bioihbjkbjnl/mcl2 huggingface dataset:
Paleolithic Diet and Exercise Study
Condition: Diet
Study type: Interventional

Summary: 
      If eating a "Paleolithic" diet helps improve these diseases, this would be the first step in
      both improving people's health as they get older as well as contributing to future national
      dietary guidelines for Americans.
    

Detailed description: 
      Because genetic evolutionary changes occur slowly in Homo sapiens, and because the
      traditional diet of Homo sapiens underwent dramatic changes within recent times, modern
      humans are better physiologically adapted to a diet similar to the one their hominid
      ancestors evolved on than to the diet typical of modern industrialized societies. The
      investigators developed a computational model to estimate the net acid load of diets from the
      nutrient composition of the diet's component ingredients, and suggest that the majority of
      these hominid diets yield a negative net acid load (that is, yield a net base load), in
      addition to being low in sodium chloride, high in potassium-containing fruits and vegetables,
      and low in saturated fats, with the majority of the non-animal-source calories coming from
      fruits and vegetables, not from acid-producing grains, separated fats and oils, starches and
      refined sugars. According to paleonutritionists, Homo sapiens' recent switch from their
      ancestral Paleolithic-type diet to the modern Western diet has contributed in a major way to
      so-called age-related diseases of civilization. The investigators hypothesize and will test
      whether:

        1. consuming a high-potassium, low-sodium, net base-producing "Paleolithic-type" diet, even
           in the short term, has detectable beneficial effects on cardiovascular physiology, serum
           lipid profiles, insulin sensitivity, and exercise performance; and

        2. their computational model predicts the measured negative net acid loads of a net
           base-producing "Paleolithic-type" diet, using steady-state values of renal net acid
           excretion as the measure of the diet net acid load (a.k.a., net endogenous acid
           production), which will be of value in constructing net-base producing diets for modern
           consumption.

      The long term complications of the combination of high blood pressure, high blood sugar and
      high fat and cholesterol levels, sometimes called the "metabolic syndrome", has been termed
      the number one medical problem in modern society today. If eating a "Paleolithic" diet helps
      improve these diseases, this would be the first step in both improving people's health as
      they get older as well as contributing to future national dietary guidelines for Americans.
    

Intervention name(s): metabolic (nutrient controlled) diet
Intervention type(s): Behavioral
Intervention description(s): metabolic (nutrient controlled) diet
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: healthy volunteers
Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"
Condition: Hypertension
MeSH terms: Hypertension; Metabolic Syndrome
Study type: Observational

Summary: 
      The purpose of this survey is designed to investigate the treatment status of hypertensive
      patient with metabolic syndrome-related risk factors treated with candesartan cilexetil
      tablets (Blopress Tablets), as well as to assess relationships between risk factors (example,
      visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an
      exploratory manner.
    

Detailed description: 
      This survey was designed to investigate the treatment status of hypertensive patients with
      metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress
      Tablets), as well as to assess relationships between risk factors (example, visceral fat
      accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory
      manner.

      For adults, 4-8 mg of candesartan cilexetil is typically administered orally once daily. The
      dose is increased up to 12 mg, as necessary. For patients with complications of renal damage,
      however, administration of candesartan cilexetil should be started at 2 mg once daily, and,
      as necessary, the dose increased up to 8 mg.
    

Intervention name(s): candesartan cilexetil
Intervention type(s): Drug
Intervention description(s): candesartan cilexetil tablets
Other intervention name(s): Blopress Tablets
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hypertension
      
Keywords: Pharmacological therapy
Development of a New Method for Analgesia
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Aim: To examine a new method to perform local anesthesia in order to diminish the
      inconvenience by the procedure in patients before performing intubation or
      oesophagogastroduodenoscopy.
    

Detailed description: 
      A phase one and two study. part one is performed as a single arm unblinded uncontrolled study
      in 16 obese patients undergoing awake intubation (investigational pill). The second part is a
      phase two study randomized single blinded study in 100 patient attending a day case endoscopy
      unit for oesophagogastroduodenoscopy (investigational pill versus lidocaine suspension).
    

Intervention name(s): CRC-Pharma 001; lidocaine suspension
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg; 5.0 ml lidocaine suspension(20mg/ml) adm. 10 min. before oesophagogastroduodenoscopy.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Analgesia Tests; Analog Pain Scale; Pain Measurement
Hypofractionated Radiotherapy Versus Stereotactic Irradiation With Hyaluronic Acid
Condition: Prostatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      The present randomized, open, multicentric Phase II trial, in parallel groups with two arms
      of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to
      treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space
      between the prostate and the rectum to preserve the rectal-wall from high doses of
      irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2
      induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a
      stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after
      an injection of hyaluronic acid between the rectal wall and the prostate.

      Ninety-six patients and 9 centers are included in the protocol.
    


Intervention name(s): Moderate hypofractionated radiotherapy; Stereotactic radiotherapy
Intervention type(s): Radiation; Radiation
Intervention description(s): Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.; Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate; Hypofractionated radiotherapy; Stereotactic irradiation; Spacer; Rectal and bladder toxicities
tDCS Effects on Chronic Low Back Pain
Condition: Low Back Pain; Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Back School (BS) is a behavioural intervention designed to treat and prevent chronic low back
      pain. Up to date clinical research studies have shown that transcranial direct current
      stimulation (tDCS) is able to decrease the intensity and duration of pain modulating the
      activity of brain areas involved in the circuits that regulate pain and facilitating the
      mechanisms inhibitors descendants of pain control.

      The aim of this study is to test the feasibility of combining tDCS with a behavioural
      intervention (i.e. BS) in subjects with chronic low back pain.
    

Detailed description: 
      Chronic low back pain involves high individual and social costs. Back School (BS) is a
      behavioural intervention designed to treat and prevent the aforementioned condition. Up to
      date clinical research studies have shown that transcranial direct current stimulation (tDCS)
      can be considered a reliable tool for chronic pain. It has been shown how tDCS is able to
      decrease the intensity and duration of pain modulating the activity of brain areas involved
      in the circuits that regulate pain, such as the thalamus, and facilitating the mechanisms
      inhibitors descendants of pain control. The aim of this study is to test the feasibility of
      combining tDCS with a behavioural intervention (i.e. BS) in subjects with chronic low back
      pain. Specifically, we will test their effects on low back pain intensity and participation
      of patients' in daily activities.
    

Intervention name(s): sham-tDCS + back school; real-tDCS + back school
Intervention type(s): Device; Device
Intervention description(s): sham tDCS + back school; real tDCS + back school
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; chronic pain; tDCS; transcranial direct current stimulation
Food-Effect and Metabolism Study in Healthy Subjects
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The
      participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of
      Fluzoparib 120mg in fasted state in Period 2.
    


Intervention name(s): Fluzoparib
Intervention type(s): Drug
Intervention description(s): 2 doses separated by 7 days.
Intervention MeSH terms: Fluzoparib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage
      form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary

      • To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose
    


Intervention name(s): LCB01-0371; LCB01-0371 400mg
Intervention type(s): Drug; Drug
Intervention description(s): Cohort1 & 3: Placebo-controlled, Single ascending dose administration; Cohort 2: Crossover designed administration
Other intervention name(s): LCB01-0371 or placebo; LCB01-0371 400mg 2 tablet
Intervention MeSH terms: Delpazolid; Oxazolidinones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With "Wearing Off" Motor Fluctuations and "On" Period Dyskinesias
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety, tolerability and efficacy of E2007 in
      Parkinson's Disease patients who have "wearing off" motor fluctuations and "on" period
      dyskenisias.
    

Detailed description: 
      This is a randomised, double-blind, placebo-controlled, dose-ranging multicentre study with
      parallel groups. Patients will be equally randomized to receive 0.5 mg, 1 mg or 2 mg of E2007
      or matching placebo for 12 weeks (84 days) in addition to their stable antiparkinsonian
      treatment. The study will involve two overnight in-patient stays. The first of these will be
      for 2 nights and 3 days and the second will be for 1 night and 2 days. The remainder of the
      study will be conducted on an outpatient basis.
    

Intervention name(s): E2007; E2007; E2007; Placebo Comparator
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Experimental 1 Drug: E2007
0.5 mg 1 tablet per day; Experimental 2 Drug: E2007
1.0 mg 1 tablet per day; Drug: E2007
2.0 mg 1 tablet per day; Placebo 1 tablet per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Emotional Perceptual Training as a Treatment for Social Anxiety: Behavioral and Neural Evidence.
Condition: Anxiety Disorders and Symptoms; Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The Perceptual Training Study is a series of studies performed with the purpose of
      identifying a potential avenue for treatment of mood disorders, particularly anxiety-based
      mood disorders. The underlying theme is that neural representations may be threat-oriented,
      and may also be generalized to non-threatening cues by means of similarity to threatening
      representations. These may result in anxiety symptoms from innocuous cues. The idea behind
      the perceptual training is to create a divorce between the threat representations and cues
      which should be considered non-threatening, enhancing perceptual acuity and potentially
      reducing anxiety symptoms.
    


Intervention name(s): Perceptual Retraining; Gender Discrimination
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants viewed faces varying in their expression of anger and were asked to identify if the face was angry or neutral via button press. Participants were provided with feedback if their categorization of the face as neutral or angry was correct. Each participant was assigned 4 levels of angry faces based on their decision point of anger detection in faces. Faces were selected based on the closest existing anger morph to the category boundary; for example, a decision point of 40% anger was closest to the 38% anger face, and so the faces used would have been 17%, 31%, 45%, and 59% anger. For this example, responses of "neutral" to the 31% angry face would be marked as correct, whereas a similar response to the 45% angry face would be incorrect, as it was above their decision point.; Participants viewed faces varying in their expression of anger and were asked to identify if the face was male or female via button press.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to either an active training group or a control group. The active participants completed 8 blocks of a perceptual training task, while the control group performed 8 blocks of a gender discrimination task
that received the perceptual retraining protocol
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Social Anxiety; Threat processing; Magnetoencephalography (MEG)
Ultrasound Versus Palpation for Spinal Anesthesia Success
Condition: Ultrasound
Study type: Interventional

Summary: 
      Aim is to investigate the difference in number of attempts to place neuraxial block comparing
      handheld ultrasound versus use of palpation alone for women with impalpable bony landmarks
      undergoing spinal anesthesia for elective cesarean delivery.
    

Detailed description: 
      Patients will be recruited prior to cesarean delivery and their site of lumbar injection will
      be examined. Women with impalpable bony landmarks will be offered recruitment to the study.
      Women will be randomly assigned to the standard of care group - palpation attempts only,
      versus an ultrasound group, where the insertion point will be identified by the handheld
      ultrasound device

      Inclusion criteria:

      Lumbar spinous processes impalpable. Elective cesarean delivery for singleton pregnancies BMI
      >30 No contraindications to neuraxial block Signed informed consent Neuraxial Block planned
      Exclusion Criteria Refuses informed consent Poor written Hebrew, no spoken English or Hebrew
      Patients will be randomized into two groups : an ultrasound (US) group and a palpation (PP)
      group.

      The primary outcome of our study is the number of needle redirections, defined as any ventral
      advancement of the needle and/or introducer, as well as any new intervertebral space
      attempted.

      Secondary outcomes include:

      The insertion site identification time, patient verbal numerical pain score (0-10) after skin
      incision.
    

Intervention name(s): Ultrasound
Intervention type(s): Device
Intervention description(s): Use of ultrasound to identify pre-puncture site
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: ultrasound
Feasibility Trial of rTMS for Cannabis Use Disorder
Condition: Cannabis
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This small pilot trial will recruit 10 cannabis use disordered participants and apply 20
      sessions of rTMS in conjunction with a two session Brief Marijuana Dependance Counseling
      treatment paradigm. The investigators are primarily seeking to determine if the proposed
      paradigm is feasible and well tolerated.
    

Detailed description: 
      The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS
      is feasible and well tolerated by a group of treatment seeking CUD patients (Aim1). The
      investigators are also hoping to preliminarily determine if a course of rTMS reduces cannabis
      cue-induced craving (Aim2). Additionally the investigators want to preliminarily explore the
      mechanistic underpinnings of any observed effect by collecting functional magnetic resonance
      imaging (fMRI) data during cannabis cue-administration before and after the treatment course
      (Aim 3). These aims will be addressed through an open label study in which 10 treatment
      seeking cannabis use disordered participants will be given 20 sessions of Active excitatory
      rTMS applied to the DLPFC. TMS will be delivered in an accelerated fashion over two weeks (2
      sessions each day, five days each week). TMS will be applied in conjunction with a validated
      two-session Motivational Enhancement Therapy (MET) behavioral intervention.
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): rTMS will be applied at 10 Hz to the DLPFC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Multiple Sclerosis Pelvic Floor Telerehabilitation
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the effects of two different pelvic floor
      telerehabilitation protocols on selected measures of quality of life and health in females
      with relapsing-remitting Multiple Sclerosis (rrMS). The main questions it aims to answer are:

        -  Is telerehabilitation sufficient to improve quality of life and health in females with
           rrMS, in particular dedicated to pelvic floor training?

        -  Are self-administered training protocols or remotely-supervised training protocols
           equally effective?

      Participants will be randomized to two intervention groups: a self-administered training
      protocol (SELF) and a remotely-supervised (REMOTE) training protocol. Both protocols will
      consist in 10 sessions of pelvic floor training lasting 45 min each, once every 5 days.

      At the start and at the end of the protocol, all participants will complete 6 questionnaires
      regarding pain, quality of life and health.
    

Detailed description: 
      In this study, the authors aim to evaluate the efficacy of two telerehabilitation protocols
      dedicated to pelvic floor and urogynecological health in females with relapsing-remitting
      Multiple Sclerosis (rrMS).

      In particular, the included participants will be randomized to:

        -  SELF protocol: 10 sessions of pelvic floor exercises, self-administered with a set of
           videos where a physiotherapist showed the different exercises in order to complete a 45
           minutes session.

        -  REMOTE protocol: 10 sessions of pelvic floor exercises, remotely conducted and
           supervised by a physiotherapist with a one-to-one videocall, showing and monitoring the
           exercises in order to complete a 45 minutes session.

      One week before the first session and one week after the last session, all the participants
      will be asked to complete a set of surveys and questionnaires to investigate participants'
      pain perception, reported quality of life and health-related parameters.
    

Intervention name(s): Telerehabilitation
Intervention type(s): Other
Intervention description(s): The intervention was administered in a telerehabilitation fashion through a videocall on the phone or tablet, by a physiotherapist, in a one-to-one session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Pelvic Floor; Telerehabilitation; Exercise
Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to
      determine the effect of ranolazine when added to glimepiride on glycemic control in adults
      with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current
      treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise.
    


Intervention name(s): Ranolazine; Placebo; Glimepiride; Diet; Exercise
Intervention type(s): Drug; Drug; Drug; Behavioral; Behavioral
Intervention description(s): Ranolazine tablet(s) administered orally; Placebo to match ranolazine for the duration of the study; Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily.; Participants are instructed to continue the diet regimen prescribed by their physician.; Participants are instructed to continue the exercise regimen prescribed by their physician.
Other intervention name(s): Ranexa®
Intervention MeSH terms: Glimepiride; Ranolazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus