bioihbjkbjnl/mcl2 huggingface dataset:
Binimetinib in Addition to Standard Chemotherapy in KRAS Mutated NSCLC.
Condition: Advanced Non-small Cell Lung Cancer; KRAS Gene Mutation; Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim is to determine the recommended phase 2 dose (RP2D) of binimetinib in combination
      with pemetrexed and cisplatin, and to demonstrate that the combination is feasible and has
      preliminary activity in previously untreated patients with advanced NSCLC and documented KRAS
      mutations.
    

Detailed description: 
      There is a need for more effective therapies for patients with advanced NSCLC driven by the
      RAS/MEK/ERK pathway. These tumors are generally aggressive, are almost exclusively of
      non-squamous histology, and represent the largest group of patients with advanced NSCLC
      harboring specific driver mutations in Western populations.

      Based on recent preclinical and clinical evidence, mitogen-activated protein kinase kinase
      (MEK)-inhibition plus first-line chemotherapy is a promising new treatment for patients with
      NSCLC and KRAS [v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog] mutations.

      Binimetinib is a medication without marketing authorization. Pemetrexed and cisplatin have
      marketing authorization in Switzerland and in EU for the treatment of non-small cell lung
      cancer (NSCLC) and will be administered as standard backbone treatment according to their
      Swissmedic-approved indication, dose and route of administration. Binimetinib, pemetrexed and
      cisplatin are IMP in the context of this phase I trial.
    

Intervention name(s): Binimetinib; Pemetrexed; Cisplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Binimetinib will be administered in combination with pemetrexed and cisplatin (induction therapy), and with pemetrexed only (maintenance therapy), during the first 2 weeks of each cycle. Cycles will be repeated every 21 days.; Pemetrexed 500 mg/m2 i.v. is applied on day 1 of each cycle, before cisplatin administration; Cisplatin 75 mg/m2 i.v. is applied on day 1 of each induction therapy cycle. The drug must be administered after pemetrexed infusion
Other intervention name(s): MEK162
Intervention MeSH terms: Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced non-small cell lung cancer; KRAS mutations; Binimetinib; Pemetrexed; Cisplatin; Phase IB trial
Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia
Condition: Herpes Simplex; Schizophrenia; Schizoaffective Disorder
MeSH terms: Herpes Simplex; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The effects of Valacyclovir (VAV) augmentation or placebo (PLA) as adjuncts to conventional
      antipsychotic drug treatment will be evaluated among patients with schizophrenia who have
      been exposed to herpes simplex virus type 1 (HSV-1). Hypothesis: Valacyclovir (VAV)
      augmentation improves (a) cognitive and (b) overall function among Herpes Simples Virus 1
      (HSV-1) exposed early course schizophrenia patients.
    

Detailed description: 
      Design: We propose a randomized double blind placebo controlled study of patients with early
      course Schizophrenia (SZ) / schizoaffective disorder (SZA) patients exposed to HSV-1, who are
      receiving antipsychotic drugs. The effects of VAV augmentation or PLA as adjuncts to
      conventional antipsychotic drug treatment will be evaluated. As outcomes, we will evaluate
      clinical symptoms, cognitive variables, overall function (including social function) and side
      effects. The participants will be under the direct care of the Indian investigators during
      the study. Ratings will be performed blind by research staff. We will pre-screen for HSV-1
      exposure. There will be a 2 week placebo run in phase, 16 week augmentation and 4 week follow
      up to identify post-treatment side effects.
    

Intervention name(s): Experimental: Valacyclovir treatment; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): Patients will have a placebo run-in for two weeks after which they will be evaluated for the variables of interest and then randomized to either VAV or placebo group in a 1:1 proportion. The VAV group will receive 1.5 g Valacyclovir by mouth, twice daily for 16 weeks, after which they will be followed up without VAV for 4 weeks to monitor delayed adverse effects.; Patients will have a placebo run-in for two weeks after which they will be evaluated for the variables of interest and then randomized to either VAV or placebo group in a 1:1 proportion. Subjects in the placebo arm will receive placebo for 16 weeks, after which they will be followed up without placebo for 4 weeks to monitor delayed adverse effects.
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Comparison of Diagnostic TESE and TESA in Non-obstructive Azoospermic
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Azoospermia , as the name suggests , refers to the condition in which there are no sperm in
      the semen. This diagnosis can come as a rude shock, because most men with a zero sperm count
      have normal libido; normal sexual function; and their semen looks completely normal too. The
      diagnosis can only be made by examining the semen under a microscope in the laboratory.Men
      with non-obstructive azoospermia have a normal passageway, but abnormal testicular function,
      and their testes do not produce sperm normally. Some of these men may have small testes on
      clinical examination. The testicular failure may be partial, which means that only a few
      areas of the testes produce sperm, but this sperm production is not enough for it to be
      ejaculated. Other men may have complete testicular failure, which means there is no sperm
      production at all in the entire testes. The only way to differentiate between complete and
      partial testicular failure is by doing multiple testicular micro-biopsies to sample different
      areas of the testes and send them for pathological examination. This technique is called
      TESA, or testicular sperm aspiration ( also known as TESE, or testicular sperm extraction) or
      mTESE ( micro-testicular sperm extraction).
    

Detailed description: 
      This study was performed on 180 men with non-obstructive azoospermia (NOA), referring to
      royan infertility center, according to inclusion and exclusion criteria. Testis selection
      (right and left) and techniques (TESE or TESA) were performed randomly in patients. For every
      patient based on random order, TESA or TESE was performed as the following procedures. The
      testis was aspirated at three separated sites (upper, middle and lower pole), using 20 ml
      syringe and 18-gauge needle or testicular biopsy (TESE) was taken from the same 3 sites.
    

Intervention name(s): extaction; testicular sperm extraction; testicular sperm aspiration
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): TESE (testicular sperm extraction), which is actually a surgical biopsy of the testis; or TESA (testicular sperm aspiration), which is performed by sticking a needle in the testis and aspirating fluid and tissue with negative pressure; testicular sperm extraction; testicular sperm aspiration
Other intervention name(s): Tecnique comparision; sperm extraction; sperm aspiration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TESE; TESA; non obstructive; azoospermi
Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation in Analgetic Dosages
Condition: Platelet Aggregation
Study type: Interventional

Summary: 
      Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of
      traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators
      conducted the study in comparing patients undergoing traumatologic, visceral or plastic
      surgical procedures. The investigators randomized them to four groups receiving common
      analgetic doses of either dipyrone, acetaminophen (paracetamol) or valdecoxib/parecoxib. The
      investigators took blood samples before initiation of the study drug, 1h, 4hs and 24hs after
      first intake. The investigators compared the aggregation via aggregometry of platelet rich
      plasma.
    


Intervention name(s): dipyrone; Ibuprofen; Acetaminophen; Acetaminophen; Parecoxib/Valdecoxib; Blood samples
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): Dipyrone is given in the operation room with 2,5 g intravenously, followed by an oral regime of 4x1g on the ward; Ibuprofen is given orally 600mg in the Post Anesthesia Care Unit, followed by an oral regime of 800mg twice a day; Acetaminophen is given 1g intravenously in the Operation room, followed by an oral regime of 1g fourth a day; Acetaminophen is given 1g intravenously in the operation room, followed by 1g orally fourth a day; 40mg Parecoxib are given intravenously in the operation room, followed by 40mg of Valdecoxib orally twice a day; Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake
Intervention MeSH terms: Acetaminophen; Dipyrone; Ibuprofen; Parecoxib; Valdecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dipyrone; platelet aggregation; neuraxial blockage; ibuprofen; platelet aggregation under dipyrone compared to ibuprofen, acetaminophen and parecoxib/valdecoxib; neuraxial blockage in patients receiving ibuprofen is critical in special circumstances, but traditionally not fpr dipyrone
Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
Condition: Reduction of Hypertrophic Skin Scarring
MeSH terms: Hypertrophy; Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will compare how well PF-06473871 works versus placebo in reducing skin scarring
      after scar revision surgery of existing breast scars. The study will also evaluate the safety
      of PF-06473871 in healthy adult subjects.
    


Intervention name(s): PF-06473871; PF-06473871
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administered by injection four different times; Single dose administered by injection three different times
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Skin scarring; cicatrix; breast scar; hypertrophic scar
Pudendal Block Versus Caudal Block for Hypospadias
Condition: Pain
MeSH terms: Hypospadias
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this prospective randomized study is to assess the analgesic efficacy and duration
      of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias
      surgery concerning intraoperative analgesic and also postoperative total analgesic
      consumption within 24 hours.
    

Detailed description: 
      In this prospective study, patients will be randomized into 2 groups, either receiving Caudal
      Block(CB) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be
      assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to
      assess postoperative pain.
    

Intervention name(s): pudendal nerve block; caudal block
Intervention type(s): Procedure; Procedure
Intervention description(s): nerve stimulator-guided Pudendal block; caudal block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: pudendal block; Hypospadias; caudal block; child; analgesia
Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome
Condition: Postoperative Dumping Syndrome
MeSH terms: Dumping Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release
      of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an
      hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known
      which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this
      trial is to evaluate :

        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying.

        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during
           OGTT).

        -  the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response (during
           OGTT).

        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters
           of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after
           an Oral Glucose Tolerance Test (OGTT) with 75g of glucose)

        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as
           measured by the combined Dumping Syndrome score

        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured
           by (a) early and (b) late phase dumping symptom score separately

        -  the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL
           SF-36)
    

Detailed description: 
      This will be a single centre, randomized, double-blind, controlled cross-over study during 35
      days.

      After a 4 weeks screening period, patients who fulfill the entrance criteria will be randomly
      assigned on a 1:1 basis to either the pasireotide treatment arm or to the placebo treatment
      arm. They will be treated with pasireotide sc or placebo sc for 2 weeks. After 2 weeks,
      patients will be switched to the other treatment arm after a 7 days wash out period. This
      phase is double-blind: both the patient and investigator will be blinded to treatment
      assignment.
    

Intervention name(s): Pasireotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): somatostatin analogue pasireotide; placebo s.c.
Other intervention name(s): SOM230
Intervention MeSH terms: Pasireotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dumping syndrome; OGTT; hypoglycemia
Action of Synbiotics on Irradiated GI Mucosa in Rectal Cancer Treatment
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to investigate how bacteria and fibre interact with the epithelial
      cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage
      caused by radiation therapy to patients diagnosed with rectal cancer.
    

Detailed description: 
      Thirty patients diagnosed with rectal cancer receiving short term radiation therapy 25 Gray
      (Gy) during one week preoperatively will be examined. The patients will be divided into three
      groups with ten patients in each group. One control group without no treatment/study product,
      one group receiving a test product of 45 g of oat bran and freezing medium only, and one
      group having a probiotic bacteria, Lactobacillus plantarum HEAL 19 (1010 CFU/g), freezed
      dried blueberry husks (13 g) and oat bran (22 g), corresponding to 8 g fibre per day in each
      of the two treated groups. The patients will consume the test product once a day 1 week
      before and during radiotherapy (2 weeks in total). Mucosal biopsies for microflora analysis
      and blood samples for analysis of SCFAs and cytokines will be collected at inclusion as well
      as faecal samples. After radiation therapy, at surgery, blood samples, faecal samples and
      mucosal biopsies are collected. Fresh faecal samples, blood samples and mucosal biopsies are
      stored at -80°C until analysis.
    

Intervention name(s): Oat bran; Oat bran and blueberry husks; No oral supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 45 g oat bran.; 13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria.; No oral supplementation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: radiotherapy, probiotics
Inhalation of 20,000 Endotoxin Units(EU) of Clinical Center Reference Endotoxin in Healthy Volunteers
Condition: Healthy Adults
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the inflammatory response to 20,000 endotoxin units
      (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy
      volunteers. Preferably these subjects will have participated in ozone exposure studies,
      allowing a direct comparison of their responses to both endotoxin and ozone. Additionally,
      cardiovascular endpoints will be investigated with the CCRE exposure.
    


Intervention name(s): Clinical Center Reference Endotoxin
Intervention type(s): Biological
Intervention description(s): 20,000 EU inhaled
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Impact of Lingual Frenotomy on Bottle Feeding Mechanics
Condition: Ankyloglossia; Feeding, Bottle; Feeding Disorder of Infancy and Childhood
MeSH terms: Ankyloglossia; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Conservative estimates show that 3-5% of all infants have tongue tie. These studies only
      focus on visible, anterior tongue tie. Deeper, more visibly subtle cases of ankyloglossia
      have not been included in these incidence numbers, so the percentage of children with
      ankyloglossia is much higher than previously thought. Previous research by the investigators
      demonstrates that posterior tongue tie can be as problematic as anterior ties.

      An available FDA-approved feeding solution allows for the measurement of infant sucking
      motions. This allows for detection of changes following surgical intervention. Previous
      ultrasound studies show the importance of the upward movement of the tongue, but further
      lingual movement parameters following frenotomy have not been reported.

      The primary goal of this study is to record changes in lingual movement following lingual
      frenotomy. The investigators plan to compare improvements over time between a control,
      non-intervention group and a frenotomy group. Secondary goals include recording validated
      outcomes of reflux and feeding efficiency.
    


Intervention name(s): Lingual frenotomy
Intervention type(s): Procedure
Intervention description(s): A lingual frenotomy will be performed using a CO2 laser - using the NFANT bottle feeding system, the intervention arm will be compared against the observation arm to determine if there are changes in lingual mobility parameters during bottle feeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tongue tie; ankyloglossia; infant feeding; bottle feeding
A Study of Bryostatin in Moderately Severe to Severe Alzheimer's Disease Subjects Not On Memantine
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized double-blind Placebo-controlled, Phase 2 study comparing bryostatin to
      placebo for the treatment of moderately severe to severe Alzheimer's disease in subjects not
      receiving memantine treatment. The study is 15 weeks in duration, including a safety and
      efficacy evaluation 30 days after the last dose of study drug. Subjects will receive 7 doses
      of study drug during the study. The primary efficacy endpoint is defined as the change from
      baseline to Week 13 in the Severe Impairment Battery (SIB) total score.
    

Detailed description: 
      Eligible subjects will be stratified based on Mini Mental State Exam (MMSE-2) scores 4-9 vs.
      10-15 and will be randomized 1:1 to one of two treatment arms: 20µg bryostatin or placebo for
      twelve weeks. The first two doses of study drug will be a loading dose 20% higher (i.e.,
      24µg) than the assigned dose and will be administered one week apart. Thereafter, the
      assigned dose of 20µg will commence with the third dose and be administered every other week.
      Drug is administered IV by continuous infusion over 45(±5) minutes. Subjects are scheduled to
      receive seven doses over 12 weeks.
    

Intervention name(s): Bryostatin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.; The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
Intervention MeSH terms: Bryostatin 1
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will be stratified based on Mini Mental State Exam (MMSE-2) scores 4-9 vs. 10-15 and will be randomized 1:1 to one of two treatment arms: 20µg bryostatin or placebo for twelve weeks (7 doses).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment