anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Plecanatide
Trial phase: Phase 2
ATC code: A06AX07
SMILES: CC(C)CC(NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(NC(=O)C(CCC(=O)O)NC(=O)C(CC(=O)O)NC(=O)C(N)CC(N)=O)CSSCC(NC(=O)C(C)NC(=O)C(C(C)C)NC(=O)C(CC(N)=O)NC(=O)C(C(C)C)NC2=O)C(=O)NC(C(C)O)C(=O)NCC(=O)N1)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Taken orally once daily in the morning for 8 weeks

Plecanatide
Eligibility criteria:
Key Inclusion Criteria:

Male or female adolescents 12 to less than 18 years of age.
Diagnosed with CIC based on the Rome III criteria for child/adolescent functional constipation (Appendix A).
Patient is able to voluntarily provide written, signed, and dated (personally and via a legally authorized representative [LAR]) assent/informed consent as applicable to participate in the study.
Subject's parent/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures (e.g., accept venipuncture, willing and able to swallow tablets, accept urine drug screen for opiates) and restrictions.

Key Exclusion Criteria:

The patient has a mental age <4 years in the investigator's opinion.
The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation.
The patient currently requires iron supplements, amitriptyline, or other tricyclic antidepressants for depression, opioid-containing medications or compounds for pain, or has other conditions that require medications known to cause constipation. A patient with an onset of constipation prior to the use of these medications and who has been on a stable dose for at least 8 weeks prior to Screening might be considered eligible for this study if the investigator deems these medications do not significantly contribute to the patient's constipation. Screening of these patients needs to be approved by the medical monitor and the sponsor.

The patient, if female of childbearing potential (defined as postmenarche), does not agree to practice 1 of the following medically acceptable methods of birth control throughout the study:

Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient's usual menstrual cycle period) before study drug administration.
Total abstinence from sexual intercourse since the last menses before study drug administration.
Intrauterine device.
Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream.
The patient follows a diet not considered normal by the investigator for the patient's age, relative to variety of food, caloric content, and quantity. The patient must have been on a stable diet for at least 30 days weeks prior to Screening.
The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion.
The patient has a history of an eating disorder.
Intervention: Ethanol
Trial phase: Phase 4
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Venous blood will be drawn from the patient receiving injection treatment. It will be spun down to form PRP and reinjected back into the SI joint.

Platelet Rich Plasma Joint Injection: 30 to 50 milliliters of venous blood will be drawn from the patients arm with a 19 gauge ¾ inch needle using universal precautions. The venous blood will be mixed with 8 milliliters of anticoagulant citrate dextrose solution-A (ACD-A). The anti-coagulated blood will then be centrifuged for 15 minutes at 3200 revolutions per minute in the office centrifuge. This will allow plasma to separate from blood cells. The portion of centrifuged blood deficient in platelets will be extracted and discarded. Once the needle is visualized entering the joint capsule via ultrasound guidance and the physician feels resistance provided by the capsule and ligaments, 3 milliliters of PRP extract will be injected (3 inch, 22 gauge needle) into the sacroiliac joint. The needles will be properly disposed.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of sacroiliitis
Age 18 to 80 years old
Chronic low back pain
SI joint pathology is the predominant source of pain
Positive Fortin Finger Test (PMT)
Joint anatomy is identifiable using ultrasonography
Patient has no other comorbidities that contraindicate the procedure
Patient has attempted physical therapy and corticosteroid injections with local anesthetic -Previous injections of lidocaine and corticosteroid provided at least minor immediate relief
Patient must not have had a corticosteroid injection in the SI joint within the last three months
Patient must consent to the procedure

Exclusion Criteria:

Patients under the age of 18 (Subjects under the age of 18 will not be included in this study due to the continued growth and development of their joints and unstudied effects on children.)
Over the age of 80
Multiple pain sources and multifactorial pain sources that complicated or confound diagnosing the SI joint as the primary and predominant pain generator that may contribute to low back pain (including but not limited to: lumbar diagnosis, lumbar radiculopathy, intra or extra-articular hip pathology to include acetabulum and femoral head, lumbo-sacral joint pathology, intervertebral disk disease, spondylolisthesis/spondylosis/spondylolysis of lumbar vertebra)
Immunosuppressed/immune compromised
Underlying comorbidities that contraindicate the procedure (including but not limited to polycythemia, coagulation disorder, or malignancy).
Intervention: Bupivacaine
Trial phase: Phase 2
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Stellate Ganglion Block Injection with bupivicaine

Stellate Ganglion Block injection with bupivicaine: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.
Eligibility criteria:
Inclusion Criteria:

Hispanic or Spanish speaking women aged 30 to 70 years
28 or more reported moderate-to-very severe hot flashes per week
a minimum of two weeks of VMS diary recording prior to SGB
current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer indication for at last six months
willingness to undergo fluoroscopy-guided SGB or sham treatment.
if participant is on an SSRI,SNRI or membrane stabilizer (pregabalin, gabapentin, for example), it must be a stable, unchanged dose for previous 3 months

Exclusion Criteria:

1. conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; goiter, cardiac/pulmonary compromise; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye); pregnancy 2. use of treatments in the past 2 months that can affect VMS (e.g., use of oral or transdermal HT or contraceptives,

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Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Saline injection

Saline: sham injection with saline
Eligibility criteria:
Inclusion Criteria:

Hispanic or Spanish speaking women aged 30 to 70 years
28 or more reported moderate-to-very severe hot flashes per week
a minimum of two weeks of VMS diary recording prior to SGB
current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer indication for at last six months
willingness to undergo fluoroscopy-guided SGB or sham treatment.
if participant is on an SSRI,SNRI or membrane stabilizer (pregabalin, gabapentin, for example), it must be a stable, unchanged dose for previous 3 months

Exclusion Criteria:

1. conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; goiter, cardiac/pulmonary compromise; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye); pregnancy 2. use of treatments in the past 2 months that can affect VMS (e.g., use of oral or transdermal HT or contraceptives,

-
Intervention: Thalidomide
Trial phase: Phase 4
ATC code: L04AX02
SMILES: O=C1CCC(N2C(=O)c3ccccc3C2=O)C(=O)N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 20
Group description: SLE/cutaneous lupus with thalidomide arm (12 months).
Eligibility criteria:
Thalidomide subproject:

Inclusion Criteria:

SLE diagnosis according to 1997 ACR criteria
Active and refractory cutaneous lupus lesions
Male gender (using contraceptive barrier method) or confirmed infertility for female gender
Normal electroneuromyography at study entry

Exclusion Criteria:

Alcoholism
History of peripheral neuropathy
Previous history of thrombophilia or positive antiphospholipid antibodies
Renal and/or central nervous system and/or hematological activity

HCQ reduced subproject:

Inclusion Criteria:

SLE diagnosis according to 1997 ACR criteria
Use of hydroxychloroquine (5 to 6.5mg/kg/day) for ≥5 years
SLEDAI-2K <4

Exclusion Criteria:

Alcoholism
Renal dialysis
Concomitant infectious process
Acute and chronic liver diseases
Concomitant use of some drugs that interact with HCQ (cimetidine, antacids, digoxin, aminoglycosides, penicillamine, neostigmine, pyridostigmine)
Signs of Retinopathy

HCQ high subproject:

Inclusion Criteria:

SLE diagnosis according to 1997 ACR criteria
No use of hydroxychloroquine for ≥ 6 months
LES/LESJ in activity (SLEDAI≥6)

Exclusion Criteria:

Alcoholism
Renal dialysis
Concomitant infectious process
Acute and chronic liver diseases
Concomitant use of some drugs that interact with HCQ (cimetidine, antacids, digoxin, aminoglycosides, penicillamine, neostigmine, pyridostigmine)
Signs of Retinopathy
Intervention: Humulene
Trial phase: Phase 1
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Single acute administration of placebo cannabis baked into a brownie
Eligibility criteria:
Inclusion Criteria:

Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission
Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
Have a body mass index (BMI) in the range of 19 to 36 kg/m2
Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
Report prior experience inhaling cannabis (either via smoking or vaporization).

Exclusion Criteria:

History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
Use of an Over-the-Counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of hemp seeds or hemp oil in any form in the past 3 months.
Use of dronabinol (Marinol) within the past 6 months.
History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Abnormal EKG result that in the investigator's opinion is clinically significant.
Epilepsy or a history of seizures.
Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing
Intervention: Humulene
Trial phase: Phase 1
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Single acute administration of cannabis containing 10mg THC baked into a brownie
Eligibility criteria:
Inclusion Criteria:

Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission
Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
Have a body mass index (BMI) in the range of 19 to 36 kg/m2
Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
Report prior experience inhaling cannabis (either via smoking or vaporization).

Exclusion Criteria:

History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
Use of an Over-the-Counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of hemp seeds or hemp oil in any form in the past 3 months.
Use of dronabinol (Marinol) within the past 6 months.
History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Abnormal EKG result that in the investigator's opinion is clinically significant.
Epilepsy or a history of seizures.
Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing
Intervention: Humulene
Trial phase: Phase 1
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Single acute administration of cannabis containing 25mg THC baked into a brownie
Eligibility criteria:
Inclusion Criteria:

Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission
Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
Have a body mass index (BMI) in the range of 19 to 36 kg/m2
Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
Report prior experience inhaling cannabis (either via smoking or vaporization).

Exclusion Criteria:

History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
Use of an Over-the-Counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of hemp seeds or hemp oil in any form in the past 3 months.
Use of dronabinol (Marinol) within the past 6 months.
History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Abnormal EKG result that in the investigator's opinion is clinically significant.
Epilepsy or a history of seizures.
Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing
Intervention: Humulene
Trial phase: Phase 1
SMILES: CC1=CCCC(C)=CCC(C)(C)C=CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Single acute administration of placebo cannabis via commercial vaporizer
Eligibility criteria:
Inclusion Criteria:

Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission
Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.
Have a body mass index (BMI) in the range of 19 to 36 kg/m2
Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
Report prior experience inhaling cannabis (either via smoking or vaporization).

Exclusion Criteria:

History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
Use of an Over-the-Counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
Use of hemp seeds or hemp oil in any form in the past 3 months.
Use of dronabinol (Marinol) within the past 6 months.
History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
Abnormal EKG result that in the investigator's opinion is clinically significant.
Epilepsy or a history of seizures.
Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing