bioihbjkbjnl/mcl2 huggingface dataset:
Health Experiences & Early Life Disadvantages
Condition: Early Life Adversity; Chronic Stress
Study type: Interventional

Summary: 
      Growing up in a low-income household has been shown to increase risk for, and susceptibility
      to many illnesses.The purpose of the study is to test an affective intervention for reversing
      biological risk factors, as related to childhood adversity, in midlife.

      Participants will be asked to make two lab visits; attend six weekly, 1-hour meditation
      classes; as well as complete brief online daily surveys for 11 weeks, five biweekly surveys,
      and two 30-minute surveys prior to each lab visit. During the lab visits, participants will
      have their psychophysiology monitored for heart rate, blood pressure, respiration, and pulse.
      Participants will also have their blood drawn.

      All surveys and questionnaires inquire about participants' current demographics, family
      history, perceptions about life and well-being, physical health, and monetary choices.
    


Intervention name(s): Meditation Workshop
Intervention type(s): Behavioral
Intervention description(s): Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome
Condition: Polycystic Ovary Syndrome; Infertility
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      It was randomised controlled study to compare the efficacy of clomiphene and letrozole in
      polycystic ovarian syndrome(PCOS) women with infertility.The aim was to select more
      appropriate treatment for ovulation induction in PCOS women.
    

Detailed description: 
      The prevalence of infertility due to polycystic ovarian syndrome in Pakistan is 21.9%.It
      leads to an ovulation which results in infertility.The objective of this study was to compare
      the efficacy of letrozole vs clomiphene citrate for ovulation induction in PCOS
      women.Methods.It was a randomised controlled trial conducted in department of gynaecology and
      obstetrics ,Services Hospital Lahore from 2016-2019.

      Total 230 patients were included in study, they were divided in two groups, out of which 220
      patients were analysed. .Group-A patients were given clomiphene citrate 50-150mg per day for
      5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg
      per day for 5 days. Transvaginal ultrasound monitoring done from day 10-12 of menstrual cycle
      to measure follicle number and size.When follicle achieved a diameter of 18-20mm, then Inj
      HCG(human chorionic gonadotropin)10,000 IU intramuscular was given. Ovulation was confirmed
      by day 21 S.progesterone. When patient conceived, they were followed up till delivery.
    

Intervention name(s): letrozole 2.5mg-7.5mg; Clomiphene Citrate 50mg-150mg
Intervention type(s): Drug; Drug
Intervention description(s): Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.; Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.
Other intervention name(s): tab lezra 2.5-7.5mg; tab clomid 50-150mg
Intervention MeSH terms: Letrozole; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Total 230 patients were randomized in study, divided in two groups by computer generated numbers, out of which 220 patients were analyzed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: polycystic ovary syndrome; Infertility; Clomiphene citrate; Letrozole
Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines
Condition: Facial Fine Lines
MeSH terms: Facies
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to assess safety and tolerability of Intradermal (ID)
      BOTOX in participants with facial fine lines.
    


Intervention name(s): Botox; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intradermal (ID) injection; Intradermal (ID) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Facial Fine Lines,BOTOX,Onabotulinum Toxin A
Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Condition: Pregnancy, Prolonged; Pre Eclampsia; Oligohydramnios
MeSH terms: Eclampsia; Pre-Eclampsia; Oligohydramnios; Pregnancy, Prolonged
Study type: Interventional

Summary: 
      PURPOSE: The purpose of this study is to determine the effectiveness of balloon dilatation
      (Foley) with vaginal misoprostol for cervical ripening and induction of labor.

      METHOD: a randomized clinical assay has been performed with 160 women with indication of
      induction of labor, randomly divided in two groups, 80 for Foley catheter and 80 for
      misoprostol.
    

Detailed description: 
      The cesarean delivery rate has risen dramatically in almost all world. Brazil shows the
      highest rate in the world so we need urgently efforts to reduce this fact. Several studies
      have shown that maternal morbidity and mortality rates are higher in cesarean deliveries. On
      the other hand an abdominal delivery cost much more than a vaginal delivery.

      A clinical trial to assess the performance of two simple and sheep methods can provide
      evidence based on local experience. Our results alow us to recommend both methods for
      clinical practice with a good possibility to reduce cesarean rates and without adverse
      events.
    

Intervention name(s): Misoprostol; Foley
Intervention type(s): Drug; Device
Intervention description(s): Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more; After Foley introduction, every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications.
Other intervention name(s): Prostokos 25 micrograms
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balloon dilatation,; misoprostol,; cervical ripening,; obstetric labor,; labor induced.
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as
      measured by serum total iron, in adult patients with iron deficiency anemia.
    


Intervention name(s): Ferric carboxymaltose
Intervention type(s): Drug
Intervention description(s): 750 mg/15 mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ferric carboxymaltose; Anemia
A Twelve Week Study of Experimental Mouth Rinses
Condition: Gingivitis; Plaque
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse
      formulations compared to a hydroalcohol control mouth rinse and a positive control mouth
      rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing
      during a twelve-week product usage period.
    


Intervention name(s): Colgate Cavity Protection Toothpaste; American Dental Association (ADA) Ref Toothbrush; Prototype 1 Mouth Rinse; Prototype 2 Mouth Rinse; Prototype 3 Mouth Rinse; Listerine Cool Mint Mouth Rinse; Hydroalcohol Mouth Rinse
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.; Participants will use soft bristled Toothbrush for brushing teeth twice daily.; Participants will use 20 mL of Prototype 1 Mouth Rinse for 30 seconds after brushing twice daily.; Participants will use 20 mL of Prototype 2 Mouth Rinse for 30 seconds after brushing twice daily.; Participants will use 20 mL of Prototype 3 Mouth Rinse for 30 seconds after brushing twice daily.; Participants will use 20 mL of Listerine Cool Mint Mouth Rinse for 30 seconds after brushing twice daily.; Participants will use 20 mL of Hydroalcohol Mouth Rinse for 30 seconds after brushing twice daily.
Intervention MeSH terms: Listerine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Impact of Environmental Nudges on Dietary Quality
Condition: Healthy Diet
Study type: Interventional

Summary: 
      Purpose: The overall purpose of this study is to evaluate the impact of a suite of
      environmentally focused nudges on the nutritional quality of consumers' food selections.

      Participants: ~2,000 US adults ages 18-25, at least 25% currently enrolled full-time in
      college, recruited from CloudResearch Prime Panels.

      Procedures: Participants will be randomly assigned to view food products with or without
      environmental nudges (eco-labels, peer comparison message, and swaps). They will be asked to
      select items that they most wish to purchase and will then be asked a series of questions
      about the products and nudges. Questions will also include standard socio-demographic
      variables.
    

Detailed description: 
      Participants will be recruited from CloudResearch Prime Panels (an online panel research
      company). Study participants include 2,000 young adults between 18 and 25 years old with at
      least 25% currently enrolled in college, recruited to match census distribution of
      race/ethnicity and gender. Participants will electronically acknowledge their consent to
      participate in the study.

      On the study platform (Qualtrics), participants will be randomly assigned to 1 of 2 arms with
      equal probability. Participants will complete a shopping task via an online 9-minute survey.
      They will view products displayed as if they were offered from a grocery store. Products will
      be frozen meals, such as burritos and pizza, snack items such as dried fruit and chips, and
      protein items, such as ground beef and chicken breasts. They will then be instructed to
      select 1 item they most wish to purchase from each category.

      Participants in the experimental arm will shop and receive environmental nudges in the form
      of labels, feedback, peer comparisons, and suggested product swaps. In the control arm,
      participants will conduct online shopping tasks without any environmental nudges. After
      selecting products, participants will answer questions about the products and labels, as well
      as standard socio-demographic questions.
    

Intervention name(s): Environmental nudges
Intervention type(s): Behavioral
Intervention description(s): Participants will view protein, frozen meal, and snack products with eco-labels applied. For each category, they will then be instructed to select 1 item from that category they wish most to purchase. Categories will be shown in random order. If a participant selects a product with a red eco-label, they will be shown a peer comparison message and will be given an opportunity to switch to a product with a yellow or green eco-label.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Walking for Stress Reduction
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The effectiveness of a mindfulness walking program is tested in subjects with a high level of
      subjectively perceived stress.
    


Intervention name(s): Mindfulness Walking
Intervention type(s): Behavioral
Intervention description(s): Mindful walking in a small group twice a week for 60 minutes within 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This single arm study will assess the pharmacokinetics, safety and activity of saquinavir
      (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination
      with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6
      years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg
      or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug
      exposures are found to be dissimilar to those previously seen in older children and adults,
      or are associated with toxicities, subsequent dose adjustments will be made. The anticipated
      time on study treatment is 3-12 months, and the target sample size is <100 individuals.
    


Intervention name(s): ritonavir; saquinavir [Invirase]
Intervention type(s): Drug; Drug
Intervention description(s): 2.5-3.0mg/kg po bid (starting dose) for 48 weeks; 50mg/kg po bid (starting dose) for 48 weeks
Intervention MeSH terms: Ritonavir; Saquinavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to characterize the metabolism and excretion (ADME) of a single
      oral dose of [14C]varespladib methyl.
    


Intervention name(s): varespladib methyl
Intervention type(s): Drug
Intervention description(s): 500 mg oral suspension
Intervention MeSH terms: Varespladib methyl
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ADME; Healthy volunteers
The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring
Condition: Infertility, Female; Endometrium
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and effectiveness of the collagen scaffold
      loaded with umbilical cord derived mesenchymal stem cells (UC-MSCs) in infetile women with
      thin endometrium or endometrial scarring.
    


Intervention name(s): UC-MSCs therapy
Intervention type(s): Procedure
Intervention description(s): After history taking, physical examination, ultrasound examination and hysteroscopy examination，infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory.
Other intervention name(s): collagen scaffold
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: thin endometrium; infertility
Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab
Condition: Severe Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Approximately, 5% of the patients with asthma suffer a difficult-to-control severe variant of
      the disease. Despite being treated with inhaled corticosteroids (ICs), long-acting
      β2-agonists (LABA), oral corticosteroids or omalizumab, one or more components of the control
      concept (symptoms, exacerbations, bronchial obstruction) remain to be resolved. Omalizumab
      has been proven to safely reduce asthma exacerbations and to decease symptoms and quality of
      life in severe allergic asthmatics. However, approximately 25% of the treated patients fail
      to respond to this monoclonal antibody. The rest of them show different degrees of response,
      although the rate of asthmatics who achieve control of the disease is unknown because
      clinical trials of omalizumab have been carried out to assess the impact of the drug on
      exacerbations, symptoms or even pulmonary function, but its effect on control was not
      evaluated. Therefore, there is a need to find new therapeutic options for those severe
      asthmatics who remain uncontrolled despite having received all the recommended therapies
      (including omalizumab). Reslizumab is a humanized anti-interleukin-5 (IL-5) monoclonal
      antibody (mAb) that has been recently found to reduce exacerbations and to improve pulmonary
      function and symptoms in patients with severe asthma and high peripheral eosinophil counts.
      It would be important to demonstrate that Reslizumab is able to improve the clinical
      condition of severe asthma patients with no therapeutic options.
    


Intervention name(s): Reslizumab
Intervention type(s): Drug
Intervention description(s): Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks
Intervention MeSH terms: Reslizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging
Condition: Schizophrenia; Schizoaffective Disorder; Hallucinations
MeSH terms: Hallucinations; Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The goal of the project is to characterize abnormalities in brain structure and function
      related to schizophrenia. The investigators will use advanced magnetic resonance imaging
      (MRI) techniques to measure the degree and distribution of neuronal activity during specific
      cognitive tasks, alterations in neuronal connectivity, and how these are related to disease
      symptoms and treatment.
    

Detailed description: 
      The goal of the project is to characterize abnormalities in brain structure and function
      related to schizophrenia. We will use advanced magnetic resonance imaging (MRI) techniques to
      measure the degree and distribution of neuronal activity during specific cognitive tasks,
      alterations in neuronal connectivity, and how these are related to disease symptoms and
      treatment. We will focus on changes in brain structure and function associated with frequent
      auditory hallucinations, one of the most disabling manifestations of schizophrenia, and with
      neuroleptic treatment. In order to address these aims, we will study four groups of subjects:

        1. patients who have frequent auditory hallucinations,

        2. patients who are beginning a regimen of anti-psychotic medication,

        3. patients who do not have frequent hallucinations and are not changing medication
           strategies, and

        4. age-matched normal controls. Each group will contain 15 subjects for a total of 60.
    

Intervention name(s): functional magnetic resonance imaging
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psychotic disorders; auditory hallucinations; brain structure; psychiatric disorder with auditory hallucinations (at least one every 20 minutes); schizophrenia/schizoaffective disorder without auditory hallucinations
Balance, Pulmonary Function, and Low Back Pain in Pregnant and Non-pregnant Women
Condition: Pregnancy Related
Study type: Observational

Summary: 
      The aims of this study were to investigate balance and pulmonary functions in pregnant and
      non-pregnant women and to determine their relationship with LBP.
    


Intervention name(s): Physical characteristic assessment
Intervention type(s): Other
Intervention description(s): Physical characteristics related to balance, pulmonary function and low back pain were evaluated
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        pregnant and non pregnant women
The Efficacy of Reiki in the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effectiveness of Reiki in the treatment of
      fibromyalgia (FM), a condition characterized by widespread muscle pain and stiffness, often
      accompanied by sleep disturbance, headaches, irritable bowel syndrome, and psychological
      distress. Reiki is a form of energy medicine in which practitioners reportedly access
      universal life energy to heal patients, either by direct contact at specific hand positions
      or from a distance.
    

Detailed description: 
      Fibromyalgia is one of the most common rheumatologic diagnoses. Treatment is generally
      unsatisfactory and most randomized, controlled treatment trials have been unable to
      demonstrate a sustained effective intervention. A vast body of anecdotal literature as well
      as two randomized controlled trials suggest that Reiki may be an effective treatment for FM,
      appearing to relieve pain and improve psychological well being. Reiki appears to have no
      adverse effects and can eventually be self-administered, making it a low-risk, low-cost,
      potentially patient-empowering intervention. This study will investigate the efficacy of
      Reiki in the treatment of FM.

      One hundred Reiki-naive FM patients will be recruited from a chronic fatigue referral clinic
      and will participate in an 8-week trial. Patients will be randomized into one of two Reiki
      groups (direct-contact and distant Reiki) or one of two control groups (sham and placebo).
      Patients will receive either Reiki or placebo 16 times during the course of the study.
      Patients will be assessed at study entry, at Weeks 4 and 8, and 12 weeks post-treatment.
    

Intervention name(s): Reiki (distant and direct-contact)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Fibromyalgia, Reiki, Energy Medicine