bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of a Ficus Carica on Improvement in Bowl Movements in Female Volunteer With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      This trial is being conducted to look for following changes when fig paste is taken by female
      subjects with functional constipation:

      To evaluate the improvement of the bowel

      To assess the quality of life and impact on female reproductive function

      To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol
    


Intervention name(s): Ficus carica (Fig paste); Placebo (Placebo paste)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ficus carica paste 300g/day; Placebo composition 300g/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ficus Carica; Functional Constipation; Dietary Supplement; Fig Paste
AZD8108 SAD/MAD in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled study of single and multiple ascending
      dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening
      period, an in-house period during which AZD8108 or placebo will be administered orally as a
      solution, and a 4- to 10-day follow-up period after discharge.
    

Detailed description: 
      In Part 1 of the study (single ascending dose portion), approximately 32 subjects will be
      randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts
      (AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108
      and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose
      of either AZD8108 or placebo on Day 1. In Part 2 of the study (multiple ascending dose
      portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be
      randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be
      randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each
      subject will receive twelve doses of either AZD8108 or placebo
    

Intervention name(s): AZD8108; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: AZD8108 Single or Multiple doses administered orally as a solution.; Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome
Condition: Endometriosis; Irritable Bowel Syndrome; Visceral Syndrome; Visceral Hypersensitivity
MeSH terms: Irritable Bowel Syndrome; Endometriosis; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      Many patients with endometriosis experience extra genital and abdominal symptoms as a major
      part of their problem. This includes gastrointestinal dysfunction with pain, urinary symptoms
      compatible with interstitial cystitis and gastrointestinal symptoms resembling the irritable
      bowel syndrome (IBS). Such problems may be secondary to changes in autonomous neuronal
      structure and function elicited by the endometriotic elements, which may cause a "visceral
      syndrome" with the above mentioned symptoms.

      The investigators hypothesize that dietary treatment will improve the experience of
      gastrointestinal symptoms, pain and quality of life in patients with endometriosis-related
      irritable bowel syndrome. The aim of this first randomized, placebo controlled pilot study
      investigating patients with both endometriosis and IBS, is to test the application of a low
      FODMAP diet and a placebo diet for endometriosis-related IBS-like symptoms in order to
      stablish a platform for a randomized controlled study. Thus, the primary aim of this pilot
      study is to investigate the applicability of a placebo diet in patients with endometriosis
      and to investigate the compliance in both intervention group and control group. In addition,
      the aim is to investigate whether the participants find the diet manageable and whether they
      are able to identify the placebo diet.
    


Intervention name(s): Diet low in fermentable carbohydrates (low FODMAP diet)
Intervention type(s): Other
Intervention description(s): The participants follow the diet in 4 weeks. They have been provided with some foods (bread, pasta, cereal products), but will by the rest themselves. They have been provided with lists of foods to include and foods to avoid. They have also been provided with suggestions to a 4 week meal plan, based in their individual need for energy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Endometriosis; IBS; Irritable bowel syndrome; low FODMAP diet; FODMAPs; visceral syndrome; fermentable carbohydrates; visceral hypersensitivity; cross organ effect
A Multi-centre, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)
Condition: Distal Subungual Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy of topical MOB015B in
      patients with mild to moderate distal subungual onychomycosis (DSO).

      The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to
      moderate DSO.
    

Detailed description: 
      Male or female subjects aged between 12 and 75 years with confirmed DSO involving 20-60% of
      at least one great toenail will be screened for randomization in this study. The diagnosis of
      DSO will be confirmed prior to randomization through a positive culture of dermatophytes. In
      addition, a central blinded assessment of the clinical disease involvement (i.e., affected
      nail area) will be performed at Screening. Subjects have to meet all eligibility criteria
      before being randomized in to the study.

      Eligible subjects will be randomized to the investigational medicinal products (MOB015B or
      vehicle) in a ratio of 2:1. The investigational medicinal products (IMPs) will be applied to
      all affected fingernails and/or toenails for 48 weeks once daily at bedtime. However,
      fingernails will not be assessed for efficacy.

      Since both the IMPs are indistinguishable in appearance and mode of administration, the study
      will be performed as a double-blind study, i.e., both the investigator and the subject will
      remain blinded throughout the entire study.

      After a 4-week follow-up period without IMP treatment the end of study (EoS) Visit will be
      performed at Week 52 (Visit 7). The primary efficacy variable will be assessed at Week 52.
      The end of the clinical study for each individual subject is defined as the EoS Visit at Week
      52 (Visit 7). The end of the clinical study is defined as the last visit of the last subject
      in the study.
    

Intervention name(s): MOB015B; MOB015B Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution; MOB015B Vehicle without the active ingredient Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
Condition: Obesity; Over-weight; Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Overweight; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for
      certain doses of beloranib in obese subjects with Prader-Willi Syndrome.
    


Intervention name(s): ZGN-440 sterile diluent; 1.2 mg ZGN-440 for injectable suspension; 1.8 mg ZGN-440 for injectable suspension
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ZGN-440 sterile diluent/placebo; 1.2 mg beloranib; 1.8 mg beloranib
Other intervention name(s): Placebo; ZGN-440 for injectable suspension; ZGN-440; ZGN-433; Beloranib; ZGN-440 for injectable suspension; ZGN-440; ZGN-433; Beloranib
Intervention MeSH terms: CKD732
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Beloranib; ZGN-440; ZGN-440 for injectable suspension; ZGN-433
Elevated FFA and Skeletal Muscle Lipid Content
Condition: Diabetes; Exercise Physiology
Study type: Interventional

Summary: 
      There is increasing evidence that skeletal muscle lipid content (IntraMyoCellular Lipid,
      IMCL) markedly increases the risk of metabolic complications, including insulin resistance
      and cardiovascular events. The investigator hypothesizes that skeletal muscle is passively
      taking up FFAs when the availability is high, thereby leading to an increased storage. To
      test this hypothesis, the investigator wants to manipulate FFA levels, by means of exercise,
      and monitor intramuscular lipid content.

      Therefore the objective is to examine the effect of an exercise-induced elevation of FFA on
      skeletal muscle lipid content in healthy lean men. To this end, skeletal muscle lipid content
      will be investigated at baseline and after an exercise protocol and again after a four-hour
      recovery period from exercise, once in a condition with high FFA concentration, once with low
      FFA concentration. To achieve high- versus low FFA concentrations, an exercise protocol was
      chosen and participants had to perform this protocol once with a glucose supplementation and
      once without.

      Skeletal muscle lipid content will be determined before, directly after exercise and 4 h post
      exercise (from muscle biopsies) with or without glucose supplementation.
    


Intervention name(s): Exercise; Glucose; Fasted
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Exercise; Ectopic fat accumulation
Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression
Condition: Metastatic Epidural Spinal Cord Compression
MeSH terms: Spinal Cord Compression
Study type: Interventional

Summary: 
      The primary aim of this randomized multi-center trial is to investigate the efficacy of the
      radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in
      patients with metastatic epidural spinal cord compression.
    

Detailed description: 
      The primary aim of this randomized multi-center trial is to investigate the efficacy of the
      radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in
      patients with metastatic epidural spinal cord compression. The response rate (improvement in
      motor function or prevention of progression) will be assessed at one month following
      radiotherapy.

      In addition, the following endpoints will be evaluated:

        1. Motor function; additional assessments directly and at 3 and at 6 months after
           radiotherapy

        2. Ability to walk; assessment directly and at 1, 3 and 6 months after radiotherapy

        3. Sensory function; assessment directly and at 1, 3 and 6 months after radiotherapy

        4. Quality of life; evaluation directly and at 1, 3 and 6 months after radiotherapy

        5. Pain assessment directly and at 1, 3 and 6 months after radiotherapy

        6. Overall survival up to 6 months following radiotherapy

        7. Local Progression-free survival up to 6 months following radiotherapy
    

Intervention name(s): radiotherapy
Intervention type(s): Radiation
Intervention description(s): external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic epidural spinal cord compression; motor function; ambulatory status; pain; quality of life; overall survival; local control; toxicity
A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to evaluate the effectiveness and safety of the
      propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the
      placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with
      oral supplementation of 2g daily for a 4 months continuous administration.
    

Detailed description: 
      This is a randomized, multi-centre, double-blind and placebo controlled clinical study.
      Propionyl-L-Carnitine (PLC) is a kind of natural derivative of L-Carnitine (LC) and is
      produced in the body and concentrated by 90% in the skeletal muscle and myocardium via an
      enzyme-mediated reaction involving propionyl-CoA and LC. For oral adminsitration, PLC shows
      that the decrease of the leg muscle carnitine of the PAD patient appears to correlate with
      poor exercise performance. It has recently been shown that the severity of the impairment in
      walking distance is correlated with the impairment in carntine metabolism at the muscle
      level. 2g daily of PLC supplementation can significantly improve the walking ability in
      patients with IC with a maximum walking capacity between 50 and 250 meters on the treadmill.
    

Intervention name(s): Propionyl-L-carnitine Tablets
Intervention type(s): Drug
Intervention description(s): 500mg tablets, oral administration of 2g daily
Other intervention name(s): DROMOS, ST261
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PLC for treatment of peripheral arterial diseases
Effectiveness of Theramine on Chronic Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This research protocol will compare Theramine to a non-steroidal anti-inflammatory drug
      (NSAID) in the treatment of chronic back pain. The study will examine the efficacy and
      tolerability of Theramine alone in patients with chronic back pain in comparison to the
      NSAID, Naproxen, and the co-administration of Naproxen with Theramine.
    

Detailed description: 
      After informed consent and screening, volunteers will be entered into a double blind,
      randomized, three-armed trial, with 40 patients in each group. Patients will receive either
      Naproxen 250 mg daily, Theramine 2 capsules two times daily, or the co-administration of
      low-dose Naproxen 250 mg daily with Theramine 2 capsules two times daily for 28 days.
    

Intervention name(s): Active Theramine and Active Naproxen; Theramine and naproxen-like placebo; Naproxen and Theramine-like placebo
Intervention type(s): Drug; Other; Drug
Intervention description(s): Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen; Theramine, a medical food, co-administered with naproxen-like placebo; naproxen co-administered with Theramine-like placebo.
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSAIDs; Theramine; naproxen; Low back pain; amino acids; CRP; Medical Food
Biomarkers of Neuroinflammation and Anti-Inflammatory Treatments in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Neuroinflammatory Diseases; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine if translocator protein total distribution volume
      (TSPO VT) is elevated in major depressive disorder that is not responding to medication and
      if adding minocycline can affect TSPO VT. Many remain treatment resistant with common
      antidepressant treatments and the investigators think it may be due to poor targeting of
      brain pathologies.
    

Detailed description: 
      There will be three Phases in the study. Only MDE subjects will be invited to continue to
      Phase 2 and 3. Subjects will be invited to continue to the subsequent Phase given they meet
      entry criteria described below:

      Phase 1: The investigators will evaluate whether TSPO is elevated in individuals during a
      current MDE compared to healthy controls. Eligible participants will receive one [18F]FEPPA
      PET scan and one MRI scan. Other measures will include urine sample, blood samples for
      genetic and peripheral biomarker analysis, a neurocognitive battery, mood scales and
      questionnaires.

      Phase 2: Participants who have elevated TSPO VT in Phase 1 and are agreeable to receiving
      minocycline will be invited to participate in Phase 2. Based on our previous results
      participants will be considered candidates for Phase 2 if TSPO VT ≥ 10.5 (HAB) or ≥8.5 (MAB)
      in any of the primary regions of interest (prefrontal cortex, anterior cingulate cortex or
      insula). Eligible participants will be invited to participate in a randomized, double blind,
      placebo controlled trial, to receive either minocycline or placebo. After the eight weeks of
      treatment, participants will receive one [18F]FEPPA PET scan. Other measures will include
      urine samples, blood samples, mood scales and questionnaires.

      Phase 3: If, after the initial eight week treatment period with either minocycline or
      placebo, any participant continues to have depressive symptoms (17-item Hamilton Depression
      Rating Scale score ≥ 8) they will be invited to participate in an eight week open label trial
      of celecoxib. Participants not eligible for Phase 2 may also be invited to participate in
      Phase 3 directly from Phase 1.
    

Intervention name(s): Minocycline; Placebo; Celecoxib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg and 100 mg capsule, oral administration; Lactose monohydrate in identical gel capsules to minocycline, oral administration.; 100 mg and 200 mg capsules, oral administration.
Other intervention name(s): Mylan-minocycline; Lactose monohydrate; Celebrex (Pfizer)
Intervention MeSH terms: Minocycline; Celecoxib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Cancer Communication Within Hispanic Social Networks
Condition: Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This trial examines cancer communication within Hispanic social networks. Hispanics have the
      lowest colorectal cancer screening rate of any major ethnic group and health interventions
      are crucially needed among Hispanics. Patient decision aids are health communication
      interventions designed to provide patients with targeted health information and have shown to
      improve colorectal cancer screening rates among Hispanics. The goal of this study is to
      investigate, in a sample of Hispanics, how a colorectal cancer decision aid aimed at
      increasing individuals' colorectal cancer screening behavior has effects on their alters'
      intention to get screened for colorectal cancer.
    

Detailed description: 
      OUTLINE:

      Participants view an educational video on cancer and cancer screening options over 12
      minutes. Participants also complete a phone survey over 10-15 minutes before attending the
      video session and 2 months after the video session.
    

Intervention name(s): Media Intervention; Survey Administration
Intervention type(s): Other; Other
Intervention description(s): View an educational video; Complete survey
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effectiveness of Aspirin in Compare With Heparin Plus Aspirin in Recurrent Pregnancy Loss Treatment
Condition: Recurrent Pregnancy Loss
MeSH terms: Abortion, Habitual
Study type: Observational

Summary: 
      This study evaluated the effect of anticoagulant treatment on the live-birth rate in women
      with a history of at least two continuous unexplained miscarriages or thrombophilia. It also
      compared two methods of treatment with aspirin and aspirin plus heparin.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This project evaluated 520 women with unexplained recurrent miscarriage for four years.
        They had referred to recurrent abortion clinic of Yazd Reproductive sciences institute.
        Women with unexplained recurrent miscarriage included in this study
High Frequency Oscillation in Pediatric Epilepsy Surgery
Condition: Pediatric Epilepsy; Epilepsy Surgery; High Frequency Oscillation
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      High Frequency Oscillation (HFO) on ElectroCorticoGraphy (ECoG) has been identified as a new
      biomarker for epileptogenic tissue. The purpose of this study is to see if epilepsy surgery
      guided by the combination of HFO on ECoG and standard clinical practice can result in a
      greater likelihood of seizure freedom, versus standard clinical practice alone, without HFOs.
    

Detailed description: 
      Intra-operative electrocorticography (ECoG), based on interictal spike and spike patterns, is
      performed to optimize delineation of the epileptogenic tissue in the operating room during
      epilepsy surgery. Similarly, extra-operative electrocorticography is often recorded over days
      to weeks with intracranial grids and depth electrodes, when the epileptogenic zone is not
      clearly localized with non-invasive studies and/or with intra-operative ECoG. Surgical
      resection following extra-operative ECoG is then "tailored' by the seizure onset zone as the
      gold standard.

      High frequency oscillations have been identified as a more precise biomarker for
      epileptogenic tissue. The aim of this double-blind randomized surgical trial is to determine
      if HFO- tailored surgery combining HFOs and current standard of care, compared to current
      standard of care alone, will lead to a better seizure outcome.
    

Intervention name(s): HFO analysis
Intervention type(s): Diagnostic Test
Intervention description(s): We hypothesize that the strategy of incorporating HFO data to a standard ECoG-guided resection in pediatric epilepsy surgery will result in improved postoperative seizure outcome than the traditional approach.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization into standard arm and the treatment arm in a 1:1 ratio.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment