bioihbjkbjnl/mcl2 huggingface dataset:
Molecular Evaluation of Endometrium After Endometrial Injury
Condition: Endometrial Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Repeated implantation failure (RIF) is determined when failure of implantation occurred
      during at least three consecutive IVF attempts while at least one high-grade embryo was
      transferred in each cycle. Several methods have been suggested to improve the implantation
      rate in RIF patients. One of the most promising methods is local injury to the endometrium.
      It has been reported that the rates of implantation, clinical pregnancy, and live birth reach
      more than double in RIF patients with local endometrial injury than patients without it. The
      population of this study included all infertile couples attending the Royan Institute, who
      have at least three consecutive cycles of ART failure. Also this study is phase 3 randomized
      clinical trial. Based on the average menstrual cycle 30-28 days, endometrial and blood
      samples were collected from two groups of patients on day 21 of luteal phase of their
      spontaneous menstrual cycle. The intervention, but not the control group underwent prior
      biopsy treatment in follicular phase on days 8 or/and 11 to 13 of that same cycle but in
      these days blood sample in both groups were collected. To investigate the impact of local
      endometrial injury in increasing the rate of pregnancy in ART - treated RIF patients, the
      investigators will examine the changes of immunological factors involved in the implantation
      including some cytokines, growth factors ( in serum and endometrial biopsies) and the
      expression of TLRs and HOX genes ( in endometrial biopsies) obtained from both groups.
    

Detailed description: 
      This study is phase 3 randomized clinical trial that the 20 infertile women with the
      following conditions will be studied in 2 groups. In the intervention group, Endometrial
      sampling is obtained twice by Pipelle [one in the follicular phase (during 8-9 or 11- 13 day
      in the beginning of buserelin cycle) and the last in the luteal phase (during 19-21 or 20-23
      day) preceding the embryo transfer cycle preceding the embryo transfer cycle]. In the control
      group endometrial sampling will be done only in the luteal phase of the cycle preceding the
      embryo transfer cycle. Blood samples (5- 10 cc) are taken in the both groups twice (one on
      the 9-8 or 11- 13 day and 19-21 or 20-23 day preceding the embryo transfer cycle).
    

Intervention name(s): PIPELLE Endometrial injury
Intervention type(s): Procedure
Intervention description(s): The endometrial injury which is induced with pipelle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acupuncture/Moxibustion (Acu/Moxa) for Distal Symmetric Peripheral Neuropathy (DSP) in HIV
Condition: Peripheral Neuropathy; HIV; AIDS; HIV Infections
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      This preliminary study will investigate the use of Acupuncture and Moxibustion (Acu/Moxa) for
      distal symmetric peripheral neuropathy (DSP) associated with HIV applying traditional Chinese
      medicine (TCM) evaluations conducted by a diagnostic acupuncturist. The investigators will
      evaluate the role of Acu/Moxa in reducing the symptoms of DSP related to HIV/AIDS and
      treatment side effects. The effects of symptom reduction on quality of life will also be
      examined. This application will establish a proof of principle for the role of Acu/Moxa in
      the treatment of DSP and provide data that will serve as a foundation for establishing a
      future larger clinical trial.
    

Detailed description: 
      This study is a prospective, randomized, sham/placebo controlled, blinded (subject and
      evaluator), parallel groups clinical trial. This preliminary study will investigate the use
      of Acupuncture and Moxibustion (Acu/Moxa) for DSP associated with HIV applying TCM
      evaluations conducted by a diagnostic acupuncturist. The investigators will evaluate the role
      of Acu/Moxa in reducing the symptoms of DSP related to HIV/AIDS and treatment side effects.
      The effects of symptom reduction on quality of life will also be examined. Data from daily
      symptom diaries and questionnaires will be analyzed with mixed model analysis of variance for
      between group difference in the temporal pattern of symptom reduction at baseline, after 6
      weeks of twice weekly treatment, and after a no-treatment follow-up session. In addition,
      exploratory analyses will assess the logistics of a CAM clinical trial for HIV/AIDS related
      DSP in preparation of a larger clinical trial.
    

Intervention name(s): Acupuncture / Moxibustion; Acupuncture/Moxibustion
Intervention type(s): Other; Other
Intervention description(s): Acupuncture/Moxibustion points will be administered per point prescription.
- Active; Sham/Placebo Acupuncture/Moxibustion - Not active
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral Neuropathy; Neuropathy; HIV; AIDS; DSP; alternative therapies
Mindfulness Based Therapy for Insomnia in Black Women
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to conduct an 8-week RCT to improve insomnia among black women
      with insomnia and evaluate its feasibility, acceptability, and efficacy of Mindfulness Based
      Therapy for Insomnia (MBTI)
    

Detailed description: 
      Study design is a randomized clinical trial (RCT) with attention control. Participants will
      be randomly assigned to participate in either Mindfulness Based Therapy for Insomnia (MBTI)
      or time and attention control. Participants in the experimental group will receive the MBTI
      that includes mindfulness meditation and behavioral strategies for sleep. Participants in the
      control group will receive healthy lifestyle education that includes healthy eating, physical
      activity and sleep hygiene practice to mitigate insomnia.
    

Intervention name(s): Mindfulness-based therapy for insomnia (MBTI); Healthy lifestyle intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.; Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mindfulness-based therapy for insomnia (MBTI)
Enhancing Systems of Care: Supporting Families and Improving Youth Outcomes
Condition: Pediatric Mental Health Services
Study type: Interventional

Summary: 
      The aim of the study is to improve access to child mental health and substance abuse (MH/SA)
      care by expanding primary care screening and increasing availability of timely mental health
      evaluation and treatment.
    

Detailed description: 
      This is a quasi-experimental, longitudinal study. Identified youth and families will receive
      the intervention within the four study site clinic locations. Comparison group families will
      receive usual care. Each primary care study site will have designated Family Support
      Specialist, Clinical Care Manager and Child Psychiatry resources. The intervention includes
      an integrated care consultation which combines diagnostic evaluation, family assessment, and
      multi-disciplinary, team-based treatment recommendations, with follow-up community linkages
      and support, as indicated.
    

Intervention name(s): Enhanced Systems of Care Team
Intervention type(s): Behavioral
Intervention description(s): E-SOC team will be increasing connections between clinical care and community partners, such as schools, juvenile justice and child-serving state agencies, to reduce disparities in access to mental health/substance use evaluation and treatment. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning. Overall goals are: earlier identification of mental health needs including child trauma; increased treatment access and adherence; care delivered in least restrictive settings; care experience reflecting active youth and family engagement; program sustainability and replicability.
Intervention model: Single Group Assignment
Intervention model description: The E-SOC Model consists of the delivery of intensively integrated clinical care within pediatrics, combined with community-based parent support from family support specialists. Innovations include child mental health specialists joining the pediatrics team for "huddles", psychiatry notes shared with pediatricians via the Electronic Medical Records and active inclusion of pediatricians in pre-evaluation discussions with the E-SOC Team and post-evaluation recommendations for the families. In addition, the E-SOC model includes active communication with school personnel, child welfare, and community-based resources, when needed.
Masking: None (Open Label)
Primary purpose: Health Services Research
Appetite Response to Exercise- Versus Mixed (Exercise + Dietary Restriction)-Induced Energy Deficit in Adolescents With Obesity
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The aim of the present study is to compare the effect of iso-energetic energy deficits
      induced by energy restriction alone or exercise + dietary restriction (Mixed deficit) on
      energy intake and appetite feelings in adolescents with obesity.
    

Detailed description: 
      The present study will compare the nutritional response to an energy deficit of 500 kcal
      induced once by dietary restriction alone and once by a mixed deficit (50% by exercise and
      50% by dietary restriction) (compared with a control condition). 18 adolescents with obesity
      will be asked to randomly complete three experimental sessions: i) one control session (CON);
      ii) one session with a dietary-induced energy deficit (Def-EI); iii) one session with a mixed
      deficit (50% by exercise and 50% by dietary restriction) (Def-Mixed).

      Their ad libitum energy intake will be assessed at dinner time. Appetite feelings will be
      assessed at regular intervals and their food reward in response to the lunch will also be
      assessed.
    

Intervention name(s): CON . control condition without exercise / rest condition; Def-Mixed. Condition with a mixed energy deficit induced by exercise + dietary restriction.; Def-EI. Condition with an energy-restriction energy deficit
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.; Def-Mixed. Condition with an exercise-induced energy deficit The adolescents will received a calibrated lundh meal with a deduction of 250 kcal compared with the lunch meal of Con; and will be asked to realise an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 250 kcal. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.; Condition with an energy-restriction energy deficit The adolescents will receive a calibrated breakfast reduced from 500 kcal compare to their CON and Def-mixed conditions. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
Intervention MeSH terms: Butyl phosphorotrithioate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: appetite control; obesity; Adolescents; exercise; Energy Deficit
Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck
Condition: Head-and-neck Cancer; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a non-randomized, phase II, open label study of postoperative concurrent
      chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and
      neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of
      concurrent chemoradiotherapy with docetaxel in HNSCC patients.
    


Intervention name(s): Docetaxel; Intensity-modulated radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): Docetaxel: 20mg/m2/w for 6 weeks; a total dose of 60Gy in 30 fractions over 6 weeks
Other intervention name(s): IMRT
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Docetaxel; Concurrent Chemoradiotherapy; High-Risk; Squamous Cell Carcinoma; Head-and-Neck Cancer
SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of
      SI-6603 in subjects with lumbar disc herniation (LDH)
    


Intervention name(s): SI-6603; Sham injection
Intervention type(s): Drug; Drug
Intervention description(s): SI-6603 will be injected into an intervertebral disc.; The injection will be performed without needle placement into an intervertebral disc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lumbar disc herniation; Radiculopathy; Sciatica; Intradiscal injection; Chemonucleolysis
Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of Hepatic Encephalopathy (HE)
Condition: Liver Cirrhosis; Hepatic Encephalopathy
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Fibrosis
Study type: Observational

Summary: 
      We wish to study patients with liver cirrhosis during and 2 weeks after an acute episode of
      liver coma (hepatic encephalopathy). By means of Positron Emission Tomography we investigate;
      brain blood flow, brain ammonia uptake and brain oxygen consumption. We hypothesize that
      blood flow an oxygen consumption is diminished and ammonia uptake increased during an acute
      episode of hepatic encephalopathy.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with hepatic encephalopathy
      
Keywords: liver cirrhosis; hepatic encephalopathy; ammonia; cerebral blood flow
Honey Used as Adjunct Therapy to Tylenol for Post-Op Tonsillectomy Patients
Condition: Tonsillectomy
Study type: Interventional

Summary: 
      Tonsillectomies are the second most common surgery with over half a million procedures in the
      United States for 2006. Tonsillectomies are considered a painful surgical procedure performed
      on children resulting in pain and nausea/vomiting for up to 7 days postoperatively. Up until
      recently, doctors have been prescribing upwards of ten days' worth of opioid pain medication
      for children following tonsillectomies due to the high incidence of pain expected afterwards.
      Effective July 1st, 2018, new laws regarding opioid restrictions came into place that
      restricted doctor's abilities to write for more than three days' worth of opioid pain
      medication without having to fill out sizeable amounts of additional paperwork. This law was
      put in place to combat the ongoing opioid epidemic that plagues this country. What the
      investigators are left with for the treatment of pain following these procedures are simply
      Tylenol and Motrin with a limited amount of opioid. With this being considered a highly
      painful surgery with a difficult recovery, more options are needed to effectively treat pain
      and reduce the incidence of emergency room visits and phone calls to the clinic regarding
      pain control in the postoperative period.

      Studies in Europe have shown that honey is an effective adjunct treatment option in the
      reduction of pain in pediatric postoperative tonsillectomies. These studies are few and far
      between and more research needs to be conducted to validate these claims particularly in the
      United States where research on this subject has been extremely limited. Further, the extent
      to which families and health care providers in the United States would be receptive to using
      honey for children's postoperative pain is unclear since honey is considered a complementary
      and alternative medicine (CAM) intervention.
    


Intervention name(s): Honey; Standard of Care
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Will give patients and families included in the honey standard of care group 40 packets of hospital approved honey to implement in the tonsillectomy post-operative care of the child; Patients will receive standard post operative medications per surgeon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Honey; Pediatrics; Post-Operative
Influence of Multi-dimensional Wellness Program on Quality of Life
Condition: Healthy; Physical Disorders; Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether multi-dimensional wellness program (diet,
      art and biofield therapy) influences the quality of life for those with different health
      status in Japan.
    

Detailed description: 
      Combination of wellness programs may be one of the best approaches to improve quality of
      life; however, the effectiveness of a treatment that combines various programs is also yet to
      be clarified. This study investigated the influence of Okada Health and Wellness program on
      the quality of life for healthy people and those with illness in Japan. Okada Health and
      Wellness program consists of 3 components: diet, art and biofield therapy.
    

Intervention name(s): Okada Health and Wellness program
Intervention type(s): Behavioral
Intervention description(s): Each participant were encouraged to practice the diet program and art therapy established by the MOA International Corporation, and to receive Okada Purifying Therapy, a domain of biofield therapy, for 3 consecutive months.
Other intervention name(s): diet program; art therapy; biofield therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cohort study; diet program; art therapy; laying-on-of-hands; quality of life
Parent Intervention to Reduce Binge Drinking
Condition: Alcohol Consumption
MeSH terms: Binge Drinking; Alcohol Drinking
Study type: Interventional

Summary: 
      Parent and peer interventions to reduce student drinking
    

Detailed description: 
      Parent and peer interventions to reduce student drinking:

      Efficacy;

      Mediation:

      Moderation
    

Intervention name(s): Parent Handbook and Peer Basics
Intervention type(s): Behavioral
Intervention description(s): Parent and Peer delivered interventions
Other intervention name(s): Parent Handbook; Peer Delivered BASICS
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: parents; peer; basics; college student drinking
Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      To trial the reactogenicity, safety and immunogenicity of the Flu-M inactivated split
      influenza vaccine in volunteers aged 18-60 years
    

Detailed description: 
      All subjects will be followed up for 21 days post-randomization. The subjects will further be
      assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be
      collected for reactogenicity and safety and immunogenicity assessments before injection and
      21 days after vaccination.
    

Intervention name(s): Flu-M [Inactivated split influenza vaccine]; Inactivated influenza split vaccine
Intervention type(s): Biological; Biological
Intervention description(s): solution for intramuscular injection, 0.5 ml; solution for intramuscular injection, 0.5 ml
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: influenza; flu; vaccine; Flu-M
Codeine on Pharyngeal and Esophageal Motility
Condition: Esophageal Motility Disorders
MeSH terms: Esophageal Motility Disorders; Esophageal Spasm, Diffuse
Study type: Interventional
Phase: Phase 4

Summary: 
      Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI)
      tract to induce changes in motility. A variety of studies have linked chronic opioid use with
      changes in intestinal and to a lesser extent esophageal motility. Less is known about acute
      administration effects on distal esophageal motility and LES and even less with respect to
      proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both
      centrally as well as in the periphery may induce changes in parts of the GI tract implicated
      in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility
      patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers
      receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled
      fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools
      (Chicago 3.0, AIMPlot analysis).
    


Intervention name(s): Codeine Phosphate; Siripus simplex
Intervention type(s): Drug; Drug
Intervention description(s): 30 mL of codeine phosphate 10mg/5mL; Sugar syrup
Intervention MeSH terms: Codeine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: codeine; Esophageal motility; Pharyngeal motility