
* Uncontrolled thyroid function disruption in the past 6 months
* Intake of coumarin derivatives and direct oral anticoagulant medication
* Anti-cancer treatment: chemo-/immunotherapy
* Immonosuppressants (transplant)
* Antiepileptic drugs
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.
* Age \> 18 years of age, both genders are eligible.
* Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.
* At least one measurable lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Any one of the following high-risk factors is present: MIPI score of 4-11, Ki67 \> 50%, TP53 abnormality, blastic or pleomorphic variation.
* Patients who are not suitable candidates for autologous hematopoietic stem cell transplantation.
* Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\^9/L, absolute neutrophil count ≥1.5×10\^9/L, hemoglobin ≥90g/L, platelet count ≥75×10\^9/L. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol/L.
* The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.
* Willing and able to participate in all required assessments and procedures of the study protocol.

Exclusion Criteria:

* Patients who have previously received treatment with BTK inhibitors.
* Patients with severe complications or serious infections.
* Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
* Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.
* HIV-infected individuals.
* Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.
* Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.
Stimgenics Open-Label, Post Market Study

The purpose of this investigational study is to study the effects of Stimgenics Spinal Cord Stimulation (SGX-SCS) in subjects with chronic, intractable pain of the trunk with lower limb pain, including unilateral or bilateral pain associated with the following conditions: failed back surgery syndrome, intractable low back pain and leg pain.

This is an open-label prospective, randomized, controlled, multi-center study comparing Stimgenics Spinal Cord Stimulation (SGX-SCS) programming approach to Standard SCS programming approach.

Subjects meeting study entrance criteria will be randomized in a 1:1 ratio to one of two study treatment groups:

* Test treatment group with SGX-SCS programming approach
* Control treatment group with Standard SCS programming approach

Data at follow-up visits will be compared between the two treatment groups, and in reference to baseline assessments collected at the beginning of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Be a candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
2. Has an average back pain intensity ≥ 5.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment with moderate to severe chronic leg pain
3. Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
4. Be willing and capable of subjective evaluation, read and understand English-written questionnaires, and read, understand and sign the written inform consent in English.
5. Be 18 years of age or older at the time of enrollment
6. Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
7. Be willing to not increase pain medications from baseline through the 3-Month Visit
8. Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

1. Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
2. Be concurrently participating in another clinical study
3. Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
4. Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
5. Has mechanical spine instability as determined by the Investigator
Investigating Engagement Patterns and Participation Trends Among Liposarcoma Patients

The study seeks to delve into the firsthand experiences of patients diagnosed with liposarcoma who partake in a separate clinical research featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

By joining this clinical study, individuals have the unique opportunity to contribute to the betterment of future liposarcoma patients and play an active role in advancing medical research.


Eligibility Criteria:
Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical research
* Patient has been diagnosed with liposarcoma
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant
Relationship of Peritoneal Solute Transport Rate With VEGF in Children Undergoing Peritoneal Dialysis

Vascular endothelial growth factor(VEGF) appears to play a central role in the process leading to peritoneal angiogenesis and increased level of VEGF may contribute to high peritoneal small-solute transport rate (PSTR) in continuous ambulatory peritoneal dialysis (CAPD) patients in adult. In children, lymphatic absorption of solute is greater than adult. VEGF-C is related to lymphogenesis, but its role in peritoneal solute transport rate is not known. In this study, we evaluated possible relationship between dialysate VEGF and VEGF-C levels and PSTR in children.

There was significant correlation between dialysate VEGF165 and VEGF-C levels and significant correlation was noted between dialysate VEGF165 and PSTR. Interestingly, dialysate VEGF-C levels had significant correlation with PSTR. High PSTR seems to be related to elevated VEGF-C and VEGF.

Eligibility Criteria:
Inclusion Criteria:

* chronic renal failure
* children
* peritoneal dialysis

Exclusion Criteria:

* acute illness
Intradialytic High-Intensity Interval Training in Hemodialysis Patients

Chronic Kidney Disease (CKD) is defined as a chronic, progressive degeneration state in the regulation of the fluid-electrolyte balance of the kidney and metabolic-endocrine functions as a result of the glomerular filtration rate (GFR) falling below 60 ml/min/1.73 m², regardless of the etiology of the kidney disease. End Stage Renal Failure (ESRD) is the last stage of CRF and is a life-threatening condition. Although the majority of ESRD patients survive on dialysis, their quality of life and functional capacity decrease due to uremic cardiomyopathy, cardiovascular diseases, anemia, diabetes mellitus, bone diseases, deconditioning, fatigue, weakness, inactivity and accompanying psychological problems.

Rehabilitation program including exercise in CKD patients; The program, which is performed under observation on non-dialysis days, can be applied in three ways: the (intradialytic) rehabilitation program performed during hemodialysis in the dialysis unit, and the home exercise program. Intradialytic exercise (IDE) is defined as exercise training performed during the hemodialysis session to increase the patient's strength and endurance and thus target various physiological and psychosocial parameters. Three types of exercises are generally recommended in the exercise program for dialysis patients. These are aerobic exercise, strengthening exercise, and combined aerobic and resistance exercise program. Aerobic exercise (both on dialysis and on non-dialysis days) is the most common type of exercise used in hemodialysis patients. It is stated that physical exercise improves the exercise capacity, muscle strength, functional capacity and quality of life of patients receiving dialysis treatment, provides blood pressure control, reduces the risk of diabetes development and cardiovascular disease, alleviates depression and anxiety symptoms, increases survival and dialysis efficiency.

When the literature is examined, no study has been found that examines how the application of high-intensity intermittent exercise training, which has very important advantages, in the intradialytic process has an effect. Therefore, the aim of our study is to compare the effects of intradialytic high-intensity intermittent exercise training and moderate-intensity exercise training on dialysis effectiveness, functional capacity and quality of life in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 20-65
* Having Stage 5 (ESRD) CRF according to GFR
* Literate
* Cooperative
* Dialysis treatment for at least three months

Exclusion Criteria:

* History of myocardial ischemia in the last 6 months
* Uncontrollable diabetes mellitus,
* Uncontrollable hypertension
* Heart failure
* Malignant disease
* Mental retardation
* Illiteracy
* Uncooperative
* Neurological or orthopedic disability
Diabetes Self-Management Plus Tai Chi Easy

The purpose of this project is to increase access to diabetes care and education for adults aged 40-64 years old who are diagnosed with Type 2 Diabetes Mellitus and are unable to attend education and support classes due to their work situation. This project will use an established, well-known program for Diabetes Self-Management Education and Support (DSMES) and combine it with Tai Chi Easy (TCE)™ to enhance physical health, psychological health, and health behaviors. Participants will be asked to attend 45 minutes of DSMES and 45 min of TCE twice a week for 6 weeks. All classes will be recorded and available online and can viewed at a time when it is most convenient to accommodate working adults. Participants will be asked to complete survey questionnaires online, at the beginning and end of the program; and have a smart phone to connect with a smart ring during the 6-week DSMES+TCE program. After the program is done, participants will be asked to return the smart ring. Upon receipt of the smart ring, they will receive a give a gift card to thank them for their participation in the program.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with T2DM
* any sex/gender
* any race/ethnicity
* any socioeconomic group
* has a smartphone
* receives care in a Federally Qualified Healthcare Center in Southern Arizona

Exclusion Criteria:

* Individuals with T1DM
* Individuals with gestational DM
* Individuals with pre-diabetes
* children
* pregnant women
* Individuals unable to provide informed consent
* Individuals with other serious co-occurring health condition (e.g., active cancer treatment)
Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software

To evaluate the safety and effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed and manufactured by Wuhan ENDOANGEL Medical Technology Co., Ltd.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤ age ≤ 75 years old, male or female;
* Subjects with colonoscopy diagnosis and screening needs;
* Sign the Written Informed Consent Form;
* With full capacity for civil conduct.

Exclusion Criteria:

* History of acute myocardial infarction (within 6 months), severe heart, liver, and renal insufficiency or mental disease;
* Patients who are taking aspirin, warfarin, and other anticoagulants;
* Patients with inflammatory bowel disease, or polyposis syndromes, or confirmed or highly suspected colon cancer;
* History of colorectal surgery;
* Patients with familial adenomatous polyposis;
* Pregnant women (if the subject is a woman of reproductive age and cannot confirm whether she is pregnant, a pregnancy test is required);
* Patients who are participating in clinical trials of other drugs or medical devices;
* Patients who are not eligible to participate in this clinical trial in the opinion of the investigator.