bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study for Healing and Safety Outcomes in Gingival Recession
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, randomized, within subjects-controlled design
    

Detailed description: 
      The objective of this trial is to evaluate clinical healing outcomes of microsurfaced
      cadaveric ADM (Markman Biologics) used in sites with < 1 mm of attached gingiva requiring
      soft tissue grafting without root coverage as compared to control cadaveric ADM (AlloDerm,
      LifeCell) over 180-day post-op period. During the treatment period, each site will be
      monitored for soft tissue healing and augmentation of keratinized tissue width. All subjects
      will be seen at post-op day 7, 14, 30, 90, and 180.
    

Intervention name(s): Markman Biologics Microsurfaced ADM; AlloDerm
Intervention type(s): Biological; Biological
Intervention description(s): an ADM which has been scored (microsurfaced); AlloDerm tissue matrix
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, within subjects-controlled design
Masking: None (Open Label)
Primary purpose: Treatment
Noninvasive Intracranial Pressure and Hydrocephalus Patients
Condition: Hydrocephalus
MeSH terms: Hydrocephalus
Study type: Observational

Summary: 
      Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure
      (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus
      are typically treated with a shunt in order to reduce ICP. At times the shunt can
      malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's
      shunt has malfunctioned.
    

Detailed description: 
      A malfunctioning ventriculoperitoneal (VP) shunt will typically cause a rise in intracranial
      pressure, which can be difficult to identify without costly imaging. Novel, state-of-the art
      machine learning techniques can be leveraged to develop an algorithm that noninvasively
      estimates intracranial pressure. The resulting algorithm will accurately determine the
      presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus.
    

Intervention name(s): Pulse oximetry
Intervention type(s): Device
Intervention description(s): Pulse oximetry
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        VP shunted patient, Normal intracranial pathology patient
      
Keywords: VP shunted; Normal intracranial pathology; patients
A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Condition: Relapsing Multiple Sclerosis
MeSH terms: COVID-19; Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is a single arm, pilot multicenter prospective study in up to 22 participants with
      relapsing multiple sclerosis. Patients screened for the study can either be scheduled for
      vaccine, have received a single vaccine with a scheduled second dose, or already completed
      full course (two dose) vaccination. Fully vaccinated participants must be able to complete
      immune assay No.1 ≥ 14 days after the second dose of vaccine
    


Intervention name(s): Ofatumumab; Covid-19 vaccine
Intervention type(s): Other; Other
Intervention description(s): Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.; Prospective observational cohort study. There is no treatment allocation. Participants will obtain the COVID-19 FDA approved Emergency Use mRNA vaccine through their HCP (private insurance) or appropriate federal, state or local program.
Intervention MeSH terms: Ofatumumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Relapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine
        after starting ofatumumab 20 mg subcutaneous treatment
      
Keywords: COVID-19; vaccine; ofatumumab; SARS-coV2; antibody; open-label
An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
Condition: Metabolism and Elimination
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single dose study in healthy male subjects.
    

Detailed description: 
      A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at
      the clinic prior to dosing on Day 1.

      On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic
      after at least 10 days since dosing and as soon as the following conditions are met:

        -  greater than 90% of the administered radioactivity has been recovered, and

        -  less than 1% of the administered radioactive dose is recovered in two consecutive
           24-hour samples each of urine and feces
    

Intervention name(s): E2609
Intervention type(s): Drug
Intervention description(s): Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolism and Elimination
A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study involves 4 injections of insulin lispro and its purpose is to:

        -  Determine if 2 formulations of insulin lispro are treated by the body in a similar way.

        -  Compare how the 2 formulations of insulin lispro affect blood sugar level.

        -  Determine the safety of each insulin lispro formulations and any side effects that might
           be associated with them when given to healthy participants. The study is expected to
           last up to approximately 9 weeks for each participant.
    


Intervention name(s): Insulin Lispro
Intervention type(s): Biological
Intervention description(s): LY275585 administered SC.
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis; Pulmonary Aspergillosis; Hematologic Neoplasms
Study type: Observational

Summary: 
      Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with
      hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL)
      samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is
      unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested
      PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at
      high risk of PA.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        hematological patients at high risk for invasive aspergillosis
      
Keywords: aspergillosis; bronchoalveolar lavage; galactomannan; pcr; hematological patients
OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS
Condition: PCOS
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is undertaken to compare the effects of treatment with commonly used OCP
      containing ethinylestradiol-cyproterone acetate and metformin in women with PCOS. Special
      attention will be paid to changes in ovarian stromal blood flow by using Color Doppler and
      they will be correlated with changes in hormonal parameters post-treatment.
    


Intervention name(s): Ethinyl Estradiol-cyprosterone acetate; Metformin Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.; Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.
Intervention MeSH terms: Metformin; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Face Validity and Cross-Cultural Acceptability of the FPS-R in Cameroon
Condition: Pain
Study type: Observational

Summary: 
      This study evaluates the face validity and cultural acceptability of the Faces Pain Scale -
      Revised in pediatric patients treated at Mbingo Baptist Hospital, Northwest Province,
      Cameroon. Participants from the four major language/cultural groups evaluated at the hospital
      with a complaint of pain will trial the Faces Pain Scale - Revised and then undergo cognitive
      interviewing to assess comprehension and clinical accuracy.
    

Detailed description: 
      Twelve to fifteen pediatric patients complaining of pain from each of the four primary
      language groups treated at Mbingo Baptist Hospital (Grammar English, Pidgin English, French,
      and Fulfulde) will be enrolled in the study. Each patient enrolled will trial the Faces Pain
      Scale - Revised (FPS-R) in his or her native tongue, before receiving standard analgesic
      treatment as ordered by the provider caring for the patient. One to two hours post analgesia,
      the patient will be reassessed and the FPS-R will be repeated. After completion of the second
      FPS-R, an audio-recorded cognitive interview will be performed by trained study personnel.
      These recordings will be transcribed into English and analyzed on a question-by-question
      basis to evaluate for themes pertaining to comprehension and understanding, ease of use, and
      reliability, within the different language groups. Enrollment in the study does not alter the
      routine pain management offered or received by patients. Rather, the FPS-R will be utilized
      on patients who are complaining of pain and who will be allocated to receive analgesia
      regardless of study enrollment.
    

Intervention name(s): Pre-treatment Faces Pain Scale - Revised; Post-treatment Faces Pain Scale - Revised; Cognitive interview
Intervention type(s): Other; Other; Other
Intervention description(s): Patients will be asked to answer the Faces Pain Scale - Revised as an assessment of pain prior to standard analgesia dosing.; Patients will be asked to answer the Faces Pain Scale - Revised 1-2 hours after receiving standard analgesia as an assessment of pain.; Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population encompasses the four primary language-defined cultural groups that present
        to Mbingo Baptist Hospital. Goal of 12-15 pediatric patients per cohort (Grammar English,
        Pidgin English, French, and Fulfulde speaking), who have pain as part of their presenting
        complaint.
      
Keywords: Pediatrics; Pain Scale; Faces Pain Scale - Revised; Cameroon
The Effect of Growth Hormone Replacement on Liver Fat
Condition: Growth Hormone, Recombinant; Fatty Liver
MeSH terms: Fatty Liver
Study type: Observational

Summary: 
      We will examine a cohort of growth hormone deficient adults starting growth hormone (GH)
      replacement. The purpose of this study is to determine whether GH replacement reduces the fat
      content of the liver.

      To compare the results we will include growth hormone deficient patients who do not start GH
      replacement as controls.
    

Detailed description: 
      Adults with untreated growth hormone deficiency (GHD), a condition mostly due to pituitary
      disease, often show metabolic features similar to those described in the 'metabolic
      syndrome'. Growth hormone (GH) replacement has been shown to reverse many of these
      unfavorable changes, with a particular evident reduction of visceral fat. In recent years, a
      strong correlation between fat accumulation in the liver and features of the metabolic
      syndrome (particularly visceral fat) has been identified, and 'fatty liver' is now being
      referred as the hepatic feature of the 'metabolic syndrome'. The effect of GH replacement on
      liver fat, however, has never been systematically studied.

      We will assess 15 patients with GHD before and 6 months after starting GH replacement. We
      will also assess 15 control patients with GHD but who don't go on GH replacement for various
      reasons.

      Liver fat will be assessed using MR spectroscopy. Changes in liver fat will be correlated to
      changes in insulin sensitivity and changes in various inflammatory markers.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS
        Trust.
      
Biospecimen description: 
      plasma, serum, leucocytes, 24-hour urine
    
Keywords: growth hormone; growth hormone deficiency; liver fat; liver steatosis; growth hormone replacement
A Pharmacokinetic Study Of SB-681323 In Subjects With Coronary Heart Disease Undergoing Percutaneous Intervention
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Study of SB-681323 (a novel p38 MAPkinase inhibitor) in subjects with documented coronary
      heart disease (CHD) undergoing elective percutaneous coronary intervention (PCI).
    


Intervention name(s): SB-681323
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: CHD; coronary heart disease; atherosclerosis; inflammation
Comparison of Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Surgery
Condition: Postoperative Pain; Analgesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi
      level erector spinae plane (ESP) block on postoperative analgesic effect in breast surgery.
    

Detailed description: 
      After being informed about the study and potential risks, written consent was obtained from
      all patients. Patients who meet eligibility requirements will be randomized in a 1:1 ratio to
      bi- level erector spinae plane block and modified pectoral block.
    

Intervention name(s): Ultrasound guided bi-level erector spinae plane block; Ultrasound guided modified pectoral nerve block
Intervention type(s): Other; Other
Intervention description(s): Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group.; Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Regional anaesthesia; Erector spinae plane block; PECs blocks; Breast cancer surgery
Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypothesis: In the management of advanced oesophageal cancer, to determine if a shorter
      regime of external beam radiotherapy (using higher daily doses, and combined with
      intraluminal high dose rate brachytherapy) is not inferior in the palliation of dysphagia
      than a more protracted course of external beam radiotherapy (using lower daily doses and
      combined with equal intraluminal high dose rate brachytherapy).
    

Detailed description: 
      This is a prospective, pragmatic and multi-centre clinical trial, without blinding or masking
      to the randomly assigned treatment. Patient registration and randomization are centralized.
      There are two arms to the study, expecting an equal numbers of patients randomized to each
      arm. Stratification will by according to: (1) treating institution/country, and (2) baseline
      Stage (M1 = distant metastases versus M0 = no distant metastases). The primary statistical
      analysis will be conducted as an "intention-to-treat" clinical trial.

      A cost-effectiveness analysis is not required because the main contrast is between 5 and 10
      fractions of EBRT, where 5 fractions are less expensive than 10 fractions. This protocol
      follows the recommendations of CONSORT for the reporting of non-inferiority and equivalence
      trials. The active control is 30 Gy in 10 fractions, and the new therapy is 20 Gy in 5
      fractions.
    

Intervention name(s): Protracted Course Radiotherapy; Short Course Radiotherapy
Intervention type(s): Radiation; Radiation
Intervention description(s): External Beam Radiation 30 Gy in 10 fractions; External Beam Radiation 20 Gy in 5 fractions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal cancer; Brachytherapy; Radiotherapy; Palliation; Dysphagia
A Safety Study of Mebendazole in Children 2 to 10 Years of Age
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg
      chewable tablet formulation in a pediatric population. Mebendazole is a drug used for the
      treatment of soil-transmitted parasitic helminth (STH) (ie, parasitic worm) infections such
      as pinworm, whipworm, common roundworm, common hookworm, and American hookworm.
    

Detailed description: 
      This is an open-label (identity of study drug will be known to study participant and
      investigator), single-center, single-dose, single-arm (ie, 1 treatment group) safety study.
      This study will consist of a screening visit on Day 1 at which time all study-related
      screening procedures will be performed. After all results are reviewed, children who meet all
      of the inclusion criteria and none of the exclusion criteria will be entered into the
      open-label phase of the study. A single mebendazole 500-mg chewable tablet will be
      administered on Day 1 and the children will remain at the study site so that adverse events
      can be recorded at approximately 30 minutes postdose. Study participants will return to the
      study site 3 days (plus or minus 1 day) postdose at which time adverse events will be
      recorded again. Safety will be monitored during the study by assessing adverse events by
      direct observation at 30 minutes after dosing and at 3 days (plus or minus 1 day) after
      dosing, by direct observation of the study participant, report by the parent or guardian, or
      both. On Day 1, a single mebendazole 500-mg chewable tablet will be chewed and swallowed by
      each study participant. If desired, study participants will be allowed to drink water when
      administered study drug.
    

Intervention name(s): Mebendazole
Intervention type(s): Drug
Intervention description(s): Type= exact number, unit= mg, number= 500, form= chewable tablet, route= oral use. One mebendazole 500-mg chewable tablet taken on Day 1.
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Parasitic Diseases; Mebendazole (VERMOX); Anthelmintics; Antiparasitic Agents; Soil-transmitted helminth (STH) infections; Pediatric
Adherence in Upper Extremity Home-based Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The objective of the proposal is to determine the feasibility of implementing Ecological
      Momentary Assessment (EMA) and Motivational Interviewing (MI) methods to enhance adherence
      for a 4-week self-initiated arm training protocol. A non-randomized feasibility study using a
      4-week UE training protocol will be conducted in 15 individuals within the first 12 months
      post-stroke living in the community. EMA data will be collected using a mobile app to
      automate real-time collection of adherence data on a daily basis. MI will be used to produce
      self-generated training plans (training goals, training schedule), guided by the therapist
      before the start of training.
    

Detailed description: 
      Using a mixed methods design, the study will collect quantitative data before, during, and
      after training. Qualitative data will be collected after the training period and analyzed to
      explain the quantitative findings in depth, within the context of everyday life. Study aim 1
      is to evaluate the feasibility of using EMA to measure adherence and of applying the MI
      approach. Quantitative data will include four indicators of adherence and accuracy. Interview
      responses will be used as qualitative data to elucidate participants' acceptance of the MI
      approach and feedback on using the EMA app. Study aim 2 is to explore to what extent UE
      outcomes change after the 4-week self-initiated home-based rehabilitation program. Outcomes
      will include UE use in real-world environments and self-perceived changes in UE use.
    

Intervention name(s): Therapist guided training; Upper extremity (UE) Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Therapist guided period delivered virtually (WebEx/Zoom). Participants will be patients associated with NYULH and will have access to Zoom. Each session will last 45 min, and will completed 3x/week by research therapists, who are part of the study.; The 4-week UE training is completed in the participants home on their own and communication with study staff is virtual. Participants will receive daily communication through the Expiwell app to answer survey questions related to adherence, and safety/adverse events. Participants will also complete weekly check-ins with their research therapist over Zoom to answer questions about difficulties related to UE training activities, refinement of training goals, and to receive feedback on their training performance. Each weekly check-in will be approximately 45 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; upper extremity; motivational interviewing; shared decision making; ecological momentary assessments; self-initiated training
A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the study medication blood levels after administration
      of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on
      the volunteers will also be assessed.
    


Intervention name(s): Bendavia 10mg; Bendavia 50mg; Bendavia 100mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; volunteers