cyrilzakka/clinical-trials huggingface dataset:
Cor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions

Clinical evaluation of conventional and modified coronally advanced flaps combined with acellular dermal matrix graft

The aim of this study was to evaluate the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I\&II ≥3 mm) treated with coronally advanced flap (CAF) and acellular dermal matrix graft (ADMG) in 22 eligible participants.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients
* Miller Class I \& II multiple buccal recession defects ≥ 3 mm on maxillary incisors, canines or premolars
* Esthetic indication for root coverage
* Probing depth \< 3mm at the recession sites

Exclusion Criteria:

* Smokers
* Pregnancy
* Bruxism and occlusal trauma
* Previous root coverage procedure
* Endodontically treated teeth at the recession sites
* Caries or restorations at the recession sites
* Use of antibiotics over the previous 3 months prior to treatment
Continuous TQL Block for Elective Cesarean Section

The aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age.
* Scheduled for elective Caesarean Section in spinal anaesthesia.
* Have received thorough information, verbally and in written, and signed the "Informed Consent" form on participation in the trial.

Exclusion Criteria:

* Inability to cooperate
* Inability to understand Danish
* Allergy to local anaesthetics or opioids
* Excessive daily intake of opioids, according to the discretion of the investigator
* Local infection at the site of injection or systemic infection
* Difficult visualisation of muscular and fascial structures on ultrasound, necessary to correct blockade and catheter placement.
Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial

SurgPASS is a pilot randomised cluster trial utilising a pre-operative checklist with the aim of reducing deaths after surgery. If SurgPASS is successful, the intervention will be implemented in a separate full-scale cluster randomised trial.

Title: Reducing deaths after surgery in low- and middle-income countries: A pilot cluster randomised trial

Aim: This pilot randomised cluster trial aims to evaluate the feasibility of a large-scale cluster randomised trial to assess the effectiveness and implementation of a pre-operative checklist to reduce deaths after surgery. If this pilot study is successful, we aim to assess the intervention in a separate full-scale cluster randomised trial.

* Objective 1: To determine feasibility and fidelity of delivering the intervention.
* Objective 2: To determine the rate recruitment to inform how long it will take to recruit to a future cluster randomised trial.
* Objective 3: To obtain information on postoperative outcomes to help inform the outcomes used and sample size of the future cluster randomised trial.

Design: Pilot cluster randomised trial.

Inclusion: Adult (\>18 years old) non-pregnant patients undergoing emergency abdominal surgery with an incision of ≥5cm.

Exclusion: Patients undergoing minimally invasive surgery, or surgery for appendicitis.

Intervention: SurgPASS is an intervention of a preoperative checklist for early recognition and treatment of acutely unwell surgical patients implemented through simulation training and clinical champions.

Comparator: Usual care as per local practice at that site.

Follow-up period: 30-days from surgery.

Number of participants: 300 participants: 25 participants in each of 12 clusters (hospitals), from 6 countries.

Outcomes: Since this is a pilot study, there are no pre-specified primary outcomes. However, there are four key outcomes of interest to assess ahead of the main phase randomised clinical trial.

* Outcome 1: Measure simulation training and checklist completion rate for participants undergoing surgery to refine future implementation (intervention clusters only)
* Outcome 2: Measure duration of time to recruit 25 participants per cluster (to determine duration of potential full trial)
* Outcome 3: Measure 30-day overall complication rates to inform overall sample size of potential full trial

Eligibility Criteria:
Inclusion criteria:

* Patients undergoing emergency major abdominal surgery (i.e., midline or non-midline) with an incision greater than or equal to 5cm
* Patient must not be pregnant
* Adults only (greater than or equal to 18 years old)

Exclusion criteria:

* Minimally invasive surgery
* Surgery for appendicitis
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy

This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects consented and currently enrolled in the Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests (DETECT) or the Long-Term Consequences of Repetitive Brain Injury in Athletes study protocols
* Can tolerate up to two PET imaging sessions
* Have the ability to provide informed consent for study procedures

Exclusion Criteria:

* Claustrophobia
* Current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG
* History of risk factors for Torsades de Pointes or are taking drugs known to cause QT-prolongation
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that the investigator believes would affect study participation or scan results
* Have had a non-study related radiopharmaceutical imaging or treatment within 7 days prior to study PET imaging sessions
Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers

To evaluate the effects of a 14-day repeated dose of 150 mg bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective feelings, after sleep deprivation in 12 healthy male subjects.

The aim of this controlled double-blind randomized 3-session cross-over designed study is to evaluate the effects of a single dose of 150 mg and a 14-day repeated dose of 300 mg bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective feelings, and some physical parameters after sleep deprivation in 12 trained healthy volunteers (18-35 years old).

Cognitive and executive functions were assessed by reaction times, critical flicker fusion test, Stroop test, digit symbol substitution test, span test and short term recal of pictures, tapping and tracking tests.

Behaviour and subjective effects explored were :

* feelings frequently experienced with psychotropic drugs assessed by ARCI,
* some mood states as tension, depression, anger, vigor, fatigue and confusion assessed by both POMS and Norris visual analogic scales,
* sleep assessed by LSEQ,
* feeding behaviour assessed by food intake during a meal test and self-ratings of appetite and satiety,

Physical parameters were :

* rest and orthostatic blood pressure and heart rate,
* body temperature and weight.

Bupropion was tested versus both placebo and 20 mg methylphenidate as positive control. Each subject received the 3 treatments, sequently randomized, with a 17-day wash-out period between sessions. Each session was organized as follow :

* 2 20-hour hospitalisations consisting in adverse effects review, physical examination, test training, sleep deprivation, drug compliance evaluation, drug dosing and dispensation, and assessments described above,
* 2 visits consisting in adverse effects review, drug compliance evaluation and drug dispensation.

The total duration of participation for the subjects was 106 days.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20.0 and 25.00
* no smoker

Exclusion Criteria:

-
Caffeine Intake and Additive Effects on Cognition

Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant properties, and their intake when in moderate doses seem to produce positive effects on stress, mood and memory. So, understanding that a positive effect of aerobic exercise can be displayed also on cognition, as caffeine, when in proper proportions, the investigators do not know if the joining of the two strategies into a single activity would be able to promote additional effects enhancing cognitive processes related to memory, attention, and motor reaction time.

Determine if 500 mg of caffeine can generate additional effects to 30 minutes of aerobic exercise enhancing cognitive memory tasks (Rey Auditory Verbal Learning Test - RAVLT), attention (sustained attention span; working speed; Percentual of errors by confusion) and simple reaction time (SRT).

Eligibility Criteria:
Inclusion Criteria:

* Fighting men
* Low levels of consumption of caffeine daily

Exclusion Criteria:

* Use more than 400 mg caffeine day
* Mental diseases
* Cognitive deficits
ATG-008 Combined With Toripalimab in Advanced Solid Tumors

This is an open-label, single-arm study with dose-escalation and expansion phases to access ATG-008 combined with Toripalimab in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Know and voluntarily sign informed consent.
2. Age 18-70 years old (including 18 and 70 years old), weight ≥45 Kg.
3. At least one measurable lesion according to the RECIST 1.1 and RANO evaluation criteria.
4. ECOG performance status score is 0 or 1.
5. Blood chemistry test results, meet the following results:

   1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × normal upper limit (ULN)
   2. Total bilirubin ≤ 1.5 × ULN
   3. Serum albumin\> 29 g / L
   4. Creatinine ≤ 1.5 × ULN or 24-hour serum creatinine clearance ≥ 50 mL / min
   5. Lipase and amylase ≤ 2 × ULN.
6. Adequate bone marrow function and meets the following results:

   1. Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L
   2. Platelets ≥ 75 × 10\^9 / L
   3. Hemoglobin ≥ 90 g / L.
7. Except for hearing loss and hair loss, all toxicity caused by previous anti-tumor therapy must have returned to ≤ Grade 1 (according to NCI-CTCAE version 5.0).
8. Life expectancy is longer than 3 months.

Exclusion Criteria:

1. Have a history of hepatic encephalopathy.
2. Have a thyroid disorder with a clinically significant thyroid dysfunction judged by the investigator (not applicable for thyroid cancer in dose expansion phase).
3. Active or history of upper gastrointestinal bleeding, ulcers, or esophageal varices with bleeding within 6 months.
4. Have a history of HIV infection and/or acquired immunodeficiency syndrome
5. Major surgery has been performed within 4 weeks before the first dose, or is expected during the study period.
6. Have a history of organ transplantation (eg., liver transplantation).
7. Poorly-controlled pleural or pericardial effusion during the screening period.
8. Other primary malignancies occurred within 5 years before the first administration of the study drug with the exception of locally curable malignancies
9. Suffering from active or previously recurring autoimmune diseases or under such a risk.
10. Systemically immunosuppressive drugs are currently used within 14 days of the first dose.
11. The investigator considers that the complications or other situations of the subject may affect compliance with the protocol, or are not suitable for participation in this study.
12. Subjects with diabetes or glycated hemoglobin (HbA1c)\> 7%.
Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)

To evaluate the effect of the Ulthera® system for facial laxity and sagging skin


Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign a written consent form
2. Willing to have of facial skin laxity and wrinkles assessed by clinician
3. Male or female, aged 39 to 65 years.
4. Willingness to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
5. Willingness to cooperate with photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
6. Must understand the ultrasound device (Ulthera) treatment may have no therapeutic effect.
7. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.

Exclusion Criteria:

1. Open wounds or lesions in the area(s) to be treated.
2. Severe or cystic acne on the area(s) to be treated.
3. Presence of an active systemic or local skin disease that may affect wound healing.
4. Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment areas (dental implants not included.).
5. Subcutaneous fillers
6. Keloid scar
7. Patients with anticoagulant treatment plan.
8. Children, pregnant women, breastfeeding women.
9. Patients with the following disease conditions: bleeding disorders or coagulation disorder that may affect wound healing, active localized disease, herpes simplex, autoimmune diseases, diabetes, epilepsy bell-type paralysis (temporary facial palsy)
Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use

This retrospective multicenter observational study will provide real-life efficacy and tolerance data for patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France, and will allow to evaluate healthcare practices from data obtained during the use of carfilzomib for routine care. Nominative expanded access was open in February 2014 and stopped in march 2016, then relayed by the compassionate program (march 2016- February 2017).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients over the age of 18 years
* Patients beginning carfilzomib treatment in the framework of expanded access or compassionate use in France (KRd or Kd regimen)
* Patients who received carfilzomib in first or second MM relapse
* Patients receiving at least one complete course of carfilzomib

Exclusion Criteria:

* Patients already included in an interventional research protocol using carfilzomib at the time of treatment initiation
* Patients refusing to allow the computerization of their data
* Patients for whom hospital medical records are not accessible
Metformin SR Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes

Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are equal to Glucophage is unclear.

To perform a RCT for the comparison between Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD and Glucophage .

Eligibility Criteria:
Inclusion Criteria:

1. Well informed of the procedures of this trial and informed consent is obtained
2. Voluntarily accept standardized treatment 3.18-75 years old, gender is not limited

4.Newly diagnosed as type 2 diabetes and have not yet received any hypoglycemic therapy 5.Unable to control the blood glucose by diet and exercise: 7.5% ≤HbA1c ≤11.0%, in screening and before randomization 6.BMI: 19\~35 kg/m2 7.Well compliance 8.Capable of self blood Glucose monitoring

Exclusion Criteria:

1. Pregnant or lactating
2. Type 1 diabetes
3. Poor blood glucose control（HbA1c\>11%）
4. A history of malignant tumor
5. Abnormal liver or renal function (defined as alanine aminotransferase(ALT)\>2.5 times higher than normal range,or eGFR\<45 mL/min per 1•73 m²)
6. Poor blood pressure control \[systolic blood pressure(SBP)\>180mmHg,or diastolic blood pressure(DBP)\>110mmHg\]
7. With severe heart disease,cardiac function worse than grade II,anemia(Hb\<9.0g/d1)
8. Continuous use of antidiabetic drugs more than one week in recent 3 months
9. History of acute metabolic complications in recent 6 months
10. Blood routine test indicates that the white blood cell count(WBC) \<3\*109/l
11. Body Mass Index(BMI)\<18.5 or ≥35kg/m2
12. Drug or alcohol abuse
13. Accompanying mental disorder who can't collaborate
14. Abnormal digestion and absorption function
15. Other endocrine diseases
16. Other chronic diseases needed long-term glucocorticoid treatment
17. With severe infection, immune dysfunction
18. A history of metformin allergies or allergic constitution
Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip

The current management of osteoarthritis is based on non-pharmacological and pharmacological means which include intra-articular injections.

The recommendations on the management of hip osteoarthritis stipulate that intra-articular injections of corticosteroid may be considered in patients with an exacerbation not responding to oral treatments. Several recent studies show the effectiveness of intra-articular corticosteroids compared with anesthetics. The intra-articular injection of viscosupplementation alone has never been validated in this indication since controlled studies did not show efficacy over placebo. At present, viscosupplementation is considered an anti-osteoarthritic symptomatic slow-acting and its interest is not yet established in hip osteoarthritis.

Show the superiority of intra-articular injection of viscosupplementation in combination with corticosteroid compared to intra-articular injection of corticosteroid alone in the treatment of hip osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* patients with hip osteoarthrosis (stage II et III according Kellgren et Lawrence)
* walking alone patients
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* Patients with hip osteoarthrosis (stage I et IV according Kellgren et Lawrence)
* patients with rapidly destructive hip osteoarthritis
* patients with inflammatory rheumatism
* patients with microcrystalline arthritis
* patients with hip osteonecrosis
* patients who received corticosteroids during the previous three months
* patients who received a intra articular injection of viscosupplementation during the previous six months
* patient with haemostatic disorder
* patient with consumption of painkillers tier 3
Heme Arginate in Transplantation Study

Organ shortage for transplant has necessitated use of kidneys from older donors, increasing the chance that the kidney will not work immediately or for as long as expected. The investigators gave the drug heme arginate (HA) to 20 kidney transplant patients in the first 24 hours after transplant, and showed that it may reduce kidney injury and is safe. The investigators plan to conduct a large study recruiting 600 patients to determine whether HA treatment increases the number of kidney transplants that work immediately. If successful, HA may be introduced into clinical practice at the end of this study.

Patients will be invited to take part in the study once listed for a kidney transplant. Further discussions will be had with them when admitted for transplant, and they will be offered the opportunity to participate. Consent will not be taken until the patient is admitted for transplantation. Following consent, participants will be randomised to receive either 2 doses of the study drug, HA, or a salt water solution, one at the time of transplant, and one approximately 24 hours later. Otherwise, treatment will be the same as any other patient undergoing a kidney transplant. Information about recovery from surgery, and specifically about kidney function, will be collected, but will not require additional blood tests. The study period ends after the first 7 days post-transplant, although longer term data will be collected from routine follow up appointments. Participants will be asked to complete a simple quality of life questionnaire 3 times: just before transplant, at approximately one week and three months after transplant.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a kidney only transplant, or a dual kidney transplant, from a deceased donor
* At least 18 years of age, no upper limit
* Receiving standard immunosuppression for the individual centre
* (where applicable) Meets co-enrolment criteria outlined in section 4.4 of the protocol

Exclusion Criteria:

* Kidney transplant patients as part of a multi-organ transplant e.g. with pancreas or liver
* Known hypersensitivity to heme arginate
* Unable to give informed consent
* Patients with porphyria, irrespective of whether they have received heme arginate or not, will be excluded
* Previous randomisation into this study (or HOT study)
* Women who are pregnant or lactating
* Kidneys that have undergone Ex-vivo Normothermic Perfusion (EVNP)
* Patients with known liver disease, epilepsy, brain injury or disease
A Biomarker and MRI Study on Troponin Release After Exercise in Hypertrophic Cardiomyopathy

Study population: 1) mutation carriers without the hypertrophic phenotype (pre-clinical Hypertrophic Cardiomyopathy (HCM)) and in 2) patients with clinically overt HCM (clinical HCM).

Hypothesis: Cardiac troponin release after exercise can be demonstrated in both clinical and pre-clinical HCM patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an echocardiographically proven hypertrophic cardiomyopathy according to the ESC guidelines or individuals with a HCM associated mutation without the clinical characteristics of hypertrophic cardiomyopathy (pre-clinical HCM patients);
* Age ≥ 18 years;
* Able to comply with the protocol;
* Written informed consent.

Exclusion Criteria:

* Known significant epicardial coronary artery disease;
* Patients with LVH in the clinical setting of other disorders that explain the myocardial hypertrophy (amyloidosis, MELAS, Anderson-Fabry, WPW etc.);
* Heart failure NYHA class III-IV;
* Patients with known hemodynamic instability or syncope during exercise due to left ventricular outflow gradient or occurrence of ventricular arrhythmia;
* History of PTSMA (percutaneous transluminal septal myocardial ablation) or Morrow myectomy;
* Patients not able to complete a bicycle test;
* Any contraindication to MR imaging (MR imaging is not obligatory for assessment of the primary objective, therefore relative exclusion criterion);
* Recent (within 30 days) admittance to the hospital for any cardiac reason (myocardial infarction, heart failure, cardiac arrhythmia, etc.);
* Severe renal insufficiency (eGFR \< 30 ml/min);
* Any other condition which, in the opinion of the investigator, may pose a significant hazard to the subject if he or she participates in the present study.