TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery
Brief Summary: This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.


Options:
A: Inclusion Criteria:

* Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy

Exclusion Criteria:

* Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
* Regional anesthesia for surgical procedure
* Chronic pain requiring opioid treatment daily
* History of allergy to the study medication
* Severe renal and liver disease
* Pregnancy
* Non English speaking
* Psychiatric disorder that will preclude completion of questionnaires
* Minor surgery that does not involve overnight admission
* Surgery that does not involve hysterectomy or vaginal intraperitoneal apical suspension
* Hypersensitivity reaction to steroids
* Evidence of systemic fungal infection
* Evidence of any systemic infection
* Uncontrolled diabetes
B: Inclusion Criteria:

* Undergoing urogynecologic surgery
* Receive postoperative catheterization

Exclusion Criteria:

* Age less than 21 years old
* Pregnancy
* Allergy, contraindication or intolerance to Nitrofurantoin
* Do not speak English
* Dependent on trans-urethral catheter to accomplish voiding preoperatively
* Undergoing interstim device placement, urethral diverticulum surgery or fistula surgery
* Sustain intraoperative urinary tract injury requiring postoperative catheterization
C: Inclusion Criteria:

All patients undergoing the following laparoscopic pelvic reconstructive procedures for pelvic organ prolapse:

* Laparoscopic sacrocervicopexy
* Laparoscopic sacrocolpopexy
* Laparoscopic sacrohysteropexy
* Laparoscopic uterosacral ligament suspension

Who understand and are willing to comply with the study requirements, including agreeing to answer the preoperative and postoperative questionnaires

Exclusion Criteria:

* Previous abdominal or laparoscopic colon surgery (not including transrectal procedures)
* History of abdominal malignancy
* History of surgical debulking for previous malignancy
* Non-english speaking
* Pregnancy
* Hx of abdomino-pelvic radiation
* Contraindications to Sodium Phosphate
* Contraindications to laparoscopic surgery
D: Inclusion Criteria:

* women with stage II of pelvic organ prolapse, preferably symptomatic and not to be submitted to surgery to correct pelvic organ prolapse during the study

Exclusion Criteria:

* Neuromuscular diseases and use of hormonal therapy

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Antibiotic Prophylaxis for Urinary Tract Infection in Patients Requiring Catheterization After Urogynecologic Surgery
Brief Summary: This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.


Options:
A: Inclusion Criteria:

* Patients at term (\> 37 weeks) undergoing a cesarean delivery.

Exclusion Criteria:

* Women younger than 18 years,
* Pre-gestational diabetes,
* Chronic hypertension,
* Collagen vascular disease,
* Multiple gestation,
* Contraindications to cefazolin administration (known anaphylactic reaction to penicillins or known cephalosporin allergy),
* Any exposure to cephalosporins in one week prior to cesarean section, OR
* Need for emergent cesarean delivery or diagnosis of chorioamnionitis.
B: * Predominant stress urinary incontinence by self-report,examination and test;
* Urethral hypermobility;
* Eligible for both surgical procedures;
* Ambulatory;
* Not pregnant;
* \>12 months post-partum;
* No systemic disease known to affect bladder function;
* No current chemotherapy or radiation therapy;
* No urethral diverticulum, augmentation cytoplasty, or artificial sphincter;
* No recent pelvic surgery;
* Available for follow-up and able to complete study assessments;
* Signed informed consent.
C: Inclusion Criteria:

* Women over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence

Exclusion Criteria:

* Exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).
D: Inclusion Criteria:

* Undergoing urogynecologic surgery
* Receive postoperative catheterization

Exclusion Criteria:

* Age less than 21 years old
* Pregnancy
* Allergy, contraindication or intolerance to Nitrofurantoin
* Do not speak English
* Dependent on trans-urethral catheter to accomplish voiding preoperatively
* Undergoing interstim device placement, urethral diverticulum surgery or fistula surgery
* Sustain intraoperative urinary tract injury requiring postoperative catheterization

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Development of Positive Psychotherapy for Smoking Cessation
Brief Summary: The primary objective of this study is to test a manualized adaptation of positive psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b research will provide the foundation for a future application to conduct a large-scale, Stage II, randomized clinical trial.


Options:
A: Inclusion Criteria:

* Pregnant AI females aged 12 to 19 years old at time of conception.
* Gestational age of 28 weeks or less (in order to complete intervention prior to delivery).
* Parent/guardian consent for youth under 18 years old.
* Reside within 1-hour transportation range (50 miles) of the local Indian Health Service medical facility.

Exclusion Criteria:

* Current participation in other mental or behavior health research project.
* Factors that preclude full participation, identified at baseline and after caseness review, including: unstable and severe medical, psychiatric or drug use problem; acute suicidal or homicidal ideation requiring immediate intervention; recent, severe stressful life event such as physical or sexual abuse, or victim of a violent crime that requires specific and high intensity intervention or out of home placement; or chronic pattern of unstable caretakers or living situation.
B: Inclusion Criteria:

* smoke at least 5 cigarettes per day for longer than one year with no other ongoing tobacco product use
* willing to use the transdermal nicotine patch
* report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking.

Exclusion Criteria:

* are currently experiencing psychotic symptoms, affective disorder (major depression, dysthymia, or mania) or substance use disorder (other than nicotine dependence)
* taking prescribed psychotropic medication or receiving other forms of psychotherapy
* concomitantly using other pharmacotherapies for smoking cessation
* have any contraindications for use of the transdermal nicotine patch.
C: Inclusion Criteria:

* Mothers who smoke at least 5 cigarettes per day
* have at least one child under 4 years of old (youngest child is target child for data collection (urine cotinine)
* report exposing youngest (target) child to at least 2 of her cigarettes/day (defined as child in the same room \[4-walls and a door that closes\] or car when someone is actively smoking a cigarette.

Exclusion Criteria:

* current diagnosis or treatment of a psychiatric disorder
* currently pregnant
* not proficient in English
D: Inclusion Criteria:

* Smoking withdrawal for at least 1 week
* Age more than 18 years

Exclusion Criteria:

* Epilepsy
* Psychiatic desease
* Dementia

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt
Brief Summary: To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.


Options:
A: Inclusion Criteria:

* Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Indication for VKA other than DVT and/or PE
* Patients in whom anticoagulant treatment for their index PE or DVT should be continued
* Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate \< 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP \[Committee for Proprietary Medicinal Products\]/ICH \[International Conference on Harmonization\]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
B: Inclusion Criteria:

* Confirmed acute symptomatic proximal DVT without symptomatic PE

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
* Other indication for VKA than DVT and/or PE
* The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
C: Inclusion criteria:

1. Patients aged 18-75
2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

1. Prior valve surgery
2. Uncontrolled hypertension
3. severe renal impairment
4. active liver disease
5. increased risk of bleeding
D: Inclusion criteria:

1. Completed study 1160.113 per protocol
2. Continuing need for anticoagulation

Exclusion criteria:

1. uncontrolled hypertension
2. severe renal impairment
3. active liver disease
4. increased risk of bleeding

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt
Brief Summary: To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.


Options:
A: Inclusion Criteria:

* Patients that received a mechanical valve while in our hospital
* Age \> 18 years

Exclusion Criteria:

* Pregnant or lactating women
* Patients that have genetic clotting disorders such as Factor 5
* Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)
B: Inclusion criteria:

1. Completed study 1160.113 per protocol
2. Continuing need for anticoagulation

Exclusion criteria:

1. uncontrolled hypertension
2. severe renal impairment
3. active liver disease
4. increased risk of bleeding
C: Inclusion Criteria:

* Over 18 years of age
* Anticoagulation to a target of 2.0-3.0
* Warfarin treatment for \> 3 months
* previous medication treatment adherence
* competence judged by demonstrable ability to utilize drug adjustment nomograms
* understand the basic theory of anticoagulation therapy

Exclusion Criteria:

* Coagulopathic disease
* significant psychiatric illness
* significant language barrier
* poor visual acuity
D: Inclusion criteria:

1. Patients aged 18-75
2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

1. Prior valve surgery
2. Uncontrolled hypertension
3. severe renal impairment
4. active liver disease
5. increased risk of bleeding

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Feasibility of Rotational Thromboelastrometry During Cardiopulmonary Bypass Using a Heparinase Modified ROTEM® Assay
Brief Summary: Coagulopathy with transfusion requirements is frequent during cardiac surgery with cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole blood point of care test used to assess the patient's coagulation status.

The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence of very high heparin concentrations as seen during cardiopulmonary bypass.


Options:
A: Inclusion Criteria:

* age \> 18 years, combined surgical procedures (ACB \& valve surgery), double valve surgery, aortic surgery, Re-Dos

Exclusion Criteria:

* none
B: Inclusion Criteria:

* Elective/subacute multivessel CABG
* Isolated CABG procedure, no concomitant surgery
* age \> 18 years
* Able to give informed consent

Exclusion Criteria:

* Myocardial infarction \<48h of surgery
* Prior CABG surgery within 1 month
* Cardiac Shock within 48h of surgery
* Atrial fibrillation
* Anticoagulation therapy with VKA
* ICH/TCI within 30 days
* Prior peptic ulcer· Platelet count \< 150 E9
* Ongoing bleeding
* Known platelet disease
* Allergic to aspirin or clopidogrel
* Liver disease with elevated ALAT/ASAT\> 1,5x normal
* Creatinine\> 0,120mmol/l
* Contrast allergy
* Alcohol or narcotics abuse
* Pregnancy
* Not able to give informed consent
* Geographically not available for follow up
C: Inclusion Criteria:

* Males and Females
* Age 6 months to 17 years
* Scheduled for elective scoliosis surgery or major craniofacial surgery
* Written informed consent has been obtained
* Intraoperative hypofibrinogenemia according to definition of treatment groups

Exclusion Criteria:

* Preexisting congenital or acquired coagulation disorder
* Medical history of estimated increased bleeding tendency
* Ongoing coagulation therapy
* Clinical signs or diagnosis of acute thromboembolism
* Intolerance of study drug
* Participation at another clinical trial
* Pregnant or lactating women
D: Inclusion Criteria:

* Patients ungergoing coronary artery bypass grafting using cardiopulmonary bypass
* Patients from 18 to 85 years old.

Exclusion Criteria:

* Patients incapable to consent.
* Known coagulopathies or platelet dysfunction.
* Patients treated with antiplatelet drugs other than aspirin.
* Patients treated with anti vitamine K anticoagulants.
* Patients treated with heparin less than 6 hours prior to surgery.

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).


Options:
A: Inclusion Criteria:

* Highly dependent smokers in the stage of preparation according to Prochaska and Di Clemente's stages of change model

Exclusion Criteria:

* History of myocardial infarction in the preceding 3 months
* Pregnancy or breast-feeding
* Use of any form of smokeless tobacco or other nicotine replacement therapy
B: Inclusion Criteria:

* 18 years or older
* Smoke \>=6 Cigarettes per day
* English or Spanish speaking
* Valid phone number
* Valid address
* Gave consent to participate in study and evaluation

Exclusion Criteria:

* Hospital stay of less than 24 hours
* Inability to communicate orally
* Hypersensitivity to nicotine
* Pregnant
* Hospitalized for psychiatric treatment
C: Inclusion Criteria:

* smoking pregnant woman unable to quit smoking during the first 3 months of pregnancy
* smoking ≥ 5 cigaret/day despite standard medical advice and cognitive-behavioral counselling
* aged ≥ 18 years
* health insured
* motivated to stop smoking; motivation score ≥ 5 on a scale ranging from 0 to 10
* amenorrhea of 9 to 20 weeks
* having signed the written informed consent

Exclusion Criteria:

* non-pregnant women
* men

Pregnant woman:

* who does not agree to use a nicotine or placebo patch
* with presence of chronic psychiatric comorbidity treated continuously by antidepressant, neuroleptic or anxiolytic
* with skin disorder contraindicating the use of a transdermal patch
* with known hypersensitivity to transdermal patch or to one of its constituents
* using other nicotine containing pharmaceutical products (gum, lozenge, inhaler, sublingual tablets)
* using other forms of tobacco than cigaret (cigaret, pipe or any form of smokeless tobacco)
D: Inclusion Criteria:

* Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
* Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) \>10 ppm at screening.
* For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.

Exclusion Criteria:

* Subjects with a past or current diagnosis of one of the following disorders:

  a. Psychotic Disorders:
* Schizophreniform
* Delusional Disorder
* Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Stage II Efficacy Study of Cognitive Behavioral Therapy for PTSD in Community Addiction Treatment
Brief Summary: The purpose of this phase of the study is to assess the efficacy of CBT for PTSD, as delivered by routine addiction counselors in community treatment programs, and to compare CBT for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on the primary outcomes.


Options:
A: Inclusion Criteria:

1. At least 18 years old;
2. Actively enrolled in outpatient addiction services and meets criteria for substance use disorder;
3. Screened positive for PTSD (results of PCL show a likely Criterion A Traumatic Event and a score equal to or greater than 44);
4. Willing and able to provide informed consent to participate in the study;
5. Diagnosis of PTSD verified by the CAPS and total symptom score equal to or greater than 44;

Exclusion Criteria:

1. Acute psychotic symptoms (however, persons with a psychotic disorder are eligible if their symptoms are stable and they are well connected with appropriate mental health services);
2. Psychiatric hospitalization or suicide attempt in the past month (however, if the hospitalization or attempt was directly related to substance intoxication or detoxification and the person is currently stable, they are eligible);
3. Medical and/or legal situations are unstable such that ability to participate in the full duration of the study seems unlikely.
B: Inclusion Criteria:

1. veteran status and VA healthcare eligibility,
2. a diagnosis of any alcohol or drug use disorder,
3. having completed an intake for outpatient SUD treatment at the VA Oakland outpatient mental health clinic, and
4. meeting criteria for a PTSD diagnosis based on a preliminary screen with the PC-PTSD and subsequent full clinical evaluation using the CAPS

Exclusion Criteria:

1. current participation in any day or inpatient mental health treatment,
2. any contraindications communicated by that patient's primary clinician,
3. acute psychosis, mania, dementia, or suicidal intent
C: Inclusion Criteria - Women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD.

Exclusion Criteria:

- Women will be excluded from the study who have current psychotic disorders, or a history of active psychosis (past two months); women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD; and women who have current psychotic disorders, or a history of active psychosis (past two months).
D: Inclusion Criteria:

* 18 years of age or older
* Fluent in English or Spanish
* Alcohol or drug dependent
* Heavy drinking in the past 30 days or recent drug use
* Provide 2 contacts to assist with follow-up
* Have no plans to move from the local area within a year of screening
* Score \>21 on Mini-Mental State Examination (no serious cognitive impairment)

Exclusion Criteria:

* Pregnant (self-report)
* Breath alcohol \>100 mg/dL
* Inability to provide informed consent determined by trained research associates

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Art Therapy as Treatment for Fear of Childbirth:a Randomized Controlled Study
Brief Summary: Earlier research has shown that pregnant women with a pronounced fear of childbirth have a significantly increased risk for birth complications and subsequent psychological trauma. In Sweden and also internationally, women in fear of childbirth are treated in many differing ways. Evidence for best care for these women is lacking. The Art Therapy method is a creative, psycho-therapeutic form of treatment which has been used for several decades within psychiatry. It has recently been seen that the Art Therapy method has positive effects during treatment for crisis reactions.

Recruitment has recently been initiated for a randomized controlled study of Art Therapy for the treatment of fear of childbirth.

The hypothesis for the study is as follows:

H1 = treatment with Art Therapy and therapeutic conversations will result in a decrease in fear of childbirth when compared to treatment by therapeutic conversations only.

The instrument which is to be used for measurement of childbirth fear is the Wijma Delivery Expectancy Questionnaire (W-DEQ). This is a well validated instrument which was developed in Sweden. A power calculation has shown a need for 62 x 2 participants; a total of 124 women.


Options:
A: Inclusion Criteria:

* Pregnant women (between 20 and 32 gestation weeks),
* Healthy,
* Nulliparous with singleton pregnancies,
* Older than 18 years.
* Involved giving birth at full term,
* Having a healthy newborn (born at 38-42 weeks of gestation)

Exclusion Criteria:

* Women taking medication for a diagnosed mental illness (e.g., antidepressants, antianxiety or antipsychotic medication),
* Women with complicated or high- risk pregnancies,
* Anticipating or experiencing a perinatal death (e.g., congenital abnormality incompatible) or stillbirth,
* Having experienced no postnatal complications (hemorrhage, puerperal infection, mastitis, thromboembolic disease or postpartum psychiatric disorder).
B: Inclusion Criteria:

* Mastery of the Swedish language,
* FOBS above 60,
* internet access

Exclusion Criteria:
C: Inclusion Criteria:

* Pregnant women
* Pronounced fear of childbirth

Exclusion Criteria:

* Women with a current psychiatric diagnosis
* Women who do not understand Swedish
* Women with a current substance misuse
D: Inclusion Criteria:

* severe fear of childbirth

Exclusion Criteria:

* twin pregnancies

Answer: C