bioihbjkbjnl/mcl2 huggingface dataset:
Radiolabeled Study of CC-220 in Healthy Male Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label study to characterize the biotransformation and excretion
      of [14C]-CC-220 in healthy male subjects. Each subject will participate in screening, a
      treatment phase (including baseline), and a follow-up phone call. Subjects will be screened
      for eligibility. Subjects who have met all inclusion criteria and none of the exclusion
      criteria at screening will return to the study site on Day -1, and will be domiciled at the
      study site from Day -1 to Day 10. On Day 1, subjects will receive a single oral dose of 1 mg
      [14C]-CC-220 under fasted conditions. Blood, urine, and fecal samples will be collected
      throughout the study for pharmacokinetic (PK; inclusive of metabolite profiling /
      characterization), mass balance, and/or clinical laboratory assessments. Safety will be
      monitored throughout the study. Subjects will be discharged from the study site on Day 10
      following completion of the scheduled study procedures and satisfactory safety review.
      Subjects will participate in a follow-up phone call within 5 to 7 days following discharge.
    


Intervention name(s): CC-220; [14C]
Intervention type(s): Drug; Radiation
Intervention description(s): 1mg [14C]-CC-220 will be administered as a single dose; Single dose of [14C]-CC-220 will contain approximately 1.4 μCi of radioactivity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; CC-220; Male
The Effect of Needle-free Injection System During Palatal Anesthesia
Condition: Pediatric Anesthesia; Local Anesthesia
Study type: Interventional

Summary: 
      Needle-free injection systems can contribute to the prevention of needle-related pain during
      palatal infiltration anesthesia (PIA) in children. Research with this topic on children is
      required.The purpose of this clinical study was to evaluate the effectiveness of the
      needle-free system versus traditional anesthesia on pain perception during PIA in
      children.The study was designed as a randomized, controlled cross-over clinical study with 48
      children aged 6 to 12 years requiring dental treatment with PIA in bilateral maxillary
      primary molars. It has been revealed that the application of a needle-free system during PIA
      ensured a decrease in pain perception in children.
    


Intervention name(s): Comfort-in injection system; traditional anesthesia
Intervention type(s): Device; Other
Intervention description(s): local anesthesia applyed with comfort-in injection system; local anesthesia applyed with dental syringe
Other intervention name(s): dental syringe
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: needle-free injection system; pain perception
PSU Lumbar Support for Prevention of Low Back Pain in Rubber Tapper
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the efficacy of lumbar support for low back pain prevention in
      rubber tapper. The investigators will randomized the participants(rubber tapper) into 2
      groups;lumbar support and no support.The participant will be instructed for brace use. The
      sample size required are 200 subjects with 100 in each group. The subject will be evaluated
      every 3 month for the incidence of low back pain and quality of life after using the support.
    


Intervention name(s): PSU lumbar back support
Intervention type(s): Device
Intervention description(s): wear PSU back supprt during doing rubber tapper
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: lumbar support; rubber tapper
Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      Metformin is a drug that is normally used to treat people with diabetes. New research has
      discovered that metformin may also kill cancer stem cells. These cancer stem cells make up
      only a small portion of a cancer, but may be responsible for resistance to chemotherapy or
      for causing recurrence of the cancer. Future studies are envisioned to that test the efficacy
      of administering metformin with chemotherapy. The purpose of this study is to assess the
      safety of administering metformin in combination with chemotherapy. Since chemotherapy and
      cancer itself both cause adverse events by themselves, this study is designed to have a
      run-in stage as well as a subsequent randomization to metformin or no metformin. The primary
      endpoint will compare the rate of dose-limiting toxicities between these two arms. After a
      period of 3 weeks for the primary endpoint comparison, all patients will receive metformin.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Metformin
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility, acceptability, and efficacy of
      self-administered transcranial direct current stimulation (tDCS) in older adults with knee
      osteoarthritis (OA)
    


Intervention name(s): Active tDCS; Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., NY) with headgear and saline-soaked surface sponge electrodes.; For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
Other intervention name(s): Soterix 1x1 tDCS mini-CT Stimulator; Soterix 1x1 tDCS mini-CT Stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adductor Canal Block and Recovery After Total Knee Replacement Surgery
Condition: Total Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the functional recovery of patients undergoing Total Knee
      Arthroplasty based on the administration of an adductor canal block during their anesthesia
      treatment
    

Detailed description: 
      The period after total knee replacement (TKR) surgery is known to be painful for the first 24
      hours, lasting up to 3 days in many cases. Successful management of pain after TKR is
      regarded as necessary to early recovery, rehabilitation and timely discharge. Severe pain
      following major joint arthroplasty can hinder early rehabilitation, may result in prolonged
      hospitalization and is a strong predictor of persistent pain beyond 3 months. Adequate
      analgesia following TKR is paramount to early recovery, rehabilitation and timely discharge.
      Therefore early postoperative analgesic and rehabilitation goals are intricately related.

      Until now, different methods of pain treatment have been used, including intravenous narcotic
      pain medication, continuous femoral nerve block (numbing medication to a nerve in the thigh)
      and epidural analgesia (identical to the numbing method for childbirth). These are all
      effective methods but each is limited by side effects. In recent years, research has focused
      on administering local anesthetic further down in the leg, trying to minimize quadriceps
      muscle weakness while giving adequate pain relief after surgery. Local Infiltration Analgesia
      (LIA) and Adductor Canal Block (ACB) are examples of new farther sites of administration.

      The purpose of this study is to determine which combination of analgesic interventions is the
      most effective treatment for pain and improvement in functional outcome for TKR.
    

Intervention name(s): Adductor Canal Block; Adductor Canal Block with Morphine; Local Infiltration
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine.; Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine and 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml); 30 ml normal saline in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine, in addition to the local infiltration.
Other intervention name(s): ropivacaine with epinephrine; ropivacaine with epinephrine and spinal intrathecal morphine; saline
Intervention MeSH terms: Epinephrine; Racepinephrine; Morphine; Ropivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adductor Canal Block; Total Knee Arthroplasty
Moisturizing Effect of Two Dexpanthenol Formulations
Condition: Skin Abnormalities
MeSH terms: Skin Abnormalities
Study type: Interventional
Phase: Phase 2

Summary: 
      The study focuses to prove the equivalent moisturizing effect of two different Dexpanthenol
      formulations
    


Intervention name(s): Dexpanthenol foam spray, new formulation; Dexpanthenol foam spray, old formulation
Intervention type(s): Drug; Drug
Intervention description(s): 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter; 2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
Intervention MeSH terms: Pantothenic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dry skin; Dexpanthenol; Moisturizing effect
Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS
      by participants with low BMD.
    

Detailed description: 
      This study aimed to evaluate the ability of participants to self-administer 300 μg
      abaloparatide-sMTS over a period of 29 days based on PK and PD markers.
    

Intervention name(s): abaloparatide-sMTS
Intervention type(s): Combination Product
Intervention description(s): Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.
Intervention MeSH terms: Abaloparatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postmenopausal osteoporosis; transdermal delivery; microstructure patch; abaloparatide
Zika Virus Purified Inactivated Vaccine (ZPIV) Accelerated Vaccination Schedule Study
Condition: Zika
MeSH terms: Zika Virus Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 trial of one or more administrations of Zika Virus Purified Inactivated
      Vaccine (ZPIV). The trial will be conducted under a placebo controlled, double-blind,
      randomized allocation of study product. There are four groups in the study. Each group is
      testing a different vaccine schedule.
    


Intervention name(s): Zika Virus Purified Inactivated Vaccine; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zika; Vaccine; ZPIV
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Condition: Colonic Polyp; Colonic Neoplasms; Colonic Diseases; Colon Adenoma; Colon Disease; Colon Adenocarcinoma; Colon Cancer
MeSH terms: Colonic Neoplasms; Adenoma; Colonic Diseases; Colonic Polyps
Study type: Interventional

Summary: 
      61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The
      primary outcome is Cecal Intubation
    

Detailed description: 
      This will be a prospective single-center non-blinded clinical investigation. Each subject
      will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All
      pathologies found will be removed. No control group is necessary as the main objective is to
      reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy
      procedures.

      Up to the first ten (10) cases for each physician will be system operation training cases.

      The primary endpoint of cecal intubation was chosen as this measure is the first quality
      objective when evaluating colonoscopy quality indicators.
    

Intervention name(s): Aer-O-Scope Colonoscopy
Intervention type(s): Device
Intervention description(s): resection or biopsy of colonic abnormalities for histopathalogical evaluation
Other intervention name(s): therapeutic intervention - polyp resection
Intervention model: Single Group Assignment
Intervention model description: A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: screening-colonoscopy; diagnostic-colonoscopy; surveillance-colonoscopy
Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Psychomotor Agitation; Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment
      sessions, parallel-group study.

      After screening period, eligible subjects will be entered 5 days treatment session I to
      compare the efficacy between risperidone oral solution combination clonazepam oral and
      haloperidol IM injection on controlling psychotic agitation, then will be followed by 6
      additional weeks treatment session II for exploring the effect of medicine switching from IM
      injection to oral.
    

Detailed description: 
      Acute psychotic agitation is a common problem in many patients with schizophrenia that
      includes agitation, aggression, excitement and violence. An investigation showed that about
      26% psychotic patients were brought to the psychiatric emergency room because of the
      psychotic agitation symptoms. The primary objective is to compare the efficacy between
      risperidone oral solution combination clonazepam oral and haloperidol IM injection on
      controlling psychotic agitation in patients of acute schizophrenia and
      schizophrenic-affective disorder.

      The secondary objectives are: (1) to explore the possibility of decreasing efficacy of acute
      6 weeks treatment from IM injection to oral; (2) to compare the safety between risperidone
      oral solution combination clonazepam oral and haloperidol IM injection.
    

Intervention name(s): risperidone oral solution; haloperidol
Intervention type(s): Drug; Drug
Intervention description(s): risperidone oral solution (2-6mg/d) combination clonazepam (4-8mg/d) oral; haloperidol IM injection (5-20mg/d)
Intervention MeSH terms: Haloperidol; Risperidone; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute psychotic agitation; schizophrenia; risperidone oral solution; clonazepam; haloperidol
Ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute
      graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling
      transplants.
    

Detailed description: 
      To evaluate the safety of sirolimus based immune suppression and ex-vivo expanded donor
      regulatory T cells for the prevention of acute graft-versus-host disease following allogeneic
      hematopoietic cell transplantation.
    

Intervention name(s): Cultured Treg cells
Intervention type(s): Biological
Intervention description(s): Co-culturing of recipient dendritic cells and donor Treg. Treg administration will occur 2 days before the allogeneic stem cell transplant (i.e. day -2 with reference of day 0 as stem cell infusion date).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GVHD; AML; ALL; MDS; CLL; NHL; HL; MM
Auriculotherapy in the Cares to the Premenstrual Syndrome
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Premenstrual syndrome (PMS) is a collection of physical and emotional symptoms related to a
      woman's menstrual cycle. These symptoms occurring only during the luteal phase of the
      menstrual cycle that are of sufficient severity to interfere with some aspects of life of
      these women, reflecting also in interpersonal relationships, workplace and in their
      productivity. For these reasons, this research was conducted with the nursing staff of the
      Samaritan Hospital in order to verify the effectiveness of auricular acupuncture to alleviate
      some of the symptoms of PMS.
    

Detailed description: 
      The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order
      to balance the body energy and to treat several kind of diseases using semipermanent needles
      in specific points of the auricular pavilion.
    

Intervention name(s): Auriculotherapy group
Intervention type(s): Other
Intervention description(s): It was used semipermanent needles (1.5mm) to stimulate points, once on a week, during 8 sessions.
Other intervention name(s): Auricular acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Premenstrual syndrome; Physical distress; Behavioral changes
Surfactant Disorders and Chronic Lung Disease
Condition: Chronic Lung Disease
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      Interstitial lung diseases (ILD) in children represent a heterogeneous group of rare and not
      well defined disorders. Genetic abnormalities of surfactant proteins B (SFTPB) and more
      recently C (SFTPC) have been shown to be related to these pathologies. However, variability
      in the lung disease phenotype suggests the involvement of other surfactant-associated genes
      such as ABCA3 (ATP-binding cassette, sub-family A, member, 3). Thus, the aim of this project
      is: 1) to assess the prevalence of SFTPC mutation in children with chronic lung diseases, 2)
      to precise clinical and radiological features of children with SFTPC mutation, and 3) to
      identify environmental or genetic factors that may explain the extreme variability of this
      disease.
    

Detailed description: 
      The first stage of this project will be to constitute a clinical, radiological, biological
      database of children (1 moth-17 years) with severe respiratory distress and/or an unexplained
      chronic ILD. Mutations in SFTPC, SFTPB and ABCA3 will be further identified by sequencing and
      documented with using the parents blood samples.
    

Intervention name(s): whole blood sample
Intervention type(s): Other
Intervention description(s): 2 ml of whole blood for children 5 ml of whole blood for parents that will be used only if 1 mutation is found in children
Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        French pulmonary units participating to the study
      
Biospecimen description: 
      Whole blood, plasma, DNA
    
Keywords: Surfactant protein C; Interstitial; lung; Children
A Study for the Treatment of Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The Primary objective of this study is to test whether LY2196044 can reduce the number of
      heavy drinking days per month in people with alcohol dependence. Each subject will undergo a
      screening and assessment period (including medication washout) prior to randomization into a
      16 week double blind treatment period.
    


Intervention name(s): LY2196044; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks; once daily, orally, 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment