anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Atogepant
Trial phase: Phase 3
ATC code: N02CD07
SMILES: C[C@@H]1[C@H](c2c(F)ccc(F)c2F)C[C@H](NC(=O)c2cnc3c(c2)C[C@@]2(C3)C(=O)Nc3ncccc32)C(=O)N1CC(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 543
Group description: Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
At least a 1-year history of migraine with or without aura consistent with a diagnosis
Age of the participant at the time of migraine onset < 50 years
History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion Criteria:

Difficulty distinguishing migraine headaches from tension-type or other headaches
Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
≥ 15 headache days per month on average across the 3 months prior to Visit 1
Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test
Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.
Intervention: Medroxyprogesterone acetate
Trial phase: Phase 1
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Participants received TV-46046 undiluted (120mg/0.3 mL of 400 mg/mL) SC injection as a test formulation.
Eligibility criteria:
Inclusion Criteria:

Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device [IUD], or consistent use of condoms)
Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
Participant had a normal mammogram within the last year, if 40 years or older

Participant has no skin disorders or skin allergies

Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Participant has hypertension
Participant has ischemic heart disease or a history of ischemic heart disease
Participant has a history of stroke
Participant has a history of thromboembolic event(s)
Participant has systemic lupus erythematosus
Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
Participant has migraine with aura
Participant has unexplained vaginal bleeding
Participant has diabetes
Participant has a strong family history of breast cancer
Participant has cervical cancer or a history of cervical cancer
Participant has severe cirrhosis (decompensated) or liver tumors
Participant has known significant renal disease
Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
Participant is currently using hormonal contraception
Participant had an injection of DMPA (Depo-Provera CI or Depo-subQ 104) in the past 12 months; or combined injectable in the last 3 months
Participant is chronically using pain medication

Participant has a plan to move to another location in the next 18 months

Additional criteria apply, please contact the investigator for more information
Intervention: Medroxyprogesterone acetate
Trial phase: Phase 1
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Participants received TV-46046 saline-diluted (60 mg/0.3 mL of 200 mg/mL) SC injection as a test formulation.
Eligibility criteria:
Inclusion Criteria:

Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device [IUD], or consistent use of condoms)
Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
Participant had a normal mammogram within the last year, if 40 years or older

Participant has no skin disorders or skin allergies

Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Participant has hypertension
Participant has ischemic heart disease or a history of ischemic heart disease
Participant has a history of stroke
Participant has a history of thromboembolic event(s)
Participant has systemic lupus erythematosus
Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
Participant has migraine with aura
Participant has unexplained vaginal bleeding
Participant has diabetes
Participant has a strong family history of breast cancer
Participant has cervical cancer or a history of cervical cancer
Participant has severe cirrhosis (decompensated) or liver tumors
Participant has known significant renal disease
Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
Participant is currently using hormonal contraception
Participant had an injection of DMPA (Depo-Provera CI or Depo-subQ 104) in the past 12 months; or combined injectable in the last 3 months
Participant is chronically using pain medication

Participant has a plan to move to another location in the next 18 months

Additional criteria apply, please contact the investigator for more information
Intervention: Medroxyprogesterone acetate
Trial phase: Phase 1
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Participants received Depo-subQ 104 (medroxyprogesterone acetate injectable suspension; 104 mg/0.65 mL) SC injection as a reference formulation.
Eligibility criteria:
Inclusion Criteria:

Participant has a low risk of pregnancy (that is, sterilized, in exclusively same-sex partnership, in menopause and/or post-menopausal, abstinent, in a monogamous relationship with vasectomized partner, using nonhormonal intrauterine device [IUD], or consistent use of condoms)
Participant is not pregnant and does not have desire to become pregnant in the subsequent 18 months
Participant had a normal mammogram within the last year, if 40 years or older

Participant has no skin disorders or skin allergies

Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

Participant has hypertension
Participant has ischemic heart disease or a history of ischemic heart disease
Participant has a history of stroke
Participant has a history of thromboembolic event(s)
Participant has systemic lupus erythematosus
Participant has rheumatoid arthritis and is undergoing immunosuppressive therapy
Participant has migraine with aura
Participant has unexplained vaginal bleeding
Participant has diabetes
Participant has a strong family history of breast cancer
Participant has cervical cancer or a history of cervical cancer
Participant has severe cirrhosis (decompensated) or liver tumors
Participant has known significant renal disease
Participant has a history of diagnosed clinical depression or bipolar disorder, with or without suicidal ideation, and/or history of suicide attempt
Participant is currently using hormonal contraception
Participant had an injection of DMPA (Depo-Provera CI or Depo-subQ 104) in the past 12 months; or combined injectable in the last 3 months
Participant is chronically using pain medication

Participant has a plan to move to another location in the next 18 months

Additional criteria apply, please contact the investigator for more information
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.

Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Eligibility criteria:
Inclusion Criteria:

age between 18-85 years
males or females
plastic surgery for abdominally-based free flap breast reconstruction.

Exclusion Criteria:

those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
those with anatomic contra-indications to performing a TAP block
those unwilling to participate in follow-up assessments
vulnerable populations
chronic pain or associated diagnosis
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 4
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.

Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
Eligibility criteria:
Inclusion Criteria:

age between 18-85 years
males or females
plastic surgery for abdominally-based free flap breast reconstruction.

Exclusion Criteria:

those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
those with anatomic contra-indications to performing a TAP block
those unwilling to participate in follow-up assessments
vulnerable populations
chronic pain or associated diagnosis
Intervention: Bupivacaine
Trial phase: Phase 3
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: LB (Liposomal Bupivacaine) group - This group will be receiving 20ml EXPAREL (266mg) and 40ml of 0.125% bupivacaine in total, 30ml on each side.

For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.

liposomal Bupivacaine: 20mL liposomal bupivacaine are injected into the liposomal bupivacaine group
Eligibility criteria:
Inclusion criteria:

Patients undergoing colorectal surgery at Indiana University Hospital
American Society of Anesthesiologists (ASA) class 1, 2, 3 or 4
Age 18 or older, male or female
Desires Regional anesthesia for postoperative pain control

Exclusion criteria:

Any contraindication for QL block.
History of substance abuse in the past 6 months.
Patients on more than 30mg morphine equivalents of opioids daily.
Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine).
Postoperative intubation.
Any BMI greater than 40.0.
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 3
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: SB (Standard Bupivacaine) group - This group will be receiving 60ml of 0.25% bupivacaine in total, 30ml on each side.

For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane.

Bupivacaine Hydrochloride: 40ml of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group.

60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group
Eligibility criteria:
Inclusion criteria:

Patients undergoing colorectal surgery at Indiana University Hospital
American Society of Anesthesiologists (ASA) class 1, 2, 3 or 4
Age 18 or older, male or female
Desires Regional anesthesia for postoperative pain control

Exclusion criteria:

Any contraindication for QL block.
History of substance abuse in the past 6 months.
Patients on more than 30mg morphine equivalents of opioids daily.
Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine).
Postoperative intubation.
Any BMI greater than 40.0.
Intervention: Flutriciclamide F-18
Trial phase: Phase 2
SMILES: CCN(CC)C(=O)[C@H]1CCCc2c1c1c(OC)cccc1n2CC[18F]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Control Group

GE180 PET Scan, 2 μg/mL IV, 185MBq
Eligibility criteria:
Inclusion Criteria:

Be enrolled in CNTN
Aged 55 to 90
Available study partners
Willing and able to participate in longitudinal follow-up study
For MCI patients, fit criteria based in Movement Disorders Task Force or NIA

Exclusion Criteria:

Significant neurological disorders other than AD or PD;
Unstable medical conditions
History of major psychiatric diseases
MRI evidence of infarction or other focal lesion or multiple lacunes
Clinically significant abnormalities in B12 or TSH
Identified as having a common polymorphism (rs6971) in the TSPO gene which has been shown to reduce binding affinity of tracers similar to GE180. This testing will be done as part of their CNTN participation.
Intervention: Flutriciclamide F-18
Trial phase: Phase 2
SMILES: CCN(CC)C(=O)[C@H]1CCCc2c1c1c(OC)cccc1n2CC[18F]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Mild Cognitive Impairment

GE180 PET Scan, 2 μg/mL IV, 185MBq
Eligibility criteria:
Inclusion Criteria:

Be enrolled in CNTN
Aged 55 to 90
Available study partners
Willing and able to participate in longitudinal follow-up study
For MCI patients, fit criteria based in Movement Disorders Task Force or NIA

Exclusion Criteria:

Significant neurological disorders other than AD or PD;
Unstable medical conditions
History of major psychiatric diseases
MRI evidence of infarction or other focal lesion or multiple lacunes
Clinically significant abnormalities in B12 or TSH
Identified as having a common polymorphism (rs6971) in the TSPO gene which has been shown to reduce binding affinity of tracers similar to GE180. This testing will be done as part of their CNTN participation.
Intervention: Flutriciclamide F-18
Trial phase: Phase 2
SMILES: CCN(CC)C(=O)[C@H]1CCCc2c1c1c(OC)cccc1n2CC[18F]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Alzheimer's Disease

GE180 PET Scan, 2 μg/mL IV, 185MBq
Eligibility criteria:
Inclusion Criteria:

Be enrolled in CNTN
Aged 55 to 90
Available study partners
Willing and able to participate in longitudinal follow-up study
For MCI patients, fit criteria based in Movement Disorders Task Force or NIA

Exclusion Criteria:

Significant neurological disorders other than AD or PD;
Unstable medical conditions
History of major psychiatric diseases
MRI evidence of infarction or other focal lesion or multiple lacunes
Clinically significant abnormalities in B12 or TSH
Identified as having a common polymorphism (rs6971) in the TSPO gene which has been shown to reduce binding affinity of tracers similar to GE180. This testing will be done as part of their CNTN participation.
Intervention: Flutriciclamide F-18
Trial phase: Phase 2
SMILES: CCN(CC)C(=O)[C@H]1CCCc2c1c1c(OC)cccc1n2CC[18F]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Parkinson's Disease

GE180 PET Scan, 2 μg/mL IV, 185MBq
Eligibility criteria:
Inclusion Criteria:

Be enrolled in CNTN
Aged 55 to 90
Available study partners
Willing and able to participate in longitudinal follow-up study
For MCI patients, fit criteria based in Movement Disorders Task Force or NIA

Exclusion Criteria:

Significant neurological disorders other than AD or PD;
Unstable medical conditions
History of major psychiatric diseases
MRI evidence of infarction or other focal lesion or multiple lacunes
Clinically significant abnormalities in B12 or TSH
Identified as having a common polymorphism (rs6971) in the TSPO gene which has been shown to reduce binding affinity of tracers similar to GE180. This testing will be done as part of their CNTN participation.
Intervention: Betamethasone
Trial phase: Phase 4
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: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Dexamethasone IV for PO solution mixed with sugar syrup to be given orally

Dexamethasone IV for PO: Common pediatric emergency department practice
Eligibility criteria:
Inclusion Criteria:

Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department
Age 1 to 7 years
Dexamethasone treatment indicated
No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis)
Have not received systemic corticosteroid for current episode prior to enrollment

Exclusion Criteria:

Allergy to dexamethasone or apple sauce and pudding
Unable to take medication orally
Intervention: Betamethasone
Trial phase: Phase 4
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: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Dexamethasone tablet crushed and placed in apple sauce or pudding to be given orally

Dexamethasone crushed tablets: Alternative route of administration for patients unable to swallow tablet whole
Eligibility criteria:
Inclusion Criteria:

Diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the Vanderbilt Children's Hospital Emergency Department
Age 1 to 7 years
Dexamethasone treatment indicated
No other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis)
Have not received systemic corticosteroid for current episode prior to enrollment

Exclusion Criteria:

Allergy to dexamethasone or apple sauce and pudding
Unable to take medication orally