anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Bivalirudin
Trial phase: Phase 4
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours (Hydrocortisone as sodium succinate, vial, equivalent to hydrocortisone 100mg, Egyptian INT, Pharmaceutical Industries CO. ARE,EIPICO.EGYPT).

hydrocortisone 100mg.: Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours
Eligibility criteria:
Inclusion Criteria:

aged 18-50 years old.
both sex.
ASA physical status I and II.
70-90 kg body weight.
height 160-180 cm.
Elective lower abdominal and pelvic surgery e.g. repair of inguinal hernia, repair of incisional hernia, varicocele and hydrocele.

Exclusion Criteria:

Patients with impaired kidney or liver functions.
history of cardiac or central nervous system disease.
uncontrolled medical disease (diabetes mellitus and hypertension)
history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery
allergy to the used medications
patient's refusal
duration of surgery more than 120 minutes.
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 17
Group description: General anesthesia for ECT will be induced with ketamine, approximately 2 mg/kg (1-2.5 mg/kg). Following application of stimulation electrodes to the patients scalp, no ECT charge will be administered.
Eligibility criteria:
Inclusion Criteria:

Treatment resistant depression requiring outpatient ECT
Planned right unilateral ECT stimulation
English speaking
Able to provide written informed consent

Exclusion Criteria:

Known brain lesion or neurological illness that causes cognitive impairment
Schizophrenia
Schizoaffective disorder
Blindness or deafness or motor impediments that may impair performance for cognitive testing battery
Inadequate ECT seizure duration with etomidate
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Group 3: Placebo dosed as per regimen 1.

Saline (0.9% NaCl): Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
Eligibility criteria:
Inclusion Criteria:

Provision of signed, written informed consent prior to participation in any study-related procedures.
Good general health as evidenced by medical history.
Between 18 and 85 years of age at time of informed consent signature.
Male or female.
Minimum of 18 teeth, excluding third molars.
Having moderate to severe periodontal disease according to AAP definition (at least 6 teeth ≥6 mm PD and ≥3 mm CAL at baseline).
Having >30 percent bleeding sites upon probing.
Willing to abstain from chewing gums and other mouth rinses for the study duration.
Ability and willingness to attend all study visits and comply with all study visits and comply with all study procedures and requirements.
Willingness to abstain from routine dental care.
For women with reproductive potential, willingness to use highly effective contraception (e.g. licensed hormonal contraception, intrauterine device, abstinence, or vasectomy in partner).

Exclusion Criteria:

Presence of orthodontic appliances.
A soft or hard tissue tumor of the oral cavity.
Any dental condition that requires immediate treatment, such as carious lesions.
Participation in any other clinical study within 30 days of screening or during the study.
Pregnancy or lactation. If a subject meets this criterion, she may be rescreened for study participation when she no longer meets this criterion.
Antibiotic therapy within the last 30 days.
Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti inflammatory drugs, steroids). Low-dose aspirin (less than 325 mg daily) is allowed.
Immunocompromised subjects.
Subjects with cancer or a history of cancer within the last 5 years of screening.
Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as diabetes, nifedipine, phenytoin (Dilantin), or anticoagulant medications (e.g., warfarin [Coumadin] etc.).
Involvement in the planning or conduct of the study.
History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or interfere with interpretation of the subject's study results.
Previous randomization for treatment in the present study
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: No
Participants at risk: 108
Group description: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.

Liposomal bupivacaine: Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Eligibility criteria:
Inclusion Criteria:

Degenerative changes of the shoulder joint (documented by radiographs) in patients planning total joint replacement with one of the study's four fellowship-trained orthopaedic surgeons.
Patients who require revision surgeries, hemiarthroplasties, or who have chronic pain issues will be included.

Exclusion Criteria:

Allergy to liposomal bupivacaine
Contraindications to the interscalene nerve block such as:
Preexisting neurologic defects
Local anesthetic allergy
Coagulopathy
Contralateral phrenic nerve dysfunction
Severe chronic obstructive pulmonary disease
Intervention: ASCORBIC ACID
Trial phase: Phase 1
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Intravenous ascorbic acid 50 mg/kg in 50 mL normal saline every six hours for 48 hours.

Ascorbic Acid: Comparing safety and efficacy of IV Vitamin C in CABG patients

4 subjects total

Age: Between 32 and 72

1 Female 3 Male

1 Black or African American/Non-Hispanic 3 White/Non-Hispanic

Region of enrollment: USA No Adverse Events
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years
Scheduled for elective non-emergent valve repair or replacement, or multi-vessel CABG surgery
No known coagulopathy prior to surgery

Exclusion Criteria:

Emergency cardiac surgery
Ejection fraction < 35%
Presence of autoimmune disease or currently receiving immunosuppressant therapy
History of renal calculi
Renal dysfunction (pre-operative creatinine clearance < 40 mL/min, or serum creatinine greater than 1.8 mg/dl)
Known bleeding diathesis
Active infection, cancer or tumor
Prior history of atrial fibrillation
Single CABG procedure (one involved coronary vessel)
Prisoner
Pregnant
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Drug: FX006 Single intra-articular injection

FX006 32 mg
Eligibility criteria:
Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female ≥40 years of age
Type 2 diabetes mellitus for at least 1 year prior to Screening and not managed with injectable agents (e.g. insulin or insulin analogs, exenatide, pramlintide, liraglutide)
Currently treated with 1 or 2 oral agents for diabetes, with stable doses for at least 2 months
HbA1c ≥6.5% and ≤ 9.0%
Currently meets American College of Rheumatology (ACR) Criteria (clinical or radiological) for OA.
Symptoms associated with OA of the knee for ≥ 6 months prior to Screening
Index knee pain on most days (>15) over the last month (as reported by the patient)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of protocol-specified restricted medications during the study
Willingness to wear a CGM device uninterrupted for 24 hours per day throughout the study, remain with receiving range and comply with calibration requirements
Accustomed to using a Standard Blood Glucose Measuring device by finger stick

Exclusion Criteria:

Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or arthritis associated with inflammatory bowel disease
History of infection in the index knee joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
Presence of surgical hardware or other foreign body in the index knee
Unstable joint (such as a torn anterior cruciate ligament) within 12 months of screening
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Use of acetaminophen, or acetaminophen containing products
Current use of a continuous glucose monitoring device
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Drug: TCA IR Single intra-articular injection

TCA IR 40 mg
Eligibility criteria:
Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female ≥40 years of age
Type 2 diabetes mellitus for at least 1 year prior to Screening and not managed with injectable agents (e.g. insulin or insulin analogs, exenatide, pramlintide, liraglutide)
Currently treated with 1 or 2 oral agents for diabetes, with stable doses for at least 2 months
HbA1c ≥6.5% and ≤ 9.0%
Currently meets American College of Rheumatology (ACR) Criteria (clinical or radiological) for OA.
Symptoms associated with OA of the knee for ≥ 6 months prior to Screening
Index knee pain on most days (>15) over the last month (as reported by the patient)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of protocol-specified restricted medications during the study
Willingness to wear a CGM device uninterrupted for 24 hours per day throughout the study, remain with receiving range and comply with calibration requirements
Accustomed to using a Standard Blood Glucose Measuring device by finger stick

Exclusion Criteria:

Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or arthritis associated with inflammatory bowel disease
History of infection in the index knee joint
Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
Presence of surgical hardware or other foreign body in the index knee
Unstable joint (such as a torn anterior cruciate ligament) within 12 months of screening
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
IV or intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Use of acetaminophen, or acetaminophen containing products
Current use of a continuous glucose monitoring device
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Four subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of Exendin-9,39 or normal saline.

Normal Saline: subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called "incretins" that are produced by the gut in health and in larger quantities after gastric bypass surgery.
Eligibility criteria:
Inclusion Criteria:

Age 20-65 years of age.
Seen at Mayo Clinic Nutrition Clinic and have received authorization for RYGB surgery.
Type 2 Diabetes Mellitus or impaired fasting glucose with BMI >35 AND not interested in surgery but are interested in supervised caloric restriction.

Exclusion Criteria:

Previous treatment with thiazolidinediones.
Chronic antibiotic therapy.
Active microvascular or macrovascular complications of diabetes.
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 2
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Bupivacaine HCI, 50 mg via injection.
Eligibility criteria:
Inclusion Criteria:

Be male or female 18 years of age or older

Female subjects are eligible only if all of the following apply:

Not pregnant (female subject of child bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before surgery)
Not lactating
Not planning to become pregnant while participating in the study
Be surgically sterile; or be at least two years post-menopausal; or have a monogamous partner who is surgically sterile; or be practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening visits and commits to the use of an acceptable form of birth control for the duration of the study and for 30 days from completion of the study
Male subjects must be surgically sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of study medication
Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair, without collateral procedures, under regional anesthesia
Subject has not had a contralateral bunionectomy in the non-study foot in the past 3 months
Have the ability and be willing to comply with the study procedures.
Must be able to understand study procedures and give informed consent for the conduct for all study procedures, using an IRB approved consent form

Exclusion Criteria:

Unwilling to sign informed consent or not willing or able to complete all study procedures
Have a contraindication or be allergic to any medication to be used during the trial period
Have clinically significant cardiac abnormalities that, in the opinion of the investigator, would pose a health risk to the subject
Have American Society of Anesthesiologists (ASA) Physical Status classification system category ≥4
Have clinically significant renal or hepatic abnormalities: for example, AST or ALT > 3x ULN, creatinine > 2x ULN
Have another pre-existing painful condition that may confound pain assessments
Have another surgery planned within 30 days of procedure
Have a known or suspected history of alcohol or drug abuse, or a positive drug screen
Currently taking analgesics for a chronically painful condition, or has taken long acting opioids within 3 days of surgery, or taken any opioids within 24 hours of scheduled surgery for this study
Subjects with documented sleep apnea or are on home continuous positive airway pressure (CPAP)
Subjects who are receiving oxygen therapy at the time of screening
Have participated in a clinical trial within 30 days of planned surgery
Intervention: Acthargel
Trial phase: Phase 4
SMILES: CSCCC(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(N)CO)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(Cc1ccccc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NCC(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)N1CCCC1C(=O)NC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)N1CCCC1C(=O)NC(CC(N)=O)C(=O)NCC(=O)NC(C)C(=O)NC(CCC(=O)O)C(=O)NC(CC(=O)O)C(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)NC(C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(Cc1ccccc1)C(=O)N1CCCC1C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)O)C(C)C)C(C)C)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.

H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly
Eligibility criteria:
Inclusion Criteria:

Subject has the ability to understand and sign the informed consent document
Subject is 18 years of age or older
Subject can be male or female
Subject has negative Purified Protein Derivative (Tuberculosis skin test) or quantiferon TB Gold Test (blood test for TB) testing done in 3 months
Subject has active ocular inflammation in at least one eye
Subject has visual acuity in at least one eye of 20/400 or better.
Subject has a history of glaucoma or has actively treated glaucoma
Subject is willing and able to comply with the study procedures
Female subjects of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must be willing to undergo pregnancy testing throughout the study

Exclusion Criteria:

Subject has any ocular infection
Subject has any systemic infection
Participant has documented immunocompromised or immune-incompetent state
Subject has any ocular co-morbidity than prevents assessment of intraocular inflammation
Subject has had any intra-ocular surgery in previous 6 weeks
Subject has any planned elective surgery ocular or systemic during study duration
Subject is pregnant or breast-feeding
Subject had a recent vaccination with live or attenuated vaccines
Subject has a sensitivity to Porcine derived proteins
Subject has a medical history which is a contraindication to receiving H.P. Acthar
Intervention: Minocycline
Trial phase: Not Applicable
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: CRP =/< 3
Eligibility criteria:
Inclusion Criteria:

Patients with Bipolar Disorder and current depressive symptoms
Hamilton Depression Scale score > 18
Failed an adequate trial of at least one antidepressant or mood stabilizer of at least 4 weeks duration. Medication history will be recorded using the Antidepressant Treatment History Form
18 years or older
Fluent in English or Arabic
Have the capacity to understand the nature of the study and sign the written informed consent.

Exclusion Criteria:

A current diagnosis of Schizophrenia or other psychotic disorder, or Dementia Alzheimer Type or related cognitive disorders.
Principal diagnosis of Post-Traumatic Stress Disorder, Anorexia or Bulimia Nervosa, Obsessive-Compulsive Disorder. We define principal as the most pressing clinical problem.
Pregnant or nursing
Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder (defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
Patients who currently meet criteria for Alcohol or other Substance-Related Dependence Disorder (with the exception of nicotine dependence) who require detoxification.
Patients who are unable to read and write English or Arabic.
Patients having serious, unstable or terminal medical or neurologic illness that would compromise study participation (i.e., metastatic or advanced malignancy, chronic renal failure requiring dialysis, recent myocardial infarction or unstable angina, or "end stage" chronic obstructive pulmonary disease). People with common conditions such as hypertension, insulin dependent diabetes mellitus, asthma, compensated congestive heart failure, a malignancy in remission, treated hypothyroidism, or epilepsy will not be excluded from participation.
Autoimmune disease or chronic inflammatory diseases such as psoriasis or Crohn's disease
Chronic infection such as hepatitis B or C or HIV
Elevated antinuclear antibody or rheumatoid factor
Oral glucocorticoids in the past 6 months
Methotrexate or NSAID use in the past two weeks