bioihbjkbjnl/mcl2 huggingface dataset:
Adipose Tissue Extract and Platelet-rich Plasma Use for Wound Healing
Condition: Wound Healing Disturbance of
MeSH terms: Wounds and Injuries
Intervention: ADIPOSE TISSUE EXTRACT; PLATELET-RICH PLASMA GEL
Intervention description: Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration; Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Adipose Tissue Extract (ATE) has been found to be an autologous source of growth factors with
      proven in vitro angiogenic and adipogenic properties.It is obtained by a simple lipoaspirate
      procedure. We sought to compare the effect of ATE with another known source, platelet-rich
      plasma to compare the wound healing characteristics on skin graft donor sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  donor site indication

        Exclusion Criteria:

          -  immunosupressive states

          -  terminal renal insufficiency

          -  pregnancy

          -  coagulation dyscrasias

          -  active infection in donor site
Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
Condition: Keratosis, Actinic
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Aminolevulinic Acid PDT (ALA); Vehicle PDT (VEH)
Intervention description: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light; Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic keratosis

Summary:

      The purpose of this study is to determine if Levulan PDT is safe and effective in the
      treatment of actinic keratoses on the upper arms and hands.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 4 Grade 1/2 AKs on each upper extremity

        Exclusion Criteria:

          -  Pregnancy

          -  history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or
             photodermatosis

          -  lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated
             skin cancers within the Treatment Area

          -  skin pathology or condition which could interfere with the evaluation of the test
             product or requires the use of interfering topical or systemic therapy

          -  Subject is immunosuppressed

          -  unsuccessful outcome from previous ALA-PDT therapy

          -  currently enrolled in an investigational drug or device study

          -  has received an investigational drug or been treated with an investigational device
             within 30 days prior to the initiation of treatment

          -  known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl
             alcohol, laureth 4, polyethylene glycol)

          -  use of the following topical preparations on the extremities to be treated:

               -  Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic
                  acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within
                  2 days of initiation of treatment.

               -  Cryotherapy within 2 weeks of initiation of treatment

               -  Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of
                  initiation of treatment.

               -  Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU,
                  diclofenac, imiquimod or other topical treatments for AK within 8 weeks of
                  initiation of treatment.

               -  Two or more ALA PDT treatments in the past 6 months

          -  use of systemic retinoid therapy within 6 months of initiation of treatment.
Vaccination Plus Ontak in Patients With Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: 4-peptide melanoma vaccine; Ontak
Intervention description: Experimental cancer vaccine given as a shot under the skin once every two weeks; A single dose of Ontak given as an intravenous infusion over 30 minutes, 4 days before the first vaccine is given.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic melanoma

Summary:

      The purpose of this study is to determine if an experimental melanoma vaccine can produce an
      immune response in patients with metastatic melanoma, and if combining this vaccine with the
      drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor
      shrinkage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Melanoma with evidence of metastatic disease

          -  Life expectancy of at least 12 weeks.

          -  Karnofsky performance status index of greater than or equal to 80%.

          -  Adequate hematopoietic, renal, and hepatic function, defined as:

          -  Patient must express HLA-A2

          -  Tumor biopsy: patient must agree to undergo biopsy of accessible tumor before and
             after therapy, when feasible, to study tumor cell properties and characteristics of
             immune cells.

          -  EKG without evidence of arrhythmia or changes that indicate acute ischemia.

          -  Pulse oximetry showing oxygen saturation of at least 90% on room air.

        Exclusion Criteria:

          -  Significant cardiovascular disease, or cardiac arrhythmia requiring medical
             intervention.

          -  Pregnant or nursing women.

          -  Biological therapy in the 4 weeks prior to the start of dosing.

          -  Patients with intrinsic immunosuppression, including seropositivity for HIV antibody.

          -  Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis
             C.

          -  Concurrent systemic corticosteroids (except physiologic replacement doses)or other
             immunosuppressive drugs (eg. cyclosporin A).

          -  Psychiatric illness that may make compliance to the clinical protocol unmanageable or
             may compromise the ability of the patient to give informed consent.

          -  Active or history of autoimmune disease

          -  Active gastrointestinal bleeding or uncontrolled peptic ulcer disease.

          -  Presence of untreated brain metastases.
Efficacy and Safety of AQX-1125 in Unstable COPD
Condition: COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: AQX-1125; Placebo
Intervention description: Synthetic SHIP1 activator; Placebo control
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Exacerbation of COPD; Unstable COPD

Summary:

      The primary objective of this study is to evaluate the effect of 12 weeks of treatment with
      once daily administration of AQX-1125 compared to placebo in subjects following exacerbations
      of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology
      2-containing Inositol-5'-Phosphatase 1) pathway.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged ≥40 years at screening

          2. History of COPD for at least 18 months prior to screening, characterised by excessive
             sputum production

          3. Chronic productive cough for at least 3 months in each of the 2 years prior to
             screening (if other causes of productive cough have been excluded) and/or an
             exacerbation of COPD with predominantly bronchitic symptoms at enrolment

          4. At least 2 documented exacerbations during the last 18 months prior to screening.

          5. Presentation of a diagnosed acute exacerbation of COPD, or have recently (within 3
             days) been discharged from hospital due to an acute exacerbation of COPD

          6. Ability to perform pulmonary function testing and with documented fixed airway
             obstruction determined by an FEV1 /FVC [forced vital capacity] ratio
             (post-bronchodilator) of <0.70 and a predicted FEV1 value of 30%-80% of normal within
             the 6 months prior to Visit 1.

          7. Former smoker or current smoker, both with a smoking history of at least 10 pack years

        Exclusion Criteria:

          1. Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or
             significant non-CF bronchiectasis)

          2. Known alpha-1-antitrypsin deficiency

          3. Treatment with roflumilast or theophylline within 1 month prior to screening

          4. Lobar pneumonia, with current positive chest X-ray (CXR) or within the 3 months prior
             to screening including the presence of any new radiological infiltrate on CXR within
             the previous two weeks

          5. Hospitalisation for more than 7 days for current acute exacerbation, or the
             requirement for intubation during hospitalisation

          6. For outpatients, prior medical history indicating that previous exacerbations required
             >3 weeks to stabilise
Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction
Condition: Breast Cancer
Intervention: Saline; 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone
Intervention description: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml); If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.
(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.
Intervention MeSH terms: Dexamethasone; Epinephrine; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Breast Reconstruction; Mastectomy

Summary:

      Subjects are being asked to participate in this study because they will be undergoing
      unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction
      involving insertion of a tissue expander.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who undergo mastectomy surgery with immediate reconstruction involving
             insertion of a tissue expander performed by the principal investigator beginning from
             the time of study approval until study enrollment is complete.

        Exclusion Criteria:

          -  Patients under the age of 18, or over the age of 79

          -  Allergy to local anesthetics or corticosteroids

          -  Patients with history of chronic pain or with chronic use of opioid analgesics

          -  Patients with history of lung disease or prior anterior thoracotomy or median
             sternotomy
Functional Electrical Stimulation in Irradiated Nasopharyngeal Carcinoma (NPC)
Condition: Dysphagia
MeSH terms: Nasopharyngeal Carcinoma; Deglutition Disorders
Intervention: Functional electrical stimulation; Exercise home program
Intervention description: 15 sessions of VitalStim® therapy, 60 minutes per session; Daily exercise training
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nasopharyngeal carcinoma; functional electrical stimulation

Summary:

      The purpose of this study is to determine whether functional electrical stimulation is
      effective in the treatment of dysphagia due to nasopharyngeal cancer post radiotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary nasopharyngeal carcinoma

          -  Post radiation therapy

          -  Mild to severe dysphagia

          -  Never underwent swallowing therapy

        Exclusion Criteria:

          -  Recurrent cancer

          -  Neurological or degenerate disease

          -  Total or partial laryngectomy

          -  Epilepsy

          -  With cardiac pacemaker
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
Condition: Advanced Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Nivolumab; Ipilimumab; Relatlimab; BMS-986205; Rucaparib
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab; Relatlimab; Rucaparib; Linrodostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability
      of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with
      advanced gastric cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or
             gastroesophageal junction (GEJ) carcinoma and have histologically confirmed
             predominant adenocarcinoma and/or squamous carcinoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

          -  At least 1 lesion with measurable disease

        Exclusion Criteria:

          -  HER2-positive tumor and previously untreated with trastuzumab

          -  Suspected, known or progressive central nervous system metastases

          -  Other active malignancy requiring concurrent intervention

          -  Active, known or suspected autoimmune disease

        Other protocol-defined inclusion/exclusion criteria apply
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: CardioFocus HeartLight Endoscopic Ablation System
Intervention description: PVI ablation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: atrial fibrillation; PAF

Summary:

      This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation
      in the treatment of paroxysmal atrial fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 70 years

          -  paroxysmal atrial fibrillation

          -  failure of at least one AAD

          -  others

        Exclusion Criteria:

          -  overall good health as established by multiple criteria
Treatment of Cocaine Dependence With Lisdexamfetamine
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: lisdexamfetamine/Behavior Therapy; placebo
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: cocaine; treatment; lisdexamfetamine; dependence; addiction; crack

Summary:

      This protocol is a 2-group double-blind placebo-controlled outpatient study investigating
      lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100
      subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and
      secondary objectives will be cocaine craving and impulsivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible participants must:

               1. Be treatment-seeking males or females between 18 and 65 years-of-age;

               2. Understand the study procedures and provide written informed consent;

               3. Be judged by the examining physician to be in generally good health with the
                  exception of health problems related to acute drug use;

               4. Meet DSM-IV criteria for cocaine-dependence.

        Exclusion Criteria:

          -  Exclusion criteria include:

               1. DSM-IV diagnoses for current psychotic disorders, mood disorders (except
                  substance-induced depression), anxiety disorders, ADHD, and other current
                  substance dependence (except marijuana and nicotine dependence); subjects may not
                  have physiological dependence upon alcohol requiring medical detoxification;

               2. Current use of any prescription medications;

               3. Females currently pregnant or nursing;

               4. Current elevation of liver enzyme levels above twice normal limits;

               5. Existing cardiovascular disease as determined by physician, EKG evaluation;

               6. History of significant acute or chronic physical illness precluding
                  participation;

               7. History of hyperthyroidism, glaucoma, or seizures.
Topical Aprepitant in Prurigo Patients
Condition: Pruritus
MeSH terms: Pruritus; Prurigo
Intervention: Aprepitant; Placebo
Intervention description: Aprepitant gel (10 mg/g); gel without active component
Intervention MeSH terms: Aprepitant; Fosaprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pruritus

Summary:

      Topical Aprepitant in Prurigo Patients - An Exploratory Phase IIa Trial With Topically
      Applied Aprepitant in Patients With Prurigo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with Prurigo suffering from chronic pruritus

          -  Disease duration > six month

          -  Therapy refractory to at least two previous antipruritic treatments with topical,
             intralesional or systemic corticosteroids, or other immunosuppressants,
             antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation

          -  Adult male or female patients, aged 18 to 80 years

        Exclusion Criteria:

          -  Concomitant medications that are primarily metabolized through Cytochrome P450 3A4

          -  Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin
             less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial

          -  UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)

          -  Prescribed systemic medications are limited

          -  Clinically significant abnormalities in Blood analyses

          -  Anamnestic excessive use of alcohol or tobacco or drugs

          -  Presence of active tumor disease or history of malignancies within five years prior to
             Visit 1 (Screening)

          -  Known or suspected hypersensitivity to component(s) of investigational products

          -  Within the last 30 days or current participation in any other interventional clinical
             trial

          -  Subjects who have received treatment with any non-marketed drug substance (i.e., an
             agent which has not yet been made available for clinical use following registration)
             within the last 6 month

          -  Previously enrolled/randomised in this clinical trial

          -  In the opinion of the investigator, the subject is unlikely to comply with the
             Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)

          -  Females who are pregnant, of child-bearing potential and wishing to become pregnant
             during the trial or are breast feeding

          -  Females of child-bearing potential with positive pregnancy test

          -  Subjects (or their partner) not using an adequate method of contraception (according
             to national requirements, as applicable)