anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bethanechol
Trial phase: Phase 2
ATC code: N07AB02
SMILES: CC(C[N+](C)(C)C)OC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.

Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover.
Eligibility criteria:
Inclusion Criteria:

Male or Female
Age 18-75
Symptoms associated with EoE such as dysphagia, heartburn, vomiting, abdominal pain, food impaction
Subject has signed informed consent for the administration of bethanechol that informs the patient of potential adverse events
Clinically or pathologically proven EoE

Exclusion Criteria:

Known allergy to bethanechol
Asthma
Pregnant or breast-feeding women
Severe neurological problems
Severe diabetes
Achalasia
Known allergy to lidocaine or other local anesthetic
Hypothyroidism
Peptic ulcer
Pronounced bradycardia or hypotension
Vasomotor instability
Coronary artery disease
Epilepsy
Parkinsonism
Weakened gastrointestinal or bladder wall
Mechanical obstruction of the gastrointestinal tract or bladder neck
Urinary bladder surgery in the 6 months prior to the study
Gastrointestinal resection and anastomosis
Spastic gastrointestinal disturbances
Acute inflammatory lesions of the gastrointestinal tract
Peritonitis
Marked vagotonia
Intervention: EXENATIDE
Trial phase: Phase 4
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours
Eligibility criteria:
Inclusion Criteria:

Adults ≥18 years
Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for an anticipated length of stay >48 hours
Two Blood glucose concentrations > 150 mg/dL and ≤300 mg/dL
Informed consent obtained via proxy

Exclusion Criteria:

Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of infusion) or lactating females
Type 1 diabetes mellitus
History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse, gall stones)
Renal insufficiency defined as creatinine clearance (CrCL) < 45 mL/min
Known history of gastroparesis
History of surgery on stomach, esophagus or duodenum
Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome
Concurrent steroid use or planned post-operative steroid use
History of organ transplantation
Brain death or suspected imminent brain death within the next 72 hours
Refractory intracranial hypertension defined as intracranial pressure (ICP) > 25 mmHg for greater than 15 minutes and refractory to medical intervention
Currently enrolled in another investigational drug or device protocol
Insulin infusion within 3 hours of study drug administration or confirmed long acting insulin or sulfonylurea use prior to admission within 24 hours of study drug administration
Known allergy to exenatide
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.

Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing shoulder surgery
Patients must be willing to give written informed consent
Patients must be able and willing to return to hospital on the first postoperative day for study follow-up procedures
Patients must have a working phone number where they can be reached daily after surgery

Exclusion Criteria:

Patients who do not receive an interscalene catheter for their respective surgery for any reason
Patients that received an interscalene catheter, but had any surgical or catheter adverse events prior to discharge
Patients with a history of adverse reactions to either study drug
Patients with a history of contralateral phrenic nerve paralysis,
Patients with a history of extensive prior lung surgery on either lung.
Patients with a history of decreased pulmonary function
Any emergent cases
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.

Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing shoulder surgery
Patients must be willing to give written informed consent
Patients must be able and willing to return to hospital on the first postoperative day for study follow-up procedures
Patients must have a working phone number where they can be reached daily after surgery

Exclusion Criteria:

Patients who do not receive an interscalene catheter for their respective surgery for any reason
Patients that received an interscalene catheter, but had any surgical or catheter adverse events prior to discharge
Patients with a history of adverse reactions to either study drug
Patients with a history of contralateral phrenic nerve paralysis,
Patients with a history of extensive prior lung surgery on either lung.
Patients with a history of decreased pulmonary function
Any emergent cases
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)

Lidocaine: Lidocaine infusion runs for a total of 24 hours
Eligibility criteria:
Inclusion Criteria:

Burn patient ≥ 18 years of age
Burn patient scheduled to go to OR for excision and/or grafting procedure

Exclusion Criteria:

Burn patient < 18 years of age
Intubated patient on sedation drip
Prolonged hypotension defined as Systolic Blood Pressure (SBP) < 90 mm/Hg for greater than 30 minutes in the pre-op area
Severe underlying cardiovascular disease (documented ejection fraction < 40%)
Documented conduction block, bradycardia or active congestive heart failure
Documented active gastritis or ulcers
Previous steroid medication history if documented adrenal insufficiency
Patient with documented liver disease
Patient with epilepsy or known seizure disorder
Pregnant Women
Intervention: Abametapir
Trial phase: Phase 3
ATC code: P03AX07
SMILES: Cc1ccc(-c2ccc(C)cn2)nc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 186
Group description: Single topical treatment administered to hair and scalp for 10 minutes. Applied at home by a subject/caregiver.

Abametapir Lotion 0.74% w/w
Eligibility criteria:
Inclusion Criteria:

Male or female, aged six months of age or older.
Is in good general health based on medical history.
Has active head lice infestation at Screening as determined by a trained evaluator with the exception of the male head of household who may self-assess as being lice-free. Active head lice infestation is defined as at least three live lice for the index subject and at least one live louse for the other household members.
The subject and/or their caregiver is physically able and willing to apply the Investigational Product at home.
Belongs to a household with an eligible index subject with active head lice infestation.
Agrees to an examination for head lice and to all visits and procedures throughout the study.
Has signed an informed consent and/or assent form.

Exclusion Criteria:

Had treatment (over-the-counter ), home remedy or prescription medication) for head lice within 14 days prior to Day 0.
Intends to use any other form of lice treatment from Day 0 through the Day 14 visit, unless provided as rescue therapy to this Protocol.
Intends to use a lice comb from the Day 0 through the Day 14 visit unless provided as rescue therapy to this Protocol.
Intends to cut their hair, use hair dye/bleach or have permanent wave hairstyling from Day 0 through the Day 14 visit.
Has a household member(s) who is infested with lice but is not willing or not eligible for enrollment.
Has a condition that, in the opinion of the Investigator, may increase the risk to the subject and/or the interpretation of the data.
Has visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or Sponsor, will interfere with safety and/or efficacy evaluations.
Has eczema or atopic dermatitis of skin/scalp.
Has had a prior reaction to Nix® or products containing permethrin.
Receiving systemic or topical medication, which in the opinion of the Investigator, may compromise the integrity of the safety and/or efficacy assessments.
Has received an investigational agent within 30 days prior to Day 0.
Does not have a known household affiliation with the household members (i.e., does not stay in one household consistently, or sleeps at one place for several nights and then at another place or location).
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 250
Group description: Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of open-angle glaucoma or ocular hypertension
No use of Lumigan® in the past 3 months

Exclusion Criteria:

Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months
Intervention: Basaglar
Trial phase: Phase 4
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine
Eligibility criteria:
Inclusion Criteria:

Males or females with known history of type 2 diabetes, treated with diet, OADs as monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale insulin.
Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL

Exclusion Criteria:

Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
Recurrent severe hypoglycemia or hypoglycemic unawareness.
Subjects with history of gastrointestinal obstruction or gastroparesis.
Patients with acute or chronic pancreatitis or pancreatic cancer.
Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 45 ml/min).
Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.
Mental condition rendering the subject unable to understand the nature and scope of the study.
Intervention: Linagliptin
Trial phase: Phase 4
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets
Eligibility criteria:
Inclusion Criteria:

Males or females with known history of type 2 diabetes, treated with diet, OADs as monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale insulin.
Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL

Exclusion Criteria:

Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
Recurrent severe hypoglycemia or hypoglycemic unawareness.
Subjects with history of gastrointestinal obstruction or gastroparesis.
Patients with acute or chronic pancreatitis or pancreatic cancer.
Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 45 ml/min).
Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.
Mental condition rendering the subject unable to understand the nature and scope of the study.
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)

Ketamine: 0.5mg/kg IV

Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
Eligibility criteria:
Inclusion Criteria:

Age 18-55
Physically healthy and not currently pregnant
Primary Diagnosis of OCD
Sufficient severity of symptoms
Currently off all psychotropic medication OR
Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission
Able to provide consent

Exclusion Criteria:

Psychiatric conditions that make participation unsafe (schizophrenia [either self or first degree relative e.g. siblings, parents], history of violence, severe depression, eating disorder, substance dependence [including nicotine])
Female patients who are either pregnant or nursing
Planning to commence EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.

period of the study

Allergy to ketamine
Participants for whom being off of medication is not clinically recommended
Medical conditions that make participation unsafe (e.g. high blood pressure, head injury)
Currently on medications that make participation unsafe
Intervention: Ephedrine
Trial phase: Phase 4
ATC code: A08AA56 | C01CA26 | R01AA03 | R01AB05 | R01BA02 | R01BA52 | R03CA02 | S01FB02
SMILES: CN[C@@H](C)[C@@H](O)c1ccccc1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 710
Group description: Ephedrine 10mg iv once at time of combined spinal epidural insertion

Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea
Eligibility criteria:
Inclusion criteria:

Ability to speak and understand English
Term (37-42 weeks' gestation)
Cephalic presentation
Singleton pregnancy
ASA 3 or less
No pregnancy-induced hypertension
No chronic hypertension
BMI <40
No evidence of pre-epidural fetal heart rate abnormality
No IUGR or low AFI. ASA 1-3 women who request epidural analgesia Informed consent signed upon admission to L&D

Exclusion Criteria:

ASA 4 women, BMI > 39
Contraindication to epidural analgesia
Twin pregnancy
Preterm labor
Severe preeclampsia
Decision to perform CS prior to epidural insertion
Unable to read or speak English
Unable or unwilling to sign the IFC
Intervention: Ketamine
Trial phase: Phase 3
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Ketamine 90mg/30 mL PCA (3 mg/mL)

Ketamine: Ketamine administered as patient-controlled analgesia.
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18 years
Total Injury Severity Score greater than 9
Functioning intravenous catheter present per standard of care
Patient planned to receive PCA for acute pain per standard of care
Patient ability to effectively use a PCA device as assessed by the primary attending trauma service
Negative pregnancy test for women of childbearing age

Exclusion Criteria:

Body mass index greater than 35
History of active psychiatric disease
Acute or chronic liver or renal failure
History of heart failure or coronary artery disease
Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy
Patients who abuse alcohol and are at high risk for alcohol withdrawal
Intubated patients
Glasgow Coma Scale score less than 13, or motor subscore less than 6
Documented allergy to ketamine, hydromorphone, or lorazepam
Pregnancy
Incarceration
Intervention: Hydromorphone
Trial phase: Phase 3
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)

Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Eligibility criteria:
Inclusion Criteria:

Age greater than or equal to 18 years
Total Injury Severity Score greater than 9
Functioning intravenous catheter present per standard of care
Patient planned to receive PCA for acute pain per standard of care
Patient ability to effectively use a PCA device as assessed by the primary attending trauma service
Negative pregnancy test for women of childbearing age

Exclusion Criteria:

Body mass index greater than 35
History of active psychiatric disease
Acute or chronic liver or renal failure
History of heart failure or coronary artery disease
Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy
Patients who abuse alcohol and are at high risk for alcohol withdrawal
Intubated patients
Glasgow Coma Scale score less than 13, or motor subscore less than 6
Documented allergy to ketamine, hydromorphone, or lorazepam
Pregnancy
Incarceration
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: OTX-DP (sustained release dexamethasone, 0.4 mg)

OTX-DP treatment
Eligibility criteria:
Inclusion Criteria:

Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

History of ocular surgical intervention within the past 3 months
Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
Use any of the following disallowed medications during the period indicated
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Eligibility criteria:
Inclusion Criteria:

18-85 years, both male and female
Undergoing elective multi-level spinal surgery with a posterior approach to the thoracolumbar spine.
Negative pregnancy test

Exclusion Criteria:

Allergy to tranexamic acid
Preoperative anemia (Hemoglobin <11 grams per deciliter [g/dL] )
Coagulopathy (preoperative platelet count <150,000, International Normalized Ratio >1.4, or Partial Thromboplastin Time > 1.5 times normal)
History of deep vein thrombosis, stroke, or pulmonary embolism
Pregnant or breast feeding
Liver function tests 2 times the upper limit of normal, and those with creatine greater than 1.6 milligrams per deciliter (mg/dL)
Infection
Revision procedure in which the only procedure is removing instrumentation
Renal impairment
Dural tear