bioihbjkbjnl/mcl2 huggingface dataset:
Linear Running Periodization x Nonlinear
Condition: Healthy
Study type: Interventional

Summary: 
      In a competitive scenario, trainers and coaches seek to improve the performance of their
      athletes organizing macrocycles (year), mesocycles (months), and microcycles (weeks) training
      aimed at a specific moment of a competition. The organization variables, mainly the intensity
      of exercise in a training routine can stimulate important physiological pathways and uphold
      superior gains to VO2max, leading to a peak aerobic performance. However, due to lack of
      evidence, and the difficulty of control on a large scale, the effects of the intensity
      organization over a mesocycle periodization are still poorly investigated.
    

Detailed description: 
      The objective of this study is compare two intensity blocks organization a) linear
      progression intensity (LP) and b) randomized or not intensity linaer (NLP) over five months
      running training, and a crossover design between subjects, on gains in VO2max, peak velocity
      (Vpeak) and critical power (CP). Furthermore, the relationship between the gains obtained
      with the training and the amount of exercise will be established. In our case all dependent
      variables will increase after training, with no significant differences between the two
      strategies on dependent variables.
    

Intervention name(s): Linear Periodization; Non Linear Periodization
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Linear Intensity Periodization Running; Non Linear Periodization Running
Other intervention name(s): LP; Progressive Periodization; NLP; Randomized Intensity
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VO2Max; Physical Conditioning; Aerobic Exercise; Performance
Evaluation of the Positive Prevention PLUS Program
Condition: Pregnancy in Adolescence
Study type: Interventional

Summary: 
      This study aims to determine if the Positive Prevention PLUS teen pregnancy prevention
      program has an impact on abstinence, birth control use, and likelihood of becoming pregnant.
    

Detailed description: 
      A clustered randomized controlled trial (CRCT) was employed where participating high school
      sites were randomly assigned either to a treatment group that implemented the Positive
      Prevention PLUS program or a control group. Students completed a self-administered survey at
      baseline (prior to program implementation) and a 6 month follow-up survey (post program
      implementation). Eligible students in the sample included all male and female 9th-grade
      students from 21 high schools enrolled in mandatory 9th-grade health, science, or physical
      education classes, to which the district assigns students randomly. Of the 7,042 eligible
      students, 4,267 received parental consent and were enrolled in the study. Outcome variables
      include initiation of sexual activity, ever been pregnant, and birth control use.
    

Intervention name(s): Positive Prevention PLUS
Intervention type(s): Behavioral
Intervention description(s): PP+ has elven 45 minute lessons: (1) Getting Started, (2) Life Planning, (3) Healthy Relationships, (4) Relationship Violence, (5) Family Planning and Contraceptives, (6) Myths and Stereotypes, (7) HIV Disease and AIDS, (8) Recognizing and Reducing Risk, (9) Peer and Media Pressures, (10) Human Immunodeficiency Virus (HIV)/Sexually Transmitted Disease (STD) Testing and Community Resources, and (11) Steps to Success.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Screening Protocol to Assess Adults and Adolescents With Down Syndrome for Eligibility For Upcoming Study of RG1662 (Study BP27832)
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Observational

Summary: 
      This is a single visit study in which people with Down syndrome aged 12-30 will attend the
      clinical center to undergo assessments to evaluate their eligibility for potential enrollment
      in the future BP27832 Phase II clinical study which will evaluate the efficacy, safety and
      tolerability of RG1662. Study participants may withdraw from this study at any time and for
      any reason.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        People with Down syndrome
Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis:
Condition: Glenohumeral Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      This monocentric randomized open-label study aims to assess the efficacy and safety of a
      treatment with medium molecular weight hyaluronic acid (HA) compared to a treatment with
      corticosteroids on patients affected by glenohumeral osteoarthritis.
    

Detailed description: 
      Glenohumeral osteoarthritis (OA) is a very common joint disease characterized by pain and
      functional limitation. No standardized protocols of treatment are available in clinical
      practice and literature data are confusing. This monocentric randomized open-label study aims
      to assess the efficacy and safety of a treatment with medium molecular weight hyaluronic acid
      (HA) compared to a treatment with corticosteroids on patients affected by glenohumeral
      osteoarthritis.

      A total of 80 consecutive patients with glenohumeral OA (Kellegren Lawrence degree II or III)
      were randomized in two different groups, intto Hymovis® (24mg/3ml) (treatment group) or into
      corticosteroids (control group), with a follow-up after 3 and 6 months. Modifications in
      terms of pain (VAS), range of motion (ROM) and quality of life (EQ-5D) were observed during
      the treatment.
    

Intervention name(s): Hyaluronic Acid 24 MG in 3 mL Prefilled Syringe; Corticosteroid injection
Intervention type(s): Device; Drug
Intervention description(s): Patients in the treatment group received two intra-articular injections with Hymovis® (24mg/3ml) a week apart from each other; Patients in control group received two intra-articular injections with corticosteroids a week apart from each other.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 80 consecutive patients with glenohumeral OA degree II or III were prospectively enrolled in our clinic from May 2021 to March 2022. The study was approved by Concordia Hospital Ethical Committee (02/2021) and performed according to ISO14155:2020 and Declaration of Helsinki.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Hyaluronic Acid; Corticosteroids
Oxidative Stress and Cardiac Arrest
Condition: Heart Arrest
MeSH terms: Heart Arrest
Study type: Observational

Summary: 
      Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to
      31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA
      is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on
      survival. But the mechanisms underlying these therapy are not clear.

      Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well
      demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a
      clinical setting.

      The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest
      treated with mild hypothermia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      Plasma
    
Keywords: heart arrest; oxidative stress; lactic acid; outcome
MoTHER Buddy Program
Condition: Physical Activity; Obesity
Study type: Interventional

Summary: 
      The purpose of the 12-week study is to determine if competing a physical activity program
      with a buddy helps increase daily physical activity when compared to completing the same
      physical activity program without a buddy.
    


Intervention name(s): mHealth Physical Activity; Buddy-partnered exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Post-Operative Evaluation of Endodontic Microsurgeries Done Using a Piezoelectric Ultrasonic Technique: An in Vivo Study
Condition: Periapical Diseases; Endodontic Overfill; Healing Surgical Wounds
MeSH terms: Periapical Diseases; Surgical Wound
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the effect of Piezosurgery and Trephine bur as cutting
      tools on post-operative sequelae including pain and swelling following guided endodontic
      microsurgeries.
    

Detailed description: 
      Materials and Methods: Twenty healthy male patients aged between 18 and 45 years old were
      selected in the study. Mandibular first molar teeth with failed non-surgical treatment or
      re-treatment due to iatrogenic errors at the apical 3mm of the mesial root canal including
      canal ledging, zipping and transportation, root perforation, separated instrument, and canal
      calcification were selected. Piezosurgery assisted cavity preparation and root-end resection
      were performed in Groups I and II, and Trephine bur assisted cavity and root-end resection
      was performed in Groups III and IV. An apical curettage was performed and the over-extended
      objects such as separated instruments or gutta percha were removed. The PRF clots was placed
      inside the bone cavity in groups I and III while the bone cavity was kept for 2 min to allow
      the blood clots to be formed in groups II and IV. The degree of pain and swelling were
      recorded for five days every 24, 48, 72, 96, and 120 hours postoperatively.
    

Intervention name(s): Piezosurgery assisted group; Trephine Bur assisted group
Intervention type(s): Procedure; Procedure
Intervention description(s): apicectomy will be done using the Piezosurgery device; apicectomy will be done using the trephine burs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endodontic Microsurgery; Piezosurgery; Trephine bur
Efficacy of an Acceptance-based Group Behavioral Therapy for Generalized Anxiety Disorder.
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Generalized anxiety disorder (GAD) shows the weakest treatment response among anxiety
      disorders. The present study aimed at examining whether an acceptance-based behavioral
      treatment, combining mindfulness and exposure strategies, would improve clinical outcome
      compared to a standard, non-directive, supportive group therapy (NDST) for clients at a
      Brazilian anxiety disorders program.
    

Detailed description: 
      Ninety-two individuals diagnosed with GAD were randomized to receive 10 sessions of either an
      acceptance-based behavior therapy (ABBT) or a Non-directive support Therapy (NDST).
      Assessments were at pretreatment, mid term, post-treatment, and 3-month follow-up.Data were
      analyzed using the Mixed effect regression models comparing both groups in primary outcome
      measures. Secondary outcome measures and putative process variables were assessed and also
      analyzed. The latter were tested as mediators of efficacy.
    

Intervention name(s): Acceptance-based Behavior Therapy; Non-directive Supportive Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The protocol is widely based on Roemer and Orsillo (2007) acceptance model of GAD, using functional assessment, psychoeducation, mindfulness, commitment to valued behavior, and exposure techniques used in a willingness improvement verbal context.; NDST consists in a form of therapeutic intervention from which all intervention principles pertaining to specific psychotherapeutic protocols are removed while maintaining the so-called common factors from different psychotherapy approaches. In other words, it is an unstructured therapy without specific psychological techniques other than those belonging to the basic interpersonal skills of the therapist, such as reflection, empathic listening, encouragement, and helping people to explore and express their experiences and emotions.
Other intervention name(s): ABBT; Mindfulness-based Behavior Therapy; NDST; Supportive Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a controlled randomized clinical trial involving 10 sessions of ABBT or 10 sessions of NDST (both in groups) completed within 14 weeks.
Masking: Single (Participant)
Primary purpose: Treatment
OTR Tablet 40 mg Fed-state Bioequivalence Study
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, single dose, randomized, cross-over study to confirm the bioequivalence (BE)
      of OTR tablet 40 mg and OXYCONTIN tablet 40 mg in a fed state in Chinese subjects with
      chronic pain.
    

Detailed description: 
      The investigation is designed as an open-label, single dose, randomized, and cross-over study
      to determine the pharmacokinetics(PK) profile of oxycodone from OTR tablet 40 mg and
      OXYCONTIN tablet 40 mg in Chinese subjects with chronic pain in a fed stat.

      Subjects with histories of chronic pain are chosen as the target population.
      Inclusion/exclusion criteria are strictly defined to reduce the potential variation of the PK
      data.
    

Intervention name(s): Oxycodone Tamper Resistant; OxyContin®
Intervention type(s): Drug; Drug
Intervention description(s): Orally taking Oxycodone Tamper Resistant 40mg in fed state; Orally taking OXYCONTIN® 40mg in fed state
Other intervention name(s): Oxycodone Tamper Resistant (OTR) Tablet; OXYCONTIN® Tablet 40 mg
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Glycemic Control With Smartphone Application
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The study is aimed to determine if a smartphone application based weekly glucose monitoring
      by a care provider is superior to the routine home glucose monitoring by patients in poorly
      controlled type 2 diabetes mellitus who are on insulin.
    

Detailed description: 
      The study is a randomized, prospective cohort study. Subjects will be enrolled randomly after
      fulfilling the meeting criteria into two groups. Group 1 (intervention group) will used
      mobile application to enter their glucose level and group 2 (control group) will record their
      glucose level on daily diary. Data collection will be standardized in order to eliminate
      bias. In addition, all statistical analyses will be performed by a departmental statistician
      and not the study investigators. Patients in each arm of the study will be selected form the
      same population in order to avoid selection bias.
    

Intervention name(s): Mobile application; Daily Diary
Intervention type(s): Device; Behavioral
Intervention description(s): participants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly; participants will use daily diary to record glucose level
Other intervention name(s): device related insulin adjustment
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Hypertension, Ocular
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this clinical study is to evaluate the safety and efficacy of NCX 470
      ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular
      hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic
      solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic
      solution.
    


Intervention name(s): NCX 470; Latanoprost 0.005%
Intervention type(s): Drug; Drug
Intervention description(s): NCX 470 Ophthalmic Solution; Latanoprost 0.005% Ophthalmic Solution
Other intervention name(s): Latanoprost
Intervention MeSH terms: Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
Condition: Hyperlipidemia; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in
      subjects with type 2 diabetes.
    


Intervention name(s): ETC-1002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ETC-1002 Daily for 4 weeks; Placebo Daily for 4 weeks
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Testing Gender-based Violence Response in Family Planning and Antenatal Care Services in Nigeria
Condition: Gender-based Violence; Reproductive Coercion; Intimate Partner Violence
Study type: Interventional

Summary: 
      To pilot and evaluate the integration of first-line response to gender- based violence (GBV),
      particularly intimate partner violence (IPV), sexual violence and reproductive coercion,
      within family planning (FP) and antenatal care (ANC) services at public health facilities in
      Ebonyi and Sokoto states in Nigeria.

      GBV first-line response in the health setting includes screening , empowerment counseling,
      safety planning, and support to connect to additional services needed.
    

Detailed description: 
      This study seeks to:

      1. Assess effectiveness of an integrated service delivery model (integration of GBV
      first-line response and empowerment counseling in standard of care FP or ANC services) in
      reducing on-going experience of intimate partner violence (IPV) and increasing utilization of
      modern contraceptive methods among clients.

      1a. Assess effectiveness of the intervention in reducing IPV, increasing utilization of
      modern contraceptive methods, and improving safety and self-efficacy among clients seeking
      interval FP services.

      1b. Assess effectiveness of the intervention in reducing IPV and improving safety and
      self-efficacy to seek GBV care among clients seeking ANC services.

      2. Explore factors influencing feasibility, acceptability and ability to implement GBV
      first-line response as part of FP and ANC services.
    

Intervention name(s): gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES)
Intervention type(s): Behavioral
Intervention description(s): Providers will (1) introduce routine client screening for GBV, including intimate partner violence, sexual violence, and reproductive coercion using a standardized screening form, in FP and ANC services,(2) for individuals disclosing GBV, provide first-line response-empathetic counseling, including listening, inquiring about experiences sensitively, and validating experiences, helping clients develop safety plans, and providing support; (3) regardless of disclosure of GBV, provide counseling and information, education and communication (IEC) materials on IPV, including reproductive coercion, and FP options, to both FP and ANC clients.
Other intervention name(s): GBV screening, LIVES and ARCHES
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effects of Treadmill Versus Cycling Endurance Training in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Aim of this study is to investigate the effects of treadmill versus cycling endurance
      training on Balance, gait performance and exercise capacity in patients with severe chronic
      obstructive pulmonary disease. Patients will be recruited during a 3-week inpatient pulmonary
      rehabilitation program and will be randomized into one of two intervention groups. Walking
      intensity in the treadmill group will be set at 80 percent of the average speed of the
      6-minute walking test. The cycling group will exercise at an intensity of 60 percent
      according to an Initial incremental cycling test.

      Patients will perform 5 to 6 training sessions per week. The total exercise duration will be
      progressively increased from 10 to 30 minutes. Walking or cycling intensity will also be
      progressively increased if perceived exertion during exercise is rated below 3 on the
      modified 10-point Borg scale.
    


Intervention name(s): treadmill endurance training; cycling endurance training
Intervention type(s): Other; Other
Intervention description(s): n = 15 patients with COPD. Walking intensity will be initially set at 80 percent of 6-minute Walking test Speed with progressive increase in Duration and intensity.; n=15 patients with COPD. Cycling intensity will initially be set at 60 percent of Peak work rate with progressive increase in Duration and intensity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; exercise; training; cycling; treadmill; walking; pulmonary rehabilitation
Resistance Training as Treatment of Achilles Tendinopathy
Condition: Achilles Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The use of eccentric resistance training as management of Achilles tendinopathy is
      widespread. The investigators have recently demonstrated that heavy slow resistance training
      was superior in the management of patellar tendinopathy.

      Hypothesis: heavy slow resistance training is more effective than eccentric resistance
      training in the clinical management of Achilles tendinopathy.
    


Intervention name(s): Heavy slow resistance training; Eccentric resistance training
Intervention type(s): Other; Other
Intervention description(s): Heel-raises. 12-6RM. each contraction performed slowly. three times weekly for 12 weeks; Eccentric heel-raises. 3 x 15 reps performed twice daily for 12 wks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tendinopathy, Achilles, Eccentric training, Heavy slow resistance training