TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Cemented Versus Uncemented Fixation of Humeral Components in Total Shoulder Arthroplasty for Osteoarthritis of the Shoulder
Brief Summary: The purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is that uncemented fixation of the humerus will result in better disease-specific quality of life, decreased incidence of radiographic loosening, decrease operative time and no increase in complications.


Options:
A: Postoperative External Range of Motion (ROM) (2 years); Postoperative Internal Range of Motion (ROM) (2 years)
B: disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales.; the Western Ontario Osteoarthritis of the Shoulder Index (WOOS); the Constant Score; American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form.; Short Form-12
C: Difference in Glenoid Component Placement (Inclination and Version) (Two weeks post surgery); Difference in Glenoid Component Placement (AP and SP). (Two weeks post surgery)
D: Migration of resurfacing prostheses (five years); Bone density around the prosthesis (five years); Pain (five years); Activities of Daily Living (ADL) (five years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Arthroscopic Surgery Versus Non-surgical Treatment of Osteoarthritis of the Knee
Brief Summary: The purpose of this trial is to evaluate the effectiveness of arthroscopy (lavage and debridement) in conjunction with the best available non-surgical treatment versus the best available non-surgical treatment alone (medication, health education and physical therapy) in patients with osteoarthritis of the knee.


Options:
A: the Knee Injury and Osteoarthritis Outcome Score (KOOS4) (Primary endpoint: Change from baseline to 12 months.)
B: Radiological assessment of OA of the knee (Kellgren-Lawrence -classification) (2 and 10 years postoperatively)
C: KOOS4 - Change From Baseline (24 months); Peak Torque Knee Extension - Change From Baseline (at 3 months); Peak Torque Knee Flexion - Change From Baseline (3 months); Knee Osteoarthritis Incidence (5 years); Radiographic Progression (the Osteoarthritis Research Society International [OARSI] Atlas) [Time Frame: At 10 Years] (10 years)
D: To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Arthroscopic Surgery Versus Non-surgical Treatment of Osteoarthritis of the Knee
Brief Summary: The purpose of this trial is to evaluate the effectiveness of arthroscopy (lavage and debridement) in conjunction with the best available non-surgical treatment versus the best available non-surgical treatment alone (medication, health education and physical therapy) in patients with osteoarthritis of the knee.


Options:
A: WOMAC Functional Status - Difference From Baseline (Baseline and 6 months)
B: Knee injury and Osteoarthritis Outcome Score - KOOS (2 year follow-up)
C: To compare between the two treatment groups the patients' disease-specific quality of life at 2 years using the Western Ontario McMaster (WOMAC) osteoarthritis index and (2 years)
D: Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (24 months follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-Herpetic Treatment Associated With Syndromic Management of Genital Ulcer in Africa: Clinical and Biological Evaluation on HIV-1 and HSV-2 Shedding (ANRS 1212)
Brief Summary: Herpes virus type 2 (HSV-2) infection - as a cofactor of human immunodeficiency virus (HIV) transmission - can be targeted by anti-herpetic specific drugs, either as a continuous prophylactic treatment during its asymptomatic shedding phase, or as an episodic treatment during clinically-apparent genital ulcerations. The main objective of this trial will be to demonstrate that acyclovir treatment given during clinical episodes (primary infection or recurrences) can reduce genital shedding of HIV, thereby contributing to a reduction of HIV infectiousness of dually infected individuals (HIV+/HSV+).


Options:
A: Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir. (11 weeks)
B: Rates of HIV acquisition in HIV-negative (neg) males and HIV-neg female partners; Rates of STD acquisition in HIV-neg and HIV positive (+) males and HIV-neg and HIV+ female partners
C: Difference of HIV-1 RNA and DNA shedding assessed by performing cervicovaginal lavage (CVL) HIV viral load, among groups; Difference of HSV-2 DNA shedding among groups
D: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-Herpetic Treatment Associated With Syndromic Management of Genital Ulcer in Africa: Clinical and Biological Evaluation on HIV-1 and HSV-2 Shedding (ANRS 1212)
Brief Summary: Herpes virus type 2 (HSV-2) infection - as a cofactor of human immunodeficiency virus (HIV) transmission - can be targeted by anti-herpetic specific drugs, either as a continuous prophylactic treatment during its asymptomatic shedding phase, or as an episodic treatment during clinically-apparent genital ulcerations. The main objective of this trial will be to demonstrate that acyclovir treatment given during clinical episodes (primary infection or recurrences) can reduce genital shedding of HIV, thereby contributing to a reduction of HIV infectiousness of dually infected individuals (HIV+/HSV+).


Options:
A: Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation. (18 weeks)
B: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)
C: Cure of syphilis defined as a negative reactive serologic test for syphilis (RPR) titer or greater than or equal to a 4-fold (2 dilution) decrease in RPR titer at 6 months following treatment and resolution of all signs and symptoms of syphilis. (Month 6.)
D: Difference of HIV-1 RNA and DNA shedding assessed by performing cervicovaginal lavage (CVL) HIV viral load, among groups; Difference of HSV-2 DNA shedding among groups

Answer: D
Please select the outcome measures 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: Rates of HIV acquisition in HIV-negative (neg) males and HIV-neg female partners; Rates of STD acquisition in HIV-neg and HIV positive (+) males and HIV-neg and HIV+ female partners
B: Serologically confirmed HIV infection (Throughout study)
C: To assess the impact of HSV-2 suppressive therapy on HIV shedding among co-infected women taking highly active antiretroviral therapy (HAART) or not needing HAART
D: Difference of HIV-1 RNA and DNA shedding assessed by performing cervicovaginal lavage (CVL) HIV viral load, among groups; Difference of HSV-2 DNA shedding among groups

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Options for Intermittent Preventive Treatment for Malaria in Infants in an Area With High Resistance to Sulfadoxine/Pyrimethamine: an Evaluation of Short and Long-acting Antimalarial Drugs
Brief Summary: Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP.

This study objectives are:

1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine.
2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi.
3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi.
4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas.

A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.


Options:
A: Efficacy:; The proportion of children with at least one episode of anemia from 3 to 18 months of life; The proportion of children with at least one episode of malaria from 3 to 18 months of life; Safety:; The proportion of children with at least one episode of an adverse event; The proportion of children with at least one episode of a serious adverse event; Rebound:; The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life
B: The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children (Onset of IPT to end of malaria season)
C: 1. Incidence of clinical malaria: [(history of fever during previous 2 days or axillary temperature >37.5ºC) + parasitaemia of any density + absence of any other obvious causes of fever] during the period of 3-11 months of age (3-11 months of age)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Options for Intermittent Preventive Treatment for Malaria in Infants in an Area With High Resistance to Sulfadoxine/Pyrimethamine: an Evaluation of Short and Long-acting Antimalarial Drugs
Brief Summary: Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP.

This study objectives are:

1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine.
2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi.
3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi.
4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas.

A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.


Options:
A: Incidence of symptomatic malaria (due to any Plasmodium species) from 3 - 15 months of age (15 months); Incidence of symptomatic P. falciparum malaria from 3 - 15 months of age (15 months); Incidence of symptomatic P. vivax malaria from 3-15 months of age (!5 months)
B: 1. Incidence of clinical malaria: [(history of fever during previous 2 days or axillary temperature >37.5ºC) + parasitaemia of any density + absence of any other obvious causes of fever] during the period of 3-11 months of age (3-11 months of age)
C: Maternal malaria at delivery (Delivery)
D: Mean Hb at the end of the high transmission season.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Options for Intermittent Preventive Treatment for Malaria in Infants in an Area With High Resistance to Sulfadoxine/Pyrimethamine: an Evaluation of Short and Long-acting Antimalarial Drugs
Brief Summary: Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP.

This study objectives are:

1. Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine.
2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi.
3. Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi.
4. Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas.

A randomised trial with four treatment regimes is proposed which will be conducted in two different transmission settings. The four treatment regimens are as follows: (1) placebo; (2) mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is the incidence of clinical malaria.


Options:
A: 1. Incidence of clinical malaria: [(history of fever during previous 2 days or axillary temperature >37.5ºC) + parasitaemia of any density + absence of any other obvious causes of fever] during the period of 3-11 months of age (3-11 months of age)
B: Prevalence of anaemia (Hb <112g/L) (March 2006)
C: Clinical episodes of malaria
D: incidence rate of clinical malaria; in vivo adequate clinical and parasitological response of P. falciparum to SP

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo Controlled, Randomised Evaluation of an Eight Week Primaquine Regimen for the Treatment of Vivax Malaria.
Brief Summary: Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school.

Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.


Options:
A: Assessment of cure rate of both arms AS-AQ + PQ and DHP+PQ (42 days)
B: Parasitological outcome after 28 days follow-up (28 days)
C: Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. (2004-March 2007)
D: malaria morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo Controlled, Randomised Evaluation of an Eight Week Primaquine Regimen for the Treatment of Vivax Malaria.
Brief Summary: Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school.

Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.


Options:
A: Recurrence of P. vivax (52 weeks)
B: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (28 Days)
C: Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. (2004-March 2007)
D: The first recurrence of Plasmodium vivax malaria (Day 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy and Pharmacokinetics of Myozyme in Patients With Late-Onset Pompe Disease.
Brief Summary: Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective is to evaluate the safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa treatment in patients with late-onset Pompe disease as compared to placebo.


Options:
A: Summary of Patients Reporting Treatment-Emergent Adverse Events (weeks 0-78); Mean Distance Walked as Measured by Six-minute Walk Test (6MWT) at Weeks 0 and 78, and Mean Change From Baseline (weeks 0, 78); Percent of Predicted Forced Vital Capacity (FVC) (weeks 0, 78); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Area Under the Curve (AUC) (weeks 0, 12 and 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Maximum Plasma Concentration(Cmax) (weeks 0, 12, 52); Recombinant Human Acid Alpha-Glucosidase (rhGAA) Pharmacokinetic Parameters: Mean Time to Maximum Plasma Concentration(Tmax) (weeks 0, 12, 52)
B: PAP: Change From Baseline in Percent Predicted FVC in Upright Position at Week 49 (Baseline, Week 49)
C: Number of Participants With a Change in Creatine Kinase (CK) Reflecting Worsening of Muscle Involvement (Any point up to week 52); Number of Participants With a Change in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Bilirubin Representing Liver Toxicity (Any point up to week 52)
D: Summary of Participants Reporting Treatment-Emergent Adverse Events For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0 to 2.5 years); Baseline Values (Week 0) of Functional Endurance as Measured by Six-Minute Walk Test (6MWT) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0); Change From Baseline (Week 0) in the Six-Minute Walk Test (6MWT) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0, Week 104); Baseline Values (Week 0) for Percent Predicted Forced Vital Capacity (FVC) For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0); Change From Baseline (Week 0) in the Percent Predicted Forced Vital Capacity (FVC) at Week 104 For Participants Treated With Alglucosidase Alfa During Study AGLU02704 (NCT00158600) (Week 0, Week 104)

Answer: A