bioihbjkbjnl/mcl2 huggingface dataset:
Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Study type: Interventional

Summary: 
      The overall purpose of this project is to to quantify the physiology of neonatal drug
      withdrawal and develop non-pharmacological techniques to help improve the therapeutic
      management of Neonatal Abstinence Syndrome (NAS).
    

Detailed description: 
      Novel approaches to diagnosing and treating Neonatal Abstinence Syndrome (NAS) are needed for
      reducing prolonged pharmacological management, minimizing hospitalization and improving
      developmental outcomes in drug exposed newborns. This study seeks to examine the physiology
      and symptoms of drug withdrawal (e.g., irritability marked by movement activity;
      cardio-respiratory instabilities) in infants exposed to drugs in utero and test whether
      sensory stimuli (tactile, auditory) reduce dysregulated systems in the withdrawing infant.

      Candidates at-risk for NAS due to fetal drug exposure will be identified to investigators by
      the infant's primary medical caregiver. Investigators will use a modified-consecutive
      sampling technique, restricted by equipment and personnel availability, for enrolling
      infants. Participants will be studied throughout their hospitalization. Effects of
      stimulation will be examined at different stages of withdrawal. Efficacy of stimulation will
      be examined as a potential complementary treatment of NAS.
    

Intervention name(s): Stochastic Vibrotactile Stimulation (SVS); Control
Intervention type(s): Device; Other
Intervention description(s): The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available; designed by Wyss Institute, Harvard University, Cofab Design LLC) to provide gentle vibrations and sounds during mattress stimulations.; Absence of mattress Stochastic Vibratory Stimulation (SVS)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stochastic Resonance; Fetus/Newborn Infant; Drug Withdrawal; Substance Abuse
Exenatide Once Weekly for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to identify a potential new treatment for smoking cessation.
    


Intervention name(s): Exenatide; NRT; Counseling; Placebo
Intervention type(s): Drug; Drug; Behavioral; Drug
Intervention description(s): Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.; Nicotine Patch (21mg) / 24 hours.; Brief individual behavioral smoking cessation counseling.; Normal saline.
Other intervention name(s): Bydureon; Nicotine patch; Smoking cessation counseling
Intervention MeSH terms: Exenatide; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking; pre-diabetes; overweight; exenatide; Glucagon-like peptide-1 (GLP-1) agonists
Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
Condition: Endometrial Hyperplasia Without Atypia
MeSH terms: Endometrial Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of the vaginal micronized progesterone
      and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial
      hyperplasia in premenopausal women.
    

Detailed description: 
      Vaginal use of micronized progesterone in the treatment of endometrial hyperplasia can result
      in better than oral administration, as it will remain away from the first pass effect, and
      depending on the local application. In this study, we aimed to compare this local treatment
      with Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial
      hyperplasia.
    

Intervention name(s): Vaginal Micronized Progesterone; Levonorgestrel-Intrauterine System
Intervention type(s): Drug; Device
Intervention description(s): Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months.; Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.
Other intervention name(s): Mirena
Intervention MeSH terms: Levonorgestrel; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Physiotherapy on Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Demographic data of patients diagnosed with chronic low back pain and planned for medical
      treatment (n:30) and physical therapy in addition to medical treatment (n:30), as well as
      before and after treatment; Visual analog scale (VAS), Oswestry Disability Index (ODI) and
      Short form 36 (SF-36) quality of life scoring, Lumbar range of motion (LHA), straight leg
      raising test (DBK) and hand-finger ground distance (EPZM) were evaluated. Hot pack,
      transcutaneous electrical nerve stimulation (TENS) and ultrasound were given as physical
      therapy agents.
    

Detailed description: 
      Patients with VAS, ODI and SF-36 quality of life values before treatment, in addition to
      demographic data, who have applied to our Physical Medicine and Rehabilitation Policlinic in
      our hospital with chronic low back pain in the last 3 (three) months, are determined, and at
      least 30 above the age of 18 who received physiotherapy and who did not receive
      physiotherapy.

      patient consents obtained and VAS, ODI and SF-36 quality of life values questioned.

      Pre- and post-treatment values compared, and intragroup changes compared in both groups and
      evaluated whether physiotherapy contributes to pain, functionality and quality of life in
      treatment.
    

Intervention name(s): Nsaid; Phsiotheraphy
Intervention type(s): Drug; Other
Intervention description(s): Medical treatment; Nsaid and phsiotheraphy (hotpack-ultrasound therapy- tens)
Other intervention name(s): Medical treatment; Medical treatment and phsiotheraphy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with VAS, ODI and SF-36 quality of life values before treatment, in addition to demographic data, who have applied to our Physical Medicine and Rehabilitation Policlinic in our hospital with chronic low back pain in the last 3 (three) months, are determined, and at least 30 above the age of 18 who received physiotherapy and who did not receive physiotherapy. By calling the patient on the phone and being called to our hospital; patient consents will be obtained and VAS, ODI and SF-36 quality of life values will be questioned.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: physiotherapy; low back pain; quality of life; functionality
Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety and tolerability of
      BI 638683 in healthy male volunteers following oral administration of single rising doses
    


Intervention name(s): BI 638683 or placebo; Placebo solution
Intervention type(s): Drug; Drug
Intervention description(s): oral doses given to 6 subjects per dose group; oral doses given to 2 subjects per dose group
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via
      hemodialysate and via two different intravenous routes in adult patients with chronic kidney
      disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.
    


Intervention name(s): Triferic
Intervention type(s): Drug
Other intervention name(s): ferric pyrophosphate citrate; FPC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; bioequivalence
Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®)
Condition: Chronic Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      This is an observational, prospective, open-label, single-arm, multicenter, real-life study
      designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen
      (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in
      participants with HCV GT1.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with CHC, genotype 1, receiving paritaprevir/ritonavir/ombitasvir with
        dasabuvir regimen (3D regimen)
      
Keywords: Chronic Hepatitis C (HCV); Genotype 1; Paritaprevir; Ritonavir; ombitasvir; Dasabuvir; Sustained Virological Response
A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in healthy people is to investigate safety, toleration and time
      course of plasma concentration of PF-04895162, following multiple oral doses for 14 days. The
      preliminary effect of food on Pharmacokinetics (PK) after single oral dose of PF-04895162
      will also be investigated.
    


Intervention name(s): PF-04895162; PF-04895162; PF-04895162; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, 300 mg, single, 1 day; Tablets, 300 mg, twice a day, 14 days; Tablets, to be decided, twice a day, 14 days; Tablets, twice a day, 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Epilepsy; Phase 1; Multiple Dose; Safety; Pharmacokinetics; Toleration
Safety and Efficiency of γδ T Cell Against Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, effects of γδT cells on human Liver Cancer in combination with tumor reducing
      surgery, for example, cryosurgery going to be investigated.
    

Detailed description: 
      A liver tumor will be removed using tumor reducing surgery such as cryosurgery.PBMC of the
      patient will be separated from peripheral blood. After making them potential cancer killer γδ
      T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

      NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to
      ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of
      majority of cancer patients could not be effectively expanded, including cell number, cell
      purity and cell function could not meet the requirements of reinfusion. Meanwhile, those
      patients could not tolerate 100ml of blood drawing for culture every 2 ~ 3 weeks.

      Therefore, we submitted new clinical study application to the ethical committee of the Fuda
      Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous
      protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted
      allogeneic cells instead of autologous in our subsequentially clinical study.
    

Intervention name(s): Cryosurgery or IRE surgery; γδ T cell; γδ T cells/ A Cryosurgery or IRE
Intervention type(s): Procedure; Biological; Other
Intervention description(s): Cryosurgery or IRE surgery will be used in local tumor; γδ T cells will be used against Liver Cancer; Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Immunotherapy, γδ T Cell, Liver Cancer
Prevention of Violence Against Children
Condition: Violence Against Children
Study type: Interventional

Summary: 
      Beside the home, the school is often the second important setting for the development and
      education of children and adolescents. Students spend a large part of their life at school.
      However, there is recurrent occurrence of violence against children and of harsh discipline
      measures used in home and school settings. These may result into negative consequences.
      Hence, prevention strategies against the use of harsh discipline use in schools become a
      priority.

      In the baseline of this study the investigators will therefore examine the prevalence and
      consequences of violence against children in Southwestern Uganda. The study will be conducted
      in schools and common disciplinary measures used by teachers, and the perceptions of
      teachers' and students' in relation to commonly used and experienced disciplinary measures we
      will be investigated.

      In the second phase, the investigators then will implement and assess the effectiveness of an
      intervention aimed at reducing the use of harsh and violent disciplinary measures in schools.
      ICC-T training in the long-term aims at fostering better relations amongst students and
      teachers. Based on feasibility studies, ICC-T intervention is expected to result into better
      teacher-student relationships, change in teachers' attitudes and behaviors concerning the use
      of violent disciplinary measures in the school setting.
    

Detailed description: 
      Study participants (i.e., teachers and students) will be recruited from six districts in
      southwestern Uganda. The sample will include 12 government-aided secondary schools from which
      60 students and 15-25 teachers will be recruited. The final sample will have 720 students and
      180-300 teachers. Investigators will assess data in the baseline (i.e., prior to
      intervention) and three months after the intervention.

      Study measures will cover the following topics: socio-demographic data, common disciplinary
      measure used at home and at school, students' mental health problems, students' and teachers'
      attitudes towards violent discipline measures, and students' exposure to peer and sexual
      violence. Questionnaire for teachers will have additional items that measure attitudes
      towards teaching and teacher stress. Additionally, the investigators will also assess the
      demand, acceptance and feasibility of the training.
    

Intervention name(s): Interaction Competencies with children - for teachers
Intervention type(s): Behavioral
Intervention description(s): Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Violence; Children; Prevalence; Abuse; Prevention
A Food Effect Study of LP-168 Tablets in Healthy Subjects
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, two-period, two-sequence two-treatment crossover design food effect
      study to evaluate the pharmacokinetic profile of LP-168 tablets in healthy subjects after
      single oral administration under fasted and fed conditions
    

Detailed description: 
      A total of 22 subjects from Cohort A and Cohort B, with a single sex ratio of not less than
      1/3, will be included in this study. Each subject will undergo two cycles of self-crossover
      dosing, respectively. 4 days of PK sample collection and safety observation period will be
      conducted after the first dose for the first cycle, followed by the 4-day second cycle of PK
      sample collection and safety observation. The washout period between the 2 doses will be 7
      days.

      Subjects who voluntarily participate in the study and complete the informed consent process
      will be randomly assigned to the fasted-fed group (Cohort A) or the fed-fasted group (Cohort
      B) in a 1:1 ratio after completion of all screening visit examinations and after the
      investigator determines that all inclusion criteria are met and all exclusion criteria are
      not met. Cohort A was administered once in Cycle 1 Day1 under fasted condition and once in
      Cycle 2 Day1 (i.e., Day8 after Cycle 1 administration) under fed condition for a total of 2
      doses; cohort B was administered once in Cycle 1 Day 1 under fed condition and once in Cycle
      2 Day 1 (i.e., D8 after Cycle 1 administration) under fasted conditions for a total of 2
      doses, both at a dose of 150 mg of LP-168 tablets.
    

Intervention name(s): LP-168 tablet
Intervention type(s): Drug
Intervention description(s): LP-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
Other intervention name(s): NWP-775
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, 2-part, open-label, fixed-sequence study evaluating potential drug-drug
      interactions between gemfibrozil (part 1) or dabigatran etexilate (part 2) and camlipixant
      (BLU-5937) 50 mg tablet in healthy participants under fasting conditions.
    


Intervention name(s): Camlipixant + Gemfibrozil; Dabigatran etexilate + camlipixant
Intervention type(s): Drug; Drug
Intervention description(s): Camlipixant will be administered alone as well as in co-administration with gemfibrozil; Dabigatran etexilate will be administered alone as well as in co-administration with camlipixant
Intervention MeSH terms: Dabigatran; Gemfibrozil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis
Condition: Low Bone Mass; Low Bone Mineral Density; Males With Osteoporosis; Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess how effective and safe denosumab is in a population of
      males with low bone mass at risk of fracture. The primary clinical hypothesis is that in men
      with low bone mineral density, the mean percent change in lumbar spine bone mineral density
      at 12 months in subjects receiving denosumab will be greater than in subjects receiving
      placebo. Denosumab is a fully human monoclonal antibody with a high affinity for Receptor
      Activator of Nuclear Factor (RANK) Ligand that can bind and neutralize the activity of human
      RANK Ligand similar to the action of endogenous osteoprotegerin.
    


Intervention name(s): 60 mg denosumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 60 mg denosumab (SC injection every 6 months); Placebo for denosumab (SC injection every 6 months)
Other intervention name(s): denosumab
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: men; male; denosumab; BMD; lumbar spine; ADAMO; The ADAMO Trial; male osteoporosis; osteoporosis in men; males with low bone mineral density
Efficacy of Training in Manual Preparation of Platelet Rich Plasma
Condition: Platelet Rich Plasma Production
Study type: Interventional

Summary: 
      This is a device study in some respects, in that specialized centrifuges are commonly used to
      make platelet rich plasma, and we are studying the use of standard laboratory equipment to do
      so. However, it is primarily interventional in that we will evaluate the percentage success
      of trainees in the concentration of viable platelets to more than 4X baseline using a generic
      speed centrifuge and a single spin method.
    


Intervention name(s): Venipuncture
Intervention type(s): Procedure
Intervention description(s): Blood draw for purposes of training in platelet rich plasma concentration. Trainees will be in pairs and each will draw blood from the other for use in the concentration process.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: PRP,; Platelet; Manual
An Insulin Sensitivity Study in Healthy Subjects
Condition: Healthy Volunteers
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will characterize insulin sensitivity in response to treatment with ALKS 3831,
      olanzapine, and placebo.
    


Intervention name(s): ALKS 3831; Olanzapine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daily dosing for 21 consecutive days; Daily dosing for 21 consecutive days; Daily dosing for 21 consecutive days
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ALKS 3831; Samidorphan; Olanzapine