bioihbjkbjnl/mcl2 huggingface dataset:
A School Program for Children Exposed to Violence
Condition: Stress Disorders, Post-Traumatic; Depression
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will develop a program to help school children deal with violence-related trauma.
    

Detailed description: 
      The number of children who have been indirectly or directly exposed to violence has
      dramatically increased in the last decade. The emotional and behavioral consequences of
      violence exposure can be particularly devastating to children. Interventions are needed that
      can reduce symptoms related to traumas already experienced and enhance children's skills for
      handling extreme stress that might be experienced in the future. The Cognitive-Behavioral
      Intervention for Trauma in Schools (CBITS) program was developed between 1998 and 2001 to
      help children in the Los Angeles school district deal with traumatic events. Although
      promising, the program required a school-based mental health clinician for implementation.
      This study will evaluate the effectiveness of a program adapted for the Los Angeles CBITS
      program that can be used by school staff in a middle school setting. The adapted CBITS
      program will be compared to a wait list to determine which is more effective in reducing
      trauma-related stress and depression among sixth grade students.

      Students who have experienced violence-related trauma will be randomly assigned to receive
      either 10 weekly sessions of group cognitive behavioral therapy or to wait 3 months.
      Self-report scales and interviews will be used to assess the emotional states of participants
      at study entry and study completion. No follow-up visits will be required.
    

Intervention name(s): School-based cognitive behavioral support group
Intervention type(s): Behavioral
Other intervention name(s): Support for Students Exposed to Trauma (SSET)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trauma; Violence; Adolescent; Schools; Cognitive behavioral therapy
Evaluation of Post Operative Pain After Sonic Activation and Different Irrigation Needles During Root Canal Treatment
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The study compares the post operative pain after root canal therapy, after using different
      irrigation protocols. The subjects are divided into 3 groups and different irrigation
      protocol is used in each group. One group undergoes final irrigation after root canal therapy
      with a sonic activation device, and in the other two groups, side-vented and open-ended
      needles are used. Post operative pain is then compared at 8, 24, and 48 hour intervals.
    

Detailed description: 
      Root canal therapy is a procedure in which inflamed pulp tissue and microorganisms are
      removed from root canals and pulp chamber, in order to eradicate infection and symptoms.
      Irrigation is a crucial step of an endodontic therapy and different methods and protocols are
      used to enhance the efficacy of irrigation. Sonic activation of root canal irrigation agent
      is one of the effective methods that enhance the outcomes and success rate of endo therapies.
      It removes the smear layer, bacterial biofilms and debris by acoustic streaming and agitating
      the irrigant inside root canals. Similarly, irrigation needles also play an important role in
      endodontic therapy, particularly by improving the delivery of irrigation agent to the apex of
      a root canal. conventionally, open ended needles have been used for irrigant delivery inside
      root canal but is not deemed very efficacious as they cannot penetrate deep into canals and
      cause extrusion of debris beyond the apex. This problem is solved by using side vented
      needles of smaller gauge (30 G) that leads to better irrigation and prevent extrusion of
      chemicals and debris outside the root apex.

      In this study, the efficacy of all three different irrigation protocols will be compared and
      assessed based on post-operative pain, measured by Visual Analog Scale (VAS).
    

Intervention name(s): Open ended needle irrigation; side vented needle irrigation; Sonic activation
Intervention type(s): Device; Device; Device
Intervention description(s): irrigation during root canal shaping and cleaning using an open-ended needle; irrigation during root canal shaping and cleaning using a 30-guage side-vented needle; Agitation of root canal irrigation solution with a sonic activation device (Endoactivator).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sonic activation; post operative pain; endoactivator; side vented needle; root canal therapy; irrigation
Women-Focused HIV Prevention in the Western Cape
Condition: HIV; Substance Abuse; Violence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to test the effectiveness of a woman-focused HIV prevention
      intervention combined with voluntary counseling and testing (VCT), compared to VCT only, and
      VCT combined with an attention-control nutrition intervention.
    

Detailed description: 
      Surveillance data indicate that HIV risk and substance use is a serious problem among South
      African women. This study, funded by the National Institute on Child Health and Human
      Development (NICHD), builds on findings from a recently completed pilot study among women in
      less affluent townships and communities in the Western Cape (Wechsberg et al., 2008). The
      pilot study tested the effectiveness of an evidence-based woman-focused intervention in
      reducing drug use, sexual risk, and victimization by addressing the intersection of these
      factors among 100 poor, substance-using women of colour.

      The primary aim of this study is to test the effectiveness, through a randomized controlled
      trial (RCT), of VCT plus a woman-focused intervention relative to VCT only to increase
      knowledge and skills to reduce substance abuse, sexual risk, and victimization, and to an
      equal-attention (nutrition) control group at 3-, 6-, 9-, and 12-month follow-ups. A secondary
      aim is to examine the moderating effect of victimization (i.e., sexual and physical) and the
      mediating effects of HIV risk knowledge, condom use skills, sexual negotiation assertiveness,
      and relationship power on the effectiveness of the woman-focused groups to decrease risk
      related to drug use, sexual risk, and sex-related-victimization relative to the rapid testing
      group and to the equal-attention control group.
    

Intervention name(s): Woman-Focused Intervention (Women's Health CoOp); Nutrition (Attention-Control); VCT Only
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants in this group will receive VCT and participate in two group sessions of the woman-focused intervention.; Participants in this group will receive VCT and participate in two group sessions of the nutrition intervention.; Participants in this group will receive VCT only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Sexual Risk; Substance Abuse; Victimization; Violence; Voluntary Counseling and Testing (VCT)
To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety, and population pharmacokinetics of a single,
      oral dose of GP681 compared with placebo in patients aged 12 to 65 years with acute
      uncomplicated influenza virus infection
    


Intervention name(s): GP681 40mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2X20mg tablets taken orally; Placebo tablets matching GP681 40mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of 7 Days of Dosing With a 10 mg Rectal Suppository of NRL001in Patients With Faecal Incontinence
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to examine the effect of alpha adrenergic stimulation of the anal canal and
      rectum on parameters affecting the control of defecation in subjects with faecal
      incontinence. The study will investigate the effects of rectal suppositories containing 10 mg
      NRL001 given for seven days, once daily. Rectal compliance and median anal resting pressure
      will be considered the primary objective of the study. A pharmacokinetic evaluation plus
      safety and tolerability assessment including monitoring of electrocardiograms (ECGs), blood
      pressure and heart rate will also be evaluated as secondary objectives.
    


Intervention name(s): NRL001; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg NRL001 in a 2 g suppository, administered once daily for 7 days; Matched placebo - administered as a 2 g suppository, once daily for 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Broadly, the objective of this study is to evaluate the fractional decline of intensity of
      tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer
      following treatment with radium-223 as a surrogate marker for tumor cell killing.
    


Intervention name(s): radium-223 dichloride
Intervention type(s): Drug
Intervention description(s): 6 doses of Radium-223
Intervention MeSH terms: Radium Ra 223 dichloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PSMA
Allogenic Stem Cell Transplantation (SCT) With Non-myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL)
Condition: Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative
      conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic
      transplantation of haematopoietic stem cells from family donor's peripheral blood.
    


Intervention name(s): Ibritumomab Tiuxetan (Zevalin)
Intervention type(s): Drug
Intervention description(s): Conditioning Regimen
Rituximab, 250 mg/m2 on days -21 and -14.
Ibritumomab tiuxetan (Zevalin): 0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.
Chemotherapy:
Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
Melphalan 70 mg/m2/day on days -3 and -2 as a 15-min infusion.
Chemotherapy for relapsing patients after autologous transplantation including melphalan over the last 6 months:
Thiotepa 5 mg/kg over 4 hours every 12 hours on day -8.
Fludarabine 30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.
Melphalan 70 mg/m2/day on day -2 as a 15-min infusion.
Other intervention name(s): Rituximab (Mabthera)
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogeneic; Lymphoma; GELTAMO; Z-RIC
Effect of Aerobic Training on Asthmatic Patients
Condition: Anxiety; Depression; Airway Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The investigators hypothesize that aerobic training can reduce anxiety, depression and airway
      inflammation and those benefits may be related to changes in autonomic system.
    

Detailed description: 
      One-hundred patients with moderate or severe persistent asthma, age ranging from 20 to 50
      years-old recruited after a medical consultation. Asthma diagnosis based on GINA1 and
      patients were under medical treatment for at least 6-months and considered clinically stable
      (no crises and changes in medication for at least 30 days). Patients diagnosed with
      cardiovascular, pulmonary or musculoskeletal diseases impairing exercise training were
      excluded.

      Experimental Design: Patients were studied between 2 medical consultation to avoid changes in
      medication during the study and patients were randomized (by drawing lots) into either
      Control or Training groups. CG was submitted to a 4-hour educational program and a breathing
      exercise program and TG was submitted to the same CG procedures plus an aerobic training
      program individually based on VO2max. Before and after the intervention, patients performed
      pulmonary function test and cardiopulmonary exercise testing and as well as fulfilled
      questionnaires to quantify asthma specific HRQL and anxiety and depression levels. Asthma
      daily symptoms were evaluated monthly.
    

Intervention name(s): Aerobic training
Intervention type(s): Other
Intervention description(s): Treadmill training
Other intervention name(s): Exercise conditioning
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aerobic Exercise; Exercise
Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease
Condition: Malignant Neoplasm of Bronchus or Lung, Unspecified
MeSH terms: Neoplasms; Bronchial Neoplasms; Lung Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy and cost difference of using a
      parenchymal stapling device versus hand sewing for a pulmonary lobectomy in patients with
      lung disease (mass or others).
    

Detailed description: 
      There are many lung diseases that need surgical treatment including malignancy lesion or
      benign lesions such as lung bleb or bullae, lung cyst, benign tumor, infection (necrotizing
      pneumonia, lung abscess, aspergilloma) etc. One of the most common procedure is pulmonary
      lobectomy. The surgical method for dividing parenchyma when performing lobectomy was divided
      in two methods. In the past, the investigators used hand-sewn technique but this procedure
      was time-consuming, high risk of air leakage, infection and re-operation, long length of
      hospital stay and high total cost of treatment. In the present time, the investigators use
      stapling device which has been used worldwide in various field of surgery since 1995. Many
      studies proved that using stapling devices can reduce post-operative complication, length of
      hospital stay and total cost of treatment and also became the standard instrument for lung
      surgery. In Thailand, these devices have been used for at least 5 years but they were not
      included in all of Health Insurance of Thai Government. Many patients had to pay for these
      devices by themselves, approximately 323-484.5 USD. Therefore, the investigators try to prove
      the hypothesis that using stapling devices for lung surgery would reduce the cost of
      treatment, post-operative air leakage, re-operative rate, length of hospital stay and time of
      surgery. The result of this study may effect the decision for including these devices in the
      Health Insurance of Thai Government.
    

Intervention name(s): stapling device
Intervention type(s): Device
Intervention description(s): Stapling device include GIA 80, TA 45, endo GIA 60, endo GIA 45
Other intervention name(s): stapler
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stapling device; lobectomy; cost utility
HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in
      participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were
      undergoing hemodialysis.
    


Intervention name(s): Peginterferon alfa-2a
Intervention type(s): Drug
Intervention description(s): Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.
Other intervention name(s): Pegasys
Intervention MeSH terms: Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
Condition: Healthy
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy
      adult subjects using an insomnia model.
    

Detailed description: 
      Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional
      open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4).

      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217 high dose; Placebo; SAGE-217 low dose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): high dose; placebo; low dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study With NLY01 in Subjects With Type 2 Diabetes
Condition: Type2 Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2
      diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic
      effects on glycemic control.
    


Intervention name(s): NLY01; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NLY01, a PEGylated form of the anti-diabetic peptide exenatide; normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Therapeutic Exercises on Kinesiophobia in Haemophilic Patients.
Condition: Haemophilia
MeSH terms: Hemophilia A; Kinesiophobia
Study type: Interventional

Summary: 
      this study evaluates the effects of therapeutic exercises on kinesiophobia and health-related
      quality of life in adult haemophilia patients. half of participants will receive therapeutic
      exercises and verbal information about the positive effects of therapeutic exercises on
      physical pathologies due to hemophilic arthropathy while the other half will receive only
      verbal information.
    

Detailed description: 
      in haemophilia patients recurrent musculoskeletal hemorrhage cause to arthropathy
      characterized by severe degeneration of joint cartilage and bones. arthropathy leads to
      decrease in the patient's health related quality of life. furthermore pain, risk of injury
      and lack of motivation lead to decreased physical activity and development of kinesiophobia.
    

Intervention name(s): therapeutic exercises
Intervention type(s): Other
Intervention description(s): aerobic- balance -stretching and strengthening exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Progressive Muscle Relaxation and Laughter Therapy on Women Undergoing In Vitro Fertilization
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      Purpose: This study was aimed to evaluate the effect of progressive muscle relaxation
      exercises and laughter therapy on the mental health and treatment outcomes of women receiving
      IVF treatment.

      Design: Randomized controlled trial with two parallel groups Methods: Participants were
      randomly assigned to the intervention (IG; n = 71) and control group (CG; n = 70). The
      progressive muscle relaxation and laughter therapy was administered to women in the
      intervention group in the IVF center for 3-4 times and 40 minutes. The CG received routine
      care. Data were collected using baseline and oocyte retrieval day STAI and BDI.
    

Detailed description: 
      Infertility, one of the important components of reproductive health, affects one in four
      couples in developing countries.The emergence of assisted reproductive techniques such as in
      vitro fertilization (IVF) gives infertile couples the opportunity to have both pregnancy and
      a baby. Couples are affected emotionally during IVF treatment and women experience more
      problems than men. The majority of women experience emotional problems such as anxiety and
      depression because of infertility, invasive treatment procedures, physiological effects of
      gonadotropin stimulation and positive outcome expectation.Considering the effect of anxiety
      and depression on infertile women, it is important to examine the effectiveness of
      progressive muscle relaxation exercises and laughter therapy as complementary therapy in
      psychosocial care.
    

Intervention name(s): Progressive muscle relaxation+laughter therapy
Intervention type(s): Behavioral
Intervention description(s): Laughter therapy:Laughter therapy is a technique that changes the mood by breathing correctly and by combining childish exercises with laughter exercises to turn into real laughter for no reason.
Progressive muscle relaxation procedure:
the participants were asked to tighten and relax large muscle groups in the body with deep breathing exercises. Progressive muscle relaxation was applied to the muscles of the head and face, neck, chest, back, arms, hands, abdomen, hips, legs and feet. The procedure was applied in a dark environment and accompanied by candlelight and relaxing music.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care