anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lipegfilgrastim
Trial phase: Not Applicable
ATC code: L03AA13 | L03AA14
SMILES: COCCOC(=O)NCC(=O)NC1C(O)CC(OCC2OC(OC(C)C(N)C(=O)O)C(NC(C)=O)C(O)C2O)(C(=O)O)OC1C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: All eligible patients will receive chemotherapy and one dose of Pegfilgrastim
Eligibility criteria:
Inclusion Criteria:

All patients with hematologic malignancies undergoing stem cell mobilization in association with chemotherapy, prior to autologous stem cell transplantation.
Prior Treatment:No parenteral cytotoxic chemotherapy within 2 weeks prior to initiation of chemo-mobilization therapy.
Performance Status: Karnofsky > 70%
Age >18
Life Expectancy > 4 months
Bone Marrow: bone marrow biopsy and aspirate
Blood counts: The patient must have adequate bone marrow function, i.e. a total WBC of > 2,000/ul, a Hgb of > 7 g/dl, and a platelet count of > 50,000/ul, unless this abnormality is believed to be due to the underlying disease.
Pulmonary function tests: DLCO > 55% predicted.
Cardiac: Left ventricular ejection fraction of > 40% by radionuclide scan or echocardiography.
Liver function tests (bilirubin, alkaline phosphatase, and SGOT/SGPT) < 3 x normal (unless believed to be elevated due to disease).
Renal function (24 hour urine for creatinine clearance, if clinically indicated): The patient must have adequate renal function (creatinine clearance >50 ml/min), except when renal insufficiency is felt related to the underlying malignancy.
No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival in the transplant setting.
No significant established splenomegaly (i.e. spleen size > 20 cm)
Informed written consent must be obtained. Patients must be able to give informed consent as a prerequisite to this procedure. The Informed Consent form will become part of his/her permanent record and a copy will be given to the patient.

Exclusion Criteria:

Patients with greater than three pre-transplant chemotherapy regimens and/or poor stem cell reserve as demonstrated by significant marrow hypocellularity (<20%) will not be mobilized on the first phase regimen
Medical, social, or psychological factors that would prevent the patient from receiving or cooperating with the full course of therapy.
Evidence on physical exam, LP, CT, or MRI scan of CNS involvement with malignancy.
Uncontrolled or severe cardiovascular disease, including recent (< 6 months) myocardial infarction, congestive heart failure, angina (symptomatic despite optimal medical management), life-threatening dysrhythmia, or clinically significant obstructive/restrictive pulmonary disease.
Serology positive for HIV.
Positive pregnancy test or presence of lactation.
Uncontrolled active infection.
Documented hypersensitivity to any of the drugs used in the protocol.
No concomitant,ongoing malignancy that is life-threatening, based on PI's evaluation.
Intervention: Pitolisant
Trial phase: Phase 2
ATC code: N07XX11
SMILES: Clc1ccc(CCCOCCCN2CCCCC2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Volunteers are given BF2.649, up to 20mg per day

BF2.649: up to 20mg per day
Eligibility criteria:
Inclusion Criteria:

DSM-IV diagnosis of schizophrenia and schizoaffective disorder and not experiencing an acute exacerbation of severe psychosis
Stable antipsychotic drug treatment for at least 4 weeks of Abilify or Haldol or willing to switch to either of these two APDs.
Able to execute written informed consent.
Males and females, between the ages of 18-55 years old, in good health (based on medical history, physical examination, electrocardiograms, and clinical laboratory tests)
All races and ethnicities fluent and literate in English.

Exclusion Criteria:

Diagnosis of DSM-IV alcohol or substance abuse within the last month or DSM-IV alcohol or substance dependence within the last 3 months.
Patients on a stable regimen of antipsychotic medication (other than Haldol or Abilify) for a minimum of 3 months who are not experiencing psychotic symptoms.
Clinically significant abnormal pre-admission vital signs, EKGs, or clinical laboratory evaluations, in which the principle investigator deems the subject-volunteer ineligible for the study.
Any patient scheduled to undergo any surgical procedure during the duration of the study
Patients suffering an acute psychotic episode within the previous 30 days as determined by the attending physician or Principal Investigator.
Patients on any antihistaminergic antipsychotic medications who are not willing to switch to either Haldol or Abilify.
Any patient who has received any known hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, etc.) for a period of 3 months before the first dose of study medication
Patients taking any concurrent medications for a major medical illness.
Any patients who test positive for HIV.
Any patient testing positive for Hepatitis B or C whose liver panel (taken during clinical laboratories) reports clinically significant abnormalities of liver enzyme ranges suggesting a cirrhotic stage.
Any patient who has donated plasma or blood within 30 days before the first dose of study medication
Concurrent treatment with electroconvulsive therapy.
Pregnant women, women in the child bearing age without an efficacious contraceptive device, or women who are breast feeding.
Mental capacity is limited to the extent that the patient cannot provide legal consent or understand information regarding the side effects or tolerance of the study drug
Any patient judged by the principal investigator to be inappropriate for the study.
Intervention: Mycapssa
Trial phase: Phase 3
ATC code: H01CB02
SMILES: CC(O)C(CO)NC(=O)C1CSSCC(NC(=O)C(N)Cc2ccccc2)C(=O)NC(Cc2ccccc2)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
Eligibility criteria:
Inclusion criteria:

Male or female patients aged 18 or greater
Patients with carcinoid tumors and symptoms (diarrhea and flushing) that are not adequately controlled by somatostatin analogues.
Female patients of child bearing potential must have a negative pregnancy test at baseline.
Patients for whom written informed consent to participate in the study has been obtained.

Exclusion criteria:

Patients receiving radiolabeled somatostatin analogue therapy within the 3 months or any cytotoxic chemotherapy or interferon therapy within the 4 weeks prior to randomization
Diabetic patients on anti-diabetic medications whose fasting blood glucose is poorly controlled as indicated by HBA1C > 8%
Patients with symptomatic cholelithiasis
Patient with malabsorption syndrome, short bowel or cholegenic diarrhea not controlled by specific therapeutic means.

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: AZD-1981
Trial phase: Phase 2
SMILES: CC(=O)Nc1cccc2c1c(Sc1ccc(Cl)cc1)c(C)n2CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: AZD1981 Oral tablet, twice daily
Eligibility criteria:
Inclusion Criteria:

FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2 and 3)
Clinical diagnosis of COPD

Exclusion Criteria:

Other clinically relevant disease or disorders
Exacerbation of COPD within 30 days
Intervention: Propofol
Trial phase: Phase 3
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Modified propofol (Propofol 0.5%)
Eligibility criteria:
Inclusion Criteria:

Male and female adults, age ≥ 18 years and ≤ 80 years
Anesthetic risk classified as ASA I-III
Patients undergoing elective surgery under general anesthesia
Signed informed consent

Exclusion Criteria:

Simultaneous participation in another trial
Known or suspected drug abuse
Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication
Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally active analgesics)
Patients taking lipid lowering drugs
History of decompensated renal failure
History of severe hepatic dysfunction, hepatic cirrhosis
Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia
History of convulsive disorders
Decompensated cardiac insufficiency
Hypovolemia
Increased intracranial pressure
Pregnancy (positive ß-HCG test) and lactation
Emergency situation
Patient who receives parenteral fat emulsion, e.g. intralipid
Patients incapable of giving consent personally
Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal
Intervention: Propofol
Trial phase: Phase 3
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Propofol 1%
Eligibility criteria:
Inclusion Criteria:

Male and female adults, age ≥ 18 years and ≤ 80 years
Anesthetic risk classified as ASA I-III
Patients undergoing elective surgery under general anesthesia
Signed informed consent

Exclusion Criteria:

Simultaneous participation in another trial
Known or suspected drug abuse
Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication
Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally active analgesics)
Patients taking lipid lowering drugs
History of decompensated renal failure
History of severe hepatic dysfunction, hepatic cirrhosis
Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia
History of convulsive disorders
Decompensated cardiac insufficiency
Hypovolemia
Increased intracranial pressure
Pregnancy (positive ß-HCG test) and lactation
Emergency situation
Patient who receives parenteral fat emulsion, e.g. intralipid
Patients incapable of giving consent personally
Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal
Intervention: CANDESARTAN CILEXETIL
Trial phase: Phase 3
SMILES: CCOc1nc2cccc(C(=O)OC(C)OC(=O)OC3CCCCC3)c2n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 35
Group description: candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.
Eligibility criteria:
Inclusion Criteria:

Must have participated in Protocol 328 (without discontinuation due to a study drug related AE).
Must sign an informed consent prior to initiating any stus dy procedures.
Have, in the opinion of the investigator, an on-going clinical indication for oral liquid formulation of candesartan cilexetil to control hypertension
Weight ≥ 10 kg and ≤ 40 kg.

Exclusion Criteria:

Any situation, clinical condition (such as clinically significant declining renal function) or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study.
Estimated glomerular filtration rate (GFR) <30 ml/min/1.73m2 for non-transplant patients and <40 ml/min/1.73m2 for transplant patients based on the Schwartz Formula (Schwartz et al 1987) as determined at enrollment into Study 328.
Impaired liver function defined as either acute liver disease or chronic liver disease with persistently elevated liver enzyme values judged clinically significant by the investigator.
Currently using any medications that, in the opinion of the investigator could negatively affect the subject when given together with candesartan cilexetil.
Intervention: Desonide
Trial phase: Phase 4
ATC code: D07AB08 | D07BB02 | S01BA11
SMILES: [H][C@@]12C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Approximately 40 male and female subjects (about 20 age 3 months to <13 years and 20 age 13 and up) with mild to moderate atopic dermatitis will apply desonate gel twice daily to ATD

topical desonide hydrogel 0.05%: apply the smallest amount of study medication possible that is just sufficient to cover all lesions of the standard cortisone-type medication twice daily (morning and evening) for up to 4 weeks to all of their AD lesions
Eligibility criteria:
Inclusion Criteria:

Male or female, age 3 months or greater.
Subjects must have diagnosis of mild to moderate atopic dermatitis by an investigator (a 2 or 3 on the IGA scale).
Subjects must have >2% BSA involvement to be enrolled.
Informed consent of participation must be given by parent or guardian if he or she is <7 years old. Children who are 7 to 18 years old will be given an assent form to sign.
Moisturizers will be allowed during the study as long as the use remains stable from screening/baseline throughout the study.

Exclusion Criteria:

Known allergy or sensitivity to topical desonide hydrogel in the subject.
Inability to complete all study-related visits.
Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Other than stable use of over the counter non-medicated moisturizers, all other topical treatments for AD must be stopped prior to study drug initiation. There will be no required washout for any topical therapies. Stable use of systemic therapies may be continued throughout the study.
Requiring >130 gm of cream in a 4 week period.
Pregnant women and women who are breastfeeding are to be excluded. Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control. Use of desonide in pregnant subjects is controversial and is only to be used when benefits outweigh the risks.
Intervention: Calcipotriol plus hydrocortisone
Trial phase: Phase 3
SMILES: C=C1C(=CC=C2CCCC3(C)C2CCC3C(C)C=CC(O)C2CC2)CC(O)CC1O.CC12CCC(=O)C=C1CCC1C2C(O)CC2(C)C1CCC2(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 351
Group description: Once daily application Calcipotriol plus hydrocortisone (LEO 80190)
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of psoriasis vulgaris involving the face
Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 100 g of ointment per week
Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face

Exclusion Criteria:

Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
UVB therapy within the 2-week period prior to randomisation
Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the double-blind phase of the study)
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
Other inflammatory skin diseases (e.g., seborrhoiec dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psorisis vulgaris on the face or on the intertriginous areas
Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study
Known or suspected severe renal insufficiency or severe hepatic disorders
Known or suspected disorders of calcium metabolism associated with hypercalcaemia
Intervention: Calcipotriol
Trial phase: Phase 3
ATC code: D05AX02 | D05AX52
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@@H](O)C3CC3)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 341
Group description: Once daily application Calcipotriol 25 mcg/g in the ointment vehicle
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of psoriasis vulgaris involving the face
Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 100 g of ointment per week
Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face

Exclusion Criteria:

Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
UVB therapy within the 2-week period prior to randomisation
Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the double-blind phase of the study)
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
Other inflammatory skin diseases (e.g., seborrhoiec dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psorisis vulgaris on the face or on the intertriginous areas
Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study
Known or suspected severe renal insufficiency or severe hepatic disorders
Known or suspected disorders of calcium metabolism associated with hypercalcaemia
Intervention: CO-TRIMOXAZOLE
Trial phase: Phase 3
ATC code: J01EE01
SMILES: COc1cc(Cc2cnc(N)nc2N)cc(OC)c1OC.Cc1cc(NS(=O)(=O)c2ccc(N)cc2)no1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 23
Group description: subjects with abscesses less than 5cm who received oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
Eligibility criteria:
Inclusion Criteria:

1.) Abscess < 5 cm (< 5 cm of induration and fluctuance) requiring incision and drainage 2.) Age > 90 days and < 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae

Exclusion Criteria:

Multiple abscesses
Abscess located on the hands, face, or perineum
Abscess as a result of a bite wound
Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (> 10 days), etc.
Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug allergy to TMP/SMX

7.) Fever > or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis, etc.

9.) Signs /symptoms of another infection or illness - i.e., influenza, croup, etc.
Intervention: Olanzapine
Trial phase: Phase 2
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication.
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria (not including amenorrhea) for AN
Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2
Patient (or family if the patient is a minor) refuses hospitalization
Free of psychotropic medication (4 weeks medication free for fluoxetine and antipsychotic medication; 2 weeks medication free for all others) OR on a stable dose of an SSRI or SNRI (venlafaxine) for 4 weeks before study entry
Prior treatment of AN

Exclusion Criteria:

Any medical or psychiatric problem requiring urgent attention and/or any significant comorbid illness not likely to benefit from proposed treatments
Allergy to olanzapine
Significant orthostatic high blood pressure
Recent commencement of psychotherapy in the community
Diabetes mellitus, with a fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose greater than 140 mg/dL
Known history of current or past jaundice
Known history of narrow angle glaucoma
Active substance abuse or dependence
Schizophrenia, schizophreniform disorder, or bipolar illness
Movement disorder or presence of tics
History of tardive dyskinesia
History of seizures
Pregnant