bioihbjkbjnl/mcl2 huggingface dataset:
CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis
Condition: Candidiasis, Chronic Mucocutaneous
MeSH terms: Candidiasis; Candidiasis, Chronic Mucocutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, dose-titration trial to study the efficacy, safety, and
      pharmacokinetics of oral cochleate amphotericin B (CAMB) in the treatment of mucocutaneous
      candidiasis infections in patients who are refractory or intolerant to standard non
      intravenous therapies.
    

Detailed description: 
      Patients aged 18 to 75 years with mucocutaneous candidiasis (esophageal, oropharyngeal, or
      vulvovaginal) who are refractory or intolerant to standard non-intravenous therapies will be
      enrolled. Patients will initially be treated in a short-term dose titration period, where the
      dose may be increased in patients that do not respond clinically. Patients who do not respond
      clinically to the highest dose of drug will discontinue the protocol. Patients that respond
      to treatment and tolerate the study medication will be eligible to enter a long-term
      extension (up to 36-months).
    

Intervention name(s): Amphotericin B
Intervention type(s): Drug
Intervention description(s): Lipid crystal nano-particle formulation of amphotericin B
Other intervention name(s): Encochleated Amphotericin B; CAMB; MAT2203
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: STAT3 deficient Hyper IgE syndrome; Gain of function STAT1 defects; Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy (APECED); IL-17/IL-22 autoantibodies from thymoma; Job's Syndrome (Hyperimmunoglobulin E Syndrome, Buckley Syndrome)
The Effects of Intra-articular Injection of Mesenchymal Stem Cells in Knee Joint Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Osteoarthritis of the knee is one of the most common causes of disability among elderly. As
      the disease progresses the cartilage become frustrated, surrounding bone react to become
      thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in
      signal density. Patients are treated initially by pain management. In patients who don't
      response to first line treatment invasive treatment like total knee replacement is done. The
      investigators designed this clinical study with the aim of evaluating therapeutic effects of
      intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in patients with
      severe knee osteoarthritis.
    

Detailed description: 
      This is single center, randomized, triple blind phase II clinical study. Patients will be
      divided into two groups of case and control. All subjects will undergo bone marrow
      aspiration. Mesenchymal stem cells will be isolated from bone marrow, cultured and
      transplanted back to the knee joint. Patients of case group will receive cell injection 1 and
      4 months after bone marrow aspiration. Placebo will be administered in this group 6 months
      after the first injection. Patients of control group will receive placebo 1 and 4 months
      after bone marrow aspiration. They all receive cell injection 6 months after first placebo
      injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first
      injection. Radiological exams will be performed before and 6 months after the first injection
      by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and
      pain by the visual analogue scale.
    

Intervention name(s): mesenchymal stem cell; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): intra articular injection of mesenchymal stem cell; Patients with knee joint osteoarthritis who underwent intra articular placebo injection
Other intervention name(s): stem cell transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee joint osteoarthritis mesenchymal stem cell
Application and Adaption of Device Specific Body Composition Formulas to Various Ethnic Groups
Condition: Bioelectrical Impedance Measurement of Healthy Adults
Study type: Observational

Summary: 
      The aim of the study is to apply and adapt device specific body composition formulas to
      various ethnic groups. Bases are prediction equations that are generated in the clinical
      investigation "Generation of prediction equation to analyze body composition of adults based
      on Bioelectrical Impedance Analysis (BIA)". The study bears the code BCA-01.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Data of 130 healthy adults are planned to be collected.
      
Biospecimen description: 
      whole blood
Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation
Condition: Pregnancy Loss; Frozen Embryo Transfer
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare two FET protocols by modifying the substituted FET cycle
      in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early
      pregnancy loss.

      Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early
      pregnancy loss.
    


Intervention name(s): Estradiol and progeterone
Intervention type(s): Drug
Intervention description(s): Estradiol and progesterone
Other intervention name(s): Estradiol and progesterone
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Physical Activity Regimens as Treatments for Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the efficacy of two different physical activity
      regimens as complementary or alternative treatment options for the treatment of obstructive
      sleep apnea. A secondary purpose of the study is to examine the effects of these activity
      regimens on various health consequences of obstructive sleep apnea, including blood pressure,
      systemic inflammation, and daytime functioning.
    


Intervention name(s): moderate-intensity aerobic and resistance training; low-intensity stretching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Individuals will complete four days of aerobic exercise of moderate intensity (60% of maximal VO2, approximated from heart rate). Duration of aerobic activity will gradually increase from weeks 1 through 4 until 180 min of aerobic exercise at the prescribed intensity is performed each week. Following aerobic exercise on two days per week, moderate-intensity resistance training will be performed using eight different resistance machines. One set of 8-12 repetitions will be performed during weeks 1-4; from week 5-on, 2 sets of 8-12 repetitions will be performed.; Individuals will perform supervised whole-body flexibility exercises on two days per week. Two sets of each exercise will be performed, with the duration of each stretch gradually increasing from 15 sec to 30 sec. A total of 15-20 stretches, focusing on whole-body flexibility, will be performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; exercise training; aerobic exercise; resistance exercise
Low Concentration Atropine for Myopia Progression in School Children
Condition: Myopia Progression
MeSH terms: Myopia; Disease Progression
Study type: Interventional

Summary: 
      Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the
      higher risk of high myopia in later life and complications such as retinal detachment and
      maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the
      effect on retarding the myopia progression. Recently the 0.01% atropine was also reported
      effective and with less visual side effects such as mydriasis. The aim of this study is to
      compare the efficacy in controlling myopia progression and visual side effects of 2 low
      concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least
      -0.5 diopters (D) and astigmatism of -1.50 D or less.
    


Intervention name(s): Atropine
Intervention type(s): Drug
Intervention description(s): Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Myopia progression; Low concentration atropine
Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
Condition: Vaginosis, Bacterial
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases
      lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy
      volunteering women and left in place for 7 days. The primary objective of this phase I study
      is to assess the safety and the tolerability of this new intravaginal delivery system.

      The eventual goal of this and related studies is to develop a vaginal ring that reduces
      recurrences in women suffering from bacterial vaginosis, which is the commonest form of
      vaginal infection.
    


Intervention name(s): Vaginal ring releasing lactic acid (racemic mixture)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
Condition: Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the
      treatment of a FS.
    

Detailed description: 
      After being informed about the study, all patients giving written informed and meet the
      inclusion criteria will be randomized a double blind manner in a 1:1 (participant and
      investigator) to oral corticosteroids or exercise.
    

Intervention name(s): Corticosteroid; Exercise
Intervention type(s): Drug; Other
Intervention description(s): The treatment will initiate with a dose of 0.5 mg/kg/day prednisolone for two weeks and the dose will halve in the next two weeks.; The exercise program will be performed two times per week for six weeks for 12 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: frozen shoulder; adhesive capsulitis; corticosteroid; exercise
The Effect of a Newly Designed Presurgical Orthopedic Appliance
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      A randomized clinical trial to compare the effectiveness of newly designed active type of
      presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral
      cleft lip and palate.
    

Detailed description: 
      It is a multicenter randomized clinical trial with two parallel arms. The patients will be
      randomly divided into two groups, group one: a passive orthopedic appliance will be used, and
      group two a new designed active orthopedic appliance will be used. Impressions will be taken
      before starting the treatment (T1) and at the end of treatment (T2) three months later. The
      effectiveness of the two appliances will be assessed and measured on digital models of the
      maxillary arch before and after the treatment.
    

Intervention name(s): Active PSIO
Intervention type(s): Device
Intervention description(s): new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cleft lip and palate; Bilateral; Presurgical orthopaedic appliance
SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is the first-in-human phase 1/2a trial of the intravenous administration of the
      SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and
      SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile,
      immunogenicity, and antiviral activity of DZIF-10c.
    

Detailed description: 
      The phase 1 component of this trial consists of a single intravenous infusion open-label
      dose-escalation phase (Groups 1A-1D and Group 2C). Subsequently, the highest tested and
      tolerated dose will be administered to an expansion cohort of SARS-CoV-2-infected individuals
      (Group 2D). In this randomized and blinded group, participants will receive DZIF-10c or
      placebo by intravenous infusion.
    

Intervention name(s): DZIF-10c; Placebo
Intervention type(s): Biological; Other
Intervention description(s): SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion; Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study consists of an open-label dose escalation phase in healthy volunteers (Groups 1A-1C) and an additional open-label lead-in phase in SARS-CoV-2-infected individuals (Group 2C).
After completion of the dose escalation phase, SARS-CoV-2-infected individuals will be enrolled into a randomized placebo-controlled expansion cohort (Group 2D).
An additional higher dose cohort may be included for healthy volunteers (Group 1D).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Covid-19; Infusion; Monoclonal Antibody
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.
Condition: HSIL of Cervix; HSIL, High Grade Squamous Intraepithelial Lesions; High-Grade Cervical Intraepithelial Neoplasia; Human Papilloma Virus; HIV Negative; Cervical Cancer; CIN - Cervical Intraepithelial Neoplasia; Cervical Neoplasm; Cervical Dysplasia
MeSH terms: Uterine Cervical Neoplasms; Neoplasms; Carcinoma in Situ; Papilloma; Uterine Cervical Dysplasia; Squamous Intraepithelial Lesions of the Cervix; Carcinoma, Squamous Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical
      precancerous lesions in females without human immunodeficiency virus (HIV) infection.
    


Intervention name(s): Topical ABI-1968
Intervention type(s): Drug
Intervention description(s): Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Mediterranean Intervention on Prediabetic Children
Condition: Prediabetic State
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Prediabetes is a pathological condition where the blood glucose concentration is higher than
      normal concentrations but lower than those considered in type 2 diabetes mellitus (DM2)
      diagnosis. Until a few years ago, this prediabetes occurred in adults with associated risk
      factors such as being overweight or obese, sedentary lifestyle, poor eating habits, and
      cardiovascular problems, among others. Recently, it has begun to be detected in children,
      with family eating habits becoming more critical. Therefore, the objectives of this study
      were to determine the efficacy of the nutritional intervention in children with analytical
      data on pre-diabetes; and the secondary ones proposed were to evaluate if an individualized
      and directed nutritional intervention compared to the standardized one supposes an
      improvement in children's dietary habits and to determine if nutritional education improves
      anthropometric parameters and adherence to a Mediterranean diet, through the evaluation of
      the Mediterranean Diet Quality Index (KIDMED).
    


Intervention name(s): KIDMED
Intervention type(s): Other
Intervention description(s): Pre-and post-intervention evaluation of the adherence to the Mediterranean diet and its effect on prediabetic state, as well as, other anthropometric values.
Intervention model: Single Group Assignment
Intervention model description: This is a study with pre-and post-intervention evaluation, randomized intervention in parallel groups EG and CG, in schoolchildren with analytical data of pre-diabetes. The study design was divided into two phases. In each phase, a follow-up was carried out with five visits, from the initial visit (v0) to the final visit (v4).
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutritional intervention; Prediabetes; Children; Mediterranean diet
Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of deep brain rTMS,
      (Transcranial Magnetic Stimulation), a new experimental procedure using the H-Coil, in
      subjects with Major Depressive Disorder that have been previously unsuccessfully treated with
      antidepressant medications.
    

Detailed description: 
      This study is a multicenter, randomized double blind, sham controlled study to evaluate the
      safety and efficacy of H-coil deep transcranial magnetic stimulation (dTMS) as a treatment
      for patients with major depressive disorder who have been previously unsuccessfully treated
      with antidepressant medications. Studies of repetitive transcranial magnetic stimulation
      (rTMS), typically using a figure-8 coil, have shown that stimulating superficial brain
      regions can be beneficial in treating major depression. Differing from traditional figure-8
      coil, the H-coil is designed to stimulate deep brain regions related to motivation, reward,
      and pleasure. Preliminary studies have been conducted and seem to indicate that through
      stimulating certain brain areas with the H-coil, dTMS may have an antidepressant effect. The
      study population will consist of patients with major depressive disorder who have failed
      adequate medication treatment or shown significant intolerance to medications. The study
      duration is 18 weeks, with a 2 week period of weaning the patient off medication, followed by
      4 weeks of 5 daily treatments and 12 weeks of biweekly treatments. Mood and mental state will
      be carefully monitored through standard psychological scales and rating during the drug
      taper-down and throughout treatment.
    

Intervention name(s): Brainsway H-Coil Deep TMS System; Brainsway H-Coil Deep TMS System (Sham treatment)
Intervention type(s): Device; Device
Intervention description(s): Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions; In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMS; Transcranial Magnetic Stimulation; MDD; Major Depressive Disorder
The Effect of the Low Fodmap Diet in Children With Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      This study assesses the effect of the low fermentable oligosaccharides, disaccharides,
      monosaccharides, and polyols (FODMAP) diet on gastrointestinal (GI) and behavioral problems
      in children with autism spectrum disorder (ASD). The objectives of this study are: -To
      determine whether the low FODMAP diet causes a decrease in gastrointestinal problems related
      to ASD -To determine whether the low FODMAP diet causes a decrease in behavioral problems -To
      assess the effect of decreased gastrointestinal problems on reduction of behavioral problems
    

Detailed description: 
      In this study, participants were children with autism spectrum disorder (ASD) ages 6-17
      years. Children with ASD were randomized to the low FODMAP diet or habitual diet for 2 weeks.
      At baseline and after a two-week intervention period, the parent/caregiver completed the
      Aberrant Behavior Checklist-Community and Pediatric Quality of Life Inventory
      Gastrointestinal Module. The parent/caregiver also completed a dietary food record, and stool
      consistency/frequency record (three days before start to intervention and the last three days
      of the intervention) of their children.
    

Intervention name(s): Low FODMAP diet
Intervention type(s): Other
Intervention description(s): The low FODMAP diet group reduced the intake of FODMAP(fermentable oligosaccharides, disaccharides, monosaccharides, and polyols)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment