bioihbjkbjnl/mcl2 huggingface dataset:
Induced Wound Healing by Application of Expanded Bone Marrow Stem Cells in Diabetic Patients With Critical Limb Ischemia
Condition: Diabetic Foot
MeSH terms: Diabetic Foot; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Diabetic foot patients with chronic limb ischemia and without the option for surgical or
      interventional revascularization were recruited and randomized to the transplant groups or
      the control group within this clinical trial. These patients are randomized to control or
      intervention group, whereas the intervention is divided into bone marrow cells administered
      intramuscular or intraarterial or expanded bone marrow cells administered intramuscular or
      intraarterial resulting in five distinct groups. To measure the therapeutic effects of the
      various treatment arms patients were evaluated for (ankle brachial index (ABI),
      transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level
      Dependent [BOLD]). Patients also underwent imaging with angiographic methods.
    

Detailed description: 
      Diabetic foot (DF) is a concomitant illness of diabetes mellitus. Diabetes is one of the main
      causes of non-traumatic amputation worldwide due to severe peripheral arterial occlusive
      disease with chronic critical limb ischemia being the most abundant problem. Ulceration
      occurs as failure of oxygenation, nutrient supply and progressive occlusion of larger blood
      vessels often exacerbates pre-existing microvascular abnormalities.

      Purified bone marrow mononuclear cells or expanded bone marrow cells enriched in Cluster of
      Differentiation 90+ (CD90+) mesenchymal stem cells (named tissue repair cells, [TRCs]) are
      used in the treatment of diabetic ulcers in comparison to bone marrow derived stem cells to
      induce revascularization of the affected limb and to enhance local perfusion. Cells are
      administered intramuscular or intraarterial. A control group of patients treated according
      national guidelines without stem cells serves as comparator.

      Diabetic foot patients with chronic limb ischemia and without the option for surgical or
      interventional revascularization were recruited and randomized to the transplant groups or
      the control group within this clinical trial. To measure the therapeutic effects of the
      various treatment arms patients were evaluated for (ankle brachial index (ABI),
      transcutaneous oxygen partial pressure (TcPO2), and reactive hyperemia (Blood Oxygen Level
      Dependent [BOLD]). Patients also underwent imaging with angiographic methods.
    

Intervention name(s): tissue repair cells (TRC); bone marrow stem cells (BMC)
Intervention type(s): Biological; Biological
Intervention description(s): expanded bone marrow cells enriched in CD90+ mesenchymal stem cells; bone marrow stem cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peripheral arterial occlusion disease (PAD); diabetic foot; critical limb ischemia (CLI); stem cell therapy
Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect
Condition: Periodontal Regeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to
      severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І
      treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) +
      PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing
      pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were
      recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT)
      was performed at baseline and 9 months post-surgery to evaluate bone level and bone density
    

Detailed description: 
      : Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to
      severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І
      treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) +
      PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing
      pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were
      recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT)
      was performed at baseline and 9 months post-surgery to evaluate bone level and bone density.
    

Intervention name(s): Minimal invasive flap technique; Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin; minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S
Intervention type(s): Procedure; Procedure; Combination Product
Intervention description(s): contained defect treated with Minimally invasive flap; contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft; contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect
Other intervention name(s): regenerative surgery; regenerative surgery; regenerative surgery
Intervention MeSH terms: Edetic Acid; Mitogens; Pentetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic periodontitis; Intra-bony defects; Minimally invasive surgical technique; Platelet rich fibrin,; Growth factor enhanced matrix 21S
Pre-operative Blood Lipid Level and Post-operative Major Adverse Cardiac Event
Condition: Lipid Metabolism Disorders; Postoperative Complications
MeSH terms: Cardiovascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Postoperative Complications
Study type: Observational

Summary: 
      Whether the pre-operative blood lipid level and post-operative cardiovascular events is
      associated is unknown. This study is to find out the main blood lipid and relative protein
      level change and the post-operative cardiovascular events occurrence.
    

Detailed description: 
      The participants collected data from their hospital.Patients under going non-cardiac surgery
      were collected. Data of Triglycerides, cholesterol, Low-density lipoprotein and High-density
      lipoprotein were collected perioperatively. The postoperative major cardiovascular and
      cerebral events were also identified and collected. Other data including perioperative
      information and surgeries and anesthesia data were gathered.

      Logistic regression models were built and selected. Independent risk factors relative to
      postoperative major cardiovascular and cerebral events were screened and identified.
      different levels of Triglycerides, cholesterol, Low-density lipoprotein and High-density
      lipoprotein were analysed.
    

Intervention name(s): laboratory test
Intervention type(s): Diagnostic Test
Intervention description(s): laboratory test
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        adult non-cardiac surgery patients
Chest Pain Pilot Study
Condition: Chest Pain; Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Chest Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of
      acid related pain or discomfort in the chest.
    


Intervention name(s): Esomeprazole
Intervention type(s): Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Gastroesophageal reflux disease; GERD
Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients
Condition: Upper Gastrointestinal Endoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compere between Propofol-Ketamine combination and
      Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in
      paediatric patients.
    


Intervention name(s): Dexmedetomidine-ketamine; propofol-ketamine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Keywords: Sedation; Pediatric Patients
Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
Condition: Poikiloderma of Civatte; Dyschromia; Pigmentation Disorders; Telangiectasia; Photosensitivity Disorders
MeSH terms: Telangiectasis; Photosensitivity Disorders; Pigmentation Disorders
Study type: Interventional

Summary: 
      This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the
      treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).
    


Intervention name(s): 532 nm KTP laser
Intervention type(s): Device
Intervention description(s): Laser treatment sessions on the neck and/or chest
Other intervention name(s): Excel V
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: poikiloderma of Civatte; red dyschromia; brown dyschromia; sun damage; neck; chest; dyschromia; pigmentation disorders; erythema; photosensitivity disorders; sun exposure; telangiectasia; hyperpigmentation; hypopigmentation
Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon
Condition: Immunity Factors in Cancer Colon Patients
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      Surgery is the primary treatment for colon cancer. However, the rate of recurrence or
      metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . Most colon
      cancer-related deaths are caused by metastatic disease . Many patients with colon cancer
      harbour micrometastases and disseminated tumour cells at the time of surgery . Whether the
      micrometastases develop into clinically significant metastases depends on the immune system's
      ability to eradicate them.The aim of the study is to declare the effect of
      epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to
      epidural inhalational based anesthetic technique in patients undergoing open surgical
      resection of colon cancer.
    


Intervention name(s): thoracic epidural
Intervention type(s): Procedure
Intervention description(s): undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections
Other intervention name(s): thoracic epidural catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group (EP) received epidural - propofol based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia and Group (EH) received epidural- inhalational based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia
Masking: Single (Participant)
Primary purpose: Prevention
Effects of Different Myofascial Release Techniques on Iliotibial Band Tightness
Condition: Fascia Lata
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effects of foam roller and instrument assisted
      soft tissue mobilization on pain, functionality and performance in athletes with iliotibial
      band tightness
    

Detailed description: 
      Subject In this study, the effects of foam roller myofascial massage and instrument assisted
      soft tissue mobilization (IASTM) (massage performed by applying light pressure to the skin
      with a tool) on pain, functionality and performance will be investigated in athletes with
      iliotibial band tightness. There are studies on both IASTM and Foam Roller Massage in the
      literature and they are popular applications recently. However, within our knowledge, when we
      look at the Turkish and English literature, no study has been found that compares these two
      therapeutic massages in terms of pain, functionality and performance.

      Purpose Poor posture, facial traumas and stiffness cause tension in the fascia of that region
      and result in pain. This disrupts the complementary mechanism of the fascia, causing the
      structures attached to the fascia to be out of the normal sequence. Facial problems have an
      important place in athletes. Facial problems cause pain in the athlete, reducing the
      athlete's sportive performance and negatively affecting their functionality. In order to
      prevent these limitations and accelerate the recovery, the rehabilitation process is started
      after the surgery. Various exercises and myofascial massages are routinely applied to
      problems seen in athletes. Myofascial massage techniques can be used in athletes' problems
      for many positive reasons such as effective in a short time, rapid results, high success
      rate, risk-free and painless if experts do. Thanks to the findings to be obtained from our
      study, it is aimed to contribute to the literature with objective, evidence-based results in
      this field.
    

Intervention name(s): Self Myofascial Relaxation; Instrument Assisted Soft Tissue Mobilization; Only Exercise (Control)
Intervention type(s): Other; Other; Other
Intervention description(s): Total of 12 times for 6 weeks; Total of 12 times for 6 weeks; Every day for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Fascia Lata; Fascia; Massage; Musculoskeletal Manipulations
Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
Condition: Muscular Dystrophy, Duchenne and Becker Types
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      Duchenne's Muscular Dystrophy and Becker Dystrophy, hereafter DMD and BMD, is a serious and
      progressive disease that affects 1 in 3,500-6,000 males born alive. Scale 6-minute walking
      test, is used for determine the inclusion of children with DMD in pharmacological studies.
      Furthemore, is used to verify a training effectiveness assessing muscular endurance and
      cardio-respiratory functions. This Research evaluates the feasibility and effectiveness of a
      multimodal physiotherapist program with virtual reality glasses.
    

Detailed description: 
      In addition a physiotherapy program, virtual reality have a lot of importance advantages for
      train while motivated the kids.

      A cross over study will be applied. In the control time, patient will received a initial
      evaluation and a final without making the physiotherapy program and without virtual reality
      glasses. The data will be collected by principal examiner.

      In the intervention time the group will received 10 multimodal physiotherapy sessions, two or
      one per week, along six weeks. Also they are going to training walking with with virtual
      games.

      Multimodal physiotherapist program describes the exercises to be performed, how long it will
      take, the number of repetitions and the way to do it with the physiotherapist in zoom
      session.

      At the end of the multimodal physiotherapy program, variables will be evaluated by the
      principal examiner.
    

Intervention name(s): multimodal physiotherapy program with RV; traditional physiotherapy program
Intervention type(s): Other; Other
Intervention description(s): Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.; Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Twelve participants were randomized to follow a multimodal physiotherapy program for 6 weeks. At the end of this period the participants will be crossed to another intervention without virtual reality glasses. The results will be measured before and after each intervention during the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Virtual Reality [L01.224.160.875], [L01.296.555]; Physical Therapy Modalities [E02.779], [E02.831.535]; Respiratory Therapy [E02.880]; Dystrophin [D12.776.210.500.250]; Becker Muscular Dystrophy [C10.668.491.175.500.300]; Resistance training [E02.831.535.483.875]; Muscular Stretching Therapy [E02.831.535.483.750]
Cocaethylene as a Treatment for Cocaine Dependence - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Cocaine has been cited as the primary drug threat in the United States. The purpose of this
      study is to determine if cocaethylene, used as a prototype drug, is a safe and effective
      treatment for cocaine dependence.
    

Detailed description: 
      Currently, there are no medications available to specifically treat cocaine addiction.
      Cocaethylene is an active metabolite of cocaine and has a similar chemical structure to
      cocaine. The purpose of this study is to determine whether substitution therapy with
      cocaethylene is a safe and effective treatment for cocaine dependence.

      This double-blind, placebo-controlled trial will occur in 3 parts. In Part 1, the individual
      pharmacokinetics of an intravenous dose of cocaethylene will be determined in order to
      estimate individualized cocaethylene infusion rates and pharmacokinetic parameters. This will
      provide important information on how cocaethylene is processed by the body. In Part 2, an
      infusion of cocaethylene, producing a venous plasma concentration of 200 ng/ml, will be
      administered over an 8-hour period. Clinical monitoring and blood sampling will occur in
      order to determine the safety profile of cocaethylene. During Part 3, the ability of
      cocaethylene to modify the acute effects of intravenous cocaine will be determined.
      Cocaethylene will be administered in plasma concentrations of 0 ng/ml, 50 ng/ml, or 200 ng/ml
      over an 8-hour period. Participants will be randomly assigned to receive a challenge
      intravenous dose of cocaine (0.5 mg/kg or 1 mg/kg) or placebo at the 4-hour mark of
      cocaethylene infusion. Following the initial 8-hour period, cocaethylene infusion will be
      continued for an additional 5 hours. Behavioral and physiological measures will be collected
      throughout the study sessions at predetermined times to evaluate whether tolerance to
      cocaethylene develops. These measures will also help to determine whether cocaethylene
      modifies or produces tolerance to the effects of an acute dose of cocaine.
    

Intervention name(s): Cocaethylene
Intervention type(s): Drug
Intervention MeSH terms: Cocaethylene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Acceptability Study of Vaginal Films for HIV Prevention
Condition: HIV Infections; Anti-Infective Agents
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This study is being done to find out what women would want in a film vaginal product for
      human immunodeficiency virus (HIV) prevention, especially what it should look like and how to
      apply it.

      The investigators hypothesize that women will prefer a smooth, clear, and rectangular
      quick-dissolve vaginal film for HIV prevention over a textured, opaque, square quick-dissolve
      vaginal film.
    

Detailed description: 
      The lives of 25 million people have ended due to HIV-related causes since the start of the
      AIDS epidemic in 1981 (1). Each year, AIDS continues to claim the lives of millions of
      people, with an estimated two million deaths worldwide in 2008 (2). Heterosexual transmission
      of HIV accounts for the majority of new infections and disproportionately affects women both
      in the United States and globally (2, 3). There is an urgent need for agents to prevent the
      sexual transmission of HIV, particularly agents that may be controlled by women.

      Quick dissolve films such as Listerene® Breath Strips have been developed for inexpensive
      delivery of drugs and vitamins. As products for HIV prevention, quick dissolve films offer a
      host of potential advantages including low cost, control by the receptive partner, discreet
      and applicator-free use, low mess, portability, easy storage, stability, targeting to site of
      exposure, reduction of systemic toxicity by bypassing first-pass metabolism, and the
      incorporation of multiple active microbicidal compounds (4, 5).

      In the course of developing agents for HIV prevention, determination of valued
      characteristics is important for product refinement and for enhancement of future use
      likelihood. Knowledge regarding acceptability can also inform product promotion and
      educational campaigns (6).
    

Intervention name(s): No intervention (not applicable)
Intervention type(s): Other
Intervention description(s): No intervention (not applicable)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women aged 18-30 years from the Pittsburgh, Pennsylvania area who express interest in the
        study. Enrollment is expected to achieve racial and ethnic demographics representative of
        Allegheny County, Pennsylvania in terms of approximately 0.2 percent American Indian and
        Alaska Native, 2.5 percent Asian, and 1.5 percent Hispanic or Latino (7). Allegheny County
        is 82.8 percent white and 13.2 percent black or African American (7). For enrollment in
        this study, we would like to achieve at least 40 percent black or African American in order
        to collect a more diverse set of film microbicide preferences. The remainder of enrollment
        is expected to be white.
      
Keywords: HIV prevention; Vaginal film; Microbicide; Administration, intravaginal
Diabetes Research on Patient Stratification
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The overarching goal of the IMI DIRECT (Innovative Medicines Initiative Diabetes Research on
      Patient Stratification) Consortium is the identification of biomarkers that aid therapeutic
      targeting in prediabetes (Study 1) or early onset type 2 diabetes (Study 2).
    

Detailed description: 
      There are two multicentre prospective cohort studies within the glycaemic deterioration work
      package of IMI DIRECT (WP2). These two cohorts are designed to address the area of glycaemic
      deterioration by amassing data and biomaterials that will be used to discover novel
      biomarkers for glycaemic deterioration in people at high risk of developing type 2 diabetes
      (Study 1) and in those who have recently been diagnosed with the disease (Study 2).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        White European (self-report of parental ethnicity), Age ≥35 and <75 years
      
Biospecimen description: 
      Blood Omics: Fasting blood samples taken for genomic, transcriptomic, proteomic and
      metabolomic assessments.

      Microbiome Urine Toenail clippings
    
Keywords: Gene-environment interaction; Genome; Glycaemic control; Lifestyle; Microbiome; Prediabetes; Proteome; Type 2 diabetes