bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open label switch over study to assess the safety and efficacy of PRX-102
      (pegunigalsidase alfa). Patients treated with agalsidase alfa for at least 2 years and on a
      stable dose (>80% labelled dose/kg) for at least 6 months. Patients will be screened and
      evaluated over 3 months while continuing on agalsidase alfa. Following the screening period,
      the patient will be enrolled and switched from their agalsidase alfa treatment to receive
      intravenous (IV) infusions of PRX-102 1 mg/kg every two weeks for 12 months. No more than 25%
      of treated patients will be female.
    

Detailed description: 
      Dosage and administration details:

      pegunigalsidase alfa individual dose for each patient was prepared according to the patient's
      weight. Pegunigalsidase alfa administrated at 1 mg/kg, intravenously over 3 hours, every 2
      weeks. After the first 2 months of treatment with pegunigalsidase alfa, infusion time may be
      reduced gradually to 1.5 hours pending patient tolerability.
    

Intervention name(s): PRX-102 (pegunigalsidase alfa)
Intervention type(s): Biological
Intervention description(s): PRX-102 1 mg/kg every 2 weeks
Other intervention name(s): pegunigalsidase alfa; Recombinant human alpha galactosidase-A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fabry disease; Enzyme-Replacement Therapy; pegunigalsidase alfa; PRX-102; alpha galactosidase-A
Food and Relative Bioavailability Study
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, randomised, single dose study to determine the pharmacokinetics,
      safety and tolerability of 2 different formulations of orvepitant 60 mg and the effect of
      food in 15 Healthy Volunteers.
    

Detailed description: 
      Orvepitant is a highly potent and selective neurokinin-1 (NK1) receptor antagonist currently
      in development for the treatment of depression and anxiety.

      This study is an open-label, randomised, single dose study to determine the pharmacokinetics,
      safety and tolerability of 2 different formulations of orvepitant 60 mg and the effect of
      food in 15 Healthy Volunteers. According to a cross over design, in three different
      occasions, each subject will receive the "old" formulation of orvepitant in fasted condition
      and the "new" formulation in fasted condition and after a FDA High-Fat Breakfast. Subjects
      will be screened within 21 days of first treatment. On each dosing occasion, subjects will be
      admitted to the clinic on Day-1 and will remain until Day 2; they will be also asked to
      return to the site 48 and 72 hours after each dosing for the PK blood sample collection. The
      wash-out period between each dosing occasion will be at least 5 days and subjects will be
      asked to return to the site 7-14 days after the administration of the last dose of orvepitant
      for a follow-up visit.
    

Intervention name(s): Orvepitant
Intervention type(s): Drug
Intervention description(s): Orvepitant 60 mg, single dose. 2 different formulation. Formulation 2 is administered with and without food.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: formulation; safety and tolerability; pharmacokinetics; NK1 antagonist; effect of food
Tolerance and Digestibility of a New Formula in Healthy Infants
Condition: Steatorrhea; Growth
MeSH terms: Steatorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The great majority of infants formula contain fats exclusively from vegetable oil.
      Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an
      infant formula closer to the nutritional composition of maternal milk.
    


Intervention name(s): dairy lipids and soluble milk proteins
Intervention type(s): Dietary Supplement
Intervention description(s): one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: infant formula; dairy fat; soluble milk protein
Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      This three week study will be conducted to determine the safety and efficacy of an
      over-the-counter (OTC) cream in children with mild to moderate atopic dermatitis.
    

Detailed description: 
      The objective of this trial is to evaluate the efficacy and safety of an OTC colloidal
      oatmeal skin protectant cream in children with mild to moderate AD in comparison to that of
      EpiCeram®
    

Intervention name(s): Colloidal Oatmeal; Topical Cream
Intervention type(s): Drug; Device
Intervention description(s): Topical cream applied twice daily (or as needed); Topical cream applied twice daily (or as needed)
Other intervention name(s): Not yet marketed; EpiCeram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eczema
Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block
Condition: Postoperative Analgesia; Lower Abdominal Cancer
MeSH terms: Abdominal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Comparing the analgesic effects of ketamine and dexmedetomidine when added to local
      anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.
    


Intervention name(s): Ketamine; dexmedetomidine; control group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ketamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block; dexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block; 20ml of 0.25% bupivacaine will be injected in each side of the TAP block
Intervention MeSH terms: Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Fresh Versus Freeze-only After CAPA IVM on PCOS Patients
Condition: PCOS; IVM; Embryo Transfer
Study type: Interventional

Summary: 
      IVM (in vitro maturation) has been proved to be a more friendly treatment protocol for PCOS
      (polycystic ovary syndrome) patients compared with conventional controlled ovarian
      stimulation, with less complications (especially ovarian hyperstimulation syndrome), shorter
      treatment duration, lower cost, and acceptable pregnancy outcomes.
    

Detailed description: 
      IVM (in vitro maturation) has been proved to be a more friendly treatment protocol for PCOS
      (polycystic ovary syndrome) patients compared with conventional controlled ovarian
      stimulation, with less complications (especially ovarian hyperstimulation syndrome), shorter
      treatment duration, lower cost, and acceptable pregnancy outcomes. CAPA (capacitation) IVM
      without hCG (human chorionic gonadotropin) priming, has routinely been used at My Duc
      hospital for nearly 3 years to replace hCG-IVM (with hCG priming) because of absolutely
      synchronized oocyte maturation stage and better embryo results and better pregnancy outcomes.
      However, with CAPA IVM, embryos are freezed-only and will be transferred in the next cycles.
      This process will increase the cost of freezing and thawing embryos, and increase the
      treatment duration, which complicates the IVM procedure and turns IVM into an unfriendly
      protocol to PCOS patients. Therefore, our group conducts this study to find out the
      effectiveness of fresh transfer protocol after CAPA IVM compared with freezing-only CAPA IVM
      protocol. The fresh transfer protocol for CAPA IVM is applied from previous hCG IVM protocol,
      with the use of hCG and exogenous estradiol and progesterone, but at different timings.
    

Intervention name(s): CAPA-Fresh; CAPA-Freeze-only
Intervention type(s): Procedure; Procedure
Intervention description(s): Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Receiving hCG 5000IU x 2 (10000IU) after Oocytes retrieval. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Fresh embryos transfer will be performed on day 3 using HRT protocol with a maximum of 2 embryos transferred.; Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Freeze-only on day 3 and frozen embryo transfer will be performed on the subsequent cycle using HRT protocol with a maximum of 2 embryos transferred.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients
Condition: Colorectal Cancer; RAS and BRAF Wild-type; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases
MeSH terms: Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Intestinal Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib
      Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with
      Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy,
      patients will receive capecitabine and anlotinib as maintenance therapy until tumor
      progression.In order to observe and evaluate the efficacy and safety of Anlotinib
      Hydrochloride Capsules combined with CAPEOX in treatment of patients with mCRC. The patients
      who are pathologically confirmed as RAS and BRAF wild-type mCRC will be enrolled.

      Condition or disease Invention/treatment Phase Colorectal Cancer Drug: Anlotinib
      Hydrochloride Drug: Capecitabine Drug: Oxaliplatin Phase 2
    

Detailed description: 
      This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib
      Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with
      Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy,
      patients will receive capecitabine and anlotinib as maintenance therapy until tumor
      progression.In order to observe and evaluate the efficacy and safety of Anlotinib
      Hydrochloride Capsules combined with CAPEOX in treatment of patients with Metastatic
      Colorectal Carcinoma(mCRC).Primary Efficacy Endpoint: Objective Response Rate (ORR),
      Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version
      1.1), Disease Control Rate (DCR) and duration of response(DoR). Safety and tolerance will be
      evaluated by incidence, severity and outcomes of AEs and categorized by severity in
      accordance with the NCI CTC AE Version 4.0.
    

Intervention name(s): Anlotinib Hydrochloride; Capecitabine; Oxaliplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off.; Capecitabine is a capsule in the form of 500 mg, orally, 850 mg/m2, twice daily, 2 weeks on/1 week off.; Oxaliplatin 130 mg/m2,D1
Intervention MeSH terms: Capecitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
VAS-2 Vasectomy With the Vax-X
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to study an experimental vasectomy device called the
      Vas-X. This is an experimental study of this new approach to vasectomy.
    

Detailed description: 
      The Vas-X works by stripping the lining of the vas deferens, the tube that sperm pass through
      during ejaculation. It is used in a way very similar to routine vasectomy, however, in a
      routine vasectomy, the vas is burned with an electrical device. With the Vas-X, there is no
      burning. The investigators are testing the Vas-X to determine whether it will offer a better
      way of performing a vasectomy.

      The investigators will conduct this study at the University of Washington Medical Center,
      Seattle.
    

Intervention name(s): Vas-X
Intervention type(s): Device
Intervention description(s): mechanical vasectomy device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vasectomy; Contraception
Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
Condition: Esketamine; Pregabalin; Acute Postoperative Pain; Neurosurgical Procedures; Perioperative Complication; Spinal Cord Neoplasms
MeSH terms: Neoplasms; Spinal Cord Neoplasms; Spinal Neoplasms; Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Postsurgical pain is now known to be one of the most common and difficult-to-treat
      complications of surgery. severe postoperative pain can significantly impair patients'
      quality of life, social functioning and contribute to excessive health care expenditures. It
      is worth noting that acute postoperative pain may play a vital role in central sensitization
      and up-regulation of pain receptors, even factors implicated in the development of CPSP.
      According to previous studies, the incidence of postoperative pain among patients undergoing
      spinal surgery was nearly 80%. At the same time, perioperative pain management of patients
      undergoing spinal surgery has not been clearly. For the past few years, pregabalin and
      esketamine are becoming important roles in perioperative pain management, lots of studies
      have shown that these two analgesics might relieve postoperative pain. The aim of this study
      was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after
      spinal cord neoplasms resection, so as to find a better way to help the patients undergoing
      spinal surgery keep away from the acute perioperative pain.
    


Intervention name(s): S-ketamine and pregabalin; Normal saline and placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Pregabalin
150mg (2hrs) pre operatively and 75mg twice daily post operatively for 7 days(POD1-7), followed by dose reduction to 75mg once daily for 7 days(POD8-14)
Drug: S-ketamine infusion
0.5 mg/kg bolus after induction of anesthesia +0.12 mg/kg/h continuous intravenous infusion for 48 h; Drug: Placebo capsules
Two placebo capsules (2hrs) preoperatively and twice daily post operatively for 7days, followed by dose reduction to single capsule once daily for 7days
Drug: Normal saline
0.9% saline bolus after induction of anesthesia + intravenous infusion for 48 hours
Intervention MeSH terms: Pregabalin; Ketamine; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) Low-frequency on Craving in Smoking Dependence
Condition: Smoking Cessation; Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The fight against smoking is a public health priority. Without help, fewer than 5% of des
      smokers are abstinent at 12 months after smoking cessation.

      Despite well-managed attempts at smoking cessation with nicotine substitutes, the rate of
      success at 12 months in patients dependent on nicotine is only 18%. Moreover, other
      therapeutic strategies (acupuncture, hypnosis…) have not proved to be effective.

      The investigators propose a new therapeutic strategy for smoking cessation, which is based on
      associating nicotine substitutes (to reduce physical symptoms of weaning from nicotine) with
      rTMS at 1 Hz to the right DorsoLateral PreFrontal Cortex (DLPFC) for 2 weeks (to diminish
      craving for tobacco). The principal objective is to improve the success rate for smoking
      cessation attempts in patients who are highly dependent on nicotine, and who have failed
      using usual smoking cessation strategies.
    


Intervention name(s): active rTMS; sham rTMS
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Study of Oligonol Supplementation to Promote Cardiovascular Health
Condition: Cardiovascular Health
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators hypothesize that acute consumption of Oligonol, a patented lychee fruit
      extract (Amino Up Chemical Co.) particularly rich in low molecular weight flavanols, will
      improve endothelial function, reduce platelet reactivity and increase circulating levels of
      flavonoids after a single intake.
    

Detailed description: 
      The investigators have demonstrated from previous studies at UC Davis that a single dose of a
      high-flavanol supplement from cocoa can improve endothelial function, measured by increased
      blood flow from peripheral arterial tonometry (PAT), reduce platelet reactivity, and increase
      circulating levels of flavonoids in the blood. The investigators seek with this proposal to
      determine if a similar response can be noted with a different high-flavanol supplement in
      normal, healthy people.
    

Intervention name(s): Oligonol
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Flavanols; cardiovascular
Abuse Liability and Human Pharmacology of Mephedrone
Condition: Amphetamine-Related Disorders
MeSH terms: Amphetamine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are 1) to evaluate the abuse liability and human pharmacology of
      mephedrone after oral administration and 2) to compare the pharmacological effects of
      mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine
      (MDMA, ecstasy).
    

Detailed description: 
      Mephedrone is a new psychoactive substance (NPS). At present, there are no randomized
      controlled trials evaluating the effects of mephedrone in humans. The current body of
      knowledge regarding the acute effects of mephedrone is based on anecdotal, self-reported
      effects (e.g. internet forums), case reports, and emergency room series and fatalities.

      The aims of this study are 1) to evaluate the abuse liability and human pharmacology of
      mephedrone after oral administration and 2) to compare the pharmacological effects of
      mephedrone with those obtained after administration of oral 3,4-methylenedioxymethamphetamine
      (MDMA, ecstasy).
    

Intervention name(s): Mephedrone; 3,4-methylenedioxymethamphetamine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose mephedrone; Single oral dose MDMA; Single oal dose placebo
Other intervention name(s): 4-methylmethcathinone; 4-MMC; MDMA; Ecstasy; Non active treatment
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Mephedrone; 3,4-methylenedioxymethamphetamine; Abuse liability; Human Pharmacology
Insulin Action in Individuals With Type 2 Diabetes by Natural Fatty Acids or the Medication Pioglitazone
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the changes in insulin (a hormone produced in the
      body by the pancreas that regulates the amount of sugar in the blood) action and adiponectin
      (a protein hormone which regulates sugar levels and fatty acid breakdown) levels after giving
      individuals with type 2 diabetes a medication, pioglitazone, for three weeks.
    

Detailed description: 
      Participants in this study will be given a 21 day supply of either pioglitazone (a medication
      used to treat diabetes) or a placebo. Changes to the body's response to insulin in the liver
      and in peripheral tissues (eg, muscle and fat) will be measured using a procedure called a
      pancreatic clamp. During the clamp procedure, glucose (a sugar) and insulin are infused with
      an intravenous catheter, and blood samples are collected periodically throughout the
      procedure to measure blood sugar levels and the levels of several hormones that are found in
      the body and are related to glucose metabolism. Small amounts of muscle and fat tissue will
      also be taken during this study to measure changes in gene expression after taking the
      medication/placebo for 3 weeks.
    

Intervention name(s): Pioglitazone 45 mg; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The optimal strategy to restore sinus rhythm in patients with atrial fibrillation (AF) of
      less than 48 hours' duration is still controversial. The investigators performed a controlled
      single-center trial to compare electrical and pharmacological (propafenone) cardioversion to
      restore the sinus rhythm in selected patients with acute atrial fibrillation.
    


Intervention name(s): electrical cardioversion; propafenone
Intervention type(s): Procedure; Drug
Intervention description(s): External cardioversion was performed in anteroposterior position (right sternal body at the third intercostal space-angle of the left scapula); patients were submitted to a biphasic wave-form sequential shock of 100-150-200 J, if necessary.; Propafenone (2 mg/kg bolus) was administered to obtain pharmacolgic sinus rhythm conversion.
Intervention MeSH terms: Propafenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: atrial fibrillation; electrical cardioversion; pharmacological cardioversion