cyrilzakka/clinical-trials huggingface dataset:
A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction

Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily provide written informed consent prior to the conduct of any study-related procedures
* Male or female, 18-65 years of age
* Meet DSM-IV-TR criteria for current opioid dependence
* Females of childbearing potential or a fertile male, must use a reliable means of contraception

Exclusion Criteria:

* Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
* Received any medication-assisted treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
* Current diagnosis of chronic pain requiring opioids for treatment
* Candidates for short-term opioid treatment (\<6 months) only, or opioid detoxification therapy
* Pregnant or lactating female?
* Previous hypersensitivity or allergy to BPN, EVA-containing substances, or naloxone
* Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* History of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin
* Meet the DSM-IV-TR criteria for dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
* Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent
* Current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study
* Exposure to any investigational drug within the previous 8 weeks
* Previous exposure to Probuphine, or prior implantation with a placebo implant in the context of a Probuphine clinical trial
* Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X the upper limit of normal, alanine aminotransferase (ALT) levels greater than or equal to 3 X the upper limit of normal, total bilirubin greater than or equal to 1.5 X the upper limit of normal, or creatinine greater than 1.5 X upper limit of normal on the screening laboratory assessments
* Clinically significant low platelet count on the screening laboratory assessments
Influenza Associated Aspergillosis In-depth Investigation

This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU.

This trial is aimed to study the immunological and pathological characteristics of influenza versus non-influenza severe community-acquired pneumonia patients in ICU, and correlate findings with occurrence of secondary invasive pulmonary aspergillosis infection.

All consecutive patients aged 18 or older admitted to ICU during the inclusion period with respiratory distress due to influenza positive/negative community acquired pneumonia (CAP) will be included.

Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years, admitted to ICU with respiratory distress with microbiologically confirmed diagnosis of influenza (for inclusion in the influenza group)
* All patients older than 18 years, admitted to ICU for respiratory distress due to community- acquired pneumonia , with a microbiologically confirmed absence of influenza (for inclusion in the control group)

Exclusion Criteria:

* Age \< 18 years old
* Pregnant women
* No informed consent
Effect of Acute Exercise on Endothelial Function in Patients With Type 1 Diabetes.

The aim of this study is to evaluate the effect of a single session of aerobic plus resistance exercises on the vascular function of patients with type 1 diabetes mellitus. The investigators hypothesize that a single aerobic exercise session would promote greater benefit in vascular function of patients with type 1 diabetes, as compared with the resistive exercise session.

The aim of this study is to compare the effect of endurance and resistance exercises on endothelial function in patients with type 1 diabetes mellitus (T1DM). For this purpose, the sample size will consist of 15 patients with DM1, aged between 18 and 45 years, which will undertake the two types of exercises, randomly distributed. Ergospirometry testing will be performed in order to assess possible contraindications to the proposed protocol as well as functional capacity, which will be used in prescription of the endurance exercise session. Similarly, a strength maximal testing will be conducted and used in the prescription of the resistance exercise session.

The endothelial function will be evaluated by vascular reactivity of the forearm and circulating endothelial progenitor cells (EPC) counting. To analyze the vascular reactivity of the forearm, non-invasive venous occlusion plethysmography will be used, whereas flow cytometry method will be used to the analysis of the number of circulating EPC. The endurance exercise session will consist of 40 minutes of cycling on heart rate corresponding to 60% of VO2 max. The resistance exercise session will last 40 minutes, consisting of 4 sets of 12 repetitions at 60% of 1RM, in four exercises for lower limbs. The research will be performed at the Exercise Pathophysiology Research Laboratory of the Hospital de Clinicas de Porto Alegre. The investigators expect to find greater increase in the number of circulating EPC after the endurance exercise session, when compared to the benefits obtained from a session of resistance exercise. Likewise, it is expected to find greater benefits in relation to vascular reactivity of the forearm after a session of endurance exercise when compared to a session of resistance exercise. Considering that most part of the studies that analyze the effects of physical exercise on vascular function does not involve patients with DM1, this project aims to provide a clearer picture of the benefits of different exercises in the acute response of endothelial function in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Male gender
* 18-45 years old

Exclusion Criteria:

* Severe autonomic neuropathy
* Diabetic nephropathy established
* Chronic kidney failure
* Limb amputation
* Disabling peripheral arterial disease
* Coronary artery disease
* Heart failure
* Diabetic proliferative retinopathy
* Neoplasms
* Smokers
* Regular physical training
Optimizing Open Label Placebo Rationales

A 3-arm randomized trial where all chronic pain patients will receive honest placebos, but the information about the placebos will differ between conditions. Outcomes are measured for 21 days and a qualitative survey will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* chronic pain
* 18 years old
* English speaking
* have a smartphone or computer with video access
* Taking prescription opioids for chronic pain
* the chronic pain is concentrated into the patient's lower back.

Exclusion Criteria:

* suspect an allergy to any placebo ingredient
* problematic substance use
* cancer diagnosis causing pain
* anticipated change in opioid script during the study period.
Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome

A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome


Eligibility Criteria:
Inclusion Criteria:

* age over 19
* Corneal staining score(Oxford grading) ≥ 2 or Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min)
* Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception

Exclusion Criteria:

* The patients with systemic or ocular disorders affected the test result
* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* Being treated with systemic steroid
* Wearing contact lenses within 72 hr of screening visit
* Pregnancy or Breastfeeding
Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis

The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.

• Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments.

Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier.

At the end of treatment, the access cavity will be sealed with composite restoration.

Eligibility Criteria:
Inclusion Criteria:

1. Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
2. Negative response of pulp tissue to electrical or thermal pulp tester.
3. Widening in lamina dura or periapical radiolucency not more than 3 mm.

Exclusion Criteria:

* 1. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.

  3. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).

  4. Teeth with previous root canal. 5. Teeth need to post and core as final restoration
Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy.

A phase 2 prospective, interventional, non-randomized clinical trial design to investigate whether Restricted Spectrum Maps (RSM) attained from RSI-MRI (On-Q Prostate) improves PI-RADS accuracy compared to PI-RADS alone for the detection of clinically significant prostate cancer. Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial.

The aims of the study are as follows:

Goal 1. Validate RSI-MRI imaging biomarker performance using a prospective clinical trial.

Goal 2. Calibrate the RSM values across different MRI scanner manufacturers. Goal 3. Translate RSI using a net clinical benefit model.

Eligibility Criteria:
Inclusion Criteria:

* Selected to undergo an MRI-fusion prostate needle biopsy of the prostate.
* Able to provide informed consent

Exclusion Criteria:

* prior diagnosis of prostate cancer (Grade Group \>1)
* metastatic prostate cancer
* prior prostate cancer treatment
* contraindication to prostate biopsy (e.g., on anticoagulation that cannot be safely discontinued)
* inability to undergo MRI (e.g., too large to be accommodated in a scanner or with an implant incompatible with MRI).
* Bilateral hip replacement
* Unable to provide informed consent.
Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children

To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.

This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.

Eligibility Criteria:
Inclusion Criteria:

1. HIV infection
2. Age \< 18 years old
3. BW \> 25 kg
4. HIV RNA viral load \< 50 copies within 6 months
5. Written informed consent

Exclusion Criteria:

1. Active opportunistic infection
2. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
3. Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir
Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer

Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system "available on request" of the kit and / or the addition of an SMS (Short Message Service) reminder.


Eligibility Criteria:
Inclusion Criteria:

* women from 30 to 66 years old
* women living in french territorial division 37 ("Indre-et-Loire")
* women with a mobile phone in database
* women who do not perform a pap smear in the last 4 years
* women who do not answer to a first "invitation" letter to perform a pap smear

Exclusion Criteria:

* STOP SMS
* HPV cervical pathology during treatment
* Hysterectomy including cervix
ACOART BTK RENEW：A Post Market Clinical Study

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old and ≤75 years old
* 2. Rutherford clinical category classification：3,4 or 5
* 3. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
* 4. Reference vessel diameter is between 2 mm and 4 mm
* 5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.

Exclusion Criteria:

* 1. Plasma creatinine clearance rate \<30 mL/min
* 2. Acute vessel occlusion or acute thrombosis in target lesion
* 3. Planned amputation on the target limb
* 4. Subjects confined to bed that are completely non-ambulatory.
* 5. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
* 6. Life expectancy \< 5 year.
* 7. Cumulative length of 100% occluded target lesion(s)\>150 mm
* 8. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
* 9. History of stroke within 90 days prior to enrollment
* 10. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
* 11. Uncorrectable bleeding diathesis
* 12. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery
* 13. Pregnant or breastfeeding female subjects
* 14. Ability to cross a guidewire through target lesion
* 15. Patients who have participated in clinical trials of other medical devices or drugs during the same period
Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA

The goal of the REMNANT study is to confirm the clinical value of detecting a new biomarker, ctDNA (circulating tumor DNA), in the follow-up of patients with operated liver cancer. In order to meet this objective, this biomarker will be measured in your blood before and after surgery, at three and six months.

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and develops in 80% of cases in the context of underlying cirrhosis1. Surgical resection, percutaneous destruction and liver transplantation are the three treatments considered curative with a non-negligible risk of recurrence of 35-50% at 2 years2.

Several data in the literature suggest that small subclinical tumors can be detected by circulating tumor DNA (ctDNA), and that the amount of tcDNA detected seems to correlate with risk factors for recurrence such as tumor size or microvascular invasion3, 4.

The objective of this pilot study is to evaluate the detection of ctDNA following tumor ablation and its impact on early recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. HCC diagnosed on consensus radiological criteria in cirrhotic patients (EASL-EORTC 2012): helical CT or MRI with triple arterial, portal and late acquisition. The diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared to non-tumor liver parenchyma) at the portal phase or late phase compared to non-tumor parenchyma.
3. HCC diagnosed histologically in the absence of a diagnosis on imaging (see IC n°2 above)
4. Patient operated on for liver resection or radiofrequency destruction
5. Treatment decision validated by the digestive oncology PCR
6. Patient having read and understood the information letter and signed the non-opposition form
7. Patient follow-up at the Charles Nicolle University Hospital in Rouen

Exclusion Criteria:

1. Other active cancer or hematological malignancy
2. Contra-indication to surgery
3. Patient not affiliated to the social security system
4. Pregnant woman or parturient or breastfeeding
5. Person under court protection, sub guardianship or curatorship
CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema

Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.

Conservative care treatment for lymphedema may include use of compression, manual lymphatic drainage (MLD, performed either by a therapist or self-MLD), exercises and skin care. Subjects presenting to a vein clinic (Center for Vein Restoration or CVR) with lymphedema of the lower extremity/ies may receive a standard-of-care prescription for conservative care or for the Flexitouch Plus pneumatic compression device along with conservative care. Subjects will be followed (by phone and in clinic) for 12 months after initiating treatment for venous- and lymphedema-related complications, unscheduled visits, changes in quality of life measures and edema measures, skin changes, and changes to wounds (if present).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 years of age or older.
2. Diagnosis of lower extremity lymphedema (including primary, secondary, chronic venous insufficiency (CVI)-related, unilateral, or bilateral).
3. Clinical Etiology Anatomy Pathophysiology (CEAP) Classification of C3 or higher.
4. Willing to comply with prescribed care, protocol requirements, and study-related visits.
5. Willing and able to provide consent to participate.

Exclusion Criteria:

1. BMI \> 50.
2. Significant venous reflux disease, as determined by the investigator (e.g., indicated for venous intervention, post intervention with inadequate venous function, or ultrasound evidence of deep venous obstruction).
3. Unresolved healing at the surgical site following a venous intervention (e.g., ablation, stenting, or venoplasty).
4. Heart failure (acute pulmonary edema, decompensated acute heart failure).
5. Acute venous disease (\< 6 weeks) such as acute thrombophlebitis, acute deep venous thrombosis, or acute pulmonary embolism.
6. Significant peripheral artery disease (ankle-brachial index (ABI) \< 0.6, critical limb ischemia including ischemic rest pain, arterial wounds or gangrene).
7. Active skin or limb infection/ inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease).
8. Active cancer (cancer that is currently under treatment, but not yet in remission).
9. Poorly controlled kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome.
10. Any circumstance where increased lymphatic or venous return is undesirable.
11. Currently pregnant or trying to become pregnant (for Flexitouch Plus and conservative care group).
12. Current participation in any drug or other device clinical studies.