TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Prophylactic Micronutrient Supplementation of Morbidity and Growth in HIV-infected and HIV-uninfected Children in South Africa
Brief Summary: The purpose of the study is to see if giving vitamin and mineral supplements helps to protect infants and children from diarrhea, which vitamins and minerals help to improve a child's weight and growth, and if the same results occur in infants and children with HIV. HIV is the virus that causes AIDS. Study participants will include 516 infants aged 4-6 months. Participants will include: (1) HIV-infected children, (2) HIV-uninfected children with HIV-infected mothers, and (3) HIV-uninfected children with HIV-uninfected mothers. Subjects will have an equal chance of receiving one of three different vitamin and/or mineral supplements during the study. Study procedures will include up to 7 blood samples and stool samples every 3 months and body composition every 6 months. Participants will be involved in the study for up to 18 months.


Options:
A: Inclusion Criteria:

4-6 months of age (stratified by HIV status) Infant able to take oral preparations Consent of parent/guardian HIV status obtained from mother and child

Exclusion Criteria:

Documented micronutrient supplementation other than vitamin A in the preceding month Less than 60% of mean weight for age by NCHS guidelines (micronutrient intervention obligatory according to WHO guidelines for management of severely malnourished children) Persistent diarrhea (\>=7 days) at the time of study enrollment Exclusive breastfeeding Infants in whom a second confirmatory HIV test cannot be obtained (when required) Co-enrollment of the infant in other clinical intervention trials e.g. antibiotic or vaccine trials
B: Inclusion Criteria:

* Singleton, live born infants born to HIV- negative women
* Mothers will need to have registered for pre-natal care before 34 weeks gestation
* intend to stay in Dar es Salaam for until delivery and 18 months thereafter.

Exclusion Criteria:

* infants born with multiple congenital abnormalities
C: Inclusion Criteria:

Children who

* Belong to institute FAN in Medellín
* Attend full time to institute FAN (eight hours)
* Have 2 to 5 years

Exclusion Criteria:

Children who

* Children at the began of the study are with acute diarrheal disease and acute respiratory infection.
* Recurrent pneumonia, cystic fibrosis, gastrointestinal malformations, persistent diarrhea of any cause, inflammatory bowel disease.
* Failure to attend the educational institution for more than 10 days
* No consumption of zinc supplementation for more than 10 days, because of insistence to the school
D: Inclusion Criteria:

* All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal.

Exclusion Criteria:

* Parent refusal

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Brief Summary: The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks.

Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.

We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.

We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.


Options:
A: Inclusion Criteria:

* patients aged 18 - 37 years
* first episode psychosis in schizophrenia spectrum
* treated for 1½ year in the five OPUS teams in the Capital Region and the OPUS teams in Region Midt
* patients who will give signed informed consent to participate in the trial

Exclusion Criteria:

* patients who are not treated in one of the OPUS team in the Capital Region and Region Midt
* patients who don't give signed informed consent to participate in the study
B: Inclusion Criteria:

* 18-45 years of age
* F2 diagnosis in ICD 10
* Address in Copenhagen, Frederiksberg or Aarhus
* Antipsychotic medication not exceeding 12 weeks
* Informed consent

Exclusion Criteria:
C: Inclusion Criteria:

1. Over 20 years old
2. Suffering from Axis I disorder
3. Had intent for suicide (confirmed more than 2 times)
4. Able to understand this study and provide informed consent
5. Able to have interview before trial registry and psycho education at hospital
6. Able to have interview for assessment at continuous follow-up care by case manager at the hospital

Exclusion Criteria:

1. Not suffering from Axis I disorder as a primary diagnosis
D: Inclusion Criteria:

* Age between 18-35 years,
* First-episode schizophrenia og schizotypal disorder in ICD-10,
* Post-acute phase of illness,
* Sufficient comprehension of Danish,
* Written informed consent

Exclusion Criteria:

* Rejection of participation,
* Organic disorder,
* Misuse of psychoactive drugs

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Continuation Phase CBT for Youth With MDD
Brief Summary: This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.


Options:
A: Inclusion criteria:

* Major depressive disorder, dysthymic disorder, or bipolar disorder (Type I or II)
* IQ greater than 70
* At least one parent/caregiver willing to participate in the study
* Able to attend six or more of the eight treatment sessions with at least 1 parent
B: Inclusion Criteria:

* Age 13-19
* Diagnosis of Major Depression

Exclusion Criteria:

* History of mania/hypomania
* Current psychotic symptoms
* Substance dependence
* Medical conditions (contraindication for sertraline)
* Pregnancy
* Past treatment with sertraline
C: Inclusion Criteria:

* Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry
* Clinical Global Impression severity score of 4 or greater
* Children's Depression Rating Scale score of 40 or greater
* Currently attending school
* Willing and able to use acceptable methods of contraception, if applicable
* In good general health
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* History of psychotic disorders
* Alcohol or substance abuse or dependence within 6 months prior to study entry
* History of anorexia nervosa or bulimia
* Chronic medical illness requiring regular medication
* Current use of medication with psychotropic effects
* First-degree relatives (e.g., mother, father, sister, brother) with bipolar I disorder
* At risk for suicide
* Failure of a previous adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
* IQ less than 80
* Pregnancy or breastfeeding
D: * between the ages of 12 and 18 years 11 months
* currently in treatment for depression
* taking Prozac,Zoloft, Luvox, Lexapro, Celexa or Paxil (Oregon and Rhode Island sites only)
* still feeling depressed

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Continuation Phase CBT for Youth With MDD
Brief Summary: This study will determine the effectiveness of cognitive behavioral therapy in preventing a relapse of depressive symptoms in children.


Options:
A: Inclusion Criteria:

* Age 13-19
* Diagnosis of Major Depression

Exclusion Criteria:

* History of mania/hypomania
* Current psychotic symptoms
* Substance dependence
* Medical conditions (contraindication for sertraline)
* Pregnancy
* Past treatment with sertraline
B: Inclusion Criteria:

* Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
* Patient's current depressive episode must be at least 12 weeks in duration
* Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.

Exclusion Criteria:

* Patients who currently meet DSM-IV criteria for:

  1. attention deficit-hyperactivity disorder
  2. obsessive-compulsive disorder
  3. posttraumatic stress disorder
  4. bipolar disorder
  5. pervasive developmental disorder
  6. mental retardation
  7. conduct disorder
  8. oppositional defiant disorder
* Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.
C: * between the ages of 12 and 18 years 11 months
* currently in treatment for depression
* taking Prozac,Zoloft, Luvox, Lexapro, Celexa or Paxil (Oregon and Rhode Island sites only)
* still feeling depressed
D: Inclusion Criteria:

* Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry
* Clinical Global Impression severity score of 4 or greater
* Children's Depression Rating Scale score of 40 or greater
* Currently attending school
* Willing and able to use acceptable methods of contraception, if applicable
* In good general health
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* History of psychotic disorders
* Alcohol or substance abuse or dependence within 6 months prior to study entry
* History of anorexia nervosa or bulimia
* Chronic medical illness requiring regular medication
* Current use of medication with psychotropic effects
* First-degree relatives (e.g., mother, father, sister, brother) with bipolar I disorder
* At risk for suicide
* Failure of a previous adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
* IQ less than 80
* Pregnancy or breastfeeding

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of an HSV2 Genital Herpes Suppressive Treatment on HIV and HSV2 Genital Shedding Among Co-Infected Patients Receiving or Not Antiretroviral Drugs
Brief Summary: Genital herpes is a long-life sexually transmitted diseases which infects a large proportion of women in Africa. Its clinical symptoms are painful sores on the genitals, which heals after a few days. HIV infection can worsen genital herpes. In turn, it is possible that genital herpes increases the quantity of HIV secreted at the genital level in women infected by the 2 viruses. This study is dedicated to verify this hypothesis.


Options:
A: Inclusion Criteria:

MALES randomized to circumcision:

* Age 15-49
* Able and willing to provide written informed consent
* Have no medical contraindications to male circumcision

FEMALE partners:

* Able and willing to provide written informed consent
* No age limit

Exclusion Criteria:

* Medical contraindications, including penile pathology or anemia (males). Unable or unwilling to provide informed consent.

Please note: for participants under age 18, the study follows informed consent/assent procedures as required under US Federal Regulations. The latter are also consistent with Ugandan policy.
B: Inclusion Criteria For All Participants:

* HIV-uninfected
* HSV-2 infected
* Plans to stay in the area for the duration of study participation
* Willing and able to provide consent, undergo clinical evaluations, take study drugs, adhere to follow-up schedule, and provide adequate locator information

Inclusion Criteria for MSM:

* At least 1 episode of anal intercourse with another man within 6 months of study entry

Inclusion Criteria for WSM:

* At least 1 episode of unprotected vaginal sex within 6 months of study entry

Exclusion Criteria For All Participants:

* Current enrollment in another HIV vaccine or prevention trial
* History of adverse reaction to acyclovir
* Current or planned use of famiciclovir, valacyclovir, or acyclovir for genital HSV. Use of short-course antiviral therapy for herpes zoster after enrollment is allowed.
* Known plans for travel away from study site for more than 2 months

Exclusion Criteria for MSM:

* In a mutually monogamous relationship with an HIV uninfected partner throughout the past 2 years
* Reported sex at birth as female

Exclusion Criteria for WSM:

* Pregnancy at screening or enrollment
C: Inclusion Criteria:

* Infection with HIV-1 and HSV-2
* If required to take antiretrovirals according to WHO recommendations, should be on HAART for at least 4 months
* Written informed consent

Exclusion Criteria:

* Pregnancy or willing to be pregnant during the next 6 months
* Breastfeeding
* Renal failure
* Expected non-compliance with follow-up or study treatment
D: Inclusion Criteria:

* Clinically confirmed ulcer
* Resident of city or planning to stay for 1 month
* Be a women

Exclusion Criteria:

* Pregnant women
* Menstruating women
* Positive protein urine test

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Modification of Disease Outcome in COPD. Shortterm Versus Longterm Treatment With Inhaled Corticosteroids, Either or Not Combined With a Long-Acting Beta2-Agonist.
Brief Summary: The hypothesis to be tested of this study is that treatment with fluticasone propionate leads to an initial improvement in symptoms, quality of life and lungfunction and a reduction in airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be influenced by longer lasting treatment. Addition of salmeterol will augment the initial benefits of fluticasone without changing the longterm decline in lungfunction.


Options:
A: Inclusion Criteria:

* \>=40 years of age
* diagnosed COPD with symptoms \>= 2 years
* pre-bronchodilatory FEV1 \<=50% of PN

Exclusion Criteria:

* Current respiratory tract disorder other than COPD
* history of asthma or rhinitis
* significant or unstable cardiovascular disorder
B: Inclusion criteria:

* COPD patients with \> 10 pack years.
* Written informed consent.
* Able to complete a diary card.
* At least one of the following symptoms: chronic cough, chronic sputum production, frequent exacerbations, or dyspnoea at exertion.
* Postbronchodilator FEV1 below 90% confidence interval of predicted and postbronchodilator FEV1/FVC below 90% confidence interval of predicted.

Exclusion criteria:

* No oral corticosteroids 3 months prior to the study or maintenance treatment with corticostroids 6 months prior to the study.
* No history of asthma, lung diseases other than COPD, other diseases likely to interfere with the study.
C: Inclusion:

* Physician documented diagnosis of asthma which has been present for at least 6 months.
* Receiving a total daily dose of 200-500mcg/day beclomethasone dipropionate or equivalent for at least 4 weeks prior to the start of the run-in period.

Exclusion:

* Has had 3 or more courses of oral corticosteroids in the 12 months previous to visit 1
D: Inclusion Criteria:

* A clinical diagnosis of COPD with symptoms for more than 2 years
* Smoking history of 10 or more pack years
* A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.

Exclusion Criteria:

* A history of asthma
* Patients taking oral steroids.
* Any significant disease or disorder that may jeopardize the safety of the patient

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: One Year Maintenance Treatment With Low Dose Haloperidol vs. Risperidone in First-Episode Schizophrenia
Brief Summary: Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.


Options:
A: Inclusion Criteria:

* first-episode schizophrenia

Exclusion Criteria:

* acute psychosis
B: Inclusion Criteria:

* Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent
* One year neuroleptic maintenance treatment
* Reaching stable course

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the german language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment
C: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* stable with respect to disease symptoms and other medical conditions
* stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study
* if female, using birth control.

Exclusion Criteria:

* Hospitalized within 8 weeks of beginning the study
* at risk to self or others
* presence of liver or kidney damage
* use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months
* pregnant or breast-feeding
* if female, not using birth control
* abusing drugs or alcohol.
D: Inclusion Criteria:

* After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the German language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia
Brief Summary: After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.


Options:
A: Inclusion Criteria:

* Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent
* One year neuroleptic maintenance treatment
* Reaching stable course

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the german language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment
B: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* stable with respect to disease symptoms and other medical conditions
* stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study
* if female, using birth control.

Exclusion Criteria:

* Hospitalized within 8 weeks of beginning the study
* at risk to self or others
* presence of liver or kidney damage
* use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months
* pregnant or breast-feeding
* if female, not using birth control
* abusing drugs or alcohol.
C: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia or schizo-affective disorder
* Capacity to provide written, informed consent
* Stabilized\* on a single oral antipsychotic for at least three months (excluding CLOZAPINE or QUETIAPINE)
* Evidence of compliance with previous antipsychotic treatment, i.e. greater than 90% \* defined as 2 consecutively identical CGI evaluations (screening and baseline, at least one week apart)

Exclusion Criteria:

* exposure to depot antipsychotic during 12 months prior to enrollment
* substance-related disorders according to DSM-IV
D: Inclusion Criteria:

* After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the German language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy
Brief Summary: The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.


Options:
A: Inclusion Criteria:

* Visual Analogue Scale (VAS) of pain is higher than 40 mm.
* Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

* Malignancy within the past 2 years.
* Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain
B: Inclusion Criteria:

* Adults with Type 1 or 2 diabetes
* Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Exclusion Criteria:

* Patients must not be in poor or unstable health.
C: Inclusion Criteria:

* The patient must have SCS implanted for at least 2 months before study start date
* The patient must be at least 18 years old
* The patient must currently be receiving pain relief from SCS usage
* The patient must be willing to participate in a 9-week study
* The patient must have at least 20% of battery life remaining in his/her spinal cord stimulator
* The patient must be able to tolerate Vicodin-Extra Strength as well as Tylenol, but can also take their own pain medication if it is not one of the two mentioned

Exclusion Criteria:

* The patient is pregnant or intends to become pregnant during the course of the study.
* The patient by report, and/or by physician assessment, exhibits any or all of the following, which might bias reporting of treatment outcome:

A strong untreated dependency on prescription medication such as benzodiazepines and narcotic analgesics.

A strong potential for secondary gain issues.

A significant, untreated psychiatric comorbidity.

* The patient possesses a coexisting clinically relevant or disabling chronic pain problem not treated by SCS
* The patient has been diagnosed with unstable angina
* The patient receives a Karnofsky's performance score of \<60
D: Inclusion Criteria:

1. FBSS, CRPS patients with neuropathic and mixed pain in low-back and/or legs refractory to conservative therapy
2. Chronic pain as a result of FBSS that exists for at least 6 months
3. ≥ 18 years of age
4. Written consent of the patient to participate in study procedures.

Exclusion Criteria:

1. Active malignancy
2. Addiction to any of the following: drugs, alcohol and/or medication
3. Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
4. Local infection or other skin disorder at site of surgical incision
5. Pregnancy

Answer: B