anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Temozolomide
Trial phase: Not Applicable
ATC code: L01AX03
SMILES: Cn1nnc2c(C(N)=O)ncn2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group.

Fractionated Radiation: Standard of care fractionated radiation therapy will be given to the tumor.

Temozolomide: Standard of care temozolomide will be given along with radiation therapy

MRI: Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed glioma, based on pathology confirmation;
At least 8 cm3 of residual enhancing tumor after surgery or significant visible tumor (As seen on immediate postoperative scan);
Scheduled to receive standard fractionated RT with concomitant temozolomide therapy;
Karnofsky Performance Score > 60.

Exclusion Criteria:

Scheduled to receive investigational chemotherapy, immunotherapy, or any other investigational agents;
Placement of GLIADEL® wafer in the resection cavity;
Significant amount of hemorrhage within the resection cavity (seen on immediate post-operative scan);
A large peritumoral infraction related to surgery (identified by new confluent diffusion restriction);
Not suitable to undergo MRI or use the MRI contrast agent (GFR<30 mL/min/1.73 m2); or the patient has known anaphylactic reaction to gadolinium based contrast agents.
Presence of serious systemic illness, including: uncontrolled infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might impact the survival endpoint of the study or limit compliance with study requirements.
Intervention: BENZOYL PEROXIDE
Trial phase: Phase 2
ATC code: D10AE01 | D10AE51
SMILES: O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 144
Group description: Component B

IDP-126 Component B: Component B
Eligibility criteria:
Inclusion Criteria:

Male or female at least 9 years of age and older.
Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit).
Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.
Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20, but no more than 100.
Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 30, but no more than 150.
Subjects with 2 or fewer facial nodules

Exclusion Criteria:

Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema.
Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
Subjects with a facial beard or mustache that could interfere with the study assessments.
Subjects with more than 2 facial nodules.
Evidence or history of cosmetic-related acne.
Intervention: ISOSORBIDE MONONITRATE
Trial phase: Phase 4
ATC code: C01DA14
SMILES: [H][C@]12OC[C@@H](O[N+](=O)[O-])[C@@]1([H])OC[C@@H]2O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 176
Group description: Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris[1] and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur,

Monoket Pill: Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor
Eligibility criteria:
Inclusion Criteria:

Women older than 18 years at the time of induction of labor with the ability to give informed consent
Induction of labor for clinical diagnosis of preeclampsia
Unfavorable cervix (Bishop's score of less than 6)
Cervical dilation 2cm or less
Singleton
Gestational age ≥ 24 weeks
English speaking

Exclusion Criteria:

• Contraindication to vaginal delivery

Contraindication to misoprostol
Fetal Demise
Major fetal anomaly
Non-english speaking women
HIV
Medical conditions requiring assisted second stage
Category III tracing
Eclampsia
Hemolysis Elevated Liver enzymes Low Platelets syndrome
DIC or active hemorrhage before randomization
Hypersensitivity to isosorbide mononitrate
Isosorbide mononitrate should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), or hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g following a head trauma and including cerebral hemorrhage.
Isosorbide mononitrate should not be used in patients with severe anemia, severe hypotension, closed angle glaucoma or severe hypovolaemia.
Isosorbide mononitrate tablets contain lactose and therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Intervention: Maraviroc
Trial phase: Phase 2 | Phase 3
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Maraviroc 300 mg daily for 60 days, plus receive rehabilitation therapy as prescribed by the doctors and via telerehabilitation.
Eligibility criteria:
Inclusion Criteria:

Transfer to inpatient rehabilitation within 4 weeks of stroke onset
Single ischemic or subcortical hemorrhagic infarct;
At the time of randomization, hemiparesis with 4/5 or less strength at the hip and ankle flexors and extensors
Functional Independence Measure (FIM) score for ambulation ≥3 to walk at least 10 steps;
Caregiver available for at least two hours a day for practice and transportation when needed;
Adequate language skills to read and understand the Informed Consent and retain information during daily therapies.

Exclusion Criteria:

Prior stroke with persisting motor impairment or disability;
Limited resources or illness that will not enable a return to living outside of a facility;
Any medical condition that had limited daily physical activity to walking no more than 2 blocks outdoors prior to the stroke (e.g., claudication, congestive heart failure or lower extremity pain);
History of dementia or Mini Mental State Examination score <24;
History of hepatitis or elevated hepatic transaminases or bilirubin;
History of renal insufficiency or serum creatinine over 1.6;
Cancer or other chronic illness that makes 3-year survival unlikely or will detract from the ability to carry out exercise and skills practice.
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: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.

Bupivacaine: Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
Eligibility criteria:
Inclusion Criteria:

patients who require major lower extremity amputations

Exclusion Criteria:

less than 18 years old, pregnant, emergency amputation, staged amputation, amputations performed by non-vascular surgeons, patients who are allergic to bupivacaine, patients who are unable to communicate symptoms of pain
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.

Saline Solution: Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
Eligibility criteria:
Inclusion Criteria:

patients who require major lower extremity amputations

Exclusion Criteria:

less than 18 years old, pregnant, emergency amputation, staged amputation, amputations performed by non-vascular surgeons, patients who are allergic to bupivacaine, patients who are unable to communicate symptoms of pain
Intervention: Apremilast
Trial phase: Phase 2
ATC code: L04AA32
SMILES: CCOc1cc([C@@H](CS(C)(=O)=O)N2C(=O)c3cccc(NC(C)=O)c3C2=O)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.
Eligibility criteria:
Inclusion Criteria:

Male or female volunteers, 18-65 years of age
Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity (AUD-MS)
In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females) per week.
Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues
Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
Negative BAC and a CIWA score of < 9 at time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures.
In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, EKG, routine urine and blood chemistry.
Females with childbearing potential must have a negative pregnancy test on the screening, randomization, and lab session visits and agree to use effective birth control for the duration required by a given study.
Able to provide informed consent and understand questionnaires and study procedure
Willing to comply with the provisions of the protocol and take daily oral medication.

Exclusion Criteria:

Active suicidal ideation, as systematically assessed with the Columbia Suicide Severity Rating Scale.
Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety disorders or substance use disorders other than alcohol or nicotine
Has a urine drug screen (UDS) positive for substances of abuse other than alcohol.
Significant medical disorders that will increase potential risk or interfere with study participation as determined by the study physician
Known hypersensitivity to apremilast
Treatment within the month prior to screening with (1) an investigational drug, (2) medications which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram [Antabuse], naltrexone [ReVia], acamprosate [Campral], anticonvulsants, or antidepressants).
Ongoing treatment with medications that may increase risk, including prescribed, over-the-counter, and herbal preparations, as determined by the study physician.
Sexually active female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective methods of birth control for the duration required by a specific protocol.
No fixed domicile and/or no availability by home or mobile telephone
History of hypersensitivity to the study drug or the ingredients.
Failure to take double-blind medication as prescribed.
Intervention: Malathion
Trial phase: Phase 4
ATC code: P03AX03
SMILES: CCOC(=O)CC(SP(=S)(OC)OC)C(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.

Proton Pump Inhibitors: Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of cirrhosis
GEVs was diagnosed by endoscopy

Exclusion Criteria:

Acute gastrointestinal bleeding need emergency surgery
Acid-related disease, such as peptic ulcer disease or gastroesophageal reflux diseases (GERD)
Hepatocellular carcinoma (HCC) or other malignant tumor
History of esophagus, stomach or liver surgery
Child-Pugh C and can't be improved to Child-Pugh A or B
Preparing to be pregnant, pregnant or breast feeding
Allergic to PPIs(proton pump inhibitors) or intolerable
Cannot provide informed consent
Intervention: Ricolinostat
Trial phase: Phase 2
SMILES: O=C(CCCCCCNC(=O)c1cnc(N(c2ccccc2)c2ccccc2)nc1)NO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)

ricolinostat: 120 mg per dose in 12 mL liquid formulation
Eligibility criteria:
Inclusion Criteria:

Type 1 or Type 2 diabetes of at least 6 months with optimized and stable glycemic control during the 3 months prior to Screening
Painful distal symmetric sensorimotor polyneuropathy due to diabetes
Douleur Neuropathique 4 (DN4) score of ≥4
Satisfactory diary data during the 14-day Pain Observation period determined by an algorithm that includes diary compliance, overall level of pain and day-to-day variability in pain

Exclusion Criteria:

Pregnant or lactating
Body Mass Index (BMI) >40 kg/m2
Presence of any neuropathy other than DPN and/or significant risk factors for neuropathy other than diabetes
Other pain conditions that could confound the results of this study, or other chronic pain condition(s) that could affect compliance with pain medication restrictions or confound pain assessments
Painful DPN patients who have undergone lower limb amputations, are non-ambulatory, or whose walking is so impaired as to require a walker or other assistance for ambulation
Have met Diagnostic and Statistical Manual of Mental Disorders V (DSM V) criteria for opioid use disorder or alcohol use disorder
Opioid use at a dose of ≥ 30 morphine milligram equivalents on 3 or more days a week during the month prior to Screening
Suicidal ideation/behavior as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The use of marijuana or cannabidiol (CBD) during the 30 days prior to starting study drug
Chronic use of over-the-counter capsaicin on extremities within 3 months of Screening and/or prescription Qutenza use within 6 months of Screening
Corrected QT interval at Screening using QTcF of ≥450 msec (male) or ≥460 msec (female)
Hemoglobin < 11.5 g/dL (female) or < 13 g/dL (male), total white blood cell count < 2500/mm3, neutrophil count < 1250/mm3, lymphocyte count < 1000/mm3, or platelet count < 100,000/mm3
HIV positive and/or active hepatitis virus (A, B, or C) infection
Current or previous (≤1 month of Screening) enrollment in a clinical trial involving treatment with an investigational product
Any known recent exposure within the 14 days prior to initial Screening to coronavirus disease 2019 (COVID-19) or symptoms of COVID-19 infection or other reason to suspect COVID-19 infection as assessed by the Investigator at the time of initial Screening
Intervention: Phenoxybenzamine
Trial phase: Phase 3
ATC code: C04AX02
SMILES: CC(COc1ccccc1)N(CCCl)Cc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: 3-4 weeks prior to date of surgery, patient will start phenoxybenzamine 10mg PO twice daily. Phenoxybenzamine will then be titrated to a blood pressure <120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).

Phenoxybenzamine: Non-selective alpha blocker
Eligibility criteria:
Inclusion Criteria:

Adults with pheochromocytoma / paraganglioma undergoing surgical resection

Exclusion Criteria:

Children < 18 years
Intervention: Doxazosin
Trial phase: Phase 3
ATC code: C02CA04 | G04CA55
SMILES: COc1cc2nc(N3CCN(C(=O)C4COc5ccccc5O4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: 3-4 weeks prior to date of surgery, patient will start doxazosin 1 mg PO daily. Phenoxybenzamine will then be titrated to a blood pressure <120/80 (sitting) with mild orthostatic hypotension (drop in systolic blood pressure by 20 points or diastolic blood pressure by 10 points from sitting to standing position); systolic blood pressure not less than 90 (standing).

Doxazosin: Selective alpha blocker
Eligibility criteria:
Inclusion Criteria:

Adults with pheochromocytoma / paraganglioma undergoing surgical resection

Exclusion Criteria:

Children < 18 years
Intervention: ICATIBANT
Trial phase: Phase 2
ATC code: B06AC02
SMILES: NC(N)=NCCCC(N)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)N1CC(O)CC1C(=O)NCC(=O)NC(Cc1cccs1)C(=O)NC(CO)C(=O)N1Cc2ccccc2CC1C(=O)N1C(C(=O)NC(CCCN=C(N)N)C(=O)O)CC2CCCCC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Icatibant will be intravenously infused at a rate of 50 ug/kg/h for 1 hour prior to the initiation of dialysis and continue through hemodialysis (4 hours).

Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
Eligibility criteria:
Inclusion Criteria:

Adult patients who have been on maintenance hemodialysis for at least 6 months

Exclusion Criteria:

History of functional transplant less than 6 months prior to study
Use of immunosuppressive drugs within 1 month prior to study
History of active connective tissue disease
History of acute infectious disease within one month prior to study
AIDS (HIV seropositivity is not an exclusion criteria)
History of myocardial infarction or cerebrovascular event within 3 months
Advanced liver disease
Gastrointestinal dysfunction requiring parental nutrition
Active malignancy excluding basal cell carcinoma of the skin
Ejection fraction less than 30%
Anticipated live donor kidney transplant
Pregnancy, breast-feeding or child-bearing potential
History of poor adherence to hemodialysis or medical regimen
Subjects with cardiac pacemaker, artificial heart valve, any metallic implant, permanent tattoo, or any retained foreign metallic bodies that are contraindicated in magnetic resonance imaging.
Inability to provide consent
Intervention: Proguanil
Trial phase: Phase 4
ATC code: P01BB01 | P01BB51 | P01BB52
SMILES: CC(C)N=C(N)N=C(N)Nc1ccc(Cl)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 81
Group description: Proguanil is the current standard of care for chemoprevention of malaria in children with SCA in Kenya. This medication will be taken on a daily basis

Proguanil Oral Tablet: Dosing of daily proguanil will be approximately 3mg/kg/day,
Eligibility criteria:
Inclusion Criteria:

Age greater than 12 months and less than 10 years at enrollment;
Current attendance at or willingness to attend the study SCA clinic at HBCH;
Residence in either Homa Bay County or the Rongo or Awendo sub-counties of Migori County;
Confirmed hemoglobin genotype of HbSS by electrophoresis, HPLC, or PCR;
No immediate, apparent, or reported plans to relocate residence from Homa Bay County or the Rongo or Awendo sub-counties of Migori County in the next 2 years;
Ability to take oral medication and be willing to adhere to the medication regimen or caregiver willingness to give the medical regimen as prescribed;
Ability and willingness of parent or legally authorized representative (LAR) to give informed consent;
Assent of child in those > 7 years.

Exclusion Criteria:

Taking routine antimalarial prophylaxis for another indication (including co-trimoxazole for HIV infection);
Temperature of ≥ 37.5C at screening or history of objective or subjective fever in the preceding 24 hours during screening;
Known allergy or sensitivity to sulfadoxine, pyrimethamine, amodiaquine, proguanil, dihydroartemisinin, piperaquine, artemether, lumefantrine, pencillin (if under 5 years old), or derivatives of these compounds;
Known chronic medical condition other than SCA (i.e. malignancy, HIV) requiring frequent medical attention;
Currently participating in another clinical research study, or having participated in one in the prior 30 days;
Living in the same household as a previously-enrolled study participant;
Chronic use of medications known to prolong the QT interval in children (see Appendix J);
Fridericia's corrected QT interval (QTcF) interval > 450msec.
Intervention: Duo-cotecxin
Trial phase: Phase 4
SMILES: CC1CCC2C(C)C(O)OC3OC4(C)CCC1C32OO4.Clc1ccc2c(N3CCN(CCCN4CCN(c5ccnc6cc(Cl)ccc56)CC4)CC3)ccnc2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 82
Group description: DP is an artemisinin-combination therapy consisting of the artemisinin derivative dihydroartemisinin and the bisquinoline piperaquine. This medication is taken on a monthly basis.

Dihydroartemisinin-Piperaquine (DP): 3) The weight-based dosing of tablets of 40/320mg of DP is described below:

Weight (kg) No. of 40/320mg tabs DP daily for 3 days

≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½
Eligibility criteria:
Inclusion Criteria:

Age greater than 12 months and less than 10 years at enrollment;
Current attendance at or willingness to attend the study SCA clinic at HBCH;
Residence in either Homa Bay County or the Rongo or Awendo sub-counties of Migori County;
Confirmed hemoglobin genotype of HbSS by electrophoresis, HPLC, or PCR;
No immediate, apparent, or reported plans to relocate residence from Homa Bay County or the Rongo or Awendo sub-counties of Migori County in the next 2 years;
Ability to take oral medication and be willing to adhere to the medication regimen or caregiver willingness to give the medical regimen as prescribed;
Ability and willingness of parent or legally authorized representative (LAR) to give informed consent;
Assent of child in those > 7 years.

Exclusion Criteria:

Taking routine antimalarial prophylaxis for another indication (including co-trimoxazole for HIV infection);
Temperature of ≥ 37.5C at screening or history of objective or subjective fever in the preceding 24 hours during screening;
Known allergy or sensitivity to sulfadoxine, pyrimethamine, amodiaquine, proguanil, dihydroartemisinin, piperaquine, artemether, lumefantrine, pencillin (if under 5 years old), or derivatives of these compounds;
Known chronic medical condition other than SCA (i.e. malignancy, HIV) requiring frequent medical attention;
Currently participating in another clinical research study, or having participated in one in the prior 30 days;
Living in the same household as a previously-enrolled study participant;
Chronic use of medications known to prolong the QT interval in children (see Appendix J);
Fridericia's corrected QT interval (QTcF) interval > 450msec.