ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02417129
Conditions: Lymphoma, Non-Hodgkin
Sponsor: Boehringer Ingelheim
Start date: 2015-04-01; Completion date: 2015-12-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, multicenter, randomized, double-blind, parallel-arm, active comparator trial to evaluate BI 695500 versus rituximab as a first-line immunotherapy treatment in patients with LTBFL. Patients will be randomly assigned in a 1:1 ratio to receive 375 mg/m2 of BI 695500 or rituximab via intravenous (IV) infusion once a week for 4 weeks (total of 4 dosages administered on Days 1, 8, 15, and 22). Disease assessments will be performed at the End of Study (EOS) Visit at Week 30.

Detailed description:

Arms: arm 1: 375 mg/m2; One intravenous infusion once a week for 4 weeks arm 2: 375 mg/m2; One intravenous infusion once a week for 4 weeks
Interventions: intervention 1: Rituximab intervention 2: BI 695500
Intervention descriptions: intervention 1: BI 695500 375 mg/M2 intervention 2: BI 695500 375 mg/M2

Protocol documents:
Clinical trial NCT02454296
Conditions: Pain
Keywords: Laminaria
Sponsor: University of Hawaii
Start date: 2015-05-01; Completion date: 2015-12-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.

Detailed description:
Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.

Arms: arm 1: A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate. arm 2: A sham block will be done prior to the placement of laminaria using a capped needle
Interventions: intervention 1: Paracervical Block with lidocaine intervention 2: Sham paracervical block
Intervention descriptions: intervention 1: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion intervention 2: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes

Protocol documents:
Clinical trial NCT02456896
Conditions: Bipolar Disorder
Keywords: Oxcarbazepine Brain Derived Neurotrophic Factor Bipolar disorder Neuroprotection
Sponsor: All India Institute of Medical Sciences, Bhubaneswar
Start date: 2015-06-01; Completion date: 2015-12-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study has been designed to evaluate the change in serum BDNF level with oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its neuroprotective effect.

Detailed description:
Bipolar disorder (BD) is a chronic psychiatric illness of partially unknown pathophysiology. BD likely involves, at a molecular and cellular level, dysfunctions of critical neurotrophic, cellular plasticity and resilience pathways and neuroprotective processes. Abnormalities of neurotrophins (NTs) and other trophic factors orchestrate important alterations which could be implicated in the etiology of BD. As consistently reported in post-mortem studies, these modifications are generally associated with the disruption of distinct subregions and functions of the brain, one of which is the deregulation of neurotrophins.

NTs are capable of signaling neurons, glial cells and other cellular systems to enable survival, differentiation and growth. BDNF is one of the most studied and abundant NTs in the brain, which plays an important role in a variety of neural processes during the development of both animals and humans. Initially, BDNF is important for neurogenesis, neuronal survival, and normal maturation of neural development pathways. In the adult, BDNF is not only important for synaptic plasticity and dendritic growth, but also for long-term memory consolidation. Several studies have proved that BDNF is significantly reduced in manic, hypomanic or depressive stages of BD, whereas euthymic patients exhibit BDNF levels similar to healthy controls.

Rafael T. de Sousa et al have observed a significant increase in serum BDNF levels after 28 days of lithium monotherapy in patients with BD and suggested neuroprotective role of lithium due to its direct regulatory effect on BDNF. Oxcarbazepine is a commonly used mood stabilizer which has demonstrated comparable efficacy to divalproate sodium and better tolerability profile but till date there is no study on its effect on BDNF. The aim of the present study is to evaluate the change in serum BDNF level with oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its neuroprotective effect.

Arms: arm 1: Twenty five (25) age and sex matched healthy individuals will serve as the control group. Control subjects will be evaluated at baseline only. arm 2: Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks.
Interventions: intervention 1: Oxcarbazepine
Intervention descriptions: intervention 1: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).

Protocol documents:
Clinical trial NCT02465632
Conditions: Acne Vulgaris
Sponsor: Glenmark Pharmaceuticals Ltd. India
Start date: 2015-04-01; Completion date: 2015-12-01
Enrollment: 1100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.

Detailed description:

Arms: arm 1: apply a thin layer of gel to the face arm 2: apply a thin layer of the gel to the face arm 3: apply a thin layer of the gel to the face
Interventions: intervention 1: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel intervention 2: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02475031
Conditions: Postoperative Pain
Keywords: transversus abdominis plane block
Sponsor: Indiana University
Start date: 2012-07-01; Completion date: 2015-12-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether continuous transversus abdominis plane (TAP) block is superior to single shot TAP for postoperative pain after laparoscopic donor nephrectomy

Detailed description:
This study is a randomized, prospective, double blind study comparing single shot versus continuous transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic live donor nephrectomy.

Good pain control after surgery has been shown to decrease complications. To address the problem of postoperative pain control in donor nephrectomy patients,the study investigators began performing Transversus Abdominis Plane (TAP) blocks. The TAP block involves injection of local anesthetic between the abdominal muscle planes (internal oblique muscle and transversus abdominis muscle), to block the somatic nerves that supply sensation to the skin, muscles, and parietal peritoneum of the anterior abdominal wall. Prior reports of TAP blocks have shown that it provides good analgesia for postoperative pain after abdominal surgery. However because the duration of postoperative pain exceeds that of the single shot TAP block, the investigators hypothesized that by placing a catheter through which a continuous infusion of local anesthetic could be delivered, investigators could provide analgesia throughout the postoperative period. The study investigators also hypothesized that improved analgesia would decrease the need for opioid pain medications, hence decreasing the side effects associated with opioid use.

This study is designed to test our hypothesis that placing a TAP catheter is superior to single shot TAP, because it provides a longer duration of analgesia and decreases narcotic use.

Arms: arm 1: (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter arm 2: (TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter
Interventions: intervention 1: TAP-C intervention 2: TAP-S
Intervention descriptions: intervention 1: TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case. intervention 2: Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case.

Protocol documents:
Clinical trial NCT02492451
Conditions: Pregnancy
Keywords: intrauterine insemination pregnancy rate endometrial injury
Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Start date: 2015-06-01; Completion date: 2015-12-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.

Detailed description:
Group 1: Endometrial biopsy is performed on days 21-24 of the spontaneous menstrual cycle proceeding the intrauterine insemination (IUI) treatment cycle. Two small biopsies are obtained from anterior and posterior walls of the uterus.

Group 2: Vaginal progesterone gel is administered for luteal phase support from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

Goup 3: Patients are undergone intrauterine insemination (IUI) cycles stimulated with gonadotropin without any intervention.

The effect of endometrial injury and luteal phase progesterone support on the pregnancy rate in patients intrauterine insemination (IUI) cycles stimulated with gonadotropin will be compared in terms of biochemical pregnancy rate, clinical pregnancy rate and ongoing pregnancy rate.

Arms: arm 1: Endometrial injury in luteal phase of preceding IUI cycle arm 2: Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy. arm 3: Only IUI
Interventions: intervention 1: Endometrial Injury intervention 2: progesterone (Crinone® %8 vaginal progesterone gel)
Intervention descriptions: intervention 1: Endometrial injury in luteal phase of preceding cycle by pipelle canula intervention 2: Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

Protocol documents:
Clinical trial NCT02493036
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)
Sponsor: Theriva Biologics, Inc.
Start date: 2015-10-01; Completion date: 2015-12-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Single-Dose, Open-Label, Extension Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients with Irritable Bowel Syndrome with Constipation

Detailed description:
This is a Phase 2, multi-center, open-label study. Up to sixty subjects with irritable bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be enrolled. Subjects must have completed the previous SB-2-010-001 study. The entire duration of the study may be up to 57 days (from enrollment to the post end-of-study \[EOS\] visit telephone call).

Arms: arm 1: 42-mg SYN-010
Interventions: intervention 1: SYN-010
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02516098
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-10-01; Completion date: 2015-12-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: hyoscine butylbromide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02526667
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Sponsor: Medline Industries
Start date: 2015-08-01; Completion date: 2015-12-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.

Detailed description:
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post Chlorhexidine Gluconate (CHG) application.

Arms: arm 1: 2% CHG, single application arm 2: Excipients on cloth arm 3: Dynahex 2% CHG
Interventions: intervention 1: Chlorhexidine gluconate intervention 2: DynaHex-2 intervention 3: Vehicle
Intervention descriptions: intervention 1: 2% CHG solution on cloth intervention 2: 2% CHG solution intervention 3: Excipients of CHG product only

Protocol documents:
Clinical trial NCT02542943
Conditions: Dentin Sensitivity
Sponsor: GlaxoSmithKline
Start date: 2015-09-01; Completion date: 2015-12-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the longitudinal efficacy of two experimental oral rinses containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH 4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.

Detailed description:

Arms: arm 1: Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks. arm 2: Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks. arm 3: Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
Interventions: intervention 1: Experimental Oral Rinse 1 intervention 2: Experimental Oral Rinse 2 intervention 3: Placebo Oral Rinse intervention 4: Standard fluoride toothpaste
Intervention descriptions: intervention 1: (1.5% w/w KOX, pH 4.5) intervention 2: (1.5% w/w KOX, pH 7) intervention 3: (0% w/w KOX, pH 4.5) intervention 4: 1000ppm fluoride as sodium monofluorophosphate

Protocol documents:
Clinical trial NCT02576041
Conditions: Allergic Rhinitis Urticaria
Keywords: driving simulator
Sponsor: Menarini International Operations Luxembourg SA
Start date: 2015-10-01; Completion date: 2015-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to evaluate the effects of Bilastine on patients' attention and reactivity levels by measuring psychophysical performance at a F1-high speed simulator driving test.

Detailed description:
This was a phase IV, interventional, prospective, mono-centric, single arm, uncontrolled, open label trial. The study included outpatient affected by Allergic Rhinitis and/or Chronic Urticaria, responding to inclusive criteria and able to perform a preliminary driving test on F1-high speed simulator (at the simulator centre) without experiencing signs or symptoms of intolerance towards the drive simulation (e.g., nausea, vomiting or dizziness etc). Each subject underwent 3 ambulatory visits at the hospital site and 3 driving test at the simulator centre.

Arms: arm 1: At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).
Interventions: intervention 1: Bilastine intervention 2: Placebo
Intervention descriptions: intervention 1: Bilastine tablets once a day for 7+3 days intervention 2: Placebo tablets once a day during 7+3 days run in period

Protocol documents:
Clinical trial NCT02578914
Conditions: Allergic Conjunctivitis Seasonal Allergies
Keywords: allergic conjunctivitis seasonal allergies ragweed allergy grass allergy tree allergy NS2 Aldeyra
Sponsor: Aldeyra Therapeutics, Inc.
Start date: 2015-08-01; Completion date: 2015-12-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%).

Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.

Detailed description:

Arms: arm 1: NS2 Ophthalmic Drops (0.5%) arm 2: NS2 Ophthalmic Drops Vehicle (0.0%) control
Interventions: intervention 1: NS2 Ophthalmic Drops (0.5%) intervention 2: NS2 Ophthalmic Drops Vehicle (0.0%)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02602275
Conditions: Acute Stress Reaction
Keywords: Stress, amygdala, functional MRI, Hariri paradigm, TSST
Sponsor: Biologische Heilmittel Heel GmbH
Start date: 2015-08-01; Completion date: 2015-12-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to explore the effect of Neurexan® on the brain response when participants undergo an emotional stressful condition in verum compared to placebo.

Detailed description:
A randomized placebo-controlled, double-blind, two-period crossover study with an explorative design. 40 healthy males aged 31-59 years will be included in the study. Participant allocation to either Neurexan® or Placebo at study start is randomized with a ratio of 1:1, i.e. 20 Neurexan® first to 20 Placebo first individuals. Participants receive totally three tablets of either Neurexan® or Placebo per treatment period orally.

Arms: arm 1: Participants received a single dose of three Neurexan tablets on trial Day 1. Following a washout period of 7 to 35 days, they received a single dose of three placebo tablets on trial Day 2. arm 2: Participants received a single dose of three Placebo tablets on trial Day 1. Following a washout period of 7 to 35 days, they received a single dose of three Neurexan tablets on trial Day 2.
Interventions: intervention 1: Neurexan intervention 2: Placebo
Intervention descriptions: intervention 1: 0.6 mg / tablet intervention 2: Neurexan-matched Placebo tablet

Protocol documents:
Clinical trial NCT02619799
Conditions: Postoperative Pain
Keywords: magnesium sulphate intrathecal route midazolam
Sponsor: Rangaraya Medical College
Start date: 2015-01-01; Completion date: 2015-12-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares whether addition of Magnesium or Midazolam intrathecally to epidurally administered isobaric Ropivacaine improves the quality of blockade, haemodynamics and duration of analgesia post-operatively. 25 parturients were given intrathecal Magnesium and rest of the 25 parturients were given intrathecal Midazolam combined with 0.75% Ropivacaine via epidural route.

Detailed description:
Magnesium sulphate and Midazolam have been used in clinical trials as adjuvants to local anaesthetics via intrathecal and epidural routes and are effective in augmenting the quality of block and prolonging post-operative analgesia.

Noxious stimulation leads to the release of glutamate and aspartate neuratransmitters which bind to various sub-classes of excitatory aminoacid, including the NMDA receptor. Intrathecal magnesium potentiates neuraxial anaesthesia by blocking NMDA receptors with out causing significant side effects as reported in various studies.

Intrathecal Midazolam produces antinociception at spinal cord-level through benzodiazepine GABA-A receptor complex which are present abundantly in the lamina 2 of spinal cord. Midazolam also releases endogenous opioid acting at spinal delta receptors and also enhances adenosine release which also augments analgesia.

Arms: arm 1: MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace. arm 2: MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
Interventions: intervention 1: intrathecal magnesium sulphate, intervention 2: Intrathecal midazolam
Intervention descriptions: intervention 1: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine intervention 2: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine

Protocol documents: