anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Dexmedetomidine will be administered to subjects during MER.

Dexmedetomidine: Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
Eligibility criteria:
Inclusion Criteria:

All patients scheduled to undergo DBS electrode implantation surgery with MER that agree to participate in the experiment and sign an informed consent are candidates to participate in the study, unless one of the exclusion criteria is met

Exclusion Criteria:

Known or suspected obstructive sleep apnea.
Suspected difficult intubation.
Pregnancy (pregnancy test is standard care for women of childbearing age)
Under 18 years of age or over 85 years of age
Cognitive disability impairing understanding the experiment or signing the informed consent form.
Intervention: Hydroxychloroquine
Trial phase: Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Administered pre-transplant through 3 months after surgery.

Hydroxychloroquine: Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.
Eligibility criteria:
Inclusion Criteria:

Clinically confirmed diagnosis of chronic pancreatitis (CP)
Intractable abdominal pain
History of failed operation(s) for CP
Recurrent acute pancreatitis
HbA1c <8.0%
Sustained alcohol remission
Chronic narcotic use

Exclusion Criteria:

Insulin dependence
Pancreatic carcinoma
Pancreatic mass suspicious for carcinoma
Cirrhosis
Portal hypertension
Continued alcohol abuse
Manufacturer's product label-contraindicated use of HCQ
History of retinopathy
Actual weight at enrollment <40 Kg
Intervention: Chlordiazepoxide
Trial phase: Phase 4
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 88
Group description: In this arm of patients, air which is currently used as standard of care will be used for insufflation

Air: Air is the standard of practice and will be used in the control arm
Eligibility criteria:
Inclusion Criteria:

Pediatric gastroenterology patients aged 6 months through 21 years undergoing endoscopic procedures in the Stead Family Children's Hospital (SFCH) Lower Level 2 procedure room or the operating room in the SFCH who willingly consent/ascent to the study. These procedures will range from Esophagogastroduodenoscopy, Colonoscopy, and those having both Esophagogastroduodenoscopy and Colonoscopy.

Exclusion Criteria:

Non English speaking families who require the services of a translator Children outside the stipulated age range of study. Children in foster care homes or wards of the court. Children and parents who do not willingly consent to the study Children with history of bronchopulmonary dysplasia or other chronic respiratory compromise.
Intervention: Valganciclovir
Trial phase: Phase 2
ATC code: J05AB14
SMILES: CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Oral Valgancyclovir 900 mg twice in a day during 4 weeks prior to initiation of cART (combined antirretroviral therapy) until suppression of HHV-8.

Valganciclovir: The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.

20 experimental included 2 eliminated

18 patients included finally.
Eligibility criteria:
Inclusion Criteria:

Patients will be included with AIDS naïve to antiretroviral therapy and severe KS, who accept to participate and who sign the letter of informed consent.
The following are the KS severity criteria: pulmonary compromise, and/or digestive tract compromise, and/or disseminated cutaneous, and/or lymphadenopathic compromise with generalized lymphedema.

Exclusion Criteria:

Patients with another synchronic malignant neoplasm
Patients receiving corticosteroids
Patients with active hepatitis B and/or hepatitis C
Patients with KS limited to skin with less than 30 lesions.
Patients with APACHE II score ≥15 points.
Intervention: Valganciclovir
Trial phase: Phase 2
ATC code: J05AB14
SMILES: CC(C)C(N)C(=O)OCC(CO)OCn1cnc2c(=O)[nH]c(N)nc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
Eligibility criteria:
Inclusion Criteria:

Parent(s)/legal guardian(s) have signed informed consent documents*
Confirmation of cytomegalovirus (CMV) by urine polymerase chain reaction (PCR) testing
Infant </= 30 days of age at initiation of study drug
Weight at study enrollment >/= 1775 grams

Gestational age >/= 32 weeks at birth

There is a screening informed consent for screening phase of study participation, and a treatment informed consent for treatment phase of study participation.

Exclusion Criteria:

Symptomatic congenital cytomegalovirus (CMV) disease*
Sensorineural hearing deficits as detected by formal brainstem evoked response (not a screening auditory brainstem response (abr)) of known etiology other than CMV
Prior or current receipt of ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
Maternal receipt of CMV hyperimmune globulin during pregnancy
Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
Infants known to be born to women who are HIV positive (HIV testing is not required for study entry)

Current receipt of other investigational drugs

Symptomatic disease is defined as one or more of the following: 1) thrombocytopenia, if known; 2) petechiae; 3) hepatomegaly; 4) splenomegaly; 5) intrauterine growth restriction; 6) hepatitis (elevated transaminases and/or direct bilirubin), if known; 7) central nervous system involvement of the CMV disease (such as microcephaly; radiographic abnormalities indicative of CMV CNS disease, if known; abnormal CSF indices for age, if known; chorioretinitis, if known; and/or positive CMV PCR from CSF, if known).
Intervention: Povidone iodine
Trial phase: Phase 4
SMILES: C=CN1CCCC1=O.II
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 63
Group description: Patients to receive povidone iodine for the surgical preparation of the vagina.

Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.
Eligibility criteria:
Inclusion Criteria:

Undergoing hysteroscopy
Gynecologic dilation & curettage
Endometrial ablation
Essure without concomitant laparoscopy

Exclusion Criteria:

Pregnant
Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or anaphylaxis to chlorhexidine gluconate or povidone iodine.
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.

Dexmedetomidine: The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
Eligibility criteria:
Inclusion Criteria:

Adults who will undergo lumbar spinal fusion, including surgeries extending into thoracic and sacral segments
Subject is non-lactating and is either:
Not of childbearing potential
Of childbearing potential but is not pregnant at time of surgery as determined by pre-surgical pregnancy testing
Subject is ASA physical status 1, 2, or 3.

Exclusion Criteria:

Subject is pregnant or breastfeeding
Any subject whom the investigators deem unable to complete any/all research related tasks
Subjects who are cognitively impaired (by history)
Subject requires antipsychotic medications
Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks prior to surgery
Subject has known allergy to dexmedetomidine
Subjects with impaired renal or hepatic function
Subjects with advanced heart block
Subjects with severe ventricular dysfunction
Intervention: Chlordiazepoxide
Trial phase: Phase 3
ATC code: N05BA02
SMILES: CNC1=Nc2ccc(Cl)cc2C(c2ccccc2)=[N+]([O-])C1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1494
Group description: The regular Lankenau cesarean section order set.

Control: The regular Lankenau cesarean section order set includes routine vital signs, labs, IV fluids, and fetal heart monitoring. Post standard cesarean section orders include IV fluids running at 125 cc/ hour, along with routine post-partum care. In terms of pain control, most patients receive 9 doses of 30mg of IV ketorolac every 6 hours, along with hydromorphone, oxycodone/acetaminophen, or a hydromorphone PCA, per patient or attending request.
Eligibility criteria:
Inclusion Criteria:

Scheduled to undergo a cesarean section

Exclusion Criteria:

Existing diagnosis of chronic pain
Need to undergo a vertical skin incision
AST > 50; ALT > 70
Platelets below 80,000 on admission
Need to undergo general anesthesia
Tubal ligation at time of Cesarean section
Prior or known allergy to any of the medications being utilized in this study
Intervention: Oxymetazoline
Trial phase: Phase 3
ATC code: D11AX27 | R01AA05 | R01AB07 | S01GA04
SMILES: Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Rhofade cream
Eligibility criteria:
Inclusion Criteria:

Male or non-pregnant, non-lactating female, 18 years of age or older.
Signed informed consent form that meets all criteria of current Food and Drug Administration regulations.
Females of childbearing potential must not be pregnant or lactating.
Females of childbearing potential must agree to the use of a reliable method of contraception throughout the study.
Have clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
Have < 3 inflammatory lesions on the face.
Have an erythema score of 3 (moderate) or 4 (severe) for both the CEA and the PSA that is reflective of the overall targeted areas.
Willing to minimize external factors that might trigger rosacea flare-ups (e.g., spicy foods, hot drinks, hot environments, prolonged sun exposure, strong winds, emotional stress and alcoholic beverages) during the study.

Exclusion Criteria:

Forms of rosacea that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of study endpoints
Patient has a skin condition that, in the opinion of the Investigator, would interfere with the diagnosis or assessment of rosacea
Patients with active sunburn or excessive facial hair such as beards, sideburns, moustaches, etc.
Patients with moderate to severe telangiectasial masses
History of blood dyscrasia.
Significant history or current evidence of any uncontrolled chronic or serious disease or medical condition that would, in the judgment of the Investigator, would put the subject at undue risk or compromise the study assessments.
History or current evidence of Raynaud's syndrome, severe, unstable or uncontrolled cardiovascular disease, orthostatic hypotension, uncontrolled hypertension or hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, renal or hepatic or renal impairment, scleroderma, Sjögren's syndrome, depression, or narrow-angle glaucoma to an extent that, in the opinion of the Investigator, would place the subject at undue risk.
Female patients taking hormonal contraceptives or oral estrogen for less than one month or those that plan to change the dosage regimen during the course of the study.
Previous participation in this study.
Employees of the Investigator or research center or their immediate family members.
Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
Intervention: Glycerin
Trial phase: Phase 4
ATC code: A06AG04 | A06AX01
SMILES: OCC(O)CO
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Glycerin Suppository: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of uncomplicated gastroschisis
Gestational age >33 weeks at time of delivery
Weight >1900g at time of delivery
Transfer of patient to Riley Hospital for Children prior to any abdominal surgery

Exclusion Criteria:

Neurological Congenital malformations and/or those known to impair intestinal motility
Additional congenital gastrointestinal abnormalities requiring surgical intervention
Congenital Cyanotic heart disease
Surgical Closure of abdominal wall defect with prosthetic material (e.g. prosthetic or bio-prosthetic mesh)
Intervention: Clobazam
Trial phase: Phase 4
ATC code: N05BA09
SMILES: CN1C(=O)CC(=O)N(c2ccccc2)c2cc(Cl)ccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 20
Group description: open label

Clobazam: Clobazam is used as an adjunct medicine for all participants.
Eligibility criteria:
Inclusion Criteria:

Established diagnosis of epilepsy, characterized by focal seizures with suspected or documented localization in the temporal lobe. All participants will have active epilepsy that requires treatment with anticonvulsant medication.

Although it is not necessary to be seizure free, a seizure baseline period will be established in the 60 days prior to enrollment into the study.
Current regimen of anticonvulsant drugs must have been stable for 30 days prior to entry into the study.
No episodes of seizure clusters of status epilepticus within 30 days prior to entry into the study.
Established symptoms of anxiety with functional impairment.
A diagnosis of an anxiety disorder based on the administration of the K-SADS Male or female participants equal to or above age 6 and below age 18 at the start of the study. No exclusion will be made on the basis of gender or minority status.
Male or female participants equal to or above age 6 and below age 18 at the start of the study. No exclusion will be made on the basis of gender or minority status.
Good general health as determined by medical history and physical examination.
Ability to swallow pills (participant will receive pill swallowing instruction if necessary). The medicine may be cut into pieces and/or mixed with applesauce.
If female of childbearing age, a negative urine or serum pregnancy test must be established or assured at baseline. Additionally, the participant must agree to use abstinence or appropriate contraception methods or be otherwise incapable of pregnancy for the duration of the study. Pregnancy test results will be shared with parent or guardian. Pregnancy status (or prevention) and abstinence or contraception methods will be addressed throughout the study for females of childbearing age as well as for post-pubertal males.
Previous subjects who failed at any point to meet continuation criteria and withdrew early may be considered for re-enrollment by the PI on a case-by-case basis.
Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.

Exclusion criteria:

Previous allergic or hypersensitivity reactions to Onfi® or benzodiazepines
Active substance abuse or dependence within 30 days of enrollment
DSM-V diagnosis of psychotic illness or imminent risk of harm to self or others.
Current standing use of benzodiazepines (except as "rescue" medicine)
Serious or unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.
Participation in a previous experimental drug study within 30 days of baseline visit.
Estimated IQ<70 as indicated by initial clinical assessment (rendering rating scales invalid)
Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min

Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring

Exclusion Criteria:

Allergy to dexmedetomidine, propofol
Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain
Hepatic disease
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min

Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring

Exclusion Criteria:

Allergy to dexmedetomidine, propofol
Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain
Hepatic disease
Intervention: Methylene Blue
Trial phase: Phase 4
ATC code: V03AB17 | V04CG05
SMILES: CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Methylene Blue 0.5% will be administered.

1 mg/kg will be administered intravenously over 5-30 minutes. If methemoglobin level remains above 30% or if clinical symptoms persist, give a repeat dose of up to 1 mg/kg one hour after the first dose.

Methylene Blue: Administration of Methylene Blue to treat acquired methaemoglobinaemia
Eligibility criteria:
Inclusion Criteria:

Pediatric or adult patients (males and females of all ages are included) diagnosed with acquired methemoglobinemia and receiving treatment with ProvayBlue™ as per the treating physician's diagnosis and hospital standard of care.

Acquired methemoglobinemia is defined as a level of methemoglobinemia >30% or ≤30% in case of clinical symptoms (e.g. sleepiness, cyanosis, dizziness, etc.).

Written informed consent obtained prior to any data collection (retrospective and prospective) for this study and study specific assessments.

Exclusion Criteria:

Known severe hypersensitivity reactions to methylene blue or any other thiazine dye;
Known deficiency in glucose-6-phosphate dehydrogenase (G6PD) due to the risk of hemolytic anemia as well as lack of therapeutic effect;
Known deficiency in Nicotinamide Adenine Dinucleotide Phosphate Hydrogen (NADPH) reductase.
Known use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), MonoAmine Oxidase (MAO) inhibitors or drugs metabolised via CYP isoenzymes anticipated during the treatment phase of the study.
Women who refuse to stop breastfeeding for up to 8 days after receiving the last dose of ProvayBlueTM.
Intervention: Hexose
Trial phase: Phase 2 | Phase 3
ATC code: V04CE01 | V06DC01
SMILES: OCC1OC(O)C(O)C(O)C1O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days.

D-Mannose: A total of 2 g D-mannose daily
Eligibility criteria:
Inclusion Criteria:

For the RCT arms of the study, the following inclusion criteria will apply:

a. Postmenopausal women with recurrent UTI

i. Recurrent UTI defined as:

≥ 2 symptomatic, culture-proven UTI in 6 months OR

≥ 3 symptomatic, culture-proven UTI in 12 months

ii. Postmenopausal defined as no menses for at least 12 months or surgical menopause

b. At least one documented prior uropathogen susceptible to D-mannose

c. Using VET for a minimum of four weeks prior to study day 1

Inclusion criteria for the Observational arm of the study are the same with the exception of item 'c.' above (using VET for a minimum of four weeks) as participants will not be on vaginal estrogen therapy.

Exclusion Criteria:

For the RCT arms of the study, the exclusion criteria are as follows:

Not postmenopausal
Currently on daily antibiotic UTI prophylaxis (If this is the only exclusion criteria met, a woman could be cleared for inclusion in study/enrollment after a 2 week washout period occurs prior to inclusion in the study (RCT or Observational arm))
Complicated UTIs (known renal tract anomaly, inability to empty bladder due to neurologic causes, performs self-catheterization or has an indwelling catheter)
Patients with incomplete bladder emptying (defined as post void residual > 150 cc when minimal voided volume is >150 cc)
Known contraindication to VET unless approved by patient's oncologist, oncologic surgeon, or primary care physician (History of or current endometrial cancer; History of estrogen sensitive breast cancer without approval of patient, patient's oncologist, oncologic surgeon, or primary care physician to use vaginal estrogen after counseling)
History of interstitial cystitis/painful bladder syndrome
Urothelial cancer
Non-English speaking
Enrolled in other clinical trials for UTIs
Currently using D-mannose or Methenamine for UTI prevention

Exclusion criteria for the Observational arm of the study are the same with the exception of item 'e.' above (known contraindication to VET) as participants will not be on vaginal estrogen therapy.