bioihbjkbjnl/mcl2 huggingface dataset:
Adipose-derived SVF for Treatment of Alopecia
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The general objective of this study is to conduct a safety and feasibility study of a single
      injection of autologous adipose-derived SVF for the treatment of alopecia.
    


Intervention name(s): GID SVF-2
Intervention type(s): Device
Intervention description(s): Comparison of the number of hairs before and after treatment of autologous adipose-derived SVF as a percentage increase or decrease in growth.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Smoking on the Effectiveness of Non Surgical Treatment of Peri-implant Mucositis
Condition: Peri-implant Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      The aim of the present study was to test the hypothesis that smoking impact non-surgical
      periodontal therapy results in a greater clinical improvement in patients with peri-implant
      mucositis.
    

Detailed description: 
      The aim of the present study was to test the hypothesis that the smoking levels at baseline
      influence full mouth disinfection results in a greater clinical and microbiological
      improvement compared with sole mechanical debridement within one session in patients with
      peri-implant mucositis.
    

Intervention name(s): Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling; Non surgical peri-implant mucositis therapy with one-stage full-mouth scaling and chlorexidine
Intervention type(s): Other; Other
Intervention description(s): Patients were treated with full mouth non surgical peri-implant mucositis therapy performed with only full mouth scaling and root planing; Patients were treated with full mouth non surgical peri-implant mucositis therapy performed with only full mouth scaling and root planing and chlorexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After randomized assignment to a test and a control group, patients received a one-stage full-mouth scaling with or without chlorhexidine. Clinical and microbiological examination was performed at baseline, after 1, 3, and 6 months.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to show the consistency of different lots of a candidate vaccine
      (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
    


Intervention name(s): GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
Intervention type(s): Biological
Intervention description(s): 4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria; Plasmodium falciparum
NIT-OCCLUD PDA Phase II Sentinel Trial
Condition: Ductus Arteriosus, Patent
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA
      Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less
      than 4 mm, and to compare one year safety and efficacy outcomes with recommended OPCs.
    

Detailed description: 
      The purpose of this clinical investigation is to evaluate whether transcatheter occlusion of
      PDAs with a minimum vessel diameter of 4 mm or smaller, by means of permanent implantation of
      the Nit-Occlud Spiral Coil for PDA Occlusion, is safe and effective.

      The device used for this purpose is a set of two items named "Nit-Occlud - PDA Occlusion
      System":

        -  Nit-Occlud coils, 2 types: flexible (3 sizes) and medium (3 sizes)

        -  Introducer Sheath, F4 or F5 85cm.

      The intended use of the device is the percutaneous, transluminal closure of PDA with an
      internal diameter or 4mm and smaller in patients who comply with the selection criteria.

      The investigation will continue until the sponsor receives FDA approval for commercial
      distribution and implantation of the system, or until the project is terminated by the
      sponsor or by the investigators.

      The objectives of this study are:

        1. To determine the safety of the spiral coil by monitoring and reporting deaths and
           adverse events associated with the device and device placement.

        2. To determine the effectiveness of the spiral coil by evaluating clinical and
           echocardiographic occlusion rates.
    

Intervention name(s): Transcatheter PDA Coil
Intervention type(s): Device
Intervention description(s): The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter < 4 mm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transcatheter occlusion of patent ductus arteriosus
Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with
      Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The
      primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine
      compared to placebo at 12 months.
    


Intervention name(s): Odanacatib; Placebo; Vitamin D3; Calcium supplement
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Odanacatib 50 mg tablets, taken orally once weekly for 24 months.; Matching placebo tablets to odanacatib taken orally once weekly for 24 months.; Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months.; Calcium supplement 500 mg tablet taken orally once daily (up to ~1200 mg total) for 24 months.
Other intervention name(s): MK-0822; calcium carbonate; calcium citrate
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Cholecalciferol; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Chronic Inflammatory Bowel Diseases (IBD) and School Absenteeism
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Study of the causes and rate of school absenteeism in children and adolescents with
      Inflammatory Bowel Disease.
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with IBD
Effect of General Anesthesia on Early Postoperative Cognitive Function in Cesarean Section
Condition: Anesthesia Morbidity; Cesarean Section Complications
Study type: Observational

Summary: 
      Cognitive dysfunction is the impairment of the mental process of perception, memory and
      information processing. The preoperative cognitive state is important, as mild cognitive
      impairment may be worsened following a cesarean section. Our study will aim to assess the
      incidence of early cognitive dysfunction after elective and emergent cesarean section under
      general anesthesia.
    

Detailed description: 
      Mechanisms that lead to cognitive decline after anesthesia and surgery remain still unclear
      and mixed. Some studies suggested that an important role is played by the immune response to
      surgery. The inflammatory response could contribute to the development of postoperative
      cognitive decline (POCD0 through secretion of cortisol, cytokines, and other inflammatory
      mediators. Comparing the effects of general and spinal anesthesia on pregnant patients
      undergoing an elective cesarean section, found no cognitive change after both anesthesias.
      Our observational comparative study will be carried out at Beni Suef University Hospital. We
      will compare early cognitive functions undergoing general anesthesia in patients undergoing
      elective and emergency cesarean section.
    

Intervention name(s): Assessment document
Intervention type(s): Other
Intervention description(s): The anesthesiologist will evaluate through his sheet women's cognitive functions.
Other intervention name(s): Anesthesiologist evaluation sheet
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women in reproductive age period between 25 and 35 years booked for an elective or
        emergency cesarean section.
      
Keywords: Cognitive function postoperative
[PETDE10] Imaging of PDE10A Enzyme Levels in Huntington's Disease Gene Expansion Carriers and Healthy Controls With PET.
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to measure the availability of the PDE10A enzyme in Huntington
      disease gene expansion carriers (HDGECs) using the recently developed radioligand
      [18F]MNI-659. The study will be cross-sectional, examining HDGECs at different stages of the
      disease (pre-manifest, stage 1 and stage 2), in comparison with Healthy Controls (HCs). The
      HDGECs included in this study will be recruited from the large database of the REGISTRY
      (NCT01590589) or ENROLL-HD (NCT01574053) studies.
    

Detailed description: 
      The study will be organized in an "adaptive-like" mode. Initially a cohort of 5 HDGECs and 5
      HCs will be studied. The data obtained in the first cohort will be analysed and depending on
      the variability of the data, there will be approximately 10 HDGECs and an equal number of HCs
      in the second cohort and the size of the third cohort may be altered to in total include
      approximately 45 HDGECs and an equal number of HCs.
    

Intervention name(s): PET Imaging with [18F]MNI-659
Intervention type(s): Radiation
Intervention description(s): The radioligands [11C]raclopride and [18F]MNI-659 will be administered at doses less than 10 micrograms, i.e. within the micro dosing concept, and no pharmacological effects are expected.
The injected radioactivity of [11C]raclopride will be 300 MBq/70 kg of body weight ± 10%.
The injected radioactivity of [18F]MNI-659 will be 185 MBq/70 kg of body weight ± 10%.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Mobile Phone Intervention to Reduce Youth Suicide in Rural Communities
Condition: Help-Seeking Behavior; Emotions; Trusted Adults; Suicide; Positive Affect
MeSH terms: Suicide
Study type: Interventional

Summary: 
      The goal of this research project is to conduct a pilot RCT of Text4Strength, an interactive
      automated text messaging extension of Sources of Strength (SoS), a universal school-based
      suicide prevention program that prepares diverse 'key opinion leaders' to conduct public
      health messaging and activities with peers to increase school-wide positive coping norms,
      communication with trusted adults, and seeking help for suicidal peers (Wyman et al., 2010).
      The investigators previously developed and field tested Text4Strength messages (RSRB#00047481
      and 53924 closed) to demonstrate feasibility, safety, student engagement, and
      student-perceived relevance for a universal texting extension. The investigators will now
      conduct a pilot randomized controlled trial in one large school in Western New York that has
      implemented Sources of Strength for the past two years. The school will continue with Sources
      of Strength in the 2016-17 school, and add this school-wide texting component as part of this
      research study. Consistent with Leon's guidelines on pilot studies, the primary focus will be
      to identify areas of promise, success in reaching proximate targets, and the need for
      additional modifications (Leon, Davis, & Kraemer, 2011). Findings from this study will inform
      further refinement of the text messaging program and provide preliminary data for a larger
      efficacy trial.
    


Intervention name(s): Intervention; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention group will receive 2-5 interactive text message sequences per week. These messages will invite students to reply using keywords and short free text replies. Messages come from a library of strength-based peer quotations (reviewed for safety), psychoeducational interactions, and games designed to promote emotional skills and use of resources.; The control group will receive 1-2 (non-interactive) text messages per week containing general SoS concepts (e.g., "Remember: more strengths are better when times get tough").
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group (receives interactive text messages) and control group (receives informative text messages)
Masking: Single (Participant)
Primary purpose: Prevention
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment
Condition: Postoperative Analgesia
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo/active-controlled study. About 387
      subjects undergoing elective abdominal operation under general anesthesia are planned to be
      enrolled and randomized into the HSK21542 group (129 subjects), tramadol group (129
      subjects), and placebo group (129 subjects).
    


Intervention name(s): HSK21542 Injection; Tramadol hydrochloride; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1μg/kg/dose; 50mg/dose; placebo
Other intervention name(s): HSK21542; Tramadol
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Open-label pharmacokinetic drug interaction study.
    

Detailed description: 
      Multi-center, phase 2, open-label, sequential-cohort, drug interaction study. Cohort 1
      subjects (tacrolimus and adefovir dipivoxil) were enrolled first. Based on the findings in
      Cohort 1, a decision was made on whether to enroll subjects in Cohort 2 (cyclosporine and
      adefovir dipivoxil)(i.e., if no interaction was observed in Cohort 1, Cohort 2 subjects would
      not be enrolled). Since no pharmacokinetic interaction was observed in Cohort 1, Cohort 2 was
      not enrolled.
    

Intervention name(s): Adefovir Dipivoxil
Intervention type(s): Drug
Intervention description(s): Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; Post-Liver Transplantation; Adefovir Dipivoxil; Tacrolimus; Cyclosporine
The Effect of Mirror Therapy in Patients With Frozen Shoulder
Condition: Pain; Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The aim of this study compares mirror therapy and visual feedback treatment with the control
      group in frozen shoulder patients.
    

Detailed description: 
      Thirty-six individuals divided three groups as mirror therapy, visual feedback, and control
      groups were included in the study for 15 sessions of treatment. All individuals received
      basic treatment as ultrasound, transcutaneous electrical nerve stimulation, cold pack,
      stretching exercises, glenohumeral range of motion exercises, scapulothoracic exercises. The
      mirror group bilateral exercised with an affected arm behind the mirror; visual feedback
      group bilateral exercised by seeing both arms in the mirror; control group bilateral
      exercised without a mirror for 10 minutes after every session. Pain severity was evaluated
      with the "Visual Analogue Scale (VAS)", ROM and proprioception were measured with a universal
      goniometer, and functional status was evaluated with "shoulder pain and disability index
      (SPADI)" and "Modified Constant Score". Evaluations were made before, day after the treatment
      and 4 weeks after the treatment by the same researcher. Data analysis was performed with
      SPSS.23.
    

Intervention name(s): Mirror therapy; Visual feedback
Intervention type(s): Other; Other
Intervention description(s): affected arm stay behind the mirror while exercising; visual feedback from mirror
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Frozen Shoulder; visual feedback; proprioception; pain insensitivity; shoulder pain
Intraperitoneal Analgesia in Pediatric Laparoscopy
Condition: Analgesia
Study type: Interventional
Phase: Phase 2

Summary: 
      It is important to keep children undergoing laparoscopic surgery pain free with rapid return
      to normal activity.
    

Detailed description: 
      Pain following laparoscopy is less intense than after laparotomy. Nevertheless, laparoscopy
      is not pain free and control of post-laparoscopy pain remains a major concern. The exact
      cause of such pain remains uncertain, and yet, diaphragmatic irritation and peritoneal
      stretching associated with gas insufflation may be responsible for shoulder and diffuse
      abdominal pain.

      additionally poor pain control could limit the activity of children following laparoscopic
      surgery.
    

Intervention name(s): Dexmedetomidine; Magnesium Sulfate; Normal saline 0.9 %
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity; 2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity; 2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.
Other intervention name(s): Presidx
Intervention MeSH terms: Magnesium Sulfate; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Effect of Food on the Pharmacokinetics of a Single JNJ-39823277 (TPI-1062) Dose in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of food on the bioavailability of a
      single oral dose of JNJ-39823277 and its active metabolites.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), open-label (all people
      know the identity of the intervention), single-center, 2 treatment-sequence, and crossover
      study (method used to switch participants from one treatment arm to another in a clinical
      study). The study consist of 3 phases: a screening phase (within 21 days before medication
      administration), a 2-period open-label treatment phase, during which each participant will
      receive 1 of 2 open-label treatment sequences, and the end-of-study or withdrawal assessments
      (within 7-11 days after the last dose of the study medication). Participants will be randomly
      assigned to 1 of 2 treatment-sequences: Treatment Sequence AB (dosing in fed [with high fat
      diet] condition followed by dosing in fasted [without food] condition) or Treatment Sequence
      BA (dosing in fasted condition followed by dosing in fed condition). Study medication
      administrations will be separated by a washout period (period when receiving no treatment) of
      7 to 14 days. The study duration for each participant will be approximately 6 weeks.
    

Intervention name(s): JNJ-39823277
Intervention type(s): Drug
Intervention description(s): Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.
Other intervention name(s): TPI-1062
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-39823277; JNJ-40917006; Pharmacokinetics
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
Condition: Analgesia; Acute Pain; Chronic Pain; Narcotic Abuse; Opioid-related Disorders
MeSH terms: Chronic Pain; Acute Pain; Opioid-Related Disorders; Narcotic-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label (both the physician and healthy volunteer know which medication will be
      administered), single-dose, 5-dosing period study to characterize the pharmacokinetics
      (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the
      body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place
      over approximately two and a half months and will consist of three phases: a screening visit
      to determine eligibility for the study, a 5-dosing period treatment phase, and an
      end-of-study visit.
    


Intervention name(s): oxycodone hydrochloride; oxycodone hydrochloride; oxycodone hydrochloride; oxycodone hydrochloride; marketed oxycodone hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oxycodone hydrochloride 5 mg tablet under fasted conditions; 2 x oxycodone hydrochloride 5 mg tablets under fasted conditions; 2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions; 2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions; 1 x oxycodone hydrochloride 15 mg tablet under fed conditions
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability; food effect; oxycodone; management of acute and chronic moderate to severe pain