anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: PAMIDRONIC ACID
Trial phase: Phase 3
ATC code: M05BA03
SMILES: NCCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 19
Group description: Subjects who received Pamidronate every 3 months for 3 years.
Eligibility criteria:
INCLUSION CRITERIA:

Children enrolled in this study will be limited to those with Sillence types III and IV OI, as determined by clinical and genetic criteria.

Most of the children who will be included in this study are already enrolled in the protocols Evaluation and Intervention for Ambulation, Growth, and Basilar Invagination in Osteogenesis Imperfecta (97-CH-0064) and Growth Hormone Therapy in Osteogenesis Imperfecta (92-CH-0034).

Screening of candidates will be based on telephone interviews with a parent, and referral records to include: AP and lateral radiographs of the lower extremities and spine, and family, developmental, fracture and medical history. An NIH clinical screening evaluation will be performed for those children who appear to have a history consistent with OI under protocol 04-CH-0077, Screening of and Diagnosis of Patients with Connective Tissue Disorder . Patients admitted for this screening visit who are less than four years of age as well as those older than 4 years of age but not meeting the criteria for inclusion in the growth hormone protocol, protocol 92-CH-0034, will be considered for enrollment in protocol 97-CH-0064 (Evaluation and Intervention for Ambulation, Growth and Basilar Invagination in OI), those older than four years who meet the criteria will be considered for co-enrollment in protocol 92-CH-0034.

The inclusion criteria for protocol 92-CH-0034 are as follows: patients must have a clinical/biochemical diagnosis of osteogenesis imperfecta types III or IV, height less than third percentile for age, and radiological evidence that long bone epiphyses have not yet fused.

Patients are excluded from protocol 92-CH-0034 if they have scoliosis of greater than 40 degrees unless scoliosis has been stable over the past two years, or evidence of severe basilar invagination.

Patients with previous exposure to bisphosphonates in outside trials will be considered for participation in this trial.

EXCLUSION CRITERIA:

Inability to comply with the visit schedule, maintenance of the physical therapy program, and ability to administer and comply with GH injections are central to our analysis of the outcomes of this study. Failure to comply with these conditions will constitute exclusion criteria.

Pregnancy.

Patients that have had or will have surgery to place instrumentation in the spine (i.e. result of spine fusion).
Intervention: PAMIDRONIC ACID
Trial phase: Phase 3
ATC code: M05BA03
SMILES: NCCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 15
Group description: Subjects who received Pamidronate every 6 months for 3 years.
Eligibility criteria:
INCLUSION CRITERIA:

Children enrolled in this study will be limited to those with Sillence types III and IV OI, as determined by clinical and genetic criteria.

Most of the children who will be included in this study are already enrolled in the protocols Evaluation and Intervention for Ambulation, Growth, and Basilar Invagination in Osteogenesis Imperfecta (97-CH-0064) and Growth Hormone Therapy in Osteogenesis Imperfecta (92-CH-0034).

Screening of candidates will be based on telephone interviews with a parent, and referral records to include: AP and lateral radiographs of the lower extremities and spine, and family, developmental, fracture and medical history. An NIH clinical screening evaluation will be performed for those children who appear to have a history consistent with OI under protocol 04-CH-0077, Screening of and Diagnosis of Patients with Connective Tissue Disorder . Patients admitted for this screening visit who are less than four years of age as well as those older than 4 years of age but not meeting the criteria for inclusion in the growth hormone protocol, protocol 92-CH-0034, will be considered for enrollment in protocol 97-CH-0064 (Evaluation and Intervention for Ambulation, Growth and Basilar Invagination in OI), those older than four years who meet the criteria will be considered for co-enrollment in protocol 92-CH-0034.

The inclusion criteria for protocol 92-CH-0034 are as follows: patients must have a clinical/biochemical diagnosis of osteogenesis imperfecta types III or IV, height less than third percentile for age, and radiological evidence that long bone epiphyses have not yet fused.

Patients are excluded from protocol 92-CH-0034 if they have scoliosis of greater than 40 degrees unless scoliosis has been stable over the past two years, or evidence of severe basilar invagination.

Patients with previous exposure to bisphosphonates in outside trials will be considered for participation in this trial.

EXCLUSION CRITERIA:

Inability to comply with the visit schedule, maintenance of the physical therapy program, and ability to administer and comply with GH injections are central to our analysis of the outcomes of this study. Failure to comply with these conditions will constitute exclusion criteria.

Pregnancy.

Patients that have had or will have surgery to place instrumentation in the spine (i.e. result of spine fusion).
Intervention: Mycapssa
Trial phase: Phase 2
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
Eligibility criteria:
INCLUSION CRITERIA:

Patients enrolled in the lymphangioleiomyomatosis natural history protocol who have symptoms associated with one of the following:

lymphangioleiomyomas
chylous pleural effusions
peripheral lymph-edema
chyloptysis
protein-losing enteropathy
chyluria

Patients will be included in this protocol if symptoms are attributed to the above processes. Patients with malabsorption disorders, diabetes, hypo/hyperthyroidism, or other endocrine-related disorders will be included if justified clinically based on severity of symptoms.

EXCLUSION CRITERIA:

Hypersensitivity to somatostatin, octreotide or its analogues
Patients with hepatitis B, hepatitis C, or other clinically significant liver diseases
Transplant patients
Pregnant women or women who are beast-feeding
Patient or another responsible party is unable to give the subcutaneous injection
Patient unwilling to be followed per the guidelines set forth
Patients with decreased renal function (creatinine greater than 1.5)
Patients with HIV infection
Immunosuppressed patients
Intervention: Selenium
Trial phase: Phase 3
SMILES: [Se]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 865
Group description: Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.

selenium: Given orally
Eligibility criteria:
RUN-IN PERIOD:

Inclusion Criteria:

Histologically confirmed, completely resected stage IA (pT1, N0) or IB (pT2, N0) non-small lung cancer (except carcinoid)*

Completion of treatment for stage I lung cancer within the past 6 to 36 months and currently disease free
At least one mediastinal lymph node sampled at resection NOTE: *Southwest Oncology Group (SWOG) and Cancer and Leukemia Group B (CALGB) patients must be T1, N0; CALGB patients may be T2, N0 provided disease was completely resected prior to June 1, 2001 and participation in CALGB 9633 was refused if offered
18 years old and over
Eastern Cooperative Oncology Group performance status 0-1
Bilirubin no greater than upper limit of normal (ULN)
Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) no greater than ULN
Prior mineral, herbal, phytochemical, or vitamin supplementation allowed
Concurrent non-selenium containing mineral, herbal, phytochemical, or vitamin supplementation allowed if schedule and supplementation prior to study remains unchanged

Exclusion Criteria:

Evidence of new or recurrent lung cancer on chest x-ray within the past 8 weeks
Synchronous lung or non-lung lesions or metastasis, even if resectable
History of more than one primary lung cancer at any time
Concurrent or other prior cancer within the past 5 years except localized non-melanoma skin cancer
Prior or concurrent chemotherapy for recurrent lung cancer
Prior or concurrent radiotherapy for recurrent lung cancer
Concurrent surgery
Concurrent supplement(s) containing more than 50 micrograms of selenium

STUDY PHASE:

Free of disease
Consumed at least 75% of tablets during 4-week run-in period
Intervention: ALENDRONIC ACID
Trial phase: Phase 2
ATC code: M05BA04 | M05BB03 | M05BB05 | M05BB06
SMILES: NCCCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
Eligibility criteria:
Eligibility Criteria:

5-14 years of age
Weight 20 kg or greater
History of one or more atraumatic fracture
Sexual development no greater than Tanner II
Osteoporosis by DXA (Diagnosis of high-turnover osteoporosis with no underlying cause (e.g., malignancy, hyperthyroidism, hyperparathyroidism, or vitamin D intoxication)

Inclusion Criteria:

Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of >20%).
Bone mineral density by DXA at 2 standard deviations (SD) below normal mean for age (Z-score at least 2 SD below normal mean at the lumbar spine or hip)
Parental consent (and patient assent after age 12 years) to participate in the study.
Sexual development at Tanner stage II or less (Prepubertal stage)
Weight 20kg and more

Exclusion Criteria:

History of severe gastritis or reflux
Marked kyphoscoliosis or inability to sit or stand for at least 30 minutes.
Abnormalities of the esophagus that delay emptying (e.g., strictures or achalasia)
Hypersensitivity to bisphosphonates
Uncorrected hypocalcemia
History of gastric or duodenal ulcers
Renal dysfunction as indicated by serum Creatinine greater than 1.5 mg/dL
Liver dysfunction as indicated by serum SGPT greater than 2 times upper limit of normal for age or serum total bilirubin greater than 2.0 mg/dL
Diagnosis of osteogenesis imperfecta (including family history) or blue sclerae or deafness
Diagnosis of active rickets, osteomalacia, or bone alkaline phosphatase > 2 times normal for age
Severe gastritis or reflux
Pregnancy

Anorexia Nervosa

Prior/Concurrent Therapy-
Prior course of prednisone allowed
No concurrent prednisone except inhaled steroids
No concurrent high-dose glucocorticoids
No concurrent salmon calcitonin
No other concurrent bisphosphonates
No concurrent long-term anti-seizure medication
Intervention: Benzoylphenylurea
Trial phase: Phase 1
SMILES: NC(=O)N(C(=O)c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: BPU, administered over a dose range of 5-320 mg
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed malignancy

Metastatic or unresectable
No effective standard curative or palliative measures exist
No known CNS or brain metastasis

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin normal
SGOT/SGPT normal

Renal:

Creatinine normal
Creatinine clearance at least 60 mL/min

Cardiovascular:

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No uncontrolled ventricular arrhythmia
No myocardial infarction within the past 3 months
No superior vena cava syndrome

Neurologic:

No grade 1 or greater peripheral neuropathy
No uncontrolled major seizure disorder
No spinal cord compression

Other:

No active serious infection requiring IV antibiotics
No concurrent uncontrolled illness
No concurrent unstable or serious medical condition
No chronic diarrhea or malabsorption
No history of allergic reactions to compounds similar in chemical or biological composition to benzoylphenylurea
No psychiatric illness or social situation that would preclude study compliance
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent immunotherapy
No concurrent growth factors during first 2 courses of study
Concurrent epoetin alfa allowed

Chemotherapy:

At least 28 days since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
No other concurrent chemotherapy

Endocrine therapy:

No concurrent hormonal therapy

Radiotherapy:

At least 28 days since prior large-field radiotherapy
Prior palliative radiotherapy for painful bone metastases allowed
No concurrent radiotherapy, including palliative or whole-brain radiotherapy for CNS disease

Surgery:

At least 28 days since prior major surgery

Other:

No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent investigational or commercial agents or therapies for the malignancy
No other concurrent investigational agents
Concurrent bisphosphonates allowed if bone metastases are not only site of measurable or evaluable disease
Intervention: Thalidomide
Trial phase: Phase 2
ATC code: L04AX02
SMILES: O=C1CCC(N2C(=O)c3ccccc3C2=O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis of recurrent or metastatic colorectal carcinoma previously resected within 12 weeks of study entry

Surgical resection combined with radiofrequency ablation allowed

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Hemoglobin at least 8.0 g/dL
Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Partial thromboplastin time (PTT)/prothrombin time (PT) no greater than 120% of control (except in therapeutically anticoagulated nonrelated medical conditions [e.g., atrial fibrillation])
Total bilirubin no greater than 2.0 mg/dL (direct bilirubin no greater than 1.0 mg/dL for patients with Gilbert's syndrome)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 2.5 times normal
No history of hepatic cirrhosis
No concurrent hepatic dysfunction

Renal:

Creatinine no greater than 2.0 mg/dL

Cardiovascular:

No severe congestive heart failure or active ischemic heart disease
No active clots within 1 year before diagnosis OR must be receiving concurrent treatment with anticoagulant (e.g., low molecular weight heparin or equivalent agent)

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for least 4 weeks before, during, and for at least 4 weeks after study participation
No history of severe hypothyroidism
No history of seizures
No significant history of other medical problems that would preclude surgery
No peripheral neuropathy greater than grade 1, except localized neuropathy due to a mechanical cause or trauma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior biologic therapy

Chemotherapy:

At least 4 weeks since prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

At least 4 weeks since prior radiotherapy

Surgery:

See Disease Characteristics

Other:

See Cardiovascular
No concurrent sedating drugs that cannot be reduced to a minimal level
No concurrent sedating recreational drugs or alcohol
No concurrent antiseizure medications
Intervention: Anastrozole
Trial phase: Phase 3
ATC code: L02BG03
SMILES: CC(C)(C#N)c1cc(Cn2cncn2)cc(C(C)(C)C#N)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: 1 mg oral dose of anastrozole every day for 24 Months in the Main phase.
Eligibility criteria:
Inclusion Criteria:

postmenopausal women;
metastatic breast cancer suitable for endocrine therapy;
positive hormone receptor status;
Human epidermal growth factor receptor 2 (HER2) overexpression.

Exclusion Criteria:

patients on hormone replacement therapy;
previous chemotherapy for metastatic disease;
uncontrolled cardiac disease and history of cardiac failure.
Intervention: Indomethacin
Trial phase: Phase 3
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 209
Group description: Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
Eligibility criteria:
Preterm infants < 1250 g birth weight
Admitted to participating institution < 6 hrs of age
No evidence for congenital malformations
Cranial US at 6 postnatal hours without evidence of Grades III - IV intraventricular hemorrhage
Intervention: CX516
Trial phase: Phase 2
SMILES: O=C(c1ccc2nccnc2c1)N1CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: CX516 - 900 mg (3 X 300 mg)

CX516 (Ampalex®)
Eligibility criteria:
Inclusion criteria

Clinical diagnosis of mild cognitive impairment
Good general health with no additional diseases that would interfere with the study.

Exclusion criteria

Any significant neurologic disease (other than suspected incipient Alzheimer's disease), such as Parkinson's disease, stroke, TIA's, multi-infarct dementia, Huntington's disease, head trauma, chronic CNS infection.
History of major depression or another major psychiatric disorder within the past 6 months.
History of schizophrenia, mania or recurrent psychotic episodes.
History of alcohol or DSM IV-diagnosed substance abuse or dependence disorder within the past year.
History of blackout, epilepsy or seizures, or an abnormal EEG as judged by the Investigator and considering the age of the participant.
Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological illness or unstable medical condition which could interfere with drug safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.
Intervention: Magnesium
Trial phase: Phase 2
SMILES: [MgH2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 198
Group description: 100 mg/kg magnesium
Eligibility criteria:
Inclusion Criteria:

Coronary heart disease

Exclusion Criteria:

Early dementia
History of psychiatric illness
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: 191
Group description: 100 mg/kg 0.9 % saline
Eligibility criteria:
Inclusion Criteria:

Coronary heart disease

Exclusion Criteria:

Early dementia
History of psychiatric illness
Intervention: Donepezil
Trial phase: Phase 2
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 34
Group description: 5 mg of donepezil for 4 weeks, followed by 10 mg of donepezil for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Autism Spectrum Disorder (ASD)
Asperger's Disorder
IQ of 75 or above
Baseline assessment tests within the acceptable range

Exclusion Criteria:

Bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
Seizure disorder requiring the use of anticonvulsant medications
Congenital rubella, cytomegalovirus, or tuberous sclerosis
Certain medications prescribed for management of behavior (please contact the investigator for a complete list)
Medications/preparations that are known to interact with donepezil HCl
Significant medical illness, endocrinopathies, cardiovascular disease, or severe chronic malnutrition
Pregnancy or sexually active females not using a reliable method of contraception
Intervention: Citalopram
Trial phase: Not Applicable
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Subjects in this arm received 20mg/day of citalopram taken orally for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Minor Depression symptoms for at least 6 months
Endorse one of the DSM-IV "A" criteria for MDD and at least one other symptom of MDD or endorse both of the "A" criteria for MDD
Global Assessment of Functioning (GAF) score < 70
Short form health survey (SF-36) social functioning score <= 75% or an emotional role functioning score <= 67%
HAM-D-17 score 10-17, inclusive
Minor depression symptoms for at least 6 months

Exclusion Criteria:

Major depressive disorder (MDD) or dysthymia within the past year or in partial remission of MDD
At least a 12-week course of either citalopram at a minimum or 40 mg/day or St. John's Wort at a minimum of 900 mg/day during the current episode of depression
Previous intolerance to either citalopram or St. John's Wort or history of nonresponse to either citalopram at a minimum of 40 mg/day or St. John's Wort at a minimum of 900 mg/day for at least 12 weeks
Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease
Uncontrolled seizure disorder
The following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last year or patients with a positive urine drug screen; schizophrenia; delusional disorder; psychotic disorders not elsewhere classified; bipolar disorder; bereavement; adjustment disorder; antisocial personality disorder; panic disorder, social phobia, generalized anxiety disorder (GAD), or obsessive compulsive disorder (OCD). Patients may have a lifetime diagnosis of an anxiety disorder as long as it is not current.
Mood-congruent or mood-incongruent psychotic features
Psychotropic drugs
Hypothyroidism
Investigational psychotropic drugs within the last year
Positive toxicology screen
Medications metabolized by the CYP3A4 system, where induction of this system poses a risk to the medical stability of the patient
Pregnancy or refusal to use a medically accepted method of contraception
Serious suicide or homicide risk
Psychotherapy beginning less than 3 months ago