bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LP-168 in Healthy Volunteers
Condition: Multiple Sclerosis; NMO Spectrum Disorder
MeSH terms: Multiple Sclerosis; Neuromyelitis Optica
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of
      LP-168 in healthy human volunteers.
    

Detailed description: 
      This study will enroll 70 healthy subjects, will set 4 SAD and 3 MAD dose cohorts, with 10
      subjects in each dose cohort. Subjects will be assigned to L-168 or placebo group by ratio of
      8:2 in each cohort. Sentinel subjects will be used in each dose cohort during the single dose
      phase.
    

Intervention name(s): LP-168 tablet; LP-168 Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration; LP-168 placebo tablets contain excipients for LP-168 tablets, but do not contain the active ingredients of the drug, and are used for comparison in clinical trials with the same usage and dosage as LP-168 tablets
Other intervention name(s): NWP-775; NWP-775 Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication
Condition: GERD
Study type: Interventional

Summary: 
      This is a long-term follow-up of a prospective randomized trial comparing open and
      laparoscopic Nissen fundoplication.
    


Intervention name(s): Laparoscopic Nissen fundoplication; Open Nissen fundoplication
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD; LNF; CNF; Laparoscopic Nissen fundoplication; Open Nissen fundoplication; Antireflux surgery
Effect of Herbal Extracts on Gingival Inflammation
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the minimal number of patches needed to get an
      effective response. Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a
      cycle by the order they enter the study. After the first 20 patients [5 cycles], the effect
      of the number of patches will be tested. If there is no distinct reduction of beta
      glucuronidase in the GCF or of gingival index at the tested sites, more patients will be
      enrolled. Patients will be added one cycle at a time with results being tested and analyzed.
      The enrollemnts of patients will stop when a dose response will be noticed or 15 cycles have
      been reached.
    


Intervention name(s): periopatch
Intervention type(s): Drug
Intervention description(s): Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gingivitis, localized treatment
The Circadian Variability of Serum Progesterone During the Day of a Frozen Embryo Transfer
Condition: Fertility Disorders
Study type: Interventional

Summary: 
      Serum progesterone levels will be evaluated at four different time points during the day of
      an artificially prepared frozen embryo transfer cycle (HRT FET cycle) and a modified natural
      cycle frozen embryo transfer cycle (mNC FET cycle) (at 08:00, 12:00, 16:00 and 20:00).The
      pairwise percentage differences in serum progesterone levels for each patient will be
      calculated. The intra-day variability of progesterone will be analyzed using mixed models.
      Pregnancy outcomes will also be assessed. The sample size calculated consisted of 22 patients
      for the HRT-FET study and 22 patients for the mNC FET study.
    

Detailed description: 
      In the HRT FET, estradiol valerate (Progynova) will be administered for endometrial
      preparation. If the endometrial thickness will be ≥ 6,5 mm during an ultrasound scan planned
      following an initial period of estrogen priming, micronized vaginal progesterone will be
      started (Utrogestan 800 mg/d). The transfer of a single blastocyst will be performed on the
      6th day of progesterone administration. In a modified NC FET, there is no intake of
      medication but endocrine and ultrasound monitoring during the proliferative phase. Ovulation
      trigger with hCG will be considered when a dominant follicle between 16 and 20 mm will be
      observed and when the endometrial thickness will be ≥ 6,5 mm. The transfer of a single
      blastocyst will take place on the 7th day after hCG injection.

      Serum progesterone levels will be evaluated at four different time points during the day of
      an artificially prepared frozen embryo transfer cycle (HRT FET cycle) and a modified natural
      cycle frozen embryo transfer cycle (mNC FET cycle) (at 08:00, 12:00, 16:00 and 20:00).
      Pairwise percentage differences in serum progesterone levels for each patient will be
      calculated. The intra-day variability of progesterone will be analyzed using mixed models.
      Pregnancy outcomes will also be assessed.
    

Intervention name(s): blood test
Intervention type(s): Biological
Intervention description(s): four blood samples will be withdrawn from the participants during the day of their frozen embryo transfer cycle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning
Condition: Neurocognitive Decline; HIV Associated Neurocognitive Disorder
MeSH terms: Neurocognitive Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effects of switching Atripla to Eviplera on neurocognition
      measured by neuropsychological testing and functional MRI
    

Detailed description: 
      Efavirenz, an antiretroviral drug used for the treatment of human immunodeficiency virus 1
      (HIV-1) infections, is known for its neurological and psychiatric adverse events. Efavirenz
      is part of Atripla®, a single tablet regimen (STR), currently the most prescribed
      antiretroviral drug in the Netherlands. Recently, a new STR has become available, Eviplera®
      containing a successor of Efavirenz, named Rilpivirin. It has been shown in the phase-3 ECHO
      and THRIVE studies that Atripla as well as Eviplera have excellent and comparable
      antiretroviral efficacy in naive HIV-infected patients. Furthermore, data from these studies
      have shown that Eviplera was associated with fewer neurological and psychiatric adverse
      events than Atripla over 48 weeks. However, this was only patient reported adverse events,
      not neuropsychological evaluation. Furthermore, they were treatment naïve for HIV. Moreover,
      there might be a bias in these kind of switch studies due to the fact that those patients who
      switch will mostly regard their new combination better than the old one. Contrary, data on
      the long term impact of Efavirenz on neuropsychological performance and symptoms are
      conflicting.

      Objective: This study aims to investigate the effect of switching from Atripla to Eviplera on
      neurocognitive performances (neurocognitive testing) and imaging (functional MRI scanning) in
      virologically suppressed HIV-infected patients.
    

Intervention name(s): Eviplera
Intervention type(s): Drug
Intervention description(s): switch from Atripla to emtricitabine/rilpivirine/tenofovir (Eviplera)
Other intervention name(s): emtricitabine/rilpivirine/tenofovir
Intervention MeSH terms: Tenofovir; Emtricitabine; Rilpivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Scalar Localization Cochlear Electrode Array Using 64 Slice CT
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Observational

Summary: 
      Insertion of electrode array in scala vestibuli, rather than the preferred location within
      scala tympani, leads to loss of native hearing in those patients with isolated high-frequency
      hearing loss undergoing cochlear implantation.
    

Detailed description: 
      We aim to determine the surgical placement in patients with high frequency who had long
      electrode array insertions because they did not meet audiometric criteria for short array
      devices.

      From this basis we will be able to determine if suboptimal insertion (e.g., in the scala
      vestibuli) leads to loss of low-frequency hearing in these patients. We also will look at the
      possibilities of using this data in predicting outcomes, modifying implant design, and
      perfecting surgical technique.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Either part of the existing Cochlear Implant data base, or those persons who have had a
        Cochlear implant with either short or long electrode array who have had a high frequency
        hear loss.
      
Keywords: Cochlear; Hearing; High frequency hearing loss
A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome
Condition: METABOLIC SYNDROME; HYPERTENSION; PRE-HYPERTENSION
MeSH terms: Hypertension; Prehypertension; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The metabolic syndrome is a classification for patients with a constellation of risk factors
      which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or
      more of these factors together constitute the metabolic syndrome and place these patients at
      a greater risk for the development of diabetes and cardiovascular diseases. The purpose of
      this study is to determine whether two common drugs to lower blood pressure, whether used
      separately or in combination, have different effects on blood sugar levels in patients
      diagnosed with the metabolic syndrome.
    


Intervention name(s): valsartan plus hydrochlorothiazide
Intervention type(s): Drug
Intervention MeSH terms: Valsartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: METABOLIC SYNDROME, VALSARTAN, HYDROCHLOROTHIAZIDE, HYPERTENSION,
ACTH Gel Therapy in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate if the study drug, ACTH Gel helps decrease
      the disease symptoms in people with Rheumatoid Arthritis (RA) who are already taking
      medications prescribed by their physician and are still experiencing disease symptoms.

      ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis
      since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use. Despite
      its FDA approval there is very limited data on its how well ACTH gel works in improving the
      symptoms of people with RA.
    

Detailed description: 
      This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis
      and who are still experiencing symptoms. Subjects are given the ACTH gel to take twice each
      week for 12 weeks as a supplement to current therapies. Subjects are required to visit the
      clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. We will obtain a
      blood sample for research purposes.
    

Intervention name(s): ACTHAR gel
Intervention type(s): Drug
Intervention description(s): Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.
Other intervention name(s): Adrenocorticotropic hormone
Intervention MeSH terms: Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; ACTH gel
Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)
Condition: Hypophosphatasia
MeSH terms: Hypophosphatasia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by
      gene mutations or changes. These gene mutations cause low levels of an enzyme needed to
      harden bone. The purpose of this study was to test the safety and efficacy of a study drug
      called asfotase alfa (human recombinant tissue non-specific alkaline phosphate fusion
      protein) to see what effects it has on patients 5 years of age or less with HPP.
    

Detailed description: 
      Asfotase alfa was formerly referred to as ENB-0040

      Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease
      characterized by defective bone mineralization and impaired phosphate and calcium regulation
      that can lead to progressive damage to multiple vital organs, including destruction and
      deformity of bones, profound muscle weakness, seizures, impaired renal function, and
      respiratory failure. There are limited data available on the natural course of this disease
      over time, particularly in patients with the juvenile-onset form.
    

Intervention name(s): asfotase alfa
Intervention type(s): Drug
Other intervention name(s): ENB-0040
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypophosphatasia; HPP; Bone Disease; Soft Bones; Low Alkaline Phosphatase; Genetic metabolic disorder; Alkaline phosphatase; Tissue-specific alkaline phosphatase (TNSALP); Rickets; Osteomalacia
Reconstruction Method and Delayed Gastric Emptying After Pancreatic Surgery
Condition: Pancreatic Cancer; Surgery; Improvement of Perioperative Outcome
MeSH terms: Pancreatic Neoplasms; Gastroparesis
Study type: Interventional

Summary: 
      Pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the
      pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater.
      For reconstruction, pylorus-preservation (PPPD) has been shown to be technically and
      oncologically equivalent to the traditional whipple operation. One issue with this technique
      is delayed gastric emptying (DGE), which occurs in 25-70% of patients, usually emerging
      between day 4 and 14 after surgery. Patients with severe DGE can not only experience
      prolonged length of hospital stay, but are also at increased risk for other complications
      like aspiration or other issues related to the inability to ingest nutrition.

      There is vast retrospective evidence and one prospective study indicating that antecolic
      reconstruction of the duodenojejunostomy can improve the rate and severity of delayed gastric
      emptying.

      The investigators have conducted a prospective randomized trial in order to test this
      hypothesis. Patients were randomized to either undergo antecolic or retrocolic reconstruction
      after PPPD. On day 10 after surgery, DGE was assessed by clinical criteria. In addition, a
      test meal including 1g paracetamol was administered to check for clinically inapparent DGE.
      Of these serum samples, kinetics of intestinal peptides like GLP-1, PYY and glucagon was alos
      measured.
    


Intervention name(s): antecolic reconstruction; retrocolic reconstruction
Intervention type(s): Procedure; Procedure
Intervention description(s): see study arm description; see study arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pancreatic cancer; pylorus-preserving pancreaticoduodenectomy; delayed gastric emptying; reconstruction
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
Condition: Myomas; Ovary Cysts; Endometriotic Cysts; Adhesions
MeSH terms: Cysts; Tissue Adhesions
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel
      was safe to use, and was effective for the prevention/reduction of adhesion formation
      following gynecological surgery
    

Detailed description: 
      Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries,
      and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction
      and infertility. This randomized, controlled, multicenter, clinical study was designed to
      evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the
      standard of care for the reduction of postoperative adhesions in subjects undergoing
      laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial
      surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical
      adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS)
      scoring system.
    

Intervention name(s): Saline; Cross-linked Hyaluronan Hydrogel
Intervention type(s): Other; Device
Intervention description(s): On the day of initial surgery; On the day of the initial surgery
Other intervention name(s): HyaRegen; Self Cross-linked Hyaluronan Gel
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adhesions; Hyaluronan; Gynaecological surgery; Clinical outcomes
Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Children with cerebral palsy present early in the childhood altered muscular properties, as
      soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are
      characterized by short muscle belly length and increased stiffness which contribute to
      contracture and limiting joint range of motion. This study assess efficacy of an acute high
      intensity and long-time stretching session of plantarflexors muscle on their viscoelasticity
      properties and maximal dorsiflexion angle gain. Single stretching session is characterized by
      high intensity and long time (5 minutes).
    


Intervention name(s): measurement evaluated with an isokinetic dynamometer; measurement evaluated with an 2D ultrasound; assessment of the level of discomfort
Intervention type(s): Other; Other; Other
Intervention description(s): measurement of the maximum dorsiflexion angle in degrees evaluated on an isokinetic dynamometer; simultaneous recording of force torque, joint angle and myotendinous junction displacement in 2D ultrasound during 5 passive mobilization cycles of ankle flexion-extension at very low speed
recording of static images in 2D ultrasound representing the proximal insertion of the gastrocnemius muscle in the internal condyle of the femur, the myotendinous junction.; visual analogue scale (0 = no discomfort and 10 = maximal discomfort)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: children; medial gastrocnemius muscle
Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance
Condition: Ageing
MeSH terms: Facies
Study type: Interventional
Phase: Phase 4

Summary: 
      Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research)
    

Detailed description: 
      Evaluate the efficacy of the BMR Face device in relation to facial appearance at 12 weeks
      compared to baseline. Efficacy will be assessed by overall facial improvement assessed live
      by the Investigator and a subject assessment of facial appearance including the Global
      Aesthetic Improvement Scale (GAIS).

      The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and
      patient independently describe the degree of improvement in facial appearance. Possible
      responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate
      improvement, (4) slight improvement, (5) no improvement

      Secondary objectives are to evaluate safety and further evaluate the subject's and
      investigator's satisfaction (both a live and blinded assessor) with the BMR Face treatment.
    

Intervention name(s): BMR Face
Intervention type(s): Device
Intervention description(s): BMR Face used in accordance with manufacturer IFU
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy females
Phase 1 LEISH-F3 + SLA-SE Vaccine Trial in Healthy Adult Volunteers
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety, tolerability, and immunogenicity in
      healthy adult subjects of an investigational vaccine being developed for the prevention of
      visceral leishmaniasis.
    


Intervention name(s): LEISH-F3 + SLA-SE; LEISH-F3 + GLA-SE
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Leishmaniasis; Visceral leishmaniasis; Vaccine; Adjuvant; GLA; SLA
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
Condition: Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation
MeSH terms: Univentricular Heart
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomisation between postoperative administration of an ACE-inhibitor or not.
    

Detailed description: 
      Children that are undergoing elective surgery for the creation of a Fontan circulation will
      be randomised to postoperative administration of an ACE-inhibitor or not.

      Determination of aldosteron, renine and ADH in serum preoperatively and 1h, 12h and 5 days
      postoperatively.
    

Intervention name(s): Administration of an ACE-inhibitor or not
Intervention type(s): Drug
Intervention MeSH terms: Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Using Botulinum Toxin Type A in Adolescents With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      A study using Botulinum Toxin Type A in adolescents with axillary hyperhidrosis.
    


Intervention name(s): Botulinum Toxin Type A
Intervention type(s): Biological
Intervention description(s): 100 U up to 6 times during the study depending on the response to treatment
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment