bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the study is to assess whether SAM-531, an investigational drug, is
      safe and well tolerated, compared with placebo (a medically inactive substance), in subjects
      with mild to moderate Alzheimer's disease.
    


Intervention name(s): SAM-531; placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes.

      IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor
      analogue, called semaglutide.

      Insulin icodec is a possible new medicine. That means that the medicine has not yet been
      approved by the authorities. Semaglutide is a medicine already approved by the authorities in
      the EU, USA, China and Japan.

      The study will look at the way insulin icodec and semaglutide reach and stay in participants
      blood after injection when given together as IcoSema or alone as insulin icodec and
      semaglutide.

      Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3
      different timepoints:

      The order in which participants get them is decided by chance. Participants will get the 3
      medicines as an injection under the skin in the thigh. The injections will be done by study
      staff. The time between injections is 6 to 9 weeks.

      The study will last for about 19 to 26 weeks. Participants will have 31 or 32 visits to the
      clinic. 3 of the visits will be in-house visits, meaning that participants will stay at the
      clinic for 5 or 6 days (4 or 5 nights).

      Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study
      period.
    


Intervention name(s): IcoSema; insulin icodec; semaglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One single dose of IcoSema administered subcutaneously, S.c. into the left thigh; One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh; One single dose of semaglutide administered subcutaneously, S.c. into the left thigh
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation
Condition: Local Anesthesia Assisted Sedation
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia
      assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection
      in local anesthesia assisted sedation.
    


Intervention name(s): Remimazolam Tosilate; Propofol Injection.
Intervention type(s): Drug; Drug
Intervention description(s): Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose; Treatment group C: Propofol Injection.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Remimazolam Tosilate compared with Propofol Injection
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Weight Loss on Myocardial Metabolism and Cardiac Relaxation in Obese Adults
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Obesity adversely affects myocardial (muscular heart tissue) metabolism, efficiency, and
      diastolic function. The objective of this study was to determine if weight loss could improve
      obesity-related myocardial metabolism and efficiency and if these improvements were directly
      related to improved diastolic function.
    

Detailed description: 
      This was a prospective, interventional study in obese adults ages 21 to 50 years of age to
      determine whether weight loss could improve obesity-related myocardial metabolism and
      efficiency. Two different mechanisms of weight loss were studied: diet and exercise and
      gastric bypass surgery. Positron emission tomography (PET) was used to quantitate myocardial
      oxygen consumption (MVO2) and myocardial fatty acid (FA) metabolism. Echocardiography with
      tissue Doppler imaging was used to quantify cardiac structure, systolic and diastolic
      function (left ventricular (LV) relaxation (E') and septal ratio (E/E')).
    

Intervention name(s): Diet; Gastric bypass surgery
Intervention type(s): Behavioral; Procedure
Intervention description(s): Participants attended 20 group behavioral modification sessions led by a behaviorist, a registered dietician, and a physical therapist. The meal plans ranged from 1200 to 1500 kilocalories per day, depending on subject sex and BMI, and were designed to achieve ≤1% body weight loss/week. Participants completed daily food records, and were taught a variety of weight management skills. The exercise component included strength, flexibility, balance, and endurance instruction, gradually increasing to 30 minutes of exercise 5 days/week.; The same surgeon performed all bypass procedures using standard techniques. A small (~20 ml) proximal gastric pouch was created by stapling the stomach, and a 75-cm Roux-en-Y limb was constructed by transecting the jejunum distal to the ligament of Treitz, and creating a jejunojejunostomy 75 cm distal to the transection.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Heart Metabolism; Obesity; Weight loss; Gastric bypass surgery; Diet and exercise
Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the drug exposure and drug effects on subjects with
      moderate hepatic impairment after a single oral dose of bexagliflozin tablets, 20mg. The
      study will also evaluate how safe the study drug is and how well the study drug is tolerated
      in subjects with moderate hepatic impairment.
    

Detailed description: 
      This was a Phase 1, open-label, parallel-group study designed to assess the effect of
      moderate hepatic impairment on the PK and PD of orally administered bexagliflozin tablets. A
      total of 16 subjects comprising eight with moderate hepatic impairment (Child Pugh total
      score 7 to 9) and eight healthy, matched controls, were enrolled and received a single oral
      dose of bexagliflozin tablets, 20 mg, after an overnight fast. Food was withheld for at least
      2 h after dosing. Water was allowed as desired except within 1 h of drug administration.

      Blood samples were collected prior to dosing, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16,
      24, 36, and 48 h post-dose.

      The unbound fraction of bexagliflozin at 24 h post dose and at the maximum plasma
      concentration for each subject was determined by equilibrium dialysis.

      Urine samples for PD analysis were collected for the 12 h interval preceding dosing and for
      the 0 - 12 h, 12 - 24 h, 24 - 36 h, and 36 - 48 h intervals following dosing.
    

Intervention name(s): Bexagliflozin
Intervention type(s): Drug
Intervention description(s): Single oral dose of bexagliflozin tablet, 20 mg
Intervention MeSH terms: Bexagliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Retrospective Study to Investigate Prevalence of Capsular Bag Distention Syndrome and Its Influencing Factors
Condition: Capsular Bag Distention Syndrome After Cataract Surgery
MeSH terms: Cataract; Capsule Opacification; Syndrome; Dilatation, Pathologic
Study type: Observational

Summary: 
      -  To Investigate the Prevalence of Capsular Bag Distention Syndrome

        -  To Analyze Influencing Factors of Capsular Bag Distention Syndrome
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients Who Underwent Cataract Surgery at Eye and ENT Hospital of Fudan University, Xuhui,
        Shanghai, China
Combined Spinal Epidural Anesthesia and General Anesthesia for Laparoscopic Cholecystectomy
Condition: Gall Stone Disease; Polyp
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Interventional

Summary: 
      The aim of this study was to compare general anesthesia (GA) and combined (epidural and
      spinal) anesthesia (CA) for laparoscopic cholecystectomy. General anesthesia is a gold
      standard for laparoscopic cholecystectomy(LC). The use of combined anesthesia may offer
      several advantages over general anesthesia.

      Fifty patients will be randomly assigned to either the CA LC (25 patients) or GA LC (25
      patients). All patients has symptomatic gall stone disease or polyp of gall bladder.
      Intraoperative events related to combined anesthesia , postoperative complications, pain
      score and duration of operation time will record.
    

Detailed description: 
      Objective of study : The aim of this study was to compare general anesthesia (GA) and
      combined (epidural and spinal) anesthesia (CA) for laparoscopic cholecystectomy. General
      anesthesia is a gold standard for laparoscopic cholecystectomy(LC). The use of combined
      anesthesia may offer several advantages over general anesthesia.

      Material and methods : Fifty patients will be randomly assigned to either the CA LC (25
      patients) or GA LC (25 patients). All patients has symptomatic gall stone disease or polyp of
      gall bladder. Intraoperative events related to combined anesthesia : abdominal
      discomfortable, shoulder pain, abdominal pain, nausea, anxiety, dermatomal level of sensory
      blockade, respiratory depression. We compare between two group; shoulder pain, postoperative
      complications, pain score, duration of operation time and length of hospital stay.

      Fifty patients will select prospectively for LC, under low pressure (10 mm Hg)
      pneumoperitoneum and under combined anesthesia and general anesthesia. Spinal anaesthesia was
      performed at L1-L2 interspace using 2 ml of 0.5% (10 mg) hyperbaric Bupivacaine mixed with
      0.5ml (25 micrograms) of Fentanyl. Epidural catheter was inserted at L1- L2 interspace too.
    

Intervention name(s): combined anesthesia; general anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy; General anesthesia for laparoscopic cholecystectomy
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Combined anesthesia; General anesthesia; Laparoscopic cholecystectomy
Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 3

Summary: 
      Depomed's Gabapentin Extended Release is an investigational, extended release formulation of
      gabapentin that is being studied for the treatment of hot flashes in postmenopausal women
    

Detailed description: 
      The primary study objective is to assess the efficacy of G-ER dosed in either of the
      following regimens:

      G-ER 1200mg daily (single evening dose)

      G-ER 1800mg daily (dosed asymmetrically; 600mg AM/1200mg PM)

      compared to placebo in reducing the average daily frequency and severity score of moderate to
      severe hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with a
      stable dose, compared with the baseline week.
    

Intervention name(s): Gabapentin Extended-Release (G-ER) 1200 mg; Gabapentin Extended-Release (G-ER) 1800 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): G-ER 1200 mg daily dosage given as two 600-mg tablets.; G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.; Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).
Other intervention name(s): Gabapentin; Gabapentin; Placebo; sugar pill
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hot Flashes; Hot Flushes; Postmenopausal symptoms; Vasomotor symptoms
A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-site, randomized, double-blinded, double-dummy, placebo- and
      positive-controlled, 4-period crossover study to evaluate the effect of two dose levels of
      Androxal on cardiac repolarization. Baseline ECGs will be obtained prior to dosing in each
      Period and ECGs will be obtained during expected peak plasma concentrations of Androxal and
      the positive control.

      In each Treatment Period subjects will be admitted to a Clinical Research Unit where study
      drug will be administered as three (3) daily single doses. Treatment Periods will be
      separated by a washout of at least 7 days between Periods.
    


Intervention name(s): Androxal 25 mg capsules; Androxal 250 Capsules; Placebo Capsules; Moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: To determine; effects; once; daily; oral doses; Androxal
Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to determine if use of rectal spacers are effective at improving protection of
      rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of
      acute effects. It is also to determine whether it provides sufficient dosimetric benefits to
      warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation)
      related clinical studies.
    

Detailed description: 
      A phase II study to assess safety and efficacy of the spacer injection process, ability of
      the spacer to effectively provide the space necessary to reduce acute events in the rectum,
      and also meet the SABR based rectal constraints, and to monitor stability of this process
      during SABR. Unlike IMRT, which uses smaller dose/fraction, when using such high
      dose/fraction, even a few mm of shift in spacer positioning may impact the dose that the
      rectum receives, and therefore, a rigorous study of stability of material during the SABR
      treatments will need to be determined. If there is some shift, by doing this study, we may be
      able to determine the margin of error that will be necessary in considering rectal organ
      dosimetry, based on the possible shift in positiong that may occur with the spacer over time.

      As the SABR therapy is strictly local, we will select for patients with prostate cancer
      locally confined to the prostate gland. As such, we will select eligibility criteria of low
      risk patients to minimize risk of extraprostatic spread, seminal vesicle invasion, and nodal
      spread. Hormonal therapy may also be used to shrink prostates that are massively enlarged as
      this may also help further reduce length of rectum that will be irradiated. As the primary
      toxicity will likely be mucosal damage, we will avoid enrolling patients with pre-existing
      mucosal dysfunction (including those with previous radiation, TURP, very large prostate
      glands, inflammatory bowel disease) and immunosuppressed individuals based on our phase I
      experience[13]. In this way, patients will be uniformly selected in a fashion that would
      identify patients likely to receive benefit from the therapy.
    

Intervention name(s): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)
Intervention type(s): Device
Intervention description(s): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of High Dose Ciclesonide on Asthma Control
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day.
      Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention description(s): During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ciclesonide; asthma
Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Condition: Nonsynostotic Plagiocephaly
MeSH terms: Plagiocephaly; Plagiocephaly, Nonsynostotic
Study type: Interventional

Summary: 
      The aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in
      reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.
    

Detailed description: 
      Nonsynostotic plagiocephaly (NSP) is defined as the deformation of the head resulting from
      external forces that mould the skull during the first months of life.

      Four months seems to be a critical age for the development of NSP, but many positional head
      shape deformities may improve with time.

      Early assessment and diagnosis is important not only for the shape of the skull, but also for
      possible clinical significant differences in gross motor development.

      In paediatric conditions the effect of osteopathic manipulative treatment is documented in
      systematic reviews; in NSP the only study, which is a pilot, reveals an average reduction of
      50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.
    

Intervention name(s): Osteopathic manipulative therapy (OMTh); Light Touch Therapy (LTT); Repositioning therapy
Intervention type(s): Other; Other; Other
Intervention description(s): The Osteopathic Manipulative Therapy includes evaluation and treatment. The evaluation considers the pelvic girdle and lower limb, thorax abdominal area, pectoral girdle and upper limbs, cervical and upper thoracic area, cranial vault, cranial base and viscero cranium. The treatment is based on balanced ligamentous tension technique, myofascial release, visceral manipulation, and balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 minutes of evaluation and 30 minutes of treatment.; The LTT is consistent with the OMT during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body, moving the hands every few seconds, and by flattening and softening the surface of the hands to minimize focal areas of force.; It consists of strategies that guide the parents to position the baby "back to sleep", by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant's head is placed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Positional Plagiocephaly, Deformational Plagiocephaly,
A Study to Assess Safety, Immunogenicity and Parasite Growth Inhibition of an Asexual Blood Stage Vaccine for P. Falciparum Malaria
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Malaria is a parasite, infection with which kills over 2 million people each year. It is a
      major problem for those who live in endemic areas and for travellers. There is a great need
      for a safe effective malaria vaccine. The purpose of this study is to examine a new vaccine
      designed to provide immunity during the blood stage of the malaria parasite's lifecycle.

      The vaccine consists of AMA1-C1 which is a mixture of two recombinant synthetic AMA1 proteins
      from two Plasmodium falciparum strains, Alhydrogel® which is an aluminium-based adjuvant and
      CPG 7909 - an oligodeoxynucleotide, which enhances immune response.

      This study will enable the investigators to assess:

        1. The ability of of a growth inhibition assay to predict the effectiveness of a malaria
           vaccine.

        2. The safety of the vaccine in healthy volunteers

        3. The response of the human immune system to the vaccine
    


Intervention name(s): AMA1-C1/Alhydrogel® + CPG 7909
Intervention type(s): Biological
Intervention description(s): A 0.55 mL dose of AMA1-C1/Alhydrogel® + CPG 7909 (corresponds to 80 µg of AMA1-C1 and 564 µg of CPG 7909)
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Vaccine