cyrilzakka/clinical-trials huggingface dataset:
Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device

The purpose of this study is to objectively assess lymphatic function before, during, and immediately after Neuroglide treatment in lower trunk and leg lymphatic vessels, torso, axillary regions, inguinal regions, upper extremities, and cervical/neck and to determine any VAS (Visual Analog Scale, a commonly used measure of pain perception) score change after Neuroglide treatment.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory and possess all four limbs
* Female participants of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration
* Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month following each imaging session in the study
* Weight less than 400 lbs

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Persons who are allergic to iodine or indocyanine green
* Heart failure, poorly controlled kidney disease (glomerular filtration rate \<30 mls per minute), hypoproteinemia, pulmonary hypertension, or hypothyroidism
* Any circumstance where increased lymphatic or venous return is undesirable
Follow-Up Study Evaluating the Long Term Outcome of ChondroMimetic in the Treatment of Osteochondral Defects in the Knee

To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee.

This is an open-label, single center, extension study to the previous interventional study 0MCM0107 designed to investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in the treatment of osteochondral defects of the knee. Follow-up to 6-months was completed as part of study 0MCM0107. All 17 subjects who received ChondroMimetic in study 0MCM0107 are eligible for enrolment into this extension study regardless of their current follow-up period.

Eligibility Criteria:
Treated with a Chondromimetic device under Protocol 0MCM0107 and completed the required follow-up.
BFR After Biceps Tendon Repair and MPFLR

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy after distal biceps tendon repair or medial patellofemoral ligament reconstruction (MPFLR) following a tear.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be recruited from our ambulatory sports medicine clinics. We will include patients aged 18-80 who suffered a biceps tear and are undergoing biceps repair or MPFLR

Exclusion Criteria:

* Subjects will be excluded if they are undergoing revision biceps repair or revision MPFLR, history of DVT, neurovascular injury, unable to tolerate BFR treatment, unable to complete physical therapy, peripheral vascular disease
* Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately. This will be facilitated by describing the reasons for withdrawal to the patient prior to initiating the study and ask patients and other providers to inform the investigators if there are any issues or concerns.
ApoE Genotyping Analysis in Patients with Suspected Non-haemorrhagic Amyloid Angiopathy

Ischaemic microangiopathic features have recently been incorporated into the criteria for cerebral amyloid angiopathy (CAA).

ApoE genotyping (presence of the E4 allele) is routinely used to help determine the aetiology of a haemorrhagic microangiopathy found on MRI.

Chronic ischaemic disease in CAA is characterised by the presence of :

* multispot pattern on the FLAIR sequence
* severe periventricular FLAIR hypersignals with posterior predominance

The main aim of this study was therefore to analyse the frequency of the presence of one (or two) E4 allele(s) on ApoE genotyping in patients with suspected CAA based on ischaemic MRI involvement with a typical radiological pattern.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ischaemic stroke (from causes other than CAA, as CAA is not a frequent cause of ischaemic stroke) with associated stigmata of microangiopathy on MRI that may suggest associated CAA.
* Patients treated at Nîmes University Hospital

Exclusion Criteria:

* Patient refusing to participate
A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

The purpose of this study are

1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and,
2. to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, primary (ie, de novo) or secondary (progression of Myelodysplastic syndrome \[MDS\] or myeloproliferative neoplasms \[MPN\], or therapy-related) acute myeloid leukemia (AML) according to the WHO classification with ≥ 20% leukemic blasts in the bone marrow
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Agree to serial bone marrow aspirate/biopsies

Exclusion Criteria:

* Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
* AML secondary to chronic myelogenous leukemia (CML)
* Received a targeted agent against an isocitrate dehydrogenase 1 (IDH1) or isocitrate dehydrogenase 2 (IDH2) mutation
* Has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening

Other protocol defined inclusion/exclusion criteria apply
SOLAR: Efficacy and Safety of Cobomarsen (MRG-106) vs. Active Comparator in Subjects With Mycosis Fungoides

The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.

Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.

Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.

Study Design:

Subjects will be randomly assigned in a 1:1 ratio to receive either cobomarsen or vorinostat. Approximately 126 subjects (63 per arm) are expected to be enrolled. Cobomarsen will be administered in the clinic by 2-hr intravenous infusion on Days 1, 3, 5 and 8, and weekly thereafter. Vorinostat will be dispensed to study subjects and taken as a daily oral dose according to the manufacturer's labeled dosing instructions. Treatment will continue until the subject becomes intolerant, develops clinically significant side effects, progresses, or the trial is terminated. An interim analysis will be conducted after approximately 40 subjects have been followed for a minimum of approximately 6 months. Enrollment will be suspended until the completion of the interim analysis.

Eligibility Criteria:
Key Inclusion Criteria:

* Biopsy-proven CTCL, MF subtype
* Clinical stage IB, II, or III, with staging based on screening assessments
* Minimum mSWAT score of 10 at screening
* Receipt of at least one prior therapy for CTCL

Key Exclusion Criteria:

* Previous enrollment in a cobomarsen study
* Prior therapy with vorinostat or other HDAC inhibitors, or contraindication to an HDAC inhibitor
* Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented history of B2 and/or B2 staging at screening
* Evidence of large cell transformation
* Lymph node involvement at screening, unless radiologically or histologically confirmed to be nonmalignant
* Visceral involvement related to MF at screening
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)

As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP).

Although there are different recommendations, almost every guideline recommend using 3 drugs as PEP both in USA and Europe.

Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.

A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases),with a high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for PEP.


Eligibility Criteria:
Inclusion Criteria:

* Potentially sexual exposition to HIV

Exclusion Criteria:

* Pregnancy
* Source case with antiretroviral resistances
* any treatment contraindicated with the drugs of study
Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery

Reliable prediction of the preoperative risk is of crucial importance for patients undergoing vascular operations. The assessment of the metabolic equivalent of task (MET) is an easy clinical evaluation of the functional capacity of an individual. A MET is defined as the resting metabolic rate, that is the amount of the consumed oxygen at rest. According to the MET concept a patient would be considered as "fit for surgery" when the stairs of two flights can be climbed and the housework can be fully managed by oneself.

Hypothesis: Patients with a functional capacity over 4 MET (fit for surgery) have less perioperative complications with the focus on cardiac pathology than patients with less than 4 MET during aortic operations.

Patients and Method: Retrospective analysis of a single center unit of 296 patients undergoing open or endovascular aortic repair.


Eligibility Criteria:
Inclusion Criteria:

* Data of all patients after open and endovascular aortic repair of the descending aorta from May 2009 till March 2016

Exclusion Criteria:

* Data of all patients with isolated operations on the ascending aorta or aortic arch
Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients

The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.

* Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the TYROSERLEUTIDE treatment group or the placebo group. No matter which group the subject is assigned, he/she would receive chemotherapy treatment through the portal vein pump which was transplanted during the carcinoma section surgery 40 days before the randomization.
* Participants will be given either TYROSERLEUTIDE or placebo through intravenous injection with an interval of 29 days, during which the participant will not take any investigational drug or any other anti-tumor treatment as well. On the day just next to the completion of each cycle of research treatment which usually lasts for 3-5 days, the participant will receive medical inspection so as to observe and ensure drug safety.
* Participants will continue to receive investigational drug for 6 cycles until being detected with recurrence or metastasis of tumor or experiencing any serious side effects.
* A CT scan or MRI scan will be performed for each participant to exclude the recurrence or metastasis of tumor and assess the effects of treatment once before the initiation of each new cycle.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Age between 18 and 75 years
3. Hepatocellular Carcinoma accompanied with branch vein thrombosis
4. Carcinoma and bolt resection Integrity, cutting edge no tumor cells by microscopic lens in operation
5. CTA or MRI no Carcinoma and bolt after operation

Exclusion Criteria:

1. hypersensitivity to the composition similarity of investigational drug
2. Concomitance other system primary tumor
3. surface area 1.47m2～1.92m2
4. HBV (-) and HCV(-)
5. Patients who have received resectional surgery for HCC
6. HCC complicating main portal vein cork
7. HCC complicating hepatic vein cork
8. Patients who have received systematicness therapy for HCC
9. Patients who have received immunoregulant 4 weeks before randomization
10. Concurrent participation in another clinical trial involving experimental treatment is excluded 4 weeks before randomization
11. uncontrolled infection, hemorrhage, guts leakage postoperative complications
12. postoperative liver function Child-pugh C
13. no evidence of extra-hepatic metastases postoperative
14. no utility sample for gene chip research
15. no physical examination, laboratory and imageology examination that baseline request
Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study

PTSD is a common consequence of war, for soldiers and civilians. PTSD results in hyperarousal, avoidance, numbing, and re-experiencing, causing persistent decreased quality of life. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health. Within health care, mindfulness is taught as an 8-week course called Mindfulness-Based Stress Reduction (MBSR). MBSR is unstudied for PTSD. We propose to assess the feasibility of MBSR as an intervention for PTSD, since it may affect hypervigilance, avoidance, and reactivity associated with this disorder.

Specific Aims: Aim 1: Assess the feasibility of recruiting and retaining a sample of veterans with PTSD to complete a study protocol that involves randomization to usual care or usual care plus MBSR. Aim 2: Apply measures of PTSD symptom severity, depression and quality of life before and after randomization, to assess whether there is evidence of benefit and whether MBSR warrants further study for PTSD, and allow calculation of standardized effect sizes. Aim 3: Apply a validated measure of mindfulness before and after treatment. Aim 4: Explore the relationship between PTSD symptoms, mindfulness score, and frequency of meditation practice.


Eligibility Criteria:
Inclusion Criteria:

* Must have PTSD

Exclusion Criteria:

* Active substance use
* Active suicidal ideations
* Borderline or antisocial personality disorder
CLE During Exercise Testing in Asthma

The purpose is to assess visualize the level of laryngeal obstruction and vocal cord dysfunction and to obtain more information on causes for dyspnea in asthma and severe asthma and to assess safety of CLE in patients with asthma and with severe asthma. Patients are examined if symptomatic during exercise.

* Questionnaires to assess breathlessness before the test.
* CLE on ergometer bicycle using any laryngoscopy setup
* Ergometry with spirometry tests with ECG, oxygen saturation, blood pressure, inspiratory and expiratory flow volume curves, bronchodilator after the exercise test
* Work load of 40W with 3 minutes intervals and increase by 40W in women. In men, work load of 50W with 3 minutes intervals and increase by 50W starting from 50W. In elderly and more severely disease work load of 30W with 3 minutes intervals and increase by 30W.
* Recording of dyspnoea, leg fatigue and chest discomfort
* Assessment of asthma by asthma control test, spirometry, exhaled NO measurements.
* Severe asthma group: physician-diagnosed asthma, moderate-high dose inhaled glucorticoid steroids and a second controller drug, exacerbations and per oral glucocorticoid steroid courses at least 2 in the past 12 months and/or 50% of the past 12 months on per oral glucocorticoidsteroids

Eligibility Criteria:
Inclusion Criteria:

* physician diagnosed asthma
* symptomatic during exercise

Exclusion Criteria:

* FEV1 \<60%
* respiratory infection in the last 14 days
* asthma excacerbation in the last 14 days
* unstable cardiovascular disease
* bleeding disorder
* anticoagulant treatment (other than ASA)
The Effect of Automatic Massage Applied to Healthcare Workers on Pain, Fatigue and Psychological Well-being

To determine the effect of automatic massage applied to healthcare workers on pain, fatigue and psychological well-being. This research is planned as a pretest-posttest type study. It will be held in the Osmaniye State Hospital maternity ward. The application will be applied by one person in the rest room. Data will be collected using the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), State-Trait Anxiety Inventory (STAI), and Piper Fatigue Scale.


Eligibility Criteria:
Inclusion Criteria:

* Working in the delivery room

Exclusion Criteria:

* Being receiving psychiatric treatment (Pharmacotherapy or psychotherapy),
* having a wound on the waist and back that prevents the application.
Early Discharge in Patients Undergoing Elbow Arthroscopy

Patients undergoing elbow arthroscopy surgery will receive standard anesthesia and analgesia (infraclavicular nerve block combined with general anesthesia for surgery; continuous infusion via infraclavicular catheter to day 3 post op). Patients in the experimental group will be discharged home after one day, with infraclavicular catheter in place; patients in the comparator group will stay in hospital for 3 or 4 days, per standard practice. The study will compare range of motion as the primary endpoint, in a non-inferiority design, to see if early discharge is feasible while providing similar recovery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective complex arthroscopic elbow surgery requiring postoperative CPM - synovectomy, capsulectomy, extensive debridement, contracture release, osteocapsular arthroplasty.
* ASA I-III

Exclusion Criteria:

* Age\>65
* Cognitively challenged patients
* Severe COPD
* Patients who, on their own or with the assistance of a caregiver, are not confident of being able to remove the local anesthetic infusion catheter at home
* Psychiatric history
* Allergy to ropivacaine.
* Opioid tolerance (\>60mg oral morphine or equivalent/day)
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.

Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of ADHD according to DSM-5 criteria.
* Provides written informed consent to participate in the study before the conduct of any study procedures.
* Male or female, aged 18 to 55 inclusive.

Exclusion Criteria:

* Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.
Ipratropium or Salbutamol Sulphate Alone or Combination Therapy Salbutamol and Ipratropium in Patients With COPD

Study to compare the effects of nebulised salbutamol or ipratropium alone in patients with COPD with those of combined salbutamol and ipratropium nebuliser solution on arterial oxygen saturation (SaO2) and to characterise patients with COPD (chronic obstructive pulmonary disease) at risk of significant arterial oxygen desaturation following nebulised salbutamol.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with moderate to severe stable COPD:

  * Patients with a diagnosis of chronic bronchitis and/or emphysema
  * FEV1 \<65% of predicted value without regard to prior treatment
  * Forced expiratory ration (FER = FEV1/VC) \<70% of predicted value without regard to prior treatment
  * Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial
  * Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial
* Patient aged ≥40 years
* Patients with a smoking history of ≥15 pack-years
* Patients must have given informed consent to participate in the trial

Exclusion Criteria:

* Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
* Patients with any of the following:

  * untreated angle closure glaucoma
  * hypertrophic obstructive cardiomyopathy
  * tachyarrhythmia
  * recent myocardial infarction (within six months of screening visit)
  * severe organic cardiac or vascular disorder
  * untreated hyperthyroidism
  * diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed)
* Patients who are pregnant, or who are planning a pregnancy, and nursing mothers
* Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists
* Patients known to abuse drugs or alcohol
* Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial
* Patients with a PaO2 (arterial carbon dioxide tension) \<56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment
* Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment
* Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial
* Patients on home oxygen concentrator therapy
* Patients who have previously participated in the randomised phase of this trial