anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tretinoin
Trial phase: Phase 4
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.

Tretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Female subjects, aged between 11 and 25 years
Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method for at least 3 months prior the study
Subjects that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks
Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form
Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol
Subjects who had never received treatment for striae in the studied area

Exclusion Criteria:

Subjects whose medical history and physical examination present clinical pathology, as marfan Syndrome, cushing, systemic autoimmune or neurological diseases
Pregnant or women in breastfeeding, or women planning to become pregnant
Previous treatment for striae in the local area of the study.
Subjects that are in use of tretinoin or glycolic acid in the local area of the study.
Presence of white striae in the local area of the study
History of Connective Tissue Disease
History of keloid development or skin healing problems
Subjects that are taking medications associated with striae development, as systemic corticosteroids, indinavir, hormonal replacement therapy
Hypersensibility to retinoic acid
Subjects who intend to get tan in the area of the study, through exposure of sun or tanning machines during the study
Subjects that have a variation in their weight of more than 2 kg in a period of four months prior the study
Predisposition for chronic inflammatory process
Subjects with chronic diseases as diabetes, cardiopathy, neoplasm, HIV and autoimmune diseases (vitiligo, lupus)
Intervention: Loteprednol etabonate/tobramycin
Trial phase: Phase 3
SMILES: CCOC(=O)OC1(C(=O)OCCl)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C.NCC1OC(OC2C(N)CC(N)C(OC3OC(CO)C(O)C(N)C3O)C2O)C(N)CC1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 177
Group description: Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Eligibility criteria:
Inclusion Criteria:

Subjects must have a clinical diagnosis of BKC in at least one eye
Subjects must be willing to discontinue contact lens use for the duration of the study
Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion Criteria:

Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
Subjects who have any uncontrolled systemic disease or debilitating disease.
Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
Subjects having ocular surgery (including laser surgery) in either eye within the past three months.
Intervention: Epirubicin
Trial phase: Phase 2
ATC code: L01DB01 | L01DB03
SMILES: COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: standard doses of MVAC given every 14 days x 3.

single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.
Eligibility criteria:
Inclusion Criteria:

histologically confirmed urothelial carcinoma of bladder, ureter, or renal pelvis. T2-T4 and muscle invasion must be established by TURBT. Upper tract must be high grade. N0-N1 are eligible.

candidate for radical cystectomy, nephroureterectomy, or segmental ureterectomy with goal of cure.

->/= 18 years old

ECOG performance status 0-1.
Adequate marrow and organ function.
May enter on therapeutic anticoagulation if it can be safely held during perioperative period.
No women of childbearing potential, pregnant or breastfeeding.
LVEF >/= 50 %
Patients with history of other non-urothelial malignancies may enroll if: 1)no evidence of distant disease w/in last year. 2)No anticancer treatment for >/= 1 year other than adjuvant treatment or treatment for secondary prevention. 3) Less than 360 mg/m2 lifetime dose of adriamycin.
ability to understand and willingness to sign written informed consent and HIPAA.

Exclusion Criteria:

Intravesicular therapy w/in 4 weeks of study entry or those who have not recovered from adverse effects of such agents administered more than 4 weeks earlier.
Patients may not be receiving any investigational agents within 4 weeks of study entry.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Methotrexate, Vinblastine, Adriamycin or Cisplatin or other agents used in the study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects of cytotoxic chemotherapy.

Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cytotoxic chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.

-. Patients who have undergone prior pelvic radiation are excluded due to risk of life threatening myelosuppression.

Patients who have received any previous systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible.
Intervention: Palonosetron
Trial phase: Phase 2
ATC code: A04AA05 | A04AA55
SMILES: [H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
Eligibility criteria:
Inclusion Criteria:

Patients > 18 years with acute myelogenous leukemia or high-risk myelodysplastic syndrome undergoing chemotherapy with high dose cytarabine (1.5 or 2gm/m^2) containing regimens.
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

Patients with emesis or grade 2 nausea (oral intake is significantly decreased) or 3 nausea (no significant intake requiring intravenous fluids)</= 24 hours before chemotherapy.
Patients with ongoing emesis due to any organic etiology.
Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists.
Intervention: Palonosetron
Trial phase: Phase 2
ATC code: A04AA05 | A04AA55
SMILES: [H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
Eligibility criteria:
Inclusion Criteria:

Patients > 18 years with acute myelogenous leukemia or high-risk myelodysplastic syndrome undergoing chemotherapy with high dose cytarabine (1.5 or 2gm/m^2) containing regimens.
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

Patients with emesis or grade 2 nausea (oral intake is significantly decreased) or 3 nausea (no significant intake requiring intravenous fluids)</= 24 hours before chemotherapy.
Patients with ongoing emesis due to any organic etiology.
Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists.
Intervention: Natrol
Trial phase: Phase 4
SMILES: O=C(O)C(O)C(O)C(=O)O.[Bi].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days

Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime.
Eligibility criteria:
Inclusion Criteria:

Male or female children,
ages 4-8 years,
diagnosed with an ASD, including
Pervasive Developmental Disorder NOS (PDD, NOS),
Asperger's Syndrome, or
Autistic Disorder, and followed in the Munroe Meyer Developmental Pediatrics Clinic. Documented impaired sleep maintenance (ISM) based on parent-report and 7 day somnolog (sleep diary).
Clinician rating of 4 (moderately ill) or worse on CGI-S. Rating is based on the clinician's experience with evaluating and treating this patient population.
Previous discussion during a clinic appointment about sleep difficulties, including review of sleep hygiene and basic behavioral interventions/strategies.
Current problems of overnight awakenings recorded on the Children's Sleep Habits Questionnaire (CSHQ) despite behavioral intervention.
Stable psychotropic medication treatment for the past 4 weeks.

Exclusion Criteria:

Treatment with Melatonin or Melatonin CR during the past month or previous failed treatment with Melatonin CR.

Presence of a previously unevaluated medical condition which may be the etiology of the nighttime awakenings. There is no contraindication for use of Melatonin CR in patients with obstructive sleep apnea.
Intervention: Acetaminophen
Trial phase: Phase 2
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
Eligibility criteria:
Inclusion Criteria:

- Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy surgery and who were willing to remain confined for approximately 4 days following surgery for study procedures.

Exclusion Criteria:

Subjects who underwent Base wedge osteotomy and/or Long-Z hart bunionectomy procedures
Allergic reaction to study medications
Pregnant or breastfeeding females
Clinically significant lab abnormalities at screening
Positive hepatitis testing at screening
Clinically significant or uncontrolled medical disorders or illness at screening
Active malignancy or chemotherapy
Any history of drug or alcohol abuse/addiction
Known or suspected history of human immunodeficiency virus (HIV); requires treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or butyrophenones
History of major depressive episode or major psychiatric disorder
Current systemic corticosteroid therapy
Inability to refrain from smoking during or alcohol during stay at investigative site
Intervention: Xylitol
Trial phase: Phase 3
SMILES: OC[C@@H](O)[C@H](O)[C@@H](O)CO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 160
Group description: Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
Eligibility criteria:
Inclusion Criteria:

Six months to five years of age
General good health
History of at least three episodes of AOM in previous 12 months, at least one of which occurred within the previous six months
English or Spanish speaking

Exclusion Criteria:

History of tympanostomy tubes
Intestinal malabsorption or chronic diarrhea
Diabetes mellitus
Any inborn error of metabolism
Parent/guardian unreachable by telephone
Known allergy to any of the study solution components (xylitol, sorbitol, sodium carboxymethylcellulose, potato starch, glycerin, potassium sorbate, natural berry flavoring).
Intervention: Minocycline hydrochloride
Trial phase: Not Applicable
SMILES: CN(C)c1ccc(O)c2c1CC1CC3C(N(C)C)C(=O)C(C(N)=O)=C(O)C3(O)C(=O)C1=C2O.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 66
Group description: Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
Eligibility criteria:
Inclusion Criteria:

Must have fragile X syndrome with molecular documentation
Current pharmacological treatment regimen has been stable for at least 4 weeks

Exclusion Criteria:

Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study
subjects who are unable to take oral medication
subjects who have been on minocycline previously
subjects who are allergic to minocycline or tetracyclines
subjects who are pregnant
subjects with history of lupus or hepatic dysfunction
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 85
Group description: Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.

hydrocodone/acetaminophen: 0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.
Eligibility criteria:
Inclusion Criteria:

Age 2 to 17 years
Laceration of the skin and/or subcutaneous tissue requiring sutures
American Society of Anesthesiologists (ASA) score of I or II

Exclusion Criteria:

Major injuries in addition to laceration (suspected fracture, intracranial, intrathoracic, or intraabdominal bleeding or organ injury)
Abnormal neurologic examination (such as head injury)
Severe congenital heart disease
Pregnancy
Known opiate or acetaminophen allergy
Require conscious sedation
Have had narcotic or acetaminophen administration within 4 previous hours
Intervention: Fesoterodine
Trial phase: Phase 4
ATC code: G04BD11
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
Eligibility criteria:
Inclusion Criteria:

Subjects must have previously completed fesoterodine study A0221045 [in Portugal]
Subjects must be recommended for inclusion by the investigator

Exclusion Criteria:

Conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine
Predominant stress incontinence as determined by the investigator
Intervention: Galantamine
Trial phase: Phase 4
ATC code: N06DA04
SMILES: [H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: 8 mg/day for 4 weeks; 16 mg/day thereafter
Eligibility criteria:
Inclusion Criteria:

Alzheimer's disease according to the criteria of DSM-IV, NINCDS-ADRDA
K-MMSE (Korean - Mini Mental State Exam) is 10 to 24
Reliable Guardian available to the patients
Patient or guardian provided written informed consent before entering into the clinical trial

Exclusion Criteria:

Acetylcholine esterase inhibitors used to treat dementia taken within 30 days of the beginning in this clinical trial
Neurodegenerative diseases (eg Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)
Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)
brain tumor, nerve syphilis, meningitis, encephalitis
epilepsy
Intervention: Flibanserin
Trial phase: Phase 3
ATC code: G02CX02
SMILES: O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 376
Group description: Flibanserin 100 mg administered at bedtime

Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks
Eligibility criteria:
Inclusion criteria:

Naturally postmenopausal women of any age with at least one ovary
Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
Stable, monogamous heterosexual relationship for at least one year
Willing to discuss sexual issues
Willing to engage in sexual activity at least once a month
Normal Pap smear
Normal mammogram
Normal uterine lining
Able to comply with daily use of handheld data entry device

Exclusion criteria:

Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
Partner with inadequately treated organic or psychosexual dysfunction
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major Depression
Suicidal behavior or ideation
Major life stress that could impair sexual function
Substance abuse
Intervention: Fentanyl
Trial phase: Phase 4
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 103
Group description: Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
Eligibility criteria:
Inclusion Criteria:

Participants who complains of cancer pain
Participants who have taken non-opioid analgesics for the past one month for cancer pain relief purpose, but still have average 4 or higher pain level on the Visual Analogue Scale (VAS) for the last 24 hours
Participants with an estimated life expectancy of at least 2 months
Participants who are able to communicate with the investigator
Participants who can avoid getting pregnant appropriately if there is a possibility of pregnancy during this study period

Exclusion Criteria:

Participants participating in another clinical trial
Participants with a history of oversensitive reaction to a narcotic analgesic or with an existing history of drug abuse
Participants who have active skin disease, avoiding application of the transdermal system
Participants with a history of CO2 (carbon di-oxide) retention (i.e. chronic obstructive pulmonary disease)
Participants undergoing chemotherapy/radiotherapy right now or is going to get chemotherapy/radiotherapy within the study period
Intervention: ZINC SULFATE
Trial phase: Phase 1 | Phase 2
ATC code: A12CB01 | B05XA18 | C05AX04
SMILES: O=S(=O)([O-])[O-].[Zn+2]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: 250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days

Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
Eligibility criteria:
Inclusion Criteria:

Admission to pediatric intensive care unit
Age between 1 month and 10 years
Pediatric Risk of Mortality III score > 5, OR presence of at least 1 new organ failure
Anticipated pediatric intensive care unit length of stay > 3 days
Ability of parent or legal guardian to provide informed consent

Exclusion Criteria:

Known zinc deficiency
Pre-existing bone marrow failure
New or existing diagnosis of diabetes mellitus
Limitation of care orders in place
New diagnosis of brain injury, encephalopathy
Clinical contraindication for zinc supplementation
Intervention: ZINC SULFATE
Trial phase: Phase 1 | Phase 2
ATC code: A12CB01 | B05XA18 | C05AX04
SMILES: O=S(=O)([O-])[O-].[Zn+2]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: 500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days

Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
Eligibility criteria:
Inclusion Criteria:

Admission to pediatric intensive care unit
Age between 1 month and 10 years
Pediatric Risk of Mortality III score > 5, OR presence of at least 1 new organ failure
Anticipated pediatric intensive care unit length of stay > 3 days
Ability of parent or legal guardian to provide informed consent

Exclusion Criteria:

Known zinc deficiency
Pre-existing bone marrow failure
New or existing diagnosis of diabetes mellitus
Limitation of care orders in place
New diagnosis of brain injury, encephalopathy
Clinical contraindication for zinc supplementation
Intervention: ZINC SULFATE
Trial phase: Phase 1 | Phase 2
ATC code: A12CB01 | B05XA18 | C05AX04
SMILES: O=S(=O)([O-])[O-].[Zn+2]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: 750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days

Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline
Eligibility criteria:
Inclusion Criteria:

Admission to pediatric intensive care unit
Age between 1 month and 10 years
Pediatric Risk of Mortality III score > 5, OR presence of at least 1 new organ failure
Anticipated pediatric intensive care unit length of stay > 3 days
Ability of parent or legal guardian to provide informed consent

Exclusion Criteria:

Known zinc deficiency
Pre-existing bone marrow failure
New or existing diagnosis of diabetes mellitus
Limitation of care orders in place
New diagnosis of brain injury, encephalopathy
Clinical contraindication for zinc supplementation
Intervention: Spironolactone
Trial phase: Phase 3
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: spironolactone is added to previous antihypertensive treatment

spironolactone : 25 uptrated if necessary to 50 mg once daily
Eligibility criteria:
Inclusion Criteria:

Age < 75 years
Type-2 diabetes
Therapy resistant hypertension (by ABPM)
Treatment with at least 3 antihypertensives

Exclusion Criteria:

HbA1c > 10.0
BP > 180/110 mmHg
Secondary hypertension
Intolerance to spironolactone
Permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids
Total cholesterol 10 mmol/l
New York Heart Association class III and IV
Pregnancy or planned pregnancy
Psychiatric disease
Malignant disease
Insufficient adherence